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MS21700	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A classical treatment for chronic adult periodontitis consists of four to six consecutive sessions of scaling and root planing at a 1- to 2-week interval . Such a so-called " quadrant or sextant therapy " might result in a reinfection of a previously disinfected area by bacteria from an untreated region . The purpose of this study was to investigate , over an 8-month period , the clinical benefits of full-mouth disinfection within a 24-hour period in the control of chronic periodontitis . Ten adult patients with advanced chronic periodontitis were r and omly assigned to a test and a control group . The control group received the st and ard scheme of initial periodontal therapy , consisting of scaling and root planing of the four quadrants was performed within 24 hours and immediately followed by a thorough supra- and subgingival chlorhexidine application to limit any transfer of bacteria . The latter involved tongue brushing with a 1 % chlorhexidine gel for 60 seconds , mouthrinsing with a 0.2 % chlorhexidine solution twice for 60 seconds , repeated subgingival irrigation of all pockets with a 1 % chlorhexidine gel ( 3 times within 10 minutes ) , and mouthrinsing twice daily with a 0.2 % chlorhexidine solution during 2 weeks . In addition , both groups received thorough oral hygiene instructions . The plaque index , gingival index , probing depth , gingival recession , and bleeding on probing were recorded prior to professional cleaning and at 1 , 2 , 4 , and 8 months afterwards . Although the test group scored higher plaque indices than the control group , especially at months 2 and 4 , the gingival index and bleeding tendency showed similar improvements with time . However , when the gingival/plaque ratio was considered , the latter was lower in the test group at all follow-up visits . For pockets > or = 7 mm , full-mouth disinfection showed a significantly ( P = 0.01 ) higher reduction in probing depth at each follow-up visit with , at month 8 , a reduction of 4 mm ( from 8 mm to 4 mm ) , in comparison to 3 mm ( from 8 mm to 5 mm ) for the classical therapy . The increase in gingival recession in the full-mouth disinfection group remained below 0.7 mm , while in the control group it reached 1.9 mm after 8 months . This result ed in a gain of clinical attachment level of 3.7 mm for the test group versus 1.9 mm for the control group . A radiographical examination also indicated a superior improvement for the test group when compared to the control group . This pilot study suggests that a full-mouth disinfection in one day results in an improved clinical outcome in chronic periodontitis as compared to scalings per quadrant at 2-week intervals over several weeks To clarify the source of re-emerging periodontal pathogens after treatment , we compared the ribotypes of Actinobacillus actinomycetemcomitans , Porphyromonas gingivalis , Prevotella intermedia/Prevotella nigrescens group and Campylobacter rectus before and after treatment in 7 periodontitis patients and in 6 of the spouses . The patients harbored A. actinomycetemcomitans , P. gingivalis , P. intermedia/P. nigrescens group or C. rectus in their subgingival or salivary sample s before treatment . The respective bacterial species were not detected 1 month after treatment , but reappeared by 6 months later . When available , 4 r and om colonies of each of the 4 species were isolated from both subgingival and salivary sample s at each sampling occasion , the isolates were subcultured , identified and typed applying pheno- and genotypic intraspecies characterization methods . Altogether 90 strains of A. actinomycetemcomitans , P. gingivalis , P. intermedia/P. nigrescens group and C. rectus were available from 2 , 3 , 2 and 4 patients , respectively . The pre- and post-treatment ribotypes of A. actinomycetemcomitans- , P. gingivalis- and P. intermedia/P. nigrescens group-isolates were identical in all respective patients . The pre- and post-treatment ribotypes of C. rectus were identical in 1 of 4 patients , whereas 2 patients harbored a previously not detected post-treatment ribotype and 1 patient harbored the initial and a previously not detected post-treatment ribotype . To study the possibility that periodontitis patients may acquire strains from the spouse after treatment , isolates of A. actinomycetemcomitans , P. gingivalis , P. intermedia/P. nigrescens group and C. rectus ( n = 95 ) from the patients ' spouses were ribotyped and compared with those of the patients . The patient exhibited his own post-treatment ribotypes , different from those of the spouse , of A. actinomycetemcomitans and P. gingivalis in 1 couple and of P. intermedia/P. nigrescens group and C. rectus in 1 couple . In the 2 patients who harbored a previously not detected post-treatment ribotype of C. rectus , one patient shared the new ribotype with the spouse , whereas the other one did not . Although an exogenous source can not be fully ruled out , the patient 's own oral flora seems to be the main source of re-emerging periodontal pathogens after treatment A treatment for periodontal infections often consists of consecutive rootplanings ( per quadrant , at a 1- to 2-week interval ) , without a proper disinfection of the remaining intra-oral niches ( untreated pockets , tongue , saliva , mucosa and tonsils ) . Such an approach , could theoretically lead to a reinfection of previously-treated pockets . The present study aims to examine the effect of a full-mouth disinfection on the microbiota in the above-mentioned niches . Moreover , the clinical benefit of such an approach was investigated . 16 patients with severe periodontitis were r and omly allocated to a test and a control group . The patients from the control group were scaled and rootplaned , per quadrant , at 2-week intervals and obtained oral hygiene instructions . The patients from the test group received a full-mouth disinfection consisting of : scaling and rootplaning of all pockets in 2 visits within 24 h , in combination with tongue brushing with 1 % chlorhexidine gel for 1 min , mouth rinsing with a 0.2 % chlorhexidine solution for 2 min and subgingival irrigation of all pockets ( 3x in 10 min ) with 1 % chlorhexidine gel . Besides oral hygiene , the test group rinsed 2x daily with 0.2 % chlorhexidine and sprayed the tonsils with a 0.2 % chlorhexidine for 2 months . Plaque sample s ( pockets , tongue , mucosa and saliva ) were taken at baseline and after 2 and 4 months , and changes in probing depth , attachment level and bleeding on probing were reported . The full-mouth disinfection result ed in a statistically significant additional reduction/elimination of periodontopathogens , especially in the subgingival pockets , but also in the other niches . These microbiological improvements were reflected in a statistically-significant higher probing depth reduction and attachment gain in the test patients . These findings suggest that a disinfection of all intra-oral niches within a short time span leads to significant clinical and microbiological improvements for up to 4 months AIM To test recolonization of periodontal lesions after full-mouth scaling and root planing ( FM-SRP ) or multiple session-SRP ( MS-SRP ) in a r and omized clinical trial and whether FM-SRP and MS-SRP result in different clinical outcomes . MATERIAL S AND METHODS Thirty-nine subjects were r and omly assigned to FM-SRP or MS-SRP groups . At baseline and after 3 months , probing pocket depth ( PPD ) , plaque index ( PlI ) and bleeding on probing ( BoP ) were recorded . At baseline , immediately after treatment , after 1 , 2 , 7 , 14 and 90 days , paper point sample s from a single site from the maxillary right quadrant were collected for microbiological analysis of five putative pathogens by polymerase chain reaction . RESULTS FM-SRP and MS-SRP result ed in significant reductions in PPD , BoP and PlI and the overall detection frequencies of the five species after 3 months without significant differences between treatments . Compared with MS-SRP , FM-SRP result ed in less recolonization of the five species , significantly for Treponema denticola , in the tested sites . CONCLUSION FM-SRP and MS-SRP result in overall clinical ly and microbiologically comparable outcomes where recolonization of periodontal lesions may be better prevented by FM-SRP OBJECTIVES The beneficial effects of the one-stage , full-mouth disinfection remain controversial in the scientific literature . This might be due to the fact that an entire mouth disinfection with the use of antiseptics has been confused with a full-mouth scaling and root planing . This parallel , single blind RCT study aim ed to compare several full-mouth treatment strategies with each other . MATERIAL AND METHODS Seventy-one patients with moderate periodontitis were r and omly allocated to one of the following treatment strategies : scaling and root planing , quadrant by quadrant , at two-week intervals ( negative control , NC ) , full-mouth scaling and root planing within 2 consecutive days ( FRP ) , or three one-stage , full-mouth disinfection ( FM ) protocol s within 2 consecutive days applying antiseptics to all intra-oral niches for periopathogens using as antiseptics : chlorhexidine ( FMCHX ) for 2 months , amine fluoride/stannous fluoride for 2 months ( FMF ) , or chlorhexidine for 2 months followed by amine fluoride/stannous fluoride for another 6 months ( FMCHX+F ) . At baseline and after 2 , 4 , and 8 a series of periodontal parameters were recorded . RESULTS All treatment strategies result ed in significant ( p<0.05 ) improvements of all clinical parameters over the entire duration of the study . Inter-treatment differences were often encountered . The NC group nearly always showed significant smaller improvements than the two CHX groups . The differences between the FRP or FM groups , and the two CHX groups only sporadically reached a statistical significance . CONCLUSION These observations indicate that the benefits of the " OSFMD " protocol are partially due to the use of the antiseptics and partially to the completion of the therapy in a short time BACKGROUND One-stage full-mouth scaling and root planing ( FM-SRP ) in combination with systemically administered azithromycin was shown to be clinical ly and bacteriologically effective in the treatment of chronic periodontitis . However , FM-SRP requires 2 hours for completion . Azithromycin has a long half-life . Therefore , if SRP of the full mouth is performed within 7 days while an effective concentration of azithromycin remains in the gingiva , the effects may be the same as FM-SRP . The aim of this study was to compare the clinical and bacteriologic effects of FM-SRP and partial-mouth scaling and root planing ( PM-SRP ) in patients with chronic periodontitis , which was performed in three sessions within 7 days , during the effective half-life of systemically administrated azithromycin . METHODS Thirty adult subjects with chronic periodontitis were r and omly divided into three groups ( FM-SRP , PM-SRP , and control ) . A clinical examination was conducted to record the probing depth , clinical attachment level gain , bleeding on probing , gingival index , and volume of gingival crevicular fluid ; bacterial sample s were obtained before treatment and 1 , 3 , 6 , 9 , and 12 months thereafter . Quantitative and qualitative analyses were performed using the polymerase chain reaction-Invader method . RESULTS All clinical parameters showed better improvement in FM-SRP and PM-SRP groups compared to the control group , with no significant differences between the two test groups . Periodontal bacteria were well controlled in the two test groups , but they tended to increase gradually 3 months after treatment in the control group . CONCLUSION PM- and FM-SRP demonstrated comparable clinical and bacteriologic results BACKGROUND / AIMS Recent studies reported significant additional clinical and microbiological improvements when severe adult periodontitis was treated by means of a " one-stage full-mouth " disinfection instead of a st and ard treatment strategy with consecutive root planings quadrant per quadrant . The one stage full-mouth disinfection procedure involves scaling and root planing of all pockets within 24 h in combination with an extensive application of chlorhexidine to all intra-oral niches such as periodontal pockets , tongue dorsum , tonsils ( chairside , and at home for 2 months ) . This study aims to examine the relative importance of the use of chlorhexidine in the one stage full-mouth disinfection protocol . METHODS Therefore , 3 groups of 12 patients each with advanced periodontitis were followed , both from a clinical and microbiological point of view , over a period of 8 months . The patients from the control group were scaled and root planed , quadrant per quadrant . at two-week intervals . The 2 other groups underwent a one stage full-mouth scaling and root planing ( all pockets within 24 h ) with ( Fdis ) or without ( FRp = full-mouth root planing ) the adjunctive use of chlorhexidine . At baseline and after 1 , 2 , 4 and 8 months , the following clinical parameters were recorded : plaque and gingivitis indices , probing depth , bleeding on probing and clinical attachment level . Microbiological sample s were taken from different intra-oral niches ( tongue , mucosa , saliva and pooled sample s from single- and multi-rooted teeth ) . The sample s were cultured on selective and non-selective media in order to evaluate the number of CFU/ml for the key-periodontopathogens . At baseline , an anonymous question naire was given to the patients to record the perception of Output:	In conclusion , on the basis of the best available data , the strength of evidence is grade B ( consistent , low- quality evidence ) for full-mouth ( with or without antiseptics ) and quadrant scaling and root planing for treatment of chronic periodontitis
MS21701	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course . Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients in the intervention and control groups had similar baseline pain ( p = 0.94 ) , self-efficacy to control pain ( p = 0.90 ) , mental health ( p = 0.10 ) , and vitality scores ( p = 0.21 ) , but those in the intervention arm had slightly less disability ( p = 0.04 ) . At 4 months , there was no significant improvement from baseline in any endpoint and no difference between patients in the intervention and control groups ( all p > 0.2 ) . Patient satisfaction with arthritis care and outcomes was no different for intervention and control patients ( all p > 0.3 ) . All types of health care re source use were similar at baseline and followup for both intervention and control groups ( all p > 0.2 ) . CONCLUSION While the ASMP course has been found to be effective in other patient groups , there were no significant clinical benefits noted at 4 months in patients recruited from primary care practice OBJECTIVE To evaluate the effects of isokinetic exercise versus a program of patient education on pain and function in older persons with knee osteoarthritis . DESIGN A r and omized , comparative clinical trial , with interventions lasting 8 weeks and evaluations of 12 weeks . SETTING An outpatient Veterans Affairs Medical Center clinic and an affiliated university hospital . PATIENTS One hundred thirteen men and women between 50 and 80 years old with diagnosed osteoarthritis of the knee ; 98 completed the entire assigned treatment . INTERVENTION Patients received either a regimen of isokinetic exercise of the quadriceps muscle three times weekly over 8 weeks or a series of 4 discussion s and lectures led by health care professionals . MAIN OUTCOME MEASURES Variables studied for change were isokinetic and isometric quadriceps strength , pain and function determined by categorical and visual analog scales , and overall status using physician and patient global evaluations by the Arthritis Impact Scale , version 2 , Western Ontario McMaster 's Arthritis Index , and Medical Outcome Study Short Form 36 . RESULTS Both treatment groups showed significant strength gains ( p < .05 ) , which occurred over a wider velocity spectrum for the exercise group . Exercised patients also had improved pain scores for more of the variables measured than those receiving education . Both groups had positive functional outcomes and slightly improved measures of overall status . CONCLUSIONS Isokinetic exercise is an effective and well-tolerated treatment for knee osteoarthritis , but a much less costly education program also showed some benefits BACKGROUND Diary recording of pain and disabling activities in osteoarthritis ( OA ) is widely recommended , but , to our knowledge , its impact on symptoms has not been investigated . Exercise programmes have been shown to be effective when patients are closely supervised by nurses or physiotherapists ; however , data are lacking on the efficacy of an unsupervised home based exercise regimen in patients with OA . OBJECTIVES To evaluate the clinical efficacy of patient administered assessment tools and an unsupervised home based exercise programme alone or in combination in patients with OA . METHODS The study was a 24 week , open cluster r and omised controlled trial with a factorial design . Rheumatologists ( n = 867 ) were assigned to four groups according to the treatment given : st and ardised tools ( ST ; n = 220 ) , exercises ( EX ; n = 213 ) , both tools and exercises ( ST+EX ; n = 213 ) , or usual care ( n = 221 ) . Each rheumatologist was to enroll four patients who met the American College of Rheumatology criteria for OA ( three with knee OA , one with hip OA ) . " Tools " consisted of weekly recording of pain and disabling activities in a diary . A home based exercise programme was performed daily at least four times per week with the aid of videotape and booklet . In addition to exercise and assessment , all patients received 12.5 mg or 25 mg of the non-steroidal anti-inflammatory drug rofecoxib once daily . Outcome variables were : pain ( measured on a visual analogue scale , 0 - 100 ) ; Western Ontario and McMaster Universities Osteoarthritis Index , function subscale ( 0 - 100 ) ; and patient assessment of the quality of care ( 0 - 100 ) . RESULTS Overall , 2957 patients with OA ( 2216 knee , 741 hip ) were included . After 24 weeks , both pain and function improved in the ST , EX , ST+EX , and usual care groups ( mean ( SD ) -17 ( 27 ) , -20 ( 29 ) , -15 ( 27 ) , -19 ( 29 ) ; and -11 ( 19 ) , -12 ( 19 ) , -10 ( 19 ) , -11 ( 20 ) , respectively ) , without significant differences between groups . However , patients in the EX and ST+EX groups were more likely to agree that their rheumatologist had done his best to preserve their functional and physical activities . CONCLUSION Although patients ' assessment s favoured the exercise programme , results from this study failed to demonstrate a short term symptomatic effect of the two non-pharmacological treatments ( weekly recording of condition and exercise ) in patients with OA concurrently receiving nonsteroidal anti-inflammatory drugs Implementation studies are recommended to assess the feasibility and effectiveness in real-life of programmes which have been tested in r and omized controlled trials ( RCTs ) . We report on an implementation study of two evidence -based exercise and health education programmes for older adults with osteoarthritis ( OA ) of the knee or hip . Three types of primary health-care providers ( n = 18 ) delivered the OA Knee programme ( n = 20 ) and the OA Hip programme ( n = 20 ) , supported by programme manuals and implementation guidelines , in four regions . The outcome measures were pain and mobility . The Knee programme had OA knowledge and self-efficacy as additional outcome measures . Differences in outcome measures and background variables of participants were assessed between the RCTs and the implementation study . Positive effects ( P < 0.05 ) were found for OA knowledge , pain and self-efficacy in the Knee programme ( n = 157 ) , and for pain in the Hip programme ( n = 132 ) . No effect was found for mobility . Effect sizes of the RCTs and the present study were comparable . Background variables did not explain the variance in the outcome measures . The outcomes of the previous RCTs and the implementation study were comparable , and indicated the ecological validity of the two programmes . The implication s for nationwide dissemination and implementation in The Netherl and s are discussed 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 < 0.01 ) . In a modified intent to treat analysis , 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 < 0.01 vs controls ) , and improvements in 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 We conducted a pilot study of a nurse-run telephone self-management programme for elderly people with osteoarthritis ( OA ) . Thirty-two subjects , aged 60 years or more , with a diagnosis of OA were recruited from two hospital rheumatology clinics and were r and omized to a control or intervention group . The intervention group received six weekly mailings of OA health education modules , a relaxation audio-tape and six weekly 45 min follow-up telephone self-management sessions . There was a 100 % compliance rate in the intervention group , and all subjects completed baseline and three-month interviews ; one subject in each group was lost to six-month follow-up . There were no significant differences in self-management between the control and intervention groups . However , at three months there were improvements in the intervention group ( relative to baseline ) on some outcome measures . The results suggest that the telephone may be a useful tool for reinforcing health-promoting activities for patients 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 ) , Output:	No beneficial effects were found from self management interventions with improving quality of life . We also found the exercise component of self management ( four trials ) demonstrated a benefit with reducing pain , improving function and quality of life . Exercise also offered a benefit over no exercise . DISCUSSION Pooled results indicate evidence of a beneficial effect from self management strategies with reducing pain and improving function . The exercise component of self management programmes appears to contribute a significant benefit . There is encouraging evidence of a small benefit from exercise in self management programs .
MS21702	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A new drug , gestrinone , was subjected to the first double blind , r and omised placebo controlled trial of any treatment of endometriosis . The disease deteriorated in eight ( 47 % ) of the 17 patients prescribed placebo ( 95 % confidence limits 23 % and 71 % ) compared with none of the 18 patients prescribed gestrinone ( p = 0.002 ) . There was a difference in elimination of the endometriosis in the gestrinone group compared with placebo but this was not statistically significant ( p = 0.057 ) . There was a significant difference in improvement of the disease in the gestrinone group compared with placebo ( p = 0.004 ) , confirming that gestrinone is an effective treatment of endometriosis . Endometriosis deteriorates in at least 23 % of patients ; as it is impossible to predict in whom this will happen , treatment appears to be warranted in all cases OBJECTIVE To compare the efficacy and safety of SC depot medroxyprogesterone acetate ( DMPA-SC 104 ) with that of leuprolide acetate in treatment of endometriosis . DESIGN Phase 3 , multicenter , r and omized , evaluator-blinded , comparator-controlled trial . SETTING Clinical trial sites in Canada and United States . PATIENT(S ) Two hundred seventy-four women with surgically diagnosed endometriosis . INTERVENTION(S ) Intramuscular injections of DMPA-SC ( 104 mg ) or leuprolide acetate ( 11.25 mg ) , given every 3 months for 6 months , with 12 months of posttreatment follow-up . MAIN OUTCOME MEASURE(S ) Reduction in five endometriosis symptoms or signs ( dysmenorrhea , dyspareunia , pelvic pain , pelvic tenderness , pelvic in duration ) ; change in bone mineral density ( BMD ) , hypoestrogenic symptoms , bleeding , and weight . RESULT ( S ) The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment ( month 6 ) and in reducing all five symptoms after 12 months ' follow-up ( month 18 ) . Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6 , with scores returning to baseline at 12 months ' follow-up . No statistically significant differences in median weight changes were observed between groups . Compared with leuprolide , DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding . CONCLUSION ( S ) Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain , with less impact on BMD and fewer hypoestrogenic side effects but more bleeding OBJECTIVE To compare the efficacy of Dienogest versus Decapeptyl at 3.75 mg as consolidation therapy for surgery in the treatment of endometriosis . DESIGN Multicenter , open , r and omized , parallel-group clinical trial . SETTING Volunteer patients in an academic research environment . PATIENT(S ) Women with grade 2 , 3 , and 4 ( < /=70 ) endometriosis at initial laparoscopy . INTERVENTION(S ) We provided 16 weeks of treatment with Dienogest , 1 mg tablet daily ; or with Decapeptyl , 3.75 mg IM injection every 4 weeks . MAIN OUTCOME MEASURE(S ) A change in the patient 's Revised American Fertility Society score at the post-treatment laparoscopy . RESULT ( S ) From June 1994 to July 1998 , 142 patients were enrolled in the trial . After exclusion for major protocol deviations , 59 patients were included in the Dienogest group and 61 in the Decapeptyl group . This study group was comparable to the first inclusion group . The patient demographic and clinical characteristics , median duration of endometriosis , Revised American Fertility Society scores , and Visual Analogic Squale ( VAS ) scores were comparable in both groups . Statistical analysis of efficacy was not significantly different between the two groups . Adverse events were reported by 87.7 % of patients in the Dienogest group and 85.1 % in the Decapeptyl group . Neither treatment affected patient body weight or vital signs . CONCLUSION ( S ) Dienogest is as effective as Decapeptyl for consolidation therapy after surgery for the treatment of endometriosis . The safety profile of dienogest differed from Decapeptyl ( 3.75 mg ) . Dienogest constitutes a new therapeutic alternative to the GnRH analogues OBJECTIVE To assess the effect of a new progestin progestogen only pill ( desogestrel ) versus an oral contraceptive in the treatment of recurrent endometriosis . STUDY DESIGN A r and omized prospect i ve clinical study . A group of women with endometriosis ( n=40 ) who showed recurrent dysmenorrhea and /or pelvic pain after conservative surgery , and did not desire a pregnancy . Continuous treatment for 6 months with desogestrel ( 75 microg/d ) ( n=20 ) versus a combined oral contraceptive ( ethinyl estradiol 20 microg plus desogestrel 150 microg ) ( n=20 ) was performed . RESULTS A significant improvement of both pelvic pain and dysmenorrhea was observed following each type of treatment ( P<0.001 ) . The use of desogestrel progestogen only pill was associated with a breakthrough bleeding in 20 % patients , while a significant body weight increase was observed in 15 % after oral contraceptive . CONCLUSIONS Both desogestrel and an oral estro-progestinic were effective , safe and low cost therapy of pain symptoms after endoscopic surgery for endometriosis , the former showing an impact on breakthrough bleeding , the later an incidence on body weight increase BACKGROUND Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis . The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate ( LA ) for treating the pain associated with endometriosis . METHODS Patients with confirmed endometriosis were r and omized to treatment with dienogest ( 2 mg/day , orally ) or LA ( 3.75 mg , depot i.m . injection , every 4 weeks ) for 24 weeks . The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment , assessed by visual analogue scale ( VAS ) . Safety variables included adverse event profile , laboratory parameters , bone mineral density ( BMD ) , bone markers and bleeding patterns . RESULTS A total of 252 women were r and omized to treatment with dienogest ( n = 124 ) or LA ( n = 128 ) ; 87.9 and 93.8 % of the respective groups completed the trial . Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA , demonstrating the equivalence of dienogest relative to LA . Hypoestrogenic effects ( e.g. hot flushes ) were reported less frequently in the dienogest group . As expected , bleeding episodes were suppressed less with dienogest than with LA . Changes in mean lumbar BMD between screening and final visit were + 0.25 % with dienogest and -4.04 % with LA subgroups ( P = 0.0003 ) . Markers of bone resorption increased with LA but not dienogest . CONCLUSIONS Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at st and ard dose in relieving the pain associated with endometriosis , although offering advantages in safety and tolerability Danazol ( 200 mg three times a day ) and medroxyprogesterone acetate ( MPA , 100 mg a day ) were compared with placebo in the treatment of infertility of patients with endometriosis . Twenty-seven patients had medical therapy alone for 6 months , and 22 patients received it after conservative surgery . The clinical characteristics of the patients in the danazol group ( n = 18 ) , the MPA group ( n = 17 ) , and the placebo group ( n = 14 ) were comparable to each other . The follow-up time was 30 months . The cumulative pregnancy rates , 33 % in the danazol group ( n = 6 ) , 42 % in the MPA group ( n = 7 ) , and 46 % in the placebo group ( n = 6 ) , did not differ significantly from each other . The time to pregnancy after the start of therapy was 17.7 + /- 8.4 ( st and ard deviation [ SD ] ) months in the danazol group , 18.0 + /- 9.0 months in the MPA group and 10.0 + /- 5.8 months in the placebo group with no significant difference between the groups . The abortion rate was 26 % , and there was no significant difference among the groups . Cox multivariant analysis did reveal ovarian endometriosis a prognostically significant negative indicator as regards fecundation in endometriosis ( P less than 0.05 ) . In summary , correction of infertility alone does not appear to be an indication for the use of danazol or MPA in the treatment of endometriosis , and ovarian endometriotic lesions but not peritoneal ones do make a worse prognosis as regards fecundation in endometriosis OBJECTIVE To evaluate the efficacy , safety , and tolerability of an estrogen-progestogen combination versus low-dose norethindrone acetate in the treatment of persistent pain after surgery for symptomatic rectovaginal endometriosis . DESIGN R and omized controlled trial . SETTING Academic center . PATIENT(S ) Ninety women with recurrent moderate or severe pelvic pain after unsuccessful conservative surgery for symptomatic rectovaginal endometriosis . INTERVENTION(S ) Twelve-month , continuous treatment with oral ethinyl E2 , 0.01 mg , plus cyproterone acetate , 3 mg/day , or norethindrone acetate , 2.5 mg/day . MAIN OUTCOME MEASURE(S ) Degree of satisfaction with therapy . RESULT ( S ) Seven women in the ethinyl E2 plus cyproterone acetate arm and five in the norethindrone acetate arm withdrew because of side effects ( n=5 ) , treatment inefficacy ( n=6 ) , or loss to follow-up ( n=1 ) . At 12 months , dysmenorrhea , deep dyspareunia , nonmenstrual pelvic pain , and dyschezia scores were substantially reduced without major between-group differences . Both regimens induced minor unfavorable variations in the serum lipid profile . According to an intention-to-treat analysis , 28 ( 62 % ) out of 45 patients in the ethinyl E2 plus cyproterone acetate group and 33 ( 73 % ) out of 45 in the norethindrone acetate group were satisfied with the treatment received . CONCLUSION ( S ) Low-dose norethindrone acetate could be considered an effective , tolerable , and inexpensive first-choice medical alternative to repeat surgery for treating symptomatic rectovaginal endometriotic lesions in patients who do not seek conception A prospect i ve , double-blind , placebo-controlled study was design ed to evaluate the clinical efficacy and tolerance of danazol and high-dose medroxyprogesterone acetate ( MPA ) in the treatment of mild-moderate endometriosis . After laparoscopical confirmation of endometriosis , 59 patients were r and omized to receive danazol ( 200 mg 3 times daily ) , MPA ( 100 mg daily ) or placebo for 6 months . Clinical examinations were done before and 1 , 3 , 6 and 12 months after the beginning of the study , and a 2nd laparoscopy 6 months after termination of the medication . Eighteen patients in the danazol group , 16 in the MPA group and 17 in the placebo group completed the trial . Total or partial resolution of peritoneal implants was observed in 60 % of the patients receiving danazol and in 63 % of the patients receiving MPA . In the placebo group , resolution was observed in 18 % , while the size of the implants was estimated to be increased in 23 % of the patients . In relation to placebo , danazol and MPA significantly alleviated endometriosis-associated pelvic pain , lower back pain and defecation pain , but they did not differ from each other in these actions . The appearance of acne , muscle cramps , edema , weight gain and spotting bleeding complicated MPA treatment . The present results indicate that because of good efficacy and tolerance , high-dose MPA is a useful alternative in the hormonal treatment of endometriosis The purpose of this r and omized double blind prospect i ve trial was to study the efficacy and safety of two doses of oral gestrinone in the treatment of endometriosis . Six patients received gestrinone 1.25 mg twice weekly ( group I ) and six patients received gestrinone 2.5 mg twice weekly ( group II ) . Patients underwent pretreatment and post-treatment laparoscopies and their endometriosis scores were recorded . The mean total endometriosis scores declined significantly from 20.0 + /- 5.2 ( mean + /- st and ard error of the mean ) pretreatment to 9.5 + /- Output:	There was no evidence of a benefit with depot administration of progestagens versus other treatments ( low dose oral contraceptive or leuprolide acetate ) for reduced symptoms . There was no overall evidence of a benefit of oral progestagens over other medical treatment at six months of follow-up for self-reported efficacy . Amenorrhoea and bleeding were more frequently reported in the progestagen group compared with other treatment groups . There was no evidence of a benefit of anti-progestagens ( gestrinone ) compared with danazol . There is only limited evidence to support the use of progestagens and anti-progestagens for pain associated with endometriosis
MS21703	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Shoulder joint dislocations collected from a r and omized population were investigated in Sweden , wherein nearly 50 % of people with primary dislocations never visit hospitals nor are treated by a physician . Thus information obtained from surgically treated patients is of limited value because cases requiring operative repair represent only a small and selected percentage of the population . The incidence of shoulder dislocation in people from 18 to 70 years of age was at least 1.7 % and was three times more common in males . Spontaneous healing of recurrent dislocations in a period of many years was not uncommon . Shoulder joint dislocation was more common among children than was generally appreciated , with the prognosis usually good . Recurrences of primary dislocations in people 15 to 25 years of age were not as frequent as was expected BACKGROUND Anterior dislocation of the glenohumeral joint in younger patients is associated with a high risk of recurrence and persistent functional deficits . The aim of this study was to assess the efficacy of a primary arthroscopic Bankart repair , while controlling for the therapeutic effects produced by the arthroscopic intervention and joint lavage . METHODS In a single-center , double-blind clinical trial , eighty-eight adult patients under thirty-five years of age who had sustained a primary anterior glenohumeral dislocation were r and omized to receive either an arthroscopic examination and joint lavage alone or together with an anatomic repair of the Bankart lesion . Assessment of the rate of recurrent instability , functional outcome ( with use of three scores ) , range of movement , patient satisfaction , direct health-service costs , and treatment complications was completed for eighty-four of these patients ( forty-two in each group ) during the subsequent two years . RESULTS In the two years after the primary dislocation , the risk of a further dislocation was reduced by 76 % and the risk of all recurrent instability was reduced by 82 % in the Bankart repair group compared with the group that had arthroscopy and lavage alone . The functional scores were also better ( p < 0.05 ) , the treatment costs were lower ( p = 0.012 ) , and patient satisfaction was higher ( p < 0.001 ) after arthroscopic repair . The improved functional outcome appeared to be mediated through the prevention of instability since the functional outcome in patients with stable shoulders was similar , irrespective of the initial treatment allocation . The patients who had a Bankart repair and played contact sports were also more likely to have returned to their sport at two years ( relative risk = 3.4 , p = 0.007 ) . CONCLUSIONS Following a first-time anterior dislocation of the shoulder , there is a marked treatment benefit from primary arthroscopic repair of a Bankart lesion , which is distinct from the so-called background therapeutic effect of the arthroscopic examination and lavage of the joint . However , primary repair does not appear to confer a functional benefit to patients with a stable shoulder at two years after the dislocation Background Nonoperative treatment of traumatic shoulder dislocations leads to a high rate of recurrent dislocations . Hypothesis Early arthroscopic treatment for shoulder dislocation will result in a lower recurrence rate than nonoperative treatment . Study Design Prospect i ve , r and omized clinical trial . Methods Two groups of patients were studied to compare nonoperative treatment with arthroscopic Bankart repair for acute , traumatic shoulder dislocations in young athletes . Fourteen nonoperatively treated patients underwent 4 weeks of immobilization followed by a supervised rehabilitation program . Ten operatively treated patients underwent arthroscopic Bankart repair with a bioabsorbable tack followed by the same rehabilitation protocol as the nonoperatively treated patients . The average follow-up was 36 months . Results Three patients were lost to follow-up . Twelve nonoperatively treated patients remained for follow-up . Nine of these ( 75 % ) developed recurrent instability . Six of the nine have required subsequent open Bankart repair for recurrent instability . Of the nine operatively treated patients available for follow-up , only one ( 11.1 % ) developed recurrent instability . Conclusions Arthroscopic stabilization of traumatic , first-time anterior shoulder dislocations is an effective and safe treatment that significantly reduces the recurrence rate of shoulder dislocations in young athletes when compared with conventional , nonoperative treatment BACKGROUND An initial anterior dislocation of the shoulder becomes recurrent in 66 % to 94 % of young patients after immobilization of the shoulder in internal rotation . Magnetic resonance imaging and studies of cadavera have shown that coaptation of the Bankart lesion is better with the arm in external rotation than it is with the arm in internal rotation . Our aim was to determine the benefit of immobilization in external rotation in a r and omized controlled trial . METHODS One hundred and ninety-eight patients with an initial anterior dislocation of the shoulder were r and omly assigned to be treated with immobilization in either internal rotation ( ninety-four shoulders ) or external rotation ( 104 shoulders ) for three weeks . The primary outcome measure was a recurrent dislocation or subluxation . The minimum follow-up period was two years . RESULTS The follow-up rate was seventy-four ( 79 % ) of ninety-four in the internal rotation group and eighty-five ( 82 % ) of 104 in the external rotation group . The compliance rate was thirty-nine ( 53 % ) of seventy-four in the internal rotation group and sixty-one ( 72 % ) of eighty-five in the external rotation group ( p = 0.013 ) . The intention-to-treat analysis revealed that the recurrence rate in the external rotation group ( twenty-two of eighty-five ; 26 % ) was significantly lower than that in the internal rotation group ( thirty-one of seventy-four ; 42 % ) ( p = 0.033 ) with a relative risk reduction of 38.2 % . In the subgroup of patients who were thirty years of age or younger , the relative risk reduction was 46.1 % . CONCLUSIONS Immobilization in external rotation after an initial shoulder dislocation reduces the risk of recurrence compared with that associated with the conventional method of immobilization in internal rotation . This treatment method appears to be particularly beneficial for patients who are thirty years of age or younger Purpose The purpose of this study was to compare clinical outcomes between a primary dislocation group ( group P ) and a recurrent dislocation group ( group R ) with combined lesion of Bankart and type II SLAP lesions ( type V SLAP lesion ) and to evaluate incidence of type V SLAP lesion . In addition , the authors evaluated clinical outcomes of these patients by dividing two groups according to the sequence for Bankart and SLAP lesion suture . Methods From May 2000 to May 2005 , 310 patients who gave informed consent , underwent the diagnostic arthroscopy and magnetic resonance arthrography ( MRA ) . One hundred and ten patients met the following criteria : ( 1 ) post-traumatic primary or recurrent anterior shoulder instability , ( 2 ) a normal contralateral shoulder , ( 3 ) a type V SLAP lesion , and ( 4 ) minimum follow-up of two years . Group P included 42 patients , and group R , 68 patients . Among all patients , 58 patients who had Bankart lesions sutured first were included in group B , and 52 who had their SLAP lesions sutured beforeh and , group S. Visual analogue scale , range of motion , Rowe and Constant score were used to compare results between group P and group R , also group B and group S. Results The incidence rates of type V SLAP lesion were 42.8 % in group P and 32.0 % in group R. The overall treatment results in our study were good . Even if the difference between the two groups was statistically insignificant , group P showed greater recovery of range of motion than group R in external rotation . No significant difference was found between the two different operative methods according to suture sequence . Conclusion The incidence rates of type V SLAP lesion were 42.8 % in the primary dislocation group and 32.0 % in the recurrent dislocation group . The overall treatment results in our study were good . Although there was no statistical significance in surgical time between the two groups , when both SLAP and Bankart lesions are present , the Bankart lesion must be sutured first to reduce surgical time Background : There is no consensus on the optimal treatment of in-season athletes with anterior shoulder instability , and limited data are available to guide return to play . Purpose : To examine the likelihood of return to sport and the recurrence of instability after an in-season anterior shoulder instability event based on the type of instability ( subluxation vs dislocation ) . Additionally , injury factors and patient-reported outcome scores administered at the time of injury were evaluated to assess the predictability of eventual successful return to sport and time to return to sport during the competitive season . Study Design : Cohort study ( prognosis ) ; Level of evidence , 2 . Methods : Over 2 academic years , 45 contact intercollegiate athletes were prospect ively enrolled in a multicenter observational study to assess return to play after in-season anterior glenohumeral instability . Baseline data collection included shoulder injury characteristics and shoulder-specific patient-reported outcome scores at the time of injury . All athletes underwent an accelerated rehabilitation program without shoulder immobilization and were followed during their competitive season to assess the success of return to play and recurrent instability . Results : Thirty-three of 45 ( 73 % ) athletes returned to sport for either all or part of the season after a median 5 days lost from competition ( interquartile range , 13 ) . Twelve athletes ( 27 % ) successfully completed the season without recurrence . Twenty-one athletes ( 64 % ) returned to in-season play and had subsequent recurrent instability including 11 recurrent dislocations and 10 recurrent subluxations . Of the 33 athletes returning to in-season sport after an instability event , 67 % ( 22/33 ) completed the season . Athletes with a subluxation were 5.3 times more likely ( odds ratio [ OR ] , 5.32 ; 95 % CI , 1.00 - 28.07 ; P = .049 ) to return to sport during the same season when compared with those with dislocations . Logistic regression analysis suggests that the Western Ontario Shoulder Instability Index ( OR , 1.05 ; 95 % CI , 1.00 - 1.09 ; P = .037 ) and Simple Shoulder Test ( OR , 1.03 ; 95 % CI , 1.00 - 1.05 ; P = .044 ) administered after the initial instability event are predictive of the ability to return to play . Time loss from sport after a shoulder instability event was most strongly and inversely correlated with the Simple Shoulder Test ( P = .007 ) at the time of initial injury . Conclusion : In the largest prospect i ve study evaluating shoulder instability in in-season contact athletes , 27 % of athletes returned to play and completed the season without subsequent instability . While the majority of athletes who return to sport complete the season , recurrent instability events are common regardless of whether the initial injury was a subluxation or dislocation BACKGROUND During 1978 and 1979 , we initiated a prospect i ve multicenter study to evaluate the results of nonoperative treatment of primary anterior shoulder dislocation . In the current report , we present the outcome after twenty-five years . METHODS Two hundred and fifty-five patients ( 257 shoulders ) with an age of twelve to forty years who had a primary anterior shoulder dislocation were managed with immobilization ( achieved by tying the arm to the torso with use of a b and age ) or without immobilization . All 227 living patients ( 229 shoulders ) completed the follow-up question naire , and 214 patients completed the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire . RESULTS Ninety-nine ( 43 % ) of 229 shoulders had not redislocated , and seventeen ( 7 % ) redislocated once . Thirty-three recurrent dislocations had become stable over time ( 14.4 % ) , and eighteen were considered to be still recurrent ( 7.9 % ) . Sixty-two shoulders ( 27 % ) had undergone surgery for the treatment of recurrent instability . Immobilization after the primary dislocation did not change the prognosis . Only two of twenty-four shoulders with a fracture of the greater tuberosity at the time of the primary dislocation redislocated ( p < 0.001 ) . When shoulders with a fracture of the greater tuberosity were excluded , forty-four ( 38 % ) of 115 shoulders in patients who had been twelve to twenty-five years of age at the time of the original dislocation and sixteen ( 18 % ) of ninety shoulders in patients who had been twenty-six to forty years of age had undergone surgical stabilization . At twenty-five years , fourteen ( 23 % ) of sixty-two shoulders that had undergone surgical stabilization were in patients who subsequently had a contralateral dislocation , compared with seven ( 7 % ) of ninety-nine shoulders in patients in whom the index dislocation had been classified as solitary ( p = 0.01 ) . Gender and athletic activity did not appear to affect the redislocation rate ; however , women had worse DASH scores than men did ( p = 0.006 ) . CONCLUSIONS After twenty-five years , half of the primary anterior shoulder dislocations that had been treated nonoperatively in patients with an age of twelve to twenty-five years had not recurred or had become stable over time Background : Conservative treatment of posttraumatic antero-inferior shoulder instability leads to a high failure rate in a young and active population . However , treatment in an adolescent age group is not well documented . Methods : We conducted a prospect i ve study with adolescent patients ( age 15 to 18 y ) who suffered a first traumatic anterior dislocation of the shoulder . Two groups of patients were formed . The first group was treated with early arthroscopic stabilization and the second was treated conservatively . There were 43 shoulders in the operative group and 29 shoulders in the conservative group . The rehabilitation protocol was the same for both groups . All patients were followed up prospect ively after 12 , 24 , and 36 months using Rowe Score . Results : A total of 38 shoulders Output:	Conclusion The outcome of immediate arthroscopic repair of primary anterior shoulder dislocation is superior and encouraging with significant reduction in failure and revision rates compared to conservative treatment . Nevertheless , the failure and revision rates are statistically insignificant compared to arthroscopic reconstruction of recurrent dislocation . Hence , there is evidence to support immediate arthroscopic repair option for primary anterior shoulder dislocations over conservative treatment in young active patients , in order to reduce the risk of failure and revision rates . However , the evidence is inconclusive compared to arthroscopic reconstruction of recurrent dislocation
MS21704	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Ferric citrate ( FC ) is a new phosphorus binder shown to increase serum iron stores while reducing intravenous iron and erythropoiesis-stimulating agent usage . Such reductions could lower hospitalization rates and associated costs . Methods : Hospitalizations during a Phase III trial were compared between FC and active control ( AC ) . Hospitalization costs were estimated using the 2013 US Renal Data System Annual Data Report . Results : 34.6 % of FC patients were hospitalized at least once versus 45.6 % of the AC group ( risk reduction 24.2 % ; p = 0.02 ) . There were 181 unique hospitalizations in the FC group versus 239 in the AC group , for a difference of 58 hospitalizations . Total potential savings was US$ 867,622 in hospitalization costs in the FC group . If the hospitalization reduction in our study was applied to the general end-stage renal disease population , this could translate into a savings of US$ 3002/patient/year . Conclusions : Patients receiving FC experienced fewer hospitalizations with the potential for significant savings BACKGROUND AND OBJECTIVES Vascular calcification and endothelial dysfunction contribute to the development of cardiovascular disease in patients with chronic kidney disease ( CKD ) . Sevelamer , a non-calcium-based phosphate binder , has been shown to attenuate cardiovascular calcification in CKD patients , although the exact mechanism has not been clarified . This study was design ed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and endothelial dysfunction seen in CKD patients . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Fifty nondiabetic stage 4 CKD patients whose phosphate levels were > or = 5.5 mg/dl were enrolled in this 8-wk r and omized prospect i ve study . Thirty-six healthy volunteers served as matched controls . Patients were treated with either sevelamer ( n = 25 , 12 males ) or calcium acetate ( n = 25 , 13 males ) . Fetuin-A , high-sensitivity C-reactive protein , Ca x PO4 product , flow-mediated dilation ( FMD ) , insulin , and homeostasis model assessment ( HOMA ) were obtained at baseline and after the treatment period . RESULTS As expected , CKD patients had significantly lower levels of fetuin-A and FMD , and significantly higher levels of intact parathyroid hormone , Ca x PO4 product , and high-sensitivity C-reactive protein than controls ( P < 0.001 for all ) . The use of sevelamer led to a significant increase in the fetuin-A concentration with improvement in FMD , whereas no significant difference was observed in the calcium acetate group . In a multiple regression analysis , FMD levels were independently related to fetuin-A both before ( beta = 0.63 , P < 0.001 ) and after ( beta = 0.38 , P = 0.004 ) treatment . CONCLUSIONS This small , r and omized , prospect i ve study shows that short-term sevelamer treatment significantly increases fetuin-A levels and improves FMD in nondiabetic stage 4 CKD patients Background Fetuin-A is known as a circulating inhibitor of vascular calcification . Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients is still uncertain . Methods In the post-hoc study , we analyzed serum fetuin-A and biochemical factors ( Ca , P , i-PTH , hsCRP , TG , LDL-C ) in 50 hemodialysis patients , who completed a 48-week , open-Label , controlled r and omized parallel-group study . 23 patients received sevelamer and 27 patients received calcium carbonate . Results After the 48-week treatment , the sevelamer group had less serum calcium increment , less iPTH decrement , more ALK-P increment , more hsCRP decrement and more LDL-C decrement . There was no significant difference in the serum fetuin-A decrement between two groups . Decreased serum fetuin-A levels were found after 48-week treatment in both groups : from 210.61 ( 104.73 ) to 153.85 ( 38.64 ) ug/dl , P = 0.003 in sevelamer group , from 203.95 ( 107.87 ) to 170.90 ( 58.02 ) ug/mL , P = 0.002 in calcium group . The decrement in serum fetuin-A ( Δfetuin-A ) levels was associated with ΔCa ( ρ = - 0.230 , P = 0.040 ) , ΔiPTH ( ρ = 0.306 , P = 0.031 ) and Δalbumin ( ρ = 0.408 , P = 0.003 ) , not associated with sevelamer use , ΔP and ΔhsCRP . Conclusion After long-term sevelamer or calcium carbonate treatment , both groups of maintenance HD patients had lower serum fetuin-A levels . Serum levels of increased calcium , decreased iPTH and decreased albumin were associated with the serum fetuin-A decrement The objective of the study was to evaluate the phosphate-binding efficacy , side effects , and cost of therapy of calcium ketoglutarate granulate as compared with calcium carbonate tablets in patients on chronic hemodialysis . The study design used was a r and omized , crossover open trial , and the main outcome measurements were plasma ionized calcium levels , plasma phosphate levels , plasma intact parathyroid hormone ( PTH ) levels , requirements for supplemental aluminum-aminoacetate therapy , patient tolerance , and cost of therapy . Nineteen patients on chronic hemodialysis were treated with a dialysate calcium concentration of 1.25 mmol/L and a fixed alfacalcidol dose for at least 2 months . All had previously tolerated therapy with calcium carbonate . Of the 19 patients included , 10 completed both treatment arms . After 12 weeks of therapy , the mean ( + /-SEM ) plasma ionized calcium level was significantly lower in the ketoglutarate arm compared with the calcium carbonate arm ( 4.8+/-0.1 mg/dL v 5.2+/-0.1 mg/dL ; P = 0.004 ) , whereas the mean plasma phosphate ( 4.5+/-0.3 mg/dL v 5.1+/-0.1 mg/dL ) and PTH levels ( 266+/-125 pg/mL v 301+/-148 pg/mL ) did not differ significantly between the two treatment arms . Supplemental aluminum-aminoacetate was not required during calcium ketoglutarate treatment , while two patients needed this supplement when treated with calcium carbonate . Five of 17 ( 29 % ) patients were withdrawn from calcium ketoglutarate therapy within 1 to 2 weeks due to intolerance ( anorexia , vomiting , diarrhea , general uneasiness ) , whereas the remaining 12 patients did not experience any side effects at all . The five patients with calcium ketoglutarate intolerance all had pre-existing gastrointestinal symptoms ; four of them had received treatment with cimetidine or omeprazol before inclusion into the study . Calculations based on median doses after 12 weeks showed that the cost of the therapy in Denmark was 10 times higher for calcium ketoglutarate compared with calcium carbonate ( US$ 6.00/d v US$ 0.65/d ) . Calcium ketoglutarate may be an effective and safe alternative to treatment with aluminum-containing phosphate binders in patients on hemodialysis who are intolerant of calcium carbonate or acetate because of hypercalcemia . However , care must be exercised when dealing with patients with pre-existing gastrointestinal discomfort . Due to the high cost of the therapy , calcium ketoglutarate should be used only for selected patients Background . Sevelamer carbonate is an improved , buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients . Sevelamer carbonate formulated as a powder for oral suspension presents a novel , patient-friendly alternative to tablet phosphate binders . This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis . Methods . This was a multi-centre , open-label , r and omized , crossover design study . Thirty-one haemodialysis patients were r and omly assigned to either sevelamer carbonate powder or sevelamer hydrochloride tablets for 4 weeks followed by a crossover to the other regimen for an additional 4 weeks . Results . The mean serum phosphorus was 1.6 ± 0.5 mmol/L ( 5.0 ± 1.5 mg/dL ) during sevelamer carbonate powder treatment and 1.7 ± 0.4 mmol/L ( 5.2 ± 1.1 mg/dL ) during sevelamer hydrochloride tablet treatment . Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus ; the geometric least square mean ratio was 0.95 ( 90 % CI 0.87–1.03 ) . No statistically significant or clinical ly meaningful differences were observed in calcium × phosphorus product and lipid levels between sevelamer carbonate powder and sevelamer hydrochloride tablets . Serum bicarbonate levels increased 2.7 ± 3.7 mmol/L ( 2.7 ± 3.7 mEq/L ) during sevelamer carbonate treatment . No statistically significant change in bicarbonate was observed during sevelamer hydrochloride treatment . Sevelamer carbonate powder and sevelamer hydrochloride were well tolerated during this study . Conclusions . Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus and well tolerated in CKD patients on haemodialysis . Bicarbonate levels improved only during sevelamer carbonate treatment . Sevelamer carbonate powder should provide a welcomed new option for the treatment of hyperphosphataemia for CKD patients on dialysis Background / Aims : Colestilan is a new non-calcium-based phosphate binder licensed in Europe for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis ( CKD 5D ) . This study was conducted to evaluate efficacy in a North American patient population and also to examine secondary actions of colestilan on lipid profile and glycated hemoglobin ( HbA1c ) . Methods : This was a multicenter , r and omized , double-blind , placebo-controlled withdrawal study , after an initial open-label titration period . Patients ( n = 245 ) with stable phosphate control received 6 - 15 g/day colestilan during a 12-week , flexible titration period after which 169 were r and omized to continue the same dose ( n = 85 ) or switch to placebo ( n = 84 ) for 4 weeks . The primary endpoint was the change in serum phosphorus level during the placebo-controlled withdrawal period . Results : A significant difference of -1.01 mg/dl ( -0.33 mmol/l ) in mean change in serum phosphorus , favoring colestilan , was seen during the placebo-controlled withdrawal period ( p < 0.001 ) . Colestilan reduced serum phosphorus significantly from baseline to week 12 ( -1.54 mg/dl ( -0.50 mmol/l ) ; p < 0.001 ) . Serum calcium levels were not affected . Colestilan significantly reduced and maintained reductions in calcium × phosphorus ion product ( Ca × P ) , parathyroid hormone , total cholesterol , low-density lipoprotein cholesterol , uric acid and also HbA1c in patients with elevated baseline HbA1c . Colestilan was generally well tolerated ; most adverse events were gastrointestinal . Conclusion : In this first clinical trial with colestilan in a North American patient population , colestilan demonstrated significant efficacy in controlling serum phosphorus levels in CKD 5D patients with hyperphosphatemia , without increasing calcium levels BACKGROUND Colestilan is a non-absorbed , non-calcium-based , phosphate binder . It also binds bile acids and reduces serum levels of low-density lipoprotein cholesterol ( LDL-C ) . This study evaluated the efficacy of a range of fixed doses of colestilan compared with placebo for the control of serum phosphorus and LDL-C levels in patients with CKD stage 5 on dialysis . METHODS This was a multicentre , r and omized , double-blind , placebo-controlled , multiple fixed-dose trial in which 642 patients with CKD stage 5 on dialysis who had both hyperphosphataemia and dyslipidaemia , were r and omized to treatment with colestilan 3 , 6 , 9 , 12 or 15 g/day or placebo for 12 weeks . The co- primary endpoints were the mean changes in serum phosphorus and the mean per cent change in LDL-C from baseline to Week 12 . RESULTS A significantly greater mean reduction in serum phosphorus level from baseline to Week 12 than seen with placebo was seen with Output:	In CKD G5D sevelamer may lead to lower death ( all causes ) ( RR 0.53 , CI 0.30 to 0.91 , low certainty ) and induce less hypercalcaemia ( RR 0.30 , CI 0.20 to 0.43 , low certainty ) when compared with calcium-based binders , and has uncertain or inestimable effects on cardiovascular death , myocardial infa rct ion , stroke , fracture , or coronary artery calcification . It is uncertain whether the effects of binders on clinical ly-relevant outcomes were different for patients who were and were not treated with dialysis in subgroup analyses . In studies of adults with CKD G5D treated with dialysis , sevelamer may lower death ( all causes ) compared to calcium-based binders and incur less treatment-related hypercalcaemia , while we found no clinical ly important benefits of any phosphate binder on cardiovascular death , myocardial infa rct ion , stroke , fracture or coronary artery calcification . In patients with CKD G2 to G5 , the effects of sevelamer , lanthanum , and iron-based phosphate binders on cardiovascular , vascular calcification , and bone outcomes compared to placebo or usual care , are also uncertain and they may incur constipation , while iron-based binders may lead to diarrhoea
MS21705	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting . We present the long-term results of a r and omized trial of induction chemotherapy in resectable oral cavity cancer . PATIENTS AND METHODS A r and omized , parallel , multicentre trial evaluated the impact of three cycles of cisplatin 100 mg/m2 and fluorouracil 1000 mg/m2 ( 120-h infusion administered every 21 days ) in stage T2-T4 , N0-N2 , previously untreated patients with advanced disease . Control group received upfront surgery . Postoperative radiation was offered to both arms when pathologic risk features were identified . The co- primary end points were the occurrence of locoregional or distant tumour relapse , and death . RESULTS Among the 198 enrolled patients , with a median follow-up of 11.5 years , there was no difference in the incidence of locoregional relapse between chemotherapy and control group ( P=0.6337 ) , nor in distant metastasis development ( P=0.1527 ) . There was also no difference between groups in overall survival ( P=0.3402 ) . Patients with a pathological complete response ( pCR ) had higher probability of survival than those without ( 10-year OS : 76.2 % versus 41.3 % , P=0.0004 ) . Late toxicities in patients with a minimum follow-up of 60 months ( 42 in each group ) were similar between arms , except from fibrosis ( cumulative incidence 40 % versus 22 % in chemotherapy arm ) and grade 2 dysphagia ( 14 % versus 5 % ) . CONCLUSIONS Long-term follow-up of this r and omized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer . Late toxicity was similar in the two arms except for fibrosis and dysphagia , which were less in the chemotherapy arm . The survival benefit for patients achieving a pCR was maintained PURPOSE To date , consensus has not been reached on which treatment modality , that is , in-continuity neck dissection or discontinuous neck dissection , is more appropriate for managing patients with squamous cell carcinoma ( SCC ) of the tongue and floor of the mouth . This study aim ed to perform a meta- analysis to compare discontinuous neck dissection with in-continuity neck dissection as a treatment modality for SCC of the tongue and floor of the mouth . MATERIAL S AND METHODS The PubMed , Web of Science , China National Knowledge Infrastructure , and Wanfang data bases were search ed for articles that compared discontinuous neck dissection with in-continuity neck dissection in SCC of the tongue and floor of the mouth until March 1 , 2017 . The predictor variable was whether discontinuous neck dissection or in-continuity neck dissection was performed in each group . The primary outcome variable was the incidence of locoregional recurrence . Two authors individually extracted the data and assessed the study quality . The meta- analysis was performed using Stata ( version 13.0 ; StataCorp , College Station , TX ) . RESULTS We included 8 studies with 796 patients in our meta- analysis . The results showed that in-continuity neck dissection had a statistically significantly lower incidence of locoregional recurrence than discontinuous neck dissection ( r and om-effects model : relative risk , 0.459 ; 95 % confidence interval , 0.240 to 0.877 ; P = .019 ) . Because significant heterogeneity among studies ( I2 = 74.5 % , P < .001 ) was found in the heterogeneity evaluation , a separate analysis was performed . However , the results still showed that in-continuity neck dissection had a statistically significantly lower rate of locoregional recurrence than discontinuous neck dissection in patients with T2 and T3 SCC of the tongue and floor of the mouth ( fixed-effects model : relative risk , 0.281 ; 95 % confidence interval , 0.183 to 0.433 ; P < .001 ) . CONCLUSIONS Compared with discontinuous neck dissection , in-continuity neck dissection can significantly reduce the rate of locoregional recurrence in patients with SCC of the tongue and floor of the mouth 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 The current r and omized , multicenter , Phase III trial was conducted to determine whether the disease free interval and overall survival of patients with T2–T4,N0–N3,M0 squamous cell carcinoma ( SCC ) of the oral cavity or oropharynx could be extended through the combination of surgery ( and radiotherapy , if required ) with perilymphatic recombinant IL‐2 ( rIL‐2 ) Either intra-arterial infusions of MTX ( 500 mg over 10 days ) or intra-arterial infusions of BLM ( 95 mg over 13 days ) were administered as initial treatment to 85 patients with untreated squamous cell carcinomas of the oral cavity . Tumour regression was assessed 10 - 15 days after the end of chemotherapy . A sequential analysis was used , and BLM demonstrated a significantly greater local efficacy after the 32nd matched pair was assessed . The same results were observed when tumour response rates were compared , ignoring the matching , on the 85 patients , ( P less than 0.001 ) . The response rate for patients with neck nodes was low ( 10/38 ) . Catheter management problems , toxic effects and lethal reactions were 2.5 times more frequent in the MTX group Between February 1978 and January 1984 , 222 eligible patients were r and omised in a multicentre trial of preoperative intra-arterial chemotherapy in the treatment of oral cavity and oropharynx carcinoma . Patients were r and omised between either surgery or preoperative chemotherapy . This latter group received vincristine and bleomycin for 12 days . Patients were stratified according to the primary site : floor of the mouth ( FM ) versus posterior oral cavity or oropharynx ( POC ) and institution . The FM group received postoperative radiotherapy depending upon quality of the margins and lymph-node pathological involvement , when it was systematic ally applied in the POC group . Tumour regression after chemotherapy either complete ( CR ) or partial ( PR greater than 50 % ) was observed in 48 % in the FM group and 41 % in the POC group , and lymph-node regression ( CR + PR ) was respectively 15 % and 23 % . Some discrepancies appeared between clinical regression and pathological response , and the number of cases without histological response was clearly higher than the number of cases without clinical response . The overall survival showed a statistically significant difference ( P = 0.048 ) between FM and POC groups . In the FM group , median survival in the chemotherapy arm was estimated at 7 years compared with 3 years in the surgery arm . In the POC group , median survival was estimated at 3 years in both treatment arms . Chemotherapy lowered the uncontrolled disease and local recurrence in the FM group . These differences do not exist in the POC group , which may be due to the systematic ally postoperative radiotherapy PURPOSE To evaluate induction chemotherapy with docetaxel , cisplatin , and fluorouracil ( TPF ) followed by surgery and postoperative radiotherapy versus up-front surgery and postoperative radiotherapy in patients with locally advanced resectable oral squamous cell carcinoma ( OSCC ) . PATIENTS AND METHODS A prospect i ve open-label phase III trial was conducted . Eligibility criteria included untreated stage III or IVA locally advanced resectable OSCC . Patients received two cycles of TPF induction chemotherapy ( docetaxel 75 mg/m(2 ) on day 1 , cisplatin 75 mg/m(2 ) on day 1 , and fluorouracil 750 mg/m(2 ) on days 1 to 5 ) followed by radical surgery and postoperative radiotherapy ( 54 to 66 Gy ) versus up-front radical surgery and postoperative radiotherapy . The primary end point was overall survival ( OS ) . Secondary end points included local control and safety . RESULTS Of the 256 patients enrolled onto this trial , 222 completed the full treatment protocol . There were no unexpected toxicities , and induction chemotherapy did not increase perioperative morbidity . The clinical response rate to induction chemotherapy was 80.6 % . After a median follow-up of 30 months , there was no significant difference in OS ( hazard ratio [ HR ] , 0.977 ; 95 % CI , 0.634 to 1.507 ; P = .918 ) or disease-free survival ( HR , 0.974 ; 95 % CI , 0.654 to 1.45 ; P = .897 ) between patients treated with and without TPF induction . Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response ( ≤ 10 % viable tumor cells ) had superior OS and locoregional and distant control . CONCLUSION Our study failed to demonstrate that TPF induction chemotherapy improves survival compared with up-front surgery in patients with resectable stage III or IVA OSCC PURPOSE Prognosis of patients with advanced oral cavity cancer is worth improving . Chemotherapy has been reported to be especially active in oral cavity tumors . Here we repeat the results of a r and omized , multicenter trial enrolling patients with a resectable , stage T2-T4 ( > 3 cm ) , N0-N2 , M0 untreated , squamous cell carcinoma of the oral cavity . PATIENTS AND METHODS Patients were r and omly assigned to three cycles of cisplatin and fluorouracil followed by surgery ( chemotherapy arm ) or surgery alone ( control arm ) . In both arms , postoperative radiotherapy was reserved to high-risk patients , and surgery was modulated depending on the tumor 's closeness to the m and ible . Patients ' accrual was opened in 1989 and closed in 1999 . It included 195 patients . RESULTS In the chemotherapy arm , three toxic deaths were recorded . No significant difference in overall survival was found . Five-year overall survival was , for both arms , 55 % . Postoperative radiotherapy was administered in 33 % of patients in the chemotherapy arm , versus 46 % in the control arm . A m and ible resection was performed in 52 % of patients in the control arm , versus 31 % in the chemotherapy arm . CONCLUSION The addition of primary chemotherapy to st and ard surgery was unable to improve survival . However , in this study , primary chemotherapy seemed to play a role in reducing the number of patients who needed to undergo m and ibulectomy and /or radiation therapy . Variations in the criteria used to select patients for these treatment options may make it difficult to generalize these results , but there appears to be room for using preoperative chemotherapy to spare destructive surgery or radiation therapy in patients with advanced , resectable oral cavity cancer Tumours of the oral cavity/oropharynx occur relatively infrequently in the UK . The management of such lesions , especially the squamous cell carcinomas , is still a little controversial . Some centres advocate radiotherapy while others adopt surgery and radiotherapy . In an attempt to resolve the question of which approach gives the better results , a multicentre r and omized trial was established to compare surgery plus postoperative radiotherapy with radical radiotherapy alone . It was anticipated that 350 patients would be required to give a statistically significant result , but , after 35 patients had been entered , the trial was closed prematurely with a marked difference in overall survival in favour of the combination arm ( P = 0.0006 ) . At this analysis , carried out 23 months after trial closure , the survival difference between the two arms remains statistically significant for all causes of mortality ( P = 0.001 ; relative death rate = 0.24 ; 95 % CI 0.10 - 0.59 ) In the final report of a prospect i ve , r and omized controlled clinical trial , we report the results of using adjuvant perioperative chemotherapy in patients with oral cancer . Our study is based on the hypothesis of Goldie and Coldman . A total of 135 patients with alveolobuccal carcinoma , classified as clinical ly stage III and IV , were entered on the protocol . After a curative resection , they were r and omized . The patients in the test arm of the study received methotrexate 50 mg/m2 on the 3rd , 10th , and 17th postoperative days . The patients in the control arm underwent observation . This analysis at 24 months showed a disease-free survival rate of 61 % in the test arm versus 37 % in the control arm , which is statistically highly significant ( P < 0.01 ) . Analysis of the recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months ( P = Output:	Conclusion There is limited available evidence on treatments for oral cancer . The main beneficial treatment reported by authors for patients with resectable oral cancer is surgery alone or in combination with radiotherapy or chemotherapy . Evidence about the benefits of the treatments for unresectable oral cancer is lacking .
MS21706	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Importance It is not clear to what extent the higher incidence of coronary heart disease ( CHD ) in men vs women is explained by differences in risk factor levels because few studies have presented adjusted risk estimates for sex . Moreover , the increase in risk of CHD in postmenopausal women , possibly hormone related , may eventually eliminate the sex contrast in risk , but age-specific risk estimates are scarce . Objective To quantify the difference in risk of incident myocardial infa rct ion ( MI ) between men and women . Design , Setting and Participants Population -based prospect i ve study from Tromsø , Norway , comprising 33 997 individuals ( 51 % women ) . Median follow-up time during ages 35 to 102 years was 17.6 years . Incidence rates ( IRs ) and incidence rate ratios ( IRRs , relative risk ) of MI were calculated in Poisson regression analysis of person-years at risk . The data analysis was performed in November 2015 . Exposures Sex , age , birth cohort , serum lipid levels , blood pressure , lifestyle factors , diabetes . Main Outcomes and Measures Incident MI . Results A total of 2793 individuals ( 886 women ) received a diagnosis of MI during follow-up in the period 1979 through 2012 . The IR increased with age in both sexes , with lower rates for women until age 95 years . Adjusted for age and birth cohort , the overall IRR for men vs women was 2.72 ( 95 % CI , 2.50 - 2.96 ) . Adjustment for high-density lipoprotein cholesterol and total cholesterol levels had the strongest impact on the risk estimate for sex , followed by diastolic blood pressure and smoking . However , the sex difference remained substantial even after adjustment for these factors ( IRR , 2.07 ; 95 % CI , 1.89 - 2.26 ) . Men had higher risk throughout life , but the IRRs decreased with age ( 3.64 [ 95 % CI , 2.85 - 4.65 ] , 2.00 [ 95 % CI , 1.76 - 2.28 ] , and 1.66 [ 95 % CI , 1.42 - 1.95 ] for age groups 35 - 54 , 55 - 74 , and 75 - 94 years , respectively ) . Adjustment for systolic blood pressure , diabetes , body mass index , and physical activity had no notable impact . Conclusions and Relevance The observed sex contrast in risk of MI can not be explained by differences in established CHD risk factors . The gender gap persisted throughout life but declined with age as a result of a more pronounced flattening of risk level changes in middle-aged men . The minor changes in IRs when moving from premenopausal to postmenopausal age in women make it unlikely that changes in female hormone levels influence the risk of MI Background and Purpose The purpose of the present analysis was to determine how lifestyle influences the risk of cerebrovascular disease in women participating in the Copenhagen City Heart Study . Methods A r and om sample of a white , lower and middle-class , urban population selected in 1976 was invited to two cardiovascular examinations at 5-year intervals . The present analysis was based on 7060 women invited to an initial examination from 1976 through 1978 , aged 35 years or more , and without previous stroke or transient ischemic attack . At the initial examination , potential risk factors were recorded . The 265 first cases of stroke and transient ischemic attack were ascertained at a second examination 5 years later and through hospital records and death certificates through 1988 . The Cox regression model was used to estimate the influence of the factors recorded on the risk of cerebrovascular disease . Results The relative risks of cigarette smoking and lack of physical activity were 1.4 and 1.45 ; 95 % confidence limits , 1.02 to 1.94 and 1.01 to 2.08 , respectively ) . The relative risk of daily consumption of tranquilizers was 1.25 ( 95 % confidence limits , 0.96 to 1.62 ) . No significant influence was found for number of cigarettes , body mass index , or alcohol intake . In postmenopausal women , there was a statistically significant interaction ( P < .041 ) between smoking and hormone replacement therapy . Smokers receiving this therapy had a 28 % lower risk of cerebrovascular disease than smokers not receiving it . Conclusions The statistically significant and equally potent effects on the risk of cerebrovascular disease were found for cigarette smoking and lack of physical activity . The risk associated with smoking seemed to be influenced by hormonal replacement therapy Objective To evaluate the impact of combinations of lifestyle factors on mortality in middle aged women . Design Prospect i ve cohort study . Setting Nurses ’ health study , United States . Participants 77 782 women aged 34 to 59 years and free from cardiovascular disease and cancer in 1980 . Main outcome measure Relative risk of mortality during 24 years of follow-up in relation to five lifestyle factors ( cigarette smoking , being overweight , taking little moderate to vigorous physical activity , no light to moderate alcohol intake , and low diet quality score ) . Results 8882 deaths were documented , including 1790 from cardiovascular disease and 4527 from cancer . Each lifestyle factor independently and significantly predicted mortality . Relative risks for five compared with zero lifestyle risk factors were 3.26 ( 95 % confidence interval 2.45 to 4.34 ) for cancer mortality , 8.17 ( 4.96 to 13.47 ) for cardiovascular mortality , and 4.31 ( 3.51 to 5.31 ) for all cause mortality . A total of 28 % ( 25 % to 31 % ) of deaths during follow-up could be attributed to smoking and 55 % ( 47 % to 62 % ) to the combination of smoking , being overweight , lack of physical activity , and a low diet quality . Additionally considering alcohol intake did not substantially change this estimate . Conclusions These results indicate that adherence to lifestyle guidelines is associated with markedly lower mortality in middle aged women . Both efforts to eradicate cigarette smoking and those to stimulate regular physical activity and a healthy diet should be intensified BACKGROUND Moderate alcohol consumption is inversely associated with cardiovascular diseases . Changes in hormone levels might in part help explain the positive health effect . This study was performed to examine the effect of moderate alcohol consumption on plasma dehydroepi and rosterone sulfate ( DHEAS ) , testosterone , and estradiol levels . METHODS In a r and omized , diet-controlled , crossover study , 10 middle-aged men and 9 postmenopausal women , all apparently healthy , nonsmoking , and moderate alcohol drinkers , consumed beer or no-alcohol beer with dinner during two successive periods of 3 weeks . During the beer period , alcohol intake equaled 40 and 30 g per day for men and women , respectively . The total diet was supplied and had essentially the same composition during these 6 weeks . Before each treatment there was a 1 week washout period , in which the subjects were not allowed to drink alcoholic beverages . At the end of each of the two experimental periods , fasting blood sample s were collected in the morning . RESULTS Moderate alcohol consumption increased plasma DHEAS level by 16.5 % ( 95 % confidence interval , 8.0 - 24.9 ) , with similar changes for men and women . Plasma testosterone level decreased in men by 6.8 % ( 95 % confidence interval , -1.0- -12.5 ) , but no effect was found in women . Plasma estradiol level was not affected . Serum high-density lipoprotein cholesterol level increased by 11.7 % ( 95 % confidence interval , 7.3 - 16.0 ) , with similar changes for men and women . The overall alcohol-induced relative changes in DHEAS , testosterone , and estradiol correlated positively with the relative increase in high-density lipoprotein cholesterol ( adjusted for the relative change in body weight ) ; however , findings were only borderline significant for DHEAS and estradiol ( r = 0.44 , p = 0.08 ; r = 0.32 , p = 0.21 ; and r = 0.46 , p = 0.06 , respectively ) . CONCLUSIONS A protective effect of moderate alcohol consumption for cardiovascular disease risk may in part be explained by increased plasma DHEAS level CONTEXT Obesity is a well-established risk factor for coronary heart disease ( CHD ) , but whether regional fat distribution contributes independently to risk remains unclear . OBJECTIVE To compare waist-hip ratio ( WHR ) and waist circumference in determining risk of CHD in women . DESIGN AND SETTING Prospect i ve cohort study among US female registered nurses participating in the Nurses ' Health Study conducted between 1986 , when the nurses completed a question naire , and follow-up in June 1994 . PARTICIPANTS A total of 44702 women aged 40 to 65 years who provided waist and hip circumferences and were free of prior CHD , stroke , or cancer in 1986 . MAIN OUTCOME MEASURES Incidence of CHD ( nonfatal myocardial infa rct ion or CHD death ) . RESULTS During 8 years of follow-up 320 CHD events ( 251 myocardial infa rct ions and 69 CHD deaths ) were documented . Higher WHR and greater waist circumference were independently associated with a significantly increased age-adjusted risk of CHD . After adjusting for body mass index ( BMI ) ( defined as weight in kilograms divided by the square of height in meters ) and other cardiac risk factors , women with a WHR of 0.88 or higher had a relative risk ( RR ) of 3.25 ( 95 % confidence interval [ CI ] , 1.78 - 5.95 ) for CHD compared with women with a WHR of less than 0.72 . A waist circumference of 96.5 cm ( 38 in ) or more was associated with an RR of 3.06 ( 95 % CI , 1.54 - 6.10 ) . The WHR and waist circumference were independently strongly associated with increased risk of CHD also among women with a BMI of 25 kg/m2 or less . After adjustment for reported hypertension , diabetes , and high cholesterol level , a WHR of 0.76 or higher or waist circumference of 76.2 cm ( 30 in ) or more was associated with more than a 2-fold higher risk of CHD . CONCLUSIONS The WHR and waist circumference are independently associated with risk of CHD in women OBJECTIVES The aim of our study was to determine the effect of the menopause on various coronary heart disease ( CHD ) risk factors and on the global risk of CHD in a population based sample of women , making the difference between menopause and age related effects . STUDY DESIGN The Third French MONICA cross-sectional survey on cardiovascular risk included 1730 r and omly selected women , aged 35 - 64 years , representative from the general population . MAIN OUTCOME MEASURES Women were defined as post-menopausal ( postM ; n=696 ) , peri-menopausal ( periM ; n=183 ) or pre-menopausal ( preM ; n=659 ) based on the date of last menses . Socio-demographic , clinical and biological data were collected . Analyses of variance were used to compare means . RESULTS PostM women had significantly higher age-adjusted levels of total cholesterol ( 6.0mmol/L in postM vs. 5.7mmol/L in preM , p<0.05 ) and LDL cholesterol ( 3.9mmol/L vs. 3.6mmol/L , p<0.05 ) . There was no difference in HDL cholesterol or triglyceride levels , glycemia or blood pressure . Further adjustment on body mass index and hormonal treatments did not modify the results . No risk factor was significantly different between periM and postM. However , the Framingham 10-year risk of CHD was higher in postM , as compared with periM ( 5.1 % vs. 5.0 % , p<0.05 ) . In postM women , lipids and the Framingham risk were not associated with elapsed time since menopause . CONCLUSIONS The CHD risk increases during the sixth decade could be explained not only by estrogen deprivation but also by an effect on lipid profile , which is likely to occur in the peri-menopause period OBJECTIVES This prospect i ve study examined whether changes in traditional and novel coronary heart disease ( CHD ) risk factors are greater within a year of the final menstrual period ( FMP ) , relative to changes that occur before or after that interval , in a multiethnic cohort . BACKGROUND Underst and ing the influence of menopause on CHD risk remains elusive and has been evaluated primarily in Caucasian sample s. METHODS SWAN ( Study of Women 's Health Across the Nation ) is a prospect i ve study of the menopausal transition in 3,302 minority ( African American , Hispanic , Japanese , or Chinese ) and Caucasian women . After 10 annual examinations , 1,054 women had achieved an FMP not due to surgery and without hormone therapy use before FMP . Measured CHD risk factors included lipids and lipoproteins , glucose , insulin , blood pressure , fibrinogen , and C-reactive protein . We assessed which Output:	This meta- analysis suggests that physical activity and moderate alcohol intake were associated with a reduced risk for CVD and mortality . Smoking and higher BMI were associated with an increased risk of these endpoints . Adherence to a healthy lifestyle may substantially lower the burden of CVD and reduce the risk of mortality among middle-aged and elderly women .
MS21707	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT Few studies consider patient 's and caregiver 's preferences when developing nonpharmacological interventions . This is important to develop acceptable and accessible nonpharmacological interventions for patients with cancer . OBJECTIVES The objective of this study was to identify the views of patients with lung cancer and their informal caregivers on the desirable components of a novel nonpharmacological intervention for the management of the symptom cluster of cough , breathlessness , and fatigue , and their needs and preferences regarding uptake and delivery of the intervention . METHODS This study was qualitative in orientation , using semistructured interviews and framework analysis to elicit the views of 37 patients with lung cancer and 23 caregivers regarding the issues that were perceived to be important regarding the development and delivery of a nonpharmacological intervention . RESULTS A number of key issues were identified that carried important implication s for patient participation and adherence to the intervention , including the perceived relevance of potential techniques ; appreciable benefits in the short term ; convenience ; variation in patient preferences ; timing of the intervention ; venue ; caregiver involvement ; the provider of the intervention , and contact with other patients . CONCLUSION The data from this study have provided insight into the key issues that are likely to influence the development , uptake , and delivery of a nonpharmacological intervention to help manage the respiratory symptom cluster of cough , breathlessness , and fatigue . It is crucial that these findings are considered when developing and modeling a nonpharmacological symptom management intervention BACKGROUND Lung cancer has high mortality rates , with up to 90 % of patients dying within one to two years of its onset . It is essential to carry out research to attempt to solve the problems . Most patients suffer serious fatigue result ing from various symptoms and its long-term treatment . Furthermore , the other related complications such as underlying disease , anemia , malnutrition , nausea , and vomiting can reduced tolerance of chemotherapy . Study showed that nurses are the only hospital staff involved in managing fatigue . As it remains unclear to how fatigue should be managed , it is important to devise a strategy for providing a better service to help these patients survive longer . OBJECTIVE To examine fatigue scores in patients with lung cancer after chemotherapy treatment , and to compare the scores of the group receiving the multidisciplinary education program in self-care group with those of the control group . MATERIAL AND METHOD A r and omized controlled trial was conducted in two groups . The control group and the trial group were 30 patients in each . Studied aged from 45 to 65 years old who were receiving chemotherapy at the Chemotherapy Unit in the Out- Patients Department , Rajavithi Hospital . For a nine-week period , the control group received the hospital 's normal care program while the trial group received the multidisciplinary education program in self-care on fatigue . Scores were allocated to each individual to reflect their levels of fatigue , nutrition , physical fitness , and depression , compared using Independent t-test , Fisher exact test , and Mann-Whitney U-test . RESULTS Sixty patients were enrolled into the study ( mean age = 56.10 ( 45 - 65 ) , male = 68.33 % ) . The basic characteristics of each individual were not significantly different between the two groups . The mean ( + /- SD ) fatigue scores were 2.98 + /- 1.96 and 3.99 + /- 1.64 for the control and the trial group respectively , and these figures were statistically significant ( p = 0.036 ) . Nutrition scores were significantly higher in the trial group than in the control group ( p = 0.002 ) , but the other scores weight , albumin , physical fitness , and depression were not significantly different between the two groups . CONCLUSION The multidisciplinary education program in self-care results in decreased fatigue in patients with lung cancer who are receiving chemotherapy . Therefore , it is recommended that more health professionals and specialists participate actively inpatient care to respond directly to patients ' needs . This strategy should be adopted as the st and ard guideline for caring for patients with cancer who are receiving chemotherapy , and for patients with other conditions Purpose Patients with advanced cancer frequently experience anxiety , depression and poor quality of life ( QOL ) , as well as physical symptoms such as fatigue and weakness . Physical exercise has potential to help control these symptoms but the optimal training prescription is still not clear . We performed a study comparing medical Qigong ( QG ) and st and ard endurance and strength training ( SET ) in patients with advanced stage non-small cell lung ( NSCLC ) and gastrointestinal ( GI ) cancers . Methods A r and omized , cross-over study was performed in patients with advanced NSCLC and GI cancers receiving or eligible for chemotherapy . Patients received supervised QG or SET twice-weekly for 6 weeks . Psychological functioning , QOL , symptoms and physical functioning were assessed before and after each intervention period . Results Nineteen patients completed both interventions . Comparing interventions revealed no difference between QG and SET on change in anxiety or depression scores or QOL . However , SET treatment was better at improving perceived strength ( P = 0.05 ) and walking distance ( P = 0.02 ) . The order in which interventions were performed had a significant impact on the improvement in certain symptoms ( sleep quality , breathlessness , P < 0.05 ) , QOL ( P = 0.01 ) and walking distance ( P = 0.008 ) . In all cases , the beneficial effects of the exercise interventions were markedly reduced during the second interval . Conclusions QG and SET are equivalent in their impact on many aspects of psychological function in cancer patients . However , SET leads to greater improvements in exercise capacity and helps reduce some symptoms . The reduction in beneficial effect of SET on exercise function when offered as the second intervention is a new finding that warrants further study CONTEXT Physical exercise can alleviate cancer-related fatigue . R and omized controlled trials in patients with advanced cancer are scarce . OBJECTIVES We test the impact of a structured , individual sports program on fatigue in patients with advanced cancer . METHODS Seventy-seven patients were invited to participate in this r and omized controlled trial exploring the effects of physical exercises on fatigue 12 and 24 weeks after baseline . Patients were r and omized into three groups . Group A received treatment as usual , Group B was taught a structured , individual sports program , and Group C received additional ambulatory physiotherapeutical supervision . Primary outcome was general fatigue , secondary outcomes included rate of severe general fatigue , further dimensions of the Multidimensional Fatigue Inventory ( MFI ) , as well as walking distance . RESULTS Mean score of general fatigue as well as other MFI subdimensions differed nonsignificantly between all groups at 12 weeks . However , the mental fatigue score demonstrated a statistically significant difference between the three groups . The rate of severe general fatigue was significantly reduced within Intervention Group C. Significant longitudinal change of MFI-dimension mental fatigue was found and reached the threshold for minimal clinical ly important difference , while all MFI-dimensions increased in Group A. CONCLUSION Our results imply that tumor- patients ' severe general fatigue can be reduced when patients conduct appropriate physical exercise . This study amends previous knowledge , as it describes the impact of outpatient physical exercise on fatigue in a heterogeneous patient cohort with various advanced cancer entities . Furthermore , this trial differentiates between patients with only a self-directed exercise program versus those receiving additional partially professional supervision Background : Few studies have evaluated an individualized home-based exercise prescription during and after cancer treatment . Objective : The purpose of this study was to evaluate the effectiveness of a home-based exercise training intervention , the Pro-self Fatigue Control Program on the management of cancer-related fatigue . Interventions / Methods : Participants ( N = 119 ) were r and omized into 1 of 3 groups : group 1 received the exercise prescription throughout the study ; group 2 received their exercise prescription after completing cancer treatment ; and group 3 received usual care . Patients completed the Piper Fatigue Scale , General Sleep Disturbance Scale , Center for Epidemiological Studies -Depression Scale , and Worst Pain Intensity Scale . Results : All groups reported mild fatigue levels , sleep disturbance , and mild pain , but not depression . Using multilevel regression analysis , significant linear and quadratic trends were found for change in fatigue and pain ( ie , scores increased , then decreased over time ) . No group differences were found in the changing scores over time . A significant quadratic effect for the trajectory of sleep disturbance was found , but no group differences were detected over time . No significant time or group effects were found for depression . Conclusions : Our home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment . The optimal timing of exercise remains to be determined . Implication s for Practice : Clinicians need to be aware that some physical activity is better than none , and there is no harm in exercise as tolerated during cancer treatment . Further analysis is needed to examine the adherence to exercise . More frequent assessment s of fatigue , sleep disturbance , depression , and pain may capture the effect of exercise The authors conducted a r and omized controlled trial to evaluate a nurse practitioner (NP)‐delivered symptom management intervention for patients initiating chemotherapy for nonmetastatic cancer . The aim was to reduce patient‐reported symptom burden by facilitating patient‐NP collaboration and the early management of symptoms Abstract Background . Patients with lung cancer are often burdened by dyspnoea , fatigue , decreased physical ability and loss of weight . Earlier studies of physical exercise of patients with COPD have shown promising results . The aim of this study was to investigate , if a well-documented COPD rehabilitation protocol can improve physical fitness and quality of life ( QoL ) in patients with lung cancer . Material and methods . Forty-five patients , with a minimum walking distance of 50 meters , absence of cognitive deficits or severe heart disease and motivated for physical training were invited to an exercise intervention . The intervention consisted of seven weeks of twice weekly training , focusing on walking training , circuit training , h and ling of dyspnoea and instructions in daily diary-based training at home . Prior to , and after the intervention , Incremental- and Endurance Shuttle Walk Test ( ISWT and ESWT ) were performed , and pulmonary function as well as self-reported QoL ( EORTC-QLQ-C30 and LC13 ) were measured . Results . Fourteen subjects dropped out before commencement of the intervention . Seven were excluded after physiotherapeutic evaluation . Of the remaining 24 , three were excluded because of insufficient attendance ( < 65 % of scheduled exercise sessions ) thus 21 patients completed the intervention . For 17 patients with complete pre- and post intervention data , ISWT increased 9 % ( −77 to 39 % ) ( median and range ) ( p = 0.021 ) , while ESWT increased 109 % ( −70 to 432 % ) ( p = 0.002 ) . Twelve of 17 improved in ISWT , while 15 improved in ESWT . No changes in pulmonary function and improvements in QoL were observed . Conclusion . Patients with pulmonary cancer can achieve significant improvements in physical fitness measured with ISWT and ESWT after completion of the intervention program . No changes in pulmonary function and QoL were observed . In addition , we found that a large number of patients dropped out before intervention and that the patients , who succeeded , often discontinued training at home Purpose 1 ) To determine the effect of a home-based walking exercise program on the sleep quality and quality of life of cancer patients , as well as 2 ) to determine if enhanced sleep quality was associated with improvement in quality of life over time . Methods This is a prospect i ve , longitudinal , two-armed , r and omized clinical trial . Participants were recruited from oncology outpatient clinics in two university-based medical centers and were allocated to either usual care ( n = 35 ) or a home-based walking exercise intervention for 8 weeks ( n = 36 ) . Measurements included the Taiwanese version of the Pittsburgh Sleep Quality Index , the Medical Outcomes Study Short Form-36 , the Taiwanese Version Ratings of the Perceived Exertion Scale , and a walking exercise log . This study was analyzed on an intention-to-treat basis . Effects of the walking exercise program on sleep quality and quality of life were analyzed by the generalized estimating equation method . Results Patients in the exercise group reported significant improvements in sleep quality ( β = −3.54 , p < 0.01 ) and the mental health dimension of quality of life ( β = 10.48 , p < 0.01 ) . Among patients who exercised , enhanced sleep quality also corresponded with reduced bodily pain ( β = 0.98 , p = 0.04 ) and improvements over time in the mental health dimension of quality of life ( β = −3.87 , p < 0.01 ) . Conclusions A home-based walking exercise program can be easily incorporated into care for cancer patients who are suffering from sleep disturbances Background Previous studies showed that exercise in cancer patients is feasible and may reduce fatigue and improve physical fitness and quality of life . However , many previous studies had method ological weaknesses related to trial design , sample size , comparison group , outcome measures , short follow-up duration s and programme content . Purpose This paper aims to present the rationale and design of the clinical research subprogramme of the Alpe d’HuZes Cancer Rehabilitation ( A-CaRe ) programme . Method A-CaRe Clinical Research includes four r and omized controlled trials in patients : ( a ) after chemotherapy , ( b ) during chemotherapy , ( c ) after stem cell transplantation and ( d ) during childhood cancer . These trials compare high-intensity resistance and endurance exercise interventions with usual care or a waiting list control group . In two studies , a second intervention arm consisting of low-to-moderate intensity exercise is included . All four A-CaRe trials use similar methods . Results Outcome measures are carefully chosen based on the International Classification of Functioning Disability and Health model . Measurements will be performed prior to r and omization ( T0 ) , after completion of the intervention ( T1 ) and at follow-up ( T2 ) . The primary outcome measures are cardiorespiratory fitness , muscle strength and fatigue . Secondary outcome measures include health-related quality of life and psychosocial functioning . Furthermore Output:	CONCLUSION The application of behavioural change tools appears sub-optimal in this group of patients . Explicit use of BCTs targeting behavioural components upon which outcomes depend may improve the uptake and effectiveness of rehabilitation interventions
MS21708	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background A post-hoc analysis was performed on the data from a 54 weeks phase III study ( Clinical Trials.gov identifier : NCT00923091 ) to measure changes in the health-related quality of life ( HRQoL ) of 2,690 patients aged ≥18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide ( OLM/AML/HCTZ ) , using the MINICHAL and EQ-5D instruments . Methods Descriptive statistics were used to assess blood pressure and HRQoL scores over the study period . Analysis of covariance ( ANCOVA ) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores . Results Patients ’ baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6 . Over the study period HRQoL improved as both MINICHAL scores decreased by 31 - 33 % . Patients ’ baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively , increasing by 6 % and 12 % over the study period . Patients ’ QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs . The ANCOVA showed that changes in patients ’ HRQoL was likely to have been influenced by patients ’ achievement of blood pressure control , the amount of concomitant medication and patients ’ last used dosage strength of antihypertensive . Linear regression showed that blood pressure improvement may have been associated with improved HRQoL. Conclusions This study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients ’ HRQoL. Achieving blood pressure control , amount of concomitant medication and dosage strength of antihypertensive impacted on patients ’ OBJECTIVE The study evaluated whether a pharmaceutical care intervention can result in better underst and ing about hypertension , increase medication adherence to antihypertensive therapy and improve overall health-related quality of life . METHODS A non- clinical r and omized control trial was conducted whereby participants received an educational intervention through hospital pharmacists . Hypertension knowledge , medication adherence and health-related quality of life were measured by means of self-administered question naires . Descriptive statistics were used to describe the demographic and disease characteristics of the patients . Inferential statistics were used for inter- and intragroup comparisons . SPSS 17 was used for data analysis . RESULTS Three hundred and eighty-five hypertensive patients were r and omly assigned ( 192 in the control group and 193 in the intervention group ) to the study . No significant differences were observed in either group for age , gender , income , locality , education , occupation or duration of disease . There was , however , a significant increase in the participants ' levels of knowledge about hypertension and medication adherence among the interventional group after completing the intervention . Significantly lower systolic and diastolic blood pressure levels were also observed among the interventional group after completion of the intervention . The interventional group , however , reported decreased yet significant health-related quality of life at the end of the interventional programme . CONCLUSION Pharmacist intervention can significantly increase disease-related knowledge , blood pressure control and medication adherence in patients with hypertension . However , further research is needed to address the decreased health-related quality of life after completion of the study Changes in coronary risk factors , health behaviours , and health-related quality of life ( HRQOL ) were examined by tertiles of social support group attendance in 440 patients ( 21 % females ) with coronary artery disease . All patients participated in the Multicenter Lifestyle Demonstration Project ( MLDP ; eight hospital sites in the USA ) , an insurance-covered multi-component cardiac prevention program including dietary changes , stress management , exercise and group support for 1 year . Significant improvements in coronary risk factors , health behaviours , and HRQOL were noted at 1 year . Several of these improvements ( i.e. systolic blood pressure , health behaviours , HRQOL ) were related to social support group attendance , favoring those who attended more sessions . The associations between support group attendance to systolic blood pressure and to four HRQOL subscales ( bodily pain , social functioning , mental health , and the mental health summary score ) remained significant when controlling for changes in health behaviours , but dropped to a non-significant level for the HRQOL subscales ‘ physical functioning ’ , ‘ general health ’ and ‘ role-emotional ’ . These results suggest an independent relationship of social support group attendance to systolic blood pressure while improvements in quality of life may be in part due to improved health behaviours facilitated by increased social support group attendance Hypertensive patients may be adversely affected by complications and other concomitant processes such as anxiety , sedation , and drug side effects . It has been suggested that some recently developed antihypertensive agents do not affect quality of life by causing adverse effects . We compared the effects of two antihypertensive drugs on quality of life : atenolol , a st and ard cardioselective β-blocker , and celiprolol , one of a new class of selective β-blockers with vasodilatory properties . One hundred thirty-two patients with mild-to-moderate hypertension were eligible to enter a 28-week , double-blind , parallel-group study . The study protocol consisted of a 4-week period on placebo and a 24-week period of dosage-adjusted treatment with either atenolol or celiprolol . We assessed both systolic and diastolic blood pressure and quality of life perception by a selected test battery that included the Bulpitt and Fletcher Quality of Life Question naire . Supine blood pressure fell from 167/101 ( range 120/95 to 200/116 ) to 150/92 mm Hg ( p < 0.0001 ) during celiprolol treatment . This antihypertensive effect was at least as good with celiprolol as with atenolol . Quality of life perception was comparable for the two drugs although adverse effects were seen more frequently with atenolol than with celiprolol , particularly after prolonged treatment . Patient compliance was better for celiprolol than for atenolol . Our results show that the selective β-blocker with vasodilatory property celiprolol is at least as effective as atenolol and that it is more advantageous in terms of some quality of life variables BACKGROUND The goal of this pilot study was to examine the effects of a structured interdisciplinary education program on blood pressure , knowledge , anthropometric measures , medication compliance , behavioural risk factors and quality of life . METHOD In this quasi-experimental study , participants were assigned to an intervention ( n = 21 ) or a regular care group ( n = 19 ) . The intervention group attended four weekly sessions related to hypertension . Anthropometric measures and blood pressure were recorded at baseline , one , three and six months for all participants . Both groups completed question naires on knowledge , health-related behaviours and quality of life at these same intervals . RESULTS The reduction in systolic blood pressure was greater in the intervention group than in the regular care group ( p = 0.05 ) . However , there were no between group differences with regard to the other variables studied . CONCLUSION Participation in a structured interdisciplinary education program was associated with a reduction of systolic blood pressure , thus contributing to a risk reduction for cardiovascular disease The impact of hostility was examined in relation to the conduct and results of a clinical field trial . Data were derived from a multi-center r and omized double-blind study of the comparative effects of antihypertensive therapy ( captopril , methyldopa and propranolol ) on the quality of life of 620 hypertensive men . Hostility levels were higher in subjects reporting skipping medication dosages compared to those reporting they always complied with the medication schedule . Reporting of symptoms often associated with antihypertensive drug regimens was positively related to hostility scores throughout the study , even during the blinded placebo period . Persons with high hostility scores showed the greatest decline in blood pressure independent of type of antihypertensive medication . However , there was some limited evidence that hostility levels were significantly reduced by one antihypertensive medication . Overall , the present findings suggest that double-blind pharmacologic clinical trials may benefit from using reliable measures of hostility as covariates in the evaluation of symptom reports and amount of blood pressure reduction The aim was to evaluate the effects of a change of treatment from beta-blocker to captopril on the quality of life of hypertensive patients . One hundred forty-nine mild to moderate hypertensive patients who were being treated with beta-blockers were r and omly assigned to receive captopril ( 12.5 to 50 mg twice daily ) , or to continue on beta-blocker treatment ( atenolol : 25 to 100 mg once daily [ n = 121 ] , or propranolol , 10 to 80 mg twice daily [ n = 12 ] ) . When required , 25 mg hydrochlorothiazide was added in each group . The patients were followed over periods ranging from 6 to 12 months . Blood pressure , treatment side effects , and quality of life were monitored . Blood pressure was equally well managed in both groups , though a lower level of treatment was required in the captopril group . The captopril treated patients exhibited favorable changes in several aspects of quality of life : sleep-related , gastrointestinal , and physical activity-related symptoms improved from baseline to end of follow-up . Drowsiness and the ability to concentrate significantly improved in the captopril group only ( P < .01 ) . Change in treatment from beta-blocker to captopril result ed in equally well controlled blood pressure on a lower drug dose . Moreover , the change to captopril had a positive impact on the quality of life In an experimental study , 150 general practitioners studied 468 apparently healthy subjects whose blood pressure ( BP ) level was unknown or had not been measured for 1 year . The study lasted for 10 weeks . If BP was > 95 mm Hg on the first two visits , subjects were r and omized into two experimental groups for 8 weeks , with cross-over from betaxolol to placebo and vice versa after 4 weeks . Quality of life was measured at visits 1 , 3 ( 2 weeks ) , 5 ( 6 weeks ) , and 7 ( 10 weeks ) in five ways : well-being , physical state , sexual functioning , sleep , and cognitive acuity . BP level appeared to be effectively controlled by betaxolol as compared with placebo . The results show that no effects on quality of life could be detected by labeling subjects as hypertensives . Equally , almost no effects of active treatment could be established . Learning effects on the two cognitive acuity measurements used were attenuated by betaxolol , however . Apparently , in a carefully controlled study , the effects of increased medical attention and care outweigh the potentially negative effects of labeling and treatment BACKGROUND Most treated hypertensive patients do not achieve adequate blood pressure ( BP ) control . Initiating therapy with two drugs has been suggested when BP is > 20/10 mm Hg above goal . To ensure patients ' compliance , such treatment needs to be well tolerated and must not compromise health-related quality of life ( HRQL ) . The primary objective of this study was to compare the effects on HRQL of initiating treatment with felodipine + metoprolol ( F+M ) fixed combination tablets , or enalapril ( E ) , or placebo ( P ) . METHODS A total of 947 patients of both sexes with primary hypertension ( diastolic BP 95 to 110 mm Hg ) , aged 20 to 70 years , participated in this r and omized , double-blind , parallel group , 12-week , multicenter trial . Treatment was initiated with F+M 5 + 50 mg , or E 10 mg , or P. Doses were doubled after 4 or 8 weeks if diastolic BP was > 90 mm Hg . The HRQL was measured at baseline and at the last visit using two vali date d question naires : the Psychological General Well-being Index ( PGWB ) and the Subjective Symptom Assessment Profile ( SSA-P ) . Office BP was measured at trough , that is , 24 h after the previous dose . RESULTS The HRQL was high at baseline and generally well maintained during the study . For example , the mean ( SD ) PGWB total score was 104 ( 16 ) at baseline and 105 ( 16 ) at 12 weeks in all three treatment groups . The BP reductions after F+M ( 18/14 mm Hg ) and E ( 12/9 mm Hg ) were significantly greater than after P ( 7/7 mm Hg ) , and the reduction after F+M was significantly greater than after E. CONCLUSIONS The HRQL is maintained in the presence of substantial BP reduction during antihypertensive treatment with F+M fixed combination tablets OBJECTIVE To determine whether pharmaceutical care provided by a pharmacist-managed hypertension clinic results in better treatment outcomes when compared with traditional health care from a primary care physician . DESIGN Prospect i ve , controlled study SETTING Veterans Affairs Medical Center , Philadelphia , Pennsylvania . PATIENTS Fifty six patients with essential hypertension ; 27 were r and omly assigned to the intervention group and 29 to the control group . INTERVENTION Patients in the intervention group were scheduled monthly to meet with a clinical pharmacist who made appropriate changes in prescribed drugs , adjusted dosages , and provided drug counseling in accordance with the hypertension guidelines in the sixth report of the Joint National Committee on the Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) . Patients in the control group received st and ard care from their physicians . The study period was 6 months . MEASUREMENTS AND MAIN RESULTS Treat Output:	CONCLUSIONS Non-pharmacological treatment improves the overall quality of life and physical domain of people with arterial hypertension . Adherence to pharmacological treatment has a positive impact on the mental and physical domains of patients , as it did on the overall quality of life score
MS21709	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The women in this study were either post-menopausal or ovariectomised for at least 1 yr prior to the study . They had also been treated for cancer of the cervix ( 27 women ) , endometrium ( 5 ) , ovaries ( 5 ) or breast ( 1 ) . All women presented with sexual troubles , mainly genital discomfort ( dyspareunia or vaginism ) . In a double-blind fashion , gynaecological capsules containing either an oestradiol diether ( ICD : promestriene ) or only the excipient were administered for 40 consecutive days . At the end of the treatment , the FSH , LH , oestrone ( E1 ) and oestradiol ( E2 ) plasma levels were not found to be significantly different from the pre-therapeutic values . These results suggest that promestriene acts on the vaginal mucosa , therefore not being converted back into the hormone from which it was derived . Also , in its dietheroxide form , promestriene is incapable of crossing the malpighian ( vaginal or epidermal ) epithelium and of reaching the general blood circulation . This discrepancy between the local anti-atrophic effects and the inability to exert systemic oestrogen activities singles out promestriene and justifies its therapeutic use when hormonally active oestrogens are contra-indicated , as in patients who have an oestrogen-sensitive cancer in their medical history Silicone vaginal rings for the continuous release of 17 beta-oestradiol ( E2 ) with 2 constant in vitro release rates were used for the treatment of symptoms of urogenital atrophy in 2 groups of postmenopausal women . The very low dose of 7 micrograms/24 h was found to alleviate atrophic symptoms effectively and to induce significant maturation of vaginal and urethral epithelium . After a brief initial peak , the serum levels of E2 over 3 mth of treatment remained close to the detection limit . The ' undetectable ' E2 release pattern was reflected only in increased levels of oestrone sulphate . There was no evidence of a systemic metabolic response and patient acceptance of the method was excellent . Continuous low-dose release of E2 via vaginal rings consequently offers an alternative means of administering local oestrogen therapy which may be particularly suitable for geriatric patients OBJECTIVE : To evaluate the efficacy of two vaginal doses of estradiol ( E2 ) compared with placebo in the treatment of atrophic vaginitis . METHODS : In a multi-center , r and omized , double-blind , parallel-group study , 230 postmenopausal women received treatment with 25 mcg or 10 mcg E2 or placebo for 12 weeks . Efficacy was measured through composite score of three vaginal symptoms and grading of vaginal health . Additional analyses included maturation of vaginal and urethral mucosa . Safety assessment s included endometrial biopsy , adverse events , changes in laboratory tests , and physical examinations . After 12 weeks of treatment , all patients were switched to the open-label extension and received treatment with 25 mcg E2 up to week 52 . RESULTS : Vaginal tablets with 25 mcg and 10 mcg E2 showed significant ( P<.001 ) improvement in composite score of vaginal health . Other results with 10 mcg E2 were not entirely consistent with those for 25 mcg E2 . Over 12 weeks , both active treatments result ed in greater decreases in vaginal pH than placebo . There were no significant differences between the 25 mcg and 10 mcg E2 groups in terms of improvements in maturation value or composite score of three vaginal symptoms . The efficacy was maintained to week 52 with 25 mcg E2 . CONCLUSION : Vaginal tablets with 25 mcg and 10 mcg E2 provided relief of vaginal symptoms , improved urogenital atrophy , decreased vaginal pH , and increased maturation of the vaginal and urethral epithelium . Those improvements were greater with 25 mcg than with 10 mcg E2 . Both doses were effective in the treatment of atrophic vaginitis . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00465192 and NCT00464971 LEVEL OF EVIDENCE : Objective : The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens ( CE ) cream for treatment of atrophic vaginitis . Methods : Postmenopausal women ( N = 423 ) with moderate-to-severe vaginal atrophy were r and omized to CE cream 0.3 mg or placebo once daily ( 21 days on/7 days off ) or twice weekly for 12 weeks , followed by open-label treatment with CE cream for 40 weeks consistent with their prior regimen . Primary endpoints were changes in vaginal maturation index ( VMI ; percentage of superficial cells ) , vaginal pH , and severity of participant-reported most bothersome symptom ( vaginal dryness , itching , burning , or dyspareunia ) at week 12 . Endometrial safety was assessed by transvaginal ultrasound and endometrial biopsy for 52 weeks . Results : At week 12 , improvements in VMI with daily and twice-weekly use of low-dose CE cream ( 27.9 % and 25.8 % , respectively ) were significantly greater compared with placebo ( 3.0 % and 1.0 % , respectively ; P < 0.001 ) . Improvements in vaginal pH with daily and twice-weekly CE cream ( −1.6 for both ) were also significantly greater relative to placebo ( −0.4 and −0.3 , respectively ; P < 0.001 ) . VMI and vaginal pH responses were sustained through 52 weeks . Both CE cream regimens significantly reduced most bothersome symptom scores compared with placebo ( P ≤ 0.001 ) , including those for dyspareunia ( P ≤ 0.01 ) . There was no report of endometrial hyperplasia or carcinoma . Adverse events occurred with similar frequency among the active and placebo groups during the double-blind phase . Conclusions : Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy . Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy Objective To assess the efficacy and safety of intravaginal estriol administration on urinary incontinence , urogenital atrophy , and recurrent urinary tract infections in postmenopausal women . Design Eighty-eight postmenopausal women with urogenital aging symptoms were enrolled in this prospect i ve , r and omized , placebo-controlled study . Participants were r and omly divided into two groups , with each group consisting of 44 women . Women in the treatment group received intravaginal estriol ovules : 1 ovule ( 1 mg ) once daily for 2 weeks and then 2 ovules once weekly for a total of 6 months as maintenance therapy . Women in the control group received inert placebo vaginal suppositories in a similar regimen . We evaluated urogenital symptomatology , urine cultures , colposcopic findings , urethral cytologic findings , urethral pressure profiles , and urethrocystometry before as well as after 6 months of treatment . Results After therapy , the symptoms and signs of urogenital atrophy significantly improved in the treatment group in comparison with the control group . Thirty ( 68 % ) of the treated participants , and only seven ( 16 % ) of the control participants registered a subjective improvement of their incontinence . In the treated participants , we observed significant improvements of colposcopic findings , and there were statistically significant increases in mean maximum urethral pressure , in mean urethral closure pressure as well as in the abdominal pressure transmission ratio to the proximal urethra . Urethrocystometry showed positive but not statistically significant modifications . Conclusions Our results show that intravaginal administration of estriol may represent a satisfactory therapeutic choice for those postmenopausal women with urogenital tract disturbances who have contraindications or refuse to undergo st and ard hormone therapy tis trial , placebo controls can be used because the riskbenet ratio of no therapy is only slightly less favorable than the risk-benet ratio of any available therapy , and the result ing knowledge may contribute to the welfare of those who suffer from allergies . On this alternative view , therapeutic benecence is maintained as the moral st and ard for determining whether participation in placebo-controlled trials may be offered to subjects . It can not be dispensed with in any event , because it provides the st and ard against which placebo use must be assessed to determine that the increment of risk to subjects is not excessive . Once this determination is made , subjects may be invited to consider whether r and omization is a matter of “ approximate indifference ” in the light of their own values and goals ( Veatch 2002 ) . However , given the vagaries of assuring adequately informed consent in the real world of clinical research , therapeutic benecence should be maintained as an independent , threshold st and ard for determining whether placebo-controlled trials can be undertaken with proper regard for the welfare of subjects . On the other h and , therapeutic benecence does not constitute an absolute priority . When placebo-controlled trials impose only a modest increment of risk compared to best available therapy , then subjects may be invited to participate if doing so is necessary to contribute to the welfare of patients as a group . Miller and Brody are right about this conclusion but wrong about the underlying rationale . Background : Vaginal atrophy is a common complication in menopause which does not improve with time and , if untreated , can affect the quality of life for women . The aim of this study was to compare the effectiveness of the vaginal cream of hyaluronic acid and conjugated estrogen ( Premarin ) in treatment of vaginal atrophy . Methods : This study was a r and omized controlled clinical trial on 56 menopausal women with symptoms of vaginal atrophy ; they were r and omly allocated to two groups ( recipient conjugated estrogen and hyaluronic acid ) . The severity of each sign of atrophy was evaluated by visual analog signals ( VAS ) and on the basis of a four point scale . Also to recognize the cellular maturation with pap smear and the maturation degree were calculated according to the formula and scores 0 - 100 . As to the vaginal PH , we used PH marker b and , the rate of which was divided into 4 degrees . Data were analyzed using SPSS , version 20 , and P≤0.05 was considered as significant . Results : The results of this study showed that the symptoms of vaginal atrophy compared with the baseline level were relieved significantly in both groups . Dryness , itching , maturation index , PH and composite score of the vaginal symptoms were relieved significantly in both groups ( P<0.001 ) . Dyspareunia in Premarin ( P<0.05 ) and hyaluronic acid ( P<0.001 ) decreased compared with pre-treatment . Urinary incontinence only showed improvement in the hyaluronic acid group ( P<0.05 ) . Improvement in urinary incontinence , dryness , maturation index ( P<0.05 ) and composite score of vaginal symptoms ( P<0.001 ) in the hyaluronic acid group was better than those in the Premarin group . Conclusion : According to the results of the present study , hyaluronic acid and conjugated estrogen improved the symptoms of vaginal atrophy . But hyaluronic acid was more effective and this drug is suggested for those who do not want to or can not take local hormone treatment . Trial Registration Number : I RCT Fifty-one post-menopausal women suffering from symptoms of oestrogen deficiency-derived atrophic vaginitis were treated intravaginally with two therapeutic regimens based on doses of 25 micrograms 17 beta-oestradiol ( E2 ) in an open , controlled study . All the patients received treatment daily for 2 weeks by way of induction therapy . They were then r and omly allocated to either once-weekly ( 17 patients ) or twice-weekly ( 34 patients ) vaginal administration for a further 50 weeks as maintenance treatment . Endometrial histopathology was evaluated before and after 1 year of treatment . The effects on symptoms and oestrogen/gonadotrophin levels were determined before and after 2 , 12 , 24 , 36 and 52 weeks of therapy . Nine women continued twice-weekly treatment for a further year , meaning that they underwent treatment for a total period of 2 years . Endometrial biopsies were obtained after 2 years of treatment . All the pretreatment endometrial biopsies indicated an atrophic endometrium . One patient out of the 14 who completed 1 year of therapy in the group treated once weekly showed weak proliferation of the endometrium , while the other 13 had an atrophic endometrium . In the group treated twice weekly , 2 out of the 31 patients who completed the study showed weak proliferation of the endometrium . The other 29 had an atrophic endometrium . All 9 women who received treatment for 2 years had an atrophic endometrium at the end of the treatment period . The twice-weekly dosage regimen gave complete relief of symptoms in almost all patients , whereas the majority of the patients in the group treated once weekly still had mild symptoms . No adverse effects were reported . ( ABSTRACT TRUNCATED AT 250 WOR Output:	AUTHORS ' CONCLUSIONS There was no evidence of a difference in efficacy between the various intravaginal oestrogenic preparations when compared with each other . However , there was low- quality evidence that intra-vaginal oestrogenic preparations improve the symptoms of vaginal atrophy in postmenopausal women when compared to placebo . There was low- quality evidence that oestrogen cream may be associated with an increase in endometrial thickness compared to oestrogen ring ; this may have been due to the higher doses of cream used . However there was no evidence of a difference in the overall body of evidence in adverse events between the various oestrogenic preparations compared with each other or with placebo
MS21710	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Regular physical exercise may improve a variety of physiological and psychological factors in depressive persons . However , there is little experimental evidence to support this assumption for adolescent population s. We conducted a r and omized controlled trial to investigate the effect of physical exercise on depressive state , the excretions of stress hormones and physiological fitness variables in adolescent females with depressive symptoms . METHODS Forty-nine female volunteers ( aged 18 - 20 years ; mean 18.8 + /- 0.7 years ) with mild-to-moderate depressive symptoms , as measured by the Centre for Epidemiologic Studies Depression ( CES-D ) scale , were r and omly assigned to either an exercise regimen or usual daily activities for 8 weeks . The subjects were then crossed over to the alternate regimen for an additional 8-week period . The exercise program consisted of five 50-min sessions per week of a group jogging training at a mild intensity . The variables measured were CES-D rating scale , urinary cortisol and epinephrine levels , and cardiorespiratory factors at rest and during exercise endurance test . RESULTS After the sessions of exercise the CES-D total depressive score showed a significant decrease , whereas no effect was observed after the period of usual daily activities ( ANOVA ) . Twenty-four hour excretions of cortisol and epinephrine in urine were reduced due to the exercise regimen . The training group had a significantly reduced resting heart rate and increased peak oxygen uptake and lung capacity . CONCLUSIONS The findings of this study suggest that a group jogging exercise may be effective in improving depressive state , hormonal response to stress and physiological fitness of adolescent females with depressive symptoms BACKGROUND Depression is common and tends to be recurrent . Alternative treatments are needed that are non-stigmatising , accessible and can be prescribed by general medical practitioners . AIMS To compare the effectiveness of three interventions for depression : physical exercise , internet-based cognitive-behavioural therapy ( ICBT ) and treatment as usual ( TAU ) . A secondary aim was to assess changes in self-rated work capacity . METHOD A total of 946 patients diagnosed with mild to moderate depression were recruited through primary healthcare centres across Sweden and r and omly assigned to one of three 12-week interventions ( trail registry : KCTR study ID : KT20110063 ) . Patients were reassessed at 3 months ( response rate 78 % ) . RESULTS Patients in the exercise and ICBT groups reported larger improvements in depressive symptoms compared with TAU . Work capacity improved over time in all three groups ( no significant differences ) . CONCLUSIONS Exercise and ICBT were more effective than TAU by a general medical practitioner , and both represent promising non-stigmatising treatment alternatives for patients with mild to moderate depression BACKGROUND Depression is a major health problem for community-dwelling elderly adults . Since limited re sources are available to decrease the high prevalence of depressive symptoms among the elderly adults , improved support for them can be provided if we can determine which intervention is superior in ridding depressive symptoms . OBJECTIVE To compare the effectiveness of the physical fitness exercise program and the cognitive behavior therapy program on primary ( depressive symptoms ) and secondary outcomes ( 6-min walk distance , quality of life , and social support ) for community-dwelling elderly adults with depressive symptoms . DESIGN AND SETTING S A prospect i ve r and omized control trial was conducted in three communities in northern Taiwan . PARTICIPANTS The elderly adults in the three communities were invited to participate by mail , phone calls , and posters . There were a total of 57 participants who had depressive symptoms and all without impaired cognition that participated in this trial . None of the participants withdrew during the 9 months of follow-up for this study . METHODS Fifty-seven participants were r and omly assigned to one of the three groups : the physical fitness exercise program group , the cognitive behavior therapy ( CBT ) group , or the control group . The primary ( Geriatric Depression Scale-15 , GDS-15 ) , and secondary outcomes ( 6-min walk distance , SF-36 , and Inventory of Socially Supportive Behaviors scales , ISSB ) were collected immediately ( T2 ) , at 3 months ( T3 ) , and at 6 months after the interventions ( T4 ) . RESULTS After the interventions , the CBT group participants demonstrated significantly lower symptoms of depression ( p=0.009 ) at T2 and perceived more social support from those around them ( p<0.001 , < 0.001 and = 0.004 , respectively ) at three time-point comparisons than the control group . Moreover , after intervention , participants in the physical fitness exercise program group had decreased GDS-15 scores at three time-point comparisons ( p=0.003 , 0.012 and 0.037 , respectively ) , had a substantially greater 6-min walk distance ( p=0.023 ) , a better quality of life ( p<0.001 ) , and a better perceived social support at T2 ( p<0.001 ) . CONCLUSIONS Immediately after a 12-week intervention , there were significant decreases in depressive symptoms and more perceived social support amongst those in the CBT group . When considering the effectiveness in the decrease of depressive symptoms longer term , the increase in the 6-min walk distance and raising the patients ' quality of life , physical fitness exercise program may be a better intervention for elderly adults with depressive symptoms BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication ( ie , antidepressants ) for treatment of MDD in older patients , we conducted a 16-week r and omized controlled trial . METHODS One hundred fifty-six men and women with MDD ( age , > or = 50 years ) were assigned r and omly to a program of aerobic exercise , antidepressants ( sertraline hydrochloride ) , or combined exercise and medication . Subjects underwent comprehensive evaluations of depression , including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and Hamilton Rating Scale for Depression ( HAM-D ) and Beck Depression Inventory ( BDI ) scores before and after treatment . Secondary outcome measures included aerobic capacity , life satisfaction , self-esteem , anxiety , and dysfunctional cognitions . RESULTS After 16 weeks of treatment , the groups did not differ statistically on HAM-D or BDI scores ( P = .67 ) ; adjustment for baseline levels of depression yielded an essentially identical result . Growth curve models revealed that all groups exhibited statistically and clinical ly significant reductions on HAM-D and BDI scores . However , patients receiving medication alone exhibited the fastest initial response ; among patients receiving combination therapy , those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms . CONCLUSIONS An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons . Although antidepressants may facilitate a more rapid initial therapeutic response than exercise , after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD BACKGROUND Nearly two-thirds of elderly patients treated for depression fail to achieve symptomatic remission and functional recovery with first-line pharmacotherapy . In this study , we ask whether a mind-body exercise , Tai Chi Chih ( TCC ) , added to escitalopram will augment the treatment of geriatric depression design ed to achieve symptomatic remission and improvements in health functioning and cognitive performance . METHODS : One hundred twelve older adults with major depression age 60 years and older were recruited and treated with escitalopram for approximately 4 weeks . Seventy-three partial responders to escitalopram continued to receive escitalopram daily and were r and omly assigned to 10 weeks of adjunct use of either 1 ) TCC for 2 hours per week or 2 ) health education ( HE ) for 2 hours per week . All participants underwent evaluations of depression , anxiety , resilience , health-related quality of life , cognition , and inflammation at baseline and during 14-week follow-up . RESULTS Subjects in the escitalopram and TCC condition were more likely to show greater reduction of depressive symptoms and to achieve a depression remission as compared with those receiving escitalopram and HE . Subjects in the escitalopram and TCC condition also showed significantly greater improvements in 36-Item Short Form Health Survey physical functioning and cognitive tests and a decline in the inflammatory marker , C-reactive protein , compared with the control group . CONCLUSION : Complementary use of a mind-body exercise , such as TCC , may provide additional improvements of clinical outcomes in the pharmacologic treatment of geriatric depression Objective : To assess whether patients receiving aerobic exercise training performed either at home or in a supervised group setting achieve reductions in depression comparable to st and ard antidepressant medication ( sertraline ) and greater reductions in depression compared to placebo controls . Methods : Between October 2000 and November 2005 , we performed a prospect i ve , r and omized controlled trial ( SMILE study ) with allocation concealment and blinded outcome assessment in a tertiary care teaching hospital . A total of 202 adults ( 153 women ; 49 men ) diagnosed with major depression were assigned r and omly to one of four conditions : supervised exercise in a group setting ; home-based exercise ; antidepressant medication ( sertraline , 50–200 mg daily ) ; or placebo pill for 16 weeks . Patients underwent the structured clinical interview for depression and completed the Hamilton Depression Rating Scale ( HAM-D ) . Results : After 4 months of treatment , 41 % of the participants achieved remission , defined as no longer meeting the criteria for major depressive disorder ( MDD ) and a HAM-D score of < 8 . Patients receiving active treatments tended to have higher remission rates than the placebo controls : supervised exercise = 45 % ; home-based exercise = 40 % ; medication = 47 % ; placebo = 31 % ( p = .057 ) . All treatment groups had lower HAM-D scores after treatment ; scores for the active treatment groups were not significantly different from the placebo group ( p = .23 ) . Conclusions : The efficacy of exercise in patients seems generally comparable with patients receiving antidepressant medication and both tend to be better than the placebo in patients with MDD . Placebo response rates were high , suggesting that a considerable portion of the therapeutic response is determined by patient expectations , ongoing symptom monitoring , attention , and other nonspecific factors . BDI = Beck Depression Inventory ; CI = confidence interval ; HAM-D = Hamilton Depression Rating Scale ; ITT = intention-to-treat ; MDD = major depressive disorder ; SD = st and ard deviation ; SSRIs = selective serotonin reuptake inhibitors ; TSH = thyroid stimulating hormone OBJECTIVE The Regenerate pilot study explored whether a 10-week , community-based progressive resistance training ( PRT ) program could reduce depressive symptoms in depressed chronic stroke survivors . METHODS Participants were screened for depressive status using the PHQ-9 and confirmed by psychiatric assessment . Eligible people ( n = 45 ) were r and omised to PRT or a waiting-list comparison group . The PRT program included two high intensity sessions/week for 10 weeks at a community-based gymnasium . Depressive status , physical and mental health and quality of life were measured at baseline , 10 weeks and 6 months . Muscle strength was assessed using 1 repetition maximum ( 1-RM ) for upper and lower limbs . RESULTS The participants ' median age was 69 years : 27 were male . The intervention group had lower depression scores than the comparison group at all time points . At 6-month follow-up , there was a trend for PRT participants to be more likely to be no longer depressed than the comparison group , but the difference was not significant after adjusting for baseline scores . There were modest improvements in health and wellbeing over time , but many scores were lower than reported in non-depressed people . Intervention participants demonstrated significant improvements in strength . Program adherence was good : on average 75 % of the 10-week program was completed . CONCLUSIONS The intervention appeared to be feasible within a community-based setting . To optimize stroke recovery and improve the quality of life of stroke survivors , health professionals should continue to focus on helping survivors ' mental health recovery as well their physical rehabilitation BACKGROUND Interventions including physical exercise may help improve the outcomes of late-life major depression , but few studies are available . AIMS To investigate whether augmenting sertraline therapy with physical exercise leads to better outcomes of late-life major depression . METHOD Primary care patients ( 465 years ) with major depression were r and omised to 24 weeks of higher-intensity , progressive aerobic exercise plus sertraline ( S+PAE ) , lower-intensity , non-progressive exercise plus sertraline ( S+NPE ) and sertraline alone . The primary outcome was remission ( a score of ≤10 on the Hamilton Rating Scale for Depression ) . RESULTS A total of 121 patients were included . At study end , 45 % of participants in the sertraline group , 73 % of those in the S+NPE group and 81 % of those in the S+PAE group achieved remission ( P = 0.001 ) . A shorter time to remission was observed in the S+PAE group than in the sertraline-only Output:	DiskussionDieser Übersichtssartikel zeigt , dass körperliche Aktivität zu einer Verminderung der Symptomatik und einer Steigerung der affektiven Befindlichkeit bei Patienten mit depressiven Erkrankungen führt .
MS21711	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Calcium controls numerous events within the vessel wall . Permeability of the endothelium is calcium dependent , as are platelet activation and adhesion , vascular smooth muscle proliferation and migration , and synthesis of fibrous connective tissue . Double-helix computerized tomography is a noninvasive technique that can detect , measure , and compare coronary calcification in the coronary arteries . Using this method , our objective was to determine whether administration of nifedipine once daily in lieu of diuretics in high-risk hypertensive patients will arrest or slow down the progression of coronary artery calcification . The study was design ed as a side arm of INSIGHT ( International Nifedipine Study : Intervention as Goal for Hypertension Therapy ) , aim ed to show the efficacy of nifedipine once daily versus co-amilozide ( hydrochlorothiazide 25 mg , amiloride 2.5 mg ) in high-risk hypertensive patients . A total of 201 patients with a total calcium score of ≥10 at the onset of study who underwent an annual double-helix computerized tomography for 3 years were analyzed for efficacy . Inhibition of coronary calcium progression was significant in the nifedipine versus the co-amilozide group during the first year ( 3.18 % versus 27 % , respectively , P = 0.02 ) , not significant during the second year ( 28.5 % versus 47 % , respectively , P = 0.14 ) , and significant during the third year ( 40 % versus 78 % , respectively , P = 0.02 ) . The results point to a slower progression of coronary calcification in hypertensive patients on nifedipine once daily versus co-amilozide Background and Aims : Calcium-containing phosphate binders have been shown to increase the progression of vascular calcification in hemodialysis patients . This is a prospect i ve study that compares the effects of calcium acetate and sevelamer on coronary calcification ( CAC ) and bone histology . Methods : 101 hemodialysis patients were r and omized for each phosphate binder and su bmi tted to multislice coronary tomographies and bone biopsies at entry and 12 months . Results : The 71 patients who concluded the study had similar baseline characteristics . On follow-up , the sevelamer group had higher levels of intact parathyroid hormone ( 498 ± 352 vs. 326 ± 236 pg/ml , p = 0.017 ) , bone alkaline phosphatase ( 38 ± 24 vs. 28 ± 15 U/l , p = 0.03 ) and deoxypyridinoline ( 135 ± 107 vs. 89 ± 71 nmol/l , p = 0.03 ) and lower LDL cholesterol ( 74 ± 21 vs. 91 ± 28 mg/dl , p = 0.015 ) . Phosphorus ( 5.8 ± 1.0 vs. 6 ± 1.0 mg/dl , p = 0.47 ) and calcium ( 1.27 ± 0.07 vs. 1.23 ± 0.08 mmol/l , p = 0.68 ) levels did not differ between groups . CAC progression ( 35 vs. 24 % , p = 0.94 ) and bone histological diagnosis at baseline and 12 months were similar in both groups . Patients of the sevelamer group with a high turnover at baseline had an increase in bone resorption ( eroded surface , ES/BS = 9.0 ± 5.9 vs. 13.1 ± 9.5 % , p = 0.05 ) , whereas patients of both groups with low turnover at baseline had an improvement in bone formation rate ( BFR/BS = 0.015 ± 0.016 vs. 0.062 ± 0.078 , p = 0.003 for calcium and 0.017 ± 0.016 vs. 0.071 ± 0.084 μm3/μm2/day , p = 0.010 for sevelamer ) . Conclusions : There was no difference in CAC progression or changes in bone remodeling between the calcium and the sevelamer groups Background — Recent clinical trials have suggested that intensive versus st and ard lipid-lowering therapy provides for additional benefit . Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification ( CAC ) in serial measurements . Methods and Results — In a multicenter , r and omized , double-blind trial , 471 patients ( age 61±8 years ) who had no history of coronary artery disease and no evidence of high- grade coronary stenoses ( > 50 % diameter reduction ) were r and omized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidence d by a CAC score ≥30 . Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months . Progression of CAC volume scores could be analyzed in 366 patients . After pretreatment with 10 mg of atorvastatin for 4 weeks , 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group r and omized to receive 80 mg of atorvastatin ( P<0.001 ) , whereas levels remained stable in the group r and omized to receive 10 mg ( 108±23 at baseline , 109±28 mg/dL at the end of the study , P = NS ) . The mean progression of CAC volume scores , corrected for the baseline CAC volume score , was 27 % ( 95 % CI 20.8 % to 33.1 % ) in the 80-mg atorvastatin group and 25 % ( 95 % CI 19.1 % to 30.8 % ) in the 10-mg atorvastatin group ( P=0.65 ) . CAC progression showed no relationship with on-treatment LDL cholesterol levels . Conclusions — We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis . Over a period of 12 months , intensive atorvastatin therapy was unable to attenuate CAC progression compared with st and ard atorvastatin therapy . The possibility remains that the time window was too short to demonstrate an effect Background —Women have been underrepresented in statin trials , and few data exist on the effectiveness and safety of statins in this gender . We used sequential electron-beam tomography ( EBT ) scanning to quantify changes in coronary artery calcium ( CAC ) as a measure of atherosclerosis burden in patients treated with statins . Methods and Results —In a double-blind , multicenter trial , we r and omized 615 hyperlipidemic , postmenopausal women to intensive ( atorvastatin 80 mg/d ) and moderate ( pravastatin 40 mg/d ) lipid-lowering therapy . Patients also su bmi tted to 2 EBT scans at a 12-month interval ( mean interval 344±55 days ) to measure percent change in total and single-artery calcium volume score ( CVS ) from baseline . Of the 615 r and omized women , 475 completed the study . Mean±SD percent LDL reductions were 46.6%±19.9 % and 24.5%±18.5 in the intensive and moderate treatment arms , respectively ( P<0.0001 ) , and National Cholesterol Education Program Adult Treatment Panel III LDL goal was reached in 85.3 % and 58.8 % of women , respectively ( P<0.0001 ) . The total CVS% change was similar in the 2 treatment groups ( median 15.1 % and 14.3 % , respectively ; P = NS ) , and single-artery CVS% changes and absolute changes were also similar ( P = NS ) . In both arms , there was a trend toward a greater CVS progression in patients with prior cardiovascular disease , diabetes mellitus , and hypertension , whereas hormone replacement therapy had no effect on progression . Conclusions —In postmenopausal women , intensive statin therapy for 1 year caused a greater LDL reduction than moderate therapy but did not result in less progression of coronary calcification . The limitations of this study ( too short a follow-up period and the absence of a placebo group ) precluded determination of whether progression of CVS was slowed in both arms or neither arm compared with the natural history of the disease BACKGROUND Aged Garlic Extract ( AGE ) reduces multiple cardiovascular risk factors , including blood pressure , cholesterol , platelet aggregation and adhesion , while stimulating nitric oxide generation in endothelial cells . However , no study has evaluated the ability of AGE to inhibit vascular calcification , a marker of plaque formation in human coronary arteries . OBJECTIVE To assess the efficacy of Aged Garlic Extract ( AGE ) on changing the rate of atherosclerosis progression as compared to placebo . DESIGN A placebo-controlled , double-blind , r and omized pilot study to determine whether the atherosclerotic plaque burden detected by electron beam tomography ( EBT ) will change at a different rate under the influence of AGE as compared to placebo . Twenty-three patients were enrolled , and 19 patients completed the study protocol . AGE 4 ml or the equivalent amount of placebo was given to subjects . Duration of the study was 1 year . S-allylcysteine ( SAC ) , one of the active compound of AGE , was measured in the blood as a compliance marker . RESULTS The mean change of the calcium score ( volumetric method ) for the AGE group ( n = 9 ) was 7.5 + /- 9.4 % over 1 year . The placebo group ( n = 10 ) demonstrated an average increase in calcium scores of 22.2 + /- 18.5 % , significantly greater than the treated cohort ( P = 0.046 ) . There were no significant differences in individual cholesterol parameters or C reactive protein between the groups . In patients r and omized to AGE , there was a nonsignificant trend for improving cholesterol/high-density lipoprotein ratio ( P = 0.07 ) and homocysteine level ( P = 0.08 ) . CONCLUSIONS This small pilot study indicates the potential ability of AGE to inhibit the rate of progression of coronary calcification , as compared to placebo over 1 year . Should these findings be extended and confirmed in larger studies , garlic may prove useful for patients who are at high risk of future cardiovascular events Purpose To assess inter-scan reproducibility of coronary calcium measurements obtained from Multi Detector-Row CT ( MDCT ) images and to evaluate whether this reproducibility is affected by different measurement protocol s , slice thickness , cardiovascular risk factors and /or technical variables . Design Cross-sectional study with repeated measurements . Material s and methods The study population comprised 76 healthy women . Coronary calcium was assessed in these women twice in one session using 16-MDCT ( Philips Mx 8000 IDT 16 ) . Images were reconstructed with 1.5 mm slice thickness and 3.0 mm slice thickness . The 76 repeated scans were scored . The Agatston score , a volume measurement and a mass measurement were assessed . Reproducibility was determined by estimation of mean , absolute , relative difference , the weighted kappa value for agreement and the Intra-class correlation coefficient ( ICCC ) . Results Fifty-five participants ( 72.4 % ) had a coronary calcification of more than zero in Agatston ( 1.5 mm slice thickness ) . The reproducibility of coronary calcium measurements between scans in terms of ranking was excellent with Intra-class correlation coefficients of > 0.98 , and kappa values above 0.80 . The absolute difference in calcium score between scans increased with increasing calcium levels , indicating that measurement error increases with increasing calcium levels . However , no relation was found between the mean difference in scores and calcium levels , indicating that the increase in measurement error is likely to result in r and om misclassification in calcium score . Reproducibility results were similar for 1.5 mm slices and for 3.0 mm slices , and equal for Agatston , volume and mass measurements . Conclusion Inter-scan reproducibilility of measurement of coronary calcium using images from MDCT is excellent , irrespective of slice thickness and type of calcium parameter Background —Coronary calcification measured by fast computed tomography techniques is a surrogate marker of coronary atherosclerotic plaque burden . In a cohort study , we prospect ively investigated whether lipid-lowering therapy with a cholesterol synthesis enzyme inhibitor reduces the progression of coronary calcification . Methods and Results —In 66 patients with coronary calcifications in electron beam tomography ( EBT ) , LDL cholesterol > 130 mg/dL , and no lipid-lowering treatment , the EBT scan was repeated after a mean interval of 14 months and treatment with cerivastatin was initiated ( 0.3 mg/d ) . After 12 months of treatment , a third EBT scan was performed . Coronary calcifications were quantified using a volumetric score . Cerivastatin therapy lowered the mean LDL cholesterol level from 164±30 to 107±21 mg/dL. The median calcified volume was 155 mm3 ( range , 15 to 1 Output:	There was no consistent or reproducible treatment effect of any therapy on this outcome measured at 1 year . The 1-year change in CAC does not appear to be a suitable surrogate end point for treatment trials in patients with CVD or chronic kidney disease
MS21712	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Polychemotherapy and biological drugs have increased therapeutic options and outcomes of advanced colorectal cancer ( CRC ) . We examined the relation between progression-free survival ( PFS ) , post-progression survival ( PPS ) and overall survival ( OS ) in trials of modern ( oxaliplatin- and irinotecan-based ) chemotherapy alone or with targeted therapies for advanced CRC . We also evaluated surrogacy of PFS and OS . PATIENTS AND METHODS A PubMed search identified 34 r and omized trials . We split the OS , PFS and PPS and evaluated the correlation between OS and either PFS or PPS . RESULTS The median PPS and PFS were 10.75 and 8.4 months , respectively . For all trials , PPS was strongly associated with OS [ regression coefficient (R2)=0.8 ; Spearman 's rank correlation coefficient (r)=0.88 ] , whereas PFS was moderately associated with OS (R2)=0.43 ; r=0.64 ) . In trials with targeted therapies , the correlation of PPS with OS was 0.88 . However , across all trials , correlation between differences in median PFS ( ΔPFS ) and median OS ( ΔOS ) is 0.59 ( P=0.0007 ) , confirming PFS/OS surrogacy . CONCLUSION Our findings indicate that in recent first-line , phase III , trials , OS becomes more associated with PPS than PFS . However , improvements in PFS are strongly associated with improvements in OS . In this setting so , PFS may be an appropriate surrogate for OS PURPOSE Mutations affecting the KRAS gene are established predictive markers of outcome with anti-epithelial growth factor receptor ( EGFR ) antibodies in advanced colorectal cancer ( CRC ) . The relevance of these markers for anti-vascular endothelial growth factor ( VEGF ) therapy is controversial . This analysis was performed to assess the predictive and prognostic impact of KRAS and BRAF gene mutation status in patients receiving capecitabine with bevacizumab ( CG ) or capecitabine without bevacizumab in the phase III AGITG MAX ( Australasian Gastrointestinal Trials Group MAX ) study . PATIENTS AND METHODS Mutation status was determined for 315 ( 66.9 % ) of the original 471 patients . Mutation status was correlated with efficacy outcomes ( response rate , progression-free survival [ PFS ] , and overall survival [ OS ] ) , and a predictive analyses was undertaken . RESULTS Mutations in KRAS and BRAF genes were observed in 28.8 % and 10.6 % of patients , respectively . KRAS gene mutation status ( wild type [ WT ] v mutated [ MT ] ) had no prognostic impact for PFS ( hazard ratio [ HR ] , 0.89 ; CI , 0.69 to 1.14 ) or OS ( HR , 0.97 ; CI , 0.73 to 1.28 ) . BRAF mutation status ( WT v MT ) was not prognostic for PFS ( HR , 0.80 ; CI , 0.54 to 1.18 ) but was prognostic for OS ( HR , 0.49 ; CI , 0.33 to 0.73 ; P = .001 ) . By using the comparison of capecitabine versus capecitabine and bevacizumab ( CB ) and CB plus mitomycin ( CBM ) , KRAS gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .95 and 0.43 , respectively ) . Similarly , BRAF gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .46 and 0.32 , respectively ) . CONCLUSION KRAS gene mutation status was neither prognostic for OS nor predictive of bevacizumab outcome in patients with advanced CRC . BRAF gene mutation status was prognostic for OS but was not predictive of outcome with bevacizumab We assessed Ki-ras mutations by single-str and conformation polymorphism followed by DNA sequencing , p53 expression by immunohistochemistry , ploidy status , and S-phase fraction in 66 stage II and 163 stage III colon cancer patients enrolled on a r and omized trial of surgery followed by observation or adjuvant levamisole or 5-fluorouracil ( 5FU ) plus levamisole ( Intergroup Trial 0035 ) to see whether these factors were independently associated with survival or with differential effects of adjuvant therapy . A Cox proportional hazards survival model was used to describe marker effects and therapy by marker interactions , with adjustment for the clinical covariates affecting survival . A Bonferroni adjustment was used to account for multiple testing . Mutation of the Ki-ras gene was found in 41 % of the cancers and was associated with a poor prognosis in stage II but not stage III . In stage II , 7-year survival was 86 % versus 58 % in those with wild type versus Ki-ras mutations . After adjustment for treatment and clinical variables , the hazard ratio ( HR ) for death was 4.5 ; 95 % confidence interval ( CI ) , 1.7 - 12.1 ( P = 0.012 ) . p53 overexpression was found in 63 % of cancers and was associated with a favorable survival in stage III but not stage II . Seven-year survival in stage III was 56 % with p53 overexpression versus 43 % with no p53 expression ( HR , 2.2 ; 95 % CI , 1.3 - 3.6 ; P = 0.012 ) . Aneuploidy was more common in stage III than in stage II ( 66 versus 47 % ; P = 0.009 ) but was not independently related to survival in either group . The proliferative rate was greater in aneuploid than in diploid cancers but was not related to survival . There was no benefit of adjuvant therapy in stage II nor in any of the stage II subgroups defined by mutational status . In stage III , adjuvant therapy with 5FU plus levamisole improved 7-year survival in patients with wild-type Ki-ras ( 76 versus 44 % ; HR , 0.4 ; 95 % CI , 0.2 - 0.8 ) and in those without p53 overexpression ( 64 versus 26 % ; HR , 0.3 ; 95 % CI , 0.1 - 0.7 ) . Adjuvant therapy did not benefit those with Ki-ras mutations or p53 overexpression . The effects of adjuvant therapy did not differ according to ploidy status or proliferative rate . Ki-ras mutation is a significant risk factor for death in stage II , and the absence of p53 expression is a significant risk factor for death in stage III colon cancer after adjustment for treatment and clinical covariates . Exploratory analyses suggest that patients with stage III colon cancer with wild-type Ki-ras or no p53 expression benefit from adjuvant 5FU plus levamisole , whereas those with Ki-ras mutations or p53 overexpression do not . An independent study will be required to determine whether response to adjuvant therapy in colon cancer depends on mutational status BACKGROUND Mutations involving the oncogene K-ras in colorectal cancer may be related to tumor aggressiveness . However , the value of K-ras gene determination as a prognostic marker has not been clearly established . PATIENTS AND METHODS The results from 98 patients recruited in a prospect i ve study analyzing the effect of a K-ras mutation as a prognostic factor in colorectal cancer are reported . RESULTS Disease-free ( P = 0.02 ) and overall survival ( P = 0.03 ) were significantly reduced for patients harboring a K-ras mutation . Two specific mutations demonstrated a significantly increased risk of disease recurrence , namely , 12-TGT ( P = 0.04 ) and 13-GAC substitutions ( P = 0.002 ) . Patients with either of these substitutions had a 2-year disease-free survival rate of 37 % compared with that of 67 % for the group of patients harboring any other mutation type or a wild-type status ( P = 0.01 ) . CONCLUSIONS The results herein presented suggest that K-ras acts as a prognostic factor in colorectal cancer and that this effect is probably related to a limited number of defined mutations BACKGROUND Despite the consistent clinical results demonstrated by studies on anti-angiogenic drugs targeted against the vascular endothelial growth factor in metastatic colorectal cancer ( mCRC ) patients , no specific direct/indirect biomarker of their efficacy has been vali date d. In this field , circulating endothelial cells ( CECs ) and endothelial progenitor cells ( CEPs ) have recently been proposed as noninvasive biomarkers . PATIENTS AND METHODS The absolute numbers of CEPs , total CECs ( tCECs ) and their resting ( rCECs ) and activated subsets were evaluated by multiparameter flow cytometry in 40 mCRC patients at baseline and before the administration of the third and sixth course of a bevacizumab-based first-line treatment . Fifty healthy subjects were utilized as control . RESULTS The overall response rate was 80 % , overall clinical benefit was 90 % and median progression-free survival ( PFS ) was 13.8 months . In our patients , tCECs and rCECs were significantly increased compared with healthy subjects . The patients who achieved a radiological response showed , at baseline , a significant decrease of rCECs and a trend in decrease of tCECs in comparison with patients not achieving response . Finally , a baseline absolute number of tCEC and rCEC < 40 cells/ml was evidence d in patients with a longer PFS . No correlation was found regarding CEP . CONCLUSIONS Our study suggests significant correlations between both tCEC and rCEC baseline levels and the antitumor efficacy of a bevacizumab-based combination therapy in mCRC patients , thus confirming that these biomarkers could be used in the clinical setting as an early predictor of tumor response PURPOSE Mutations in the K-ras gene are frequent in human cancer . ras activation in primary cells results in a cellular senescence phenotype that is precluded by inactivation of p16 . At the clinical level , this may imply a differential behavior for tumors with alternative or cooperative activation of K-ras function and impairment of p16 pathways . PATIENTS AND METHODS We have determined the presence of mutations in the K-ras gene and the methylation status of p16 promoter in a series of 119 prospect ively collected colorectal carcinomas . p53 mutations and p14 alternative reading frame methylation status were also assessed . Associations with survival were investigated . RESULTS K-ras mutations were present in 44 ( 38 % ) of 115 cases , and p16 methylation was present in 42 ( 37 % ) of 113 cases . p53 mutations were detected in 50 % ( 56 of 115 ) and p14 methylation in 29 % ( 32 of 112 ) of cases . K-ras and p16 alterations were independent genetic events . Presence of K-ras or p16 genetic alterations ( analyzed independently ) was associated with shorter survival , although differences were not statistically significant . Cox analysis of the two variables combined showed a diminished survival as the results of an interaction between p16 and K-ras . Alternative alteration of K-ras and p16 genes was an independent prognostic factor in human colorectal cancer in univariate and multivariate analysis . Differences were maintained when cases undergoing radical surgery and without distant metastases were considered . CONCLUSION These results suggest that the combined K-ras and p16 analyses may be of prognostic use in human colorectal cancer BACKGROUND Hypertension is associated with antivascular endothelial growth factor treatment , but the clinical implication s of hypertension are uncertain . To assess the prognostic and predictive value of bevacizumab-related hypertension , a comprehensive analysis of whether hypertension and efficacy outcomes are associated was conducted on seven company-sponsored placebo-controlled phase III studies of bevacizumab . METHODS Patient-specific data were available from 6,486 patients with metastatic colorectal , breast , non-small cell lung , pancreatic , and renal cell cancers . Primary hypertension endpoint was a blood pressure ( BP ) increase of > 20 mmHg systolic or > 10 mmHg diastolic within the first 60 days of treatment . Additional endpoints included other predefined thresholds of change in BP and severity of hypertension grade d using the National Cancer Institute 's Common Terminology Criteria for Adverse Events . To analyze the general prognostic importance of an early BP increase , multivariate Cox regression models were used to assess the correlation between BP changes and progression-free ( PFS ) and overall survival ( OS ) outcomes in the control groups . To analyze whether early BP increases could predict for benefit from bevacizumab , similar analyses were conducted in the bevacizumab-treated and control groups . RESULTS In six of seven studies , early BP increase was neither predictive of clinical benefit from bevacizumab nor prognostic for the course of the disease . For study AVF2107 g , early increased BP was associated with longer PFS and OS times in the bevacizumab group but shorter OS time in the control group . CONCLUSIONS Output:	This pooled analysis of 12 published studies shows that KRAS wt status is a good prognostic factor for B-based chemotherapy . Also , KRAS wt CRC is associated with a better RR with B plus chemotherapy than mut counterpart
MS21713	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The present study investigated memory for intention in individuals with Parkinson 's disease ( PD ) who were newly diagnosed and not yet treated to avoid the effect of therapy as a potential confounding variable . A comprehensive neuropsychological battery and an event-based prospect i ve memory task were administered to 41 subjects with de novo PD and 40 control subjects . Separate scores were computed for correct execution of intended action ( prospect i ve component ) and recall of intention ( retrospective component ) . PD patients performed marginally worse ( p = .053 ) than controls on the prospect i ve component of the task . On the other h and , the performance of the two groups was comparable for the retrospective component . Neuropsychological findings revealed lower performance of the PD group in episodic memory and in some measures of executive functions . These results suggested a subtle prospect i ve memory dysfunction present at the initial stage of PD , which may be related to disruption of fronto-striatal circuitry BACKGROUND The clinical manifestations of drug-induced parkinsonism ( DIP ) and Parkinson disease ( PD ) are nearly indistinguishable , making it difficult to differentiate DIP from PD , especially in the early stages . We compared non-motor symptoms between patients with DIP and those with drug-naïve PD in the early stages using the Non Motor Symptoms Scale ( NMSS ) . METHODS We prospect ively enrolled 28 patients with DIP , 35 patients with drug-naïve PD , and 32 controls with no history of neurological diseases or related medical problems . We investigated demographic characteristics , medical and drug history , parkinsonian motor symptoms , and non-motor symptoms . We used the NMSS to evaluate non-motor symptoms in all patients . RESULTS The total NMSS scores were higher in patients with PD than those with DIP , as were the scores for certain domains , including the cardiovascular , sleep/fatigue , urinary , sexual , and miscellaneous domains . When controlling for age and gender , the correlation analysis revealed that scores for urinary symptoms ( urgency , frequency and nocturia ) , sleep disturbances ( daytime sleep , restless legs ) , concentration , taste or smell were significantly associated with PD . CONCLUSIONS Our data suggest that non-motor symptoms , particularly urinary symptoms , excessive daytime sleepiness , restless leg syndrome , attention deficit and hyposmia may be helpful to differentiate between DIP and PD in the early stages Background Non-motor symptoms are very common among patients with Parkinson 's disease since the earliest stage , but little is known about their progression and their relationship with dopaminergic replacement therapy . Methods We studied non-motor symptoms before and after 2 years from dopaminergic therapy introduction in ninety-one newly diagnosed previously untreated PD patients . Results At baseline , nearly all patients ( 97.8 % ) referred at least one non-motor symptom . At follow-up , only few non-motor symptoms significantly changed . Particularly , depression and concentration became less frequent , while weight change significantly increased after introduction of dopamine agonists . Conclusions We reported for the first time a 2-year prospect i ve study on non-motor symptoms before and after starting therapy in newly diagnosed PD patients . Even if non-motor symptoms are very frequent in early stage , they tend to remain stable during the early phase of disease , being only few non-motor symptoms affected from dopaminergic therapy and , specifically , by the use of dopamine agonists BACKGROUND It is accepted that orthostatic hypotension is a clinical marker for the diagnosis of multiple system atrophy , but conflicting data indicate that it may also be present in Parkinson disease ( PD ) . OBJECTIVES To evaluate the prevalence of autonomic cardiovascular impairment and orthostatic hypotension in a large group of patients with de novo PD , followed up for at least 7 years , to clinical ly confirm the diagnosis of the disease . METHODS During a 2-year recruiting period , 60 untreated patients diagnosed as having idiopathic PD underwent autonomic cardiovascular function evaluation using the Ewing test . Patients subsequently received dopaminergic therapy and their condition was followed up for at least 7 years . RESULTS Nine ( 15 % ) of 60 patients were excluded from the study because during the follow-up period a parkinsonian syndrome was diagnosed ( 5 had multiple system atrophy and 4 had progressive supranuclear palsy ) . Data from 51 patients with PD underwent final statistical analysis and the results were compared with those of 51 age-matched healthy control subjects who had taken the same battery of autonomic tests . A statistically significant difference was found in postural hypotension ( P = .02 ) and deep breathing test results ( P = .03 ) between patients and controls . Seven ( 14 % ) of 51 patients with PD and 3 ( 60 % ) of 5 patients with multiple system atrophy had a decrease of more than 20 mm Hg in systolic blood pressure on st and ing . CONCLUSIONS Data from this study indicate a high prevalence of sympathetic and parasympathetic failure in patients with de novo PD , and when using a decrease of at least 20 mm Hg in systolic blood pressure , manometric orthostatic hypotension was found in 7 ( 14 % ) of the 51 patients with de novo PD BACKGROUND Gastrointestinal tract ( GIT ) dysfunction is common in Parkinson 's disease ( PD ) patients . However , it remains unclear whether levodopa affects GIT function in PD . OBJECTIVE To perform an open study of levodopa 's effects on anorectal constipation in de novo PD patients by the quantitative lower-gastrointestinal autonomic test ( QL-GAT ) . METHODS Nineteen unselected de novo PD patients ( 10 men , 9 women ; mean age , 66 years ; mean duration of the disease , 2.2 years ) were recruited for the study . Eighteen of the patients reported constipation . These patients were treated with 200/20 mg b.i.d . of levodopa/carbidopa for 3 months . Pre- and post-treatment , objective parameters in the QL-GAT that comprised the colonic transit time ( CTT ) and rectoanal videomanometry were obtained . RESULTS Levodopa was well tolerated by all patients . There was a trend toward subjective improvements in bowel frequency and difficulty defecating . Levodopa did not significantly change CTT of the total colon or any segment of the colon . During rectal filling , levodopa significantly lessened the first sensation ( p < 0.05 ) . It also tended to augment the amplitude of spontaneous phasic rectal contraction ( not statistically significant ) . During defecation , levodopa significantly lessened the amplitude in paradoxical sphincter contraction upon defecation ( PSD ) ( p < 0.01 ) . It also tended to augment the amplitude of rectal contraction and lessen the amplitude of abdominal strain ( not statistically significant ) . Overall , levodopa significantly lessened post-defecation residuals ( p < 0.05 ) . CONCLUSIONS The QL-GAT in the present study showed for the first time that levodopa augmented rectal contraction , lessened PSD , and thereby ameliorated anorectal constipation in de novo PD patients Objective : To determine nonmotor signs ( NMS ) and evaluate the utility of several diagnostic tools in patients with de novo Parkinson disease ( PD ) . Methods : This is a large single-center study of the DeNoPa cohort , including frequency-matched healthy controls . This study covers motor signs , NMS , and a combination of diagnostic tests including olfactory testing , transcranial sonography of substantia nigra ( TCS ) , and polysomnography ( PSG ) . We report the frequency and characteristics of NMS and the outcomes of nonmotor tests at the time of diagnosis . Results : Cross-sectional analyses of baseline investigations identified significant differences in the NMS Question naire ( NMSQuest ) and the Scopa-AUT Gastrointestinal score in 159 drug-naïve PD patients vs 110 controls . In addition , patients with PD showed reduced olfactory function , hyperechogenicity on TCS , and higher frequency of REM sleep behavior disorder ( RBD ) . In exploring predictive markers , we found that the combination of several investigations , i.e. , the NMSQuest , Scopa-AUT Gastrointestinal score , and Smell Identification Test reached an area under the receiver operating characteristic curve ( AUC ) of 0.913 ( 95 % confidence interval [ CI ] 0.878–0.948 ) . With the addition of serum cholesterol and mean heart rate values , the AUC value reached 0.919 ( 95 % CI 886–0.953 ) ; when TCS and PSG were added , the AUC increased to 0.963 ( 95 % CI 0.943–0.982 ) . Conclusions : We show feasibility and utility of st and ardized data acquisition in a large , single-center cohort of patients with de novo PD and matched healthy controls . The baseline results from our prospect i ve investigations reached a value of > 0.9 sensitivity and specificity for biological markers when we added routine laboratory investigations and quantified nonmotor features including sleep Objectives : Fatigue is common in Parkinson 's disease ( PD ) , causing serious negative effects on quality of life . Despite its clinical importance , the nature of fatigue in PD is poorly understood because its underlying neurobiology is unknown . Fatigue can be more complicated in advanced PD because of its chronicity . In order to find features that are innate to fatigue in PD , it would be useful to conduct a study looking at de novo PD . Assessing fatigue in de novo patients allows excluding at least one confounding factor . Methods : We prospect ively investigated 87 drug-naïve PD patients . Thirty-nine patients ( 44.8 % ) were found to have fatigue around the time of diagnosis of PD . Results : We found that depression and difficulties with activities of daily living were independent risk factors for fatigue ; however , motor dysfunction was not related . Clinical ly meaningful responses to dopaminergic medication were observed . Discussion : Our study determined that fatigue occurs in the early stages of PD . It can inform clinical decision-making to significantly benefit PD patients with fatigue Background : Fatigue is a common complaint in Parkinson disease ( PD ) . We investigated fatigue in a cohort of previously untreated patients with early PD enrolled in the Earlier vs Later Levodopa ( ELLDOPA ) clinical trial . Methods : A total of 361 patients were enrolled in the r and omized , double-blind , placebo-controlled ELLDOPA trial and assigned to receive placebo or carbidopa-levodopa 37.5/150 mg , 75/300 mg , or 150/600 mg daily for 40 weeks , followed by a 2-week medication washout period . Subjects who scored > 4 on the Fatigue Severity Scale were classified as fatigued . PD severity was assessed using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Hoehn-Yahr scale , and Schwab-Engl and Activities of Daily Living Scale . A subgroup of subjects underwent [123I]-β-CIT SPECT to measure striatal dopamine transporter density . Results : Of the 349 ELLDOPA subjects who completed fatigue measures , 128 were classified as fatigued at baseline . The fatigued group was significantly more impaired neurologically ( UPDRS , all subscales and Hoehn and Yahr staging ) and functionally ( Schwab-Engl and Scale ) but no significant differences were observed in β-CIT measurements between the two groups . Analysis of covariance showed a greater increase in fatigue score from baseline to the end of the 2-week washout in the placebo group ( 0.75 points ) than in the three groups receiving levodopa ( increases of 0.30 [ 150 mg/day ] , 0.36 [ 300 mg/day ] , and 0.33 [ 600 mg/day ] ; p = 0.03 for heterogeneity ) . Conclusions : Fatigue is a frequent symptom in early , untreated , non-depressed patients with Parkinson disease ( PD ) , affecting over 1/3 of the patients in this cohort at baseline and 50 % by week 42 . Fatigue was associated with the severity of PD , and progressed less in patients treated with levodopa OBJECTIVE Rapid eye movement ( REM ) sleep behavior disorder ( RBD ) is a risk factor for dementia in Parkinson disease ( PD ) patients . The objectives of our study were to prospect ively evaluate the frequency of RBD in a sample of treatment-naïve , newly diagnosed PD patients and compare sleep characteristics and cognition in RBD and non-RBD groups . METHODS Fifty-seven newly diagnosed PD patients were consecutively recruited in a university medical center . All patients underwent two overnight polysomnography ( PSG ) sessions and were diagnosed with RBD according to the International Classification of Sleep Disorders , Second Revision criteria . Daytime sleepiness was measured in a multiple sleep latency test ( MSLT ) . Cognition was assessed in a st and ard neuropsychologic examination . RESULTS Seventeen PD patients ( 30 % ) met the criteria for RBD . The RBD patients and non-RBD patients did not significantly differ in mean age , gender ratio , disease duration , motor symptom subtype and severity , total sleep time , percentage of REM sleep , apnea-hypopnea index , mean oxygen saturation , and importantly cognitive performance . However , non-RBD patients had a significantly shorter mean daytime sleep latency than RBD patients ( 15 vs. 18 min , respectively ; P=.0 Output:	The current review confirms the increasing research being conducted into NMS in DNPD patients as well as the necessity for further investigation into less-studied NMS , such as pain .
MS21714	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Lay health workers ( LHWs ) play a pivotal role in addressing the high TB burden in Malawi . LHWs report lack of training to be a key barrier to their role as TB care providers . Given the cost of traditional off-site training , an alternative approach is needed . Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs . Methods The study design is a pragmatic cluster r and omized trial . The study was embedded within a larger trial , PALMPLUS , and compared three arms which included 28 health centers in Zomba district , Malawi . The control arm included 14 health centers r and omized as controls in the larger trial and maintained as control sites . Seven of 14 PALMPLUS intervention sites were r and omized to the LHW intervention ( PALM/LHW intervention arm ) , and the remaining 7 PALMPLUS sites maintained as a PALM only arm . PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers . LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs . Control sites received no intervention . The main outcome measure is the proportion of treatment successes . Results Among the 28 sites , there were 178 incident TB cases with 46/80 ( 0.58 ) successes in the control group , 44/68 ( 0.65 ) successes in the PALMPLUS group , and 21/30 ( 0.70 ) successes in the PALM/LHW intervention group . There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster r and omization ( p = 0.578 ) or multivariate analysis controlling for covariates with significant model effects ( p = 0.760 ) . The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance ( p = 0.056 ) , with the interaction significant only in the control arm [ RR of treatment success for pulmonary TB relative to non-pulmonary TB , 1.18 , 95 % CI 1.05–1.31 ] . Conclusions We found no significant treatment effect of our intervention . Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training , further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted . Trial registration Clinical Trials.gov NCT01356095 Objective To assess the effectiveness of a community based lifestyle intervention on blood pressure in children and young adults in a developing country setting . Design Cluster r and omised controlled trial . Setting 12 r and omly selected geographical census based clusters in Karachi , Pakistan . Participants 4023 people aged 5 - 39 years . Intervention Three monthly family based home health education delivered by lay health workers . Main outcome measure Change in blood pressure from r and omisation to end of follow-up at 2 years . Results Analysed using the intention to treat principle , the change in systolic blood pressure ( adjusted for age , sex , and baseline blood pressure ) was significant ; it increased by 1.5 ( 95 % confidence interval 1.1 to 1.9 ) mm Hg in the control group and by 0.1 ( −0.3 to 0.5 ) mm Hg in the home health education group ( P for difference between groups=0.02 ) . Findings for diastolic blood pressure were similar ; the change was 1.5 mm Hg greater in the control group than in the intervention group ( P=0.002 ) . Conclusions Simple , family based home health education delivered by trained lay health workers significantly ameliorated the usual increase in blood pressure with age in children and young adults in the general population of Pakistan , a low income developing country . This strategy is potentially feasible for up-scaling within the existing healthcare systems of Indo-Asia . Trial registration Clinical trials NCT00327574 BACKGROUND Adherence to drugs and healthy lifestyles is low after acute coronary syndrome . We assessed whether trained community health workers could improve adherence to drugs , lifestyle changes , and clinical risk markers in patients with acute coronary syndrome in India . METHODS In this study done at 14 hospitals in India we r and omly assigned ( 1:1 ) patients with acute coronary syndrome 1 or 2 days before discharge from hospital to a community health worker-based intervention group or a st and ard care group . Patients were r and omly assigned with a telephone r and omisation service . In the intervention group , during four in-hospital and two home visits , community health workers used unstructured discussion s , visual methods , and patient diaries to educate patients on healthy lifestyle and drugs , and measures to enhance adherence . The primary outcome was adherence to proven secondary prevention drugs ( antiplatelet drugs , β blockers , angiotensin-converting enzyme inhibitors or angiotensin receptor blockers , and statins ) estimated using a Composite Medication Adherence Scale at 1 year . The secondary outcomes were difference in lifestyle factors ( diet , exercise , and tobacco and alcohol use ) , and clinical risk markers ( blood pressure , bodyweight , BMI , heart rate , and lipids ) . All analyses were by intention to treat . This trial is registered with the Clinical Trial Registry of India , number REF/2013/03/004737 , and Clinical Trials.gov , number NCT01207700 . RESULTS Between Aug 23 , 2011 , and June 25 , 2012 , 806 participants were r and omly assigned ( 405 to a community health worker-based intervention group and 401 to a st and ard care group ) . At 1 year , 40 patients had died and 15 had discontinued or been lost to follow-up , so 750 ( 93 % ) were included in the analyses ( 375 in each group ) . Secondary prevention drugs prescribed at discharge were 98 % ( 786/803 ) for any antiplatelet drug , 79 % ( 638/803 ) for dual antiplatelet drugs , 69 % ( 555/803 ) for β blockers , 69 % ( 552/803 ) for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers , and 95 % ( 762/803 ) for statins . At one year , overall adherence ( ≥80 % ) to prescribed evidence -based drugs was higher in the intervention group than in the control group ( 97 % vs 92 % , odds ratio [ OR ] 2·62 , 95 % CI 1·32 - 5·19 ; p=0·006 ) . For individual drugs , we recorded significant differences for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers ( 97 % [ 233/240 ] in the intervention group vs 93 % [ 223/240 ] in the control group ; p=0·036 ) and statins ( 97 % [ 346/356 ] vs 93 % [ 321/345 ] ; p=0·011 ) . The intervention group had significantly greater adherence to smoking cessation ( 85 % [ 110/129 ] vs 52 % [ 71/138 ] , OR 5·46 , 95 % CI 3·03 - 9·86 ; p<0·0001 ) , regular physical activity ( 89 % [ 333/375 ] vs 60 % [ 226/375 ] , OR 5·23 , 95 % CI 3·57 - 7·66 ; p<0·0001 ) , and healthy diet ( score 5·0 vs 3·0 , OR 2·47 , 95 % CI 1·88 - 3·25 ; p<0·0001 ) . More patients in the intervention group had stopped alcohol use at 1 year ( 87 % [ 64/74 ] vs 46 % [ 46/67 ] , OR 2·92 , 95 % CI 1·26 - 6·79 ; p = 0·010 ) . At 1 year , the mean systolic blood pressure ( 124·4 mm Hg [ SD 13·5 ] vs 128·0 mm Hg [ 15·9 ] ; p=0·002 ) , weight ( 65·0 kg [ 11·0 ] vs 66·5 kg [ 11·5 ] ; p<0·0001 ) , cholesterol ( 157·0 [ 40·2 ] vs 166·9 [ 48·4 ] ; p=0·184 ) , LDL ( 81·0 [ 20·6 ] vs 87·3 [ 29·9 ] ; p=0·191 ) , HDL ( 42·0 [ 11·4 ] vs 38·2 [ 6·5 ] ; p=0·042 ) , and BMI ( 24·4 kg/m(2 ) [ SD 3·7 ] vs 25·0 kg/m(2 ) [ 3·8 ] ; p<0·0001 ) were lower in the intervention group than in the control group . However , we noted no significant difference in diastolic blood pressure and heart rate . INTERPRETATION A community health worker-based personalised intervention strategy in patients with acute coronary syndrome improved adherence to evidence -based drugs and healthy lifestyles , and result ed in an improvement in clinical risk markers . Integration of trained community health workers can improve secondary prevention in coronary artery disease . FUNDING US National Heart , Lung , and Blood Institute ( NHLBI ) , National Institutes of Health , Department of Health and Human Services , and the UnitedHealth group , USA Background In Africa hypertension is common and stroke is increasing . Detection , treatment and control of high blood pressure ( BP ) is limited . BP can be lowered by reducing salt intake . In Africa salt is added to the food by the consumer , as processed food is rare . A population -wide approach with programmes based on health education and promotion is thus possible . Methods We carried out a community-based cluster r and omised trial of health promotion in 1,013 participants from 12 villages ( 628 women , 481 rural dwellers ) ; mean age 55 years to reduce salt intake and BP . Average BP was 125/74 mmHg and urinary sodium ( UNa ) 101 mmol/day . A health promotion intervention was provided over 6 months to all villages . Assessment s were made at 3 and 6 months . Primary end-points were urinary sodium excretion and BP levels . Results There was a significant positive relationship between salt intake and both systolic ( 2.17 mmHg [ 95 % CI 0.44 to 3.91 ] per 50 mmol of UNa per day , p < 0.001 ) and diastolic BP ( 1.10 mmHg [ 0.08 to 1.94 ] , p < 0.001 ) at baseline . At six months the intervention group showed a reduction in systolic ( 2.54 mmHg [ -1.45 to 6.54 ] ) and diastolic ( 3.95 mmHg [ 0.78 to 7.11 ] , p = 0.015 ) BP when compared to control . There was no significant change in UNa . Smaller villages showed greater reductions in UNa than larger villages ( p = 0.042 ) . Irrespective of r and omisation , there was a consistent and significant relationship between change in UNa and change in systolic BP , when adjusted for confounders . A difference in 24-hour UNa of 50 mmol was associated with a lower systolic BP of 2.12 mmHg ( 1.03 to 3.21 ) at 3 months and 1.34 mmHg ( 0.08 to 2.60 ) at 6 months ( both p < 0.001 ) . Conclusion In West Africa the lower the salt intake , the lower the BP . It would appear that a reduction in the average salt intake in the whole community may lead to a small but significant reduction in population systolic BP 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 . CONCL Output:	Conclusion The results of the eight included studies suggest that CHWs can be trained effectively for CVD prevention and management .
MS21715	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objectives : Recent data have suggested an association between the use of dexmedetomidine and a decreased incidence of acute kidney injury in adult patients after cardiopulmonary bypass . However , no study has focused on this association among pediatric population s where the incidence of acute kidney injury is particularly high and of critical significance . The primary objective of this study was to assess the relationship between the use of postoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass . The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay . Design : Single-center retrospective matched cohort study . Setting : A 20-bed quaternary cardiovascular ICU in a university-based pediatric hospital in California . Patients : Children less than 18 years old admitted after cardiac surgery with cardiopulmonary bypass between January 1 , 2012 , and May 31 , 2014 . Interventions : None . Measurements and Main Results : Data from a cohort of 102 patients receiving dexmedetomidine during the first postoperative day after cardiac surgery were compared to an age- and procedure-matched cohort not receiving dexmedetomidine . Cohorts had similar baseline and demographic characteristics . Patients receiving dexmedetomidine were less likely to develop acute kidney injury ( 24 % vs 36 % ; odds ratio , 0.54 ; 95 % CI , 0.29–0.99 ; p = 0.046 ) . After adjusting for age , bypass time , nephrotoxin use , and vasoactive inotropic score , the use of dexmedetomidine was associated with a lower incidence of acute kidney injury with adjusted odds ratio of 0.43 ( 95 % CI , 0.27–0.98 ; p = 0.048 ) . There was no difference between the cohorts with respect to the duration of mechanical duration ( 1 d each ; p = 0.98 ) or cardiovascular ICU stays ( 5 vs 6 d ; p = 0.91 ) . Conclusions : The use of a dexmedetomidine infusion in pediatric patients after congenital heart surgery was associated with a decreased incidence of acute kidney injury ; however , it was not associated with changes in clinical outcomes . Further prospect i ve study is necessary to vali date these findings Introduction : Incidence of junctional ectopic tachycardia ( JET ) after repair of tetralogy of Fallot ( TOF ) is 5.6–14 % . Dexmeditomidine is a α-2 adrenoceptor agonist modulates the release of catecholamine , result ing in bradycardia and hypotension . These effects are being explored as a therapeutic option for the prevention of perioperative tachyarrhythmia . We undertook this study to examine possible preventive effects of dexmedetomidine on postoperative JET and its impact on the duration of ventilation time and length of Intensive Care Unit stay . Methods : After obtaining approval from the hospitals ethics committee and written informed consent from parents , this quasi-r and omized trial was initiated . Of 94 patients , 47 patients received dexmedetomidine ( dexmedetomidine group ) and 47 patients did not receive the drug ( control group ) . Results : Dexmedetomidine group had more number of complex variants like TOF with an absent pulmonary valve or pulmonary atresia ( P = 0.041 ) . Hematocrit on cardiopulmonary bypass ( CPB ) , heart rate while coming off from CPB and inotrope score was significantly low in the dexmedetomidine group compared to control group . The incidence of JET was significantly low in dexmedetomidine group ( P = 0.040 ) compared to control group . Conclusions : Dexmedetomidine may have a potential benefit of preventing perioperative JET Objective : The objective of this study was to assess the effectiveness of pre-emptive dexmedetomidine versus amiodarone in preventing junctional ectopic tachycardia ( JET ) in pediatric cardiac surgery . Design : This is a prospect i ve , controlled study . Setting : This study was carried out at a single university hospital . Subjects and Methods : Ninety patients of both sexes , American Society of Anesthesiologists Physical Status II and III , age range from 2 to 18 years , and scheduled for elective cardiac surgery for congenital and acquired heart diseases were selected as the study participants . Interventions : Patients were r and omized into three groups ( 30 each ) . Group I received dexmedetomidine 1 mcg/kg diluted in 100 ml of normal saline intravenously ( IV ) over a period of 20 min , and the infusion was completed 10 min before the induction followed by a 0.5 mcg/kg/h infusion for 72 h postoperative , Group II received amiodarone 5 mg/kg diluted in 100 ml of normal saline IV over a period of 20 min , and the infusion was completed 10 min before the induction followed by a 10–15 mcg/kg/h infusion for 72 h postoperative , and Group III received 100 ml of normal saline IV . Primary outcome was the incidence of postoperative JET . Secondary outcomes included vasoactive-inotropic score , ventilation time ( VT ) , pediatric cardiac care unit stay , hospital length of stay , and perioperative mortality . Measurements and Main Results : The incidence of JET was significantly reduced in Group I and Group II ( P = 0.004 ) compared to Group III . Heart rate while coming off from cardiopulmonary bypass ( CPB ) was significantly low in Group I compared to Group II and Group III ( P = 0.000 ) . Mean VT , mean duration of Intensive Care Unit stay , and length of hospital stay ( day ) were significantly short ( P = 0.000 ) in Group I and Group II compared to Group III ( P = 0.000 ) . Conclusion : Perioperative use of dexmedetomidine and amiodarone is associated with significantly decreased incidence of JET as compared to placebo without significant side effects This study was design ed to evaluate the incidence and risk factors associated with the occurrence of junctional ectopic tachycardia ( JET ) in patients after congenital heart surgery . We prospect ively analyzed cardiac rhythm status in 336 consecutive patients undergoing surgery for congenital heart disease at our institution during a 1-year period . The incidence of JET was 8 % ( 27/336 ) . Repairs with the highest incidence of JET were arterial switch operation ( 3/13 , 23 % ) , atrioventricular ( AV ) canal repair ( 4/19 , 21 % ) , and Norwood repair ( 2/10 , 20 % ) . Compared to patients with no arrhythmias , patients with JET were more likely to be younger ( 2.75 ± 2.44 vs 5.38 ± 7.25 years , p < 0.01 ) , have had longer cardiopulmonary bypass times ( 126 ± 50 vs 85 ± 73 , p < 0.01 ) , and have a higher inotrope score ( 6.26 ± 7.55 vs 2.41 ± 8.11 , p < 0.01 ) . By multivariate analysis , ischemic time was the only factor associated with JET [ odds ratio , 1.01 ( confidence interval , 1.005–1.02 ) ; p = 0.0014 ) . The presence of JET did not correlate with electrolyte abnormalities . JET is not necessarily related to surgery near the His bundle or hypomagnesemia . Longer ischemic time is the best predictor of JET . Patients undergoing arterial switch operation , AV canal repair , and Norwood repair are at highest risk of postoperative JET and should be considered for prophylactic therapy Background : Junctional ectopic tachycardia occurs frequently after congenital cardiac surgery and can be a cause of increased morbidity and mortality . Dexmedetomidine ( DEX ) is an α2 adrenoreceptor agonist , has properties of controlling tachyarrhythmia by regulating the sympatho-adrenal system . Objective : To evaluate the efficacy of DEX for control of junctional ectopic tachycardia after repair of Tetralogy of Fallot ( TOF ) . Material s and Methods : Two hundred and twenty pediatric cardiac patients with TOFs were enrolled in a prospect i ve r and omized control study . Patients underwent correction surgery . They were divided into two groups , i.e. , Group 1 ( DEX ) and Group 2 ( control ) . Heart rate , rhythm , mean arterial pressure ( MAP ) were recorded after the anesthetic induction ( T1 ) , after termination of bypass ( T2 ) , after 04 hours ( T3 ) , and 08 hours after transferring the patient to intensive care unit ( ICU ; T4 ) . Results : Heart rate was comparable between two groups before starting the drug but statistically significant after bypass until 08 hours after transferring the patient to ICU . Junctional ectopic tachycardia occurred more in Group-2 ( 20 % ) as compared to Group-1 ( 9.09 % ; P = 0.022 ) . Junctional ectopic tachycardia occurs early in Group-2 ( 0.14 ± 0.527 hours ) as compared to Group 1 ( 0.31 ± 1.29 hours ; P = 0.042 ) . The duration of junctional ectopic tachycardia was more prolonged in Group-2 ( 1.63 ± 3.64 hours ) as compared to Group-1 ( 0.382 ± 1.60 hours ; P = 0.012 ) . The time to withdraw from mechanical ventilation and ICU stay of Group 1 patient was less than of Group 2 patients ( P = < 0.001 ) . Conclusion : DEX had a therapeutic role in the prevention of junctional ectopic tachycardia in patients undergoing repair for TOF OBJECTIVE Early postoperative arrhythmias are a known complication of cardiac surgery ; however , little data exists specific to pediatrics . The purpose of this study was to determine the incidence and risk factors associated with the development of arrhythmias immediately after surgery in a pediatric population . METHODS Data were collected in a prospect i ve observational format from pediatric patients undergoing cardiac surgery between September 2000 and May 2003 . This format included age , anatomy , surgical repair , and serum magnesium and calcium levels , as well as cardiopulmonary bypass and aortic crossclamp times . Patients were continuously monitored , and hemodynamically significant arrhythmias were recorded . RESULTS Arrhythmias occurred in 28 of the 189 patients enrolled ( 15 % ) including 16 with junctional ectopic tachycardia , 7 with complete atrioventricular block , 4 with ventricular tachycardia , and 1 with re-entrant supraventricular tachycardia . Significant differences were found between the arrhythmia and nonarrhythmia groups with regard to age ( 22 vs 45 months ) , cardiopulmonary bypass time ( 189 vs 109 minutes ) , and aortic crossclamp time ( 105 vs 44 minutes ) ; P < .05 . Magnesium and calcium levels were not significantly different between the groups . Two repairs carried an increased risk : complete atrioventricular septal defect repair , 8 of 11 patients ( 72 % ) , and the arterial switch 5 of 8 patients ( 62.5 % ) ; P < .05 . Atrioventricular septal defects had an even higher incidence when controlled for age , bypass time , and crossclamp time ( odds ratio = 7.65 ) . CONCLUSIONS Hemodynamically significant postoperative arrhythmias are a frequent complication of pediatric cardiac surgery . Younger age and longer bypass and crossclamp times are risk factors for arrhythmia . In addition , the repair of atrioventricular septal defects carries an independent risk of arrhythmias Background : Dexmedetomidine has been reported to have a renal protective effect after adult open heart surgery . The authors hypothesized that intraoperative infusion of dexmedetomidine would attenuate the decrease in renal function after pediatric open heart surgery . Methods : Twenty-nine pediatric patients ( 1–6 years ) scheduled for atrial or ventricular septal defect repair were r and omly assigned to receive either continuous infusion of normal saline ( control group , n = 14 ) or dexmedetomidine ( a bolus dose of 0.5 & mgr;g/kg and then an infusion of 0.5 & mgr;g/kg/h ) ( dexmedetomidine group , n = 15 ) from anesthesia induction to the end of cardiopulmonary bypass . Serum creatinine ( Scr ) was measured before surgery ( T0 ) , 10 minutes after anesthesia induction ( T1 ) , 5 minutes after cardiopulmonary bypass weaning ( T2 ) , 2 hours after T2 ( T3 ) , and after postoperative day 1 ( POD1 ) and postoperative day 2 ( POD2 ) and estimated glomerular filtration rates ( eGFRs ) were calculated . Renal biomarkers were measured at T1 , T2 , and T3 . Acute kidney injury ( Output:	The administration of perioperative dexmedetomidine effectively prevents JET in pediatric patients undergoing cardiac surgery but has no significant effect on postoperative renal function .
MS21716	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The majority of patients with primary or metastatic malignancies confined to the liver are not c and i date s for resection because of tumor size , location , multifocality , or inadequate functional hepatic reserve . Cryoablation has become a common treatment in select groups of these patients with unresectable liver tumors . However , hepatic cryoablation is associated with significant morbidity . Radiofrequency ablation ( RFA ) is a technique that destroys liver tumors in situ by localized application of heat to produce coagulative necrosis . In this study , we compared the complication and early local recurrence rates in patients with unresectable malignant liver tumors treated with either cryoablation or RFA . PATIENTS AND METHODS Patients with hepatic malignancies were entered into two consecutive prospect i ve , nonr and omized trials . The liver tumors were treated intraoperatively with cryoablation or RFA ; intraoperative ultrasonography was used to guide placement of cryoprobes or RFA needles . All patients were followed up postoperatively to assess complications , treatment response , and local recurrence of malignant disease . RESULTS Cryoablation was performed on 88 tumors in 54 patients , and RFA was used to treat 138 tumors in 92 patients . Treatment-related complications , including 1 postoperative death , occurred in 22 of the 54 patients treated with cryoablation ( 40.7 % complication rate ) . In contrast , there were no treatment-related deaths and only 3 complications after RFA ( 3.3 % complication rate , P<0.001 ) . With a median follow-up of 15 months in both patient groups , tumor has recurred in 3 of 138 lesions treated with RFA ( 2.2 % ) , versus 12 of 88 tumors treated with cryoablation ( 13.6 % , P<0.01 ) . CONCLUSIONS RFA is a safe , well-tolerated treatment for patients with unresectable hepatic malignancies . This study indicates that ( 1 ) complications occur much less frequently following RFA of liver tumors compared with cryoablation of liver tumors , and ( 2 ) early local tumor recurrence is infrequent following RFA OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials HYPOTHESIS The complication and success rates in patients treated with either percutaneous cryosurgery ( PCS ) or percutaneous radiofrequency ( PRF ) for unresectable hepatic malignancies are similar . DESIGN Retrospective study . SETTING University hospital . PATIENTS AND METHODS Sixty-four patients were treated with either PCS ( n = 31 ) or PRF ( n = 33 ) . Patient treatment was based on the r and om availability of the probes . Tumors were evaluated by a blinded comparison of pretreatment and posttreatment helical computed tomographic scans . All living patients had at least a 6-month follow-up . MAIN OUTCOME MEASURES Complication rate , initial treatment success ( complete devascularization of the tumor ) , and local recurrence ( tumor revascularization within or at its periphery ) . RESULTS The distribution of tumor types was similar in the 2 groups ( P = .76 ) . One patient with cirrhosis died of variceal hemorrhage on day 30 after PCS ( mortality , 3.2 % ) , while no mortality was observed after PRF ( P = .48 ) . Complications occurred in 9 ( 29 % ) of the patients following PCS and in 8 ( 24 % ) of the patients following PRF ( P = .66 ) . Initial treatment success was comparable in the 2 treatment groups ( 30 [ 83 % ] of 36 tumors following PCS vs 34 [ 83 % ] of 41 tumors following PRF ) . However , local recurrences occurred more frequently after PCS than after PRF ( 16 [ 53 % ] of 30 vs 6 [ 18 % ] of 34 ; P = .003 ) . The higher rate of local recurrence was identified for metastases ( 10 [ 71 % ] of 14 after PCS vs 3 [ 19 % ] of 16 after PRF ; P = .004 ) , while the difference was not significant for hepatocellular carcinoma ( 6 [ 38 % ] of 16 after PCS vs 3 [ 17 % ] of 18 after PRF ; P = .25 ) . Multivariate analysis demonstrated that the use of PCS ( P = .003 ) and more than 1 treatment ( P = .05 ) were independent risk factors for local tumor recurrence . CONCLUSION While similar initial treatment success and complication rates are observed following either PCS or PRF , local recurrences occur more frequently following PCS , particularly for metastases BACKGROUND Thermal ablation of unresectable hepatic tumors can be achieved by cryosurgical ablation ( CSA ) or radiofrequency ablation ( RFA ) . The relative advantages and disadvantages of each technique have not yet been determined . HYPOTHESIS Radiofrequency ablation of malignant hepatic neoplasms can be performed safely , but is currently limited by size . Cryosurgical ablation , while associated with higher morbidity , is more effective for larger unresectable hepatic malignant neoplasms . DESIGN Retrospective analysis of prospect i ve patient data base . PATIENTS AND METHODS Between July 1992 and September 1999 , 308 patients with liver tumors not amenable to curative surgical resection were treated with CSA and /or RFA ( percutaneous , laparoscopic , celiotomy ) . No patient had preoperative evidence of extrahepatic disease . All patients underwent laparoscopy with intraoperative ultrasound if technically possible . Both RFA and CSA were performed under ultrasound guidance . Resection , as an adjunctive procedure , was combined with ablation in certain patients . RESULTS Laparoscopy identified extrahepatic disease in 12 % of patients , and intraoperative hepatic ultrasound identified additional lesions in 33 % of patients , despite extensive preoperative imaging . Radiofrequency ablation alone or combined with resection or CSA result ed in reduced blood loss ( P<.05 ) , thrombocytopenia ( P<.05 ) , and shorter hospital stay compared with CSA alone ( P<.05 ) . Median ablation times for lesions greater than 3 cm were 60 minutes with RFA and 15 minutes with CSA ( P<.001 ) . Local recurrence rates for lesions greater than 3 cm were also greater with RFA ( 38 % vs 17 % ) . CONCLUSIONS Laparoscopy and intraoperative ultrasound are essential in staging patients with hepatic malignant neoplasms . Radiofrequency ablation when combined with CSA reduces the morbidity of multiple freezes . Although RFA is safer than CSA and can be performed via different approaches ( percutaneously , laparoscopically , or at celiotomy ) , it is limited by tumor size ( <3 cm ) . Percutaneous RFA should be considered in high-risk patients or those with small local recurrences BACKGROUND / AIMS This study aim ed to assess the main features of hepatocellular carcinoma at the time of diagnosis in Italy , particularly in relation to the presence or absence of underlying cirrhosis , hepatitis virus marker patterns , age of the subjects and alpha-foetoprotein values . METHODS A total of 1148 patients with hepatocellular carcinoma seen at 14 Italian hospitals in the 1-year period from May 1996 to May 1997 were the subjects of this prevalence study . Both newly diagnosed cases ( incident cases ) and cases diagnosed before May 1996 but still attending the hospitals during the study period ( prevalent cases ) were included . RESULTS We found that 71.1 % of cases were positive for hepatitis C virus antibodies but negative for HBsAg ; in contrast , 11.5 % were negative for anti-HCV but positive for HBsAg ; 5.3 % were positive for both markers ; and 12.1 % were negative for both viruses . The mean age of detection was over 60 years , with a younger mean age in HBsAg-positive compared to anti-HCV-positive patients ( 59.3 years vs. 65.6 years , p<0.01 ) . The male-to-female ratio among HBsAg-positive patients was 10.4:1 , in contrast to 2.8:1 among anti-HCV-positive patients ( p<0.01 ) . The majority of cases ( 93.1 % ) had underlying cirrhosis . Cirrhotic patients were more likely to be anti-HCV positive than non-cirrhotic cases ( 73.2 % vs 43.9 % ; p<0.01 ) ; conversely , absence of hepatitis virus markers was more frequently observed in the non-cirrhotic than in the cirrhotic population ( 40.9 % vs. 10.0 % ; p<0.01 ) . Overall , the alpha-foetoprotein level was altered ( > 20 ng/ml ) in 57.9 % of patients ; only 18 % of cases presented diagnostic ( > 400 ng/ml ) values . Anti-HCV positivity ( O.R. 2.0 ; CI 95%=1.3 - 3.1 ) but not HBsAg positivity ( O.R. 1.0 ; CI 95%=0.6 - 1.8 ) was shown to be an independent predictor of the likelihood of altered alpha-foetoprotein values by multivariate analysis . CONCLUSIONS These findings point to differences in the characteristics of the population s infected by hepatitis B and hepatitis C. Factors other than the hepatitis viruses are important in non-cirrhotic patients . A change in the relative prevalence of hepatitis virus markers among hepatocellular carcinoma cases was demonstrated , reflecting a significant change in the rate of HBV endemicity in the Italian population . Finally , the increased trend in the mortality rate from liver cancer in Italy from 4.8 per 100,000 in 1969 to 10.9 in 1994 may reflect the large cohort of subjects infected with HCV via the iatrogenic route during 1950s and 1960s when glass syringes were commonly used for medical treatment Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . OBJECTIVE The authors evaluate the results of cryosurgery in malignant liver tumors . SUMMARY BACKGROUND DATA The outcome of primary or secondary liver tumors is poor when resection can not be achieved . Encouraging results of cryosurgery have been reported in unresectable liver tumors , but this treatment needs further evaluation of its efficacy in homogeneous groups of patients . METHODS From 63 patients with malignant liver tumors with various histology treated by cryosurgery in a 2.5-year period , the authors evaluated the results of 34 patients with nonresectable hepatocellular carcinoma ( 9 patients ) or nonresectable metastases from colorectal cancer ( 25 patients ) . Cryosurgery was used either as a single treatment ( 4 hepatocellular carcinomas , 5 metastases ) or in association with liver resection ( 5 hepatocellular carcinomas , 20 metastases ) . Systemic chemotherapy was used routinely before surgery and after surgery . RESULTS There was no intraoperative mortality . Mortality within 2 months was 3 % and was unrelated to the procedure . Postoperative morbidity consisted of one sterile fluid collection and one bili Output:	This retrospective study compared percutaneous cryotherapy with percutaneous radiofrequency . Both severe and non-severe adverse events were reported , but the true nature and extent of harm was difficult to asses . At present , there is no evidence to recommend or refute cryotherapy for patients with hepatocellular carcinoma .
MS21717	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The current study was design ed to explore the use of behavioral ( i.e. , accuracy and reaction times ) and electrophysiological measures ( i.e. , event-related potentials ) to assess the impact of a family-based preventive intervention for preschool-aged , maltreated children in foster care . These measures were recorded during a computerized flanker task design ed to assess cognitive control and response monitoring . The sample was recruited from a larger r and omized efficacy trial of Multidimensional Treatment Foster Care for Preschoolers ( MTFC-P ) and included foster children assigned to the intervention condition ( n = 10 ) , foster children assigned to a services-as-usual comparison condition ( n = 13 ) , and low-income , nonmaltreated community children ( n = 11 ) . The children ’s behavioral and electrophysiological performance on the task was generally consistent with previous research with adults and older children . There were no group differences on the behavioral measures of cognitive control or response monitoring . Notably , however , group differences were observed on the electrophysiological measures of response monitoring . Specifically , the foster children who received services as usual were significantly less responsive to performance feedback about errors than the foster children who received the intervention and the nonmaltreated children . Applications of this methodology and implication s of the results for future prevention research are discussed The relative effectiveness of group care ( GC ) and multidimensional treatment foster care ( MTFC ) was compared in terms of their impact on criminal offending , incarceration rates , and program completion outcomes for 79 male adolescents who had histories of chronic and serious juvenile delinquency . Results show that boys who participated in MTFC had significantly fewer criminal referrals and returned to live with relatives more often . Multiple regression analyses showed that assignment to a treatment condition ( i.e. , GC or MTFC ) predicted official and self-reported criminality in follow-up beyond other well-known predictors of chronic juvenile offending ( i.e. , age at 1st offense , number of previous offenses , age at referral ) The purpose of this study was to evaluate the effectiveness of a 2-component intervention for biological and foster parent ( pairs ) to improve parenting practice s , co-parenting , and child externalizing problems . Participants were biological and foster parents ( N=128 ) of primarily neglected children ( ages 3 to 10 years ) placed in regular foster homes . Biological and foster parents were r and omly assigned in pairs to the intervention ( n=80 ) or a usual care ( n=48 ) condition . Intervention families received a 12-week parenting course ( Incredible Years ) and a newly developed co-parenting component . Key findings included significant gains in positive parenting and collaborative co-parenting for both biological and foster parents at the end of the intervention . At follow-up , intervention parents sustained greater improvement in positive parenting , showed gains in clear expectations , and reported a trend for fewer child externalizing problems . Findings supported the feasibility of offering joint parenting training to meet the needs of participating families and demonstrated that the co-parenting construct applied to families in the foster care system was amenable to intervention Young children who enter foster care experience disruptions in care and maltreatment at a point when maintaining attachment relationships is a key , biologically based task . In previous research , we have found that young children experience challenges as they form attachments with new caregivers . They tend to push their new caregivers away , even though such children are especially in need of nurturing care . Further , many caregivers do not respond in nurturing ways when their children are distressed , which we have found is problematic for young children in foster care . We developed an intervention that is design ed to help caregivers provide nurturance even when children do not elicit it , and even when it does not come naturally to them . This paper presents preliminary findings of the effectiveness of this intervention on children ’s attachment behaviors . Forty-six children were r and omly assigned to either the experimental intervention or to an educational intervention . For three consecutive days , attachment behaviors were reported across three distress-eliciting situations . Children whose parents had received the experimental intervention showed significantly less avoidance than children whose parents had received the educational intervention . These preliminary results suggest that the intervention is successful in helping children develop trusting relationships with new caregivers Studies with nonhuman primates and rodents , as well as with human children , have suggested that early separations from caregivers are often associated with changes in the functioning of the hypothalamus-pituitary-adrenal ( HPA ) axis . On the basis of these findings , we design ed a relational intervention that was intended to normalize HPA functioning among children in foster care . This paper presents findings from a r and omized clinical trial that assessed the effectiveness of a relational intervention ( Attachment and Biobehavioral Catch-up [ ABC ] ) with regard to HPA functioning . The ABC intervention was intended to enhance children 's ability to regulate physiology and behavior . The control intervention ( Developmental Education for Families ) was intended to enhance children 's cognitive skills . A comparison group of children who had never been in foster care was also included . Children 's cortisol production was assessed upon arrival at the lab , and 15 and 30 min following the Strange Situation . R and om effects analyses of variance were performed to assess differences in initial values and change between children in the two intervention groups . Children in the ABC intervention and comparison group children showed lower initial values of cortisol than children in the treatment control group , considering arrival at lab as initial values ( p < .05 ) . Groups did not differ significantly in change over time . These results suggest that the ABC intervention is effective in helping children regulate biology in ways more characteristic of children who have not experienced early adversity Placement disruptions undermine efforts of child welfare agencies to promote safety , permanency , and child well-being . Child behavior problems significantly contribute to placement changes . The aims of this investigation were to examine the impact of a foster parent training and support intervention ( KEEP ) on placement changes and to determine whether the intervention mitigates placement disruption risks associated with children 's placement histories . The sample included 700 families with children between ages 5 and 12 years , from a variety of ethnic background s. Families were r and omly assigned to the intervention or control condition . The number of prior placements was predictive of negative exits from current foster placements . The intervention increased chances of a positive exit ( e.g. , parent/child reunification ) and mitigated the risk-enhancing effect of a history of multiple placements . Incorporating intervention approaches based on a parent management training model into child welfare services may improve placement outcomes for children in foster care The lack of prepared and available foster parents for children with prenatal substance effects is of increasing concern to the child welfare field . The research study reported here evaluated a multimodal inservice training program design ed to enhance the competency of foster parents caring for infants with prenatal substance effects , and to promote an intent to foster such infants . Findings suggest that future foster parent training efforts in this area should focus on knowledge and skill attainment AIMS To evaluate the impact of training foster carers on children 's emotional and behavioural functioning . METHODS In a r and omised controlled trial in 17 Scottish local council areas , with immediate and nine month follow up , 182 children and their foster families were r and omly allocated to either st and ard services alone or st and ard services plus extra training for foster carers on communication and attachment . Main outcome measures were child psychopathology , attachment disorder , self esteem , and cost of foster care . RESULTS Over 60 % of children had measurable psychopathology at baseline . The training was perceived as beneficial by participants . Scores for parent reported psychopathology and attachment disorders decreased by around 5 % , self esteem increased by 2 % , and costs by 22 % in the intervention group . Results were non-significant . CONCLUSIONS Despite being well received by foster carers , the training was not sufficient to make a useful impact on the high level of psychopathology . This group may warrant more intensive interventions Abstract This study examined change in attachment-related behaviors among foster preschoolers participating in a r and omized trial of the Multidimensional Treatment Foster Care Program for Preschoolers ( MTFC-P ) . Measures of secure , resistant , and avoidant behaviors were collected using a caregiver-report diary at 3-month intervals during the 12 months following a new foster placement . Children r and omly assigned to the MTFC-P intervention condition ( n = 57 ) showed significant increases in secure behavior and significant decreases in avoidant behavior relative to children assigned to a regular foster care condition ( n = 60 ) . Both groups showed significant decreases in resistant behavior over time . Analyses also revealed a significant interaction between treatment condition and age at first foster placement on change in secure behavior . Results are discussed in terms of the importance of early intervention and prevention services for foster preschoolers Parent training for foster parents is m and ated by federal law and supported by state statues in nearly all states ; however , little is known about the efficacy of that training , and recent review s underscore that the most widely used curricula in the child welfare system ( CWS ) have virtually no empirical support ( Grimm , Youth Law News , April – June:3–29 , 2003 ) . On the other h and , numerous theoretically based , developmentally sensitive parent training interventions have been found to be effective in experimental clinical and prevention intervention trials ( e.g. , Kazdin and Wassell , Journal of the American Academy of Child and Adolescent Psychiatry , 39:414–420 , 2000 ; McMahon and Foreh and , Helping the noncompliant child , Guilford Press , New York , USA , 2003 ; Patterson and Forgatch , Parents and adolescents : I. Living together , Castalia Publishing , Eugene , OR , USA , 1987 ; Webster-Stratton et al. , Journal of Clinical Child Pyschology Psychiatry , 42:943–952 , 2001 ) . One of these , Multidimensional Treatment Foster Care ( MTFC ; Chamberlain , Treating chronic juvenile offenders : Advances made through the Oregon Multidimensional Treatment Foster Care model , American Psychological Association , Washington , DC , USA , 2003 ) , has been used with foster parents of youth referred from juvenile justice . The effectiveness of a universal intervention , KEEP ( Keeping Foster Parents Trained and Supported ) based on MTFC ( but less intensive ) was tested in a universal r and omized trial with 700 foster and kinship parents in the San Diego County CWS . The goal of the intervention was to reduce child problem behaviors through strengthening foster parents ’ skills . The trial was design ed to examine effects on both child behavior and parenting practice s , allowing for specific assessment of the extent to which improvements in child behavior were mediated by the parenting practice s targeted in the intervention . Child behavior problems were reduced significantly more in the intervention condition than in the control condition , and specific parenting practice s were found to mediate these reductions , especially for high-risk children in foster families reporting more than six behavior problems per day at baseline Most foster parents in the United States are required to participate in training , yet no empirical support exists for the training 's effectiveness . During the past two decades , high- quality clinical trials have documented that parent management training ( PMT ) programs produce positive outcomes for children and families in clinical and school setting s ; yet , these advances have not transferred to foster/kinship parents . Here , we describe a r and omized control trial testing the effectiveness of a PMT-based treatment with 700 foster/kinship parents in San Diego County . The collaborative processes to engage stakeholders , the strategies for involving parents , and the results of two levels of developer involvement in training and supervision on child behavioral outcomes are also described OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVE To determine the effectiveness of an intervention design ed to improve outcomes for infants and Output:	It was found that there was good support for wraparound services and relational interventions , but little support for widely used carer training programmes .
MS21718	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background The reward value of food is partly dependent on learned associations . It is not yet known whether replacing sugar with non-caloric sweeteners in food is affecting long-term acceptance . Objective To determine the effect of replacing sugar with non-caloric sweeteners in a nutrient-empty drink ( soft drink ) versus nutrient-rich drink ( yoghurt drink ) on reward value after repeated exposure . Design We used a r and omized crossover design whereby forty subjects ( 15 men , 25 women ) with a mean±SD age of 21±2 y and BMI of 21.5±1.7 kg/m2 consumed a fixed portion of a non-caloric sweetened ( NS ) and sugar sweetened ( SS ) versions of either a soft drink or a yoghurt drink ( counterbalanced ) for breakfast which were distinguishable by means of colored labels . Each version of a drink was offered 10 times in semi-r and om order . Before and after conditioning the reward value of the drinks was assessed using behavioral tasks on wanting , liking , and expected satiety . In a subgroup ( n=18 ) fMRI was performed to assess brain reward responses to the drinks . Results Outcomes of both the behavioral tasks and fMRI showed that conditioning did not affect the reward value of the NS and SS versions of the drinks significantly . Overall , subjects preferred the yoghurt drinks to the soft drinks and the ss drinks to the NS drinks . In addition , they expected the yoghurt drinks to be more satiating , they reduced hunger more , and delayed the first eating episode more . Conditioning did not influence these effects . Conclusion Our study showed that repeated consumption of a non-caloric sweetened beverage , instead of a sugar sweetened version , appears not to result in changes in the reward value . It can not be ruled out that learned associations between sensory attributes and food satiating capacity which developed preceding the conditioning period , during lifetime , affected the reward value of the drinks In this study , the representation of taste in the orbitofrontal cortex was investigated to determine whether or not a pleasant and an aversive taste have distinct or overlapping representations in this region . The pleasant stimulus used was sweet taste ( 1 M glucose ) , and the unpleasant stimulus was salt taste ( 0.1 M NaCl ) . We used an ON/OFF block design in a 3 T fMRI scanner with a tasteless solution delivered in the OFF period to control for somatosensory or swallowing-related effects . It was found that parts of the orbitofrontal cortex were activated ( P < 0.005 corrected ) by glucose ( in 6/7 subjects ) and by salt ( in 6/7 subjects ) . In the group analysis , separate areas of the orbitofrontal cortex were found to be activated by pleasant and aversive tastes . The involvement of the amygdala in the representation of pleasant as well as aversive tastes was also investigated . The amygdala was activated ( region of interest analysis , P < 0.025 corrected ) by the pleasant taste of glucose ( 5/7 subjects ) as well as by the aversive taste of salt ( 4/7 subjects ) . Activation by both stimuli was also found in the frontal opercular/insular ( primary ) taste cortex . We conclude that the orbitofrontal cortex is involved in processing tastes that have both positive and negative affective valence and that different areas of the orbitofrontal cortex may be activated by pleasant and unpleasant tastes . We also conclude that the amygdala is activated not only by an affectively unpleasant taste , but also by a taste that is affectively pleasant , thus providing evidence that the amygdala is involved in effects produced by positively affective as well as by negatively affective stimuli Vision provides a primary sensory input for food perception . It raises expectations on taste and nutritional value and drives acceptance or rejection . So far , the impact of visual food cues varying in energy content on subsequent taste integration remains unexplored . Using electrical neuroimaging , we assessed whether high- and low-calorie food cues differentially influence the brain processing and perception of a subsequent neutral electric taste . When viewing high-calorie food images , participants reported the subsequent taste to be more pleasant than when low-calorie food images preceded the identical taste . Moreover , the taste-evoked neural activity was stronger in the bilateral insula and the adjacent frontal operculum ( FOP ) within 100 ms after taste onset when preceded by high- versus low-calorie cues . A similar pattern evolved in the anterior cingulate ( ACC ) and medial orbitofrontal cortex ( OFC ) around 180 ms , as well as , in the right insula , around 360 ms . The activation differences in the OFC correlated positively with changes in taste pleasantness , a finding that is an accord with the role of the OFC in the hedonic evaluation of taste . Later activation differences in the right insula likely indicate revaluation of interoceptive taste awareness . Our findings reveal previously unknown mechanisms of cross-modal , visual-gustatory , sensory interactions underlying food evaluation Sensory-specific satiety , which is defined as a relative decrease in pleasantness , is increased by greater oro-sensory stimulation . Both sensory-specific satiety and pleasantness affect taste activation in the orbitofrontal cortex . In contrast , metabolic satiety , which results from energy intake , is expected to modulate taste activation in reward areas . The aim of this study was to determine the effects of the amount of oro-sensory stimulation and energy content on consumption-induced changes in taste activation . Ten men participated in a 2 × 2 r and omized crossover study . Subjects were scanned twice using functional magnetic resonance imaging : after fasting for at least 2h and after treatment , on four occasions . Treatment consisted of the ingestion of 450 mL of orangeade ( sweetened with 10 % sucrose or non-caloric sweeteners ) at 150 mL/min , with either small ( 5 mL ) or large ( 20 mL ) sips . During scanning , subjects alternately tasted orangeade , milk and tomato juice and rated its pleasantness . Before and after the scans , subjects rated pleasantness , prospect i ve consumption , desire to eat and sweetness for all tastants . Main findings were that , before treatment , the amygdala was activated more by non-caloric than by caloric orangeade . Caloric orangeade activated part of the striatum before , but not after treatment . We observed no main effects of sip size on taste activation and no interaction between sip size and caloric content . In conclusion , the brain responds differentially to caloric and non-caloric versions of a sweet drink and consumption of calories can modulate taste activation in the striatum . Further research is needed to confirm that the observed differences are due to caloric content and not to ( subliminal ) differences in the sensory profile . In addition , implication s for the effectiveness of non-caloric sweeteners in decreasing energy intake need to be established Research indicates that dysfunctional food reward processing may contribute to pathological eating behaviour . It is widely recognized that both the amygdala and the orbitofrontal cortex ( OFC ) are essential parts of the brain 's reward circuitry . The aims of this fMRI study were ( 1 ) to examine the effects of food deprivation and calorie content on reward processing in the amygdala and the OFC , and ( 2 ) to examine whether an explicit evaluation of foods is necessary for OFC , but not amygdalar activity . Addressing the first aim , healthy females were presented with high and low calorie food pictures while being either hungry or satiated . For the second aim , attention focus was manipulated by directing participants ' attention either to the food or to a neutral aspect . This study shows that hunger interacts with the energy content of foods , modulating activity in the posterior cingulate cortex , medial OFC , insula , cau date putamen and fusiform gyrus . Results show that satiated healthy females show an increased reward processing in response to low calorie foods . Confirming our hypothesis , food deprivation increased activity following the presentation of high calorie foods , which may explain why treatments of obesity energy restricting diets often are unsuccessful . Interestingly , activity in both the amygdala and mOFC was only evident when participants explicitly evaluated foods . However , attention independent activity was found in the mPFC following the high calorie foods cues when participants where hungry . Current findings indicate that research on how attention modulates food reward processing might prove especially insightful in the study of the neural substrates of healthy and pathological eating behaviour BACKGROUND A preference for sweet tastes has been repeatedly shown to be associated with alcohol preference in both animals and humans . In this study , we tested the extent to which recent drinking is related to blood oxygen level-dependent ( BOLD ) activation from an intensely sweet solution in orbitofrontal areas known to respond to primary rewards . METHODS Sixteen right-h and ed , non-treatment-seeking , healthy volunteers ( mean age : 26 years ; 75 % male ) were recruited from the community . All underwent a taste test using a range of sucrose concentrations , as well as functional magnetic resonance imaging ( fMRI ) during pseudor and om , event-driven stimulation with water and a 0.83 M concentration of sucrose in water . RESULTS [ Sucrose > water ] provoked a significant BOLD activation in primary gustatory cortex and amygdala , as well as in the right ventral striatum and in bilateral orbitofrontal cortex . Drinks/drinking day correlated significantly with the activation as extracted from the left orbital area ( r = 0.52 , p = 0.04 after correcting for a bilateral comparison ) . Using stepwise multiple regression , the addition of rated sucrose liking accounted for significantly more variance in drinks/drinking day than did left orbital activation alone ( multiple R = 0.79 , p = 0.002 ) . CONCLUSIONS Both the orbitofrontal response to an intensely sweet taste and rated liking of that taste accounted for significant variance in drinking behavior . The brain response to sweet tastes may be an important phenotype of alcoholism risk Output:	We confirm the importance of primary taste areas for gustatory processing in human adults . We also provide tentative evidence for reward-related cau date activity in relation to the sweet taste of caloric sugars .
MS21719	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND AIMS Small colorectal polyps are encountered frequently and may be incompletely removed during colonoscopy . The optimal technique for removal of small colorectal polyps is uncertain . The aim of this study was to compare the incomplete resection rate ( IRR ) by using EMR or cold snare polypectomy ( CSP ) for the removal of small adenomatous polyps . METHODS This was a prospect i ve r and omized controlled study from a tertiary-care referral center . A total of 358 patients who satisfied the inclusion criteria ( polyp sized 6 - 9 mm ) were r and omized to the EMR ( n = 179 ) and CSP ( n = 179 ) groups , and their polyps were treated with conventional EMR or CSP , respectively . After polypectomy , an additional 5 forceps biopsies were performed at the base and margins of polypectomy sites to assess the presence of residual polyp tissue . The EMR and CSP sample s were compared to assess the IRR . RESULTS Among a total of 525 polyps , 415 ( 79.0 % ) were adenomatous polyps , and 41 ( 16.4 % ) were advanced adenomas . The overall IRR for adenomatous polyps was significantly higher in the CSP group compared with the EMR group ( 18/212 , 8.5 % vs 3/203 , 1.5 % ; P = .001 ) . Logistic regression analysis revealed that the CSP procedure was a stronger risk factor for the IRR ( odds ratio [ OR ] 6.924 ; 95 % confidence interval [ CI ] , 2.098 - 24.393 ; P = .003 ) . In addition , piecemeal resection was the most important risk factor for the IRR ( OR 28.696 ; 95 % CI , 3.620 - 227.497 ; P = .001 ) . The mean procedure time for polypectomy was not significantly different between the EMR and CSP groups ( 5.5 ± 2.7 vs 4.7 ± 3.4 minutes ; P = .410 ) . None of these patients presented with delayed bleeding . There were no severe adverse events related to the biopsies . CONCLUSIONS EMR was significantly superior to CSP for achieving complete endoscopic resection of small colorectal polyps . Patients with piecemeal resection of polyps had a higher risk for incomplete resection . ( Clinical trial registration number : Hongwei-1102 - 12 . ) BACKGROUND AND STUDY AIMS Cold snare polypectomy is an established method for the resection of small colorectal polyps ; however , significant incomplete resection rates still leave room for improvement . We aim ed to assess the efficacy of cold snare endoscopic mucosal resection ( CS-EMR ) , compared with hot snare endoscopic mucosal resection ( HS-EMR ) , for nonpedunculated polyps sized 6 - 10 mm . PATIENTS AND METHODS This study was a dual-center , r and omized , noninferiority trial . Consecutive adult patients with at least one nonpedunculated polyp sized 6 - 10 mm were enrolled . Eligible polyps were r and omized ( 1:1 ) to be treated with either CS-EMR or HS-EMR . Both methods involved submucosal injection of a methylene blue-tinted normal saline solution . The primary noninferiority end point was histological eradication evaluated by postpolypectomy biopsies ( noninferiority margin - 10 % ) . Secondary outcomes included occurrence of intraprocedural bleeding , clinical ly significant postprocedural bleeding , and perforation . RESULTS Among 689 patients screened , 155 patients with 164 eligible polyps were included ( CS-EMR n = 83 , HS-EMR n = 81 ) . The overall rate of histological complete resection was 92.8 % in the CS-EMR group and 96.3 % in the HS-EMR group ( difference 3.5 % ; 95 % confidence interval [ CI ] - 4.15 to 11.56 ) , showing noninferiority of CS-EMR compared with HS-EMR . CS-EMR was shown to be noninferior both for polyps measuring 6 - 7 mm ( CS-EMR 93.3 % ; HS-EMR 100 % ; 95 % CI - 7.95 to 21.3 ) and those of 8 - 10 mm ( 92.5 % vs. 94.7 % , respectively ; 95 % CI - 7.91 to 13.16 ) . Rates of intraprocedural bleeding were similar between the two groups ( CS-EMR 3.6 % , HS-EMR 1.2 % ; P = 0.30 ) . No clinical ly significant postprocedural bleeding or perforation occurred in either group . CONCLUSIONS CS-EMR appears to be a valuable modification of the st and ard cold snare technique , obviating the need to use diathermy for nonpedunculated colorectal polyps sized 6 - 10 mm BACKGROUND AND AIMS Curability is associated with resection width and depth in polypectomy . We evaluated the resection width and depth achieved with hot snare polypectomy ( HSP ) and cold snare polypectomy ( CSP ) for small colorectal polyps . METHODS In this single-center , prospect i ve , r and omized controlled study , patients with rectal or rectosigmoid polyps ≤10 mm in diameter were treated with HSP or CSP . Resection width was evaluated as mucosal defect size , measured immediately postprocedure and 1 day later . Resection depth was histologically evaluated using obtained specimens . RESULTS Fifty-two patients were enrolled . Mean lesion size was 5.6 mm with HSP ( n = 27 ) and 5.8 mm with CSP ( n = 25 ) . Mean mucosal defect diameter immediately after HSP and CSP was 5.1 mm and 7.5 mm , respectively ( P < .001 ) . The diameter 1 day after the procedure increased by 29 % ( 95 % confidence interval [ CI ] , 17%-41 % ) with HSP and decreased by 25 % ( 95 % CI , 18%-32 % ) with CSP ( P < .001 ) . Muscularis mucosa was obtained similarly with HSP and CSP ( 96 % [ 95 % CI , 82%-99 % ] vs 92 % [ 95 % CI , 75%-98 % ] ; P = .603 ) . Submucosal tissue was obtained significantly more frequently with HSP than with CSP ( 81 % [ 95 % CI , 63%-92 % ] vs 24 % [ 95 % CI , 11%-43 % ] ; P < .001 ) . CONCLUSIONS The resection width immediately after CSP was larger than that after HSP but was significantly smaller at day 1 after resection . Although the resection depth after CSP was more superficial , muscularis mucosa was obtained in most specimens . Thus , CSP has sufficient resection width and depth to enable complete polyp resection and potentially has a superior safety profile than HSP BACKGROUND Both cold-only snare and hot polypectomy snare are used for the removal of small colorectal polyps . OBJECTIVE To compare the outcome of cold snare polypectomy of small colorectal polyps with a snare exclusively design ed as a cold snare versus cold snare polypectomy by using a traditional polypectomy snare . DESIGN Prospect i ve , r and omized , controlled study . SETTING Municipal hospital in Japan . INTERVENTIONS Patients with colorectal polyps 10 mm or smaller in diameter were r and omized to dedicated cold snare ( dedicated cold snare group ) or traditional cold snare ( traditional cold snare group ) . The primary outcome measure was complete resection rates by cold snaring based on pathological examination . Secondary outcomes included bleeding within 2 weeks after polypectomy and identification of submucosal arteries and injured arteries in the resected specimens . RESULTS Seventy-six patients having 210 eligible polyps were r and omized : dedicated cold snare group , N = 37 ( 98 polyps ) and traditional cold snare group , N = 39 ( 112 polyps ) . Patient demographic characteristics including the number , size , and shape of the polyps removed were similar in the 2 groups . The complete resection rate was significantly greater with the dedicated cold than with the traditional cold snare ( 91 % [ 89/98 ] vs 79 % [ 88/112 ] , P = .015 ) , with a marked difference with 8- to 10-mm polyps , both flat and pedunculated . Immediate bleeding and hematochezia rates were similar ( 19 % vs 21 % , P = .86 ; 5.4 % vs 7.7 % , P = .69 ) . No delayed bleeding occurred . Histology demonstrated a similar prevalence of arteries and injured arteries in the submucosa ( 33 % [ 32/96 ] vs 30 % [ 31/104 ] , P = .59 ; 3.1 % [ 3/96 ] vs 6.7 % [ 7/104 ] , P = .24 ) . LIMITATIONS Small sample size , single-center study . CONCLUSION Polypectomy by using a dedicated cold snare result ed in complete polyp removal more often than did cold snaring with a traditional snare , especially polyps 8 to 10 mm in diameter , whether flat or pedunculated . ( CLINICAL TRIAL REGISTRATION NUMBER NCT02036047 . BACKGROUND Cold snare techniques are widely used for removal of diminutive and small colorectal polyps . The influence of resection technique on the effectiveness of polypectomy is unknown . We therefore compared st and ard cold snare polypectomy with a newly described suction pseudopolyp technique , for completeness of excision and for complications . PATIENTS AND METHODS In this single-center study , 112 patients were r and omized to cold snare polypectomy or the suction pseudopolyp technique . Primary outcome was endoscopic completeness of excision . Consensus regarding the endoscopic assessment of completeness of excision was st and ardized and aided by chromoendoscopy . Secondary outcomes included : completeness of histological excision , polyp " fly away " and retrieval rates , early bleeding ( 48 hours ) , delayed bleeding ( 2 weeks ) , and perforation . RESULTS 148 polyps were removed , with size range 3 - 7 mm , 60 % in the left colon , and 90 % being sessile . Regarding completeness of excision ( with uncertain findings omitted ) : endoscopically , this was higher with the suction pseudopolyp technique compared with cold snare polypectomy but not statistically significantly so ( 73/74 [ 98.6 % ] vs. 63/68 [ 92.6 % ] ; P = 0.08 ) . A trend towards a higher complete histological excision rate with the suction pseudopolyp technique was also not statistically significant ( 45/59 [ 76.3 % ] vs. 37/58 [ 63.8 % ] ; P = 0.14 ) . Polyp retrieval rate was not significantly different ( suction 68/76 [ 89.5 % ] vs. cold snare 64/72 [ 88.9 % ] ; P = 0.91 ) . No perforation or bleeding requiring hemostasis occurred in either group . CONCLUSION In this study both polypectomy techniques were found to be safe and highly effective , but further large multicenter trials are required . Clinical trial registration at www . clinical trials.gov : NCT02208401 BACKGROUND The bleeding risk after cold snare polypectomy in anticoagulated patients is not known . OBJECTIVE To compare the bleeding risk after cold snare polypectomy or conventional polypectomy for small colorectal polyps in anticoagulated patients . DESIGN Prospect i ve r and omized controlled study . SETTING Municipal hospital in Japan . INTERVENTIONS Anticoagulated patients with colorectal polyps up to 10 mm in diameter were enrolled . Patients were r and omized to polypectomy with either cold snare technique ( Cold group ) or conventional polypectomy ( Conventional group ) without discontinuation of warfarin . The primary outcome measure was delayed bleeding ( ie , requiring endoscopic intervention within 2 weeks after polypectomy ) . Secondary outcome measures were immediate bleeding and retrieval rate of colorectal polyps . RESULTS Seventy patients were r and omized ( 159 polyps ) : Cold group ( n = 35 , 78 polyps ) and Conventional group ( n = 35 ; 81 polyps ) . The patients ' demographic characteristics including international normalized ratio and the number , size , and shape of polyps removed were similar between the 2 techniques . Immediate bleeding during the procedure was more common with conventional polypectomy ( 23 % [ 8/35 ] ) compared with cold polypectomy ( 5.7 % [ 2/35 ] ) ( P = .042 ) . No delayed bleeding occurred in the Cold group , whereas 5 patients ( 14 % ) required endoscopic hemostasis in the Conventional group ( P = .027 ) . Complete polyp retrieval rates were identical ( 94 % [ 73/78 ] vs 93 % [ 75/81 ] ) . The presence of histologically demonstrated injured arteries in the submucosal layer with cold snare Output:	Conclusions : CSP and HSP may result in the same complete resection rates for polyps ≤10 mm .
MS21720	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND & AIMS Confocal laser endomicroscopy allows subsurface analysis of the intestinal mucosa and in vivo histology during ongoing endoscopy . Here , we have applied this technique to the in vivo diagnosis of Barrett 's epithelium and associated neoplasia . METHODS Fluorescein-aided endomicroscopy was performed by applying the endomicroscope over the whole columnar-lined lower esophagus . Images obtained within 1 cm of the columnar-lined lower esophagus were stored digitally and a targeted biopsy examination or endoscopic mucosal resection of the examined areas was performed . In vivo histology was compared with the histologic specimens . All digitally stored images were re-assessed by a blinded investigator by the confocal Barrett classification system to predict histology . Intraobserver and interobserver variations of the involved endoscopists were evaluated by using kappa statistics . RESULTS Endomicroscopy allowed distinguishing between different types of epithelial cells and detected cellular and vascular changes in Barrett 's epithelium at high resolution during ongoing endoscopy in 63 patients . Barrett 's esophagus and associated neoplasia could be predicted with a sensitivity of 98.1 % and 92.9 % and a specificity of 94.1 % and 98.4 % , respectively ( accuracy , 96.8 % and 97.4 % ) . The mean kappa value for interobserver agreement for the prediction of histopathological diagnosis was .843 , whereas the intraobserver agreement showed a mean kappa value of .892 . CONCLUSIONS Fluorescence-aided endomicroscopy of Barrett 's esophagus allows in vivo histology of the mucosal layer during ongoing endoscopy . Gastric and Barrett 's epithelium and Barrett's-associated neoplastic changes can be diagnosed with high accuracy . Thus , endomicroscopy may be helpful in the management of patients with Barrett 's esophagus Objectives Loss of intestinal barrier function plays an important role in the pathogenesis of inflammatory bowel disease ( IBD ) . Shedding of intestinal epithelial cells is a potential cause of barrier loss during inflammation . The objectives of the study were ( 1 ) to determine whether cell shedding and barrier loss in humans can be detected by confocal endomicroscopy and ( 2 ) whether these parameters predict relapse of IBD . Methods Confocal endomicroscopy was performed in IBD and control patients using intravenous fluorescein to determine the relationship between cell shedding and local barrier dysfunction . A grading system based on appearances at confocal endomicroscopy in humans was devised and used to predict relapse in a prospect i ve pilot study of 47 patients with ulcerative colitis and 11 patients with Crohn 's disease . Results Confocal endomicroscopy in humans detected shedding epithelial cells and local barrier defects as plumes of fluorescein effluxing through the epithelium . Mouse experiments demonstrated inward flow through some leakage-associated shedding events , which was increased when luminal osmolarity was decreased . In IBD patients in clinical remission , increased cell shedding with fluorescein leakage was associated with subsequent relapse within 12 months after endomicroscopic examination ( p<0.001 ) . The sensitivity , specificity and accuracy for the grading system to predict a flare were 62.5 % ( 95 % CI 40.8 % to 80.4 % ) , 91.2 % ( 95 % CI 75.2 to 97.7 ) and 79 % ( 95 % CI 57.7 to 95.5 ) , respectively . Conclusions Cell shedding and barrier loss detected by confocal endomicroscopy predicts relapse of IBD and has potential as a diagnostic tool for the management of the disease OBJECTIVES : Epithelial gaps result ing from intestinal cell extrusions can be visualized with confocal laser endomicroscopy ( CLE ) during colonoscopy and increased in normal-appearing terminal ileum of inflammatory bowel disease ( IBD ) patients . Cell-shedding events on CLE were found to be predictive of disease relapse . The aim of this study was to assess the prognostic value of epithelial gap densities for major clinical events ( hospitalization or surgery ) in follow-up . METHODS : We prospect ively followed IBD patients undergoing colonoscopy with probe-based CLE ( pCLE ) for clinical events including symptom flares , medication changes , hospitalization , or surgery . Survival analysis methods were used to compare event times for the composite outcome of hospitalization or surgery using log-rank tests and Cox proportional hazards models . We also examined the relationship of gap density with IBD flares , need for anti-tumor necrosis factor therapy , disease duration , gender and endoscopic disease severity , and location . RESULTS : A total of 21 Crohn 's disease and 20 ulcerative colitis patients with a median follow-up of 14 ( 11–31 ) months were studied . Patients with elevated gap density were at significantly higher risk for hospitalization or surgery ( log-rank test P=0.02 ) . Gap density was a significant predictor for risk of major events , with a hazard ratio of 1.10 ( 95 % confidence interval=1.01 , 1.20 ) associated with each increase of 1 % in gap density . Gap density was also correlated with IBD disease duration ( Spearman 's correlation coefficient rho=0.44 , P=0.004 ) , and was higher in male patients ( 9.0 vs. 3.6 gaps per 100 cells , P=0.038 ) . CONCLUSIONS : Increased epithelial gaps in the small intestine as determined by pCLE are a predictor for future hospitalization or surgery in IBD patients BACKGROUND Confocal endomicroscopy is a newly developed endoscopic imaging technology that produces 1000-fold magnification cross-sectional images of the GI surface and subsurface tissue during routine endoscopy . The gastric pit patterns identified by confocal endomicroscopy and correlation with histopathologic examination have not yet been established . OBJECTIVE Our purpose was to explore the appearance of various kinds of gastric pits and clarify the relationship between gastric pit patterns and the histopathologic findings . DESIGN Descriptive study . SETTING Qilu Hospital , Sh and ong University , Jinan , China . PATIENTS A total of 132 consecutive patients underwent confocal endomicroscopy after 7 healthy volunteers had been examined in vivo and 10 sample s resected from 10 patients with gastric cancer had been examined ex vivo by use of confocal endomicroscopy . The confocal images obtained from the 132 patients were compared with the histopathologic findings of the biopsy specimens from the corresponding confocal imaging sites in a prospect i ve and blinded fashion . MAIN OUTCOME MEASUREMENTS The relationship between the pit patterns and the histopathologic findings . RESULTS Gastric pit patterns were classified into 7 types . Normal mucosa with fundic gl and s mainly showed type A ( round pits ) , and corporal mucosa with histologic gastritis showed type B ( noncontinuous short rod-like ) ; normal mucosa with pyloric gl and s mainly showed type C ( continuous short rod-like ) , and antral mucosa with histologic gastritis showed type D ( elongated and tortuous branch-like ) . Goblet cells were easily distinguished by confocal endomicroscopy in intestinal metaplasia mucosa , which showed type F. The sensitivity and specificity of the type E pattern for predicting gastric atrophy were 83.6 % and 99.6 % , respectively . Corresponding values of the type G pattern for predicting gastric cancer were 90.0 % and 99.4 % . LIMITATIONS No data on interobserver and intraobserver variability . CONCLUSIONS The patterns of gastric pits identified by confocal endomicroscopy correlate well with the histopathologic findings . Confocal endomicroscopy may prove useful in predicting histopathologic diagnoses during routine endoscopic procedures Background Patients with ulcerative colitis and Crohn 's colitis have increased risk of colorectal cancer . Current screening endoscopy protocol s based on white light endoscopy ( WLE ) and r and om biopsies are laborious and of uncertain sensitivity . Novel endoscopic techniques include chromoendoscopy ( CE ) and confocal laser endomicroscopy ( CLE ) . Aim The aim was to compare WLE and CE for the detection of intraepithelial neoplasia ( IEN ) . Furthermore , we analysed the sensitivity and specificity of CE and CLE for the diagnosis of IEN . Methods The cohort consisted of 30 patients examined by WLE , CE with 0.4 % indigocarmine , and by a CLE system Pentax EC-3870CIFK during one examination . Additional 15 patients were examined by conventional protocol only . R and om biopsies and biopsies from all suspicious lesions were taken . We compared the number of IENs detected by WLE and CE and analysed the predictive values of CE and CLE for the histology diagnosis . Results There were 1584 r and om biopsies ( 35.2 per patient ) taken . There were 78 targeted biopsies ( 1.7 per patient ) taken in 24 of 45 patients examined by WLE and an additional 36 biopsies in 16 of 30 patients examined by CE ( 1.17 additional per patient ) . There were no IENs found on r and om biopsies versus six low- grade or high- grade IENs in four patients ( two detected by WLE , four additional by CE ) from targeted biopsies , P=0.02 . A total of 100 suspicious lesions were detected and analysed by CE and histology . CLE could not examine 32 of 100 lesions ( two of 30 flat vs. 30 of 70 pedunculated lesions , P=0.0002 , odds ratio 10.5 ) . The sensitivity of CE/CLE for low- grade or high- grade IEN was 100/100 % , the specificity 96.8/98.4 % , positive predictive value was 62.5/66.7 % and negative predictive value was 100/100 % . Conclusion Targeted biopsies are superior to r and om biopsies in the screening of IEN in patients with inflammatory bowel disease . CE increases the diagnostic yield of WLE . In our study CLE did not provide additional clinical benefits Background : Increased cell shedding with gap formation and local barrier dysfunction can be identified endomicroscopically in the terminal ileum of patients with inflammatory bowel disease . We aim to evaluate whether these changes are also present in the duodenum of patients with inflammatory bowel disease . Methods : Fifteen patients with Crohn 's disease ( CD ) , 10 patients with ulcerative colitis ( UC ) , and 10 controls underwent fluorescein-aided confocal laser endomicroscopy ( CLE ) . CLE was performed on macroscopically normal antral and duodenal ( D1 , D2 , D3 , D4 ) mucosa . Representative CLE images were prospect ively analyzed . Images were scored for the number of epithelial gaps , cell shedding , and the degree of fluorescein leakage into the intestinal lumen . Results : Both CD and UC patients had significantly more epithelial gaps , epithelial cell shedding , and leakage of fluorescein into the duodenal lumen than controls . The degree of cell shedding and epithelial gap formation was similar in CD and UC patients . In all cases , macroscopic endoscopic appearances of the duodenum were normal , and conventional histological analysis showed a mild nonspecific duodenitis in 7 of 15 patients with CD . Patients with UC had a histologically normal duodenum . Gap formation , cell shedding , and fluorescein leakage was similar in CD with active compared with inactive disease , except for D2 shedding . Conclusions : CLE can detect epithelial damage and barrier loss in the duodenum of CD and UC patients that is not apparent on conventional endoscopy or histology BACKGROUND The diagnosis of pancreatic cystic neoplasms ( PCNs ) , which now depends on morphology , cytology , and fluid analysis , is still challenging . A novel confocal laser endomicroscopy probe that can be inserted through a 19-gauge FNA needle allows needle-based confocal laser endomicroscopy ( nCLE ) , and the feasibility of nCLE has been reported in PCNs . The combination of cystoscopy by using a through-the-needle fiberoptic probe in combination with nCLE under EUS guidance may improve the diagnosis of PCNs . OBJECTIVE To assess the feasibility , safety , and diagnostic yield of the combination of cystoscopy and nCLE in the clinical diagnosis of PCNs . DESIGN A prospect i ve feasibility study . SETTING An academic tertiary referral center . PATIENTS Thirty patients with PCNs . INTERVENTIONS EUS-guided dual through-the-needle imaging ( cystoscopy and nCLE ) for PCNs . MAIN OUTCOME MEASUREMENTS Technical feasibility and safety . Associations of cystoscopy and nCLE findings with clinical diagnosis of PCNs . RESULTS The procedure was technically successful with the exception of 1 probe exchange failure . In 2 patients ( 7 % ) , postprocedure pancreatitis developed . Specific features associated with the clinical diagnosis of mucinous cysts were identified : mucin on cystoscopy and papillary projections and dark rings on nC Output:	CLE demonstrated high sensitivity and specificity in the detection of dysplasia in Barrett 's esophagus , gastric neoplasms and polyps , colorectal cancers in inflammatory bowel disease , malignant pancreatobiliary strictures , and pancreatic cysts .
MS21721	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A tendency toward abstract and overgeneral processing is a cognitive bias hypothesized to causally contribute to symptoms of depression . This hypothesis predicts that training dysphoric individuals to become more concrete and specific in their thinking would reduce depressive symptoms . To test this prediction , 60 participants with dysphoria were r and omly allocated either to ( a ) concreteness training ; ( b ) bogus concreteness training , matched with concreteness training for treatment rationale , experimenter contact , and treatment duration but without active engagement in concrete thinking ; ( c ) a waiting-list , no training control . Concreteness training result ed in significantly greater decreases in depressive symptoms and significantly greater increases in concrete thinking than the waiting-list and the bogus training control , and significantly greater decreases in rumination than the waiting-list control . These findings suggest that concreteness training has potential as a guided self-help intervention for mild-to-moderate depressive symptoms BACKGROUND Behavioural activation appears as effective as cognitive-behaviour therapy ( CBT ) in the treatment of depression . If equally effective , then behavioural activation may be the preferred treatment option because it may be suitable for delivery by therapists with less training . This is the first r and omised controlled trial to look at this possibility . AIMS To examine whether generic mental health workers can deliver effective behavioural activation as a step-three high-intensity intervention . METHOD A r and omised controlled trial ( IS RCT N27045243 ) comparing behavioural activation ( n=24 ) with treatment as usual ( n=23 ) in primary care . RESULTS Intention-to-treat analyses indicated a difference in favour of behavioural activation of -15.79 ( 95 % CI -24.55 to -7.02 ) on the Beck Depression Inventory-II and Work and Social Adjustment Scale ( mean difference -11.12 , 95 % CI -17.53 to -4.70 ) . CONCLUSIONS Effective behavioural activation appears suitable for delivery by generic mental health professionals without previous experience as therapists . Large-scale trial comparisons with an active comparator ( CBT ) are needed OBJECTIVE Depression is highly prevalent among illicit drug users , and this co-occurrence is associated with poorer treatment outcomes . However , there has been limited empirical attention toward developing and assessing behavioral interventions for depression among illicit drug users . The objective of the current study was to test the efficacy of integrating a brief behavioral intervention for depression into st and ard inpatient substance abuse treatment . METHOD Forty-four adult illicit drug users with mild to moderate depressive symptoms ( Beck Depression Inventory-II [ BDI-II ] score > or= 10 ) who were receiving inpatient substance abuse treatment were r and omly assigned to either treatment as usual ( TAU ) alone or TAU plus brief behavioral therapy for depression ( i.e. , Life Enhancement Treatment for Substance Use [ LETS Act ! ] ) . Patients were assessed at baseline for DSM-IV psychiatric diagnoses , depressive symptoms ( Hamilton Rating Scale for Depression , BDI-II ) , anxiety symptoms ( Beck Anxiety Inventory ) , and enjoyment and reward value of activities ( Environmental Reward Observation Scale ) . Patients were again assessed at posttreatment and at 2-week follow-up . Treatment satisfaction and attrition rates also were assessed at posttreatment . Data were collected from November 2005 to March 2006 . RESULTS Patients who received the LETS Act ! intervention ( N = 22 ) evidence d significantly greater improvements than the TAU group ( N = 22 ) in severity of depression , anxiety symptoms , and enjoyment and reward value of activities at posttreatment and in depressive symptoms at 2-week follow-up . The LETS Act ! group also reported significantly higher treatment satisfaction ratings . CONCLUSIONS This study supports the efficacy of LETS Act ! in treating depressive symptoms and improving the enjoyment and reward value of activities among illicit drug users currently receiving inpatient substance use treatment . Data also indicate the intervention may help prevent treatment attrition . LETS Act ! appears to be a feasible and parsimonious intervention to improve the treatment of depression and overall quality of care within inpatient substance abuse treatment setting BACKGROUND Depressed patients are often characterised by marital distress , but few studies investigate the effects of marital therapy on depressed mood and relationship dysfunction . METHOD Twenty-seven depressed patients experiencing marital distress were r and omly assigned to either individual behavioural-cognitive therapy or marital therapy . The individual treatment condition focused on depressed mood , behavioural activity and dysfunctional cognitions , whereas in the marital condition the partner was involved in the treatment and the focus was on the communication process in the marital relationship . MANOVAs revealed that treatment led to statistically significant improvements in depressed mood , behavioural activity and dysfunctional cognitions , an increase in relationship satisfaction and improvement of communication in patients and spouses . A significant interaction effect was found , showing that marital therapy had more impact on relationship variables than the individual treatment . CONCLUSION Both individual cognitive-behaviour therapy and marital therapy lead to less depressive complaints , and both treatment conditions have a positive effect on the relationship , although the effect on the relationship is significantly stronger in couples who were tested by marital therapy compared with patients who were treated individually Background Despite the high prevalence of postnatal depression ( PND ) , few women seek help . Internet interventions may overcome many of the barriers to PND treatment use . We report a phase II evaluation of a 12-session , modular , guided Internet behavioural activation ( BA ) treatment modified to address postnatal-specific concerns [ Netmums Helping With Depression ( NetmumsHWD ) ] . Method To assess feasibility , we measured recruitment and attrition to the trial and examined telephone session support and treatment adherence . We investigated sociodemographic and psychological predictors of treatment adherence . Effectiveness outcomes were estimated with the Edinburgh Postnatal Depression Scale ( EPDS ) , Generalized Anxiety Disorder-7 , Work and Social Adjustment Scale , Postnatal Bonding Question naire , and Social Provisions Scale . Results A total of 249 women were recruited via a UK parenting site , Netmums.com . A total of 83 women meeting DSM-IV criteria for major depressive disorder were r and omized to NetmumsHWD ( n = 41 ) or treatment-as-usual ( TAU ; n = 42 ) . Of the 83 women , 71 ( 86 % ) completed the EPDS at post-treatment , and 71 % ( 59/83 ) at the 6-month follow-up . Women completed an average of eight out of 12 telephone support sessions and five out of 12 modules . Working women and those with less support completed fewer modules . There was a large effect size favouring women who received NetmumsHWD on depression , work and social impairment , and anxiety scores at post-treatment compared with women in the TAU group , and a large effect size on depression at 6 months post-treatment . There were small effect sizes for postnatal bonding and perceived social support . Conclusions A supported , modular , Internet BA programme can be feasibly delivered to postpartum women , offering promise to improve depression , anxiety and functioning BACKGROUND Behavioural activation might be a viable alternative to antidepressant medication for major depressive disorder . AIMS To compare the effectiveness of behavioural activation and treatment as usual ( TAU , antidepressant medication ) for major depressive disorder in routine clinical practice in Iran . METHOD Patients with major depressive disorder ( n = 100 ) were r and omised to 16 sessions of behavioural activation ( n = 50 ) or antidepressant medication ( n = 50 ) ( I RCT 138807192573N1 ) . The main outcome was depression , measured with the Beck Depression Inventory ( BDI ) and the Hamilton Rating Scale for Depression ( HRSD ) , assessed at 0 , 4 , 13 and 49 weeks . RESULTS Symptom reduction was greater in the behavioural activation group than in the TAU group on both the BDI and the HRSD at 13 and 49 weeks in multilevel analysis . Baseline depression severity was a moderator , with relatively better effects for behavioural activation in individuals who were more severely depressed . Also , there was better retention in the behavioural activation than in the TAU group . CONCLUSIONS Behavioural activation is a viable and effective treatment for people with major depressive disorder , especially for those who are more severely depressed , and it can successfully be disseminated into routine practice setting s in a non-Western country such as Iran The purpose of this study was to provide an experimental test of the theory of change put forth by A. T. Beck , A. J. Rush , B. F. Shaw , and G. Emery ( 1979 ) to explain the efficacy of cognitive-behavioral therapy ( CT ) for depression . The comparison involved r and omly assigning 150 out patients with major depression to a treatment focused exclusively on the behavioral activation ( BA ) component of CT , a treatment that included both BA and the teaching of skills to modify automatic thoughts ( AT ) , but excluding the components of CT focused on core schema , or the full CT treatment . Four experienced cognitive therapists conducted all treatments . Despite excellent adherence to treatment protocol s by the therapists , a clear bias favoring CT , and the competent performance of CT , there was no evidence that the complete treatment produced better outcomes , at either the termination of acute treatment or the 6-month follow-up , than either component treatment . Furthermore , both BA and AT treatments were just as effective as CT at altering negative thinking as well as dysfunctional attributional styles . Finally , attributional style was highly predictive of both short- and long-term outcomes in the BA condition , but not in the CT condition This study followed treatment responders from a r and omized controlled trial of adults with major depression . Patients treated with medication but withdrawn onto pill-placebo had more relapse through 1 year of follow-up compared to patients who received prior behavioral activation , prior cognitive therapy , or continued medication . Prior psychotherapy was also superior to medication withdrawal in the prevention of recurrence across the 2nd year of follow-up . Specific comparisons indicated that patients previously exposed to cognitive therapy were significantly less likely to relapse following treatment termination than patients withdrawn from medication , and patients previously exposed to behavioral activation did almost as well relative to patients withdrawn from medication , although the difference was not significantly different . Differences between behavioral activation and cognitive therapy were small in magnitude and not significantly different across the full 2-year follow-up , and each therapy was at least as efficacious as the continuation of medication . These findings suggest that behavioral activation may be nearly as enduring as cognitive therapy and that both psychotherapies are less expensive and longer lasting alternatives to medication in the treatment of depression In a study design ed to maximize the effectiveness of treatment by allowing participants to select the target of treatment , 40 depressed older adults were r and omly assigned to a waiting-list control condition or to conditions in which the target of treatment was either chosen or assigned . All participants received self-management therapy and the choice was between changing behavior or changing cognition . It was found that individually administered self-management therapy was effective in treating depression for older adults . There were no differences in outcome between versions of self-management therapy that targeted behavioral or cognitive change . Among those who completed treatment , there were no differences in outcome between those who received a choice and those who did not . Individuals who were given a choice of treatment options , however , were less likely to drop out of treatment prematurely OBJECTIVE Major depression is the most common psychiatric disorder among breast cancer patients and is associated with substantial impairment . Although some research has explored the utility of psychotherapy with breast cancer patients , only 2 small trials have investigated the potential benefits of behavior therapy among patients with well-diagnosed depression . METHOD In a primarily Caucasian , well-educated sample of women ( age = 55.4 years , SD = 11.9 ) diagnosed with breast cancer and major depression ( n = 80 ) , this study was a r and omized clinical trial testing the efficacy of 8 sessions of behavioral activation treatment for depression ( BATD ) compared to problem-solving therapy . Primary outcome measures assessed depression , environmental reward , anxiety , quality of life , social support , and medical outcomes . RESULTS Across both treatments , results revealed strong treatment integrity , excellent patient satisfaction with treatment protocol s , and low patient attrition ( 19 % ) . Intent-to-treat analyses suggested both treatments were efficacious , with both evidencing significant pre-post treatment gains across all outcome measures . Across both treatments , gains were associated with strong effect sizes , and based on response and remission criteria , a reliable change index , and numbers-needed-to-treat analyses , approximately ¾ of patients exhibited clinical ly significant improvement . No significant group differences were found at posttreatment . Treatment gains were maintained at 12-month follow-up , with some support for stronger maintenance of gains in the BATD group . CONCLUSIONS BATD and problem-solving interventions represent practical interventions that may improve psychological outcomes and quality of life among depressed breast cancer patients . Study limitations and future research directions are discussed Depression presents a significant public health burden for Latinos , the largest and fastest-growing minority group in the United States . The current study performed a r and omized controlled trial of Behavioral Activation ( BA ) for Latinos ( BAL , n=21 ) , with relatively minor modifications , compared to treatment as usual ( TAU , n=22 ) in a community mental health clinic setting with a sample of depressed , Spanish-speaking Latinos . TAU was a strong comparison condition , taking place at the same clinic , under the same guidelines and clinic protocol s , with similar levels of ongoing consultation , and using the same pool of therapists as BAL . Results indicated that BAL performed well with respect to treatment engagement and retention . Regarding acute treatment out Output:	The results in this meta- analysis support and strengthen the evidence base indicating Behavioural Activation is an effective treatment for depression .
MS21722	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: INTRODUCTION Reporting of r and omized controlled trials ( RCTs ) should be of high quality to support the conclusions reached by the authors . Poor- quality reporting has been associated with an overestimation in intervention efficacy . Within the field of paediatric dentistry , no study has assessed the quality of reporting . OBJECTIVE The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for : ( i ) whether quality of reporting allows readers to assess the validity of trials ; and ( ii ) whether quality of reporting has improved since the introduction of the Consoli date d St and ards of Reporting Trials ( CONSORT ) guidelines . METHODS H and search of the main paediatric dentistry journals ; inclusion criteria were : the trial was performed on children , and RCT . CONSORT guidelines were made into an operational checklist . Trials published between 1985 and 1997 , and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines . RESULTS One hundred and seventy-three of 5635 articles met the inclusion criteria . Reporting quality was poor overall and showed heterogeneity . It had improved slightly since the publication of CONSORT . Few trials were reported adequately . CONCLUSION The quality of reporting of clinical trials is poor , and often not adequate to allow readers to assess trial validity . Overall quality of reporting has not substantially improved since the publication of CONSORT There is consensus that children have question able decisional capacity and , therefore , in general a parent or a guardian must give permission to enroll a child in a research study . Moreover , freedom from duress and coercion , the cardinal rule in research involving adults , is even more important for children . This principle is embodied prominently in the Nuremberg Code ( 1947 ) and is embodied in various federal human research protection regulations . In a program named " SATURN " ( Student Athletic Testing Using R and om Notification ) , each school in the Oregon public-school system may implement a m and atory drug-testing program for high school student athletes . A prospect i ve study to identify drug use among student-athletes , SATURN is design ed both to evaluate the influence of r and om drug testing and to vali date the survey data through identification of individuals who do not report drug use . The enrollment of students in the drug-testing study is a requirement for playing a school sport . In addition to the coercive nature of this study design , there were ethically question able practice s in recruitment , informed consent , and confidentiality . This article concerns the question of whether research can be conducted with high school students in conjunction with a m and atory drug-testing program , while adhering to prevailing ethical st and ards regarding human-subjects research and specifically the participation of children in research Background All r and omized clinical trials ( RCTs ) require a protocol ; however , numerous studies have highlighted protocol deficiencies . Reporting guidelines may improve the content of research reports and , if developed using robust methods , may increase the utility of reports to stakeholders . The objective of this study was to systematic ally identify and review RCT protocol guidelines , to assess their characteristics and methods of development , and to compare recommendations . Methods We conducted a systematic review of indexed literature ( MEDLINE , EMBASE and the Cochrane Methodology Register from inception to September 2010 ; reference lists ; related article features ; forward citation search ing ) and a targeted search of supplementary sources , including a survey of major trial funding agencies in six countries . Records were eligible if they described a content guideline in English or French relevant to RCT protocol s. Guidelines were excluded if they specified content for protocol s for trials of specific procedures or conditions or were intended to assess trial quality . We extracted guideline characteristics and methods . Content was mapped for a subset of guidelines that described development methods or had institutional endorsement . Results Forty guidelines published in journals , books and institutional reports were included in the review ; seven were specific to RCT protocol s. Only eight ( 20 % ) described development methods which included informal consensus methods , pilot testing and formal validation ; no guideline described all of these methods . No guideline described formal consensus methods or a systematic retrieval of empirical evidence to inform its development . The guidelines included a median of 23 concepts per guideline ( interquartile range ( IQR ) = 14 to 34 ; range = 7 to 109 ) . Among the subset of guidelines ( n = 23 ) for which content was mapped , approximately 380 concepts were explicitly addressed ( median concepts per guideline IQR = 31 ( 24,80 ) ; range = 16 to 150 ) ; most concepts were addressed in a minority of guidelines . Conclusions Existing guidelines for RCT protocol content varied substantially in their recommendations . Few reports described the methods of guideline development , limiting comparisons of guideline validity . Given the importance of protocol s to diverse stakeholders , we believe a systematic ally developed , evidence -informed guideline for clinical trial protocol s is needed BACKGROUND Despite the high prevalence and negative physical and psychosocial consequences of overweight and obesity in adolescents , very little research has evaluated treatment in this population . Consequently , clinicians working with overweight and obese adolescents have little empirical research on which to base their practise . Cognitive behavioural therapy has demonstrated efficacy in promoting behaviour change in many treatment resistant disorders . Motivational interviewing has been used to increase motivation for change and improve treatment outcomes . In this paper we describe the rationale and design of a r and omised controlled trial testing the efficacy of motivational interviewing and cognitive behaviour therapy in the treatment of overweight and obese adolescents . METHODS Participants took part in a motivational interview or a st and ard semi-structured assessment interview and were then r and omly allocated to a cognitive behavioural intervention or a wait-list control condition . The cognitive behavioural intervention , the CHOOSE HEALTH Program , consisted of 13 individual treatment sessions ( 12 face-to-face , 1 phone call ) followed by 9 maintenance sessions ( 7 phone calls , 2 face-to-face ) . Assessment s were conducted prior to participation , after the treatment phase and after the maintenance phase of intervention . Improvement in body composition was the primary outcome ; secondary outcomes included improved cardiovascular fitness , eating and physical activity habits , family and psychosocial functioning . CONCLUSION Despite the demonstrated effectiveness of motivational interviewing and cognitive behavioural therapy in the long-term management of many treatment resistant disorders , these approaches have been under-utilised in adolescent overweight and obesity treatment . This study provides baseline data and a thorough review of the study design and treatment approach to allow for the assessment of the efficacy of motivational interviewing and cognitive behavioural therapy in the treatment of adolescent overweight and obesity . Data obtained in this study will also provide much needed information about the behavioural and psychosocial factors associated with adolescent overweight and obesity Purpose This article is aim ed at describing the methodology of “ ethical reasoning ” that finally led TEDDYNoE ( Task-force in Europe for Drug Development for the Young ) to propose the integration of international human rights law to develop coherent and exhaustive ethical recommendations on paediatric research at a European level . Methods A large number of ethical guidelines and texts of varying legal force existing in the field of clinical research and in particular related to paediatrics are analysed . Differences and non-coordinated implementation are pointed out . Results Differences , tensions or outright contradictions among the provisions of these texts can generate confusion leading to the adoption of different ethical st and ards across Europe . In this context , the real challenge is to ensure that each child involved in a clinical trial in the EU territory may rely directly on the same principles and rights . Taking international human rights law as the main starting point to develop a coherent framework for paediatric research that incorporates all the relevant ethical considerations and existing guidelines is a way of achieving this objective . Conclusions The implementation , at national and local level , of the “ European Ethical Recommendations ” ( Eudralex 2008 vol . 10 ) , based on international human rights law , seems to be the next step in facilitating a coordinated approach to the application of the Directive 2001/20/EC , as well as developing quality and ethically sound paediatric research Cortisol does not exhibit a straightforward relationship with mood states ; administration of glucocorticoids to human subjects has produced mixed effects on mood and emotional processing . In this study , participants ( N=46 ) received intravenous hydrocortisone ( synthetic cortisol ; 0.1mg/kg body weight ) and placebo in r and omized order over two sessions 48h apart . Following the infusion , participants rated neutral and unpleasant pictures . In Session 1 , participants reported elevated negative affect ( NA ) following the picture-rating task , regardless of treatment . In Session 2 , however , only participants who received cortisol ( and thus who had received placebo in Session 1 ) reported elevated NA . Arousal ratings for unpleasant pictures followed a similar pattern . These findings suggest that the effects of cortisol on emotion vary based on situational factors , such as drug administration order or familiarity with the tasks and setting . Such factors can influence cortisol 's effects on emotion in two ways : ( A ) cortisol may only potentiate NA and arousal ratings in the absence of other , overwhelming influences on affect , such as the novelty of the setting and tasks in Session 1 ; and ( B ) cortisol in Session 1 may facilitate learning processes ( e.g. , habituation to the stimuli and setting ; extinction of aversive responses ) such that emotional responses to the pictures are lessened in Session 2 . This interpretation is compatible with a body of literature on the effects of glucocorticoids on learning and memory processes CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion Objective To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in r and omised trials . Design Retrospective cohort study . Data source Protocol s and journal publications of published r and omised parallel group trials initially approved in 1994 - 5 by the scientific-ethics committees for Copenhagen and Frederiksberg , Denmark ( n=70 ) . Main outcome measure Proportion of protocol s and publications that did not provide key information about sample size calculations and statistical methods ; proportion of trials with discrepancies between information presented in the protocol and the publication . Results Only 11/62 trials described existing sample size calculations fully and consistently in both the protocol and the publication . The method of h and ling protocol deviations was described in 37 protocol s and 43 publications . The method of h and ling missing data was described in 16 protocol s and 49 publications . 39/49 protocol s and 42/43 publications reported the statistical test used to analyse primary outcome measures . Unacknowledged discrepancies between protocol s and publications were found for sample size calculations ( 18/34 trials ) , methods of h and ling protocol deviations ( 19/43 ) and missing data ( 39/49 ) , primary outcome analyses ( 25/42 ) , subgroup analyses ( 25/25 ) , and adjusted analyses ( 23/28 ) . Interim analyses were described in 13 protocol s but mentioned in only five corresponding publications . Conclusion When reported in publications , sample size calculations and statistical methods were often explicitly discrepant with the protocol or not pre-specified . Such amendments were rarely acknowledged in the trial publication . The reliability of trial reports can not be assessed without having access to the full protocol The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . 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 . Treating malaria before immunizing Output:	Conclusion These systematic review s are the first to systematic ally gather evidence and recommendations for the reporting of specific items in pediatric protocol s and trials . They provide useful and translatable evidence on which to build pediatric extensions to the SPIRIT and CONSORT reporting guidelines . The result ing SPIRIT-C and CONSORT-C will provide guidance to the authors of pediatric protocol s and reports , respectively , helping to alleviate concerns of inappropriate and inconsistent reporting , and reduce research waste
MS21723	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Loss of muscle mass with aging is a major public health concern . Omega-3 ( n-3 ) fatty acids stimulate protein anabolism in animals and might therefore be useful for the treatment of sarcopenia . However , the effect of omega-3 fatty acids on human protein metabolism is unknown . OBJECTIVE The objective of this study was to evaluate the effect of omega-3 fatty acid supplementation on the rate of muscle protein synthesis in older adults . DESIGN Sixteen healthy , older adults were r and omly assigned to receive either omega-3 fatty acids or corn oil for 8 wk . The rate of muscle protein synthesis and the phosphorylation of key elements of the anabolic signaling pathway were evaluated before and after supplementation during basal , postabsorptive conditions and during a hyperaminoacidemic-hyperinsulinemic clamp . RESULTS Corn oil supplementation had no effect on the muscle protein synthesis rate and the extent of anabolic signaling element phosphorylation in muscle . Omega-3 fatty acid supplementation had no effect on the basal rate of muscle protein synthesis ( mean ± SEM : 0.051 ± 0.005%/h compared with 0.053 ± 0.008%/h before and after supplementation , respectively ; P = 0.80 ) but augmented the hyperaminoacidemia-hyperinsulinemia-induced increase in the rate of muscle protein synthesis ( from 0.009 ± 0.005%/h above basal values to 0.031 ± 0.003%/h above basal values ; P < 0.01 ) , which was accompanied by greater increases in muscle mTOR(Ser2448 ) ( P = 0.08 ) and p70s6k(Thr389 ) ( P < 0.01 ) phosphorylation . CONCLUSION Omega-3 fatty acids stimulate muscle protein synthesis in older adults and may be useful for the prevention and treatment of sarcopenia . This trial was registered at clinical trials.gov as NCT00794079 Men have more muscle than women , but most studies evaluating sex differences in muscle protein metabolism have been unable to discern sexual dimorphism in basal muscle protein turnover rates in young and middle-aged adults . We hypothesized that the anabolic response to nutritional stimuli ( i.e. , amino acids and insulin ) would be greater in young/middle-aged men than women . We therefore measured the rates of muscle protein synthesis ( MPS ) in 16 healthy individuals [ 8 men and 8 women , matched for age ( mean + /- SE : 37.7 + /- 1.5 yr ) and body mass index ( 25.2 + /- 0.7 kg/m2 ) ] after an overnight fast ( plasma insulin approximately 5 microU/ml and plasma phenylalanine approximately 60 microM ) and during a hyperinsulinemic-hyperaminoacidemic-euglycemic clamp ( plasma insulin approximately 28 microU/ml ; plasma phenylalanine approximately 110 microM ; plasma glucose approximately 5.4 mM ) . The rates of MPS were not different between men and women ( ANOVA main effect for sex ; P = 0.49 ) . During the clamp , the rate of MPS increased by approximately 50 % ( P = 0.003 ) with no difference in the increases from basal values between men and women ( + 0.019 + /- 0.004 vs. + 0.018 + /- 0.010%/h , respectively ; P = 0.93 ) . There were also no differences between men and women in the basal concentrations of muscle phosphorylated Akt(Ser473 ) , Akt(Thr308 ) , mTOR(Ser2448 ) , and p70s6k(Thr389 ) or in the hyperinsulinemia-hyperaminoacidemia-induced increases in phosphorylation of those signaling elements ( P > or = 0.25 ) . We conclude that there are no major differences in the rate of MPS and its intracellular control during basal conditions and during hyperinsulinemia-hyperaminoacidema between young and middle-aged adult men and women To determine the in vivo effect of amino acids ( AAs ) alone or in combination with insulin on splanchnic and muscle protein dynamics , we infused stable isotope tracers of AAs in 36 healthy subjects and sample d from femoral artery and vein and hepatic vein . The subjects were r and omized into six groups and were studied at baseline and during infusions of saline ( group 1 ) , insulin ( 0.5 mU. kg(-1 ) . min(-1 ) ) ( group 2 ) , insulin plus replacement of AAs ( group 3 ) insulin plus high-dose AAs ( group 4 ) , or somatostatin and baseline replacement doses of insulin , glucagon and GH plus high dose of AAs ( group 5 ) or saline ( group 6 ) . Insulin reduced muscle release of AAs mainly by inhibition of protein breakdown . Insulin also enhanced AA-induced muscle protein synthesis ( PS ) and reduced leucine transamination . The main effect of AAs on muscle was the enhancement of PS . Insulin had no effect on protein dynamics or leucine transamination in splanchnic bed . However , AAs reduced protein breakdown and increased synthesis in splanchnic bed in a dose-dependent manner . AAs also enhanced leucine transamination in both splanchnic and muscle beds . Thus insulin 's anabolic effect was mostly on muscle , whereas AAs acted on muscle as well as on splanchnic bed . Insulin achieved anabolic effect in muscle by inhibition of protein breakdown , enhancing AA-induced PS , and reducing leucine transamination . AAs largely determined protein anabolism in splanchnic bed by stimulating PS and decreasing protein breakdown OBJECTIVE Skeletal muscle protein metabolism is resistant to the anabolic action of insulin in healthy , nondiabetic older adults . This defect is associated with impaired insulin-induced vasodilation and mTORC1 signaling . We hypothesized that , in older subjects , pharmacological restoration of insulin-induced capillary recruitment would improve the response of muscle protein synthesis and anabolism to insulin . RESEARCH DESIGN AND METHODS Twelve healthy , nondiabetic older subjects ( 71 ± 2 years ) were r and omized to two groups . Subjects were studied at baseline and during local infusion in one leg of insulin alone ( Control ) or insulin plus sodium nitroprusside ( SNP ) at variable rate to double leg blood flow . We measured leg blood flow by dye dilution ; muscle microvascular perfusion with contrast enhanced ultrasound ; Akt/mTORC1 signaling by Western blotting ; and muscle protein synthesis , amino acid , and glucose kinetics using stable isotope method ologies . RESULTS There were no baseline differences between groups . Blood flow , muscle perfusion , phenylalanine delivery to the leg , and intracellular availability of phenylalanine increased significantly ( P < 0.05 ) in SNP only . Akt phosphorylation increased in both groups but increased more in SNP ( P < 0.05 ) . Muscle protein synthesis and net balance ( nmol · min−1 · 100 ml · leg−1 ) increased significantly ( P < 0.05 ) in SNP ( synthesis , 43 ± 6 to 129 ± 25 ; net balance , −16 ± 3 to 26 ± 12 ) but not in Control ( synthesis , 41 ± 10 to 53 ± 8 ; net balance , −17 ± 3 to −2 ± 3 ) . CONCLUSIONS Pharmacological enhancement of muscle perfusion and amino acid availability during hyperinsulinemia improves the muscle protein anabolic effect of insulin in older adults To define the mechanism of insulin 's anticatabolic action , the effects of three different dosages of insulin ( 0.25 , 0.5 , and 1.0 mU x kg(-1 ) x min(-1 ) ) versus saline on protein dynamics across splanchnic and skeletal muscle ( leg ) beds were determined using stable isotopes of phenylalanine , tyrosine , and leucine in 24 healthy subjects . After an overnight fast , protein breakdown in muscle exceeded protein synthesis , causing a net release of amino acids from muscle bed , while in the splanchnic bed protein synthesis exceeded protein breakdown , result ing in a net uptake of these amino acids . Insulin decreased ( P < 0.003 ) muscle protein breakdown in a dose-dependent manner with no effect on muscle protein synthesis , thus decreasing the net amino acid release from the muscle bed . In contrast , insulin decreased protein synthesis ( P < 0.03 ) in the splanchnic region with no effect on protein breakdown , thereby decreasing the net uptake of the amino acids . In addition , insulin also decreased ( P < 0.001 ) leucine nitrogen flux substantially more than leucine carbon flux , indicating increased leucine transamination ( an important biochemical process for nitrogen transfer between amino acids and across the organs ) , in a dose-dependent manner , with the magnitude of effect being greater on skeletal muscle than on the splanchnic bed . In conclusion , muscle is in a catabolic state in human subjects after an overnight fast and provides amino acids for synthesis of essential proteins in the splanchnic bed . Insulin achieves amino acid balance across splanchnic and skeletal muscle beds through its differential effects on protein dynamics in these tissue beds We have determined the individual and combined effects of insulin and prior exercise on leg muscle protein synthesis and degradation , amino acid transport , glucose uptake , and alanine metabolism . Normal volunteers were studied in the postabsorptive state at rest and about 3 h after a heavy leg resistance exercise routine . The leg arteriovenous balance technique was used in combination with stable isotopic tracers of amino acids and biopsies of the vastus lateralis muscle . Insulin was infused into a femoral artery to increase the leg insulin concentrations to high physiologic levels without substantively affecting the whole-body level . Protein synthesis and degradation were determined as rates of intramuscular phenylalanine utilization and appearance , and muscle fractional synthetic rate ( FSR ) was also determined . Leg blood flow was greater after exercise than at rest ( P<0.05 ) . Insulin accelerated blood flow at rest but not after exercise ( P<0.05 ) . The rates of protein synthesis and degradation were greater during the postexercise recovery ( 65+/-10 and 74+/-10 nmol x min(-1 ) x 100 ml(-1 ) leg volume , respectively ) than at rest ( 30+/-7 and 46+/-8 nmol x min(-1 ) x 100 ml(-1 ) leg volume , respectively ; P<0.05 ) . Insulin infusion increased protein synthesis at rest ( 51+/-4 nmol x min(-1 ) x 100 ml(-1 ) leg volume ) but not during the postexercise recovery ( 64+/-9 nmol x min(-1 ) x 100 ml(-1 ) leg volume ; P<0.05 ) . Insulin infusion at rest did not change the rate of protein degradation ( 48+/-3 nmol x min(-1 ) 100 ml(-1 ) leg volume ) . In contrast , insulin infusion after exercise significantly decreased the rate of protein degradation ( 52+/-9 nmol x min(-1 ) x 100 ml(-1 ) leg volume ) . The insulin stimulatory effects on inward alanine transport and glucose uptake were three times greater during the postexercise recovery than at rest ( P<0.05 ) . In contrast , the insulin effects on phenylalanine , leucine , and lysine transport were similar at rest and after exercise . In conclusion , the ability of insulin to stimulate glucose uptake and alanine transport and to suppress protein degradation in skeletal muscle is increased after resistance exercise . Decreased amino acid availability may limit the stimulatory effect of insulin on muscle protein synthesis after exercise We have investigated the mechanisms of the anabolic effect of insulin on muscle protein metabolism in healthy volunteers , using stable isotopic tracers of amino acids . Calculations of muscle protein synthesis , breakdown , and amino acid transport were based on data obtained with the leg arteriovenous catheterization and muscle biopsy . Insulin was infused ( 0.15 mU/min per 100 ml leg ) into the femoral artery to increase femoral venous insulin concentration ( from 10 + /- 2 to 77 + /- 9 microU/ml ) with minimal systemic perturbations . Tissue concentrations of free essential amino acids decreased ( P < 0.05 ) after insulin . The fractional synthesis rate of muscle protein ( precursor-product approach ) increased ( P < 0.01 ) after insulin from 0.0401 + /- 0.0072 to 0.0677 + /- 0.0101%/h . Consistent with this observation , rates of utilization for protein synthesis of intracellular phenylalanine and lysine ( arteriovenous balance approach ) also increased from 40 + /- 8 to 59 + /- 8 ( P < 0.05 ) and from 2 Output:	CONCLUSIONS From the presented data in the current systematic review , we conclude that : i ) exogenous insulin and amino acid administration effectively increase muscle protein synthesis , but this effect is attributed to the hyperaminoacidemia ; ii ) exogenous insulin administered systemically induces hypoaminoacidemia which obviates any insulin-stimulatory effect on muscle protein synthesis ; iii ) exogenous insulin result ing in supraphysiological insulin levels exceeding 50 , 000 pmol/l may effectively augment muscle protein synthesis ; iv ) exogenous insulin may have a diminished effect on muscle protein synthesis in older adults due to age-related anabolic resistance ; and v ) exogenous insulin administered systemically does not increase muscle protein synthesis in healthy , young adults
MS21724	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Patients with irritable bowel syndrome ( IBS ) often feel they have some form of dietary intolerance and frequently try exclusion diets . Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies . Aims : To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food . Patients : A total of 150 out patients with IBS were r and omised to receive , for three months , either a diet excluding all foods to which they had raised IgG antibodies ( enzyme linked immunosorbant assay test ) or a sham diet excluding the same number of foods but not those to which they had antibodies . Methods : Primary outcome measures were change in IBS symptom severity and global rating scores . Non-colonic symptomatology , quality of life , and anxiety/depression were secondary outcomes . Intention to treat analysis was undertaken using a generalised linear model . Results : After 12 weeks , the true diet result ed in a 10 % greater reduction in symptom score than the sham diet ( mean difference 39 ( 95 % confidence intervals ( CI ) 5–72 ) ; p = 0.024 ) with this value increasing to 26 % in fully compliant patients ( difference 98 ( 95 % CI 52–144 ) ; p<0.001 ) . Global rating also significantly improved in the true diet group as a whole ( p = 0.048 , NNT = 9 ) and even more in compliant patients ( p = 0.006 , NNT = 2.5 ) . All other outcomes showed trends favouring the true diet . Relaxing the diet led to a 24 % greater deterioration in symptoms in those on the true diet ( difference 52 ( 95 % CI 18–88 ) ; p = 0.003 ) . Conclusion : Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research BACKGROUND The cause of irritable bowel syndrome ( IBS ) is unknown . It may follow gastroenteritis and be associated with an abnormal gut flora and with food intolerance . Our study was design ed to assess whether these factors were associated with colonic malfermentation . METHODS We carried out a crossover controlled trial of a st and ard diet and an exclusion diet matched for macronutrients in six female IBS patients and six female controls . During the final 72 h on each diet , faecal excretion of fat , nitrogen , starch , and non-starch polysaccharide NSP was measured , and total excretion of hydrogen and methane collected over 24 h in a purpose -built 1.4 m3 whole-body calorimeter . Breath hydrogen and methane excretion were then measured for 3 h after 20 g oral lactulose . FINDINGS The maximum rate of gas excretion was significantly greater in patients than in controls ( 2.4 mL/min IQR 1.7 - 2.6 vs 0.6 , 0.4 - 1.1 ) . Although total gas production in patients was not greater than in controls ( median 527 mL/24 h IQR 387 - 660 vs 412 , 234 - 507 ) , hydrogen production was higher ( 332 , 318 - 478 vs 162 , 126 - 217 , p=0.009 ) . In patients , the exclusion diet reduced symptoms and produced a fall in maximum gas excretion ( 0.5 mL/min IQR 0.3 - 0.7 ) . After lactulose , breath hydrogen was greater on the st and ard than on the exclusion diet . INTERPRETATION Colonic-gas production , particularly of hydrogen , is greater in patients with IBS than in controls , and both symptoms and gas production are reduced by an exclusion diet . This reduction may be associated with alterations in the activity of hydrogen-consuming bacteria . Fermentation may be an important factor in the pathogenesis of IBS CONTEXT Irritable bowel syndrome ( IBS ) is a common functional bowel disorder for which there is no reliable medical treatment . OBJECTIVE To determine whether Chinese herbal medicine ( CHM ) is of any benefit in the treatment of IBS . DESIGN R and omized , double-blind , placebo-controlled trial conducted during 1996 through 1997 . SETTING Patients were recruited through 2 teaching hospitals and 5 private practice s of gastroenterologists , and received CHM in 3 Chinese herbal clinics . PATIENTS A total of 116 patients who fulfilled the Rome criteria , an established st and ard for diagnosis of IBS . INTERVENTION Patients were r and omly allocated to 1 of 3 treatment groups : individualized Chinese herbal formulations ( n = 38 ) , a st and ard Chinese herbal formulation ( n = 43 ) , or placebo ( n = 35 ) . Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist . Patients , gastroenterologists , and herbalists were all blinded to treatment group . MAIN OUTCOME MEASURES Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients . RESULTS Compared with patients in the placebo group , patients in the active treatment groups ( st and ard and individualized CHM ) had significant improvement in bowel symptom scores as rated by patients ( P=.03 ) and by gastroenterologists ( P=.001 ) , and significant global improvement as rated by patients ( P=.007 ) and by gastroenterologists ( P=.002 ) . Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms ( P=.03 ) . Chinese herbal formulations individually tailored to the patient proved no more effective than st and ard CHM treatment . On follow-up 14 weeks after completion of treatment , only the individualized CHM treatment group maintained improvement . CONCLUSION Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS AIM Irritable bowel syndrome ( IBS ) is a common disorder and many patients fail to find adequate relief from conventional therapies for their symptoms . This study tests the cl aim that acupuncture is effective for a majority of these patients . METHODS A prospect i ve , blinded , sham acupuncture-controlled trial of traditional Chinese acupuncture was performed at a single postgraduate teaching hospital in Europe . Sixty patients with well-established IBS were recruited . The blinded comparator was sham acupuncture administered by the second of two acupuncturists who alone was aware of the r and omization , and who otherwise followed the prescription of the first . The primary end-point was a defined fall in the symptom score at 13 wk ( by intention to treat ) . The prior expectation was a 30 % placebo response , and a response rate of 70 % from acupuncture , for which the study was adequately powered . RESULTS Patients in treated and sham groups improved significantly during the study -mean improvement in scores being equal ( minus 1.9 ) and significant for both ( P<0.05 ; one-tailed t test ) . There was a small numeric but non-significant difference between the response rate in patients receiving acupuncture ( 40.7 % ) and sham treatment ( 31.2 % ) . Several secondary end-points marginally favored active treatment , but an improved symptom score of any degree of magnitude occurred more often with sham therapy ( 65.6 % vs 59.2 % ) . For no criterion was statistical significance approached . CONCLUSION Traditional Chinese acupuncture is relatively ineffective in IBS in the European hospital setting , and the magnitude of any effect appears insufficient to warrant investment in acupuncture services 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 < or = .001 ) . The therapies increasing the most included 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 BACKGROUND Irritable bowel syndrome ( IBS ) is a significant problem for primary care , as treatment options are limited and it can frequently develop into a chronic condition . Complementary and alternative medicine , including reflexology , is being turned to increasingly in an attempt to manage symptoms . There are currently no studies which address the effectiveness of reflexology for IBS . Despite this , it continues to be advocated and used . AIM To provide the first evidence on the effectiveness of reflexology in the management of the core defining symptoms of IBS . DESIGN OF STUDY A single-blind trial carried out in primary care setting s. SETTING Thirty-four participants diagnosed with IBS on the basis of the Rome Criteria . METHOD Participants were allocated to receive either a reflexology foot massage or a non-reflexology foot massage control group . RESULTS On none of the three symptoms monitored -- abdominal pain , constipation/diarrhoea , and abdominal distention -- was there a statistically or clinical ly significant difference between reflexology and control groups . CONCLUSION On the basis of these results there is nothing to suggest that reflexology produces any specific benefit for patients with IBS . There is currently no evidence to support its use . However this was one ( relatively ) small scale study ; further research that , for example , assesses the impact of therapist ( professional and lay ) versus therapy , is still needed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffect Output:	As many of these therapies have not been subjected to controlled clinical trials , some , at least , of their efficacy may reflect the high-placebo response rate that is characteristic of irritable bowel syndrome . There is , however , evidence to support efficacy for hypnotherapy , some forms of herbal therapy and certain probiotics in irritable bowel syndrome . All complementary and alternative medicine is not the same and some , such as hypnotherapy , forms of herbal therapy , specific diets and probiotics , may well have efficacy in irritable bowel syndrome .
MS21725	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Potential predictive/prognostic angiogenic markers were prospect ively examined in a phase II trial of bevacizumab in epithelial ovarian cancer (EOC)/ primary peritoneal cancer ( PPC ) . METHODS Recurrent/persistent EOC/PPC patients were treated with bevacizumab ( 15 mg/kg IV q21days ) until disease progression . Vali date d-immunohistochemistry ( IHC ) assays were performed on pre-cycle 1/4 tumor biopsies for CD31-microvessel density ( MVD ) , VEGF-histoscore ( HS ) , p53-HS , and TSP1 image analysis score ( IA ) . Pre-cycle 1/4 serum and plasma VEGF were quantified using a vali date d-ELISA . RESULTS CD31-MVD and serum VEGF , evaluated pre-cycle 1 in 41/61 and 51/61 eligible patients , respectively , did not appear to be correlated . High CD31-MVD , categorized at the median , appeared to be associated with tumor response , a 13-month shorter median survival , and an increased risk of death ( unadjusted hazard ratio [ HR ] = 2.2 , 95 % confidence interval [ CI ] = 1.067 - 4.467 ) . In addition , each st and ard deviation ( SD ) increase in CD31-MVD appeared to be associated with worse survival in unadjusted and adjusted analyses . IHC and plasma biomarkers did not change with bevacizumab treatment except for serum VEGF , which appeared to decrease during bevacizumab treatment . This decrease was not associated with response . High pre-cycle 1 serum VEGF , categorized at the median , was associated with 22-month shorter median survival and an increased risk of death ( unadjusted HR = 2.7 , 95 % CI = 1.369 - 5.191 ) . Categorized p53 appeared to be associated with unadjusted survival and each SD increase in TSP1-IA appeared to be associated with a decreased risk of progression in unadjusted and adjusted analyses . CONCLUSIONS Despite the limitations in sample size and exploratory nature of the study , angiogenic markers in tumor and serum may provide prognostic value in recurrent/persistent EOC/PPC , and are being prospect ively evaluated in the GOG phase III trial of carboplatin , paclitaxel and bevacizumab/placebo in previously untreated EOC/PPC BACKGROUND Axillary lymph node status has been the most important prognostic factor in operable breast carcinoma , but it does not fully account for the varied disease outcome . More accurate prognostic indicators would help in selection of patients at high risk for disease recurrence and death who are c and i date s for systemic adjuvant therapy . Our recent findings indicated that microvessel density ( count or grade ) in invasive breast carcinoma ( a measure of tumor angiogenesis ) is associated with metastasis and thus may be a prognostic indicator . PURPOSE This study was design ed to further define the relationship of microvessel density with overall and relapse-free survival and with other reported prognostic indicators in breast carcinoma . METHODS In a prospect i ve , blinded study of 165 consecutive patients , the microvessels within primary invasive breast carcinoma were highlighted by immunocytochemical staining to detect factor VIII-related antigen . Using light microscopy , we counted microvessels per 200x field in the most active areas of neovascularization and grade d microvessel density . These findings were correlated , by univariate and multivariate analyses , with overall and relapse-free survival , axillary node status , and other prognostic indicators ( median follow-up , 51 months ) . RESULTS There was a highly significant ( P < or = .001 ) association of microvessel density with overall survival and relapse-free survival in all patients , including node-negative and node-positive subsets . All patients with breast carcinomas having more than 100 microvessels per 200x field experienced tumor recurrence within 33 months of diagnosis , compared with less than 5 % of the patients with breast carcinoma having 33 or fewer microvessels per 200x field . Moreover , microvessel density was the only statistically significant predictor of overall survival among node-negative women ( P < .001 ) . Only microvessel density ( P < .001 ) and histologic grade ( P = .04 ) showed statistically significant correlations with relapse-free survival in the node-negative subset . CONCLUSIONS Microvessel density in the area of the most intense neovascularization in invasive breast carcinoma is an independent and highly significant prognostic indicator for overall and relapse-free survival in patients with early-stage breast carcinoma ( I or II by International Union Against Cancer criteria ) . IMPLICATION S Such an indicator would be useful in selection of those node-negative patients with breast carcinoma who are at high risk for having occult metastasis at presentation . These patients could then be given systemic adjuvant therapy BACKGROUND Some r and omised controlled trials ( RCTs ) done in German-speaking Europe are published in international English- language journals and others in national German- language journals . We assessed whether authors are more likely to report trials with statistically significant results in English than in German . METHODS We studied pairs of RCT reports , matched for first author and time of publication , with one report published in German and the other in English . Pairs were identified from reports round in a manual search of five leading German- language journals and from reports published by the same authors in English found on Medline . Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors ' identities , affiliations , and other characteristics of trial reports . Main study endpoints were selected by two investigators who were unaware of trial results . Our main outcome was the number of pairs of studies in which the levels of significance ( shown by p values ) were discordant . FINDINGS 62 eligible pairs of reports were identified but 19 ( 31 % ) were excluded because they were duplicate publications . A further three pairs ( 5 % ) were excluded because no p values were given . The remaining 40 pairs were analysed . Design characteristics and quality features were similar for reports in both language s. Only 35 % of German- language articles , compared with 62 % of English- language articles , reported significant ( p < 0.05 ) differences in the main endpoint between study and control groups ( p = 0.002 by McNemar 's test ) . Logistic regression showed that the only characteristic that predicted publication in an English- language journal was a significant result . The odds ratio for publication of trials with significant results in English was 3.75 ( 95 % CI 1.25 - 11.3 ) . INTERPRETATION Authors were more likely to publish RCTs in an English- language journal if the results were statistically significant . English language bias may , therefore , be introduced in review s and meta-analyses if they include only trials reported in English . The effort of the Cochrane Collaboration to identify as many controlled trials as possible , through the manual search of many medical journals published in different language s will help to reduce such bias Hazard ratios ( HRs ) are used commonly to report results from r and omized clinical trials in oncology . However , they remain one of the most perplexing concepts for clinicians . A good underst and ing of HRs is needed to effectively interpret the medical literature to make important treatment decisions . This article provides clear guidelines to clinicians about how to appropriately interpret HRs . While this article focuses on the commonly used methods , the authors acknowledge that other statistical methods exist for analyzing survival data OBJECTIVES The aims of this study were to examine prognostic significance of microvessel density ( MVD ) in previously-untreated , advanced epithelial ovarian cancer ( EOC ) and explore associations between MVD and factors that affect angiogenesis . METHODS MVD was determined by immunohistochemical expression of CD31 or CD105 in tumor sections from 106 women treated on GOG r and omized phase III trials . Average MVD hotspots were quantified by light microscopy at high power ( x400 ) and categorized as low ( or = upper quartile ) . Immunoblot expression of MASPIN , THBS-1 , bFGF , VEGF , VEGFR-1 and p53 status ( mutation and overexpression ) was previously determined . RESULTS Of 106 evaluable cases , 25 % exhibited high CD31-MVD ( > 24.25 vessels/high power field [ HPF ] ) or high CD105-MVD ( > 19.25 vessels/HPF ) . After adjusting for age and stratifying by GOG performance status , stage , cell type , grade , debulking status and treatment regimen , high versus low CD105-MVD was associated with increased risk of disease progression ( hazard ratio [HR]=1.873 ; 95 % confidence interval [ CI ] : 1.102 - 3.184 ; p=0.020 ) , but not death ( HR=1.125 ; 95 % CI : 0.654 - 1.935 ; p=0.670 ) whereas CD31-MVD was not associated with risk of disease progression ( HR=1.578 ; 95 % CI=0.918 - 2.711 ; p=0.099 ) or death ( HR=1.678 ; 95 % CI=0.957 - 2.943 ; p=0.071 ) . CD31-MVD was correlated with CD105-MVD ( p=0.001 ) and MASPIN ( p=0.016 ) . Neither CD31-MVD nor CD105-MVD was associated with p53 status , THBS-1 , bFGF , VEGF or VEGFR-1 . CONCLUSIONS High MVD assessed using CD105 , a marker of proliferating endothelial cells and neoangiogenesis , but not CD31 a pan-endothelial marker , appeared to be an independent prognostic factor for worse progression-free survival in women with advanced EOC after adjusting for prognostic clinical covariates Output:	The OS and PFS with high MVD were significant poorer than with low MVD in ovarian cancer patients . However , high MVD detected by CD34 seems to be more associated with survival for patients without pre-chemotherapy
MS21726	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract —Single dose administration of dietary inorganic nitrate acutely reduces blood pressure ( BP ) in normotensive healthy volunteers , via bioconversion to the vasodilator nitric oxide . We assessed whether dietary nitrate might provide sustained BP lowering in patients with hypertension . We r and omly assigned 68 patients with hypertension in a double-blind , placebo-controlled clinical trial to receive daily dietary supplementation for 4 weeks with either dietary nitrate ( 250 mL daily , as beetroot juice ) or a placebo ( 250 mL daily , as nitrate-free beetroot juice ) after a 2-week run-in period and followed by a 2-week washout . We performed stratified r and omization of drug-naive ( n=34 ) and treated ( n=34 ) patients with hypertension aged 18 to 85 years . The primary end point was change in clinic , ambulatory , and home BP compared with placebo . Daily supplementation with dietary nitrate was associated with reduction in BP measured by 3 different methods . Mean ( 95 % confidence interval ) reduction in clinic BP was 7.7/2.4 mm Hg ( 3.6–11.8/0.0–4.9 , P<0.001 and P=0.050 ) . Twenty-four-hour ambulatory BP was reduced by 7.7/5.2 mm Hg ( 4.1–11.2/2.7–7.7 , P<0.001 for both ) . Home BP was reduced by 8.1/3.8 mm Hg ( 3.8–12.4/0.7–6.9 , P<0.001 and P<0.01 ) with no evidence of tachyphylaxis over the 4-week intervention period . Endothelial function improved by ≈20 % ( P<0.001 ) , and arterial stiffness was reduced by 0.59 m/s ( 0.24–0.93 ; P<0.01 ) after dietary nitrate consumption with no change after placebo . The intervention was well tolerated . This is the first evidence of durable BP reduction with dietary nitrate supplementation in a relevant patient group . These findings suggest a role for dietary nitrate as an affordable , readily-available , adjunctive treatment in the management of patients with hypertension ( funded by The British Heart Foundation ) . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01405898 Beetroot has a high concentration of inorganic nitrate , which can serially reduced to form nitrite and nitric oxide ( NO ) after oral ingestion . Increased renal resistive index ( RRI ) measured by Doppler ultrasonography is associated with higher cardiovascular mortality in hypertensive patients with reduced renal function over time defined as chronic kidney disease ( CKD ) . Our aim was to investigate whether the supplementation of dietary nitrate by administration of beetroot juice is able to reduce blood pressure and renal resistive index ( RRI ) as prognostic markers for cardiovascular mortality in CKD patients . In a cross-over study design , 17 CKD patients were r and omized to either a dietary nitrate load ( 300 mg ) by highly concentrated beetroot juice ( BJ ) or placebo ( water ) . Hemodynamic parameters as well as plasma nitrate concentration and RRI were measured before and 4 h after treatment . In this cohort , CKD was mainly caused by hypertensive or diabetic nephropathy . The mean eGFR was 41.6 ± 12.0 ml/min/m2 . Plasma nitrate concentrations were significantly increased after ingestion of BJ compared to control . Peripheral systolic and diastolic blood pressure as well as mean arterial pressure ( MAP ) were significantly reduced secondary to the dietary nitrate load compared to control ( e.g. ΔMAPBJ = -8.2 ± 7.6 mmHg vs. ΔMAPcontrol = -2.2 ± 6.0 mmHg , p = 0.012 ) . BJ also led to significantly reduced RRI values ( ΔRRIBJ = -0.03 ± 0.04 versus ΔRRIcontrol = 0.01 ± 0.04 ; p = 0.017 ) . Serum potassium levels were not altered secondary to the treatment . In this study , administration of the nitrate donor BJ led to significantly reduced RRI values and peripheral blood pressure which might be explained by release of the vasodilatator NO after oral intake . Whether supplementation of dietary nitrate in addition to routine pharmacologic therapy is able to decelerate progression of cardiovascular and renal disease in CKD , remains to be investigated PURPOSE Dietary nitrate supplementation has been shown to reduce the O2 cost of submaximal exercise and to improve high-intensity exercise tolerance . However , it is presently unknown whether it may enhance performance during simulated competition . The present study investigated the effects of acute dietary nitrate supplementation on power output ( PO ) , VO2 , and performance during 4- and 16.1-km cycling time trials ( TT ) . METHODS After familiarization , nine club-level competitive male cyclists were assigned in a r and omized , crossover design to consume 0.5 L of beetroot juice ( BR ; containing ∼ 6.2 mmol of nitrate ) or 0.5 L of nitrate-depleted BR ( placebo , PL ; containing ∼ 0.0047 mmol of nitrate ) , ∼ 2.5 h before the completion of a 4- and a 16.1-km TT . RESULTS BR supplementation elevated plasma [ nitrite ] ( PL = 241 ± 125 vs BR = 575 ± 199 nM , P < 0.05 ) . The VO2 values during the TT were not significantly different between the BR and PL conditions at any elapsed distance ( P > 0.05 ) , but BR significantly increased mean PO during the 4-km ( PL = 279 ± 51 vs BR = 292 ± 44 W , P < 0.05 ) and 16.1-km TT ( PL = 233 ± 43 vs BR = 247 ± 44 W , P < 0.01 ) . Consequently , BR improved 4-km performance by 2.8 % ( PL = 6.45 ± 0.42 vs BR = 6.27 ± 0.35 min , P < 0.05 ) and 16.1-km performance by 2.7 % ( PL = 27.7 ± 2.1 vs BR = 26.9 ± 1.8 min , P < 0.01 ) . CONCLUSIONS These results suggest that acute dietary nitrate supplementation with 0.5 L of BR improves cycling economy , as demonstrated by a higher PO for the same VO2 and enhances both 4- and 16.1-km cycling TT performance Circulating nitrate ( NO3− ) , derived from dietary sources or endogenous nitric oxide production , is extracted from blood by the salivary gl and s , accumulates in saliva , and is then reduced to nitrite ( NO2− ) by the oral microflora . This process has historically been viewed as harmful , because nitrite can promote formation of potentially carcinogenic N-nitrosamines . More recent research , however , suggests that nitrite can also serve as a precursor for systemic generation of vasodilatory nitric oxide , and exogenous administration of nitrate reduces blood pressure in humans . However , whether oral nitrate-reducing bacteria participate in “ setting ” blood pressure is unknown . We investigated whether suppression of the oral microflora affects systemic nitrite levels and hence blood pressure in healthy individuals . We measured blood pressure ( clinic , home , and 24-h ambulatory ) in 19 healthy volunteers during an initial 7-day control period followed by a 7-day treatment period with a chlorhexidine-based antiseptic mouthwash . Oral nitrate-reducing capacity and nitrite levels were measured after each study period . Antiseptic mouthwash treatment reduced oral nitrite production by 90 % ( p < 0.001 ) and plasma nitrite levels by 25 % ( p = 0.001 ) compared to the control period . Systolic and diastolic blood pressure increased by 2–3 .5 mm Hg , increases correlated to a decrease in circulating nitrite concentrations ( r2 = 0.56 , p = 0.002 ) . The blood pressure effect appeared within 1 day of disruption of the oral microflora and was sustained during the 7-day mouthwash intervention . These results suggest that the recycling of endogenous nitrate by oral bacteria plays an important role in determination of plasma nitrite levels and thereby in the physiological control of blood pressure Nitric oxide ( NO ) synthase inhibition reduces leg glucose uptake during cycling without reducing leg blood flow ( LBF ) in young , healthy individuals . This study sought to determine the role of NO in glucose uptake during exercise in individuals with type 2 diabetes . Nine men with type 2 diabetes and nine control subjects matched for age , sex , peak pulmonary oxygen uptake ( VO(2 ) peak ) , and weight completed two 25-min bouts of cycling exercise at 60 + /- 2 % VO(2 ) peak , separated by 90 min . N(G)-monomethyl-L-arginine ( L-NMMA ) ( total dose 6 mg/kg ) or placebo was administered into the femoral artery for the final 15 min of exercise in a counterbalanced , blinded , crossover design . LBF was measured by thermodilution in the femoral vein , and leg glucose uptake was calculated as the product of LBF and femoral arteriovenous glucose difference . During exercise with placebo , glucose uptake was not different between control subjects and individuals with diabetes ; however , LBF was lower and arterial plasma glucose and insulin levels were higher in individuals with diabetes . L-NMMA had no effect on LBF or arterial plasma glucose and insulin concentrations during exercise in both groups . L-NMMA significantly reduced leg glucose uptake in both groups , with a significantly greater reduction ( P = 0.04 ) in the diabetic group ( 75 + /- 13 % , 5 min after L-NMMA ) compared with the control group ( 34 + /- 14 % , 5 min after L-NMMA ) . These data suggest a greater reliance on NO for glucose uptake during exercise in individuals with type 2 diabetes compared with control subjects Diets rich in green , leafy vegetables have been shown to lower blood pressure ( BP ) and reduce the risk of cardiovascular disease . Green , leafy vegetables and beetroot are particularly rich in inorganic nitrate . Dietary nitrate supplementation , via sequential reduction to nitrite and NO , has previously been shown to lower BP and improve endothelial function in healthy humans . We sought to determine if supplementing dietary nitrate with beetroot juice , a rich source of nitrate , will lower BP and improve endothelial function and insulin sensitivity in individuals with type 2 diabetes ( T2DM ) . Twenty-seven patients , age 67.2±4.9 years ( 18 male ) , were recruited for a double-blind , r and omized , placebo-controlled crossover trial . Participants were r and omized to begin , in either order , a 2-week period of supplementation with 250ml beetroot juice daily ( active ) or 250ml nitrate-depleted beetroot juice ( placebo ) . At the conclusion of each intervention period 24-h ambulatory blood pressure monitoring , tests of macro- and microvascular endothelial function , and a hyperinsulinemic isoglycemic clamp were performed . After 2 weeks administration of beetroot juice mean ambulatory systolic BP was unchanged : 134.6±8.4mmHg versus 135.1±7.8mmHg ( mean±SD ) , placebo vs active-mean difference of -0.5mmHg ( placebo-active ) , p=0.737 ( 95 % CI -3.9 to 2.8 ) . There were no changes in macrovascular or microvascular endothelial function or insulin sensitivity . Supplementation of the diet with 7.5mmol of nitrate per day for 2 weeks caused an increase in plasma nitrite and nitrate concentration , but did not lower BP , improve endothelial function , or improve insulin sensitivity in individuals with T2DM Although dietary nitrate ( NO3- ) ingestion appears to enhance exercise capacity and performance in young individuals , inconclusive findings have been reported in older people . Therefore , we conducted a double-blind , crossover r and omized clinical trial using beetroot juice in older healthy participants , who were classified as normal weight and overweight . We tested whether consumption of beetroot juice ( a rich source of NO3- ) for 1 week would increase nitric oxide bioavailability via the nonenzymatic pathway and enhance ( 1 ) exercise capacity during an incremental exercise test , ( 2 ) physical capability , and ( 3 ) free-living physical activity . Twenty nonsmoking , healthy participants between 60 and 75 years of age and with a body mass index of 20.0 to 29.9 kg/m2 were included . Presupplementation and postsupplementation resting , submaximal , maximal , and recovery gas exchanges were measured . Physical capability was measured by h and -grip strength , time-up- and -go , repeated chair rising test , and Output:	The current literature indicates positive effects of dietary NO3− supplementation in older adults on physiological performance , with some evidence indicating benefits on cardiovascular and cerebrovascular health . Effects on cognitive performance were mixed and studies on metabolic health indicated no benefit .
MS21727	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS AND OBJECTIVES To investigate the efficacy of acupressure in decreasing agitated behaviours associated with dementia . BACKGROUND Agitated behaviour is found in nearly half of all patients who have dementia . The presence of these behaviours increases the likelihood of injury , weakness , dehydration and lack of sleep and contributes to caregiver frustration and fatigue . DESIGN This pilot study was design ed with subjects receiving both acupressure and the control treatment . Each subject served as his or her own control . Subjects received four weeks of acupressure protocol s ; to avoid a carry-over effect there was a treatment-free period of one week . Subjects then were visited by one of the investigators for a six-week period . METHODS Participants were recruited from a nursing home caring specifically for patients with dementia . Twenty of the 31 subjects ( 64.5 % ) completed the study , while 11 were discharged or hospitalized . All the subjects were assigned to an experimental protocol and had a six-week acupressure treatment program . Baseline data were collected in the first week . Individual treatment sessions began at the second week of the study and lasted 15 minutes , twice a day , five days a week for four weeks . After a treatment-free period of one week , all the subjects served as controls undergoing a four-week control protocol consisting of companionship and conversation . RESULTS Comparison between the control and experimental phases indicated significant differences between the two groups on all outcome measures ( Cohen-Mansfield Agitation Inventory , daily agitation records about physical attack , verbal and non-verbal attack and non-physical attack ) with better results found during the acupressure phase . CONCLUSIONS Acupressure is recommended as an efficacious and non-intrusive method for decreasing the agitation behaviours in patients with dementia . RELEVANCE TO CLINICAL PRACTICE Conducting the acupressure treatment takes 15 minutes . It could provide caregivers with a viable alternative to deal with patients with dementia Alzheimer 's disease is characterized by progressive cognitive decline . However , little is known about the " typical " rate of decline , the degree of individual heterogeneity evident in decline , or the types of factors that influence such decline . This study investigated these questions in a sample of 106 patients with Alzheimer 's disease , assessed at 1 - 5 points in time , spanning up to three years . At each time point , the Mini-Mental State Exam , a measure of global cognitive function , was administered to all patients . Measures of behavioral disturbance ( including the presence/absence of hallucinations , depression , incontinence , w and ering , and agitation ) , health status ( including presence/absence of neurological , cardiovascular , and other diseases ) , and descriptive information ( such as gender , age at time of onset , and duration of deficits ) were obtained at entry into the study . A two-stage r and om effects regression model was fit to the data and then used to assess the effect of these behavioral , health , and descriptive measures on the rate of decline . Results indicate that the rate of cognitive decline in Alzheimer 's disease is quite variable . Patients with various health and behavioral problems declined at a rate between 1.4 and 5 times faster than patients without such problems . Alcohol abuse , additional neurological disease , and agitation were significantly related to rate of decline . Overall number of problems was not . The association of these problems with accelerated decline may have prognostic and treatment implication Background Disruptive behaviors are prevalent in nursing home residents with dementia and often have negative consequences for the resident , caregiver , and others in the environment . Behavioral interventions might ameliorate them and have a positive effect on residents ’ mood ( affect ) . Objectives This study tested two interventions —an activities of daily living and a psychosocial activity intervention— and a combination of the two to determine their efficacy in reducing disruptive behaviors and improving affect in nursing home residents with dementia . Methods The study had three treatment groups ( activities of daily living , psychosocial activity , and a combination ) and two control groups ( placebo and no intervention ) . Nursing assistants hired specifically for this study enacted the interventions under the direction of a master ’s prepared gerontological clinical nurse specialist . Nursing assistants employed at the nursing homes recorded the occurrence of disruptive behaviors . Raters analyzed videotapes filmed during the study to determine the interventions ’ influence on affect . Results Findings indicated significantly more positive affect but not reduced disruptive behaviors in treatment groups compared to control groups . Conclusions The treatments did not specifically address the factors that may have been triggering disruptive behaviors . Interventions much more precisely design ed than those employed in this study require development to quell disruptive behaviors . Nontargeted interventions might increase positive affect . Treatments that produce even a brief improvement in affect indicate improved quality of mental health as m and ated by federal law Background : Treatment of agitation is a crucial problem in the care of patients with AD . Although antipsychotic and antidepressant medications and behavior management techniques ( BMT ) have each been used to treat agitation , clinical trials of these treatments have been characterized by small sample sizes and uncontrolled treatment design s. Objective : To compare haloperidol , trazodone , and BMT with placebo in the treatment of agitation in AD out patients . Methods : A total of 149 patients with AD and their caregivers participated in a r and omized , placebo-controlled , multicenter trial . Blind assessment was conducted at baseline and after 16 weeks of treatment . The three active treatments were haloperidol , trazodone , and BMT . The Alzheimer ’s Disease Cooperative Study Clinical Global Impression of Change was the primary outcome measure . Secondary outcomes included patient agitation , cognition , and function , and caregiver burden . Results : Thirty-four percent of subjects improved relative to baseline . No significant differences on outcome were obtained between haloperidol ( mean dose , 1.8 mg/d ) , trazodone ( mean dose , 200 mg/d ) , BMT , or placebo . Significantly fewer adverse events of bradykinesia and parkinsonian gait were evident in the BMT arm . No other significant difference in adverse events was seen . Symptoms did not respond differentially to the different treatments . Conclusions : Comparable modest reductions in agitation occurred in patients receiving haloperidol , trazodone , BMT , and placebo . More effective pharmacologic , nonpharmacologic , and combination treatments are needed Output:	Types of outcome measures : Studies will be included if they have assessed the effects of a strategy on the following outcomes : 1 . severity of agitated behaviours 2 . frequency of agitated behaviours 3 . use of pharmacotherapy in relation to agitated
MS21728	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Many epidemiologic studies have reported a positive association between dairy products and prostate cancer . Calcium or saturated fatty acid in dairy products has been suspected as the causative agent . To investigate the association between dairy products , calcium , and saturated fatty acid and prostate cancer in Japan , where both the intake of these items and the incidence of prostate cancer are low , we conducted a population -based prospect i ve study in 43,435 Japanese men ages 45 to 74 years . Participants responded to a vali date d question naire that included 138 food items . During 7.5 years of follow-up , 329 men were newly diagnosed with prostate cancer . Dairy products were associated with a dose-dependent increase in the risk of prostate cancer . The relative risks ( 95 % confidence intervals ) comparing the highest with the lowest quartiles of total dairy products , milk , and yogurt were 1.63 ( 1.14 - 2.32 ) , 1.53 ( 1.07 - 2.19 ) , and 1.52 ( 1.10 - 2.12 ) , respectively . A statistically significant increase in risk was observed for both calcium and saturated fatty acid , but the associations for these were attenuated after controlling for potential confounding factors . Some specific saturated fatty acids increased the risk of prostate cancer in a dose-dependent manner . Relative risks ( 95 % confidence intervals ) on comparison of the highest with the lowest quartiles of myristic acid and palmitic acid were 1.62 ( 1.15 - 2.29 ) and 1.53 ( 1.07 - 2.20 ) , respectively . In conclusion , our results suggest that the intake of dairy products may be associated with an increased risk of prostate cancer . ( Cancer Epidemiol Biomarkers Prev 2008;17(4):930–7 CONTEXT Although increased intake of grain products has been recommended to prevent cardiovascular disease ( CVD ) , prospect i ve data examining the relation of whole grain intake to risk of ischemic stroke are sparse , especially among women . OBJECTIVE To examine the hypothesis that higher whole grain intake reduces the risk of ischemic stroke in women . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve cohort of 75,521 US women aged 38 to 63 years without previous diagnosis of diabetes mellitus , coronary heart disease , stroke , or other CVDs in 1984 , who completed detailed food frequency question naires ( FFQs ) in 1984 , 1986 , 1990 , and 1994 , and were followed up for 12 years as part of the Nurses ' Health Study . MAIN OUTCOME MEASURE Incidence of ischemic stroke , confirmed by medical records , by quintile of whole grain intake according to FFQ responses . RESULTS During 861,900 person-years of follow-up , 352 confirmed incident cases of ischemic stroke occurred . We observed an inverse association between whole grain intake and ischemic stroke risk . The age-adjusted relative risks ( RRs ) from the lowest to highest quintiles of whole grain intake were 1.00 ( referent ) , 0.68 ( 95 % confidence interval [ CI ] , 0.49 - 0.94 ) , 0.69 ( 95 % CI , 0.51 - 0.95 ) , 0.49 ( 95 % CI , 0.35 - 0.69 ) , and 0.57 ( 95 % CI , 0.42 - 0.78 ; P = .003 for trend ) . Adjustment for smoking modestly attenuated this association ( RR comparing extreme quintiles , 0.64 ; 95 % CI , 0.47 - 0.89 ) . This inverse association remained essentially unchanged with further adjustment for known CVD risk factors , including saturated fat and transfatty acid intake ( multivariate-adjusted RR comparing extreme quintiles , 0.69 ; 95 % CI , 0.50 - 0.98 ) . The inverse relation between whole grain intake and risk of ischemic stroke was also consistently observed among subgroups of women who never smoked , did not drink alcohol , did not exercise regularly , or who did not use postmenopausal hormones . No significant association was observed between total grain intake and risk of ischemic stroke . CONCLUSIONS In this cohort , higher intake of whole grain foods was associated with a lower risk of ischemic stroke among women , independent of known CVD risk factors . These prospect i ve data support the notion that higher intake of whole grains may reduce the risk of ischemic stroke Background — Little is known about the role of dietary intake in the development of deep vein thrombosis or pulmonary embolus ( venous thromboembolism [ VTE ] ) . Homocysteine , factor VIII , and von Willebr and factor levels , risk factors for VTE , are influenced by dietary intake . We tested the hypothesis that foods rich in B vitamins and & ohgr;-3 fatty acids are negatively associated and meat intake is positively associated with incidence of VTE . Methods and Results — In a prospect i ve study over 12 years , 14 962 middle-aged adults participating in the Atherosclerosis Risk in Communities study were followed up for incident VTE . All hospitalizations were identified , and 196 VTEs were vali date d by chart review . A food frequency question naire assessed dietary intake at baseline and year 6 . In separate proportional hazards regression analyses , risk of developing VTE was computed across quintiles of selected nutrients , major food groups , and the Western diet pattern , with adjustment for demographic and lifestyle factors , body mass index , and diabetes . Hazard ratios and 95 % confidence intervals of VTE incidence across quintiles of fruit and vegetable intake were 1.0 ( reference ) , 0.73 ( 0.48 to 1.11 ) , 0.57 ( 0.37 to 0.90 ) , 0.47 ( 0.29 to 0.77 ) , and 0.59 ( 0.36 to 0.99 ) ( Ptrend=0.03 ) . Eating fish 1 or more times per week was associated with 30 % to 45 % lower incidence of VTE for quintiles 2 to 5 compared with quintile 1 , suggestive of a threshold effect . Hazard ratios of VTE across quintiles of red and processed meat intake were 1.0 , 1.24 ( 0.78 to 1.98 ) , 1.21 ( 0.74 to 1.98 ) , 1.09 ( 0.64 to 1.87 ) , and 2.01 ( 1.15 to 3.53 ) ( Ptrend=0.02 ) . Hazard ratios were attenuated only slightly after adjustment for factors VIIc and VIIIc and von Willebr and factor . Conclusions — A diet including more plant food and fish and less red and processed meat is associated with a lower incidence of VTE Background : Calcium , vitamin D , and dairy products are highly correlated factors , each with potential roles in breast carcinogenesis . Few prospect i ve studies have examined these relationships in postmenopausal women . Methods : Participants in the Cancer Prevention Study II Nutrition Cohort completed a detailed question naire on diet , vitamin and mineral supplement use , medical history , and lifestyle in 1992 to 1993 . After exclusion of women with a history of cancer and incomplete dietary data , 68,567 postmenopausal women remained for analysis . During follow-up through August 31 , 2001 , we identified 2,855 incident cases of breast cancer . Multivariate-adjusted rate ratios ( RR ) were calculated using Cox proportional hazards models . Results : Women with the highest intake of dietary calcium ( > 1,250 mg/d ) were at a lower risk of breast cancer than those reporting ≤500 mg/d [ RR , 0.80 ; 95 % confidence interval ( 95 % CI ) , 0.67 - 0.95 ; Ptrend = 0.02 ] ; however , neither use of supplemental calcium nor vitamin D intake was associated with risk . Consumption starting at two or more servings of dairy products per day was likewise inversely associated with risk ( RR , 0.81 ; 95 % CI , 0.69 - 0.95 ; Ptrend = 0.002 , compared with < 0.5 servings/d ) . The associations were slightly stronger in women with estrogen receptor – positive tumors comparing highest to lowest intake : dietary calcium ( RR , 0.67 ; 95 % CI , 0.51 - 0.88 ; Ptrend = 0.004 ) ; dairy products ( RR , 0.73 ; 95 % CI , 0.57 - 0.93 ; Ptrend = 0.0003 ) , and dietary vitamin D ( RR , 0.74 ; 95 % CI , 0.59 - 0.93 ; Ptrend = 0.006 ) . Conclusions : Our results support the hypothesis that dietary calcium and /or some other components in dairy products may modestly reduce risk of postmenopausal breast cancer . The stronger inverse associations among estrogen receptor – positive tumors deserve further study . ( Cancer Epidemiol Biomarkers Prev 2005;14(12):2898–904 We examined prospect ively the association between whole grain consumption and colorectal cancer risk in the population -based Swedish Mammography Cohort . A total of 61 433 women completed a food-frequency question naire at baseline ( 1987–1990 ) and , through linkage with the Swedish Cancer Registry , 805 incident cases of colorectal cancer were identified during a mean follow-up of 14.8 years . High consumption of whole grains was associated with a lower risk of colon cancer , but not of rectal cancer . The multivariate rate ratio ( RR ) of colon cancer for the top category of whole grain consumption ( ⩾4.5 servings day−1 ) compared with the bottom category ( < 1.5 servings day−1 ) was 0.67 ( 95 % confidence interval ( CI ) , 0.47–0.96 ; P-value for trend=0.06 ) . The corresponding RR after excluding cases occurring within the first 2 years of follow-up was 0.65 ( 95 % CI , 0.45–0.94 ; P-value for trend=0.04 ) . Our findings suggest that high consumption of whole grains may decrease the risk of colon cancer in women Background Control of body weight by balancing energy intake and energy expenditure is of major importance for the prevention of type 2 diabetes , but the role of specific dietary factors in the etiology of type 2 diabetes is less well established . We evaluated intakes of whole grain , bran , and germ in relation to risk of type 2 diabetes in prospect i ve cohort studies . Methods and Findings We followed 161,737 US women of the Nurses ' Health Studies ( NHSs ) I and II , without history of diabetes , cardiovascular disease , or cancer at baseline . The age at baseline was 37–65 y for NHSI and 26–46 y for NHSII . Dietary intakes and potential confounders were assessed with regularly administered question naires . We documented 6,486 cases of type 2 diabetes during 12–18 y of follow-up . Other prospect i ve cohort studies on whole grain intake and risk of type 2 diabetes were identified in search es of MEDLINE and EMBASE up to January 2007 , and data were independently extracted by two review ers . The median whole grain intake in the lowest and highest quintile of intake was , respectively , 3.7 and 31.2 g/d for NHSI and 6.2 and 39.9 g/d for NHSII . After adjustment for potential confounders , the relative risks ( RRs ) for the highest as compared with the lowest quintile of whole grain intake was 0.63 ( 95 % confidence interval [ CI ] 0.57–0.69 ) for NHSI and 0.68 ( 95 % CI 0.57–0.81 ) for NHSII ( both : p-value , test for trend < 0.001 ) . After further adjustment for body mass index ( BMI ) , these RRs were 0.75 ( 95 % CI 0.68–0.83 ; p-value , test for trend < 0.001 ) and 0.86 ( 95 % CI 0.72–1.02 ; p-value , test for trend 0.03 ) respectively . Associations for bran intake were similar to those for total whole grain intake , whereas no significant association was observed for germ intake after adjustment for bran . Based on pooled data for six cohort studies including 286,125 participants and 10,944 cases of type 2 diabetes , a two-serving-per-day increment in whole grain consumption was associated with a 21 % ( 95 % CI 13%–28 % ) decrease in risk of type 2 diabetes after adjustment for potential confounders and BMI . Conclusions Whole grain intake is inversely associated with risk of type 2 diabetes , and this association is stronger for bran than for germ . Findings from prospect i ve cohort studies consistently support increasing whole grain consumption for Output:	Results Based on 7,282 abstract s , 57 studies met the quality criteria and were evidence grade d. The data were too limited to draw any conclusions regarding : red and processed meat intake in relation to cardiovascular disease ( CVD ) and iron status ; potatoes and berries regarding any study outcomes ; and dairy consumption in relation to risk of breast cancer and CVD . However , dairy consumption seemed unlikely to increase CVD risk ( moderate- grade evidence ) . There was probable evidence ( moderate- grade ) for whole grains protecting against type 2 diabetes and CVD , and suggestive evidence ( low- grade ) for colorectal cancer and for dairy consumption being associated with decreased risk of type 2 diabetes and increased risk of prostate cancer . The WCRF/AICR concludes that red and processed meat is a convincing cause of colorectal cancer . Conclusions Probable ( moderate ) evidence was only observed for whole grains protecting against type 2 diabetes and CVD .
MS21729	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The study aim ed to assess the effectiveness of an 18-hr cognitive behavioral group intervention in reducing depressive symptoms ( and associated outcomes ) in a universal sample of students in mainstream schools in Engl and . The intervention , the UK Resilience Programme ( UKRP ) , was based on the Penn Resiliency Program for Children and Adolescents . METHOD Students ( N = 2,844 ; 49 % female ; 67 % White ) were ages 11 - 12 at 16 schools . Classes of students were assigned arbitrarily into intervention ( UKRP ) or control ( usual school provision ) conditions based on class timetables . Outcome measures were the Children 's Depression Inventory ( Kovacs , 1992 ) ( depressive symptoms , primary outcome ) ; Revised Children 's Manifest Anxiety Scale ( C. R. Reynolds & Richmond , 1985 ) ( anxiety ) ; and child-reported Goodman ( 1997 ) Strengths and Difficulties Question naire ( behavior ) . Students were surveyed at baseline , postintervention , 1-year follow-up , and 2-year follow-up . RESULTS At postintervention , UKRP students reported lower levels of depressive symptoms than control group students , but the effect was small ( d = 0.093 , 95 % CI [ -0.178 , -0.007 ] , p = .034 ) and did not persist to 1-year or 2-year follow-ups . There was no significant impact on symptoms of anxiety or behavior at any point . CONCLUSIONS UKRP produced small , short-term impacts on depression symptoms and did not reduce anxiety or behavioral problems . These findings suggest that interventions may produce reduced impacts when rolled out and taught by regular school staff . We discuss the implication s of these findings for policy and for future dissemination efforts BACKGROUND Anxiety in children is common , impairs everyday functioning , and increases the risk of severe mental health disorders in adulthood . We investigated the effect of a classroom-based cognitive behaviour therapy prevention programme ( FRIENDS ) on anxiety symptoms in children . METHODS Preventing Anxiety in Children though Education in Schools ( PACES ) is a three-group parallel cluster r and omised controlled trial . Interventions were given between September , 2011 , and July , 2012 , with schools as the unit of allocation and individual participants as the unit of analysis . We enrolled state-funded junior schools in southwest Engl and . We sent information to all eligible schools ( state-funded junior schools in southwest Engl and ) inviting them to enrol in the study . School year groups were assigned by computer-generated r and omisation ( 1:1:1 ) to receive either school-led FRIENDS ( led by teacher or school staff member ) , health-led FRIENDS ( led by two trained health facilitators ) , or usual school provision . Children were not masked to treatment allocation . The allocated programme was given to all students ( aged 9 - 10 years ) in the school year ( ie , universal delivery ) as part of the school curriculum as nine , 60 min weekly sessions . Outcomes were collected by self-completed question naire administered by research ers masked to allocation . Primary outcome was symptoms of anxiety and low mood at 12 months assessed by the Revised Child Anxiety and Depression Scale ( RCADS 30 ) . Analyses were intention to treat and accounted for the clustered nature of the design . The study is registered , number IS RCT N23563048 . FINDINGS 45 schools were enrolled : 14 ( n=497 children ) were r and omly assigned to school-led FRIENDS , 14 ( n=509 ) to health-led FRIENDS , and 12 ( n=442 ) to usual school provision . 1257 ( 92 % ) children completed 12 month assessment s ( 449 in health-led FRIENDS , 436 in school-led FRIENDS , and 372 in usual school provision ) . We recorded a difference at 12 months in adjusted mean child-reported RCADS scores for health-led versus school-led FRIENDS ( 19·49 [ SD 14·81 ] vs 22·86 [ 15·24 ] ; adjusted difference -3·91 , 95 % CI -6·48 to -1·35 ; p=0·0004 ) and health-led FRIENDS versus usual school provision ( 19·49 [ 14·81 ] vs 22·48 [ 15·74 ] ; -2·66 , -5·22 to -0·09 ; p=0·043 ) . We noted no differences in parent or teacher ratings . Training teachers to deliver mental health programmes was not as effective as delivery by health professionals . INTERPRETATION Universally delivered anxiety prevention programmes can be effective when used in schools . However , programme effectiveness varies depending on who delivers them . FUNDING National Institute for Health Research Public Health Research Programme Objectives To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents . Design A pragmatic cluster r and omised controlled trial compared education alone with education plus contact . Blocking was used to r and omly stratify classes within schools to condition . R and om allocation was concealed , generated by a computer algorithm , and undertaken after pretest . Data was collected at pretest and 2-week follow-up . Analyses use an intention-to-treat basis . Setting Secondary schools in Birmingham , UK . Participants The parents and guardians of all students in year 8 ( age 12–13 years ) were approached to take part . Interventions A 1-day educational programme in each school led by mental health professional staff . Students in the ‘ contact ’ condition received an interactive session with a young person with lived experience of mental illness . Outcomes The primary outcome was students ’ attitudinal stigma of mental illness . Secondary outcomes included knowledge-based stigma , mental health literacy , emotional well-being and resilience , and help-seeking attitudes . Results Participants were recruited between 1 May 2011 and 30 April 2012 . 769 participants completed the pretest and were r and omised to condition . 657 ( 85 % ) provided follow-up data . At 2-week follow-up , attitudinal stigma improved in both conditions with no significant effect of condition ( 95 % CI −0.40 to 0.22 , p=0.5 , d=0.01 ) . Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma , mental health literacy , emotional well-being and resilience , and help-seeking attitudes . Conclusions Contact was found to reduce the impact of the intervention for a number of outcomes . Caution is advised before employing intergroup contact with younger student age groups . The education intervention appeared to be successful in reducing stigma , promoting mental health knowledge , and increasing mental health literacy , as well as improving emotional well-being and resilience . A larger trial is needed to confirm these results . Trial registration number IS RCT N07406026 ; Results BACKGROUND Mindfulness-based approaches for adults are effective at enhancing mental health , but few controlled trials have evaluated their effectiveness among young people . AIMS To assess the acceptability and efficacy of a schools-based universal mindfulness intervention to enhance mental health and well-being . METHOD A total of 522 young people aged 12 - 16 in 12 secondary schools either participated in the Mindfulness in Schools Programme ( intervention ) or took part in the usual school curriculum ( control ) . RESULTS Rates of acceptability were high . Relative to the controls , and after adjusting for baseline imbalances , children who participated in the intervention reported fewer depressive symptoms post-treatment ( P = 0.004 ) and at follow-up ( P = 0.005 ) and lower stress ( P = 0.05 ) and greater well-being ( P = 0.05 ) at follow-up . The degree to which students in the intervention group practised the mindfulness skills was associated with better well-being ( P<0.001 ) and less stress ( P = 0.03 ) at 3-month follow-up . CONCLUSIONS The findings provide promising evidence of the programme 's acceptability and efficacy Background Effective methods to prevent adolescent depressive symptoms could reduce suffering and burden across the lifespan . However , psychological interventions delivered to adolescents show efficacy only in symptomatic or high-risk youth . Targeting causal risk factors and assessing mechanistic change can help devise efficacious universal or classroom based prevention programs . Methods A non-r and omized longitudinal design was used to compare three classroom-based prevention programs for adolescent depression ( Behavioral Activation with Reward Processing , “ Thinking about Reward in Young People ” ( TRY ) ; Cognitive Behavioral Therapy ( CBT ) and Mindfulness Based Cognitive Therapy ( MBCT ) ) , and determine cognitive mechanisms of change in these programs . Cognitive mechanisms examined were reward-seeking , negative self-beliefs ( assessed with behavioral tasks ) and over-general autobiographical memory . 256 healthy adolescents aged 13–14 participated with 236 ( 92 % ) and 227 ( 89 % ) completing the pre- and post- assessment s. Results TRY was the only intervention associated with a reduction in depressive symptoms at follow-up . Reward-seeking increased following TRY . In the other programs there were non-significant changes in cognitive mechanisms , with more reflective negative self-beliefs in CBT and fewer over-general autobiographical memories in MBCT In the TRY program , which focused on increasing sensitivity to rewarding activities , reward seeking increased and this was associated with decreased depressive symptoms . Limitations Due to the infeasibility of a cluster r and omized controlled trial , a non-r and omized design was used . Conclusions Increased reward-seeking was associated with decreased depressive symptoms and may be a mechanism of depressive symptom change in the intervention with a focus on enhancing sensitivity and awareness of reward . This study provides preliminary evidence to suggest that incorporating activities to enhance reward sensitivity may be fruitful in r and omized controlled trials of universal prevention programs for depression 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 Research suggests that the sequelae of childhood anxiety disorders , if left untreated , can include chronic anxiety , depression , and substance abuse . The current study evaluated the maintenance of outcomes of children who received a 16-week cognitive-behavioral treatment for primary anxiety disorders ( generalized , separation , and social anxiety disorders ) an average of 7.4 years earlier . The 86 participants ( ages 15 to 22 years ; 91 % of the original sample ) and their parents completed diagnostic interviews and self- and parent-report measures . According to the diagnostic interviews , a meaningful percentage of participants maintained significant improvements in anxiety at long-term follow-up . With regard to sequelae , positive responders to anxiety treatment , as compared with less positive responders , had a reduced amount of substance use involvement and related problems at long-term follow-up . The findings are discussed with regard to child anxiety and some of its sequelae Output:	1 RESULTS : Effectiveness of school-based universal interventions was found to be neutral or small with more positive effects found for poorer quality studies and those based in primary schools ( pupils aged 9 - 12 years ) . Overall , results suggested a trend whereby higher quality studies reported less positive effects . The current evidence suggests there are neutral to small effects of universal , school-based interventions in the UK that aim to promote emotional or mental well-being or the prevention of mental health difficulties .
MS21730	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In a double-blind , placebo-controlled study we investigated the effects of dietary fish oil supplementation on arterial wall characteristics in 20 patients with non-insulin-dependent diabetes mellitus . Estimates reflecting compliance values in the large arteries and more peripheral vasculature , as measured by pulse-contour analysis , improved significantly after 6 weeks of fish oil therapy compared with values recorded at baseline and after 6 weeks ' administration of olive oil . The large-artery compliance estimate increased from 1.50 ( confidence interval [ CI ] , 1.31 to 1.69 ) mL/mm Hg at baseline to 1.68 ( CI , 1.52 to 1.84 ) mL/mm Hg after fish oil administration ( P < .01 ) . The oscillatory compliance value increased from 0.015 ( CI , 0.011 to 0.019 ) mL/mm Hg at baseline to 0.022 ( CI , 0.016 to 0.028 ) mL/mm Hg after fish oil ingestion ( P < .05 ) . No changes occurred in arterial blood pressure , cardiac output , stroke volume , or systemic vascular resistance with either intervention . The improved compliance estimates with fish oil ingestion occurred without altering fasting blood glucose and cholesterol concentrations . These results support the hypothesis that fish oils alter vascular reactivity and favorably influence arterial wall characteristics in patients with non-insulin-dependent diabetes mellitus . These direct vascular effects , expressed at the level of the vessel wall , may contribute to the cardioprotective actions of fish oil in humans Objective : Fish oil supplement has been proposed as a non-pharmacological strategy to correct the atherogenic lipid profile associated with type 2 diabetes mellitus . However , fish oil may have deleterious effects on lipid peroxidation and glycemic control . Design : In this study , 44 type 2 diabetic patients were r and omized to vitamin E st and ardized ( 53.6 mg/day ) supplementation ( capsules ) with 4 g daily of either fish oil ( n=23 ) or corn oil ( n=21 ) for 8 weeks preceded by a 4 week run-in period of corn oil supplementation . LDL was isolated by density gradient ultracentrifugation and oxidized in vitro with Cu2 + . As a marker of in vivo oxidation malondialdehyde concentration in LDL ( LDL-MDA ) was measured . Results : Fish oil reduced both mean lag time ( before , 57.8 ; after , 48.8 min , P<0.001 ) and mean propagation rate ( before , 0.018 ΔOD/min ; after , 0.015 ΔOD/min , P<0.001 ) , whereas corn oil had no influence on lag time and propagation rate . The changes in lag time and propagation rate differed significantly between fish oil and corn oil treatment . LDL-MDA changes differed borderline significantly between groups ( FO , 110.4 pmol/mg protein ; CO , 6.7 pmol/mg protein ; P=0.057 ) . Fish oil supplementation had no influence on glycemic control as assessed from HbA1c and fasting blood glucose . Conclusion : According to our findings , fish oil supplementation leads to increased in vivo oxidation and increased in vitro oxidation susceptibility of LDL particles . More studies are needed to clarify the clinical importance of this finding . Sponsorship : Financially supported by The Danish Heart Association and Dansk Droge A/S. Dansk Droge A/S generously provided the fish oil and corn oil capsules Summary This study was conducted to examine the effect of ω3 fatty acid supplementation on plasma lipid , cholesterol and lipoprotein fatty acid content of non-insulin-dependent diabetic individuals consuming a higher ( 0.65 , n = 10 ) or lower ( 0.44 , n = 18 ) ratio of dietary polyunsaturated to saturated fatty acid ( P/S ) . The participants were initially given an olive oil supplement ( placebo ) equivalent to 35 mg of 18:1 · kg body weight–1 · day–1 for 3 months . This was followed by two ω3 supplement periods in a r and omized crossover . In these 3-month periods , participants were given a linseed oil supplement equivalent to 35 mg of 18:3ω3 · kg body weight–1 · day–1 or a fish oil supplement equivalent to 35 mg of 20:5ω3 + 22:6ω3 · kg body weight–1 · day–1 . At the end of each supplement period , a blood sample was drawn from each participant for lipid , lipoprotein , insulin , glucagon and C-peptide analyses . At the end of each 3-month period a 7-day dietary record was completed to calculate dietary fat intake and P/S ratio . Results indicate that fish oil significantly reduced plasma triacylglycerol level ( p < 0.05 ) and increased 20:5ω3 and 22:6ω3 content of all lipoprotein lipid classes . Linolenic acid supplementation had no effect on plasma triacylglycerol level , but it increased 18:3ω3 content of lipoprotein cholesterol ester fractions ( p < 0.05 ) . A slight increase in 20:5ω3 , but not 22:6ω3 , content was noted in lipoprotein lipid classes as a result of 18:3ω3 supplementation . LDL and HDL cholesterol , insulin , glucagon and C-peptide levels were not affected by either ω3 supplement . It is concluded that a modest intake of ω3 fatty acids , such as could be obtained from consuming fish regularly , will reduce plasma triglyceride level without affecting LDL or HDL cholesterol levels . [ Diabetologia ( 1997 ) 40 : 45–52 The study assessed the efficacy of fish oil supplementation in counteracting the classic dyslipidemia of the atherogenic lipoprotein phenotype ( ALP ) . In addition , the impact of the common apolipoprotein E ( apoE ) polymorphism on the fasting and postpr and ial lipid profile and on responsiveness to the dietary intervention was established . Fifty-five ALP males ( aged 34 to 69 years , body mass index 22 to 35 kg/m(2 ) , triglyceride [ TG ] levels 1.5 to 4.0 mmol/L , high density lipoprotein cholesterol [ HDL-C ] < 1.1 mmol/l , and percent low density lipoprotein [LDL]-3 > 40 % total LDL ) completed a r and omized placebo-controlled crossover trial of fish oil ( 3.0 g eicosapentaenoic acid/docosahexaenoic acid per day ) and placebo ( olive oil ) capsules with the 6-week treatment arms separated by a 12-week washout period . In addition to fasting blood sample s , at the end of each intervention arm , a postpr and ial assessment of lipid metabolism was carried out . Fish oil supplementation result ed in a reduction in fasting TG level of 35 % ( P<0.001 ) , in postpr and ial TG response of 26 % ( TG area under the curve , P<0.001 ) , and in percent LDL-3 of 26 % ( P<0.05 ) . However , no change in HDL-C levels was evident ( P=0.752 ) . ANCOVA showed that baseline HDL-C levels were significantly lower in apoE4 carriers ( P=0.035 ) . The apoE genotype also had a striking impact on lipid responses to fish oil intervention . Individuals with an apoE2 allele displayed a marked reduction in postpr and ial incremental TG response ( TG incremental area under the curve , P=0.023 ) and a trend toward an increase in lipoprotein lipase activity relative to non-E2 carriers . In apoE4 individuals , a significant increase in total cholesterol and a trend toward a reduction in HDL-C relative to the common homozygous E3/E3 profile was evident . Our data demonstrate the efficacy of fish oil fatty acids in counteracting the proatherogenic lipid profile of the ALP but also that the apoE genotype influences responsiveness to this dietary treatment BACKGROUND There is conflicting evidence on the benefits of foods rich in vitamin E ( alpha-tocopherol ) , n-3 polyunsaturated fatty acids ( PUFA ) , and their pharmacological substitutes . We investigated the effects of these substances as supplements in patients who had myocardial infa rct ion . METHODS From October , 1993 , to September , 1995 , 11,324 patients surviving recent ( < or = 3 months ) myocardial infa rct ion were r and omly assigned supplements of n-3 PUFA ( 1 g daily , n=2836 ) , vitamin E ( 300 mg daily , n=2830 ) , both ( n=2830 ) , or none ( control , n=2828 ) for 3.5 years . The primary combined efficacy endpoint was death , non-fatal myocardial infa rct ion , and stroke . Intention-to-treat analyses were done according to a factorial design ( two-way ) and by treatment group ( four-way ) . FINDINGS Treatment with n-3 PUFA , but not vitamin E , significantly lowered the risk of the primary endpoint ( relative-risk decrease 10 % [ 95 % CI 1 - 18 ] by two-way analysis , 15 % [ 2 - 26 ] by four-way analysis ) . Benefit was attributable to a decrease in the risk of death ( 14 % [ 3 - 24 ] two-way , 20 % [ 6 - 33 ] four-way ) and cardiovascular death ( 17 % [ 3 - 29 ] two-way , 30 % [ 13 - 44 ] four-way ) . The effect of the combined treatment was similar to that for n-3 PUFA for the primary endpoint ( 14 % [ 1 - 26 ] ) and for fatal events ( 20 % [ 5 - 33 ] ) . INTERPRETATION Dietary supplementation with n-3 PUFA led to a clinical ly important and statistically significant benefit . Vitamin E had no benefit . Its effects on fatal cardiovascular events require further exploration Eicosapentaenoic acid ( EPA ) ethyl ester ( 1.8 g/d ) was administered to 16 diabetic patients ( 5 insulin-dependent and 11 noninsulin-dependent diabetics ) for 6 mon . EPA in total plasma fatty acids increased from 4.0±2.4 mol% ( mean±SD ) to 7.5±3.1 mol% ( p<0.001 ) . Albumin excretion , measured with spot urine , was significantly reduced from 65 to 36 mg/g creatinine ( geometric means , p<0.001 ) . Fasting blood sugar levels , glycohemoglobin , body weight and blood pressure did not change significantly during the study . There were also no significant changes in serum levels of creatinine , urea nitrogen , total cholesterol and triglycerides . Although no overt hemorrhage was observed in the patients , hematocrit was reduced from 42.6±2.8 % to 41.0±3.9 % ( p<0.02 ) . Ten other similar diabetic patients ( 4 insulin-dependent and 6 non-insulin-dependent diabetics ) were followed as a reference group , not concomitantly , for 6 mon with neither EPA ethyl ester nor placebo . The parameters mentioned above were not changed significantly in this group during 6 mon . EPA administration might retard the appearance of overt diabetic nephropathy The short-term effect of high fiber intake on fish-oil treatment in 15 free-living , non-insulin-dependent diabetic patients was evaluated by using a controlled , sequential study design . During an 8-wk fish-oil-treatment period when patients received 20 g fish oil/d , the usual daily fiber intake was increased with a 15-g pectin supplement at midpoint . Fish oil alone lowered triacylglycerol and very-low-density-lipoprotein-cholesterol concentrations by 41 % and 36 % , respectively ( both P < 0.01 by the end of the treatment period ) with unchanged mean total , low-density- , and high-density-lipoprotein-cholesterol concentrations . When the fiber intake was increased , however , total and low-density-lipoprotein-cholesterol concentrations decreased significantly ( P < 0.001 and < 0.05 , respectively ) with fish-oil treatment . The cholesterol ester fraction of plasma lipids was reduced by 34 % when compared with fish oil alone ( P < 0.05 ) . The plasma triacylglycerol fraction decreased further by 44 % ( P < 0.001 ) . Other beneficial effects observed included a 30 % decline in the fatty acid fraction ( P < 0.002 ) by end of the treatment period . Diabetic control was maintained during the 12-wk study . In conclusion , a high fiber intake may be beneficial in fish oil-treated diabetic patients Fish-oil supplementation decreases serum triacylglycerols but may worsen hyperglycemia in patients with non-insulin-dependent diabetes mellitus . The reason for the possible deterioration of glycemia is unclear . We examined whether inhibition of tri Output:	No significant change in or total or HDL cholesterol , HbA1c , fasting glucose , fasting insulin or body weight was observed . The increase in VLDL remained significant only in trials of longer duration and in hypertriglyceridemic patients . The elevation in LDL cholesterol was non-significant in subgroup analyses . No adverse effects of the intervention were reported . Omega-3 PUFA supplementation in type 2 diabetes lowers triglycerides and VLDL cholesterol , but may raise LDL cholesterol ( although results were non-significant in subgroups ) and has no statistically significant effect on glycemic control or fasting insulin .
MS21731	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To compare the efficacy of immediate functionally loaded implants placed with a flapless procedure ( test group ) versus implants placed after flap elevation and conventional load-free healing ( control group ) in partially edentulous patients . MATERIAL S AND METHODS Forty patients were r and omized : 20 to the flapless immediately loaded group and 20 to the conventional group . To be immediately loaded , implants had to be inserted with a minimum torque > 45 Ncm . Implants in the immediately loaded group were provided with full acrylic resin temporary restorations the same day . Implants in the conventional group were submerged ( anterior region ) or left unsubmerged ( posterior region ) and were left load-free for 3 months ( m and ibles ) or 4 months ( maxillae ) . Provisional restorations were replaced with definitive single metal-ceramic crowns 1 month postloading . Outcome measures were prosthesis and implant failures , biological and prosthetic complications , postoperative edema , pain , and use of analgesics . Independent sample chi2 tests , Mann-Whitney tests , t tests , and paired t tests were used with a significance level of .05 . RESULTS Fifty-two implants were placed in the flapless group and 56 in the conventionally loaded group . In the flapless group , 1 flap had to be raised to control the direction of the bur and 1 implant did not reach the planned primary stability and was treated as belonging to the conventional group . After 3 years no dropouts or failures occurred . There was no statistically significant difference for complications ; however , patients in the conventional group had significantly more postoperative edema and pain and consumed more analgesics than those in the flapless group . Osstell values were significantly higher at baseline in the flapless group ( P = .033 ) . When comparing baseline data with years 1 , 2 , and 3 within each group , mean Osstell values of the flapless group did not increase , whereas there were statistically significant increases in the Periotest values . CONCLUSIONS Implants can be successfully placed flapless and loaded immediately without compromising success rates ; the procedure decreases treatment time and patient discomfort The aim of this study was to compare the success rates after 1 and 2 years of conventionally and early loaded pairs of unsplinted ITI implants supporting m and ibular overdentures in edentulous patients . Twenty-four participants ( age range 55 - 80 years ) were r and omly allocated with maximum concealment to two treatment groups . In the first group , the implants were allowed to heal for 12 weeks before being functionally loaded ( control ) and the second group had 6 weeks of healing with identical loading . All participants had new conventional complete maxillary and m and ibular dentures prior to the study . Two s and blasted large-grit acid-etched ( SLA ) surface ITI implants were placed in the m and ibular interforaminal area , following a st and ardized nonsubmerged surgical protocol . After 6 or 12 weeks of healing , matrices were processed into the fitting surface of the pre-existing m and ibular dentures and the implants loaded . Implant success was determined using mobility tests and radiographs taken at baseline and 52 and 104 weeks after surgery . Clinical peri-implant parameters were also documented . Results showed all implants successfully osseointegrated , according to accepted criteria , after 2 years . Mean loss of crestal bone height after 1 year was 0.35 + /- 0.22 mm ( control ) vs. 0.27 + /- 0.18 mm ( test ) . After 2 years this reduced to 0.09 + /- 0.06 mm ( control ) vs. 0.12 + /- 0.17 mm ( test ) . The mean Periotest value after 1 year was -4.9 ( control ) vs.-3.78 ( test ) . After 2 years , the mean resonance frequency value for the control implants was 6797 Hz [ mean implant stability quotient ( ISQ ) = 64.77 ] and for the test implants 6670 Hz ( mean ISQ = 62.0 ) . Shortened loading periods for these ITI implants did not cause any statistically significant differences in osseointegration or peri-implant parameters . We conclude that pairs of unsplinted SLA-surface ITI implants can be successfully loaded with m and ibular overdentures 6 weeks after surgery AIM this study compared the outcome of immediate non-occlusal loading with conventional loading for single implants in the maxillary aesthetic zone . It was hypothesized that immediate non-occlusal loading is not inferior to conventional loading . MATERIAL S AND METHODS sixty-two patients with a missing maxillary anterior tooth were r and omly assigned to be treated with an implant that was either restored with a non-occluding temporary crown within 24 h after implant placement ( the " immediate group " ) or was restored according to a two-stage procedure after 3 months ( the " conventional group " ) . All implants were installed in healed sites . Follow-up visits were conducted after 6 and 18 months post-implant placement . Outcome measures were radiographic marginal bone-level changes , survival , soft tissue aspects ( probing depth , plaque , bleeding , soft tissue level ) , aesthetics and patient satisfaction . RESULTS no significant differences were found between both study groups regarding marginal bone loss ( immediate group 0.91 ± 0.61 mm , conventional group 0.90 ± 0.57 mm ) , survival ( immediate group 96.8 % : one implant lost , conventional group 100 % ) , soft tissue aspects , aesthetic outcome and patient satisfaction . CONCLUSION within the limitations of this study ( sample size , follow-up duration ) , it was demonstrated that , for single implants in the anterior maxilla , the outcome of immediate non-occlusal loading was not less favourable than conventional loading The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . 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 . PURPOSE The aim of this study was to report a clinical comparative assessment of crestal bone level change around single implants in fresh extraction sockets in the esthetic zone of the maxilla either immediately loaded or loaded after a delay . MATERIAL S AND METHODS Forty patients were included in a prospect i ve , r and omized study . All patients required 1 tooth extraction ( ie , 1 tooth with a hopeless prognosis ) and were r and omized into either the test group or the control group . Implants were positioned immediately after tooth extraction and were loaded immediately in the test group ( 20 implants ) and after 3 months in the control group ( 20 implants ) . The implant site was prepared , with at least 4 mm of sound apical bone below the implant apex , and the coronal margin of the implant was placed at the buccal level of the bone crest . All implants were 13 mm long ; 30 implants had a diameter of 5 mm , and 10 had a diameter of 3.75 mm . Radiographic examinations were made at baseline , at 6 months , and at 24 months . To compare the mean values between test and control group , a paired t test was performed ( considered statistically significant at P < .05 ) . RESULTS After a 24-month follow-up period , a cumulative survival rate of 100 % was reported for all implants . The control group result ed in a mean mesial bone loss of 1.16 + /- 0.32 mm and a mean distal bone loss of 1.17 + /- 0.41 ( mean bone loss , 1.16 + /- 0.51 mm ) . The test group result ed in a mesial bone loss of 0.93 + /- 0.51 mm and a distal bone loss of 1.1 + /- 0.27 mm ( mean bone loss , 1.02 + /- 0.53 mm ) . No statistically significant difference between control and test groups ( P > .05 ) was found . CONCLUSION The success rate and radiographic results of immediate restorations of dental implants placed in fresh extraction sockets were comparable to those obtained in delayed loading group PURPOSE This prospect i ve r and omized controlled trial aim ed to compare single implant-supported m and ibular molar restorations using either an immediate or a delayed loading protocol . MATERIAL S AND METHODS Thirty subjects requiring single m and ibular molar replacement were consecutively treated . One implant was placed in each patient . Fifteen subjects were assigned to delayed loading protocol and 15 to immediate loading protocol according to a r and omization table . After insertion , the delayed loaded implants were connected to a healing abutment and restored after 3 to 4 months of healing without loading . The immediately loaded implants were loaded within 24 hours of surgery with a provisional restoration . The interim prosthesis was placed in centric occlusion . All contacts in lateral excursions were eliminated . At implant placement the maximum value of insertion torque was recorded . Radiographic bone level change was measured on periapical radiographs obtained at the time of implant placement and 12 months after loading . Means of the 2 groups were compared by Student t test and analysis of variance ( ANOVA ) . The level of significance was set at .05 . RESULTS No implants were lost in the delayed loading group ( 0/15 ) , whereas 1 implant failed ( 1/15 ) in the immediate loading group . No differences were observed in relation to implant length or insertion torque between the groups . The average radiographic bone level change after 1 year of function was 1.2 + /- 0.55 mm ( range , 0.5 to 2.6 mm ) and 0.77 + /- 0.38 mm ( range , 0.29 to 1.23 mm ) for the delayed loaded and the immediately loaded implants , respectively . The difference in radiographic bone level change between the delayed and immediate loading groups was statistically significant ( P = .022 ; CI = -0.79 to -0.06 ; Student t test ) . CONCLUSIONS Immediate loading of wide-diameter implants supporting single restorations in m and ibular molar sites seems to be a suitable clinical option . Moreover , the radiographic bone level change observed after 12 months of loading was significantly less for immediately loaded implants BACKGROUND Recent studies have showed that immediate/early loading of dental implants is a clinical ly feasible concept with results similar to those for st and ard two-stage procedures , especially in the m and ible . However , there are only a few studies regarding the immediate/early loading of maxillary implants supporting single-tooth crowns . PURPOSE The aim of this study was to compare the clinical and radiological outcomes of early- and delayed-loaded dental implants supporting single-tooth crowns in the maxilla . MATERIAL S AND METHODS Twenty-nine patients were consecutively treated between 2000 and 2002 with 59 Brånemark System MK III TiUnite implants ( Nobel Biocare AB , Göteborg , Sweden ) in the maxilla . Two groups were formed according to the loading protocol s. In the test group , definitive implant-supported single crowns were delivered to 19 patients 6 weeks after the implant placement . In the control group , definitive implant-supported single crowns were delivered to 10 patients 6 months after the implant placement . Clinical and radiographic parameters were recorded at baseline , 1 to 4 years . Implant stability measurements have only been performed at 4-year follow-up recall . RESULTS Overall , three implants were lost during the study period . Two implants were lost in the test group including 36 implants , which indicated a survival rate of 94.4 % . One of the lost implants was replaced and then osseointegrated successfully . One implant was lost in the control group during the healing period , which indicated a survival rate of 95.7 % . The average marginal bone loss was 1.11 mm for 56 implants after 4 years . There were no significant differences in marginal bone levels , insertion torque , and resonance frequency values between the two groups . CONCLUSION The results of this study indicate that 6 weeks of early loading period for TiUnite-surface titanium implants in the maxilla is reliable and predictable for this patient population and may offer an alternative to the st and ard loading protocol The aim of this r and omized controlled clinical trial was to compare the efficacy of implants placed with a flapless procedure and restored immediately ( test group ) or early ( 6 weeks ) ( control group ) in partially edentulous patients up to 1 year after loading . Both groups were nonocclusally loaded . Ten patients were included in each group . No patients dropped out and no failures were recorded . Two complications occurred in the early loading group , but both were resolved . It can be concluded that the use of a flapless technique for placing implants in conjunction with nonocclusal immediate loading in select patients can provide excellent clinical results . These preliminary findings should be confirmed by larger r and omized clinical trials PURPOSE Achieving primary implant stability in areas with poor bone density is often challenging to the clinician . Previous research has suggested that modified surgical protocol s might be beneficial in such situations . The objective of the present clinical study was to evaluate the survival rate of implants placed using undersized implant site preparation in areas with poor bone density . MATERIAL S AND METHODS A total of 52 implants were placed in 29 patients . Of the 52 implants , 26 were surgically placed according to the st and ard drilling protocol ( control group ) and 26 were placed in low-density bone using an adapted bone drilling method ( test group ) . The maximum insertion torque values and resonance frequency analysis measurements were also recorded . All implants were examined clinical ly and radiographically at follow-up visits during the study period . Oral hygiene status , bleeding on probing , peri-implant probing depth , and implant survival rate were ass Output:	This meta- analysis does not show an effect of the timing of restorations on implant MBL . The selection of restoration protocol s should be based on factors other than MBL
MS21732	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We have determined whole body protein kinetics , i.e. , protein synthesis ( PS ) , breakdown ( PB ) , and net balance ( NB ) in human subjects in the fasted state and following ingestion of ~40 g [ moderate protein ( MP ) ] , which has been reported to maximize the protein synthetic response or ~70 g [ higher protein ( HP ) ] protein , more representative of the amount of protein in the dinner of an average American diet . Twenty-three healthy young adults who had performed prior resistance exercise ( X-MP or X-HP ) or time-matched resting ( R-MP or R-HP ) were studied during a primed continuous infusion of l-[(2)H5]phenylalanine and l-[(2)H2]tyrosine . Subjects were r and omly assigned into an exercise ( X , n = 12 ) or resting ( R , n = 11 ) group , and each group was studied at the two levels of dietary protein intake in r and om order . PS , PB , and NB were expressed as increases above the basal , fasting values ( mg·kg lean body mass(-1)·min(-1 ) ) . Exercise did not significantly affect protein kinetics and blood chemistry . Feeding result ed in positive NB at both levels of protein intake : NB was greater in response to the meal containing HP vs. MP ( P < 0.00001 ) . The greater NB with HP was achieved primarily through a greater reduction in PB and to a lesser extent stimulation of protein synthesis ( for all , P < 0.0001 ) . HP result ed in greater plasma essential amino acid responses ( P < 0.01 ) vs. MP , with no differences in insulin and glucose responses . In conclusion , whole body net protein balance improves with greater protein intake above that previously suggested to maximally stimulating muscle protein synthesis because of a simultaneous reduction in protein breakdown Manipulating joint range of motion during squat training may have differential effects on adaptations to strength training with implication s for sports and rehabilitation . Consequently , the purpose of this study was to compare the effects of squat training with a short vs. a long range of motion . Male students ( n = 17 ) were r and omly assigned to 12 weeks of progressive squat training ( repetition matched , repetition maximum sets ) performed as either a ) deep squat ( 0–120 ° of knee flexion ) ; n = 8 ( DS ) or ( b ) shallow squat ( 0–60 of knee flexion ) ; n = 9 ( SS ) . Strength ( 1 RM and isometric strength ) , jump performance , muscle architecture and cross-sectional area ( CSA ) of the thigh muscles , as well as CSA and collagen synthesis in the patellar tendon , were assessed before and after the intervention . The DS group increased 1 RM in both the SS and DS with ~20 ± 3 % , while the SS group achieved a 36 ± 4 % increase in the SS , and 9 ± 2 % in the DS ( P < 0.05 ) . However , the main finding was that DS training result ed in superior increases in front thigh muscle CSA ( 4–7 % ) compared to SS training , whereas no differences were observed in patellar tendon CSA . In parallel with the larger increase in front thigh muscle CSA , a superior increase in isometric knee extension strength at 75 ° ( 6 ± 2 % ) and 105 ° ( 8 ± 1 % ) knee flexion , and squat-jump performance ( 15 ± 3 % ) were observed in the DS group compared to the SS group . Training deep squats elicited favourable adaptations on knee extensor muscle size and function compared to training shallow squats Abstract The currently accepted amount of protein required to achieve maximal stimulation of myofibrillar protein synthesis ( MPS ) following resistance exercise is 20–25 g. However , the influence of lean body mass ( LBM ) on the response of MPS to protein ingestion is unclear . Our aim was to assess the influence of LBM , both total and the amount activated during exercise , on the maximal response of MPS to ingestion of 20 or 40 g of whey protein following a bout of whole‐body resistance exercise . Resistance‐trained males were assigned to a group with lower LBM ( ≤65 kg ; LLBM n = 15 ) or higher LBM ( ≥70 kg ; HLBM n = 15 ) and participated in two trials in r and om order . MPS was measured with the infusion of 13C6‐phenylalanine tracer and collection of muscle biopsies following ingestion of either 20 or 40 g protein during recovery from a single bout of whole‐body resistance exercise . A similar response of MPS during exercise recovery was observed between LBM groups following protein ingestion ( 20 g – LLBM : 0.048 ± 0.018%·h−1 ; HLBM : 0.051 ± 0.014%·h−1 ; 40 g – LLBM : 0.059 ± 0.021%·h−1 ; HLBM : 0.059 ± 0.012%·h−1 ) . Overall ( groups combined ) , MPS was stimulated to a greater extent following ingestion of 40 g ( 0.059 ± 0.020%·h−1 ) compared with 20 g ( 0.049 ± 0.020%·h−1 ; P = 0.005 ) of protein . Our data indicate that ingestion of 40 g whey protein following whole‐body resistance exercise stimulates a greater MPS response than 20 g in young resistance‐trained men . However , with the current doses , the total amount of LBM does not seem to influence the response 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 . Summary Six healthy women ( 21.8±0.4 y ) did isometric strength training of the left plantarflexors at an ankle joint angle of 90 ° . Training sessions , done 3 times per week for 6 weeks , consisted of 2 sets of ten 5 s maximal voluntary contractions . Prior to and following the training , and in r and om order , voluntary and evoked isometric contraction strength was measured at the training angle and at additional angles : 5 ° , 10 ° , 15 ° , and 20 ° intervals in the plantarflexion and dorsiflexion directions . Evoked contraction strength was measured as the peak torque of maximal twitch contractions of triceps surae . Training increased voluntary strength at the training angle and the two adjacent angles only ( p<0.05 ) . Time to peak twitch torque was not affected by training . Twitch half relaxation time increased after training ( p=0.013 ) , but the increase was not specific to the training angle . There was a small ( 1.1 % , p<0.05 ) increase in calf circumference after training . Evoked twitch torque did not increase significantly at any joint angle . It was therefore concluded that a neural mechanism is responsible for the specificity of joint angle observed in isometric training Abstract Pinto , RS , Gomes , N , Radaelli , R , Botton , CE , Brown , LE , and Bottaro , M. Effect of range of motion on muscle strength and thickness . J Strength Cond Res 26(8 ) : 2140–2145 , 2012—The purpose of this investigation was to compare partial range-of-motion vs. full range-of-motion upper-body resistance training on strength and muscle thickness ( MT ) in young men . Volunteers were r and omly assigned to 3 groups : ( a ) full range of motion ( FULL ; n = 15 ) , ( b ) partial range of motion ( PART ; n = 15 ) , or ( c ) control ( CON ; n = 10 ) . The subjects trained 2 d·wk−1 for 10 weeks in a periodized program . Primary outcome measures included elbow flexion maximal strength measured by 1 repetition maximum ( 1RM ) and elbow flexors MT measured by ultrasound . The results indicated that elbow flexion 1RM significantly increased ( p < 0.05 ) for the FULL ( 25.7 ± 9.6 % ) and PART groups ( 16.0 ± 6.7 % ) but not for the CON group ( 1.7 ± 5.5 % ) . Also , FULL 1RM strength was significantly greater than the PART 1RM after the training period . Average elbow flexor MT significantly increased for both training groups ( 9.65 ± 4.4 % for FULL and 7.83 ± 4.9 for PART ) . These data suggest that muscle strength and MT can be improved with both FULL and PART resistance training , but FULL may lead to greater strength gains Abstract Baroni , BM , Pompermayer , MG , Cini , A , Peruzzolo , AS , Radaelli , R , Brusco , CM , and Pinto , RS . Full range of motion induces greater muscle damage than partial range of motion in elbow flexion exercise with free weights . J Strength Cond Res 31(8 ) : 2223–2230 , 2017—Load and range of motion ( ROM ) applied in resistance training ( RT ) affect the muscle damage magnitude and the recovery time-course . Because exercises performed with partial ROM allow a higher load compared with those with full ROM , this study investigated the acute effect of a traditional RT exercise using full ROM or partial ROM on muscle damage markers . Fourteen healthy men performed 4 sets of 10 concentric-eccentric repetitions of unilateral elbow flexion on the Scott bench . Arms were r and omly assigned to partial-ROM ( 50–100 ° ) and full-ROM ( 0–130 ° ) conditions , and load was determined as 80 % of 1 repetition maximum ( 1RM ) in the full- and partial-ROM tests . Muscle damage markers were assessed preexercise , immediately , and 24 , 48 , and 72 hours after exercise . Primary outcomes were peak torque , muscle soreness during palpation and elbow extension , arm circumference , and joint ROM . The load lifted in the partial-ROM condition ( 1RM = 19.1 ± 3.0 kg ) was 40 ± 18 % higher compared with the full-ROM condition ( 1RM = 13.7 ± 2.2 kg ) . Seventy-two hours after exercise , the full-ROM condition led to significant higher soreness sensation during elbow extension ( 1.3–4.1 cm vs. 1.0–1.9 cm ) and smaller ROM values ( 97.5–106.1 ° vs. 103.6–115.7 ° ) . Peak torque , soreness from palpation , and arm circumference were statistically similar between conditions , although mean values in all time points of these outcomes have suggested more expressive muscle damage for the full-ROM condition . In conclusion , elbow flexion exercise with full ROM seems to induce greater muscle damage than partial-ROM exercises , even though higher absolute load was achieved with partial ROM Purpose The purpose of this study was to determine the effect of a 15-week partial range of motion ( ROM ) resistance training program on the vastus lateralis ( VL ) architecture and mechanical properties , when the time under tension ( TUT ) was equalized . Methods Nineteen untrained male subjects were r and omly assigned to a control ( Control ; n = 8) or training ( TG ; n = 11 ) group . In the TG , the dominant and nondominant legs were r and omly selected to be trained with a full ROM ( FULL ) or a partial ROM ( PART ) in an isokinetic dynamometer . Training volume was equalized based on the TUT by manipulating sets and repetitions . The VL muscle architecture was assessed by B-mode ultrasonography at rest and during maximal isometric knee extension contractions ( MVCs ) at ten knee angles . The VL fascicle force and specific tension were calculated from the MVCs with superimposed stimuli , accounting for the moment arm length , muscle architecture , and antagonist coactivation . Results The FULL training induced changes in fascicle length ( FL ) ( 4.9 ± 2.0 % , P < 0.001 ) and specific tension ( 25.8 ± 18.7 % , P < 0.001 ) . There was a moderate effect Output:	When assessing the current body of literature , it can be inferred that performing RT through a full ROM confers beneficial effects on hypertrophy of the lower body musculature versus training with a partial ROM . No study to date has investigated how ROM influences muscle growth of the trunk musculature .
MS21733	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study evaluated the impact of telemedicine technology on the provision of neurosurgical health services . We focused on the differences between the use of real time audio-visual teleconferencing and teleradiology versus conventional telephone consultations in the referral of neurosurgical patients from a large district general hospital . All patients requiring emergency neurosurgical consultation were included for r and omization into telephone consultation only ( Mode A ) , teleradiology and telephone consultation ( Mode B ) and video-consultation ( Mode C ) . Measures of effectiveness included diagnostic accuracy and adverse events during the transfer and Glasgow Outcome Score . In a 10-month period , 327 patients were recruited and r and omized into the study : the male/female ratio was 2:1 and the number of patients required to be transferred to the neurosurgical unit was 125 ( 38 % ) . There was a trend towards a more favourable outcome in the video-consultation mode ( 44 % , Mode C ) , versus teleradiology ( 31 % , Mode B ) , versus telephone consultation ( 38 % , Mode A ) . The interim data of this prospect i ve r and omized trial suggests that video-consultation may have a favourable impact on emergency neurosurgical consultations Background Inter-hospital teleconsultation improves stroke care . To transfer this concept into the emergency medical service ( EMS ) , the feasibility and effects of prehospital teleconsultation were investigated . Methodology /Principal Findings Teleconsultation enabling audio communication , real-time video streaming , vital data and still picture transmission was conducted between an ambulance and a teleconsultation center . Pre-notification of the hospital was carried out with a 14-item stroke history checklist via e-mail-to-fax . Beside technical assessment s possible influences on prehospital and initial in-hospital time intervals , prehospital diagnostic accuracy and the transfer of stroke specific data were investigated by comparing telemedically assisted prehospital care ( telemedicine group ) with local regular EMS care ( control group ) . All prehospital stroke patients over a 5-month period were included during weekdays ( 7.30 a.m. –4.00 p.m. ) . In 3 of 18 missions partial dropouts of the system occurred ; neurological co-evaluation via video transmission was conducted in 12 cases . The stroke checklist was transmitted in 14 cases ( 78 % ) . Telemedicine group ( n = 18 ) vs. control group ( n = 47 ) : Prehospital time intervals were comparable , but in both groups the door to brain imaging times were longer than recommended ( median 59.5 vs. 57.5 min , p = 0.6447 ) . The prehospital stroke diagnosis was confirmed in 61 % vs. 67 % , p = 0.8451 . Medians of 14 ( IQR 9 ) vs. 5 ( IQR 2 ) stroke specific items were transferred in written form to the in-hospital setting , p<0.0001 . In 3 of 10 vs. 5 of 27 patients with cerebral ischemia thrombolytics were administered , p = 0.655 . Conclusions Teleconsultation was feasible but technical performance and reliability have to be improved . The approach led to better stroke specific information ; however , a superiority over regular EMS care was not found and in-hospital time intervals were unacceptably long in both groups . The feasibility of prehospital tele-stroke consultation has future potential to improve emergency care especially when no highly trained personnel are on-scene . Trial Registration International St and ard R and omised Controlled Trial Number Register ( IS RCT N ) IS RCT N83270177 83270177 OBJECTIVE To evaluate the reliability of strabismus assessment using telemedicine ( TM ) technology . DESIGN Two prospect i ve interobserver agreement studies . One study compared the agreement between a st and ard and a TM examination , whereas the other assessed agreement between two independent st and ard examinations . PARTICIPANTS Strabismus patients over 4 years of age examined at a remote community clinic and patients assessed in a strabismologist 's urban practice . METHODS Forty-two patients were examined in person by a pediatric ophthalmologist at the remote community and independently by a pediatric ophthalmology fellow by means of TM ( TM-st and ard study ) . The TM examination was performed with the help of a qualified ophthalmic assistant at the remote telecommunication center using a Power Cam 100 camera , a Picture Tel Concorde 4500 teleconferencing system , and a 224 kilobyte b and width . For comparison , independent in person examinations were performed on 43 patients by both examiners ( st and ard-st and ard study ) . Agreement was measured using unweighted kappa ( k ) for categorical data , the intraclass correlation coefficient ( ICC ) for continuous data , and percent agreement . The odds of disagreement with TM ( comparing the TM-st and ard versus st and ard-st and ard studies ) was assessed with logistic regression analysis . MAIN OUTCOME MEASURES Three parameters were assessed : ( 1 ) category of strabismus , determined by observation without cover test ; ( 2 ) angle of deviation at 0.33 and 6.0 m ; and ( 3 ) ocular muscle action . RESULTS Agreement on the category of strabismus was good ( k > 0.61 ) other than for vertical deviations . However , there was good to excellent agreement between TM and st and ard examinations on the vertical ( ICC = 0.78 ) and horizontal ( ICC = 0.79 ) angles of deviation with 6-m fixation with the cover test . Muscle ratings agreed within one point for the lateral , superior , and inferior rectus muscle actions in more than 90 % of the eyes examined . Although good agreement was observed in the TM-st and ard study , it was inferior to the agreement in the st and ard-st and ard study . Examination by TM increased the odds of disagreement compared with examination in person by twofold to threefold . CONCLUSIONS Strabismus examination can be performed with a good level of reliability with the use of medium b and width video teleconferencing equipment . However , reduced reliability has been noted in the detection of small vertical deviations by inspection and in evaluating oblique muscle actions OBJECTIVE To prospect ively measure accuracy , reliability , and image quality of telemedical retinopathy of prematurity ( ROP ) diagnosis . METHODS Two-hundred forty-eight eyes from 67 consecutive infants underwent wide-angle retinal imaging by a trained neonatal nurse at 31 to 33 weeks ' and /or 35 to 37 weeks ' postmenstrual age ( PMA ) using a st and ard protocol . Data were uploaded to a Web-based telemedicine system and interpreted by 3 expert retinal specialist grade rs who provided a diagnosis ( no ROP , mild ROP , type 2 prethreshold ROP , treatment-requiring ROP ) and an evaluation of image quality for each eye . Findings were compared with a reference st and ard of indirect ophthalmoscopy by an experienced pediatric ophthalmologist . RESULTS At 35 to 37 weeks ' PMA , sensitivity and specificity for diagnosis of mild or worse ROP were 0.908 and 1.000 for grade r A , 0.971 and 1.000 for grade r B , and 0.908 and 0.977 for grade r C. Sensitivity and specificity for diagnosis of type 2 prethreshold or worse ROP were 1.000 and 0.943 for grade r A , 1.000 and 0.930 for grade r B , and 1.000 and 0.851 for grade r C. At 35 to 37 weeks ' PMA , weighted kappa for inter grade r reliability was 0.791 to 0.889 , and kappa for intra grade r reliability for detection of type 2 prethreshold or worse ROP was 0.769 to 1.000 . Image technical quality was rated as " adequate " or " possibly adequate " for diagnosis in 93.3 % to 100 % of eyes . CONCLUSION A telemedicine system using nurse-captured retinal images has the potential to improve existing shortcomings of ROP management , particularly at later PMAs Objective : Evaluate whether telemedicine can be used to perform dysmorphology and neurologic examinations in the neonatal intensive care unit ( NICU ) by determining the examination accuracy , limitations and optimized procedures . Study Design : Prospect i ve evaluation of NICU patients referred for subspecialty consultation for dysmorphic features ( n=10 ) or encephalopathy ( n=10 ) . A physician at bedside ( bedside clinician ) performed an in-person examination that was viewed in real time by a remote physician ( remote consultant ) . St and ardized examinations were recorded and compared . Subsequently , a qualitative approach established technique adjustments and optimization procedures necessary to improve visualization . Result : Telemedicine examinations identified 81 of 87 ( 93 % ) dysmorphology examination abnormalities and 37 of 39 ( 92 % ) neurologic examination abnormalities . Optimization of remote consultant visualization required an active bedside clinician assisting in camera and patient adjustments . Conclusion : Telemedicine can be used to perform accurately many components of the dysmorphology or neurologic examinations in NICU patients , but physicians must be mindful of specific limitations Introduction . Diabetic retinopathy ( DR ) is the leading cause of preventable blindness in Australia . Up to 50 % of people with proliferative DR who do not receive timely treatment will become legally blind within five years . Innovative and accessible screening , involving a variety of primary care providers , will become increasingly important if patients with diabetes are to receive optimal eye care . Method . An open controlled trial design was used . Five intervention practice s in urban , regional , and rural Australia partnered with ophthalmologists via telehealth undertook DR screening and monitoring of type 2 diabetes patients and were compared with control practice s undertaking usual care 2011–2014 . Results . Recorded screening rates were 100 % across intervention practice s , compared with 22–53 % in control practice s. 31/577 ( 5 % ) of patients in the control practice s were diagnosed with mild-moderate DR , of whom 9 ( 29 % ) had appropriate follow-up recorded . This was compared with 39/447 ( 9 % ) of patients in the intervention group , of whom 37 ( 95 % ) had appropriate follow-up recorded . Discussion and Conclusion . General practice -based DR screening via Annual Cycle of Care arrangements is effective across differing practice locations . It offers improved recording of screening outcomes for Australians with type 2 diabetes and better follow-up of those with screen abnormalities Background / aims Digital retinal imaging using store- and -forward technology is used to screen for diabetic retinopathy ( DR ) . Its usefulness in detecting non-diabetic eye diseases is uncertain . We determined the level of agreement between teleretinal imaging supplemented with visual acuity and intraocular pressure ( IOP ) measurements ( ie , technology-assisted eye ( TAE ) exam ) and a comprehensive eye exam in evaluation for DR and non-diabetic ocular conditions . Methods We conducted a prospect i ve , observational study with two parallel evaluations . Patients with diabetes ( n=317 ) had a TAE exam and a comprehensive eye exam on the same day . A subset of participants with normal baseline exams ( n=72 ) had follow-up exams 1 year later . We measured the level of agreement for referable ocular findings . Results Agreement for referable ocular findings was moderate ( n=389 , agreement : 77 % ; κ : 0.55 ) , due in part to ungradable exams ( 22 % ) . However , about half of the ungradable exams had findings that warranted referral . There was substantial agreement for follow-up exams ( n=72 , agreement : 93 % ; κ : 0.63 ) . Among all gradable exams ( n=303 ) , the TAE exam had 86 % sensitivity and 84 % specificity for referable ocular findings , with high agreement ( ≥94 % ) for DR and other major ocular diagnoses . Conclusions There was moderate-to-substantial agreement between a TAE exam and a comprehensive eye exam for referable ocular findings in patients with diabetes . Ungradable exams were a frequent marker of ocular pathology . Teleretinal imaging may be a useful evaluation for both diabetic and non-diabetic ocular conditions OBJECTIVE To report a pilot study of telemedical direct ophthalmoscopy in the diagnosis of acquired immune deficiency syndrome (AIDS)-related retinopathy in a human immunodeficiency virus (HIV)-positive population and in the diagnosis of glaucoma , cataract , and retinopathy in a diabetic population . DESIGN Prospect i ve comparative case series . PARTICIPANTS Seventeen HIV-positive and 20 diabetic patients . METHODS A direct ophthalmoscope custom-fitted with a digital microcamera capable of transmitting images from any of 61 sites within the Georgia Statewide Telemedicine Program was used by a nonophthalmologist to examine 34 eyes of 17 HIV-positive patients and 39 eyes of 20 patients with diabetes . Fundus images were transmitted in real-time to a review ing ophthalmologist . An in-person , comprehensive examination including indirect ophthalmoscopy , was performed by a second ophthalmologist . Telemedical examination was compared to the in-person comprehensive examination . RESULTS For the HIV Output:	Store- and -forward image transmission coupled with real-time videoconferencing is a suitable alternative to overcome poor internet transmission speeds
MS21734	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE For patients with advanced gastric or gastroesophageal cancer ( AGGEC ) providing clinical benefit with improved palliation is highly desirable . However , a prospect i ve evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting . PATIENTS AND METHODS In a multinational trial ( V325 ) , 445 patients were r and omly assigned and treated with either docetaxel plus cisplatin and fluorouracil ( DCF ) or cisplatin and fluorouracil ( CF ) . Clinical benefit was prospect ively evaluated in this trial as a secondary end point . The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status ( KPS ) . Secondary clinical benefit end points included time to 5 % definitive weight loss , time to definitive worsening of appetite by one grade , pain-free survival ( defined as time to first appearance of pain ) , and time to first cancer pain-related opioid intake . Clinical benefit assessment s were recorded at each clinic visit . RESULTS Clinical benefit assessment s were performed in more than 75 % of patients throughout V325 . DCF significantly prolonged time to definitive worsening of KPS compared with CF ( median , 6.1 v 4.8 months ; hazard ratio , 1.38 ; 95 % CI , 1.08 to 1.76 ; log-rank P = .009 ) . Although time to definitive weight loss and time to definitive worsening of appetite favored DCF , the results were not statistically significant . Pain-free survival and time to first cancer pain-related opioid intake were comparable . CONCLUSION To our knowledge , V325 is the first phase III trial to report clinical benefit in AGGEC patients . Clinical benefit was assessed beyond protocol -specific chemotherapy . The addition of D to CF not only significantly improved clinical benefit but also improved quality of life , time to progression , and overall survival compared with CF Purpose The aim of this retrospective study ( from January 2007 to December 2011 ) was to investigate the efficacy and tolerability of mDCF schedule for chemotherapy-naïve AGC patients . Patients Patients ( n = 54 ) with locally inoperable or distant metastasis and performance status of 0–2 were eligible . The triplet combination chemotherapy consisting of docetaxel 60 mg/m2 on day 1 , cisplatin 60 mg/m2 on day 1 , and 5-fluorouracil 600 mg/m2 for 5 days of continuous infusion were administered every 21 days , up to nine cycles . Prophylactic G-CSF was not allowed . Results In all , 36 ( 67 % ) patients were male and 18 ( 33 % ) were female ; median age was 59 years . The majority of patients ( n = 46 , 85 % ) had metastatic disease and 8 ( 15 % ) of them had locally advanced disease . Liver metastasis and peritonitis carcinomatosa were found in 20 ( 43 % ) and 18 ( 39 % ) of the 46 cases , respectively . The median cycle of chemotherapy was 6 . In assessing 50 patients for response evaluation , one had complete response . Partial response was achieved in 27 ( 54 % ) patients . Seventeen patients ( 34 % ) had stable disease and 5 ( 10 % ) had progressive disease , while 4 % ( n = 2 ) and 11 % ( n = 6 ) of the patients developed severe ( grade 3–4 ) neutropenia and anemia , respectively . During the median follow-up time ( 6.9 months , range 0.4–24 ) , 28 ( 52 % ) patients died . The overall and progression-free survival were 10.7 [ 95 % CI 8.9–12.4 ] and 6.8 [ 95 % CI 5.8–7.8 ] months , respectively . Conclusions Although this was not a prospect i ve comparative study , the mDCF regimen seems to be as effective as the original DCF in AGC with acceptable and manageable side effects Gastric cancer is the second most common among cancer-related deaths in the world . Systemic chemotherapy for patients with gastric cancer has limited impact on overall survival . We performed a retrospective analysis of the efficacy and side effects of Docetaxel and Cisplatin Plus Fluorouracil ( DCF ) versus Modified-Dose Docetaxel , Cisplatin , and 5-Fluorouracil ( mDCF ) in the metastatic gastric cancer with first-line chemotherapy treated patients . Retrospectively were review ed 107 locally advanced or metastatic gastric cancer patients who were treated DCF or mDCF as first-line treatment from June 2007 to August 2011 in Dicle University Hospital , Department of Medical Oncology . The DCF protocol included 75 mg/m2 docetaxel and cisplatin on day 1 and 750 mg/m2/day 5-FU infusion for 5 days , repeated every 3 weeks . The mDCF protocol included 60 mg/m² docetaxel and cisplatin on day 1 and 600 mg/m² 5-Fluorouracil continuous infusion per day on days 1 - 5 , every 3 weeks . Patients were treated using DCF arm 85 ( M : 56 , F : 29 ) , the mDCF arm 22 ( M : 13 , F : 9 ) After treatment toxicities were : Grade III-IV neutropenia ( 48.2 % vs 13.6 % p=0.003 ) , anemia ( 21.2 % vs 4.5 % p=0.06 ) , nausea ( 44.7 % vs 13.6 % p=0.008 ) and vomiting ( 31.8 % vs 4.5 % , p=0.01 ) was higher in the DCF arm . Other toxicities profile was similar in both groups ( p>0.05 ) . The rate of response was similar in both arm . Among patients with the DCF and mDCF arm rate complete response ( 10.3 % vs 6.7 % , p>0.05 ) , partial response ( 35.3 % vs 40.0 % , p>0.05 ) , stable disease ( 32.4 % vs 33.3 % , p>0.05 ) , progressive disease ( 22.1 % vs 20.0 % , p>0.05 ) and overall response ( 45.6 % vs 46.7 % , p>0.05 ) did not have a statistically difference ( p>0.05 ) . Progression-free survival ( PFS ) and overall survival ( OS ) were more favorable in the DCF arm than mDCF arm , but the difference was not significant statistically ( 9.9 vs 8.6 , 7.4 vs 6.5 p>0.05)In conclusion , the response rate , median PFS and median OS are similar in both arms , while the mDCF regimen are more favorable than the DCF for toxicity profile regimen in advanced gastric cancer patients who were undergoing first-line palliative treatment . Therefore , a prospect i ve and larger clinical trials are needed Background This study was conducted to determine the optimal dosage of the docetaxel-capecitabine-cisplatin ( DXP ) regimen and to evaluate its efficacy and safety in patients with advanced gastric cancer . Methods Patients with advanced gastric or esophagogastric junctional adenocarcinoma received capecitabine ( days 1–14 ) and intravenous docetaxel and cisplatin ( day 1 ) every 3 weeks . Results In the phase I study , 15 patients were treated with 4 different dose levels . Asthenia and neutropenic fever were the dose-limiting toxicities . For the phase II study , 1,125 mg/m2 of capecitabine was initially recommended with 60 mg/m2 docetaxel and 60 mg/m2 cisplatin . However , frequent dose modifications at this dose level result ed in a final optimal dose of 937.5 mg/m2 capecitabine . Among the 40 patients enrolled in the phase II study , 4 complete and 23 partial responses were observed , presenting objective response rate of 68 % . Ten patients achieving good response with complete disappearance of distant metastases underwent surgery , and 4 pathologic complete responses were identified . After the median follow-up of 83.7 months ( range , 20.2–86.5 ) in surviving patients , the median overall survival was 14.4 months and median progression-free survival was 7.6 months . The most frequent grade 3/4 adverse events were neutropenia ( 62.5 % ) and asthenia ( 37.5 % ) . Ten per cent of the patients experienced neutropenic fever , with one case of sepsis-induced death . Conclusion DXP displays considerable antitumor activity , and may thus present effective first-line treatment for advanced gastric cancer . Further investigation of the efficacy and safety of this regimen in both first-line and neoadjuvant setting s is warranted BACKGROUND Phase II and III trials of docetaxel , cisplatin and fluorouracil ( DCF ) have shown superior efficacy versus cisplatin and fluorouracil alone but high rates of hematologic toxicity in advanced gastric cancer . To reduce toxicity while maintaining the efficacy of DCF , we investigated split doses of docetaxel ( T ) , cisplatin ( P ) , leucovorin ( L ) and fluorouracil ( F ) . PATIENTS AND METHODS Chemotherapy-naive patients with advanced gastric-/esophageal adenocarcinomas received T 50 mg/m(2 ) and P 50 mg/m(2 ) on days 1 , 15 and 29 and L 500 mg/m(2 ) plus F 2000 mg/m(2 ) weekly , every 8 weeks . Because significant dose reductions to < 80 % became necessary in 80 % of patients , the regimen was amended after the first 15 patients to T 40 mg/m(2 ) , P 40 mg/m(2 ) , L 200 mg/m(2 ) and F 2000 mg/m(2 ) . The primary endpoint was response rate . RESULTS Sixty patients were enrolled : 24 had locally advanced ( LA ) tumors and 36 had metastatic disease . Grade 3/4 toxicities included neutropenia ( 22 % ) , febrile neutropenia ( 5 % ) , diarrhea ( 20 % ) and lethargy ( 18 % ) . The overall response rate was 47 % . Twenty-three LA patients underwent secondary surgical resection ( 96 % ) ; complete resection was achieved in 87 % . Overall , median time to progression and overall survival were 9.4 and 17.9 months , respectively ( 8.1 and 15.1 months , respectively , for patients with metastatic disease ) . CONCLUSION T-PLF regimen is highly active and has a favorable toxicity profile Background The V325 study showed that docetaxel , cisplatin , and fluorouracil ( DCF ) prolonged overall survival ( OS ) of patients with advanced gastric cancer , but with a high incidence of dose-limiting toxicities . We investigated the efficacy and safety of a modified DCF ( mDCF ) regimen for Chinese patients with advanced gastric cancer . Methods Untreated advanced gastric cancer patients r and omly received docetaxel and cisplatin at 60 mg/m2 ( day 1 ) followed by fluorouracil at 600 mg/m2/day ( days 1–5 ; mDCF regimen ) or cisplatin at 75 mg/m2 ( day 1 ) followed by fluorouracil at 600 mg/m2/day ( days 1–5 ; CF ) every 3 weeks . The primary end point was progression-free survival ( PFS ) . The secondary end points were OS , overall response rate ( ORR ) , time-to-treatment failure ( TTF ) , and safety . Results In total , 243 patients were r and omized to treatment ( mDCF regimen 121 ; CF 122 ) . Compared with CF , the mDCF regimen significantly improved PFS and OS : the median PFS was 7.2 and 4.9 months , respectively [ hazard ratio ( HR ) 0.58 , log-rank P = 0.0008 ] , and the median OS was 10.2 and 8.5 months , respectively ( HR = 0.71 , P = 0.0319 ) . Additionally , the mDCF regimen improved the parameters used as secondary objectives : the ORR was 48.7 % with the mDCF regimen versus 33.9 % with CF ( P = 0.0244 ) ; the median TTF was 3.4 months with the mDCF regimen and 2.4 months with CF ( HR = 0.67 , P = 0.0027 ) . Grade 3 and grade 4 treatment-related adverse events occurred in 77.3 % of patients who received the mDCF regimen versus 46.1 % of patients who received CF ( P < 0.001 ) . Conclusions The mDCF regimen , compared with CF , significantly prolonged PFS and OS and enhanced ORR of Chinese patients with advanced gastric cancer . The mDCF regimen achieved efficacy comparable to that of DCF but with fewer toxicities , which is appropriate for the Chinese population Purpose This phase II trial aim ed to evaluate the efficacy and safety of docetaxel , cis Output:	mDCF chemotherapy with splitted weekly or biweekly schedules , or reduced 3-weekly doses , is a very effective and well-tolerated regimen in metastatic GC . By providing a 50 % ORR , such regimens may be particularly indicated for younger and fit patients for cytoreductive purpose s ( conversion therapy ) or in case of symptomatic tumor burden
MS21735	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A double-blind , placebo-controlled trial of immunotherapy was conducted in patients with Dermatophagoides pteronyssinus rhinitis . Thirty patients received an extract with a high content of Der p I ( Pharmalgen ) , 20 received a conventional mite extract ( Allpyral ) , and 30 patients received histamine chloride ( placebo ) . Specific IgG and subclasses were measured before and after 3 and 12 months of treatment by RIA and /or ELISA , and specific IgE by RAST . Clinical outcome was assessed by skin prick tests , nasal challenge , visual analogue , and diary-card symptom and drug scores ; from these findings , a clinical index was derived . An IgG response occurred only in the Pharmalgen-treated group : D. pter IgG and IgG1 increased by 3 months ( p less than 0.05 ) and then plateaued to 12 months ( p less than 0.05 ) . IgG4 levels increased throughout treatment ( p less than 0.05 and p less than 0.01 ) , as did the IgG/IgE ratio . A subclass switch from IgG1 to IgG4 occurred . D. pter IgE rose at 3 months ( p less than 0.05 ) . Clinical improvement occurred at 3 and 12 months in the Pharmalgen-treated group only . Pretreatment levels of IgE , IgG1 , or IgG4 did not predict clinical outcome . Our findings are compatible with the hypothesis that IgG subclasses may modulate antigen-IgE interactions , although the antibody response to this potent extract need not be causally related to improvement The present work reports the results of a double‐blind clinical trial , comparing the effects of hyposensitization treatment versus placebo in 33 patients with allergic rhinitis , sensitive to a crude extract of the pollen of four different grasses ( Dactylis glamerata , Lolium perenne , Secale cereale , and Phlewn pratense ) . The distribution of these patients in the two groups was done r and omly and gave two comparable groups , as far as clinical and biological features are concerned . The treatment course included five low doses of the aqueous extract followed by 12 injections of Al(OH)3‐adsorbed aliquots of the same extract . Evaluation of the clinical scores was based on diary cards on which symptoms and medications were recorded . A reevaluation of the significance of the symptom and medication scores is presented and the link between both scores is studied . Particular attention is given to the method ological and statistical problems raised during this study . The non‐parametric tests reveal a significant difference ( P < 0.03 ) in the total clinical score between the treated and the placebo groups for the second half of the observation period , when the pathology was most intense Background Little information is available on the effect of allergen-specific immunotherapy on airway responsiveness and markers in exhaled air . The aims of this study were to assess the safety of immunotherapy with purified natural Alt a1 and its effect on airway responsiveness to direct and indirect bronchoconstrictor agents and markers in exhaled air . Methods This was a r and omized double-blind trial . Subjects with allergic rhinitis with or without mild/moderate asthma sensitized to A alternata and who also had a positive skin prick test to Alt a1 were r and omized to treatment with placebo ( n = 18 ) or purified natural Alt a1 ( n = 22 ) subcutaneously for 12 months . Bronchial responsiveness to adenosine 5'-monophosphate ( AMP ) and methacholine , exhaled nitric oxide ( ENO ) , exhaled breath condensate ( EBC ) pH , and serum Alt a1-specific IgG4 antibodies were measured at baseline and after 6 and 12 months of treatment . Local and systemic adverse events were also registered . Results The mean ( 95 % CI ) allergen-specific IgG4 value for the active treatment group increased from 0.07 μg/mL ( 0.03 - 0.11 ) at baseline to 1.21 μg/mL ( 0.69 - 1.73 , P < 0.001 ) at 6 months and to 1.62 μg/mL ( 1.02 - 2.22 , P < 0.001 ) at 12 months of treatment . In the placebo group , IgG4 value increased nonsignificantly from 0.09 μg/mL ( 0.06 - 0.12 ) at baseline to 0.13 μg/mL ( 0.07 - 0.18 ) at 6 months and to 0.11 μg/mL ( 0.07 - 0.15 ) at 12 months of treatment . Changes in the active treatment group were significantly higher than in the placebo group both at 6 months ( P < 0.001 ) and at 12 months of treatment ( P < 0.0001 ) . However , changes in AMP and methacholine responsiveness , ENO and EBC pH levels were not significantly different between treatment groups . The overall incidence of adverse events was comparable between the treatment groups . Conclusion Although allergen-specific immunotherapy with purified natural Alt a1 is well tolerated and induces an allergen-specific IgG4 response , treatment is not associated with changes in AMP or methacholine responsiveness or with significant improvements in markers of inflammation in exhaled air . These findings suggest dissociation between the immunotherapy-induced increase in IgG4 levels and its effect on airway responsiveness and inflammation Background Calcium phosphate‐adsorbed allergen extracts are used for subcutaneous immunotherapy to avoid the use of aluminium adjuvants Inl and areas of northern California have an intense grass pollination in the spring of each year . This is accompanied by a stirking rise in the incidence of asthma . We documented this relationship and design ed a trial to test the efficacy of immunotherapy for grass-pollen asthma . Aeroallergen counts were performed on the roof of the allergy clinic of David Grant Medical Center from January 1981 to December 1984 by a gravity collector . These counts were compared to counts done on a Rotorod at a nearby hospital from July 1982 to September 1984 . Climatologic factors were also tabulated . Visits for asthma and rhinitis to our emergency room and asthma admissions to our hospital were counted for the 4-year period . A r and omized , double-blinded , placebo-controlled trial of immunotherapy with grass-pollen extract was performed from November 1984 to June 1985 . Two groups of clinical ly and immunologically well-matched subjects were started on an accelerated preseasonal trial of immunotherapy . One group received a st and ardized grass extract , and the other group did not . Both groups received other extracts of aeroallergens to which they were skin test positive that occur locally in the spring and summer . This was done because of our dissatisfaction with a histamine placebo used in a previous pilot study . Symptom medication scores ( SMS ) and immunologic parameters were followed . For the 4-year period , grass-pollen count ( GPC ) correlated strongly with asthma emergency room visits ( r = 0.90 ; p less than 0.001 ) and for rhinitis ( r = 0.92 ; p less than 0.001 ) . Asthma admissions also correlated strongly with GPC ( r = 0.72 ; p less than 0.001 ) . Other aeroallergens either did not correlate significantly or occurred in such small numbers that they could not be seriously considered . Rotorod counts supported these conclusions with the exceptions of some Basidiomycetes . Climatologic factors demonstrated no relationship to the incidence of asthma . Asthma SMS were lower in the grass-treated group , p less than 0.05 . Rhinitis SMS were also lower but did not reach significance , p = 0.11 . RGGI sIgE did not rise significantly in the grass-treated group but did in the placebo-treated group . RGGI sIgE rose in both groups , although to significantly higher levels in the grass-treated group , p less than 0.001 . The asthma SMS were inversely related to increasing RGGI cumulative dose , p less than 0.10 . Linear regression analysis of the dose-response scattergram suggests that a cumulative dose of approximately 90 micrograms of RGGI may be desirable . ( ABSTRACT TRUNCATED AT 400 WORDS We have performed a comparative study to evaluate seasonal and perennial schedules after 3 years of immunotherapy . Sixty patients suffering from rhinitis and /or asthma due to grass pollen sensitization were r and omly allocated to receive a semi-depot extract of Phleum pratense according to a perennial or seasonal schedule . The last year of the study , 14 patients were recruited as a control group without immunotherapy . The cumulative dose was 602 BU in the perennial group and 372 BU in the seasonal group . The frequency and severity of side-effects were similar and very low in both treated groups . The IgE level was significantly lower after perennial immunotherapy at the end of the first 2 years . A seasonal decrease in specific IgG levels was observed in patients who interrupted immunotherapy , while this was not observed in patients under the perennial schedule . Symptoms and medication scores did not show differences between groups . Nevertheless , we found a significant difference between treated patients and the control group OBJECTIVE --To evaluate the efficacy and safety of immunotherapy ( hyposensitisation ) in patients with severe summer hay fever . DESIGN --A r and omised , double blind , placebo controlled study of a biologically st and ardised depot grass pollen extract . SETTING --Allergy clinic , Royal Brompton and National Heart Hospital , London . PATIENTS --40 adults ( mean age 35 years ) with a history of severe grass pollen allergy uncontrolled by st and ard antiallergic drugs . Patients with perennial asthma were specifically excluded . INTERVENTION-- Patients were r and omised to receive either an active preparation ( Alutard SQ , a grass pollen ( Phleum pratense ) extract ) or placebo at a rate of two subcutaneous injections a week in increasing doses until a maintenance dose was reached . This maintenance dose was given once a month . MAIN OUTCOME MEASURES -- Clinical efficacy was evaluated by symptom and drug diary cards , visual analogue scores during the grass pollen season , and a postseasonal assessment by the patients and a doctor . Conjunctival and skin sensitivity to local allergen provocation was measured before and after eight months of treatment . RESULTS --There was a highly significant decrease ( median Alutard SQ v median placebo ( 95 % confidence interval for difference between medians ] in total symptom scores ( p=0.001 ) in the Alutard SQ treated group ( 360 v 928 ( 238 to 825 ] . Significant differences were also found in total drug use ( p=0.002 , 129 v 627 ( 178 to 574 ] . Visual analogue symptom scores were also reduced in the active group ( p=0.02 , 2.2 v 5.5 ( -4.8 to -0.5 ] . The postseasonal assessment , by either the doctor or the patients , showed a large improvement ( p less than 0.001 ) in favour of Alutard SQ . Provocation tests showed a greater than 10-fold reduction for the active group in immediate conjunctival allergen sensitivity ( p=0.001 ) , a 40 % decrease in early phase response ( p=0.02 ) , and a 57 % decrease in the late phase ( p=0.001 ) cutaneous response after intradermal allergen . A total of 523 active injections were given . There was one systemic reaction at 10 minutes after injection , which was rapidly reversed with intramuscular adrenaline . There was one mild delayed urticarial reaction at 2 1/2 hours . CONCLUSION --Immunotherapy is effective in patients with severe summer hay fever , but immediate anaphylactic reactions limit its use to specialised centres . Patient selection is extremely important , and chronic perennial asthma should be specifically excluded . As serious reactions occur within minutes a two hour wait for all patients after each injection seems unnecessary BACKGROUND Grass pollen immunotherapy for allergic rhinitis is a disease-modifying treatment that results in long-term clinical tolerance lasting years after treatment discontinuation . Active treatment is associated with generation of inhibitory grass pollen-specific IgG antibodies capable of blocking allergen-IgE interactions . OBJECTIVES We sought to investigate the involvement of IgG-associated inhibitory antibodies with long-term clinical tolerance after discontinuation of grass pollen immunotherapy . METHODS We conducted a 4-year study in which patients who had moderate-to-severe allergic rhinitis underwent a r and omized , double-blind , placebo-controlled discontinuation of subcutaneous grass pollen immunotherapy . All subjects received grass pollen immunotherapy injections for 2 years ( n = 13 ) , followed by a further 2 years of either active ( n = 7 ) or placebo ( n = 6 ) injections . Clinical outcomes included seasonal symptoms and use of rescue medication . Serum specimens were collected at baseline and after 2 and 4 years for quantification of allergen-specific IgG antibodies . Sera were also tested for IgG-dependent inhibitory bioactivity against IgE-allergen binding in cellular assays by using flow cytometry and confocal microscopy to detect binding of IgE-grass pollen allergen complexes to B cells . RESULTS Clinical improvement was maintained after 2 years of discontinuation . Although immunotherapy-induced grass pollen-specific IgG1 and IgG4 levels decre Output:	The literature provides high- grade evidence that SCIT reduces asthma symptoms , asthma medication usage , rhinitis/rhinoconjunctivitis symptoms , conjunctivitis symptoms , and rhinitis/rhinoconjunctivitis disease-specific quality of life in comparison to placebo or usual care . There is moderate evidence that SCIT decreases rhinitis/rhinoconjunctivitis medication usage . Respiratory reactions were the most common systemic reaction . Generally moderate to strong evidence supports the effectiveness of SCIT for treatment of allergic rhinitis and asthma , particularly with single-allergen immunotherapy regimens . Adverse reactions to SCIT are common , but no deaths were reported in the included studies
MS21736	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years . 90 % of deliveries in the poorest quintile of households happen at home . We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates . METHODS We pair-matched 42 geopolitical clusters in Makwanpur district , Nepal , selected 12 pairs r and omly , and r and omly assigned one of each pair to intervention or control . In each intervention cluster ( average population 7000 ) , a female facilitator convened nine women 's group meetings every month . The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them . We monitored birth outcomes in a cohort of 28?931 women , of whom 8 % joined the groups . The primary outcome was neonatal mortality rate . Other outcomes included stillbirths and maternal deaths , uptake of antenatal and delivery services , home care practice s , infant morbidity , and health-care seeking . Analysis was by intention to treat . The study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N31137309 . FINDINGS From 2001 to 2003 , the neonatal mortality rate was 26.2 per 1000 ( 76 deaths per 2899 livebirths ) in intervention clusters compared with 36.9 per 1000 ( 119 deaths per 3226 livebirths ) in controls ( adjusted odds ratio 0.70 [ 95 % CI 0.53 - 0.94 ] ) . Stillbirth rates were similar in both groups . The maternal mortality ratio was 69 per 100000 ( two deaths per 2899 livebirths ) in intervention clusters compared with 341 per 100000 ( 11 deaths per 3226 livebirths ) in control clusters ( 0.22 [ 0.05 - 0.90 ] ) . Women in intervention clusters were more likely to have antenatal care , institutional delivery , trained birth attendance , and hygienic care than were controls . INTERPRETATION Birth outcomes in a poor rural population improved greatly through a low cost , potentially sustainable and scalable , participatory intervention with women 's groups OBJECTIVE : Preterm infants are prone to hypothermia immediately following birth . Among other factors , excessive evaporative heat loss and the relatively cool ambient temperature of the delivery room may be important contributors . Most infants < 29 weeks gestation had temperatures < 36.4 ° C on admission to our neonatal unit ( NICU ) . Therefore we conducted a r and omized , controlled trial to evaluate the effect of placing these infants in polyurethane bags in the delivery room to prevent heat loss and reduce the occurrence of hypothermia on admission to the NICU . METHODS : After parental consent was obtained , infants expected to be < 29 weeks gestation were r and omized to intervention or control groups just prior to their birth . Infants r and omized to the intervention group were placed in polyurethane bags up to their necks immediately after delivery before being dried . They were then resuscitated per NRP guidelines , covered with warm blankets , and transported to the NICU , where the bags were removed and rectal temperatures were recorded . Control infants were resuscitated , covered with warm blankets , and transported without being placed in polyurethane bags . Delivery room temperatures were recorded so this potentially confounding variable could be assessed . RESULTS : Intervention patients were less likely than control patients to have temperature < 36.4 ° C on admission , 44 vs 70 % ( p<0.01 ) and the intervention group had a higher mean admission temperature , 36.5 ° C vs 36.0 ° C ( p<0.003 ) . This effect remained significant ( p<0.0001 ) when delivery room temperature was controlled in analysis . Warmer delivery room temperatures ( ≥26 ° C ) were associated with higher admission temperatures in both intervention and control infants , but only the subgroup of intervention patients born in warmer delivery rooms had a mean admission temperature > 36.4 ° C . CONCLUSIONS : Placing infants < 29 weeks gestation in polyurethane bags in the delivery room reduced the occurrence of hypothermia and increased their NICU admission temperatures . Maintaining warmer delivery rooms helped but was insufficient in preventing hypothermia in most of these vulnerable patients without the adjunctive use of the polyurethane bags Objective : To describe the effects of out-of-hospital birth on early neonatal morbidity and outcome among referred newborns . Methods : Using a structured case record form , we prospect ively collected data on place of birth , morbidity , and outcome of all neonates admitted to the Emergency Ward , University College Hospital , Ibadan , in the first week of life . Results : Of the 541 admitted in the early neonatal period , 61.8 % and 38.2 % were delivered outside and inside the hospital setting , respectively . Babies were delivered at religious or " mission " house ( 46.7 % ) , house of residence ( 38.0 % ) , traditional birth attendants ' homes ( 8.4 % ) , and on the way to the hospital ( 6.9 % ) . Births outside the hospital significantly increased as the birth order increased ( χ = 34.04 ; P = 0.000 ) . Over half of the out-of-hospital deliveries took place under personnel whose primary responsibilities did not include labor care . Women who had less than secondary level of education and those from the lower social class were more likely to deliver outside the hospital ( P < 0.05 ) . Out-of-hospital births were significantly associated with many complications , namely , hypothermia ( 53.6 % ) , perinatal asphyxia ( 48.5 % ) , hemorrhage ( 26.5 % ) , cephalhematoma ( 12.9 % ) , prematurity ( 9.9 % ) , and neonatal tetanus ( 4.2 % ) . Neonatal mortality rate of 12.6 % in the out-of-hospital group was significantly higher than 6.3 % obtained in the hospital birth group ( P = 0.019 ) . Conclusions : Out-of-hospital births had greater risk of morbidity than hospital births . There is need to retrain and monitor the activities of birth attendants and midwives involved in births outside the hospitals closer than it is presently done The objective of this study is to correlate the severity of hypothermia in sick extramural neonates with fatality and physiological derangements . This is a prospect i ve observational study carried out at the referral neonatal unit of a teaching hospital admitting extramural neonates . The subjects comprised of 100 extramural hypothermic neonates transported to the Referral neonatal unit . Neonates weighing more than 1000 g , with abdominal skin temperature less than 36.5 degrees C at admission were included in the study . Hypothermia was classified as per WHO recommendations . Clinical features including age , weight , gestational age , clinical diagnosis , vitals , place of delivery , details of transportation and capillary filling time were recorded at the time of admission . Oxygen saturation was recorded by a pulse oximeter . Sample s for sepsis screen , blood culture and blood glucose were taken at admission . During the study it was observed that fatality was 39.3 % in mildly hypothermic babies , 51.6 % in moderately hypothermic babies and 80 % in severely hypothermic babies . However , the presence of associated illness ( birth asphyxia , neonatal sepsis and respiratory distress ) , physiological derangements ( hypoxia , hypoglycemia and shock ) and weight less than 2000 g were associated with more than 50 % fatality even in mildly hypothermic babies . When moderate hypothermia was associated with hypoxia or shock , the fatality was 83.3 % and 90.9 % respectively . Similarly , mild hypothermia with hypoglycemia was associated with 71.4 % fatality . The conclusion drawn from this study is that the WHO classification of severity of hypothermia correlates with the risk of fatality . However , it considers only body temperature to classify severity of hypothermia . The presence of associated illness ( birth asphyxia , neonatal sepsis and respiratory distress ) , physiological derangements ( hypoxia , hypoglycemia and shock ) and weight less than 2000 g should be considered adverse factors in hypothermic neonates . Their presence should classify hypothermia in the next higher category of severity in WHO classification A prospect i ve cohort study was carried out at the University Teaching Hospital , Lusaka , Zambia , to investigate the prevalence of neonatal hypothermia , type of infant care and incidence of mortality . Two-hundred- and -sixty-one infants , aged 0 - 7 days , admitted to the pediatric unit during the ' warm ' season were recruited to the study . Forty-four per cent of the infants were hypothermic ( < 36 degrees C ) on admission , and admission hypothermia correlated to admission weight and home delivery in the youngest age group ( 0 - 24 hours ) . Exclusively breastfed infants ( age group 1 - 7 days ) were less likely to be hypothermic at admission . ' Hypothermia ' was not recorded as an admission diagnosis and no special attention was given to those infants in terms of clinical management . Mean time to reach a body temperature above 35.9 degrees C did not differ between infants kept in a cot and in an incubator . Total numbers of death was 82 ( 31 per cent ) and the mortality was higher in infants who were hypothermic at admission compared to those who were not . This study demonstrates that a change of existing care routines is needed OBJECTIVE To determine the incidence rate and factors associated with hypothermia in Iranian newborns and to discover the effect of hypothermia on neonatal morbidity and mortality . METHODS We selected a r and om sample of 1952 neonates using a multistage sampling technique from February 2004 to February 2005 in University Teaching Hospitals in Iran . We measured repeatedly at different time points the rectal temperature of these newborns . At each time of measurement , those with rectal temperature < 36 degrees C were considered as hypothermic . RESULTS The obtained results showed that approximately one third of newborns became hypothermic immediately after birth . In addition , the regression analysis revealed that low birth weights , prematures , low apgar scores , infants of multiple pregnancies and those who received cardiopulmonary resuscitation had higher risk for being hypothermic . It was also found that hypothermia increases the risk of metabolic acidosis , jaundice , respiratory distress , hypoglycemia , pulmonary hemorrhage and death , regardless of the newborn 's weight and gestational age . CONCLUSION There is an urgent need to train mothers and all levels of neonatal care staff to control this health problem in our country Aim : To eluci date the impact of bathing on the prevalence of hypothermia among newborn babies exposed to the skin‐to‐skin ( STS ) care technique before and after bathing . Methods : Non‐asphyxiated newborns after vaginal delivery ( n=249 ) in a Ug and an referral hospital were consecutively enrolled and r and omized either to bathing at 60 min postpartum ( n=126 ) or no bathing ( n=123 ) . All mothers practised skin‐to‐skin care of their newborns . Four rectal and tympanic registration s of newborn temperatures were carried out in both groups directly after drying at birth , and at 60 , 70 and 90 min postpartum . Results : Bathing of newborns in the first hour after delivery result ed in a significantly increased prevalence of hypothermia , defined as temperature < 36.5 ° C , at 70 and at 90 min postpartum despite the use of warmed water and the application of the STS method . There was no neonatal mortality . Aside from the bathing procedure , no background factor potentially predisposing the newborns to hypothermia was identified An assessment of the incubators in use at the Kathm and u Maternity Hospital neonatal unit was undertaken ; this was followed by a prospect i ve survey of neonatal temperatures on the unit . In the incubator assessment 11 studies were carried out in five incubators . Three of the thermostats in the five incubators did not work at all and those in the other two incubators were more than 3 degrees C inaccurate . All the incubator thermometers gave recordings less than the actual temperature ( with a range of error : 1.3 - 4.4 degrees C ) . Six out of the 11 babies studied were hypothermic ( defined as rectal temperature < 36 degrees C ) . In the prospect i ve survey of temperatures a high incidence of hypothermia was found on the neonatal unit at the time of first temperature measurement ( 64 per cent had a rectal temperature of < 36 degrees C ) . A significant association between admission hypothermia and mortality was noted . Sixteen per cent ( 10/64 ) of babies admitted with temperatures < 36 degrees C died within the first week , compared to 0 ( 0/36 ) of those admitted with temperatures > or = 36 degrees Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a re source poor country with limited access to healthcare . Design Prospect i ve , cluster r and omised and controlled effectiveness study . Setting Lufwanyama , an agrarian , poorly developed district located in the Copperbelt province , Zambia . All births carried out by study birth attendants occurred at mothers ’ homes Output:	The introduction of simple hypothermia prevention messages and interventions into evidence -based , cost-effective packages for maternal and newborn care has promising potential to decrease the heavy global burden of newborn deaths attributable to severe infections , prematurity , and asphyxia . Because preventing and treating newborn hypothermia in health institutions and communities is relatively easy , addressing this widespread challenge might play a substantial role in reaching Millennium Development Goal 4 , a reduction of child mortality
MS21737	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT High levels of lipoprotein(a ) are associated with increased risk of myocardial infa rct ion ( MI ) . OBJECTIVE To assess whether genetic data are consistent with this association being causal . DESIGN , SETTING , AND PARTICIPANTS Three studies of white individuals from Copenhagen , Denmark , were used : the Copenhagen City Heart Study ( CCHS ) , a prospect i ve general population study with 16 years of follow-up ( 1991 - 2007 , n = 8637 , 599 MI events ) ; the Copenhagen General Population Study ( CGPS ) , a cross-sectional general population study ( 2003 - 2006 , n = 29 388 , 994 MI events ) ; and the Copenhagen Ischemic Heart Disease Study ( CIHDS ) , a case-control study ( 1991 - 2004 , n = 2461 , 1231 MI events ) . MAIN OUTCOME MEASURES Plasma lipoprotein(a ) levels , lipoprotein(a ) kringle IV type 2 ( KIV-2 ) size polymorphism genotype , and MIs recorded from 1976 through July 2007 for all participants . RESULTS In the CCHS , multivariable-adjusted hazard ratios ( HRs ) for MI for elevated lipoprotein(a ) levels were 1.2 ( 95 % confidence interval [ CI ] , 0.9 - 1.6 ; events/10,000 person-years , 59 ) for levels between the 22nd and 66th percentile , 1.6 ( 95 % CI , 1.1 - 2.2 ; events/10,000 person-years , 75 ) for the 67th to 89th percentile , 1.9 ( 95 % CI , 1.2 - 3.0 ; events/10,000 person-years , 84 ) for the 90th to 95th percentile , and 2.6 ( 95 % CI , 1.6 - 4.1 ; events/10,000 person-years , 108 ) for levels greater than the 95th percentile , respectively , vs levels less than the 22nd percentile ( events/10,000 person-years , 55 ) ( trend P < .001 ) . Numbers of KIV-2 repeats ( sum of repeats on both alleles ) ranged from 6 to 99 and on analysis of variance explained 21 % and 27 % of all variation in plasma lipoprotein(a ) levels in the CCHS and CGPS , respectively . Mean lipoprotein(a ) levels were 56 , 31 , 20 , and 15 mg/dL for the first , second , third , and fourth quartiles of KIV-2 repeats in the CCHS , respectively ( trend P < .001 ) ; corresponding values in the CGPS were 60 , 34 , 22 , and 19 mg/dL ( trend P < .001 ) . In the CCHS , multivariable-adjusted HRs for MI were 1.5 ( 95 % CI , 1.2 - 1.9 ; events/10,000 person-years , 75 ) , 1.3 ( 95 % CI , 1.0 - 1.6 ; events/10,000 person-years , 66 ) , and 1.1 ( 95 % CI , 0.9 - 1.4 ; events/10,000 person-years , 57 ) for individuals in the first , second , and third quartiles , respectively , as compared with individuals in the fourth quartile of KIV-2 repeats ( events/10,000 person-years , 51 ) ( trend P < .001 ) . Corresponding odds ratios were 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.1 ( 95 % CI , 0.9 - 1.3 ) , and 0.9 ( 95 % CI , 0.8 - 1.1 ) in the CGPS ( trend P = .005 ) , and 1.4 ( 95 % CI , 1.1 - 1.7 ) , 1.2 ( 95 % CI , 1.0 - 1.6 ) , and 1.3 ( 95 % CI , 1.0 - 1.6 ) in the CIHDS ( trend P = .01 ) . Genetically elevated lipoprotein(a ) was associated with an HR of 1.22 ( 95 % CI , 1.09 - 1.37 ) per doubling of lipoprotein(a ) level on instrumental variable analysis , while the corresponding value for plasma lipoprotein(a ) levels on Cox regression was 1.08 ( 95 % CI , 1.03 - 1.12 ) . CONCLUSION These data are consistent with a causal association between elevated lipoprotein(a ) levels and increased risk of MI A size polymorphism ( K IV VNTR ) and largely unknown sequence variation in the apolipoprotein(a ) [ apo(a ) ] gene on chromosome 6q26–q27 together determine most of the extreme variation in apo(a ) glycoprotein expression and lipoprotein(a ) [ Lp(a ) ] plasma concentration in Caucasians . We have determined Lp(a ) plasma concentrations , the number of kringle IV ( K IV ) repeats in the apo(a ) gene and the expression of the apo(a ) glycoprotein in four ethnic groups ( Khoi San , South African Blacks , Hong Kong Chinese and Caucasians from the Tyrol , total n = 788 ) . The distributions of Lp(a ) concentrations , the frequencies of expressed and non-expressed apo(a ) K IV alleles , and the impact of the size polymorphism on Lp(a ) concentrations were all heterogeneous across population s. In contrast , the effect of the K IV repeat alleles appeared homogeneous . Lp(a ) concentrations were higher in Africans and Chinese than in Caucasians , but this was not explained by differences in K IV repeat allele frequencies among population s. Lp(a ) concentrations were highest in Khoi San , suggesting that high Lp(a ) is an old African trait . When expressed as Spearman rank correlations the impact of the size polymorphism was smallest in African Blacks ( R = −0.386 ) and largest in the Chinese ( R = −0.692 ) . In all four population s , the distribution of non-expressed apo(a ) alleles was non-r and om . Rather they were significantly associated with distinct size alleles and overall positively with high K IV repeat numbers . The negative correlation of K IV repeat length with Lp(a ) concentration was nonlinear in Khoi San and the average apo(a)-size-allele-associated Lp(a ) concentrations were markedly different between all population s. We conclude that besides the apo(a ) size variation , other factors affect Lp(a ) concentrations to different degrees in the study population s. Most likely , this is sequence variation in apo(a ) which is not the same in the different ethnic groups BACKGROUND Experimental studies have suggested both atherogenic and thrombogenic properties of lipoprotein(a ) [ Lp(a ) ] , depending on Lp(a ) plasma concentrations and varying antifibrinolytic capacity of apolipoprotein(a ) [ apo(a ) ] isoforms . Epidemiological studies may contribute to assessment of the relevance of these findings in the general population . METHODS AND RESULTS This study prospect ively investigated the association between Lp(a ) plasma concentrations , apo(a ) phenotypes , and the 5-year progression of carotid atherosclerosis assessed by high-resolution duplex ultrasound in a r and om sample population of 826 individuals . We differentiated early atherogenesis ( incident nonstenotic atherosclerosis ) from advanced ( stenotic ) stages in atherosclerosis that originate mainly from atherothrombotic mechanisms . Lp(a ) plasma concentrations predicted the risk of early atherogenesis in a dose-dependent fashion , with this association being confined to subjects with LDL cholesterol levels above the population median ( 3.3 mmol/L ) . Apo(a ) phenotypes were distributed similarly in subjects with and without early carotid atherosclerosis . In contrast , apo(a ) phenotypes of low molecular weight emerged as one of the strongest risk predictors of advanced stenotic atherosclerosis , especially when associated with high Lp(a ) plasma concentrations ( odds ratio , 6.4 ; 95 % CI , 2.8 to 14 . 9 ) . CONCLUSIONS Lp(a ) is one of the few risk factors capable of promoting both early and advanced stages of atherogenesis . Lp(a ) plasma concentrations predicted the risk of early atherogenesis synergistically with high LDL cholesterol . Low-molecular-weight apo(a ) phenotypes with a putatively high antifibrinolytic capacity in turn emerged as one of the leading risk conditions of advanced stenotic stages of atherosclerosis 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 The objective of the present study was to examine the possible associations between low molecular weight ( LMW ) apolipoprotein(a ) ( apo(a ) ) isoforms ( F , B , S1,S2 ) and coronary heart disease ( CHD ) . We conducted a nested case-control ( prospect i ve ) study of five cohorts of white men : The 1936 cohort ( baseline 1976 , n = 548 ) and four cohorts from MONICA I born in 1923 ( n = 463 ) , 1933 ( n = 491 ) , 1943 ( n = 504 ) and 1953 ( n = 448 ) studied at baseline in 1983 . At follow up in 1991 , 52 subjects had developed a first myocardial infa rct ion and 22 had been hospitalized with angina pectoris . Plasma sample s obtained at baseline were stored frozen until 1993 - 94 , when case sample s ( n = 74 ) were analyzed together with sample s from matched ( disease free ) controls ( n = 190 ) . In a statistical model ( conditional logistic regression ) including all age groups , cholesterol ( or apo B ) level ( P < 0.01 ) , systolic blood pressure ( P = 0.05 ) and smoking ( P = 0.02 ) predicted CHD . In the statistical model Lp(a ) interacted significantly with age ( OR = 5.7 ; 95 % CI : 1.4 - 23.6 ; P = 0.016 ) , and high Lp(a ) ( over 45 mg/dl ) was associated with significantly increased risk in subjects under 60 years ( OR = 3.82 ; 95 % CI : 1.47 - 9.96 ) , but not in older men ( OR = 0.67 ; 95 % CI : 0.235 - 1.89 ) . Therefore , we studied the impact of Lp(a)/apo(a ) and other variables in subjects who had been under 60 years when they became cases . Among the younger subjects the presence of LMW apo(a ) isoforms significantly predicted the development of CHD ( OR = 3.83 ; 95 % CI : 1.18 - 12.4 ) . The increased risk pertained to Output:	CONCLUSIONS People with smaller apo(a ) isoforms have an approximately 2-fold higher risk of CHD or ischemic stroke than those with larger proteins .
MS21738	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES : To determine whether intravaginal clindamycin cream reduces the incidence of abnormal pregnancy outcome in women with abnormal vaginal microbial flora grade d as intermediate or BV and to investigate the effect of the antibiotic on vaginal microbial flora . METHODS : A prospect i ve cohort study of pregnant women in an antenatal clinic of a district general hospital . The subjects were 268 women who had abnormal vaginal microbial flora at first clinic visit by examination of a Gram-stained vaginal smear and 34 women with a normal vaginal flora . Two hundred and thirty-seven women were evaluable . Women with abnormal Gram-stained smears ( grade d as II or III ) on clinic recall were r and omised to receive treatment ( intravaginal clindamycin cream ) or placebo and followed to assess outcome of pregnancy , vaginal flora , and detection of Mycoplasma hominis and Ureaplasma urealyticum after treatment . RESULTS : Abnormal outcomes of pregnancy were not significantly different in treated and placebo groups by Chi square ( P = 0.2 ) . However , women with grade III flora responded better to clindamycin than women with grade II flora by numbers of abnormal outcomes ( P = 0.03 ) and return to normal vaginal flora ( P = 0.01 ) ( logistic regression analysis model ) . This may be due to differences in vaginal bacterial species in these grade s. Women whose abnormal vaginal flora had spontaneously returned to normal on follow-up and were therefore not treated ( revertants ) had as many abnormal outcomes as placebos suggesting that damage by abnormal bacterial species occurred early in pregnancy . CONCLUSIONS : Gram-stain screening distinguishing grade II from grade III flora may be helpful in prescribing treatment other than clindamycin for women with grade II flora . Earlier diagnosis and treatment may be more effective in preventing an abnormal outcome , possibly as soon as pregnancy is diagnosed or even offered as a pre-conception screen Available information suggests that some instances of preterm birth or premature rupture of membranes are associated with clinical ly unrecognized infection and inflammation of the lower uterine segment , decidua , and fetal membranes . Various cervicovaginal microorganisms have been recovered from these sites . Many of these microorganisms produce factors that may lead to weakening of the fetal membranes , release of prostagl and ins , or both . This study evaluated the presence of various lower genital tract microflora and bacterial conditions in 229 women enrolled in a double-blind , placebo-controlled trial of short-course erythromycin treatment at 26 to 30 weeks ' gestation to prevent preterm birth . Demographic , obstetric , and microbiologic parameters were prospect ively evaluated . Premature rupture of membranes occurred less frequently ( p less than 0.01 ) among women who received erythromycin ( 6 % ) versus placebo ( 16 % ) . Preterm premature rupture of membranes also occurred less frequently , although not significantly ( p = 0.3 ) in patients who received erythromycin ( 2 % ) versus placebo ( 5 % ) . Erythromycin treatment significantly decreased the occurrence of premature rupture of membranes among women who were initially positive for Chlamydia trachomatis infection . Logistic regression analysis demonstrated that C. trachomatis ( p = 0.05 ; odds ratio , 9 ) , vaginal wash phospholipase C ( p = 0.08 ; odds ratio , 6 ) and prior preterm birth ( p = 0.007 ; odds ratio 17 ) were associated with increased risk of preterm birth . Bacterial vaginosis , Mycoplasma hominis , Ureaplasma urealyticum were not significantly associated with increased risk of preterm birth or preterm rupture of membranes . These findings support a role for selected lower genital tract microflora in preterm birth and premature rupture . Large controlled treatment trials of specific infections or conditions associated with preterm birth and premature rupture of membranes are required to confirm the value of antimicrobial treatments in prevention of microbial-associated preterm birth In a prospect i ve study of 202 women ( gestational age 24 + /- 4 weeks ) , we evaluated possible influences of lower genital tract infection or bacterial conditions on obstetric outcomes , including preterm labor , preterm premature rupture of membranes , and preterm birth . The presence of bacterial vaginosis ( 18.7 % ) was associated with an increased risk of preterm labor ( relative risk , 2.6 ; 95 % confidence interval , 1.08 to 6.46 ) . For women with bacterial vaginosis who also had Mobiluncus species morphotypes identified on Gram stain , the relative risk of preterm labor was 3.8 ( 95 % confidence interval , 1.32 to 11.5 ) . Presence of vaginal Mycoplasma hominis ( 10.8 % of patients ) was associated with both preterm labor ( relative risk , 1.8 ; 95 % confidence interval , 0.77 to 4.4 ) and preterm birth ( relative risk , 5.1 ; 95 % confidence interval , 1.45 to 17.9 ) . Recovery of Staphylococcus aureus ( 3.0 % ) was associated with preterm labor ( relative risk , 3.1 ; 95 % confidence interval 1.12 to 8.7 ) . Identification of two or more bacterial-linked abnormalities was also associated with preterm labor ( relative risk , 3.3 ; 95 % confidence interval , 1.44 to 7.58 ) . An increased level of vaginal wash protease ( greater than or equal to 10 trypsin units ) ( 16 % ) was associated with preterm labor and was noted in 50 % of women with preterm premature rupture of membranes . A history of prior preterm birth was the single best historical predictor of both preterm labor ( relative risk , 3.6 ; 95 % confidence interval , 1.92 to 6.83 ) and preterm birth ( relative risk , 6.7 ; 95 % confidence interval , 2.2 to 20.4 ) . History of three or more abortions , antenatal urinary tract infection , and occurrence of medical complications during pregnancy also correlated with increased risk of preterm labor . These findings affirm and refine associations of various maternal reproductive tract infections with preterm labor , premature rupture of membranes , and birth , allowing for controlled treatment trials aim ed at prevention of preterm birth OBJECTIVE To assess the ability of clindamycin vaginal cream to reduce the incidence of preterm birth in women with abnormal genital tract flora in the second trimester of pregnancy . METHODS This was a r and omized , double-blind , placebo-controlled , tricenter study . A total of 409 women with abnormal genital tract flora on Gram stain of vaginal secretions at 13–20 weeks ' gestation were r and omized to receive a 3-day course of clindamycin vaginal cream or placebo . Those women who still had abnormal vaginal flora 3 weeks later received a 7-day course of the original study drug ( ie , either clindamycin vaginal cream or placebo as per original r and omization ) . The primary outcome measure was the incidence of preterm birth . RESULTS There was a statistically significant reduction in the incidence of preterm birth in the clindamycin vaginal cream group ( 4 % ) compared with placebo ( 10 % ) ( P < .03 ) . Significantly more babies born preterm ( 63 % ) required admission to the neonatal intensive care unit compared with term infants ( 4 % ) ( P < .001 ) . CONCLUSION A 2 % clindamycin vaginal cream , when compared with placebo administered to women with abnormal genital tract flora before 20 weeks ' gestation , can reduce the incidence of preterm birth by 60 % and hence the need for neonatal intensive care OBJECTIVE The purpose of this study was to assess the association of presumptive Trichomonas vaginalis treatment during pregnancy and birth outcomes . STUDY DESIGN A community-r and omized trial of presumptive sexually transmitted disease treatment during pregnancy was conducted between 1994 and 1999 in Rakai district , Ug and a. A sub analysis of a trial of presumptive therapy with azithromycin , cefixime , and metronidazole assessed Trichomonas vaginalis treatment in pregnant women . RESULTS Children of 94 women with Trichomonas who were treated had increased low birth weight ( relative risk , 2.49 ; 95 % CI , 1.12 - 5.50 ) , preterm birth rate ( relative risk , 1.28 ; 95 % CI , 0.81 - 2.02 ) , and 2-year mortality rate ( relative risk , 1.58 ; 95 % CI , 0.99 - 2.52 ) , compared with children of 112 women with Trichomonas who were not treated . CONCLUSION Treatment of Trichomonas vaginalis during pregnancy may be deleterious , and we infer that this may be due to metronidazole . This is consistent with a National Institute for Child Health and Human Development trial that found an excess of preterm births in children of women with Trichomonas vaginalis infection who were treated with metronidazole OBJECTIVE Our purpose was to analyze ( 1 ) the effects of prevalent lower reproductive tract infections and ( 2 ) the effect of systematic diagnosis and treatment to reduce risks of early pregnancy loss ( < 22 weeks ) , preterm premature rupture of membrances , and overall preterm birth . STUDY DESIGN A prospect i ve , controlled treatment trial was conducted on 1260 women . During the first 7 months of the program ( observation , phase I ) , women were examined at initiation of prenatal care for a panel of lower genital tract microorganisms and bacterial vaginosis . Women were followed up with reexaminations at 22 to 29 weeks and after 32 weeks ' gestation . The recommended treatments of the Centers for Disease Control ( i.e. , 300 mg of clindamycin orally twice daily for 7 days for bacterial vaginosis ) were used for infected women during the second 8 months of the study ( treatment , phase II ) . Data were analyzed according to intent to treat by means of univariate and multivariate methods . RESULTS Overall , presence of bacterial vaginosis ( 32.5 % ) at enrollment was associated with pregnancy loss at < 22 weeks ' gestation ( relative risk 3.1 , 95 % confidence interval 1.4 to 6.9 ) . Among women in the observation phase bacterial vaginosis was associated with increased risk of both preterm birth ( relative risk 1.9 , 95 % confidence interval 1.2 to 3.0 ) and preterm premature rupture of membranes ( relative risk 3.5 , 95 % confidence interval 1.4 to 8.9 ) . Within this population ( phase I ) 21.9 % of preterm birth overall ( 43.8 % premature rupture of membranes ) is estimated as attributable to bacterial vaginosis . Among women with bacterial vaginosis phase II ( treatment ) was associated with reduced preterm birth ( relative risk 0.5 , 95 % confidence interval 0.3 to 0.9 ) ; there was a similar reduction for women with preterm premature rupture of membranes ( relative risk 0.5 , 95 % confidence interval 0.2 to 1.4 ) . Women with both bacterial vaginosis and trichomoniasis were at highest risk of preterm birth ( 28 % ) ; treatment of both conditions ( phase II ) reduced preterm birth ( 17 % ) but did not eliminate this risk . Earlier patient enrollment and oral antibiotic treatment were associated with reduced preterm birth . CONCLUSIONS This prospect i ve , controlled trial confirms that the presence of bacterial vaginosis is associated with increased risks of pregnancy loss at < 22 weeks , preterm premature rupture of membranes , and preterm birth . Orally administered clindamycin treatment is associated with a 50 % reduction of bacterial vaginosis-linked preterm birth and preterm premature rupture of membranes . Women at risk for preterm birth or preterm premature rupture of membranes because of bacterial vaginosis or common genital tract infections should be screened , treated , reevaluated for cure , and re-treated if necessary BACKGROUND Pregnant women with bacterial vaginosis may be at increased risk for preterm delivery . We investigated whether treatment with metronidazole and erythromycin during the second trimester would lower the incidence of delivery before 37 weeks ' gestation . METHODS In 624 pregnant women at risk for delivering prematurely , vaginal and cervical cultures and other laboratory tests for bacterial vaginosis were performed at a mean of 22.9 weeks ' gestation . We then performed a 2:1 double-blind r and omization to treatment with metronidazole and erythromycin ( 433 women ) or placebo ( 191 women ) . After treatment , the vaginal and cervical tests were repeated and a second course of treatment was given to women who had bacterial vaginosis at that time ( a mean of 27.6 weeks ' gestation ) . RESULTS A total of 178 women ( 29 percent ) delivered infants at less than 37 weeks ' gestation . Eight women were lost to follow-up . In the remaining population , 110 of the Output:	For women with bacterial vaginosis , antibiotics reduced the risk of persistent infection but did not reduce the risk of preterm birth or the incidence of associated adverse outcomes for the general population or for any subgroup analyzed . For women with Trichomonas vaginalis , metronidazole reduced the risk of persistent infection but increased the incidence of preterm birth . CONCLUSION : Contrary to the conclusions of 3 recent systematic review s , we found no evidence to support the use of antibiotic treatment for bacterial vaginosis or Trichomonas vaginalis in pregnancy to reduce the risk of preterm birth or its associated morbidities in low- or high-risk women
MS21739	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A disease-specific question naire was developed for patients receiving chronic hemodialysis by interviewing patients to determine which aspects of their quality of life were adversely affected by their disease . The final question naire contained 26 questions in five dimensions ( physical symptoms , fatigue , depression , relationships with others , frustration ) . The question naire demonstrated construct validity when compared with the Sickness Impact Profile , time trade-off technique and an exercise stress test . It was reproducible in stable , placebo-treated patients ( correlation coefficient 0.85 - 0.98 for the 5 dimensions ) . It was more responsive than other measures in detecting an improvement with erythropoietin therapy in a r and omized , placebo-controlled trial . This question naire should be useful for the assessment of the effect of various interventions upon the quality of life of hemodialysis patients In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials The Normal Hematocrit Trial ( NHT ) was the largest trial of epoetin r and omizing 1265 hemodialysis patients with cardiac disease to lower ( 9–11 g/dl ) or higher ( 13–15 g/dl ) hemoglobin ( Hgb ) , hypothesizing that higher Hgb would reduce mortality , and improve survival and quality of life . The trial was terminated early , and a 1998 publication reported that targeting higher hematocrit levels led to an insignificant increase in the primary end points ( death or myocardial infa rct ) , or risk ratio 1.3 , 95 % confidence interval ( CI ) , 0.9–1.90 , but the P-value was not given , and all-cause death risk was not reported . A higher target reportedly did not increase hospitalization rates , but did significantly improve the ‘ physical function ' domain of quality of life . Comparing the 1996 Food and Drug Administration ( FDA ) -filed clinical trial report to the 1998 publication , however , found several discrepancies . Among these , the 1998 article reported interim trial results with only the adjusted CI but did not state that the unadjusted CIs were 99.912th percentile , and despite being a secondary end point , reported only the association of achieved Hgb with higher quality of life score . R and omization to the higher target had actually increased the risk for the primary end point ( risk ratio 1.28 , 95 % CI=1.06–1.56 ; P=0.0112 ; 99.92 % CI=0.92–1.78 ) , the risk of death ( risk ratio 1.27 , 95 % CI=1.04–1.54 ) , non-access thrombotic events ( P=0.041 ) , and hospitalization rate ( P=0.04 ) , while ‘ physical function ' did not improve ( P=0.88 ) . Hence , disclosure of these results in the 1998 publication or access to the FDA -filed report on the NHT in the late 1990s would likely have led to earlier concerns about epoetin safety and greater doubts about its benefits BACKGROUND The Dialysis Outcomes and Practice Patterns Study ( DOPPS ) is a prospect i ve , observational study based on data collected from nationally representative sample s of haemodialysis facilities . The burden of anaemia in haemodialysis patients is substantial , leading to considerable morbidity , mortality and reduced quality of life . This study examines anaemia management and outcomes based on data from five European countries participating in the DOPPS : France , Germany , Italy , Spain and the UK . METHODS Baseline data on demographics , co-morbidities and anaemia management in 4591 haemodialysis patients from 101 nephrology facilities were collected in 1998 - 2000 . Using multivariate Cox survival analyses to adjust for patient characteristics , relationships between haemoglobin concentration at study entry and rates of mortality and hospitalization were evaluated . RESULTS For a year 2000 sample of prevalent patients on haemodialysis > 180 days , mean haemoglobin concentration was 11.0 g/dl ; 53 % had a haemoglobin concentration > or = 11 g/dl [ 1998 - 1999 = 44 % ( P < 0.05 ) ] . In 2000 , 84 % of prevalent patients were prescribed recombinant human erythropoietin ( rHuEpo ) . Higher haemoglobin concentrations were associated with decreased relative risk ( RR ) for mortality ( RR = 0.95 for every 1 g/dl higher haemoglobin , P = 0.03 ) and hospitalization ( RR = 0.96 , P = 0.02 ) . Patients with haemoglobin < 10 g/dl were 29 % more likely to be hospitalized than patients with haemoglobin 11 - 12 g/dl ( P < 0.001 ) . CONCLUSION Even after adjustment , lower haemoglobin concentrations were associated with higher morbidity and mortality in European haemodialysis patients . A trend to increased haemoglobin concentrations was observed following publication of the European Best Practice Guidelines ( EBPG ) on anaemia management for chronic kidney disease patients , but efforts must continue to achieve EBPG goals BACKGROUND AND OBJECTIVES The effects of different hemoglobin targets when using erythropoiesis-stimulating agents on quality of life are somewhat controversial , and predictors of change in quality of life in endstage renal disease have not been well characterized . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Five hundred ninety-six incident hemodialysis patients without symptomatic cardiac disease were r and omly assigned to hemoglobin targets of 9.5 to 11.5 g/dl or 13.5 to 14.5 g/dl for 96 weeks , using epoetin_alfa as primary therapy . Patients and attending physicians were masked to treatment assignment . Quality of life , a secondary outcome , was prospect ively recorded using the Kidney Disease Quality of Life ( KDQoL ) question naire at weeks 0 , 24 , 36 , 48 , 60 , 72 , 84 , and 96 , with prespecified outcomes being fatigue and quality of social interaction . RESULTS The mean age and prior duration of dialysis therapy of the study population were 50.8 and 0.8 yr . Mortality was low , reflecting the relatively healthy group enrolled . Of 20 domains within the KDQoL only the prespecified domain of fatigue showed significant change over time between the two groups . Improvement in fatigue scores in the high-target group ranged from 3.2 to 7.9 over time ( P = 0.007 ) compared with change in the low-target group . Higher body mass index and lower erythropoietin dose at baseline were independent predictors of improvement in multiple KDQoL domains . CONCLUSIONS In relatively healthy hemodialysis patients , normal hemoglobin targets may have beneficial effects on fatigue . Improvement in multiple domains of quality of life is associated with higher body mass index and lower erythropoietin requirements BACKGROUND Patients with diabetes and anemia are at high risk of cardiovascular disease . The Anemia CORrection in Diabetes ( ACORD ) Study aim ed to investigate the effect of anemia correction on cardiac structure , function , and outcomes in patients with diabetes with anemia and early diabetic nephropathy . METHODS One hundred seventy-two patients with type 1 or 2 diabetes mellitus , mild to moderate anemia , and stage 1 to 3 chronic kidney disease were r and omly assigned to attain a target hemoglobin ( Hb ) level of either 13 to 15 g/dL ( 130 to 150 g/L ; group 1 ) or 10.5 to 11.5 g/dL ( 105 to 115 g/L ; group 2 ) . The primary end point was change in left ventricular mass index ( LVMI ) . Secondary end points included echocardiographic variables , renal function , quality of life , and safety . RESULTS Median Hb level and LVMI were similar in groups 1 and 2 ( Hb , 11.9 and 11.7 g/dL [ 119 and 117 g/L ] ; LVMI , 113.5 and 112.3 g/m(2 ) , respectively ) . At study end , Hb levels were 13.5 g/dL ( 135 g/L ) in group 1 and 12.1 g/dL ( 121 g/L ) in group 2 ( P < 0.001 ) . No significant differences were observed in median LVMI at month 15 between study groups ( group 1 , 112.3 g/m(2 ) ; group 2 , 116.5 g/m(2 ) ) . Multivariate analysis showed a nonsignificant decrease in LVMI ( P = 0.15 ) in group 1 versus group 2 . Anemia correction had no effect on the rate of decrease in creatinine clearance , but result ed in significantly improved quality of life in group 1 ( P = 0.04 ) . There were no clinical ly relevant differences in adverse events between study groups . CONCLUSION In patients with diabetes with mild to moderate anemia and moderate left ventricular hypertrophy , correction to an Hb target level of 13 to 15 g/dL ( 130 to 150 g/L ) does not decrease LVMI . However , normalization of Hb level prevented an additional increase in left ventricular hypertrophy , was safe , and improved quality of life BACKGROUND This r and omized clinical trial is design ed to assess whether the prevention and /or correction of anemia , by immediate versus delayed treatment with erythropoietin alfa in patients with chronic kidney disease , would delay left ventricular ( LV ) growth . Study design and sample size calculations were based on previously published Canadian data . METHODS One hundred seventy-two patients were r and omly assigned . The treatment group received therapy with erythropoietin alfa subcutaneously to maintain or achieve hemoglobin ( Hgb ) level targets of 12.0 to 14.0 g/dL ( 120 to 140 g/L ) . The control/delayed treatment group had Hgb levels of 9.0 + /- 0.5 g/dL ( 90 + /- 5 g/L ) before therapy was started : target level was 9.0 to 10.5 g/dL ( 90 to 105 g/L ) . Optimal blood pressure and parathyroid hormone , calcium , and phosphate level targets were prescribed ; all patients were iron replete . The primary end point is LV growth at 24 months . RESULTS One hundred fifty-two patients were eligible for the intention-to-treat analysis : mean age was 57 years , 30 % were women , 38 % had diabetes , and median glomerular filtration rate was 29 mL/min ( 0.48 mL/s ; range , 12 to 55 mL/min [ 0.20 to 0.92 mL/s ] ) . Blood pressure and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use were similar in the control/delayed treatment and treatment groups at baseline . Erythropoietin therapy was administered to 77 of 78 patients in the treatment group , with a median final dose of 2,000 IU/wk . Sixteen patients in the control/delayed treatment group were administered erythropoietin at a median final dose of 3,000 IU/wk . There was no statistically significant difference between groups for the primary outcome of mean change in LV mass index ( LVMI ) from baseline to 24 months , which was 5.21 + /- 30.3 g/m2 in the control/delayed treatment group versus 0.37 + /- 25.0 g/m2 in the treatment group . Absolute mean difference between groups was 4.85 g/m2 ( 95 % confidence interval , -4.0 to 13.7 ; P = 0.28 ) . Mean Hgb level was greater in the treatment group throughout the study and at study end was 12.75 g/dL ( 127.5 g/L in treatment group versus 11.46 g/dL [ 114.6 g/L ] in control/delayed treatment group ; P = 0.0001 ) . LV growth occurred in 20.1 % in the treatment group versus 31 % in the control/delayed treatment group ( P = 0.136 ) . In patients with a stable Hgb level , mean LVMI did not change ( -0.25 + /- 26.7 g/m2 ) , but it increased in those with decreasing Hgb levels ( 1 Output:	In particular , younger , healthier patients may benefit from higher hemoglobin targets , and the harm may be concentrated in older individuals with preexisting cardiovascular risk factors .
MS21740	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The aim of this study was to evaluate the behavior of the transverse dimension of the maxilla after surgically assisted rapid expansion with and without using a transpalatal arch fixed retention . Sixty cast models of the maxilla and 60 posteroanterior radiographs from 30 adult subjects , 16 male subjects and 14 female subjects , were evaluated . The subjects were 18.1 to 53.2 years old ( mean age , 27.3 years ) , had been su bmi tted to surgically assisted rapid maxillary expansion , and were using the expansion appliance for four months . The subjects were r and omly assigned into two groups of 15 subjects . One group , called the group with retention , received a transpalatal arch fixed retention and another group , which received no retention , was called the group without retention . The assessment s were performed at two time points : at the removal of the expansion appliance ( T1 ) and 6 months after the removal of the expansion appliance ( T2 ) . In the cast models , interpremolar distances ( A-A1 ) and intermolar distances ( B-B1 ) were measured and in the posteroanterior radiographs , maxillom and ibular discrepancy was used . A reduction in the distances A-A1 ( −0.76 mm ) and B-B1 ( −1.54 mm ) was observed among the time points studied in the group without retention and this difference was statistically significant . In the group with retention , the difference between the time points T1 and T2 was not statistically significant . The assessment of the maxillom and ibular difference showed an increase between the time points T1 and T2 in the group with retention ( 1.54 mm ) and the group without retention ( 0.84 mm ) , which means a reduction in the maxillary width in the posteroanterior radiograph . In the comparison between the groups , the assessment of the cast models and the assessment of the posteroanterior radiograph showed no statistically significant difference in any of the variables studied OBJECTIVE : To investigate , by digital radiology , the bone regeneration process in rats su bmi tted to femoral osteotomy and treated with low power laser therapy . METHODS : Forty-five Wistar rats were subjected to transverse osteotomy of the right femur and divided r and omly into three experimental groups ( n = 15 ) : animals not treated with laser therapy G ( C ) , animals that received laser therapy with λ : 660 nm G ( 660 nm ) and animals that received laser therapy with λ : 830 nm G ( 830 nm ) . Animals were sacrificed after 7 , 14 and 21 days . The bone calluses were evaluated by digital X-ray at 65 kVp , 7mA and 0.032 s exposures . RESULTS : The values obtained were su bmi tted to variance analysis ( ANOVA ) followed by the Tukey-Kramer test . The significance level adopted was 5 % . The groups G ( C ) , G ( 660 nm ) , and G ( 830 nm ) at the 7th day showed a significant bone development , with p < 0.0116 ; the groups G ( C ) , G ( 660 nm ) , and G ( 830 nm ) at the 14th day showed values of p < 0.0001 ; at the 21st day , a higher degree of bone repair were observed in group G ( 830 nm ) , and G ( 660 nm ) , with p < 0.0169 . CONCLUSION : Based on the radiographic findings , G ( 830 nm ) showed more complete bone regeneration , as shown in the gray shades of the images . Level of Evidence II , Individual Study With Experimental Design This study evaluated the effect of low-level laser therapy ( LLLT ) on bone regeneration at the midpalatal suture ( MPS ) after rapid maxillary expansion ( RME ) , using cone beam computed tomography . Fourteen 8–14-year-old patients with transverse maxillary deficiency underwent RME with a Hyrax-type exp and er activated with one full turn after installation and two half turn daily activations until achieving overcorrection . Patients were r and omly assigned to either a control group ( RME alone , n = 4 ) or an experimental group ( n = 10 ) in which RME was followed by 12 LLLT sessions ( GaAlAs , p = 70 mW , λ = 780 nm , Ø = 0.04 cm2 ) . Two tomographic images of the MPS were obtained — T0 , after disjunction and T1 , after 4 months . Bone regeneration was evaluated by measuring the optical density ( OD ) on the tomographic images using InVivo Dental 5.0 software . Data were analyzed by the paired Student ’s t test ( α = 0.05 % ) . A statistically significant difference between T0 and T1 OD values was observed in the laser-treated group ( p = 0.00 ) , but this difference was not significant in the control group ( p = 0.20 ) . Intergroup comparison of OD values at T1 revealed higher OD in the laser-treated group ( p = 0.05 ) . In conclusion , LLLT had a positive influence on bone regeneration of the midpalatal suture by accelerating the repair process To evaluate the effectiveness low-level laser therapy ( LLLT ) on the repair of the mid palatal suture , after rapid maxillary expansion ( RME ) . A single-operator , r and omized single-blind placebo-controlled study was performed at the Orthodontic Department at the Dental Hospital of Bellvitge . Barcelona University , Hospitalet de Llobregat , Spain . Thirty-nine children ( range 6–12 years old ) , completed RME and were r and omized to receive active LLLT ( n = 20 ) or placebo ( n = 19 ) . The laser parameters and dose were 660 nm , 100 mW , CW , InGaAlP laser , illuminated area 0.26 cm2 , 332 mW/cm2 , 60 s to four points along midpalatal suture , and 30 s to a point each side of the suture . A total of seven applications were made on days 1 , 7 , 14 , 28 , 42 , 56 , and 70 of the retention phase RME . A cone beam computed tomography ( CBCT ) scan was carried out on the day of the first laser treatment , and at day 75 , a second CBCT scan was performed . Two radiologists synchronized the slices of two scans to be assessed . P = 0.05 was considered to be statistically significant . At day 75 of the suture , the irradiated patients presented a greater percentage of approximate zones in the anterior ( p = 0.008 ) and posterior ( p = 0.001 ) superior suture— and less approximation in the posterior superior suture ( p = 0.040)—than the placebo group . LLLT appears to stimulate the repair process during retention phase after RME OBJECTIVE The aim of this study was to evaluate the effects of laser therapy on bone regeneration in the midpalatal anterior suture ( MPAS ) after surgically assisted rapid maxillary expansion ( SARME ) . METHODS Thirteen patients aged between 18 and 33 years old with maxillary transverse deficiency ( > or = 7.0 mm ) were evaluated . All patients underwent subtotal Le Fort I osteotomy with separation of the pterygomaxillary suture with the use of Hyrax exp and er , and were divided into 2 groups : control group ( n = 6 ) and laser group ( n = 7 ) . A GaAlAs laser ( P = 100 mW , lambda = 830 nm , Ø = 0.06 cm(2 ) ) was used . The laser was applied in 8 treatment sessions with intervals of 48 hours . Each treatment session consisted of laser applications , per point ( E = 8.4J , ED = 140J/cm(2 ) ) , at 3 points on the MPAS , and total dose of E = 25.2 J , ED = 420 J/cm(2 ) . Digital radiographs were taken before the surgical procedure and at 1- , 2- , 3- , 4- , and 7-month follow-up visits . Optical density analysis of the regenerated bone was performed using Adobe Photoshop 8.0 software . RESULTS Bone regeneration associated with the use of laser after SARME showed a statistically significant difference . A higher mineralization rate was found in the laser group ( 26.3 % , P < .001 ) than the control group . CONCLUSION Low-level laser irradiation ( GaAlAs ) accelerates bone regeneration in MPAS after SARME . However , the optical density measurements after 7 months of follow-up were lower in comparison with the preoperative measurements ABSTRACT Objective : To assess the volumetric changes that occur in the nasomaxillary complex of mouth-breathing patients with transverse maxillary deficiency subjected to rapid maxillary expansion ( RME ) . Methods : This was a controlled , prospect i ve intervention study involving 38 mouth-breathing patients presenting with transverse maxillary deficiency , regardless of malocclusion type or race . Twenty-three of them comprised the experimental group , which was composed of 11 ( 47.8 % ) boys , and 12 ( 52.2 % ) girls , with a mean age of 9.6 years , ranging from 6.4 to 14.2 years and st and ard deviation of 2.3 years ; and 15 of them comprised the control group , composed of 9 ( 60 % ) boys and 6 ( 40 % ) girls with an mean age of 10.5 years , ranging from 8.0 to 13.6 years , and st and ard deviation of 1.9 years . All patients were scanned ( CT ) according to a st and ard protocol : Initial CT ( T1 ) , and CT three months thereafter ( T2 ) , and the patients in the experimental group were treated with RME using a Hyrax exp and er for the correction of maxillary deficiency during the T1-T2 interval . The CT scans were manipulated using Dolphin ® Imaging version 11.7 software for total and partial volumetric assessment of the nasomaxillary complex . Results : The results revealed that in the experimental group there was a significant increase in the size of the structures of interest compared to the control group , both in general aspect and in specific regions . Conclusions : Rapid maxillary expansion ( RME ) provided a significant expansion in all the structures of the nasomaxillary complex ( nasal cavity , oropharynx , right and left maxillary sinuses ) This study evaluated rapid maxillary expansion ( RME ) dentoskeletal effects by means of computed tomography ( CT ) , comparing tooth tissue-borne and tooth-borne exp and ers . The sample comprised eight girls aged 11 to 14 years presenting Class I or II malocclusions with posterior unilateral or bilateral crossbite that were r and omly divided into two treatment groups , palatal acrylic ( Haas-type ) and hygienic ( Hyrax ) exp and ers . All appliances were activated up to the full seven mm capacity of the expansion screw . The patients were subjected to a spiral CT scan before expansion and after a three-month retention period when the exp and er was removed . One-millimeter-thick axial sections were scanned parallel to the palatal plane , comprising the dentoalveolar area and the base of the maxilla up to the inferior third of the nasal cavity . Multiplanar reconstruction was used to measure maxillary transverse dimensions and posterior teeth inclination by means of a computerized method . The results showed that RME produced a significant increase in all measured transverse linear dimensions , decreasing in magnitude from dental arch to basal bone . The transverse increase at the level of the nasal floor corresponded to one-third of the amount of screw activation . Tooth-borne ( Hyrax ) and tooth tissue-borne ( Haas-type ) exp and ers tended to produce similar orthopedic effects . In both methods , RME led to buccal movement of the maxillary posterior teeth , by tipping and bodily translation . The second premolars displayed more buccal tipping than the appliance-supporting teeth . The tooth tissue-borne exp and er produced a greater change in the axial inclination of appliance-supporting teeth , especially first premolars , compared with the tooth-borne exp and er Immediate dental implant placement in the molar region is critical , because of the high amount of bone loss and the discrepancy between alveolar crest thickness and the implant platform . Laser phototherapy ( LPT ) improves bone repair . The aim of this study was to evaluate the human alveolar bone repair 40 days after molar extraction in patients su bmi tted to LPT . Twenty patients were selected for this r and omized controlled clinical trial ; 10 underwent LPT ( laser group ) with a GaAlAs diode laser ( 808 nm , 100 mW , 0.04 cm(2 ) , 75 J/cm(2 ) , 30s per point , 3 J per point , at five points ) . The control group patients ( n=10 ) were not irradiated . Forty days later , the tissue formed inside the sockets was analyzed by micro-computed tomography and histomorphometry . Data from the two groups were compared with Student 's t-test and Pearson 's correlation test . The relative bone volume was significantly higher in the laser group ( P<0.0001 ) . The control group showed negative correlations ( P<0.01 ) between number and thickness , and between number and separation of trabeculae , and a positive correlation between thickness and separation of trabeculae . The laser group showed a significant negative correlation between the number and thickness of trabeculae ( P<0.01 ) . The results suggest that LPT is able to accelerate alveolar b Output:	Based on the RCTs available , LLLT is better to be used at initial phase of RME , because it has some benefits in increasing the rate of bone remodeling
MS21741	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background — Diffuse myocardial fibrosis is a final end point in most cardiac diseases . It is missed by the cardiovascular magnetic resonance ( CMR ) late gadolinium enhancement technique . Currently , quantifying diffuse myocardial fibrosis requires invasive biopsy , with inherent risk and sampling error . We have developed a robust and noninvasive technique , equilibrium contrast CMR ( EQ – CMR ) to quantify diffuse fibrosis and have vali date d it against the current gold st and ard of surgical myocardial biopsy . Methods and Results — The 3 principles of EQ – CMR are a bolus of extracellular gadolinium contrast followed by continuous infusion to achieve equilibrium ; a blood sample to measure blood volume of distribution ( 1−hematocrit ) ; and CMR to measure pre- and postequilibrium T1 ( with heart rate correction ) . The myocardial volume of distribution is calculated , reflecting diffuse myocardial fibrosis . Clinical validation occurred in patients undergoing aortic valve replacement for aortic stenosis or myectomy in hypertrophic cardiomyopathy ( n=18 and n=8 , respectively ) . Surgical biopsies were analyzed for picrosirius red fibrosis quantification on histology . The mean histological fibrosis was 20.5±11 % in aortic stenosis and 17.1±7.4 % in hypertrophic cardiomyopathy . EQ – CMR correlated strongly with biopsy histological fibrosis : aortic stenosis , r2=0.86 , Kendall Tau coefficient (T)=0.71 , P<0.001 ; hypertrophic cardiomyopathy , r2=0.62 , T=0.52 , P=0.08 ; combined r2=0.80 , T=0.67 , P<0.001 . Conclusions — We have developed and vali date d a new technique , EQ – CMR , to measure diffuse myocardial fibrosis as an add-on to a st and ard CMR scan , which allows for the noninvasive quantification of the diffuse fibrosis burden in myocardial diseases Background — The pathophysiology of aortic stenosis is incompletely understood , and the relative contributions of valvular calcification and inflammation to disease progression are unknown . Methods and Results — Patients with aortic sclerosis and mild , moderate , and severe stenosis were compared prospect ively with age- and sex-matched control subjects . Aortic valve severity was determined by echocardiography . Calcification and inflammation in the aortic valve were assessed by 18F-sodium fluoride ( 18F-NaF ) and 18F-fluorodeoxyglucose ( 18F-FDG ) uptake with the use of positron emission tomography . One hundred twenty-one subjects ( 20 controls ; 20 aortic sclerosis ; 25 mild , 33 moderate , and 23 severe aortic stenosis ) were administered both 18F-NaF and 18F-FDG . Quantification of tracer uptake within the valve demonstrated excellent interobserver repeatability with no fixed or proportional biases and limits of agreement of ±0.21 ( 18F-NaF ) and ±0.13 ( 18F-FDG ) for maximum tissue-to- background ratios . Activity of both tracers was higher in patients with aortic stenosis than in control subjects ( 18F-NaF : 2.87±0.82 versus 1.55±0.17 ; 18F-FDG : 1.58±0.21 versus 1.30±0.13 ; both P<0.001 ) . 18F-NaF uptake displayed a progressive rise with valve severity ( r2=0.540 , P<0.001 ) , with a more modest increase observed for 18F-FDG ( r2=0.218 , P<0.001 ) . Among patients with aortic stenosis , 91 % had increased 18F-NaF uptake ( > 1.97 ) , and 35 % had increased 18F-FDG uptake ( > 1.63 ) . A weak correlation between the activities of these tracers was observed ( r2=0.174 , P<0.001 ) . Conclusions — Positron emission tomography is a novel , feasible , and repeatable approach to the evaluation of valvular calcification and inflammation in patients with aortic stenosis . The frequency and magnitude of increased tracer activity correlate with disease severity and are strongest for 18F-NaF. Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01358513 Background —Aortic valve calcification ( AVC ) is the intrinsic mechanism of valvular obstruction leading to aortic stenosis ( AS ) and is measurable by multidetector computed tomography . The link between sex and AS is controversial and that with AVC is unknown . Methods and Results —We prospect ively performed multidetector computed tomography in 665 patients with AS ( aortic valve area , 1.05±0.35 cm2 ; mean gradient , 39±19 mm Hg ) to measure AVC and to assess the impact of sex on the AVC – AS severity link in men and women . AS severity was comparable between women and men ( peak aortic jet velocity : 4.05±0.99 versus 3.93±0.91 m/s , P=0.11 ; aortic valve area index : 0.55±0.20 versus 0.56±0.18 cm2/m2 ; P=0.46 ) . Conversely , AVC load was lower in women versus men ( 1703±1321 versus 2694±1628 arbitrary units ; P<0.0001 ) even after adjustment for their smaller body surface area or aortic annular area ( both P<0.0001 ) . Thus , odds of high-AVC load were much greater in men than in women ( odds ratio , 5.07 ; P<0.0001 ) . Although AVC showed good associations with hemodynamic AS severity in men and women ( all r>0.67 ; P<0.0001 ) , for any level of AS severity measured by peak aortic jet velocity or aortic valve area index , AVC load , absolute or indexed , was higher in men versus women ( all P⩽0.01 ) . Conclusions —In this large AS population , women incurred similar AS severity than men for lower AVC loads , even after indexing for their smaller body size . Hence , the relationship between valvular calcification process and AS severity differs in women and men , warranting further pathophysiological inquiry . For AS severity diagnostic purpose s , interpretation of AVC load should be different in men and in women 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 Background Aortic valve stenosis ( AS ) is a progressive disease , but the impact of baseline AS haemodynamic or anatomic severity on AS progression remains unclear . Methods In 149 patients ( 104 mild AS , 36 moderate AS and 9 severe AS ) enrolled in 2 ongoing prospect i ve cohorts ( COFRASA/GENERAC ) , we evaluated AS haemodynamic severity at baseline and yearly , thereafter , using echocardiography ( mean pressure gradient ( MPG ) ) and AS anatomic severity using CT ( degree of aortic valve calcification ( AVC ) ) . Results After a mean follow-up of 2.9±1.0 years , mean MGP increased from 22±11 to 30±16 mm Hg ( + 3±3 mm Hg/year ) , and mean AVC from 1108±891 to 1640±1251 AU ( arbitrary units ) ( + 188±176 AU/year ) . Progression of AS was strongly related to baseline haemodynamic severity ( + 2±3 mm Hg/year in mild AS , + 4±3 mm Hg/year in moderate AS and + 5±5 mm Hg/year in severe AS ( p=0.01 ) ) , and baseline haemodynamic severity was an independent predictor of haemodynamic progression ( p=0.0003 ) . Annualised haemodynamic and anatomic progression rates were significantly correlated ( r=0.55 , p<0.0001 ) , but AVC progression rate was also significantly associated with baseline haemodynamic severity ( + 141±133 AU/year in mild AS , + 279±189 AU/year in moderate AS and + 361±293 AU/year in severe AS , p<0.0001 ) , and both baseline MPG and baseline AVC were independent determinants of AVC progression ( p<0.0001 ) . Conclusions AS progressed faster with increasing haemodynamic or anatomic severity . Our results suggest that a medical strategy aim ed at preventing AVC progression may be useful in all subsets of patients with AS including those with severe AS and support the recommended closer follow-up of patients with AS as AS severity increases . Clinical trial registration COFRASA ( clinical Trial.gov number NCT 00338676 ) and GENERAC ( clinical Trial.gov number NCT00647088 ) Background — In this prospect i ve follow-up study , the effect of myocardial fibrosis on myocardial performance in symptomatic severe aortic stenosis was investigated , and the impact of fibrosis on clinical outcome after aortic valve replacement ( AVR ) was estimated . Methods and Results — Fifty-eight consecutive patients with isolated symptomatic severe aortic stenosis underwent extensive baseline characterization before AVR . St and ard and tissue Doppler echocardiography and cardiac magnetic resonance imaging ( late-enhancement imaging for replacement fibrosis ) were performed at baseline and 9 months after AVR . Endomyocardial biopsies were obtained intraoperatively to determine the degree of myocardial fibrosis . Patients were analyzed according to the severity of interstitial fibrosis in cardiac biopsies ( severe , n=21 ; mild , n=15 ; none , n=22 ) . The extent of histologically determined cardiac fibrosis at baseline correlated closely with New York Heart Association functional class and markers of longitudinal systolic function ( all P<0.001 ) but not global ejection fraction or aortic valve area . Nine months after AVR , the degree of late enhancement remained unchanged , implying that AVR failed to reduce the degree of replacement fibrosis . Patients with no fibrosis experienced a marked improvement in New York Heart Association class from 2.8±0.4 to 1.4±0.5 ( P<0.001 ) . Only parameters of longitudinal systolic function predicted this functional improvement . Four patients with severe fibrosis died during follow-up , but no patient from the other groups died . Conclusions — Myocardial fibrosis is an important morphological substrate of postoperative clinical outcome in patients with severe aortic stenosis and was not reversible after AVR over the 9 months of follow-up examined in this study . Because markers of longitudinal systolic function appear to indicate sensitively both the severity of myocardial fibrosis and the clinical outcome , they may prove valuable for preoperative risk assessment in patients with aortic stenosis Objectives Cardiac magnetic resonance ( CMR ) was used to investigate the extracellular compartment and myocardial fibrosis in patients with aortic stenosis , as well as their association with other measures of left ventricular decompensation and mortality . Background Progressive myocardial fibrosis drives the transition from hypertrophy to heart failure in aortic stenosis . Diffuse fibrosis is associated with extracellular volume expansion that is detectable by T1 mapping , whereas late gadolinium enhancement ( LGE ) detects replacement fibrosis . Methods In a prospect i ve observational cohort study , 203 subjects ( 166 with aortic stenosis [ 69 years ; 69 % male ] ; 37 healthy volunteers [ 68 years ; 65 % male ] ) underwent comprehensive phenotypic characterization with clinical imaging and biomarker evaluation . On CMR , we quantified the total extracellular volume of the myocardium indexed to body surface area ( iECV ) . The iECV upper limit of normal from the control group ( 22.5 ml/m2 ) was used to define extracellular compartment expansion . Areas of replacement mid-wall LGE were also identified . All-cause mortality was determined during 2.9 ± 0.8 years of follow up . Results iECV demonstrated a good correlation with diffuse histological fibrosis on myocardial biopsies ( r = 0.87 ; p < 0.001 ; n = 11 ) and was increased in patients with aortic stenosis ( 23.6 ± 7.2 ml/m2 vs. 16.1 ± 3.2 ml/m2 in control subjects ; p < 0.001 ) . iECV was used together with LGE to categorize patients with normal myocardium ( iECV < 22.5 ml/m2 ; 51 % of patients ) , extracellular expansion ( iECV ≥22.5 ml/m2 ; 22 % ) , and replacement fibrosis ( presence of mid-wall LGE , 27 % ) . There was evidence of increasing hypertrophy , myocardial injury , diastolic Output:	Conclusion : AVC and myocardial fibrosis imaging biomarkers predict the outcomes in AS , and help underst and ing AS pathophysiology and setting therapeutic targets
MS21742	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To compare nutrient intakes between vegetarians and nonvegetarians with similar health practice s , and to assess relationships with eating behavior scores from the Three-Factor Eating Question naire . DESIGN Survey . SETTING Metropolitan area in western Canada . SUBJECTS Subjects ( n = 45 ) were participants in a study comparing sub clinical menstrual disturbances between vegetarians and nonvegetarians . To be included , women had to be 20 to 40 years old , be weight stable with a body mass index ( BMI ; kg/m2 ) of 18 to 25 , be a nonsmoker , exercise 7 hours a week or less , consume one alcoholic drink or less a day , and not be using oral contraceptives . Nonvegetarians ( n = 22 ) ate red meat three times a week or more , and vegetarians ( n = 23 , 8 vegans and 15 lactovegetarians ) had excluded all meat , fish , and poultry for 2 years or more . MAIN OUTCOME MEASURES Nutrient intake assessed by three 3-day diet records ; supplement use ; body composition ; and dietary restraint ( conscious limitation of food intake ) , disinhibition , and hunger assessed by the Three-Factor Eating Question naire . STATISTICAL ANALYSES PERFORMED Anthropometric variables , nutrient intakes , and eating behavior scores were compared between vegetarians and nonvegetarians using unpaired t tests , and among vegans , lactovegetarians , and nonvegetarians using one-way analysis of variance and Duncan 's test . Supplement use was compared using chi 2 analysis . The Pearson correlation coefficient was used to evaluate relationships between variables . RESULTS Diets of all women adhered closely to current nutrition recommendations . Vegetarians had lower protein and cholesterol intakes and higher percentage of energy as carbohydrate , ratio of polyunsaturated fat to saturated fat ( P : S ratio ) , and fiber intake than nonvegetarians . Vegetarians had lower riboflavin , niacin , vitamin B-12 , zinc , and sodium intakes and higher folate , vitamin C , and copper intakes . However , many differences were not apparent between the subgroup of lactovegetarians and nonvegetarians ( their P : S ratios and carbohydrate , fiber , riboflavin , folate , vitamin C , and copper intakes were similar ) . In contrast , differences existed between the lactovegetarian and the vegan subgroups . Supplement use was similar between groups , except for greater vitamin C use by vegetarians . Vegetarians were leaner than nonvegetarians , had lower restraint scores , and had significant associations between restraint and BMI ( r = .49 ; P < .05 ) and energy per kilogram body weight ( r = -.60 ; P < .01 ) . APPLICATIONS/ CONCLUSIONS Current nutrition recommendations can be attained by vegetarians and nonvegetarians alike , but nutrient intakes can not be inferred from dietary pattern . In this study , the intakes of health-conscious nonvegetarians and lactovegetarians were more similar than the intakes of lactovegetarians and vegans . Vegans ' calcium and vitamin B-12 intakes may need attention . Vegetarians ' lower restraint scores suggest that they are not at increased risk for eating disorders Exercise has been found to be effective for prevention of weight gain and maintenance of a stable weight in adults . The objective of this study was to evaluate the effect of a school-based aerobic exercise program on the obesity indexes of preschool children . Subjects were 292 second-year elementary school pupils from 2 kindergartens in Hat Yai municipality , Songkhla province , southern Thail and . A specially design ed exercise program , including a 15-min walk before beginning the morning class and a 20-min aerobic dance session after the afternoon nap , 3 times a week , was conducted for 29.6 wk . Weight , height , and triceps skinfold thickness were measured 4 times . At the end of the study , the prevalence of obesity , using 95th percentile National Center for Health Statistics triceps-skinfold-thickness cutoffs , of both the exercise and control groups decreased . That of the exercise group decreased from 12.2 % at baseline to 8.8 % ( Wilcoxon signed-rank test , P = 0.058 ) , whereas that of the control group decreased from 11.7 % to 9.7 % ( Wilcoxon signed-rank test , P = 0.179 ) . A sex difference in the response of body mass index ( BMI ) to exercise was observed . Girls in the exercise group had a lower likelihood of having an increasing BMI slope than the control girls did ( odds ratio : 0.32 ; 95 % CI : 0.18 , 0.56 ) . In conclusion , our study suggests that a 29.6-wk school-based exercise program can prevent BMI gain in girls and may induce a remission of obesity in preschool-age children We report 10-year treatment outcomes for obese children in 4 r and omized treatment studies . At 10 years , 34 % decreased percentage overweight by 20 % or more , and 30 % were not obese . Significant effects were observed when parents and children were targeted and reinforced for weight loss in comparison with nontargeted controls and for children given lifestyle or aerobic exercise in comparison with a calisthenics control . Thirty-four percent of the variance in change in percentage overweight was predicted from sex , baseline percentage overweight , self-monitoring weight , meals eaten at home , and family and friends ' support for eating and exercise . Results show long-term changes in children depend on the treatment , and evidence converges on the importance of the family and other sources of support for eating and activity change This study examined whether preschool children differed on measures of psychosocial functioning both cross-sectionally and longitudinally . One hundred and thirty-two children who varied in levels of body fat participated in the study along with their natural parents . Results indicated that the children did not differ in levels of self-esteem and family functioning as a function of their body fat . Prospect ively , physical self-esteem weakly ( but significantly ) correlated with body fat at 1 and 2 years , and father 's perception of family functioning predicted body fat at 1 year only . Results suggested that childhood obesity may not develop as a result of psychosocial factors OBJECTIVE --To examine the patterns of physical activity among British schoolchildren aged 11 to 16 and to assess whether the children experience the intensity and duration of physical activity that are believed to stress the cardiopulmonary system appropriately . DESIGN --Cross sectional study of a sample of children drawn from a larger survey of coronary risk factors in children . Continuous monitoring of heart rate for 12 hour periods on three school days and one Saturday . SETTING --Two communities in Devon . SUBJECTS--266 Children ( 163 girls , 103 boys ) aged 11 to 16 r and omly selected from a sample of 707 children . MAIN OUTCOME MEASURES --Percentage of time and number of sustained periods in which heart rate was greater than 139 beats/min . Anthropometric measures and external assessment of sexual maturity with Tanner 's indices . RESULTS --The boys had heart rates greater than 139 beats/min for a significantly higher percentage of time than the girls ( p less than 0.01 ) during the weekday ( 6.2 % v 4.3 % ) and the Saturday ( 5.6 % v 2.6 % ) . The boys had significantly more five and 10 minute periods with heart rates greater than 139 beats/min than the girls during the Saturday and weekdays and more 20 minute periods during the weekdays . 84 Girls and 37 boys had no 10 minute period with a heart rate greater than 139 beats/min during the three weekdays and 112 girls and 65 boys had no such 10 minute period during the Saturday . No significant relation was detected in either sex between the amount or habitual physical activity ( heart rate ) and skinfold thickness or maturity group . CONCLUSIONS --British children have surprisingly low levels of habitual physical activity , and many children seldom undertake the volume of physical activity believed to benefit the cardiopulmonary system . Boys are more active than girls . The pubertal stage of development or body fatness , or both , do not seem to be sensitive indicators of physical activity in either girls or boys Using the Princeton School Family Study cohort , our specific aim was to determine whether , and to what degree , parent-offspring and sibling associations for measures of body habitus outlast the period of shared common household environment in a single well characterized community . Familial associations of measures in body habitus were assessed in two and three generation kindreds , in parents and their pediatric offspring ( less than 20-yr-old ) , parents and their adult offspring ( less than or equal to 20-yr-old ) , and in pediatric and adult siblings . The cohort included 177 r and omly recalled prob and s and 202 prob and s from a hyperlipidemic recall group ( top decile plasma cholesterol and /or triglyceride ) . In r and omly recalled whites , significant associations of body mass indices in parents and pediatric offspring and in pediatric siblings , and the absence of significant correlations in parents and adult offspring and in adult siblings , emphasize the potency of common household environmental effects relative to within-family similarities for shared body habitus . In whites from the hyperlipidemic recall group , only the mother-pediatric and adult offspring correlations for body mass indices were significant . We speculate that mothers and their offspring from kindreds selected by hyperlipidemic prob and s are more likely than fathers and their offspring to share eating habits and relative ponderosity , with these communal behaviors outlasting the period of common household environment . Alternatively , and speculatively , in the hyperlipidemic recall group , determinants for ponderosity may be shared more by mothers and their offspring than by fathers and their offspring . Particularly in the r and om recall group , within-family associations of body mass indices primarily reflect shared common household environments , and probably secondarily , the outcome of genes held in common Recent research has shown weight maintenance for obese preadolescent children over 60 and 120 month intervals , while studies on adults consistently show they fail to maintain weight loss . This paper is design ed to examine differences in percent overweight changes at 6 , 60 and 120 months in obese parents and children from 113 families who participated in r and omized controlled outcome studies evaluating family-based behavioral treatment . Analyses showed children had significantly greater changes in percent overweight than their parents at each time point . Chi-Square and Logistic Regression analyses showed children were more likely than their parents at each time point to have percent overweight decreases greater than 20 % , with over 20 % of the children and less than 1 % of the parents showing changes this large . The implication s of these results for weight control are discussed . These results suggest there may be differences in the efficacy of treating obesity in children versus adults The possible effect of maternal attitude to sweet eating habits on their offspring 's risk of overweight is a common concern . This study addresses the influence of mothers ' reports on and attitude to sweet eating habits on the subsequent risk of overweight of their offspring in young adulthood . A study of a r and omly selected cohort of 9 - 10 year old children from schools in the Copenhagen municipality was performed in 1974 . A decade later a follow-up was carried out , and 86 % of the target population participated . Overweight was defined as the 90th percentile of body mass index distribution ( weight/height2 ( kg/m2 ) ) . The odds ratio of overweight in young adulthood was assessed by logistic regression analysis taking into account body mass index in childhood , gender and social background ( both parents ' school education , householder 's occupational status , and quality of dwellings in childhood rearing areas ) . The results showed that the risk of overweight was significantly increased if the mother reported lacking knowledge about her offspring 's sweet eating habits ( OR = 4.5 ; 95 % confidence limits : 1.7 - 12.1 ; P = 0.003 ) . The risk was insignificantly increased if the mothers expressed acceptance of sweet eating habits ( OR = 1.9 ; 0.8 - 4.2 ; P = 0.1 ) , and if more than an average amount of money was given for sweets ( OR = 2.0 ; 1.0 - 3.8 ; P = 0.06 ) . On the other h and , how often the child was actually allowed to eat sweets , and the mother 's acceptance of sugary food did not significantly influence the risk . ( ABSTRACT TRUNCATED AT 250 WORDS Objectives : To examine the effect of measurement error in dietary data on the relationship between diet and body mass index ( BMI ) . To correct for the effect of measurement error on diet– BMI association by using replicate measurements of diet . The effect of measurement error on diet– BMI relationship was simulated , and its implication s are discussed . Design : Prospect i ve study design . Setting : The first and second China Health and Nutrition Survey conducted in 1989 and 1991 , respectively . Subjects : Three thous and , four hundred and seventy-nine adults age 20–45 y at the 1989 survey . Methods : Statistical methods were used to demonstrate the effect of measurement error in dietary data on the diet- BMI association . Results : By using the average of three replicate 24 h dietary recalls , the attenuation of diet- BMI association was reduced substantially . The regression coefficients of fat and energy intakes differed markedly from those computed by using only single measurement of diet . Conclusions : Measurement error in dietary data may significantly attenuate the diet-disease association . Where appropriate , specific emphasis may be needed to address the problem of measurement error in the study of diet-disease relationship . Spnosorship : This research was supported by the National Institute of Output:	Offspring of obese parent(s ) were consistently seen to be at increased risk of fatness , although few studies have looked at this relationship over longer periods of childhood and into adulthood . No clear relationship is reported between socio-economic status ( SES ) in early life and childhood fatness . However , a strong consistent relationship is observed between low SES in early life and increased fatness in adulthood . Studies investigating SES were generally large but very few considered confounding by parental fatness . Women who change social class ( social mobility ) show the prevalence of obesity of the class they join , an association which is not present in men . There is good evidence from large and reasonably long-term studies for an apparently clear relationship for increased fatness with higher birth weight , but in studies which attempted to address potential confounding by gestational age , parental fatness , or social group , the relationship was less consistent . There was almost no evidence for an influence of activity in infancy on later fatness , and inconsistent but suggestive evidence for a protective effect of activity in childhood on later fatness .
MS21743	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A preliminary trial of oral delta-9-tetrahydrocannabinol ( THC ) demonstrated an analgesic effect of the drug in patients experiencing cancer pain . Placebo and 5 , 10 , 15 , and 20 mg THC were administered double blind to ten patients . Pain relief significantly superior to placebo was demonstrated at high dose levels ( 15 and 20 mg ) . At these levels , substantial sedation and mental clouding were reported Context Because the same systems metabolize cannabinoids and protease inhibitors , cannabinoids might alter viral loads in HIV-infected patients taking protease inhibitors . Contribution In this r and omized trial , 62 HIV-infected patients taking indinavir or nelfinavir received a marijuana cigarette , dronabinol capsule , or placebo capsule three times daily for 21 days . Half of the patients in all three groups had undetectable viral loads during the study , and average changes in viral load with marijuana and dronabinol , relative to placebo , were small . Caution s The findings of no large harmful effects on viral loads with either smoked or oral cannabinoids need to be confirmed in larger and longer trials . The Editors Marijuana has been smoked for medicinal purpose s for centuries ( 1 ) . Introduced into western medicine in 1842 , marijuana was used to treat various illnesses on the basis of its purported analgesic , anticonvulsant , sedative , hypnotic , and antispasmodic properties . With the passage of the Marihuana Tax Act in 1937 , use of marijuana as a therapeutic agent in the United States waned until the substance was removed from the U.S. Pharmacopoeia in 1942 . The Controlled Substances Act of 1970 placed marijuana in the Schedule I category along with other substances deemed to have no medicinal value and high potential for abuse . In 1986 , the U.S. Food and Drug Administration approved a synthetic , oral form of marijuana 's main psychoactive component , delta-9-tetrahydrocannabinol ( dronabinol , Marinol , Roxane Laboratories , Columbus , Ohio ) , for treating chemotherapy-induced nausea and vomiting ( 2 - 5 ) . A r and omized , controlled trial demonstrated that dronabinol increased self-reported appetite but not weight in patients with AIDS-related wasting syndrome ; these findings led to an expansion of the labeling indication for this use in 1992 ( 6 , 7 ) . Before the advent of highly active antiretroviral therapy in the 1990s , many patients infected with HIV-1 experienced wasting as a preterminal manifestation of the disease ( 8) . Patients with AIDS-related wasting syndrome often reported that they preferred smoked marijuana to dronabinol because it was easier to titrate the dose to achieve the desired effect ; smoked marijuana delivers cannabinoids to the bloodstream much more rapidly than dronabinol ( 9 ) . By the mid-1990s , cannabis buyers ' clubs in the San Francisco Bay area were reportedly selling marijuana to 11 000 patients with HIV infection ( 10 - 12 ) . With the increased availability of protease inhibitorcontaining antiretroviral regimens in the mid-1990s , the incidence of AIDS-related wasting syndrome decreased markedly , as did most of the other late-stage opportunistic manifestations of advanced HIV disease ( 13 - 15 ) . Protease inhibitors , which can inhibit or stimulate the hepatic cytochrome P-450 enzyme system , are subject to many significant drugdrug interactions with other agents used in treating HIV infection and its complications ( 16 , 17 ) . The potential for a drugdrug interaction between protease inhibitors and marijuana is worrisome since many HIV-infected patients continue to smoke marijuana as an appetite stimulant or to decrease nausea associated with their antiretroviral therapy ( 18 , 19 ) . The likelihood of such an interaction is supported by the facts that cannabinoids are metabolized by some of the same cytochrome P-450 enzyme isoforms that metabolize the more widely prescribed protease inhibitors and that tetrahydrocannabinol has been shown to inhibit the metabolism of other drugs ( 20 - 23 ) . Although few recent clinical trials have evaluated the potential therapeutic effects of smoked marijuana , significant progress has been made in underst and ing the pharmacology of cannabinoids in humans . Of the two cannabinoid receptors identified , CB1 ( found mainly in cells of the central nervous system ) is thought to be responsible for the neurologic and behavioral effects of marijuana ( 24 , 25 ) . The identification of a CB2 receptor , found predominantly on B lymphocytes and natural killer cells , suggests that cannabinoids may also affect the immune response . Some studies suggest that marijuana can impair the immune system through B-lymphocyte modulation , tumor necrosis factor inhibition , or changes in the phenotype and function of circulating lymphocytes ( 26 - 29 ) . The hallmark of successful antiretroviral therapy is sustained suppression of HIV RNA levels associated with increasing CD4 + cell counts ( 30 - 32 ) . Considering the potential for both a protease inhibitorcannabinoid interaction and an effect of smoked marijuana on the immune system , we design ed a study to determine the safety or toxicity profile of cannabinoids ( smoked and oral ) in persons with HIV infection . We chose HIV RNA levels as our primary outcome because an intervention that interacted unfavorably with either the antiretroviral agent pharmacokinetics or the immune system directly could cause a perturbation of viral suppression . We report the overall safety results of this r and omized , controlled inpatient clinical trial . Methods Study Group Study participants were recruited by referrals from local physicians and advertisements in newspapers . Volunteers from across the country telephoned to determine whether they might be eligible to participate . Participants were required to be at least 18 years of age , have documented HIV infection , and be receiving a stable antiretroviral treatment regimen of either indinavir ( Crixivan , Merck & Co. , Inc. , North Wales , Pennsylvania ) or nelfinavir ( Viracept , Agouron Pharmaceuticals , Inc. , La Jolla , California ) for at least 8 weeks before enrollment . When enrolled , participants who had been taking the recently recommended dose of nelfinavir , 1250 mg twice daily , were switched to 750 mg three times daily for consistency of our pharmacokinetic evaluations ( 33 ) . No additional protease inhibitors were allowed for the duration of the study . Participants were also required to have a stable viral load , defined as less than a threefold ( 0.5 log10 ) change in HIV RNA level for the 16 weeks before enrollment . All participants were required to have previous experience smoking marijuana ( defined as six or more times ) to ensure that they knew how to inhale and what neuropsychiatric effects to expect . The institutional review board of the University of California , San Francisco , approved the study , and signed , informed consent was obtained from each participant before enrollment . Exclusion criteria included any active opportunistic infection or malignant condition requiring acute treatment , unintentional loss of 10 % or more of body weight during the previous 6 months , current substance dependence ascertained by completion of a confidential drug screening form and an alcohol screening form , methadone maintenance , use of tobacco or cannabinoids ( smoked or oral ) within 30 days of enrollment , history of serious pulmonary disease , pregnancy , or stage II or higher AIDS dementia complex . Laboratory exclusion criteria were hematocrit less than 0.25 and elevation of hepatic aminotransferase levels to greater than five times the upper limit of normal . Therapeutic exclusions were concurrent use within the past 8 weeks of anabolic hormones , prednisone , interleukin-2 , or other agents known to alter immune system function . Study Medications The National Institute on Drug Abuse provided prerolled marijuana cigarettes , weighing on average 0.9 g and containing 3.95 % delta-9-tetrahydrocannabinol . These cigarettes were kept in a locked and alarmed freezer until they were dispensed to a locked freezer in the General Clinical Research Center at the San Francisco General Hospital , where the inpatient study was conducted . The frozen marijuana cigarettes required rehydration overnight in a humidifier . Participants r and omly assigned to the smoked marijuana group were housed in a room with a fan ventilating to the outside . To maximize st and ardization of inhaled doses , research staff monitored participants while they followed the uniform puff procedure outlined by Foltin and colleagues ( 34 ) . Research staff weighed the marijuana cigarettes immediately before and after they were administered to participants and returned all leftover material to the pharmacy . Study participants smoked up to three complete marijuana cigarettes daily , as tolerated , 1 hour before meals . Study participants were r and omly assigned in a double-blind fashion to the oral regimens , which were given on the same schedule as the smoked marijuana . Research staff observed participants taking all treatments . Research Design and Procedures Study clinicians admitted study participants to the General Clinical Research Center for a 4-day lead-in period to obtain baseline variables . A urine sample obtained on the day of admission ( day 4 ) had to be negative for tetrahydrocannabinol . The second phase of the trial was a 21-day intervention period beginning with r and om assignment of treatments on day 0 . Patients were stratified by protease inhibitor ( indinavir or nelfinavir ) and then allocated with equal probability in blocks of 12 to the study agents ( marijuana , dronabinol , and placebo ) . The statistician generated the r and om allocation sequences , and the pharmacists maintained the sequences in a secure location and distributed the assignments to the study coordinator on day 0 . Study participants were not permitted to have visitors or to leave the General Clinical Research Center unless accompanied by research personnel during the 25-day study . All clinical laboratory tests and study procedures were obtained or performed in the center . Patients were weighed on the same calibrated scale each morning while wearing a hospital gown . Baseline blood specimens were collected on days 4 and 0 to examine within-participant variation in HIV RNA level in the absence of experimental therapies . Follow-up specimens were obtained on days 2 , 5 , 8 , 11 , 14 , 17 , 19 , and 21 . Sample s were stored at 70 C and batch-tested for HIV RNA at the end Abstract Objective To evaluate the effect of the oral synthetic δ-9-tetrahydrocannabinol dronabinol on central neuropathic pain in patients with multiple sclerosis . Design R and omised double blind placebo controlled crossovertrial . Setting Outpatient clinic , University Hospital of Aarhus , Denmark . Participants 24 patients aged between 23 and 55 years with multiple sclerosis and central pain . Intervention Orally administered dronabinol at a maximum doseof 10 mg daily or corresponding placebo for three weeks ( 15 - 21days ) , separated by a three week washout period . Main outcome measure Median spontaneous pain intensity ( numericalrating scale ) in the last week of treatment . Results Median spontaneous pain intensity was significantlylower during dronabinol treatment than during placebo treatment(4.0 ( 25th to 75th centiles 2.3 to 6.0 ) v 5.0 ( 4.0 to 6.4),P = 0.02 ) , and median pain relief score ( numerical rating scale)was higher ( 3.0 ( 0 to 6.7 ) v > 0 ( 0 to 2.3 ) , P = 0.035 ) . Thenumber needed to treat for 50 % pain relief was 3.5 ( 95 % confidenceinterval 1.9 to 24.8 ) . On the SF-36 quality of life scale , thetwo items bodily pain and mental health indicated benefits fromactive treatment compared with placebo . The number of patients with adverse events was higher during active treatment , especiallyin the first week of treatment . The functional ability of themultiple sclerosis patients did not change . Conclusions Dronabinol has a modest but clinical ly relevantanalgesic effect on central pain in patients with multiple sclerosis . Adverse events , including dizziness , were more frequent withdronabinol than with placebo during the first week of treatment The objective was to determine whether a cannabis-based medicinal extract ( CBME ) benefits a range of symptoms due to multiple sclerosis ( MS ) . A parallel group , double-blind , r and omized , placebo-controlled study was undertaken in three centres , recruiting 160 out patients with MS experiencing significant problems from at least one of the following : spasticity , spasms , bladder problems , tremor or pain . The interventions were oromucosal sprays of matched placebo , or whole plant CBME containing equal amounts of delta-9- tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ) at a dose of 2.5- 120 mg of each daily , in divided doses . The primary outcome measure was a Visual Analogue Scale ( VAS ) score for each patient ’s most troublesome symptom . Additional measures included VAS scores of other symptoms , and measures of disability , cognition , mood , sleep and fatigue . Following CBME the primary Output:	INTERPRETATION Short-term use of existing medical cannabinoids appeared to increase the risk of nonserious adverse events .
MS21744	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Early-onset dementia is common in Down syndrome adults , who have trisomy 21 . The amyloid precursor protein gene is on chromosome 21 , and so is over-expressed in Down syndrome , leading to amyloid β ( Aβ ) over-production , a major upstream pathway leading to Alzheimer disease ( AD ) . Statins ( microsomal 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ) , have pleiotropic effects including potentially increasing brain amyloid clearance , making them plausible agents to reduce AD risk . Animal models , human observational studies , and small scale trials support this rationale , however , there are no AD primary prevention trials in Down syndrome adults . In this study we study aim to inform the design of a full-scale primary prevention trial . Methods / Design TOP-COG is a feasibility and pilot double-blind r and omized controlled trial ( RCT ) , with a nested qualitative study , conducted in the general community . About 60 Down syndrome adults , aged ≥50 will be included . The intervention is oral simvastatin 40 mg at night for 12 months , versus placebo . The primary endpoint is recruitment and retention rates . Secondary endpoints are ( 1 ) tolerability and safety ; ( 2 ) detection of the most sensitive neurocognitive instruments ; ( 3 ) perceptions of Down syndrome adults and caregivers on whether to participate , and assessment experiences ; ( 4 ) distributions of cognitive decline , adaptive behavior , general health/ quality of life , service use , caregiver strain , and sample size implication s ; ( 5 ) whether Aβ42/Aβ40 is a cognitive decline biomarker . We will describe percentages recruited from each source , the number of contacts to achieve this , plus recruitment rate by general population size . We will calculate summary statistics with 90 % confidence limits where appropriate , for each study outcome as a whole , by treatment group and in relation to baseline age , cognitive function , cholesterol and other characteristics . Changes over time will be summarized graphically . The sample size for a definitive RCT will be estimated under alternative assumptions . Discussion This study is important , as AD is a major problem for Down syndrome adults , for whom there are currently no effective preventions or treatments . It will also delineate the most suitable assessment instruments for this population . Recruitment of intellectually disabled adults is notoriously difficult , and we shall provide valuable information on this , informing future studies .Trial registration Current Controlled Trials IS RCT N Register ID : IS RCT N67338640 ( 17 November 2011 Summary Background The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . Methods Of 19 342 hypertensive patients ( aged 40–79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10 305 with nonfasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . Findings Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50–0.83 ] , p = 0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56–0.96 ] , p = 0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69–0.90 ] , p = 0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59–0.86 ] , p = 0.0005 ) were also significantly lowered . There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71–1.06 ] , p = 0.16 ) . Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up . Interpretation The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time . These findings may have implication s for future lipid-lowering guidelines BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people Sleep disturbances and decrements of daytime performance have been attributed to HMG-CoA reductase inhibitors . As a rule , lipophilic compounds more readily cross the blood-brain barrier and are more likely to affect central nervous system function . The authors compared the effects of lovastatin ( 40 mg ) , a lipophilic compound , to pravastatin ( 40 mg ) , a hydrophilic compound , in a 6-week , double-blind , r and omized , placebo-controlled , three-way Latin square design , cross-over study on 22 men with hypercholesterolemia . Patients had LDL cholesterol of more than 165 mg/dL and triglyceride of less than 350 mg/dL after 6 weeks of a low-fat ( < 30 % ) , low-cholesterol ( < 300 mg/day ) diet . Compared with placebo , there were no significant effects of lovastatin or pravastatin on the following subjective and polysomnographic sleep measures : changes in total sleep time , time in each sleep stage , sleep efficiency , sleep latency , REM density , REM activity , and number of arousals . Similarly , there were no effects of the two drugs on measures of cognitive performance . A significant increase in the duration of nocturnal tumescence ( NPT ) was observed after 2 weeks of treatment with both study drugs . This effect was not significant after 6 weeks of treatment . Both lovastatin and pravastatin caused significant ( P < .05 compared with placebo ) decreases in total cholesterol ( by 20.9 and 20.6 % , respectively ) , LDL cholesterol ( by 27.8 and 29.9 % ) , and triglycerides ( by 13.6 and 3.7 % ) . Subjects ' HDL increased by 2.3 % with lovastatin ( NS ) and by 3.1 % with pravastatin ( P < .05 ) . Lipoprotein(a ) increased by 20.5 % with lovastatin and by 1.1 % with pravastatin ; these changes were not significantly different from placebo . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Few strategies are available for the prevention of cognitive impairment in elderly persons . Serum lipoprotein levels may be important predictors of cognitive function , and drugs that lower cholesterol may be effective for the prevention of cognitive impairment . OBJECTIVE To determine whether serum lipoprotein levels , the 4-year change in serum lipoprotein levels , and the use of statin drugs are associated with cognition in older women without dementia . DESIGN , SETTING , AND PARTICIPANTS An observational study of 1037 postmenopausal women with coronary heart disease enrolled in the Heart and Estrogen/progestin Replacement Study ( participants at 10 of 20 centers ) . MAIN OUTCOME MEASURE The Modified Mini-Mental State Examination was administered at the end of the study after 4 years of follow-up . Women whose score was less than 84 points ( > 1.5 SDs below the mean ) were classified as having cognitive impairment . Lipoprotein levels ( total , high-density lipoprotein , and low-density lipoprotein [ LDL ] cholesterol and triglycerides ) were measured at baseline and at the end of the study ; statin use was documented at each visit . RESULTS Compared with women in the lower quartiles , women in the highest LDL cholesterol quartile at cognitive testing had worse mean plus minus SD Modified Mini-Mental State Examination scores ( 93.7 plus minus 6.0 vs 91.9 plus minus 7.6 ; P = .002 ) and an increased likelihood of cognitive impairment ( adjusted odds ratio , 1.76 ; 95 % confidence interval , 1.04 - 2.97 ) . A reduction in the LDL cholesterol level during the 4 years tended to be associated with a lower odds of impairment ( adjusted odds ratio , 0.61 ; 95 % confidence interval , 0.36 - 1.03 ) compared with women whose levels increased . Higher total and LDL cholesterol levels , corrected for lipoprotein(a ) levels , were also associated with a worse Modified Mini-Mental State Examination score and a higher likelihood of impairment , whereas high-density lipoprotein cholesterol and triglyceride levels were not associated with cognition . Compared with nonusers , statin users had higher mean plus minus SD Modified Mini-Mental State Examination scores ( 92.7 plus minus 7.1 vs 93.7 plus minus 6.1 ; P = .02 ) and a trend for a lower likelihood of cognitive impairment ( odds ratio , 0.67 ; 95 % confidence interval , 0.42 - 1.05 ) , findings that seemed to be independent of lipid levels . CONCLUSIONS High LDL and total cholesterol levels are associated with cognitive impairment , and lowering these lipoprotein levels may be a strategy for preventing impairment . The association between statin use and better cognitive function in women without dementia requires further study The aim of this prospect i ve cohort study was to evaluate the effects of lipid lowering agent ( LLA ) intake on cognitive function in 6,830 community-dwelling elderly persons . Cognitive performance ( global cognitive functioning , visual memory , verbal fluency , psychomotor speed , and executive function ) , clinical diagnosis of dementia , and fibrate and statin use , were evaluated at baseline , and 2 , 4 , and 7 year follow-up . Multivariate Cox models were stratified by gender and adjusted for sociodemographic characteristics , mental and physical health including vascular risk factors , and genetic vulnerability ( apolipoprotein E and cholesteryl ester transfer protein ) . For women but not men , fibrate use was specifically associated with an increased risk over 7 years of decline in visual memory only ( HR = 1.29 , 95 % CI = 1.09 Output:	In conclusion , our meta- analysis suggests that the use of statins may reduce the risk of all-type dementia , AD , and MCI , but not of incident
MS21745	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Recent meta-analyses suggest that once-daily dihydropyridines and angiotensin-converting enzyme inhibitors cause similar decreases in left ventricular ( LV ) mass for comparable decreases in blood pressure ( BP ) . However , some dihydropyridines , such as felodipine-extended release ( ER ) , still increase sympathetic activity and may , therefore , be less effective in decreasing LV mass . OBJECTIVES To evaluate the effects of long term antihypertensive treatment with nifedipine-gastrointestinal therapeutic system ( GITS ) and felodipine-ER compared with enalapril on LV mass relative to the extent of BP control ( assessed by 24 h ambulatory BP monitoring ) and sympathetic activity ( assessed by plasma catecholamine concentrations ) . PATIENTS AND METHODS Enalapril was started at 10 mg/day , felodipine-ER at 5 mg/day and nifedipine-GITS at 30 mg/day , all once daily . Doses were increased to 20 mg/day , 10 mg/day or 60 mg/day , respectively , if the office BP remained 160/90 mmHg or greater at the end of the dosing interval . Evaluable echocardiograms were obtained for 116 patients at the end of the study ( 30 weeks of treatment ) . RESULTS On 24 h ambulatory BP monitoring , nifedipine-GITS caused a consistent decrease in BP throughout the 24 h dosing interval , whereas felodipine-ER caused a more marked fall in BP during the day , and enalapril 's effects diminished during the night and had disappeared by the morning . Only felodipine-ER significantly increased supine and st and ing plasma noradrenaline by more than 50 % similarly after six , 18 , and 30 weeks of treatment . In BP responders ( decrease in systolic BP 10 mmHg or greater ) , enalapril and nifedipine-GITS caused clear decreases in LV mass by 12 to 16 g/m2 , whereas felodipine-ER was less effective ( decrease by only 6 g/m2 , P<0.01 versus enalapril ) . CONCLUSIONS Once-daily dihydropyridines should not be regarded as one homogeneous class and , compared with felodipine-ER , nifedipine-GITS exhibits a better profile regarding 24 h BP control , sympathetic activation and regression of LV mass Objective To compare the effects of amlodipine and nifedipine on heart rate and parameters of sympathetic nerve activity during the acute and chronic treatment periods in order to eluci date their influence on cardiovascular outcome . Design A r and omized and single-blind study . Methods We performed 24 h ambulatory electrocardiography and blood pressure monitoring of 45 essential hypertensive in patients . Plasma and urinary catecholamine levels were measured during the control ( pretreatment ) period , on the first day ( acute period ) and after 4 weeks ( chronic period ) of administration of amlodipine and of short-acting nifedipine or its slow-releasing formulation . The low-frequency and high-frequency power spectral densities and low-frequency : high-frequency ratio were obtained by heart rate power spectral analysis . Results Blood pressure was significantly and similarly reduced by administrations of amlodipine , short-acting nifedipine and slow-releasing nifedipine during the chronic period . The total QRS count per 24 h , which remained constant during the chronic period of administration of slow-releasing nifedipine and was increased by administration of nifedipine , was decreased by 2.8 % by administration of amlodipine . Administration of amlodipine decreased the plasma and urinary norepinephrine levels during the chronic period , whereas the levels were significantly increased by administration of short-acting nifedipine and not changed by administration of slow-release nifedipine . Although low-frequency : high-frequency ratio was increased significantly by administration of short-acting nifedipine and slightly by administration of slow-releasing nifedipine , administration of amlodipine reduced it during the acute and chronic periods . Conclusions Administration of amlodipine did not induce an increase in sympathetic nerve activity in essential hypertensive patients during the chronic period , suggesting that beneficial effects on essential hypertension can be expected after its long-term administration . Administration of slow-releasing nifedipine induces milder reflex sympathetic activation than does that of short-acting nifedipine The sympathetic nervous system ( SNS ) is an important regulator of the circulation . Its activity is increased in hypertension and heart failure and adversely affects prognosis . Although certain drugs inhibit SNS , dihydropyridine calcium antagonists may stimulate the system . Phenylalkylamine calcium antagonists such as verapamil have a different pharmacological profile . We therefore tested the hypothesis of whether amlodipine , nifedipine , or verapamil differs in the effects on muscle sympathetic nerve activity ( MSA ) . Forty-three patients ( 31 men , 12 women ) with mild to moderate hypertension were r and omly assigned to 1 drug for 8 weeks . Blood pressure , heart rate , and MSA ( by microneurography ) were measured at baseline and after 8 weeks of treatment . All calcium antagonists led to a similar decrease in blood pressure of 5.0±1.5 to 6.4±1.4 mm Hg at 8 weeks ( P < 0.001 versus baseline ) . There were no significant differences in MSA between groups . With amlodipine , MSA averaged 49±3 bursts/min ( 3 versus baseline ) ; with nifedipine , 48±3 bursts/min ( 2 versus baseline ) ; and with verapamil , 49±2 bursts/min ( all , P = NS ) . With verapamil , norepinephrine decreased by 4 % but tended to increase by about one third with amlodipine or nifedipine ( P = NS ) . Thus , in hypertension slow release forms of verapamil , nifedipine , and amlodipine exert comparable antihypertensive effects and do not change MSA , although there was a trend toward decreased MSA and plasma norepinephrine with verapamil This study aim ed to compare the effects of two long-acting dihydropyridine calcium channel blockers ( CCBs ) with different pharmacologic properties , lercanidipine and nifedipine Gastro-Intestinal Therapeutic System ( GITS ) , in the chronic treatment of essential hypertension . After a 4-week placebo run-in period , 60 patients of both sexes were r and omly treated with lercanidipine 10 to 20 mg or nifedipine GITS 30 to 60 mg taken orally for 48 weeks , according to a double-blind , parallel group design . For the first 4 weeks of treatment , the lowest dose of each drug was used , followed by higher doses if diastolic blood pressure ( BP ) was > 90 mm Hg . At the end of the placebo period and after 4 , 8 , 12 , 24 , and 48 weeks of active treatment BP , heart rate ( HR ) , and plasma norepinephrine ( NE ) levels were assessed . Lercanidipine and nifedipine GITS similarly reduced BP values after 48 weeks ( -21.7/15.9 mm Hg and -20.7/14.6 mm Hg , respectively , both P < .001 v placebo ) , with no change in HR . Despite the similar lack of effect on HR , the two drugs displayed different influences on plasma NE , which was significantly increased by nifedipine GITS ( + 56 pg/mL , P < .05 v placebo ) but not by lercanidipine . These findings suggest that 1 ) sympathetic activation occurs during chronic therapy with nifedipine GITS but not with lercanidipine , which might be related to the different pharmacologic characteristics of the two CCBs at the doses evaluated ; and 2 ) nifedipine GITS seems to activate peripheral but not cardiac sympathetic nerves , consistent with differing regulation of cardiac and peripheral sympathetic activity Intravenous , sublingual , or aerosolized nitroglycerin was administered to 19 patients with coronary artery disease during clinical ly indicated cardiac catheterization . Eight blood sample s were collected over 15 min from each patient , and analyzed for content of nitroglycerin , 1,2‐glycerol dinitrate , and 1,3‐glycerol dinitrate . Simultaneously , heart rate ( HR ) , systolic blood pressure ( SBP ) , and left ventricular end‐diastolic pressure ( LVEDP ) were recorded . Plasma concentrations of nitroglycerin were highest after intravenous injection and lowest after sublingual tablets . Metabolite concentrations were highest after intravenous injection at early time‐points ; at later time‐points , no betweengroup differences could be detected . SBP was minimally affected by intravenous nitroglycerin but was significantly reduced by sublingual and aerosolized formulations . Minor fluctuations in HR were observed in association with all three formulations . LVEDP was reduced by all three formulations of nitroglycerin but most rapidly by the intravenous form . Overall , no differences were detected in hemodynamic responses caused by sublingual and aerosolized nitroglycerin . Efficacy of sublingual and aerosolized nitroglycerin in patients undergoing cardiac catheterization is equivalent Objective To compare the acute and chronic effects of nifedipine retard ( NPA ) , nifedipine gastrointestinal therapeutic system ( NGITS ) and amlodipine at trough and peak plasma concentrations of drug on blood pressure and heart rate , and on plasma norepinephrine and epinephrine levels in patients with mild-to-moderate hypertension ( diastolic blood pressure 95–115 mmHg ) . Design and methods After 3 - 4 weeks ' placebo treatment , patients of both sexes were r and omly allocated to be administered 10 or 20 mg NPA twice a day , 30 or 60 mg NGITS once a day , and 5 or 10 mg amlodipine once a day for 6 weeks . Initially , for the first 2 weeks , the lowest dose of each drug was used , but higher doses were administered after 2 weeks if sitting diastolic blood pressure was > 90 mmHg . Patients were evaluated after administration of the first dose and after 6 weeks ' therapy in a hospital setting . Blood sample s were taken for high-performance liquid chromatography measurement of catecholamine and drug levels at various intervals for a period covering trough to peak drug level ranges . Results Administration of all three drugs reduced clinic blood pressure to the same level after 6 weeks ' therapy , but heart rate was increased slightly only with amlodipine ( P < 0.05 ) . Administration of NPA reduced blood pressure more abruptly whereas administrations of NGITS and amlodipine induced smoother falls after acute and chronic treatments : a significant increase in heart rate was observed with amlodipine after chronic treatment . Both acute and chronic treatments with NPA ( n = 19 ) increased norepinephrine levels ( P < 0.01 ) transiently ( 2 - 4 h ) . In contrast , administration of NGITS ( n = 22 ) did not increase norepinephrine levels and even induced a slight but significant decrease in norepinephrine levels 5 - 6 h after chronic treatments . Although administration of amlodipine ( n = 22 ) did not increase norepinephrine levels transiently either after acute or after chronic administration , it did induce a sustained rise in basal norepinephrine levels by more than 50 % after chronic therapy ( P < 0.01 ) . Plasma epinephrine levels were not increased by any of the treatments and even a slight decrease was observed 4 h after administration of a dose following chronic treatments with NGITS and amlodipine ( P < 0.05 ) . Conclusions The transient increase in norepinephrine levels observed with NPA and the sustained increases in norepinephrine levels observed after chronic treatment with amlodipine suggest that sympathetic activation occurs with those two drugs . The lack of increase in norepinephrine levels after administration of NGITS suggests that this formulation does not activate the sympathetic system . The lowering of epinephrine levels after administrations of NGITS and amlodipine suggests that inhibition of release of epinephrine by the adrenal medulla occurs with longer-acting dihydropyridine formulations N-Type calcium channel antagonists may suppress sympathetic activity . The purpose of this study was to assess the effects of amlodipine and cilnidipine on the cardiac sympathetic nervous system and the neurohormonal status of essential hypertension . 123I-metaiodobenzylguanidine ( MIBG ) cardiac imaging was performed and blood sample s were taken to determine plasma renin activity and plasma norepinephrine concentration before and 3 months after drug administration in 47 patients with mild essential hypertension . Twenty-four of the patients were treated with 5 to 10 mg/d of amlodipine ; the other 23 were treated with 10 to 20 mg/d of cilnidipine . For comparison , 12 normotensive subjects were also studied . No significant differences were found in the basal characteristics between the 2 hypertensive groups . In both hypertensive groups , both the systolic and diastolic Output:	Overall , each drug lowered blood pressure in hypertensive patients in association with only small changes in heart rate ( i.e. < 1 beat/min ) . Plasma norepinephrine concentrations , as the most widely reported marker of sympathetic nervous system activity , showed greater increases in patients treated with amlodipine than with nifedipine GITS . The evidence indicates that both these once-daily dihydropyridine CCBs lower blood pressure effectively with minimal effects on heart rate . There are small differences between the drugs in the extent to which each activates the sympathetic nervous system with an overall non-significant trend in favour of nifedipine GITS
MS21746	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Compromised urinary bladder syndrome ( CUBS ) , a combination of frequency and incontinence , causes multiple discomforts for community-dwelling adults . A holistic intervention -- audiotaped cognitive strategies -- was design ed to augment the effects of an educational program design ed to treat CUBS . CUBS was operationalized with a voiding diary , and comfort related to bladder health was operationalized in a question naire . In this quasi-experimental design the outcomes were measured at four time points . Repeated measures multivariate analyses of variance and nonparametric analyses were conducted to assess differences between the two groups . Results indicated that the treatment group had more comfort and improved CUBS compared with the control group OBJECTIVE To evaluate the effect of a low‐intensity behavioral therapy program on urinary incontinence in older women . METHODS A r and omized clinical trial for community‐dwelling women at least 55 years reporting at least one urinary incontinent episode per week was conducted . Women were r and omly assigned to a behavioral therapy group ( n = 77 ) or a control group ( n = 75 ) . The treatment group had six weekly instructional sessions on bladder training and followed individualized voiding schedules . The control group received no instruction but kept urinary diaries for 6 weeks . After this period , the control group underwent the behavioral therapy protocol . Using per‐ protocol analyses , t and χ2 tests were used to compare the treatment and control groups , and paired t tests were used to evaluate the efficacy of behavioral therapy for all women ( treatment and control groups before and after behavioral therapy ) . RESULTS Women in the treatment group experienced a 50 % reduction in mean number of incontinent episodes recorded on a 7‐day urinary diary compared with a 15 % reduction for controls ( P = .001 ) . After behavioral therapy , all women had a 40 % decrease in mean weekly incontinent episodes ( P = .001 ) , which was maintained over 6 months ( P < .004 ) . Thirty ( 31 % ) women were 100 % improved ( dry ) , 40 ( 41 % ) were at least 75 % improved , and 50 ( 52 % ) at least 50 % improved . There were no differences in treatment efficacy by type of incontinence ( stress , urge , mixed ) or group assignment ( treatment , control ) . CONCLUSION A low‐intensity behavioral therapy intervention for urinary incontinence was effective and should be considered as a first‐line treatment for urinary incontinence in older women The efficacy of bladder training was evaluated in a r and omized clinical trial involving 123 noninstitutionalized women 55 years and older with urinary incontinence . Subjects were urodynamically categorized as those with urethral sphincteric incompetence ( N = 88 ) and those with detrusor instability with or without concomitant sphincteric incompetence ( N = 35 ) . Bladder training reduced the number of incontinent episodes by 57 % ; the effect was similar for both urodynamic diagnostic groups . The quantity of fluid loss was reduced by 54 % . This was greater for patients with detrusor instability than for those without it . Diurnal and nocturnal voluntary micturitions were also reduced . The effect on nocturnal micturition , however , was not observed in subjects with unstable detrusor function . It is recommended that bladder training be considered as an initial step in treatment of women with urinary incontinence . Provided prior comprehensive clinical evaluation is done , it can be prescribed without the need for urodynamic characterization Objectives To compare , in a r and omized trial , the effects of individual and group physiotherapy for urinary incontinence in women referred by their general practitioner ( GP ) The purpose of this study was to explore changes in psychological distress associated with behavioral treatment and drug treatment for urge incontinence in community-dwelling older women . Participants were 197 ambulatory , nondemented women ( aged 55 years or older ) with persistent urge urinary incontinence . Participants were patients in a r and omized clinical trial comparing biofeedback-assisted behavioral treatment , drug treatment with oxybutynin chloride , and a placebo-control condition . Psychological distress was measured before and after treatment using the Hopkins Symptom Checklist ( SCL-90-R ) . Multivariate and univariate analyses of variance showed that the two treatment groups and the control group had similar significant improvements on the nine subscales and the global severity index . Analysis of individual SCL-90-R subscale scores revealed trends suggesting that behavioral treatment tended to produce the largest improvements . The reductions of distress were not correlated consistently with reduction of incontinence . The results of this study showed that psychological distress was significantly reduced after treatment , regardless of the type of treatment Summary — Fifty women with urinary incontinence due to derisory instability entered a controlled clinical trial to compare in-patient bladder drill with out-patient drug therapy . Following bladder drill , 84 % of patients were continent , whereas following treatment with flavoxate hydrochloride and imipramine , 56 % 01 patients were continent . Side effects due to drug therapy were significant Abstract The current emphasis on community-based health care makes necessary the implementation and evaluation of nursing practice models that address specific health problems , such as urinary incontinence , of older women living at home in rural communities BACKGROUND The short-term efficacy of combined lifestyle and behavioural interventions led by nurses in the management of urinary incontinence has not been rigorously evaluated by r and omized controlled trial . We conducted a 6-month r and omized controlled trial to determine whether a model of service delivery that included lifestyle and behavioural interventions led by " nurse continence advisers " in collaboration with a physician with expertise in continence management could reduce urinary incontinence and pad use in an outpatient population . We also aim ed to evaluate the impact of this approach on subjects ' knowledge about incontinence and their quality of life . METHODS We used advertising in the mainstream media , newsletters to family physicians and community information sessions in 1991 to invite volunteers who were 26 years of age or older and suffered from incontinence to participate in a r and omized controlled trial . Men and women who met the eligibility criteria were r and omly allocated to receive either counselling from specialized nurses to manage incontinence using behavioural and lifestyle modification sessions every 4 weeks for 25 weeks or usual care . Symptoms of incontinence and the use of incontinence pads were the primary outcome measures . RESULTS Using sealed envelopes , 421 patients were r and omly allocated to the treatment or control groups . On average , patients in the treatment group experienced 2.1 " incontinent events " per 24 hours before treatment and 1.0 incontinent event per 24 hours at the end of the study . Control patients had an average of 2.4 incontinent events per 24 hours before the study and 2.2 incontinent events per 24 hours at the end of the study . The mean decrease in events in the treatment group was 1.2 and in the control group 0.2 ( p = 0.001 ) . Pad use declined from a mean of 2.2 per 24 hours before r and omization in the treatment group to 1.2 per 24 hours at the end of the study , compared with 2.6 pads per 24 hours in the control group at the start of the study and 2.4 per 24 hours at the end . Pad use per 24 hours decreased on average by 0.9 pads in the treatment group and 0.1 in the control group ( p = 0.021 ) . INTERPRETATION Behavioural and lifestyle counselling provided by specialized nurses with training in managing incontinence reduces incontinent events and incontinence pad use The aim of this study was to assess the usefulness of pelvic floor exercises in the treatment of urinary incontinence in women and to analyse the factors which determine a successful outcome . The study involved 66 women who had reported ' genuine stress incontinence ' to their general practitioner . They were assigned at r and om to the treatment or control group . The treatment group received instructions in pelvic floor exercises from a general practitioner . The control group received no therapy . At the start of the trial the severity of the patients ' incontinence was assessed objective ly . This assessment was repeated after three months and patients were also asked for their own perception of whether their incontinence had improved . After the three months ' evaluation the patients in the control group were also given instructions in pelvic floor exercises . After another three months they were assessed in the same way . About 60 % of the patients in the treatment group were dry or mildly incontinent after three months compared with only one patient in the control group ; the mean weekly frequency of incontinence episodes fell from 17 to five in the treatment group but remained virtually unchanged in the control group ; and about 85 % of the women in the treatment group felt that their incontinence had improved or was cured compared with no one in the control group . These results were later corroborated by those for the control group . The most important factor in the success of the treatment was the patients ' motivation , as demonstrated by their adherence to the daily exercises . ( ABSTRACT TRUNCATED AT 250 WORDS Abstract Objectives : To assess the effect of nurse assessment with reinforcement of pelvic floor muscle training exercises and bladder training compared with st and ard management among women with persistent incontinence three months postnatally . Design : R and omised controlled trial with nine months ' follow up . Setting : Community intervention in three centres ( Dunedin , New Zeal and ; Birmingham ; Aberdeen ) . Participants : 747 women with urinary incontinence three months postnatally , allocated at r and om to intervention ( 371 ) or control ( 376 ) groups . Intervention : Assessment by nurses of urinary incontinence with conservative advice on pelvic floor exercises at five , seven , and nine months after delivery supplemented with bladder training if appropriate at seven and nine months . Main outcome measures : Primary : persistence and severity of urinary incontinence 12 months after delivery . Secondary : performance of pelvic floor exercises , change in coexisting faecal incontinence , wellbeing , anxiety , and depression . Results : Women in the intervention group had significantly less urinary incontinence : 167/279 ( 59.9 % ) v 169/245 ( 69.0 % ) , difference 9.1 % ( 95 % confidence interval 1.0 % to 17.3 % , P=0.037 ) for any incontinence and 55/279 ( 19.7 % ) v 78/245 ( 31.8 % ) , difference 12.1 % ( 4.7 % to 19.6 % , P=0.002 ) for severe incontinence . Faecal incontinence was also less common : 12/273 ( 4.4 % ) v 25/237 ( 10.5 % ) , difference 6.1 % ( 1.6 % to 10.8 % , P=0.012 ) . At 12 months women in the intervention group were more likely to be performing pelvic floor exercises ( 218/278 ( 79 % ) v 118/244 ( 48 % ) , P<0.001 ) . Conclusions : A third of women may have some urinary incontinence three months after childbirth . Conservative management provided by nurses seems to reduce the likelihood of urinary and coexisting faecal incontinence persisting 12 months postpartum . Further trials for faecal incontinence are needed . What is already known on this topic Vaginal delivery is a risk factor for urinary incontinence Three months after childbirth 20 - 30 % of women still experience urinary incontinence Most women do not seek treatment What this study adds Women will use conservative treatments such as pelvic floor exercises or bladder training Conservative management prevents persistent urinary incontinence in about one in 10 women who have postnatal incontinence Coexisting persistent faecal incontinence is also CONTEXT Previous research on urge urinary incontinence has demonstrated that multicomponent behavioral training with biofeedback is safe and effective , yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy . OBJECTIVE To examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in community-dwelling older women . DESIGN Prospect i ve , r and omized controlled trial conducted from April 1 , 1995 , to March 30 , 2001 . SETTING University-based outpatient continence clinic in the United States . PATIENTS A volunteer sample of 222 ambulatory , nondemented , community-dwelling women aged 55 to 92 years with urge incontinence or mixed incontinence with urge as the predominant pattern . Patients were stratified by race , type of incontinence ( urge only vs mixed ) , and severity ( frequency of accidents ) . INTERVENTIONS Patients were r and omly assigned to receive 8 weeks ( 4 visits ) of biofeedback-assisted behavioral training ( n = 73 ) , 8 weeks ( 4 visits ) of behavioral training without biofeedback ( verbal feedback based on vaginal palpation ; n = 74 ) , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ; n = 75 ) . MAIN OUTCOME MEASURES Reduction in the number of incontinence episodes as documented in bladder diaries , patients ' perceptions and satisfaction , and changes in quality of life . RESULTS Intention-to-treat analysis showed that behavioral training with biofeedback yielded a mean 63.1 % Output:	There was not enough evidence to show whether drug therapy was better than bladder training or useful as a supplement to it
MS21747	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In a prospect i ve , r and omized study , 58 patients with primary cemented hip arthroplasty and 39 patients with primary cemented knee arthroplasty were divided into groups with postoperative closed-suction drainage and without drainage . There was no difference in healing of the wounds , postoperative blood transfusions , complications , or range of motion . Although there was more soaked dressing requiring reinforcements in the groups without drainage , as a result of this study , we no longer use drains in uncomplicated cemented primary hip and knee arthroplasties for osteoarthritis The purpose of this prospect i ve study was to analyze the biochemical markers of muscle damage and inflammation in patients treated with the mini-midvastus approach or the medial parapatellar approach for total knee arthroplasty . Of 60 patients who underwent unilateral total knee arthroplasty , 30 were treated with the mini-midvastus approach ( MMV group ) and 30 were treated with the medial parapatellar approach ( MPP group ) . Serum creatine kinase , myoglobin , lactate dehydrogenase , glutamic oxaloacetic transaminase , C-reactive protein , interleukin-6 , and interleukin-1β levels were measured preoperatively , immediately postoperatively ( except for C-reactive protein level ) , and on postoperative days 1 , 2 , and 3 . Student 's t test , Pearson 's chi-square test , and Fisher 's exact test were used to compare the outcomes between the 2 groups . Compared with the MPP group , a significant increase in serum creatine kinase level existed in the MMV group on postoperative days 2 ( P=.08 ) and 3 ( P=.09 ) and cumulatively ( P=.02 ) . However , significantly elevated C-reactive protein and interleukin-6 levels existed in the MPP group . According to the serum creatine kinase levels , the mini-midvastus approach has no superiority over the medial parapatellar approach in terms of sparing muscle and may cause more muscle damage . Further study is warranted to determine the correlation between biochemical markers and functional deficits Closed suction drains reduce postoperative hematoma formation , but create an entry portal for bacteria and thus increase the risk of infection . This study attempts to establish when the risks of wound drainage outweigh the benefits . In a prospect i ve clinical trial , wound drains were used in all patients having a total knee or total hip arthroplasty . Timing of drain removal and amount drained were recorded . Drain-site swabs were sent with drain tips for bacteriology . Results suggest that the likelihood of bacterial colonization increases while wound drainage decreases with time . The authors conclude that the optimal time to remove drains is 24 hours after total joint arthroplasty Background : The purpose of this study was to determine whether repeated clamping of a suction drainage system will result in less external blood loss , blood transfusion and no increase in complications compared to a routine continuous suction drainage system . This was a r and omized prospect i ve study on patients undergoing total knee arthroplasty Total knee arthroplasty is sometimes associated with major post-operative bleeding , often requiring transfusion . A prospect i ve , r and omised study was undertaken to assess the effect on post-operative bleeding of delaying release of the clamp on the suction drains . One hundred patients were allocated into two groups : Group A- immediate release of drain following release of tourniquet , and Group B- delayed release of the drain clamp by one hour . There was a statistically significant reduction ( p = < 0.001 ) in postoperative bleeding between group A ( 1050 ml ; 95%CI 728 - 1172 ml ) compared to group B ( 732 ml ; 95 % CI 620- 845 ml ) . Average drop in corrected haemoglobin and postoperative transfusion requirement were also less in the delayed group . The results show that delaying release of the drains by one hour reduces postoperative blood loss and transfusion requirement following total knee arthroplasty Total knee replacement in severe osteoarthritis usually requires extensive soft tissue releases often associated with considerable bleeding . In a prospect i ve , r and omised trial we compared postoperative conventional suction drainage versus four hour clamping drainage in 60 patients undergoing total knee arthroplasty for severe osteoarthritis . We compared blood loss , number of transfusions , postoperative complications and knee function and found significantly less postoperative blood loss through the drains ( p < 0.001 ) , and fewer blood transfusions ( p = 0.09 ) were needed in the clamped group . We conclude that clamping drainage after total knee arthroplasty in severe osteoarthritis reduces blood loss through the drains and the need for blood transfusions . RésuméLa prothèse totale du genou dans les gonarthroses sévères nécessite souvent une résection tissulaire importante , celle-ci étant souvent associée à un saignement important . Nous avons réalisé une étude prospect i ve r and omisée comparant le drainage conventionnel post-opératoire versus clampage du drain durant 4 heures chez 60 patients ayant bénéficié d’une prothèse totale du genou pour une gonarthrose importante . Nous avons comparé les pertes sanguines , le nombre de transfusion , les complications post-opératoires , la fonction du genou . Nous avons observé qu’il y avait beaucoup moins de pertes sanguines dans les drains ( p < 0.001 ) et beaucoup moins de transfusions ( p = 0.009 ) dans le groupe des patients do nt le drain avait été clampé pendant 4 heures . Nous pouvons conclure que le clampage du drain après prothèse totale du genou dans les gonarthroses sévères permet de réduire les pertes sanguines et le nombre de transfusions Background Total knee arthroplasty ( TKA ) is a common procedure that has a risk of significant blood loss and blood transfusion , and carries a substantial risk for immunologic reactions and disease transmission . Drain clamping is a popular method that is applied to reduce blood loss after TKA . However , the clamping protocol remains controversial . Therefore , we established a new protocol , 3-h interval clamping , and compared the bleeding control efficacy of this protocol following TKA with the non-clamping technique . Methods Between March and July 2008 , we enrolled 100 patients ( 100 knees ) who underwent uncomplicated TKA using a minimally invasive surgical technique . The patients were r and omly assigned into two groups based on the draining protocol : non-clamping ( group A ) and 3-h interval clamping ( group B ) . For group A , a vacuum drain was connected to a container and was run continuously during the first postoperative day , whereas the vacuum was stopped twice ( for ~3 h each time ) for group B. Demographic characteristics and clinical data were collected , including the levels of hemoglobin and hematocrit , the total blood loss volume , the number of patients who required a blood transfusion , and any complications that developed . The perioperative data were compared between the two groups . Results The drainage blood volume in the interval-clamping group ( group B ) was significantly lower than that in the non-clamping group ( group A ) during the first 48 h following the procedure ( p < 0.001 and p = 0.005 for first and second postoperative days , respectively ) . The mean fall in hemoglobin levels at 12 h in the interval-clamping group ( 2.8 ± 0.9 g/dL ) was also lower than in the non-clamping group ( 3.2 ± 0.8 g/dL ) . In the 3-h interval clamping protocol , the number of patients requiring a transfusion was 2.2 times less than the number in the non-clamping protocol , but was not significantly different ( odds ratio = 2.20 , p = 0.24 ) , and the significant predictor of blood transfusion was the preoperative hemoglobin level ( odds ratio = 7.73 , p < 0.001 ) . No wound infection or clinical venous thromboembolisms were detected in our study . Conclusion The 3-h interval clamping is a newly developed protocol for reducing blood loss after TKA . The protocol lessens the decrease in postoperative hemoglobin levels . This protocol can be applied easily without increasing clinical thromboembolic events and wound complications We prospect ively r and omized 415 total joint replacements for either a closed wound-drainage system or no postoperative drainage . Drainage was not used in 200 total joint replacements , of which 138 were total knee replacements and sixty-two , total hip replacements . Drainage was used in 215 total joint replacements , of which 137 were total knee replacements and seventy-eight , total hip replacements . All patients were evaluated for the presence of excessive postoperative drainage that necessitated cessation of the range-of-motion exercises , the amount of transfused blood ( homologous and autologous ) , and the preoperative and postoperative hemoglobin levels . The range of motion was assessed daily in the patients who had a total knee replacement . No statistical difference was found in the number of patients who had excessive postoperative drainage from a drained or non-drained wound . There was also no statistical difference with respect to the amount of transfused blood and the preoperative and postoperative hemoglobin levels . Furthermore , in the patients who had a total knee replacement , there were no statistical differences between drained and non-drained wounds with respect to the daily range of motion during the first seven days postoperatively . The mean amount of blood transfused was 157 milliliters in the total knee replacements with drains , 160 milliliters in the total knee replacements without drains , 188 milliliters in the total hip replacements with drains , and ninety-three milliliters in the total hip replacements without drains . ( ABSTRACT TRUNCATED AT 250 WORDS We undertook a prospect i ve , r and omised study in order to evaluate the efficacy of clamping the drains after intra-articular injection of saline with 1:500 000 adrenaline compared with post-operative blood salvage in reducing blood loss in 212 total knee arthroplasties . The mean post-operative drained blood volume after drain clamping was 352.1 ml compared to 662.3 ml after blood salvage ( p < 0.0001 ) . Allogenic blood transfusion was needed in one patient in the drain group and for three in the blood salvage group . Drain clamping with intra-articular injection of saline with adrenaline is more effective than post-operative autologous blood transfusion in reducing blood loss during total knee arthroplasty We prospect ively studied the cases of 121 patients who were being operated on for insertion of a unilateral total knee prosthesis with cement , and we placed them r and omly in four groups . In Group I , the tourniquet was inflated throughout the operative procedure , and we released it postoperatively after a compressive dressing had been applied ; a splint was used postoperatively for three days . In Group II , the tourniquet remained inflated throughout the operation , but no splint was applied postoperatively , and continuous passive motion was started immediately in the recovery room . In Group III , the tourniquet was released intraoperatively , and hemostasis was achieved by cauterization ; postoperatively , a compressive dressing was applied , and a splint was used for three days . In Group IV , the tourniquet was released intraoperatively , hemostasis was established , and then the tourniquet was reinflated ; a compressive dressing was applied , and continuous passive motion was started immediately in the recovery room . Hemoglobin and hematocrit values were monitored in all patients . Blood loss in suction drainage was recorded , and the total blood loss was calculated . The results show that total knee arthroplasty is associated with major loss of blood ( mean , 1518 milliliters ) . The calculated blood loss for Groups I , II , and III averaged 1443 milliliters , while that for Group IV averaged 1793 milliliters . Loss in suction drainage correlated with total estimated blood loss and averaged 511 milliliters . The magnitude of blood loss after total knee arthroplasty should be appreciated , and special attention should be paid to the availability of adequate fluid and blood products , preferably blood donated by the patient preoperatively We prospect ively r and omised 100 patients undergoing cemented total knee replacement to receive either a single deep closed-suction drain or no drain . The total blood loss was significantly greater in those with a drain ( 568 ml versus 119 ml , p < 0.01 ; 95 % CI 360 to 520 ) although those without lost more blood into the dressings ( 55 ml versus 119 ml , p < 0.01 ; 95 % CI -70 to 10 ) . There was no statistical difference in the postoperative swelling or pain score , or in the incidence of pyrexia , ecchymosis , time at which flexion was regained or the need for manipulation , or in the incidence of infection at a minimum of five years after surgery in the two groups . We have been unable to provide evidence to support the use of a closed-suction drain in cemented knee arthroplasty . It merely interferes with mobilisation and complicates nursing . Reinfusion drains may , however , prove to be beneficial A prospect i ve r and om Output:	The results indicate that temporary clamping could significantly reduce the drainage volume , including total drainage volume , drainage volume within 24 hours postoperatively , and drainage volume within 48 hours postoperatively . Furthermore , patients treated with temporary drainage clamping for 4 hours or more had a higher hemoglobin level 24 hours postoperatively than the patients treated with no clamping , and the number of blood transfusions per patient decreased significantly . No significant difference was identified between the 2 practice s regarding postoperative range of motion , wound-related complications , and deep vein thrombosis .
MS21748	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND A total of 738 volunteer blood donors who were positive for anti-hepatitis C virus ( HCV ) were assessed for risk factors and outcomes for up to 15 years within the study and up to 54 years from the estimated onset of infection . METHODS A third-generation recombinant immunoblot assay ( RIBA ) was performed to distinguish true from false anti-HCV reactivity . Findings of HCV polymerase chain reaction classified subjects as having chronic HCV infection or as having recovered . Liver biopsy specimens were staged by Ishak fibrosis score and grade d by histologic activity index . RESULTS Of 738 anti-HCV-positive subjects , 469 ( 64 % ) had positive RIBA results , 217 ( 29 % ) had negative results , and 52 ( 7 % ) had indeterminate results . Primary independent risk factors were injection drug use ( odds ratio [ OR ] , 35.0 ; P < .0001 ) , blood transfusion ( OR , 9.9 ; P < .0001 ) , and intranasal cocaine use , including 79 " snorters " who repeatedly denied injection drug use or blood transfusion ( OR , 8.5 ; P < .0001 ) . Classification and regression tree and r and om forest analyses confirmed these risk factors . A total of 384 RIBA-positive donors ( 82 % ) were HCV RNA positive ; of these , liver biopsy specimens from 185 ( 48 % ) showed no fibrosis in 33 % , mild fibrosis in 52 % , bridging fibrosis in 12 % , and cirrhosis in 2 % a mean duration of 25 years after infection . Analysis of 63 repeat biopsy specimens showed that 8 % progressed ≥2 Ishak stages over 5 years ( mean progression , 0.06 Ishak stages/year ) . CONCLUSIONS Injection drug use and blood transfusion before 1990 are dominant risk factors for HCV acquisition ; intranasal cocaine use may be a surreptitious route of parenteral spread . After a mean of 25 years of HCV infection , histologic outcomes were relatively mild : 85 % had no or mild fibrosis , and only 2 % had cirrhosis . Nearly one-fifth spontaneously recovered BACKGROUND Liver-related mortality among those infected with hepatitis C virus ( HCV ) has been described , but little is known about non-liver-related mortality . Our objective was to determine HCV-associated all-cause , liver- , and non-liver-related mortality in the general US population . METHODS A prospect i ve cohort study of 9378 nationally representative adults aged 17 - 59 years was performed utilizing the Third National Health and Nutrition Examination Survey ( NHANES III ) Linked Mortality File that was made publicly available in 2010 . HCV status was assessed from 1988 to 1994 , with mortality follow-up of the same individuals through 2006 . RESULTS There were 614 deaths over a median follow-up of 14.8 years . After adjusting for all covariate risk factors , HCV chronic infection had a 2.37 times higher all-cause mortality rate ratio [ MRR ] ( 95 % CI : 1.28 - 4.38 ; P = .008 ) , a 26.46 times higher liver-related MRR ( 95 % CI : 8.00 - 87.48 ; P < .001 ) , and 1.79 times higher non-liver-related MRR ( 95 % CI : .77 - 4.19 ; P = .18 ) , compared with being HCV-negative . This represents an estimated 2.46 million US adults aged 17 - 59 years with chronic HCV infection who had an estimated 31,163 deaths from all causes per year , of which 57.8 % ( 95 % CI : 21.9%-77.2 % ) were attributable to HCV . Among those , there was an estimated 9569 liver-related deaths per year , of which 96.2 % ( 95 % CI : 87.5 - 98.9 % ) were attributable to HCV . Non-liver-related deaths were not significantly associated with HCV status . CONCLUSIONS Chronic HCV all-cause mortality is more than twice that of HCV-negative individuals . This suggests that those with chronic HCV infection are at a higher risk of death even after accounting for liver-related morbidity and should be closely monitored Objective : The purpose of this study was to eluci date the long-term outcome after interferon ( IFN ) therapy in chronic hepatitis C elderly patients . Methods : We studied the incidence of hepatocellular carcinoma ( HCC ) and survival probability after the initiation of IFN therapy in 500 Japanese chronic hepatitis C patients > 60 years . The mean age of initiation of IFN was 63 years and the mean follow-up period was 7.4 years . Cox proportional hazard regression analysis was used to evaluate the long-term outcome after initiation of IFN therapy . Sustained virological response ( SVR ) was defined as negative HCV-RNA by RT-nested PCR 6 months after the completion of long-term IFN therapy . Non-response ( NR ) was applied to patients who did not show SVR . Hepatic fibrosis was defined as the fibrosis score ( score 0–4 ) according to Knodell et al. Results : 140 patients ( 28 % ) had an SVR and 360 patients ( 72 % ) had an NR . 71 of 500 patients developed HCC during follow-up . The cumulative incidence of HCC was 9.6 % at the 5th year , 17.4 % at the 10th year , and 31.3 % at the 15th year . HCC developed with significance when : ( 1 ) HCV was not cleared after IFN therapy ( p < 0.0001 ) , ( 2 ) sex was male ( p < 0.0001 ) , and ( 3 ) staging of liver fibrosis was > 2 ( p = 0.008 ) . 53 of the patients died . The cumulative survival probability was 95.7 % at the 5th year , 86.4 % at the 10th year , and 78 % at the 15th year . Patients achieved a long survival with significance when : ( 1 ) staging of liver fibrosis was 1 ( p < 0.0001 ) , ( 2 ) HCV was cleared after IFN therapy ( p = 0.034 ) , and ( 3 ) sex was female ( p = 0.015 ) . Conclusion : Chronic hepatitis C patients with clearance of HCV after IFN therapy had a significantly reduced risk of HCC appearance and achieved prolonged survival even if they are ≧60 years Background No study has compared the long-term prognoses of hepatitis C patients with hepatitis C virus ( HCV ) antibody-negative individuals and investigated the effects of interferon ( IFN ) treatment . To clarify the long-term prognosis of HCV-positive residents of an isolated Japanese isl and and prospect ively investigate the effects of IFN treatment in comparison with the HCV-negative general population . Methods HCV antibody was positive in 1,343 ( 7.6 % ) of the 17,712 individuals screened . 792 HCV RNA-positive , HBsAg-negative subjects were enrolled . 1,584 HCV antibody-negative , HBsAg-negative general residents were sex- and age-matched to the 792 subjects . A total of 154 < 70-year-old patients without liver cirrhosis ( LC ) or hepatocellular carcinoma ( HCC ) underwent IFN treatment . The survival rate with all-cause death as the endpoint was determined and causes of death were compared . Results The 10- and 20-year survival rates of the hepatitis C and general resident groups were 65.4 % and 87.8 % , and 40.8 % and 62.5 % , respectively ( p < 0.001 ; hazard risk ratio , 0.444 ; 95 % confidence interval ( CI ) : 0.389–0.507 ) . There were 167 liver disease-related deaths and 223 deaths from other causes in the hepatitis C group , and 7 and 451 , respectively , in the general resident group . Liver disease-related death accounted for 43.8 % and 1.5 % of deaths in the hepatitis C and general resident groups ( p < 0.0001 ) . The cumulative survival rate of the hepatitis C patients without IFN ( n = 328 ) was significantly lower than the gender- and age-matched general resident group ( n = 656 ) ( p < 0.0001 ) but there was no significant difference between the IFN-treated ( n = 154 ) and general resident groups ( n = 308 ) . Conclusions In the hepatitis C group , the proportion of liver disease-related death was markedly higher , and the survival rate lower , than the general resident group . Introduction of IFN treatment in < 70-year-old patients with hepatitis C without LC or HCC improved the survival rate to a level comparable to that of the general residents BACKGROUND / AIMS HCV infection recurs almost in all HCV-positive patients receiving liver transplantation and carries a poor prognosis . Aim of this study was to analyze efficacy and effect on survival of antiviral therapy in this clinical setting . METHODS Pegylated-interferon alpha-2b and ribavirin were administered at a dose of 1 microg/kg of bwt weekly and 600 - 800 mg/day . Planned duration of treatment was 24 or 48 weeks according to HCV genotype . Patients who failed to respond at week 24 were considered as non-responders . RESULTS 61 patients were enrolled . According to intention-to-treat analysis , 44 ( 72 % ) patients were considered as treatment failure ( 31 non-responders , 4 relapsers , 9 dropout ) . Sustained virological response was achieved in 17 cases ( 28 % ) . Genotype 2 , higher doses of antivirals and absence of histological cirrhosis were predictors of sustained virological response . In the follow up , patients with sustained virological response had a significantly lower mortality compared to patients with treatment failure ( chi2=6.9 ; P<0.01 ) . CONCLUSIONS Response rate to antiviral therapy in HCV reinfection after liver transplantation is higher if a full dose of antiviral drugs is administered and if treatment starts before histological cirrhosis has developed . Sustained virological response improves patient survival BACKGROUND & AIMS The natural history of HCV-related compensated cirrhosis has been poorly investigated in Latin-American countries . Our study evaluated mortality and clinical outcomes in compensated cirrhotic patients followed for 6 years . METHODS Four hundred and two patients with compensated HCV-related cirrhosis were prospect ively recruited in a tertiary care academic center . At the time of admission , patients were stratified as compensated ( absence [ stage 1 ] or presence [ stage 2 ] of esophageal varices ) as defined by D'Amico et al. Subjects were followed to identify overall mortality or liver transplantation and clinical complication rates . RESULTS Among 402 subjects , 294 were categorized as stage 1 and 108 as stage 2 . Over a median of 176 weeks , 42 deaths occurred ( 10 % ) , of which 30 were considered liver-related ( 7 % ) and 12 non-liver-related ( 3 % ) ; eight individuals ( 2 % ) underwent liver transplantation ; 30 patients ( 7 % ) developed HCC , 67 individuals in stage 1 ( 22 % ) developed varices and any event of clinical decompensation occurred in 80 patients ( 20 % ) . The 6-year cumulative overall mortality or liver transplantation was 15 % and 45 % , for stages 1 and 2 , respectively ( p<0.001 ) . The cumulative 6-year HCC incidence was significantly higher among patients with varices ( 29 % ) than those without varices ( 9 % ) , p<0.001 . Similarly , the cumulative 6-year incidence of any clinical liver-related complication was higher in patients with stage 2 ( 66 % ) as compared to 26 % in those with stage 1 , respectively ( p<0.001 ) . CONCLUSIONS Our results indicate significant morbidity and mortality and clinical outcome rates in compensated cirrhotic patients with varices ( stage 2 ) OBJECTIVES : The identification of prognostic factors associated with mortality is crucial in any clinical setting . METHODS : We enrolled in a prospect i ve study 352 patients with compensated hepatitis C virus (HCV)-induced cirrhosis , consecutively observed between 1989 and 1992 . At entry , patients underwent upper endoscopy to detect esophageal varices , and were then surveilled by serial clinical and ultrasonographic examination . The model for end-stage liver disease ( MELD ) score was calculated with information collected at enrollment . Baseline predictors and intercurrent events associated with mortality were assessed using the Cox regression model . RESULTS : During a median follow-up of 14.4 years , 194 subjects received a single course of interferon monotherapy , Output:	Published estimates of fatality are high among certain population s of chronic HCV patients , with liver-specific causes being an important contributor .
MS21749	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The diagnosis of breast cancer , the most common type of cancer among American women , elicits greater distress than any other diagnosis regardless of prognosis . Therefore , the present study examined the efficacy of a stress reduction intervention for women with breast cancer . METHODS As part of a larger , r and omized , controlled study of the effects on measures of stress of a mindfulness-based stress reduction ( MBSR ) intervention for women with breast cancer , the current analyses examined the effects on sleep complaints . RESULTS Analyses of the data indicated that both MBSR and a free choice ( FC ) control condition produced significant improvement on daily diary sleep quality measures though neither showed significant improvement on sleep-efficiency . Participants in the MBSR who reported greater mindfulness practice improved significantly more on the sleep quality measure most strongly associated with distress . CONCLUSION MBSR appears to be a promising intervention to improve the quality of sleep in woman with breast cancer whose sleep complaints are due to stress Objective The objective of this study was to assess the effects of participation in a mindfulness meditation – based stress reduction program on mood disturbance and symptoms of stress in cancer out patients . Methods A r and omized , wait-list controlled design was used . A convenience sample of eligible cancer patients enrolled after giving informed consent and were r and omly assigned to either an immediate treatment condition or a wait-list control condition . Patients completed the Profile of Mood States and the Symptoms of Stress Inventory both before and after the intervention . The intervention consisted of a weekly meditation group lasting 1.5 hours for 7 weeks plus home meditation practice . Results Ninety patients ( mean age , 51 years ) completed the study . The group was heterogeneous in type and stage of cancer . Patients ’ mean preintervention scores on dependent measures were equivalent between groups . After the intervention , patients in the treatment group had significantly lower scores on Total Mood Disturbance and subscales of Depression , Anxiety , Anger , and Confusion and more Vigor than control subjects . The treatment group also had fewer overall Symptoms of Stress ; fewer Cardiopulmonary and Gastrointestinal symptoms ; less Emotional Irritability , Depression , and Cognitive Disorganization ; and fewer Habitual Patterns of stress . Overall reduction in Total Mood Disturbance was 65 % , with a 31 % reduction in Symptoms of Stress . Conclusions This program was effective in decreasing mood disturbance and stress symptoms in both male and female patients with a wide variety of cancer diagnoses , stages of illness , and ages OBJECTIVES The purpose of this study was to examine the effects of a structured , 8-week , Mindfulness-Based Stress Reduction ( MBSR ) program on perceived stress , mood , endocrine function , immunity , and functional health outcomes in individuals infected with the human immunodeficiency virus ( HIV ) . DESIGN This study used a quasiexperimental , nonr and omized design . METHODS Subjects were specifically recruited ( nonr and om ) for intervention ( MBSR ) or comparison group . Data were collected at pretest and post-test in the MBSR group and at matched times in the comparison group . t Tests where performed to determine within-group changes and between-group differences . RESULTS Natural killer cell activity and number increased significantly in the MBSR group compared to the comparison group . No significant changes or differences were found for psychological , endocrine , or functional health variables . CONCLUSIONS These results provide tentative evidence that MBSR may assist in improving immunity in individuals infected with HIV PURPOSE Epidemiological and laboratory evidence indicates that a Western diet is associated with an increased incidence of prostate cancer . Specific components of the diet , such as high saturated fat , low fiber and high meat content , may have greatest clinical significance in the later stages of tumor promotion and progression . However , departure from the conventional diet is difficult to initiate and maintain . Therefore , we combined the well-known Mindfulness-Based Stress Reduction ( MBSR ) program with a low saturated fat , high-fiber , plant-based diet to determine the effect on the rate of change in prostate specific antigen ( PSA ) in patients with biochemical recurrence after prostatectomy . MATERIAL S AND METHODS We enrolled 10 men and their partners in a 4-month group-based diet and MBSR intervention . A pre- study post- study design in which each subject served as his own control was used to compare the rate of increase in and doubling time of PSA before and after intervention . RESULTS The rate of PSA increase decreased in 8 of 10 men , while 3 had a decrease in absolute PSA . Results of the signed rank test indicated a significant decrease in the rate of increase in the intervention period ( p = 0.01 ) . Estimated median doubling time increased from 6.5 months ( 95 % confidence interval 3.7 to 10.1 ) before to 17.7 months ( 95 % confidence interval 7.8 to infinity ) after the intervention . CONCLUSIONS Our small study provides evidence that a plant-based diet delivered in the context of MBSR decreases the rate of PSA increase and may slow the rate of tumor progression in cases of biochemically recurrent prostate cancer . Larger-scale r and omized studies are warranted to explore further the preventive and therapeutic potential of diet and lifestyle modification in men with prostate cancer OBJECTIVES This study investigated the relationships between a mindfulness-based stress reduction meditation program for early stage breast and prostate cancer patients and quality of life , mood states , stress symptoms , and levels of cortisol , dehydroepi and rosterone-sulfate ( DHEAS ) and melatonin . METHODS Fifty-nine patients with breast cancer and 10 with prostate cancer enrolled in an eight-week Mindfulness-Based Stress Reduction ( MBSR ) program that incorporated relaxation , meditation , gentle yoga , and daily home practice . Demographic and health behavior variables , quality of life , mood , stress , and the hormone measures of salivary cortisol ( assessed three times/day ) , plasma DHEAS , and salivary melatonin were assessed pre- and post-intervention . RESULTS Fifty-eight and 42 patients were assessed pre- and post-intervention , respectively . Significant improvements were seen in overall quality of life , symptoms of stress , and sleep quality , but these improvements were not significantly correlated with the degree of program attendance or minutes of home practice . No significant improvements were seen in mood disturbance . Improvements in quality of life were associated with decreases in afternoon cortisol levels , but not with morning or evening levels . Changes in stress symptoms or mood were not related to changes in hormone levels . Approximately 40 % of the sample demonstrated abnormal cortisol secretion patterns both pre- and post-intervention , but within that group patterns shifted from " inverted-V-shaped " patterns towards more " V-shaped " patterns of secretion . No overall changes in DHEAS or melatonin were found , but nonsignificant shifts in DHEAS patterns were consistent with healthier profiles for both men and women . CONCLUSIONS MBSR program enrollment was associated with enhanced quality of life and decreased stress symptoms in breast and prostate cancer patients , and result ed in possibly beneficial changes in hypothalamic-pituitary-adrenal ( HPA ) axis functioning . These pilot data represent a preliminary investigation of the relationships between MBSR program participation and hormone levels , highlighting the need for better-controlled studies in this area Two hundred fifteen r and omly accessed cancer patients who were new admissions to three collaborating cancer centers were examined for the presence of formal psychiatric disorder . Each patient was assessed in a common protocol via a psychiatric interview and st and ardized psychological tests . The American Psychiatric Association 's DSM-III diagnostic system was used in making the diagnoses . Results indicated that 47 % of the patients received a DSM-III diagnosis , with 44 % being diagnosed as manifesting a clinical syndrome and 3 % with personality disorders . Approximately 68 % of the psychiatric diagnoses consisted of adjustment disorders , with 13 % representing major affective disorders ( depression ) . The remaining diagnoses were split among organic mental disorders ( 8 % ) , personality disorders ( 7 % ) , and anxiety disorders ( 4 % ) . Approximately 85 % of those patients with a positive psychiatric condition were experiencing a disorder with depression or anxiety as the central symptom . The large majority of conditions were judged to represent highly treatable disorders Abstract The goals of this work were to assess the effects of participation in a mindfulness meditation-based stress reduction program on mood disturbance and symptoms of stress in cancer out patients immediately after and 6 months after program completion . A convenience sample of eligible cancer patients were enrolled after they had given informed consent . All patients completed the Profile of Mood States ( POMS ) and Symptoms of Stress Inventory ( SOSI ) both before and after the intervention and 6 months later . The intervention consisted of a mindfulness meditation group lasting 1.5 h each week for 7 weeks , plus daily home meditation practice . A total of 89 patients , average age 51 , provided pre-intervention data . Eighty patients provided post-intervention data , and 54 completed the 6-month follow-up The participants were heterogeneous with respect to type and stage of cancer . Patients ' scores decreased significantly from before to after the intervention on the POMS and SOSI total scores and most subscales , indicating less mood disturbance and fewer symptoms of stress , and these improvements were maintained at the 6-month follow-up . More advanced stages of cancer were associated with less initial mood disturbance , while more home practice and higher initial POMS scores predicted improvements on the POMS between the pre- and post-intervention scores . Female gender and more education were associated with higher initial SOSI scores , and improvements on the SOSI were predicted by more education and greater initial mood disturbance . This program was effective in decreasing mood disturbance and stress symptoms for up to 6 months in both male and female patients with a wide variety of cancer diagnoses , stages of illness , and educational background , and with disparate ages Output:	Studies report positive results , including improvements in mood , sleep quality and reductions in stress . A dose-response effect has been observed between practice of Mindfulness-Based Stress Reduction and improved outcome . Mindfulness-Based Stress Reduction has potential as a clinical ly valuable self-administered intervention for cancer patients .
MS21750	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We investigated the relationship between oxidative stress and poor oocyte quality and whether the antioxidant melatonin improves oocyte quality . Follicular fluid was sample d at oocyte retrieval during in vitro fertilization and embryo transfer ( IVF-ET ) . Intrafollicular concentrations of 8-hydroxy-2'-deoxyguanosine ( 8-OHdG ) in women with high rates of degenerate oocytes were significantly higher than those with low rates of degenerate oocytes . As there was a negative correlation between intrafollicular concentrations of 8-OHdG and melatonin , 18 patients undergoing IVF-ET were given melatonin ( 3 mg/day ) , vitamin E ( 600 mg/day ) or both melatonin and vitamin E. Intrafollicular concentrations of 8-OHdG and hexanoyl-lysine adduct were significantly reduced by these antioxidant treatments . One hundred and fifteen patients who failed to become pregnant with a low fertilization rate ( < or = 50 % ) in the previous IVF-ET cycle were divided into two groups during the next IVF-ET procedure ; 56 patients with melatonin treatment ( 3 mg/day ) and 59 patients without melatonin treatment . The fertilization rate was improved by melatonin treatment compared to the previous IVF-ET cycle . However , the fertilization rate was not significantly changed without melatonin treatment . Oocytes recovered from preovulatory follicles in mice were incubated with H2O2 for 12 hr . The percentage of mature oocytes with a first polar body was significantly reduced by addition of H2O2 ( 300 microm ) . The inhibitory effect of H2O2 was significantly blocked by simultaneous addition of melatonin . In conclusion , oxidative stress causes toxic effects on oocyte maturation and melatonin protects oocytes from oxidative stress . Melatonin is likely to improve oocyte quality and fertilization rates Satureja khuzestanica is an endemic plant of Iran that is widely distributed in the Southern part of the country . It has antioxidant properties and thus it seems to be useful in diseases related to oxidative stress such as diabetes and hyperlipidemia . The present study investigates the effect of S. khuzestanica supplement in metabolic parameters of hyperlipidemic patients with type 2 diabetes mellitus . Twenty-one hyperlipidemic patients with type 2 diabetes mellitus were r and omized in a double blind , placebo controlled clinical trial to receive either S. khuzestanica ( tablets contain 250 mg dried leaves ) or placebo once a day for 60 days . Blood sample s were obtained at baseline and at the end of the study . Sample s were analyzed for levels of glucose , total cholesterol , LDL-cholesterol , HDL-cholesterol , triglyceride , creatinine , thiobarbituric acid reactive substances ( TBARS ) as marker of lipid peroxidation and ferric reducing ability ( total antioxidant power , TAP ) . Treatment of patients by S. khuzestanica for 60 days induced significant decrease in total cholesterol ( P = 0.008 ) and LDL-cholesterol ( P = 0.03 ) while increased HDL-cholesterol ( P = 0.02 ) and TAP ( P = 0.007 ) in comparison with the baseline values . S. khuzestanica did not alter blood glucose , triglyceride , creatinin and TBARS levels . In comparison with baseline values , no significant change was observed in blood glucose , total cholesterol , LDL-cholesterol , HDL-cholesterol , triglyceride , creatinine , TBARS and TAP in placebo-treated group . Usage of S. khuzestanica as a supplement to drug regimen of diabetic type 2 patients with hyperlipidemia is recommended OBJECTIVE To assess the effect of treatment with a combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant on the incidence of pregnancy and sperm variables in men with idiopathic oligozoospermia and infertility . DESIGN Prospect i ve , r and omized , placebo-controlled trial . SETTING The outpatient and rology clinic at a university hospital . PATIENT(S ) Sixty infertile men with idiopathic oligoasthenozoospermia . INTERVENTION(S ) Patients were r and omly assigned to two treatment groups : a group receiving the combination of clomiphene citrate ( 25 mg/day ) and vitamin E ( 400 mg/day ; n = 30 ) against a placebo group ( n = 30 ) . Treatment was maintained for 6 months . MAIN OUTCOME MEASURE(S ) Pregnancy incidence and variations in semen parameters . RESULT ( S ) A significantly higher pregnancy rate was found among the combination treatment group in comparison to the control group . The odds ratio was 3.76 and the 95 % confidence interval was 1.03 - 13.64 , with a 36.7 % pregnancy rate ( 11/30 ) in the combination treatment group compared with 13.3 % pregnancy rate ( 4/30 ) in the control group . The trial showed a significantly higher increase in sperm count and progressive sperm motility with nonsignificant changes in total sperm motility , percentage of abnormal forms and semen volume in the combination treatment group as compared to the control group . CONCLUSION ( S ) The combination of clomiphene citrate as an antiestrogen and vitamin E as an antioxidant can significantly increase the pregnancy rate and improve sperm count and progressive sperm motility in cases of idiopathic oligoasthenozoospermia Sperm DNA fragmentation is known to compromise male fertility . Previous findings have suggested the implication of oxidative stress in the etiology of this pathological condition . The present study was conducted to find out if the pathologically increased incidence of DNA fragmentation in ejaculated spermatozoa can be reduced by oral treatment with two antioxidants , vitamins C and E. Sixty-four men with unexplained infertility and an elevated ( > or = 15 % ) percentage of DNA-fragmented spermatozoa in the ejaculate were r and omized between an antioxidant treatment ( 1 g vitamin C and 1 g vitamin E daily for 2 months ) group and a placebo group . Sperm DNA fragmentation was evaluated by terminal deoxyribonucleotidyl transferase-mediated dUTP nick-end labeling assay before and after treatment . No differences in basic sperm parameters were found between the antioxidant treatment and the placebo group before or after treatment . However , the percentage of DNA-fragmented spermatozoa was markedly reduced ( P < .001 ) in the antioxidant treatment group after the treatment ( 9.1 + /- 7.2 ) as compared with the pretreatment values ( 22.1 + /- 7.7 ) . No difference in the pretreatment and posttreatment incidence of sperm DNA fragmentation was observed in the placebo group . These data show that sperm DNA damage can be efficiently treated with oral antioxidants administered during a relatively short time period Peroxidative damage induced by reactive oxygen species ( ROS ) has been proposed as one of the major causes of defective sperm function . The ROS detected in semen reflect an imbalance between ROS generation and degradation . The objective of the present study was to investigate the relationship between the oxidative and anti-oxidative potential in semen of infertile patients and healthy donors . Specimens were obtained from 28 patients and 18 healthy donors ( controls ) . A conventional spermiogram , measurement of luminol-chemiluminescence ( CL ) in washed semen , and high performance liquid chromatography determination of ascorbic acid and urate concentrations in seminal plasma were performed . Oligozoospermic patients exhibited higher CL signals than controls ( P < 0.001 ) . Normozoospermic patients showed lower ascorbic acid ( mean + /- SE : 491 + /- 46 microM , P < 0.04 ) and urate concentrations ( 320 + /- 22 microM , P < 0.009 ) than controls ( 612 + /- 35 and 426 + /- 26 microM respectively ) . Seminal plasma ascorbic acid was negatively correlated with the CL signals ( P < 0.0006 ) and positively correlated with the percentage of spermatozoa with normal morphology ( P < 0.006 ) . This is the first report of a correlation between the anti-oxidant ascorbic acid in seminal plasma and ROS generation in human semen . Furthermore , the reduced ascorbic acid/urate concentrations found in semen of normozoospermic patients might be indicative of a reduced anti-oxidative protection OBJECTIVE To evaluate whether the association of antioxidants and anti-inflammatory compounds may be beneficial in treatment of patients with abacterial prostatovesiculoepididymitis ( PVE ) and elevated seminal leukocyte concentrations . DESIGN Open , prospect i ve , r and om study . SETTING Academic research environment . PATIENT(S ) Ninety-eight patients with PVE who had increased seminal leukocyte concentrations ( > 1 x 10(6 ) cells/mL ) . Carnitines ( group A ; n = 30 ) or nonsteroidal anti-inflammatory drugs ( group B ; n = 16 ) for 4 months ; nonsteroidal anti-inflammatory drugs for 2 months , followed by treatment with carnitines for 2 months ( group C ; n = 26 ) ; or nonsteroidal anti-inflammatory treatment given concomitantly with carnitines ( group D ; n = 26 ) for 4 months . MAIN OUTCOME MEASURE(S ) Semen variables , production of reactive oxygen species , and pregnancy outcome were evaluated before and after treatment and following a 3-month washout period . RESULT ( S ) Patients in group C had the highest reduction in production of reactive oxygen species associated with increased sperm motility and viability . Groups B and D experienced intermediate effects , and group A experienced the least effect . CONCLUSION ( S ) Antioxidant treatment with carnitines is effective in patients with abacterial PVE and increased seminal leukocyte concentrations if these patients have been pretreated with nonsteroidal anti-inflammatory drugs Numerous studies have reported beneficial effects of antioxidant drugs on semen quality , but there is no well-defined therapeutical protocol in male infertility . This study aim ed to test the effects of vitamin E and selenium supplementation on lipid peroxidation and on sperm parameters . The study included 54 voluntary and infertile men who produced semen sample s for spermiogram and for spectrophotometric measurement of a lipid peroxidatio n marker , the malondialdehyde ( MDA ) , and produced blood sample s for high-perf ormance liquid chromatography assessment of serum vitamin E level . The trial was r and omized and open . Twenty-eight men were supplemented daily by vitamin E ( 400 mg ) and selenium ( 225 µg ) , during 3 months . The remaining 26 patients received vitamin B ( 4,5 g/day ) for the same duration . Only 20 patients achieved their treatment and returned for control analysis . MDA concentrations in sperm were much less than in seminal plasma and motility and viability were inversely correlated with semen MDA levels . In contrast to vitamin B supplementation , vitamin E and selenium supplementation produced a significant decrease in MDA concentrations and an improvement of sperm motility . The results confirm the protective and beneficial effects of vitamin E and selenium on semen quality and advocate their use in male infertility treatment Asthenospermia is the main factor of male infertility among patients consulting the Asir Infertility Center in Abha , Saudi Arabia . Lipid peroxidation occurring in both the seminal plasma and spermatozoa was estimated by malondialdehyde ( MDA ) concentration . Spermatozoal MDA concentration was higher in men with decreased sperm motility . The MDA concentration in the seminal plasma exhibited no relationship with sperm concentration , sperm motility , the number of immotile spermatozoa , or even the absence of spermatozoa . The MDA concentration in sperm pellet suspensions of asthenospermic and oligoasthenospermic patients was almost twice that of the normospermic males . The MDA concentration in the sperm pellet suspension from normospermic or oligospermic patients was about 10 % that in the seminal plasma . However , the MDA concentration in the sperm pellet suspension of asthenospermic or oligoasthenospermic patients was about 15 % that in the seminal plasma . Treatment of asthenospermic patients with oral Vitamin E significantly decreased the MDA concentration in spermatozoa and improved sperm motility . Eleven out of the 52 treated patients ( 21 % ) impregnated their spouses ; nine of the spouses successfully ended with normal term deliveries , whereas the other two aborted in the first trimester . No pregnancies were reported in the spouses of the placebo-treated patients The present study aim ed to evaluate whether ascorbate , a reactive oxygen species ( ROS ) scavenger , can improve fertilization and development of human embryos in vitro when added to the simple salt solution human tubal fluid ( HTF ) or the complex tissue culture medium Ham 's F-10 , which contains iron and copper in its formulation . Human oocytes , spermatozoa and embryos from 83 infertile IVF couples were r and omly allocated and cultured in the presence or absence of 62. Output:	The human and animal studies of Satureja Khuzestanica showed a significant antioxidative potential of the plant and its effectiveness for infertility improvement . The use of oral antioxidants in infertility could improve sperm quality and pregnancy rates . Improved fertility observed by SKEO in rats might be due to its antioxidative effect .
MS21751	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: An increased consumption of fruits and vegetables ( F&V ) has been suggested as a way to limit , or even lower , energy and fat intakes . The present study examined the effects of incorporating F&V supplements into the diets of adults who reported consuming < 240 g ( three portions ) of F&V per d on energy and fat intakes , and change in body weight , over 8 weeks using a r and omised parallel design . Thirty-four males and twenty-eight females ( age 42.6 ( sd 11.1 ) years , BMI 23.7 ( sd 2.7 ) kg/m(2 ) ) were each provided with supplements of 0 , 300 or 600 g F&V per d. Food , nutrient and energy intakes were measured before , during and at the end of the supplementation period using 7 d weighed records . Mean daily energy intakes were not different among the three groups before ( P = 0.151 ) or during the supplementation periods ( P = 0.407 ) , although changes in energy intakes over the study period tended to be more positive with increasing amounts of F&V supplements ( P = 0.078 ) . There was no difference in changes of body weights during the study ( P = 0.242 ) . Carbohydrate ( P < 0.001 ) , sugar ( P < 0.001 ) , fibre ( P < 0.001 ) and weight of food consumed ( P = 0.022 ) increased in the treatment groups . There were no significant differences , or changes , in fat intakes among the three groups . Consumption of m and atory F&V supplements for 8 weeks produced beneficial changes in diet composition , but did not result in lower reported energy or fat intakes , and did not result in loss of body weight Definitive solutions wo n’t come from another million observational papers or small r and omized trials BACKGROUND Altering the macronutrient composition of the diet influences hunger and satiety . Studies have compared high- and low-protein diets , but there are few data on carbohydrate content and ketosis on motivation to eat and ad libitum intake . OBJECTIVE We aim ed to compare the hunger , appetite , and weight-loss responses to a high-protein , low-carbohydrate [ ( LC ) ketogenic ] and those to a high-protein , medium-carbohydrate [ ( MC ) nonketogenic ] diet in obese men feeding ad libitum . DESIGN Seventeen obese men were studied in a residential trial ; food was provided daily . Subjects were offered 2 high-protein ( 30 % of energy ) ad libitum diets , each for a 4-wk period-an LC ( 4 % carbohydrate ) ketogenic diet and an MC ( 35 % carbohydrate ) diet-r and omized in a crossover design . Body weight was measured daily , and ketosis was monitored by analysis of plasma and urine sample s. Hunger was assessed by using a computerized visual analogue system . RESULTS Ad libitum energy intakes were lower with the LC diet than with the MC diet [ P=0.02 ; SE of the difference ( SED ) : 0.27 ] at 7.25 and 7.95 MJ/d , respectively . Over the 4-wk period , hunger was significantly lower ( P=0.014 ; SED : 1.76 ) and weight loss was significantly greater ( P=0.006 ; SED : 0.62 ) with the LC diet ( 6.34 kg ) than with the MC diet ( 4.35 kg ) . The LC diet induced ketosis with mean 3-hydroxybutyrate concentrations of 1.52 mmol/L in plasma ( P=0.036 from baseline ; SED : 0.62 ) and 2.99 mmol/L in urine ( P<0.001 from baseline ; SED : 0.36 ) . CONCLUSION In the short term , high-protein , low-carbohydrate ketogenic diets reduce hunger and lower food intake significantly more than do high-protein , medium-carbohydrate nonketogenic diets OBJECTIVES We examined the viability and efficacy of a known quantity of exercise in facilitating weight loss among previously sedentary or irregularly active overweight and obese adult women residing in a slum ( favela ) in Brazil . METHODS In this r and omized controlled trial , 156 women were r and omized to a control or intervention group ( 78 in each group ) . Exercise was supervised , consisting of three 50-minute aerobic sessions each week for 6 months . RESULTS Ninety-one percent ( 71 ) of the participants in the intervention group completed 6 months of the exercise program . At 6 months , women in the treatment group showed significant reduction in weight ( mean=-1.69 kg ; 95 % confidence interval [CI]=-2.36,-1.03 ) and body mass index ( mean=-0.63 kg/m2 ; 95 % CI=-0.97 , -0.30 ) compared with controls ( P for both<.001 ) . CONCLUSIONS A moderately intense , structured exercise program result ed in modest weight loss in women when sustained for 6 months 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 < 0.01 ) , skeletal muscle fat ( 117 - 221 % ; P < 0.05 ) , visceral fat ( 24 - 31 % ; P < 0.05 ) , blood triglycerides ( 32 % ; P < 0.01 ) , and total cholesterol ( 11 % ; P < 0.01 ) . 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 < 0.05 ) . Otherwise , 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 Coronary artery disease ( CAD ) is a substantial cause of death and disability in South Africa and Western society , with research showing obesity to be one of the most common CAD risk factors . Furthermore , obesity is speculated to be the fastest-growing CAD risk factor and to become the most prevalent CAD risk factor . Research on obesity is therefore essential , and we propose some preventative measures that will hopefully limit the expansion of this risk factor for CAD . Most of the literature has focused primarily on aerobic modes of exercise . The aim of this study , therefore , was to investigate whether resistance training would improve body composition . Twenty-eight males were matched by age , percentage of body fat and waist-to-hip ratio and r and omly assigned either to a resistance-training group ( n = 13 ) or a control group ( n = 15 ) . Each subject 's body mass , percentage body fat , lean mass , fat mass , waist-to-hip ratio and body mass index were assessed both pre- and post-experimentally following the eight-week experimental period . The resistance-training group trained three times weekly at 60 % of their one-repetition maximum using nine resistance exercises . Each exercise was performed for three sets of 15 repetitions each , whereas the control group did not exercise over this period . The dependent t-test indicated that resistance training significantly changed body mass , percentage of body fat , lean mass and fat mass ( all had a p-value of 0.00 ; p < or= 0.01 ) . Furthermore , the independent t-test demonstrated that lean mass , fat mass and percentage of body fat were statistically significantly different between the control and resistance-training groups . In conclusion , resistance training improved four of the six measured body composition variables , therefore implying that resistance training does in fact improve the majority of body composition variables and therefore CAD risk Objective : Clinical and epidemiological studies have reported the beneficial effects of tree nuts and peanuts on serum lipid levels . We studied the effects of consuming 15 % of the daily caloric intake in the form of pistachio nuts on the lipid profiles of free-living human subjects with primary , moderate hypercholesterolemia ( serum cholesterol greater than 210 mg/dL ) . Methods : Design : R and omized crossover trial . Setting : Outpatient dietary counseling and blood analysis . Subjects : 15 subjects with moderate hypercholesterolemia . Intervention : Fours weeks of dietary modification with 15 % caloric intake from pistachio nuts . Measures of Outcome : Endpoints were serum lipid levels of total cholesterol , HDL-C , LDL-C , VLDL-C , triglycerides and apolipoproteins A-1 and B-100 . BMI , blood pressure , and nutrient intake ( total energy , fat , protein , and fiber ) were also measured at baseline , during , and after dietary intervention . Results : No statistically significant differences were observed for total energy or percent of energy from protein , carbohydrate or fat . On the pistachio nut diet , a statistically significant decrease was seen for percent energy from saturated fat ( mean difference , −2.7 % ; 95 % CI , −5.4 % to −0.08 % ; p = 0.04 ) . On the pistachio nut diet , statistically significant increases were seen for percent energy from polyunsaturated fat ( mean difference , 6.5 % ; 95 % CI , 4.2 % to 8.9 % ; p<.0001 ) and fiber intake ( mean difference , 15 g ; 95 % CI , 8.4 g to 22 g ; p = 0.0003 ) . On the pistachio diet , statistically significant reductions were seen in TC/HDL-C ( mean difference , −0.38 ; 95 % CI , −0.57 to −0.19 ; p = 0.001 ) , LDL-C/HDL-C ( mean difference , −0.40 ; 95 % CI , −0.66 to −0.15 ; p = 0.004 ) , B-100/A-1 ( mean difference , −0.11 ; 95 % CI , −0.19 to −0.03 ; p = 0.009 ) and a statistically significant increase was seen in HDL-C ( mean difference , 2.3 ; 95 % CI , 0.48 to 4.0 ; p = 0.02 ) . No statistically significant differences were seen for total cholesterol , triglycerides , LDL-C , VLDL-C , apolipoprotein A-1 or apolipoprotein B-100 . No changes were observed in BMI or blood pressure . Conclusion : A diet consisting of 15 % of calories as pistachio nuts ( about 2–3 ounces per day ) over a four week period can favorably improve some lipid profiles in subjects with moderate hypercholesterolemia and may reduce risk of coronary disease To determine the effect of a 12-week high intensity intermittent exercise ( HIIE ) intervention on total body , abdominal , trunk , visceral fat mass , and fat free mass of young overweight males . Participants were r and omly assigned to either exercise or control group . The intervention group received HIIE three times per week , 20 min per session , for 12 weeks . Aerobic power improved significantly ( P < 0.001 ) by 15 % for the exercising group . Exercisers compared to controls experienced significant weight loss of 1.5 kg ( P < 0.005 ) and a significant reduction in total fat mass of 2 kg ( P < 0.001 ) . Abdominal and trunk adiposity was also significantly reduced in the exercising group by 0.1 kg ( P < 0.05 ) and 1.5 kg ( P < 0.001 ) . Also the exercise group had a significant ( P < 0.01 ) 17 % reduction in visceral fat after 12 weeks of HIIE , whereas waist circumference was significantly decreased by week six ( P < 0.001 ) . Fat free mass was significantly increased ( P < 0.05 ) in the exercising group by 0.4 kg for the leg and 0.7 kg for the trunk . No significant change ( P > 0.05 ) occurred in levels of insulin , HO Output:	Interpretation : Compensation is substantial even in high-compliance conditions , result ing in far less weight change than would be expected . The simple algorithm we report allows for more realistic predictions of intervention effects in free-living population s by accounting for the significant compensation that occurs
MS21752	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective Our aim was to evaluate the association between adherence to the Mediterranean Diet ( MedDiet ) and cognitive function in 823 participants ( 62 ± 6 years at baseline ) from a Spanish prospect i ve cohort ( SUN project ) . Method A vali date d 136-item food frequency question naire was used to assess the adherence to the MedDiet at baseline . The 10-point ( 0 to 9 ) MedDiet Score was used to categorize adherence to MedDiet . Cognitive function was assessed twice at follow-up with a mean follow-up time between exposure and outcome assessment of 6 and 8y using the Telephone Interview of Cognitive Status-modified ( TICS-m , range 0 to 54 points ) . ANCOVA models were used to assess the association between adherence to the MedDiet and cognitive decline . Results In the multivariable-adjusted analysis of 2-year changes , a higher cognitive decline was observed among participants with low or moderate baseline adherence to the MedDiet than among those with better adherence ( adjusted difference = −0.56 points in TICS-m , 95 % CI = −0.99 to −0.13 ) . Conclusion A higher adherence to the MedDiet might be associated with better cognitive function . However , observed differences were of small magnitude and further studies are needed to confirm this finding BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk ratios ranging from 1.64 to 2.86 with count > 9x10(9)/L ) , female sex ( adjusted risk ratios , 0.27 to 0 . 46 ) , and aspirin use ( adjusted risk ratios , 0.59 to 0.82 ) were each significantly and independently associated with recurrence . CONCLUSIONS The protective effect of the Mediterranean dietary pattern was maintained up to 4 years after the first infa rct ion , confirming previous intermediate analyses . Major traditional risk factors , such as high blood cholesterol and blood pressure , were shown to be independent and joint predictors of recurrence , indicating that the Mediterranean dietary pattern did not alter , at least qualitatively , the usual relationships between major risk factors and recurrence . Thus , a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet . It should be associated with other ( pharmacological ? ) means aim ed at reducing modifiable risk factors . Further trials combining the 2 approaches are warranted CONTEXT Higher adherence to a Mediterranean-type diet is linked to lower risk for mortality and chronic diseases , but its association with cognitive decline is unclear . OBJECTIVE To investigate the association of a Mediterranean diet with change in cognitive performance and risk for dementia in elderly French persons . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1410 adults ( > or = 65 years ) from Bordeaux , France , included in the Three-City cohort in 2001 - 2002 and reexamined at least once over 5 years . Adherence to a Mediterranean diet ( scored as 0 to 9 ) was computed from a food frequency question naire and 24-hour recall . MAIN OUTCOME MEASURES Cognitive performance was assessed on 4 neuropsychological tests : the Mini-Mental State Examination ( MMSE ) , Isaacs Set Test ( IST ) , Benton Visual Retention Test ( BVRT ) , and Free and Cued Selective Reminding Test ( FCSRT ) . Incident cases of dementia ( n = 99 ) were vali date d by an independent expert committee of neurologists . RESULTS Adjusting for age , sex , education , marital status , energy intake , physical activity , depressive symptomatology , taking 5 medications/d or more , apolipoprotein E genotype , cardiovascular risk factors , and stroke , higher Mediterranean diet score was associated with fewer MMSE errors ( beta = -0.006 ; 95 % confidence interval [ CI ] , -0.01 to -0.0003 ; P = .04 for 1 point of the Mediterranean diet score ) . Performance on the IST , BVRT , or FCSRT over time was not significantly associated with Mediterranean diet adherence . Greater adherence as a categorical variable ( score 6 - 9 ) was not significantly associated with fewer MMSE errors and better FCSRT scores in the entire cohort , but among individuals who remained free from dementia over 5 years , the association for the highest compared with the lowest group was significant ( adjusted for all factors , for MMSE : beta = -0.03 ; 95 % CI , -0.05 to -0.001 ; P = .04 ; for FCSRT : beta = 0.21 ; 95 % CI , 0.008 to 0.41 ; P = .04 ) . Mediterranean diet adherence was not associated with the risk for incident dementia ( fully adjusted model : hazard ratio , 1.12 ; 95 % CI , 0.60 to 2.10 ; P = .72 ) , although power to detect a difference was limited . CONCLUSIONS Higher adherence to a Mediterranean diet was associated with slower MMSE cognitive decline but not consistently with other cognitive tests . Higher adherence was not associated with risk for incident dementia The aim of the present study was to assess reproducibility and relative validity of a self-administered FFQ used in the PREDIMED Study , a clinical trial for primary prevention of CVD by Mediterranean diet in a population at high cardiovascular risk . The FFQ was administered twice ( FFQ1 and FFQ2 ) to explore reproducibility at 1 year . Four 3 d dietary records ( DR ) were used as reference to explore validity ; participants therefore recorded their food intake over 12 d in the course of 1 year . The degree of misclassification in the FFQ was also evaluated by a contingency table of quintiles comparing the information from the FFQ2 and the DR . A total of 158 men and women ( aged 55 - 80 years ) were asked not to modify their dietary habits during the study period . Reproducibility for food groups , energy and nutrient intake , explored by the Pearson correlation coefficient ( r ) ranged 0.50 - 0.82 , and the intraclass correlation coefficient ( ICC ) ranged from 0.63 to 0.90 . The FFQ2 tended to report higher energy and nutrient intake than the DR . The validity indices of the FFQ in relation to the DR for food groups and energy and nutrient intake ranged ( r ) from 0.24 to 0.72 , while the range of the ICC was between 0.40 and 0.84 . With regard to food groups , 68 - 83 % of individuals were in the same or adjacent quintile in both methods , a figure which decreased to 55 - 75 % for energy and nutrient intake . We concluded that FFQ measurements had good reproducibility and a relative validity similar to those of FFQ used in other prospect i ve studies OBJECTIVE To explore the associations of low serum levels of vitamin B(12 ) and folate with AD occurrence . METHODS A population -based longitudinal study in Sweden , the Kungsholmen PROJECT A r and om sample of 370 nondemented persons , aged 75 years and older and not treated with B(12 ) and folate , was followed for 3 years to detect incident AD cases . Two cut-off points were used to define low levels of vitamin B(12 ) ( < or = 150 and < or = 250 pmol/L ) and folate ( < or = 10 and < or = 12 nmol/L ) , and all analyses were performed using both definitions . AD and other types of dementia were diagnosed by specialists according to DSM-III-R criteria . RESULTS When using B(12 ) < or = 150 pmol/L and folate < or = 10 nmol/L to define low levels , compared with people with normal levels of both vitamins , subjects with low levels of B(12 ) or folate had twice higher risks of developing AD ( relative risk [ RR ] = 2.1 , 95 % CI = 1.2 to 3.5 ) . These associations were even stronger in subjects with good baseline cognition ( RR = 3.1 , 95 % CI = 1.1 to 8.4 ) . Similar relative risks of AD were found in subjects with low levels of B(12 ) or folate and among those with both vitamins at low levels . A comparable pattern was detected when low vitamin levels were defined as B(12 ) < or = 250 pmol/L and folate < or = 12 nmol/L. CONCLUSIONS This study suggests that vitamin B(12 ) and folate may be involved in the development of AD . A clear association was detected only when both vitamins were taken into account , especially among the cognitively intact subjects . No interaction was found between the two vitamins . Monitoring serum B(12 ) and folate concentration in the elderly may be relevant for prevention of AD IMPORTANCE Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline , a strong risk factor for development of dementia . Epidemiologic studies suggest that a Mediterranean diet , an antioxidant-rich cardioprotective dietary pattern , delays cognitive decline , but clinical trial evidence is lacking . OBJECTIVE To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet . DESIGN , SETTING , AND PARTICIPANTS Parallel-group r and omized clinical trial of 447 cognitively healthy volunteers from Barcelona , Spain ( 233 women [ 52.1 % ] ; mean age , 66.9 years ) , at high cardiovascular risk were enrolled into the Prevención con Dieta Mediterránea nutrition intervention trial from October 1 , 2003 , through December 31 , 2009 . All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study . INTERVENTIONS Participants were r and omly assigned to a Mediterranean diet supplemented with extravirgin olive oil ( 1 L/wk ) , a Mediterranean diet supplemented with mixed nuts ( 30 g/d ) , or a control diet ( advice to reduce dietary fat ) . MAIN OUTCOMES AND MEASURES Rates of cogn Output:	These revealed that higher adherence to a MedDiet is associated with slower rates of cognitive decline , reduced conversion to Alzheimer 's disease , and improvements in cognitive function . The specific cognitive domains that were found to benefit with improved Mediterranean Diet Score were memory ( delayed recognition , long-term , and working memory ) , executive function , and visual constructs .
MS21753	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES To determine the comparative effectiveness and cost-effectiveness of three dressing products , N-A , Inadine and Aquacel , for patients with diabetic foot ulcers , as well as the feasibility and consequences of less frequent dressing changes by health-care professionals . DESIGN A multicentre , prospect i ve , observer-blinded , parallel group , r and omised controlled trial , with three arms . SETTING Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK . PARTICIPANTS Patients over age 18 with type 1 or type 2 diabetes with a chronic ( present for at least 6 weeks ) full-thickness foot ulcer ( on or below the malleoli ) not penetrating to tendon , periosteum or bone , and with a cross-sectional area between 25 and 2500 mm(2 ) . INTERVENTIONS Participants were r and omised 1:1:1 to treatment with one of N-A ( a non-adherent , knitted , viscose filament gauze ) , Inadine ( an iodine-impregnated dressing ) , both traditional dressings , or Aquacel , a newer product . MAIN OUTCOME MEASURES The primary outcome measure was the number of ulcers healed in each group at week 24 . Secondary measures included time to healing , new ulcerations , major and minor amputations , and episodes of secondary infection . RESULTS A total of 317 patients were r and omised . After 88 withdrawals , 229 remained evaluable . A greater proportion of smaller ( 25 - 100 mm(2 ) ulcers healed within the specified time ( 48.3 % versus 37.3 % ; p = 0.048 ) . There was , however , no difference between the three dressings in terms of percentage healed by 24 weeks , or in the mean time to healing , whether analysed on the basis of intention to treat ( Inadine 44.4 % , N-A 38.7 % , Aquacel 44.7 % ; not significant ) or per protocol ( Inadine 55.2 % , N-A 59.4 % , Aquacel 63.0 % ; not significant ) . There was no difference in the quality of healing , as reflected in the incidence of recurrence within 12 weeks . Likewise , there was no difference in the incidence of adverse events , although a greater proportion of those r and omised to the non-adherent dressings were withdrawn from the study ( 34.9 % versus 29.1 % Aquacel and 19.4 % Inadine ; p = 0.038 ) . The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings ( mean cost per patient : N-A 14.85 pounds , Inadine 17.48 pounds , Aquacel 43.60 pounds ) . The higher cost of Aquacel was not offset by the fewer dressings required . There was no difference in measures of either generic or condition-specific measures of quality of life . However , there was a significant difference in the change in pain associated with dressing changes between the first and second visits , with least pain reported by those receiving non-adherent dressings ( p = 0.012 ) . There was no difference in the costs of professional time , and this may relate to the number of dressing changes undertaken by non-professionals . Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer , although this ranged from 22 % to 82 % between the different centres . CONCLUSIONS As there was no difference in effectiveness , there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service , thus generating potentially substantial savings . The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs . TRIAL REGISTRATION Current Controlled Trials IS RCT N78366977 OBJECTIVE To compare the healing response of sequential topically applied cytokines to that of each cytokine alone and to a placebo in pressure ulcers , and to evaluate the molecular and cellular responses . SUMMARY BACKGROUND DATA Because of a deficiency of cytokine growth factors in chronic wounds and the reversal of impaired healing in animal models , pressure ulcer trials have been performed with several exogenously applied growth factors . Because single-factor therapy has not been uniformly successful , combination or sequential cytokine therapy has been proposed . Laboratory data have suggested that sequential treatment with granulocyte-macrophage/colony-stimulating factor (GM-CSF)/basic fibroblast growth factor ( bFGF ) might augment the previously reported effect of bFGF alone . METHODS A masked , r and omized pressure ulcer trial was performed comparing sequential GM-CSF/bFGF therapy with that of each cytokine alone and with placebo during a 35-day period . The primary measure was wound volume decrease over time . Cytokine wound levels and mRNA levels were serially determined . Fibroblast-populated collagen lattices ( FPCLs ) were constructed from serial fibroblast biopsies . Cellular ultrastructure was evaluated by electron microscopy . Changes in ease of surgical closure and its relative cost were determined . RESULTS Ulcers treated with cytokines had greater closure than those in placebo-treated patients . Patients treated with bFGF alone did the best , followed by the GM-CSF/bFGF group . Patients treated with GM-CSF or bFGF had higher levels of their respective cytokine after treatment . Patients with the greatest amount of healing showed higher levels of platelet-derived growth factor ( PDGF ) on day 10 and transforming growth factor beta ( TGFbeta1 ) on day 36 . Message for the bFGF gene was upregulated after treatment with exogenous bFGF , suggesting autoinduction of the cytokine . FPCLs did not mimic the wound responses . Ultrastructure of wound biopsies showed response to bFGF . Treatment with any of the cytokines improved the wound by allowing easier wound closure . This was most marked for the bFGF-alone treatment , with a cost savings of $ 9,000 to $ 9,200 . CONCLUSIONS Treatment with bFGF result ed in significantly greater healing than the other treatments in this trial . The clinical response appeared to be related to upregulation of the bFGF message and to increased levels of PDGF-AB , bFGF , and TGFbeta1 in the wounds and changes in ultrastructure . The result ant improvements could be correlated with cost savings The study investigated the cost‐effectiveness of four‐layer and short‐stretch compression b and ages for treating venous leg ulcers OBJECTIVE : Evaluate the effectiveness of telemedicine ( TM ) with digital cameras in treating wounds in a home care setting . DESIGN : R and omized controlled study . PARTICIPANTS AND SETTING : One hundred three subjects with 160 pressure ulcers ( PrUs ) or nonhealing surgical wounds referred to a metropolitan Visiting Nurse Agency . INTERVENTIONS : Subjects were r and omly assigned to 1 of 3 groups . Group A ( n = 40 ) : weekly visits with TM and wound care specialist ( WCS ) consults ; group B ( n = 28 ) : weekly visits with weekly consults with WCSs ; and group C ( n = 35 ) : usual and customary care . MAIN OUTCOME MEASURES : Outcome measures were time to heal , costs , length of stay ( LOS ) , nursing visits , wound status , and change in size . RESULTS : There was a similar distribution of subject characteristics in all 3 groups , but group A had disproportionally larger and more numerous PrUs and larger nonhealing surgical wounds . Group A had increased time to heal , LOS , costs , and visits compared with groups B and C ; wound status was similar in all groups . CONCLUSIONS : Uneven distribution of severity and type of wounds among groups , with greatest percentage of large wounds in TM group . Larger wounds consume more re sources . TM is a useful communication tool in wound management but with limited power when r and omization does not include wound size or type . Two important benchmarks were established for home care . First , it took 51 days , on average , to heal or improve PrUs and 34 days to heal or improve surgical wounds regardless of group . Second , nearly 90 % of wounds improved or healed OBJECTIVE —This study was design ed to test the safety , effectiveness , and costs of off-loading with a novel , off-the-shelf irremovable device in the management of diabetic foot ulceration ( DFU ) . RESEARCH DESIGN AND METHODS —We prospect ively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic out patients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up , number and severity of adverse events , healing time , costs and applicability of the device , and patients ’ satisfaction between those r and omly assigned to total contact casting ( TCC ; group A ) or to the Optima Diab walker ( group B ) . Deep or infected ulcers were excluded . RESULTS —No difference between groups A and B was observed in healing rates at 12 weeks ( 95 vs. 85 % ) , healing time ( 6.5 ± 4.4 vs. 6.7 ± 3.4 weeks ) , and number of adverse events ( six versus four ) . Treatment was significantly less expensive in group B , which showed a mean reduction of costs of 78 % compared with group A ( P < 0.001 ) . Practicability was more favorable in group B , with a reduction of 77 and 58 % of the time required for application and removal of the devices , respectively ( P < 0.001 ) . Patients ’ satisfaction with the treatment was higher in group B ( P < 0.01 ) . CONCLUSIONS —The Optima Diab walker is as safe and effective as TCC in the management of DFU , but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot Abstract Objectives : To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression b and aging versus usual care provided by district nurses . Design : R and omised controlled trial with 1 year of follow up . Setting : Eight community based research clinics in four trusts in Trent . Subjects : 233 patients with venous leg ulcers allocated at r and om to intervention ( 120 ) or control ( 113 ) group . Interventions : Weekly treatment with four layer b and aging in a leg ulcer clinic ( clinic group ) or usual care at home by the district nursing service ( control group ) . Main outcome measures : Time to complete ulcer healing , patient health status , and recurrence of ulcers . Satisfaction with care , use of services , and personal costs were also monitored . Results : The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up ( log rank P=0.03 ) . At 12 weeks , 34 % of patients in the clinic group were healed compared with 24 % in the control . The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 ( 95 % confidence interval 1.04 to 2.03 ) . No significant differences were found between the groups in health status . Mean total NHS costs were £ 878.06 per year for the clinic group and £ 859.34 for the control ( P=0.89 ) . Conclusions : Community based leg ulcer clinics with trained nurses using four layer b and aging is more effective than traditional home based treatment . This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used . Key messages Leg ulcer clinics based in the community using four layer compression b and aging can be more clinical ly effective than usual care provided by the district nursing service Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care It is difficult to measure improvements in health related quality of life among people with venous leg " Least costly but most effective " has never been more important to healthcare delivery than in the current healthcare environment of changing reimbursement systems . In wound care , the high costs associated with renting advanced support surfaces may be an area where expenses can be decreased if similar outcomes can be attained by using more affordable mattresses . This article compares the healing rates and eventual outcomes of wounds among two groups of patients r and omly assigned to one of two support surfaces . A commonly used low-air-loss mattress was compared with the study mattress , an advanced , non-powered , air and foam surface . Subjects were patients admitted to either of two long-term healthcare setting s for the treatment of wounds . The result ing two groups of 10 patients each were evenly matched for average age and percentage of patients who were nutritionally deficient as indicated by albumin or pre-albumin levels . The presence of gastrointestinal tubes and ventilator dependency also was recorded . Consistent wound care protocol s were used on both groups , including turning schedules , nutrition , topical medication , and dressings . The study period covered a maximum of 8 weeks ; interest was centered on the rate of wound healing and progress toward a goal rather than the length of time to completely close a wound . After 8 weeks , or upon discharge from the study pressure ulcers in the study mattress group closed at an average rate per week of 9.0 % + /- 4.8 versus 5.0 % + /- 3.7 in the low-air-loss mattress group . This study indicates that the study mattress can provide benefits to the wound healing process similar to or better than low-air-loss mattresses at a substantially reduced cost OBJECTIVE ischa Output:	Our analysis also highlights specific treatments that are not cost-effective , thereby indicating areas of re source savings .
MS21754	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract A key element of the physical preparation of athletes is the taper period in the weeks immediately preceding competition . Existing research has defined the taper , identified various forms used in contemporary sport , and examined the prescription of training volume , load , intensity , duration , and type ( progressive or step ) . Current limitations include : the lack of studies on team , combative , racquet , and precision ( target ) sports ; the relatively small number of r and omized controlled trials ; the narrow focus on a single competition ( single peak ) compared with multiple peaking for weekly , multi-day or multiple events ; and limited underst and ing of the physiological , neuromuscular , and biomechanical basis of the taper . Future research should address these limitations , together with the influence of prior training on optimal tapering strategies , and the interactions between the taper and long-haul travel , heat , and altitude . Practitioners seek information on how to prescribe tapers from season to season during an athlete 's career , or a team 's progression through a domestic league season , or multi-year Olympic or World Cup cycle . Practical guidelines for planning effective tapers for the Vancouver 2010 and London 2012 Olympics will evolve from both experimental investigations and modelling of successful tapers currently employed in a wide range of sports OBJECTIVES To investigate the physical dem and s of professional rugby league match-play using microtechnology , and to compare these dem and s with typical training activities used to prepare players for competition . DESIGN Prospect i ve cohort study . METHODS Thirty elite rugby league players participated in this study . Seven hundred and eighty-six . training data sets and 104 data sets from National Rugby League matches were collected over one playing season . Movement was recorded using a commercially available microtechnology unit ( minimaxX , Catapult Innovations ) , which provided information on speeds , distances , accelerations , physical collisions and repeated high-intensity efforts . RESULTS Mean distances covered during match-play by the hit-up forwards , wide-running forwards , adjustables , and outside backs were 3,569 m , 5,561 m , 6,411 m , and 6,819 m , respectively . Hit-up forwards and wide-running forwards were engaged in a greater number of moderate and heavy collisions than the adjustables and outside backs , and more repeated high-intensity effort bouts per minute of play ( 1 bout every 4.8 - 6.3 min ) . The physical dem and s of traditional conditioning , repeated high-intensity effort exercise , and skill training activities were all lower than the physical dem and s of competition . CONCLUSIONS These results demonstrate that absolute distances covered during professional rugby league matches are greater for outside backs , while the collision and repeated high-intensity effort dem and s are higher for hit-up forwards and wide-running forwards . The specific physical dem and s of competitive play , especially those dem and s associated with collisions and repeated high-intensity efforts , were not well matched by those observed in traditional conditioning , repeated high-intensity effort exercise , and skills training activities . Further research is required to investigate whether modifications need to be made to these training activities to better prepare players for the dem and s of National Rugby League competition Background —A classic , unresolved physiological question is whether central cardiorespiratory and /or local skeletal muscle circulatory factors limit maximal aerobic capacity ( & OV0312;o2max ) in humans . Severe heat stress drastically reduces & OV0312;o2max , but the mechanisms have never been studied . Methods and Results —To determine the main contributing factor that limits & OV0312;o2max with and without heat stress , we measured hemodynamics in 8 healthy males performing intense upright cycling exercise until exhaustion starting with either high or normal skin and core temperatures ( + 10 ° C and + 1 ° C ) . Heat stress reduced & OV0312;o2max , 2-legged & OV0312;o2 , and time to fatigue by 0.4±0.1 L/min ( 8 % ) , 0.5±0.2 L/min ( 11 % ) , and 2.2±0.4 minutes ( 28 % ) , respectively ( all P < 0.05 ) , despite heart rate and core temperature reaching similar peak values . However , before exhaustion in both heat stress and normal conditions , cardiac output , leg blood flow , mean arterial pressure , and systemic and leg O2 delivery declined significantly ( all 5 % to 11 % , P < 0.05 ) , yet arterial O2 content and leg vascular conductance remained unchanged . Despite increasing leg O2 extraction , leg & OV0312;o2 declined 5 % to 6 % before exhaustion in both heat stress and normal conditions , accompanied by enhanced muscle lactate accumulation and ATP and creatine phosphate hydrolysis . Conclusions —These results demonstrate that in trained humans , severe heat stress reduces & OV0312;o2max by accelerating the declines in cardiac output and mean arterial pressure that lead to decrements in exercising muscle blood flow , O2 delivery , and O2 uptake . Furthermore , the impaired systemic and skeletal muscle aerobic capacity that precedes fatigue with or without heat stress is largely related to the failure of the heart to maintain cardiac output and O2 delivery to locomotive muscle In order to compare the effectiveness of a daily to an intermittent acclimation protocol , 14 competitive rowers ( mean + /- SD VO2peak = 48 + /- 7 ml x kg x min(-1 ) ) were r and omly assigned to either a consecutive ( 10 consecutive days ) or intermittent acclimation group ( 10 sessions over 3 weeks ) . For every heat exposure , subjects in each group exercised for 30 min at 70 % VO2peak in an environmental chamber set at 38 degrees C and 70 % relative humidity . Acclimation state was monitored by measuring heart rate ( HR ) , rectal and skin temperature ( Tre and Tsk ) , ratings of perceived exertion ( RPE ) and whole body sweat rate ( SR ) during each heat exposure . Final exercise Tre decreased significantly by 0.6 + /- 0.7 degrees C with intermittent heat exposure but the decrease was significantly larger ( p < 0.05 ) with consecutive day heat exposure ( 1.0 + /- 0.1 degrees C ) . Final exercise HR also decreased significantly by 13 + /- 12 bpm ( p < 0.05 ) in the consecutive group , and non-significantly by 5 + /- 13 bpm in the intermittent group . RPE decreased with daily ( 5 + /- 1 , p < 0.05 ) but did not significantly decrease with intermittent heat exposure ( 1 + /- 3 ) . Similarly , Tsk significantly decreased with consecutive ( 0.4 + /- 0.2 degrees C , p < 0.05 ) but not intermittent exposure ( 0.2 + /- 0.3 degrees C ) and SR did not change in either group . Minimal adaptation occurs with intermittent heat exposure and it appears that daily heat exposure is the most effective acclimation strategy We tested the hypothesis that local sweat rates would not display a systematic postadaptation redistribution toward the limbs after humid heat acclimation . Eleven nonadapted males were acclimated over 3 wk ( 16 exposures ) , cycling 90 min/day , 6 days/wk ( 40 degrees C , 60 % relative humidity ) , using the controlled-hyperthermia acclimation technique , in which work rate was modified to achieve and maintain a target core temperature ( 38.5 degrees C ) . Local sudomotor adaptation ( forehead , chest , scapula , forearm , thigh ) and onset thresholds were studied during constant work intensity heat stress tests ( 39.8 degrees C , 59.2 % relative humidity ) conducted on days 1 , 8 , and 22 of acclimation . The mean body temperature ( Tb ) at which sweating commenced ( threshold ) was reduced on days 8 and 22 ( P < 0.05 ) , and these displacements paralleled the resting thermoneutral Tb shift , such that the Tb change to elicit sweating remained constant from days 1 to 22 . Whole body sweat rate increased significantly from 0.87 + /- 0.06 l/h on day 1 to 1.09 + /- 0.08 and 1.16 + /- 0.11 l/h on days 8 and 22 , respectively . However , not all skin regions exhibited equivalent relative sweat rate elevations from day 1 to day 22 . The relative increase in forearm sweat rate ( 117 + /- 31 % ) exceeded that at the forehead ( 47 + /- 18 % ; P < 0.05 ) and thigh ( 42 + /- 16 % ; P < 0.05 ) , while the chest sweat rate elevation ( 106 + /- 29 % ) also exceeded the thigh ( P < 0.05 ) . Two unique postacclimation observations arose from this project . First , reduced sweat thresholds appeared to be primarily related to a lower resting Tb , and more dependent on Tb change . Second , our data did not support the hypothesis of a generalized and preferential trunk-to-limb sweat redistribution after heat acclimation This study determined the influence of exercise intensity , protective clothing level , and climate on physiological tolerance to uncompensable heat stress . It also compared the relationship between core temperature and the incidence of exhaustion from heat strain for persons wearing protective clothing to previously published data of unclothed persons during uncompensable heat stress . Seven heat-acclimated men attempted 180-min treadmill walks at metabolic rates of approximately 425 and 600 W while wearing full ( clo = 1.5 ) or partial ( clo = 1.3 ) protective clothing in both a desert ( 43 degrees C dry bulb , 20 % relative humidity , wind 2.2 m/s ) and tropical ( 35 degrees C dry bulb , 50 % relative humidity , wind 2.2 m/s ) climate . During these trials , the evaporative cooling required to maintain thermal balance exceeded the maximal evaporative capacity of the environment and core temperature continued to rise until exhaustion from heat strain occurred . Our findings concerning exhaustion from heat strain are 1 ) full encapsulation in protective clothing reduces physiological tolerance as core temperature at exhaustion was lower ( P < 0.05 ) in fully than in partially clothed persons , 2 ) partial encapsulation results in physiological tolerance similar to that reported for unclothed persons , 3 ) raising metabolic rate from 400 to 600 W does not alter physiological tolerance when subjects are fully clothed , and 4 ) physiological tolerance is similar when subjects are wearing protective clothing in desert and tropical climates having the same wet bulb globe thermometer . These findings can improve occupational safety guidelines for human heat exposure , as they provide further evidence that the incidence of exhaustion from heat strain can be predicted from core temperature UNLABELLED Cricketers are often required to play in hot/humid environments with little time for heat adaptation . PURPOSE We examined the effect of a short 4-d hot/humid acclimation program on classical physiological indicators of heat acclimation . METHODS Male club cricketers were r and omly assigned into heat acclimation ( ACC , n = 6 ) or control ( CON , n = 6 ) groups , and 30 min treadmill trials ( 10 km/h , approx . 30 ± 1.0 ° C , approx . 65 ± 6 % RH ) were conducted at baseline and postacclimation . The ACC group completed four high intensity ( 30 - 45 min ) acclimation sessions on consecutive days at approx . 30 ° C and approx . 60 % RH using a cycle ergometer . The CON group completed matched cycle training in moderate conditions ( approx . 20 ° C , approx . 60 % RH ) . Physiological measures during each treadmill trial included heart rate ; core and skin temperatures ; sweat Na+ , K+ and Cl- electrolyte concentrations ; and sweat rate . RESULTS After the 4-d intervention , the ACC group had a moderate decrease of -11 ( 3 to -24 beats/min ; mean and 90 % CI ) in the 30 min heart rate , and moderate to large reductions in electrolyte concentrations : Na+ -18 % ( -4 to -31 % ) , K+ -15 % ( 0 to -27 % ) , Cl- -22 % ( -9 to -33 % ) . Both ACC and CON groups had only trivial changes in core and skin temperatures and sweat rate . After the intervention , both groups perceived they were more comfortable exercising in the heat . The 4-d heat intervention had no detrimental effect on performance . CONCLUSIONS Four 30 - 45 min high intensity cycle sessions in hot/humid conditions elicited partial heat acclimation . For full heat acclimation a more intensive and extensive ( and modality-specific ) acclimation intervention is needed for cricket players Abstract The aim of this study was to determine the effect of 10 days of heat acclimation with and without pre-cooling on intermittent sprint exercise performance in the heat . Eight males completed three intermittent cycling sprint protocol s before and after 10 days of heat acclimation . Before acclimation , one sprint protocol was conducted in control conditions ( 21.8 ± 2.2 ° C , 42.8 ± 6.7 % relative humidity ) and two sprint protocol s in hot , humid conditions ( 33.3 ± 0.6 ° C , 52.2 ± 6.8 % relative humidity ) in a r and omized order . One hot , humid condition was preceded by 20 min of thigh pre-cooling with ice packs ( −16.2 ± 4.5 ° C ) . After heat acclimation , the two hot , humid sprint protocol s were repeated . Before heat acclimation , peak power Output:	The review identified aerobic-based tests of performance benefit from STHA training . Peak anaerobic power efforts have not been demonstrated to improve . Conclusions The review identified that aerobic-based tests of performance benefit from STHA training . This is possibly through a number of cardiovascular , thermoregulatory , and metabolic adaptations improving the perception of effort and fatigue through a reduction in anaerobic energy release and elevation of the anaerobic threshold . STHA training can be applied in the team-sport environment during a range of instances within the competitive season . A mixed high-intensity protocol may only require five sessions with a duration of 60 min to potentially improve aerobic-based performance in trained athletes
MS21755	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care 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 : BACKGROUND Patients with proximal femoral fracture ( PFF ) are at high risk of postoperative complications . Goal -directed haemodynamic treatment ( GDHT ) in other high-risk surgical patients reduces postoperative complications . We aim ed to compare effects of GDHT and routine fluid treatment ( RFT ) on postoperative outcomes after PFF surgery . METHODS PFF patients ( ≥70 yr ) were enrolled in this single-centre , open , r and omized , controlled , parallel-group superiority trial with concealed allocation using computer-generated r and omization . TREATMENTS ( i ) GDHT to attain oxygen delivery index > 600 ml min(-1 ) m(-2 ) using fluids and dobutamine and ( ii ) a protocol -guided RFT . After 150 enrolled patients , the trial was stopped due to slow recruitment . The short-term primary outcome measure was the relative risk ( RR ) of postoperative complications ; secondary measures were ( i ) administered fluid levels , ( ii ) vasopressor requirements , and ( iii ) haemodynamic responses . RESULTS For the GDHT group , 74 and for the RFT group 75 patients were design ated . The RR of postoperative complications ( GDHT vs RFT ) was 0.79 ( 95 % confidence interval 0.54 - 1.16 ) ; the volumes of i.v . fluids decreased ( 1078 vs 1440 ml , P=0.01 ) ; fewer patients required treatment of hypotension ( 18.5 % vs 75 % , P<0.005 ) ; there were more patients with increased oxygen delivery at the end of operation ( 28 % vs 8 % , P=0.04 ) , but the haemodynamic goal was achieved in only 27 % of patients in the GDHT group . CONCLUSIONS The magnitude of risk reduction of postoperative complications is clinical ly relevant , but the trial was underpowered and the null hypothesis can not be rejected Introduction Little is known about mortality rates following general surgical procedures in the United Kingdom . Deaths are most common in the ' high-risk ' surgical population consisting mainly of older patients , with coexisting medical disease , who undergo major surgery . Only limited data are presently available to describe this population . The aim of the present study was to estimate the size of the high-risk general surgical population and to describe the outcome and intensive care unit ( ICU ) re source use . Methods Data on inpatient general surgical procedures and ICU admissions in 94 National Health Service hospitals between January 1999 and October 2004 were extracted from the Intensive Care National Audit & Research Centre data base and the CHKS data base . High-risk surgical procedures were defined prospect ively as those for which the mortality rate was 5 % or greater . Results There were 4,117,727 surgical procedures ; 2,893,432 were elective ( 12,704 deaths ; 0.44 % ) and 1,224,295 were emergencies ( 65,674 deaths ; 5.4 % ) . A high-risk population of 513,924 patients was identified ( 63,340 deaths ; 12.3 % ) , which accounted for 83.8 % of deaths but for only 12.5 % of procedures . This population had a prolonged hospital stay ( median , 16 days ; interquartile range , 9–29 days ) . There were 59,424 ICU admissions ( 11,398 deaths ; 19 % ) . Among admissions directly to the ICU following surgery , there were 31,633 elective admissions with 3,199 deaths ( 10.1 % ) and 24,764 emergency admissions with 7,084 deaths ( 28.6 % ) . The ICU stays were short ( median , 1.6 days ; interquartile range , 0.8–3.7 days ) but hospital admissions for those admitted to the ICU were prolonged ( median , 16 days ; interquartile range , 10–30 days ) . Among the ICU population , 40.8 % of deaths occurred after the initial discharge from the ICU . The highest mortality rate ( 39 % ) occurred in the population admitted to the ICU following initial postoperative care on a st and ard ward . Conclusion A large high-risk surgical population accounts for 12.5 % of surgical procedures but for more than 80 % of deaths . Despite high mortality rates , fewer than 15 % of these patients are admitted to the ICU Background Our aim was to determine whether substitution of goal -directed fluid therapy ( GDT ) ( perioperative fluid administration ) for traditional therapy to manage elderly patients with coronary heart disease scheduled for gastrointestinal ( GI ) surgery was advantageous . We determined if it would reduce cardiac complications and shorten time to recovery and discharge . Methods Altogether , 60 of these elderly patients were r and omized into GDT ( n = 30 ) and control ( n = 30 ) groups . In the GDT group , fluid management was carried out under guidance of hemodynamic status indicators . Types and quantities of fluids administered , blood loss , intraoperative urine output , time of extubation , intensive care unit ( ICU ) stay , hospital stay , postoperative adverse cardiac events , and GI complications were recorded . Results Total fluids infused were 2,910 ± 645 ml ( GDT group ) and 3,640 ± 771 ml ( control group ) ( p < 0.05 ) . Numbers of adverse cardiac events in the two groups were not significantly different ( p = 0.121 ) . Return of GI function was significantly faster in the GDT group ( p < 0.001 ) . Median ICU stay was 32.5 h in the GDT group and 47.5 h in the control group ( p < 0.001 ) . Median hospital stay was 18 days in the GDT group and 22 days in the control group ( p < 0.001 ) . Conclusions GDT was associated with shorter ICU stay and time to discharge and faster return of GI function compared to traditional fluid therapy . The number of adverse cardiac events was similar in the two groups OBJECTIVES : This pilot study was design ed to utilize stroke volume variation and cardiac index to ensure fluid optimization during one-lung ventilation in patients undergoing thoracoscopic lobectomies . METHODS : Eighty patients undergoing thoracoscopic lobectomy were r and omized into either a goal -directed therapy group or a control group . In the goal -directed therapy group , the stroke volume variation was controlled at 10%±1 % , and the cardiac index was controlled at a minimum of 2.5 L.min-1.m-2 . In the control group , the MAP was maintained at between 65 mm Hg and 90 mm Hg , heart rate was maintained at between 60 BPM and 100 BPM , and urinary output was greater than 0.5 mL/kg-1/h-1 . The hemodynamic variables , arterial blood gas analyses , total administered fluid volume and side effects were recorded . RESULTS : The PaO2/FiO2-ratio before the end of one-lung ventilation in the goal -directed therapy group was significantly higher than that of the control group , but there were no differences between the goal -directed therapy group and the control group for the PaO2/FiO2-ratio or other arterial blood gas analysis indices prior to anesthesia . The extubation time was significantly earlier in the goal -directed therapy group , but there was no difference in the length of hospital stay . Patients in the control group had greater urine volumes , and they were given greater colloid and overall fluid volumes . Nausea and vomiting were significantly reduced in the goal -directed therapy group . CONCLUSION : The results of this study demonstrated that an optimization protocol , based on stroke volume variation and cardiac index obtained with a FloTrac/Vigileo device , increased the PaO2/FiO2-ratio and reduced the overall fluid volume , intubation time and postoperative complications ( nausea and vomiting ) in thoracic surgery patients requiring one-lung ventilation BACKGROUND A prospect i ve , r and omized controlled trial comparing conventional intraoperative fluid management with two differing methods of invasive haemodynamic monitoring to optimize intraoperative fluid therapy , in patients undergoing proximal femoral fracture repair under general anaesthesia . METHODS Ninety patients r and omized to three groups ; conventional intraoperative fluid management ( Gp CON , n=29 ) , and two groups receiving additional repeated colloid fluid challenges guided by central venous pressure ( Gp CVP , n=31 ) or oesophageal Doppler ultrasonography ( Gp DOP , n=30 ) . Primary outcome measures were time to medical fitness to discharge , hospital stay and postoperative morbidity . RESULTS The fluid challenge result ed in significantly greater perioperative changes in central venous pressure between Gp CVP and Gp CON ( mean 5 ( 95 % confidence interval 3 - 7 ) mm Hg ) ( P<0.0001 ) . Important perioperative changes were also shown in Gp DOP with increases of 49.4 ms ( 19.7 - 79.1 ms ) in the corrected flow time , 13.5 ml ( 7.4 - 19.6 ml ) in stroke volume , and 0.9 ( 0.49 - 1.39 ) litre min(-1 ) in cardiac output . As a result , fewer patients in Gp CVP and Gp DOP experienced severe intraoperative hypotension ( Gp CON 28 % ( 8/29 ) , Gp CVP 9 % ( 3/31 ) , Gp DOP 7 % ( 2/30 ) , P=0.048 ( chi-squared , 2 degrees of freedom ( df ) . Output:	Intraoperative goal directed hemodynamic therapy with minimally invasive monitoring decreases postoperative complications in noncardiac surgery , although it was not able to show a significant decrease in mortality rate
MS21756	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE In carefully matched patients , the length of hospital stay after laparoscopic colectomy is shorter than after open surgery . Higher operating room costs for laparoscopic surgery are offset by lower costs for hospitalization because of less utilization of pharmacy , laboratory , and nursing services . Clinical outcome is comparable . We examined the effect of the surgical approach for colectomy ( open vs. laparoscopic ) regarding the reasons for disease-related group assignment to disease-related group 148 , and institutional cost under Part A of the U.S. Medicare system . METHODS Colectomy patients were assigned to either disease-related group 148 ( colorectal resection with complications ) or disease-related group 149 ( colorectal resection without complications ) with significant institutional reimbursement implication s ( disease-related group 149 , $ 8,310 ; disease-related group 148 , $ 20,291 ) . A total of 100 consecutive disease-related group 148 patients undergoing laparoscopic colectomy from July 2000 to September 2002 were identified from a prospect i ve data base and case-matched with 100 patients undergoing open colectomy . Patients were matched for gender , age , operative procedure , and pathology . A certified coder determined the reason(s ) for disease-related group 148 assignment , which were grouped into : preoperative comorbidity , a combination of preoperative comorbidity/postoperative complications , or postoperative complications alone . RESULTS Significantly more lapararoscopy patients were assigned to disease-related group 148 solely because of preoperative comorbidities ( 62 percent vs. 21 percent ; P < 0.0001 ) . Significantly more patients in the open surgery group were classified as disease-related group 148 solely because of postoperative complications ( 22 percent vs. 42 percent ; P < 0.0001 ) . An additional group of patients were assigned to the disease-related group 148 category based on a combination of preoperative and postoperative diagnoses ( 16 percent vs. 37 percent ) . The mean direct hospital costs were significantly less for laparoscopy patients ( $ 3971 vs. $ 5997 ; P = 0.0095 ) . Increased cost to Part A of Medicare for 20 open surgery patients who “ migrated ” to disease-related group 148 because of postoperative complications was $ 239,620 . CONCLUSIONS Our data are the first to demonstrate that disease related group assignment can change solely because of a differential rate of postoperative complications for two competing operative techniques . This change occurred at twice the rate for open colectomy and result ed in significantly increased cost to the insurer under a prospect i ve payment program . The savings to the institution coupled with the shortened length of stay offset the potential loss in revenue to the institution Abstract Background : The role and feasibility of laparoscopic assisted colectomy ( LAC ) in both benign and malignant disease of the colon are not clear . We have review ed our series in an effort to further delineate whether or not LAC is appropriate in the treatment of colonic disease . Methods : This is a retrospective view of a personal series focusing on feasibility , cure of malignant disease , and length of stay ( LOS ) . Results : One hundred and two LACs were completed out of 104 attempts ( 98 % ) . There were no wound or trocar implants in the Dukes A , B and C patients . Lymph node retrieval was similar in the laparoscopic and open historical controls . The LOS was 5.9 days in the LAC group as compared with 11 days in the open group . There was a 4.8 % major morbidity rate and a 1 % mortality rate in this series . Conclusions : LAC is technically feasible in a high percentage of patients . While a definite statement regarding its use in malignant disease can not be ascertained from this review , the preliminary results are encouraging . A r and omized trial comparing open and LAC is warranted Robotic laparoscopic surgery is postulated to result in better surgical results by allowing improved instrument manipulation and three-dimensional vision . The authors ’ experience performing robot-assisted laparoscopic colorectal surgery is reported . METHOD : St and ard laparoscopic procedures with robot-assisted laparoscopic colon mobilization and vascular ligation were performed . Data relating to the operative procedure , hospital stay , and direct costs were collected . Results were compared with age , gender , and procedure case-matched controls taken from a prospect i ve laparoscopic colorectal surgery data base . RESULTS : Six robot-assisted laparoscopic surgeries ( 2 right hemicolectomies , 3 sigmoid colectomies , and 1 Wells rectopexy ) were performed between December 2001 and June 2002 . There was no associated morbidity . Operative time was increased from a median time of 108 minutes for st and ard laparoscopic colorectal surgery to 165 minutes for robot-assisted laparoscopic surgeries ( P = 0.0313 ; Wilcoxon matched-pairs signed-rank test for non-parametric data ) . This was primarily a result of the time required for robot set-up . Blood loss , length of stay , and hospital cost were not significantly different between groups . Additional direct equipment costs for RAC cases included robotic laparoscopic instruments and sterile drapes ( approximately US $ 350 per case ) , without including acquisition and maintenance costs for the robot . CONCLUSION : Robot-assisted laparoscopic colectomy is a feasible and safe procedure . Although three-dimensional vision and dexterity are facilitated , operative time is increased and the overall additional expense of robotics is of concern . Robot-assisted laparoscopic colectomy requires further evaluation to establish clinical and financial benefits before introduction to routine practice . Such techniques may , in the future , facilitate complex laparoscopic techniques BACKGROUND Minimally invasive , laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer . Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence ( based on frequent reports of tumor recurrences within surgical wounds ) prompted a controlled trial evaluation . METHODS We conducted a noninferiority trial at 48 institutions and r and omly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons . The median follow-up was 4.4 years . The primary end point was the time to tumor recurrence . RESULTS At three years , the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group ( two-sided P=0.32 ; hazard ratio for recurrence , 0.86 ; 95 percent confidence interval , 0.63 to 1.17 ) . Recurrence rates in surgical wounds were less than 1 percent in both groups ( P=0.50 ) . The overall survival rate at three years was also very similar in the two groups ( 86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group ; P=0.51 ; hazard ratio for death in the laparoscopic-surgery group , 0.91 ; 95 percent confidence interval , 0.68 to 1.21 ) , with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer . Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group , as reflected by a shorter median hospital stay ( five days vs. six days , P<0.001 ) and briefer use of parenteral narcotics ( three days vs. four days , P<0.001 ) and oral analgesics ( one day vs. two days , P=0.02 ) . The rates of intraoperative complications , 30-day postoperative mortality , complications at discharge and 60 days , hospital readmission , and reoperation were very similar between groups . CONCLUSIONS In this multi-institutional study , the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy , suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer BACKGROUND The appropriateness of laparoscopic colon resection ( LCR ) as treatment for malignancy has been question ed . METHODS From 1992 to 1997 , 91 patients were entered into a prospect i ve study of LCR for cancer . Clinical , pathologic , and economic parameters of LCR were compared in a cohort of patients matched for age , tumor stage , and type of colectomy who underwent open colon resection ( OCR ) during the same time period . RESULTS With a median follow-up of 26 months , there were no significant differences in survival rate for patients in the LCR , converted colon resection , and OCR groups . There were no port-site recurrences and the number of lymph nodes harvested was similar among the procedures . Hospital stay was significantly shorter if laparoscopic resection was successful . Total hospital costs were similar for LCR and OCR ; however , the costs were significantly higher for converted colon resection . CONCLUSIONS LCR is a sound oncologic procedure that can be performed with costs similar to OCR Objective The authors studied the results of laparoscopic colectomies performed by a surgical team on 80 consecutive patients and compared these results with st and ard open colectomies . Methods Eighty consecutive laparoscopic-assisted colectomies were performed by Norfolk Surgical Group in a 14-month period and compared to 53 patients who had a conventional open colectomies . Analysis included indications for surgery , types of procedure , complications , incidence and causes for conversion , length of procedure , duration of postoperative ileus , hospital stay , operating room and total hospital charges , and examination of the pathologic specimens . Results Many different types of colectomies were performed successfully and safely for a variety of surgical indications . The conversion rate was 22.5 % , which decreased to 15 % in the second half of the series . Complications in patients who underwent laparoscopic operations were not severe in number or type . The length of the operative procedure , operating room charge , and the total hospital charge were greater for patients undergoing laparoscopic-assisted colectomies . Patients who underwent laparoscopic operations had a shorter period of postoperative ileus and less pain , resumed a regular diet sooner , and were discharged from the hospital sooner than patients who underwent open colectomies . There was no significant difference in the pathology specimens obtained by laparoscopic-assisted colectomies compared with conventional open colectomies for length of specimen , surgical margins , and number of lymph nodes retrieved . Conclusions This study indicated that laparoscopic techniques can be applied safely and effectively to a broad range of colonic operations . Laparoscopic-assisted colectomies take longer to perform and are more costly , but are associated with less paralytic ileus , less pain , and reduced hospital stay . Laparoscopic colectomies for the treatment of malignancy are achievable technically , but will require careful long-term study BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable . The multicentre COLOR ( COlon cancer Laparoscopic or Open Resection ) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon . METHODS 627 patients were r and omly assigned to laparoscopic surgery and 621 patients to open surgery . The primary endpoint was cancer-free survival 3 years after surgery . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , metastasis , overall survival , and blood loss during surgery . Analysis was by intention to treat . Here , clinical characteristics , operative findings , and postoperative outcome are reported . FINDINGS Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection ( median 100 mL [ range 0 - 2700 ] vs 175 mL [ 0 - 2000 ] , p<0.0001 ) , although laparoscopic surgery lasted 30 min longer than did open surgery ( p<0.0001 ) . Conversion to open surgery was needed for 91 ( 17 % ) patients undergoing the laparoscopic procedure . Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups . Laparoscopic colectomy was associated with earlier recovery of bowel function ( p<0.0001 ) , need for fewer analgesics , and with a shorter hospital stay ( p<0.0001 ) compared with open colectomy . Morbidity and mortality 28 days after colectomy did not differ between groups . INTERPRETATION Laparoscopic surgery can be used for safe and radical resection of cancer in the right , left , and sigmoid colon The objectives of this study were to compare both subjective clinical outcomes and the objective stress response of laparoscopic and open abdominal rectopexy in patients with full‐thickness rectal prolapse . Abdominal rectopexy for patients with rectal prolapse is well suited for a laparoscopic approach as no resection or anastomosis is necessary PURPOSE : This study was undertaken to compare morbidity , mortality , and pathology after laparoscopically assisted right hemicolectomy ( LARHC ) or open right hemicolectomy Output:	Conclusions Operating room costs are greater for laparoscopic colorectal surgery than open surgery . Total hospital costs are similar . There may be societal benefits associated with lower indirect costs for laparoscopic colorectal surgery .
MS21757	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The Chinese Hypertension Intervention Efficacy Study ( CHIEF ) is a multi-centre r and omized controlled clinical trial comparing the effects of amlodipine+angiotensin II receptor blocker and amlodipine+diuretics on the incidence of cardiovascular events , represented as a composite of non-fatal stroke , non-fatal myocardial infa rct ion and cardiovascular death events in high-risk Chinese hypertensive patients . The study also evaluates the long-term effects of lipid-lowering treatment and lifestyle modification . From October 2007 to October 2008 , 13 542 patients were enrolled into the study in 180 centres in China . Patients will be followed up for 4 years . There was no difference in baseline characteristics between the two blood pressure arms Many patients with hypertension require ≥3 agents to achieve target blood pressure ( BP ) . The efficacy/safety of the dual combinations of valsartan (Val)/hydrochlorothiazide ( HCTZ ) and amlodipine (Aml)/Val in hypertension are well established . This r and omized , double-blind study evaluated the efficacy/safety of triple therapy with Aml/Val/HCTZ for moderate or severe hypertension ( mean sitting systolic BP : ≥145 mm Hg ; mean sitting diastolic BP : ≥100 mm Hg ) . The study included a single-blind , placebo run-in period , followed by double-blind treatment for 8 weeks ; patients were r and omly assigned to 1 of 4 groups titrated to Aml/Val/HCTZ 10/320/25 mg , Val/HCTZ 320/25 mg , Aml/Val 10/320 mg , or Aml/HCTZ 10/25 mg once daily . Dual-therapy recipients received half of the target doses of both agents for the first 2 weeks , titrating to target doses during week 3 . Those on triple therapy received Val/HCTZ 160.0/12.5 mg during week 1 , Aml/Val/HCTZ 5.0/160.0/12.5 mg during week 2 , and target doses of all 3 of the agents during week 3 . Of the 4285 patients enrolled , 2271 were r and omly assigned to treatment , and 2060 completed the study . Triple therapy was significantly superior to all of the dual therapies in reducing mean sitting systolic BP and mean sitting diastolic BP from baseline to end point ( all P<0.0001 ) . Significantly more patients on triple therapy achieved overall BP control ( < 140/90 mm Hg ; P<0.0001 ) and systolic and diastolic control ( P≤0.0002 ) compared with each dual therapy . Aml/Val/HCTZ was well tolerated . The benefits of triple therapy over dual therapy were observed regardless of age , sex , race , ethnicity , or baseline mean sitting systolic BP . In conclusion , this study demonstrates the efficacy/safety of treating moderate and severe hypertension with Aml/Val/HCTZ 10/320/25 mg The purpose of this study was to compare the combination treatments of manidipine/delapril and olmesartan/hydrochlorothiazide ( HCTZ ) in elderly diabetic hypertensives . After a 4-week placebo period , 158 hypertensive patients with type 2 diabetes ( age range : 66 to 74 years ) were r and omized to receive combination treatment of 10 mg manidipine plus 30 mg delapril or 20 mg olmesartan plus 12.5 mg HCTZ for 48 weeks in a prospect i ve , parallel arm trial . After 12 weeks , manidipine or HCTZ was doubled in nonresponders ( systolic blood pressure [ SBP ] ≥130 mmHg and /or diastolic blood pressure [ DBP ] ≥80 mmHg ) . Patients were checked at the end of the placebo period and every 12 weeks thereafter . At each visit , lying , sitting and st and ing BP as well as fasting glycemia , glycosylated hemoglobin ( HbA1c ) , electrolytes , uric acid , total cholesterol ( TC ) , high-density lipoprotein-cholesterol ( HDL-C ) and triglycerides ( TG ) were evaluated . Both combinations reduced sitting SBP ( −27.7 and −28.3 mmHg , respectively ; both p<0.001 ) and DBP ( −15.1 and −14.8 mmHg , respectively ; both p<0.01 ) with no difference between the two treatments . St and ing DBP was more markedly reduced by olmesartan/HCTZ ( −19.5 mmHg ; p<0.001 ) than by manidipine/delapril ( −14.7 mmHg ; p<0.05 vs. olmesartan/HCTZ ) . No changes in metabolic parameters were observed with manidipine/delapril , whereas an increase in HbA1c ( + 0.7 % ; p<0.05 ) , uric acid ( + 0.4 mg/dL ; p<0.05 ) and TG ( + 41.3 mg/dL ; p<0.05 ) , and a decrease in serum potassium ( −0.3 mmol/L ; p<0.05 ) and HDL-C ( −3.4 mg/dL ; p<0.05 ) were found in the olmesartan/HCTZ group . In conclusion , both combinations were similarly effective in reducing BP in elderly hypertensive diabetic patients . However , manidipine/delapril offered some advantages in terms of the less-pronounced BP orthostatic changes and absence of metabolic adverse effects . ( Hypertens Res 2008 ; 31 : 43−50 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The & bgr;-blocker atenolol is less effective than angiotensin-receptor blockers and calcium-channel blockers for reducing central blood pressure ( BP ) . The trial was design ed to determine whether the advantages of angiotensin-receptor blockers over atenolol remained significant when both were combined with the calcium-channel blocker amlodipine . A prospect i ve , r and omized , blinded endpoint ( PROBE design ) parallel group , multicenter trial including 393 patients with essential hypertension resistant to 4 weeks of 5 mg of amlodipine was set out . Central systolic BP , augmentation index ( AIx ; either rough or adjusted on heart rate ) , and carotid-to-femoral pulse wave velocity were measured with applanation tonometry ( SphygmoCor ) at inclusion and after 8 and 24 weeks of active treatment with an amlodipine-valsartan combination ( 5/80 mg and then 10/160 mg ) or an amlodipine-atenolol combination ( 5/50 mg and then 10/100 mg ) . From baseline to week 24 , central systolic BP decreased significantly more in the amlodipine-valsartan group ( −13.70±1.15 mm Hg ; P<0.0001 ) than in the amlodipine-atenolol group ( −9.70±1.10 mm Hg ; P<0.0001 ; difference : −4.00 mm Hg [ 95 % CI : −7.10 to −0.90 ] ; P=0.013 ) , despite similar changes in brachial systolic BP . The difference in rough AIx reduction was −6.5 % ( 95 % CI : −8.3 to −4.7 ; P<0.0001 ) in favor of amlodipine-valsartan . AIx adjusted on heart rate was significantly reduced in favor of amlodipine-valsartan ( −2.8 % [ 95 % CI : −4.92 to −0.68 ] ; P<0.01 ) . Heart rate decreased significantly more with amlodipine-atenolol ( difference : −11 bpm [ 95 % CI : −14 to −8 bpm ] ; P<0.001 ) . Pulse wave velocity decreased by 0.95 m/s in both groups with no significant difference . Differences in central systolic BP and rough AIx remained significant after adjustment to the changes in heart rate . The amlodipine-valsartan combination decreased central ( systolic and pulse ) pressure and AIx more than the amlodipine-atenolol combination Angiotensin receptor blockers ( ARBs ) with calcium channel blockers ( CCBs ) or diuretics are a widely used combination therapy for hypertensive patients . The present study aim ed to determine which combination was better for elderly hypertension patients aged ≧ 65 years . We design ed a multicentre , r and omized , open-label , parallel comparison study . Hypertensive out patients aged ≧ 65 years who did not achieve the target blood pressure ( BP < 140/90 mmHg ) with usual dosages of ARBs were r and omly assigned to switch treatment to losartan 50 mg/hydrochlorothiazide 12.5 mg or amlodipine 5 mg in addition to ARBs . The primary endpoint was a change in the systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) after the 3-month treatment period , while secondary endpoints were changes in the BP , albuminuria , laboratory values , and cognitive function with the mini-mental state examination ( MMSE ) at baseline and after one year . The results from the CAMUI trial should provide new evidence for selecting optimal combination therapies for elderly hypertensive patients Objectives Current guidelines recommend the use of multiple medications for hypertension . The present study was aim ed at determining which combination was optimal to prevent cardiovascular events . Methods We conducted a prospect i ve , r and omized , open-label , blinded-endpoint trial . Hypertensive out patients aged between 40 and 85 years who did not achieve target blood pressure ( BP<140/90 mmHg ) with calcium channel blocker ( CCB ) benidipine 4 mg/day were r and omly assigned to receive angiotensin receptor blocker ( ARB ) , & bgr;-blocker , or thiazide diuretic in addition to benidipine . Results Among a total of 3501 patients ( 1167 , benidipine-ARB ; 1166 , benidipine-&bgr;-blocker ; and 1168 , benidipine-thiazide ) , 3293 patients ( 1110 , 1089 , and 1094 , respectively ) who received each combination treatment were included in the analysis . Median follow-up was 3.61 years . At the end of the treatment , 64.1 , 66.9 , and 66.0 % of patients in the benidipine-ARB , benidipine-&bgr;-blocker , and benidipine-thiazide groups achieved target BP , respectively . The cardiovascular composite endpoint occurred in 41 ( 3.7 % ) , 48 ( 4.4 % ) , and 32 ( 2.9 % ) patients , respectively : the hazard ratio was 1.26 in the benidipine-ARB ( P = 0.3505 ) and 1.54 in the benidipine-&bgr;-blocker ( P = 0.0567 ) groups compared with the benidipine-thiazide group . The secondary analyses revealed that benidipine and thiazide diuretic significantly reduced the incidence of fatal or nonfatal strokes ( P = 0.0109 ) and benidipine and ARB significantly reduced new-onset diabetes ( P = 0.0240 ) compared with benidipine and & bgr;-blocker . All trial treatments were safe and well tolerated . Conclusion CCB combined with ARB , & bgr;-blocker , or thiazide diuretic was similarly effective for the prevention of cardiovascular events and the achievement of target BP BACKGROUND Blood pressure reduction achieved with beta-blockers and diuretics is the best recorded intervention to date for prevention of cardiovascular morbidity and death in patients with hypertension . Left ventricular hypertrophy ( LVH ) is a strong independent indicator of risk of cardiovascular morbidity and death . We aim ed to establish whether selective blocking of angiotensin II improves LVH beyond reducing blood pressure and , consequently , reduces cardiovascular morbidity and death . METHODS We did a double-masked , r and omised , parallel-group trial in 9193 participants aged 55 - 80 years with essential hypertension ( sitting blood pressure 160 - 200/95 - 115 mm Hg ) and LVH ascertained by electrocardiography ( ECG ) . We assigned participants once daily losartan-based or atenolol-based antihypertensive treatment for at least 4 years and until 1040 patients had a primary cardiovascular event ( death , myocardial infa rct ion , or stroke ) . We used Cox regression analysis to compare regimens . FINDINGS Blood pressure fell by 30.2/16.6 ( SD 18.5/10.1 ) Output:	Our meta- analysis indicates that RASIs plus CCBs provide a superior safety and prevention of CV events to RASIs plus diuretics , whereas this combination is also safer than CCBs plus diuretics .
MS21758	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Self-efficacy is arguably the strongest correlate of physical activity , yet some research ers suggest this is because the construct confounds ability with motivation . We examine a more circumscribed construct , called perceived capability ( PC ) , meant to measure ability but not motivation and propose that the construct will not be related to unskilled physical activities but may be linked to skilled behaviors . The purpose of this paper was to examine whether a PC construct can be stripped of motivation using a vignette approach in both walking and resistance training behaviors . Participants were a r and om sample of 248 university students , who were then r and omly assigned to either answer resistance training or walking behavior questions . Both groups completed a PC measure and reasons for their answer before and after reading a vignette that clarified the phrasing of capability to a literal use of the term . PC was significantly ( p < .01 ) higher post- compared to pre-vignette and the differences were greater ( p < .01 ) for walking than for resistance training . PC had significantly ( p < .01 ) smaller correlations with intention and self-reported behavior post-disambiguation , which result ed in a null relationship with walking but a small correlation with resistance training behavior . When PC was combined with intention to predict behavior , however , there was no significant ( p > .05 ) difference in the amount of variance explained pre- to post-vignette . Thought listing showed that participants did not report capability barriers to walking and over half of the sample construed capability as motivation/other priorities pre-vignette . The findings support use of a vignette approach for research ers who wish to disentangle the assessment of PC from motivation while creating no overall loss in explained variance of physical activity Background Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors , with guidelines recognising the importance of these behaviors for cancer survivors . Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed . The aim of this study was to determine the effects of a group-based , face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers . Methods The Exercise and Nutrition Routine Improving Cancer Health ( ENRICH ) intervention was evaluated using a two-group pragmatic r and omized controlled trial . Cancer survivors and carers ( n = 174 ) were r and omly allocated to the face-to-face , group-based intervention ( six , theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [ PA ] ) or wait-list control ( after completion of 20-week data collection ) . Assessment of the primary outcome ( pedometer-assessed mean daily step counts ) and secondary outcomes ( diet and alcohol intake [ Food Frequency Question naire ] , self-reported PA , weight , body mass index , and waist circumference ) were assessed at baseline , 8- and 20-weeks . Results There was a significant difference between the change over time in the intervention group and the control group . At 20 weeks , the intervention group had increased by 478 steps , and the control group had decreased by 1282 steps ; this represented an adjusted mean difference of 1761 steps ( 184 to 3337 ; P = 0.0028 ) . Significant intervention effects for secondary outcomes , included a half serving increase in vegetable intake ( difference 39 g/day ; 95 % CI : 12 to 67 ; P = 0.02 ) , weight loss ( kg ) ( difference -1.5 kg ; 95 % CI , -2.6 to -0.3 ; P = 0.014 ) and change in body mass index ( kg/m2 ) ( difference -0.55 kg/m2 ; 95 % CI , -0.97 to -0.13 ; P = 0.012 ) . No significant intervention effects were found for self-reported PA , total sitting time , waist circumference , fruit , energy , fibre , alcohol , meat , or fat consumption . Conclusions The ENRICH intervention was effective for improving PA , weight , body mass index , and vegetable consumption even with the inclusion of multiple cancer types and carers . As an example of successful research translation , the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program . Trial registration Australian New Zeal and Clinical Trials Register identifier : ANZCTRN1260901086257 Background : In terms of motivation and long-term adherence , low-resistance exercise might be more suitable for older adults than high-resistance exercise . However , more data are needed to support this cl aim . Objective : The objective was to investigate the effect of low- and high-resistance exercise protocol s on long-term adherence and motivation . Methods : This study was design ed as an exploratory 24-week follow-up of a r and omized 12-week resistance training intervention in older adults . Participants were free to decide whether or not they continued resistance training at their own expense following the intervention . Fifty-six older adults were r and omly assigned to HIGH [ 2 × 10 - 15 repetitions at 80 % of one repetition maximum ( 1RM ) ] , LOW ( 1 × 80 - 100 repetitions at 20 % of 1RM ) , or LOW+ ( 1 × 60 repetitions at 20 % of 1RM + 1 × 10 - 20 repetitions at 40 % 1RM ) . Motivation , self-efficacy and the perceived barriers for continuing resistance exercise were measured after cessation of each supervised intervention and at follow-up , while long-term adherence was probed retrospectively at follow-up . Results : Participants reported high levels of self-determined motivation before , during , and after the supervised intervention , with no differences between groups ( p > 0.05 ) . Nevertheless , only few participants continued strength training after the intervention : 17 % in HIGH , 21 % in LOW+ , and 11 % in LOW ( p > 0.05 ) . The most commonly reported barriers for continuing resistance exercise were perceived lack of time ( 46 % ) , being more interested in other physical activities ( 40 % ) , seasonal reasons ( 40 % ) , and financial cost ( 28 % ) . Conclusion : The results suggest no difference in long-term adherence after the end of a supervised exercise intervention at high or low external resistances . Long-term adherence was limited despite high levels of self-determined motivation during the interventions . These findings highlight the importance of further research on developing strategies to overcome barriers of older adults to adhere to resistance exercise without supervision OBJECTIVE Progressive resistance training ( PRT ) counteracts sarcopenia and has been demonstrated to improve physical function and quality of life in older adults . Despite the clear benefits of PRT , participation remains low . The core self-evaluation ( CSE ) construct is theoretically antecedent to four personality traits : locus of control , self-esteem , neuroticism ( emotional stability ) , and generalized self-efficacy . We have examined the association of CSE with exercise adoption among older adults invited to participate in a PRT trial . We hypothesized that CSE would positively predict adoption of PRT . STUDY DESIGN All residents of two retirement communities were invited to complete question naires with items on demographics , physical activity , CSE , and general health . Following completion of question naires , residents were invited to take part in an on-site , 10-week r and omized controlled trial of a PRT-based exercise trial . RESULTS Thirty-eight of 358 residents ( 63.2 % women ; 76.6±6.1 year ; range 58 - 92 ) enrolled and 118 residents completed the question naires . Multiple regression analysis predicting PRT adoption indicated that the demographic variables accounted for 38 % of the variance . Inclusion of CSE ( β=.405 ) accounted for an additional 10 % of the variance in PRT adoption . CONCLUSION CSE was predictive of PRT adoption in this cohort , adding significantly to the predictive efficacy of known demographic predictors . This is the first study to show that CSE may influence adoption of PRT in any cohort A poor underst and ing of behaviour change mechanisms has hindered the development of effective physical activity interventions . The aim of this study was to identify potential mediators of change in a home-based resistance training ( RT ) program for obese individuals with type 2 diabetes . Obese individuals with type 2 diabetes ( N = 48 ) were r and omly allocated to either an RT intervention ( n = 27 ) or a control group ( n = 21 ) for the 16-week study period . The study sample included 16 men and 32 women and the mean age of participants was 54.4 ( ±11.7 ) years . Participants in the RT group received a multi-gym and dumbbells and home supervision from a certified personal trainer . RT behaviour was measured using a modified Godin Leisure Time Question naire . Social-cognitive constructs were measured and tested in a mediating variable framework using a product-of-coefficients test . The intervention had a significant effect on RT behaviour ( p < 0.001 ) and muscular strength ( p < 0.001 ) . The intervention had a significant effect on RT planning strategies ( p < 0.01 ) , which mediated the effect of the intervention on RT behaviour . The home-based RT program successfully targeted participants ’ RT planning strategies which contributed to their exercise adherence This study identified factors associated with exercise participation and adherence in a sample of 102 sedentary , functionally limited , community-dwelling adults aged 60 to 94 years who participated in a home-based resistance training program . Stepwise regression analyses revealed that baseline physical factors ( i.e. , higher levels of mobility , weaker muscle strength , and fewer numbers of new medical conditions ) were associated with higher rates of participation in the home program . Positive attitudes and a sense of control toward exercise , lower levels of confusion and depressive moods , and the development of fewer new medical problems during the program were related to higher levels of adherence to the program . Findings revealed that although physical health variables were the primary indicators of an older person 's overall participation in the program , it was the psychological factors that were most important to adherence to this home-based program Background Reaction time , coordination , and cognition performance typically diminish in older adults , which may lead to gait impairments , falls , and injuries . Regular strength – balance exercises are highly recommended to reduce this problem and to improve health , well-being , and independence in old age . However , many older people face a lack of motivation in addition to other strong barriers to exercise . We developed ActiveLifestyle , an information technology (IT)-based system for active and healthy aging aim ing at improving balance and strength . ActiveLifestyle is a training app that runs on a tablet and assists , monitors , and motivates older people to follow personalized training plans autonomously at home . Objective The objectives were to ( 1 ) investigate which IT-mediated motivation strategies increase adherence to physical exercise training plans in older people , ( 2 ) assess the impact of ActiveLifestyle on physical activity behavior change , and ( 3 ) demonstrate the effectiveness of the ActiveLifestyle training to improve gait speed . Methods A total of 44 older adults followed personalized , 12-week strength and balance training plans . All participants performed the exercises autonomously at home . Question naires were used to assess the technological familiarity and stage of behavior change , as well as the effectiveness of the motivation instruments adopted by ActiveLifestyle . Adherence to the exercise plan was evaluated using performance data collected by the app and through information given by the participants during the study . Pretests and posttests were performed to evaluate gait speed of the participants before and after the study . Results Participants were 75 years ( SD 6 ) , predominantly female ( 64 % ) , held a trade or professional diploma ( 54 % ) , and their past profession was in a sitting position ( 43 % ) . Of the 44 participants who enrolled , 33 ( 75 % ) completed the study . The app proved to assist and motivate independently living and healthy older adults to autonomously perform strength – balance exercises ( median 6 on a 7-point Likert scale ) . Social motivation strategies proved more effective than individual strategies to stimulate the participants to comply with the training plan , as well as to change their behavior permanently toward a more physically active lifestyle . The exercises were effective to improve preferred and fast gait speed . Conclusions ActiveLifestyle assisted and motivated independently living and healthy older people to autonomously perform strength – balance exercises over 12 weeks and had low dropout rates . The social motivation strategies were more effective to stimulate the participants to comply with the training plan and remain on the intervention . The adoption of assistive technology devices for physical intervention tends to motivate and retain older people exercising for longer periods of time Background Aerobic physical activity ( PA ) and resistance training are paramount in the treatment and management of type 2 diabetes ( T2D ) , but few studies have examined the determinants of both types of exercise in the same sample . Objective The primary purpose was to investigate the utility of the Theory of Planned Behavior ( TPB ) in explaining aerobic PA and resistance training in a population sample of T2D adults . Methods A total of 244 individuals were recruited through a r and om national sample which was created by generating a r and om list of household phone numbers . The list was proportionate to the actual number of household telephone numbers for each Canadian province ( with the exception of Quebec ) . These individuals completed self-report TPB constructs of attitude , subjective norm , perceived behavioral control and intention , and a 3-month follow-up that assessed aerobic PA and resistance training . Results TPB explained 10 % and 8 % of the variance respectively for aerobic PA and resistance training ; and accounted for 39 % and 45 % of the variance respectively for aerobic PA and resistance training intentions . Conclusion These results may guide the development of appropriate PA interventions for aerobic PA and resistance training based on the TPB The aim of this study was to determine the efficacy and Output:	Education , perceived health status , quality of life , affective judgements , self-efficacy , intention , self-regulation behaviours , subjective norm and programme leadership were associated with RT . Conclusion Low education levels and poor health status were associated with low participation rates in RT . Intrapersonal factors including affective judgements , self-efficacy , and self-regulation behaviours , and interpersonal factors including subjective norms and programme leadership may be important for promoting RT behaviours
MS21759	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To investigate the efficacy of hyaluronan-enriched transfer media in cleavage-stage frozen embryo transfer cycles . DESIGN Two commercially available transfer media were prospect ively compared in an observational study . SETTING Hospital-based in vitro fertilization clinic . PATIENT(S ) Patients ( n = 425 ) undergoing frozen-thawed embryo transfer ( FET ) . The embryos transferred were included in either a study group ( high hyaluronic acid [ HA ] , n = 199 ) or a control group ( low HA , n = 226 ) . INTERVENTION(S ) Delivery rate per FET ; positive hCG rate , biochemical pregnancy rate , clinical pregnancy rate , implantation rate , and clinical abortion rate were secondary outcomes . RESULT ( S ) The use of HA in the transfer media significantly increased the positive hCG rate ( 37.2 % vs. 25.2 % ) and implantation rate ( 23.1 % vs. 15.8 % ) without increasing the delivery rate ( 21.6 % vs. 21.2 % ) . More subjects in the study group with a positive hCG test experienced biochemical pregnancy ( 28.4 % vs. 8.9 % ) . CONCLUSION ( S ) Addition of HA to transfer media seems to favor attachment of early embryos in FETs without increasing the delivery rate Purpose To ascertain whether the use of hyaluronan-enriched transfer medium ( HETM ) improves pregnancy and implantation rates among embryo transfer patients with a history of multiple implantation failures . Methods Patients ( n = 314 ) under the age of 40 and with a history of multiple unsuccessful embryo transfers were enrolled . There were three groups of patients : those undergoing fresh embryo transfer ( fresh ET [ n = 111 ] ) , those undergoing vitrified-warmed ET in the natural cycle ( WET-N [ n = 101 ] ) and those undergoing WET in a hormone replacement cycle ( WET-H [ n = 102 ] ) . On the day of ET , patients were r and omized to HETM ( 0.5 mg/ml hyaluronan ) or control medium containing no hyaluronan . Only patients with good quality embryos on day 3 were included . Results For all three patients groups ( fresh ET , WET-N and WET-H ) pregnancy rates ( 37.5 % , 31.4 % and 41.2 % , respectively ) were significantly higher when using HETM compared with control medium ( 10.9 % , 10.0 % and 15.7 % , respectively ; p < 0.05 ) , and implantation rates when using HETM were also significantly higher compared with control medium ( p < 0.05 ) . Miscarriage rates were similar in both groups . Conclusion HETM significantly increased pregnancy and implantation rates among embryo transfer patients with a history of multiple unsuccessful implantations – regardless of method used to prepare the endometrium Purpose : The aim of this prospect i ve , r and omized trial was to evaluate the efficacy of Embryo-Glue ® as a human embryo transfer medium in IVF/ICSI cycles . Method : A total of 815 nonselected patients undergoing IVF/ICSI treatment between September 2003 and February 2004 were r and omly allocated into the test ( 417 patients ) and the control ( 398 patients ) groups . In both groups , embryos were cultured in G-1 ™ ver 3 , supplemented with 10 % recombinant human albumin . On the day of embryo transfer ( day 3 ) , the best or good quality embryos were selected for intrauterine transfer . In the test group , the selected embryos were treated with EmbryoGlue ® prior to the transfer , whereas in the control group they were transferred without any treatment . Results : The patients ’ characteristics such as age and the number of ART cycles and also the number of patients in each indication of infertility and the number of embryos selected for transfer were all similar between the two groups . In the test group , the clinical pregnancy rate in the tubal factors and the implantation rate in the tubal factors and recurrent implantation failures increased significantly compared with those in the control group . In the test group , life birth and the triplet delivery rates increased significantly compared with those in the control group . Conclusion : EmbryoGlue ® is a useful embryo transfer medium , and at least in some infertile patients it can improve clinical implantation and ongoing pregnancy rates OBJECTIVE To analyze whether the use of a hyaluronan-enriched transfer medium ( HETM ) increases rates of implantation ( IRs ) and clinical pregnancy ( CPRs ) , compared with the use of a conventional transfer medium after day 3 and day 5 embryo transfers . DESIGN Prospect i ve r and omized controlled trial . SETTING An assisted reproduction program in a private tertiary-care hospital in Turkey . PATIENT(S ) A total of 1,282 consecutive fresh embryo transfer cycles ( 825 day 3 and 457 day 5 ) were r and omly allocated into two groups . In 639 women , ET was effected with HETM , and in 643 , it was effected with a conventional embryo transfer medium . INTERVENTION(S ) Embryo transfer using HETM or conventional embryo transfer medium . MAIN OUTCOME MEASURE(S ) Clinical pregnancy rates and IRs were compared with regard to day of embryo transfer , women 's age , quality of the transferred embryos , and presence of previous implantation failures . RESULT ( S ) Overall CPRs and IRs significantly increased with the use of HETM ( CPR : 54.6 % vs. 48.5 % , odds ratio : 1.28 , 95 % confidence interval : 1.03 - 1.59 ; IR : 32 % vs. 25 % , odds ratio : 1.43 , 95 % confidence interval : 1.23 - 1.66 , for HETM and control groups , respectively ) . The number needed to treat ( NNT ) for one additional pregnancy with routine use of HETM was 17 . The beneficial effect was more prominent in women who were > 35 years of age ( NNT = 7 ) , in women who had previous failed cycles ( NNT = 7 ) , and in women who had poor- quality embryos ( NNT = 8) . CONCLUSION ( S ) The enrichment of transfer medium with hyaluronan increases CPRs and IRs , both for day 3 and day 5 embryo transfers . The beneficial effect was most evident in women who were > 35 years of age , in women who had only poor- quality embryos available for transfer , and in women who had previous implantation failures BACKGROUND We aim ed to examine the efficacy of using an embryo transfer medium enriched with hyaluronan ( HA ) to improve implantation in a selected group of patients aged < 43 years with repeated ( > 4 ) implantation failures after IVF-embryo transfer . METHODS About 101 patients , meeting our selection criteria , were r and omly allocated to undergo embryo transfer either using our routine embryo transfer medium without HA ( control group ) or a HA enriched commercial embryo transfer medium ( study group ) . The primary outcome was clinical pregnancy rate . RESULTS After a similar treatment protocol , the ovarian hormonal response , the mean number of ova retrieved and injected per patient , fertilization and cleavage rates and mean embryo quality were comparable between the study and control groups . Although a similar number of embryos was transferred in both groups ( 3.1 + /- 0.7 versus 2.9 + /- 0.6 , mean + /- SD ) , a significantly higher implantation rate ( 16.3 % versus 4.8 % , P = 0.002 ) and clinical pregnancy rate ( 35.2 % versus 10.0 % , P = 0.004 ) and delivered or ongoing pregnancy rate ( 31.3 % versus 4.0 % , P = 0.0005 ) were observed in the study group . When mean implantation rate per patient was calculated , the difference between the study ( 0.148 + /- 0.23 ) and control ( 0.04 + /- 0.13 ) group was significant ( P = 0.003 ) . CONCLUSIONS In this selected group of patients after multiple IVF-embryo transfer failures , the use of HA enriched embryo transfer medium is beneficial This study was undertaken to compare the outcome of day 3 , day 5 , and frozen-thawed embryo transfer cycles where embryo culture was undertaken using the G1.2-G2.2 versus GIII series sequential media . A total of 400 day 3 , 73 day 5 and 126 frozen-thawed embryo transfer cycles were analysed . Treatment cycles were quasi-r and omized on the day of oocyte retrieval to embryo culture in G1.2-G2.2 versus GIII series sequential media . R and omization was undertaken according to alternating weekdays . Significantly more embryos were of grade 1 or 2 quality on day 3 in the GIII group ( P < 0.05 ) . Likewise , more embryos in the GIII group had eight blastomeres on day 3 ( P < 0.05 ) and were able to hatch spontaneously ( P < 0.05 ) . For day 3 embryo transfer cycles , implantation and clinical pregnancy rates were 14.4 and 25.7 % versus 37.8 and 50.3 % in G1.2-G2.2 and GIII groups respectively ( P < 0.05 ) . For day 5 embryo transfer cycles , implantation rates were significantly higher ( 29 versus 45 % ; P < 0.05 ) in the GIII group . There was a trend towards higher pregnancy rates ; however , this did not reach statistical significance due to fewer cycles analysed in this group . In-vitro culture in GIII series sequential media yields better quality embryos that implant more efficiently , compared with culture in G1.2-G2.2 media The purpose of this prospect i ve r and omized study was to evaluate use of a hyaluronan-rich transfer medium in fresh and frozen-thawed single blastocyst transfer . The study included 279 single blastocyst transfers in women aged<37 years in their first , second or third treatment cycle . According to the type of single blastocyst transfer ( fresh elective or frozen-thawed ) the women were divided into two study and two control groups . In both study groups ( n=130 ) transfers were performed using hyaluronan and in the control groups ( n=149 ) a conventional transfer medium was used . The results indicate that fresh elective single blastocyst transfer with hyaluronan results in significantly higher pregnancy rates in a selected subgroup of women ; those with > or=2 blastocysts developed to day 5 and a previous implantation failure ( 55 % versus 10 % ; P=0.012 ) . Overall pregnancy rates after fresh elective and frozen-thawed single blastocyst transfer were similar in both study and control groups Purpose To compare the effects of 2 different media on embryo morphology and development at days 2/3 . MethodS ix hundred seventy-six attempts from 512 couples were included in this prospect i ve auto-controlled study . Sibling oocytes of all couples undergoing an IVF ( n = 286 ) or ICSI ( n = 390 ) attempt were r and omly assigned to either GIII series ( Vitrolife ) or ISM ( Medicult ) media . Primary end points were fertilization and embryo morphology rates . Results Fertilization rates in GIII series and ISM ( IVF : 59.9 vs 62.0 % and ICSI : 65.7 vs 66.8 % ) respectively were not different . GIII series showed an increase , compared to ISM , of early cleavage rate , ( IVF : 25.8 vs 16.2 % ( p = 0.005 ) ; ICSI : 40.8 vs 25.5 % ( p < 0.0001 ) , and good embryo morphology rate at day 2 [ IVF : 64.6 vs 57.3 % ( p = 0.01 ) ; ICSI : 74.2 vs 69.4 ( p = 0.03 ) ] and at day 3 [ IVF : 57.5 vs 49.0 % ( p = 0.02 ) ; ICSI : 67.2 vs 61.6 % ( p = 0.01 ) ] . Conclusions Embryo morphology at days 2/3 was significantly enhanced when the embryos were cultured in GIII series OBJECTIVE To evaluate the role of fibrin sealant for embryo transfer ( ET ) and the effect of patient mobilization after ET on pregnancy rates . DESIGN A prospect i ve , r and omized , controlled study . METHODS Two hundred eleven patients who were admitted to the IVF Unit over a period of 6 months participated in the study . Patients who had three or more embryos were r and omly divided into two groups : group 1 ( study group ) , in which ET was performed using fibrin sealant , and group 2 , who served as the controls . Ovulation induction was carried out using the long GnRH-a suppression protocol . RESULTS Comparison of the results regarding the implantation and pregnancy rates and ectopic pregnancy rate revealed a nonsignificant difference between the two groups . However , analysis of the results according to the patients ' age revealed a significant increase in pregnancy ( P < .05 ) and implantation ( P < .01 ) rate in elderly patients ( aged 39 - 42 ) using fibrin sealant for ET as Output:	No evidence was found of a treatment effect of fibrin sealant as an adherence compound . Evidence suggests improved clinical pregnancy and live birth rates with the use of functional concentrations of HA as an adherence compound in ART cycles . The increase in multiple pregnancy rate may be the result of use of a combination of an adherence compound and a policy of transferring more than one embryo .
MS21760	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To examine the effects of 2 manual therapy methods compared with one counselling session with a physiotherapist with " advice-only to stay active " for treating low back pain/leg pain and disability . DESIGN A r and omized , controlled trial with a 1-year follow-up . SUBJECTS A total of 134 subjects with low back disorders . METHODS Participants with acute to chronic first or recurrent low back pain , excluding those with " red flag " criteria , were assigned r and omly to one of the 3 intervention groups : an orthopaedic manual therapy group ( n=45 ) , a McKenzie method group ( n=52 ) , and an " advice only to be active " group ( advice-only ) ( n=37 ) . Data on leg and low back pain intensity and disability ( Rol and -Morris Disability question naire ) were collected at baseline , and at 3- , 6- , and 12-month follow-up points . RESULTS At the 3-month follow-up point , significant improvements had occurred in all groups in leg and low back pain and in the disability index , but with no significant differences between the groups . At the 6-month follow-up , leg pain ( -15 mm ; 95 % confidence interval ( CI ) -30 to -1 ) , back pain ( effect : -15 mm ; -27 to -4 ) , and disability index ( -4 points ; -7 to -1 ) improved ( p < 0.05 ) more in the McKenzie method group than in the advice-only group . At the 1-year follow-up , the McKenzie method group had ( p=0.028 ) a better disability index ( -3 points ; -6 to 0 ) than did the advice-only group . In the orthopaedic manual therapy group at the 6-month and 1-year follow-up visits , improvements in the pain and disability index were somewhat better than in the advice-only group ( p=0.067 and 0.068 , respectively ) . No differences emerged between the orthopaedic manual therapy and McKenzie method groups in pain- and disability-score changes at any follow-up . CONCLUSION The orthopaedic manual therapy and McKenzie methods seemed to be only marginally more effective than was one session of assessment and advice-only RésuméLe repos au lit est habituellement considéré comme un traitement efficace de la lombalgie aiguë . Cependant la durée optimale de cette mise au repos au lit est encore discutée , variant selon les écoles de 2 jours à 2 semaines . C'est un paramètre imporant à considérer , compte tenu des préjudices économiques et fonctionnels d'une inactivité prolongée . Le but de ce travail est de faire une évaluation objective de l'efficacité de deux durées de repos différentes , à l'aide d'une mesure dynamométrique de la fonction musculaire du tronc pratiquée à la suite d'une mise au repos plus ou moins longue . Cinquante et un patients , étudiants ou travaillant à leur propre compte , consultant pour des lombalgies aiguës , ont été r and omisés en deux groupes . Au groupe I a été prescrit un repos au lit de 3 jours et au groupe II un repos de 7 jours . Nous avons utilisé un appareil dynamométrique ( Isostation B200 , Isotechnologies , USA ) pour l'évaluation isoinertielle de la fonction musculaire du tronc dans les différents plans . Les patients ont été évalués au ler et au 5e jour dans le groupe I ; la seconde évaluation a été reportée au 9e jour dans le groupe II . Les variables mesurées dans le plan sagittal ont été les forces isometriques en flexion et extension , l'amplitude des mouvements sans résistance , la valeur moyenne des forces développées dans les mouvements de flexion et d'extension ainsi que les vitesses moyennes . On a également dem and é aux patients de situer sur une échelle graphique l'intensité de la douleur ressentie le jour de l'évaluation . L'amélioration de tous les paramètres mesurées a été importante et hautement significative ( P<0,001 ) dans les deux groupes . Les résultats du testing fonctionnel et de l'échelle des douleurs n'ont pas montré de différences significatives entre ces deux groupes . Chez ces patients relativement jeunes et motivés , un repos au lit de trois jours a abouti à la même amélioration de la fonction et de la douleur que le repos de sept jours . Compte tenu des résultats objectifs identiques et aussi des avantages physiologiques et économiques indiscutables , il est préférable de prescrire une mise au repos plus brève . Summary Bed rest is usually considered an efficient treatment for acute low back pain . However , the optimal duration of bed rest is still being discussed . The recommended periods vary from 2 days to 2 weeks . The duration of optimum length is an important topic given the economical and physiological drawbacks of prolonged inactivity . The purpose of this work is to measure objective ly the efficacy of two different duration s of bed rest through a dynamometric measure of trunk function . Some 51 male patients , students or self-employed , being treated for acute low back pain were r and omized into two groups . Group I was prescribed a bed rest period of 3 days and group II , a period of 7 days . We used a multiaxis isoinertial trunk testing dynamometric device ( Isostation B200 , Isotechnologies , USA ) . Patients were all assessed on day 1 and also on day 5 for group I or on day 9 for group II . The variables measured in the sagittal plane were isometric torques in flexion and extension , unresisted range of motion , average dynamic torques and average velocities . Patients were also asked to fill in a visual analogue pain scale on both assessment days . The improvement of all performance measures were important and highly significant ( P<0.001 ) in both groups . The results of the functional testing and the visual analogue pain scale showed no significant differences between the groups . In these relatively young and motivated patients , a duration of bed rest of 3 days result ed in the same objective functional improvement of trunk function and pain rating as a period of 7 days . This shorter duration should be considered as preferable , given the same objective results but important physiological and economical advantages The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work . Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone OBJECT The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica . Their hypothesis was that bed rest , physiotherapy , and continuation of activities of daily living ( ADLs ) ( control treatment ) are each of equivalent efficacy . METHODS This r and omized controlled trial was design ed for comparison of bed rest , physiotherapy , and continuation of ADLs . The setting was an outpatient clinic . General practitioners were asked to refer patients for treatment as soon as possible . The authors enrolled 250 patients ( < 60 years of age ) with sciatica of less than 1-month 's duration and who had not yet been treated with bed rest or physiotherapy . Primary outcome measures were radicular pain ( based on a visual analog pain scale [ VAPS ] ) and hampered ADLs ( Quebec Disability Scale [ QDS ] ) . Secondary outcome measures were the rates of treatment-related failure and surgical treatment . Measures were assessed at baseline and during follow up at 1 , 2 , and 6 months . Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 ( 95 % confidence interval [ CI ] -6.4 to 11.4 ) and -4.8 ( 95 % CI -10.6 to 0.9 ) at 1 month and 0.9 ( 95 % CI -8.7 to 10.4 ) and -2.7 ( 95 % CI -9.9 to 4.4 ) at 2 months , respectively . The respective differences between physiotherapy and control treatment were 0.8 ( 95 % CI -8.2 to 9.8 ) and -0.5 ( 95 % CI -6.3 to 5.3 ) at 1 month and -0.3 ( 95 % CI -9.4 to 10 ) and 0.0 ( 95 % CI -7.2 to 7.3 ) at 2 months . The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 ( 95 % CI 0.8 - 3.5 ) and 1.5 ( 95 % CI 0.7 - 3.6 ) at 6 months . When physiotherapy was compared with control treatment , these ratios were 1.5 ( 95 % CI 0.7 - 3.2 ) and 1.2 ( 95 % CI 0.5 - 2.9 ) at 6 months , respectively . CONCLUSIONS Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs A controlled trial of continuous lumbar traction in the treatment of back pain and sciatica showed similar improvements in both the treated group ( weighted traction ) and the control group ( simulated traction ) . The findings of this study question the justification of admitting patients with back pain into hospitals for purpose s of traction alone The results of a multicentered r and omised clinical trial are reported of bed rest and of a physiotherapy and education programme for patients who presented in family practice with an acute episode of low back pain . No beneficial effect of either treatment was observed on several clinical outcome measures , including straight leg raising , lumbar flexion , activities of daily living , and pain . In fact the results favoured early mobilisation over bed rest and suggested that the physiotherapy and education programme was doing more harm than good . Moreover , additional analyses , which focused on clinical ly interesting patient subgroups , discovered no subset of patients who benefited from either of the treatments under study . Having failed to identify any clinical ly important benefits , or other explanations for these negative results , we can only conclude that family doctors have little reason to prescribe either bed rest or isometric exercises to patients who suffer from low back pain Background . The management of common low back pain has two principal objectives : to relieve acute pain and to attempt prevention of transition to chronicity . Several studies have shown the ineffectiveness of prolonged periods of bed rest . Objective . To compare 4 days of bed rest with continued normal daily activity in acute low back pain , taking into account the type of work ( physical or sedentary labor ) . Methods . This open , comparative multicenter study enrolled 281 ambulatory patients , ages 18 to 65 years , with low back pain ( onset < 72 hours ) . The subjects did not have pain radiating below the buttocks and did not have work-related injuries . They were r and omized into two treatment groups : one instructed to continue normal activity ( insofar as the pain allowed ) , and the other prescribed 4 days of bed rest . After inclusion , patients were seen at three visits : on day 6 or 7 , after 1 month , and after 3 months . Results . On day 6 or 7 , pain intensity was similar for both groups , as was the overall judgment of the treatment by patients and physicians . At 1 and 3 months , the groups again had equivalent intensity of back pain , functional disability , and vertebral stiffness . A higher proportion of patients in the bed rest group than in the normal activity group had an initial sick leave ( 86%vs 52%;P < 0.0001 ) . This difference was greater for the patients whose work was sedentary . Conclusions . For patients with acute low back pain , normal activity is at least equivalent to bed rest . The findings of this study indicate that prescriptions for bed rest , and thus for sick leaves , should be limited when the physical dem and s of the job are similar to those for daily life activities Bed rest is usually recommended for acute low back pain . Although the optimal duration of bed rest is uncertain , a given prescription may directly affect the number of days lost from work or other activities . In a r and omized trial , we compared the consequences of recommending two days of bed rest ( Group I ) with those of recommending seven days ( Group II ) . The subjects were 203 walk-in patients with mechanical low back pain ; 78 percent had acute pain ( less than or equal to 30 days ) , and none had marked neurologic deficits . Follow-up data were obtained at three weeks ( 93 percent ) and three months ( 88 percent ) . Although compliance with the recommendation of bed rest was variable , patients r and omly assigned to Group I missed 45 percent fewer days of work than those assigned to Group II ( 3.1 vs. 5.6 days , P = 0.01 ) , and no differences were observed in other functional , physiologic , or perceived outcomes . For many patients without neuromotor deficits , clinicians may be able to recommend two days of bed rest rather than longer periods , without any perceptible difference in clinical outcome . If widely applied , this policy might substantially reduce absenteeism from work and the result ing indirect costs of low back pain for both patients and employers BACKGROUND AND METHODS Bed rest is widely advocated for sciatica , but its effectiveness has not been established . To study the effectiveness of bed rest in patients with a lumbosacral radicular syndrome of sufficient severity to justify treatment with bed rest for two weeks , we r and omly assigned 183 subjects Output:	Moderate quality evidence shows that patients with acute LBP may experience small benefits in pain relief and functional improvement from advice to stay active compared to advice to rest in bed ; patients with sciatica experience little or no difference between the two approaches . Low quality evidence suggests little or no difference between those who received advice to stay active , exercises or physiotherapy .
MS21761	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Taking even this restricted group of patients , the aim of establishing clear cut differences between the drugs has not been achieved . The most clear cut finding was that no statistically significant difference was found between the ability of the two drugs , chlorpromazine and trifluoperazine , to improve motor activity in underactive schizophrenic patients . There were however , a number of observations which may be of interest . For the more active patients an overall measure of performance at the factory task showed an inconstant and non-significant initial improvement with both active drugs with maximum effect at the end of six weeks . There-after performance deteriorated , and when active drugs were reintroduced this deterioration was not reversed . The less active behaved differently . At the factory task they improved progressively through-out the experiment , but the greatest increment in their performance occurred during the Pl phase . No group 's speed of work was changed differentially by the two drugs . The least active group A increased their speed of work more during the six weeks Pl phase than at any other time ; Group B showed similar improvement during the P1 phase , but did not improve further when drugs were reintroduced ; Group C showed virtually no change in speed of work during the three phases of the experiment . When on drugs there was a small but highly statistically significant improvement over pre-drug scores on the Venables scale , indicating that the two drugs were effective . No significant difference between drugs was found , and after the first six weeks of treatment the maximum response was reached , with some worsening thereafter . There is a strong suggestion that the worsening in behaviour during the intervening placebo phase seen on the Venables scale occurs only in those previously treated with chlorpromazine . To this extent , therefore , trifluoperazine is to be preferred as a treatment . On this scale , as with the factory task , gains in behaviour obtained during the first six weeks of treatment were not repeated during the latter part of the cross-over . Strenuous attempts were made to maintain the environment constant for all groups , so that it is unlikely that chance environmental stimulation could be the sole explanation for these changes . A more likely explanation seems to be that , for the very inactive , once new patterns of behaviour have been initiated with the aid of drugs further improvement may occur without continuous medication . For the more active , however , starting drugs may also produce a temporary improvement , but the improvement is inconstant , it does not last as long and may be lost even when drugs are continued . Intermittent medication is evidently effective for inactive patients and may be advantageous . The more active seem to be improved to a much smaller extent by these drugs . The correlation , steadily increasing with treatment , between the two factors of the Venables scale suggests that both drugs have a beneficial effect on another puzzling aspect of the chronic schizophrenic : the differences between tests within individuals which they show on most measures of behaviour . This is an area of performance of importance therapeutically , but one which hitherto has been neglected in drug studies . We found no evidence to suggest that intermittent medication would have an adverse effect on this aspect of behaviour The attempt in one hospital to model a drug study after the NIMH nine-hospital collaborative study result ed in a useful modification in which relatively small numbers of newly admitted , acutely exacerbated chronic schizophrenic patients were studied for a period of four weeks . Statistically significant drug : placebo differences were easily detected on most psychiatric and behavioral variables , but not on the psychological performance tasks used . The overall design appears to be suitable for sequential analysis and might provide the basis for an early screening program for antipsychotic drugs in which very small numbers of subjects would be required for relatively short periods of observation . A possible differential drug response favoring thioridazine over chlorpromazine hydrochloride and fluphenazine hydrochloride on several variables was not statistically significant • Presently marketed antiparkinsonism drugs are potent anticholinergic agents that , while effective in treating extrapyramidal symptoms ( EPS ) , also are productive of or can exacerbate a number of side effects associated with psychotropic drugs . Some of these include gastrointestinal disturbances , visual difficulties , and tardive dyskinesia . A double-blind study was carried out to assess the efficacy ( and adverse effects ) of amantadine hydrochloride — an agent without appreciable anticholinergic activity — for the treatment of drug-induced EPS . Amantadine was found to be comparable in effect to benztropine mesylate , but with fewer side effects . The potential role of amantadine may be in the treatment of patients with druginduced EPS for whom medication with anticholinergic properties is contraindicated Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness , 120 entered a r and omised placebo-controlled trial of maintenance neuroleptic medication on discharge ; they were followed to relapse or loss to follow-up , for two years or to the end of the study . Of those on active medication , 46 % relapsed , as did 62 % of those on placebo ; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication . This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis , or because susceptibility to relapse is reduced by early institution of treatment . The study provides no data on which a decision between these alternative explanations can be based OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate A double-blind , placebo-controlled trial was carried out to determine the value of maintenance therapy with phenothiazines in a population of out patients who had recently recovered from an acute episode of schizophrenia . The drug was shown to be significantly more effective than the placebo in preventing relapse . The relationship of the trial patients to the population from which they were selected was defined in terms of clinical , historical , and social data . Maintenance therapy seems of little value in patients with a good prognosis and in the severely ill , but it is of value in the indeterminate group between these two extremes Poor neuroleptic response is a major unresolved clinical problem . Precise data concerning the frequency of poor neuroleptic response are not available . The implementation of treatment modalities that are specifically recommended for non‐responders ( such as clozapine ) increases the desirability of such data . This study evaluated the proportion of acutely exacerbated schizophrenics who remained unimproved by consecutive administration of haloperidol , chlorpromazine and perphenazine , in r and omly determined order . The overall improvement rate was 95 % . The frequency of good responses to the first , second and third drug were 67 % , 55 % , and 67 % respectively . Differences in receptor affinity profile might explain the added beneficial effect of a second or third drug CONTEXT Second-generation ( atypical ) antipsychotics ( SGAs ) are more expensive than first-generation ( typical ) antipsychotics ( FGAs ) but are perceived to be more effective , with fewer adverse effects , and preferable to patients . Most evidence comes from short-term efficacy trials of symptoms . OBJECTIVE To test the hypothesis that in people with schizophrenia requiring a change in treatment , SGAs other than clozapine are associated with improved quality of life across 1 year compared with FGAs . DESIGN A noncommercially funded , pragmatic , multisite , r and omized controlled trial of antipsychotic drug classes , with blind assessment s at 12 , 26 , and 56 weeks using intention-to-treat analysis . SETTING Fourteen community psychiatric services in the English National Health Service . PARTICIPANTS Two hundred twenty-seven people aged 18 to 65 years with DSM-IV schizophrenia and related disorders assessed for medication review because of inadequate response or adverse effects . INTERVENTIONS R and omized prescription of either FGAs or SGAs ( other than clozapine ) , with the choice of individual drug made by the managing psychiatrist . MAIN OUTCOME MEASURES Quality of Life Scale scores , symptoms , adverse effects , participant satisfaction , and costs of care . RESULTS The primary hypothesis of significant improvement in Quality of Life Scale scores during the year after commencement of SGAs vs FGAs was excluded . Participants in the FGA arm showed a trend toward greater improvements in Quality of Life Scale and symptom scores . Participants reported no clear preference for either drug group ; costs were similar . CONCLUSIONS In people with schizophrenia whose medication is changed for clinical reasons , there is no disadvantage across 1 year in terms of quality of life , symptoms , or associated costs of care in using FGAs rather than nonclozapine SGAs . Neither inadequate power nor patterns of drug discontinuation accounted for the result The relative efficacy of 4 tranquilizers was investigated in 66 chronic schizophrenics who had been hospitalized for 10.01 years ( mean ) . The role of adding an anti-depressant was also studied . Following a 4 week placebo period , high dosage tranquilizers were given for 16 weeks and amitriptyline was added for the following 16 weeks . Statistical analyses of the various change measures revealed that patients worsened significantly on placebo , all 4 tranquilizers were significantly better than placebo for symptom reduction and maximum improvement was attained within 16 weeks of tranquilizer administration . No significant differences in efficacy were observed among the 4 tranquilizers and addition of amitriptyline did not confer any additional therapeutic advantage The efficacy of oral concentrate in the rapid tranquilization of 159 acutely disturbed patients in a psychiatric emergency service was evaluated . Patients were r and omly assigned to 1 of 10 treatment groups : 7 oral groups and 3 comparison intramuscular groups . Although intramuscular medication produced a faster response , concentrate also proved to be effective for rapid tranquilization . Side effects were benign and minimal . Age , sex , race , and diagnosis had no effect on outcome . The use of concentrate as a paradigm for treating acutely psychotic patients is discussed Research on strategies using low doses of neuroleptics in the long-term maintenance and /or prophylactic treatment of schizophrenia is review ed . The evidence available from prospect i ve controlled trials suggests that substantial dosage reduction is feasible for a subgroup of outpatient schizophrenics and that the incidence of abnormal involuntary movements might be reduced by such a strategy . In addition , lowering dosages may bring about some improvement in psychosocial adjustment . Further work is clearly needed to explore fully the benefit to risk ratio of this strategy and to identify those patients for whom it is most appropriate Urinary MHPG excretion in patients with acute schizophrenia was studied before and during a trial of the isomers of flupenthixol and placebo . Pretrial MHPG excretion was not related to severity of illness before the trial or to other pretrial clinical variables . In male subjects higher pretrial MHPG excretion was associated with a better outcome 1 year post-trial . However in females no relationship between MHPG excretion and outcome was established . During the trial there was a reduction in MHPG excretion in patients treated with β-flupenthixol but no decrease in the group treated with α-flupenthixol or chlorpromazine . In patients on placebo there was a reduction in MHPG excretion in those who dit well clinical ly , but not in those who did poorly . Thus low MHPG excretion may be a predictor of poor outcome in schizophrenia , but MHPG excretion also changes both as a function of clinical state and of neuroleptic drug administration Subjects Thirty-four newly admitted acute schizophrenic patients were studied : they included first admissions and others undergoing acute exacerbations with a history of previous acute schizophrenic episodes . None of these patients had received tranquillizing medication for at least one month prior to admission to hospital , or electroconvulsive therapy for at least two months . They ranged in age from seventeen to fifty-four years with a mean age of thirty-four . Some preliminary . findings with the first twenty subjects in this series have already been published ( 4 ) . coefficient of variation ( CV ) than the other fifty-five patients who were receiving a variety of drugs . The procedure described here permitted a more detailed analysis of the effects of two antipsychotic agents ( quite different in chemical structure ) upon the integrated EEG measures in a more systematic comparative design of shortterm drug effects . It also permitted a comparison of effects , both clinical and EEG , over a time period ( seven days ) similar to that in which the clinician might ordinarily decide whether his patient was showing Output:	AUTHORS ' CONCLUSIONS The results did not show a difference in efficacy between trifluoperazine and low-potency antipsychotics . Trifluoperazine produced more movement disorders .
MS21762	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Sustained employability and health are generating awareness of employers in an aging and more complex work force . To meet these needs , employers may offer their employees health surveillance programs , to increase opportunities to work on health and sustained employability . However , evidence for these health surveillance programs is lacking . The FLESH study ( Functional Labour Evaluation for Sustained Health and employment ) was developed to evaluate a comprehensive workers ’ health promotion program on its effectiveness , cost-benefit , and process of the intervention . Methods The study is design ed as a cluster r and omised stepped wedge trial with r and omisation at company plant level and is carried out in a large meat processing company . Every contracted employee is offered the opportunity to participate in the POSE program ( Promotion Of Sustained Employability ) . The main goals of the POSE program are 1 ) providing employee ’s insight into their current employability and health status , 2 ) offering opportunities to improve employability and decrease health risks and 3 ) improving employability and health sustainably in order to keep them healthy at work . The program consists of a broad assessment followed by a counselling session and , if needed , a tailored intervention . Measurements will be performed at baseline and will be followed up at 20 , 40 , 60 , 80 , 106 and 132 weeks . The primary outcome measures are work ability , productivity and absenteeism . Secondary outcomes include health status , vitality , and psychosocial workload . A cost-benefit study will be conducted from the employers ’ perspective . A process evaluation will be conducted and the satisfaction of employer and employees with the program will be assessed . Discussion This study provides information on the effectiveness of the POSE program on sustained employment . When the program proves to be effective , employees benefit by improved work ability , and health . Employers benefit from healthier employees , reduced sick leave ( costs ) and higher productivity . The study can expose key elements for a successful implementation and execution of the POSE program and may serve as an example to other companies inside and outside the industry . Trial registration The trial is registered at the Dutch Trial Register ( http://www.trialregister.nl ) : The study presented is a r and omized , controlled intervention study with the purpose of implementing an evidence ‐based skin disease prevention programme . The hypothesis explored in this article is whether a high‐fat petrolatum‐based moisturizer can be an alternative to protective gloves in wet‐work occupations . The study population was all gut cleaners in Danish swine slaughterhouses , and data were collected by telephone interviews using a st and ardized question naire – The Nordic Occupational Skin Question naire ( NOSQ‐2002 ) . At baseline , 644 ( 88 % ) gut cleaners responded and at 1‐year follow‐up 622 ( 72 % ) . 135 gut cleaners in the intervention and 277 in the comparison group responded at both telephone interviews . In the intervention group , the eczema frequency was reduced significantly . Detailed analyses revealed that protective gloves are the overall most effective protective means and did not indicate that a high‐fat moisturizer could be an alternative . Furthermore , the most extensive improvements could not be explained by combinations of protective behaviour but was found among those who had received information on , and was having discussion s on prevention of skin problems . This only applied to the intervention group . A continuous focus on prevention of skin problems with information and discussion s on the shop floor therefore seemed to be most important for reducing skin problems Objectives : The objective of the present implementation study is to document how an intervention to reduce work-related skin problems by means of implementing an evidence -based skin protection programme in six gut-cleaning departments in swine slaughterhouses was understood , accepted and carried out . The association between the degree of implementation and the reduction of work-related skin problems in each department is examined . The intervention included a top-down strategy with establishment of a management system focusing on skin risks and a bottom-up strategy with participation of a selected group of shop floor workers and the safety representative , as change agents , as well as an empowerment-based educational programme , where the middle management and representatives from the top management also participated . Methods : The study design was a r and omized controlled intervention study with a 1-year study period . The outcome of the intervention was evaluated by telephone interviews . Data on the implementation process consisted of self-administered question naires , focus interviews and compiled written material s. Four indexes referring to the management system and the change agents ’ intervention activities were constructed . Finally , the Pearson correlation coefficient was used to test the correlation between the degree of implementation and the eczema frequency at 1-year follow-up . Results : There was a statistically significant association ( p < 0.05 ) between both the index for the combined implementation method and the eczema frequency after 1 year of intervention , and between the activities of the change agents and the eczema frequency . In contrast to this there was only a weak association between the establishment of a formal management system alone and the outcome . Conclusion : The study evidence s that a combination of a top-down and a bottom-up implementation method is effective to reduce work-related skin problems , and that the process of implementation is a significant determinant of the overall results This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence A novel procedure is described to establish knife steeling schedules for poultry and meat- processing operations based on increased force due to knife dullness from repetitive use to minimize operator exertions and physical stress associated with work-related musculoskeletal disorders . Knife dullness was quantified using a novel apparatus described in this article that measures the area cut by a knife into a carrageenan gel target for a controlled dynamic load at the knife h and le . Two meat-cleaning jobs in a poultry-processing plant were studied . One job required significantly more force and a greater number of cuts than the other . Eight experienced operators participated in the study . Four freshly ground and honed knives were r and omly used by each operator for 4 , 45 , 75 , or 125 cutting cycles , measured for dullness and reconditioned by the operator using a steel sharpening rod . An empirical model for knife dulling and reconditioning was developed , and the corresponding increase in force was predicted for various cutting and reconditioning frequencies . The model showed that it took 57 and 125 cutting cycles for the high- and low-force jobs , respectively , to achieve a similar reduction in target surface area of 30 % . This reduction in target surface area corresponded to a similar percentage increase in force needed for the same cut in carrageenan gel as compared to a freshly honed knife as measured using strain gages . This method may be used in meat processing plants for determining effective reconditioning schedules that reduce operator exertions with minimum effect on quality and productivity Aims : To evaluate the effect of an intervention to reduce work related skin problems in gut cleaning departments in Danish swine slaughterhouses . The intervention consisted of an evidence based prevention programme and a documented method for implementation . Methods : R and omised controlled intervention study with a one year follow up . The intervention included educational activities and evidence based recommendations . The effect of the intervention was evaluated by telephone interviews using a st and ardised question naire based on the Nordic Occupational Skin Question naire ( NOSQ-2002 ) with modified and additional questions on exposure , preventive measures , information , and discussion s on prevention of skin problems , etc . Results : A total of 644 ( 87.5 % ) responded at the baseline interview and 622 ( 71.6 % ) at the one year follow up interview . A total of 495 participated in both interviews ( 67.3 % ) . In the intervention departments the frequency of eczema on h and s or forearms within the past three months at follow up was reduced significantly from 56.2 % at baseline to 41.0 % at follow up , while a slight non-significant increase was observed in the comparison departments ( from 45.9 % to 50.2 % ) . The intervention activities result ed in more frequent use of protective gloves in general and the use of cotton gloves worn underneath rubber and plastic gloves . At follow up three times as many in the intervention departments used the recommended high fat skin care products introduced as part of the intervention activities . At follow up , discussion of skin problems was increased in the intervention group while no changes were observed in the comparison group . Conclusions : A significant 27 % relative reduction of occupational eczema in a high risk group was feasible through implementation of an evidence based prevention programme A limited , r and omized , blind , placebo-controlled trial of Q fever and influenza vaccines has been conducted in three Queensl and abattoirs on a sequential analysis design . Ninety-eight subjects were given Q fever vaccine and 102 influenza vaccine . Q fever cases were observed in unvaccinated workers in all three abattoirs during the period of observation . A total of seven Q fever cases in one group , one more than the number required to achieve statistical significance between the two vaccine groups , was reached after 15 months with the cases coming from two of the abattoirs . These Q fever cases were in the group which had been given influenza vaccine and none in that given Q fever vaccine . Symptomless seroconversion rates of 24 % were found in the remaining influenza virus vaccinees , and those without immunity were given Q fever vaccine OBJECTIVES A program called the Project on Research and Intervention in Monotonous Work ( PRIM ) was initiated in 1994 as a prospect i ve cohort study of work-related musculoskeletal disorders . The group-based exposure assessment strategy , focusing on task-related exposure and used to obtain baseline measures of physical exposures , is reported in this paper . METHODS Monotonous , repetitive worktasks were evaluated at 19 factories . Tasks with an estimated similarity in physical exposure were aggregated before 103 exposure groups were formed . Subjects from the exposure groups were r and omly sample d for measurements , and task-related exposure levels were quantified by 43 single exposure items using a real-time video-based observation method that allowed computerized estimates of repetitiveness , body postures , force , and velocity . In combination with question naire-based data on task distribution , the duration of exposure was calculated at the individual level . RESULTS The video-based observational method and the large number of exposure variables enabled the establishment of detailed quantitative exposure profiles in 103 task-based exposure groups . However , method ological problems associated with the use of grouped exposure assessment were revealed . Despite efforts to optimize group homogeneity , the within-group variance was larger than the between-group variance for several shoulder postural variables . CONCLUSIONS A task-based exposure- assessment strategy can be successful in solving some of the main problems associated with the assessment of physical workplace exposures . The large within-group variance in exposure to nonneutral shoulder postures may eventually require individual assessment or the inclusion of groups with maximal contrast in exposure or both Output:	There was limited evidence for added rest breaks result ing in improved productivity at the end of a workday and in reductions of perceived discomfort in various body regions at the end of the workday . Conclusion This review presents evidence for the effectiveness of a variety of workplace interventions . There was limited evidence for effectiveness of ergonomic interventions , moderate evidence of a skin protection intervention , and strong evidence for Q fever vaccination
MS21763	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We prospect ively estimated the prevalence of the polycystic ovary syndrome ( PCOS ) , as defined by the NIH/NICHHD 1990 endocrine criteria , in a population of 154 Caucasian women of reproductive age reporting spontaneously for blood donation . Anthropometric data ; the presence of hirsutism , acne , and and rogenic alopecia ; and the menstrual history were recorded by a single investigator . In 145 women , blood sample s were also obtained for measurement of serum and rogen levels . PCOS was defined by the presence of 1 ) oligomenorrhea , 2 ) clinical and /or biochemical hyper and rogenism , and 3 ) exclusion of hyperprolactinemia , thyroid disorders , and nonclassic 21-hydroxylase deficiency . Hirsutism was defined by a modified Ferriman-Gallwey score of 8 or more , acne was considered as a sign of hyper and rogenism when persistent after the second decade of life , and hyper and rogenemia was defined by an increase in circulating testosterone or dehydroepi and rosterone sulfate or an increase in the free and rogen index above the 95th percentile of the control values derived from the nonhirsute , nonacneic women having regular menses who were not receiving hormonal therapy . PCOS was present in 10(6.5 % ) , hirsutism was present in 11 ( 7.1 % ) , and acne was present in 19 ( 12.3 % ) of the 154 women . Our results demonstrate a 6.5 % prevalence of PCOS , as defined , in a minimally biased population of Caucasian women from Spain . The polycystic ovary syndrome , hirsutism , and acne are common endocrine disorders in women OBJECTIVE : Polycystic ovary syndrome ( PCOS ) is characterized by obesity and insulin resistance ( IR ) , which result in elevated plasminogen activator inhibitor-1 ( PAI-1 ) levels . We aim ed to assess the changes in PAI-1 levels in PCOS during treatment with metformin and during weight loss . DESIGN : Twenty-three normal weight women with PCOS were given metformin 850 mg bid for 6 months . Fifty overweight/obese women with PCOS were prescribed an energy-restricted diet , were instructed to exercise and were r and omized to orlistat 120 mg tid or sibutramine 10 mg qd for 6 months . RESULTS : In normal weight women , treatment with metformin reduced the body mass index ( BMI ) and circulating and rogens , improved markers of IR and lowered PAI-1 levels . In overweight/obese women , sibutramine and orlistat yielded comparable reductions in BMI and markers of IR . In contrast , the effects on the free and rogen index ( FAI ) differed ( p=0.027 ) : sibutramine reduced the FAI ( p=0.005 ) , whereas orlistat had no effect . The effects of sibutramine and orlistat on PAI-1 levels also differed ( p=0.042 ) : sibutramine reduced PAI-1 levels ( p<0.001 ) , whereas orlistat had no effect . CONCLUSIONS : Metformin and sibutramine , but not orlistat , reduce PAI-1 levels in PCOS . The reduction in circulating and rogens during metformin and sibutramine treatment might be implicated in this decline BACKGROUND This prospect i ve study evaluated the effect of weight reduction on anthropometric indices and ovarian morphology in anovulatory overweight patients with polycystic ovary syndrome ( PCOS ) . METHODS Thirty-three anovulatory overweight patients with PCOS were enrolled in the study . All had patent Fallopian tubes and chronic anovulation : 27 of them were oligo-amenorrhoeic . The partners were normospermic . Patients were prescribed a 1200 kcal/day diet , and physical exercise was recommended . Anthropometric indices and ovarian imaging parameters were assessed at baseline and after weight loss of 5 and 10 % . RESULTS Twenty-five patients ( 76 % ) lost at least 5 % of their body weight . Eleven of these patients ( 33 % ) reached a 10 % decrease in weight . Waist circumference at the umbilical level , hip circumference , four skin folds , body mass index and fatty mass ratio were significantly reduced after 5 and 10 % weight loss . Ovarian morphology changed during the diet : we observed a significant reduction in ovarian volume and in the number of microfollicles per ovary . Among the 27 patients with oligo-amenorrhoea , 18 had a resumption of regular cycles and 15 experienced spontaneous ovulation ; 10 spontaneous pregnancies occurred in patients who lost at least 5 % of their weight . CONCLUSIONS Weight loss through a controlled low-calorie diet improves anthropometric indices in obese PCOS patients , reduces ovarian volume and microfollicle number and can restore ovulatory cycles , allowing spontaneous pregnancy The effect of orlistat , a nonabsorbed inhibitor of gastric and pancreatic lipases , was examined in patients with primary hyperlipidaemia ( serum cholesterol ≥6.2 mmol·l−1 and triglycerides ≤5.0 mmol·l−1 ) not responsive to dietary change alone . In a multicentre , r and omised , double-blind study , 103 men and 70 women received 30 , 90 , 180 , or 360 mg of orlistat or placebo for 8 weeks . Total and low-density lipoprotein cholesterol levels were reduced by 4 % and 5 % with 30 mg orlistat , by 7 % and 8 % with 90 mg orlistat , by 7 % and 7 % with 180 mg orlistat and by 11 % and 10 % with 360 mg orlistat compared to placebo . High density lipoprotein cholesterol levels significantly decreased in the 360 mg orlistat group . Triglyceride levels significantly increased in the placebo group but not in the drug groups . Body weight decreased by 1.2 kg with 360 mg orlistat , despite a weight maintenance diet . Decreases in vitamin E and D levels occurred , although both vitamins remained within the normal range . Adverse effects from the gastrointestinal tract were frequent , but led to discontinuation of therapy in only seven patients . Orlistat is a new therapeutic drug for the treatment of hyperlipidaemia that may be particularly useful among overweight patients . Its potential place in therapy will await long-term studies . Vitamin supplementation should be considered during treatment CONTEXT The polycystic ovary syndrome ( PCOS ) is the commonest endocrine abnormality in women of reproductive age . OBJECTIVE To determine the rate of hospital admissions for women with PCOS in Western Australian population in comparison to women without PCOS . DESIGN A population -based retrospective cohort study using data linkage in a statewide hospital morbidity data base system . SETTING All hospitals within Western Australia . PARTICIPANTS A total of 2566 women with PCOS hospitalized from 1997 - 2011 and 25 660 r and omly selected age-matched women without a PCOS diagnosis derived from the electoral roll . MAIN OUTCOME MEASURES Hospitalizations by ICD-10-M diagnoses from 15 years were compared . RESULTS Hospitalizations were followed until a median age of 35.8 years ( interquartile range , 31.0 - 39.9 ) . PCOS was associated with more nonobstetric and non-injury-related hospital admissions ( median , 5 vs 2 ; P < .001 ) , a diagnosis of adult-onset diabetes ( 12.5 vs 3.8 % ) , obesity ( 16.0 vs 3.7 % ) , hypertensive disorder ( 3.8 vs 0.7 % ) , ischemic heart disease ( 0.8 vs 0.2 % ) , cerebrovascular disease ( 0.6 vs 0.2 % ) , arterial and venous disease ( 0.5 vs 0.2 % and 10.4 vs 5.6 % , respectively ) , asthma ( 10.6 vs 4.5 % ) , stress/anxiety ( 14.0 vs 5.9 % ) , depression ( 9.8 vs 4.3 % ) , licit/illicit drug-related admissions ( 8.8 vs 4.5 % ) , self-harm ( 7.2 vs 2.9 % ) , l and transport accidents ( 5.2 vs 3.8 % ) , and mortality ( 0.7 vs 0.4 % ) ( all P < .001 ) . Women with PCOS had a higher rate of admissions for menorrhagia ( 14.1 vs 3.6 % ) , treatment of infertility ( 40.9 vs 4.6 % ) , and miscarriage ( 11.1 vs 6.1 % ) and were more likely to require in vitro fertilization ( 17.2 vs 2.0 % ) . CONCLUSION PCOS has profound medical implication s for the health of women , and health care re sources should be directed accordingly Purpose : To implement an evidence ‐based lifestyle modification intervention , guided by motivational interviewing , among a sample of infertile overweight and obese women with polycystic ovary syndrome to increase chances of conception while improving overall health . Data sources : A prospect i ve quantitative design was utilized ( n = 12 ) . Infertile overweight and obese women with polycystic ovary syndrome at an infertility practice completed question naires to assess diet and exercise practice s at study onset and completion . Body mass index and weight measurements were obtained on participants at study onset and completion of intervention . Menstrual history was assessed by interview . Conclusions : There was a mean weight loss ( p = .005 ) of 7(±5 ) pounds although a 5 % weight reduction did not occur . Mean daily calorie ( p = .005 ) , fat ( p = .006 ) , and carbohydrate intake ( p = .014 ) were significantly reduced . Frequency in brisk walking exercise significantly increased ( p = .024 ) . Frequency in home or gym exercise increased ( p = .050 ) . Menstrual cyclicity improved by 50 % among prior amenorrheic subjects . Implication s for practice : An evidence ‐based lifestyle modification guideline could prove to be a cost effective intervention for infertile women with polycystic ovary syndrome ( PCOS ) who desire pregnancy . This intervention could be integrated into the primary care and reproductive medicine visits as sole therapy or in conjunction with infertility treatment Obesity can affect ovulation and the chances of pregnancy . In this prospect i ve study , a weight loss programme was assessed to determine whether it could help infertile overweight anovulatory women to establish ovulation and assist in achieving pregnancy , ideally without further medical intervention . The subjects acted as their own historical controls . They underwent a weekly programme of behavioural change in relation to exercise and diet over 6 months ; those who did not complete the 6 months were treated as the comparison group . Women in the study group lost an average of 6.3 kg , with 12 of the 13 subjects resuming ovulation and 11 becoming pregnant , five of these spontaneously . Fitness , diet and psychometric measurements all improved . Fasting insulin and testosterone concentrations dropped significantly , while sex hormone binding globulin concentrations rose . None of these changes occurred in the comparison group . Thus , weight loss with a result ant improvement in ovulation , pregnancy outcome , self-esteem and endocrine parameters is the first therapeutic option for women who are infertile and overweight Purpose Comparing the effects of metformin or orlistat on hormone , lipid profile and ovulation status in obese women with polycystic ovary syndrome . Methods A total of 80 women were prospect ively recruited to receive either metformin ( n = 40 ) or orlistat ( n = 40 ) . Weight , BMI , waist , serum LH , total serum testosterone and lipid profile were assessed at baseline and after 3 months . The subjects ’ ovulatory status was assessed after 3 months . Results There was no significant difference in ovulation between the two treatment groups ( 30 % vs 15 % ) . Treatment with either drug showed a significant decline in body weight , BMI ( Body Mass Index ) , and waist circumference , but the degree of decline in both groups was the same . Patients who were treated with orlistat , showed a significant reduction in total testosterone and serum lipid . Women in metformin group showed a significant reduction in serum LH . Conclusions Both metformin and orlistat showed a similar effect on weight loss and ovulation rates OBJECTIVE It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity . A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated . We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight , and thus the incidence of type 2 diabetes , in obese patients . RESEARCH DESIGN AND METHODS In a 4-year , double-blind , prospect i ve study , we r and omized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo , three times daily . Participants had a BMI > /=30 kg/m2 and normal ( 79 % ) or impaired ( 21 % ) glucose tolerance ( IGT ) . Primary endpoints were time to onset of type 2 diabetes and change in body Output:	( S ) The present results suggest that orlistat leads to significant reduction in BMI /body weight in PCOS . In addition , the available evidence indicates that orlistat and metformin have similar effects in reducing BMI , HOMA , testosterone and insulin in overweight/obese PCOS women .
MS21764	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Age is considered to be the strongest predictive factor of postoperative cognitive dysfunction ( POCD ) after cardiac surgery . Coronary artery bypass grafting ( CABG ) without the use of cardiopulmonary bypass is considered to be less harmful to the patient , especially in terms of neurological complications . METHODS The study was a sub- study of the r and omized best bypass surgery trial that compares off-pump to on-pump treatment , with respect to peri- and postoperative morbidity in patients with a moderate to high-predicted preoperative risk . We investigated cognitive outcomes . A total of 120 elderly patients ( mean age 76 years , SD 4.5 years ) underwent cognitive testing before surgery , of which 90 patients ( 47 vs 43 ) were available for retesting at 1 year ( mean 370 days ) postoperatively , using a neuropsychological test battery that included seven parameters from four tests . POCD was defined as the occurrence of at least two deficits out of the seven possible scores . Secondary analysis was performed based on definition of 20 % decline in cognitive scores compared to baseline , and using z-score analysis . RESULTS The incidence of POCD was 19 % ( 95 % CI 9 - 33 ) in the off-pump group and 9 % ( 95 % CI 3 - 22 ) in the on-pump group ( p=0.18 ) . There were no significant differences in the incidence of cognitive decline between the off-pump and on-pump group regardless of the definition applied . CONCLUSIONS We were unable to detect that CABG surgery without cardiopulmonary bypass was associated with significantly better cognitive outcome in elderly high-risk patients 1 year after the operation BACKGROUND The objective of this r and omized clinical trial of elective coronary artery bypass grafting was to investigate whether intraoperative mean arterial pressure below autoregulatory limits of the coronary and cerebral circulations was a principal determinant of postoperative complications . The trial compared the impact of two strategies of hemodynamic management during cardiopulmonary bypass on outcome . Patients were r and omized to a low mean arterial pressure of 50 to 60 mm Hg or a high mean arterial pressure of 80 to 100 mm Hg during cardiopulmonary bypass . METHODS A total of 248 patients undergoing primary , nonemergency coronary bypass were r and omized to either low ( n = 124 ) or high ( n = 124 ) mean arterial pressure during cardiopulmonary bypass . The impact of the mean arterial pressure strategies on the following outcomes was assessed : mortality , cardiac morbidity , neurologic morbidity , cognitive deterioration , and changes in quality of life . All patients were observed prospect ively to 6 months after the operation . RESULTS The overall incidence of combined cardiac and neurologic complications was significantly lower in the high pressure group at 4.8 % than in the low pressure group at 12.9 % ( p = 0.026 ) . For each of the individual outcomes , the trend favored the high pressure group . At 6 months after coronary bypass for the high and low pressure groups , respectively , total mortality rate was 1.6 % versus 4.0 % , stroke rate 2.4 % versus 7.2 % , and cardiac complication rate 2.4 % versus 4.8 % . Cognitive and functional status outcomes did not differ between the groups . CONCLUSION Higher mean arterial pressures during cardiopulmonary bypass can be achieved in a technically safe manner and effectively improve outcomes after coronary bypass OBJECTIVE In a r and omized trial of 223 patients undergoing coronary artery surgery with cardiopulmonary bypass , we have reported a neuroprotective effect of mild hypothermia . To determine whether the beneficial effect of mild hypothermia was long-lasting , we repeated the psychometric tests in 131 patients after 5 years . METHODS Patients were cooled to 32 degrees C during aortic crossclamping and then r and omized to rewarming to either 34 degrees C or 37 degrees C , with no further rewarming until arrival in intensive care unit . Cognitive function was measured preoperatively and 1 week and 5 years postoperatively with a battery of 11 psychometric tests interrogating verbal memory , attention , and psychomotor speed and dexterity . RESULTS Patients who had greater cognitive decline 1 week after surgery showed poorer performance 5 years later . The magnitude of cognitive decline over 5 years was modest . The incidence of deficits defined as a 1 st and ard deviation [ SD ] decline in at least 1 of 3 factors was not different between temperature groups . Fewer patients in the hypothermic group had deficits that persisted over the 5 years , but this difference did not attain statistical significance ( RR = 0.64 , P = .16 ) . CONCLUSIONS The effect of surgery on cognitive function observed early after surgery is an important predictor of cognitive performance 5 years later . Although there was evidence of a neuroprotective effect of mild hypothermia early after surgery in the original cohort , the results after 5 years were inconclusive . In general , the magnitude of cognitive changes over 5 years was modest . We believe that further trials investigating the efficacy of mild hypothermia in patients having cardiac surgery are warranted BACKGROUND AND PURPOSE Percutaneous transluminal angioplasty ( PTA ) is currently being assessed for the treatment of carotid stenosis . In comparison with carotid endarterectomy ( CEA ) , there is evidence of an increased risk of cerebral microembolism during the procedure . We have sought evidence of any neuropsychological sequelae of carotid PTA and compared it with CEA to demonstrate the relative safety of the 2 treatment options . METHODS The neuropsychological outcomes after CEA and PTA were compared in 2 matched groups of patients with severe symptomatic carotid stenosis , 96 % of whom had been r and omized in the Carotid and Vertebral Artery Transluminal Angioplasty Study ( CAVATAS ) , at a single center . Transcranial Doppler insonation of the middle cerebral artery was used to measure cerebral reactivity in response to carbon dioxide inhalation before treatment and then to detect microembolization of the ipsilateral cerebral hemisphere and measure changes in blood flow velocity during the procedures . The performance on a neuropsychological test battery administered before , 6 weeks after , and 6 months after the procedure was compared in 20 patients undergoing PTA and 26 having CEA . RESULTS At 6 weeks , 5 patients in each group showed a similar decline in neuropsychological performance ; global measures showed no significant difference between the 2 procedures , despite a significantly higher incidence of microemboli during PTA . Both groups showed a marked reduction in anxiety after treatment . CONCLUSIONS The findings provide some reassurance that PTA is not associated with greater cerebral complications than CEA , despite the higher embolic load recorded by transcranial Doppler ultrasonography during angioplasty OBJECTIVE To investigate cognitive outcome after on and off pump coronary artery bypass grafting . METHODS Seventy patients between 50 and 80 years with stable angina pectoris , ejection fraction > 30 % , serum creatinine < 150 micromol/l , and lack of tight main stem stenosis were r and omized to on or off pump coronary artery bypass grafting . St and ardized neuropsychological tests evaluated attention , verbal and visuo-spatial short-term and working memory , verbal learning , delayed recall , visuo-motor speed , and aspects of executive functions . Levels of anxiety and depression were also investigated . Testing was performed before and at 1 week , 1 and 6 months after surgery . RESULTS There was no difference in cognitive impairment ( defined as a 20 % reduction in at least 20 % of the tests ) between groups . The incidence at 1 week post-operatively was 57 % in the on pump group and 58 % in the off pump group , after 1 month 30 % and 12 % and after 6 months 19 % and 15 % , respectively ( p for interaction=0.19 ) . There was no difference between groups in anxiety ( p=0.18 ) or depression ( p=0.48 ) . CONCLUSIONS This prospect i ve , r and omized study showed no differences in post-operative cognitive function after on pump compared to off pump coronary artery bypass grafting in low risk patients BACKGROUND Previously , we reported that there was no significant difference at 30 days in the rate of a primary composite outcome of death , myocardial infa rct ion , stroke , or new renal failure requiring dialysis between patients who underwent coronary-artery bypass grafting ( CABG ) performed with a beating-heart technique ( off-pump ) and those who underwent CABG performed with cardiopulmonary bypass ( on-pump ) . We now report results on quality of life and cognitive function and on clinical outcomes at 1 year . METHODS We enrolled 4752 patients with coronary artery disease who were scheduled to undergo CABG and r and omly assigned them to undergo the procedure off-pump or on-pump . Patients were enrolled at 79 centers in 19 countries . We assessed quality of life and cognitive function at discharge , at 30 days , and at 1 year and clinical outcomes at 1 year . RESULTS At 1 year , there was no significant difference in the rate of the primary composite outcome between off-pump and on-pump CABG ( 12.1 % and 13.3 % , respectively ; hazard ratio with off-pump CABG , 0.91 ; 95 % confidence interval [ CI ] , 0.77 to 1.07 ; P=0.24 ) . The rate of the primary outcome was also similar in the two groups in the period between 31 days and 1 year ( hazard ratio , 0.79 ; 95 % CI , 0.55 to 1.13 ; P=0.19 ) . The rate of repeat coronary revascularization at 1 year was 1.4 % in the off-pump group and 0.8 % in the on-pump group ( hazard ratio , 1.66 ; 95 % CI , 0.95 to 2.89 ; P=0.07 ) . There were no significant differences between the two groups at 1 year in measures of quality of life or neurocognitive function . CONCLUSIONS At 1 year after CABG , there was no significant difference between off-pump and on-pump CABG with respect to the primary composite outcome , the rate of repeat coronary revascularization , quality of life , or neurocognitive function . ( Funded by the Canadian Institutes of Health Research ; CORONARY Clinical Trials.gov number , NCT00463294 . ) 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 BACKGROUND Neurologic and clinical morbidity after coronary artery bypass grafting ( CABG ) can be significant . By avoiding cardiopulmonary bypass , off-pump CABG ( OPCAB ) may reduce morbidity . METHODS Sixty patients ( 30 CABG and 30 OPCAB ) were prospect ively r and omized . Neurocognitive testing was performed before the operation and 2 weeks and 1 year after the operation . Neurologic testing to detect stroke and (99m)Tc-HMPAO whole-brain single photon emission computed tomography scanning to assess cerebral perfusion were performed before the operation and 3 days afterward . Bilateral middle cerebral artery transcranial Doppler scanning was performed intraoperatively to detect cerebral microemboli . All examiners were blinded to treatment group . Clinical morbidity and costs were compared . RESULTS Coronary artery bypass grafting was associated with more cerebral microemboli ( 575 + /- 278.5 CABG versus 16.0 + /- 19.5 OPCAB ( median + /- semiinterquartile range ) and significantly reduced cerebral perfusion after the operation to the bilateral occipital , cerebellar , precunei , thalami , and left temporal lobes ( p < or = 0.01 ) . Cerebral perfusion with OPCAB was unchanged . Compared with base line , OPCAB patients performed better on the Rey Auditory Verbal Learning Test ( total and recognition scores ) at both 2 weeks and at 1 year ( p < or = 0.05 ) , whereas CABG performance was statistically unchanged for all cognitive measures . Patients who underwent CABG had more chest tube drainage ( 1389 + /- 1256 mL CABG versus 789 + /- 586 mL OPCAB , p = 0.02 ) and required more blood ( 3.9 + /- 5.8 U CABG versus 1.2 + /- 2.2 U OPCAB , p = 0.02 ) , fresh frozen plasma ( 3.0 + /- 6.0 U CABG versus 0.5 + /- 2.2 U OPCAB , p = 0.03 ) , and hours of postoperative use of dopamine ( 16.3 + /- 21.2 hours CABG versus 7.3 + /- 9.7 hours OPCAB , p = 0.04 ) . Output:	It found that both the CABG and medical groups had small to moderate improvements in memory versus baseline at 1 year and no changes versus baseline at 6 years for all neuropsychological tests measured . Further , there were no between-group differences at any follow-up or in change from baseline to any follow-up .
MS21765	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In the evaluation of a diagnostic imaging test for the diagnosis of a particular illness in a particular category of patients , the test should be construed as leading to a test result in the sense of a set of descriptive readings from the image(s ) , not interpretation of these ; and in the evaluation of the test , therefore , the first challenge is the translation of each test result ( set of readings ) into the corresponding probability that the illness is present . This interpretive translation should not be subjective , nor should it be based on an objective algorithm founded on clinical judgments . Instead , a suitable diagnostic probability function ( of the elements in the test result ) should be derived empirically by logistic regression analysis of suitable data . We illustrate this alternative outlook by re analysis of the data from the Prospect i ve Investigation of Pulmonary Embolism Diagnosis The performance of a predictive model is overestimated when simply determined on the sample of subjects that was used to construct the model . Several internal validation methods are available that aim to provide a more accurate estimate of model performance in new subjects . We evaluated several variants of split- sample , cross-validation and bootstrapping methods with a logistic regression model that included eight predictors for 30-day mortality after an acute myocardial infa rct ion . R and om sample s with a size between n = 572 and n = 9165 were drawn from a large data set ( GUSTO-I ; n = 40,830 ; 2851 deaths ) to reflect modeling in data sets with between 5 and 80 events per variable . Independent performance was determined on the remaining subjects . Performance measures included discriminative ability , calibration and overall accuracy . We found that split- sample analyses gave overly pessimistic estimates of performance , with large variability . Cross-validation on 10 % of the sample had low bias and low variability , but was not suitable for all performance measures . Internal validity could best be estimated with bootstrapping , which provided stable estimates with low bias . We conclude that split- sample validation is inefficient , and recommend bootstrapping for estimation of internal validity of a predictive logistic regression model Abstract Objective : To assess the extent to which different forms of summarising diagnostic test information influence general practitioners ' ability to estimate disease probabilities . Design : Controlled question naire study . Setting : Three Swiss conferences in continuous medical education . Participants : 263 general practitioners . Intervention : Question naire with multiple choice questions about terms of test accuracy and a clinical vignette with the results of a diagnostic test described in three different ways ( test result only , test result plus test sensitivity and specificity , test result plus the positive likelihood ratio presented in plain language ) . Main outcome measures : Doctors ' knowledge and application of terms of test accuracy and estimation of disease probability in the clinical vignette . Results : The correct definitions for sensitivity and predictive value were chosen by 76 % and 61 % of the doctors respectively , but only 22 % chose the correct answer for the post-test probability of a positive screening test . In the clinical vignette doctors given the test result only overestimated its diagnostic value ( median attributed likelihood ratio (aLR)=9.0 , against 2.54 reported in the literature ) . Providing the scan 's sensitivity and specificity reduced the overestimation ( median aLR=6.0 ) but to a lesser extent than simple wording of the likelihood ratio ( median aLR=3.0 ) . Conclusion : Most general practitioners recognised the correct definitions for sensitivity and positive predictive value but did not apply them correctly . Conveying test accuracy information in simple , non-technical language improved their ability to estimate disease probabilities accurately . What is already known on this topic Many doctors confuse the sensitivity of clinical tests and their positive predictive value Doctors tend to overestimate information derived from such tests and underestimate information from a patient 's clinical history Most primary research on diagnostic accuracy is reported using sensitivity and specificity or likelihood ratios What this study adds In a cohort of experienced Swiss general practitioners most were unable to interpret correctly numerical information on the diagnostic accuracy of a screening test When presented with a positive result alone they grossly overestimated its value Adding information on the test 's sensitivity and specificity moderated these overestimates , and expressing the same numerical information as a positive likelihood ratio in simple , non-technical language brought the estimates still closer to their true Each year 1.5 million patients are admitted to coronary-care units ( CCUs ) for suspected acute ischemic heart disease ; for half of these , the diagnosis is ultimately " ruled out . " In this study , conducted in the emergency rooms of six New Engl and hospitals ranging in type from urban teaching centers to rural nonteaching hospitals , we sought to develop a diagnostic aid to help emergency room physicians reduce the number of their CCU admissions of patients without acute cardiac ischemia . From data on 2801 patients , we developed a predictive instrument for use in a h and -held programmable calculator , which requires only 20 seconds to compute a patient 's probability of having acute cardiac ischemia . In a prospect i ve trial that included 2320 patients in the six hospitals , physicians ' diagnostic specificity for acute ischemia increased when the probability value determined by the instrument was made available to them . Rates of false-positive diagnosis decreased without any increase in rates of false-negative diagnosis . Among study patients with a final diagnosis of " not acute ischemia , " the number of CCU admissions decreased 30 per cent , without any increase in missed diagnoses of ischemia . The proportion of CCU admissions that represented patients without acute ischemia dropped from 44 to 33 per cent . Widespread use of this predictive instrument could reduce the number of CCU admissions in this country by more than 250,000 per year OBJECTIVE To determine the accuracy of ultrasound scan in the diagnosis of endometrial hyperplasia and cancer in postmenopausal bleeding . DESIGN A prospect i ve diagnostic accuracy study ( 1996 - 97 ) . SETTING Minimal access surgical training centers in two large teaching hospitals . METHODS Ultrasound scan and outpatient endometrial sampling were performed on 96 patients with postmenopausal bleeding . Patients unable to have these outpatient procedures had a formal inpatient hysteroscopy and curettage . Test performance characteristics were computed for ultrasound scan comparing its estimate of endometrial thickness with histologic diagnosis that served as a ' gold ' st and ard . OUTCOME MEASURES Accuracy of the ultrasonic endometrial thickness was estimated using sensitivity , specificity and predictive values for binary data . For multilevel data , the diagnostic accuracy was computed using likelihood ratios ( LRs ) . An LR < decreased the probability that endometrial hyperplasia/cancer was present , whereas an LR > 1 increased the probability that such lesion was present . RESULTS Using endometrial thickness > or = 4 mm , the sensitivity of ultrasound to detect the endometrial malignancy was 92.9 % , the specificity was 500 % , and the positive and negative predictive values were 24.1 % and 97.6 % respectively . Analysis using likelihood ratio ( LR ) revealed that LR was 0.14 for endometrial thickness > or = 4.0 mm , 0.94 for endometrial thickness 4.1 - 9.0 mm , and 3.3 for endometrial thickness > 9.0 mm . CONCLUSION In women with postmenopausal bleeding , malignancy can probably be safely excluded if sonographic endometrial thickness is < or = 4.0 mm . However , the probability of endometrial hyperplasia/cancer is not particularly altered by the knowledge that endometrial thickness on scan is > 4.0 mm BACKGROUND Systematic review s that " compare " the accuracy of 2 or more tests often include different sets of studies for each test . PURPOSE To investigate the availability of direct comparative studies of test accuracy and to assess whether summary estimates of accuracy differ between meta-analyses of noncomparative and comparative studies . DATA SOURCES Systematic review s in any language from the Data base of Abstract s of Review s of Effects and the Cochrane Data base of Systematic Review s from 1994 to October 2012 . STUDY SELECTION 1 of 2 assessors selected review s that evaluated at least 2 tests and identified meta-analyses that included both noncomparative studies and comparative studies . DATA EXTRACTION 1 of 3 assessors extracted data about review and study characteristics and test performance . DATA SYNTHESIS 248 review s compared test accuracy ; of the 6915 studies , 2113 ( 31 % ) were comparative . Thirty-six review s ( with 52 meta-analyses ) had adequate studies to compare results of noncomparative and comparative studies by using a hierarchical summary receiver-operating characteristic meta-regression model for each test comparison . In 10 meta-analyses , noncomparative studies ranked tests in the opposite order of comparative studies . A total of 25 meta-analyses showed more than a 2-fold discrepancy in the relative diagnostic odds ratio between noncomparative and comparative studies . Differences in accuracy estimates between noncomparative and comparative studies were greater than expected by chance ( P < 0.001 ) . LIMITATION A paucity of comparative studies limited exploration of direction in bias . CONCLUSION Evidence derived from noncomparative studies often differs from that derived from comparative studies . Robustly design ed studies in which all patients receive all tests or are r and omly assigned to receive one or other of the tests should be more routinely undertaken and are preferred for evidence to guide test selection . PRIMARY FUNDING SOURCE National Institute for Health Research ( United Kingdom ) Output:	Most primary accuracy studies lack statistical power to do this , particularly because of the small absolute number of disease events per test included in the diagnostic work . Synthesis using their raw data can overcome this problem , but meta-analysts will have limited success if there are difficulties in obtaining the large majority of valid studies , without ' missing ' data on the tests relevant in clinical decision-making .
MS21766	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Venous thromboembolism ( VTE ) has a significant impact on healthcare costs but is largely preventable with anticoagulant prophylaxis using low-molecular-weight heparins ( LMWHs ) , such as enoxaparin or dalteparin . Rivaroxaban and dabigatran etexilate are two new oral anticoagulants ( NOACs ) both compared with enoxaparin in separate trials . A decision analytic model with a healthcare and national payer perspective over a five-year time horizon was used to evaluate the cost-effectiveness of the NOACs for VTE prophylaxis after total hip replacement ( THR ) or total knee replacement ( TKR ) in France , Italy and Spain . Efficacy and safety data were obtained from r and omised controlled trials of rivaroxaban vs enoxaparin and an indirect statistical comparison for rivaroxaban vs dabigatran . Rivaroxaban demonstrated dominance across all comparisons , indications and countries . In THR , total per-patient costs were reduced by up to € 160 in the enoxaparin comparison and € 115 in the dabigatran comparison , respectively . In addition , quality -adjusted life-years ( QALYs ) were increased by up to 0.0011 and 0.0012 in each comparison , respectively . Similarly , total costs were reduced in TKR by up to € 137 and € 28 in the enoxaparin and dabigatran comparisons , respectively . The total number of QALYs was increased by up to 0.0014 in the enoxaparin comparison and 0.0005 in the dabigatran comparison . The results were driven by costs since the incremental benefits were minimal . Rivaroxaban use could result in substantial healthcare cost savings and improved quality of life . The results are applicable across three European countries with differing healthcare systems so , potentially , could be generalised to a much wider population BACKGROUND After hip replacement surgery , prophylaxis following discharge from hospital is recommended to reduce the risk of venous thromboembolism . Our aim was to assess the oral , direct thrombin inhibitor dabigatran etexilate for such prophylaxis . METHODS In this double-blind study , we r and omised 3494 patients undergoing total hip replacement to treatment for 28 - 35 days with dabigatran etexilate 220 mg ( n=1157 ) or 150 mg ( 1174 ) once daily , starting with a half-dose 1 - 4 h after surgery , or subcutaneous enoxaparin 40 mg once daily ( 1162 ) , starting the evening before surgery . The primary efficacy outcome was the composite of total venous thromboembolism ( venographic or symptomatic ) and death from all causes during treatment . On the basis of the absolute difference in rates of venous thromboembolism with enoxaparin versus placebo , the non-inferiority margin for the difference in rates of thromboembolism was defined as 7.7 % . Efficacy analyses were done by modified intention to treat . This trial is registered with Clinical Trials.gov , number NCT00168818 . FINDINGS Median treatment duration was 33 days . 880 patients in the dabigatran etexilate 220 mg group , 874 in the dabigatran etexilate 150 mg group , and 897 in the enoxaparin group were available for the primary efficacy outcome analysis ; the main reasons for exclusion in all three groups were the lack of adequate venographic data . The primary efficacy outcome occurred in 60 ( 6.7 % ) of 897 individuals in the enoxaparin group versus 53 ( 6.0 % ) of 880 patients in the dabigatran etexilate 220 mg group ( absolute difference -0.7 % , 95 % CI -2.9 to 1.6 % ) and 75 ( 8.6 % ) of 874 people in the 150 mg group ( 1.9 % , -0.6 to 4.4 % ) . Both doses were thus non-inferior to enoxaparin . There was no significant difference in major bleeding rates with either dose of dabigatran etexilate compared with enoxaparin ( p=0.44 for 220 mg , p=0.60 for 150 mg ) . The frequency of increases in liver enzyme concentrations and of acute coronary events during the study did not differ significantly between the groups . INTERPRETATION Oral dabigatran etexilate was as effective as enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery , with a similar safety profile BACKGROUND Chronic thromboembolic pulmonary hypertension ( CTPH ) is associated with considerable morbidity and mortality . Its incidence after pulmonary embolism and associated risk factors are not well documented . METHODS We conducted a prospect i ve , long-term , follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism . Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and , if supportive findings were present , ventilation-perfusion lung scanning and pulmonary angiography . CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg , respectively ; pulmonary-capillary wedge pressure was normal ; and there was angiographic evidence of disease . RESULTS The cumulative incidence of symptomatic CTPH was 1.0 percent ( 95 percent confidence interval , 0.0 to 2.4 ) at six months , 3.1 percent ( 95 percent confidence interval , 0.7 to 5.5 ) at one year , and 3.8 percent ( 95 percent confidence interval , 1.1 to 6.5 ) at two years . No cases occurred after two years among the patients with more than two years of follow-up data . The following increased the risk of CTPH : a previous pulmonary embolism ( odds ratio , 19.0 ) , younger age ( odds ratio , 1.79 per decade ) , a larger perfusion defect ( odds ratio , 2.22 per decile decrement in perfusion ) , and idiopathic pulmonary embolism at presentation ( odds ratio , 5.70 ) . CONCLUSIONS CTPH is a relatively common , serious complication of pulmonary embolism . Diagnostic and therapeutic strategies for the early identification and prevention of CTPH are needed BACKGROUND Oral anticoagulants , such as dabigatran etexilate , an oral , direct thrombin inhibitor , that do not require monitoring or dose adjustment offer potential for prophylaxis against venous thromboembolism ( VTE ) after total knee replacement surgery . METHODS In this r and omized , double-blind study , 2076 patients undergoing total knee replacement received dabigatran etexilate , 150 mg or 220 mg once-daily , starting with a half-dose 1 - 4 hours after surgery , or subcutaneous enoxaparin 40 mg once-daily , starting the evening before surgery , for 6 - 10 days . Patients were followed-up for 3 months . The primary efficacy outcome was a composite of total VTE ( venographic or symptomatic ) and mortality during treatment , and the primary safety outcome was the incidence of bleeding events . RESULTS The primary efficacy outcome occurred in 37.7 % ( 193 of 512 ) of the enoxaparin group versus 36.4 % ( 183 of 503 ) of the dabigatran etexilate 220 mg group ( absolute difference , -1.3 % ; 95 % CI , -7.3 to 4.6 ) and 40.5 % ( 213 of 526 ) of the 150 mg group ( 2.8 % ; 95 % CI , -3.1 to 8.7 ) . Both doses were noninferior to enoxaparin based on the pre-specified noninferiority criterion . The incidence of major bleeding did not differ significantly between the three groups ( 1.3 % versus 1.5 % and 1.3 % respectively ) . No significant differences in the incidences of liver enzyme elevation and acute coronary events were observed during treatment or follow-up . CONCLUSIONS Dabigatran etexilate ( 220 mg or 150 mg ) was at least as effective and with a similar safety profile as enoxaparin for prevention of VTE after total knee-replacement surgery This trial compared the efficacy and safety of oral dabigatran , a direct thrombin inhibitor , versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplasty . A total of 2,055 patients were r and omised to 28 - 35 days treatment with oral dabigatran , 220 mg once-daily , starting with a half-dose 1 - 4 hours after surgery , or subcutaneous enoxaparin 40 mg once-daily , starting the evening before surgery . The primary efficacy outcome was a composite of total venous thromboembolism [ VTE ] ( venographic or symptomatic ) and death from all-causes . The main secondary composite outcome was major VTE ( proximal deep-vein thrombosis or non-fatal pulmonary embolism ) plus VTE-related death . The main safety outcome was major bleeding . In total , 2,013 were treated , of whom 1,577 operated patients were included in the primary efficacy analysis . The primary efficacy outcome occurred in 7.7 % of the dabigatran group versus 8.8 % of the enoxaparin group , risk difference ( RD ) -1.1 % ( 95%CI -3.8 to 1.6 % ) ; p<0.0001 for the pre-specified non-inferiority margin . Major VTE plus VTE-related death occurred in 2.2 % of the dabigatran group versus 4.2 % of the enoxaparin group , RD -1.9 % ( -3.6 % to -0.2 % ) ; p=0.03 . Major bleeding occurred in 1.4 % of the dabigatran group and 0.9 % of the enoxaparin group ( p=0.40 ) . The incidence of adverse events , including liver enzyme elevations and cardiac events , during treatment was similar between the groups . Extended prophylaxis with oral dabigatran 220 mg once-daily was as effective as subcutaneous enoxaparin 40 mg once-daily in reducing the risk of VTE after total hip arthroplasty , and superior to enoxaparin for reducing the risk of major VTE . The risk of bleeding and safety profiles were similar BACKGROUND We investigated the efficacy of rivaroxaban , an orally active direct factor Xa inhibitor , in preventing venous thrombosis after total knee arthroplasty . METHODS In this r and omized , double-blind trial , 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban , 10 mg once daily , beginning 6 to 8 hours after surgery , or subcutaneous enoxaparin , 40 mg once daily , beginning 12 hours before surgery . The primary efficacy outcome was the composite of any deep-vein thrombosis , nonfatal pulmonary embolism , or death from any cause within 13 to 17 days after surgery . Secondary efficacy outcomes included major venous thromboembolism ( i.e. , proximal deep-vein thrombosis , nonfatal pulmonary embolism , or death related to venous thromboembolism ) and symptomatic venous thromboembolism . The primary safety outcome was major bleeding . RESULTS The primary efficacy outcome occurred in 79 of 824 patients ( 9.6 % ) who received rivaroxaban and in 166 of 878 ( 18.9 % ) who received enoxaparin ( absolute risk reduction , 9.2 % ; 95 % confidence interval [ CI ] , 5.9 to 12.4 ; P<0.001 ) . Major venous thromboembolism occurred in 9 of 908 patients ( 1.0 % ) given rivaroxaban and 24 of 925 ( 2.6 % ) given enoxaparin ( absolute risk reduction , 1.6 % ; 95 % CI , 0.4 to 2.8 ; P=0.01 ) . Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin ( P=0.005 ) . Major bleeding occurred in 0.6 % of patients in the rivaroxaban group and 0.5 % of patients in the enoxaparin group . The incidence of drug-related adverse events , mainly gastrointestinal , was 12.0 % in the rivaroxaban group and 13.0 % in the enoxaparin group . CONCLUSIONS Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty , with similar rates of bleeding . ( Clinical Trials.gov number , NCT00361894 . BACKGROUND Low-molecular-weight heparins such as enoxaparin are preferred for prevention of venous thromboembolism after major joint replacement . Apixaban , an orally active factor Xa inhibitor , might be as effective , have lower bleeding risk , and be easier to use than is enoxaparin . We assessed efficacy and safety Output:	Conclusions The economic analyses showed reasonable consistency in the model structures used and the events captured . The results strongly suggested that NOACs are cost effective alternatives to low molecular-weight heparin . Dabigatran appeared to be the least cost effective NOAC .
MS21767	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Rationale : Recent research suggests that chewing gum may improve aspects of cognitive function and mood . There is also evidence suggesting that chewing gum reduces stress . It is important , therefore , to examine these two areas and to determine whether context ual factors ( chewing habit , type of gum , and personality ) modify such effects . Objectives : The aims of the present study were : ( i ) to determine whether chewing gum improved mood and mental performance ; ( ii ) to determine whether chewing gum had benefits in stressed individuals ; and ( iii ) to determine whether chewing habit , type of gum and level of anxiety modified the effects of gum . Subjects and methods : A cross-over study involving 133 volunteers was carried out . Each volunteer carried out a test session when they were chewing gum and without gum , with order of gum conditions counterbalanced across subjects . Baseline sessions were conducted prior to each test session . Approximately half of the volunteers were tested in 75 dBA noise ( the stress condition ) and the rest in quiet . Volunteers were stratified on chewing habit and anxiety level . Approximately , half of the volunteers were given mint gum and half fruit gum . The volunteers rated their mood at the start and end of each session and had their heart rate monitored over the session . Saliva sample s were taken to allow cortisol levels ( good indicator of alertness and stress ) to be assayed . During the session , volunteers carried out tasks measuring a range of cognitive functions ( aspects of memory , selective and sustained attention , psychomotor speed and accuracy ) . Results : Chewing gum was associated with greater alertness and a more positive mood . Reaction times were quicker in the gum condition , and this effect became bigger as the task became more difficult . Chewing gum also improved selective and sustained attention . Heart rate and cortisol levels were higher when chewing which confirms the alerting effect of chewing gum . Conclusions : Overall , the results suggest that chewing gum produces a number of benefits that are generally observed and not context -dependent . In contrast to some previous research , chewing gum failed to improve memory . Further research is now required to increase our knowledge of the behavioral effects of chewing gum and to identify the underlying mechanisms RATIONALE Recent research has shown that even small doses ( < 40 mg ) of caffeine can improve alertness and increase performance efficiency on attention tasks . Previous studies have given the caffeine in a variety of beverages or in capsules and it was of interest to see whether similar effects could be observed when the caffeine was given in gum . In addition , chewing gum has been shown to have behavioural effects and the present study extended our knowledge of this topic . OBJECTIVES To compare the effects of caffeinated gum ( 40 mg ) , placebo gum and no gum conditions on mood and attention . METHODS A double blind placebo controlled study was conducted with volunteers being r and omly assigned to one of the three conditions . Baseline measures of mood and attention were taken prior to chewing and a test session was then conducted . One hundred and eighteen young adults participated in the study . RESULTS Caffeinated gum was associated with a more positive mood and better performance on tasks requiring sustained attention . The caffeine improved the speed of encoding of new information which is consistent with previous findings . Chewing placebo gum was also found to be associated with more positive mood , both shortly after chewing and at the end of the study . CONCLUSIONS The implication s of the present study are that chewing caffeinated gum has been shown to improve performance efficiency and mood by its alerting and energising effects . The profile of caffeine effects is what one would predict from the existing caffeine literature and such effects may be extremely beneficial in real-life situations . Prior chewing of placebo gum was associated with a more positive mood and this also confirms previous findings This study tests the hypothesis that chewing gum leads to cognitive benefits through improved delivery of glucose to the brain , by comparing the cognitive performance effects of gum and glucose administered separately and together . Participants completed a battery of cognitive tests in a fully related 2 x 2 design , where one factor was Chewing Gum ( gum vs. mint sweet ) and the other factor was Glucose Co-administration ( consuming a 25 g glucose drink vs. consuming water ) . For four tests ( AVLT Immediate Recall , Digit Span , Spatial Span and Grammatical Transformation ) , beneficial effects of chewing and glucose were found , supporting the study hypothesis . However , on AVLT Delayed Recall , enhancement due to chewing gum was not paralleled by glucose enhancement , suggesting an alternative mechanism . The glucose delivery model is supported with respect to the cognitive domains : working memory , immediate episodic long-term memory and language -based attention and processing speed . However , some other mechanism is more likely to underlie the facilitatory effect of chewing gum on delayed episodic long-term memory Chewing has been shown to alleviate feelings of sleepiness and improve cognitive performance during the day . This study investigated the effect of chewing on alertness and cognitive performance across one night without sleep as well as the possible mediating role of cardiac autonomic activity . Fourteen adults participated in a r and omized , counterbalanced protocol employing a chewing , placebo and caffeine condition . Participants completed tasks assessing psychomotor vigilance , tracking , grammatical reasoning , alertness and sleepiness each hour across the night . All participants received either placebo or caffeine ( 200 mg ) , while the chewing condition also chewed on a tasteless and odorless substance for 15 min each hour . Heart rate ( HR ) , root mean square of the successive differences in R-R intervals on the ECG ( RMSSD ) , and preejection period ( PEP ) were simultaneously recorded . Alertness and cognitive performance amongst the chewing condition did not differ or were in fact worse when compared with placebo . Similarly , measures of HR and RMSSD remained the same between these two conditions ; however , PEP was reduced in the later part of the night in the chewing condition compared with a relative increase for placebo . Caffeine led to improved speed and accuracy on cognitive tasks and increased alertness when compared with chewing . Relative increases in RMSSD and reductions in HR were demonstrated following caffeine ; however , no change in PEP was seen . Strong associations between cardiac parasympathetic activity and complex cognitive tasks , as well as between subjective alertness and simpler cognitive tasks , suggest a differential process mediating complex versus simple cognitive performance during sleep deprivation The present study aim ed to examine the psychosomatic effect in the chewing of marketed gum using electroencephalogram ( EEG ) as an index . The EEG were taken in two sets : ( i ) a resting period before chewing ( control recording ) and a resting record ( post-resting recording ) for examining reproducibility ; and ( ii ) a control recording and resting period after gum-chewing for 3 min ( post-chewing recording ) . The ratio of each frequency b and to the total frequency power , the mean frequency of the alpha b and and laterality of the frequency power was calculated . In the examination of the reproducibility , no statistically significant differences were observed between control recording and post-resting recording in all indices . In the reflection of EEG after gum-chewing , there were no significant differences between control recording and the post-chewing recording . However , a significant interaction was observed among these indices by analysis of variance . In addition , the alpha power in the post-chewing recording was significantly higher than that in the control recording at almost all the positions . In conclusion , the intra-individual reproducibility of EEG was confirmed in the recording method . Furthermore , it was suggested that a significant interaction and a rising trend of the mean frequency of the alpha b and after gum-chewing reflected ' arousal ' psychosomatic responses by the chewing of marketed gum OBJECTIVES To investigate the relationship between periodontal disease and cognitive decline . DESIGN Analysis of a prospect i ve cohort study . SETTING The Health , Aging and Body Composition ( Health ABC ) Study . PARTICIPANTS One thous and fifty-three participants who were administered the Modified Mini-Mental State Examination ( 3MS ) at Year 1 ( baseline ) and Year 3 and had participated in a comprehensive periodontal examination at Year 2 . MEASUREMENTS The prospect i ve association between a range of oral health parameters and cognitive function was examined . Decline in 3MS score from Year 3 to 5 was investigated in 947 ( 89.9 % ) participants . Covariates included age , sex , education , race , cardiovascular disease and risk , and depressive symptoms . RESULTS Most indicators of adverse oral health at Year 2 were associated with cognitive impairment based on averaged 3MS scores less than 80 for Years 1 and 3 , but education and race substantially confounded these associations . Higher gingival index , a measure of gingival inflammation , at Year 2 remained independently associated with this definition of cognitive impairment and , in fully adjusted analyses , was also an independent predictor of a more-than-5-point cognitive decline from Year 3 to 5 . CONCLUSION Periodontitis may be a risk factor for cognitive decline . Gingivitis is reversible , and periodontitis to some degree is preventable and controllable when manifest . Therefore , further research is needed to clarify potential underlying mechanisms and oral health interventions that might ameliorate cognitive decline CognitiveDrug Research Ltd.,ReadingRG301EA , UKMany people chew gum partly due to the belief that itincreases aspects of mental performance , including concen-tration . To the best of our knowledge no empirical evidence exists to support this contention . The present experiment , therefore , examined the effects of chewing gum using acomprehensive and sensitive cognitive assessment battery and two tasks manipulating cognitive load . Heart rateresponses were also measured . Seventy-five healthy adult participants ( mean age 246years ) were r and omly assigned to one of three experimentalconditions ( N‹25 per group ) : ‘ ‘ chewing ’ ’ – a piece of sugar-free chewing gum ( Wrigley ’s Extra Spearmint ) was chewednaturally and constantly throughout the procedure ; ‘ ‘ shamchewing ’ ’ – participants mimicked chewing movements in theabsence of gum ; ‘ ‘ quiet control ’ ’ – no chewing behaviour wasperformed . Aspects of attention , working memory and long-termmemory were assessed using the Cognitive Drug Research ( CDR ) computerised battery . Stimuli were presented on acolour monitor and , except for two written word recall tasks , responses were collected automatically using a ‘ ‘ Yes’’/‘‘No’’responsemodule . Thetaskswerepresentedintheorder : Wordpresentation , Immediate Word Recall , Picture Presentation , SimpleReactionTime , DigitVigilance , ChoiceReactionTime , Spatial Working Memory , Numeric Working Memory , Delayed Word Recall , Word Recognition and PictureRecognition ( for details , e.g. see Kennedy et al. 2000).Following the CDR battery , participants performed compu-terised Serial Subtractions tasks . These assess concentration and working memory and allow manipulation of cognitiveload ( see Scholey et al. , 2001 for details ) . In the present study SerialThrees(involvingtherepeatedsubtractionofthreefroma r and omly generated starting number using the computer’snumerickeypad)thenSerialSevens(subtractionofseven)wereused , each for 2min . Eachcognitive task outcome measurewasanalysedby one-way analysis ofvariance , withDunnettcomparisonstoisolatebetween-group effects where appropriate . The most strikingfindingwasasignificanteffectonbothimmediate and delayedword recall , with more words being recalled in the chewingconditioncomparedwiththequietcontrolcondition(Table1).The Spatial Working Memory sensitivity index and Numericworkingmemoryreactiontimeweresimilarlyimprovedinthechewingcondition , and alsointheshamchewingconditionforthe latter measure ( which reflects the efficiency of workingmemory operations ) . In addition , simple reaction times wereslowerintheshamchewingconditionthaninthequietcontrolcondition . Baseline heart rate recordings ( sample d at 30-s intervals)began 240s prior to treatment and continued during a 180-speriod of chewing , sham chewing or sitting quietly prior tocognitive assessment ( which lasted about 30min in all ) . Heartrate ( mean bpm ) was calculated during baseline , treatment , each of the 10 CDR tasks and both Serial Subtraction tasks . Heart rate changes relative to baseline were subjected to a3(Condition ) 14(Phase ) factorial ANOVA with repeated measures on the latter factor . The main effect of conditionapproached significance , F(2,936)‹30 , p‹006 ; heart ratesweresignificantlyhigherinthechewingconditionthaninquietcontrols , p<005 ( Fig. 1 ) . There was also a significant maineffect oftask , F(13,936)‹130,p<001:with theexceptionofSimple Reaction Time and Delayed Word Recall , all taskphasesofthe study wereassociatedwithsignificantincreasesinheart rate . There was also a significant task conditioninteraction , F(26,936)‹256 , p<001.These results providedthefirst evidence thatthechewingofgum can improve episodic memory ( involving the learning , storage and retrieval of information ) and working memory(where information is held ‘ ‘ on line ’ ’ ) . They did not indicatethat gum-chewing improves aspects of attention , at least asmeasured here . The impaired Simple Reaction Time during sham chewingmay reflect diversion of attentional re sources during initialstages of performing this unfamiliar behaviour . This is con-sistent with the elevated heart rate observed while shamchewing in earlierphases of the experiment ( Fig. 1 ) . Althoughanactivecontrolisimportant , shamchewingmaynotbeidealfor this purpose , because most cognitive scores ( except , nota-E-mail : [email protected] bly , Numeric Working Memory Reaction Time ) in this group0195–6663/02/$ – see front matter # 2002 Elsevier Science Ltd. All rights reserved The notion that chewing gum may relieve stress was investigated Output:	These effects also appeared with improvement in mood and stress relief and were influenced by time-on-task effect . Further studies are needed , but chewing could be useful for modifying cognitive function
MS21768	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE effects of Fosfomycin ( FOM ) nebulizer therapy were studied in patients with chronic sinusitis . METHODS about 28 patients with chronic sinusitis were administered 2 ml of FOM sodium ( 3 % w/v ) by nebulizer three times per week for 4 weeks . Levels of IL-1 beta , IL-6 , IL-8 , and TNF-alpha in nasal lavage were also measured before and at the end of treatment . RESULTS the overall efficacy of this treatment on the basis of both subjective and objective symptoms , was ' excellent ' for 28.6 % , ' good ' for 10.7 % , ' fair ' for 39.4 % , and yield ' no change ' for 21.4 % of the patients . Both IL-1 beta and IL-6 concentrations were significantly decreased after treatment . Although the IL-8 level did not significantly decrease , it seems to be related to the overall efficacy . TNF-alpha was not detected in all of the sample s. CONCLUSION FOM nebulization therapy is highly effective in treatment for chronic sinusitis , and efficacy may be due to an immunomodulatory mechanism , as well as its bactericidal effect BACKGROUND Chronic rhinosinusitis ( CRS ) is one of the most common chronic diseases . Recently , it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease . On the basis of this hypothesis , intranasal treatment with amphotericin B should benefit patients with CRS . Data from 2 uncontrolled and 2 controlled trials are conflicting , however . OBJECTIVE To clarify the role of intranasal antifungal drugs in the treatment of CRS , we conducted a large , double-blind , placebo-controlled , multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo . METHODS A total of 116 r and omly selected patients with CRS were instructed to instill 25 mL amphotericin B ( 100 microg/mL ) or placebo to each nostril twice daily for 3 months . Primary outcomes included a reduction in total visual analog scale ( VAS ) score and nasal endoscopy score . Secondary outcome measures included peak nasal inspiratory flow , polyp score , quality of life ( Short Form-36 , Rhinosinusitis Outcome Measure-31 ) , and individual VAS scores . RESULTS Analysis was based on intention to treat and involved all patients r and omly assigned . Mean VAS scores , Short Form-36 and Rhinosinusitis Outcome Measure-31 data , peak nasal inspiratory flow values , nasal endoscopy scores , and polyp scores were similar in both treatment groups at the time of r and omization , and no significant differences were observed after 13 weeks of treatment . CONCLUSION Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS . CLINICAL IMPLICATION S Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS Efficacy and safety of a new oral third generation Cephalosporin , Cefotiam Hexetil ( CTM ) 200 mg bid were compared with those of Cefixime ( CX ) 200 mg bid over 10 day duration of treatment . One hundred and twenty two ambulatory adults suffering from chronic sinusitis were r and omized by ENT specialists in this multicentre prospect i ve double blind , doubled dummy study . Sinusitis diagnosis evocated in front of fascial pain , purulent nasal discharge and /or obstruction was confirmed with sinus X-ray . Use of antibiotics or corticosteroids concomitantly or 15 days prior inclusion represented one of the major exclusion criterion . One hundred and seventy one patients were evaluated for efficacy analysis ( 62 and 59 respectively in CTM and CX groups ) . Regarding demographic data , clinical and radiological signs , the two population s were comparable at inclusion excepted for sex and weight ( female : 73 % in CTM group versus 47 % in CX group ) . The overall clinical success rate at the end of treatment ( cure+improvement ) was not significantly different between the two groups ( CTM : 82 % versus CX : 80 % ) . The incidence of adverse events was less frequent in the CTM group ( 14.5 % versus 19 % ) . In conclusion , CTM 200 mg bid is as efficacious and as well tolerated as CX 200 mg bid in the treatment of chronic sinusitis in adults BACKGROUND There is little scientific evidence to support the current practice of using oral glucocorticosteroids and antibiotics to treat patients with chronic rhinosinusitis and nasal polyps . OBJECTIVE We evaluated the effects of oral glucocorticoids and doxycycline on symptoms and objective clinical and biological parameters in patients with chronic rhinosinusitis and nasal polyps . METHODS In a double-blind , placebo-controlled , multicenter trial , we r and omly assigned 47 participants with bilateral nasal polyps to receive either methylprednisolone in decreasing doses ( 32 - 8 mg once daily ) , doxycycline ( 200 mg on the first day , followed by 100 mg once daily ) , or placebo for 20 days . Participants were followed for 12 weeks . Patients were assessed for nasal peak inspiratory flow and symptoms and by nasal endoscopy . Markers of inflammation such as eosinophilic cationic protein ( ECP ) , IL-5 , myeloperoxidase , matrix metalloproteinase 9 , and IgE were measured in nasal secretions . Concentrations of eosinophils , ECP , and soluble IL-5 receptor alpha were measured in peripheral blood sample s. RESULTS Methylprednisolone and doxycycline each significantly decreased nasal polyp size compared with placebo . The effect of methylprednisolone was maximal at week 3 and lasted until week 8 , whereas the effect of doxycycline was moderate but present for 12 weeks . Methylprednisolone significantly reduced levels of ECP , IL-5 , and IgE in nasal secretions , whereas doxycycline significantly reduced levels of myeloperoxidase , ECP , and matrix metalloproteinase 9 in nasal secretions . CONCLUSION This is the first double-blind , placebo-controlled study to show a significant effect of oral methylprednisolone and doxycycline on size of nasal polyps , nasal symptoms , and mucosal and systemic markers of inflammation BACKGROUND Recently , fungal elements were suspected to be the causative agent of chronic rhinosinusitis , and benefits of topical amphotericin B therapy have been reported . OBJECTIVE The effects of amphotericin B versus control nasal spray on chronic rhinosinusitis were compared in a double-blind , r and omized clinical trial . METHODS Patients with chronic rhinosinusitis were administered 200 microL per nostril amphotericin B ( 3 mg/mL ) or saline nasal spray 4 times daily over a period of 8 weeks . The response rate , defined as a 50 % reduction of pretreatment computed tomography score , was the primary outcome variable . Additional outcome variables included a symptom score , a quality of life score , and an endoscopy score . Before and after treatment , nasal lavages were pretreated with dithiothreitol and examined for fungal elements by PCR and st and ard culture techniques . RESULTS Seventy-eight patients were included , and 60 patients finished the study per protocol . In the control group , no positive response ( 0 of 32 ) was observed , and 2 of 28 patients responded in the amphotericin B group ( P>.2 ) . The symptom scores were distinctly worse after amphotericin B therapy ( P < .005 ) . The other parameters investigated did not differ remarkably between the treatment groups . CONCLUSION Nasal amphotericin B spray in the described dosing and time schedule is ineffective and deteriorates patient symptoms OBJECTIVES /HYPOTHESIS To examine the efficacy and tolerability of topical mupirocin for the management of surgically recalcitrant chronic rhinosinusitis ( CRS ) associated with Staphylococcus aureus infection . STUDY DESIGN Prospect i ve open-label pilot study . METHODS Patients with surgically recalcitrant CRS who had positive nasendoscopically guided cultures for Staphylococcus aureus were treated with twice daily nasal lavages containing 0.05 % Mupirocin and lactated ringers salts . The duration of treatment was 3 weeks . Patients were assessed before and after treatment in terms of nasendoscopic findings , microbiology results , and Sinonasal Outcome Test ( SNOT-20 ) and visual analogue scale question naires . RESULTS Fifteen of 16 patients had improved nasendoscopic findings after treatment . Twelve of 16 patients noted overall symptom improvement . Fifteen of 16 patients had negative swab results for Staphylococcus aureus after treatment . Only minimal adverse effects were experienced . CONCLUSIONS Nasal Lavage with 0.05 % Mupirocin may represent an effective and well tolerated alternative treatment for postsurgical recalcitrant CRS OBJECTIVES Conventional management of allergic fungal rhinosinusitis ( AFRS ) after surgery consists of the use of steroids to immunomodulate the body 's response to fungi . However , there are many side effects to prolonged steroid use , and some patients are unresponsive to st and ard treatment . The role of systemic antifungal drugs in AFRS is still largely unknown . This was a pilot study to evaluate the effectiveness of itraconazole , an oral antifungal drug , in the treatment of refractory AFRS . METHOD Thirty-two patients with AFRS who had had surgery and were refractory to prednisone , steroid , and amphotericin B nasal sprays were treated with itraconazole for at least 3 months . They were evaluated with pre- and posttreatment endoscopic examinations , serum immunoglobulin E ( IgE ) , and the 31-Item Rhinosinusitis Outcome Measure ( RSOM-31 ) question naires . Monthly liver function tests were done to monitor for the hepatic side effects of itraconazole . RESULTS Twelve cases had endoscopic improvement . Fifteen had no difference , and five had a worse endoscopic stage after 3 months . One patient had to stop treatment due to abnormal liver function tests . The mean pre- and posttreatment IgE levels were 581 microg/L and 766 microg/L , respectively . Subjectively , 9 patients ( 28 % ) reported a significant improvement , 9 ( 28 % ) had moderate improvements , and 14 ( 44 % ) reported little or no change . There was no correlation between the subjective and the endoscopic changes . CONCLUSION Itraconazole may be useful as an adjunct in the management of AFRS . However , more studies , including a prospect i ve r and omized clinical trial , are required to determine if itraconazole is effective in the management of AFRS BACKGROUND It has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of chronic rhinosinusitis ( CRS ) . Based on this rationale , the use of topical antifungals ( amphotericin B ) has been advocated . Studies on its clinical effectiveness are , however , contradictory . OBJECTIVES To examine the effect of nasal antifungal treatment on secreted mediators in sample s of nasal lavage fluid from patients with CRS with or without nasal polyps ( NP ) . METHODS Part two of a prospect i ve double-blind , placebo-controlled multicenter clinical trial investigating the effect of 13 weeks of treatment with amphotericin B or placebo on the levels of pro-inflammatory cytokines , chemokines and growth factors ( i.e. , IL-1beta , IL-1RA , IL-2 , IL-2R , IL-3 , IL-4 , IL-5 , IL-6 , IL-7 , IL-8 , IL-10 , IL-12 ( p40/p70 subunits ) , IL-13 , IL-15 , IL-17 , TNF-alpha , IFN-alpha , IFN-gamma , G-CSF , GM-CSF , MIP-1alpha , MIP-1beta , IP-10 , MIG , eotaxin , RANTES , MCP-1 , MCP-2 , MCP-3 , VEGF , EGF , FGF-basic , HGF , Gro-alpha ) and albumin via a fluorescent enzyme immunoassay in nasal lavage specimens of CRS patients with or without NP . RESULTS Topical amphotericin B had no significant effect on the level of any of the tested pro-inflammatory cytokines , chemokines , and growth factors in CRS nasal lavage sample s. Treatment with placebo , however , increased the level of MIP-1alpha and MIP-1beta , which are mediators involved in wound healing . CONCLUSIONS Topical amphotericin B has no significant effect on activation markers of nasal inflammatory cells in chronic rhinosinusitis with or without nasal polyps BACKGROUND The treatment of acute , recurrent , and chronic sinusitis remains controversial because of the presence of a wide variety of aerobic and anaerobic bacteria in the sinuses . DESIGN This double-blind , r and omized trial compared cefaclor with amoxicillin in the treatment of acute , recurrent , and chronic maxillary sinusitis using clinical evaluation , roentgenography , and microbiologic evaluation of antral aspirates . SETTING Outpatient Output:	CONCLUSION Based on the available evidence , oral antibacterial antibiotics and prolonged macrolide antibiotics are considered therapeutic options in the treatment of CRS while the use of topical antibacterial antibiotics , intravenous antibacterial antibiotics and oral , topical , or intravenous antifungals would be recommended against .
MS21769	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A total of 5082 men and women in the Framingham Heart Study population who were free of any glucose abnormality and aged 33 to 67 years were followed prospect ively over 14 years for the occurrence of glucose intolerance . The diagnosis of glucose intolerance was defined as developing documented hyperglycemia or being placed on justified treatment by a physician . The 14-year incidence was 6.7 % in men and 5.5 % in women . Multivariate analysis was used and future glucose intolerance in men and women was highly associated with casual blood glucose , Metropolitan Relative Weight and very low density lipoproteins at the baseline exam . Other factors showed only sex-specific or univariate associations . Obesity and lipoprotein abnormalities were shown to be independent markers in the prediction of future glucose intolerance OBJECTIVE Traditional blood glucose – lowering agents do not sustain adequate glycemic control in most type 2 diabetic patients . Pre clinical studies with exenatide have suggested sustained improvements in β-cell function . We investigated the effects of 52 weeks of treatment with exenatide or insulin glargine followed by an off-drug period on hyperglycemic clamp – derived measures of β-cell function , glycemic control , and body weight . RESEARCH DESIGN AND METHODS Sixty-nine metformin-treated patients with type 2 diabetes were r and omly assigned to exenatide ( n = 36 ) or insulin glargine ( n = 33 ) . β-Cell function was measured during an arginine-stimulated hyperglycemic clamp at week 0 , at week 52 , and after a 4-week off-drug period . Additional end points included effects on glycemic control , body weight , and safety . RESULTS Treatment-induced change in combined glucose- and arginine-stimulated C-peptide secretion was 2.46-fold ( 95 % CI 2.09–2.90 , P < 0.0001 ) greater after a 52-week exenatide treatment compared with insulin glargine treatment . Both exenatide and insulin glargine reduced A1C similarly : −0.8 ± 0.1 and −0.7 ± 0.2 % , respectively ( P = 0.55 ) . Exenatide reduced body weight compared with insulin glargine ( difference −4.6 kg , P < 0.0001 ) . β-Cell function measures returned to pretreatment values in both groups after a 4-week off-drug period . A1C and body weight rose to pretreatment values 12 weeks after discontinuation of either exenatide or insulin glargine therapy . CONCLUSIONS Exenatide significantly improves β-cell function during 1 year of treatment compared with titrated insulin glargine . After cessation of both exenatide and insulin glargine therapy , β-cell function and glycemic control returned to pretreatment values , suggesting that ongoing treatment is necessary to maintain the beneficial effects of either therapy OBJECTIVE Intensive glucose-lowering therapy ( INT ) did not reduce macrovascular events in the recent r and omized trials , possibly because it did not improve or worsen other traditional or novel cardiovascular risk factors . RESEARCH DESIGN AND METHODS St and ard plasma lipids , cholesterol content of lipoprotein subfractions , and plasma inflammatory and prothrombotic markers were determined in a subgroup of the Veterans Affairs Diabetes Trial ( VADT ) participants ( n = 266 ) at baseline and after 9 months of INT or st and ard therapy . RESULTS INT lowered glycated hemoglobin ( by a median of 2 % vs. a median of 0.7 % by st and ard treatment ; P < 0.0001 ) ; increased BMI ( 4 vs. 1 % ; P < 0.001 ) , total HDL ( 9 vs. 4 % ; P < 0.05 ) , HDL2 ( 14 vs. 0 % ; P = 0.009 ) , LDL2 ( 36 vs. 1 % ; P < 0.0001 ) , and plasma adiponectin ( 130 vs. 80 % ; P < 0.01 ) ; and reduced triglycerides ( −13 vs. −4 % ; P = 0.02 ) and small , dense LDL4 ( −39 vs. −13 % ; P < 0.001 ) , but had no effect on levels of plasma apolipoproteins B-100 and B-48 , C-reactive protein , interleukin-6 , lipoprotein-associated phospholipase A2 , myeloperoxidase , fibrinogen , and plasminogen activator inhibitor 1 . Incident macrovascular events were associated with baseline interleukin-6 ( hazard ratio per each quartile increase 1.33 [ 95 % CI 1.06–1.66 ] ) , total LDL ( 1.25 [ 1.01–1.55 ] ) , apolipoprotein B-100 ( 1.29 [ 1.01–1.65 ] ) , and fibrinogen ( 1.26 [ 1.01–1.57 ] ) but not changes in any cardiovascular risk factors at 9 months . CONCLUSIONS INT was associated with improved adiponectin , lipid levels , and a favorable shift in LDL and HDL subfractions after 9 months . These data suggest that the failure of INT to lower cardiovascular outcomes occurred despite generally favorable changes in st and ard and novel risk factors early in the study Abstract Background : An increase in body weight is a commonly perceived effect of insulin therapy for type 2 diabetes mellitus , and this may serve as a barrier to insulin initiation and usage . Objective : To investigate the baseline clinical and demographic factors associated with weight gain during insulin glargine therapy , and the implication s of weight change on clinical outcomes . Methods : This was a retrospective analysis of patient-level data from phase 3 or 4 r and omized controlled , treat-to-target ( fasting plasma glucose [ FPG ] ≤ 100 mg/dL ) trials evaluating basal insulin glargine for ≥ 24 weeks . The Pearson correlation coefficient and Cochran-Armitage trend statistic were used to calculate the existence of a trend between absolute and relative weight change , and relative glycated hemoglobin ( HbA1c ) change from baseline ; likelihood of achieving target HbA1c < 7.0 % ; change from baseline FPG ; insulin dose requirements ; incidence of hypoglycemia ; and adverse events . Results : Eleven studies were included , encompassing a total of 2140 patients . Patients starting insulin glargine treatment gained a mean ± st and ard deviation 1.8 ± 3.7 kg ( 4.0 ± 8.2 lb ) . Most patients had limited weight change ( ± 2.5 kg or 5.5 lb ) . Younger age , higher baseline HbA1c , and higher baseline FPG were predictive of greater weight gain ( P < 0.0001 ) . Those who gained more weight experienced the largest decrease from baseline in HbA1c and FPG . More weight gain was associated with higher insulin dose requirements , an increased risk of experiencing either symptomatic or glucose-confirmed ( < 70 mg/dL ) hypoglycemia , and more adverse events . Older patients ( > 65 years ) were less likely to gain weight or to experience glucose-confirmed hypoglycemia , but more likely to experience severe hypoglycemia . Conclusions : In this retrospective analysis of patient-level data , most patients had a stable weight ( defined as ± 2.5 kg ) after 24 weeks of insulin glargine , and weight gain varied with patient demographics . Therefore , insulin glargine can be used in these patient groups with type 2 diabetes without expectation of significant weight gain Background Both insulin and thiazolidinediones ( TZDs ) are effective in the treatment of hyperglycaemia and amelioration of insulin resistance in type 2 diabetes but have side effects including weight gain and fluid retention . The use of TZDs has been further hampered by the risk of adverse cardiovascular events including heart failure . The present study evaluated the effect of pioglitazone or insulin glargine on cardiac function and size as well as on surrogate markers of fluid retention such as weight , haemoglobin and natriuretic peptides . Methods Thirty patients with inadequate glycaemic control on metformin and sulfonylurea were r and omised to receive add-on therapy with insulin glargine or pioglitazone for 26 weeks . Echocardiographic data and blood sample s were collected from the two groups before the start of the treatment and after 26 weeks . Left ventricular end-diastolic and left atrial end-systolic volumes were quantified , weight measured and blood sample s analyzed . Results After 26 weeks of treatment , the changes in HbA1c , weight and haemoglobin were similar between the two groups . HDL increased significantly in the pioglitazone group . While there was an increase in natriuretic peptides in the pioglitazone group ( NT-proBNP 11.4 ± 19.6 to 22.8 ± 44.0 , p = 0.046 ) , the difference between the treatment groups was not significant . Left ventricular end-diastolic volume increased by 11 % and left atrial end-systolic volume by 17 % in the pioglitazone group ( Both , p < 0.05 , between treatment groups ) . There was a borderline significant increase in ejection fraction in the pioglitazone group . Conclusion This r and omised pilot- study showed that six-month treatment with pioglitazone induced significant increases in natriuretic peptides and alterations of cardiac size . These changes were not observed with insulin glargine , which also is known to induce fluid retention . Larger r and omised trials are warranted to confirm these findings AIM We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus ( T2DM ) treated with liraglutide versus comparator diabetes therapies . METHODS Twenty-six-week data from seven phase 3 , r and omized trials in the liraglutide T2DM development programme were analysed by trial and treatment group : liraglutide ( 1.2 and 1.8 mg ) , active comparator and placebo . Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline ; impact of body mass index ( BMI ) and gastrointestinal ( GI ) adverse events ( AEs ) on weight change and correlation of weight change with change in glycosylated haemoglobin ( HbA1c ) . RESULTS A number of subjects experienced > 5 % weight loss during the trials ( 24.4 % liraglutide 1.8 mg and 17.7 % liraglutide 1.2 mg ; 17.7 % exenatide , 10.0 % sitagliptin , 3.6 - 7.0 % sulphonylurea , 2.6 % thiazolidinedione and 2.6 % glargine ; 9.9 % placebo ) . More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide . Across trials , higher initial BMI was associated with slightly greater weight loss with liraglutide . Mean weight loss increased slightly the longer GI AEs persisted . Although HbA1c reduction was slightly larger in higher weight loss categories across treatments ( including placebo ) , sample sizes were small and no clear correlation could be determined . Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced ; thus , not all HbA1c-lowering effect appears weight mediated . CONCLUSIONS The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis . Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects OBJECTIVE Mealtime insulin is commonly added to manage hyperglycemia in type 2 diabetes when basal insulin is insufficient . However , this complex regimen is associated with weight gain and hypoglycemia . This study compared the efficacy and safety of exenatide twice daily or mealtime insulin lispro in patients inadequately controlled by insulin glargine and metformin despite up-titration . RESEARCH DESIGN AND METHODS In this 30-week , open-label , multicenter , r and omized , noninferiority trial with 12 weeks prior insulin optimization , 627 patients with insufficient postoptimization glycated hemoglobin A1c ( HbA1c ) were r and omized to exenatide ( 10–20 µg/day ) or thrice-daily mealtime lispro titrated to premeal glucose of 5.6–6.0 mmol/L , both added to insulin glargine ( mean 61 units/day at r and omization ) and metformin ( mean 2,000 mg/day ) . RESULTS R and omization HbA1c and fasting glucose ( FG ) were 8.3 % ( 67 mmol/mol ) and 7.1 mmol/L for exenatide and 8.2 % ( 66 mmol/mol ) and 7.1 mm Output:	There was no difference in the risk of all-cause mortality and adverse cardiovascular ( CV ) events between Insulin and non-insulin GLTs . Insulin was associated with superior reduction in HbA1c ; least reduction in weight and higher risk of hypoglycaemia . Both showed similar proportion of patients achieving HbA1c target . Non-insulin GLTs were associated with a higher risk in reported adverse drug events
MS21770	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The double-blind , placebo-controlled food challenge ( DBPCFC ) is the " gold st and ard " for diagnosis of food hypersensitivity . Skin prick tests and RASTs are sensitive indicators of food-specific IgE antibodies but poor predictors of clinical reactivity . Previous studies suggested that high concentrations of food-specific IgE antibody were predictive of food-induced clinical symptoms . Because the CAP System FEIA ( Pharmacia Diagnostics , Uppsala , Sweden ) provides a quantitative assessment of allergen-specific IgE antibody , this study was undertaken to determine the potential utility of the CAP System FEIA in diagnosis of IgE-mediated food hypersensitivity . METHODS Sera from 196 patients with food allergy were analyzed for specific IgE antibodies to egg , milk , peanut , soy , wheat , and fish by CAP System FEIA . Sera were r and omly selected from 300 stored sample s of children and adolescents who had been evaluated by history , skin prick tests , and DBPCFCs . The study population was highly atopic ; all patients had atopic dermatitis , and approximately 50 % had asthma and allergic rhinitis at the time of initial evaluation . The performance characteristics of the CAP System FEIA were compared with those of skin prick tests and the outcome of DBPCFCs or " convincing " histories of anaphylactic reactions . RESULTS The prevalence of specific food allergies in the study population varied from 22 % for wheat to 73 % for egg . Allergy to egg , milk , peanut , and soy accounted for 87 % of confirmed reactions . The performance characteristics of skin prick tests and CAP System FEIA ( egg , milk , peanut , fish ) were comparable , with excellent sensitivity and negative predictive accuracy but poor specificity and positive predictive accuracy . The performance characteristics of the CAP System FEIA for soy and wheat were poor . For egg , milk , peanut , and fish allergy , diagnostic levels of IgE , which could predict clinical reactivity in this population with greater than 95 % certainty , were identified : egg , 6 kilounits of allergen-specific IgE per liter ( kU[A]/L ) ; milk , 32 kU(A)/L ; peanut , 15 kU(A)/L ; and fish , 20 kU(A)/L. CONCLUSIONS When compared with the outcome of DBPCFCs , results of CAP System FEIA are generally comparable to those of skin prick tests in predicting symptomatic food hypersensitivity . Furthermore , by measuring the concentrations of food-specific IgE antibodies with the CAP System FEIA , it is possible to identify a subset of patients who are highly likely ( > 95 % ) to experience clinical reactions to egg , milk , peanut , or fish . This could eliminate the need to perform DBPCFCs in a significant number of patients suspected of having IgE-mediated food allergy BACKGROUND Little is known about the cause of food-induced anaphylaxis in children or about the factors that might affect its clinical severity . OBJECTIVE The aim of this study was to investigate the cause of food-induced anaphylaxis in children in Italy and to identify factors that could influence the appearance of symptoms and the severity of anaphylaxis . METHODS One hundred and sixty-three children with anaphylaxis consecutively attending 29 outpatient allergy clinics throughout Italy were enrolled in this prospect i ve study . Information about past anaphylaxis episodes was collected with a st and ardized question naire . Food sensitization was evaluated by skin-prick test . RESULTS A clinical history of asthma increased the risk of wheezing [ odds ratio ( OR ) 2.2 ; 95 % confidence interval ( CI ) 1.1 - 4.5 ] and respiratory arrest ( OR 6.9 ; 95 % CI 1.4 - 34.2 ) . A clinical history of chronic/relapsing gastrointestinal symptoms increased the risk of vomiting ( OR 2.1 ; 95 % CI 0.9 - 4.3 ) , hypotension ( OR 7.9 ; 95 % CI 1.9 - 32.0 ) , and bradycardia/cardiac arrest ( OR 9.2 ; 95 % CI 0.9 - 91.3 ) . The severity of present and previous episodes was similar only in patients with mild or moderate anaphylaxis . Peanut and egg were the most frequent causes of severe anaphylaxis . CONCLUSIONS A clinical history of asthma and chronic/relapsing gastrointestinal symptoms ( probably linked to food allergy ) may predict the development of respiratory and gastrointestinal symptoms and the severity of anaphylaxis Background : The objective of the present study was to evaluate the relevance of skin tests and the concentration of cow 's milk‐specific IgE antibodies in correlation with oral cow 's milk challenge in infants with suspected cow 's milk allergy Five children aged 12‐40 months with IgE‐mediated adverse reactions to cow milk ( immediate onset clinical pattern of cow milk allergy ) were orally challenged double‐blind in r and om order with three different milk preparations processed from the same batch of milk 1 ) raw untreated cow milk , 2 ) pasteurized cow milk , 3 ) homogenized and pasteurized cow milk , and 4 ) Nutramigen ® (a commercial hypoallergenic infant formula based on hydrolysed casein ) as placebo . Skin prick tests with the same preparations were also performed . On oral challenge the three different processed milk types provoked significant and similar allergic reactions in each child , and no adverse reactions followed the challenge with placebo ( Nutramigen ) . Skin prick test with the same milk products were positive in all children and comparable to the results with an extract of purified raw cow milk protein ( Soluprickreg ; ) , whereas Nutramigen did not elicit any skin reactions . A tendency towards a lower threshold of reaction and larger skin reactions induced by the processed milk preparations might indicate an increased ability of pasteurized and homogenized/pasteurized milk to evoke allergic reactions in patients allergic to milk BACKGROUND A milk-free diet with substitute formula should be established when immediate symptomatic hypersensitivity to cows ' milk protein ( CMP ) is diagnosed , and therefore an accurate diagnosis is very important . OBJECTIVE This study aims to find the optimal cutoff values for specific IgE antibody levels that discriminate between allergic and tolerant infants by using cows ' milk and its principal proteins as allergens . METHODS A prospect i ve study was carried out on 170 patients under 1 year old ( mean , 4.8 months ) . These patients were seen consecutively over a 4-year period in our outpatient clinic and for the first time because of a reaction suggesting immediate hypersensitivity after ingestion of cows ' milk formula . A clinical history , prick test with cows ' milk and its proteins ( alpha-lact-albumin , beta-lactoglobulin , and casein ) , determination of specific IgE antibodies with the CAP system FEIA for the same allergens as for the prick test , and a challenge test according to the diagnostic protocol were performed in all of the children . A study of validity of the prick test ( cutoff point , 3 mm ) and CAP system by using different cutoff points in the specific IgE values for cows ' milk and its proteins were also analyzed . RESULTS Prevalence of immediate symptomatic hypersensitivity to CMP in this study was 44 % . When both the whole milk and its principal milk proteins were used in the prick test , the negative predictive value was very high , and a negative value excluded allergy in 97 % of the patients . When the different cutoff points of the specific IgE for milk were analyzed , 2.5 KU(A)/L had a positive predictive value of 90 % and 5 KU(A)/L had a positive predictive value of 95 % . CONCLUSIONS When diagnosing immediate hypersensitivity to CMP in infants , negative skin test responses exclude allergy in most of the patients . If the prick test response is positive , specific IgE levels for cows ' milk may be helpful . If these values are 2.5 KU(A)/L or greater , the challenge test should not be performed because of its high positive predictive value ( 90 % ) Skin Prick Test ( SPT 's ) are performed to identify the causes of allergy . However , low diagnostic accuracy is a limitation to SPT , for which many possible causes have been suggested . The protein composition and allergenicity of crude allergen extracts from foods and commercial allergen extracts for SPT were analyzed . Clinical significance s of SPT using crude allergen extracts from foods were compared with those using commercial allergen extracts . A total of 292 atopic dermatitis patients were involved in this study . Crude allergen extracts were prepared from milk , egg white , egg yolk , and soybean . The protein composition of food allergen extracts and commercial allergen extracts of milk , whole egg , white , egg yolk , and soybean were compared by SDS-PAGE . The allergenicity was tested by the immunoblotting method using immune sera . SPTs were performed using crude and commercial allergen . Double-blind placebo- controlled food challenge ( DBPCFC ) was performed to verify the SPT results and to compare the clinical significance of crude and commercial allergen extracts . Protein composition differed markedly between crude and commercial allergen extracts . By immunoblotting , crude and commercial allergen extracts showed different allergenicity . The SPT results using crude and commercial allergen extracts showed significant differences . The prevalence of milk , egg and soybean allergy was over 35 % in atopic dermatitis . The accuracy of SPT using crude allergen extracts from foods was significantly higher than that using commercial allergen extracts . In the case of soybeans , the result of SPT using commercial allergen extract was clinical ly insignificant for the prediction of soybean allergy . The source of allergen extract was very important for the appropriate SPT in food allergy . The accuracy of SPT might be improved using the appropriate allergen source for food allergy We evaluated the value of the patch test , skin prick test , and milk‐specific IgE by CAP RAST in 301 infants with suspected hypersensitivity to cow 's milk . The patch test was carried out with milk powder , and the skin prick test with cow 's milk‐based formula . Hypersensitivity to cow 's milk was determined with double‐blind , placebo‐controlled challenge . An immediate reaction to cow 's milk challenge was observed in 100 infants ( 33 % ) , a delayed reaction in 76 ( 25 % ) , and a negative result in 125 ( 42 % ) . Skin prick test wheals were significantly greater in infants with immediate reactions than in infants with delayed or negative reactions . Milk‐specific IgE was correlated with the skin prick test ( r=0.78 , P<0.001 , n=268 ) but did not contribute to further discrimination of immediate reactions from delayed or negative reactions compared to skin prick test alone . In our study population , the skin prick test ( diameter ≥3 mm ) showed a specificity and sensitivity of 91 % and 69 % ; the results for milk‐specific IgE ( ≥0.7 kU/l ) were 88 % and 58 % , respectively . The patch test did not distinguish subjects with immediate or delayed reactions from those with negative reactions BACKGROUND The double-blind , placebo-controlled food challenge is considered the gold st and ard for diagnosing food allergy . However , in a retrospective analysis of children and adolescents with atopic dermatitis and food allergy , discrete food-specific IgE concentrations were established that could predict clinical reactivity to egg , milk , peanut , and fish with greater than 95 % certainty . OBJECTIVE The purpose of this investigation was to determine the utility of these 95 % predictive decision points in a prospect i ve evaluation of food allergy . METHODS Sera from 100 consecutive children and adolescents referred for evaluation of food allergy were analyzed for specific IgE antibodies to egg , milk , peanut , soy , wheat , and fish by using the Pharmacia CAP System FEIA . Food-specific IgE values were compared with history and the results of skin prick tests and food challenges to determine the efficacy of previously established 95 % predictive decision points in identifying patients with increased probability of reacting during a specific food challenge . RESULTS One hundred children ( 62 % male ; median age , 3.8 years ; range , 0.4 - 14.3 years ) were evaluated for food allergy . The diagnosis of food allergy was established by means of history or oral food challenge . On the basis of the previously established 95 % predictive decision points for egg , milk , peanut , and fish allergy , greater than 95 % of food allergies diagnosed in this prospect i ve study were correctly identified by quantifying serum food-specific IgE concentrations . CONCLUSION In a prospect i ve study of children and adolescents referred for evaluation of food allergy , previously established 95 % predictive decision points of food-specific IgE antibody concentrations for 4 major food allergens were effective in predicting clinical reactivity . Quantification of food-specific IgE is a useful test for diagnosing symptomatic allergy to egg , milk , peanut , and fish in the pediatric population and could eliminate the need to perform double-blind , placebo-controlled food challenges in a significant number of children Output:	Any cut-offs are proposed for single cow ’s milk proteins and for baked milk allergy in children younger than 2 years . In Children ≥ 2 years of age it is hard to define practical cut-offs for allergy to fresh and baked cow ’s milk . Conclusions None of the cut-offs proposed in the literature can be used to definitely confirm cow ’s milk allergy diagnosis , either to fresh pasteurized or to baked milk .
MS21771	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study assessed the minimum dose of clonidine required to prolong the duration of both anesthesia and analgesia after axillary brachial plexus blockade . Eighty patients scheduled for elective h and surgery were divided into eight groups in a r and omized , double-blind fashion . An axillary brachial plexus block was performed with 40 mL 1 % mepivacaine plus 1:200,000 epinephrine . The control group received no clonidine . In the other groups , increasing doses of clonidine ( 0.1 , 0.2 , 0.3 , 0.4 , 0.5 , 1 , and 1.5 micro g/kg ) were added to the local anesthetic solution . Onset time , duration of anesthesia and analgesia , postoperative pain score , intake of analgesics , and adverse effects were recorded . The eight groups were comparable in terms of onset time , postoperative pain score , and analgesic requirement . The minimum dose of clonidine required to significantly prolong the duration of analgesia and anesthesia was , respectively , 0.1 and 0.5 micro g/kg . No side effects ( sedation , drowsiness , bradycardia , arterial hypotension ) were reported . We conclude that the dose of clonidine required to prolong significantly the duration of both anesthesia and analgesia after axillary brachial plexus blockade is 0.5 micro g/kg and that , at this dose , clonidine may be used without important reported side effects even in out patients . ( Anesth Analg 1996;83:1046 - 50 STUDY OBJECTIVE To determine whether the addition of morphine to the axillary block local anesthetic solution provides improved or prolonged postoperative analgesia . DESIGN Prospect i ve , r and omized , double-blind clinical trial with 24-hour follow-up . SETTING Ambulatory unit of a large academic referral center . PATIENTS Consecutive healthy volunteers scheduled for elective upper extremity surgery . INTERVENTIONS Patients in the treatment group ( AX ) were given intravenous ( IV ) saline and had morphine 0.1 mg/kg added to their axillary block solution . Control subjects ( CT ) received morphine 0.1 mg/kg IV and had saline added to their axillary block solution . All axillary blocks were performed using 0.55 ml/kg of 1.5 % lidocaine with epinephrine 1:200,000 . MEASUREMENTS AND MAIN RESULTS During the first 24 hours after surgery , visual analog scale ( VAS ) scores , supplementary analgesic ( oxycodone 5 mg with acetaminophen 500 mg ) use , and complications were recorded . Both groups had similar VAS scores throughout the study . In the 24-hour postoperative study period , AX patients required approximately half as many doses ( median , 2 doses ; range , 0 to 7 doses of supplemental analgesic as CT patients ( median , 4 doses ; range , 0 to 12 doses ) . There were no major complications in either group . CONCLUSIONS The addition of morphine 0.1 mg/kg to the local anesthetic axillary block solution provided improved postoperative analgesia without an increased frequency of side effects or major complications We have reported recently that continuous administration of butorphanol into the brachial plexus sheath provided analgesia of a quality superior to that of continuous i.v . administration . In the present study , we have compared postoperative pain relief produced by continuous infusion of one of three types of solution into the axillary sheath : opioid alone , local anaesthetic alone or a mixture of local anaesthetic and opioid . In patients undergoing upper extremity surgery with continuous axillary brachial plexus block , we injected one of the three solutions into the axillary neurovascular sheath : butorphanol 2 mg ( group B ) , 0.5 % mepivacaine alone ( group M ) and 0.5 % mepivacaine-butorphanol ( group MB ) ; the volume of each solution was 50 ml , administered at a rate of 50 ml per 24 h. At 3 h after operation , visual analogue scale ( VAS ) scores were significantly higher in group M than in group MB ( P < 0.01 ) , and higher in group B than in group MB ( P < 0.05 ) Background : Although addition of clonidine to local anesthetics can prolong pain relief after peripheral nerve block , a dose‐range effect has not been determined . Methods : Fifty‐six out patients undergoing carpal tunnel release were r and omly assigned to receive in a double‐blind fashion 45 ml of a mixture containing either 400 mg lidocaine plus saline or 400 mg lidocaine plus 30 , 90 or 300 micro gram clonidine for axillary nerve block . In each group ( n = 14 ) , blocks were evaluated at regular time intervals to determine sensory and motor functions in the five nerve regions of the h and and forearm . Also , adequacy of the block for surgery , postoperative pain intensity , and side effects were evaluated . Results : Compared with saline , each dose of clonidine reduced the onset time of sensory block and extended the field of adequate anesthesia . Ten minutes after injection , 30 micro gram clonidine was more effective than 90 micro gram clonidine in producing sensory blockade . Sedation occurred with clonidine 30 and 300 micro gram . Clonidine reduced the use of supplementary intravenous anesthetic agents for surgery and produced dose‐dependent prolongation of analgesia , reaching a mean 770 min ( range , 190–1440 min ) for the largest dose . Clonidine also produced a dose‐dependent decrease in systolic arterial pressure of up to ‐22.5 % ( range , ‐6.0–29.9 % ) of baseline . With clonidine , 300 micro gram , three patients had mean arterial pressure of < 55 mmHg ; four patients had episodes of arterial oxyhemoglobin saturation of < 90 % , and two others were not discharged because of hypotension . Conclusion : This study suggests that a small dose of clonidine enhances the quality of the peripheral blocks from lidocaine and limits the classical alpha2 ‐agonist side effects to sedation The effectiveness of buprenorphine and morphine , administered into the brachial plexus sheath , was evaluated in 40 patients , aged 18 - 90 years . All patients received 40 ml of 0.5 % bupivacaine , injected into the brachial plexus sheath using the supraclavicular technique . In addition , the 20 patients in Group I received morphine hydrochloride ( 50 μg/kg ) , while the 20 patients in Group II received buprenorphine hydrochloride ( 3 μg/kg ) . Using a three-point pain scale , the quality of analgesia was evaluated every hour for six hours , every two hours for the next six hours , and then at 12 , 24 , 36 and 48 hours . A significant difference in the quality of analgesia was found ; and was consistently superior with buprenorphine as compared with morphine . The duration of analgesia was nearly twice as long in the buprenorphine group as in the morphine group ( 35.05 ± 1.95 hour versus 18.25 ± 1.15 hour ) . We conclude that buprenorphine injection into the brachial plexus sheath is an efficient way to assure control of postoperative pain after upper limb surgery We have studied 40 patients undergoing elective shoulder surgery for chronically painful conditions . Patients were allocated r and omly to two groups and received interscalene brachial plexus block with 0.5 % bupivacaine and adrenaline 1/200,000 40 ml either alone or with the addition of morphine 5 mg . All patients also received a general anaesthetic . The quality of the block , analgesic requirements and any complications or side effects were noted in the intraoperative period and during the 48 h after operation . No significant difference was seen in quality of analgesia or patient satisfaction between the two groups Peripheral administration of opioids has been suggested as a means of improving regional block . We studied 60 patients receiving axillary brachial plexus anaesthesia , allocated r and omly to receive either normal saline 10 ml or normal saline 10 ml with alfentanil 10 micrograms/kg body weight through an axillary cannula . All patients received 1.5 % lignocaine at a dose of 7 mg/kg body weight with adrenaline 1 in 200,000 . The incidence of satisfactory block was similar in both groups . Although the percentage of patients with complete anaesthesia in the median nerve distribution was greater in the alfentanil group , there was no significant difference in any other distribution . The time to return of sensation and motor function was prolonged significantly in the alfentanil group ( P < 0.05 ) . After return of normal sensation , there was no significant difference between groups in postoperative analgesia . In a second part of the study , there was no significant increase in plasma concentrations of alfentanil in 10 patients given lignocaine and alfentanil , as outlined above . These observations suggest that alfentanil may have a peripheral local anaesthetic action The effects of clonidine and epinephrine , administered into the brachial plexus sheath , were evaluated in 60 patients who underwent surgery of the upper limb . All patients received 40 to 50 ml of 0.25 % bupivacaine , injected into the brachial plexus sheath , using the supraclavicular technique . The patients were r and omly allocated to two groups so that 30 patients received 150 μg clonidine hydrochloride ( Group I ) , and 30 received 200 μg epinephrine ( Group II ) . The quality and the duration of analgesia were assessed as well as , the possible side-effects . The block produced with the addition of clonidine was longer ( 994.2±34.2 vs 728.3±35.8 min ) and superior to that with epinephrine ( P<0.001 ) . No major side-effects were recorded . We conclude that the injection of clonidine into the brachial plexus sheath is an attractive alternative to epinephrine to prolong the duration of analgesia following upper limb surgery under conduction anaesthesia . RésuméLes effets de l’addition d’agents agonistes alpha-adrénergiques à la bupivacaïne lors de blocs du plexus brachial ont été évalués chez soixante patients ayant une intervention chirurgicale sur le membre supérieur . L’ensemble des patients a reçu 40 à 50 ml de bupivacaïne à 0.25 % pour réaliser un bloc du plexus brachial par voie sus-claviculaire . Les patients du groupe I ( n=30 ) recevaient par la même voie 150 μg de clonidine , ceux du groupe II ( n=30 ) 200 μg d ’ adrénaline . La durée et la qualité de l’analgésie sont ensuite étudiées ainsi que les éventuels effets adverses . Une différence statistiquement significative a été retrouvée en ce qui concerne la durée d’analgésie qui était supérieure dans le groupe clonidine ( 994,2±34,2 min vs 728,3 ±35,8 min ; P<0.001 ) . Aucun effet adverse majeur n’est retrouvé . Les auteurs concluent à l’intérêt particulier de la clonidine pour prolonger la durée d ’ analgésie après chirurgie du membre supérieur réalisée sous anesthésie régionale The admixture of clonidine or epinephrine to lidocaine for brachial plexus block was studied with regard to duration of block , postoperative analgesia , and plasma concentrations of lidocaine . Thirty-three patients of ASA physical status I and II received an admixture of either clonidine ( 150 micrograms ; n = 15 ) or epinephrine ( 200 micrograms ; n = 18 ) to 40 mL of 1 % lidocaine in a r and omized , double-blind fashion . Bone surgery predominated in those patients receiving clonidine and soft-tissue surgery in those receiving epinephrine ( P less than 0.05 ) . Onset and duration of block were not different between the groups . With the admixture of clonidine , fewer patients were completely pain free for greater than 12 h ( 13.3 % ) and pain scores ( visual analogue scale 0 - 10 ) were higher 6 h after the block ( median 4 ; range 0 - 6 ) than with epinephrine ( 61.1 % ; median 2 ; range 0 - 7 , respectively ; P less than 0.05 ) . In patients who had received clonidine , peak plasma concentrations of lidocaine were higher ( 10.29 + /- 2.96 mumol/L ) and occurred earlier ( 23.7 + /- 9.3 min ; mean + /- SD ) than in those treated with epinephrine ( 6.9 + /- 1.71 mumol/L ; 72.5 + /- 56.2 min ; P less than 0.05 ) . This indicates the absence of a local vasoconstrictor effect of clonidine and implies a reduced margin of safety with regard to local anesthetic Output:	Clonidine appears to have significant analgesic benefit and to cause minimal adverse effects when used in doses up to 150 microg .
MS21772	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Unplanned recannulations are a common occurrence in a number of hospitals both in the UK and worldwide ( Schwengel , 2004 ; Jackson , 2007 ) . In May 2008 the Clinical Nurse Specialist in IV Therapy at Brighton and Sussex University Hospital ( BSUH ) NHS Trust initiated a clinical audit to assess i.v . practice and determine the impact of recannulations within the Trust . The audit , which was initially carried out on 1000 sequential cannula insertions , and is currently ongoing , showed that 69.2 % of the cannulas failed well before the routine change of 72 hours , and that 36.3 % were removed because they had infiltrated . With the aim of reducing these numbers of unscheduled recannulations , the Nurse Specialist initiated a real-time , prospect i ve clinical evaluation of a new cannula stabilization device at BSUH . This assessed the impact of the device alongside the currently used securement strategy ( i.v . dressing ) on unscheduled i.v . restarts in 50 cannulas compared with the baseline data . During the clinical evaluation , all i.v.s were tracked every 4 hours and all complication/ reasons for removal were noted . On initiation of the use of the stabilization device , the infiltration rate was reduced from the baseline level by 100%.There was also an 81 % reduction in the rate of unscheduled i.v . restarts . The data from the clinical evaluation demonstrated the considerable benefits of using a cannula stabilization device compared with the current hospital practice of using i.v . dressings only for securement with regard to infiltration levels and unplanned restarts . This device may have significant future benefits in terms of improving patient care and reducing healthcare expenditure A prospect i ve r and omized clinical trial has been conducted to compare the clinical performance , with prolonged use , of two film-type transparent dressings used over subclavian and jugular single-lumen venous catheters . ' OpSite ' , a traditional dressing with a moderate moisture vapour permeability was compared with a new dressing of high moisture vapour permeability , ' OpSite IV3000 ' . Information was collected daily to assess the nature and incidence of complications , dressing durability and the ease of application and removal . One hundred and one patients provided two well-matched population s receiving a total of 153 dressings for a total of 780 catheter-days . No differences between the two dressings were noted with respect to the incidence of complications , such as moisture accumulation or lifting , and dressing durability . The low incidence of catheter-related sepsis ( ' OpSite ' group three episodes and ' OpSite IV3000 ' group one episode ) suggests that transparent dressings do not increase this risk . This clinical study demonstrated the new ' OpSite IV3000 ' to be easier to h and le , leading to better application , improved catheter fixation and easy removal Background Peripheral intravenous device ( IVD ) complications were traditionally thought to be reduced by limiting dwell time . Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins . Recent evidence suggests routine resite is unnecessary , at least if devices are inserted by a specialised IV team . The aim of this study was to compare the impact of peripheral IVD ' routine resite ' with ' removal on clinical indication ' on IVD complications in a general hospital without an IV team . Methods A r and omised , controlled trial was conducted in a regional teaching hospital . After ethics approval , 362 patients ( 603 IVDs ) were r and omised to have IVDs replaced on clinical indication ( 185 patients ) or routine change every 3 days ( 177 patients ) . IVDs were inserted and managed by the general hospital medical and nursing staff ; there was no IV team . The primary endpoint was a composite of IVD complications : phlebitis , infiltration , occlusion , accidental removal , local infection , and device-related bloodstream infection . Results IVD complication rates were 68 per 1,000 IVD days ( clinical ly indicated ) and 66 per 1,000 IVD days ( routine replacement ) ( P = 0.86 ; HR 1.03 ; 95 % CI , 0.74 - 1.43 ) . Time to first complication per patient did not differ between groups ( KM with log rank , P = 0.53 ) . There were no local infections or IVD-related bloodstream infections in either group . IV therapy duration did not differ between groups ( P = 0.22 ) , but more ( P = 0.004 ) IVDs were placed per patient in the routine replacement ( mean , 1.8 ) than the clinical indication group ( mean , 1.5 ) , with significantly higher hospital costs per patient ( P < 0.001 ) . Conclusions Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment , as opposed to one in five patients managed with routine resite ; overall complication rates appear similar . Clinical ly indicated resite would achieve savings in equipment , staff time and patient discomfort . There is growing evidence to support the extended use of peripheral IVDs with removal only on clinical indication . Registration numberAustralian New Zeal and Clinical Trials Registry ( ANZCTR ) Number ACTRN12608000421336 Four dressing regimens for peripheral venous catheters were studied in a prospect i ve r and omized clinical trial with 2088 Teflon catheters : ( 1 ) sterile gauze , replaced every other day , and three dressings left on for the lifetime of the catheter ; ( 2 ) gauze ; ( 3 ) a transparent polyurethane dressing ; and ( 4 ) an iodophor-transparent dressing . The four dressings provided comparable coverage , except moisture accumulated more frequently under the transparent dressings ( 26 % to 28 % vs 20 % to 21 % ) . Cutaneous colonization under the dressing was low level and comparable with all four dressings ( range , 10(0.58 ) to 10(0.70 ) colony-forming units ) . The rate of local catheter-related infection ( greater than or equal to 15 colony-forming units ) was also low and did not differ significantly ( range , 4.6 % to 5.9 % ) ; no catheter caused bacteremia . Stepwise logistic multivariate analysis showed cutaneous colonization of the insertion site ( relative risk [ RR ] of infection , 3.86 ) , contamination of the catheter hub ( RR , 3.78 ) , moisture under the dressing ( RR , 2.48 ) , and prolonged catheterization ( RR , 1.75 ) to be significant risk factors for catheter-related infection . These data indicate that it is not cost-effective to redress peripheral venous catheters at periodic intervals ; for most patients , either sterile gauze or a transparent dressing can be used and left on until the catheter is removed The use of a sterile transparent dressing ( Venigard , Consoli date d Medical Equipment , London ) was compared to the use of a non-sterile tape ( Mefix , Molnlycke , Sweden ) for securing peripheral cannulae in paediatric patients . Children from all medical specialties were prospect ively r and omised into one of two groups . The failure of a cannula ( defined as the removal of the cannula before treatment was completed ) was plotted against duration in each of the two groups . Statistical tests ( life table analysis ) suggested no significant difference ( p = > 0.05 ) . The authors conclude that the use of a sterile transparent dressing secures peripheral cannula as effectively as non-sterile tape A prospect i ve , controlled study was undertaken in a skilled nursing facility to determine whether a sterile catheter securement device ( StatLock i.v . , Venetec International , Mission Viejo , CA ) would provide better intravenous therapy outcomes than a st and ard securement technique . The StatLock-device result ed in significantly longer average catheter dwell times ( 3.95 days versus 2.45 days ) and significantly fewer total complications ( 65 versus 155 ) . In addition , the securement device reduced the total time spent managing a vascular access device by 13.5 minutes per patient . Thus , the StatLock i.v . device improved overall clinical outcomes of i.v . therapy and the quality of care OBJECTIVE To identify risk factors for infusion-related phlebitis with peripheral intravenous catheters . DESIGN A r and omized trial of two catheter material s , with consideration of 21 potential risk factors . SETTING A university hospital . PATIENTS Hospitalized adults without granulocytopenia who received a peripheral intravenous catheter . INTERVENTIONS House officers or ward nurses inserted the catheters , and each insertion was r and omized to a catheter made of tetrafluoroethylene-hexafluoropropylene ( FEP-Teflon ) or a novel polyetherurethane without leachable additives ( PEU-Vialon ) . MEASUREMENTS Research nurses scored insertion sites each day for inflammation and cultured catheters at removal . RESULTS The Kaplan-Meier risk for phlebitis exceeded 50 % by day 4 after catheterization . intravenous antibiotics ( relative risk , 2.00 ) , female sex ( relative risk , 1.88 ) , prolonged ( greater than 48 hours ) catheterization ( relative risk , 1.79 ) , and catheter material ( PEU-Vialon : FEP-Teflon ) ( relative risk , 0.73 ) strongly predicted phlebitis in a Cox proportional hazards model ( each , P less than 0.003 ) . The best-fit model for severe phlebitis identified the same predictors plus catheter-related infection ( relative risk , 6.19 ) , phlebitis with a previous catheter ( relative risk , 1.54 ) , and anatomic site ( h and : forearm , relative risk , 0.71 ; wrist : forearm , relative risk , 0.60 ) . The low incidence of local catheter-related infection was comparable with the two catheter material s ( 5.4 % [ 95 % CI , 3.8 % to 7.6 % ] and 6.9 % [ CI , 4.9 % to 9.6 % ] ) ; none of the 1054 catheters prospect ively studied caused bacteremia . CONCLUSIONS Multiple factors , including the infusate and the duration of cannulation , contribute to the development of infusion-related phlebitis . The use of peripheral intravenous catheters made of PEU-Vialon appears to pose the same risk for catheter-related infection as the use of catheters made of FEP-Teflon , and PEU-Vialon can permit longer cannulation with less risk for phlebitis . The risk for catheter-related bacteremia with FEP-Teflon and PEU-Vialon catheters is sufficiently low that it no longer seems justifiable to recommend the use of small steel needles for most peripheral intravenous therapy STUDY OBJECTIVES To prospect ively assess the relative risk for phlebitis in a series of consecutive patients with pneumonia and to identify risk factors that predict an increased risk for phlebitis . SETTING Internal medicine department of a tertiary teaching hospital . PATIENTS Seven hundred sixty-six consecutive patients with acute pneumonia receiving IV therapy . INTERVENTIONS Only the first catheter was taken into account . There were 308 short lines ( a 51-mm , 18-gauge Teflon catheter ) ; 307 midsized lines ( a 28-cm , 16-gauge polyvinyl chloride catheter ) ; and 151 long lines ( 71-cm , 14-gauge plain polyurethane catheter ) . Eighteen variables were prospect ively evaluated in an open , nonr and omized study for their contribution to the occurrence of phlebitis . RESULTS The overall phlebitis rate was 39 % . Phlebitis developed in 53 % of patients with short lines , in 41 % of patients with midsized lines , and in 10 % of patients with long lines , and these catheters remained in place an average ( + /- SD ) of 3.0+/-2.4 days , 4.6+/-3.4 days , and 7.8+/-6.6 days , respectively . The variables that influenced the development of phlebitis , as determined by multivariate analysis , were the following : type of catheter ; blood hemoglobin levels ; and IV therapy with either corticosteroids or erythromycin . CONCLUSIONS According to our data , when the use of a catheter is expected to be required for < or = 36 h , a short line can be used . If a longer duration is expected , a longer line is warranted . Ours is the first study in which the relationship between blood hemoglobin levels and phlebitis has been reported . Because the use of intravascular devices is increasingly common , a more complete knowledge of the factors that influence their acceptance has become essential Previous studies of various br and s of polyurethane dressings have noted differences in the rates of catheter colonization . We compared Bioclusive transparent polyurethane ( TP ) dressing with a cotton gauze ( CG ) dressing on peripheral intravenous ( IV ) access sites for the incidence of phlebitis , catheter tip colonization , skin colonization , and catheter-related bacteremia . The study , involving 598 ward patients , was case controlled , prospect i ve , and r and omized for a period of 4 months . Each patient was entered into the study only once , and all dressings were applied by a member of the IV therapy team . No significant difference was seen for phlebitis rate ( TP : 9 Output:	It is not clear if any one dressing or securement device is better than any other in securing peripheral venous catheters .
MS21773	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The authors present results of a r and omized clinical trial of the efficacy of extended treatment with bupropion SR in producing longer term cigarette smoking cessation . Adult smokers ( N = 362 ) received open-label treatment ( 11 weeks ) that combined relapse prevention training , bupropion SR , and nicotine patch followed by extended treatment ( 14 weeks ) with bupropion SR or matching placebo . Abstinence percentages were relatively high ( week 11 : 52 % ; week 25 : bupropion , 42 % ; placebo , 38 % ; week 52 : bupropion , 33 % ; placebo , 34 % ) , but bupropion SR did not surpass placebo . Gender and baseline craving level were identified as significant , independent moderators of treatment response . Men were more likely to abstain than women ( week 11 : 59 % vs. 43 % , p = .001 ; week 25 : 48 % vs. 31 % , p = .001 ; week 52 : 39 % vs. 27 % , p = .01 ) . Because most smokers suffer relapse with any current cessation treatment , the comparatively high abstinence percentages achieved in this trial are of interest INTRODUCTION Varenicline , a first-line non-nicotine medication , has not been evaluated in Black smokers , and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials . This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence . METHODS Seventy-two Black smokers ( > 10 cigarettes per day ; cpd ) were r and omly assigned to adherence support ( AS ; n = 36 ) or st and ard care ( n = 36 ) . All participants received 3 months of varenicline and a single counseling session focused on making a quit plan . AS participants received 5 additional counseling sessions to encourage medication use . Outcome measures included salivary cotinine , and carbon monoxide confirmed smoking abstinence , reductions in self-reported cpd , and pill counts of varenicline adherence at Months 1 , 2 , and 3 . RESULTS Sixty-one participants ( 84.7 % ) completed follow-up at Month 3 . Participants were female ( 62.5 % ) , 46.8 years of age , and smoked 16.3 cpd . No treatment group differences were found on the smoking or adherence outcome measures ( p > .05 ) . Collapsing across treatment , varenicline adherence was adequate ( 86.1 % ) , yet despite a reduction of 12.2 ( 6.5 ) cpd from baseline to Month 3 ( p < 0.001 ) , only 23.6 % were confirmed quit at Month 3 . Participants who were quit at Month 3 had higher varenicline adherence rates ( 95.8 % ) than those who continued to smoke ( 80.8 % , p ≤ .05 ) . CONCLUSIONS Studies are needed to examine the efficacy of varenicline among Black smokers . Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence Rationale There are over 300 million Chinese smokers , but use of nicotine replacement therapy ( NRT ) is rare . On the other h and , data on the factors associated with quitting and adherence to NRT use are scarce in the East . Objectives To describe adherence and other predictors of quitting smoking at the 12-month follow-up amongst Chinese smokers in Hong Kong . Methods Chinese smokers ( 1186 ) who attended the Smoking Cessation Health Centre from August 2000 through January 2002 were studied . Trained counsellors provided individual counselling and carried out follow-up interviews . We used structured question naires at baseline and at 1 , 3 and 12 months and an intention-to-treat approach for analysis . Results Among those who received NRT ( 1051/1186 ) , the prevalence of adherence ( self-reported NRT use for at least 4 weeks ) was 16 % ( 95 % confidence interval 14–18 % ) . The 7-day point prevalence quit rate at 12 months ( not smoking any cigarette during the past 7 days at the 12 month follow-up ) was 27 % ( 95 % CI , CI 24–29 % ) . Stepwise logistic regression model showed that adherence to NRT use , a higher income , good perceived health and having more confidence in quitting were significant predictors of quitting . The quit rate in the adherent group ( 40 % ) was greater than that of the non-adherent group ( 25 % ) ( P<0.001 ) . Older age , male , higher education , experience of NRT use , perceiving quitting as more difficult and willingness to pay were significant predictors of adherence . Conclusions Clinical ly significant smoking cessation rates can be achieved among Chinese smokers in a clinic-based smoking cessation service . The NRT adherence was low and low adherence was associated with a lower quit rate . Trials of interventions to improve adherence and increase quit rates are needed BACKGROUND A high proportion of African-American smokers are light smokers , and they experience low smoking cessation rates and disproportionately high tobacco-related morbidity ; yet no studies have examined tobacco treatment adherence in this group . OBJECTIVES To determine the predictors of adherence to nicotine gum and counseling among African-American light smokers ( defined as smoking ≤10 cigarettes/day ) , and the effects of adherence on smoking cessation . DESIGN Data were from a 2 × 2 r and omized , placebo-controlled smoking cessation trial of nicotine gum ( 2 mg versus placebo ) and counseling ( motivational interviewing versus health education ) . PARTICIPANTS Seven hundred fifty-five African-American light smokers at a community-based clinic . MEASUREMENTS Demographic and health-related information , smoking behaviors , psychosocial variables , adherence to nicotine gum and counseling , and cotinine-verified 7-day abstinence from smoking at week-26 follow-up . RESULTS A logistic regression model showed that having a higher body mass index ( OR = 1.03 , 95 % CI = 1.01 to 1.05 ) , more quit attempts in the past year ( OR = 1.04 , 95 % CI = 1.01 to 1.07 ) , higher baseline exhaled carbon monoxide ( OR = 1.22 , 95 % CI = 1.01 to 1.48 ) , and higher perceived stress ( OR = 1.12 , 95 % CI = 1.03 to 1.22 ) increased the likelihood of adherence to nicotine gum . Being a high school graduate was a predictor of adherence to counseling ( OR = 1.58 , 95 % CI = 1.02 to 2.44 ) . Surprisingly , being adherent to nicotine gum significantly reduced the odds of smoking cessation ( OR = 0.50 , CI = 0.28 to 0.87 ) . On the other h and , adherence to counseling dramatically increased the likelihood of smoking cessation ( OR = 3.32 , CI = 1.36 to 8.08 ) . CONCLUSIONS Individual risk factors may influence adherence to nicotine gum and counseling . Improving psychological interventions and promoting adherence to counseling may increase overall smoking cessation success among African-American light smokers Nicotine gum has been shown to be effective in improving abstinence rates , and in reducing post-cessation withdrawal distress and weight gain . However , the dose effects of nicotine gum on these outcomes is not known . In the present study , we varied the amount of 2 mg nicotine gum prescribed to motivated quitters to explore the hypotheses ( a ) that motivated quitters would use more pieces of gum when coached and counseled to do so and ( b ) that there would be a dose-related effect of gum use on abstinence , withdrawal symptoms , and weight gain . One hundred seventy-seven volunteers were assigned to chew either 0 , 7 , 15 , or 30 , pieces per day of 2 mg nicotine gum . Biological verification of gum use and smoking abstinence were assessed in community volunteers who attended an intensive behavioral counseling program for smoking cessation while using nicotine gum for 3 months . In the survival analysis at 12 weeks , gum-group assignment was not related to successful abstinence . In the subset of 42 abstinent subjects , there was a strong positive relationship between pieces per day of nicotine gum used and saliva cotinine . However , there was substantial variability in groups of subjects reporting similar amounts of gum use . Withdrawal symptom reporting was not related to either gum use or cotinine levels . Weight gain was significantly related in a dose-dependent manner to salivary cotinine levels , but not to gum group assignment , with high and low cotinine subjects gaining on average , 4.0 and 6.6 pounds , respectively . Discussion of the use of high levels of nicotine gum is addressed . Consistent with earlier work , the study provided further support for the relationship between nicotine replacement level and post-cessation weight gain PURPOSE To determine the effectiveness of the 4-mg and 2-mg dosages of nicotine polacrilex vs placebo through the first 6 weeks of treatment ( during which 75 % of relapse occurs when there is no treatment ) in assisting high-dependent smokers to stop smoking when instructed to use a fixed number ( 12 pieces ) of medication daily . SUBJECTS AND METHODS Ninety high-dependent ( Fagerström Tolerance Question naire score > or = 7 plus baseline carbon monoxide level > 15 ppm ) healthy male and female smokers , highly motivated to quit smoking , were enrolled in a 6-week , r and omized , double-blind , placebo-controlled trial in which they were instructed to use 12 pieces per day of their assigned dosage formulation : 4 mg , 2 mg , or 0.5 mg ( placebo ) of nicotine polacrilex . The behavioral intervention did not depend on providing any special psychological training , skills , or services but rather employed a st and ard medical practice model that could easily be implemented by any primary care physician . RESULTS Sustained abstinence from weeks 2 through 6 , determined at each visit by absolutely no cigarette use plus a carbon monoxide level of 8 ppm or lower was 59 % ( 4-mg group ) , 30 % ( 2-mg group ) , and 39 % ( placebo group ) ( P < .02 ) . For the 55 of the 90 smokers who met the originally planned definition of high dependence ( Fagerström Tolerance Question naire score > or = 7 plus baseline smoking serum cotinine level > 250 ng/mL plus baseline carbon monoxide level > 15 ppm ) , results were 63 % ( 4-mg group ) , 25 % ( 2-mg group ) , and 25 % ( placebo group ) ( P < .02 ) . In addition , the 4-mg dose produced statistically significantly higher abstinence rates in compliant subjects ( P < .02 ) and also in subjects with high baseline serum continine levels who were compliant ( P < .01 ) than did either the 2-mg dose or placebo . CONCLUSIONS It appears that the 4-mg dose of nicotine polacrilex is the drug and dose of choice for the initial phase of tobacco dependence treatment in high-dependent smokers ; the 2-mg dose of nicotine polacrilex is not better than placebo during the first 6 weeks of treatment for high-dependent cigarette smokers , and thus should not be used for these patients during the initial treatment phase This correlational study examined the adherence rates of transdermal nicotine ( TN ) use among a population of males and females 18 years of age and older ( N = 619 ) who received varying levels of behavioral intervention . Rates of patch adherence were assessed for demographic ( e.g. , gender , ethnicity , and age ) , income- , smoking- [ e.g. , baseline carbon monoxide ( CO ) , nicotine dependence , and follow-up quit status ] , and treatment-related ( e.g. , condition , and drop status ) variables . Loglinear and logistic regression analyses were performed to assess adherence rates . Results indicated that male gender [ chi2(2 , n = 485 ) = 20.39 , P = .038 ] , not dropping out of the study [ chi2(2 , n = 485 ) = 13.94 , P < .001 ] , and intensive treatment ( compared to the st and ard care ) [ chi2(4 , n = 485 ) = 14.96 , P = .005 ] were associated with greater adherence to TN . Furthermore , patch adherence was associated with quit status at 6 months ( OR = 2.47 , CI = 1.56 - 3.91 , P < .001 ) and 12 months ( OR = 2.12 , CI = 1.34 - 3.37 , P = .001 ) . Complete and partial patch adherence ( compared to minimal/no adherence ) were associated with a greater number of telephone intervention contacts completed ( OR = 2.621 , CI = 1.421 - Output:	There is modest evidence to support the assumption that lack of adherence to nicotine replacement therapy regimens undermines effectiveness in clinical studies
MS21774	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background — Aortic stiffness is a marker of cardiovascular disease and an independent predictor of cardiovascular risk . Although an association between inflammatory markers and increased arterial stiffness has been suggested , the causative relationship between inflammation and arterial stiffness has not been investigated . Methods and Results — One hundred healthy individuals were studied according to a r and omized , double-blind , sham procedure-controlled design . Each sub study consisted of 2 treatment arms , 1 with Salmonella typhi vaccination and 1 with sham vaccination . Vaccination produced a significant ( P<0.01 ) increase in pulse wave velocity ( at 8 hours by 0.43 m/s ) , denoting an increase in aortic stiffness . Wave reflections were reduced significantly ( P<0.01 ) by vaccination ( decrease in augmentation index of 5.0 % at 8 hours and 2.5 % at 32 hours ) as a result of peripheral vasodilatation . These effects were associated with significant increases in inflammatory markers such as high-sensitivity C-reactive protein ( P<0.001 ) , high-sensitivity interleukin-6 ( P<0.001 ) , and matrix metalloproteinase-9 ( P<0.01 ) . With aspirin pretreatment ( 1200 mg PO ) , neither pulse wave velocity nor augmentation index changed significantly after vaccination ( increase of 0.11 m/s and 0.4 % , respectively ; P = NS for both ) . Conclusions — This is the first study to show through a cause- and -effect relationship that acute systemic inflammation leads to deterioration of large-artery stiffness and to a decrease in wave reflections . These findings have important implication s , given the importance of aortic stiffness for cardiovascular function and risk and the potential of therapeutic interventions with antiinflammatory properties Background —Aortic pulse wave velocity ( PWV ) is a predictor of mortality in patients with end-stage renal failure ( ESRF ) . The PWV is partly dependent on blood pressure ( BP ) , and a decrease in BP can attenuate the stiffness . Whether the changes in PWV in response to decreases in BP can predict mortality in ESRF patients has never been investigated . Methods and Results —One hundred fifty ESRF patients ( aged 52±16 years ) were monitored for 51±38 months . From entry until the end of follow-up , the changes of PWV in response to decreased BP were measured ultrasonographically . BP was controlled by adjustment of “ dry weight ” and , when necessary , with ACE inhibitors , calcium antagonists , and /or & bgr;-blockers , in combination if necessary . Fifty-nine deaths occurred , including 40 cardiovascular and 19 noncardiovascular events . Cox analyses demonstrated that independent of BP changes , the predictors of all-cause and cardiovascular mortality were as follows : absence of PWV decrease in response to BP decrease , increased left ventricular mass , age , and preexisting cardiovascular disease . Survival was positively associated with ACE inhibitor use . After adjustment for all confounding factors , the risk ratio for the absence of PWV decrease was 2.59 ( 95 % CI 1.51 to 4.43 ) for all-cause mortality and 2.35 ( 95 % CI 1.23 to 4.41 ) for cardiovascular mortality . The risk ratio for ACE inhibitor use was 0.19 ( 95 % CI 0.14 to 0.43 ) for all-cause mortality and 0.18 ( 95 % CI 0.06 to 0.55 ) for cardiovascular mortality . Conclusions —These results indicate that in ESRF patients , the insensitivity of PWV to decreased BP is an independent predictor of mortality and that use of ACE inhibitors has a favorable effect on survival that is independent of BP changes Introduction Exposure to air pollution is associated with increased cardiovascular morbidity , although the underlying mechanisms are unclear . Vascular dysfunction reduces arterial compliance and increases central arterial pressure and left ventricular after-load . We determined the effect of diesel exhaust exposure on arterial compliance using a vali date d non-invasive measure of arterial stiffness . Methods In a double-blind r and omized fashion , 12 healthy volunteers were exposed to diesel exhaust ( approximately 350 μg/m3 ) or filtered air for one hour during moderate exercise . Arterial stiffness was measured using applanation tonometry at the radial artery for pulse wave analysis ( PWA ) , as well as at the femoral and carotid arteries for pulse wave velocity ( PWV ) . PWA was performed 10 , 20 and 30 min , and carotid-femoral PWV 40 min , post-exposure . Augmentation pressure ( AP ) , augmentation index ( AIx ) and time to wave reflection ( Tr ) were calculated . Results Blood pressure , AP and AIx were generally low reflecting compliant arteries . In comparison to filtered air , diesel exhaust exposure induced an increase in AP of 2.5 mmHg ( p = 0.02 ) and in AIx of 7.8 % ( p = 0.01 ) , along with a 16 ms reduction in Tr ( p = 0.03 ) , 10 minutes post-exposure . Conclusion Acute exposure to diesel exhaust is associated with an immediate and transient increase in arterial stiffness . This may , in part , explain the increased risk for cardiovascular disease associated with air pollution exposure . If our findings are confirmed in larger cohorts of susceptible population s , this simple non-invasive method of assessing arterial stiffness may become a useful technique in measuring the impact of real world exposures to combustion derived-air pollution Background — Rheumatoid arthritis ( RA ) is associated with increased cardiovascular risk , which is not explained by traditional cardiovascular risk factors but may be due in part to increased aortic stiffness , an independent predictor of cardiovascular mortality . In the present study , our aim was to establish whether aortic stiffness is increased in RA and to investigate the relationship between inflammation and aortic stiffness . In addition , we tested the hypothesis that aortic stiffness could be reduced with anti – tumor necrosis factor-&agr ; ( TNF-&agr ; ) therapy . Methods and Results — Aortic pulse-wave velocity ( PWV ) , augmentation index , and blood pressure were measured in 77 patients with RA and in 142 healthy individuals . Both acute and chronic inflammatory measures and disease activity were determined . The effect of anti-TNF-&agr ; therapy on PWV and endothelial function was measured in 9 RA patients at 0 , 4 , and 12 weeks . Median ( interquartile range ) aortic PWV was significantly higher in subjects with RA than in control subjects ( 8.35 [ 7.14 to 10.24 ] versus 7.52 [ 6.56 to 9.18 ] m/s , respectively ; P=0.005 ) . In multiple regression analyses , aortic PWV correlated independently with age , mean arterial pressure , and log-transformed C-reactive protein ( R2=0.701 ; P<0.0001 ) . Aortic PWV was reduced significantly by anti-TNF-&agr ; therapy ( 8.82±2.04 versus 7.94±1.86 versus 7.68±1.56 m/s at weeks 0 , 4 , and 12 , respectively ; P<0.001 ) ; concomitantly , endothelial function improved . Conclusions — RA is associated with increased aortic stiffness , which correlates with current but not historical measures of inflammation , suggesting that increased aortic stiffness may be reversible . Indeed , anti-TNF-&agr ; therapy reduced aortic stiffness to a level comparable to that of healthy individuals . Therefore , effective control of inflammation may be of benefit in reducing cardiovascular risk in patients with RA AIMS Episodes of increased air pollution are associated with increases in hospital admissions for cardiovascular disease . Even modest acute phase responses are associated with increased risk of coronary heart disease . The study investigates whether induction of an acute phase response by exposure to air pollution may contribute to cardiovascular pathology . METHODS AND RESULTS A prospect i ve cohort study based on a survey in 1984/85 with a 3-year follow-up was conducted in 631 r and omly selected men aged 45 to 64 years free of cardiovascular disease at entry 1984/85 . Serum C-reactive protein concentrations were determined by a high sensitivity immunoradiometric assay . C-reactive protein concentration was increased in association with the 1985 air pollution episode . In multivariate analyses , elevated concentrations were independently associated with concentrations of total suspended particles and the sulphur dioxide episode . At ambient concentrations of pollution , as noted during the 1985 air pollution episode , the odds of observing C-reactive protein concentrations above 5.7 mg . l(-1)(>90th percentile ) tripled , and increases of 26 microg . m(-3)total suspended particles ( mean of 5 days ) raised the odds of C-reactive protein levels 50 % above the 90th percentile . CONCLUSIONS Exposure to current levels of particulate matter in the atmosphere elicits an acute phase response in r and omly selected healthy middle-aged men , which may contribute to the increased cardiovascular risk caused by air pollution Output:	In conclusion , available evidence supports an association of main air pollutants with increased arterial stiffness and reflected waves . This finding may have implication s for population -based strategies for the reduction of arterial stiffness , a vascular biomarker and an intermediate endpoint for cardiovascular disease
MS21775	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To assess the association between favourable neurological outcome and hospital characteristics such as hospital volume and number of critical care centres ( CCMCs ) after out-of-hospital cardiac arrest ( OHCA ) . METHODS This retrospective , population -based observational study conducted in Osaka Prefecture , Japan included adult patients with OHCA , aged ≥18 years who were transported to acute care hospitals between January 2005 and December 2012 . We divided acute care hospitals into CCMCs or non-CCMCs , the latter of which were divided into the following three groups according to the annual average number of transported OHCA cases : low-volume ( ≤10 cases ) , middle-volume ( 11 - 39 cases ) , and high-volume ( ≥40 cases ) groups . R and om effects logistic regression models , with hospital treated as a r and om effect , were used to assess factors potentially associated with a favourable neurological outcome . RESULTS A total of 44,474 patients were eligible . The proportions of favourable neurological outcome from OHCA were 0.9 % ( 31/3559 ) in the low-volume group , 1.2 % ( 106/9171 ) in the middle-volume group , 1.6 % ( 222/14,007 ) in the high-volume group , and 4.3 % ( 766/17,737 ) in the CCMC group ( P<0.001 ) . In the multivariable analysis , transport to CCMCs was significantly associated with favourable neurological outcome , compared with transport to non-CCMCs ( adjusted odds ratio 1.63 ; 95 % confidence interval , 1.60 - 1.66 ) . Among the non-CCMC group , there was no significant relationship between hospital volume and favourable neurological outcome . CONCLUSIONS In this population , transport of OHCA patients to CCMCs led to significantly higher one-month survival rates with favourable neurological outcome from OHCA , whereas no significant association was noted among the hospitals with different volumes BACKGROUND Wide variation exists in inter-hospital survival from out-of-hospital cardiac arrest ( OHCA ) . Regionalisation of care into cardiac arrest centres ( CAC ) may improve this . We report a pilot r and omised trial of expedited transfer to a CAC following OHCA without ST-elevation . The objective was to assess the feasibility of performing a large-scale r and omised controlled trial . METHODS Adult witnessed ventricular fibrillation OHCA of presumed cardiac cause were r and omised 1:1 to either : ( 1 ) treatment : comprising expedited transfer to a CAC for goal -directed therapy including access to immediate reperfusion , or ( 2 ) control : comprising current st and ard of care involving delivery to the geographically closest hospital . The feasibility of r and omisation , protocol adherence and data collection of the primary ( 30-day all-cause mortality ) and secondary ( cerebral performance category ( CPC ) ) and in-hospital major cardiovascular and cerebrovascular events ( MACCE ) clinical outcome measures were assessed . RESULTS Between November 2014 and April 2016 , 118 cases were screened , of which 63 patients ( 53 % ) met eligibility criteria and 40 of the 63 patients ( 63 % ) were r and omised . There were no protocol deviations in the treatment arm . Data collection of primary and secondary outcomes was achieved in 83 % . There was no difference in baseline characteristics between the groups : 30-day mortality ( Intervention 9/18 , 50 % vs. Control 6/15 , 40 % ; P=0.73 ) , CPC 1/2 ( Intervention : 9/18 , 50 % vs. Control 7/14 , 50 % ; P>0.99 ) or MACCE ( Intervention : 9/18 , 50 % vs. Control 6/15 , 40 % ; P=0.73 ) . CONCLUSIONS These findings support the feasibility and acceptability of conducting a large-scale r and omised controlled trial of expedited transfer to CAC following OHCA to address a remaining uncertainty in post-arrest care AIM Survival after out-of-hospital cardiac arrest ( OOHCA ) varies between regions , but the contribution of different factors to this variability is unknown . This study examined whether survival to hospital discharge was related to receiving hospital characteristics , including bed number , capability of performing cardiac catheterization and hospital volume of OOHCA cases . MATERIAL AND METHODS Prospect i ve observational data base of non-traumatic OOHCA assessed by emergency medical services was created in 8 US and 2 Canadian sites from December 1 , 2005 to July 1 , 2007 . Subjects received hospital care after OOHCA , defined as either ( 1 ) arriving at hospital with pulses , or ( 2 ) arriving at hospital without pulses , but discharged or died > or = 1 day later . RESULTS A total of 4087 OOHCA subjects were treated at 254 hospitals , and 32 % survived to hospital discharge . A majority of subjects ( 68 % ) were treated at 116 ( 46 % ) hospitals capable of cardiac catheterization . Unadjusted survival to discharge was greater in hospitals performing cardiac catheterization ( 34 % vs. 27 % , p=0.001 ) , and in hospitals that received > or = 40 patients /year compared to those that received < 40 ( 37 % vs. 30 % , p=0.01 ) . Survival was not associated with hospital bed number , teaching status or trauma center design ation . Length of stay ( LOS ) for surviving subjects was shorter at hospitals performing cardiac catheterization ( p<0.01 ) . After adjusting for all variables , there were no independent associations between survival or LOS and hospital characteristics . CONCLUSIONS Some subsets of hospitals displayed higher survival and shorter LOS for OOHCA subjects but there was no independent association between hospital characteristics and outcome INTRODUCTION The aim of the EuReCa ONE study was to determine the incidence , process , and outcome for out of hospital cardiac arrest ( OHCA ) throughout Europe . METHODS This was an international , prospect i ve , multi-centre one-month study . Patients who suffered an OHCA during October 2014 who were attended and /or treated by an Emergency Medical Service ( EMS ) were eligible for inclusion in the study . Data were extracted from national , regional or local registries . RESULTS Data on 10,682 confirmed OHCAs from 248 regions in 27 countries , covering an estimated population of 174 million . In 7146 ( 66 % ) cases , CPR was started by a byst and er or by the EMS . The incidence of CPR attempts ranged from 19.0 to 104.0 per 100,000 population per year . 1735 had ROSC on arrival at hospital ( 25.2 % ) , Overall , 662/6414 ( 10.3 % ) in all cases with CPR attempted survived for at least 30 days or to hospital discharge . CONCLUSION The results of EuReCa ONE highlight that OHCA is still a major public health problem accounting for a substantial number of deaths in Europe . EuReCa ONE very clearly demonstrates marked differences in the processes for data collection and reported outcomes following OHCA all over Europe . Using these data and analyses , different countries , regions , systems , and concepts can benchmark themselves and may learn from each other to further improve survival following one of our major health care events PURPOSE As post-cardiac arrest care may influence patients ' outcome , characteristics of receiving hospitals should be integrated in the evaluation of survival . We aim ed at assessing the influence of care level center on patients ' survival at hospital discharge using a regional registry of out-of-hospital cardiac arrest patients ( OHCA ) . METHODS We retrospectively analysed a Utstein and in-hospital data prospect ively collected for all non-traumatic OHCA patients , in whom a successful return of spontaneous circulation ( ROSC ) had been obtained , from a large metropolitan area ( Great Paris ) . Receiving hospitals were categorized in 3 groups as follows : A centers ( High-case volume with cath-lab 24/7 ) , B centers ( Intermediate-case volume with cath-lab partly available ) and C centers ( Low-case volume and no cath-lab ) We compared patients ' characteristics and outcome in the 3 groups and performed a multivariate logistic regression using survival to discharge as primary endpoint . RESULTS Between May 2011 and December 2013 , 1476 patients were admitted in 48 hospitals ( group A : n=917 ; group B : n=428 ; group C : n=91 ) . Overall survival rate at discharge was 433/1436 ( 30 % ) . Patients ' baseline characteristics significantly differed , as hospitals from group A received younger patients with a higher rate of shockable cardiac rhythms ( p<0.001 ) . Unadjusted survival rate differed significantly among the 3 groups of hospitals ( respectively 34 % , 25 % and 15.4 % for A-C , p<0.01 ) . In multivariate analysis , the category of receiving hospital was no longer associated with survival , even in the subgroup of witnessed arrest and shockable patients . CONCLUSION In this population -based study , characteristics of receiving hospitals are not associated with survival rate at discharge . This might be partially explained by the prehospital triage organization used in France 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 CONTEXT The health and policy implication s of regional variation in incidence and outcome of out-of-hospital cardiac arrest remain to be determined . OBJECTIVE To evaluate whether cardiac arrest incidence and outcome differ across geographic regions . DESIGN , SETTING , AND PATIENTS Prospect i ve observational study ( the Resuscitation Outcomes Consortium ) of all out-of-hospital cardiac arrests in 10 North American sites ( 8 US and 2 Canadian ) from May 1 , 2006 , to April 30 , 2007 , followed up to hospital discharge , and including data available as of June 28 , 2008 . Cases ( aged 0 - 108 years ) were assessed by organized emergency medical services ( EMS ) personnel , did not have traumatic injury , and received attempts at external defibrillation or chest compressions or resuscitation was not attempted . Census data were used to determine rates adjusted for age and sex . MAIN OUTCOME MEASURES Incidence rate , mortality rate , case-fatality rate , and survival to discharge for patients assessed or treated by EMS personnel or with an initial rhythm of ventricular fibrillation . RESULTS Among the 10 sites , the total catchment population was 21.4 million , and there were 20,520 cardiac arrests . A total of 11,898 ( 58.0 % ) had resuscitation attempted ; 2729 ( 22.9 % of treated ) had initial rhythm of ventricular fibrillation or ventricular tachycardia or rhythms that were shockable by an automated external defibrillator ; and 954 ( 4.6 % of total ) were discharged alive . The median incidence of EMS-treated cardiac arrest across sites was 52.1 ( interquartile range [ IQR ] , 48.0 - 70.1 ) per 100,000 population ; survival ranged from 3.0 % to 16.3 % , with a median of 8.4 % ( IQR , 5.4%-10.4 % ) . Median ventricular fibrillation incidence was 12.6 ( IQR , 10.6 - 5.2 ) per 100,000 population ; survival ranged from 7.7 % to 39.9 % , with a median of 22.0 % ( IQR , 15.0%-24.4 % ) , with significant differences across sites for incidence and survival ( P<.001 ) . CONCLUSION In this study involving 10 geographic regions in North America , there were significant and important regional differences in out-of-hospital cardiac arrest incidence and outcome Objective : To investigate the relationship between trauma center volume and outcome . Background : The Resuscitation Outcomes Consortium is a network of 11 centers and 60 hospitals conducting emergency care research . For many procedures , high-volume centers demonstrate superior outcomes versus low-volume centers . This remains controversial for trauma center outcomes . Methods : This study was a secondary analysis of prospect ively collected data from the Resuscitation Outcomes Consortium multicenter out-of-hospital Hypertonic Saline Trial in patients with Glasgow Coma Scale score of 8 or less ( traumatic brain injury ) or systolic blood pressure of 90 or less and pulse of 110 or more ( shock ) . Regression analyses evaluated associations between trauma volume and the following outcomes : 24-hour mortality , 28-day mortality , ventilator-free days , Multiple Organ Dysfunction Scale incidence , worst Multiple Organ Dysfunction Scale score , and poor 6-month Glasgow Outcome Scale Output:	Very low certainty of evidence suggests that post-cardiac arrest care at CACs is associated with improved outcomes at hospital discharge .
MS21776	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES To study the efficacy of alfuzosin compared with tamsulosin in the management of lower ureteral stones . METHODS A total of 102 patients with stones < 1 cm size and located in the lower ureter were enrolled in the present study and r and omized into 3 equal groups . Group 1 patients ( n = 34 ) received 0.4 mg tamsulosin daily , group 2 patients ( n = 34 ) received 10 mg alfuzosin daily , and group 3 patients ( n = 34 ) received placebo ( control group ) . The patients were given 75 mg diclofenac injection intramuscularly on dem and and were followed up for 4 weeks . RESULTS The average stone size for groups 1 , 2 , and 3 was comparable ( 6.17 , 6.70 , and 6.35 mm , respectively ) . Stone expulsion was observed in 28 of 34 patients ( 82.3 % ) in group 1 , 24 of 34 patients ( 70.5 % ) in group 2 , and 12 of 34 patients ( 35.2 % ) in group 3 . The average expulsion time for groups 1 , 2 , and 3 was 12.3 , 14.5 , and 24.5 days , respectively . The results of both study groups ( groups 1 and 2 ) were superior to those in the placebo group ( P = .003 and P = .001 , respectively ) , but the study failed to show any statistically significant differences between tamsulosin and alfuzosin ( P = .25 ) . Alfuzosin was associated with fewer side effects than tamsulosin , especially in terms of retro grade ejaculation . CONCLUSIONS Medical treatment of lower ureteral calculi with tamsulosin and alfuzosin result ed in a significantly increased stone expulsion rate , decreased expulsion time , and a reduced need for analgesic therapy Abstract Objective : To evaluate and compare the efficacy of tamsulosin and alfuzosin as medical expulsive therapy for ureteric stones . Patients and methods : In all , 112 patients with ureteric stones of ⩽10 mm , located along the ureter , were r and omly divided into three groups . In group I , 32 patients received no α-blockers ( controls ) , in group II 40 patients received tamsulosin 0.4 mg daily , and in group III 40 patients received alfuzosin 10 mg daily . All patients were given analgesia and antibiotics when indicated . The follow-up was weekly for 4 weeks . Results : The mean stone size and age were comparable in the three groups . The stone expulsion rate was 44 % , 85 % and 75 % in groups I , II and III , respectively . Half of the stones in group II passed within 2 weeks , half in group III passed within 3 weeks , while more than half of the stones in group I did not pass even after 4 weeks . The mean number of painful episodes was 2.45 , 1.38 and 1.64 in groups I , II and III , respectively . The drug-related side-effects reported by patients were mild and transient . Conclusion : The use of tamsulosin or alfuzosin as medical expulsive therapy for ureteric stones in the three sections of the ureter ( upper , middle and lower ) was safe and effective , as shown by the increased overall stone expulsion rate , reduced stone expulsion time and fewer pain episodes . Tamsulosin was associated with a greater rate of stone expulsion than was alfuzosin PURPOSE We evaluated the effectiveness of doxazosin in children with distal ureteral stones in terms of stone expulsion rates and time to expulsion . MATERIAL S AND METHODS A total of 39 patients 2 to 14 years old with lower ureteral stones smaller than 10 mm were enrolled and r and omly divided into 2 groups . Group 1 consisted of 20 controls receiving ibuprofen for pain and group 2 consisted of 19 patients receiving doxazosin . Doxazosin dose was approximately 0.03 mg/kg daily . All patients were evaluated with x-ray , ultrasound or spiral computerized tomography . Stone expulsion rates and time to expulsion between the groups were compared . Mean followup was 19 days . Effects of doxazosin were also evaluated by comparing subgroups with stones smaller than 5 mm and 5 to 10 mm . Results were also evaluated with special emphasis on gender and age . RESULTS Expulsion was observed in 14 patients ( 70 % ) in group 1 and 16 ( 84 % ) in group 2 ( p > 0.05 ) . Mean expulsion times for groups 1 and 2 were 6.1 and 5.9 days , respectively ( p > 0.05 ) . Although fewer pain episodes were observed in the treatment group , this finding could not be evaluated objective ly . None of the patients experienced any adverse effects . CONCLUSIONS Administration of 0.03 mg/kg doxazosin daily in children to treat distal ureteral stones up to 10 mm is not superior to analgesic alone . This result is not affected by gender , stone size or patient age . However , additional r and omized controlled studies , especially including larger stone volumes , and different doses of doxazosin and other alpha-blockers , might highlight the usefulness of alpha-blockers for ureteral stones in children BACKGROUND Using a selective α-blocker for medical expulsive therapy ( MET ) is a cost-effective treatment approach widely used for ureteral stones . OBJECTIVE To evaluate the efficacy of silodosin , a selective α-1a receptor antagonist , in this setting . DESIGN , SETTING , AND PARTICIPANTS This was a multicenter , phase 2 study conducted in adult patients with a unilateral ureteral calculus of 4 - 10 mm . Of 239 patients in the safety population , six discontinued due to adverse events . INTERVENTION Patients were r and omized 1:1 to receive silodosin 8 mg or placebo for up to 4 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was spontaneous stone passage , analyzed using logistic regression . Secondary outcomes included time to stone passage , emergency room ( ER ) visits , hospital admissions , analgesic use , and incidence and severity of pain . RESULTS AND LIMITATIONS No significant differences between the silodosin and placebo groups were observed for passage rate of all stones ( 52 % vs 44 % , respectively ; p=0.2 ) . However , silodosin achieved a significantly greater rate of distal ureter stone passage than placebo ( p=0.01 ) . Significant differences were not observed for ER visits , hospital admission , or use of analgesics . The number of patients in the intent-to-treat population was slightly below the calculated sample size ( 232 vs 240 ) and sample sizes were not calculated for subgroup analyses . CONCLUSIONS This is among the first prospect i ve , r and omized , multi-institutional trials to examine the efficacy of a selective α-1a antagonist as MET in patients with ureteral calculi and did not demonstrate a benefit to the entire ureter . However , silodosin was found to be well tolerated and beneficial in facilitating the passage of distal ureteral stones , warranting additional future studies on distal stone elimination . PATIENT SUMMARY In this report , we looked at the efficacy of silodosin for the treatment of ureteral stones . We found that silodosin increased passage of distal ureteral stones BACKGROUND α-Blockers induce selective relaxation of ureteral smooth muscle with subsequent inhibition of ureteral spasms and dilatation of the ureteral lumen . The aim of the study was to evaluate the efficacy and safety of the α-blocker tamsulosin hydrochloride in patients with ureteral colic owing to a distal ureteral stone . METHODS This was a multicenter , placebo-controlled , r and omized , double-blind study . Patients with emergency admission for ureteral colic with a 2- to 7-mm-diameter radio-opaque distal ureteral stone were included in the study . They received tamsulosin ( 0.4 mg/d ) or matching placebo until stone expulsion or day 42 , whichever came first . The main end point was time to stone expulsion between inclusion and day 42 . Sequential statistical analysis was performed using the triangular test . RESULTS A total of 129 patients with acute renal colic were recruited from emergency wards between February 1 , 2002 , and December 8 , 2006 , in 6 French hospitals . Of these 129 r and omized patients ( placebo , 63 ; tamsulosin , 66 ) , 7 were excluded from analyses : 5 for major deviations from inclusion criteria , 1 for stone expulsion before the first treatment administration , and 1 for consent withdrawal . At inclusion , mean ( SD ) stone diameters were 3.2 ( 1.2 ) and 2.9 ( 1.0 ) mm in the placebo and tamsulosin groups , respectively ( P = .23 ) . Expulsion delay distributions during 42 days did not show any difference ( P = .30 ) . The numbers of patients who spontaneously expelled their stone within 42 days were 43 of 61 ( 70.5 % ) and 47 of 61 ( 77.0 % ) in the placebo and tamsulosin groups , respectively ( P = .41 ) . Corresponding delays were 10.1 ( 10.0 ) and 9.6 ( 9.8 ) days ( P = .82 ) . Other secondary end points and tolerance were not different between groups . CONCLUSION Although well tolerated , a daily administration of 0.4 mg of tamsulosin did not accelerate the expulsion of distal ureteral stones in patients with ureteral colic . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00151567 Purpose We evaluated and compared the efficacy of tamsulosin and alfuzosin in the medical treatment of symptomatic , uncomplicated distal ureteral stones . Material s and Methods A total of 87 patients with distal ureteral stones of ≤10 mm were r and omly divided into 3 groups . Group I patients ( n=29 ) received 0.4 mg tamsulosin daily , group II patients ( n=30 ) received 10 mg alfuzosin daily , and group III patients ( n=28 ) were not given tamsulosin or alfuzosin . Patients in all groups received Diclofenac sodium regularly for 1 week and then on dem and . Follow-up was done on a weekly basis for 30 days . Results The mean stone size was comparable in the 3 groups ( 4.97±2.24 , 5.47±2.13 , and 5.39±1.81 mm , respectively ) . The stone expulsion rate was 86.2 % , 76.6 % , and 50 % in groups I , II , and III , respectively . The difference in groups I and II with respect to group III was significant ( p=0.0028 and 0.035 ) . The mean expulsion time for groups I to III was 7.52±7.06 , 8.26±7.34 , and 13.90±6.99 days , respectively . The expulsion time was significantly shorter in groups I and II than in group III ( p=0.0097 and 0.026 ) . Patients taking tamsulosin and alfuzosin had fewer pain attacks than did group III patients ( 1.24±0.57 vs. 1.43±0.67 vs. 1.75±1.17 ) . Only 3 cases of drug side effects , 2 in group I and 1 in group II , were recorded . Conclusions The use of tamsulosin or alfuzosin for the medical treatment of lower ureteric stones proved to be safe and effective . Moreover , tamsulosin did not have any significant benefits over alfuzosin Background : Alpha – 1 blockers decrease the tension and release the spasm of smooth muscles and thus lessen the obstruction and irritation symptoms in the lower urinary tract ( LUTS ) . They make a faster passing of calculi from the terminal part of the ureters possible . Objectives : The goal of this study was to objective ly assess the improvement of difficulties caused by obstructions in ureterolithiasis localized in the lower part of the ureters of 104 r and omly chosen patients ( pts . ) in a double-blind study . Methods : During a period of 2 and half years ( June 1999–January 2002 ) 104 pts . suffering from ureterolithiasis of the lower urinary tract were treated and observed . Patients were divided into two groups : A ( n:53 ; later only 51 were evaluated ) which was subjected to st and ard treatment and group B ( n:51 ) where the st and ard treatment was supplemented by the alpha – 1 blocker . As alpha – 1 blocker one capsule of Tamsulosin /OMNIC 0.4 / was administered daily . Results : With alpha – 1 blocker , we have registered a more speedy passing of calculi from the terminal parts of ureters in 17.6 % of pts . Recurrence of renal colics was less frequent and occurred in one of eight pts . as compared with group A ( without the alpha – 1 blocker ) where a recurrence of the renal colic was observed in about every fifth pts . In group A ( n:51 ) , 62.8 % of the pts . passed the calculi , whereas in group B ( n:51 ) , where st and ard treatment was supplemented by the administration of the alpha – 1 blocker Tamsulosin , this percentage increased to 80.4 % . Conclusion : Output:	The use of alpha-blockers in patients with ureteral stones results in a higher stone-free rate and a shorter time to stone expulsion .
MS21777	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This was a prospect i ve study involving 205 women seeking medical abortion with gestational age ⩽ 63 days . Question naires regarding expectations , experience and satisfaction with medical abortion were self-completed at the end of the procedure . Women 's satisfaction was assessed using the visual analogue scale from 0 to 10 . Satisfaction and acceptability parameters were correlated with socio-demographic and obstetric data . The mean degree of overall satisfaction was 8.3 ( range 1 – 10 ) . Around 90 % of women would select the method again and would recommend it to a friend or relative . The degree of satisfaction showed a positive correlation with women 's age ( P < 0.001 ) and number of children ( P < 0.05 ) and a significant negative correlation with gestational age ( P < 0.005 ) . Marital status , type of financial support and acceptable pain and bleeding experience also showed a correlation with the satisfaction score . On the other h and , acceptability was correlated with husb and /partner agreement and support during the procedure and adequate counselling regarding pain and bleeding Background Despite changes to the abortion legislation in South Africa in 1996 , barriers to women accessing abortion services still exist including provider opposition to abortions and a shortage of trained and willing abortion care providers . The dearth of abortion providers undermines the availability of safe , legal abortion , and has serious implication s for women 's access to abortion services and health service planning . In South Africa , little is known about the personal and professional attitudes of individuals who are currently working in abortion service provision . Exploring the factors which determine health care providers ' involvement or disengagement in abortion services may facilitate improvement in the planning and provision of future services . Methods Qualitative research methods were used to collect data . Thirty four in-depth interviews and one focus group discussion were conducted during 2006 and 2007 with health care providers who were involved in a range of abortion provision in the Western Cape Province , South Africa . Data were analysed using a thematic analysis approach . Results Complex patterns of service delivery were prevalent throughout many of the health care facilities , and fragmented levels of service provision operated in order to accommo date health care providers ' willingness to be involved in different aspects of abortion provision . Related to this was the need expressed by many providers for dedicated , st and -alone abortion clinics thereby creating a more supportive environment for both clients and providers . Almost all providers were concerned about the numerous difficulties women faced in seeking an abortion and their general quality of care . An overriding concern was poor pre and post abortion counselling including contraceptive counselling and provision . Conclusion This is the first known qualitative study undertaken in South Africa exploring providers ' attitudes towards abortion and adds to the body of information addressing the barriers to safe abortion services . In order to sustain a pool of abortion providers , programmes which both attract prospect i ve abortion providers , and retain existing providers , needs to be developed and financial compensation for abortion care providers needs to be considered OBJECTIVE To determine the acceptability of taking mifepristone at home for early medical abortion in the United States . STUDY DESIGN This prospect i ve , non-r and omized , open-label study at six Planned Parenthood centers gave women with pregnancies up to 63 days ' gestation seeking medical abortion the choice of taking mifepristone in the center or at home . Participants were interviewed at a follow-up visit 1 - 2 weeks after mifepristone administration to assess their experience with the option they selected . RESULTS Four-hundred women were enrolled between April 2013 and June 2014 of which 32 % ( n=128 ) chose to take mifepristone at home . Abortion success rates did not differ between home and center users ( 96 % and 97 % ) . Among home users , 82 % reported taking the mifepristone at the time they planned with their provider and no participant took it after 63 days ' gestation . The most common reason cited for selecting home use was scheduling flexibility and significantly more home users took misoprostol on the weekend ( 50 % vs. 36 % , p=.02 ) . Home users were more likely than center users to report missing no days of work due to the abortion ( 47 % vs. 28 % , p=.08 ) . Ninety-nine percent of home users reported that they would take mifepristone at home again and 96 % would recommend home use to a friend . Offering this option did not increase the service delivery burden on study providers , who would recommend home use in the future for most participants . CONCLUSIONS Home use of mifepristone is a highly acceptable practice for which there is current dem and , and it should be offered as part of routine medical abortion services . IMPLICATION S Offering the option of home use of mifepristone to medical abortion patients can provide women and clinics with more flexibility while maintaining a safe , effective and acceptable service . These results provide support for telemedicine or pharmacy distribution BACKGROUND The aim of the study was to compare satisfaction with medical and surgical abortion and to identify potential confounders affecting satisfaction . METHODS 1033 women with gestational age ( GA ) < or = 63 days had either a medical ( 600 mg mifepristone followed by 1 mg gemeprost ) or a surgical abortion ( vacuum aspiration in general anaesthesia ) . The procedure was determined either by r and omization ( n = 111 ) or by choice ( n = 922 ) . Data on satisfaction , side effects and expectations were collected from question naires 2 and 8 weeks after termination . RESULTS More women were very satisfied or satisfied after a surgical than a medical abortion both after choosing method ( 92 % vs 82 % , P < 0.0001 ) , and after r and omization ( 94 % vs 68 % , P < 0.001 ) . Satisfaction was higher after choosing a medical procedure than after r and omization to the same procedure ; 82 % and 68 % , respectively , P < 0.05 . Satisfaction with the medical procedure was inversely correlated with GA and the intensity of pain , nausea , vomiting and dizziness , while satisfaction with the surgical procedure was unaffected by these side effects . Fewer women with a failed medical than a failed surgical abortion were satisfied ( 17 % vs 62 % ) , P < 0.05 . CONCLUSIONS Satisfaction with both medical and surgical abortions is high , although higher with the surgical than the medical procedure , and higher after choosing method than after r and omization CONTEXT Annually , more than 700,000 women turn to menstrual regulation , or uterine evacuation with vacuum aspiration ; many more resort to unsafe abortion . Using pills for the evacuation of the uterus could increase women 's access to safe menstrual regulation services and reduce the high levels of abortion- and menstrual regulation- related morbidity in Bangladesh . METHODS At 10 facilities in Bangladesh , 651 consenting women who were seeking menstrual regulation services and who were 63 days or less past their last menstrual period received 200 mg of mifepristone followed 24 hours later by 800 mcg of buccal misoprostol , administered either at home or in the clinic . Prospect i ve data were collected to determine women 's experience and satisfaction with the procedure , menstrual regulation outcome , and the human and physical re sources required for providing the method . Focus group discussion s were conducted with a purposively sample d group of service providers at each site to underst and their attitudes about the introduction of menstrual regulation with medication . RESULTS The majority of women ( 93 % ) with known menstrual regulation outcomes evacuated the uterus without surgical intervention . Overall , most women ( 92 % ) were satisfied with use of pills for their menstrual regulation . Providers faced initial challenges and concerns , particularly related to the additional counseling requirements and lack of control over the final outcome , but became more confident after successful use of the medication regimen . CONCLUSIONS Mifepristone-misoprostol can be safely offered within existing menstrual regulation services in urban and periurban areas in Bangladesh and is highly acceptable to women . Providers ' initial concerns diminish with increased experience with the method BACKGROUND A sublingual misoprostol-alone regimen was used in 50 women requesting medical abortion at up to 12 weeks gestation . The efficacy and acceptability of this regimen were studied . METHODS The women were given 600 microg misoprostol sublingually every 3 h for a maximum of 5 doses . RESULTS The overall complete abortion rate was 86 % ( 95 % confidence interval : 74 - 93 ) . The mean number of doses of misoprostol required was 4.1 + /- 1.1 . There was no significant change in haemoglobin concentration and the median duration of vaginal bleeding was 15 days ( range : 7 - 56 ) . Diarrhoea , fever and chills were the most common side-effects . The acceptability of this regimen of misoprostol was good : 97.7 % of the women who had a complete abortion would choose this method again and 88.4 % would recommend it to others . They preferred sublingual misoprostol as it is convenient to take , avoids the painful vaginal administration and gives more privacy during the abortion process . CONCLUSION This regimen of sublingual misoprostol is an effective and acceptable method of medical abortion . R and omized controlled trials are required to compare the efficacy of various misoprostol-alone regimens of medical abortion . Pharmacokinetic studies and clinical trials are needed to find out the most appropriate dose , dosing interval and route of administration of misoprostol Please cite this paper as : Rodriguez M , Seuc A , Kapp N , von Hertzen H , Huong N , Wojdyla D , Mittal S , Arustamyan K , Shah R , the World Health Organization Research Group on Post‐Ovulatory Methods of Fertility Regulation . Acceptability of misoprostol‐only medical termination of pregnancy compared with vacuum aspiration : an international , multicentre trial . BJOG 2012;119:817–823 OBJECTIVE To test the feasibility and acceptability of a simplified mifepristone-misoprostol regimen for early abortion in 2 tertiary teaching hospitals and 2 family planning clinics in Nepal . METHODS Consenting pregnant women ( n=400 ) with amenorrhea of 56 days or less seeking termination of pregnancy received 200 mg of oral mifepristone followed 48 hours later with 400 microg of oral misoprostol , administered either at home or at the clinic . Prospect i ve data were collected to determine the women 's experience , abortion outcome , and the operational requirements for providing the method . RESULTS Most ( 91.3 % ) of the 367 women with known outcomes had successful medical abortions . Given the option , most ( 89.7 % ) women elected to administer the misoprostol at home . CONCLUSION A simplified medical abortion protocol , including home administration of misoprostol , can be successfully integrated into clinical services in Nepal , where abortion services were recently legalized OBJECTIVE To evaluate the need for and outcome of self-administered medical abortion with mifepristone and misoprostol in Brazil , provided through Women on Web , a global telemedicine abortion service . STUDY DESIGN A retrospective case review of women from Brazil who contacted Women on Web in 2011 . Information from the online consultation , follow-up question naire and emails were used to analyze data including demographics , gestational age , outcome of the medical abortion and symptoms that lead to surgical interventions . RESULTS The Women on Web website had 109779 unique visitors from Brazil , 2104 women contacted the helpdesk by email . Of the 1401 women who completed the online consultation , 602 women continued their request for a medical abortion . Of the 370 women who used the medicines , 307 women gave follow-up information about the outcome of the medical abortion . Of these , 207 ( 67.4 % ) women were 9 weeks or less pregnant , 71 ( 23.1 % ) were 10 , 11 or 12 weeks pregnant , and 29 ( 9.5 % ) women were 13 weeks or more pregnant . There was a significant difference in surgical intervention rates after the medical abortion ( 19.3 % at < 9 weeks , 15.5 % at 11 - 12 weeks and 44.8 % at > 13 weeks , p=.06 ) . However , 42.2 % of the women who had a surgical intervention had no symptoms of a complication . CONCLUSION There is large need for medical abortion in Brazil . Home use of mifepristone and misoprostol provided through telemedicine is safe and effective . However , after 13 weeks gestation , there is an increased risk of surgical intervention that may be due to the regimen used and local clinical practice s in Brazil . IMPLICATION S The current study shows that there is an unmet need for medical abortion in Brazil , a country with legal restrictions on access to safe abortion services . Telemedicine can help fulfill the need and self administration of medical abortion is safe and effective even at late first trimester abortion . Prospect i ve trials are needed to establish safety , effectiveness and acceptability of home use of medical abortion beyond 12 weeks of pregnancy OBJECTIVE To document abortion practice s and contraceptive use among women of reproductive age in an urban slum of Delhi . METHODS Data were collected as part of a cross-sectional study conducted in an urban resettlement colony in the North East District of Delhi between November 2010 and December 2011 . Systematic r and om sampling was used to enroll 200 married women aged 15 - 49 years from each of the four blocks of the colony . Participants were interviewed and Output:	Country-specific abortion laws , implementing protocol s , side-effects , rates of failures , and the need to verify the abortion shaped women 's preference for abortion methods . Overall , women who preferred medical abortions did so because they perceived it as a ' natural ' and safe procedure that can be self-conducted at home , thereby reducing their dependency on the health system . However , women face significant barriers to medical abortion care . These include legal requirements around type of provider , site of service , need for follow-up , providers ' limited knowledge of the procedure , and preferences for surgical abortions . Borderless internet-based services have enabled some women to circumvent these barriers . Our review suggests that medical abortions are used by women either in countries where the health system is fully supportive or where the health system is completely disengaged , usually due to restricted abortion laws . In those countries where abortions are legal but often difficult to access due to health system barriers , women tend to prefer surgical abortions
MS21778	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results OBJECTIVES The objective of the study is to evaluate the effects of levonorgestrel transferred through breast milk on thyroid stimulating hormone ( TSH ) and luteinizing hormone ( LH ) levels in full breast-fed infants . METHODS Forty healthy postpartum women and their male newborns were recruited for the study . Women were r and omly allocated to two study groups : Group 1 , IUD users and group 2 , Norplant users . Blood and milk sample s were collected on the day of IUD or Norplant insertion and 3 and 6 months later for TSH and levonorgestrel measurements . RESULTS The results disclosed a significant decrease in TSH levels , and a negative relationship between LNG levels and TSH concentration in breast feeding infants at 3 months after implant insertion . The lowest TSH levels were observed at 6 months in the women from group 2 . CONCLUSIONS The overall data indicate that the LNG levels transferred to fully breast-fed infants through breast milk from Norplant users significantly modified their TSH levels Recent empirical evidence supports the importance of adequate r and omization in controlled trials . Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment . While that provides empirical evidence of bias being interjected into trials , trial investigators rarely document the sensitive details of subverting the intended purpose of r and omization . This article relates anonymous accounts run the gamut from simple to intricate operations , from transillumination of envelopes to search ing for code in the office files of the principal investigator . They indicate that deciphering is something more frequent than a rate occurrence . These accounts prompt some method ological recommendations to help prevent deciphering . R and omized controlled trials appear to annoy human nature -- if properly conducted , indeed they should Eighty healthy single births born at a gestational age of 259 - 294 days were studied in an open , non-r and omized , group comparative fashion . The mothers were on average 6 weeks postpartum , healthy , and fully breastfeeding at the start of treatment . Forty-two mothers elected to use the etonogestrel-releasing implant , Implanon , while 38 chose use of a non-hormone medicated intrauterine device ( IUD ) . One month after implant placement , the dose of etonogestrel ingested by the infants via breast milk was 19.86 ng/kg/day , which decreased to 10.45 ng/kg/day at the end of the study period ( month 4 ) . The volume of breast milk production was not affected by the use of Implanon . There were no significant differences between groups in milk content of total fat , total protein , and lactose . The timing and quantity of supplementary feedings did not differ between the two groups . Growth of the infants was analyzed by treatment and gender . For the girls , no differences between groups were seen for body weight , body length , and head circumference . The same applied to the boys except for a somewhat larger , although not statistically significant , increase in body weight for boys whose mother used Implanon . There was a low incidence of intercurrent illnesses in the infants of both groups . None of the conditions was of a serious nature . From the present study , we conclude that Implanon did not change the volume and composition of breast milk . The low concentration of etonogestrel ingested by the infant was not associated with adverse effects OBJECTIVE : To evaluate lactogenesis after early postpartum insertion of the etonogestrel contraceptive implant . METHODS : Healthy peripartum women with healthy , term newborns who desired the etonogestrel implant for contraception were r and omly assigned to early ( 1–3 days ) or st and ard ( 4–8 weeks ) postpartum insertion . The primary outcomes , time to lactogenesis stage II and lactation failure , were documented by a vali date d measure . The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 8 additional hours . Secondary data ( device continuation and contraceptive use , breast milk analysis , supplementation rates , side effects , and bleeding patterns ) were collected at periodic intervals for 6 months . RESULTS : Sixty-nine women were enrolled . Thirty-five were r and omly assigned to early insertion and 34 to st and ard insertion . There were no statistically significant differences between the groups in age , race , parity , mode of delivery , use of anesthesia , or prior breastfeeding experience . Early insertion was demonstrated to be noninferior to st and ard insertion in time to lactogenesis stage II ( early : [ mean±st and ard deviation ] 64.3±19.6 hours ; st and ard : 65.2±18.5 hours , mean difference , −1.4 hours , 95 % confidence interval [ CI ] −10.6 to 7.7 hours ) . Early insertion was also demonstrated to be noninferior to st and ard insertion in incidence of lactation failure ( 1/34 [ 3 % ] in the early insertion group , 0/35 [ 0 % ] in the st and ard insertion group [ risk difference , 0.03 , 95 % CI −0.02 to 0.08 ] ) . Use of formula supplementation was not significantly different between the groups . Milk composition at 6 weeks was not significantly different between the groups . CONCLUSION : Breastfeeding outcomes were similar in women who underwent early compared with st and ard postpartum insertion of the etonogestrel implant . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00847587 . LEVEL OF EVIDENCE : OBJECTIVE : To estimate whether 6-month use of the levonorgestrel-releasing intrauterine device ( IUD ) would be higher when insertion occurred within 10 minutes of placental delivery compared with 6–8 weeks postpartum . METHODS : We enrolled pregnant women planning vaginal deliveries and desiring a postpartum levonorgestrel-releasing IUD . Patients were r and omly assigned when admitted in labor to postplacental or delayed IUD insertion . The women followed up in person at 6–8 weeks and 6 months and were contacted by telephone at 3 months . Women were ineligible for a study IUD postenrollment for intrapartum events including infection , hemorrhage , and cesarean delivery ; these women were contacted by phone at 3 and 6 months . Expelled IUDs were replaced per patient preference . RESULTS : Successful IUD placement occurred in 50 of 51 participants ( 98.0 % ) and 46 of 51 participants ( 90.2 % ) in the postplacental and delayed groups , respectively ( P=.2 ) . Expulsion within 6 months occurred in 12 of 50 ( 24.0 % ; 95 % confidence interval [ CI ] , 13.1–38.2 ) and two of 46 ( 4.4 % ; 95 % CI 0.5–14.8 ) participants , respectively ( P=.008 ) . Intrauterine device use at 6 months was 43 of 51 ( 84.3 % ; 95 % CI 71.4–93.0 ) and 39 of 51 ( 76.5 % ; 95 % CI 62.5–87.2 ) , respectively ( P=.32 ) . For ineligible patients , only 11 of 41 ( 26.8 % ) women were using IUDs at 6 months and two ( 4.9 % ) had become pregnant . CONCLUSION : Intrauterine device use 6 months after delivery is similar in women who have postpartum or scheduled delayed IUD placement through a study after replacement of expelled IUDs . Expulsions are significantly higher with postplacental compared with delayed IUD placement . Women asked to follow up with their own health care providers for delayed insertion are significantly less likely to receive an IUD . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00476021 . LEVEL OF EVIDENCE : Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity A study was conducted to determine whether the onset or maintenance of lactation might be influenced by the administration of ovulation-inhibiting drugs for contraceptive purpose s when they were taken : 1 ) before the beginning of the lactation-period ; or 2 ) during the lactation period . The milk yield of 100 mothers who received an ovulation inhibitor ( 2.5 . mg lynestrenol ) from Day 1 postpartum was investigated . In order to exclude psychic factors 50 % of the tablets were placebos of identical appearance . The administration of the ovulation-inhibitor from Day 1 postpartum did not influence the commencement of lactation of the total milk yield in the first 10 days of the child-bed period . No clear influence on the milk yeild was observed during the subsequent observation period of 4 weeks . No differences were observed in another double group of mothers 70 women altogether who received the ovulation-inhibitor or the placebo from Day 10 postpartum BACKGROUND Mirena is a levonorgestrel-releasing intrauterine system ( LNG-IUS ) that provides highly effective and long-acting progestogen-only contraception . OBJECTIVE The objective of this study was to analyze the possible effects of using LNG-20 microg IUS on breast-feeding performance , infant growth and infant development during the first postpartum year as compared with the Copper T380A intrauterine device ( Cu T380A IUD ) . DESIGN This study is a prospect i ve , controlled and r and omized trial . SETTING The study was conducted at the Department of Obstetrics and Gynecology , Assiut University Hospital , Egypt . METHODS Three hundred twenty lactating women asking for initiation of contraception during the early postpartum stage were assigned r and omly into two groups , the LNG-20 microg IUS group ( n=163 ) and the Cu T380A group ( n=157 ) . The insertions were done 6 - 8 weeks postpartum . Each participant was followed up at three monthly intervals after insertion and until the first birthday of her baby . During these visits , the breast-feeding pattern was assessed , certain infant physical growth parameters were measured and a set of infant development tests was performed . RESULTS No pregnancy occurred in both groups . There were no significant differences in the net continuation rates between the two groups ( 89.3 for LNG-IUS vs. 90.9 for Cu T380A ) . The LNG-20 microg IUS group had comparable rates of breast-feeding continuation , complete weaning , full breast-feeding and partial breast-feeding , with the Cu-IUD group . No statistically significant differences were found between groups with regard to all infant physical growth parameters and various infant development tests . CONCLUSION The findings of the current study confirm that the use of LNG-20 microg IUS during the first postpartum year in lactating women provides highly effective and acceptable contraception and does not negatively influence breast-feeding or the growth and development of breast-fed infants Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as Output:	One showed greater weight gain in the etonogestrel implant group versus no method but less versus DMPA
MS21779	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Acute stress disorder ( ASD ) is a precursor of chronic posttraumatic stress disorder ( PTSD ) . Twenty-four participants with ASD following civilian trauma were given 5 sessions of either cognitive-behavioral therapy ( CBT ) or supportive counseling ( SC ) within 2 weeks of their trauma . Fewer participants in CBT ( 8 % ) than in SC ( 83 % ) met criteria for PTSD at posttreatment . There were also fewer cases of PTSD in the CBT condition ( 17 % ) than in the SC condition ( 67 % ) 6 months posttrauma . There were greater statistically and clinical ly significant reductions in intrusive , avoidance , and depressive symptomatology among the CBT participants than among the SC participants . This study represents the 1st demonstration of successful treatment of ASD with CBT and its efficacy in preventing chronic PTSD This research represents the first controlled treatment study of hypnosis and cognitive- behavioral therapy ( CBT ) of acute stress disorder ( ASD ) . Civilian trauma survivors ( N=87 ) who met criteria for ASD were r and omly allocated to 6 sessions of CBT , CBT combined with hypnosis ( CBT-hypnosis ) , or supportive counseling ( SC ) . CBT comprised exposure , cognitive restructuring , and anxiety management . CBT-hypnosis comprised the CBT components with each imaginal exposure preceded by a hypnotic induction and suggestions to engage fully in the exposure . In terms of treatment completers ( n=69 ) , fewer participants in the CBT and CBT-hypnosis groups met criteria for posttraumatic stress disorder at posttreatment and 6-month follow-up than those in the SC group . CBT-hypnosis result ed in greater reduction in reexperiencing symptoms at posttreatment than CBT . These findings suggest that hypnosis may have use in facilitating the treatment effects of CBT for posttraumatic stress Ninety female recent assault survivors who met symptom criteria for posttraumatic stress disorder ( PTSD ) were r and omized to one of three interventions : Brief Cognitive Behavioral Intervention , which focused on processing the traumatic event ( B-CBT ) ; assessment condition ( AC ) ; or supportive counseling ( SC ) . Within 4 weeks of an assault , participants met weekly with a therapist for four 2-hr sessions . Across all interventions , participants reported decreases in PTSD symptoms , depression , and anxiety over time . At postintervention , participants in B-CBT reported greater decreases in self-reported PTSD severity and a trend toward lower anxiety than those in SC . At 3-month follow-up , participants in B-CBT evidence d lower general anxiety than those in SC and a trend toward lower self-reported PTSD severity . At last available follow-up ( on average , 9-months postassault ) , all three interventions were generally similar in outcome . These findings suggest that a trauma-focused intervention aim ed at those with severe PTSD symptoms after an assault can accelerate recovery OBJECTIVE Acute stress disorder permits an early identification of trauma survivors who are at risk of developing chronic posttraumatic stress disorder ( PTSD ) . This study aim ed to prevent PTSD by an early provision of cognitive behavior therapy . Specifically , this study indexed the relative efficacy of prolonged exposure and anxiety management in the treatment of acute stress disorder . METHOD Forty-five civilian trauma survivors with acute stress disorder were given five sessions of 1 ) prolonged exposure ( N = 14 ) , 2 ) a combination of prolonged exposure and anxiety management ( N = 15 ) , or 3 ) supportive counseling ( N = 16 ) within 2 weeks of their trauma . Forty-one trauma survivors were assessed at the 6-month follow-up . RESULTS Fewer patients with prolonged exposure ( 14 % , N = 2 of 14 ) and prolonged exposure plus anxiety management ( 20 % , N = 3 of 15 ) than supportive counseling ( 56 % , N = 9 of 16 ) met the criteria for PTSD after treatment . There were also fewer cases of PTSD in the prolonged exposure group ( 15 % , N = 2 of 13 ) and the prolonged exposure plus anxiety management group ( 23 % , N = 3 of 13 ) than in the supportive counseling group ( 67 % , N = 10 of 15 ) 6 months after the trauma . Chronic PTSD in the supportive counseling condition was characterized by greater avoidance behaviors than in the prolonged exposure condition or the prolonged exposure plus anxiety management condition . CONCLUSIONS These findings suggest that PTSD can be effectively prevented with an early provision of cognitive behavior therapy and that prolonged exposure may be the most critical component in the treatment of acute stress disorder The aim of this study was to index the long-term benefits of early provision of cognitive behavior therapy to trauma survivors with acute stress disorder . Civilian trauma survivors ( n = 80 ) with acute stress disorder were r and omly allocated to either cognitive behavior therapy ( CBT ) or supportive counseling ( SC ) - 69 completed treatment , and 41 were assessed four years post-treatment for post-traumatic stress disorder ( PTSD ) with the Clinician Administered PTSD Scale . Two CBT patients ( 8 % ) and four SC patients ( 25 % ) met PTSD criteria at four-year follow-up . Patients who received CBT reported less intense PTSD symptoms , and particularly less frequent and less avoidance symptoms , than patients who received SC . These findings suggest that early provision of CBT in the initial month after trauma has long-term benefits for people who are at risk of developing PTSD The long-term benefits of cognitive behaviour therapy ( CBT ) for trauma survivors with acute stress disorder were investigated by assessing patients 3 years after treatment . Civilian trauma survivors ( n=87 ) were r and omly allocated to six sessions of CBT , CBT combined with hypnosis , or supportive counselling ( SC ) , 69 completed treatment , and 53 were assessed 2 years post-treatment for post-traumatic stress disorder ( PTSD ) with the Clinician-Administered PTSD Scale . In terms of treatment completers , 2 CBT patients ( 10 % ) , 4 CBT/hypnosis patients ( 22 % ) , and 10 SC patients ( 63 % ) met PTSD criteria at 2-years follow-up . Intent-to-treat analyses indicated that 12 CBT patients ( 36 % ) , 14 CBT/hypnosis patients ( 46 % ) , and 16 SC patients ( 67 % ) met PTSD criteria at 2-year follow-up . Patients who received CBT and CBT/hypnosis reported less re-experiencing and less avoidance symptoms than patients who received SC . These findings point to the long-term benefits of early provision of CBT in the initial month after trauma Output:	Anxiety and depression scores were generally lower in the TFCBT groups than in the SC groups . Conclusion There is evidence for the effectiveness of TFCBT compared to SC in preventing chronic PTSD in patients with an initial ASD diagnosis .
MS21780	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background / Objectives : Animal studies and pilot experiments in men indicate that the hypothalamic neuropeptide oxytocin limits food intake , and raise the question of its potential to improve metabolic control in obesity . Subjects/ Methods : We compared the effect of central nervous oxytocin administration ( 24 IU ) via the intranasal route on ingestive behaviour and metabolic function in 18 young obese men with the results in a group of 20 normal-weight men . In double-blind , placebo-controlled experiments , ad libitum food intake from a test buffet was examined in fasted subjects 45 min after oxytocin administration , followed by the assessment of postpr and ial , reward-driven snack intake . Energy expenditure was repeatedly assessed by indirect calorimetry and blood was sample d to determine concentrations of blood glucose and hormones . Results : Oxytocin markedly reduced hunger-driven food intake in the fasted state in obese but not in normal-weight men , and led to a reduction in snack consumption in both groups , whereas energy expenditure remained generally unaffected . Hypothalamic – pituitary – adrenal axis secretion and the postpr and ial rise in plasma glucose were blunted by oxytocin in both groups . Conclusions : Oxytocin exerts an acutely inhibitory impact on food intake that is enhanced rather than decreased in obese compared with normal-weight men . This pattern puts it in contrast to other metabolically active neuropeptides and bodes well for clinical applications of oxytocin in the treatment of metabolic disorders Fragile X syndrome ( FXS ) is a rare inherited genetic disorder causing severe intellectual disability and autistic-like symptoms . Individuals with FXS , males in particular , often exhibit extreme eye gaze avoidance and hyperarousal when they encounter stressful social situations . We investigated whether oxytocin ( OT ) , a hormone with prosocial and anxiolytic effects , could alleviate symptoms of social anxiety in this population . A r and omized double-blind placebo-controlled single-dose trial was performed with intranasal administration of placebo , 24 IU OT and 48 IU OT . Measures of eye gaze frequency , heart rate , respiratory sinus arrhythmia ( RSA ) , heart rate variability ( HRV ) and salivary cortisol were obtained during a structured social challenge conducted 50 min following OT administration . Ten low-functioning males with FXS ( aged 13 - 28 years ) traveled to Stanford for the initial visit : 8 completed the study . Eye gaze frequency improved significantly in response to the 24 IU OT dose and salivary cortisol levels decreased significantly in response to the 48 IU OT dose . There was no effect of OT on heart rate , RSA or HRV although individual plots of the heart rate data suggested that OT increased heart rate in some participants and decreased heart rate in others . These findings suggest that intranasal administration of OT may ameliorate some symptoms of social anxiety in patients with FXS . Further double-blind placebo-controlled studies of OT , conducted in combination with behavioral treatment programs , may be warranted We investigated the effects of intranasal oxytocin ( OXT ) on trust and cooperation in borderline personality disorder ( BPD ) , a disorder marked by interpersonal instability and difficulties with cooperation . Although studies in healthy adults show that intranasal OXT increases trust , individuals with BPD may show an altered response to exogenous OXT because the effects of OXT on trust and pro-social behavior may vary depending on the relationship representations and expectations people possess and /or altered OXT system functioning in BPD . BPD and control participants received intranasal OXT and played a social dilemma game with a partner . Results showed that OXT produced divergent effects in BPD participants , decreasing trust and the likelihood of cooperative responses . Additional analyses focusing on individual differences in attachment anxiety and avoidance across BPD and control participants indicate that these divergent effects were driven by the anxiously attached , rejection-sensitive participants . These data suggest that OXT does not uniformly facilitate trust and pro-social behavior in humans ; indeed , OXT may impede trust and pro-social behavior depending on chronic interpersonal insecurities , and /or possible neurochemical differences in the OXT system . Although popularly dubbed the ' hormone of love ' , these data suggest a more circumspect answer to the question of who will benefit from OXT Background and Aim Social difficulties and problems related to eating behaviour are common features of both anorexia nervosa ( AN ) and bulimia nervosa ( BN ) . The aim of this study was to examine the impact of intranasal oxytocin on consummatory behaviour and emotional recognition in patients with AN and BN in comparison to healthy controls . Material s A total of 102 women , including 35 patients with anorexia nervosa ( AN ) , 34 patients with bulimia nervosa ( BN ) , and 33 healthy university students of comparable age and intelligence , participated in a double-blind , single dose placebo-controlled cross-over study . A single dose of intranasal administration of oxytocin ( 40 IU ) ( or a placebo ) was followed by an emotional recognition task and an apple juice drink . Food intake was then recorded for 24 hours post-test . Results Oxytocin produced no significant change in appetite in the acute or 24 hours free living setting s in healthy controls , whereas there was a decrease in calorie consumption over 24 hours in patients with BN . Oxytocin produced a small increase in emotion recognition sensitivity in healthy controls and in patients with BN , In patients with AN , oxytocin had no effect on emotion recognition sensitivity or on consummatory behaviour . Conclusions The impact of oxytocin on appetite and social cognition varied between people with AN and BN . A single dose of intranasal oxytocin decreased caloric intake over 24 hours in people with BN . People with BN showed enhanced emotional sensitivity under oxytocin condition similar to healthy controls . Those effects of oxytocin were not found in patients with AN . Trial Registration Clinical Trials.gov Rationale Social cognition influences social interactions . Alcohol reportedly facilitates social interactions . However , the acute effects of alcohol on social cognition are relatively poorly studied . Methods We investigated the effects of alcoholic or non-alcoholic beer on emotion recognition , empathy , and sexual arousal using the dynamic face emotion recognition task ( FERT ) , Multifaceted Empathy Test ( MET ) , and Sexual Arousal Task ( SAT ) in a double-blind , r and om-order , cross-over study in 60 healthy social drinkers . We also assessed subjective effects using visual analog scales ( VASs ) , blood alcohol concentrations , and plasma oxytocin levels . Results Alcohol increased VAS ratings of stimulated , happy , talkative , open , and want to be with others . The subjective effects of alcohol were greater in participants with higher trait inhibitedness . Alcohol facilitated the recognition of happy faces on the FERT and enhanced emotional empathy for positive stimuli on the MET , particularly in participants with low trait empathy . Pictures of explicit sexual content were rated as less pleasant than neutral pictures after non-alcoholic beer but not after alcoholic beer . Explicit sexual pictures were rated as more pleasant after alcoholic beer compared with non-alcoholic beer , particularly in women . Alcohol did not alter the levels of circulating oxytocin . Conclusions Alcohol biased emotion recognition toward better decoding of positive emotions and increased emotional concern for positive stimuli . No support was found for a modulatory role of oxytocin . Alcohol also facilitated the viewing of sexual images , consistent with disinhibition , but it did not actually enhance sexual arousal . These effects of alcohol on social cognition likely enhance sociability . Trial registration www . clinical Objective Pre clinical studies indicate that oxytocin is anorexigenic and has beneficial metabolic effects . Oxytocin effects on nutrition and metabolism in humans are not well defined . We hypothesized that oxytocin would reduce caloric intake and appetite , and alter levels of appetite-regulating hormones . We also explored metabolic effects of oxytocin . Methods We performed a r and omized , placebo-controlled crossover study of single-dose intranasal oxytocin ( 24 IU ) in 25 fasting healthy men . After oxytocin/placebo , subjects selected breakfast from a menu , and were given double portions . Caloric content of food consumed was measured . Visual analogue scales were used to assess appetite and blood was drawn for appetite-regulating hormones , insulin , and glucose before and after oxytocin/placebo . Indirect calorimetry assessed resting energy expenditure ( REE ) and substrate utilization . Results Oxytocin reduced caloric intake with a preferential effect on fat intake and increased levels of the anorexigenic hormone cholecystokinin without affecting appetite or other appetite-regulating hormones . There was no effect of oxytocin on REE . Oxytocin result ed in a shift from carbohydrate to fat utilization and improved insulin sensitivity . Conclusions Intranasal oxytocin reduces caloric intake and has beneficial metabolic effects in men without concerning side effects . The efficacy and safety of sustained oxytocin administration in the treatment of obesity warrants investigation OBJECTIVE To find out if cholecystokinin ( CCK ) stimulates the secretion of oxytocin in humans , and if there are any differences in secretion between healthy women and those with normal-transit constipation . DESIGN Prospect i ve open study . SETTING Teaching hospital , Sweden . SUBJECTS 8 healthy female volunteers and 6 women with chronic refractory normal-transit constipation . INTERVENTIONS Subjects were fasted before experiments . On one day they were given emulsified corn oil and another an intravenous injection of 1 Ivy dog unit ( IDU ) CCK/kg body weight . Blood sample s were taken before each experiment at 10 minutes and at the time the experiments started . Blood sample s were also taken after each experiment at 10 , 20 , 30 , 45 , 60 , 90 and 120 minutes . MAIN OUTCOME MEASURES Concentrations of CCK and oxytocin . RESULTS Ingestion of corn oil significantly increased the plasma concentration of CCK in both groups ( healthy women p = 0.03 and constipated women p = 0.008 ) . Injection of CCK also led as expected to hypercholecystokininaemia in both groups ( p = 0.008 and p = 0.03 , respectively ) . The corn oil increased oxytocin secretion in both groups ( p = 0.02 and 0.03 , respectively ) and exogenous CCK increased the secretion still further ( p = 0.008 and 0.03 , respectively ) . CONCLUSIONS Both corn oil and injection of CCK led to an increased CCK concentration in plasma . Oxytocin was secreted in response to endogenous as well as exogenous CCK stimulation . There was no difference between healthy and constipated women in either parameter analysed Output:	Dietary intake and behaviors appear to have some influence on oxytocin , with more pronounced effects found with exogenously administered oxytocin
MS21781	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : The novel oral anticoagulants ( NOACs ) are used for stroke prevention in atrial fibrillation ( AF ) , but their safety and efficacy in the periablation period are not well established . Additionally , no st and ard procedure for managing periprocedural and intraprocedural anticoagulation has been established . Objective : To evaluate the frequency of hemorrhagic and thrombotic events as well as periprocedural management strategies of NOACs compared with warfarin as anticoagulation therapy for AF ablation . Methods : This was a retrospective cohort study from a prospect i ve AF ablation registry maintained at a large , academic medical center . Results : A total of 374 cases ( 173 warfarin , 123 dabigatran , 61 rivaroxaban , and 17 apixaban ) were included in the analysis . The overall hemorrhagic/thrombotic event rate was 14.2 % ( major hemorrhage 2.7 % , minor hemorrhage 11.2 % , thrombotic stroke 0.5 % ) . The frequency of minor hemorrhage was significantly higher with warfarin compared with dabigatran ( 15 % vs 5.7 % , P = 0.012 ) . The average heparin dose required to reach the goal activated clotting time ( ACT ) was 5600 units for warfarin , 12 900 units for dabigatran ( P < 0.001 ) , 15 100 units for rivaroxaban ( P < 0.001 ) , and 14 700 units for apixaban ( P < 0.001 ) . The average time in minutes to reach the goal ACT was significantly longer , compared with warfarin , for dabigatran ( 57 vs 28 , P < 0.001 ) , rivaroxaban ( 63 vs 28 , P < 0.001 ) , and apixaban ( 72 vs 28 , P < 0.001 ) . Conclusions : Compared with warfarin , periprocedural anticoagulation with dabigatran result ed in fewer minor hemorrhages and total adverse events after AF ablation . Patients anticoagulated with NOACs required larger doses of heparin and took longer to reach the goal ACT compared with patients anticoagulated with warfarin OBJECTIVES The purpose of this study was to evaluate the feasibility and safety of periprocedural dabigatran during atrial fibrillation ( AF ) ablation . BACKGROUND AF ablation requires optimal periprocedural anticoagulation for minimizing bleeding and thromboembolic complications . The safety and efficacy of dabigatran as a periprocedural anticoagulant for AF ablation are unknown . METHODS We performed a multicenter , observational study from a prospect i ve registry including all consecutive patients undergoing AF ablation in 8 high-volume centers in the United States . All patients receiving dabigatran therapy who underwent AF ablation on periprocedural dabigatran , with the dose held on the morning of the procedure , were matched by age , sex , and type of AF with an equal number of patients undergoing AF ablation with uninterrupted warfarin therapy over the same period . RESULTS A total of 290 patients , including 145 taking periprocedural dabigatran and an equal number of matched patients taking uninterrupted periprocedural warfarin , were included in the study . The mean age was 60 years with 79 % being male and 57 % having paroxysmal AF . Both groups had a similar CHADS(2 ) score , left atrial size , and left ventricular ejection fraction . Three thromboembolic complications ( 2.1 % ) occurred in the dabigatran group compared with none in the warfarin group ( p = 0.25 ) . The dabigatran group had a significantly higher major bleeding rate ( 6 % vs. 1 % ; p = 0.019 ) , total bleeding rate ( 14 % vs. 6 % ; p = 0.031 ) , and composite of bleeding and thromboembolic complications ( 16 % vs. 6 % ; p = 0.009 ) compared with the warfarin group . Dabigatran use was confirmed as an independent predictor of bleeding or thromboembolic complications ( odds ratio : 2.76 , 95 % confidence interval : 1.22 to 6.25 ; p = 0.01 ) on multivariate regression analysis . CONCLUSIONS In patients undergoing AF ablation , periprocedural dabigatran use significantly increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy BACKGROUND We aim ed to evaluate the feasibility of an oral direct thrombin inhibitor , dabigatran , as a periprocedural anticoagulant for use with ablation of atrial fibrillation ( AF ) . METHODS Consecutive patients scheduled to undergo an AF ablation were r and omly assigned to receive dabigatran ( n = 45 ) or warfarin ( n = 45 ) to compare their clinical feasibility . Both of those oral anticoagulants were discontinued the day before the ablation and were resumed after confirming hemostasis of the venipuncture site . A bridging therapy with heparin was not used in either of the patient groups . RESULTS Dabigatran was switched to warfarin before the ablation because of dyspepsia in three patients . An occurrence of rebleeding from the venipuncture site was less common in dabigatran-allocated patients than in warfarin-allocated patients ( 20 % vs 44 % ; P = 0.013 ) . The reduction in the D-dimer level after the initiation of oral anticoagulants was greater in the dabigatran-allocated patients than in the warfarin-allocated patients . The time from the initiation of the anticoagulants to the ablation was significantly shorter in the dabigatran-allocated patients than in the warfarin-allocated patients ( 43 ± 7 vs 63 ± 13 days ; P < 0.0001 ) . There was only one fatal periprocedural complication in a patient receiving warfarin , who had a mesenteric arterial thrombosis after the ablation . CONCLUSIONS An anticoagulation strategy with dabigatran may surpass that with warfarin in reducing both the periprocedural risk of minor bleeding and a hypercoagulable state , and the time to ablation in patients undergoing ablation of AF Background and Objectives Two new oral anticoagulants , rivaroxaban and dabigatran , with no need for anticoagulation monitoring , are available for patients with atrial fibrillation ( AF ) . We aim ed to compare their anticoagulant effects and safety when used during the AF ablation periprocedural period . Methods Patients undergoing AF ablation were r and omly assigned to receive rivaroxaban 15 mg once daily ( N = 30 ) or dabigatran 110 mg twice daily ( N = 30 ) . Rivaroxaban was withheld on the morning of the day before the ablation , and dabigatran was discontinued from the evening of the day before the procedure . Both anticoagulants were then resumed after haemostasis of the access site . D-dimer levels were measured just before the ablation , at the end of the ablation , and at 24 h and 48 h after the procedure . Results The baseline D-dimer levels were identical in both groups . However , D-dimer levels increased more markedly following the ablation procedure in patients receiving rivaroxaban than in those receiving dabigatran ( mean ± st and ard deviation from 0.62 ± 0.16 to 1.09 ± 0.38 μg/mL vs from 0.59 ± 0.08 to 0.75 ± 0.17 μg/mL ; p < 0.0001 ) . The rate of rebleeding from the access site was similar in patients receiving rivaroxaban and those receiving dabigatran ( 33 vs 27 % ; p = 0.78 ) . Conclusion As compared with dabigatran , rivaroxaban may increase the risk of hypercoagulability when used during the periprocedural period of AF ablation , suggesting a potential rebound effect of rivaroxaban or a mismatch between its half-life and dose regimen Background Systemic thromboembolism and bleeding remain the two most common and serious complications of catheter ablation of atrial fibrillation . A variety of periprocedure anticoagulation strategies have been proposed to mitigate these risks . Although operators are now routinely administering dabigatran for anticoagulation in this setting , its relative safety and effectiveness compared to warfarin are unknown . Methods and results A total of 202 patients received dabigatran as part of their periprocedural anticoagulation regimen at the time of initial or redo catheter ablation for symptomatic atrial fibrillation . A comparison group of 202 patients treated with warfarin was r and omly selected from patients undergoing atrial fibrillation ( AF ) ablation during the same time period . AF types were paroxysmal in 223 patients , persistent in 158 patients , and longst and ing persistent in 13 patients . Mean age was 60.0 ± 10.5 years , 55 % had a history of hypertension , and mean CHADS-VASc score was 1.7 ± 1.3 . “ Continuous ” warfarin or dabigatran was administered in 80 and 32 % of patients , respectively . Time to first dose of dabigatran post-procedure was 12.2 ± 10.3 h. Two dabigatran and no warfarin-treated patients had systemic thromboembolism ( p = NS ) ; five dabigatran and three warfarin-treated patients had bleeding complications ( p = NS , combined endpoint p = 0.116 ) . One dabigatran patient had severe pericardial bleeding ( 3 L blood loss ) . Conclusions In a retrospective pilot trial comparing the risks of systemic thromboembolism or bleeding complications in patients treated with warfarin or dabigatran anticoagulation , the outcomes were similar . A prospect i ve trial is warranted BACKGROUND Periprocedural anticoagulation using uninterrupted warfarin could reduce the risk of thromboembolic complications of atrial fibrillation ( AF ) ablation . Few studies , however , have evaluated the efficacy and safety of periprocedural dabigatran in AF ablation . METHODS AND RESULTS A total of 211 consecutive patients who underwent AF ablation , including 110 patients who received 110 mg dabigatran twice daily ( group D ) and 101 patients who received dose-adjusted warfarin ( international normalized ratio , 2.0 - 3.0 ; group W ) , were evaluated . Dabigatran was discontinued on the morning of the procedure , and resumed on the next morning . Warfarin was continued throughout the procedure . During the procedure , heparin infusion was maintained to achieve an activated clotting time of > 300s . Postprocedural cerebral magnetic resonance imaging ( MRI ) was performed in 60 patients ( group D , n=31 ; group W , n=29 ) . No periprocedural deaths or symptomatic thromboembolic complications were observed in either group . MRI indicated a silent cerebral infa rct ion in 1 patient in each group . Five patients in group D and 11 in group W had minor bleeding ( P=0.12 ) . Cardiac tamponade occurred in 2 patients in group W , but in none in group D. Total bleeding complications occurred less frequently in group D ( 4.5 % ) than in group W ( 12.9 % ; P<0.05 ) . CONCLUSIONS Dabigatran at a dose of 110 mg twice daily was safe for AF ablation in patients with a relatively low risk of thromboemboli , suggesting that it may become an alternative to warfarin in those patients AIMS Experiences with novel oral anticoagulants ( NOACs ) early after atrial fibrillation ( AF ) catheter ablation are limited and show controversial results . We aim ed to assess the longer-term safety , efficacy , and acceptance of NOACs in a large real-world cohort of patients presenting for AF catheter ablation . METHODS AND RESULTS From July 2010 until June 2012 , 259 patients undergoing AF catheter ablation were prospect ively included . Novel oral anticoagulants were given for at least 3 months post-ablation . Clinical outcome ( stroke , thromboembolic events , major bleeding ) , adverse effects , and drug adherence were assessed at discharge and follow-up . On admission patients were presented with a variety of anticoagulants including 54 patients ( 21 % ) already on NOACs prior ablation . After ablation 38 % of patients received dabigatran 110 mg , 56 % 150 mg , and 6 % received rivaroxaban 20 mg . There were four periprocedural thromboembolic and major bleeding complications ( 1.5 % ) , all in patients without NOACs prior ablation ( two on warfarin and two on heparin ) . During long-term follow-up [ 311 ( 199 ; 418 ) days ] no stroke , systemic embolism , or major haemorrhage could be observed . Uneventful electrical cardioversions and reablation procedures were performed in 27 and 12 patients on dab Output:	With respect to total bleeding risk , no significant difference was observed between dabigatran , rivaroxaban , apixaban , and vitamin K antagonists ( VKAs ) by mixed-treatment comparison . The similar results were seen in the direct comparison . Conclusions Risks of bleeding with dabigatran , rivaroxaban , apixaban , and VKAs were similar in peri-procedural period of CA for AF
MS21782	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Severe acquired aplastic anaemia ( SAA ) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow . Autologous T lymphocytes are thought to cause bone marrow failure by immune-mediated excessive apoptosis of stem and progenitor cells . The disease is subclassified into a severe ( neutrophil count , > 0.2 x 10(9)/L [ > 200/microL ] ) and a very severe ( < 0.2 x 10(9)/L [ < 200/microL ] ) ( vSAA ) form . We report the results of a prospect i ve multicenter trial with a combined immunosuppressive regimen of cyclosporin A ( CSA ) , anti-thymocyte globulin ( ATG ) and , in cases with neutrophil counts fewer than 0.5 x 10(9)/L ( < 500/microL ) , granulocyte colony-stimulating factor ( G-CSF ) for treatment of SAA in children . Children with vSAA showed a higher rate of complete response than did children with SAA ( 68 % versus 45 % ; P = .009 ) , as well as better survival ( 93 % versus 81 % ; P < .001 ) . Thus , in children with SAA a more severe disease stage at diagnosis indicates a favorable outcome with immunosuppressive therapy BACKGROUND In severe acquired aplastic anemia , hematopoietic failure is the result of immune-mediated destruction of bone marrow stem and progenitor cells . Immunosuppressive therapy with antithymocyte globulin ( ATG ) plus cyclosporine is an effective alternative to stem-cell transplantation and improves blood counts and survival . Although horse ATG is the st and ard therapy , rabbit ATG is more potent in depleting peripheral-blood lymphocytes and is preferred in other clinical circumstances . METHODS From December 2005 through July 2010 , we performed a r and omized trial comparing these two ATG formulations in conventional regimens . Patients were treated at a single facility . The primary outcome was hematologic response at 6 months , as determined by blood counts . The study was design ed to enroll 60 patients each for the rabbit-ATG and horse-ATG groups and was powered to detect a difference of 25 percentage points in the response rate . RESULTS A large , unexpected difference was observed in the rate of hematologic response at 6 months in favor of horse ATG ( 68 % ; 95 % confidence interval [ CI ] , 56 to 80 ) as compared with rabbit ATG ( 37 % ; 95 % CI , 24 to 49 ; P<0.001 ) . Overall survival at 3 years also differed , with a survival rate of 96 % ( 95 % CI , 90 to 100 ) in the horse-ATG group as compared with 76 % ( 95 % CI , 61 to 95 ) in the rabbit-ATG group ( P=0.04 ) when data were censored at the time of stem-cell transplantation , and 94 % ( 95 % CI , 88 to 100 ) as compared with 70 % ( 95 % CI , 56 to 86 ; P=0.008 ) in the respective groups when stem-cell-transplantation events were not censored . CONCLUSIONS In a r and omized study , rabbit ATG was inferior to horse ATG as a first treatment for severe aplastic anemia , as indicated by hematologic response and survival . ( Funded by the Intramural Research Program of the National Institutes of Health ; Clinical Trials.gov number , NCT00260689 . ) Aplastic anemia ( AA ) is a rare , life threatening disease . Allogeneic bone marrow transplantation ( BMT ) offers the only possibility of cure , i. e. life-long remission . The probability of survival after BMT from an HLA-identical sibling has clearly improved over the last years and at present is about 80 % in patients < 16 years . Transplantation from alternative donors , however , faces unsolved immunological problems . For demographic reasons most patients lack a matched sibling donor . For these patients immunosuppressive therapy ( IST ) is the only alternative therapeutic approach . However this treatment has frequently result ed in clonal , i. e. potentially malignant disease . Overall probability of survival here is only 50 % , in severely granulocytopenic patients ( < 0.2 G/l ) even lower . These individuals represent an important subgroup in pediatric AA . Some patients show only partial reconstitution of their hematopoiesis but satisfactory quality of life . Based on the results of prospect i ve studies a protocol for IST in AA using anti-lymphocyte globulin ( ALG ) , cyclosporin A ( CSA ) and G-CSF is presented . For BMT- patients likewise a protocol for conditioning ( ALG , cyclophosphamide ) and GvHD-prophylaxis is suggested . St and ardisation and improvement of supportive therapy is the third important objective of this pilot protocol 58 patients with severe aplastic anemia ( SAA ) were treated and evaluated in a prospect i ve study either by bone marrow transplantation ( BMT ) or by antilymphocyte globulin ( ALG ) . 19 patients were treated with BMT ; 9 are still alive 6 months to 5 years after BMT ( 47 % ) . 39 patients were treated with ALG ; 28 are alive 5 months to 5 years after ALG ( 72 % ) . 24 of these 28 are self-sustaining and in remission . The results show that treatment with ALG is probably superior to treatment with BMT , and also demonstrate that most patients with SAA have a pool of hematopoietic stem cells able to repopulate the marrow after this type of treatment Output:	There are insufficient and biased data that do not allow any firm conclusions to be made about the comparative effectiveness of first-line allogeneic haematopoietic stem cell transplantation of HLA-matched sibling donors and first-line immunosuppressive therapy of patients with acquired severe aplastic anaemia
MS21783	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain Abstract Objective : To assess the association between competing interests and authors ' conclusions in r and omised clinical trials . Design : Epidemiological study of r and omised clinical trials published in the BMJ from January 1997 to June 2001 . Financial competing interests were defined as funding by for profit organisations and other competing interests as personal , academic , or political . Studies : 159 trials from 12 medical specialties . Main outcome measures : Authors ' conclusions defined as interpretation of extent to which overall results favoured experimental intervention . Conclusions appraised on 6 point scale ; higher scores favour experimental intervention . Results : Authors ' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests ( mean difference 0.48 ( SE 0.13 ) , P=0.014 ) , trials funded by both for profit and non-profit organisations ( 0.30 ( SE 0.10 ) , P=0.003 ) , and trials with other competing interests ( 0.45 ( SE 0.13 ) , P=0.006 ) . Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors ' conclusions . The association between financial competing interests and authors ' conclusions was not explained by method ological quality , statistical power , type of experimental intervention ( pharmacological or non-pharmacological ) , type of control intervention ( for example , placebo or active drug ) , or medical specialty . Conclusions : Authors ' conclusions in r and omised clinical trials significantly favoured experimental interventions if financial competing interests were declared . Other competing interests were not significantly associated with authors ' conclusions OBJECTIVE To assess the overall effectiveness of spa therapy compared with usual routine drug therapy in chronic low back pain ( LBP ) . METHODS One hundred and twenty-one patients were r and omly allocated to treatment ( n = 59 ) and control ( n = 62 ) groups . In the treatment group , patients underwent routine drug therapy and spa therapy 6 days/week for 3 consecutive weeks in Saint-Nectaire , France . In the control group , patients received routine drug therapy . Effectiveness was assessed based on clinical measures , duration and intensity of pain , Rol and and Morris ' disability question naire , the patient 's overall evaluation of back health , and drug consumption ( analgesic and antiinflammatory ) . Groups were compared using analysis of covariance with repeated measures . RESULTS At 3 weeks , patients in the treatment group had significant improvement in all outcome variables ( p < 0.0001 ) except for the Schober index and analgesic and antiinflammatory drug consumption . At 6 months , improvement was still significant for the same outcome variables ( p < 0.0001 ) , plus a significant reduction in analgesic consumption . CONCLUSION This study suggests both immediate and 6 month effectiveness of spa therapy in chronic LBP . Spa therapy may be beneficial in the management of chronic LBP Three treatments for non-specific lumbar pain -- balneotherapy , underwater traction bath , and underwater massage -- were assessed in a r and omised prospect i ve controlled trial in 158 out patients . Each group was treated for four weeks and patients were review ed at the end of this period and at 12 months after entry to the trial . The prescription of analgesics and the pain score were significantly reduced in all three treated groups , but there was no difference between the three groups . No significant change occurred in spinal motion and the straight leg raising test . After one year only the analgesic consumption was significantly lower than in the control group OBJECTIVE --To compare the effectiveness of manipulative therapy , physiotherapy , treatment by the general practitioner , and placebo therapy in patients with persistent non-specific back and neck complaints . DESIGN --R and omised clinical trial . SETTING -- Primary health care in the Netherl and s. PATIENTS --256 patients with non-specific back and neck complaints of at least six weeks ' duration who had not received physiotherapy or manipulative therapy in the past two years . INTERVENTIONS --At the discretion of the manipulative therapists , physiotherapists , and general practitioners . Physiotherapy consisted of exercises , massage , and physical therapy ( heat , electrotherapy , ultrasound , shortwave diathermy ) . Manipulative therapy consisted of manipulation and mobilisation of the spine . Treatment by general practitioners consisted of drugs ( for example , analgesics ) , advice about posture , home exercises , and (bed)rest . Placebo treatment consisted of detuned shortwave diathermy ( 10 minutes ) and detuned ultrasound ( 10 minutes ) . MAIN OUTCOME MEASURES --Changes in severity of the main complaint and limitation of physical functioning measured on 10 point scales by a blinded research assistant and global perceived effect measured on a 6 point scale by the patients . RESULTS --Many patients in the general practitioner and placebo groups received other treatment during follow up . Improvement in the main complaint was larger with manipulative therapy ( 4.5 ) than with physiotherapy ( 3.8 ) after 12 months ' follow up ( difference 0.9 ; 95 % confidence interval 0.1 to 1.7 ) . Manipulative therapy also gave larger improvements in physical functioning ( difference 0.6 ; -0.1 to 1.3 ) . The global perceived effect after six and 12 months ' follow up was similar for both treatments . CONCLUSIONS --Manipulative therapy and physiotherapy are better than general practitioner and placebo treatment . Furthermore , manipulative therapy is slightly better than physiotherapy after 12 months BACKGROUND AND PURPOSE Since the release of acute low back pain management guidelines in 1994 , little was known about the effect of these guidelines on clinical practice . The purpose of this study was to examine physical therapists ' reported management of acute and subacute lumbar impairment . SUBJECTS One in 10 registered physical therapists who were r and omly selected from southern Ontario , Canada , ( n=454 ) and all registered physical therapists from northern Ontario ( n=331 ) were surveyed . METHODS In the question naire , case scenarios covered 3 areas related to the management of lumbar impairment : ( 1 ) physical examination , ( 2 ) treatment and recommendations , and ( 3 ) therapists ' beliefs regarding its management . RESULTS Five hundred sixty-nine question naires were returned ( response rate=72.5 % ) . Only data obtained for therapists ( n=274 ) whose weekly workload included more than 10 % of people with lumbar impairment were used in the analysis . Overall , patient education , exercise , and electrotherapeutic and thermal modalities were the preferred interventions for acute lumbar impairment ( symptom onset of less than 5 weeks ) with or without sciatica , whereas exercise and work modification were preferred for subacute lumbar impairment ( symptom onset of 5 weeks or longer ) . There was a trend of using electrotherapeutic and thermal modalities with uncertain effectiveness . Only 46.3 % of the therapists agreed or strongly agreed that practice guidelines were useful for managing lumbar impairment . DISCUSSION AND CONCLUSION Although the physical therapists surveyed , in general , followed the guidelines in managing acute lumbar impairment , they felt uncertain regarding the value of practice guidelines . Future research should focus on identifying effective treatment approaches and exploring the effectiveness of practice guidelines BACKGROUND CONTEXT Restorative exercise and palliative modalities are frequently used together for the treatment of acute low back pain . However , little is known about the effects of combining these treatments . PURPOSE To evaluate the efficacy of combining continuous low-level heat wrap therapy with directional preference-based exercise on the functional ability of patients with acute low back pain . STUDY DESIGN / SETTING A r and omized controlled trial was conducted at three outpatient medical facilities . PATIENT SAMPLE One hundred individuals ( age 31.2+/-10.6 years ) with low back pain of less than 3 months duration . OUTCOME MEASURES The primary outcome measure was functional ability assessed by the Multidimensional Task Ability Profile question naire . Secondary outcomes were disability assessed by the Rol and -Morris Disability Question naire and pain relief assessed by a 6-point verbal rating scale . METHODS Participants were r and omized to one of four groups : Heat wrap therapy alone ( heat wrap , n=25 ) ; directional preference-based exercise alone ( exercise , n=25 ) ; combination of heat wrap therapy and exercise ( heat+exercise , n=24 ) ; or control ( booklet , n=26 ) . Treatment was administered for five consecutive days and included four visits to the study center over 1 week . RESULTS At 2 days after the conclusion of treatment ( Day 7 ) , functional improvement for heat+exercise was 84 % , 95 % , and 175 % greater than heat wrap , exercise , and booklet , respectively ( p<.05 ) . Seventy-two percent of the subjects in the heat+exercise group demonstrated a return to pre-injury function compared with 20 % , 20 % , and 19 % for heat wrap , exercise , and booklet , respectively ( p<.05 ) . Disability reduction for heat+exercise was 93 % , 139 % , and 400 % greater than heat wrap , exercise , and booklet , respectively ( p<.05 ) . Pain relief for heat+exercise was 70 % and 143 % greater than exercise and booklet , respectively ( p<.05 ) . CONCLUSIONS Combining continuous low-level heat wrap therapy with directional preference-based exercise during the treatment of acute low back pain significantly improves functional outcomes compared with either intervention alone or control . Either intervention alone tends to be more effective than control Ninety-four patients with non-specific lumbar pain referred to hospital rheumatology and orthopaedic clinics participated in a double-blind controlled trial comparing mobilisation and manipulation with placebo physiotherapy . Results were assessed immediately after the tratment course , two months later , and at one year . Many patients showed improvement , but in contrast to a study on general-practitioner patients with nonspecific back pain no definite advantage could be associated with mobilisation and manipulation . The benefits of mobilisation and manipulation for low back pain are probably restricted to hastening recovery in patients likely rapidly to improve spontaneously . Hence patients whose severity and duration of symptoms warrant specialist referral are less likely to benefit from the technique OBJECTIVE To determine whether traditional bone- setting or continuous light exercise therapy could case back pain and improve function better than ordinary physiotherapy . DESIGN Observer-blinded , r and omized clinical trial with a 6-month follow-up . SETTING An outpatient institution for folk medicine research . PATIENTS Of 147 back pain patients recruited from local health centers and by newspaper announcements , 132 were found eligible ( non-retired-no contraindications to manipulation ) and entered . A final 114 ( one dropout ) with back pain for longer than 7 weeks were included in this intent to treat analysis . INTERVENTIONS Bone- setting , guidance for continuous light back movements or physiotherapy for up to ten 1-hour sessions during 6 weeks . MAIN OUTCOME Output:	There is insufficient evidence to evaluate the effects of cold for low-back pain , and conflicting evidence for any differences between heat and cold for low-back pain . There is moderate evidence in a small number of trials that heat wrap therapy provides a small short-term reduction in pain and disability in a population with a mix of acute and sub-acute low-back pain , and that the addition of exercise further reduces pain and improves function . No conclusions can be drawn about the use of cold for low-back pain . There is conflicting evidence to determine the differences between heat and cold for low-back pain
MS21784	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Aims To determine whether the additional interventions to st and ard care are cost-effective in addressing cocaine and alcohol abuse at 4 months ( 4 M ) and 12 months ( 12 M ) from baseline . Method We conducted a cost-effectiveness analysis of a r and omized controlled trial with three arms : ( 1 ) NIDA 's St and ard intervention ( SI ) ; ( 2 ) SI plus a Well Woman Exam ( WWE ) ; and , ( 3 ) SI , WWE , plus four Educational Sessions ( 4ES ) . Results To obtain an additional cocaine abstainer , WWE compared to SI cost $ 7,223 at 4 M and $ 3,611 at 12 M. Per additional alcohol abstainer , WWE compared to SI cost $ 3,611 and $ 7,223 at 4 M and 12 M , respectively . At 12 M , 4ES was dominated ( more costly and less effective ) by WWE for abstinence outcomes . Conclusions To our knowledge , this is the first cost-effectiveness analysis simultaneously examining cocaine and alcohol abuse in women . Depending on primary outcomes sought and priorities of policy makers , peer-delivered interventions can be a cost-effective way to address the needs of this growing , underserved population . Trial Registration Clinical Trials.gov 82 Ss were studied in a comparative evaluation of a behavioral vs supportive treatment for illegal drug use . Behavioral treatment included stimulus control , urge , control , contracting/family support and competing response procedures for an average of 19 sessions . 37 % of Ss in the behavioral condition were drug-free at 2 months , 54 % at 6 months , and 65 % at 12 months vs 20 + /- 6 % for the alternative treatment during all 12 months . The behavioral treatment was more effective across sex , age , educational level , marital status and type of drug ( hard-drugs , cocaine , and marijuana ) . Greater improvement for this condition was also noted on measures of employment/school attendance , family relationships , depression , institutionalization and alcohol use AIMS This study aim ed to determine the relative effectiveness of 12 months of interim methadone ( IM ; supervised methadone with emergency counseling only for the first 4 months of treatment ) , st and ard methadone treatment ( SM ; with routine counseling ) and restored methadone treatment ( RM : routine counseling with smaller case-loads ) . DESIGN A r and omized controlled trial was conducted comparing IM , SM and RM treatment . IM lasted for 4 months , after which participants were transferred to SM . SETTING The study was conducted in two methadone treatment programs in Baltimore , MD , USA . PARTICIPANTS The study included 230 adult methadone patients newly admitted through waiting-lists . MEASUREMENTS We administered the Addiction Severity Index and a supplemental question naire at baseline , 4 and 12 months post- baseline . Measurements included retention in treatment , self-reported days of heroin and cocaine use , criminal behavior and arrests and urine tests for heroin and cocaine metabolites . FINDINGS At 12 months , on an intent-to-treat basis , there were no significant differences in retention in treatment among the IM , SM and RM groups ( 60.6 % , 54.8 % and 37.0 % , respectively ) . Positive urine tests for the three groups declined significantly from baseline ( Ps < 0.001 and 0.003 , for heroin and cocaine metabolites , respectively ) but there were no significant group x time interactions for these measures . At least one arrest was reported by 30.6 % of the sample during the year , but there were no significant between-group effects . CONCLUSIONS Limited availability of drug counseling services should not be a barrier to providing supervised methadone to adults dependent on heroin -- at least for the first 4 months of treatment Introduction While the impacts of illicit drug use on mortality have been well described , the impact of poly-substance that includes alcohol has received less attention . We examined the impact of binge alcohol use on mortality among a cohort of people who inject drugs ( PWID ) in a Canadian setting . Methods Using data derived from a prospect i ve cohort study of PWID in Vancouver , Canada recruited between May 1996 and November 2013 . We ascertained date s and causes of death through a confidential linkage with the provincial registry and examined the impact of binge alcohol use . The primary outcome of interest was all-cause mortality . We used Cox proportional hazard regression to determine factors associated with mortality , including socio-demographic characteristics , drug use patterns and other risk behaviours . Results During the study period , 2550 individuals were followed ( 844 of whom were HIV positive at baseline ) for a median of 75.4 months ( interquartile range 37.9–113.2 ) . Of these , 795 ( 31 % ) participants reported binge alcohol use at some time during the study period . In multivariable analyses , binge alcohol use remained independently associated with all-cause-mortality ( adjusted hazard ratio = 1.41 ; 95 % confidence interval : 1.06–1.88 ) after adjustment for other drug use patterns . Conclusions Binge alcohol use was associated with time to all-cause mortality among PWID in this setting . Since alcohol use is often overlooked as a risk factor for mortality among this population , these findings highlight the continued need to incorporate addiction treatment and public health interventions and policies that address binge alcohol use to reduce alcohol related-harms Interventions for alcohol- and substance-dependent adults with comorbid depressive disorders are needed , but few have been empirically tested . In a r and omized clinical trial of two psychotherapy interventions for these disorders , we examined whether initial focus of treatment was related to retention , substance use , and depression outcomes . Both interventions , integrated cognitive-behavioral therapy ( ICBT ; n = 105 ) and twelve-step facilitation ( n = 92 ) , were delivered in group formats with entry points every 4 weeks at the beginning of three content-distinct modules . Entry module ( i.e. , initial treatment focus ) was not related to percentage days abstinent , proportion of the sample abstinent , or depression symptoms for either intervention . This was true at both 12 and 24 weeks postbaseline . Furthermore , attendance was similar for both treatments , regardless of initial treatment focus , with a single exception in the ICBT condition . Our findings support the use of modular formats with multiple or rotating entry points for psychotherapy group interventions Active injection drug users ( IDUs ) who are also hazardous alcohol users are at particularly high risk for HIV transmission due to sharing of injection equipment . We recruited AUDIT-positive injectors from the Providence , RI needle exchange program for a r and omized clinical trial testing the effect of a brief motivational intervention ( MI ) on frequency of injection-related HIV risk behavior ( IRRB ) . HIV drug risk behavior was measured as the number of days on which subjects reported sharing works using the 30-day Timeline Followback Method . Overall , 109 subjects reported a mean reduction of IRRB days of 9.1 days from baseline to 6-month follow-up ( p < .001 ) . When compared to controls , there was a trend in reduction of IRRB days to zero at follow-up for MI subject ( OR = 2.1 ; 95 % CI = 0.9 - 4.5 ) , and strongly significant reductions in IRRB days across a range of alternative improvement thresholds . Results from this study demonstrate that MI reduces drug-related HIV risk behaviors among active IDUs . As a brief intervention , MI may be a useful adjunct to existing services intended to reduce harm BACKGROUND Few r and omised controlled trials have been aim ed specifically at substance use reduction among people with psychotic disorders . AIMS To investigate whether a 10-session intervention consisting of motivational interviewing and cognitive-behavioural therapy ( CBT ) was more efficacious than routine treatment in reducing substance use and improving symptomatology and general functioning . METHOD A community sample of people with a psychotic disorder and who reported hazardous alcohol , cannabis and /or amphetamine use during the preceding month was recruited . Participants were r and omly allocated to motivational interviewing/CBT ( n = 65 ) or treatment as usual ( n = 65 ) , and were assessed on multiple outcomes at baseline , 15 weeks , 6 months and 12 months . RESULTS There was a short-term improvement in depression and a similar trend with regard to cannabis use among participants who received the motivational interviewing/CBT intervention , together with effects on general functioning at 12 months . There was no differential benefit of the intervention on substance use at 12 months , except for a potentially clinical ly important effect on amphetamine use . CONCLUSIONS The motivational interviewing/CBT intervention was associated with modest improvements Smoking treatment for newly recovering drug and alcohol-dependent smokers in a residential rehabilitation program was examined . The r and omly assigned conditions ( n = 50 each ) were multicomponent smoking treatment ( MST ) , MST plus generalization training of smoking cessation to drug and alcohol cessation ( MST+G ) , or usual care ( UC ) . Fifty participants who declined smoking treatment ( treatment refusers ) also were studied . Both treatment conditions achieved continuous smoking abstinence rates ( MST : 12 % , MST+G : 10 % , at 12-month follow-up ) that were significantly higher than in the UC condition ( 0 % ) . The MST condition had a continuous drug and alcohol abstinence rate that was significantly higher than that of the MST+G condition ( 40 % vs. 20 % at 12-month follow-up ) although neither differed significantly from that of the UC condition ( 33 % ) . These results support the feasibility of smoking treatment for this population and provide information regarding appropriate treatment components OBJECTIVES We compared the effects of 2 interventions on alcohol use , use of a new syringe at last injection , and condom use at last sexual encounter in a community sample of injection drug users . METHODS Between 2003 and 2006 , 851 out-of-treatment injection drug users were recruited in Raleigh , NC , and Durham , NC , through street outreach and were r and omly assigned to either a 6-session educational intervention or a 6-session motivational intervention . Intervention effects were examined at 6 and 12 months after enrollment . RESULTS In multiple logistic regression analyses adjusted for baseline alcohol use and HCV status , participants assigned to the motivational intervention were significantly less likely than were participants in the educational intervention to be drinking at the 6-month follow-up ( odds ratio = 0.67 ; 95 % confidence interval = 0.46 , 0.97 ) . There were no significant between-group differences in use of a new syringe at last injection or condom use at last sexual encounter at either follow-up . CONCLUSIONS Reducing alcohol use among persons with HCV may slow disease progression and provide important health benefits . Additional strategies are needed for slowing HCV disease progression until more effective HCV treatments are available Background Alcohol use is an important issue among problem drug users . Although screening and brief intervention ( SBI ) are effective in reducing problem alcohol use in primary care , no research has examined this issue among problem drug users . Objective The objective of this study is to determine if a complex intervention including SBI for problem alcohol use among problem drug users is feasible and acceptable in practice . This study also aims to evaluate the effectiveness of the intervention in reducing the proportion of patients with problem alcohol use . Methods Psychosocial intervention for alcohol use among problem drug users ( PINTA ) is a pilot feasibility study of a complex intervention comprising SBI for problem alcohol use among problem drug users with cluster r and omization at the level of general practice , integrated qualitative process evaluation , and involving general practice s in two socioeconomically deprived regions . Practice s ( N=16 ) will be eligible to participate if they are registered to prescribe methadone and /or at least 10 patients of the practice are currently receiving addiction treatment . Patient must meet the following inclusion criteria to participate in this study : 18 years of age or older , receiving addiction treatment/care ( eg , methadone ) , or known to be a problem drug user . This study is based on a complex intervention supporting SBI for problem alcohol use among problem drug users ( experimental group ) compared to an “ assessment -only ” control group . Control practice s will be provided with a delayed intervention after follow-up . Primary outcomes of the study are feasibility and acceptability of the intervention to patients and practitioners . Secondary outcome includes the effectiveness of the intervention on care process ( documented rates of SBI ) and outcome ( proportion of patients with problem alcohol use at the follow-up ) . A stratified r and om sampling method will be used to select general practice s based on the level of training for providing addiction-related care and geographical area . In this study , general practitioners and practice staff , research ers , and trainers will not be blinded to treatment , but patients and remote r and omizers will be unaware of the treatment . Results This study is ongoing and a protocol system is being developed for the study . This study may inform future research among the high-risk population of problem drug users by providing initial indications as to whether psychosocial interventions for problem alcohol use are feasible , acceptable , and also effective among problem drug users attending primary care . Conclusions This is the first study to examine the feasibility and acceptability of complex intervention in primary care to enhance alcohol SBI among problem drug users . Results of this study will inform future research among this high-risk population and guide policy and service development locally and internationally Aim To develop and evaluate the comparative effectiveness of behavioural interventions of enhanced prevention counselling ( EPC ) and simple educational counselling ( SEC ) in reducing hepatitis C viral ( HCV ) infection in sero-negative injecting drug users ( IDU ) Output:	There is low- quality evidence to suggest that there is no difference in effectiveness between different types of interventions to reduce alcohol consumption in concurrent problem alcohol and illicit drug users and that brief interventions are not superior to assessment -only or to treatment as usual .
MS21785	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice Two formulations of posterior composite resin ( P-30 and Bisfil-P ) were evaluated and compared to a high-copper , dispersed-phase amalgam ( Dispersalloy ) . One hundred twenty-eight restorations were placed in 27 patients so that each patient received at least one of each material . After 3 years of clinical service , all three restorative material s produced clinical ly acceptable restorations , according to US Public Health Service and Leinfelder criteria . The amalgam restorations , however , underwent less wear ( 44 microns ) than did the posterior composite resin restorations ( 60 to 74 microns ) . Stratification of data by type of tooth , class of restoration , and size of restoration produced the same ranking of wear from lowest to highest : Dispersalloy , Bisfil-P , and P-30 . Resin restorations showed 45 % more wear in molars than in premolars , and more wear was associated with moderately sized restorations than with conservative restorations . The surface texture of restorations of composite resin with porous strontium glass filler was nearly as smooth as that of enamel and was significantly smoother than that of the restorations of composite resin with zinc glass filler or of unpolished amalgam Previous studies noted specific changes in urinary porphyrin excretion patterns associated with exposure to mercury ( Hg ) in animals and humans . In our study , urinary porphyrin concentrations were examined in normal children 8–18 years-old from a re analysis of data provided from a r and omized , prospect i ve clinical trial that was design ed to evaluate the potential health consequences of prolonged exposure to Hg from dental amalgam fillings ( the parent study ) . Our analysis examined dose-dependent correlations between increasing Hg exposure from dental amalgams and urinary porphyrins utilizing statistical models with adjustments for the baseline level ( i.e. study year 1 ) of the following variables : urinary Hg , each urinary porphyrin measure , gender , race , and the level of lead ( Pb ) in each subject ’s blood . Significant dose-dependent correlations between cumulative exposure to Hg from dental amalgams and urinary porphyrins associated with Hg body-burden ( pentacarboxyporphyrin , precoproporphyrin , and coproporphyrin ) were observed . Overall , 5–10 % increases in Hg-associated porphyrins for subjects receiving an average number of dental amalgam fillings in comparison to subjects receiving only composite fillings were observed over the 8-year course of the study . In contrast , no significant correlations were observed between cumulative exposure to Hg from dental amalgams and urinary porphyrins not associated with Hg body-burden ( uroporphyrin , heptacarboxyporphyrin , and hexacarboxyporphyrin ) . In conclusion , our study , in contrast to the no-effect results published from the parent study , further establishes the sensitivity and specificity of specific urinary porphyrins as a biomarker for low-level Hg body-burden , and also reveals that dental amalgams are a significant chronic contributor to Hg body-burden In 41 patients class 11 cavities each of the lower jaw were filled with the material s Adaptic , Concise cap , Epoxydent or amalgam . The models made from impressions were systemically measured by a coordinate measuring machine according to a procedure determined by us ( measuring error of this method about 15 micron ) . After one year the following abrasions were found : amalgam 18 micron + /- 58 micron , Adaptic 92 micron + /- 97 micron , Concise Cap 146 micron + /- 75 micron , Epoxydent 38 micron + /- 50 micron . Evaluation of the clinical examination showed that the material s Concise and Epoxydent were significantly inferior as regards border closure than amalgam and Adaptic . We determined further that a large percentage of composite filling showed visible discoloration of the borders ( Adaptic 42 % , Concise 55 % , Epoxydent 80 % ) . Many of the fillings were discolored after a year . Adaptic was highly significantly different with 31.6 % discolored fillings to both other material s ( Concise 79 % , Epoxydent 78.4 % ) Dental amalgams are a commonly used dental restorative material , and amalgams are about 50 % mercury ( Hg ) . In our study , urinary Hg levels was examined in children of age 8–18 years , with and without dental amalgam fillings , from a completed clinical trial ( parent study ) that was design ed to evaluate the potential health consequences of prolonged exposure to Hg from dental amalgam fillings . Our study was design ed to determine whether there was a significant dose-dependent correlation between increasing Hg exposure from dental amalgams and urinary Hg levels . Hg exposure depends on the size and number of teeth with dental amalgams . Overall , consistent with the results observed in the parent study , there was a statistically significant dose-dependent correlation between cumulative exposure to Hg from dental amalgams and urinary Hg levels , after covariate adjustment . Further , it was observed that urinary Hg levels increased by 18 % to 52 % among 8 to 18 year old individuals , respectively , with an average exposure to amalgams , in comparison to study subjects with no exposure to amalgams . The results of our study suggest that dental amalgams contribute to ongoing Hg exposure in a dose-dependent fashion Resin-based composite dental restoration material s may release bisphenol-A , an endocrine-disrupting chemical . Using secondary analysis of a r and omized clinical safety trial of amalgam vs. composites , we tested the hypothesis that dental restoration material s affect children ’s growth . Children ( N = 218 boys , N = 256 girls ) aged 6 to 10 yrs at baseline with ≥ 2 decayed posterior teeth were r and omized to amalgam or composites ( bisphenol-A-diglycidyl-dimethacrylate composite for permanent teeth , urethane-dimethacrylate compomer for primary teeth ) for treatment of posterior caries throughout follow-up . Primary outcomes for this analysis were 5-year changes in BMI -for-age z-scores , body fat percentage ( BF% ) , and height velocity ; exploratory analyses ( n = 113 ) examined age at menarche . Results showed no significant differences between treatment assignment and changes in physical development in boys [ ( composites vs. amalgam ) BF% , 4.9 vs. 5.7 , p = 0.49 ; ( BMI -z-score ) 0.13 vs. 0.25 , p = 0.36 ] or girls ( 8.8 vs. 7.7 , p = 0.95 ; 0.36 vs. 0.21 , p = 0.49 ) . Children with more treatment on primary teeth had greater increases in BF% regardless of material type . Girls assigned to composites had lower risk of menarche during follow-up ( hazard ratio = 0.57 , 95 % CI 0.35 - 0.95 ) . Overall , there were no significant differences in physical development over 5 years in children treated with composites or amalgam . Additional studies examining these restoration material s in relation to age at menarche are warranted ( clinical trials.gov number NCT00065988 ) CONTEXT Dental ( silver ) amalgam is a widely used restorative material containing 50 % elemental mercury that emits small amounts of mercury vapor . No r and omized clinical trials have determined whether there are significant health risks associated with this low-level mercury exposure . OBJECTIVE To assess the safety of dental amalgam restorations in children . DESIGN A r and omized clinical trial in which children requiring dental restorative treatment were r and omized to either amalgam for posterior restorations or resin composite instead of amalgam . Enrollment commenced February 1997 , with annual follow-up for 7 years concluding in July 2005 . SETTING AND PARTICIPANTS A total of 507 children in Lisbon , Portugal , aged 8 to 10 years with at least 1 carious lesion on a permanent tooth , no previous exposure to amalgam , urinary mercury level < 10 microg/L , blood lead level < 15 microg/dL , Comprehensive Test of Nonverbal Intelligence IQ > or = 67 , and with no interfering health conditions . INTERVENTION Routine , st and ard-of-care dental treatment , with one group receiving amalgam restorations for posterior lesions ( n = 253 ) and the other group receiving resin composite restorations instead of amalgam ( n = 254 ) . MAIN OUTCOME MEASURES Neurobehavioral assessment s of memory , attention/concentration , and motor/visuomotor domains , as well as nerve conduction velocities . RESULTS During the 7-year trial period , children had a mean of 18.7 tooth surfaces ( median , 16 ) restored in the amalgam group and 21.3 ( median , 18 ) restored in the composite group . Baseline mean creatinine-adjusted urinary mercury levels were 1.8 microg/g in the amalgam group and 1.9 microg/g in the composite group , but during follow-up were 1.0 to 1.5 microg/g higher in the amalgam group than in the composite group ( P<.001 ) . There were no statistically significant differences in measures of memory , attention , visuomotor function , or nerve conduction velocities ( average z scores were very similar , near zero ) for the amalgam and composite groups over all 7 years of follow-up , with no statistically significant differences observed at any time point ( P values from .29 to .91 ) . Starting at 5 years after initial treatment , the need for additional restorative treatment was approximately 50 % higher in the composite group . CONCLUSIONS In this study , children who received dental restorative treatment with amalgam did not , on average , have statistically significant differences in neurobehavioral assessment s or in nerve conduction velocity when compared with children who received resin composite material s without amalgam . These findings , combined with the trend of higher treatment need later among those receiving composite , suggest that amalgam should remain a viable dental restorative option for children . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00066118 A three-year clinical study was completed at the College of Dentistry comparing the overall performance of Class I amalgam restorations with preventive resin restorations ( PRRs ) . Seventy-four PRRs and fifty-two amalgam restorations were placed in the posterior teeth of thirty-eight patients . The PRR was composed of two material s : P-50 ( 3 M Corp. ) , a heavily filled composite resin , and White Sealant ( 3 M Corp. ) , a light-cured sealant . Fast-set Dispersalloy ( Johnson and Johnson Corp. ) was used for the amalgam restorations . The restorations were evaluated at six months , one year , two years and three years . The USPHS/Ryge system was used to evaluate anatomic form , marginal adaptation , marginal discoloration and recurrent caries of both type restorations . A restoration was considered a failure if any part of the restoration was replaced due to secondary caries . There were two failures of PRRs at six months , and four failures at one year . Failures were due to non retention of the sealant of the PRR and possibly related to operator error . The failures were easily repaired and removed from the study . No PRR failed at the two or three year evaluations . No amalgam restoration failed within the three year period The aim of this study was to obtain information on the restorative dental care of adults in Finl and . A r and om sample of private dentists was drawn from the register , and in spring 2000 they were sent a question naire requesting them to record information for each restoration placed during one ordinary working day . A total of 800 dentists were contacted and 548 responded . The dentists reported placement of 3,455 restorations . Of these , 5 % were Class I , 36 % were Class II , 13 % were Class III , 9 % were Class IV , 21 % were Class V , and 16 % were extensive restorations including 4 or more surfaces . Overall , composite resin was the most common restorative material , and it was used in 79 % of the restorations , whereas amalgam was used in 5 % , compomers in 4 % , and glass ionomers ( either conventional or resin‐modified ) in 7 % of cases . In 5 % of the cases , the tooth was restored with indirect restorative methods , using either gold or ceramic material s. Of the treatments , 65 % were replacements of previous restorations . Secondary caries was the most common reason for replacement ( 36 % , 52 % , and 41 % for composite , glass ionomer , and amalgam , respectively ) . Other common reasons were fractures of the tooth or Output:	The investigators found no difference in adverse effects between composite and amalgam restorations . There is low- quality evidence to suggest that resin composites lead to higher failure rates and risk of secondary caries than amalgam restorations . This review reinforces the benefit of amalgam restorations and the results are particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries .
MS21786	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Human papillomavirus (HPV)-related head and neck cancer has been associated with an improved prognosis in patients treated with radiotherapy ( RT ) + /− chemotherapy ( CT ) ; however , RT combined with epidermal growth factor receptor ( EGFR ) inhibitors has not been fully studied in this group of patients . Methods Immunohistochemical expression of p16 and PCR of HPV16 DNA were retrospectively analyzed in tumor blocks from 108 stage III/IV head and neck cancer patients treated with RT+CT ( 56 ) or RT+EGFR inhibitors ( 52 ) . Disease-free survival ( DFS ) and overall survival ( OS ) were analyzed by the Kaplan-Meier method . Results DNA of HPV16 was found in 12 of 108 tumors ( 11 % ) and p16 positivity in 18 tumors ( 17 % ) , with similar rates in both arms of treatment . After a median follow-up time of 35 months ( range 6–135 ) , p16-positive patients treated with RT+EGFR inhibitors showed improved survival compared with those treated with RT+CT ( 2-year OS 88 % vs. 60 % , HR 0.18 ; 95 % CI 0.04 to 0.88 ; p = 0.01 ; and 2-year DFS 75 % vs. 47 % , HR 0.17 ; 95 % CI 0.03 to 0.8 ; p = 0.01 ) . However , no differences were observed in p16-negative patients ( 2-year OS 56 % vs. 53 % , HR 0.97 ; 95 % CI 0.55 to 1.7 ; p = 0.9 ; and 2-year DFS 43 % vs. 45 % , HR 0.99 ; 95 % CI 0.57 to 1.7 ; p = 0.9 ) . Conclusions This is the first study to show that p16-positive patients may benefit more from RT+EGFR inhibitors than conventional RT+CT . These results are hypothesis-generating and should be confirmed in prospect i ve trials BACKGROUND We conducted a multinational , r and omized study to compare radiotherapy alone with radiotherapy plus cetuximab , a monoclonal antibody against the epidermal growth factor receptor , in the treatment of locoregionally advanced squamous-cell carcinoma of the head and neck . METHODS Patients with locoregionally advanced head and neck cancer were r and omly assigned to treatment with high-dose radiotherapy alone ( 213 patients ) or high-dose radiotherapy plus weekly cetuximab ( 211 patients ) at an initial dose of 400 mg per square meter of body-surface area , followed by 250 mg per square meter weekly for the duration of radiotherapy . The primary end point was the duration of control of locoregional disease ; secondary end points were overall survival , progression-free survival , the response rate , and safety . RESULTS The median duration of locoregional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radiotherapy alone ( hazard ratio for locoregional progression or death , 0.68 ; P=0.005 ) . With a median follow-up of 54.0 months , the median duration of overall survival was 49.0 months among patients treated with combined therapy and 29.3 months among those treated with radiotherapy alone ( hazard ratio for death , 0.74 ; P=0.03 ) . Radiotherapy plus cetuximab significantly prolonged progression-free survival ( hazard ratio for disease progression or death , 0.70 ; P=0.006 ) . With the exception of acneiform rash and infusion reactions , the incidence of grade 3 or greater toxic effects , including mucositis , did not differ significantly between the two groups . CONCLUSIONS Treatment of locoregionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves locoregional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck . ( Clinical Trials.gov number , NCT00004227 . BACKGROUND The phase III EXTREME and CRYSTAL studies demonstrated that the addition of cetuximab to chemotherapy significantly improved survival in the first-line treatment of recurrent/metastatic squamous cell carcinoma of the head and neck ( SCCHN ) and KRAS wild-type metastatic colorectal cancer ( mCRC ) . In advanced non-small-cell lung cancer ( NSCLC ) , high EGFR expression was identified as a tumour biomarker that can predict survival benefit associated with the addition of cetuximab to first-line chemotherapy . We investigated whether tumour EGFR expression level was predictive of cetuximab benefit in EXTREME and CRYSTAL study patients . METHODS Prospect ively collected tumour immunohistochemistry data were used to generate an EGFR immunohistochemistry score ( scale 1 - 300 ) for patients in the EXTREME and CRYSTAL studies . For each study , the association between tumour immunohistochemistry score and cetuximab benefit was investigated . The EXTREME and CRYSTAL studies are registered with Clinical Trials.gov , numbers NCT00122460 and NCT00154102 , respectively . FINDINGS Tumour EGFR immunohistochemistry data were available for 411 of 442 ( 93 % ) patients from the EXTREME study intention-to-treat ( ITT ) population and 664 of 666 ( 100 % ) patients from the ITT population of the CRYSTAL study with EGFR-expressing , KRAS wild-type disease . The distribution of immunohistochemistry scores was similar between the treatment arms of each study , but differed between studies . A clinical ly relevant benefit for progression-free and overall survival associated with the addition of cetuximab to chemotherapy was seen across the full score range in EXTREME study patients . Similarly , CRYSTAL study patients derived a clinical benefit across the full score range , with no meaningful association between EGFR expression level and benefit . INTERPRETATION The addition of cetuximab to chemotherapy improved survival in the first-line treatment of recurrent/metastatic SCCHN and KRAS wild-type mCRC regardless of tumour EGFR expression level , indicating that in contrast to findings in NSCLC , EGFR expression level is not a clinical ly useful predictive biomarker in these setting BACKGROUND The role of neoadjuvant chemoradiotherapy in the treatment of patients with esophageal or esophagogastric-junction cancer is not well established . We compared chemoradiotherapy followed by surgery with surgery alone in this patient population . METHODS We r and omly assigned patients with resectable tumors to receive surgery alone or weekly administration of carboplatin ( doses titrated to achieve an area under the curve of 2 mg per milliliter per minute ) and paclitaxel ( 50 mg per square meter of body-surface area ) for 5 weeks and concurrent radiotherapy ( 41.4 Gy in 23 fractions , 5 days per week ) , followed by surgery . RESULTS From March 2004 through December 2008 , we enrolled 368 patients , 366 of whom were included in the analysis : 275 ( 75 % ) had adenocarcinoma , 84 ( 23 % ) had squamous-cell carcinoma , and 7 ( 2 % ) had large-cell undifferentiated carcinoma . Of the 366 patients , 178 were r and omly assigned to chemoradiotherapy followed by surgery , and 188 to surgery alone . The most common major hematologic toxic effects in the chemoradiotherapy-surgery group were leukopenia ( 6 % ) and neutropenia ( 2 % ) ; the most common major nonhematologic toxic effects were anorexia ( 5 % ) and fatigue ( 3 % ) . Complete resection with no tumor within 1 mm of the resection margins ( R0 ) was achieved in 92 % of patients in the chemoradiotherapy-surgery group versus 69 % in the surgery group ( P<0.001 ) . A pathological complete response was achieved in 47 of 161 patients ( 29 % ) who underwent resection after chemoradiotherapy . Postoperative complications were similar in the two treatment groups , and in-hospital mortality was 4 % in both . Median overall survival was 49.4 months in the chemoradiotherapy-surgery group versus 24.0 months in the surgery group . Overall survival was significantly better in the chemoradiotherapy-surgery group ( hazard ratio , 0.657 ; 95 % confidence interval , 0.495 to 0.871 ; P=0.003 ) . CONCLUSIONS Preoperative chemoradiotherapy improved survival among patients with potentially curable esophageal or esophagogastric-junction cancer . The regimen was associated with acceptable adverse-event rates . ( Funded by the Dutch Cancer Foundation [ KWF Kankerbestrijding ] ; Netherl and s Trial Register number , NTR487 . ) BACKGROUND Concomitant chemoradiotherapy ( CT/RT ) is the st and ard treatment of locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) . We evaluated the efficacy of induction docetaxel ( Taxotere ) , cisplatin , and 5-fluorouracil ( TPF ) before CT/RT versus CT/RT alone . PATIENTS AND METHODS Patients with stage III-IVM0 SCCHN , Eastern Cooperative Oncology Group performance status of zero to one , were r and omly assigned to receive CT/RT alone ( arm A : two cycles of cisplatin 20 mg/m(2 ) , days1 - 4 , plus 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion , during weeks 1 and 6 of radiotherapy ) or three cycles of TPF ( arm B : docetaxel 75 mg/m(2 ) and cisplatin 80 mg/m(2 ) , day 1 , and 5-fluorouracil 800 mg/m(2)/day 96 h continuous infusion , every 3 weeks ) followed by the same CT/RT . The primary end point was the rate of radiologic complete response ( CR ) at 6 - 8 weeks after the end of CT/RT . RESULTS A total of 101 patients were r and omly allocated to the study ( 51 arm A ; 50 arm B ) . CR rates were 21.2 % ( arm A ) versus 50 % ( arm B ) . Median progression-free survival and overall survival were , respectively , 19.7 and 33.3 months ( arm A ) and 30.4 and 39.6 months ( arm B ) . Hematologic and non-hematologic toxic effects during CT/RT were similar in the two arms . CONCLUSION Induction TPF followed by CT/RT was associated with higher radiologic CR in patients with locally advanced SCCHN with no negative impact on CT/RT feasibility PURPOSE To compare the efficacy and safety of induction chemotherapy ( ICT ) followed by chemoradiotherapy ( CRT ) or bioradiotherapy ( BRT ) for larynx preservation ( LP ) . PATIENTS AND METHODS Previously untreated patients with stage III to IV larynx/hypopharynx squamous cell carcinoma received three cycles of ICT-docetaxel and cisplatin 75 mg/m(2 ) each on day 1 and fluorouracil 750 mg/m(2 ) per day on days 1 through 5 . Poor responders ( < 50 % response ) underwent salvage surgery . Responders ( ≥ 50 % response ) were r and omly assigned to conventional radiotherapy ( RT ; 70 Gy ) with concurrent cisplatin 100 mg/m(2 ) per day on days 1 , 22 , and 43 of RT ( arm A ) or concurrent cetuximab 400 mg/m(2 ) loading dose and 250 mg/m(2 ) per week during RT ( arm B ) . Primary end point was LP at 3 months . Secondary end points were larynx function preservation ( LFP ) and overall survival ( OS ) at 18 months . RESULTS Of the 153 enrolled patients , 116 were r and omly assigned after ICT ( 60 , arm A ; 56 , arm B ) . Overall toxicity of both CRT and BRT was substantial following ICT . However , treatment compliance was higher in the BRT arm . In an intent-to-treat analysis , there was no significant difference in LP at 3 months between arms A and B ( 95 % and 93 % , respectively ) , LFP ( 87 % and 82 % , respectively ) , and OS at 18 months ( 92 % and 89 % , respectively ) . There were fewer local treatment failures in arm A than in arm B ; salvage surgery was feasible in arm B only . CONCLUSION There is no evidence that one treatment was superior to the other or could improve the outcome reported with ICT followed by RT alone ( French Groupe Oncologie Radiothérapie Tête et Cou [ GORTEC ] 2000 - 01 trial [ Induction CT by Cisplatin , 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma ] ) . The protocol Output:	For the treatment of locally advanced HNSCC , platinum-based CTRT is associated with a better OS and PFS compared to RT+CET , and this is probably attributed to improved locoregional disease control .
MS21787	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To study the effect of a computerized medical record and other practice factors on the delivery of preventive health care . DESIGN Prospect i ve , controlled trial . SETTING University general internal medicine teaching clinic . PARTICIPANTS Forty-five internal medicine residents and their 4 supervising attending physicians . INTERVENTION The study group used a computerized ambulatory medical record system that included health care maintenance reminders . The control group used a conventional paper record with a health care maintenance flow sheet . MEASUREMENTS AND MAIN RESULTS The computer reminders significantly increased health care maintenance recommendations made to patients for proctosigmoidoscopy , tetanus vaccination , influenza vaccination , and pneumococcal vaccination , but not for fecal occult blood testing , mammography , Pap smears , or serum thyroxine screening in the elderly . First-year residents were nearly twice as successful as third-year residents in overall health care maintenance . Success scores varied markedly depending on which attending physician was supervising the residents . We found a strong interaction among group assignment , supervising attending , and level of training such that the reminders doubled success scores among first-year residents supervised by two of the attending physicians but had little effect on other subgroups . The time of year and the format of the reminder also had important effects for some of the maneuvers . CONCLUSIONS Although computerized medical records markedly improved the performance of prevention maneuvers by committed physicians , many physicians using computer systems failed to make use of the re source . The reasons for this were complex . Future work in this area should carefully control for personal behaviors and focus upon administrative changes that more effectively implement these potentially powerful tools Advance directives name a surrogate decision maker or provide written instructions with the intent of extending patient autonomy with respect to end-of-life decisions [ 1 - 3 ] . Supported on various grounds by the public [ 1 ] , physicians [ 4 ] , ethicists [ 5 ] , and legislators [ 6 ] , advance directives have also been promoted as a way to control the high costs of health care at the end of life [ 7 , 8 ] . Most patients are interested in establishing advance directives , but few actually complete them [ 1 , 9 , 10 ] . In 1990 , the U.S. Congress passed the Patient Self-Determination Act , which requires hospitals to inform admitted patients about their right to record advance directives [ 6 , 11 ] . The Act does not dictate who should initiate these discussion s ( patients , physicians , or an admissions officer , for example ) [ 12 , 13 ] . It is therefore not surprising that the Act has had little effect on the rate of completion of advance directives [ 11 , 13 - 15 ] . Because hospitalized patients are often acutely ill and lose their ability to make decisions [ 3 ] , it may be more appropriate to discuss such issues before hospitalization [ 12 , 16 , 17 ] . Other interventions aim ed at increasing the establishment of advance directives have met with mixed success [ 18 ] . With one exception [ 19 ] , patient education has had little or no effect [ 20 - 24 ] . More effective interventions have trained physicians , social workers , or counselors to discuss advance directives [ 18 , 22 , 25 - 27 ] ; this has led to the conclusion that counseling by a clinician is the best catalyst for the completion of advance directives [ 28 ] . However , little is known about how to educate and motivate clinicians to solicit advance directives [ 28 ] . We [ 29 - 31 ] and others [ 32 ] have previously shown that computer reminders increase physician compliance with practice guidelines . In this study , we tested the hypothesis that reminding primary care physicians to discuss advance directives would stimulate such discussion s and lead to the establishment of more advance directives . Methods Setting and Patients This study was approved by the institutional review board of Indiana University as expedited research with waiver of informed consent from both patients and physicians . It was conducted in the General Medicine Practice [ 31 ] , an academic primary care practice affiliated with an urban public teaching hospital . This practice is staffed by general internal medicine faculty , fellows , and residents . Each resident and fellow attends the General Medicine Practice one half-day per week ; faculty attend one to four half-days per week . Residents always practice with the same attending faculty physicians . All physicians , except for study investigators , were eligible to participate . At the time of this study , the General Medicine Practice comprised four separate practice s with separate waiting areas , clerks , and nurses . Each practice held eight half-day sessions per week . Each session was attended by two faculty members and two or three residents , each of whom provided primary care to assigned panels of patients . Residents were required to briefly discuss each patient with the attending faculty . Fellows served as faculty and were treated as such . Since 1981 , a computerized program has r and omly assigned new physicians to the practice sessions [ 31 ] . New patients have been sequentially assigned to open appointment slots ; this result ed in no important differences in patients or clinical practice among the sessions [ 29 , 33 ] . We included patients who were at risk for acute deterioration ( and therefore might benefit from advance directives ) because of advanced age ( 75 years , the typical threshold for the oldest old ) or because they were 50 years of age or older and had one of the following chronic conditions : cardiac ischemia , heart failure , chronic lung disease , cancer other than nonmelanomatous skin cancer , cerebrovascular disease , renal insufficiency , or cirrhosis . We chose 50 years of age as a cut-off to yield sufficient numbers of patients . A computer program identified eligible patients among those with scheduled appointments at the General Medicine Practice by using problem lists and test results stored in the Regenstrief Medical Record System [ 34 ] . Eligible patients who kept appointments at the General Medicine Practice were approached by research assistants in the waiting room . The research assistants , who were blinded at all times to the patients ' study groups , explained the study to the patients , invited them to participate , and interviewed those who agreed to participate ; patients from nursing homes and prisons and patients who were deaf or did not speak English were excluded . The assistants then administered the Pfeiffer Mental Status Question naire [ 35 ] ; patients whose scores indicated cognitive dysfunction were excluded . The remaining patients provided sociodemographic information and stated whether they had previously discussed or completed advance directives ; patients who had completed advance directives were excluded . Patients also stated their preferences with regard to six treatments in the event of a terminal illness [ 36 ] . Advance Directives Before the study , we created two separate forms for instruction directives and proxy directives ; these forms became the official advance directive documents of the hospital and its outpatient services . The instruction directive allowed patients to indicate whether , in the event of terminal illness and mental incapacity , they wanted or did not want eight types of care : cardiopulmonary resuscitation , mechanical ventilation , surgery , invasive procedures , nutrition and hydration , transfusion of blood or blood products , antibiotics , or noninvasive diagnostic tests . The primary care physician had to sign each completed instruction directive form to indicate that he or she was aware of its contents . The proxy directive design ated both primary and secondary health care representatives . We placed both advance directive forms in a drawer of the desk of each physician in the General Medicine Practice . We also placed the forms in a bin near the door of the staff room along with other forms and requisitions and business reply envelopes for patients who wanted to complete the forms at home . Research assistants entered the data from completed forms into the Regenstrief Medical Record System , where the forms were available for viewing through computer terminals and workstations in all inpatient and outpatient venues [ 34 ] . Before the study , the three physician-investigators presented the basic concepts of advance directives at gr and rounds . They also had face-to-face meetings with each physician in the General Medicine Practice and explained how to complete and process the forms . We encouraged physicians to discuss advance directives with their elderly and debilitated patients and posted flyers in each practice staffing room suggesting that physicians discuss advance directives with patients who had the target study conditions . Study Methods The intent of the r and omization scheme was to expose physicians to the same type of reminder or reminders , or no reminders , during all of their scheduled primary care visits with enrolled patients . At the time of this study , 32 weekly half-day sessions took place on the four General Medicine Practice practice s. Two sessions attended by study investigators were excluded . We r and omly assigned all of the physicians who worked in a particular half-day session to the same reminder category . At the time of r and omization , 16 physicians ( all of whom were faculty members ) practice d in more than 1 session per week ( 14 practice d in 2 sessions and 2 practice d in 3 sessions ) . Therefore , we r and omly assigned the sessions in a stepped manner by first allocating the 16 physicians and all of their associated sessions to four categories : control ( no reminders ) , computer-generated reminders for instruction directives , computer-generated reminders for proxy directives , and computer-generated reminders for both types of directives . We then r and omly assigned the remaining 8 sessions and their physicians to the four categories ( Table 1 ) . Each practice contained sessions in all four categories , which were equally distributed between mornings and afternoons . Table 1 . Results of R and omization All physicians routinely received computer-generated reminders for patients with scheduled visits . They were reminded to give preventive care , note abnormal test results , and avoid drug interactions [ 29 , 34 ] . These reminders appeared at the bottom of computer-generated printed encounter forms [ 34 ] ( Figure 1 ) . Physicians routinely review ed the encounter forms and the practice chart immediately before visiting the patient . As recommended by Litzelman and coworkers [ 37 ] , the advance directive reminders were followed by a choice list ( discussed today , next visit , not applicable , patient too ill , patient refuses to discuss , I disagree with advance directives ) . Instruction directives were called advance directives , and proxies were called health care representatives ( Figure 1 ) . Figure 1 . General Medicine Practice encounter form showing reminders for both types of advance directive . After patients were enrolled , research assistants attempted to interview them in the waiting room after each scheduled appointment to assess whether they had discussed advance directives with their physicians that day . Patients who answered yes were defined as having had an advance directive discussion . During the first scheduled General Medicine Practice visit in the 5-month period between 11 and 16 months after enrollment , a close-out interview was attempted . If no scheduled visit had occurred by 15 months after enrollment , the close-out interview was attempted by telephone . Form completion was defined as having occurred if either completed form was received between study enrollment and 30 days after the final interview ( this made it possible to receive by mail forms that were completed after the close-out BACKGROUND We compared the efficacy of a computer-generated prompt sheet placed on the front of patients ' charts with a patient-carried prompt card to remind physicians to perform selected health maintenance items . METHODS A r and omized prospect i ve single-blind study was performed in private practice offices in rural eastern North Carolina , with 28 family practitioners and nine general internists participating . Twenty-two physicians were r and omized to the computer prompt group and 22 to the card prompt group . Four physicians in the computer group did not complete the study because of computer software problems , and three physicians did not complete the study because their limited staff was unable to enter patient data into the computer . Before the intervention , 20 patient charts ( 10 males and 10 females ) from each physician were audited for the performance of influenza vaccinations , stool for occult blood , pap smears , breast examinations performed by the physicians , and mammograms . One year after the intervention was instituted , chart audits for the above five items were done again on 20 different patient charts for each physician . RESULTS There was a 7 % increase in the performance of influenza vaccinations in the card group ( 17 % vs 24 % ) compared with a 6 % increase in the computer group ( 20 % vs 26 % ) . There was a 5 % decrease in the performance of stool for occult blood in the card group ( 28 % vs 23 % ) compared with a 1 % increase in the computer group ( 30 % vs 31 % ) . There was an 11 % decrease in the performance of pap smears in the card group ( 26 % vs 15 % ) compared with a 3 % increase in the computer group ( 23 % vs 26 % ) . There was a 2 % decrease in the performance of breast examinations by the physician in the card group ( 35 % vs 33 % ) compared with a 3 % increase in the computer group ( 30 % vs 33 % ) . Finally , there was a 3 % increase in the performance of mammograms in the card group ( 22 % vs 25 % ) compared with an 11 % increase in the computer group ( 15 % vs 26 % ) . CONCLUSIONS Our data show a greater increase in performance of health maintenance items in the computer-prompted group . The performance of stool for occult blood , pap smears , breast examinations performed by the physician , and mammograms were increased more in the computer-prompted group than in the card group . However , there was not a statistically significant difference after intervention for any of the audited health maintenance items for either the computer group or the card group . Overall , health maintenance measures were performed in only a minority of appropriate patients Computers are steadily being incorporated in clinical practice . We conducted a nonr and omised , controlled , prospect i ve trial of electronic messages design ed to enhance adherence to clinical practice guidelines . We studied 126 physicians and nurse practitioners who used electronic medical records when caring for 349 patients with HIV infection in a primary care practice . We analysed the response times of clinicians to the situations that triggered alerts and reminders , the number of ambulatory visits , and hospitalisation . The median response times to 303 alerts in the intervention group and 388 alerts in the control group were 11 and 52 days ( p < 0.0001 ) , respectively . The median response time to 432 reminders in the inter Output:	Communication services were present most often in systems integrated with electronic medical records .
MS21788	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: There have been cl aims that the postoperative course of patients may be improved by presentation during general anesthesia of therapeutic suggestions which predict a rapid and comfortable postoperative recovery . This study evaluated the effectiveness of such therapeutic suggestions under double-blind and r and omized conditions . A tape recording predicting a smooth recovery during a short postoperative stay without pain , nausea , or vomiting was played during anesthesia to about half the patients ( N = 109 ) , while the remaining , control patients were played a blank tape instead ( N = 100 ) . The patients were primarily undergoing operations on the fallopian tubes , total abdominal hysterectomy , vertical b and ing gastroplasty , cholecystectomy , and ovarian cystectomy or myomectomy . The anesthesia methods consisted of either isoflurane with 70 % nitrous oxide in oxygen to produce end-tidal concentrations of 1.0 , 1.3 , or 1.5 MAC ; or 70 % nitrous oxide in oxygen combined with high or low doses of opioids . Assessment s of the efficacy of the therapeutic suggestions in the recovery room and throughout the postoperative hospital stay included : the frequency of administration of analgesic and antiemetic drugs ; opioid doses ; the incidence of fever ; nausea , retching , and vomiting ; other gastrointestinal and urinary symptoms ; ratings of pain ; ratings of anxiety ; global ratings of the patients ' physical and psychological recoveries by the patients and their nurses ; and length of postoperative hospital stay . There were no meaningful , significant differences in postoperative recovery of patients receiving therapeutic suggestions and controls . These negative results were not likely to be due to insensitivity of the assessment s of recovery , as they showed meaningful interrelations among themselves and numerous differences in recovery following different types of surgery . Widespread utilization of therapeutic suggestions as a routine operating room procedure seems premature in the absence of adequate replication of previously published positive studies In a double‐blind r and omised study , we investigated the influence of positive intra‐operative suggestions , presented to anaesthetised patients undergoing total abdominal hysterectomy , on postoperative pain , nausea and vomiting . One hundred and forty patients were r and omly allocated to listen to one of four tapes containing either white noise or positive suggestions . The positive suggestions related to pain , postoperative nausea and vomiting , or both . We found that the positive intra‐operative suggestions had no beneficial effects in reducing postoperative pain or nausea scores , nor was the consumption of morphine or anti‐emetics reduced Background A high incidence of intraoperative awareness during cardiac surgery has been reported . Midlatency auditory evoked potentials ( MLAEP ) have been used recently as an indicator of awareness . In the current study , memory for information presented during anesthesia was investigated using MLAEP as one experimental indicator in 45 patients scheduled for elective cardiac surgery . Methods In all patients general anesthesia was maintained using high-dosage fentanyl ( 1.2 mg · h−1 ) . In addition , the patients of group 1 ( n = 10 ) received flunitrazepam ( 1.2 mg · h−1 ) , the patients of group 2 ( n = 10 ) isoflurane ( 0.6–1.2 vol% ) , and the patients of group 3 ( n = 10 ) propofol ( 4–8 mg · kg−1 . h−1 ) . Group 4 ( n = 15 ) served as a control , and those patients were assigned r and omly to one of the anesthetic regimes . After sternotomy and before cardiopulmonary bypass , an audiotape , which included an implicit memory task , was presented to the patients of groups 1–3 . Auditory evoked potentials were recorded while the patients were awake and during general anesthesia immediately before and after the audiotape presentation . Latencies of the brain stem peak V and the early cortical potentials Na and Pa were measured . Results Three to 5 days postoperatively no patient had a clear explicit memory of intraoperative events . However , there were statistically significant differences in the incidence of implicit recall among the groups . Five patients in the flunitrazepam-fentanyl group , 1 patient in the isoflurane-fentanyl group , 1 patient in the propofol-fentanyl group , and no patient in the control group showed an implicit memory of the intraoperative tape message . In the awake state , MLAEP showed high peak-to-peak amplitudes and a periodic waveform . In the patients with implicit memory postoperatively , MLAEP continued to show this pattern during general anesthesia . The early cortical potentials Na and Pa did not increase in latency or decrease in amplitude before or after the audiotape presentation . In contrast , in the patients without implicit memory , MLAEP waveform was severely attenuated or abolished . Na and Pa showed marked increases in latencies and decreases in amplitudes or were completely suppressed . In 9 patients , including all patients ( 7 of 9 ) with implicit memory , Pa latency increased less than 12 ms , and 21 of 23 patients without implicit memory showed a Pa latency increase of greater than 12 ms during anesthesia and the audiotape presentation . Therefore , the Pa latency increase of greater or less than 12 ms may provide sensitivity of 100 % and specificity of 77 % in distinguishing patients with implicit memory from patients without implicit memory postoperatively . Conclusions When the early cortical potentials of MLAEP are preserved during general anesthesia , auditory information may be processed and remembered postoperatively by an implicit memory task Ninety-one patients undergoing biliary tract surgery were r and omly assigned to one of three treatment groups in which different sounds were administered , by means of earphones , in a double-blind design . The effects of the administration of positive suggestions , noise or operating theatre sounds on the postoperative course were studied . Results showed that exposure to positive suggestions during general anaesthesia , as compared with noise or operating theatre sounds , protected patients older than 55 yr against prolonged postoperative stay in hospital The clinical value of therapeutic suggestions during general anaesthesia was assessed in a double-blind r and omised placebo-controlled study . 39 unselected patients were allocated to suggestion ( n = 19 ) or control ( n = 20 ) groups who were played either recorded therapeutic suggestions or a blank tape , respectively , during hysterectomy . The patients in the suggestion group spent significantly less time in hospital after surgery , suffered from a significantly shorter period of pyrexia , and were generally rated by nurses as having made a better than expected recovery . Patients in the suggestion group , unlike those in the control group , guessed accurately that they had been played an instruction tape To determine if improved postoperative recovery in surgical in patients receiving intraoperative therapeutic suggestions are applicable in an outpatient population , 70 consenting , unpremedicated adults undergoing elective outpatient hernia repair under general anaesthesia were allocated r and omly to either a therapeutic tape ( TT ) or a comparison tape ( CT ) group . A st and ardized general anaesthetic technique was used with propofol , fentanyl or alfentanil , isoflurane and nitrous oxide in oxygen . Pain , and nausea and vomiting were assessed after operation at 30 , 60 and 90 min and at 2 , 6 and 24 h. The presence of other side effects , such as headache and muscular discomfort , in addition to recall of tape contents , were also evaluated after operation . Absorption ability was measured before operation . The groups were similar in patient characteristics , preoperative , surgical and anaesthetic characteristics , and level of absorption . There were no differences in pain ratings or need for analgesics administered at any time after operation . Nausea/vomiting was experienced significantly fewer times by patients in group TT compared with group CT over the first 90 min ( group CT 15 % , group TT 4 % ; P < 0.02 ) , but not over the last three assessment times ( group CT 10 % , group TT 14 % ; P < 0.25 ) . The therapeutic tape group experienced fewer side effects over the entire postoperative assessment period ( P = 0.03 ) , in particular less headaches ( P = 0.03 ) and less muscular discomfort ( P < 0.02 ) . Use of intraoperative therapeutic suggestions could present mildly significant postoperative benefits in out patients Background : The authors studied whether playing a taped cognitive-behavior message during and immediately following bariatric surgery will improve performance of a postoperative regimen design ed to enhance recovery . Methods : The double-blinded placebo-controlled study consisted of 27 morbidly obese bariatric surgical patients r and omly assigned to listen to either a blank ( Controls ) or a positive therapeutic message audiotape ( Tape ) . A Postoperative Regimen Checklist ( PRC ) quantified different parts of the postoperative recovery regimen . Results : The data showed that patients in the Tape group , compared to the Controls : 1 ) achieved better scores at most PRC assessment points ( p<0.05 ) , 2 ) required less encouragement to perform tasks ( p<0.05 ) , and 3 ) were discharged from the hospital a mean of 1.6 days earlier . Conclusions : A taped cognitive-behavioral message , played to patients repetitively during and immediately following bariatric surgery , is effective in enhancing postoperative compliance and reducing in-patient length of stay In a double-blind , r and omized study , we have examined the influence of positive therapeutic suggestions , presented to anaesthetized patients undergoing total abdominal hysterectomy , on postoperative morbidity and duration of hospital stay . Seventy-five patients were allocated r and omly to be exposed to one of three tapes containing positive therapeutic suggestions , a modified history of the Queen 's Medical Centre , or no message . We found that neither therapeutic suggestions nor the presence of a voice during anaesthesia improved postoperative outcome or reduced duration of hospital stay after total abdominal hysterectomy Purpose : This study was design ed to determine whether music or music in combination with therapeutic suggestions in the intra‐operative period under general anaesthesia could improve the recovery of hysterectomy patients In a double-blind study , 33 patients ( herniorraphy , cholecystectomy and orthopaedic ) were r and omly assigned to either suggestion or control groups . Under known clinical levels of nitrous oxide and enflurane or halothane anaesthesia , suggestion patients were exposed to statements of the importance of touching their ear during a postoperative interview . Compared with controls , suggestion patients did touch their ear ( tetrachoric correlation 0.61 , P less than 0.001 ) and they did so more frequently ( Mann-Whitney U test , P less than 0.02 ) . All suggestion patients were completely amnesic for the intraoperative spoken suggestion , despite inquiries which included hypnotic regression to the operation Background : The authors previously demonstrated memory function during apparently adequate general anesthesia in trauma patients . Hypnotic state fluctuations , stress , and variable amnesic qualities of commonly used anesthetics could account for this effect . Methods : The authors replicated the trauma investigation in 90 elective surgical patients to enable anesthetic titration to a bispectral index value of 50–55 during auditory presentation of word stimuli . Patients were r and omly assigned to maintenance with propofol ( n = 48 ) or isoflurane ( n = 42 ) . Before surgery , state anxiety and trait anxiety were assessed using self-report measures . Postoperative memory assessment relied on the process dissociation procedure using a word stem completion task . Results : There were no differences between groups for relevant demographic , preoperative , or supplemental drug variables . Ninety-eight percent of words were presented within a bispectral index range of 40–60 , with values averaging 48.8 ( SD = 5.7 ) during word presentation . Neither the process dissociation procedure nor st and ard measures of conscious recall and recognition memory showed evidence of explicit or implicit memory . Preoperative stress levels did not correlate with postoperative memory test scores in either study group . Conclusions : In contrast to the results of their previous study , the authors found no evidence of memory function with close control of hypnotic state . This suggests that hypnotic state fluctuations are important to memory activation under anesthesia . Other variables may contribute to preserved memory function as well . Propofol and isoflurane block memory equally well during adequate anesthesia A double-blind , r and omized study was conducted to examine the effect of different types of therapeutic suggestions , administered during general anaesthesia , on post-operative course . Eighty-two patients undergoing cholecystectomy were intra-operatively exposed to either affirmative and non-affirmative suggestions , affirmative or non-affirmative suggestions separately , or some irrelevant text . Patients who had received both affirmative and non-affirmative suggestions spent less time in hospital than patients in the other three groups . No significant differences were demonstrated for subjective well-being measured on the third and sixth days In a double-blind , r and omized study , patients undergoing cholecystectomy were administered one of four different sounds during general anaesthesia : positive suggestions , nonsense suggestions , seaside sounds or sounds from the operating theatre . The effect of these sounds on the postoperative course was examined to assess intraoperative auditory registration . No differences were found between the four groups in postoperative variables Thirty‐two ASA I or II women undergoing abdominal hysterectomy were r and omly allocated to four groups to determine what type , if any , of recorded intraoperative message they would receive . Groups I and II heard a neutral recording with no verbal content . Group III heard an experimental recording with a positive suggestion for a rapid recovery . Group IV had a self‐prepared message . The tapes were played during general anesthesia when anesthetic depth was judged Output:	Conclusions Even though effects were small , our results provide indications that intraoperative suggestions can have the potential to reduce the need for medication and enhance recovery .
MS21789	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract Purpose Women with breast cancer may experience symptoms of depression , anxiety , pain , fatigue and sleep disturbances during chemotherapy . However , there are few modalities that address multiple , commonly occurring symptoms that may occur in individuals receiving cancer treatment . Cranial electrical stimulation ( CES ) is a treatment that is FDA cleared for depression , anxiety and insomnia . CES is applied via electrodes placed on the ear that deliver pulsed , low amplitude electrical current to the head . Methods This phase III r and omized , sham-controlled study aim ed to examine the effects of cranial microcurrent stimulation on symptoms of depression , anxiety , pain , fatigue , and sleep disturbances in women receiving chemotherapy for early-stage breast cancer . Patients were r and omly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinical trials.gov , NCT00902330 . Results The sample included N = 167 women with early-stage breast cancer . Symptom severity of depression , anxiety , and fatigue and sleep disturbances were generally mild to moderate . Levels of pain were low . Anxiety was highest prior to the initial chemotherapy and decreased over time . The primary outcome assessment ( symptoms of depression , anxiety , fatigue , pain , sleep disturbances ) revealed no statistically significant differences between the two groups , actual CES vs. sham . Conclusion In this study , women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range . Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer , further symptom management modalities should be evaluated to mitigate symptoms of depression , anxiety , fatigue , pain and sleep disturbances over the course of chemotherapy BACKGROUND Various interventions , including the superior hypogastric plexus block and ganglion impar block , are commonly used for the treatment of pelvic or perineal pain caused by cancer . The inferior hypogastric plexus block ( performed using a trans-sacral approach under fluoroscopy and using a local anesthetics⁄steroid combination ) for the diagnosis and treatment of chronic pain conditions involving the lower pelvic viscera was first described in 2007 . Neurolysis of the inferior hypogastric plexus may be useful for the treatment of pelvic and perineal pain caused by cancer . OBJECTIVES To assess the feasibility , safety and efficacy of the newly introduced inferior hypogastric plexus block , performed using a trans-sacral approach , for the relief of cancer-related pelvic and perineal pain . METHODS A total of 20 patients with cancer pain in the pelvis and ⁄or perineum were injected with 6 mL to 8 mL of 10 % phenol bilaterally by passing a spinal needle through the sacral foramen to perform the inferior hypogastric block . Pain intensity ( measured using a visual analogue scale ) , sleep score , activity score , psychological score and oral morphine consumption pre- and postprocedure were measured . RESULTS Two of the 20 patients died during the follow-up period and were , therefore , excluded from the study . All patients presented with cancer-related pelvic , perineal or pelviperineal pain . Pain scores were reduced from a mean ( ± SD ) of 7.22±1.31 preprocedurally to 4.06±1.73 one week postprocedurally ( P<0.05 ) . In addition , the mean consumption of morphine ( delivered via 30 mg sustained-release morphine tablets ) was reduced from 106.67±32.90 mg to 61.67±40.48 mg after one week ( P<0.05 ) . No complications or serious side effects were encountered during or after the block . DISCUSSION AND CONCLUSION The approach provides a good alternative technique for the treatment of low pelvic and perineal cancer-related pain . Additional studies are required for evaluation and refinement of the technique using other radiological techniques Background : Pain is 1 of the most common symptoms that a cancer patient would experience . A significant barrier to positive pain management is patients ’ misconceptions regarding analgesics and inadequate use of nonpharmacological strategies as pain relief . Objective : The purpose of this study was to investigate the effectiveness of a pain management program ( PMP ) on pain intensity , use of PRN drugs and nonpharmacological strategies as pain relief , and barriers to managing pain in cancer patients . Methods : The study was conducted in the palliative care and hospice ward of a public hospital in Hong Kong . Patients were r and omized to either an experimental group ( receiving the PMP ) or a control group ( routine care ) . There were 38 hospitalized patients , with 20 ( 13 males and 7 females ) in the experimental group and 18 ( 11 males and 7 females ) in the control group ; mean age was 61.95 years ( experimental group ) to 63.94 years ( control group ) . Results : Upon the completion of PMP , pain scores were significantly reduced in both groups , yet patients in the experimental group showed a significant increase in the use of PRN analgesics and nonpharmacological strategies to relieve pain ( P < .05 ) and significantly reduce barriers to managing their cancer pain ( P < .05 ) compared with the control group . Conclusion : Cancer patients should be empowered with pain management education to gain knowledge and correct misconceptions in managing their cancer pain . Implication s for Practice : Integration of the PMP into routine clinical work may help to improve the st and ard of care for cancer patients . It is recommended to provide pain management education to all cancer patients AIM Checklists may improve management of patients in different setting s. However , no studies have been conducted to investigate the use of this tool to improve inpatient pain control . This study , conducted in Italy , aims to describe the experience , in terms of pain control , of the widespread introduction of a checklist for pain control in oncological patients , according to current Italian legislation . MATERIAL S & METHODS In total , 92 Italian centers were r and omly assigned to the use of the 38Checkpain to monitor pain management or to continue their st and ard practice without the use of this tool . RESULTS The 38Checkpain improved the control of pain compared with centers who did not use this tool . CONCLUSION Overall , the findings of this study suggest that the application of the 38Checkpain may help improve control of pain of hospitalized oncological patients PURPOSE / OBJECTIVES To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management , decreasing pain intensity , and improving functional status and quality of life ( QOL ) . DESIGN R and omized clinical trial . SETTING Six outpatient oncology clinics ( three Veterans Affairs [ VA ] facilities , one county hospital , and one community-based practice in California , and one VA clinic in New Jersey ) Sample : 318 adults with various types of cancer-related pain . METHODS Patients were r and omly assigned to one of three groups : control , st and ardized education , or coaching . Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain . In addition , patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management . Question naires were completed at baseline and six weeks after the final telephone calls . Analysis of covariance was used to evaluate for differences in study outcomes among the three groups . MAIN RESEARCH VARIABLES Pain intensity , pain relief , pain interference , attitudinal barriers , functional status , and QOL . FINDINGS Attitudinal barrier scores did not change over time among groups . Patients r and omized to the coaching group reported significant improvement in their ratings of pain-related interference with function , as well as general health , vitality , and mental health . CONCLUSIONS Although additional evaluation is needed , coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain . IMPLICATION S FOR NURSING By using motivational interviewing techniques , advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms BACKGROUND Arthralgia is a common and debilitating side-effect experienced by breast cancer patients receiving aromatase inhibitors ( AIs ) and often results in premature drug discontinuation . METHODS We conducted a r and omised controlled trial of electro-acupuncture ( EA ) as compared to waitlist control ( WLC ) and sham acupuncture ( SA ) in postmenopausal women with breast cancer who self-reported arthralgia attributable to AIs . Acupuncturists performed 10 EA/SA treatments over 8 weeks using a manualised protocol with 2 Hz electro-stimulation delivered by a TENS unit . Acupuncturists administered SA using Streitberger ( non-penetrating ) needles at non-traditional acupuncture points without electro-stimulation . The primary end-point was pain severity by Brief Pain Inventory ( BPI ) between EA and WLC at Week 8 ; durability of response at Week 12 and comparison of EA to SA were secondary aims . FINDINGS Of the 67 r and omly assigned patients , mean reduction in pain severity was greater in the EA group than in the WLC group at Week 8 ( -2.2 versus -0.2 , p=0.0004 ) and at Week 12 ( -2.4 versus -0.2 , p<0.0001 ) . Pain-related interference measured by BPI also improved in the EA group compared to the WLC group at both Week 8 ( -2.0 versus 0.2 , p=0.0006 ) and Week 12 ( -2.1 versus -0.1 , p=0.0034 ) . SA produced a magnitude of change in pain severity and pain-related interference at Week 8 ( -2.3 , -1.5 respectively ) and Week 12 ( -1.7 , -1.3 respectively ) similar to that of EA . Participants in both EA and SA groups reported few minor adverse events . INTERPRETATIONS Compared to usual care , EA produced clinical ly important and durable improvement in arthralgia related to AIs in breast cancer patients , and SA had a similar effect . Both EA and SA were safe CONTEXT Integrated interventions with combined elements of body movement and psychotherapy on treatment-related symptoms in cancer patients are relatively scarce . OBJECTIVES The aim of the present study is to investigate the effectiveness of dance movement therapy ( DMT ) on improving treatment-related symptoms in a r and omized controlled trial . METHODS A total of 139 Chinese patients with breast cancer awaiting adjuvant radiotherapy were r and omized to DMT or control group . The intervention included six 1.5-hour DMT sessions provided twice a week over the course of radiotherapy . Self-report measures on perceived stress , anxiety , depression , fatigue , pain , sleep disturbance , and quality of life were completed before and after the three-week program . RESULTS DMT showed significant effects on buffering the deterioration in perceived stress , pain severity , and pain interference ( Cohen d = 0.34 - 0.36 , P < 0.05 ) . No significant intervention effects were found on anxiety , depression , fatigue , sleep disturbance , and quality of life ( Cohen d = 0.01 - 0.20 , P > 0.05 ) . CONCLUSION The short-term DMT program can counter the anticipated worsening of stress and pain in women with breast cancer during radiotherapy The objective of this study was to assess the impact of a Swedish massage intervention on oncology patients ' perceived level of distress . Each patient 's distress level was measured using 4 distinct dimensions : pain , physical discomfort , emotional discomfort , and fatigue . A total of 251 oncology patients volunteered to participate in this nonr and omized single-group pre- and post design study for over a 3-year period at a university hospital setting in southeastern Georgia . The analysis found a statistically significant reduction in patient-reported distress for all 4 measures : pain ( F = 638.208 , P = .000 ) , physical discomfort ( F = 742.575 , P = .000 ) , emotional discomfort ( F = 512.000 , P = .000 ) , and fatigue ( F = 597.976 , P = .000 ) . This reduction in patient distress was observed regardless of gender , age , ethnicity , or cancer type . These results lend support for the inclusion of a complementary massage therapy program for hospitalized oncology patients as a means of enhancing their course of treatment BACKGROUND Pancreatic cancer is often accompanied by severe abdominal or back pain . It 's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain . A r and omized controlled trial compared electroacupuncture with control acupuncture using the placebo needle . METHODS Sixty patients with pancreatic cancer pain were r and omly assigned to the electroacupuncture group ( n = 30 ) and the placebo control group ( n = 30 ) . Patients were treated on Jiaji ( Ex-B2 ) points T8-T12 bilaterally for 30 min once a day for 3 days . Pain intensity was assessed with numerical rated scales ( NRS ) before the treatment ( Baseline ) , after 3 treatments , and 2 days follow-up . RESULTS Baseline characteristics were similar in the two groups . After 3 treatment , pain intensity on NRS decreased compared with Baseline ( -1.67 , 95 % confidence interval [ CI ] -1.46 to -1.87 ) in the electroacupuncture group ; there was little change ( -0.13 , 95 % CI 0.08 to -0.35 ) in control group ; the difference between two groups was statistically significant ( P < 0.001 ) . Follow-up also found a significant reduction in pain intensity in the electroacupuncture Output:	FINDINGS : Based on evidence , recommended interventions to reduce chronic cancer pain are celiac plexus block for pain related to pancreatic and abdominal cancers and radiation therapy for bone pain .
MS21790	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE . Injury risk , depressive symptoms , and substance use are the leading causes of adolescent morbidity and death . The goal of this r and omized , controlled trial was to determine whether computerized screening with real-time printing of results for pediatricians increased the identification of these adolescent behavioral concerns . METHODS . A total of 878 primary care patients 11 to 20 years of age participated in computerized behavioral screening ( the Health eTouch system ) in waiting rooms of 9 urban clinics . These clinics all served predominantly low-income patients . The clinics were r and omly assigned to have pediatricians receive screening results either just before face-to-face encounters with patients ( immediate- results condition ) or 2 to 3 business days later ( delayed- results condition ) . RESULTS . Fifty-nine percent of Health eTouch respondents had positive results for ≥1 of the following behavioral concerns : injury risk behaviors , significant depressive symptoms , or substance use . Sixty-eight percent of youths in the immediate- results condition who screened positive were identified as having a problem by their pediatrician . This was significantly higher than the recognition rate of 52 % for youths in the delayed- results condition . CONCLUSION . Immediate provision of an adolescent 's self-report of behavioral concerns to a pediatrician increased recognition of those problems , compared with the delayed provision of results Background Asthma is a chronic lung disease in which recurrent asthma symptoms create a substantial burden to individuals and their families . At the same time the economic burden associated with asthma is considerable . Methods The cost-effectiveness study was part of a single centre prospect i ve r and omised controlled trial comparing a nurse-led telemonitoring programme to usual care in a population of asthmatic out patients . The study included 109 asthmatic out patients ( 56 children ; 53 adults ) . The duration of follow-up was 12 months , and measurements were performed at baseline , 4 , 8 , and 12 months . Patients were asked to transfer their monitor data at least twice daily and by judging the received data and following a stepwise intervention protocol a nurse was able to act as the main caregiver in the intervention group . In both groups the EQ-5D and the SF-6D were used to obtain estimates of health state utilities . One year health care costs , patient and family costs , and productivity losses were calculated . The mean incremental costs were weighted against the mean incremental effect in terms of QALY . Results The study population generally represented mild to moderate asthmatics . No significant differences were found between the groups with regard to the generic quality of life . Overall , the mean health care costs per patient were higher in the intervention group than in the control group . The intervention costs mainly caused the cost difference between the groups . The intervention costs the society € 31,035/QALY gained with regard to adults and with regard to children € 59,071/QALY gained . Conclusion If the outcome is measured by generic quality of life the nurse-led telemonitoring programme is of limited cost-effectiveness in the study population . From the societal perspective the probability of the programme being cost-effective compared to regular care was 85 % at a ceiling ratio of € 80,000/QALY gained among the adults and 68 % among the children . A decrease in the price of the asthma monitor will substantial increase the probability of the programme to be cost-effective . Trial registration Number : OBJECTIVE ( 1 ) To evaluate preliminary effects of a computerized support system on congruence between patients ' reported symptoms and preferences and those addressed in the patient consultation and ( 2 ) to investigate the system 's ease of use , time requirements , and patient satisfaction . DESIGN Fifty-two patients were r and omly assigned to intervention or control conditions . MEASUREMENTS Cancer patients scheduled for an outpatient visit used the system on a tablet computer to report their symptoms and preferences prior to their consultation . This information was processed , printed , and provided to the patient and clinician in the subsequent consultation in the experimental group but not in the control group . RESULTS While patients in both groups were equivalent at baseline in symptom characteristics , there was significantly greater congruence between patients ' reported symptoms and those addressed by their clinicians in the experimental group . The system scored high on ease of use . There were no significant group differences in patient satisfaction . CONCLUSION This study provided beginning evidence that eliciting patients ' symptoms and preferences and providing clinicians with this information prior to consultation can be an effective and feasible strategy to improve patient-centered care A r and omized , controlled trial was conducted to assess the effectiveness of Blue Angel for Asthma Kids , an Internet-based interactive asthma educational and monitoring program , used in the management of asthmatic children . One hundred sixty-four ( n = 164 ) pediatric patients with persistent asthma were enrolled and r and omized into two study groups for a 12-week controlled trial . The intervention group had 88 participants who were taught to monitor their peak expiratory flows ( PEF ) and asthma symptoms daily on the Internet . They also received an interactive response consisting of a self-management plan from the Blue Angel monitoring program . The control group had 76 participants who received a traditional asthma care plan consisting of a written asthma diary supplemented with instructions for self-management . Disease control was assessed by weekly averaged PEF values , symptom scores , and asthma control tests . Adherence measures were assessed by therapeutic and diagnostic monitoring . Outcome was assessed by examining quality of life and retention of asthma knowledge . The data were analyzed by comparing results before and after the trial . At the end of trial , the intervention group decreased nighttime ( -0.08 + /- 0.33 vs. 0.00 + /- 0.20 , p = 0.028 ) and daytime symptoms ( -0.08 + /- 0.33 vs. 0.01 + /- 0.18 , p = 0.009 ) ; improved morning ( 241.9 + /- 81.4 vs. 223.1 + /- 55.5 , p = 0.017 ) and night PEF ( 255.6 + /- 86.7 vs. 232.5 + /- 55.3 , p = 0.010 ) ; increased adherence rates ( p < 0.05 ) ; improved well-controlled rates ( 70.4 % vs. 55.3 % , p < 0.05 ) ; improved knowledge regarding self-management ( 93.2 % vs. 70.3 % , p < 0.05 ) ; and improved quality of life ( 6.5 + /- 0.5 vs. 4.3 + /- 1.2 on a 7-point scale , p < 0.05 ) when compared with conventional management . The Internet-based asthma telemonitoring program increases selfmanagement skills , improves asthma outcomes , and appears to be an effective and well-accepted technology for the care of children with asthma and their caregivers Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit Objective To determine the feasibility and efficacy of a six-month , cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease ( COPD ) following pulmonary rehabilitation . Methods Participants who completed a two-week run-in were r and omly assigned to either MOBILE-Coached ( n = 9 ) or MOBILE-Self-Monitored ( n = 8) . All participants met with a nurse to develop an individualized exercise plan , were issued a pedometer and exercise booklet , and instructed to continue to log their daily exercise and symptoms . MOBILE-Coached also received weekly reinforcement text messages on their cell phones ; reports of worsening symptoms were automatically flagged for follow-up . Usability and satisfaction were assessed . Participants completed incremental cycle and six minute walk ( 6MW ) tests , wore an activity monitor for 14 days , and reported their health-related quality of life ( HRQL ) at baseline , three , and six months . Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18 % predicted . Participants reported that logging their exercise and symptoms ( FEV1 ) of 40 ± was easy and that keeping track of their exercise helped them remain active . There were no differences between groups over time in maximal workload , 6MW distance , or HRQL ( p > 0.05 ) ; however , MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months ( p = 0.04 ) . Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring . The latter finding needs to be interpreted with caution since this was a purely exploratory study . Trial registration Clinical Trials.gov ( NCT00373932 ) Internet-delivered psychological treatment of major depression has been investigated in several trials , but the role of personalized treatment is less investigated . Studies suggest that guidance is important and that automated computerized programmes without therapist support are less effective . Individualized e-mail therapy for depression has not been studied in a controlled trial . Eighty-eight individuals with major depression were r and omized to two different forms of Internet-delivered cognitive behaviour therapy ( CBT ) , or to a waiting-list control group . One form of Internet treatment consisted of guided self-help , with weekly modules and homework assignments . St and ard CBT components were presented and brief support was provided during the treatment . The other group received e-mail therapy , which was tailored and did not use the self-help texts i.e. , all e-mails were written for the unique patient . Both treatments lasted for 8 weeks . In the guided self-help 93 % completed ( 27/29 ) and in the e-mail therapy 96 % ( 29/30 ) completed the posttreatment assessment . Results showed significant symptom reductions in both treatment groups with moderate to large effect sizes . At posttreatment 34.5 % of the guided self-help group and 30 % of the e-mail therapy group reached the criteria of high-end-state functioning ( Beck Depression Inventory score below 9 ) . At six-month follow-up the corresponding figures were 47.4 % and 43.3 % . Overall , the difference between guided self-help and e-mail therapy was small , but in favour of the latter . These findings indicate that both guided self-help and individualized e-mail therapy can be effective BACKGROUND : Interactive Health Communication Applications ( IHCAs ) are computer-based , usually web-based health information packages for patients that combine information with at least one of social support , decision support , or behaviour change support . These are innovations in health care and their effects on health are uncertain . OBJECTIVES : To assess the effects of IHCAs for people with chronic disease . SEARCH STRATEGY : We design ed a four-part search strategy . First , we search ed electronic bibliographic data bases for published work ; second , we search ed the grey literature and third , we search ed for ongoing and recently completed clinical trials in the appropriate data bases . Finally , research ers of included studies were contacted , and reference lists from relevant primary and review articles were followed up . As IHCAs require relatively new technology , the search commenced at 1990 where possible . SELECTION CRITERIA : R and omised controlled trials ( RCTs ) of Interactive Health Communication Applications for adults and children with chronic disease . DATA COLLECTION AND ANALYSIS : One review er screened abstract s. Two review ers screened all c and i date studies to determine eligibility , apply quality criteria , and extract data from included studies . Authors of included RCTs were contacted for missing data . Results of RCTs were pooled using a r and om effects model and st and ardised mean differences ( SMDs ) were calculated to provide net effect sizes . MAIN RESULTS : We screened 24,757 unique citations and retrieved 958 papers for further assessment , yielding 28 RCTs involving 4042 participants . One of these had an inadequate method of concealment of allocation , and sensitivity analyses were performed to determine the effects of including or excluding these data in the meta-analyses . Results in the abstract are from the meta-analyses excluding data from this study .IHCAs were found to have a positive effect on knowledge ( SMD 0.49 ; 95 % confidence interval ( CI ) 0.14 to 0.84 ) and on social support ( SMD 0.47 ; 95 % CI 0.28 to 0.66 ) . IHCAs were found to have no effect on self-efficacy ( SMD 0.15 ; 95 % CI -0.13 to 0.43 ) or behavioural outcomes ( SMD -0.09 ; 95 % CI -0.49 to 0.32 ) . IHCAs had a negative effect on clinical outcomes ( SMD -0.32 ; 95 % CI -0.63 to -0.02 ) . REVIEW ERS ' CONCLUS Output:	All interventions were feasible to implement in a real-life setting , and theoretical evidence was provided for almost all studies . All except one self-management interventions were equally effective to or better than the control option . The self-management articles document substantial benefits for patients , and partly also for health professionals and the health care system . Supporting self-management seems to be especially promising , but consultation support also shows encouraging results
MS21791	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Intensive statin therapy can lower the risk of recurrence of major cardiac events in patients with acute coronary syndromes . This could be related to the ability of statins to increase levels of Endothelial Progenitor Cells ( EPCs ) , which were demonstrated to be favorably associated with a better prognosis and post-infa rct ion left ventricular remodeling in patients with ischemic heart disease . AIM OF THE STUDY First , to evaluate , in a r and omized clinical trial , the effect of an intensive vs a st and ard treatment with statins on EPC mobilization in patients undergoing a successful primary or rescue percutaneous coronary intervention ; secondary , to evaluate whether left ventricular remodeling could be influenced by statin therapy through EPC mobilization . METHODS Forty ST-segment elevation myocardial infa rct ion ( STEMI ) patients undergoing a successful primary or rescue PCI were r and omized to receive atorvastatin 80 mg immediately after the admission ( Intensive Treatment , IT ) or atorvastatin 20 mg from the day of the discharge ( St and ard Treatment , ST ) . CD34+/KDR+ EPC count by flow cytometry and left ventricular function by 2-D Echo were measured on admission , at discharge and at 4 months follow up . RESULTS We found that EPC count was similar in the two groups of patients both on admission and at discharge . At follow up , however , EPC count was higher in patients r and omized to IT compared to patients r and omized to ST ( 7.59+/-7.30 vs 3.04+/-3.93 , p=0.04 ) . However , LV volumes , ejection fraction and wall motion score index were similar in both groups . CONCLUSIONS An intensive statin treatment after primary or rescue PCI is associated with a higher EPC count at follow up as compared to st and ard treatment . This beneficial effect did not translate in an improvement of LV function Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival . The present trial was design ed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease ( CHD ) . 4444 patients with angina pectoris or previous myocardial infa rct ion and serum cholesterol 5.5 - 8.0 mmol/L on a lipid-lowering diet were r and omised to double-blind treatment with simvastatin or placebo . Over the 5.4 years median follow-up period , simvastatin produced mean changes in total cholesterol , low-density-lipoprotein cholesterol , and high-density-lipoprotein cholesterol of -25 % , -35 % , and + 8 % , respectively , with few adverse effects . 256 patients ( 12 % ) in the placebo group died , compared with 182 ( 8 % ) in the simvastatin group . The relative risk of death in the simvastatin group was 0.70 ( 95 % CI 0.58 - 0.85 , p = 0.0003 ) . The 6-year probabilities of survival in the placebo and simvastatin groups were 87.6 % and 91.3 % , respectively . There were 189 coronary deaths in the placebo group and 111 in the simvastatin group ( relative risk 0.58 , 95 % CI 0.46 - 0.73 ) , while noncardiovascular causes accounted for 49 and 46 deaths , respectively . 622 patients ( 28 % ) in the placebo group and 431 ( 19 % ) in the simvastatin group had one or more major coronary events . The relative risk was 0.66 ( 95 % CI 0.59 - 0.75 , p < 0.00001 ) , and the respective probabilities of escaping such events were 70.5 % and 79.6 % . This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more . Other benefits of treatment included a 37 % reduction ( p < 0.00001 ) in the risk of undergoing myocardial revascularisation procedures . This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients 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<.001 ) . CONCLUSION For 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 Objectives We investigated the effects of short-term use of atorvastatin on CD34+/VEGF-R2+/CD133+/CD45- endothelial progenitor cell ( EPC ) count after on-pump coronary artery bypass surgery ( CABG ) . Methods Between Feb-2010 and May-2010 , we r and omly assigned , in a placebo-controlled , double-blind study , 60 consecutive patients who underwent isolated , first-time CABG to receive either 14-day atorvastatin ( 40 mg/day ) or placebo preoperatively . Urgent CABG and recent myocardial infa rct ion were excluded . EPCs were quantified ( cells/μl ) by flow cytometric phenotyping obtained from venous blood sample s collected preoperatively ( T1 ) , 6-hours ( T2 ) , and on the 5th day postoperatively ( T3 ) . Levels of markers of inflammation and serum cardiac troponin I were also measured preoperatively and daily until day-5 after surgery . Results There were no differences in baseline risk factors including cholesterol profiles , and EuroSCORES between the groups . The composite primary end-point , favored statin group with higher amount of circulating , early EPC count ( cells/μl ) at all time points compared with placebo ( T1 , 2.30 ± 0.02 versus 1.58 ± 0.03 , p < 0.001 ; T2 , 5.00 ± 0.06 versus 2.19 ± 0.06 , p < 0.001 ; T3 , 3.03 ± 0.08 versus 1.78 ± 0.02 , p < 0.001 ) . Postoperative hsCRP rise were inversely correlated with EPC count , and were significantly lower in the statin group ( T1 , 0.8 ± 0.1 versus 2.2 ± 1.5 , p < 0.001 ; T2 , 72.9 ± 3.2 versus 96.0 ± 3.6 , p < 0.001 ; T3 , 4.3 ± 1.2 versus 11.4 ± 4.1 , p < 0.001 ) . Furthermore , the incidence of postoperative atrial fibrillation was significantly lower in the statin group compared to placebo ( 3.3 % versus 23 % , p = 0.02 ) . Conclusions Short-term atorvastatin use increases circulating early EPCs both pre- and post-operatively and is associated with better preservation of sinus rhythm and reduced hsCRP levels . ( Clinical Trials.gov number , NCT01096875 BACKGROUND Smoking is a major cardiovascular risk factor , leading to endothelial dysfunction . The present study investigated the hypothesis that pitavastatin , an HMG-CoA reductase inhibitor , may improve endothelial function in chronic smokers via its antioxidant properties . METHODS AND RESULTS The 30 male chronic smokers who exhibited mild hypercholesterolemia at the time of physical check-up were enrolled and r and omized to the pitavastatin group ( 2 mg/day , n=15 ) or the untreated control group ( n=15 ) . Before and after the 4-week treatment period , endothelium-dependent flow-mediated dilation ( FMD ) and endothelium-independent dilation by glyceryl trinitrate ( GTD ) were examined , and the FMD/GTD ratio was calculated . The pitavastatin group showed a significant restoration of endothelial function ( percent change in FMD : + 49.6 % vs + 1.4 % ; percent change in FMD/GTD ratio : + 26.6 % vs 4.5 % , P<0.05 respectively ) , and a significant reduction in oxidative stress levels ( malondialdehyde-low-density lipoprotein-cholesterol : 16.6 % vs + 7.5 % ; free radical activity : 1.8 % vs + 9.7 % , P<0.05 respectively ) compared with the control group . Pitavastatin had no effect on the number of circulating CD34(+)CD133(+ ) progenitor cells , endothelial progenitor cells , or the MMP-2 , MMP-9 and VEGF levels . In vitro oxidative stress monitoring assay revealed that pitavastatin protected endothelial cells against oxidative stress . CONCLUSIONS Pitavastatin restores endothelial function , even in chronic smokers , possibly through its antioxidative properties . ( Circ J 2010 ; 74 : 195 - 202 ) Background —Endothelial nitric oxide ( eNO ) bioavailability is severely reduced after myocardial infa rct ion ( MI ) and in heart failure . Statins enhance eNO availability by both increasing eNO production and reducing NO inactivation . We therefore studied the effect of statin treatment on eNO availability after MI and tested its role for endothelial progenitor cell mobilization , myocardial neovascularization , left ventricular ( LV ) dysfunction , remodeling , and survival after MI . Methods and Results —Wild-type ( WT ) and eNO synthase (eNOS)−/− mice with extensive anterior MI were r and omized to treatment with vehicle ( V ) or atorvastatin ( Ator , 50 mg/kg QD by gavage ) for 4 weeks starting on day 1 after MI . Ator markedly improved endothelium-dependent , NO-mediated vasorelaxation ; mobilization of endothelial progenitor cells ; and myocardial neovascularization of the infa rct border in WT mice after MI while having no effect in eNOS−/− mice . LV dysfunction and interstitial fibrosis were markedly attenuated by Ator in WT mice , whereas no effect was observed in eNOS−/− mice after MI . Importantly , Ator significantly increased the survival rate during 4 weeks after MI in WT mice ( Ator Output:	In conclusion , r and omized studies in humans suggest that statin therapy mobilizes EPCs into the circulation .
MS21792	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers . DESIGN Single blind r and omised controlled trial . Assessors were blinded for treatment allocation . SETTING Memory clinic and day clinic of a geriatrics department and participants ' homes . PARTICIPANTS 135 patients aged > or = 65 with mild to moderate dementia living in the community and their primary care givers . INTERVENTIONS 10 sessions of occupational therapy over five weeks , including cognitive and behavioural interventions , to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision . MAIN OUTCOME MEASURES Patients ' daily functioning assessed with the assessment of motor and process skills ( AMPS ) and the performance scale of the interview of deterioration in daily activities in dementia ( IDDD ) . Care giver burden assessed with the sense of competence question naire ( SCQ ) . Participants were evaluated at baseline , six weeks , and three months . RESULTS Scores improved significantly relative to baseline in patients and care givers in the intervention group compared with the controls ( differences were 1.5 ( 95 % confidence interval 1.3 to 1.7 ) for the process scale ; -11.7 ( -13.6 to -9.7 ) for the performance scale ; and ( 11.0 ; 9.2 to 12.8 ) for the competence scale ) . This improvement was still significant at three months . The number needed to treat to reach a clinical ly relevant improvement in motor and process skills score was 1.3 ( 1.2 to 1.4 ) at six weeks . Effect sizes were 2.5 , 2.3 , and 1.2 , respectively , at six weeks and 2.7 , 2.4 , and 0.8 , respectively , at 12 weeks . CONCLUSIONS Occupational therapy improved patients ' daily functioning and reduced the burden on the care giver , despite the patients ' limited learning ability . Effects were still present at 12 weeks , which justifies implementation of this intervention . TRIAL REGISTRATION Clinical Trials NCT00295152 [ Clinical Trials.gov ] CONTEXT Optimal treatment to postpone functional decline in patients with dementia is not established . OBJECTIVE To test a nonpharmacologic intervention realigning environmental dem and s with patient capabilities . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve 2-group r and omized trial ( Care of Persons with Dementia in their Environments [ COPE ] ) involving patients with dementia and family caregivers ( community-living dyads ) recruited from March 2006 through June 2008 in Pennsylvania . INTERVENTIONS Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits ; obtained blood and urine sample s ; and trained families in home safety , simplifying tasks , and stress reduction . Control group caregivers received 3 telephone calls and educational material s. MAIN OUTCOME MEASURES Functional dependence , quality of life , frequency of agitated behaviors , and engagement for patients and well-being , confidence using activities , and perceived benefits for caregivers at 4 months . RESULTS Of 284 dyads screened , 270 ( 95 % ) were eligible and 237 ( 88 % ) r and omized . Data were collected from 209 dyads ( 88 % ) at 4 months and 173 ( 73 % ) at 9 months . At 4 months , compared with controls , COPE patients had less functional dependence ( adjusted mean difference , 0.24 ; 95 % CI , 0.03 - 0.44 ; P = .02 ; Cohen d = 0.21 ) and less dependence in instrumental activities of daily living ( adjusted mean difference , 0.32 ; 95 % CI , 0.09 - 0.55 ; P = .007 ; Cohen d = 0.43 ) , measured by a 15-item scale modeled after the Functional Independence Measure ; COPE patients also had improved engagement ( adjusted mean difference , 0.12 ; 95 % CI , 0.07 - 0.22 ; P = .03 ; Cohen d = 0.26 ) , measured by a 5-item scale . COPE caregivers improved in their well-being ( adjusted mean difference in Perceived Change Index , 0.22 ; 95 % CI , 0.08 - 0.36 ; P = .002 ; Cohen d = 0.30 ) and confidence using activities ( adjusted mean difference , 0.81 ; 95 % CI , 0.30 - 1.32 ; P = .002 ; Cohen d = 0.54 ) , measured by a 5-item scale . By 4 months , 64 COPE dyads ( 62.7 % ) vs 48 control group dyads ( 44.9 % ) eliminated 1 or more caregiver-identified problems ( chi(2/1 ) = 6.72 , P = . 01 ) . CONCLUSION Among community-living dyads , a nonpharmacologic biobehavioral environmental intervention compared with control result ed in better outcomes for COPE dyads at 4 months . Although no group differences were observed at 9 months for patients , COPE caregivers perceived greater benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00259454 Background Agitation in Alzheimer ’s disease ( AD ) is common and associated with poor patient life- quality and carer distress . The best evidence -based pharmacological treatments are antipsychotics which have limited benefits with increased morbidity and mortality . There are no memantine trials in clinical ly significant agitation but post-hoc analyses in other population s found reduced agitation . We tested the primary hypothesis , memantine is superior to placebo for clinical ly significant agitation , in patients with moderate-to-severe AD . Methods and Findings We recruited 153 participants with AD and clinical ly significant agitation from care-homes or hospitals for a double-blind r and omised-controlled trial and 149 people started the trial of memantine versus placebo . The primary outcome was 6 weeks mixed model autoregressive analysis of Cohen-Mansfield Agitation Inventory ( CMAI ) . Secondary outcomes were : 12 weeks CMAI ; 6 and 12 weeks Neuropsychiatric symptoms ( NPI ) , Clinical Global Impression Change ( CGI-C ) , St and ardised Mini Mental State Examination , Severe Impairment Battery . Using a mixed effects model we found no significant differences in the primary outcome , 6 weeks CMAI , between memantine and placebo ( memantine lower −3.0 ; −8.3 to 2.2 , p = 0.26 ) ; or 12 weeks CMAI ; or CGI-C or adverse events at 6 or 12 weeks . NPI mean difference favoured memantine at weeks 6 ( −6.9 ; −12.2 to −1.6 ; p = 0.012 ) and 12 ( −9.6 ; −15.0 to −4.3 p = 0.0005 ) . Memantine was significantly better than placebo for cognition . The main study limitation is that it still remains to be determined whether memantine has a role in milder agitation in AD . Conclusions Memantine did not improve significant agitation in people with in moderate-to-severe AD . Future studies are urgently needed to test other pharmacological c and i date s in this group and memantine for neuropsychiatric symptoms . Trial Registration Clinical Trials.gov NCT00371059 Trial Registration International St and ard R and omised Controlled Trial PURPOSE OF STUDY The authors determined short-term effects of a home environmental intervention on self-efficacy and upset in caregivers and daily function of dementia patients . They also determined if treatment effect varied by caregiver gender , race , and relationship to patient . DESIGN AND METHODS Families ( N = 171 ) of dementia patients were r and omized to intervention or usual care control group . The intervention involved 5 90-min home visits by occupational therapists who provided education and physical and social environmental modifications . RESULTS Compared with controls , intervention caregivers reported fewer declines in patients ' instrumental activities of daily living ( p = .030 ) and less decline in self-care and fewer behavior problems in patients at 3 months post-test . Also , intervention spouses reported reduced upset ( p = .049 ) , women reported enhanced self-efficacy in managing behaviors ( p = .038 ) , and women ( p = .049 ) and minorities ( p = .037 ) reported enhanced self-efficacy in managing functional dependency . IMPLICATION S The environmental program appears to have a modest effect on dementia patients ' IADL dependence . Also , among certain subgroups of caregivers the program improves self-efficacy and reduces upset in specific areas of caregiving BACKGROUND Second-generation ( atypical ) antipsychotic drugs are widely used to treat psychosis , aggression , and agitation in patients with Alzheimer 's disease , but their benefits are uncertain and concerns about safety have emerged . We assessed the effectiveness of atypical antipsychotic drugs in out patients with Alzheimer 's disease . METHODS In this 42-site , double-blind , placebo-controlled trial , 421 out patients with Alzheimer 's disease and psychosis , aggression , or agitation were r and omly assigned to receive olanzapine ( mean dose , 5.5 mg per day ) , quetiapine ( mean dose , 56.5 mg per day ) , risperidone ( mean dose , 1.0 mg per day ) , or placebo . Doses were adjusted as needed , and patients were followed for up to 36 weeks . The main outcomes were the time from initial treatment to the discontinuation of treatment for any reason and the number of patients with at least minimal improvement on the Clinical Global Impression of Change ( CGIC ) scale at 12 weeks . RESULTS There were no significant differences among treatments with regard to the time to the discontinuation of treatment for any reason : olanzapine ( median , 8.1 weeks ) , quetiapine ( median , 5.3 weeks ) , risperidone ( median , 7.4 weeks ) , and placebo ( median , 8.0 weeks ) ( P=0.52 ) . The median time to the discontinuation of treatment due to a lack of efficacy favored olanzapine ( 22.1 weeks ) and risperidone ( 26.7 weeks ) as compared with quetiapine ( 9.1 weeks ) and placebo ( 9.0 weeks ) ( P=0.002 ) . The time to the discontinuation of treatment due to adverse events or intolerability favored placebo . Overall , 24 % of patients who received olanzapine , 16 % of patients who received quetiapine , 18 % of patients who received risperidone , and 5 % of patients who received placebo discontinued their assigned treatment owing to intolerability ( P=0.009 ) . No significant differences were noted among the groups with regard to improvement on the CGIC scale . Improvement was observed in 32 % of patients assigned to olanzapine , 26 % of patients assigned to quetiapine , 29 % of patients assigned to risperidone , and 21 % of patients assigned to placebo ( P=0.22 ) . CONCLUSIONS Adverse effects offset advantages in the efficacy of atypical antipsychotic drugs for the treatment of psychosis , aggression , or agitation in patients with Alzheimer 's disease . ( Clinical Trials.gov number , NCT00015548 [ Clinical Trials.gov ] . ) CONTEXT Most older adults with dementia will be cared for by primary care physicians , but the primary care practice environment presents important challenges to providing quality care . OBJECTIVE To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease . DESIGN , SETTING , AND PATIENTS Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were r and omized by physician to receive collaborative care management ( n = 84 ) or augmented usual care ( n = 69 ) at primary care practice s within 2 US university-affiliated health care systems from January 2002 through August 2004 . Eligible patients ( identified via screening or medical record ) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver . INTERVENTION Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient 's family caregiver and integrated within primary care . The team used st and ard protocol s to initiate treatment and identify , monitor , and treat behavioral and psychological symptoms of dementia , stressing nonpharmacological management . MAIN OUTCOME MEASURES Neuropsychiatric Inventory ( NPI ) administered at baseline and at 6 , 12 , and 18 months . Secondary outcomes included the Cornell Scale for Depression in Dementia ( CSDD ) , cognition , activities of daily living , re source use , and caregiver 's depression severity . RESULTS Initiated by caregivers ' reports , 89 % of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocol s. Intervention patients were more likely to receive cholinesterase inhibitors ( 79.8 % vs 55.1 % ; P = .002 ) and antidepressants ( 45.2 % vs 27.5 % ; P = .03 ) . Intervention patients had significantly fewer behavioral and psychological symptoms Output:	Conclusion : The current literature provides clinical trial evidence that non-pharmacologic interventions can delay progression of functional impairment or disability among community-dwelling dementia patients .
MS21793	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Although the underlying pathology is initially confined to the lungs , the associated emotional responses to chronic obstructive pulmonary disease ( COPD ) contribute greatly to the result ing morbidity . The objective of this study was to examine the effect of an antidepressant drug on disease-specific quality of life in patients with end-stage COPD who present significant depressive symptoms . METHODS We conducted a 12-week , r and omized double-blind placebo-controlled trial of Paroxetine in which quality of life measured by the Chronic Respiratory Question naire ( CRQ ) , an evaluative COPD -specific quality -of-life question naire , was the primary outcome . RESULTS 23 patients were r and omized and 15 completed the trial ( 8 on Paroxetine ; 7 on placebo ) . In the per- protocol analysis , we observed statistically and clinical ly significant improvements favoring the active treatment in 2 of the 4 domains of the CRQ : emotional function ( adjusted mean difference : 1.1 ; 95 % confidence interval [ CI ] : 0.0 - 2.2 ) and mastery ( difference : 1.1 ; CI : 0.4 - 1.8 ) . Dyspnea and fatigue improved , but to an extent that did not reach statistical significance . In the intention-to-treat analysis , none of the differences in CRQ scores was significant . Paroxetine was not associated to any worsening of respiratory symptoms . CONCLUSIONS The results of this small r and omized trial indicated that patients with end-stage COPD may benefit from antidepressant drug therapy when significant depressive symptoms are present . This study underlined the difficulties in conducting experimental studies in frail and elderly patients with COPD Chronic obstructive pulmonary disease ( COPD ) affects over 16 million people in the United States and is a major cause of disability and death worldwide . Its prevalence and mortality are increasing disproportionately among the elderly , women , African-Americans , persons of lower socioeconomic status , and the population s of developing countries in which tobacco is aggressively marketed . In contrast to other major chronic diseases such as heart disease and cancer , medical treatments for COPD have not made decisive inroads into its morbidity or death rates over the last 20 years , result ing in continuing efforts to reduce disability in patients with established disease . Depression is a source of increased disability in COPD , and , as in other chronically ill patient population s , is often unrecognized and untreated in the primary and specialty care sectors . Nearly half of all patients experience some depressive symptoms and at least one-fifth have had one or more major depressive episodes , frequently of long duration . Evidence from r and omized controlled trials supports the thesis that patients with mild depression improve with multidisciplinary rehabilitation , whereas patients with major depression may require specific pharmacotherapy to achieve significant improvement in mood disorder and day-to-day function . In addition to its impact on disability , depression may contribute indirectly to the etiology and progression of COPD through its relationship to addictive smoking . Mood disorder in adolescence and early adulthood contributes to early smoking and failure to quit , even after the onset of respiratory disease in later life . Patients with a history of major depression are more likely to fail in smoking cessation programs and to develop a major depressive episode when they do stop . This relationship calls for psychiatrically informed intervention models to improve long-term abstinence rates . The functional impairments associated with COPD are themselves potential promoters of depressive morbidity and chronicity , acting through complex causal pathways . Progressive hypoxia due to respiratory insufficiency leads to structural brain changes and neurocognitive deficits that impair day-to-day function and reduce adaptive potential ; and oxygen therapy , as now practice d , offers minimal neurocognitive and mood benefits to most patients . Limited data from studies of experimental hypoxia in animals suggest that relatively mild lack of oxygen impairs the function and plasticity of critical neurotransmitter systems implicated in both cognition and mood , although current practice st and ards withhold oxygen therapy until late in the course of disease when the damaging effects of hypoxia on the brain have become well established . Neuropsychiatric approaches to the prevention , delay , and treatment of brain dysfunction should be a primary objective of research to improve patient outcomes . A comprehensive relational model that links pulmonary disease , hypoxia , neurocognitive impairment , and structural brain disease with depression provides a useful framework for the design of such studies . The near-term research agenda should include three components : ( 1 ) practical methods for improving physician and patient recognition of depression and neurocognitive impairment as targets for intervention ; ( 2 ) additional trials of st and ard antidepressant treatment approaches for both major and minor depression ; and ( 3 ) tests of the hypothesis that late-onset depression in patients with COPD is a marker for the presence of neurocognitive deficits and structural brain changes . The long-range research agenda must aim at preventive interventions design ed to forestall brain deterioration . Controlled clinical trials of supplemental oxygen in patients with mild hypoxia and minimal cognitive deficits are needed to determine whether early treatment can reverse or moderate decline , reduce the incidence and chronicity of depression , and improve response to antidepressant treatment . Novel neuroprotective therapies such as antioxidant supplementation and modulation of monoaminergic neurotransmission , coupled with overall improvements in long-term respiratory disease management that minimize episodes of increased systemic oxidative stress , should be considered for multisite trials design ed to define optimal treatment and prevention Buspirone is an anxiolytic agent that appears to have no sedative effects . The aim of this study was to assess the effects of buspirone on breathlessness and exercise tolerance in patients with chronic airway obstruction . Sixteen patients , age 56.9 + /- 17.0 ; forced expiratory volume in 1 s ( FEV1 ) 1.15 + /- 0.42 l ; FEV1/forced vital capacity ( FVC ) 50.7 + /- 15.0 % ; PaCO2 42.2 + /- 5.5 mm Hg ; and PaO2 57.6 + /- 10 mm Hg , underwent a 6-min walking test , an incremental cycle ergometer test , an incremental treadmill walking test with self- assessment of dyspnea on Borg 's scale during exercise and an assessment of respiratory drive ( P 0.1 ) , timing [ inspiration time (TI)/total breathing time ( Ttot ) ] , PaO2 , PaCO2 , FVC , FEV1 , following oral administration for 14 days of placebo or buspirone ( 20 mg daily ) in a double-blind , cross-over r and omized way . We also used the symptom check list-90-R for the assessment of subjective complaints and symptomatic behavior . A significant improvement in anxiety , depression and obsessive symptoms and complaints was noted after buspirone treatment . The P 0.1 , TI/Ttot , arterial blood gases and respiratory mechanics did not change after drug treatment . There was an improvement in exercise tolerance and in the sensation of dyspnea during the buspirone period . Thus , as given in this study , oral buspirone has therapeutic potential in the treatment of dyspnea in patients with chronic lung disease Over the ensuing seven months she had three more clinical relapses , each accompanied by reappearance in the stools of either the organism or its cytotoxin , or both . Each improvement after vancomycin ( eight to 14-daycourses ) was accompanied by disappearance of the organism . At one point she was given cholestyramine , but she was unable to tolerate it . Her illness was punctuated by malnutrition and episodes of heart failure . She was given no other antibiotics . After the sixth relapse maintenance treatment with oral vancomycin 125 mg eight-hourly was begun . With this regimen diarrhoea was controlled and stools over the next 10 weeks remained negative for C difficile and its cytotoxin . There was no adverse reaction to vancomycin throughout Although recent epidemiologic studies have established that patients with chronic medical illness and depressed mood are more disabled than euthymic patients , detailed data on the benefits and risks of antidepressant treatment in medically high-risk patients have been slow to accumulate . The authors have examined multiple outcome indicators in patients with disabling chronic obstructive pulmonary disease and comorbid depression . Thirty patients completed a 12-week , r and omized controlled trial of nortriptyline . Nortriptyline was clearly superior to placebo for treatment of depression . Nortriptyline treatment was accompanied by marked improvements in anxiety , certain respiratory symptoms , overall physical comfort , and day-to-day function ; placebo effects were negligible . Physiological measures reflecting pulmonary insufficiency were generally unaffected by treatment . These data provide impetus for renewed efforts to improve recognition and treatment of mood disorders in even severely disabled medical patients There is controversy as to whether effects on mood play a role in mediating the response to corticosteroids in chronic obstructive pulmonary disease ( COPD ) . If alterations in mood are important , it is conceivable that psychotropic drugs such as mianserin might produce similar responses to prednisolone in patients with COPD .Twelve patients age 62.5 y , with FEV1 29 % of predicted and < 15 % reversibility to salbutamol completed a r and omised , double-blind crossover study . After an initial three week placebo run-in period patients received three weeks of prednisolone 40 mg daily or mianserin 60–90 mg daily with an intervening three week placebo washout period . Full respiratory function tests , bicycle ergometry and 6 minute walks were performed before and after the run-in and at the end of each period . Psychological and functional assessment s were also made at each visit . Prednisolone significantly increased FVC , maximum ventilation ( VEmax ) and maximum heart rate ( HRmax ) compared with placebo , with mean for the difference of 0.251 , 2.561 · min−1 and 12 beats · min−1 respectively . FVC , maximum oxygen uptake ( VO2max ) and HRmax were also significantly increased with prednisolone compared with mianserin . Anxiety scores were significantly lower with prednisolone compared with placebo . In contrast , mianserin had no significant effects on lung function , exercise or psychological parameters compared with placebo . The improvements in ventilation , exercise and anxiety scores following treatment with prednisolone were not reproduced by mianserin , suggesting that the effects of prednisolone in COPD are unlikely to be due to alterations in mood The objective of this study was to determine if buspirone would alleviate anxiety and improve exercise tolerance of anxious patients with chronic airflow obstruction ( CAO ) . Eleven male patients with mild to moderate anxiety and CAO completed this study comparing buspirone , 10 to 20 mg given three times a day , with placebo . Patients were evaluated with State Trait Anxiety Inventory , spirometry , 12-min walk , incremental exercise on a cycle ergometer to symptom limitation and measurement of dyspnea with a modified Borg scale at exercise levels and the end of each 2 min on 12-min walk . There were no significant differences in anxiety scores , work load , maximum oxygen consumption per minute , maximum expired volume per minute , PETCO2 , PETO2 , 12-min walking distance or dyspnea scores after 6 weeks of buspirone or placebo therapy . We conclude that administration of buspirone has no significant effect on anxiety levels , exercise capabilities or PETO2 or PETCO2 in patients with CAO and mild anxiety The aim of this study was to determine whether treating concomitant depression improves quality of life and exercise tolerance in COPD patients . Out- patients with moderate to severe , stable COPD completed Hospital Anxiety-Depression ( HAD ) and General Health question naires . A psychiatrist interviewed those with high scores . In a r and omised , double-blind fashion , 28 depressed COPD patients took a selective serotonin re-uptake inhibitor , Paroxetine 20 mg daily , or matched placebo for 6 weeks . Subsequently , all patients took un-blinded Paroxetine for 3 months . From these question naires , 35 % of 135 patients had significant depression , but this was confirmed by psychiatric interview in only 21 % . Throughout the study , there were no changes in laboratory lung function nor in home peak flow . Six weeks ' treatment produced no significant differences between placebo and treatment group in either depression , quality of life scores or 6-minute walking distances , although overall improvements in depression , correlated with increases in walking distance . Three months of un-blinded treatment , significantly improved depression scores ( self-complete HAD , Beck 's Depression and psychiatrist-completed Montgomery-Asberg scores ) , walking distances ( 369 to 427 m , p = 0.0003 ) and St. George 's Respiratory Question naire Total Scores ( 65 to 58 , p = 0.033 ) . Although self-complete question naires over-diagnose depression , the condition is nevertheless common in patients with moderately severe COPD . Six weeks of antidepressants is insufficient to improve either depression , quality of life or exercise tolerance . However , our study suggests that a longer course of treatment may be effective and that improvements in depression are associated with improvements in exercise tolerance . A larger , double blind study with a longer treatment period is indicated During each of two six-week treatment periods , 12 depressed out patients with chronic obstructive pulmonary disease received increasing doses of doxepin hydrochloride or a placebo as tolerated . The mean maximal doses of doxepin hydrochloride and placebo were 105 and Output:	Due to the sub-optimal quality of the trials and statistically non-significant results , it is not possible to draw any conclusions for treatment .
MS21794	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To evaluate the effectiveness of a positive deviance strategy for the improvement of h and hygiene compliance in 2 adult step-down units . DESIGN A 9-month , controlled trial comparing the effect of positive deviance on compliance with h and hygiene . SETTING Two 20-bed step-down units at a tertiary care private hospital . METHODS The first phase of our study was a 3-month baseline period ( from April to June 2008 ) in which h and hygiene episodes were counted by use of electronic h and washing counters . From July to September 2008 ( ie , the second phase ) , a positive deviance strategy was implemented in the east unit ; the west unit was the control unit . During the period from October to December 2008 ( ie , the third phase ) , positive deviance was applied in both units . RESULTS During the first phase , there was no statistically significant difference between the 2 step-down units in the number of episodes of h and hygiene per 1,000 patient-days or in the incidence density of healthcare-associated infections ( HAIs ) per 1,000 patient-days . During the second phase , there were 62,000 h and hygiene episodes per 1,000 patient-days in the east unit and 33,570 h and hygiene episodes per 1,000 patient-days in the west unit ( P < .01 ) . The incidence density of HAIs per 1,000 patient-days was 6.5 in the east unit and 12.7 in the west unit ( p = .04 ) . During the third phase , there was no statistically significant difference in h and hygiene episodes per 1,000 patient-days ( P = .16 ) or in incidence density of HAIs per 1,000 patient-days . CONCLUSION A positive deviance strategy yielded a significant improvement in h and hygiene , which was associated with a decrease in the overall incidence of HAIs UNLABELLED RATIONALE , AIMS & OBJECTIVE : Tools for the assessment of the quality of research studies tend to be specific to a particular research design ( e.g. r and omized controlled trials , or qualitative interviews ) . This makes it difficult to assess the quality of a body of research that addresses the same or a similar research question but using different approaches . The aim of this paper is to describe the development and preliminary evaluation of a quality assessment tool that can be applied to a method ologically diverse set of research articles . METHODS The 16-item quality assessment tool ( QATSDD ) was assessed to determine its reliability and validity when used by health services research ers in the disciplines of psychology , sociology and nursing . Qualitative feedback was also gathered from mixed- methods health research ers regarding the comprehension , content , perceived value and usability of the tool . RESULTS Reference to existing widely used quality assessment tools and experts in systematic review confirmed that the components of the tool represented the construct of ' good research technique ' being assessed . Face validity was subsequently established through feedback from a sample of nine health research ers . Inter-rater reliability was established through substantial agreement between three review ers when applying the tool to a set of three research papers ( κ = 71.5 % ) , and good to substantial agreement between their scores at time 1 and after a 6-week interval at time 2 confirmed test-retest reliability . CONCLUSIONS The QATSDD shows good reliability and validity for use in the quality assessment of a diversity of studies , and may be an extremely useful tool for review ers to st and ardize and increase the rigour of their assessment s in review s of the published papers which include qualitative and quantitative work BACKGROUND Family planning programmes in developing countries need a better underst and ing of nurse-patient communication in order to improve the quality of counselling . OBJECTIVES To identify factors in the clinic and in the community that enable nurses and patients to communicate effectively with one another . DESIGN The study explored the personal experiences of nurses and patients who communicate especially effectively during family planning consultations ( so-called " positive deviants " ) . SETTING Sixty-four r and omly selected public clinics located in East Java , Indonesia . PARTICIPANTS Seven positive deviant nurses and 32 positive deviant patients were identified from among 64 nurses and 768 patients who participated in an earlier patient coaching study . Flooding prevented 5 patients from participating in the study , reducing their number to 27 . METHODS Investigators conducted : ( 1 ) a content analysis of qualitative data collected by structured in-depth interviews and focus-group discussion s ( FGDs ) with positive deviant nurses and patients , and ( 2 ) analyses of variance ( ANOVA ) of quantitative data on clinic , nurse , and patient characteristics . RESULTS Positive deviant nurses identified four factors , listed in rough order of importance , that helped them communicate effectively : independent study to strengthen their knowledge and skills ; communication aids ; feedback from colleagues ; and motivation stemming from a desire to help people , patients ' appreciation , husb and 's support , and increased income . Positive deviant patients identified five enabling factors : motivation due to their need for a service ; confidence in their own communication skills ; positive feedback from nurses ; belief in patients ' right and responsibility to communicate with nurses ; and communication aids . CONCLUSIONS Insights from positive deviant nurses and patients suggest that efforts to improve nurse-patient communication should go beyond conventional communication skills training . Managers should consider a mix of clinic-based interventions ( such as peer feedback , communication aids , and better management of patient flow ) and community-based interventions ( such as patient education and mass media ) UNLABELLED Improvement of chronic disease management in primary care entails monitoring indicators of quality over time and across patients and practice s. Informatics tools are needed , yet implementing them remains challenging . OBJECTIVE To identify critical success factors enabling the translation of clinical and operational knowledge about effective and efficient chronic care management into primary care practice . DESIGN A prospect i ve case study of positive deviants using key informant interviews , process observation , and document review . SETTING A chronic disease management ( CDM ) collaborative of primary care physicians with documented improvement in adherence to clinical practice guidelines using a web-based patient registry system with CDM guideline -based flow sheet . PARTICIPANTS Thirty community-based physician participants using predominantly paper records , plus a project management team including the physician lead , project manager , evaluator and support team . ANALYSIS A critical success factor ( CSF ) analysis of necessary and sufficient pathways to the translation of knowledge into clinical practice . RESULTS A web-based CDM ' toolkit ' was found to be a direct CSF that allowed this group of physicians to improve their practice by tracking patient care processes using evidence -based clinical practice guideline -based flow sheets . Moreover , the information and communication technology ' factor ' was sufficient for success only as part of a set of seven direct CSF components including : health delivery system enhancements , organizational partnerships , funding mechanisms , project management , practice models , and formal knowledge translation practice s. Indirect factors that orchestrated success through the direct factor components were also identified . A central insight of this analysis is that a comprehensive quality improvement model was the CSF that drew this set of factors into a functional framework for successful knowledge translation . CONCLUSIONS In complex primary care setting s environment where physicians have low adoption rates of electronic tools to support the care of patients with chronic conditions , successful implementation may require a set of interrelated system and technology factors Output:	The positive deviance approach was most frequently applied within North America , in secondary care , and to address healthcare-associated infections . Research predominantly identified positive deviants and generated hypotheses about how they succeeded . Applications of positive deviance typically lacked staff and /or patient involvement , and the methods used often required extensive re sources .
MS21795	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND / OBJECTIVE Very low-carbohydrate , high-fat ( LC ) diets are used for type 2 diabetes ( T2DM ) management , but their effects on psychological health remain largely unknown . This study examined the long-term effects of an LC diet on psychological health . METHODS One hundred and fifteen obese adults [ age : 58.5 ± 7.1 years ; body mass index : 34.6 ± 4.3 kg m(-2 ) ; HbA1c : 7.3 ± 1.1 % ] with T2DM were r and omized to consume either an energy-restricted ( ~6 to 7 MJ ) , planned isocaloric LC or high-carbohydrate , low-fat ( HC ) diet , combined with a supervised exercise programme ( 3 days week(-1 ) ) for 1 year . Body weight , psychological mood state and well-being [ Profile of Mood States ( POMS ) , Beck Depression Inventory ( BDI ) and Spielberger State Anxiety Inventory ( SAI ) ] and diabetes-specific emotional distress [ Problem Areas in Diabetes ( PAID ) Question naire ] and quality of life [ QoL Diabetes-39 ( D-39 ) ] were assessed . RESULTS Overall weight loss was 9.5 ± 0.5 kg ( mean ± SE ) , with no difference between groups ( P = 0.91 time × diet ) . Significant improvements occurred in BDI , POMS ( total mood disturbance and the six subscales of anger-hostility , confusion-bewilderment , depression-dejection , fatigue-inertia , vigour-activity and tension-anxiety ) , PAID ( total score ) and the D-39 dimensions of diabetes control , anxiety and worry , sexual functioning and energy and mobility , P < 0.05 time . SAI and the D-39 dimension of social burden remained unchanged ( P ≥ 0.08 time ) . Diet composition had no effect on the responses for the outcomes assessed ( P ≥ 0.22 time × diet ) . CONCLUSION In obese adults with T2DM , both diets achieved substantial weight loss and comparable improvements in QoL , mood state and affect . These results suggest that either an LC or HC diet within a lifestyle modification programme that includes exercise training improves psychological well-being OBJECTIVE To investigate the effects of weight loss diets on mood , food cravings , and other self-reported symptoms . RESEARCH METHODS AND PROCEDURES Mood and other symptoms were evaluated by participant self-report using the Atkins Health Indicator Test ( AHIT ) in individuals undergoing weight loss following either a low-carbohydrate , ketogenic diet ( LCKD ) or a low-fat diet ( LFD ) . Participants were 119 overweight community volunteers r and omized to an LCKD or an LFD . An additional 51 participants who had completed an earlier trial contributed data for the psychometric analyses but were not included in the prospect i ve analyses . Self-reported symptom levels on seven scales factor-analytically derived from the AHIT ( negative affect , fatigue , somatic symptoms , physical effects of hunger , insomnia , hunger , and stomach problems ) were acquired during 12 visits . RESULTS After adjusting for the change in BMI over the course of the trial , participants experienced significant improvements in most symptoms regardless of diet . Diet group x visit interactions were observed for negative affect [ F(9,803 ) = 2.30 , p = 0.015 ] and hunger [ F(9,803 ) = 3.62 , p < 0.0002 ] . Examination of means indicated that the LCKD group reported less negative affect and hunger , compared with the LFD group . DISCUSSION Regardless of diet , participants experienced significant improvement in a broad range of symptoms . Symptoms of negative affect and hunger improved to a greater degree in patients following an LCKD compared with those following an LFD . Whether these symptom changes explain the greater short-term weight loss generally experienced by LCKD followers deserves further research Objective To compare the effects of isocaloric , energy-restricted very low-carbohydrate ketogenic ( VLCK ) and low-fat ( LF ) diets on weight loss , body composition , trunk fat mass , and resting energy expenditure ( REE ) in overweight/obese men and women . Design R and omized , balanced , two diet period clinical intervention study . Subjects were prescribed two energy-restricted ( -500 kcal/day ) diets : a VLCK diet with a goal to decrease carbohydrate levels below 10 % of energy and induce ketosis and a LF diet with a goal similar to national recommendations ( % carbohydrate : fat : protein = ~60:25:15%).Subjects15 healthy , overweight/obese men ( mean ± s.e.m . : age 33.2 ± 2.9 y , body mass 109.1 ± 4.6 kg , body mass index 34.1 ± 1.1 kg/m2 ) and 13 premenopausal women ( age 34.0 ± 2.4 y , body mass 76.3 ± 3.6 kg , body mass index 29.6 ± 1.1 kg/m2 ) . Measurements Weight loss , body composition , trunk fat ( by dual-energy X-ray absorptiometry ) , and resting energy expenditure ( REE ) were determined at baseline and after each diet intervention . Data were analyzed for between group differences considering the first diet phase only and within group differences considering the response to both diets within each person . Results Actual nutrient intakes from food records during the VLCK ( % carbohydrate : fat : protein = ~9:63:28 % ) and the LF ( ~58:22:20 % ) were significantly different . Dietary energy was restricted , but was slightly higher during the VLCK ( 1855 kcal/day ) compared to the LF ( 1562 kcal/day ) diet for men . Both between and within group comparisons revealed a distinct advantage of a VLCK over a LF diet for weight loss , total fat loss , and trunk fat loss for men ( despite significantly greater energy intake ) . The majority of women also responded more favorably to the VLCK diet , especially in terms of trunk fat loss . The greater reduction in trunk fat was not merely due to the greater total fat loss , because the ratio of trunk fat/total fat was also significantly reduced during the VLCK diet in men and women . Absolute REE ( kcal/day ) was decreased with both diets as expected , but REE expressed relative to body mass ( kcal/kg ) , was better maintained on the VLCK diet for men only . Individual responses clearly show the majority of men and women experience greater weight and fat loss on a VLCK than a LF diet . Conclusion This study shows a clear benefit of a VLCK over LF diet for short-term body weight and fat loss , especially in men . A preferential loss of fat in the trunk region with a VLCK diet is novel and potentially clinical ly significant but requires further validation . These data provide additional support for the concept of metabolic advantage with diets representing extremes in macronutrient distribution BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed BACKGROUND In the United States , obesity is a major clinical and public health problem causing diabetes , dyslipidemia , and hypertension , as well as increasing cardiovascular and total mortality . Dietary restrictions of calories and saturated fat are beneficial . However , it remains unclear whether replacement of saturated fat with carbohydrates ( as in the US National Cholesterol Education Program [ NCEP ] diet ) or protein and monounsaturated fat ( as in our isocaloric modified low-carbohydrate [ MLC ] diet , which is lower in total carbohydrates but higher in protein , monounsaturated fat , and complex carbohydrates ) is optimal . METHODS We r and omized 60 participants ( 29 women and 31 men ) to the NCEP or the MLC diet and evaluated them every 2 weeks for 12 weeks . They were aged 28 to 71 years ( mean age , 44 years in the NCEP and 46 years in the MLC group ) . A total of 36 % of participants from the NCEP group and 35 % from the MLC group had a body mass index ( calculated as weight in kilograms divided by the square of height in meters ) greater than 27 . The primary end point was weight loss , and secondary end points were blood lipid levels and waist-to-hip ratio . RESULTS Weight loss was significantly greater in the MLC ( 13.6 lb ) than in the NCEP group ( 7.5 lb ) , a difference of 6.1 lb ( P = .02 ) . There were no significant differences between the groups for total , low density , and high-density lipoprotein cholesterol , triglycerides , or the proportion of small , dense low-density lipoprotein particles . There were significantly favorable changes in all lipid levels within the MLC but not within the NCEP group . Waist-to-hip ratio was not significantly reduced between the groups ( P = .27 ) , but it significantly decreased within the MLC group ( P = .009 ) . CONCLUSIONS Compared with the NCEP diet , the MLC diet , which is lower in total carbohydrates but higher in complex carbohydrates , protein , and monounsaturated fat , caused significantly greater weight loss over 12 weeks . There were no significant differences between the groups in blood lipid levels , but favorable changes were observed within the MLC diet group OBJECTIVE We examined the effects of an intensive lifestyle intervention ( ILI ) , compared with a diabetes support and education ( DSE ) control intervention , on long-term changes in depression symptoms , antidepressant medication ( ADM ) use , and health-related quality of life ( HRQoL ) in overweight/obese individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS Look AHEAD was a multisite r and omized controlled trial of 5,145 overweight/obese participants assigned to ILI ( design ed to produce weight loss ) or DSE and followed for a median of 9.6 years . The Beck Depression Inventory ( BDI ) was administered at baseline , annually at years 1–4 , and again at year 8 . Mean BDI scores and incidence of BDI scores ≥10 , indicative of likely mild or greater depression , were examined . Annually through year 10 , participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 ( SF-36 ) question naire , which yields physical component summary ( PCS ) and mental component summary ( MCS ) scores . RESULTS ILI significantly reduced the incidence of mild or greater depression symptoms ( BDI scores ≥10 ) compared with DSE ( hazard ratio [ HR ] = 0.85 ; 95 % CI 0.75–0.97 ; P = 0.0145 ) . Although SF-36 PCS scores worsened over time in both groups , ILI participants reported better physical function than DSE throughout the first 8 years ( all P values < 0.01 ) . There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores . CONCLUSIONS ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinical ly significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs This study Output:	RESULTS Eight r and omized controlled studies met the inclusion criteria , and their subsequent analysis revealed that improvements in psychological and social outcomes do occur during short- and long-term weight loss programmes , but that low-carbohydrate diets have no greater effect on psychosocial outcomes when compared to diets of different macronutrient composition at either short- or long-term follow-up ( one-year ) . The short- and long-term improvements in psychosocial outcomes seen in patients undergoing weight-loss treatment appear to be independent of the macronutrient composition of their diet
MS21796	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vomiting/diarrhoea ( 5 % versus 20 % ; p<0.01 ) and infantile colic ( 9 % versus 24 % ; p<0.01 ) . The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p<0.05 ) . In both high‐risk groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p<0.01 ) . The main difference between the prevention group and the control group was the diet . Thus , feeding with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life We have previously reported a protective effect of maternal omega-3 long-chain polyunsaturated fatty acids ( ω-3 LCPUFA ) supplementation in pregnancy and lactation on IgE-associated eczema and food allergy in the infant during the first year of life . Here we investigate whether the effects of the LCPUFA supplementation on IgE-associated diseases last up to 2 yr of age and assess the relationship between plasma proportions of ω-3 PUFAs and the frequency and severity of infant allergic disease . 145 pregnant women , at risk of having an allergic infant , were r and omized to daily supplementation with 1.6 g eicosapentaenoic acid ( EPA ) and 1.1 g docosahexaenoic acid ( DHA ) or placebo starting in the 25th gestational week and continuing through 3.5 months of breastfeeding . Clinical examinations , skin prick tests and analysis of maternal and infant plasma phospholipid fatty acids and infant specific IgE were performed . No difference in the prevalence of allergic symptoms was found between the intervention groups . The cumulative incidence of IgE-associated disease was lower in the ω-3-supplemented group ( 6/54 , 13 % ) compared with the placebo group ( 19/62 , 30 % , p=0.01 ) . Higher maternal and infant proportions of DHA and EPA were associated with lower prevalence of IgE associated disease ( p=0.01 - 0.05 ) in a dose-dependent manner . Higher maternal and infant proportions of DHA and EPA were found if the infants presented none , when compared with multiple allergic symptoms , ( p<0.05 ) regardless of sensitization . In summary , the ω-3 supplementation offered no obvious preventive effect on the prevalence of clinical symptoms of allergic disease , but the decrease in cumulative incidence of IgE-associated disease seen during the first year still remained until 2 yr of age . Furthermore , high proportions of DHA and EPA in maternal and infant plasma phospholipids were associated with less IgE-associated disease and a reduced severity of the allergic phenotype BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy formula ( odds ratio , 1.26 ; 95 % CI , 0.84 - 1.88 ) were at a lower risk of allergic manifestations in infancy compared with conventional formula . There was also no evidence of reduced risk of skin prick test reactivity or childhood allergic disease . CONCLUSION Despite current dietary guidelines , we found no evidence to support recommending the use of pHWF at weaning for the prevention of allergic disease in high-risk infants BACKGROUND Maternal diet during pregnancy might be one of the factors that influences fetal immune responses associated with childhood allergy . OBJECTIVE We analyzed the association between maternal diet during the last 4 wk of pregnancy and allergic sensitization and eczema in the offspring at 2 y of age . DESIGN Data from 2641 children at 2 y of age were analyzed within a German prospect i ve birth cohort study ( LISA ) . Maternal diet during the last 4 wk of pregnancy was assessed with a semiquantitative food-frequency question naire , which was administered shortly after childbirth . RESULTS High maternal intake of margarine [ adjusted odds ratio ( aOR ) : 1 . 49 ; 95 % CI : 1.08 , 2.04 ] and vegetable oils ( aOR : 1.48 ; 95 % CI : 1.14 , 1.91 ) during the last 4 wk of pregnancy was positively associated and high maternal fish intake ( aOR : 0.75 ; 95 % CI : 0.57 , 0.98 ) was inversely associated with eczema during the first 2 y in the offspring . High celery ( aOR : 1.85 ; 95 % CI : 1.18 , 2.89 ) and citrus fruit ( aOR : 1.73 ; 95 % CI : 1.18 , 2.53 ) intakes increased the risk of sensitization against food allergens . In turn , sensitization against inhalant allergens was positively related to a high maternal intake of deep-frying vegetable fat ( aOR : 1.61 ; 95 % CI : 1.02 , 2.54 ) , raw sweet pepper ( aOR : 2.16 ; 95 % CI : 1.20 , 3.90 ) , and citrus fruit ( aOR : 1.72 ; 95 % CI : 1.02 , 2.92 ) . CONCLUSIONS We suggest that the intake of allergenic foods and foods rich in n-6 polyunsaturated fatty acids during pregnancy may increase and foods rich in n-3 polyunsaturated fatty acids may decrease the risk of allergic diseases in the offspring BACKGROUND Early feeding with cow 's milk ( CM ) may increase the risk of cow 's milk allergy ( CMA ) . OBJECTIVE We sought to examine prospect ively whether supplementary feeding of CM at the maternity hospital would increase the risk when compared with feeding with pasteurized human milk or hydrolyzed formula . METHODS We studied 6209 unselected healthy , full-term infants , of whom 5385 ( 87 % ) required supplementary milk while in the hospital . The infants were r and omly assigned to receive CM formula ( 1789 infants ) , pasteurized human milk ( 1859 infants ) , or whey hydrolysate formula ( 1737 infants ) . The comparison group ( 824 infants ) was composed of infants who were exclusively breast-fed . The infants were followed for 18 to 34 months for symptoms suggestive of CMA . The primary endpoint was a challenge-proven adverse reaction to CM after a successful CM elimination diet . RESULTS The cumulative incidence of CMA in the infants fed CM was 2.4 % compared with 1.7 % in the pasteurized human milk group ( odds ratio [ OR ] , 0.70 ; 95 % confidence interval [ CI ] , 0 . 44 - 1.12 ) and 1.5 % in the whey hydrolysate group ( OR , 0.61 ; 95 % CI , 0 . 38 - 1.00 ) . In the comparison group , CMA developed in 2.1 % of the infants . Among the infants who required supplementary feeding at hospital , both exposure to CM while in the hospital ( OR , 1.54 ; 95 % CI , 1.04 - 2.30 ; P = .03 ) and obvious parental atopy ( OR , 2.32 ; 95 % CI , 1.53 - 3.52 ; P < .001 ) increased the risk of CMA . CONCLUSIONS Our data indicate that feeding of CM at maternity hospitals increases the risk of CMA when compared with feeding of other supplements , but exclusive breast-feeding does not eliminate the risk The aim of this study was to assess the preventive effect of exclusive breast-feeding and early solid food avoidance on atopic dermatitis ( AD ) in infancy . This study is part of a dietary clinical trial in a prospect i ve cohort of healthy term newborns at risk of atopy . It was recommended to breast-feed for at least 4 months and to avoid solid food in the same time-period . Eight hundred and sixty-five infants exclusively breast-fed , and 256 infants partially or exclusively formula-fed , were followed-up until the end of the first year following birth . AD and sensitization to milk and egg were considered as study end-points . The 1-year incidence of AD was compared between the two study groups . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were calculated by multiple logistic regression . The incidence of AD was calculated in relation to age at introduction of solid food and amount of food given . In the breast-fed group , the adjusted OR for AD was 0.47 ( 95 % CI 0.30 - 0.74 ) . The strongest risk factor was the occurrence of AD in the subject 's core family . The risk of infants with AD to be sensitized to milk was four times higher , and to egg eight times higher , than in infants without AD . Age at first introduction of solid food and diversity of solid food showed no effect on AD incidence . We conclude that in infants at atopic risk , exclusive breast-feeding for at least 4 months is effective in preventing AD in the first year of life This prospect i ve , long-term study assessed the effects of a protein hydrolysate formula on allergy prevention in infants with a family history of allergy . Infants were r and omly assigned to receive either the hydrolysate formula ( n = 92 ) or an adapted cow milk formula ( n = 85 ) alone or with breast-feeding for 4 months . The groups did not differ in family allergy history scores or cord blood IgE levels . After 4 months , total IgE levels and allergic reactions did not differ significantly between groups , although the hydrolysate group had a lower prevalence of eczema . At 12 months of age , neither IgE levels nor allergic reactions were significantly different . At 2 years of age , however , 18 allergic reactions had occurred in the hydrolysate group and 31 had occurred in the control group ; the differences were significant for eczema ( p < 0.001 ) but not for asthma . At 4 years of age , allergic signs were found in 11 children in the hydrolysate group and in 17 children in the control group ; the difference was significant only for eczema ( p < 0.01 ) . These results suggest that early feeding of a protein hydrolysate formula to infants at risk for allergies had a long-term preventive effect on the prevalence of eczema but not of asthma In a prospect i ve study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk , a casein hydrolysate ( Nutramigen ) or a new ultrafil Output:	There was no good evidence to recommend that pregnant or breastfeeding women should change their diet or take supplements to prevent allergies in infants at high or normal risk . There were mixed findings about the preventive benefits of breastfeeding for infants at high or normal risk , but there was evidence to recommend avoiding cow 's milk and substituting with extensively or partially hydrolyzed whey or casein formulas for infants at high risk for the first 4 months . Soy milk and delaying the introduction of solid foods beyond 4 months did not have preventive benefits in those at high or normal risk . There was very little evidence about strategies for preventing food allergy in older children or adults .
MS21797	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Purpose — Integrated care pathways ( ICP ) may not reduce disability , institutionalization , or duration of hospitalization compared with conventional multidisciplinary team ( MDT ) care in organized stroke rehabilitation . Their potential to improve patient heath status or satisfaction with care is not known . Methods — A comparison of quality of life , caregiver strain , and patient/caregiver satisfaction at 6 months after stroke was undertaken in 152 stroke patients r and omized to receive ICP or MDT care . Differences in processes of care were recorded with the use of a predefined schedule . Multivariate analyses were undertaken to identify the effect of age , sex , stroke severity , functional status , mood , and use of care pathway on quality of life score . Results — The 2 groups were comparable for baseline characteristics of age , sex , stroke severity , and initial disability . MDT care was characterized by greater emphasis on return of higher function and caregiver needs compared with ICP . EuroQol Visual Analogue Scale ( EQ-VAS ) scores were higher in the MDT group ( median , 72 versus 63;P < 0.005 ) , who also had higher scores for EuroQol dimension of social functioning ( P = 0.014 ) . Higher EQ-VAS scores were independently related to MDT care ( P = 0.04 ) , Rankin score ( P = 0.01 ) , and psychological function ( P < 0.0001 ) but not to age , sex , or stroke severity . There were no significant differences in patient or caregiver satisfaction between the 2 setting s. Conclusions — Better quality of life in patients receiving conventional MDT care may be attributable to improved social functioning and greater attention to higher function and caregiver needs during rehabilitation BACKGROUND AND PURPOSE We report the findings of a r and omized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program ( SEP ) for patients and their informal carers . METHODS Two hundred four patients admitted with acute stroke and their 176 informal carers were r and omized to receive an invitation to the SEP or to receive conventional stroke unit care . The SEP consisted of one 1-hour small group educational session for in patients followed by six 1-hour sessions after discharge . The primary outcome measure was patient- and carer-perceived health status ( SF-36 ) at 6 months after stroke . Knowledge of stroke , satisfaction with services , emotional outcome , disability , and h and icap and were secondary outcome measures . RESULTS Only 51 of 108 ( 47 % ) surviving patients r and omized to the SEP completed the program , as did 20 of 93 ( 22 % ) informal carers of surviving patients . Perceived health status ( Short Form 36 [ SF-36 ] health survey ) scores were similar for SEP patients and controls . Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group ( P=0.04 ) . Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls ( patients , P=0.02 ; carers , P=0 . 01 ) . Patients in the SEP group were more satisfied with the information that they had received about stroke ( P=0.004 ) . There were no differences in emotional or functional outcomes between groups . CONCLUSIONS Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services , this was not associated with an improvement in their perceived health status . Indeed , the social functioning of informal carers r and omized to the SEP was less than in the control group The impact of clinical ly diagnosed depression on recovery in activities of daily living over a 2-year follow-up was examined in a prospect i ve study of 63 stroke patients . Although impairment in activities of daily living , neurologic diagnoses and findings , lesion location and volume as measured on computed tomographic scan , demographic variables , cognitive impairment , and social functioning were comparable between depressed ( n = 25 ) and nondepressed ( n = 38 ) patients during their acute hospitalization , the two groups had different patterns of recovery in activities of daily living . At 2 years after suffering a stroke , patients with an in-hospital diagnosis of depression ( either major or minor depression ) were significantly more impaired in both physical activities and language functioning than were non-depressed patients . Among patients with major depression , this disparity in the recovery profile was present even after the depression had remitted . This study emphasizes the need for early recognition and treatment of poststroke depression BACKGROUND Attention is currently focused on family care of stroke survivors , but the effectiveness of support services is unclear . We did a single-blind , r and omised , controlled trial to assess the impact of family support on stroke patients and their carers . METHODS Patients with acute stroke admitted to hospitals in Oxford , UK , were assigned family support or normal care within 6 weeks of stroke . After 6 months , we assessed , for carers , knowledge about stroke , Frenchay activities index , general health question naire-28 scores , caregiver strain index , Dartmouth co-op charts , short form 36 ( SF-36 ) , and satisfaction scores , and , for patients , knowledge about stroke and use of services , Barthel index , Rivermead mobility index , Frenchay activities index , London h and icap scale , hospital anxiety and depression scales , Dartmouth co-op charts , and satisfaction . FINDINGS 323 patients and 267 carers were followed up . Carers in the intervention group had significantly better Frenchay activities indices ( p=0.03 ) , SF-36 scores ( energy p=0.02 , mental health p=0.004 , pain p=0.03 , physical function p=0.025 , and general health perception p=0.02 ) , quality of life on the Dartmouth co-op chart ( p=0.01 ) , and satisfaction with underst and ing of stroke ( 82 vs 71 % , p=0.04 ) than those in the control group . Patients ' knowledge about stroke , disability , h and icap , quality of life , and satisfaction with services and underst and ing of stroke did not differ between groups . Fewer patients in the intervention group than in the control group saw a physiotherapist after discharge ( 44 vs 56 % , p=0.04 ) , but use of other services was similar . INTERPRETATION Family support significantly increased social activities and improved quality of life for carers , with no significant effects on patients Background and Purpose — The efficacy and safety of the selective serotonin reuptake inhibitor fluoxetine have rarely been studied in the treatment of poststroke emotional disturbances . Methods — Stroke patients ( 152 ) who had poststroke depression ( PSD ) , emotional incontinence ( PSEI ) , or anger proneness ( PSAP ) were studied . PSD was evaluated by Beck Depression Inventory and Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , PSEI by Kim ’s criteria , and PSAP was assessed by Spielberger Trait Anger Scale . Subjects were r and omly given either fluoxetine 20 mg/day ( n=76 ) or placebo ( n=76 ) for 3 months . Follow-up evaluations were done 1 , 3 , and 6 months after the beginning of the treatment . The primary outcome measurement was the scores of emotional disturbances at each follow-up assessment . The secondary outcome measurements were the percentage changes of the scores and the subjective responses of the patients . Results — Although patients in the fluoxetine group more often dropped out because of adverse effects , fluoxetine administration was generally safe . Fluoxetine significantly improved PSEI and PSAP , whereas no definitive improvement of PSD was found . Improvement of PSAP was noted even at 3 months after the discontinuation of the treatment . Conclusions — Fluoxetine is efficacious in the treatment of PSEI and PSAP . Its effect on PSD is not solidly confirmed Background and Purpose — The purpose of this study was to determine whether motivational interviewing , a patient-centered counseling technique , can benefit patients ' mood 3 months after stroke . Methods — A single-center , open , r and omized , controlled trial was conducted at a single hospital with a stroke unit . Subjects consisted of 411 consecutive patients on the stroke register who were over 18 years of age and who did not have severe cognitive and communication problems that would prevent them from taking part in an interview ; were not known to be moving out of the area after discharge ; and were not already receiving psychiatric or clinical psychology intervention . All patients received usual stroke care . Patients in the intervention group received 4 individual , weekly sessions of motivational interviewing with a trained therapist in addition to usual stroke care . The primary outcome was the proportion of patients with normal mood at 3 months poststroke measured by the 28-item General Health Question naire ( normal , < 5 ; low ≥5 ) using a mailed question naire . Results — Eighty-one of 207 ( 39.1 % ) patients in the control group and 100 of 204 ( 49.0 % ) patients in the intervention group had normal mood at follow up . A significant benefit of motivational interviewing over usual stroke care ( OR : 1.60 , 95 % CI : 1.04 to 2.46 , P=0.03 ) was found . Conclusion — Our results suggest motivational interviewing leads to an improvement in patients ' mood 3 months after stroke Background : The involvement of five specialist nurses in providing a stroke support service was evaluated quantitatively in a recent r and omized controlled trial . This complementary study used qualitative methods to evaluate trial outcomes more comprehensively . Aims : To identify whether the nurses ' intervention may have influenced the process of stroke recovery . Method : A purpose fully selected sub sample of 30 patients and 15 care-givers were interviewed within 1 - 3 months of their final quantitative assessment ( 12 months after recruitment to the r and omized trial ) . Fifteen of the patients and eight of the care-givers had received visits from a specialist nurse . A semi- structured interview was design ed to include questions on perceptions of the recovery process and evaluation of services received . Results : Some differences were evident between the accounts of control and intervention group subjects . The less tangible aspects of nurses ' interventions - concern , attention , empathy and interest , when combined with sound professional knowledge , had identifiable value to the patients and care-givers . It appeared that the nurses had employed considerable sensitivity and skill in identifying and responding to particular needs at appropriate times . Conclusion : The qualitative evaluation offers a different picture to the quantitative results of the r and omized controlled trial . In general , the findings of the qualitative study are more positive and encouraging than the quantitative results . The majority of patients and care-givers in the intervention group believed that they had benefited from the specialist nurse 's visits Purpose : To evaluate the feasibility and effectiveness of early supported discharge ( ESD ) following acute stroke . Method : An ESD scheme was compared to conventional rehabilitation in a r and omized controlled trial . All patients admitted with acute stroke were considered for inclusion . Eighty-eight ( 20.2 % ) were found to be eligible and 82 were r and omized either to early supported discharge ( n=42 ) or conventional rehabilitation ( n=40 ) . The primary outcome measure was the Nottingham Extended Activities of Daily Living Scale . The General Health Question naire , the Montgomery Aasberg Depression Rating Scale , mortality , placement and patient and carer satisfaction served as secondary outcome measures . Results : Median length of stay was reduced from 31 days in the conventional hospital rehabilitation group to 22 days in the early supported discharge group ( p=0.09 ) . No differences were found regarding primary outcome . The General Health Question naire score showed a significant difference in favour of the early supported discharge group at three months ( 19.5/24 , p = 0.02 ) , but not at six . At six months , the proportion of patients being dead or in institution showed a trend of being higher in the conventional rehabilitation group ( OR 3.8 , 95 % CI 0.8 - 23 ) . Conclusions : Early supported discharge after stroke is feasible and it is possible that it has benefits compared with conventional rehabilitation Background and Purpose — There is inconclusive evidence of the effectiveness of the Stroke Family Support Organiser ( FSO ) service . We report the results from a r and omized controlled trial of the service . Methods — Stroke patients admitted to hospital and their informal caregivers were r and omly allocated to receive the FSO service ( n=126 ) or st and ard care ( n=124 ) . Outcome assessment s were undertaken 4 and 9 months after recruitment with the General Health Question naire 12 , Carer Strain Index , Barthel Index , Extended Activities of Daily Living scale , and a specially design ed question naire to determine knowledge of stroke and satisfaction with services . Results — There were no significant differences between groups in patients ’ mood and independence in personal or instrumental activities of daily living or caregivers ’ mood , strain , or independence . Patients in the intervention group were significantly more knowledgeable about whom to contact for stroke information , reducing the risk of stroke , practical help , community services , and emotional support . Patients in the intervention group were also significantly more satisfied with the stroke information received . Caregivers in the intervention group were significantly more knowledgeable about whom to contact for information on stroke , reducing the risk of stroke , community services , and emotional support . Caregivers in the intervention group were also significantly more satisfied with stroke information . Conclusions — The FSO service had no significant effect on mood , independence in activities of daily living , or reduction in caregiver strain , but it did increase knowledge of stroke and satisfaction with that knowledge . The results may not be representative of all FSO services , and the sample was small relative to the heterogeneity of the participants . However , results suggest that the policies and training procedures of FSOs need to be evaluated to ensure that a cost-effective service is being provided to stroke patients and their caregivers BACKGROUND AND PURPOSE Patients with poststroke major depression have a greater severity of cognitive impairment than nondepressed patients even when matched for size and location of stroke lesion . Prior treatment studies have consistently failed to show an improvement in cognitive function even when poststroke mood Output:	There was no clear effect of pharmacological therapy on the prevention of depression or other endpoints . A significant improvement in mood and the prevention of depression was evident for psychotherapy , but the treatment effects were small . A small but significant effect of psychotherapy on improving mood and preventing depression was identified .
MS21798	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To study the hip muscle strength and cross sectional area ( CSA ) in men with hip osteoarthritis ( OA ) compared to age and sex matched healthy controls . METHODS Based on the American College of Rheumatology criteria regarding classification of hip OA , 27 men ( aged 47 - 64 yrs ) with unilateral or bilateral hip OA and 30 age matched r and omly selected healthy male controls were studied . The maximal isometric hip abductor , adductor , flexor , and extensor strength ( Nm ) at 0 degree of hip flexion in the supine position was determined with a dynamometer . The isokinetic hip flexion and extension strength ( peak torque , Nm ) was determined using angular velocities of 60 degrees /s and 120 degrees /s . The subjective severity of hip pain was rated by visual analog scale prior to the muscle strength test . CSA of the pelvic and thigh muscles was measured from magnetic resonance images . RESULTS The reliability of intraclass correlation coefficients for repeated measures of muscle strength varied from 0.70 to 0.94 in controls and from 0.84 to 0.98 in subjects with OA . Hip isometric adductor and abductor strength was 25 % and 31 % lower ( p < 0.001 ) in OA subjects than in controls , respectively . The hip isometric and isokinetic flexion strength was 18 - 22 % lower ( p < 0.01 ) in OA subjects than in controls , but extension strength did not differ between groups . In OA subjects , the hip flexion and extension isometric and isokinetic strength values were 13 - 22 % lower ( p < 0.05 ) on the more deteriorated side compared to the better side . CSA of the pelvic and thigh muscles did not differ between the groups . However , in OA subjects , the CSA of the pelvic and thigh muscles was 6 - 13 % less ( p < 0.05 to < 0.001 ) on the more severely affected hip compared to the better hip . CONCLUSION Men with hip OA have significantly lower abduction , adduction , and flexion muscle strength than controls . The decrease of muscle size and hip pain may contribute to the decrease of muscle strength in hip OA . Other possible underlying causes of the muscle weakness need to be studied OBJECTIVE To compare treadmill training with partial body-weight support ( TT-BWS ) and conventional physical therapy ( PT ) in ambulatory patients with hip arthroplasty . DESIGN R and omized controlled trial . SETTING Rehabilitation center . PARTICIPANTS Eighty patients with a fully loadable implant who could walk independently with crutches after unilateral total hip arthroplasty were r and omized to receive either TT-BWS ( treatment group ) or conventional PT ( controls ) , for 10 working days . INTERVENTIONS Each patient received 45 minutes of individualized PT , either treadmill training plus PT in the experimental or PT alone in the control group . MAIN OUTCOME MEASURES The Harris score , recorded by blind assessors , served as the primary outcome measure . Secondary outcome measures were the hip extension deficit , gait velocity , gait symmetry , affected hip abductor power ; hip abductor amplitude of electromyographic activation ; and the interval from surgery to ab and oning crutches . RESULTS At the end of training , the treatment group 's Harris score was 13.6 points higher ( P<.0001 ) than the control group 's score . Further , hip extension deficit was 6.8 degrees less ( P<.0001 ) , gait symmetry was 10 % greater ( P=.001 ) , affected hip abductor was stronger ( Medical Research Council grade s 4.24 vs 3.73 ; P<.0001 ) , and the amplitude of gluteus medius activity was 41.5 % greater ( P=.001 ) than those measures for controls . Gait velocity did not differ in the 2 groups . These significant differences in favor of the treatment group persisted at 3 and 12 months . The treatment group ab and oned crutches sooner than the control group ( 3 vs 8wk ) . In the treatment group , 39 patients finished treatment , 35 appeared at 3 , and 26 at 12 months for follow-up . In the control group , the corresponding numbers were 40 , 35 , and 24 patients , respectively . CONCLUSION TT-BWS is more effective than conventional PT at restoring symmetrical independent walking after hip replacement AIM Benefits of less damage of soft tissues and muscles in minimally invasive hip replacement lead to expectations of better results in gait rehabilitation . The aim of the study is to evaluate post-operative walking ability in terms of different surgical approaches . METHOD 16 patients underwent a minimally invasive total hip replacement ( MIS group ) and 16 other patients got a THA using a transgluteal approach ( st and ard group ) . Differences in functional indices of ground reaction forces and symmetry indices were measured one day pre-operatively as well as 8 , 14 and 28 weeks post-operatively . The results were compared between the surgical approaches and to an age-matched healthy control group . RESULTS There are significantly reduced pain symptoms and a higher functional ability in both surgical groups 8 weeks post-operatively . There are no differences in gait parameters between the surgical groups after 28 weeks . Trends in gait velocity , temporal parameters and in functional indices of ground reaction forces show advantages for the minimally invasive group 8 and 14 weeks post-operatively . Patients do not reach the age-matched control group . CONCLUSION Obviously the immediate post-operative advantages of minimally invasive hip replacement provide better chances for gait rehabilitation compared to the transgluteal approach . Due to the complexity of the problem clinical and gait analysis studies should be linked more closely This study examined the effect of the surgical approach used in total hip arthroplasty ( THA ) on gait mechanics six months following surgery . Quantitative gait analysis was performed on 29 subjects : 10 anterolateral ( A-L ) and 10 posterolateral ( P-L ) THA patients and nine able-bodied , velocity-matched subjects . Discriminant function analysis was used to determine the distinction of the groups with respect to sagittal plane hip range of motion , index of symmetry , trunk inclination , pelvic drop , hip abduction , and foot progression angles . The A-L group had the largest trunk inclination ( 3.0+/-2.4 degrees ) and the smallest hip range of motion ( 34.0+/-7.4 degrees ) . Both THA groups demonstrated greater asymmetry as expressed by the smaller symmetry index ( 0.97+/-0.04 for A-L and 0.98+/-0.05 for the P-L ) than the able-bodied group ( 0.99+/-0.01 ) . The classification procedure correctly classified 89 % of the control group cases , 90 % of the A-L cases , and 50 % of the P-L cases . These results support the conclusion that six months following surgery , the gait of the majority ( 85 % ) of THA patients has not returned to normal . The A-L patients displayed distinct gait patterns , while a small percentage ( 30 % ) of the P-L patients demonstrated normal gait . While these differences are statistically significant , the clinical significance is unknown and linked to the duration that they persist OBJECTIVE To compare gait patterns in patients with total hip arthroplasty ( THA ) and surface hip arthroplasty . DESIGN Observational study . SETTING Outpatient biomechanical laboratory . PARTICIPANTS Two groups of 10 surface hip arthroplasty and THA patients and 10 control subjects participated in the study ( N=30 ) . The patients were volunteers recruited from a larger r and omized study . INTERVENTIONS Not applicable . MAIN OUTCOMES MEASURES Gait patterns , hip abductor muscle strength , clinical outcomes , and radiographic analyses were compared between groups . RESULTS In the sagittal plane , the THA group showed a larger flexor moment and larger mechanical work in H2S and K3S power bursts compared with surface hip arthroplasty and control subjects . In the frontal plane , both THA and surface hip arthroplasty patients had smaller hip abductor muscles energy generation ( H3F ) than the control group . No difference was found for the hip abductor muscles strength . CONCLUSIONS In the THA group , the larger energy absorption in H2S and K3S would be a cost-effective mechanical adaptation to increase stability . The surface hip arthroplasty characteristics could allow the return to a more normative gait pattern compared with THA . The modification in the frontal plane in surface hip arthroplasty and THA would be related to the hip abductor muscles strength The hip-rating question naire was developed for the assessment of the outcome of total hip replacement . The purpose of this study was to evaluate its reproducibility , validity , and responsiveness . The question naire uses a 100-point scale in which equal weight is given to the domains of global or over-all impact of arthritis , pain , walking , and function . Ninety-eight patients were enrolled in the prospect i ve study and have been followed for at least three months ; sixty-two patients have been followed for six months ; and forty-two patients have been followed for one year . Reproducibility was tested with the use of the kappa statistic in fifty patients whose condition was stable clinical ly , and it was found to be good or excellent both for individual questions and for the total score . The validity of the question naire was assessed by comparison with the scores from a six-minute walking-distance test and arthritis impact-measurement scales . The result of the six-minute walking-distance test correlated with the patient 's response concerning walking distance on the hip-rating question naire . The score for pain from the hip-rating question naire correlated well with the score for pain from the arthritis impact-measurement scales , and the total score from the hip-rating question naire correlated well with the total score from the arthritis impact-measurement scales . The score on the hip-rating question naire was responsive to the change in the clinical condition of the patient , as indicated by a favorable index of responsiveness . The results of the question naire were sensitive enough to demonstrate differences among treatment groups with relatively small sample sizes . This question naire has the characteristics of a useful instrument for assessment of outcomes , such as that after an operation OBJECTIVE To quantify gait impairments in women with pregnancy-related pain in the pelvis which persisted post-partum . Design . Nine patients and nine healthy subjects were studied during treadmill walking at different velocities . BACKGROUND Walking problems in patients with pregnancy-related pain in the pelvis have been known to exist for a long time . To date , no quantitative gait studies have been conducted in this population . METHODS Maximum attainable walking velocity was determined , amplitudes of pelvic and thoracic rotations were calculated , and spectral analysis was used to assess the harmonicity of these rotations . Coordination between pelvic and thoracic rotations was characterized as mean relative Fourier phase and weighted coherence . RESULTS Maximum attainable walking velocity was highly variable between patients , but on average significantly lower than in healthy controls . Moreover , patients had a significantly lower mean relative Fourier phase ( again , highly variable ) and higher weighted coherence . The other parameters did not differ significantly between groups . CONCLUSIONS Coordination between pelvic and thoracic rotations in the transverse plane was affected in patients with pregnancy-related pain in the pelvis . Individual patients may apply different strategies during walking to cope with the underlying problems . RELEVANCE Pregnancy-related pain in the pelvis is poorly understood . Patients with this condition are known to have problems with locomotion . The present study reveals that gait coordination is altered . Theoretically , this underlines the importance of analysing coordination in pathological movement . Clinical ly , better underst and ing the gait problems of women with pregnancy-related pain in the pelvis may contribute to more appropriate treatments Purpose sPost arthroplasty gait analysis has up till now been performed on subjects walking slowly on flat ground rather than challenging them at faster speeds or walking uphill . We therefore asked : ( 1 ) Is there a measurable difference in the performance of hip resurfacing arthroplasty ( HRA ) and total hip arthroplasty ( THA ) limbs at patients ’ self-determined fastest walking speeds and steepest inclines ? and ( 2 ) Is there a relationship between the observed differences between the gait of HRA and THA implanted limbs and patient walking speeds and inclines . Methods In an ethically approved study we recruited patients with bilateral hip arthroplasties : one HRA and one THA . Nine subjects were assessed using an instrumented treadmill at a range of speeds and inclines by a blinded observer . The ground reaction forces of subjects were recorded and an age , sex and BMI matched control group was used for comparison . Results Increasing walking speed correlated strongly with between leg differences in weight acceptance ( r = 0.9 , p = 0.000 ) and push-off force ( r = 0.79 , p = 0.002 ) . HRA implanted limbs accepted significantly more weight at top walking speeds ( 1208 N ± 320 versus 1279 N ± 370 , p = 0.026 ) and pushed off with greater force when walking uphill ( 818 N ± 163 versus 855 ± 166 , p = 0.012 ) . HRA limbs more closely approximated to the gait of the normal control group . Conclusions Arthroplasty implants do have an impact on the gait characteristics of patients . Differences in gait are more likely to be evident when assessment is made at fast speeds and walking uphill . This study suggests that HRA may enable a more normal gait Although treatments for osteoarthritis of the knee are often directed at relieving pain , pain may cause patients to alter how they perform activities to decrease the loads on the joints . The knee-adduction moment is a Output:	Compared to controls , reductions were identified in the operated hip in sagittal range of motion , peak extension , sagittal power generation , abduction moment and external rotation moment . During stair ascent , these reductions did not become more apparent , although deficits in hip kinetics in all three planes were found . Walking speed and step length were reduced compared to controls at longer-term follow-up , but not at short-term follow-up . INTERPRETATION The hip abduction moment deficit was present both in level walking and in stair ascent in total hip arthroplasty patients compared to controls . Reduced sagittal hip power generation and external rotation moment were also found , of which the clinical relevance remains to be established .
MS21799	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Oropharyngeal squamous-cell carcinomas caused by human papillomavirus ( HPV ) are associated with favorable survival , but the independent prognostic significance of tumor HPV status remains unknown . METHODS We performed a retrospective analysis of the association between tumor HPV status and survival among patients with stage III or IV oropharyngeal squamous-cell carcinoma who were enrolled in a r and omized trial comparing accelerated-fractionation radiotherapy ( with acceleration by means of concomitant boost radiotherapy ) with st and ard-fractionation radiotherapy , each combined with cisplatin therapy , in patients with squamous-cell carcinoma of the head and neck . Proportional-hazards models were used to compare the risk of death among patients with HPV-positive cancer and those with HPV-negative cancer . RESULTS The median follow-up period was 4.8 years . The 3-year rate of overall survival was similar in the group receiving accelerated-fractionation radiotherapy and the group receiving st and ard-fractionation radiotherapy ( 70.3 % vs. 64.3 % ; P=0.18 ; hazard ratio for death with accelerated-fractionation radiotherapy , 0.90 ; 95 % confidence interval [ CI ] , 0.72 to 1.13 ) , as were the rates of high- grade acute and late toxic events . A total of 63.8 % of patients with oropharyngeal cancer ( 206 of 323 ) had HPV-positive tumors ; these patients had better 3-year rates of overall survival ( 82.4 % , vs. 57.1 % among patients with HPV-negative tumors ; P<0.001 by the log-rank test ) and , after adjustment for age , race , tumor and nodal stage , tobacco exposure , and treatment assignment , had a 58 % reduction in the risk of death ( hazard ratio , 0.42 ; 95 % CI , 0.27 to 0.66 ) . The risk of death significantly increased with each additional pack-year of tobacco smoking . Using recursive-partitioning analysis , we classified our patients as having a low , intermediate , or high risk of death on the basis of four factors : HPV status , pack-years of tobacco smoking , tumor stage , and nodal stage . CONCLUSIONS Tumor HPV status is a strong and independent prognostic factor for survival among patients with oropharyngeal cancer . ( Clinical Trials.gov number , NCT00047008 . Purpose Treatment of oropharyngeal squamous cell carcinoma ( OPSCC ) is evolving toward risk-based modification of therapeutic intensity , which requires patient-specific estimates of overall survival ( OS ) and progression-free survival ( PFS ) . Methods To develop and vali date nomograms for OS and PFS , we used a derivation cohort of 493 patients with OPSCC with known p16 tumor status ( surrogate of human papillomavirus ) and cigarette smoking history ( pack-years ) r and omly assigned to clinical trials using platinum-based chemoradiotherapy ( NRG Oncology Radiation Therapy Oncology Group [ RTOG ] 0129 and 0522 ) . Nomograms were created from Cox models and internally vali date d by use of bootstrap and cross-validation . Model discrimination was measured by calibration plots and the concordance index . Nomograms were externally vali date d in a cohort of 153 patients with OPSCC r and omly assigned to a third trial , NRG Oncology RTOG 9003 . Results Both models included age , Zubrod performance status , pack-years , education , p16 status , and T and N stage ; the OS model also included anemia and age × pack-years interaction ; and the PFS model also included marital status , weight loss , and p16 × Zubrod interaction . Predictions correlated well with observed 2-year and 5-year outcomes . The uncorrected concordance index was 0.76 ( 95 % CI , 0.72 to 0.80 ) for OS and 0.70 ( 95 % CI , 0.66 to 0.74 ) for PFS , and bias-corrected indices were similar . In the validation set , OS and PFS models were well calibrated , and OS and PFS were significantly different across tertiles of nomogram scores ( log-rank P = .003 ; < .001 ) . Conclusion The vali date d nomograms provided useful prediction of OS and PFS for patients with OPSCC treated with primary radiation-based therapy Purpose The aim of this prospect i ve case series study was to determine the prevalence of HPV-DNA , analyze the E6 mRNA expression , identify intra-type variation in the E6 oncogene in upper aerodigestive tract ( UADT ) squamous cell carcinoma ( SCC ) , and correlate the presence of HPV-DNA with several clinical parameters and outcome . Methods Frozen sample s of UADT-SCC were analyzed for the presence and characterization of HPV-DNA and RNA sequences by means of polymerase chain reaction ( PCR ) , reverse transcriptase-PCR , and direct sequencing of amplified products . Results HPV-DNA sequences were detected in 10 % of the tumors , all of which were typed as HPV-16 . Positivity for HPV-16 E6/E7 mRNA was observed in five of the eight HPV-positive tumors ( 62.5 % ) . The HPV-16 E6 L83V variant was present in five cases . Multivariate analysis identified a history of absence of smoking ( P = 0.009 ) as a predictor of HPV-positive tumor . No significant differences in overall and disease free survival curves were observed between patients with HPV-positive tumors and patients with tumors without detectable HPV-DNA . Conclusion Our findings support the etiological participation of HPV-16 in a subset of UADT-SCCs from patients lacking traditional risk factors . The potential prognostic significance of HPV-16 E6 L83V variant in HPV-16 positive UADT-SCCs should be more extensively investigated PURPOSE Although p16 protein expression , a surrogate marker of oncogenic human papillomavirus ( HPV ) infection , is recognized as a prognostic marker in oropharyngeal squamous cell carcinoma ( OPSCC ) , its prevalence and significance have not been well established in cancer of the oral cavity , hypopharynx , or larynx , collectively referred as non-OPSCC , where HPV infection is less common than in the oropharynx . PATIENTS AND METHODS p16 expression and high-risk HPV status in non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies were determined by immunohistochemistry ( IHC ) and in situ hybridization ( ISH ) . Hazard ratios from Cox models were expressed as positive or negative , stratified by trial , and adjusted for clinical characteristics . RESULTS p16 expression was positive in 14.1 % ( 12 of 85 ) , 24.2 % ( 23 of 95 ) , and 19.0 % ( 27 of 142 ) and HPV ISH was positive in 6.5 % ( six of 93 ) , 14.6 % ( 15 of 103 ) , and 6.9 % ( seven of 101 ) of non-OPSCCs from RTOG 0129 , 0234 , and 0522 studies , respectively . Hazard ratios for p16 expression were 0.63 ( 95 % CI , 0.42 to 0.95 ; P = .03 ) and 0.56 ( 95 % CI , 0.35 to 0.89 ; P = .01 ) for progression-free ( PFS ) and overall survival ( OS ) , respectively . Comparing OPSCC and non-OPSCC , patients with p16-positive OPSCC have better PFS and OS than patients with p16-positive non-OPSCC , but patients with p16-negative OPSCC and non-OPSCC have similar outcomes . CONCLUSION Similar to results in patients with OPSCC , patients with p16-negative non-OPSCC have worse outcomes than patients with p16-positive non-OPSCC , and HPV may also have a role in outcome in a subset of non-OPSCC . However , further development of a p16 IHC scoring system in non-OPSCC and improvement of HPV detection methods are warranted before broad application in the clinical setting PURPOSE To determine the prognostic importance of p16 and human papillomavirus ( HPV ) in patients with oropharyngeal cancer treated on a phase III concurrent chemoradiotherapy trial . PATIENTS AND METHODS Patients with stage III or IV head and neck squamous cell cancer were r and omly assigned to concurrent radiotherapy and cisplatin with or without tirapazamine . In this sub study , analyses were restricted to patients with oropharyngeal cancer . p16 was detected by immunohistochemistry , and HPV was detected by in situ hybridization and polymerase chain reaction . RESULTS Slides were available for p16 assay in 206 of 465 patients , of which 185 were eligible , and p16 and HPV were evaluable in 172 patients . One hundred six ( 57 % ) of 185 were p16-positive , and in patients evaluable for both p16 and HPV , 88 ( 86 % ) of 102 p16-positive patients were also HPV-positive . Patients who were p16-positive had lower T and higher N categories and better Eastern Cooperative Oncology Group ( ECOG ) performance status . p16-positive tumors compared with p16-negative tumors were associated with better 2-year overall survival ( 91 % v 74 % ; hazard ratio [ HR ] , 0.36 ; 95 % CI , 0.17 to 0.74 ; P = .004 ) and failure-free survival ( 87 % v 72 % ; HR , 0.39 ; 95 % CI , 0.20 to 0.74 ; P = .003 ) . p16 was a significant prognostic factor on multivariable analysis ( HR , 0.45 ; 95 % CI , 0.21 to 0.96 ; P = .04 ) . p16-positive patients had lower rates of locoregional failure and deaths due to other causes . There was a trend favoring the tirapazamine arm for improved locoregional control in p16-negative patients ( HR , 0.33 ; 95 % CI , 0.09 to 1.24 ; P = .13 ) . CONCLUSION HPV-associated oropharyngeal cancer is a distinct entity with a favorable prognosis compared with HPV-negative oropharyngeal cancer when treated with cisplatin-based chemoradiotherapy Background : Following chemo-radiotherapy ( CCRT ) for human papilloma virus positive ( HPV+ ) locally advanced head and neck cancer , patients frequently undergo unnecessary neck dissection ( ND ) and /or repeated biopsies for abnormal PET-CT , which causes significant morbidity . We assessed the role of circulating HPV DNA in identifying ‘ true ’ residual disease . Methods : We prospect ively recruited test ( n=55 ) and validation ( n=33 ) cohorts . HPV status was confirmed by E7 RT-PCR . We developed a novel amplicon-based next generation sequencing assay ( HPV16-detect ) to detect circulating HPV DNA . Circulating HPV DNA levels post-CCRT were correlated to disease response ( PET-CT ) . Results : In pre-CCRT plasma , HPV-detect demonstrated 100 % sensitivity and 93 % specificity , and 90 % sensitivity and 100 % specificity for the test ( 27 HPV+ ) and validation ( 20 HPV+ ) cohorts , respectively . Thirty-six out of 37 patients ( test and validation cohort ) with complete sample s-set had negative HPV-detect at end of treatment . Six patients underwent ND ( 3 ) and repeat primary site biopsies ( 3 ) for positive PET-CT but had no viable tumour . One patient had positive HPV-detect and positive PET-CT and liver biopsy , indicating 100 % agreement for HPV-detect and residual cancer . Conclusions : We demonstrate that HPV16-detect is a highly sensitive and specific test for identification of HPV DNA in plasma at diagnosis . HPV DNA post-treatment correlates with clinical response Output:	Conclusion This study evaluated the survival impact of HPV infection in LSCC patients . The OS of the HPV‐positive group was better than that of the HPV‐negative group in terms of short‐term survival .

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