id
stringlengths 4
8
| query
stringlengths 571
17.5k
| answer
stringlengths 12
3.68k
|
|---|---|---|
MS211700 | ***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: First through fourth grade rs from 22 suburban elementary schools were screened for cross- setting disruptive behavior as eligibility criteria for participation in a longitudinal secondary prevention study aim ed at reducing the risk for serious externalizing behavioral disorders . Three hundred nine subjects participated in either a multicomponent competence enhancement intervention ( MCEI ) or an information/attention control ( IAC ) condition over a 2-year period . Following baseline measurements , initial intervention effects were assessed at the end of intervention Year 1 , at the beginning of intervention Year 2 ( fall of the next school year ) , and at the end of intervention Year 2 . Multi source assessment s were not supportive of the efficacy of the MCEI over the IAC condition . Children in both groups rated themselves as improved over time in terms of increased adaptive skills and decreased school problems and internalizing symptoms . Teacher and parent ratings of externalizing behavior did not yield evidence of positive change , but teachers noted improved problem solving and observers noted a decrease in behavioral interference in both groups over time , possibly as a result of maturation An attributional intervention was design ed to reduce aggressive males ' tendency to attribute hostile intentions to peers following ambiguously caused peer provocations . African-American elementary school boys ( N = 101 ) , aggressive and nonaggressive , were r and omly assigned to the attributional intervention , an attention training program , or a no-treatment control group . Data were collected on subjects ' attributions about hypothetical and laboratory simulations of peer provocation , disciplinary referrals to the school office , and teacher ratings of aggressive behavior . Aggressive subjects in the attributional intervention were less likely to presume hostile intent by peers in hypothetical and laboratory simulations of ambiguous provocation . They were also less likely to endorse hostile retaliation on judgment measures and to engage in verbally hostile behaviors in the laboratory task . Further , intervention subjects were rated as less aggressive by their teachers following the treatment . Both the benefits of attributional change and its limitations in the African-American population are discussed From a school population of normal children third through fifth grade s ) , thirty children initially identified as “ angry”were r and omly assigned to either an affective imagery training group , an attention group , or a control group . The treatment group received three sessions of affective imagery in which they focused on physiological changes and on their thoughts associated with prior emotional experiences . Teachers recorded pre- , post- , and short term follow-up aggressive behaviors for all thirty children . Cognitive perceptions and attributions were recorded at the same three occasions on the Affect Question naire . Results suggested that , as a result of affective imagery training , angry children 's perceptions and cognitions shifted from “ angry ” towards “ sad , ” and there was a concomitant decrease in observed aggressive classroom behavior V and alism is a major problem facing educators and taxpayers alike . The present investigation analyzed how v and alism costs and student disruption were related to the implementation of a training and consultation package design ed to increase the reinforcing ambience of the school . A positive environment , it was posited , would displace previous events that may have set the occasion for v and alism , with cues to promote productive school performance . Eighteen elementary and junior high schools were involved over a 3-year period . Using a delayed treatment control design , treatment was delivered following either 4 or 13 months of baseline . During treatment , teams of school personnel attended training workshops in behavioral strategies for reducing v and alism and disruption by students in school . Each team also met regularly on its campus to plan and implement programs on a schoolwide basis . To demonstrate that reinforcing procedures were actually implemented and accompanied by change in student performance , these variables were periodically probed throughout the study . Project staff also provided consultation . V and alism costs decreased significantly ( p less than .05 ) more in treatment than control schools , with an average reduction of 78.5 % for all project schools . Rates of praise delivered by project teachers and other r and omly selected teachers in the school increased significantly ( p less than .05 ) , and rates of off-task behavior by students decreased significantly ( p less than .05 ) following treatment . The staff development model used in this study appeared to be both feasible and economical
Output:
| School-based violence prevention programs may produce reductions in aggressive and violent behaviors in children who already exhibit such behavior . |
MS211701 | ***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 AND METHODS Although a high prevalence of adjustment disorders and anticipatory nausea secondary to adjuvant chemotherapy ( CT ) has been reported , little has been done to develop strategies to prevent these problems . A double-blind , placebo-controlled study was therefore design ed to assess the usefulness of adding low-dose alprazolam ( 0.5 mg to 2 mg per day ) to a psychologic support program including progressive relaxation training design ed to prevent the aforementioned conditions . Fifty-seven women undergoing adjuvant CT for stage II primary breast cancer agreed to participate in the assessment , which was conducted at four time points : before starting CT , 6 weeks after CT , before the fourth CT , and after the fourth CT . The Hospital Anxiety and Depression Scale ( HADS ) , Montgomery and Asberg Depression Rating Scale ( MADRS ) , Hamilton Anxiety Scale ( HAS ) , Revised Symptom Checklist ( SCL-90-R ) , Morrow Assessment of Nausea and Emesis ( MANE ) , and World Health Organization ( WHO ) grading of acute and subacute toxicities were used to compare the alprazolam ( AA ) and placebo ( PA ) arms of the study . RESULTS At the second evaluation , the results showed a higher rate of anticipatory nausea ( 18 % v 0 % ) in the PA compared with the AA arm ( P = .038 ) . These differences were no more significant at each of the further assessment s. Significant differences were found for the intake of hypnotics at each assessment visit , with the rate of hypnotic users being significantly higher in the PA ( 19 % ) compared with the AA ( 0 % ) arm at the fourth assessment ( P < .05 ) . Anxiety and depression scores of self- and observer-report were similar in the two arms . A significant relationship was found between the development of anticipatory nausea and the self-report of anxiety and depression score measured by HADS at baseline . The average HADS total score at baseline was 15.33 ( SD = 6.56 ) for patients who developed anticipatory nausea and 11.23 ( SD = 6.67 ) for other patients . CONCLUSION The adjunct of alprazolam to a psychologic support program delays the occurrence of anticipatory nausea and controls sleeping problems secondary to adjunct CT . Although studies are needed to improve the efficacy reported here , physicians may already consider the use of alprazolam for cancer patients undergoing CT Fifty-four pediatric cancer patients were studied to determine the relative efficacy of two forms of behavioral intervention for reducing chemotherapy-related distress . Following baseline assessment , subjects were r and omly assigned to receive either hypnosis , non-hypnotic distraction/relaxation , or attention placebo ( control ) during the subsequent identical chemotherapy course . Observational and interview measures of anticipatory and postchemotherapy nausea , vomiting , distress , and functional disruption served as outcome data . Results indicated that treatment condition was the single best predictor of change from baseline to intervention , with children in the hypnosis group reporting the greatest reduction of both anticipatory and postchemotherapy symptoms . The cognitive distraction/relaxation intervention appeared to have a maintenance effect in which symptoms did not get much worse or much better , while children in the control group had symptoms that consistently became worse over time . Emetic potential of the chemotherapy and the prophylactic use of antiemetics each appeared to contribute to the overall severity of symptoms . While the efficacy of hypnosis in the management of chemotherapy distress is supported , the complexities of interacting biologic and psychologic factors are highlighted We examine whether overshadowing by salient stimuli is effective in reducing the ability of a certain environment ( the putative conditioned stimulus ) to evoke conditioned nausea in healthy humans that experience nausea-evoking rotation ( as the unconditioned stimulus , US ) in that environment . Twenty-four rotation-susceptible subjects ( 12 males , 12 females ) were r and omly assigned to receive either overshadowing by salient tasting beverages ( OS+ ) , or a control treatment ( a familiar beverage , water ; OS− ) prior to rotation on three consecutive days ( acquisition ) . To control for taste experiences , the alternative beverage was consumed 12 h later in the home environment ( OS+ : water , OS− : salient beverage ) . At Day 4 ( test ) , all subjects drank the familiar beverage ( water ) prior to rotation ( US ) . Rotation was st and ardized as 2 × 1-min rotation/day . Nausea was determined by a 7-item symptom scale measuring symptom number ( SN ) prior to ( anticipatory ) , immediately after , and 15 and 30 min after rotation and by the Nausea Profile ( NP ) question naire immediately after rotation . Cortisol and tumour necrosis factor (TNF)-α in saliva were sample d at the same time-points . SN and cortisol were also measured at home . Overshadowing reduced anticipatory ( conditioned ) SN . Post-rotation nausea ( i.e. the unconditioned response ) measured by the NP decreased within the OS+ group only . Anticipatory cortisol and TNF-α were not affected by overshadowing . Treatment × gender interactions manifested for post-rotation cortisol and TNF-α . Groups did not differ in SN and cortisol at home . Overshadowing is effective in reducing symptoms of anticipatory nausea and rotation-induced unconditioned nausea ; its effect on endocrine and immunological parameters is gender specific . Its application in alleviation of anticipatory nausea in cancer patients is considered The infusion of cytotoxic drugs in cancer patients is often accompanied by posttreatment nausea ( PN ) . In addition , patients complain about nausea prior to an infusion [ i.e. , anticipatory nausea ( AN ) ] . AN is mainly explained by classical conditioning , with the infusion as the unconditioned stimulus ( US ) and with the stimuli signaling the infusion as conditioned stimuli ( CS ) . Despite this conditioning etiology , a specifically derived therapy to attenuate the CS-US contingency is missing . The purpose of this study is to develop and to test an overshadowing procedure for prevention of AN , and also for the modification of PN intensity . Sixteen cancer patients were assigned to one of two groups : Overshadowing+ ( OV+ ) and Overshadowing- ( OV- ) . At the start of all infusions of two consecutive chemotherapy cycles A and B ( acquisition ) , OV+ subjects drank a saliently tasting beverage ( the overshadowing CS ) , whereas group OV- drank water . All patients received water in cycle C ( test ) . Self-reported symptoms and heart rates were recorded . As expected , in cycle C ( test ) , no patient of group OV+ showed AN , whereas two patients of group OV- developed AN . There was a tendency for a reduction of the intensity of PN , in terms of duration and latency after overshadowing , in cycle C : OV+ patients tended to show a shorter duration and a longer latency between end of infusion and PN onset . In OV- , there was a significantly larger heart rate deceleration in both measurement periods , in the anticipatory and the posttreatment measurement period . Data suggest to apply overshadowing for prevention of AN and modification of PN . Physiological markers of conditioned nausea are revealed . After its procedural implementation , the technique can be used in larger sample s now CONTEXT Demographic , personal , clinical , and behavioral factors predicting chemotherapy-induced nausea and vomiting ( CINV ) have been assessed in the past , but inconsistencies exist in the literature , studies have method ological shortcomings , and many risk factors have been examined in cross-sectional studies and univariate analyses . OBJECTIVES To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV , using a large and prospect ively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy . METHODS This was a multicountry , multisite prospect i ve study over three cycles of chemotherapy . Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited . Clinicians completed a case report form at or before the initial chemotherapy treatment , recording patient demographic and baseline clinical characteristics . Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience . Baseline patient data also included a history of nausea/vomiting ( yes/no ) , patient expectation of nausea ( 0 - 100 mm visual analogue scale [ VAS ] ) , prechemotherapy anxiety ( 0 - 100 mm VAS ) , and prechemotherapy nausea ( 0 - 100 mm VAS ) measured during the 24-hour period before chemotherapy initiation . RESULTS There were 991 evaluable patients with complete Cycle 1 data , 888 for Cycle 2 data , and 769 for Cycle 3 data . A complex picture of predictor variables was shown , with different contribution of variables to the acute , delayed , and overall phases of CINV . Key predictor variables included the use of antiemetics inconsistent with international guidelines , younger age , prechemotherapy nausea , and no CINV complete response in an earlier cycle ( all at P < 0.05 ) . Anxiety , history of nausea/vomiting , and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway . CONCLUSION The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV . Following evidence -based clinical antiemetic guidelines is of paramount importance , alongside treating patients with increased risk for CINV more aggressively , which both could lead to more optimal CINV management . These data can assist clinicians in making decisions about the antiemetic management of their patients Purpose Some patients experience nausea and /or vomiting ( NV ) before receipt of chemotherapy . Our objective was to evaluate the impact of prior chemotherapy-induced NV ( CINV ) on the incidence of anticipatory NV in later cycles . Methods This multicenter , prospect i ve non-interventional study enrolled chemotherapy-naïve adults scheduled to receive highly or moderately emetogenic chemotherapy ( HEC/MEC ) for cancer in six Asia Pacific countries , excluding those with emesis within 24 h before cycle 1 chemotherapy . On day 1 before chemotherapy , patients answered four questions regarding emesis in the past 24 h , nausea , expectation of post-chemotherapy nausea , and anxiety in the past 24 h , the latter three scored from 0–10 ( none – maximum ) . Multivariate logistic regression was used to assess the impact of prior CINV on anticipatory NV in cycles 2 and 3 . Results Five hundred ninety-eight patients ( 59 % female ) were evaluable in cycle 2 ( 49 % HEC , 51 % MEC ) . The incidence of anticipatory emesis was low before cycles 2 and 3 ( 1.5–2.3 % ) . The incidence of clinical ly significant anticipatory nausea ( score of ≥3 ) was 4.8 , 7.9 , and 8.3 % before cycles 1 , 2 , and 3 , respectively , with adjusted odds ratio ( OR ) , 3.95 ( 95 % confidence interval ( CI ) , 2.23–7.00 ; p < 0.001 ) for patients with clinical ly significant nausea in prior cycles , compared with none . The adjusted ORs for other anticipatory NV endpoints ranged from 4.54–4.74 for patients with prior CINV . The occurrence of clinical ly significant anxiety in the prior cycle also result ed in a significantly increased likelihood of anticipatory nausea . Conclusions These findings highlight the importance of preventing CINV in cycle 1 to reduce anticipatory NV in subsequent cycles Adequate control of side effects during medical treatment of cancer increases patient compliance and quality of life . Antiemetic drugs are not an effective treatment for the one in three cancer patients on chemotherapy who experience anticipatory nausea and vomiting ( ANV ) ; the behavioral treatment of systematic desensitization has been found effective for ANV when delivered by clinical psychologists . This study examined the effectiveness of systematic desensitization when delivered by medical personnel versus clinical psychologists . Seventy-two consecutive cancer patients with ANV were r and omly assigned to no-treatment control or to systematic desensitization from 5 behaviorally trained clinical psychologists , 6 clinical oncologists , or 10 oncology nurses . The treatment was found effective in reducing anticipatory nausea , anticipatory vomiting , posttreatment nausea , and posttreatment vomiting compared to control patients , with no significant differences in effectiveness found between clinical psychologists and oncology staff . Although medical personnel should not engage patients in psychotherapy or other interventions that can not be completed successfully , they can treat patients effectively with systematic desensitization and should be encouraged to learn and use this and other behavioral intervention techniques to benefit total patient care This study was design ed to determine ( a ) the relationship of coping style to cancer chemotherapy side efects and ( b ) whether coping style moderated the impact of a relaxation intervention on anxiety , depression , and nausea associated with chemotherapy . Forty-eight cancer patients were assigned r and omly to receive either progressive muscle relaxation training before chemotherapy ( experimental group ) or st and ard care ( control group ) . Spearman correlations indicated that a “ blunting ” or distraction-oriented coping style was associated with less anticipatory anxiety , less depression , and less nausea during and after chemotherapy . Spearman correlations also indicated that a “ monitoring ” or information-gathering coping style was associated with more anticipatory anxiety , and more nausea before and during chemotherapy . Although there was a signijicant effect of the relaxation intervention on posttreatment nausea , there were no other between-group differences . The results did suggest , however , that relaxation was efective in reducing anticipatory anxiety among “ blunters , ” but not “ monitors , ” perhaps because relaxation is a distraction strategy and therefore is consistent with a blunting coping style . The effects of coping and
Output:
| The guideline panel continues to recommend that anticipatory nausea and vomiting are best prevented through optimization of acute and delayed phase chemotherapy-induced nausea and vomiting control .
Benzodiazepines and behavioral therapies , in particular progressive muscle relaxation training , systematic desensitization and hypnosis , continue to be recommended for the treatment of anticipatory nausea and vomiting . |
MS211702 | ***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 highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures Background Recent studies suggest that some of the clinical effectiveness of soy or daidzein , which is a type of isoflavone , may be attributed to a person ’s ability to produce equol from daidzein . Equol , which is a metabolite of one of the major soybean isoflavones called daidzein , is produced in the gastrointestinal tract by certain intestinal microbiota where present . Habitual dietary patterns may alter the intestinal bacterial profile , and influence the metabolism of isoflavones and the production of equol . Fructooligosaccharides ( FOS ) have a prebiotic activity as well as being a dietary fibre . The purpose of the present study was to determine whether FOS supplementation increases equol production in equol producers and stimulates equol production in equol non-producers in Japanese postmenopausal women . Methods A soy challenge was used to assess equol-producer status prior to the start of the study in healthy postmenopausal Japanese women . The study involved 4 separate groups in r and omised crossover design . First , subjects were classified as equol producers ( n = 25 ) or non-producers ( n = 18 ) , and then they were r and omly assigned to the FOS or control group . All subjects received a daily dose of 37 mg isoflavone conjugates in the capsule ( 21 mg aglycone form ) and either FOS ( 5g/day ) or sucrose as control , in a r and omised crossover study design . Equol -production was assessed by testing the serum and urine before and after the 2-week supplementation period . Results The analyses were conducted on 34 subjects completed the study , 21 ( 61.8 % ) were classified as equol producers , and 13 ( 38.2 % ) as non-producers . Significant differences were observed in the interaction effect of time × equol state after 1 week of intervention ( p = 0.006 ) . However there were no effects after 2 weeks of intervention ( p = 0.516 ) . Finally , in both equol producers and non-producers , FOS supplementation did not affect the serum equol concentration or the urinary equol to daidzein concentration ratios . Conclusions We have reported that FOS intervention ( 5 g/day for 2 weeks ) does not significantly modulate the capacity of intestinal microbiota to produce equol in postmenopausal Japanese women , in either equol producers or non-producers in this pilot study . Further larger investigations that explore the roles of specific intestinal microbiota in equol production will enable the establishment of dietary conditions that are required to enhance equol production Long-term dietary intake influences the structure and activity of the trillions of microorganisms residing in the human gut , but it remains unclear how rapidly and reproducibly the human gut microbiome responds to short-term macronutrient change . Here we show that the short-term consumption of diets composed entirely of animal or plant products alters microbial community structure and overwhelms inter-individual differences in microbial gene expression . The animal-based diet increased the abundance of bile-tolerant microorganisms ( Alistipes , Bilophila and Bacteroides ) and decreased the levels of Firmicutes that metabolize dietary plant polysaccharides ( Roseburia , Eubacterium rectale and Ruminococcus bromii ) . Microbial activity mirrored differences between herbivorous and carnivorous mammals , reflecting trade-offs between carbohydrate and protein fermentation . Foodborne microbes from both diets transiently colonized the gut , including bacteria , fungi and even viruses . Finally , increases in the abundance and activity of Bilophila wadsworthia on the animal-based diet support a link between dietary fat , bile acids and the outgrowth of microorganisms capable of triggering inflammatory bowel disease . In concert , these results demonstrate that the gut microbiome can rapidly respond to altered diet , potentially facilitating the diversity of human dietary lifestyles OBJECTIVES : The prebiotic potential of NUTRIOSE ® – a sugar-free , digestion-resistant dextrin — was evaluated in two r and omized , placebo-controlled trials that included 48 and 40 healthy volunteers , respectively . METHODS : In study 1 , the effect on colonic bacteria of NUTRIOSE ® 10 , 15 or 20 g/day administered for 14 days was examined ; in study 2 , gut microbial changes in response to NUTRIOSE ® 8 g/day for 14 days were monitored using real-time polymerase chain reaction analysis . RESULTS : NUTRIOSE ® increased proliferation of Bacteroides and inhibited Clostridum perfringens in both studies , increased β-glucosidase activity ( at 10 and 15 g/day ) and decreased colonic pH ( at 20 g/day ) . The increase in short-chain fatty acid production with NUTRIOSE ® consumption was not statistically significant . There were no indications of gastrointestinal intolerance at any dose . CONCLUSIONS : According to commonly accepted definitions , NUTRIOSE ® is a prebiotic soluble fibre that provides a beneficial effect on colonic ecology while preserving digestive comfort Dietary phytoestrogens , such as isoflavones , are used as food additives to prevent menopause-related disorders . In addition to other factors , their bioavailability strongly depends on the activity of intestinal bacteria but the underlying interactions remain poorly understood . A r and omized , double-blind , placebo-controlled study was undertaken with 39 postmenopausal women to characterize changes in the dominant microbial communities of the intestinal tract after 2 mo of isoflavone supplementation with and without pro- or prebiotic . The diversity and composition of the dominant microbiota were analyzed by temporal temperature-gradient gel electrophoresis ( TTGE ) and fluorescent in situ hybridization . Isoflavones alone stimulated dominant microorganisms of the Clostridium coccoides-Eubacterium rectale cluster , Lactobacillus-Enterococcus group , Faecalibacterium prausnitzii subgroup , and Bifidobacterium genus . The stimulation of the Clostridium coccoides-Eubacterium rectale cluster depended on the women 's equol excretion and was transient , with the exception of a prolonged bifidogenic effect . Lasting changes in the diversity of the dominant species were also observed . The probiotic strain supplied could be detected by TTGE during its passage through the intestinal tract , and ingestion of fructooligosaccharides triggered a marked and specific bifidogenic effect . In conclusion , this is the first human study that shows changes in the diversity and composition of dominant bacterial communities in response to dietary supplementation with hormone-related compounds combined with functional foods BACKGROUND Bacterial intestinal glucosidases exert an important role in isoflavone absorption . Insoluble dietary fibers such as inulin may stimulate the growth of these bacteria in the colon and , hence , stimulate the absorption of these substances in subjects who may need isoflavone supplementation . OBJECTIVE The objective was to assess the influence of inulin on plasma isoflavone concentrations after intake of soybean isoflavones in healthy postmenopausal women . DESIGN Twelve healthy postmenopausal women participated in a r and omized , double-blind , crossover study . They consumed 40 mg of a conjugated form of soybean isoflavones ( 6 mg daidzein and 18 mg genistein as free form ) with or without 3.66 g inulin twice daily in two 21-d experimental phases . Blood sample s were collected 0 , 1 , 2 , 3 , 4 , 6 , 10 , 12 , and 24 h after intake of isoflavones with breakfast and dinner at the end of each 21-d experimental phase . Plasma concentrations of isoflavones were assessed by HPLC with an electrochemical detector . RESULTS Plasma 24-h areas under the curve indicated that the intake of soybean isoflavones with inulin for 21 d was followed by higher plasma concentrations of daidzein and genistein ( 38 % and 91 % , respectively ) compared with the formulation without inulin . Furthermore , the time for the maximum concentration of daidzein and genistein appeared to be lower after the 21-d intake of soybean isoflavones , with or without inulin . However , the time for the maximum concentration of daidzein and genistein after supplementation with the inulin-containing formulation on day 21 was not significantly different from that after supplementation with the formulation without inulin . CONCLUSIONS Inulin may increase the apparent plasma concentrations of the soybean isoflavones daidzein and genistein in postmenopausal women . The higher plasma concentrations of the 2 isoflavones suggests that the absorption of each was facilitated by the presence of inulin Wheat bran extract ( WBE ) is a food- grade soluble fibre preparation that is highly enriched in arabinoxylan oligosaccharides . In this placebo-controlled cross-over human intervention trial , tolerance and effects on colonic protein and carbohydrate fermentation were studied . After a 1-week run-in period , sixty-three healthy adult volunteers consumed 3 , 10 and 0 g WBE/d for 3 weeks in a r and om order , with 2 weeks ' washout between each treatment period . Fasting blood sample s were collected at the end of the run-in period and at the end of each treatment period for analysis of haematological and clinical chemistry parameters . Additionally , subjects collected a stool sample for analysis of microbiota , SCFA and pH. A urine sample , collected over 48 h , was used for analysis of p-cresol and phenol content . Finally , the subjects completed question naires scoring occurrence frequency and distress severity of eighteen gastrointestinal symptoms . Urinary p-cresol excretion was significantly decreased after WBE consumption at 10 g/d . Faecal bifidobacteria levels were significantly increased after daily intake of 10 g WBE . Additionally , WBE intake at 10 g/d increased faecal SCFA concentrations and lowered faecal pH , indicating increased colonic fermentation of WBE into desired metabolites . At 10 g/d , WBE caused a mild increase in flatulence occurrence frequency and distress severity and a tendency for a mild decrease in constipation occurrence frequency . In conclusion , WBE is well tolerated at doses up to 10 g/d in healthy adults volunteers . Intake of 10 g WBE/d exerts beneficial effects on gut health parameters BACKGROUND A major portion of the catechins in green tea is not absorbed in the small intestine . Bacteria in the colon convert nonabsorbed catechins into simpler phenolic compounds , which may also be absorbed . During the production of black tea , most catechins are polymerized to complex molecules called thearubigins . Little is known about the microbial degradation of these complex polyphenols , but hippuric acid has been identified as a major excretion product associated with black tea consumption . OBJECTIVE To investigate whether green tea and black tea have the same metabolic fate in humans . DESIGN Seventeen healthy male volunteers were studied with a r and omized , full-crossover design . Each intervention period lasted 4 d , ie , a 2-d run-in period with a low-polyphenol diet followed by a 2-d treatment period . Volunteers consumed a daily dose of 6 g green tea solids , 6 g black tea solids , or 360 mg caffeine . Intervention periods were separated by a 10-d washout period . Twenty-four-hour urine sample s were collected during the second day of each treatment period . Hipp
Output:
| Results Studies show that the IM plays a key role in the metabolism of the substrates studied .
However , with the exception of studies focusing on fibre and polyphenols , there have been relatively few recent human studies specifically evaluating microbial metabolism .
Nevertheless , it appears that the IM plays a role in energy homeostasis and that protein microbial breakdown and fermentation produced ammonia , amines , phenols and branch chain fatty acids , and a greater diversity in the microbes present .
Few recent studies appear to have evaluated the effect of the IM composition and metabolism per se in relation with digestible dietary carbohydrate or fat in humans .
Intakes of RS and prebiotics altered levels of specific taxa that selectively metabolised specific prebiotic/carbohydrate-type substances and levels of bifidobacteria and lactobacilli were observed to increase .
In the polyphenol-related studies , a large amount of inter-individual variation was observed in the microbial metabolism and absorption of certain polyphenols .
Conclusions The systematic review demonstrates that the IM plays a major role in the breakdown and transformation of the dietary substrates examined .
Current evidence suggests that more detailed knowledge of the metabolic activities and interactions of the IM hold considerable promise in relation with host health |
MS211703 | ***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 Lanthanum carbonate ( LC ) , an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease ( CKD ) on dialysis . Recently , the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved . METHODS A multicenter , r and omized , double-blind , placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis . After a 4-week run-in period , 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were r and omized ( 2 : 1 ) to receive LC or placebo ( 88 vs. 55 ) for 8 weeks ; 119 subjects completed the study ( 76 vs. 43 ) . The starting LC dose was 750 mg/day , which was then up-titrated to 2,250 mg/day as needed while tolerated . Primary efficacy analysis was performed on the intent-to-treat ( ITT ) population of 141 patients ( 86 vs. 55 ) . RESULTS LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment ( difference , 0.97 ( 95 % CI : 0.58 , 1.37 ) mg/ dL ; p < 0.0001 ) . The cumulative proportion of subjects with controlled phosphate levels ≤ 4.6 mg/dL was higher in the LC group than the placebo group ( 59.56 % vs. 10.46 % ) . LC caused significantly greater reductions in serum Ca × P product and urinary phosphate excretion compared with placebo . The safety profile of LC was similar to that of placebo . CONCLUSIONS This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients BACKGROUND JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient . METHODS In this Phase 3 , multicenter , r and omized , open-label , parallel-group study , we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis . A total of 230 patients with a serum phosphate ≥1.97 and < 3.23 mmol/L were r and omized to JTT-751 ( dose adjusted between 1.5 and 6.0 g/day ) or sevelamer hydrochloride ( dose adjusted between 3.0 and 9.0 g/day ) for 12 weeks . The primary outcome was change in serum phosphate from baseline to end of treatment . Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone ( PTH ) . The changes in ferritin , transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes . RESULTS Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group , establishing non-inferiority of JTT-751 compared with sevelamer ( least squares mean , -0.03 mmol/L ; 95 % confidence interval , -0.13 to 0.07 mmol/L ) . Corrected serum calcium increased and PTH decreased from baseline within both groups ; changes between groups were similar . Gastrointestinal disorders were the most common adverse events in both groups ; the incidence of diarrhea was higher in the JTT-751 group , while constipation occurred frequently in the sevelamer group . Treatment with JTT-751 result ed in significant relative increases in serum ferritin and transferrin saturation . CONCLUSIONS Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia . Differential adverse effects were observed ; biochemical markers of iron status increased in patients treated with JTT-751 . TRIAL REGISTRATION NUMBER CTI-111433 ( The Japan Pharmaceutical Information Center at : http//www . clinical trials.jp ) . Date of registration : 7 March 2011 Background Secondary hyperparathyroidism ( SHPTH ) is present in many patients with end-stage renal disease ( ESRD ) and has been linked to uremic bone disease . Parathyroid hormone ( PTH ) levels are affected by calcium , vitamin D , and phosphorus . Recent data suggests that serum magnesium may also modulate PTH levels . Objective The aim of this retrospective study was to investigate the impact of different calcium ( Ca ) and magnesium ( Mg ) concentrations of dialysis solutions on serum Mg and serum PTH levels in peritoneal dialysis ( PD ) patients . Patients and methods Two groups of PD patients -group A ( n = 17 ) on “ st and ard ” Ca and Mg dialysis solution ( SCa – MgD ) ( Ca : 1.62 mmol/l , Mg : 0.75 mmol/l and Lactate 35 mmol/l ) , and group B ( n = 29 ) on “ low ” Ca and Mg dialysis solution ( LCa – MgD ) ( Ca : 1.25 mmol/l , Mg : 0.25 mmol/l and Lactate 40 mmol/l ) , on PD for more than 6 months , were studied . Calcium carbonate ( CaCO3 ) was used as the phosphate ( P ) binder in 87 % ( 40/46 ) of the patients . Biochemical parameters were evaluated every 1–2 months over 6 months and the mean values were computed . Results No significant differences were found between the two groups in all parameters except for serum Mg and PTH . Serum Mg was higher in SCa – MgD group compared to those in the LCa – MgD group ( 1.05 ± 0.19 vs 0.90 ± 0.23 mmol/l , respectively ) and serum PTH was higher in LCa – MgD group compared to those in SCa – MgD group ( 72.3 ± 64.2 vs 31.1 ± 39.0 pmol/l , respectively ) even though serum Ca was not different . There was a statistically significant inverse correlation between serum Mg and PTH levels ( r = −0.357 , p < 0.05 ) . ConclusionS erum Mg is lower and serum PTH higher in patients dialyzed with lower Mg concentration dialysis solution compared to those with higher Mg concentration dialysis solution . Our study confirms previous reports that serum Mg may have a suppressive role on PTH synthesis and /or secretion , and thus may play a role in pathogenesis of adynamic bone disease that often develops in patients on chronic PD with high calcium and high magnesium concentrations 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 Parathyroid hormone ( PTH ) is a cardinal factor in the pathogenesis of bone disease in the dialysis population . The spectrum of renal osteodystrophy has been reported to have changed during the past years , and adynamic bone disease has emerged as the most common bone disorder in these patients . Continuous ambulatory peritoneal dialysis ( CAPD ) is considered a risk factor for the development of this condition , and furthermore , the adynamic bone lesion is associated with a state of relative hypoparathyroidism ( hypo-PTH ) . Calcium , vitamin D , and phosphorus play a key role in the control of parathyroid gl and function in uremic patients . However , magnesium may also be able to modulate PTH secretion in a way similar to calcium . Objective The aims of this study were ( 1 ) to analyze the serum Mg concentration in a large group of CAPD patients , ( 2 ) to study the relationship between serum Mg and PTH levels , and ( 3 ) to investigate whether this relationship is independent of other factors , such as calcium , phosphorus , and calcitriol , that regulate parathyroid function . Patients and Methods We studied 51 stable patients , aged 23 – 77 years , under maintenance CAPD for more than 6 months ( range 8 – 48 months ) . Calcium carbonate was used as a phosphate binder in all patients , and 9 subjects also received aluminum hydroxide . No patient had been previously treated with vitamin D. Biochemical parameters were prospect ively evaluated over 6 months , and the mean values were computed . Results The mean serum Mg was 1.08 ± 0.19 mmol/L , and hypermagnesemia , defined as a Mg level higher than 1.01 mmol/L , was found in 30 patients ( 59 % ) . Thirty-one subjects ( 60 % ) had an intact PTH ( iPTH ) level lower than 120 pg/mL and were diagnosed as having relative hypo-PTH . Except for the values of iPTH and alkaline phosphatase , the only difference between the two groups was the serum Mg concentration , which was significantly higher in patients with hypo-PTH ( 1.16 ± 0.15 mmol/L vs 0.91 ± 0.14 mmol/L ; p < 0.001 ) . Furthermore , iPTH levels were lower in patients with hypermagnesemia than in subjects with normal serum Mg ( 69 ± 49 pg/mL vs 190 ± 89 pg/mL , p < 0.001 ) . There was a significant correlation between serum Mg and PTH levels ( r = –0.70 , p < 0.01 ) . After controlling for the effect of other variables by partial correlation analysis , a significant positive association between P and PTH ( r = 0.25 , p < 0.05 ) , and a negative relationship between Mg and PTH ( r = –0.57 , p < 0.001 ) were evident . A forward stepwise multiple regression analysis showed that only P and Mg predicted PTH values ( multiple r = 0.59 , p < 0.001 ) . Conclusions Hypermagnesemia and hypoparathyroidism are frequent in CAPD patients . There is a significant inverse relationship between serum Mg concentration and iPTH levels . Furthermore , this association is independent of the most important factors regulating parathyroid gl and function ( calcium , phosphorus , and calcitriol ) . These results suggest that hypermagnesemia may have a suppressive effect on PTH synthesis and /or secretion . Therefore , elevated serum Mg levels may play a role in the pathogenesis of adynamic bone disease Background High levels of circulating fibroblast growth factor 23 ( FGF23 ) are associated with chronic kidney disease ( CKD ) progression and high mortality . In the Phosphate Reduction Evaluation of FGF23 in Early CKD Treatment ( PREFECT ) study , we assessed the effect of reducing intestinal phosphate absorption using lanthanum carbonate on FGF23 levels in norm
Output:
| Sevelamer , lanthanum , calcium , iron , diet and combinations of active treatments ( calcium or sevelamer or lanthanum and combination of calcium and sevelamer ) result ed in significantly lower serum phosphate as compared to placebo ( moderate to very low quality of evidence ) .
We found no statistically significant differences between active treatment categories in lowering serum phosphate .
Sevelamer , lanthanum and diet result ed in lower serum calcium compared to calcium ( moderate quality evidence for lanthanum and diet ; low quality evidence for Sevelamer ) .
Iron , sevelamer and calcium yielded lower parathyroid hormone levels as compared to lanthanum .
Meta-regression analyses did not yield a statistically significant association between treatment effect and trial duration .
DISCUSSION / CONCLUSIONS We found few differences between treatments in impact on phosphate and differences in parathyroid hormone .
Relative to calcium , sevelamer , lanthanum and diet showed significant reduction in serum calcium from baseline . |
MS211704 | ***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: Moderate-intensity endurance exercise training improves vascular endothelial vasomotor function ; however , the impact of high-intensity exercise training has been equivocal . Thus , the effect of the physiological stress of the exercise remains poorly understood . Furthermore , enhanced vascular repair mediated by circulating progenitor cells may also be improved . To address whether the physiological stress of exercise training is an important factor contributing to these adaptations , 20 healthy participants trained for 6 weeks . Training involved either moderate ( MSIT ; n= 9 ) or heavy metabolic stress ( HSIT ; n= 11 ) interval exercise training programmes matched for total work and duration of exercise . Before and after training , flow-mediated dilatation , low-flow-mediated constriction and total vessel reactivity were measured at the brachial artery using Doppler ultrasound . Circulating progenitor cells ( CD34 + , CD133 + and CD309/KDR+ ) were measured by flow cytometry ( means ± SD ) . Relative ( MSIT pre- 5.5 ± 3.4 versus post-training 6.6 ± 2.5 % ; HSIT pre- 6.6 ± 4.1 versus post-training 7.0 ± 3.4 % , P= 0.33 ) and normalized ( P= 0.16 ) flow-mediated dilatation did not increase with either training programme . However , low-flow-mediated constriction was greater after training in both groups ( MSIT pre- −0.5 ± 3.2 versus post-training −1.9 ± 3.1 % ; HSIT pre- −1.0 ± 1.7 versus post-training −2.9 ± 3.0 % , P= 0.04 ) and contributed to greater total vessel reactivity ( MSIT pre- 7.4 ± 3.3 versus post-training 10.1 ± 3.7 % ; HSIT pre- 10.9 ± 5.9 versus post-training 12.7 ± 6.2 % , P= 0.01 ) . Peak reactive hyperaemia and the area under the shear rate curve were not different between groups , either before or after training . Although circulating progenitor cell numbers increased following heavy-intensity interval exercise training , variability was great amongst participants [ MSIT pre- 16 ± 18 versus post-training 14 ± 12 cells ( ml whole blood)−1 ; HSIT pre- 8 ± 6 versus post-training 19 ± 23 cells ( ml whole blood)−1 , P= 0.50 ] . Overall , vasoconstrictor function may be augmented by moderate- and heavy-intensity interval exercise training in young adults . However , circulating progenitor cell numbers were not increased , suggesting that these cells are not likely to be upregulated as a result of training OBJECTIVES Our goal was to test feasibility and efficacy of a dietary intervention based on daily intake of flavanol-containing cocoa for improving vascular function of medicated diabetic patients . BACKGROUND Even in fully medicated diabetic patients , overall prognosis is unfavorable due to deteriorated cardiovascular function . Based on epidemiological data , diets rich in flavanols are associated with a reduced cardiovascular risk . METHODS In a feasibility study with 10 diabetic patients , we assessed vascular function as flow-mediated dilation ( FMD ) of the brachial artery , plasma levels of flavanol metabolites , and tolerability after an acute , single-dose ingestion of cocoa , containing increasing concentrations of flavanols ( 75 , 371 , and 963 mg ) . In a subsequent efficacy study , changes in vascular function in 41 medicated diabetic patients were assessed after a 30-day , thrice-daily dietary intervention with either flavanol-rich cocoa ( 321 mg flavanols per dose ) or a nutrient-matched control ( 25 mg flavanols per dose ) . Both studies were undertaken in a r and omized , double-masked fashion . Primary and secondary outcome measures included changes in FMD and plasma flavanol metabolites , respectively . RESULTS A single ingestion of flavanol-containing cocoa was dose-dependently associated with significant acute increases in circulating flavanols and FMD ( at 2 h : from 3.7 + /- 0.2 % to 5.5 + /- 0.4 % , p < 0.001 ) . A 30-day , thrice-daily consumption of flavanol-containing cocoa increased baseline FMD by 30 % ( p < 0.0001 ) , while acute increases of FMD upon ingestion of flavanol-containing cocoa continued to be manifest throughout the study . Treatment was well tolerated without evidence of tachyphylaxia . Endothelium-independent responses , blood pressure , heart rate , and glycemic control were unaffected . CONCLUSIONS Diets rich in flavanols reverse vascular dysfunction in diabetes , highlighting therapeutic potentials in cardiovascular disease An inverse relation exists between intake of flavonoid-rich foods , such as cocoa , and cardiovascular-related mortality . Favorable effects of flavonoids on the endothelium may underlie these associations . We performed a r and omized , double-blind , placebo-controlled study to test the hypothesis that acute cocoa ingestion dose dependently increases endothelium-dependent vasodilation , as measured by an increase in brachial artery flow-mediated dilation ( FMD ) , in healthy older adults . Measurements were obtained before ( preingestion ) and after ( 1- and 2-h postingestion ) ingestion of 0 ( placebo ) , 2 , 5 , 13 , and 26 g of cocoa in 23 adults ( 63 ± 2 yr old , mean ± SE ) . Changes in brachial artery FMD 1- and 2-h postingestion compared with preingestion were used to determine the effects of cocoa . FMD was unchanged 1 ( Δ-0.3 ± 0.2%)- and 2-h ( Δ0.1 ± 0.1 % ) after placebo ( 0 g cocoa ) . In contrast , FMD increased both 1-h postingestion ( 2 g cocoa Δ0.0 ± 0.2 % , 5 g cocoa Δ0.8 ± 0.3 % , 13 g cocoa Δ1.0 ± 0.3 % , and 26 g cocoa Δ1.6 ± 0.3 % : P < 0.05 compared with placebo for 5 , 13 , and 26 g cocoa ) and 2-h postingestion ( 2 g cocoa Δ0.5 ± 0.3 % , 5 g cocoa Δ1.0 ± 0.3 % , 13 g cocoa Δ1.4 ± 0.2 % , and 26 g cocoa Δ2.5 ± 0.4 % : P < 0.05 compared with placebo for 5 , 13 , and 26 g cocoa ) on the other study days . A serum marker of cocoa ingestion ( total epicatechin ) correlated with increased FMD 1- and 2-h postingestion ( r = 0.44 - 0.48 ; both P < 0.05 ) . Collectively , these results indicate that acute cocoa ingestion dose dependently increases brachial artery FMD in healthy older humans . These responses may help to explain associations between flavonoid intake and cardiovascular-related mortality in humans
Output:
| Red blood cell velocity in arterioles and blood flow in the artery were significantly increased 5 min after the administration of 10 mg/kg flavan-3-ols compared with distilled water treatment .
The number of capillaries recruited in the cremaster muscle was also significantly increased 15 min after treatment .
Microscopic observation confirmed that increased shear stress on endothelial cells was maintained during the measurement period .
The mean arterial blood pressure and heart rate were also significantly elevated soon after administration and returned to baseline before the end of the observation period .
Plasma nitrate and nitrite levels , and NO phosphorylation of aortic tissue were significantly increased at 60 min after administration of flavan-3-ols .
According to these results , a single oral dose of flavan-3-ols elevates blood pressure and flow transiently , and these effects induce NO production through increased shear stress on endothelial cells |
MS211705 | ***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 investigated the associations between dietary patterns and risk of prostate cancer in the Health Professionals Follow-up Study . Between 1986 and 2000 , 3,002 incident prostate cancer cases were identified in our cohort . Using factor analysis , two major dietary patterns were identified , a prudent and a western dietary pattern . Dietary patterns were not appreciably associated with risk of total prostate cancer . For the highest versus the lowest quintiles , the multivariable relative risk ( RR ) for the prudent pattern was 0.94 [ 95 % confidence interval ( CI ) , 0.83 - 1.06 ] , and for the western pattern , the multivariable RR was 1.03 ( 95 % CI , 0.92 - 1.17 ) . Neither were these associated with risk of advanced prostate cancer [ highest versus lowest quintile , prudent pattern ( RR , 1.01 ; 95 % CI , 0.68 - 1.49 ) ; western pattern ( RR , 1.13 ; 95 % CI , 0.77 - 1.67 ) ] . Higher western pattern scores were suggestively associated with a greater risk of advanced prostate cancer among older men [ highest versus lowest quintile ( RR , 1.35 ; 95 % CI , 0.97 - 1.90 ) ] , but not after adding processed meat to the model [ highest versus lowest quintile ( RR , 1.11 ; 95 % CI , 0.75 - 1.65 ) ] . We did not find any evidence for a protective association between prudent pattern and risk of prostate cancer . The lack of association between a western dietary pattern as identified by factor analysis in our cohort and prostate cancer risk suggests that dietary risk factors for prostate cancer are likely to differ from those for other conditions , such as cardiovascular disease and type 2 diabetes , that have been associated with a western dietary pattern in this cohort . ( Cancer Epidemiol Biomarkers Prev 2006;15(1):167–71 BACKGROUND Multivitamin supplements are used by millions of Americans because of their potential health benefits , but the relationship between multivitamin use and prostate cancer is unclear . METHODS We prospect ively investigated the association between multivitamin use and risk of prostate cancer ( localized , advanced , and fatal ) in 295,344 men enrolled in the National Institutes of Health (NIH)-AARP Diet and Health Study who were cancer free at enrollment in 1995 and 1996 . During 5 years of follow-up , 10,241 participants were diagnosed with incident prostate cancer , including 8765 localized and 1476 advanced cancers . In a separate mortality analysis with 6 years of follow-up , 179 cases of fatal prostate cancer were ascertained . Multivitamin use was assessed at baseline as part of a self-administered , mailed food-frequency question naire . Relative risks ( RRs ) and 95 % confidence intervals ( CIs ) were calculated by use of Cox proportional hazards regression , adjusted for established or suspected prostate cancer risk factors . RESULTS No association was observed between multivitamin use and risk of localized prostate cancer . However , we found an increased risk of advanced and fatal prostate cancers ( RR = 1.32 , 95 % CI = 1.04 to 1.67 and RR = 1.98 , 95 % CI = 1.07 to 3.66 , respectively ) among men reporting excessive use of multivitamins ( more than seven times per week ) when compared with never users . The incidence rates per 100,000 person-years for advanced and fatal prostate cancers for those who took a multivitamin more than seven times per week were 143.8 and 18.9 , respectively , compared with 113.4 and 11.4 in never users . The positive associations with excessive multivitamin use were strongest in men with a family history of prostate cancer or who took individual micronutrient supplements , including selenium , beta-carotene , or zinc . CONCLUSION These results suggest that regular multivitamin use is not associated with the risk of early or localized prostate cancer . The possibility that men taking high levels of multivitamins along with other supplements have increased risk of advanced and fatal prostate cancers is of concern and merits further evaluation BACKGROUND Anticarcinogenic activities of vitamin K have been observed in various cancer cell lines , including prostate cancer cells . Epidemiologic studies linking dietary intake of vitamin K with the development of prostate cancer have not yet been conducted . OBJECTIVE We evaluated the association between dietary intake of phylloquinone ( vitamin K1 ) and menaquinones ( vitamin K2 ) and total and advanced prostate cancer in the Heidelberg cohort of the European Prospect i ve Investigation into Cancer and Nutrition . DESIGN At baseline , habitual dietary intake was assessed by means of a food-frequency question naire . Dietary intake of phylloquinone and menaquinones ( MK-4 - 14 ) was estimated by using previously published HPLC-based food-content data . Multivariate-adjusted relative risks of total and advanced prostate cancer in relation to intakes of phylloquinone and menaquinones were calculated in 11 319 men by means of Cox proportional hazards regression . RESULTS During a mean follow-up time of 8.6 y , 268 incident cases of prostate cancer , including 113 advanced cases , were identified . We observed a nonsignificant inverse association between total prostate cancer and total menaquinone intake [ multivariate relative risk ( highest compared with lowest quartile ) : 0.65 ; 95 % CI : 0.39 , 1.06 ] . The association was stronger for advanced prostate cancer ( 0.37 ; 0.16 , 0.88 ; P for trend = 0.03 ) . Menaquinones from dairy products had a stronger inverse association with advanced prostate cancer than did menaquinones from meat . Phylloquinone intake was unrelated to prostate cancer incidence ( 1.02 ; 0.70 , 1.48 ) . CONCLUSIONS Our results suggest an inverse association between the intake of menaquinones , but not that of phylloquinone , and prostate cancer . Further studies of dietary vitamin K and prostate cancer are warranted We examined consumption of animal foods , protein and calcium in relation to risk of prostate cancer among 142 251 men in the European Prospect i ve Investigation into Cancer and Nutrition . Associations were examined using Cox regression , stratified by recruitment centre and adjusted for height , weight , education , marital status and energy intake . After an average of 8.7 years of follow-up , there were 2727 incident cases of prostate cancer , of which 1131 were known to be localised and 541 advanced-stage disease . A high intake of dairy protein was associated with an increased risk , with a hazard ratio for the top versus the bottom fifth of intake of 1.22 ( 95 % confidence interval ( CI ) : 1.07–1.41 , Ptrend=0.02 ) . After calibration to allow for measurement error , we estimated that a 35-g day−1 increase in consumption of dairy protein was associated with an increase in the risk of prostate cancer of 32 % ( 95 % CI : 1–72 % , Ptrend=0.04 ) . Calcium from dairy products was also positively associated with risk , but not calcium from other foods . The results support the hypothesis that a high intake of protein or calcium from dairy products may increase the risk for prostate cancer The incidence of prostate cancer is much lower in Asian than Western population s. Given that environmental factors such as dietary habits may play a major role in the causation of prostate cancer and the high consumption of green tea in Asian population s , this low incidence may be partly due to the effects of green tea . The JPHC Study ( Japan Public Health Center-based Prospect i ve Study ) was established in 1990 for cohort I and in 1993 for cohort II . The subjects were 49,920 men aged 40 - 69 years who completed a question naire that included their green tea consumption habit at baseline and were followed until the end of 2004 . During this time , 404 men were newly diagnosed with prostate cancer , of whom 114 had advanced cases , 271 were localized , and 19 were of an undetermined stage . Green tea was not associated with localized prostate cancer . However , consumption was associated with a dose-dependent decrease in the risk of advanced prostate cancer . The multivariate relative risk was 0.52 ( 95 % confidence interval : 0.28 , 0.96 ) for men drinking 5 or more cups/day compared with less than 1 cup/day ( p(trend ) = 0.01 ) . Green tea may be associated with a decreased risk of advanced prostate cancer Phytanic acid is a saturated fatty acid found predominantly in red meat and dairy products and may contribute to increases in prostate cancer risk that are observed with higher intakes of these foods . We constructed a novel summary measure of phytanic acid intake and prospect ively examined its association with prostate cancer risk in the Alpha-Tocopherol , Beta-Carotene Cancer Prevention Study --a cohort of Finnish male smokers aged 50 - 69 years . Diet was assessed at baseline in 27,111 participants using a vali date d 276-item dietary question naire . Since phytanic acid is not currently included in food composition tables , we used the published phytanic acid content of 151 major food items to estimate total daily intake . During up to 21 years of follow-up , a total of 1,929 incident prostate cancer cases ( including 438 advanced cases ) were identified . Higher phytanic acid intake , though unrelated to the risk of localized disease [ relative risks ( RR ) and 95 % confidence intervals ( CI ) for increasing quartiles of intake = 1.00 ( ref ) , 0.83 ( 0.68 - 1.01 ) , 0.76 ( 0.62 - 0.94 ) and 0.91 ( 0.74 - 1.13 ) ; p trend = 0.23 ] , was associated with increased risks of advanced prostate cancer [ RR and 95 % CI = 1.00 ( ref ) , 1.43 ( 1.09 - 1.89 ) , 1.31 ( 0.99 - 1.75 ) and 1.38 ( 1.02 - 1.89 ) ; p trend = 0.06 ] . This association appeared to be driven predominantly by phytanic acid obtained from dairy products ( particularly butter ) . Our study indicates that phytanic acid may contribute to previously observed associations between high-fat animal foods ( particularly dairy products ) and prostate cancer risk , although some caution is warranted as it may be acting as a surrogate marker of dairy fat Supplemental vitamin E ( α-tocopherol ) has been linked to lower prostate cancer incidence in one r and omized trial and several , although not all , observational studies . The evidence regarding dietary intake of individual vitamin E isoforms and prostate cancer is limited and inconclusive , however . We prospect ively examined the relations of supplemental vitamin E and dietary intakes of α- , β- , γ- , and δ- tocopherols to prostate cancer risk among 295,344 men , ages 50 to 71 years and cancer-free at enrollment in 1995 to 1996 , in the NIH-AARP Diet and Health Study . At baseline , participants completed a question naire that captured information on diet , supplement use , and other factors . Proportional hazards models were used to estimate relative risks ( RR ) and 95 % confidence intervals ( 95 % CI ) of prostate cancer . During 5 years of follow-up , 10,241 incident prostate cancers were identified . Supplemental vitamin E intake was not related to prostate cancer risk ( for > 0 - 99 , 100 - 199 , 200 - 399 , 400 - 799 , and ≥800 IU/d versus never use : RR , 0.97 , 0.89 , 1.03 , 0.99 , and 0.97 ( 95 % CI , 0.87 - 1.07 ) respectively ; Ptrend = 0.90 ) . However , dietary γ-tocopherol , the most commonly consumed form of vitamin E in the United States , was significantly inversely related to the risk of advanced prostate cancer ( for highest versus lowest quintile : RR , 0.68 ; 95 % CI , 0.56 - 0.84 ; Ptrend = 0.001 ) . These results suggest that supplemental vitamin E does not protect against prostate cancer , but that increased consumption of γ-tocopherol from foods is associated with a reduced risk of clinical ly relevant disease . The potential benefit of γ-tocopherol for prostate cancer prevention deserves further attention . ( Cancer Epidemiol Biomarkers Prev 2007;16(6):1128–35 High-temperature cooked meat contains heterocyclic amines , including 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine ( PhIP ) , and polycyclic aromatic hydrocarbons , such as benzo(a)pyrene ( BaP ) . In rodents , a high intake of PhIP induces prostate tumors . We prospect ively investigated the association between meat and meat mutagens
Output:
| Epidemiologic studies have shown that , overall , the habitual consumption of a diet high in saturated fat , well-done meats , and calcium is associated with an increased risk for advanced prostate cancer .
An inconsistent association was observed for intake of total meat , fruits , and vegetables .
Although most case-control studies suggest that intake of these nutrients or foods significantly alters advanced prostate cancer risk , cohort studies yielded mixed results .
No apparent effect of fish and zinc intake on advanced prostate cancer was found in most epidemiologic studies .
Epidemiologic studies conducted to date have revealed that some dietary factors modulate the risk for advanced prostate cancer .
If these findings are confirmed by more adequately powered epidemiologic studies , especially prospect i ve cohort studies that measure the nutrients and their biochemical indicators , the risk of advanced prostate cancer , which is fatal and thus clinical ly significant , may be reduced by dietary modification or chemoprevention |
MS211706 | ***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 schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease , lifestyle and the use of medications , which are related to weight gain . Methods A multicentric , r and omized , controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program ( LWP ) . The program consists of a one-hour weekly session to discuss topics like dietary choices , lifestyle , physical activity and self-esteem with patients and their relatives . Patients were r and omized into two groups : st and ard care ( SC ) and st and ard care plus intervention ( LWP ) . Primary outcome was defined as the weight and body mass index ( BMI ) . Results 160 patients participated in the study ( 81 in the intervention group and 79 in the SC group ) . On an intent to treat analysis , after three months the patients in the intervention group presented a decrease of 0.48 kg ( CI 95 % -0.65 to 1.13 ) while the st and ard care group showed an increase of 0.48 kg ( CI 95 % 0.13 to 0.83 ; p=0.055 ) . At six-month follow-up , there was a significant weight decrease of −1.15 kg , ( CI 95 % -2.11 to 0.19 ) in the intervention group compared to a weight increase in the st and ard care group ( + 0.5 kg , CI 95 % -0.42–1.42 , p=0.017 ) . Conclusion In conclusion , this was a multicentric r and omized clinical trial with a lifestyle intervention for individuals with schizophrenia , where the intervention group maintained weight and presented a tendency to decrease weight after 6 months . It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight . Clinical trials.gov The study objective was to evaluate the feasibility of a telephone delivered intervention consisting of motivational interviewing and cognitive behavioural strategies aim ed at improving diet and physical activity in people diagnosed with psychotic disorders . Twenty participants diagnosed with a non-acute psychotic disorder were recruited . The intervention consisted of eight telephone delivered sessions targeting fruit and vegetable ( F&V ) consumption and leisure screen time , as well as smoking and alcohol use ( as appropriate ) . F&V frequency and variety , and overall diet quality ( measured by the Australian Recommended Food Score , ARFS ) , leisure screen time , overall sitting and walking time , smoking , alcohol consumption , mood , quality of life , and global functioning were examined before and 4-weeks post-treatment . Nineteen participants ( 95 % ) completed all intervention sessions , and 17 ( 85 % ) completed follow-up assessment s. Significant increases from baseline to post-treatment were seen in ARFS fruit , vegetable and overall diet quality scores , quality of life and global functioning . Significant reductions in leisure screen time and overall sitting time were also seen . Results indicated that a telephone delivered intervention targeting key cardiovascular disease risk behaviours appears to be feasible and relatively effective in the short-term for people diagnosed with psychosis . A r and omized controlled trial is warranted to replicate and extend these findings The objective of this multicenter r and omised clinical trial was to examine the effect of exercise versus occupational therapy on mental and physical health in schizophrenia patients BACKGROUND The aim of this r and omized clinical trial follow-up at three months was to evaluate the effectiveness of an educational intervention with a focus on diet and physical activity ( PA ) to change the amount of PA , body mass index ( BMI ) and the waist circumference ( WC ) in patients with severe mental illness . METHODS We recruited 332 out patients with severe mental disorders undergoing treatment with antipsychotic medication from Mental Healthcare Centers of Barcelona . They were r and omly assigned to an intervention or a control group . The patients in the intervention group participated in a group PA and diet educational program . The blinded measurements at 0 and 3 months were : the level of PA ( IPAQ question naire ) , BMI , WC , blood pressure , dietary habits ( PREDIMED question naire ) , quality of life ( SF-36 question naire ) and laboratory parameters ( cholesterol , triglycerides , glucose ) . RESULTS The average age was 46.7 years and 55 % were males . Schizophrenia had been diagnosed in 67.1 % of them . At 3 months , the average weekly walking METs rose significantly in the IG 266.05 METs ( 95%CI : 16.86 to 515.25 ; P=0.036 ) . The total MET average also rose although not significantly : 191.38 METs ( 95%CI : 1.38 to 381.38 ; P=0.086 ) . However , the BMI decreased significantly more in the CG , by 0.26kg/m(2 ) ( 95%CI : 0.02 to 0.51 ; P=0.038 ) , than in the IG . There were no significant differences in the WC . CONCLUSIONS The short-term results suggest that the intervention increases the level of PA , but does not improve physical or laboratory parameters . TRIAL REGISTRATION Clinical trials.gov NCT01729650 ( effectiveness of a physical activity and diet program in patients with psychotic disorder [ CAPiCOR ] ) BACKGROUND People with psychosis often experience weight gain , which places them at risk of cardiovascular disease , diabetes , and early death . OBJECTIVE To determine the uptake , adherence , and clinical effectiveness of a healthy living intervention design ed to reduce weight gain . METHOD An exploratory r and omized controlled trial , comparing the intervention with treatment as usual ( TAU ) in 2 early intervention services for psychosis in Engl and . DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses . The primary outcome was change in body mass index ( BMI ) from baseline to 12-month follow-up . The study was conducted between February 2009 and October 2012 . RESULTS 105 service users , with a BMI of ≥ 25 ( ≥ 24 in South Asians ) , were r and omized to intervention ( n = 54 ) or TAU ( n = 51 ) after stratification by recent commencement of antipsychotic medication . Ninety-three service users ( 89 % ) were followed up at 12 months . Between-group difference in change in BMI was not significant ( effect size = 0.11 ) . The effect of the intervention was larger ( effect size = 0.54 , not significant ) in 15 intervention ( 28 % ) and 10 TAU ( 20 % ) participants who were taking olanzapine or clozapine at r and omization . CONCLUSIONS The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group . TRIAL REGISTRATION www.is rct n.org identifier : IS RCT N22581937 Ninety seven out patients with schizophrenia spectrum disorders ( SSDs ) were r and omly assigned to the Walk , Address Sensations , Learn About Exercise , Cue Exercise Behavior for SSDs ( WALC-S ) , a motivational intervention design ed to increase exercise in SSDs ( n = 48 ) , or a time and attention control group ( TAC , n = 49 ) . WALC-S and TAC groups met weekly for 4 weeks before a 16 week walking program was offered to all subjects . We compared the exercise attendance , persistence and compliance of the groups during the walking program . WALC-S recipients attended more walking groups , for more weeks and walked more minutes than those receiving TAC . Percent of WALC-S or TAC groups attended was significantly correlated with overall attendance ( r = 0.38 , P = 0.001 ) and persistence ( r = −.29 , P = 0.01 ) , as well as number of minutes walked . This study is among the first to examine interventions design ed to enhance exercise motivation in SSDs AIM Initiating antipsychotic medication frequently induces rapid , clinical ly significant weight gain . We aim ed to evaluate the effectiveness of a lifestyle and life skills intervention , delivered within 4 weeks of antipsychotic medication initiation , in attenuating weight gain in youth aged 14 - 25 years with first-episode psychosis ( FEP ) . METHODS We undertook a prospect i ve , controlled study in two early psychosis community services . Intervention participants ( n = 16 ) received a 12-week individualized intervention delivered by specialist clinical staff ( nurse , dietician and exercise physiologist ) and youth peer wellness coaches , in addition to st and ard care . A comparison group was recruited from a similar service and received st and ard care ( n = 12 ) . RESULTS The intervention group experienced significantly less weight gain at 12 weeks compared to st and ard care ( 1.8 kg , 95 % CI -0.4 to 2.8 vs. 7.8 kg , 4.8 - 10.7 , P < 0.001 ) . Thirteen per cent ( 2/16 ) of the intervention group experienced clinical ly significant weight gain ( greater than 7 % of baseline weight ) , while 75 % ( 9/12 ) of the st and ard care group experienced this level of weight gain . Similar positive effects of the intervention were observed for waist circumference . CONCLUSIONS A lifestyle and life skills intervention delivered as part of st and ard care attenuated antipsychotic-induced weight gain in young people with FEP . The intervention was acceptable to the young people referred to the service . Such interventions may prevent the seeding of future disease risk and in the long-term help reduce the life expectancy gap for people living with serious mental illness PURPOSE We tested the feasibility and preliminary efficacy of a lifestyle intervention for middle-aged and older patients with schizophrenia and type-2 diabetes mellitus , using a r and omized pre-test , post-test control group design . METHOD Individuals with a diagnosis of schizophrenia or schizoaffective disorder over the age of 40 were r and omly assigned to 24-week Diabetes Awareness and Rehabilitation Training ( DART ; n=32 ) groups or Usual Care plus Information ( UCI ; n=32 ) comparison groups . Participants were recruited from board- and -care facilities and day treatment programs . Fifty-seven patients completed baseline and 6-month assessment s consisting of an interview , measures of body mass index , blood pressure , fasting blood chemistry , and accelerometry . A mixed-model analysis of variance was used to analyze the data . RESULTS A significant group x time interaction was found for body weight , with patients in the DART group losing a mean of 5 lb and those in the UCI gaining a mean 6 lb . Significant group x time interactions were also found for triglycerides , diabetes knowledge , diabetes self-efficacy , and self-reported physical activity , but not for fasting plasma glucose or glycosylated hemoglobin . CONCLUSIONS Group-based lifestyle interventions are feasible and produce positive health changes in middle-aged and older patients with schizophrenia and diabetes mellitus
Output:
| Depressive symptoms and older age were associated with less vigorous PA in meta-regression analyses .
Our data confirm that people with schizophrenia engage in significantly less moderate and vigorous PA versus controls . |
MS211707 | ***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 AIM While lispro insulin has been reported to lower postpr and ial blood glucose concentrations , less consistent effects have been shown for glycosylated hemoglobin ( HbA1c ) levels . Aim of this study was to determine whether pre-meal association of NPH , an intermediate-acting insulin , with lispro improves overall glycemic control in type 1 diabetic patients . METHODS AND RESULTS Eighty-five type 1 diabetic patients were studied in a multicenter r and omized comparative ( human regular vs lispro insulin ) crossover ( 3-month ) study in which NPH insulin was given as a dinner or bedtime injection and at breakfast and lunch if necessary . The number of injections was kept constant : 42 % and 58 % of patients injected insulin 3 and 4 times per day , respectively . Fasting and prepr and ial blood glucose levels were similar , while postpr and ial levels improved after lispro compared to human regular insulin ( breakfast : 8.28 + /- 2.39 vs 9.28 + /- 2.72 mmol/l ; lunch : 8.33 + /- 2.67 vs 9.06 + /- 2.67 mmol/l , dinner : 8.06 + /- 2.72 vs 9.28 + /- 2.44 mmol/l , ANOVA : p = 0.003 ) . HbA1c also improved after lispro : 8.1 + /- 0.9 vs 8.3 + /- 0.8 % , p < 0.05 . The rate of hypoglycemia was similar . Patients showed better acceptance of lispro treatment ( p < 0.001 ) . CONCLUSIONS Lispro improves overall blood glucose control in type 1 diabetic patients without increasing the incidence of hypoglycemia . This can be achieved by an optimal combination of lispro insulin with NPH whenever the time intervals between meals are too long OBJECTIVE Insulin administered by jet injectors is dispensed over a larger subcutaneous area than insulin injected with a syringe , which may facilitate a more rapid absorption . This study compared the pharmacologic profile of administration of insulin aspart by jet injection to that by conventional insulin pen . RESEARCH DESIGN AND METHODS Euglycemic glucose clamp tests were performed in 18 healthy volunteers after subcutaneous administration of 0.2 units/kg body wt of aspart , either administered by jet injection or by conventional pen , using a r and omized , double-blind , double-dummy , cross over study design . Pharmacodynamic and pharmacokinetic profiles were derived from the glucose infusion rate ( GIR ) needed to maintain euglycemia and from plasma insulin levels , respectively . RESULTS The time to maximal GIR was significantly shorter when insulin was injected with the jet injector compared with conventional pen administration ( 51 ± 3 vs. 105 ± 11 min , P < 0.0001 ) . The time to peak insulin concentration was similarly reduced ( 31 ± 3 vs. 64 ± 6 min , P < 0.0001 ) and peak insulin concentrations were increased ( 108 ± 13 vs. 79 ± 7 mU/L , P = 0.01 ) when insulin was injected by jet injection compared with conventional pen injection . Jet injector insulin administration reduced the time to 50 % glucose disposal by ∼40 min ( P < 0.0001 ) . There were no differences in maximal GIR , total insulin absorption , or total insulin action between the two devices . CONCLUSIONS Administration of insulin aspart by jet injection enhances insulin absorption and reduces the duration of glucose-lowering action . This profile resembles more closely the pattern of endogenous insulin secretion and may help to achieve better meal insulin coverage and correction of postpr and ial glucose excursions OBJECTIVE To evaluate the progression of retinopathy during pregnancy and postpartum in ( insulin-dependent ) women with type 1 diabetes treated with insulin lispro or with regular human insulin . RESEARCH DESIGN AND METHODS A prospect i ve open study of 69 pregnant women with diabetes was performed . A total of 36 of the women were treated with insulin lispro ( lispro group ) and 33 were treated with conventional short-acting human insulin ( regular insulin group ) . The retinopathy level was estimated by color fundus photography every trimester and postpartum . Glycemic control during pregnancy , hypoglycemia ( blood glucose level <3 mmol/l ) in 24-h glucose profile , blood pressure , and proteinuria were registered . RESULTS HbA(1c ) values were similar at baseline in the first trimester but thereafter were lower in the lispro group than in the regular insulin group throughout pregnancy ( P = 0.022 , repeated- measures ANOVA ) . The number of hypoglycemic episodes did not differ between the treatment groups . In multivariable logistic regression analysis with retinopathy severity ( Diabetes Control and Complications Trial level ) in the third trimester as the dependent variable , only nulliparity qualified as a predictor in the model [ Exp(B ) = 4.0 , 95 % CI 1.1 - 13.7 , P = 0.030 ] . Factors such as duration of diabetes , type of insulin used , mean HbA(1c ) level throughout pregnancy , blood pressure ( systolic or diastolic ) , preeclampsia in the current pregnancy , smoking , or prepregnancy planning did not explain the retinopathy progression . CONCLUSIONS Insulin lispro improves glycemic control during diabetic pregnancy compared with regular insulin with no adverse impact on progression of diabetic retinopathy INTRODUCTION Insulin glulisine ( glulisine ) was evaluated versus regular human insulin ( RHI ) in Type 2 diabetes ( T2DM ) patients . METHODS Patients previously on > 6 months ' continuous insulin treatment aged > or=18 years in a r and omized , multinational , controlled , open-label , parallel group , 26-week study received twice-daily NPH insulin and either glulisine ( 0 - 15 min before breakfast and dinner ; n=448 ) or RHI ( 30 - 45 min before breakfast and dinner ; n=442 ) at least twice daily . RESULTS Mean baseline characteristics were similar between groups . There were no differences in baseline to endpoint HbA(1c ) reductions ( glulisine : -0.32 % ; RHI : -0.35 % ; p=0.5726 ) , and the non-inferiority of glulisine versus RHI was demonstrated ( difference in adjusted mean change 0.03 % ; 95 % CI : -0.07 , 0.13 ) . Postpr and ially , glulisine lowered plasma glucose significantly more versus RHI at 2h ( 14.14 mmol/L versus 15.28 mmol/L ; p=0.0025 ) and excursions at 1h ( 3.99 versus 4.59 ; p=0.0151 ) and 2h ( 4.87 versus 6.03 ; p=0.0002 ) . No between-group differences occurred in the frequencies and monthly rates of all symptomatic hypoglycaemia ; nocturnal hypoglycaemia from Month 4 to treatment end was less frequent with glulisine versus RHI ( 9.1 % versus 14.5 % ; p=0.029 ) . CONCLUSION Glulisine was non-inferior to RHI in reducing HbA(1c ) in T2DM . Glulisine demonstrated superior postpr and ial glucose control and was associated with fewer nocturnal hypoglycaemic episodes , indicating clinical benefits Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Today , insulin analogs are used in millions of diabetic patients . Insulin analogs have been developed to achieve more physiological insulin replacement in terms of time-course of the effect . Modifications in the amino acid sequence of the insulin molecule change the pharmacokinetics and pharmacodynamics of the analogs in respect to human insulin . However , these changes can also modify the molecular and biological effects of the analogs . The rapid-acting insulin analogs , lispro , aspart , and glulisine , have a rapid onset and shorter duration of action . The long-acting insulin analogs glargine and detemir have a protracted duration of action and a relatively smooth serum concentration profile . Insulin and its analogs may function as growth factors and therefore have a theoretical potential to promote tumor proliferation . A major question is whether analogs have an increased mitogenic activity in respect to insulin . These lig and s can promote cell proliferation through many mechanisms like the prolonged stimulation of the insulin receptor , stimulation of the IGF-1 receptor ( IGF-1R ) , prevalent activation of the extracellular-signaling-regulated kinase ( ERK ) rather than the protein kinase B ( PKB/AKT ) intracellular post-receptor pathways . Studies on in vitro models indicate that short-acting analogs elicit molecular and biological effects that are similar to those of insulin . In contrast , long-acting analogs behave differently . Although not all data are homogeneous , both glargine and detemir have been found to have a decreased binding to receptors for insulin but an increased binding to IGF-1R , a prevalent activation of the ERK pathway , and an increased mitogenic effect in respect to insulin . Recent retrospective epidemiological clinical studies have suggested that treatment with long-acting analogs ( specifically glargine ) may increase the relative risk for cancer . Results are controversial and method ologically weak . Therefore prospect i ve clinical studies are needed to evaluate the possible tumor growth-promoting effects of these insulin analogs Summary The objective of this study was to identify possible risk factors of severe hypoglycaemia ( SH ) in a prospect i ve population based study of adult Type I ( insulin-dependent ) diabetic patients . A representative sample of 684 patients ( 41 % women , mean ± SD age 36 ± 11 , diabetes duration 18 ± 11 years ) , living in the district of Northrhine ( 9.5 million inhabitants ) , Germany , were examined in their homes using a mobile ambulance . A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables , hypoglycaemia awareness , diabetes management , and attitudes and behavioural aspects as expressed by the patients . After a mean of 19 ± 6 months 669 ( 98 % ) patients were interviewed about events of SH since the baseline examination . Using the multiple Cox proportional hazards model , five risk factors of SH were identified : SH during the preceding year [ hazard ratio ( HR ) 2.7 , 95 % confidence intervals ( CI ) 1.8–4.2 ] , any history of SH ( HR 1.9 , CI 1.1–3.4 ) , C-peptide negativity ( HR 4.0 , CI 1
Output:
| We also found no clear evidence for a substantial effect of insulin analogues on health-related quality of life .
However , there were few results only based on subgroups of the trial population s. None of the trials reported substantial effects regarding weight gain or any other adverse events .
Our analysis suggests only a minor benefit of short-acting insulin analogues on blood glucose control in people with type 1 diabetes . |
MS211708 | ***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 analyse the factors affecting the clinical performance and those influencing the survival of resin-retained bridgework provided at a UK dental teaching hospital between 1994 and 2001 . Design A prospect i ve analysis of restorations provided at a single centre using case notes with all patients invited for review to corroborate findings . Setting Department of Restorative Dentistry , University of Bristol Dental Hospital and School , Bristol , United Kingdom . Subjects and methods Between January 1994 and December 2001 , data regarding 1,000 consecutive resin-retained bridges provided at Bristol Dental Hospital and School were recorded . Data was available for 805 patients at the time of the study . Following invitation , 621 patients attended for a review appointment . Life table and Kaplan-Meir survival analysis were carried out for all restorations provided . Results The five-year and ten-year survival rates estimated by the life-table method are 80.8 % ( 95 % confidence interval 78.0–83.6 % ) and 80.4 % ( 95 % confidence interval 77.6–83.2 % ) respectively . The median survival can not be estimated for this study as the survival probability remains above 80 % even at the longest follow-up . Analysis of clinical variables influencing survival revealed that design of the restoration and experience of the operator providing the restoration were significant factors . Resin-retained bridges made with minimal tooth preparation are shown to be superior in terms of longevity than those for which other types of tooth preparation is made . Patient satisfaction with their treatment was high The etched-cast restoration was introduced in 1980 , and a prospect i ve study was initiated in March 1981 to determine if resin-bonded prostheses would prove to be a long-term alternative to traditional complete and partial coverage restorations . All resin-bonded restorations placed since that time in the author 's private prosthodontic practice have been recorded in the study . The success rate of 127 restorations has been 92.9 % , with a mean longevity of 5 years and 8 months PURPOSE The aim of this prospect i ve clinical evaluation was to show the long-term clinical behavior of resin-bonded fixed partial dentures ( RBFPD ) with a retentive , minimally invasive preparation design . MATERIAL S AND METHODS Since 1985 , 232 RBFPDs with a retentive preparation design were placed under controlled clinical conditions . In 2005 and 2006 , 84 fixed partial dentures could be re-evaluated . Using Kaplan-Meier analysis , the survival rate was determined . The probability of survival was calculated with several risk factors : location ( anterior/posterior , maxilla/m and ible ) , metal alloy of the framework ( titanium/CoCr ) , number of pontics , and number of supporting teeth . RESULTS A total of 12 failures was observed and result ed in a survival rate of 77 % after 10 years . However , only 4 catastrophic failures occurred . In such cases , the restoration was lost , or could not be re-bonded or repaired ( survival rate 88 % after 10 years ) . RBFPDs made of a titanium alloy exhibited a statistically significantly higher survival rate than RBFPDs made of a nonprecious CoCr alloy in terms of all failures . Only slight but not statistically significant differences between the covariates maxilla , m and ible , anterior/posterior region , number of pontics , and number of abutment teeth were observed . CONCLUSION Within the limitations of this study , RBFPDs seem to be a reliable restorative alternative to conventional short-span fixed dental prostheses OBJECTIVES The purpose of this clinical study was to evaluate the long-term outcome of 3-unit anterior fixed partial dentures ( FPDs ) made of fiber-reinforced resin composite ( FRC ) , and to identify design factors influencing the survival rate . METHODS 52 patients ( 26 females , 26 males ) received 60 indirectly made FRC FPDs , using pre-impregnated unidirectional glass fibers , requiring manual wetting , as framework material . FPDs were surface ( n=48 ) or hybrid ( n=12 ) retained and mainly located in the upper jaw . Hybrid FPDs had a combination of retainers ; i.e. crown at one and surface retention at the other abutment tooth . Surface FPDs were either purely adhesively retained ( n=29 ) or with additional mechanical retention ( n=19 ) . Follow-up period was at minimum 5 years , with check-ups every 1 - 2 years . Six operators were involved , in three centers in the Netherl and s , Finl and and Sweden . Survival rates , including repairable defects of FPDs , and success rates were determined . RESULTS Kaplan-Meier survival rate at 5 years was 64 % ( SE 7 % ) . For the level of success , values were 45 % ( SE 7 % ) and the estimated median survival time 58 ( SE 10.1 ) months . For surface FPDs , additional mechanical retention did not improve survival significantly . There was a trend towards better survival of surface FPDs over hybrid FPDs , but differences were not significant . Main failure modes were fracture of the FPD and delamination of veneering composite . SIGNIFICANCE A success rate of 45 % and a survival rate of 64 % after 5 years was found . Fracture of the framework and delamination are the most prevalent failure modes , especially for surface FPDs OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Abstract Within the framework of an on-going prospect i ve clinical study begun in 1985 , 120 adhesive-fixed partial dentures ( AFPD ) continued to be examined . The manufacture and the fitting of the AFPDs were carried out following a st and ard procedure . The preparation technique and the metal framework conditioning ( silica-coating , s and blasting and electrochemical etching ) has varied throughout the duration of the study . Using Kaplan-Meier analysis , the survival rate was determined and an analysis of risk with regard to location factors ( anterior , posterior ; maxilla , m and ible ) , conditioning and preparation techniques ( retentive/non-retentive ) was determined using the Cox regression model . The location of the AFPD had no influence on the survival rate . The survival time was determined mainly by the preparation technique . Strict preparation of seating grooves and pin holes made a 95 % survival rate possible after 10 years ( Kaplan-Meier estimation ) . Without retention , the risk of failure increased by a factor of 3.7 OBJECTIVES This prospect i ve clinical study evaluated the performance of indirect , anterior , surface-retained , fibre-reinforced-composite restorations ( ISFRCR ) . METHODS Between June-2003 and January-2011 , a total of 134 patients ( 83 females , 51 males , 16 - 68 years old ) received 175 ISFRCRs ( local ethical registration number : 14/9/4 ) . All restorations were made indirectly on a plaster model using unidirectional E-glass fibres ( everStick C&B , StickTech ) in combination with a laboratory resin composite ( Dialogue , Schütz Dental ) and cemented according to the instructions of 4 resin cements [ ( RelyX ARC , 3M-ESPE , n=61 ) , Bifix DC , VOCO , n=45 ) , Variolink II ( Ivoclar Vivadent , n=32 ) and Multilink ( Ivoclar Vivadent , n=37 ) ] . After baseline recordings , patients were followed at 6 months and thereafter annually up to 7.5 years . The evaluation protocol involved technical ( chipping , debonding or fracture of tooth/restoration ) and biological failures ( caries ) . RESULTS Mean observation period was 58 months . Altogether , 13 failures were observed [ survival rate : 97.7 % ] ( Kaplan-Meier ) . One catastrophic fracture [ ( cement : RelyX ARC ) , eight partial debonding ( cement : Bifix DC ( 5 ) , Multilink ( 1 ) , RelyX ARC ( 1 ) , Variolink II ( 1 ) ] and four delaminations of veneering composite [ ( cement : Bifix DC ( 2 ) , RelyX ARC ( 1 ) , Multilink ( 1 ) ] were observed . Except one replacement , all defective restorations were repaired or recemented . Annual failure rate of ISFRCRs was 1.73 % . The survival rates with the four resin cements did not show significant differences ( RelyX ARC : 98.3 % ; Bifix DC : 93.5 % ; Variolink 2 : 100 % ; Multilink : 100 % ) ( p=0.114 ) . Secondary caries did not occur in any of the teeth . CONCLUSION The 3-unit anterior indirect surface-retained resin-bonded FRC FDPs showed similar clinical survival rate when cemented with the resin cements tested . Experienced failures in general were due to debonding of the restoration or delamination of the veneering composite . CLINICAL SIGNIFICANCE 3-unit surface retained resin-bonded FRC FDPs could be considered minimal invasive and cost-effective alternatives to conventional tooth- or implant-borne FDPs . Failures were mainly repairable in the form of chipping or debonding depending on the resin cement type Removable partial dentures may adversely affect remaining tissues and have a low prevalence of use . This r and omized controlled trial was design ed to compare the time to survival of cantilever resin-bonded fixed partial dentures and conventional removable partial dentures to restore shortened lower dental arches . We r and omly allocated 25 male and 35 female patients ( median age , 67 years ) to fixed or removable partial denture groups of 30 persons , matched for age and sex . Survival of the prostheses was assessed , based on listed criteria , at each review or when problems arose . Although the removable partial denture group required rather more maintenance visits , the difference in survival rates was not statistically significant ( hazard ratio = 0.59 , with 95 % CI 0.27 , 1.29 ) . In the absence of significant differences in five-year survival , the reported advantages of fixed partial dentures , including reduced maintenance frequency , offer positive support for the use of resin-bonded fixed partial dentures PURPOSE To retrospectively evaluate the 6-year survival rates and technical/ biologic complication rates of single-retainer glass-ceramic resin-bonded fixed dental prostheses ( RBFDPs ) . MATERIAL S AND METHODS Forty patients with 49 anterior/posterior glass-ceramic RBFDPs were included . The RBFDPs replaced 11 maxillary/m and ibular central incisors , 18 lateral incisors , 18 premolars , and 2 molars . Patients willing to participate were clinical ly and radiologically examined . The technical outcome was assessed with modified United States Public Health Service criteria . Fracture and /or chipping of the restoration , occlusal wear , marginal adaptation , marginal discoloration , shape , surface texture , and esthetic integration were recorded . Tooth vitality and postoperative sensitivity were tested . The following biologic parameters were assessed at test and control teeth : probing pocket depth , gingival recession , attachment loss , bleeding on probing , furcation involvement , and periodontal mobility . Statistical analysis was performed with exact 95 % confidence intervals to relative frequencies and the paired t test . RESULTS Twenty-eight patients with 35 RBFDPs participated . The mean follow-up of the RBFDPs was 6 years . Twelve patients with 14 RBFDPs were not willing to participate or not available . No catastrophic failures occurred . The 6-year survival rate
Output:
| Technical complications were the main reason for failures .
The 5-year clinical performance of RBFPDs is similar to the performance of conventional fixed partial dentures ( FPDs ) and implant-supported crowns . |
MS211709 | ***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 Abnormal bleeding after cardiopulmonary bypass ( CPB ) is a common complication of cardiac surgery , with important health and economic consequences . Coagulation test – based algorithms may reduce transfusion of non-erythrocyte allogeneic blood in patients with abnormal bleeding . Methods The authors performed a r and omized prospect i ve trial comparing allogeneic transfusion practice s in 92 adult patients with abnormal bleeding after CPB . Patients with abnormal bleeding were r and omized to one of two groups : a control group following individual anesthesiologist ’s transfusion practice s and a protocol group using a transfusion algorithm guided by coagulation tests . Results Among 836 eligible patients having all types of elective cardiac surgery requiring CPB , 92 patients developed abnormal bleeding after CPB ( incidence , 11 % ) . The transfusion algorithm group received less allogeneic fresh frozen plasma in the operating room after CPB ( median , 0 units ; range , 0–7 units ) than the control group ( median , 3 units ; range , 0–10 units ) ( P = 0.0002 ) . The median number of platelet units transfused in the operating room after CPB was 4 ( range , 0–12 ) in the algorithm group compared with 6 ( range , 0–18 ) in the control group ( P = 0.0001 ) . Intensive care unit ( ICU ) mediastinal blood loss was significantly less in the algorithm group . Multivariate analysis demonstrated that transfusion algorithm use result ed in reduced ICU blood loss . The control group also had a significantly greater incidence of surgical reoperation of the mediastinum for bleeding ( 11.8%vs . 0%;P = 0.032 ) . Conclusions Use of a coagulation test – based transfusion algorithm in cardiac surgery patients with abnormal bleeding after CPB reduced non-erythrocyte allogeneic transfusions in the operating room and ICU blood loss BACKGROUND Using algorithms based on point of care coagulation tests can decrease blood loss and blood component transfusion after cardiac surgery . We wished to test the hypothesis that a management algorithm based on near-patient tests would reduce blood loss and blood component use after routine coronary artery surgery with cardiopulmonary bypass when compared with an algorithm based on routine laboratory assays or with clinical judgement . METHODS Patients ( n=102 ) undergoing elective coronary artery surgery with cardiac bypass were r and omized into two groups . In the point of care group , the management algorithm was based on information provided by three devices , the Hepcon , thromboelastography and the PFA-100 platelet function analyser . Management in the laboratory test group depended on rapidly available laboratory clotting tests and transfusion of haemostatic blood components only if specific criteria were met . Blood loss and transfusion was compared between these two groups and with a retrospective case-control group ( n=108 ) , in which management of bleeding had been according to the clinician 's discretion . RESULTS All three groups had similar median blood losses . The transfusion of packed red blood cells ( PRBCs ) and blood components was greater in the clinician discretion group ( P<0.05 ) but there was no difference in the transfusion of PRBCs and blood components between the two algorithm-guided groups . CONCLUSION Following algorithms based on point of care tests or on structured clinical practice with st and ard laboratory tests does not decrease blood loss , but reduces the transfusion of PRBCs and blood components after routine cardiac surgery , when compared with clinician discretion . Cardiac surgery services should use transfusion guidelines based on laboratory-guided algorithms , and the possible benefits of point of care testing should be tested against this st and ard We set out to determine if the heparinase-modified thrombelastogram using anticoagulated blood from patients during cardiac surgery could guide treatment with haemostatic components . In 60 patients a simple algorithm predicted a possible 60 - 80 % decrease in the use of haemostatic components . In a second series , 30 patients were allocated to receive components using this intra-operative algorithm and 30 using clinical criteria and laboratory-based tests . Ten patients in the clinical group received a total of 16 units of fresh frozen plasma and nine platelet concentrates compared with five patients transfused with five units of fresh frozen plasma and one platelet concentrate in the algorithm group . Twelve-hour chest tube losses [ algorithm group 470 ( 295 - 820 ) ml , clinical ly managed group 390 ( 240 - 820 ) ml ( median , quartile values ) ] were not different between groups despite the threefold reduction in the use of haemostatic products , showing that intra-operative monitoring of coagulation in the anticoagulated patient can be used to guide treatment OBJECTIVE Aortic surgical procedures requiring hypothermic circulatory arrest are associated with altered hemostasis and increased bleeding . In a r and omized clinical trial , we evaluated effects of thromboelastometrically guided algorithm on transfusion requirements . METHODS Fifty-six consecutive patients ( 25 with acute type A dissection ) undergoing aortic surgery with hypothermic circulatory arrest were enrolled in a r and omized trial during a 6-month period . Patients were r and omly allocated to treatment group ( n = 27 ) with thromboelastometrically guided transfusion algorithm or control group ( n = 29 ) with routine transfusion practice s ( clinical judgment-guided transfusion followed by transfusion according to coagulation test results ) . Primary end point was cumulative allogeneic blood units ( red blood cells , fresh-frozen plasma , and platelets ) transfused . RESULTS Transfusion of allogeneic blood was significantly reduced in the thromboelastometry group : median 9.0 units ( interquartile range , 2.0 - 30.0 units ) versus . 16.0 units ( 9.0 - 23.0 units , P = .02 ) . Most significant decrease was in the use of fresh-frozen plasma ( 3.0 units , 0 - 12.0 units , vs 8.0 units , 4.0 - 18.0 units , P = .005 ) . Postoperative blood loss ( 890 mL/d , 600 - 1250 mL/d vs 950 mL/d , 650 - 1400 mL/d , p = 0.5 ) and rate of surgical re-exploration ( 19 % vs 24 % , P = .7 ) were similar between groups . Thromboelastometrically guided algorithm significantly decreased need for massive perioperative transfusion ( odds ratio , 0.45 ; 95 % confidence interval , 0.2 - 0.9 ; P = .03 ) in multivariable logistic regression analysis . CONCLUSIONS Thromboelastometrically guided transfusion is associated with a decreased use of allogeneic blood units and reduced incidence of massive transfusion in patients undergoing aortic surgery with circulatory arrest BACKGROUND Thromboelastometric evaluation of coagulation might be useful for prediction and management of bleeding after paediatric cardiac surgery . We tested the hypothesis that the use of a thromboelastometry-guided algorithm for blood product management reduces blood loss and transfusion requirements . METHODS We studied 78 patients undergoing paediatric cardiac surgery with cardiopulmonary bypass ( CPB ) for the initial 12 h after operation . Stepwise multiple linear regression was used to develop an algorithm to guide blood product transfusions . Thereafter , we r and omly assigned 100 patients to conventional or algorithm-guided blood product management , and assessed bleeding and red cell transfusion requirements . RESULTS CPB time , post-bypass rotational thromboelastometry ( ROTEM ( ® ) ) EXTEM amplitude at 10 min ( A10 ) , and FIBTEM-A10 were independently associated with chest tube drainage volume during the initial 12 h after operation . Discriminative analysis determined cut-off values of 30 mm for EXTEM-A10 and 5 mm for FIBTEM-A10 , and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes . Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding ( 9 vs 16 ml kg(-1 ) , P<0.001 ) and packed red cell transfusion requirement ( 11 vs 23 ml kg(-1 ) , P=0.005 ) at 12 h after surgery , and duration of critical care stay ( 60 vs 71 h , P=0.014 ) . CONCLUSIONS Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A10 and FIBTEM-A10 reduced blood loss and red cell transfusion requirements after CPB , and reduced critical care duration in paediatric cardiac surgical patients . CLINICAL TRIAL REGISTRATION UMIN Clinical Trials Registry UMIN000006832 ( December 4 , 2011 ) UNLABELLED Transfusion therapy after cardiac surgery is empirically guided , partly due to a lack of specific point-of-care hemostasis monitors . In a r and omized , blinded , prospect i ve trial , we studied cardiac surgical patients at moderate to high risk of transfusion . Patients were r and omly assigned to either a thromboelastography (TEG)-guided transfusion algorithm ( n = 53 ) or routine transfusion therapy ( n = 52 ) for intervention after cardiopulmonary bypass . Coagulation tests , TEG variables , mediastinal tube drainage , and transfusions were compared at multiple time points . There were no demographic or hemostatic test result differences between groups , and all patients were given prophylactic antifibrinolytic therapy . Intraoperative transfusion rates did not differ , but there were significantly fewer postoperative and total transfusions in the TEG group . The proportion of patients receiving fresh-frozen plasma ( FFP ) was 4 of 53 in the TEG group compared with 16 of 52 in the control group ( P < 0.002 ) . Patients receiving platelets were 7 of 53 in the TEG group compared with 15 of 52 in the control group ( P < 0.05 ) . Patients in the TEG group also received less volume of FFP ( 36 + /- 142 vs 217 + /- 463 mL ; P < 0.04 ) . Mediastinal tube drainage was not statistically different 6 , 12 , or 24 h postoperatively . Point-of-care coagulation monitoring using TEG result ed in fewer transfusions in the postoperative period . We conclude that the reduction in transfusions may have been due to improved hemostasis in these patients who had earlier and specific identification of the hemostasis abnormality and thus received more appropriate intraoperative transfusion therapy . These data support the use of TEG in an algorithm to guide transfusion therapy in complex cardiac surgery . IMPLICATION S Transfusion of allogeneic blood products is common during complex cardiac surgical procedures . In a prospect i ve , r and omized trial , we compared a transfusion algorithm using point-of-care coagulation testing with routine laboratory testing , and found the algorithm to be effective in reducing transfusion requirements BACKGROUND Allogenic blood transfusion may affect clinical outcomes negatively . Up to 20 % of blood transfusions in the United States are associated with cardiac surgery and so strategies to conserve usage are of importance . This study compares administration according to physician 's choice based on laboratory coagulation tests with application of a strict protocol based on the thromboelastograph ( TEG ) . METHODS Sixty-nine patients presenting for cardiac surgery were r and omised to either study or control groups . In the study group a strict protocol was followed covering usage of all blood products according to TEG patterns . In the control group , the physician directed product administration with reference to activated partial thromboplastin time ( APTT ) , international normalised ratio ( INR ) , fibrinogen and platelet count . Bleeding , re-sternotomy , minimum haemoglobin , intubation time , and ICU stay were documented . RESULTS TEG-based management reduced total product usage by 58.8 % in the study group but this was not statistically significant . This was associated with a statistically insignificant trend towards better short-term outcomes . CONCLUSIONS This pilot study suggests that a strict protocol for blood product replacement based on the TEG might be highly effective in reducing usage without impairing short-term outcome OBJECTIVE Bleeding and allogeneic transfusion remain constant problems in cardiac surgical procedures . In this study , we aim ed to test the role of a routine thromboelastography (TEG)-based algorithm on bleeding and transfusions in patients undergoing elective coronary artery bypass grafting ( CABG ) . METHODS Patients ( n = 224 ) undergoing elective CABG with cardiopulmonary bypass were prospect ively r and omized into two groups according to transfusion strategy : in group 1 ( clinician-directed transfusion , n = 110 ) need for blood transfusion was based on clinician 's discretion and st and ard coagulation tests and in group 2 ( TEG algorithm group , n = 114 ) kaolin-activated ( k ) TEG-based algorithm-guided perioperative transfusion management . Transfusion , blood loss , and outcome data were recorded . RESULTS There were no differences in consumption of packed cell units , blood loss , re-exploration for bleeding , and early clinical outcome between the groups . Patients in the TEG group had significantly lower median units of fresh frozen plasma and platelets compared with the other group ( p = 0.001 ) . The median number of total allogeneic units transfused
Output:
| Trial sequential analysis of continuous data on blood loss and dichotomous outcomes on transfusion of blood products suggested the benefits of a TEG/ROTEM-guided algorithm .
Conclusions TEG or ROTEM-guided transfusion strategies may reduce blood loss volume and the transfusion rates in adult patients undergoing cardiac surgery |
MS211710 | ***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 examine the effect of weekly completion of a patient-held quality -of-life ( QOL ) diary in routine oncology practice for palliative care patients . PATIENTS AND METHODS In a pragmatic r and omized controlled trial , 115 patients with inoperable lung cancer were r and omly assigned to receive either st and ard care or a structured QOL diary ( European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 and the related lung cancer module LC13 ) that they completed at home each week for 16 weeks . Patients were encouraged to share the QOL information with health professionals involved in their care . Changes in QOL over time ( measured by the Functional Assessment of Cancer Therapy-Lung question naire and the Palliative Care Quality of Life Index ) , discussion of patient problems , and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline . RESULTS Analysis of QOL indicated a small but consistent difference between patients in the diary group and the st and ard care group . The diary group had a poorer QOL in many domains . Two different QOL summary scores ( total and overall QOL ) indicated a statistically significant between-group difference . No effects were found in relation to satisfaction with care , communication , or the discussion of patient problems . CONCLUSION The regular completion of a QOL question naire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients . Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL question naires in routine patient care Sc and J Prim Health Care 2003;21:00 - 00 . ISSN 0281 - 3432 Objective r - r To investigate general practitioner ( GP ) assessment of a structured oncology information pack sent to GPs when newly referred patients had visited a department of oncology for the first time , and to compare their assessment of this material with their assessment of traditional information provided by the department . Design r - r R and omised , unblinded clinical trial . Setting r - r Patients and GPs in the catchment area of a regional oncology department . Subjects / patients r - r 248 cancer patients and their 199 GPs . Main outcome measures r - r GP assessment of the quality of the information material received for each patient . Results r - r 88.3 % of the 248 question naires were returned . The structured information pack improved GP knowledge of oncology ; GPs found themselves better equipped to support and counsel patients during the course of their illness , and practitioner satisfaction with the department rose . Conclusion r - r Intervention , though reasonably simple , inexpensive and not particularly time-consuming , improved cooperation between the specialist department and the GP . While this is a small step in the right direction , the need remains for new initiatives and further studies into how to improve cooperation and communication between the primary and secondary healthcare sectors OBJECTIVES --To measure effects on terminally ill cancer patients and their families of coordinating the services available within the NHS and from local authorities and the voluntary sector . DESIGN --R and omised controlled trial . SETTING --Inner London health district . PATIENTS --Cancer patients were routinely notified from 1987 to 1990 . 554 patients expected to survive less than one year entered the trial and were r and omly allocated to a coordination or a control group . INTERVENTION -- All patients received routinely available services . Coordination group patients received the assistance of two nurse coordinators , whose role was to ensure that patients received appropriate and well coordinated services , tailored to their individual needs and circumstances . MAIN OUTCOME MEASURES -- Patients and carers were interviewed at home on entry to the trial and at intervals until death . Interviews after bereavement were also conducted . Outcome measures included the presence and severity of physical symptoms , psychiatric morbidity , use of and satisfaction with services , and carers ' problems . Results from the baseline interview , the interview closest to death , and the interview after bereavement were analysed . RESULTS --Few differences between groups were significant . Coordination group patients were less likely to suffer from vomiting , were more likely to report effective treatment for it , and less likely to be concerned about having an itchy skin . Their carers were more likely to report that in the last week of life the patient had had a cough and had had effective treatment for constipation , and they were less likely to rate the patient 's difficulty swallowing as severe or to report effective treatment for anxiety . Coordination group patients were more likely to have seen a chiropodist and their carers were more likely to contact a specialist nurse in a night time emergency . These carers were less likely to feel angry about the death of the patient . CONCLUSIONS --This coordinating service made little difference to patient or family outcomes , perhaps because the service did not have a budget with which it could obtain services or because the professional skills of the nurse-coordinators may have conflicted with the requirements of the coordinating role Objective : To assess the effectiveness of nurse led follow up in the management of patients with lung cancer . Design : R and omised controlled trial . Setting : Specialist cancer hospital and three cancer units in southeastern Engl and Participants : 203 patients with lung cancer who had completed their initial treatment and were expected to survive for at least 3 months . Intervention : Nurse led follow up of out patients compared with conventional medical follow up . Outcome measures : Quality of life , patients ' satisfaction , general practitioners ' satisfaction , survival , symptom-free survival , progression-free survival , use of re sources , and comparison of costs . Results : Patient acceptability of nurse led follow up was high : 75 % ( 203/271 ) of eligible patients consented to participate . Patients who received the intervention had less severe dyspnoea at 3 months ( P=0.03 ) and had better scores for emotional functioning ( P=0.03 ) and less peripheral neuropathy ( P=0.05 ) at 12 months . Intervention group patients scored significantly better in most satisfaction subscales at 3 , 6 , and 12 months ( P<0.01 for all subscales at 3 months ) . No significant differences in general practitioners ' overall satisfaction were seen between the two groups . No differences were seen in survival or rates of objective progression , although nurses recorded progression of symptoms sooner than doctors ( P=0.01 ) . Intervention patients were more likely to die at home rather than in a hospital or hospice ( P=0.04 ) , attended fewer consultations with a hospital doctor during the first 3 months ( P=0.004 ) , had fewer radiographs during the first 6 months ( P=0.04 ) , and had more radiotherapy within the first 3 months ( P=0.01 ) . No other differences were seen between the two groups in terms of the use of re sources . Conclusion : Nurse led follow up was acceptable to lung cancer patients and general practitioners and led to positive outcomes This study reports results from a r and omised controlled trial of nurse-led care and was design ed to determine whether nurse-led follow up improved patients morbidity and satisfaction with care in men treated with radical radiotherapy for prostate and bladder cancer . The aim was to compare outcomes in terms of toxicity , symptoms experienced , quality of life , satisfaction with care and health care costs , between those receiving nurse-led care and a group receiving st and ard care . The study population was of men prescribed radical radiotherapy ( greater than 60 Gy ) . Participants completed self- assessment question naires for symptoms and quality of life within the first week of radiotherapy treatment , at week 3 , 6 and 12 weeks from start of radiotherapy . Satisfaction with clinical care was also assessed at 12 weeks post-treatment . Observer-rated RTOG toxicity scores were recorded pre-treatment , weeks 1 , 3 , 6 and 12 weeks from start of radiotherapy . The results presented in this paper are on 115 of 132 ( 87 % ) of eligible men who agreed to enter the r and omised trial . 6 men ( 4 % ) refused and 11 ( 8 % ) were missed for inclusion in the study . Data were analysed as a comparison at cross-sectional time points and as a general linear model using multiple regression . There was no significant difference in maximum symptom scores over the time of the trial between nurse-led follow-up care and conventional medical care . Differences were seen in scores in the initial self assessment of symptoms ( week 1 ) that may have been as a result of early nursing intervention . Those men who had received nurse-led care were significantly more satisfied ( P < 0.002 ) at 12 weeks and valued the continuity of the service provided . There were also significant ( P < 0.001 ) cost benefits , with a 31 % reduction in costs with nurse-led , compared to medically led care . Evidence from this study suggests that a specialist nurse is able to provide safe follow up for men undergoing radiotherapy . The intervention focused on coping with symptoms , and provided continuity of care and telephone support . Further work is required to improve the management of patients during and after radiotherapy . © 2001 Cancer Research Campaign Objective : To determine the effect of a shared care programme on the attitudes of newly referred cancer patients towards the healthcare system and their health related quality of life and performance status , and to assess patients ’ reports on contacts with their general practitioner ( GP ) . Setting : Department of Oncology at Aarhus University Hospital and general practice s. Design : R and omised controlled trial in which patients completed question naires at three time points . The shared care programme included transfer of knowledge from the oncologist to the GP , improved communication between the parties , and active patient involvement . Participants : 248 consecutive cancer patients recently referred to the department . Main outcome measures : Patients ’ attitudes towards the healthcare services , their health related quality of life , performance status , and reports on contacts with their GPs . Results : The shared care programme had a positive effect on patient evaluation of cooperation between the primary and secondary healthcare sectors . The effect was particularly significant in men and in younger patients ( 18–49 years ) who felt they received more care from the GP and were left less in limbo . Young patients in the intervention group rated the GP ’s knowledge of disease and treatment significantly higher than young patients in the control group . The number of contacts with the GP was significantly higher in the intervention group . The EORTC quality of life question naire and performance status showed no significant differences between the two groups . Conclusions : An intersectoral shared care programme in which GPs and patients are actively involved has a positive influence on patients ’ attitudes towards the healthcare system . Young patients and men particularly benefit from the programme Abstract Objective : To assess the medical and psychosocial effects of early hospital discharge after surgery for breast cancer on complication rate , patient satisfaction , and psychosocial outcomes . Design : R and omised trial comparing discharge from hospital 4 days after surgery ( with drain in situ ) with discharge after drain removal ( mean 9 days in hospital ) . Psychosocial measurements performed before surgery and 1 and 4 months after . Setting : General hospital and cancer clinic in Rotterdam with a socioeconomically diverse population . Subjects : 125 women with operable breast cancer . Main outcome measures : Incidence of complications after surgery for breast cancer , patient satisfaction with treatment , and psychosocial effects of short stay or long stay in hospital . Results : Patient satisfaction with the short stay in hospital was high ; only 4 % ( 2/56 at 1 month after surgery and 2/52 at 4 months after surgery ) of patients indicated that they would have preferred a longer stay . There were no significant differences in duration of drainage from the axilla between the short stay and long stay groups ( median 8 v 9 days respectively , P=0.45 ) or the incidence of wound complications ( 10 patients v 9 patients ) . The median number of seroma aspirations per patient was higher for the long stay group ( 1 v 3.5 , P=0.04 ) . Leakage along the drain occurred more frequently in short stay patients ( 21 v 10 patients , P=0.04 ) . The two groups did not differ in scores for psychosocial problems ( uncertainty , anxiety , loneliness , disturbed sleep , loss of control , threat to self esteem ) , physical or psychological complaints , or in the coping strategies used . Before surgery , short stay patients scored higher on scales of depression ( P=0.03 ) and after surgery they were more likely to discuss their disease with their families ( at 1 month P=0.004 , at 4 months P=0.04 ) . Conclusions : Early discharge from hospital after surgery for breast cancer is safe and is well received by patients . Early discharge seems to enhance the opportunity for social support within the family . Key messages Early discharge from hospital after breast cancer surgery does not lead to an increase in the incidence of wound infection or seroma formation A short stay in hospital , with support from community nurses on the patient 's return home , is acceptable to patients Psychosocial rehabilitation is not influenced by early discharge Recovery in the family environment may facilitate discussion of the illness Patients recovering from surgery for breast cancer need not spend more than three days in hospital provided that they are in good physical condition and there is adequate nursing support available in the PURPOSE To describe a r and omized trial of a cognitive behavioral intervention on reducing symptom severity among patients diagnosed with solid tumors and undergoing a first course of chemotherapy and to determine whether the intervention had an additive or interactive effect on symptom severity in the presence of supportive care medications . PATIENTS AND METHODS Patients ( N = 237 ) were accrued from comprehensive and community cancer centers , interviewed , and r and omly assigned to either the experimental intervention ( n = 118 ) or conventional care ( n = 119 ) . A symptom severity index , based on summed severity scores across 15 symptoms , was the primary outcome . Each patient 's site of cancer , stage at diagnosis , chemotherapy protocol s , and use of supportive medications were learned from medical records . RESULTS Groups were equivalent at baseline , and attrition by characteristics by group was not different . The proportion of patients not receiving chemotherapy at 10 and 20 weeks did not differ by group . At the 10- and 20-week observations , there was a significant interaction between the experimental
Output:
| Based on the median effect size estimates , no significant difference in patient health-related outcomes was found between patients assigned to interventions and those assigned to usual care .
Results from this Cochrane review do not allow us to conclude on the effectiveness of included interventions to improve continuity of care on patient , healthcare provider or process of care outcomes . |
MS211711 | ***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 Thrombosis of tunneled central venous catheters ( CVC ) in hemodialysis ( HD ) patients is common and it can lead to the elimination of vascular sites . To compare the efficacy of alteplase vs. urokinase in reestablishing adequate blood flow through completely occluded vascular catheters . Methods In this r and omized study , patients with completely occluded tunneled HD catheters received 40 minutes intracatheter dwell with alteplase ( 1 mg/mL ) or urokinase ( 5000 IU/mL ) . Primary endpoint was the proportion of patients with occluded catheters achieving post-thrombolytic blood flow of ≥250 mL/min . Safety endpoints included the incidence of hemorrhagic and infectious complications . Findings Eligible adult patients ( n = 100 ) were treated with alteplase ( n = 44 ) or urokinase ( n = 56 ) . The two groups were similar in gender ( male : 51.8 % vs. 56.8 % , P = 0.35 ) , age ( 60 ± 12 vs. 59 ± 13 years , P = 0.71 ) , time on dialysis ( 678 ± 203 vs. 548 ± 189 days , P = 0.77 ) , diabetes and cardiovascular disease ( 55.6 % vs. 70.4 % , P = 0.08 and 17.8 % vs. 22.7 % , P = 0.38 , respectively ) , jugular vein as main vascular access ( 54.8 % vs. 62.5 % , P = 0.57 ) , and time of CVC ( 278 ± 63 vs. 218 ± 59 days , P = 0.67 ) . Primary success with alteplase and urokinase occurred in 42/44 ( 95 % ) vs. 46/56 ( 82 % ) , P = 0.06 . Success was not achieved after the second dose of alteplase and urokinase in 1 and 7 cases , respectively ( 2 % vs. 12 % , P = 0.075 ) . Serious adverse effects were not observed in both groups . There was no difference between the two groups in infectious complications ( P = 0.94 ) . Discussion Alteplase and urokinase are effective thrombolytic agents for restoring HD catheter patency . Our study has revealed a likely slight superiority of alteplase over urokinase for unblocking central lines , but which has enrolled too few patients to be able to detect a difference of this size BACKGROUND The effectiveness of various solutions instilled into the central venous catheter lumens after each hemodialysis session ( catheter locking solutions ) to decrease the risk of catheter malfunction and bacteremia in patients undergoing hemodialysis is unknown . METHODS We r and omly assigned 225 patients undergoing long-term hemodialysis in whom a central venous catheter had been newly inserted to a catheter-locking regimen of heparin ( 5000 U per milliliter ) three times per week or recombinant tissue plasminogen activator ( rt-PA ) ( 1 mg in each lumen ) substituted for heparin at the midweek session ( with heparin used in the other two sessions ) . The primary outcome was catheter malfunction , and the secondary outcome was catheter-related bacteremia . The treatment period was 6 months ; treatment assignments were concealed from the patients , investigators , and trial personnel . RESULTS A catheter malfunction occurred in 40 of the 115 patients assigned to heparin only ( 34.8 % ) and 22 of the 110 patients assigned to rt-PA (20.0%)--an increase in the risk of catheter malfunction by a factor of almost 2 among patients treated with heparin only as compared with those treated with rt-PA once weekly ( hazard ratio , 1.91 ; 95 % confidence interval [ CI ] , 1.13 to 3.22 ; P = 0.02 ) . Catheter-related bacteremia occurred in 15 patients ( 13.0 % ) assigned to heparin only , as compared with 5 ( 4.5 % ) assigned to rt-PA ( corresponding to 1.37 and 0.40 episodes per 1000 patient-days in the heparin and rt-PA groups , respectively ; P = 0.02 ) . The risk of bacteremia from any cause was higher in the heparin group than in the rt-PA group by a factor of 3 ( hazard ratio , 3.30 ; 95 % CI , 1.18 to 9.22 ; P = 0.02 ) . The risk of adverse events , including bleeding , was similar in the two groups . CONCLUSIONS The use of rt-PA instead of heparin once weekly , as compared with the use of heparin three times a week , as a locking solution for central venous catheters significantly reduced the incidence of catheter malfunction and bacteremia . ( Current Controlled Trials number , IS RCT N35253449 . ) Objective : To compare dialysis catheter function according to catheter site . Design : Multicenter , open , r and omized controlled trial . Setting : Nine university-affiliated hospitals and three general hospitals in France . Patients : Seven hundred thirty-six patients in intensive care units who required a first venous catheterization to perform either intermittent hemodialysis ( 470 patients with 1275 sessions ) or continuous renal replacement therapy ( 266 patients with 1003 days ) . Intervention : Patients r and omly received either femoral ( n = 370 ) or jugular ( n = 366 ) catheterization . For the jugular site , right-side position ( n = 252 ) was recommended . Measurements and Main Results : Time to catheter ablation for dysfunction , urea reduction ratio ( intermittent hemodialysis ) , and downtime ( continuous renal replacement therapy ) were assessed for all participants and evaluated by r and omly assigned catheterization site ( femoral or jugular ) . Baseline demography and dialysis prescriptions were similar between the site arms . In modified intent-to-treat , catheter dysfunction occurred in 36 of 348 ( 10.3 % ) and 38 of 342 ( 11.1 % ) patients in the femoral and jugular groups , respectively . The risk of catheter dysfunction did not significantly differ between r and omized groups ( hazard ratio , 1.06 ; 95 % confidence interval , 0.67–1.68 ; p = .80 ) . Compared to the femoral site , the observed risk of dysfunction decreased in the right jugular position ( 15 of 226 ; 6.6 % ; adjusted hazard ratio , 0.58 ; 95 % confidence interval , 0.31–1.07 ; p = .09 ) and significantly increased in the left jugular position ( 23 of 118 ; 19.5 % ; adjusted hazard ratio , 1.89 ; 95 % confidence interval , 1.12–3.21 ; p < .02 ) . The postintermittent hemodialysis mean urea reduction ratio per session was 50.8 % ( st and ard deviation , 16.1 ) for femoral vs. 52.8 % ( st and ard deviation , 15.8 ) for jugular ( p = .30 ) sites , and the median continuous renal replacement therapy downtime per patient-day was 1.17 hrs ( interquartile range , 0.75–1.50 ) for both sites ( p = .98 ) . Conclusions : In terms of catheter dysfunction and dialysis performance among critically ill adults requiring acute renal replacement therapy , jugular site did not significantly outperform femoral site placement . ( Crit Care Med 2010 ; 38:1118–1125 PURPOSE To compare the effectiveness of two treatments for tunneled hemodialysis catheter malfunction : percutaneous fibrin sheath stripping ( PFSS ) and over-the-wire catheter exchange ( EX ) . MATERIAL S AND METHODS Adult patients with poorly functioning tunneled hemodialysis catheters ( flow rates < 200 mL/min ) were r and omly assigned to receive either PFSS or EX . Over the course of 20 months , 30 patients ( 37 encounters ) referred to a single institution met the inclusion criteria and consented to participate . PFSS employed transcatheter snares via femoral vein puncture , whereas EX was performed over a guide wire with use of fluoroscopic guidance . Patients were followed up to determine the duration of continued adequate hemodialysis via manipulated catheters for up to 4 months ( primary outcome measure ) . RESULTS Overall technical success rate was 97 % . Mean catheter patency for the PFSS group was 24.5 + /- 29.3 days , and 52.2 + /- 43 days for the EX group ( P < .0001 ) . After EX , patency rates at 1 , 2 , 3 , and 4 months were 71 % , 33 % , 27 % , and 27 % , compared to 31 % , 16 % , 7 % , and 0 % after PFSS ( P = .04 , logrank test ) . Exchanged catheters were significantly more likely to be patent for as long as 4 months ( 23 % versus 0 % ; P < .05 , chi2 test ) . CONCLUSIONS Malfunctioning tunneled hemodialysis catheters treated by means of EX are significantly more likely to remain patent for up to 4 months than are those treated by means of PFSS . According to the results of this trial , PFSS should not be performed as a routine therapy for catheter malfunction Background . A well-functioning vascular access ( VA ) is essential to efficient dialysis therapy . Guidelines have been implemented improving care , yet access use varies widely across countries and VA complications remain a problem . This study took advantage of the unique opportunity to utilize data from the Dialysis Outcomes and Practice Patterns Study ( DOPPS ) to examine international trends in VA use and trends in patient characteristics and practice s associated with VA use from 1996 to 2007 . DOPPS is a prospect i ve , observational study of haemodialysis ( HD ) practice s and patient outcomes at > 300 HD units from 12 countries and has collected data thus far from > 35 000 r and omly selected patients . Methods . VA data were collected for each patient at study entry ( 1996–2007 ) . Practice pattern data from the facility medical director , nurse manager and VA surgeon were also analysed . Results . Since 2005 , a native arteriovenous fistula ( AVF ) was used by 67–91 % of prevalent patients in Japan , Italy , Germany , France , Spain , the UK , Australia and New Zeal and , and 50–59 % in Belgium , Sweden and Canada . From 1996 to 2007 , AVF use rose from 24 % to 47 % in the USA but declined in Italy , Germany and Spain . Moreover , graft use fell by 50 % in the USA from 58 % use in 1996 to 28 % by 2007 . Across three phases of data collection , patients consistently were less likely to use an AVF versus other VA types if female , of older age , having greater body mass index , diabetes , peripheral vascular disease or recurrent cellulitis/gangrene . In addition , countries with a greater prevalence of diabetes in HD patients had a significantly lower percentage of patients using an AVF . Despite poorer outcomes for central vein catheters , catheter use rose 1.5- to 3-fold among prevalent patients in many countries from 1996 to 2007 , even among non-diabetic patients 18–70 years old . Furthermore , 58–73 % of patients new to end-stage renal disease ( ESRD ) used a catheter for the initiation of HD in five countries despite 60–79 % of patients having been seen by a nephrologist > 4 months prior to ESRD . Patients were significantly ( P < 0.05 ) less likely to start dialysis with a permanent VA if treated in a faciity that ( 1 ) had a longer time from referral to access surgery evaluation or from evaluation to access creation and ( 2 ) had longer time from access creation until first AVF cannulation . The median time from referral until access creation varied from 5–6 days in Italy , Japan and Germany to 40–43 days in the UK and Canada . Compared to patients using an AVF , patients with a catheter displayed significantly lower mean Kt/V levels . Conclusions . Most countries meet the contemporary National Kidney Foundation 's Kidney Disease Outcomes Quality Initiative goal for AVF use ; however , there is still a wide variation in VA preference . Delays between the creation and cannulation must be improved to enhance the chances of a future permanent VA . Native arteriovenous fistula is the VA of choice ensuring dialysis adequacy and better patient outcomes . Graft is , however , a better alternative than catheter for patients where the creation of an attempted AVF failed or could not be created for different reasons BACKGROUND AND OBJECTIVES Hemodialysis catheters are frequently complicated by dysfunction from fibrin sheaths . Previous studies of sheath disruption have method ologic limitations but suggest that the patency after disruption is short . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS A r and omized , controlled
Output:
| Catheter exchange was reported to be superior to sheath disruption with respect to catheter survival ( 30 participants : MD 213.00 days , 95 % CI 205.70 to 220.30).There is insufficient evidence to suggest any specific intervention is superior in terms of ensuring either dialysis adequacy or reduced risk of adverse events .
AUTHORS ' CONCLUSIONS Thrombolysis , fibrin sheath disruption and over-the-wire catheter exchange are effective and appropriate therapies for immediately restoring catheter patency in dysfunctional cuffed and tunnelled HD catheters .
On current data there is no evidence to support physical intervention over the use of pharmaceutical agents in the acute setting .
Pharmacological interventions appear to have a bridging role and long-term catheter survival may be improved by fibrin sheath disruption and is probably superior following catheter exchange .
There is no evidence favouring any of these approaches with respect to dialysis adequacy or risk of adverse events . |
MS211712 | ***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 Associations between adiposity and circulating inflammation markers are assumed to be causal , although the direction of the relationship has not been proven . OBJECTIVE The aim of the study was to explore the causal direction of the relationship between adiposity and inflammation using a bidirectional Mendelian r and omization approach . METHODS In the PROSPER study of 5804 elderly patients , we related C-reactive protein ( CRP ) single nucleotide polymorphisms ( SNPs ) ( rs1800947 and rs1205 ) and adiposity SNPs ( FTO and MC4R ) to body mass index ( BMI ) as well as circulating levels of CRP and leptin . We gave each individual two allele scores ranging from zero to 4 , counting each pair of alleles related to CRP levels or BMI . RESULTS With increasing CRP allele score , there was a stepwise decrease in CRP levels ( P for trend < 0.0001 ) and a 1.98 mg/liter difference between extremes of the allele score distribution , but there was no associated change in BMI or leptin levels ( P > or= 0.89 ) . By contrast , adiposity allele score was associated with 1 ) an increase in BMI ( 1.2 kg/m(2 ) difference between extremes ; P for trend 0.002 ) ; 2 ) an increase in circulating leptin ( 5.77 ng/ml difference between extremes ; P for trend 0.0027 ) ; and 3 ) increased CRP levels ( 1.24 mg/liter difference between extremes ; P for trend 0.002 ) . CONCLUSIONS Greater adiposity conferred by FTO and MC4R SNPs led to higher CRP levels , with no evidence for any reverse pathway . Future studies should extend our findings to other circulating inflammatory parameters . This study illustrates the potential power of Mendelian r and omization to dissect directions of causality between intercorrelated metabolic factors This study was performed to evaluate the relation of high-sensitivity C-reactive protein ( hsCRP ) with several cardiovascular risk factors such as age , blood pressure , smoking habit and serum lipids , body mass index , blood glucose , regular exercise , alcohol drinking , white blood cell counts in a cross-sectional survey . Plasma hsCRP was measured by immunoturbidimetry in 202 subjects , aged over 50 yr , who participated in health-check survey in a rural area of Jeollanamdo , Korea . Plasma hsCRP level was 1.9±3.0 mg/dL. There were significant associations between hsCRP levels and age , white blood cell counts , blood glucose , diastolic blood pressure , HDL-cholesterol , body mass index and smoking status . In stepwise multivariate regression analysis , white blood cell counts , age , blood glucose , smoking status and body mass index were independent correlates of hsCRP levels . In conclusion , plasma hsCRP levels were associated with several cardiovascular risk factors , and these data are compatible with the hypothesis that CRP levels may be a marker for pre clinical cardiovascular disease . Further what we need now are prospect i ve studies to evaluate the association of C-reactive protein concentrations with subsequent cardiac events CONTEXT There are few data directly comparing the effects of physical activity and body weight on cardiovascular biomarkers . OBJECTIVE To examine the association of physical activity and body mass index ( BMI , defined as weight in kilograms divided by the square of height in meters ) alone and in combination with cardiovascular biomarkers . DESIGN , SETTING , AND PARTICIPANTS Cross-sectional analysis of 27,158 apparently healthy US women ( mean age , 54.7 years ) at the time of enrollment ( 1992 - 1995 ) in the Women 's Health Study , a r and omized , double-blind , placebo-controlled trial of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer . MAIN OUTCOME MEASURES The association of physical activity and BMI with high-sensitivity C-reactive protein ( CRP ) , fibrinogen , soluble intracellular adhesion molecule 1 ( ICAM-1 ) , homocysteine , low- and high-density lipoprotein ( LDL and HDL ) cholesterol , total cholesterol , apolipoprotein A-1 and B100 , lipoprotein(a ) , and creatinine . RESULTS Lower levels of physical activity and higher levels of BMI were independently associated ( P for trend < .001 ) with adverse levels of nearly all lipid and inflammatory biomarkers . High BMI showed stronger associations with these biomarkers than physical inactivity . For example , using the reference group of physically active , normal weight women ( energy expenditure > or = 1000 kcal/week ; BMI , 18.5 - 24.9 ) and adjusting for age , race , smoking , blood pressure , diabetes , menopausal status , and hormone use , the odds ratios ( 95 % confidence intervals [ CIs ] ) for having CRP > 3 mg/L were : for inactive , normal weight women 1.26 ( 1.15 - 1.37 ) ; active , overweight 2.68 ( 2.41 - 2.98 ) ; inactive , overweight 3.11 ( 2.84 - 3.41 ) ; active , obese 8.25 ( 7.15 - 9.51 ) ; and inactive , obese 9.86 ( 8.84 - 10.99 ) . In similar analyses , the odds ratios ( 95 % CIs ) for having HDL cholesterol < 50 mg/dL were 1.20 ( 1.11 - 1.30 ) ; 2.25 ( 2.04 - 2.49 ) ; 2.62 ( 2.41 - 2.85 ) ; 4.21 ( 3.68 - 4.81 ) ; and 5.27 ( 4.77 - 5.84 ) , respectively , and for having apolipoprotein B100 > 120 mg/dL they were 1.21 ( 1.11 - 1.33 ) ; 1.86 ( 1.66 - 2.08 ) ; 2.06 ( 1.88 - 2.67 ) ; 2.35 ( 2.04 - 2.70 ) ; and 2.33 ( 2.09 - 2.59 ) . Fibrinogen , ICAM-1 , apolipoprotein A1 , total cholesterol , and LDL cholesterol showed similar associations . By contrast , homocysteine , lipoprotein ( a ) , and creatinine showed weak or nonsignificant associations . CONCLUSIONS High BMI was more strongly related to adverse cardiovascular biomarker levels than physical inactivity . However , within BMI categories , physical activity was generally associated with more favorable cardiovascular biomarker levels than inactivity BACKGROUND Recent prospect i ve data suggest that intake of rapidly digested and absorbed carbohydrates with a high dietary glycemic load is associated with an increased risk of ischemic heart disease . OBJECTIVE We examined whether a high dietary glycemic load was associated with elevated hs-CRP concentrations and whether this association was modified by body mass index ( BMI ; in kg/m(2 ) ) . DESIGN In 244 apparently healthy women , we measured plasma hs-CRP concentrations and determined average dietary glycemic loads with a vali date d semiquantitative food-frequency question naire . Using multiple regression models , we evaluated the association between dietary glycemic load and plasma hs-CRP after adjusting for age ; treatment status ; smoking status ; BMI ; physical activity level ; parental history of myocardial infa rct ion ; history of hypertension , diabetes , and high cholesterol ; postmenopausal hormone use ; alcohol intake ; and other dietary variables . RESULTS We found a strong and statistically significant positive association between dietary glycemic load and plasma hs-CRP . The median hs-CRP concentration for the lowest quintile of dietary glycemic load was 1.9 mg/L and for the highest quintile was 3.7 mg/L ; corresponding multivariate-adjusted geometric means were 1.4 and 3.8 mg/L , respectively ( P for trend < 0.01 ) . This association was significantly modified by BMI . Among women with a BMI greater-than-or-equal 25 , the multivariate-adjusted geometric mean hs-CRP concentration in the lowest quintile was 1.6 mg/L and in the highest quintile was 5.0 mg/L ; however , among women with a BMI < 25 , the corresponding means were 1.1 and 3.1 mg/L , respectively ( P = 0.01 for interaction ) . CONCLUSIONS Dietary glycemic load is significantly and positively associated with plasma hs-CRP in healthy middle-aged women , independent of conventional risk factors for ischemic heart disease . Exacerbation of the proinflammatory process may be a mechanism whereby a high intake of rapidly digested and absorbed carbohydrates increases the risk of ischemic heart disease , especially in overweight women prone to insulin resistance CONTEXT The link between C-reactive protein ( CRP ) and adiposity deserves to be further explored , considering the controversial diabetogenic role of CRP . OBJECTIVE We explored the potential causal role of CRP on measures of adiposity . DESIGN We used a Mendelian r and omization approach with the CRP and LEPR genes as instrumental variables in a cross-sectional Caucasian population -based study comprising 2526 men and 2836 women . Adiposity was measured using body mass index ( BMI ) , fat and lean mass estimated by bioelectrical impedance , and waist circumference . RESULTS Log-transformed CRP explained by the rs7553007 single-nucleotide polymorphism tagging the CRP gene was significantly associated with BMI [ regression coefficient : 1.22 ( 0.18 ; 2.25 ) , P = 0.02 ] and fat mass [ 2.67 ( 0.65 ; 4.68 ) , P = 0.01 ] but not with lean mass in women , whereas no association was found in men . Log-transformed CRP explained by the rs1805096 LEPR single-nucleotide polymorphism was also positively associated , although not significantly , with BMI or fat mass . The combined CRP-LEPR instrument explained 2.24 and 0.77 % of CRP variance in women and men , respectively . Log-transformed CRP explained by this combined instrument was significantly associated with BMI [ 0.98 ( 0.32 ; 1.63 ) , P = 0.004 ] , fat mass [ 2.07 ( 0.79 ; 3.34 ) , P = 0.001 ] , and waist [ 2.09 ( 0.39 ; 3.78 ) , P = 0.01 ] in women but not men . CONCLUSION Our data suggest that CRP is causally and positively related to BMI in women and that this is mainly due to fat mass . Results on the combined CRP-LEPR instrument suggest that leptin may play a role in the causal association between CRP and adiposity in women . Results in men were not significant OBJECTIVE We evaluated the association of obesity with various markers of chronic inflammation , in a population -based sample of 3,042 adults . METHODS During 2001 - 2002 , we r and omly enrolled 1,514 men ( 18 - 87 years old ) and 1,528 women ( 18 - 89 years old ) , from the Attica area , Greece ; the sampling was stratified by the age-sex distribution of the region ( census 2001 ) . Among several variables , we also measured various inflammatory markers ( C-reactive protein , tumor necrosis factor alpha , amyloid A , white blood cells and interleukin-6 ) and anthropometric variables ( weight , height , waist and hip circumferences ) . Central fat was defined as waist-to-hip ratio > or=0.95 in men and > or=0.8 in women , while obesity as body mass index ( BMI ) > 29.9 kg/m(2 ) . RESULTS Central fat prevailed in 36 % of men and 43 % of women ( p<0.001 ) , while obesity prevailed in 20 % of men and 15 % of women , respectively . Compared to participants with normal body fat distribution , those with central fat exhibited 53 % higher C-reactive protein levels , 30 % higher tumor necrosis factor , alpha levels , 26 % higher amyloid A levels , 17 % higher white blood cell counts and 42 % higher interleukin-6 levels ( all p<0.05 ) . We observed that all inflammation markers were related to BMI ( index for obesity ) , waist and to waist-to-hip ratio ( indices for central fat ) , in both genders . Moreover , the models that included waist or waist-to-hip ratio as independent variable had higher explanatory ability ( i.e. R(2 ) ) than the models included BMI , especially in women , even after adjusting for age and various other potential confounders . CONCLUSION Our results suggest a relationship between central adiposity and inflammation process , irrespective of age and other potential confounders . This association was more prominent than the relationship between total obesity and inflammation . It could be hypothesized that a
Output:
| Obesity is associated with elevated levels of CRP and the association is stronger in women and North Americans/Europeans .
The sex difference only emerges in adulthood |
MS211713 | ***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 The purpose of this article was to investigate the role of control beliefs in mediating the relationship between driving cessation and change in depressive symptoms in a population -based sample of older adults . DESIGN AND METHODS We report results from a prospect i ve , community-based cohort study that included two waves of data collected in 1992 and 1994 . Participants consisted of 700 men and women aged 70 and older , including 647 drivers and 53 participants who ceased driving between baseline ( 1992 ) and follow-up ( 1994 ) . Participants took part in interviews that included assessment s of driving status , sociodemographic characteristics , self-rated health , sensory function , depressive symptoms ( through the Center for Epidemiologic Studies -Depression scale ) , and expectancy of control . Using multilevel general linear models , we examined the extent to which driving status , expectancy of control , and relevant covariates explained change in depressive-symptom scores between baseline and follow-up . RESULTS Driving cessation was associated with an increase in depressive symptoms from baseline to follow-up . The higher depressive-symptom scores of ceased drivers relative to those of individuals who remained drivers at both waves was partly explained by a corresponding decrease in the sense of control among ceased drivers , and increased control beliefs among drivers . IMPLICATION S Interventions aim ed at promoting the maintenance of personal agency and associated control beliefs could be protective against the negative psychological concomitants of driving cessation Driving has been regarded as an activity of daily living that is important in maintaining a person 's independence in the community , access to employment , and social activities . Many patients , however , using opioid medications on a regular basis ( Chronic Opioid Analgesic Therapy : COAT ) to ameliorate their intractable pain have been restricted from driving out of concern that skills would be impaired and driving safety compromised by these medications . Yet there are no driving studies which have explored the effects of using opioid analgesics for an extended period of time . This pilot study was design ed to determine the effects of medically prescribed , stable opioid use on the driving abilities of patients with persistent , nonmalignant pain . Sixteen patients with chronic nonmalignant pain on COAT , who met criteria for participation in the study , underwent a comprehensive off-road driving evaluation using measures which have been shown to be sensitive in predicting on-road driving performance . The evaluation consisted of a pre-driver evaluation ( PDE ) , a simulator evaluation ( SDE ) , and behavioral observation during simulator performance . Patients in the COAT group were compared to a historical control group of 327 cerebrally compromised patients ( CComp ) who had undergone the same evaluation and then passed an on-road , behind-the-wheel evaluation ( BTW Pass ; n = 162 ) or failed ( BTW Fail ; n = 165 ) . Results revealed that COAT patients generally outperformed the CComp patients as a group by equaling or exceeding PDE and SDE scores of the BTW Fail patients as well as the BTW Pass patients on all measures that differentiated the groups . Notably , COAT patients had a relatively poorer performance than CComp patients on specific neuropsychometric tests in the PDE ; however , the differences were not statistically significant and did not imply a systematic pattern of scores that reflected domain-specific deficits . Behaviorally , COAT patients were generally superior to CComp patients , also ; however , COAT patients had greater difficulty in following instructions and as well as a tendency toward impulsivity , like the BTW fail group . While there was general support for the notion that COAT did not significantly impair the perception , cognition , coordination , and behavior measured in off-road tests that have been regarded as requisite for on-road driving , method ological problems may limit the generalizability of results and recommendations are made for research beyond a pilot study & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Abstract Objective To determine the efficacy of oral morphine in relieving the sensation of breathlessness in patients in whom the underlying aetiology is maximally treated . Design R and omised , double blind , placebo controlled crossover study . Setting Four outpatient clinics at a hospital in South Australia . Participants 48 participants who had not previously been treated with opioids ( mean age 76 , SD 5 ) with predominantly chronic obstructive pulmonary disease ( 42 , 88 % ) were r and omised to four days of 20 mg oral morphine with sustained release followed by four days of identically formulated placebo , or vice versa . Laxatives were provided as needed . Main outcome measures Dyspnoea in the morning and evening as shown on a 100 mm visual analogue scale , quality of sleep , wellbeing , performance on physical exertion , and side effects as measured at the end of the four day treatment period . Results 38 participants completed the study ; three withdrew because of definite and two because of possible side effects of morphine ( nausea , vomiting , and sedation ) . Participants reported significantly different dyspnoea scores when treated with morphine : an improvement of 6.6 mm ( 95 % confidence interval 1.6 mm to 11.6 mm ) in the morning and of 9.5 mm ( 3.0 mm to 16.1 mm ) in the evening ( P = 0.011 and P = 0.006 , respectively ) . During the period in which they were taking morphine participants also reported better sleep ( P = 0.039 ) . More participants reported distressing constipation while taking morphine ( 9 v 1 , P = 0.021 ) in spite of using laxatives . All other side effects were not significantly worse with morphine , although the study was not powered to address side effects . Conclusions Sustained release , oral morphine at low dosage provides significant symptomatic improvement in refractory dyspnoea in the community setting OBJECTIVES Increasing age , socioeconomic factors , and declining function and health have been linked to driving cessation , but little is known about the consequences of stopping driving . This study was design ed to test the hypothesis that driving cessation leads to a decline in out-of-home activity levels . METHODS In 1989 a survey of driving practice s was administered to surviving noninstitutionalized members of the New Haven Established Population s for Epidemiologic Studies of the Elderly ( EPESE ) cohort . Of 1,316 respondents , 502 were active drivers as of 1988 , 92 had stopped driving between 1982 and 1987 , and 722 never drove or stopped before 1982 . Information on sociodemographic and health-related variables came from in-home EPESE interviews in 1982 , 1985 , and 1988 , and from yearly phone interviews . Activity was measured at all three in-home interviews , and an activity measure was created based on self-reported participation in nine out-of-home activities . A repeated measures r and om-effects model was used to test the effect of driving cessation on activity while controlling for potential confounders . RESULTS Driving cessation was strongly associated with decreased out-of-home activity levels ( coefficient-1.081 , st and ard error 0.264 , p < .001 ) after adjustment for sociodemographic and health-related factors . DISCUSSION The potential consequences of driving limitations or cessation should be taken into account when advising older drivers and developing alternative transportation strategies to help maintain their mobility Context Obstructive sleep apnea ( OSA ) is associated with sleepiness and poor concentration , symptoms that could impair driving performance . Contribution This study evaluated simulated driving performance in 38 patients with untreated OSA and 20 control participants under 3 conditions : unrestricted sleep , sleep restriction , and consumption of alcohol . Compared with control participants , patients with untreated OSA had worse simulated driving performance . Patients with OSA also had greater decrements in driving performance after sleep restriction and after alcohol consumption . Implication Consider alerting patients about the potential negative influence of untreated OSA on driving performance and their heightened vulnerability after sleep deprivation and alcohol consumption . The Editors Obstructive sleep apnea ( OSA ) causes excessive daytime somnolence and reduced vigilance , concentration , and neurocognitive function ( 1 , 2 ) . Patients with OSA , particularly those with moderate to severe disease , have a 2- to 7-fold increased risk for motor vehicle accidents ( 310 ) . Community surveys have shown that approximately 7 % of the middle-aged population has at least mild OSA ( > 10 obstructive events per hour of sleep ) ( 1113 ) , and up to 80 % of these cases are undiagnosed ( 1416 ) . For patients whose condition is diagnosed , delays in instituting treatment are common ( 17 ) . Between 46 % and 83 % of patients do not adhere to treatment over the long term ( 18 ) . The many patients with undiagnosed or untreated OSA represent a serious public health concern with respect to road safety . Accidents related to OSA result in an estimated 1400 road fatalities and cost $ 15.9 billion annually in the United States alone ( 19 ) . Improving access to diagnosis and treatment may help reduce this public health burden . However , even with improved sleep medicine services , many unidentified or untreated patients with OSA will probably remain at increased risk for motor vehicle accidents . A better underst and ing of the factors contributing to motor vehicle accidents among patients with OSA is therefore needed to develop cost-effective prevention strategies . This study was design ed to compare the effects of 2 common lifestyle factors , low-dose alcohol and acute partial sleep deprivation , on driving simulator performance between untreated patients with OSA and healthy matched control participants . We postulated that because of previous chronic sleep disruption and possible hypoxia-induced brain damage ( 2 , 2026 ) , patients with OSA would be more vulnerable to the effects of these common , mild central nervous system stressors and would experience significantly greater decrements in driving performance . Methods The study was approved by the Human Research Ethics Committees of the Repatriation General Hospital , University of South Australia , and University of Adelaide . Participants were introduced to the study objectives and protocol during an introductory session , gave written informed consent , and were remunerated for their participation . Study Design Patients with OSA and control participants underwent driving simulator assessment s under 3 conditions that were presented in r and om and counterbalanced order : after a normal nighttime sleep , after a single night of sleep restriction ( 4 hours in bed from 2:00 a.m. to 6:00 a.m. ) , and after acute administration of low-dose alcohol ( target blood alcohol concentration , 0.05 g/dL ) . All driving simulator sessions began at 2:00 p.m. and were conducted at least 5 days apart to avoid carryover effects from the previous interventions . Participant Selection Thirty-eight untreated patients with OSA of varying severity were recruited after diagnostic polysomnography . Neither they nor their referring physician had specific concerns about their driving . To minimize selection bias , patients were told that the study objective was to investigate general neurocognitive performance ; they were unaware that the trial measured driving performance until after they agreed to attend an introductory session . Twenty healthy control participants matched for age and sex were recruited from the general population through newspaper advertisements , which only generally described the study and did not mention driving performance measures . Exclusion criteria were employment as a professional driver or shift worker ; history of driving less than 2 years or less than 2 hours per week ; notable medical comorbid conditions ( such as cardiac or respiratory failure ) , periodic limb movement disorder ( periodic limb movement arousal index > 5 per hour ) , or past head injury or depression ; use of alertness-altering prescription medications that may change neurocognitive function ( such as antihistamines , opiates , or antidepressants ) ; and history of alcohol abuse or current use of recreational drugs . Control participants were also excluded if they had higher-than-normal scores on sleep quality and daytime drowsiness question naires . Baseline Measures Before the driving simulator assessment , all participants completed question naires that evaluated general health ( medical conditions , medication , alcohol intake , caffeine
Output:
| No significant impact of regular therapeutic opioid agonists on people ’s driving-related psychomotor skills was reported . |
MS211714 | ***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: Quetiapine is an atypical antipsychotic used for treatment of schizophrenia . Variability in response to this drug may be associated with pharmacogenetics . The aim of this study was to identify genetic markers related to the pharmacokinetics , pharmacodynamics , and adverse effects of quetiapine . The study population comprised 79 healthy volunteers from two bioequivalence trials who were genotyped to identify polymorphisms in genes encoding enzymes , receptors , and transporters . Quetiapine plasma levels were quantified using high-performance liquid chromatography/mass spectrometry . Prolactin plasma levels were detected by indirect chemiluminescence . Possible adverse effects were recorded throughout the study . Factors with P value of 0.1 or less in the univariate analysis were included in a multiple regression analysis ( logistic regression for adverse reactions ) . The area under the curve and clearance of quetiapine were affected by polymorphisms in CYP1A2 and DRD3 , respectively . Men had a lower quetiapine area under the curve compared with women . Prolactin iCmax was higher in volunteers harboring polymorphisms in CYP2C19 and AGT . An association was detected between polymorphisms in CYP1A1 and CYP2C9 and somnolence . Several polymorphisms are responsible for differences in the pharmacokinetics , pharmacodynamics , and safety of quetiapine in healthy individuals Objectives Hyperprolactinemia is a common side effect of first-generation antipsychotics mediated by antagonism of dopaminergic neurotransmission in the pituitary . Most first-generation antipsychotics are metabolized by CYP2D6 in the liver . Further , CYP2D6 is expressed in the human brain as a 5-methoxyindolethylamine O-demethylase potentially contributing to regeneration of serotonin from 5-methoxytryptamine . As dopaminergic neurotransmission is subject to regulation by serotonin , CYP2D6 may exert a nuanced ( serotonergic ) influence on dopaminergic tone in the pituitary . CYP2D6 * 10 is an allele associated with reduced enzyme function and occurs in high frequency ( about 50 % ) in Asians . We prospect ively evaluated significance of CYP2D6 genetic variation for prolactin response to perphenazine ( a model first-generation antipsychotic ) in Asians . Methods A single oral dose of perphenazine ( 0.1 mg/kg ) or placebo was administered to 22 medication-free nonsmoker healthy male Chinese – Canadian volunteers , following a double-blind within-subject r and omized design . Blood sample s were drawn at baseline and 2 , 3 , 4 , 5 and 6 h after drug administration . Results In volunteers with CYP2D6 * 10/CYP2D6 * 10 genotype , the mean area under curve ( AUC0−6 ) for perphenazine concentration was 2.9-fold higher than those who carry the CYP2D6 * 1 allele ( P<0.01 ) . Notably , volunteers homozygous for CYP2D6 * 10 exhibited a significant reduction ( 66 % ) in mean pharmacodynamic tissue sensitivity as measured by the ( prolactin-AUC0−6/perphenazine-AUC0−6 ) ratio ( P=0.02 ) . Conclusions CYP2D6 genotype is a significant contributor to perphenazine concentration in Chinese – Canadians . Importantly , prolactin response , when normalized per unit perphenazine concentration , appears to be blunted in volunteers homozygous for CYP2D6 * 10 . We suggest that CYP2D6 genetic variation may potentially influence pharmacodynamic tissue sensitivity in the pituitary , presumably through disposition of an endogenous substrate ( e.g. 5-methoxytryptamine ) The effect of pharmacogenetic testing for CYP450 2D6 and 2C19 on treatment costs have not yet been documented . This study used Danish patient registers to calculate healthcare costs of treating patients with diagnoses within the schizophrenic spectrum for 1 year with or without pharmacogenetic testing for polymorphisms in the genes for the CYP2D6 and CYP2C19 enzymes . In a r and omized , controlled trial , stratified with respect to metabolizer genotype , 104 patients were assigned to treatment based on pharmacogenetic testing and 103 patients to treatment as usual . R and om exclusion of extensive and intermediate metabolizers was used to increase the frequency of extreme metabolizers ( poor metabolizers and ultrarapid metabolizers for CYP2D6 ) to 20 % in both groups . Cost differences were analysed at several levels including ( i ) overall healthcare expenditure , ( ii ) psychiatric hospital cost ( iii ) nonpsychiatric hospital cost , ( iv ) primary care spending and ( v ) pharmaceuticals . Statistically significant differences in costs of psychiatric care dependent on metabolizer status were found between intervention groups . Pharmacogenetic testing significantly reduced costs among the extreme metabolizers ( poor metabolizers and ultrarapid metabolizers ) to 28 % . Use of primary care services and pharmaceuticals was also affected by the intervention . This study confirms earlier findings that extreme metabolizers ( poor and ultrarapid metabolizers ) incur higher costs than similar patients with a normal metabolizer genotype . However , this study shows that these excess costs can be reduced by pharmacogenetic testing . Pharmacogenetic testing for CYP2D6 and CYP2C19 could thus be considered as a means of curtailing high psychiatric treatment costs among extreme metabolizers Abstract The role of the polymorphic cytochrome P450 2D6 ( CYP2D6 ) in the metabolism of risperidone to its major active metabolite , 9-hydroxyrisperidone ( 9-OH-risperidone ) , has been documented after single oral doses of the drug . In this study , the influence of the CYP2D6 polymorphism on the steady-state plasma concentrations of risperidone and 9-OH-risperidone was investigated . Thirty-seven schizophrenic patients on monotherapy with risperidone , 4–8 mg/day , were genotyped by RFLP and PCR for the major functional variants of the CYP2D6 gene . Steady state plasma levels of risperidone and 9-OH-risperidone were analysed by HPLC . Based on the genotype analysis , three patients were classified as ultrarapid metabolizers ( UM ) with an extra functional CYP2D6 gene , 16 were homozygous extensive metabolizers ( EM ) , 15 heterozygous EM and three poor metabolizers ( PM ) . The median steady-state plasma concentration-to-dose ( C/D ) ratios of risperidone were 0.6 , 1.1 , 9.7 and 17.4 nmol/l per mg in UM , homozygous EM , heterozygous EM and PM , respectively , with statistically significant differences between PM and the other genotypes ( P<0.02 ) . The C/D of 9-OH-risperidone also varied widely but was not related to the genotype . The risperidone/9-OH-risperidone ratio was strongly associated with the CYP2D6 genotype , with the highest ratios in PM ( median 0.79 ) . Heterozygous EM also had significantly higher ratios than homozygous EM ( median value 0.23 versus 0.04 ; P<0.01 ) or UM ( median 0.03 ; P<0.02 ) . No significant differences were found in the C/D of the sum of the plasma concentrations of risperidone and 9-OH-risperidone between the genotype groups . In conclusion , the steady-state plasma concentrations of risperidone and the risperidone/9-OH-risperidone ratio are highly dependent on the CYP2D6 genotype . However , as risperidone and 9-OH-risperidone are considered to have similar pharmacological activity , the lack of relationship between the genotype and the sum of risperidone and 9-OH-risperidone indicates that the CYP2D6 polymorphism may be of limited importance for the clinical outcome of the treatment OBJECTIVE The prevalence of hyperprolactinemia during treatment with conventional antipsychotic drugs or risperidone is under-recognized and requires further investigation . This open-label study was design ed to determine the extent of this potential problem in a routine clinical setting . METHODS Four hundred and two adult in patients or out patients with a diagnosis of schizophrenia , schizophreniform disorder , or schizoaffective disorder were studied in a 1-day , point prevalence trial . Neither clinicians nor patients had any prior knowledge of serum prolactin levels or any potential associated adverse events , and patients were required to have been treated with a conventional antipsychotic drug or risperidone for a minimum of 3 months prior to study entry . Patients taking concomitant medications known to elevate prolactin were excluded . Rigorous assessment of serum prolactin was performed to estimate the prevalence rate of hyperprolactinemia , defined as a level above the upper limit of normal ( > 18.77 ng/ml for males , and > 24.20 ng/ml for females ) . Patients were stratified within antipsychotic treatment by gender and , for females , by menopausal status . RESULTS Serum prolactin was obtained from 147 females ( age range : 21 - 69 years ; mean age=44.51 years ) and 255 males ( age range : 18 - 66 years ; mean age=40.76 years ) . The prevalence of hyperprolactinemia among women of reproductive age ( n=90 ) was 65.6 % ( mean serum prolactin=69.0 ng/ml ) , and among postmenopausal women ( n=51 ) , it was 45.1 % ( mean serum PRL=49.0 ng/ml ) . The prevalence of hyperprolactinemia across all males ( n=255 ) was 42.4 % ( mean serum PRL= 32.4 ng/ml ) . The prevalence of hyperprolactinemia among females taking risperidone ( N=42 ) was 88 % versus 47.6 % of those taking conventional antipsychotic drugs ( N=105 ) , with 48 % of those females of reproductive age on risperidone experiencing abnormal menstrual cycles ( secondary amenorrhea , oligomenorrhea , or polymenorrhea ) . Of all premenopausal females with hyperprolactinemia , 31.6 % had estradiol levels < or=19.8 pg/ml ( which is the mean estradiol level in postmenopausal female patients with normal prolactin ) . Across both genders , there were trends of low key reproductive hormone levels associated with prolactin elevations . Additionally , there was a trend correlation ( p=0.064 ) between prolactin concentration and the risk of menstrual abnormality among females of reproductive age . CONCLUSIONS Hyperprolactinemia is very prevalent among women and men treated with conventional antipsychotic medications or risperidone . Due to the adverse effects associated with hyperprolactinemia , this likelihood should be seriously considered when choosing an antipsychotic suitable for the patient Part I of this article discussed the potential functional importance of genetic mutations and alleles of the human cytochrome P450 2D6 ( CYP2D6 ) gene . The impact of CYP2D6 polymorphisms on the clearance of and response to a series of cardiovascular drugs was addressed . Since CYP2D6 plays a major role in the metabolism of a large number of other drugs , Part II of the article highlights the impact of CYP2D6 polymorphisms on the response to other groups of clinical ly used drugs . Although clinical studies have observed a gene-dose effect for some tricyclic antidepressants , it is difficult to establish clear relationships of their pharmacokinetics and pharmacodynamic parameters to genetic variations of CYP2D6 ; therefore , dosage adjustment based on the CYP2D6 phenotype can not be recommended at present . There is initial evidence for a gene-dose effect on commonly used selective serotonin reuptake inhibitors ( SSRIs ) , but data on the effect of the CYP2D6 genotype/phenotype on the response to SSRIs and their adverse effects are scanty . Therefore , recommendations for dose adjustment of prescribed SSRIs based on the CYP2D6 genotype/phenotype may be premature . A number of clinical studies have indicated that there are significant relationships between the CYP2D6 genotype and steady-state concentrations of perphenazine , zuclopenthixol , risperidone and haloperidol . However , findings on the relationships between the CYP2D6 genotype and parkinsonism or tardive dyskinesia treatment with traditional antipsychotics are conflicting , probably because of small sample size , inclusion of antipsychotics with variable CYP2D6 metabolism , and co-medication . CYP2D6 phenotyping and genotyping appear to be useful in predicting steady-state concentrations of some classical antipsychotic drugs , but their usefulness in predicting clinical effects must be explored . Therapeutic drug monitoring has been strongly recommended for many antipsychotics , including haloperidol , chlorpromazine , fluphenazine , perphenazine , risperidone and thioridazine , which are
Output:
| We found no significant differences in prolactin levels between CYP2D6 metabolic groups .
Current evidence does not support using CYP2D6 genotyping to reduce risk of antipsychotic-induced hyperprolactinemia . |
MS211715 | ***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: Reproducibility and validity are prerequisites for a useful clinical scale . We therefore prospect ively tested the reproducibility and validity of the New York Heart Association criteria and the Canadian Cardiovascular Society criteria for the assessment of cardiac functional class and compared these criteria with a new Specific Activity Scale based on the metabolic costs of specific activities . The New York Heart Association estimates made by two physicians had a reproducibility of only 56 % , and only 51 % of the estimates agreed with treadmill exercise performance . Functional estimates based on the Canadian Cardiovascular Society criteria were significantly more reproducible ( 73 % ) , but not significantly more valid . The Specific Activity Scale was as reproducible as the Canadian Cardiovascular Society criteria , and its 68 % validity was significantly higher than the validities of the other systems . The easily administered Specific Activity Scale was equally reproducible and valid when used by a nonphysician . It was especially better than the other systems for the evaluation of true class II patients and was significantly less likely to underestimate treadmill performance . Although no set of questions can perfectly predict exercise tolerance , the Specific Activity Scale deserves wider prospect i ve testing Background — In animal models , brief periods of ischemia performed just at the time of reperfusion can reduce infa rct size , a phenomenon called postconditioning . In this prospect i ve , r and omized , controlled , multicenter study , we investigated whether postconditioning may protect the human heart during coronary angioplasty for acute myocardial infa rct ion . Methods and Results — Thirty patients , su bmi tted to coronary angioplasty for ongoing acute myocardial infa rct ion , contributed to the study . Patients were r and omly assigned to either a control or a postconditioning group . After reperfusion by direct stenting , control subjects underwent no further intervention , whereas postconditioning was performed within 1 minute of reflow by 4 episodes of 1-minute inflation and 1-minute deflation of the angioplasty balloon . Infa rct size was assessed by measuring total creatine kinase release over 72 hours . Area at risk and collateral blood flow were estimated on left ventricular and coronary angiograms . No adverse events occurred in the postconditioning group . Determinants of infa rct size , including ischemia time , size of the area at risk , and collateral flow , were comparable between the 2 groups . Area under the curve of creatine kinase release was significantly reduced in the postconditioning compared with the control group , averaging 208 984±26 576 compared with 326 095±48 779 ( arbitrary units ) in control subjects , ie , a 36 % reduction in infa rct size . Blush grade , a marker of myocardial reperfusion , was significantly increased in postconditioned compared with control subjects : 2.44±0.17 versus 1.95±0.27 , respectively ( P<0.05 ) . Conclusions — This study suggests that postconditioning by coronary angioplasty protects the human heart during acute myocardial infa rct ion Background Reduction of infa rct size by ischemic postconditioning ( IPost ) has been reported in smaller proof‐of‐concept clinical studies , but has not been confirmed in other smaller studies . The principle needs to be evaluated in larger groups of ST‐elevation myocardial infa rct ion ( STEMI ) patients before being implemented in clinical practice . This study assessed the effect of ischemic postcoditioning ( IPost ) on infa rct size in patients with STEMI treated by primary percutaneous coronary intervention ( PCI ) . Methods and Results Patients with first‐time STEMI , < 6 hours from symptom onset , referred to primary PCI were r and omized to IPost or control groups . IPost was administered by 4 cycles of 1‐minute reocclusion and 1‐minute reperfusion , starting 1 minute after opening , followed by stenting . In the control group , stenting was performed immediately after reperfusion . The primary endpoint was infa rct size measured by cardiac magnetic resonance after 4 months . A total of 272 patients were r and omized . Infa rct size ( percent of left ventricular mass ) after 4 months ( median values and interquartile range ) was 14.4 % ( 7.7 , 24.6 ) and 13.5 % ( 8.1 , 19.3 ) in the control group and IPost group , respectively ( P=0.18 ) . No significant impact of IPost was found when controlling for baseline risk factors of infa rct size in a multivariate linear regression model ( P=0.16 ) . The effects of IPost on secondary endpoints , including markers of necrosis , myocardial salvage , and ejection fraction , as well as adverse cardiac events during follow‐up , were consistently neutral . Conclusions In contrast to several smaller trials reported previously , we found no significant effects of IPost on infa rct size or secondary study outcomes . Clinical Trial Registration URL : http://www . clinical trials.gov Unique identifier : NCT.No . PO1506 Background —Postconditioning has been suggested to reduce myocardial damage during primary percutaneous coronary intervention ( PPCI ) in patients with ST-segment – elevation myocardial infa rct ion . However , because clinical experience is limited , we examined the cardioprotective effects of postconditioning , using cardiac MRI in patients treated with PPCI . Methods and Results —One hundred eighteen patients with ST-segment – elevation myocardial infa rct ion referred for PPCI were r and omly assigned to have either conventional PPCI or PPCI with postconditioning . Postconditioning was performed immediately after obtained reperfusion with 4 balloon occlusions , each lasting 30 seconds , followed by 30 seconds of reperfusion . The primary end point was myocardial salvage after 3 months as judged by delayed enhancement cardiac MRI . We found a 19 % relative reduction of infa rct size in the postconditioning group ( 51±16 % of total area at risk versus 63±17 % , P<0.01 ) , corresponding to a 31 % increase in salvage ratio . The number of patients developing heart failure was significantly fewer in the postconditioning group ( 27 % versus 46 % , P=0.048 ) . No significant evidence of interaction between the impact of postconditioning and the location of the culprit lesion or size of the myocardium at risk was detected ( P=0.21 and P=0.71 ) . Conclusions —Mechanical postconditioning reduces infa rct size in patients with ST-segment – elevation myocardial infa rct ion treated with PPCI . The impact of mechanical postconditioning seems to be independent of the size of myocardium at risk . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique Identifier : NCT00507156 AIMS To assess the short- and long-term effects of postconditioning ( p-cond ) on infa rct size , extent of myocardial salvage , and left ventricular ejection fraction ( LVEF ) in a series of patients presenting with evolving ST-elevation myocardial infa rct ion ( STEMI ) . Previous studies have shown that p-cond during primary percutaneous coronary intervention ( PCI ) confers protection against ischaemia-reperfusion injury and thus might reduce myocardial infa rct size . METHODS AND RESULTS Seventy-nine patients undergoing PCI for a first STEMI with TIMI grade flow 0 - 1 and no collaterals were r and omized to p-cond ( n= 39 ) or controls ( n= 40 ) . Postconditioning was performed by applying four consecutive cycles of 1 min balloon inflation , each followed by 1 min deflation . Infa rct size , myocardial salvage , and LVEF were assessed by cardiac-MRI 1 week and 6 months after MI . Postconditioning was associated with lower myocardial salvage ( 4.1 ± 7.2 vs. 9.1 ± 5.8 % in controls ; P= 0.004 ) and lower myocardial salvage index ( 18.9 ± 27.4 vs. 30.9 ± 20.5 % in controls ; P= 0.038 ) . No significant differences in infa rct size and LVEF were found between the groups at 1 week and 6 months after MI . CONCLUSION This r and omized study suggests that p-cond during primary PCI does not reduce infa rct size or improve myocardial function recovery at both short- and long-term follow-up and might have a potential harmful effect Background — We previously demonstrated that ischemic postconditioning decreases creatine kinase release , a surrogate marker for infa rct size , in patients with acute myocardial infa rct ion . Our objective was to determine whether ischemic postconditioning could afford ( 1 ) a persistent infa rct size limitation and ( 2 ) an improved recovery of myocardial contractile function several months after infa rct ion . Methods and Results — Patients presenting within 6 hours of the onset of chest pain , with suspicion for a first ST-segment – elevation myocardial infa rct ion , and for whom the clinical decision was made to treat with percutaneous coronary intervention , were eligible for enrollment . After reperfusion by direct stenting , 38 patients were r and omly assigned to a control ( no intervention ; n=21 ) or postconditioned group ( repeated inflation and deflation of the angioplasty balloon ; n=17 ) . Infa rct size was assessed both by cardiac enzyme release during early reperfusion and by 201thallium single photon emission computed tomography at 6 months after acute myocardial infa rct ion . At 1 year , global and regional contractile function was evaluated by echocardiography . At 6 months after acute myocardial infa rct ion , single photon emission computed tomography rest-redistribution index ( a surrogate for infa rct size ) averaged 11.8±10.3 % versus 19.5±13.3 % in the postconditioned versus control group ( P=0.04 ) , in agreement with the significant reduction in creatine kinase and troponin I release observed in the postconditioned versus control group ( −40 % and −47 % , respectively ) . At 1 year , the postconditioned group exhibited a 7 % increase in left ventricular ejection fraction compared with control ( P=0.04 ) . Conclusions — Postconditioning affords persistent infa rct size reduction and improves long-term functional recovery in patients with acute myocardial infa rct ion 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 No-reflow phenomenon is a serious complication of percutaneous coronary intervention ( PCI ) which is closely related to the incidence of major adverse cardiovascular events . It has been demonstrated that Postconditioning ( PostC ) during primary PCI confers protection against ischemia – reperfusion injury and thus might reduce infa rct size . However , whether PostC may exert its beneficial effects on acute myocardial infa rct ion ( AMI ) patients by reducing no-reflow phenomenon is still unknown . Sixty two patients diagnosed with ST-elevation AMI were r and omly assigned to study group ( n = 32 ) or control group ( n = 30 ) . Blood sample s were obtained and assayed for creatine kinase MB ( CK-MB ) and high-sensitive C-reactive protein ( hs-CRP ) . Determinants of reflow , including final thrombolysis in myocardial infa rct ion ( TIMI ) grade -3 flow , ST-segment resolution ( STR ) , myocardial blush grade s-3 ( MBG-3 ) and corrected thrombolysis in myocardial infa rct ion frame count ( cTFC ) , were comparative between the two groups . Compared with control group , more patients in study group were identified as the final TIMI grade -3 flow ( 81.3 vs. 56.7 % , P = 0.036 ) , MBG-3 ( 23 vs. 14 % , P = 0.043 ) and STR ≥50 % ( 93.8 vs. 73.3 % , P = 0.029 ) , while patients in study group had less cTFC ( 28.5 ± 9.1 vs. 37.4 ± 12.4 , P = 0.002 ) After PCI , study group was associated with lower levels of CK-MB ( 2,397.6 ± 470.2 vs. 2,159.9 ± 485.5 , P = 0.028 ) , Troponin-I ( 197.5 ± 32.5 vs. 154 ± 43.1 , P = 0.041 ) and hs-CRP ( 5.5 ± 4.5 vs. 9.5 ± 5.2 mg/L , P = 0.019 ) in comparison with control group . Left ventricle ejection fraction was better in the study group than in the control group ( 55.1 ± 9.8 vs. 42.9 ± 10.7 , P = 0.042 ) . PostC could improve myocardial reperfusion in patients with ST-elevation AMI undergoing PCI by reducing no-reflow . However , due to the limited sample size , the results of our study should not be considered conclusive BACKGROUND Postconditioning has been shown to reduce infa rct size during reperfusion ( < 72 hours ) . However , it is unknown whether the infa rct size reduction with postconditioning is a long-term effect after
Output:
| No effects by IPost on ST-segment resolution or on the majority of adverse clinical events were observed during follow up , except the incidence of congestive heart failure was found .
Evidence from this study suggests no cardioprotection from IPost , on surrogate and the majority of clinical end points . |
MS211716 | ***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 AIM Entecavir is a potent inhibitor of both wild-type and lamivudine-resistant hepatitis B virus ( HBV ) with proven clinical efficacy . We conducted a r and omized , double-blind , multicenter study in Japan ( ETV-052 ) evaluating the efficacy and safety of two doses of entecavir in adult patients with lamivudine-refractory chronic hepatitis B infection . METHODS Eighty-four patients with chronic hepatitis B who were refractory to lamivudine therapy were switched from lamivudine to daily oral doses of 0.5 mg entecavir ( 41 patients ) or 1 mg entecavir ( 43 patients ) for 52 weeks . RESULTS The proportions of patients achieving the primary end-point ( > or=2 log(10 ) reduction in HBV-DNA from baseline by polymerase chain reaction assay or undetectable HBV-DNA levels [ < 400 copies/mL ] at week 48 ) were 90 % and 93 % for entecavir 0.5 mg and 1 mg , respectively , with 33 % of patients in each dosing group achieving < 400 copies/mL. The mean reduction in HBV-DNA from baseline was 3.58 and 3.75 log(10 ) copies/mL for entecavir 0.5 mg and 1 mg , respectively . High proportions of patients achieved alanine aminotransferase normalization at week 48 ( 0.5 mg 86 % , 1 mg 78 % ) . Histological improvement was observed in most patients ( 0.5 mg 52 % , 1 mg 60 % ) . Virological breakthrough ( increase in HBV-DNA of > or=1 log(10 ) copies/mL from nadir ) was observed in one patient but was not associated with selection of entecavir-associated resistance substitutions . Entecavir was well tolerated , with no patients discontinuing study drug due to adverse events . CONCLUSIONS These findings indicate that entecavir is safe and effective for the treatment of Japanese adults with lamivudine-refractory chronic hepatitis BACKGROUND Entecavir is a potent and selective guanosine analogue with significant activity against hepatitis B virus ( HBV ) . METHODS In this phase 3 , double-blind trial , we r and omly assigned 715 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B who had not previously received a nucleoside analogue to receive either 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks . The primary efficacy end point was histologic improvement ( a decrease by at least two points in the Knodell necroinflammatory score , without worsening of fibrosis ) at week 48 . Secondary end points included a reduction in the serum HBV DNA level , HBeAg loss and seroconversion , and normalization of the alanine aminotransferase level . RESULTS Histologic improvement after 48 weeks occurred in 226 of 314 patients in the entecavir group ( 72 percent ) and 195 of 314 patients in the lamivudine group ( 62 percent , P=0.009 ) . More patients in the entecavir group than in the lamivudine group had undetectable serum HBV DNA levels according to a polymerase-chain-reaction assay ( 67 percent vs. 36 percent , P<0.001 ) and normalization of alanine aminotransferase levels ( 68 percent vs. 60 percent , P=0.02 ) . The mean reduction in serum HBV DNA from baseline to week 48 was greater with entecavir than with lamivudine ( 6.9 vs. 5.4 log [ on a base-10 scale ] copies per milliliter , P<0.001 ) . HBeAg seroconversion occurred in 21 percent of entecavir-treated patients and 18 percent of those treated with lamivudine ( P=0.33 ) . No viral resistance to entecavir was detected . Safety was similar in the two groups . CONCLUSIONS Among patients with HBeAg-positive chronic hepatitis B , the rates of histologic , virologic , and biochemical improvement are significantly higher with entecavir than with lamivudine . The safety profile of the two agents is similar , and there is no evidence of viral resistance to entecavir . ( Clinical Trials.gov number , NCT00035633 . ) BACKGROUND Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B. METHODS In this phase 3 , double-blind trial , we r and omly assigned 648 patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue to receive 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks . The primary efficacy end point was histologic improvement ( a decrease by at least two points in the Knodell necroinflammatory score , without worsening of fibrosis ) . RESULTS Histologic improvement after 48 weeks of treatment occurred in 208 of 296 patients in the entecavir group who had adequate baseline liver-biopsy specimens that could be evaluated ( 70 percent ) , as compared with 174 of 287 such patients in the lamivudine group ( 61 percent , P=0.01 ) . More patients in the entecavir group than in the lamivudine group had undetectable serum hepatitis B virus ( HBV ) DNA levels according to a polymerase-chain-reaction assay ( 90 percent vs. 72 percent , P<0.001 ) and normalization of alanine aminotransferase levels ( 78 percent vs. 71 percent , P=0.045 ) . The mean reduction in serum HBV DNA levels from baseline to week 48 was greater with entecavir than with lamivudine ( 5.0 vs. 4.5 log [ on a base-10 scale ] copies per milliliter , P<0.001 ) . There was no evidence of resistance to entecavir . Safety and adverse-event profiles were similar in the two groups . CONCLUSIONS Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue , the rates of histologic improvement , virologic response , and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine . The safety profile of the two agents was similar , and there was no evidence of viral resistance to entecavir . ( Clinical Trials.gov number , NCT00035789 . ) AIM To compare the efficacy of a combination of a-interferon ( IFN-a ) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B ( CHB ) . METHODS Sixty-eight treatment-naove patients with HBeAg-positive CHB were r and omized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily ( Group 1 ) , or IFN-a2a alone in the same dosage ( Group 2 ) , for 12 months . Serum ALT , HBeAg , anti-HBe and HBV DNA were tested at the end of treatment and 6 months later . Complete response was defined as normal ALT , negative HBeAg and negative HBV DNA , six months after stopping treatment . RESULTS Of the 68 patients , 64 completed the study . In Group 1 ( n=31 ) , mean ( SD ) ALT levels decreased from 124 ( 59 ) IU/L to 39 ( 18 ) IU/L at 12 months ; corresponding values in Group 2 ( n=33 ) were 128 ( 57 ) and 56 ( 11 ) IU/L ( p < 0.05 ) . Absence of HBV DNA at the end of treatment was more common in Group 1 ( 28/31 ) than in Group 2 ( 22/33 ; p < 0.022 ) . The number of patients with seroconversion to anti-HBe ( 4/31 [ 13 % ] vs. 4/33 [ 12 % ] , respectively ; p>0.05 ) , as also those with complete response ( 4/31 [ 13 % ] and 4/33 [ 12 % ] , respectively ; p>0.05 ) six months after completion of treatment was similar in Group 1 and Group 2 . CONCLUSION Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA ; however , it did not have a better sustained response rate than IFN-a alone BACKGROUND Pegylated interferon (PEG-IFN)-alpha monotherapy is the current st and ard of care for short-term antiviral treatment of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B ( CHB ) . We aim ed to assess the safety and efficacy of PEG-IFN-alpha plus adefovir dipivoxil ( ADV ) versus PEG-IFN-alpha monotherapy for compensated HBeAg-negative CHB . METHODS A multicentre r and omized controlled trial was performed in eight outpatient hepatology/infectious disease clinics in central Italy . A total of 60 patients ( 67 % male and median age 48 years ) with biopsy-proven HBeAg-negative compensated CHB ( mean alanine aminotranferase [ ALT ] levels 3.3 + /-3x the upper normal limit and serum hepatitis B virus [ HBV ] DNA 5.8 + /-0.9 log(10 ) IU/ml ) were r and omized at baseline to receive PEG-IFN-alpha2a 180 microg/week plus ADV 10 mg/day or PEG-IFN-alpha2a monotherapy for 48 weeks . Post-treatment follow-up was for 24 additional weeks . The primary end point was sustained HBV DNA suppression defined as serum HBV DNA<2,000 IU/ml after 24 weeks of post-treatment follow-up . The secondary end point was ALT normalization at the end of follow-up . RESULTS At week 48 , HBV DNA was undetectable in 20/30 ( 67 % ) in the combination group versus 11/30 ( 37 % ) patients in the monotherapy group ( P=0.02 ) . ALT normalization was achieved in 17/30 ( 57 % ) versus 10/30 ( 30 % ) patients , respectively ( P=0.03 ) . At week 72 , sustained virological response was achieved in 7/30 ( 23.3 % ) in the combination group versus 6/30 ( 20 % ) patients in the monotherapy group ( P=0.75 ) ; 5 ( 16 % ) patients in each group dropped out because of adverse events or non-compliance . CONCLUSIONS In HBeAg-negative CHB , combination PEG-IFN-alpha2a plus ADV for 48 weeks is safe and result ed in greater on-treatment efficacy than PEG-IFN-alpha2a monotherapy . No difference in sustained virological and biochemical response rates were observed between the two treatment regimens BACKGROUND & AIMS Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B ( CHB ) . We evaluated continued entecavir and lamivudine treatment through 96 weeks . METHODS 709 HBeAg-positive CHB patients were r and omized to entecavir 0.5 mg ( n = 354 ) or lamivudine 100 mg ( n = 355 ) once daily . At week 52 , protocol -defined virologic responders could continue blinded treatment for up to 96 weeks . Patients continuing in year 2 ( entecavir , n = 243 ; lamivudine , n = 164 ) were assessed for serum hepatitis B virus ( HBV ) DNA , alanine aminotransferase ( ALT ) normalization , HBeAg seroconversion , and safety . Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed . RESULTS Among patients treated in year 2 , 74 % of entecavir-treated versus 37 % of lamivudine-treated patients achieved HBV DNA < 300 copies/mL by polymerase chain reaction ( PCR ) , and 79 % of entecavir-treated versus 68 % of lamivudine-treated patients normalized ALT levels . Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion ( 11 % vs 12 % , respectively ) . Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA < 300 copies/mL by PCR ( 80 % vs 39 % ; P < .0001 ) and ALT normalization ( 87 % vs 79 % ; P = .
Output:
| In the sensitivity analysis , adefovir showed lower cost-utility than telbivudine in some situations .
In this study , tenofovir presented the best cost-utility ratio . |
MS211717 | ***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: Stroke incidence in Copenhagen , Denmark was recorded in a r and om population sample of 19,327 persons invited for two health examinations with 5 years ' interval from 1976 to 1983 . Stroke incidence increased exponentially with age . After adjustment to the age and sex distribution of the Danish population in 1980 , the estimated incidence of first stroke was 1.41/1000 women and 2.48/1000 men ; the total incidence was 1.94/1000 population . Risk factor analysis was based on the initial examination of 13,088 persons greater than 35 years old without previous stroke who responded to the first invitation , in whom 295 first strokes were subsequently observed . We used the regression model of Cox . However , our use of this model differs from the somewhat automatic procedures normally used to develop prognostic models . Evaluation of the causative effect of a particular risk factor requires that the direction of mutual influences between the factor in question and other risk factors is established/postulated . Among the 16 potential risk factors for stroke we examined , significant effects were found for age , sex , household income , smoking habits , systolic blood pressure , diabetes , plasma cholesterol concentration , ischemic heart disease , and atrial fibrillation . No significant effect could be demonstrated for a positive family history of stroke , years of school education , marital status , alcohol consumption , daily use of tranquilizers , body mass index , or postmenopausal hormone treatment Background and Purpose — The role of serum fatty acids as a risk factor for stroke and stroke subtypes is largely unknown . Methods — A prospect i ve nested case-control study of Japanese 40 to 85 years of age was conducted through the use of frozen serum sample s from 7450 participants in cardiovascular risk surveys collected from 1984 to 1989 for 1 community and 1989 to 1992 for the other 2 communities . By the end of 1998 , we identified 197 incident strokes whose subtypes were confirmed by imaging studies . Three controls per case were selected by matching for sex , age , community , year of serum storage , and fasting status . Results — Compared with controls , total ( n=197 ) , hemorrhagic ( n=75 ) , and ischemic ( n=122 ) strokes had similar proportions of n3 polyunsaturated fatty acids , lower proportions of linoleic and arachidonic acids , and higher proportions of saturated and monosaturated acids , determined by gas chromatography . The multivariate odds ratios associated with a 1-SD increase in linoleic acid ( 5 % ) after adjustment for hypertension , diabetes , serum total cholesterol , and other cardiovascular risk factors were 0.72 [ 95 % confidence interval ( CI ) , 0.59 to 0.89 ] for total stroke , 0.66 ( 95 % CI , 0.49 to 0.88 ) for ischemic stroke , 0.63 ( 95 % CI , 0.46 to 0.88 ) for lacunar infa rct ion , and 0.81 ( 95 % CI , 0.59 to 1.12 ) for hemorrhagic stroke . The respective odds ratios for saturated fatty acids ( 4 % ) were 1.13 ( 95 % CI , 1.05 to 1.65 ) , 1.35 ( 95 % CI , 1.01 to 1.79 ) , 1.44 ( 95 % CI , 1.03 to 2.01 ) , and 1.21 ( 95 % CI , 0.82 to 1.80 ) . Further adjustment for other fatty acids attenuated these relations , but the relation between linoleic acid and risk of ischemic stroke remained statistically significant . Conclusions — A higher intake of linoleic acid may protect against ischemic stroke , possibly through potential mechanisms of decreased blood pressure , reduced platelet aggregation , and enhanced deformability of erythrocyte cells Background and Purpose — Although aspirin is effective in prevention of stroke , fewer studies have examined the impact of aspirin on stroke morbidity . Methods — The Women ’s Health Study is a completed r and omized , placebo-controlled trial design ed to test the effect of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer , which enrolled 39 876 women . We used multinomial logistic regression to evaluate the relationship between r and omized aspirin assignment and functional outcomes from stroke . Possible functional outcomes were neither stroke nor transient ischemic attack ( TIA ) , modified Rankin scale ( mRS ) score 0 to 1 , 2 to 3 , and 4 to 6 . Results — After a mean of 9.9 years of follow-up , 460 confirmed strokes ( 366 ischemic , 90 hemorrhagic , and 4 unknown type ) and 405 confirmed TIAs occurred . With regard to total and ischemic stroke , women who were r and omized to aspirin had a nonsignificant decrease in risk of any outcome compared to women not r and omized to aspirin . This decrease in risk only reached statistical significance for those experiencing TIA compared to participants without stroke or TIA ( odds ratio=0.77 ; 95 % confidence interval , 0.63–0.94 ) . For hemorrhagic stroke , a nonsignificant increase in the risk of achieving an mRS score 2 to 3 or 4 to 6 compared with no stroke or TIA was observed for the women r and omized to aspirin compared to those r and omized to placebo . Conclusions — Results from this large r and omized clinical trial provide evidence that 100 mg of aspirin every other day may reduce the risk of ischemic cerebral vascular events but does not have differential effects on functional outcomes from stroke OBJECTIVE ω-3 fatty acids , including eicosapentaenoic acid ( EPA ) , prevent ischemic stroke . However , the clinical importance of EPA for ischemic stroke and its subtype has not been fully eluci date d. METHODS In a cross-sectional study , we determined whether ω-3 fatty acids were predictive factors for ischemic stroke . We compared common clinical parameters among 65 patients with ischemic stroke and 65 control subjects . The parameters included blood chemistry data ; concentrations of EPA , docosahexaenoic acid , and arachidonic acid ( AA ) ; EPA/AA ratio ; smoking ; alcohol intake ; fish consumption more than four times per week ; and the incidence of underlying diseases . The comparisons were performed using the Mann-Whitney U test , and multiple logistic regression analysis was applied to the significant factors in the non-parametric test . We also applied the same approach to the ischemic stroke subtypes , cardioembolism and large-artery atherosclerosis . RESULTS In the multiple logistic regression analysis after the Mann-Whitney U test , a lower EPA concentration was one of the significant risk factors for ischemic stroke , as were a lower body mass index , lower high-density lipoprotein cholesterol , and smoking ( sensitivity 0.846 , specificity 0.831 , positive predictive value 0.833 ) . In the analysis of subtypes , a lower EPA/AA ratio and a lower body mass index were the significant risk factors for cardioembolism ( sensitivity 0.800 , specificity 0.733 , positive predictive value 0.750 ) . However , large-artery atherosclerosis was not related to the EPA concentration or the EPA/AA ratio . CONCLUSIONS In this study , the plasma EPA concentration and the EPA/AA ratio were potential predictive risk factors for ischemic stroke , especially for cardioembolism . Further prospect i ve studies are necessary Background and Purpose The etiology of ischemic stroke affects prognosis , outcome , and management . Trials of therapies for patients with acute stroke should include measurements of responses as influenced by subtype of ischemic stroke . A system for categorization of subtypes of ischemic stroke mainly based on etiology has been developed for the Trial of Org 10172 in Acute Stroke Treatment ( TOAST ) . Methods A classification of subtypes was prepared using clinical features and the results of ancillary diagnostic studies . “ Possible ” and “ probable ” diagnoses can be made based on the physician 's certainty of diagnosis . The usefulness and interrater agreement of the classification were tested by two neurologists who had not participated in the writing of the criteria . The neurologists independently used the TOAST classification system in their bedside evaluation of 20 patients , first based only on clinical features and then after review ing the results of diagnostic tests . Results The TOAST classification denotes five subtypes of ischemic stroke : 1 ) large-artery atherosclerosis , 2 ) cardioembolism , 3 ) small-vessel occlusion , 4 ) stroke of other determined etiology , and 5 ) stroke of undetermined etiology . Using this rating system , interphysician agreement was very high . The two physicians disagreed in only one patient . They were both able to reach a specific etiologic diagnosis in 11 patients , whereas the cause of stroke was not determined in nine . Conclusions The TOAST stroke subtype classification system is easy to use and has good interobserver agreement . This system should allow investigators to report responses to treatment among important subgroups of patients with ischemic stroke . Clinical trials testing treatments for acute ischemic stroke should include similar methods to diagnose subtypes of stroke Arachidonic acid ( AA ) is the precursor of thromboxane and prostacyclin , two of the most active compounds related to platelet function . The effect of dietary AA on platelet function in humans is not understood although a previous study suggested dietary AA might have adverse physiological consequences on platelet function . Here normal healthy male volunteers ( n=10 ) were fed diets containing 1.7 g/d of AA for 50 d. The control diet contained 210 mg/d of AA . Platelet aggregation in the platelet-rich plasma was determined using ADP , collagen , and AA . No statistical differences could be detected between the aggregation before and after consuming the high-AA diet . The prothrombin time , partial thromboplastin time , and the antithrombin III levels in the subjects were determined also . There were no statistically significant differences in these three parameters when the values were compared before and after they consumed the high-AA diet . The in vivo bleeding times also did not show a significant difference before and after the subjects consumed the high-AA diet . Platelets exhibited only small changes in their AA content during the AA feeding period . The results from this study on blood clotting parameters and in vitro platelet aggregation suggest that adding 1.5 g/d of dietary AA for 50 d to a typical Western diet containing about 200 mg of AA produces no observable physiological changes in blood coagulation and thrombotic tendencies in healthy , adult males compared to the unsupplemented diet . Thus , moderate intakes of foods high in AA have few effects on blood coagulation , platelet function , or platelet fatty acid composition Background and Purpose — Although studies have linked types of fatty acids with coronary heart disease , data on individual fatty acids and risk of ischemic stroke are limited . We aim ed to examine the associations between serum fatty acid concentrations and incidence of ischemic stroke and its subtypes . Methods — We conducted a prospect i ve case – control study nested in the Women ’s Health Initiative Observational Study cohort of postmenopausal US women aged 50 to 79 years . Between 1993 and 2003 , incident cases of ischemic stroke were matched 1:1 to controls on age , race , and length of follow-up ( 964 matched pairs ) . Conditional logistic regression was used to estimate odds ratios and 99.9 % confidence intervals ( CI ) for ischemic stroke and its subtypes . Results — The multivariable-adjusted odds ratios and 99.9 % CI of ischemic stroke associated with a 1-SD increment in serum fatty acid concentration were 1.38 ( 99.9 % CI , 1.05–1.83 ) for linoelaidic acid ( 18:2tt , SD=0.04 % ) , 1.27 ( 99.9 % CI , 1.06–1.51 ) for palmitic acid ( 16:0 , SD=2.74 % ) , 1.20 ( 99.9 % CI , 1.01–1.43 ) for oleic acid ( 18:1n9 , SD=2.32 % ) , 0.72 ( 99.9 % CI , 0.59–0.87 ) for docosapentaenoic acid ( 22:5n3 , SD=0.18 % ) , 0.72 ( 99.9 % CI , 0.59–0.87 ) for docosahexaenoic acid ( 22:6n3 , SD=0.91 % ) , and 0.81 ( 99.9 % CI , 0.67–0.98 ) for arachidonic acid ( 20:4n6 , SD=2.02 % ) . These associations were generally consistent for atherothrombotic and lacunar stroke but not cardioembolic stroke . Conclusions — These findings suggest that individual serum trans , saturated , and monounsaturated fatty acids are positively associated with particular ischemic stroke subtypes , whereas individual n3 and n6 polyunsaturated fatty acids are inversely associated Background and Purpose We sought to improve the reliability of the Trial of ORG 10172 in Acute Stroke Treatment ( TOAST ) classification of stroke subtype for retrospective use in clinical , health services , and quality of care outcome studies . The TOAST investigators devised a series of 11 definitions to classify patients with ischemic
Output:
| Key Messages : We did not find a positive association between ARA exposure and cerebral ischemia risk .
Eligible studies reported inconsistent findings : cerebral ischemia risk did not change or significantly decreased . |
MS211718 | ***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 s Limited evidence is available regarding pharmacist managed anticoagulation clinic in the Southeast Asian region where there is marked difference in terms of care model , genetic composition and patient demographics . Objectives This study aim ed at comparing the anticoagulation clinic managed by the pharmacist with physician advisory and the usual medical care provided in Kuala Lumpur Hospital ( KLH ) in terms of anticoagulation control and adverse outcomes . Setting A 2,302 bedded government tertiary referral hospital in Malaysia . Methods A 6-month retrospective cohort study of the effectiveness of two models of anticoagulation care , the pharmacist managed anticoagulation clinic which is known as warfarin medication therapy adherence clinic ( WMTAC ) and usual medical clinic ( UMC ) in KLH was conducted , where a r and om number generator was used to recruit patients . The UMC patients received st and ard medical care where they are managed by rotational medical officers in the physicians ’ clinic . As for the WMTAC with physician advisory , the pharmacist will counsel and review the patients internationalised normalization ratio at each clinic visit and also adjust the patients ’ warfarin dose accordingly . Patients are referred to physicians if immediate attention is required . Main outcome measure The main therapeutic outcome is time in therapeutic range ( TTR ) both actual and exp and ed TTR and thromboembolic and bleeding complications . Results Each of the WMTAC and usual medical care recruited 92 patients , which totals to 184 patients . The patient demographics in terms of age , race and indication of treatment were comparable . At the end of the 6 months follow-up , patients in the WMTAC group had significantly higher actual-TTR ( 65.1 vs. 48.3 % ; p < 0.05 ) compared to those in usual medical care group . Rates of admission were 6.5 versus 28.2 events per 100 person-years for the WMTAC and UMC groups , respectively . Though the bleeding incidences were not significantly different , it was reduced . Conclusions These findings will impact local warfarin patient management services and policies because there was no available evidence supporting the role of pharmacists in the management of warfarin patients prior to this study Background The beneficial outcomes of oral anticoagulation therapy are dependent upon achieving and maintaining an optimal INR therapeutic range . There is growing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by family physicians . This study compared a pharmacist managed anticoagulation program ( PC ) to usual physician care ( UC ) in a family medicine clinic . Methods A retrospective cohort study was carried out in a family medicine clinic which included a clinical pharmacist . In 2006 , the pharmacist assumed anticoagulation management . For a 17-month period , the PC group ( n = 112 ) of patients on warfarin were compared to the UC patients ( n = 81 ) for a similar period prior to 2006 . The primary outcome was the percentage of time patients ' INR was in the therapeutic range ( TTR ) . Secondary outcomes were the percentage of time in therapeutic range within ± 0.3 units of the recommended range ( exp and ed TTR ) and percentage of time the INR was > 5.0 or < 1.5 . Results The baseline characteristics were similar between the groups . Fifty-five percent of the PC group was male with a mean age of 67 years ; 51 % of the UC group was male with a mean age of 71 years . The most common indications for warfarin in both groups were atrial fibrillation , mechanical heart valves and deep vein thrombosis . The TTR was 73 % for PC and 65 % for UC ( p < 0.0001 ) . The exp and ed TTR for PC was 91 % and 85 % for UC ( p < 0.0001 ) . The percentage of time INR values were < 1.5 was 0.7 % for PC patients and 1.9 % for UC patients ( p < 0.0001 ) , and > 5 were 0.3 % for PC patients and 0.1 % for UC ( p < 0.0001 ) . Conclusion The pharmacist-managed anticoagulation program within a family practice clinic compared to usual care by the physicians achieved significantly better INR control as measured by the percentage of time patients ' INR values were kept in both the therapeutic and exp and ed range . Based on the results of this study , a collaborative family practice clinic using pharmacists and physicians may be an effective model for anticoagulation management with these results verified in future prospect i ve r and omized studies BACKGROUND There is growing evidence that better outcomes are achieved when anticoagulation is managed by anticoagulation clinics rather than by family physicians . We carried out a r and omized controlled trial to evaluate these 2 models of anticoagulant care . METHODS We r and omly allocated patients who were expected to require warfarin sodium for 3 months either to anticoagulation clinics located in 3 Canadian tertiary hospitals or to their family physician practice s. We evaluated the quality of oral anticoagulant management by comparing the proportion of time that the international normalized ratio ( INR ) of patients receiving warfarin sodium was within the target therapeutic range + /- 0.2 INR units ( exp and ed therapeutic range ) while they were managed in anticoagulation clinics as opposed to family physicians ' care over 3 months . We measured the rates of thromboembolic and major hemorrhagic events and patient satisfaction in the 2 groups . RESULTS Of the 221 patients enrolled , 112 were r and omly assigned to anticoagulation clinics and 109 to family physicians . The INR values of patients who were managed by anticoagulation clinics were within the exp and ed therapeutic range 82 % of the time versus 76 % of the time for those managed by family physicians ( p = 0.034 ) . High-risk INR values ( defined as being < 1.5 or > 5.0 ) were more commonly observed in patients managed by family physicians ( 40 % ) than in patients managed by anticoagulation clinics ( 30 % , p = 0.005 ) . More INR measurements were performed by family physicians than by anticoagulation clinics ( 13 v. 11 , p = 0.001 ) . Major bleeding events ( 2 [ 2 % ] v. 1 [ 1 % ] ) , thromboembolic events ( 1 [ 1 % ] v. 2 [ 2 % ] ) and deaths ( 5 [ 4 % ] v. 6 [ 6 % ] ) occurred at a similar frequency in the anticoagulation clinic and family physician groups respectively . Of the 170 ( 77 % ) patients who completed the patient satisfaction question naire , more were satisfied when their anticoagulant management was managed through anticoagulation clinics than by their family physicians ( p = 0.001 ) . INTERPRETATION Anticoagulation clinics provided better oral anticoagulant management than family physicians , but the differences were relatively modest AIM To compare the treatment outcomes of a clinical pharmacist-managed anticoagulation service with physician-managed service in Chinese patients . METHODS A prospect i ve , r and omized clinical trial was conducted at the anticoagulation clinic of a teaching hospital in Hong Kong . Patients aged > or = 18 years who would required warfarin therapy for at least 3 months were recruited . Patients were r and omized to the pharmacist-managed or physician-managed group . Primary clinical outcome was assessed by the percentage of patient time spent within the target international normalized ratio ( INR ) range . The incidence of major thromboembolic events ( TEs ) and major bleeding was assessed as secondary clinical outcomes . The cost per patient per month ( cPPPM ) was calculated and patient satisfaction was assessed by patient satisfaction question naire (PSQ)-18 . RESULTS One hundred and forty-one patients were recruited at the anticoagulation clinic and 137 patients completed the study . Patients in the pharmacist-managed group ( n = 68 ) were in the target INR 64 % of patient time vs. 59 % in the physician-managed group ( n = 69 ) ( P < 0.001 ) . There was no significant difference in incidence of major TEs or bleeding . The cPPPM in the pharmacist-managed group ( 76 + /- 95 US dollar ) ( 43 + /- 53 British pound ) was lower than in the physician-managed group ( 98 + /- 158 US dollar ) ( 55 + /- 89 British pound ) ( P < 0.001 ) . The PSQ-18 score of the pharmacist-managed group ( 3.8 + /- 0.2 ) was higher than that of the physician-managed group ( 3.6 + /- 0.3 ) ( P < 0.001 ) . CONCLUSION The pharmacist-managed anticoagulation service was more effective and less costly than the physician-managed service in achieving target anticoagulation control for Chinese patients on warfarin therapy Hospitalized patients receiving anticoagulants such as warfarin are at increased risk for adverse events because of difficulties maintaining a therapeutic international normalized ratio ( INR ) . We sought to determine whether a detailed warfarin dosing protocol administered by pharmacists with minimal physician oversight significantly reduced the proportion of hospitalized patients with a supratherapeutic INR . We conducted a prospect i ve , nonr and omized trial with patients on cardiology , internal medicine , and family medicine inpatient services who received at least 1 dose of warfarin while hospitalized . The baseline group included 293 patients , and the intervention group comprised 217 patients . Baseline characteristics were similar in each group , except that more patients received antibiotics in the intervention group . The defect rate ( INR > 5 after receiving warfarin ) in the baseline group was significantly higher than in the intervention group ( 7.85 vs. 1.85 % ) . Conversely , the percentage of patients with an INR less than 1.7 after 4 warfarin doses was lower in the intervention patients , indicating overall improvement in therapeutic levels . Dosing discussion s were required between the pharmacist and a physician for only 6 % of intervention patients . The protocol effectively reduced overanticoagulation without increasing under anticoagulation during hospitalization and reduced the need for close physician oversight 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 STUDY OBJECTIVE To evaluate the safety and economic impact of three models of anticoagulation management services : usual medical care , a nurse-managed service , and a pharmacist-managed service . DESIGN Retrospective medical record review . SETTING An eight-county health care system in central New York State . PATIENTS Nine hundred ninety-six patients ( age range 19 - 99 yrs ) who were receiving warfarin therapy for at least 6 months and who had three or more international normalized ratio ( INR ) values reported during the 1-year study period ; 489 patients ( 6243 INR values ) were in the pharmacist-managed group , 307 patients ( 3618 INR values ) were in the nurse-managed group , and 200 patients ( 3142 INR values ) were in the usual care group . MEASUREMENTS AND MAIN RESULTS All INR measurements were performed by the central laboratory or by on-site point-of-care testing . Data were queried from calendar year 2003 for the usual care and nurse-managed services and calendar year 2006 for the pharmacist-managed service . Anticoagulation indication , INR goal , baseline characteristics , and rates and costs of hospitalization
Output:
| The study supported PMWT regarding cost saving and patient satisfaction .
The results showed that the PMWT model is superior to UMC in managing warfarin therapy based on observational studies .
As well , it is comparable to UMC based on RCT studies |
MS211719 | ***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 evaluate the predictive effects of subjective measures of physical activity ( PA ) and objective measures of physical fitness ( PF ) on dementia risk , Participants of the prospect i ve population -based ILSE- study ( * 1930 - 1932 ; 12-year follow-up ) were examined at three examination waves ( t1 : 1993/94 ; t2 : 1997/98 ; t3 : 2005/07 ) . 381 subjects of the original cohort ( n = 500 ) were re-examined at t3 . 29 % of the subjects who were cognitively healthy at baseline received the diagnosis of mild cognitive impairment ( MCI ) and 7 % of Alzheimer 's disease ( AD ) . Subjects were screened for physical and mental health using medical interviews , physical , and neuropsychological examinations . Participants completed a question naire on their current and past PA at t1 . Subjects were classified as physically active if they reported a regular sport activity for at least 2 hours per week in the past year . Muscular strength ( h and grip ) and motor coordination ( balance ) served as objective indicators of PF . Subjects who passed the balance-test at t1 had a reduced risk of developing MCI/AD at t3 ( OR = 0.35 , 95%CI 0.19 - 0.66 , p < 0.01 ) and performed significantly better on various neuropsychological measures . Muscular strength or subjective reports of PA did not predict MCI/AD development . Our results confirm the hypothesis that PF acts as a protective factor for the development of cognitive disorders . In our study , context , motor coordination served as a better predictor than muscular strength or self-rated PA . Since subjects with cognitive disorders due to cerebral and /or systemic disorders were excluded from the analyses , our findings suggest that the effect of skill-related PF extends beyond the reduction of cardiovascular risk factors BACKGROUND Participation in leisure activities has been associated with a lower risk of dementia . It is unclear whether increased participation in leisure activities lowers the risk of dementia or participation in leisure activities declines during the pre clinical phase of dementia . METHODS We examined the relation between leisure activities and the risk of dementia in a prospect i ve cohort of 469 subjects older than 75 years of age who resided in the community and did not have dementia at base line . We examined the frequency of participation in leisure activities at enrollment and derived cognitive-activity and physical-activity scales in which the units of measure were activity-days per week . Cox proportional-hazards analysis was used to evaluate the risk of dementia according to the base-line level of participation in leisure activities , with adjustment for age , sex , educational level , presence or absence of chronic medical illnesses , and base-line cognitive status . RESULTS Over a median follow-up period of 5.1 years , dementia developed in 124 subjects ( Alzheimer 's disease in 61 subjects , vascular dementia in 30 , mixed dementia in 25 , and other types of dementia in 8) . Among leisure activities , reading , playing board games , playing musical instruments , and dancing were associated with a reduced risk of dementia . A one-point increment in the cognitive-activity score was significantly associated with a reduced risk of dementia ( hazard ratio , 0.93 [ 95 percent confidence interval , 0.90 to 0.97 ] ) , but a one-point increment in the physical-activity score was not ( hazard ratio , 1.00 ) . The association with the cognitive-activity score persisted after the exclusion of the subjects with possible pre clinical dementia at base line . Results were similar for Alzheimer 's disease and vascular dementia . In linear mixed models , increased participation in cognitive activities at base line was associated with reduced rates of decline in memory . CONCLUSIONS Participation in leisure activities is associated with a reduced risk of dementia , even after adjustment for base-line cognitive status and after the exclusion of subjects with possible pre clinical dementia . Controlled trials are needed to assess the protective effect of cognitive leisure activities on the risk of dementia Background Older adults free of dementia but with subjective memory complaints ( SMC ) or mild cognitive impairment ( MCI ) are considered at increased risk of cognitive decline . Vascular risk factors ( VRF ) , including hypertension , heart disease , smoking , hypercholesterolemia and lack of physical activity ( PA ) have been identified as modifiable risk factors contributing to cognitive decline , and white matter hyperintensities ( WMH ) are associated with VRF , SMC and cognitive impairment . Findings from a growing number of clinical trials with older adults are providing strong evidence for the benefits of physical activity for maintaining cognitive function , but few studies are investigating these benefits in high-risk population s. The aim of AIBL Active is to determine whether a 24-month physical activity program can delay the progression of white matter changes on magnetic resonance imaging ( MRI ) . Methods / design This single-blind r and omized controlled trial ( RCT ) is offered to 156 participants , aged 60 and older , in the Melbourne arm of the Australian Imaging Biomarkers and Lifestyle Flagship Study of Aging ( AIBL ) . Participants must have SMC with or without MCI and at least one VRF . The PA intervention is a modification of the intervention previously trialed in older adults with SMC and MCI ( Fitness for the Ageing Brain Study ) . It comprises 24 months of moderate , home-based PA ( 150 minutes per week ) and a behavioral intervention package . The primary outcome measure will be change in WMH after 24 months on MRI . Cognition , quality of life , functional fitness , level of physical activity , plasma biomarkers for cerebrovascular disease and amyloid positron emission tomography ( PET ) imaging comprise secondary measures . Discussion Currently , there is no effective pharmacological treatment available to delay cognitive decline and dementia in older adults at risk . Should our findings show that physical activity can slow down the progression of WMH , this RCT would provide an important proof of concept . Since imbedded in AIBL this RCT will also be able to investigate the interaction between vascular and Alzheimer 's disease pathologies . Trial Registration Australia New Zeal and Clinical Trials Registry BACKGROUND Data regarding the relationship between physical activity and cognitive impairment are limited and controversial . We examined whether physical activity is associated with incident cognitive impairment during follow-up . METHODS As part of a community-based prospect i ve cohort study in southern Bavaria , Germany , 3903 participants older than 55 years were enrolled between 2001 and 2003 and followed up for 2 years . Physical activity ( classified as no activity , moderate activity [ <3 times/wk ] , and high activity [ > or =3 times/wk ] ) , cognitive function ( assessed by the 6-Item Cognitive Impairment Test ) , and potential confounders were evaluated . The main outcome measure was incident cognitive impairment after 2 years of follow-up . RESULTS At baseline , 418 participants ( 10.7 % ) had cognitive impairment . After a 2-year follow-up , 207 of 3485 initially unimpaired subjects ( 5.9 % ) developed incident cognitive impairment . Compared with participants without physical activity , fully adjusted multiple logistic regression analysis showed a significantly reduced risk of incident cognitive impairment after 2 years for participants with moderate or high physical activity at baseline ( odds ratio [ OR ] , 0.57 ; 95 % confidence interval [ CI ] , 0.37 - 0.87 [ P = .01 ] ; and OR , 0.54 ; 95 % CI , 0.35 - 0.83 [ P = .005 ] ; respectively ) . Further sub analysis including participants ( n = 2029 ) without functional impairment and without prodromal phase of dementia result ed in an even higher reduction of risk of incident cognitive impairment for participants with moderate or high physical activity ( OR , 0.44 ; 95 % CI , 0.24 - 0.83 [ P = .01 ] ; and OR , 0.46 ; 95 % CI , 0.25 - 0.85 [ P = .01 ] ; respectively ) compared with no activity . CONCLUSION Moderate or high physical activity is associated with a reduced incidence of cognitive impairment after 2 years in a large population -based cohort of elderly subjects CONTEXT Evidence suggests that physical activity may be related to the clinical expression of dementia . Whether the association includes low-intensity activity such as walking is not known . OBJECTIVE To examine the association between walking and future risk of dementia in older men . DESIGN Prospect i ve cohort study . SETTING AND PARTICIPANTS Distance walked per day was assessed from 1991 to 1993 in 2257 physically capable men aged 71 to 93 years in the Honolulu-Asia Aging Study . Follow-up for incident dementia was based on neurological assessment at 2 repeat examinations ( 1994 - 1996 and 1997 - 1999 ) . MAIN OUTCOME MEASURES Overall dementia , Alzheimer disease , and vascular dementia . RESULTS During the course of follow-up , 158 cases of dementia were identified ( 15.6/1000 person-years ) . After adjusting for age , men who walked the least ( < 0.25 mile/d ) experienced a 1.8-fold excess risk of dementia compared with those who walked more than 2 mile/d ( 17.8 vs 10.3/1000 person-years ; relative hazard [ RH ] , 1.77 ; 95 % confidence interval [ CI ] , 1.04 - 3.01 ) . Compared with men who walked the most ( > 2 mile/d ) , an excess risk of dementia was also observed in those who walked 0.25 to 1 mile/d ( 17.6 vs 10.3/1000 person-years ; RH , 1.71 ; 95 % CI , 1.02 - 2.86 ) . These associations persisted after accounting for other factors , including the possibility that limited amounts of walking could be the result of a decline in physical function due to pre clinical dementia . CONCLUSIONS Findings suggest that walking is associated with a reduced risk of dementia . Promoting active lifestyles in physically capable men could help late-life cognitive function CONTEXT Both higher adherence to a Mediterranean-type diet and more physical activity have been independently associated with lower Alzheimer disease ( AD ) risk but their combined association has not been investigated . OBJECTIVE To investigate the combined association of diet and physical activity with AD risk . DESIGN , SETTING , AND PATIENTS Prospect i ve cohort study of 2 cohorts comprising 1880 community-dwelling elders without dementia living in New York , New York , with both diet and physical activity information available . St and ardized neurological and neuropsychological measures were administered approximately every 1.5 years from 1992 through 2006 . Adherence to a Mediterranean-type diet ( scale of 0 - 9 ; trichotomized into low , middle , or high ; and dichotomized into low or high ) and physical activity ( sum of weekly participation in various physical activities , weighted by the type of physical activity [ light , moderate , vigorous ] ; trichotomized into no physical activity , some , or much ; and dichotomized into low or high ) , separately and combined , were the main predictors in Cox models . Models were adjusted for cohort , age , sex , ethnicity , education , apolipoprotein E genotype , caloric intake , body mass index , smoking status , depression , leisure activities , a comorbidity index , and baseline Clinical Dementia Rating score . MAIN OUTCOME MEASURE Time to incident AD . RESULTS A total of 282 incident AD cases occurred during a mean ( SD ) of 5.4 ( 3.3 ) years of follow-up . When considered simultaneously , both Mediterranean-type diet adherence ( compared with low diet score , hazard ratio [ HR ] for middle diet score was 0.98 [ 95 % confidence interval { CI } , 0.72 - 1.33 ] ; the HR for high diet score was 0.60 [ 95 % CI , 0.42 - 0.87 ] ; P = .008 for trend ) and physical activity ( compared with no physical activity , the HR for some physical activity was 0.75 [ 95 % CI , 0.54 - 1.04 ] ; the HR for much physical activity was 0.67 [ 95 % CI , 0.47 - 0.95 ] ; P = .03 for trend ) were associated with lower AD risk . Compared with individuals neither adhering to the diet nor participating in physical activity ( low diet score and no physical activity ; absolute AD risk of 19 % ) , those both adhering to the diet and participating in physical activity ( high diet score and high physical activity ) had a lower risk of AD ( absolute risk , 12 % ; HR , 0.65 [ 95 % CI , 0.44 - 0.96 ] ; P = .03 for trend ) . CONCLUSION In this study , both higher Mediterranean-type diet adherence and higher physical activity were independently associated with reduced risk for AD Objective : This study evaluated the protective role of physical activity ( PA ) against cognitive impairment ( CI ) in the oldest old ( age ≥ 85 ) . Method : Prospect i ve data on 66 optimally healthy , oldest old adults ( mean age
Output:
| Conclusions Longitudinal observational studies show an association between higher levels of physical activity and a reduced risk of cognitive decline and dementia . |
MS211720 | ***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: Resistant starch ( RS ) , a non-viscous dietary fibre , may have postpr and ial effects on appetite regulation and metabolism , although the exact effects and mechanisms are unknown . An acute r and omised , single-blind crossover study , aim ed to determine the effects of consumption of 48 g RS on appetite compared to energy and available carbohydrate-matched placebo . Twenty young healthy adult males consumed either 48 g RS or the placebo divided equally between two mixed meals on two separate occasions . Effects on appetite were assessed , using an ad libitum test meal and 24-h diet diaries for energy intake , and using visual analogue scales for subjective measures . Changes to postpr and ial glucose , insulin and C-peptide were also assessed . There was a significantly lower energy intake following the RS supplement compared to the placebo supplement at both the ad libitum test meal ( 5241 ( sem 313 ) v. 5606 ( sem 345 ) kJ , P = 0.033 ) and over the 24 h ( 12 603 ( sem 519 ) v. 13 949 ( sem 755 ) kJ , P = 0.044 ) . However , there was no associated effect on subjective appetite measures . Postpr and ial plasma glucose concentrations were not significantly different between supplements , but there was a significantly lower postpr and ial insulin response following the RS supplement ( P = 0.029 ) . The corresponding C-peptide concentrations were not significantly different , although the ratio of C-peptide to insulin was higher following the RS supplement compared to placebo ( P = 0.059 ) . These results suggest that consumption of 48 g RS , over a 24-h period , may be useful in the management of the metabolic syndrome and appetite . Further studies are required to determine the exact mechanisms Fibres which are soluble or insoluble in water have different physiochemical properties and may therefore be expected to exert different effects on post-ingestive satiety signals . This study compared the effects on short-term ( 24 h ) appetite of two equienergetic high ( 22 g ) fibre breakfasts , an equienergetic low fibre breakfast and a low energy , ' light ' breakfast . Psyllium gum ( the soluble fibre ) and wheat bran ( the insoluble fibre ) were incorporated into breakfast cereals and consumed at breakfast by sixteen healthy , normal weight males after an overnight fast using a repeated measures , counterbalanced design . Ad libitum energy intake was assessed at a test snack 1.5 h after breakfast , later in the day using food boxes and the following day using food diaries . Motivation to eat and gastrointestinal sensations were tracked for the next 24 h. Hunger ratings showed a trend towards the subjects being less hungry and they consumed significantly less energy at snack time after the high insoluble than after the high soluble fibre breakfast cereal . The soluble fibre breakfast produced a greater suppression of snack intake than the light breakfast , but smaller suppression than the other breakfasts . Interestingly there was a trend toward reduced hunger and voluntary energy consumption following the soluble fibre compared with the insoluble fibre much later in the day ( 9.5 - 13.5 h after breakfast ) although this was not significant . There was no significant effect of breakfast type on total day energy intake . The results suggest that different types of fibre modulate the timecourse of appetite control and may produce alterations in the experience of motivation and patterns of eating without necessarily effecting total energy intake Objective : To assess whether the addition of viscous fiber at an amount recommended by the US FDA to allow a ‘ low saturated fat , cholesterol , soluble fiber and coronary heart disease ’ , health cl aim label on a food package ( 1.7 g psyllium ) and /or fat ( 30 g sunflower oil and 3 g sodium propionate ) to a pasta meal would affect gastric emptying , postpr and ial glucose , insulin and GLP-1 concentrations . Design : Ten subjects participated in a two-by-two single blind r and omized crossover study . Four meals containing 50 g of available carbohydrate were consumed : pasta with or without psyllium enrichment served with a tomato sauce with ( 520 kcal per meal ) and without ( 240 kcal per meal ) fat . Blood sample s were taken for 240 min following the meal and all subjects consumed a buffet meal at the end of the study . Gastric empting was measured using the paracetamol absorption test . Blood was analysed for glucose , insulin , GLP-1 . Visual analog scales were used to record feelings of hunger , pleasantness and nausea . Results : The psyllium-enriched pasta had no significant effect on gastric emptying or the incremental area under the curve ( IAUC ) for GLP-1 , insulin or glucose compared with the control pasta . The addition of polyunsaturated fat and sodium propionate significantly increased the IAUC for GLP-1 ( P<0.001 ) , delaying gastric emptying ( P<0.002 ) , and decreasing glucose ( P<0.002 ) . Conclusions : A dose of 1.7 g psyllium did not evoke measurable effects on gastric emptying , postpr and ial GLP-1 , insulin or glucose metabolism . However the addition of 30 g of oil and 3 g of sodium propionate to the pasta did reduce gastric emptying , increase GLP-1 and reduce glucose and insulin concentrations . While this short-term study may have implication s in terms of reducing the risk of diabetes and improving coronary risk factor profiles the long term effects of these nutrients need to be studied . Sponsorship : This study was supported by Kellogg Company Dietary fibre consumption may help to control appetite and to reduce calorie intake . Underlying molecular mechanisms were not fully investigated . The aim of this study was to evaluate the effect of barley beta-glucans on short-term appetite and on satiety-related hormones in healthy subjects . Fourteen volunteers were selected and r and omly assigned to have isocaloric breakfasts including a 3 % beta-glucan-enriched bread ( betaGB ) or a control bread ( CB ) . Post-breakfast individual self-records of appetite ratings and measure of calorie intake at an ad libitum lunch as well as measure of blood glucose , insulin , ghrelin and PYY concentrations , were performed . betaGB determined a significant higher reduction of hunger and increase of fullness and satiety than CB . Accordingly , a 19 % reduction of energy intake at lunch subsequent to betaGB consumption compared to CB , was recorded . A 23 % lower AUC(60 - 180 ) of plasma ghrelin and a 16 % higher total AUC of PYY response after betaGB than CB consumption , independent from insulin response , was found . Glucose response was also blunted by betaGB vs CB . Barley beta-glucans were able to control appetite in the short term by modulating sensations and reducing energy intake . Data suggested for the first time that satiety effect of beta-glucans are mediated by ghrelin and PYY Although subjective appetite scores are widely used , studies on the reproducibility of this method are scarce . In the present study nine healthy , normal weight , young men recorded their subjective appetite sensations before and during 5 h after two different test meals A and B. The subjects tested each meal twice and in r and omized order . Visual analogue scale ( VAS ) scores , 10 cm in length , were used to assess hunger , satiety , fullness , prospect i ve food consumption and palatability of the meals . Plasma glucose and lactate concentrations were determined concomitantly . The repeatability was investigated for fasting values , delta-mean 5 h and mean 5 h values , delta-peak/nadir and peak/nadir values . Although the profiles of the postpr and ial responses were similar , the coefficients of repeatability ( CR = 2SD ) on the mean differences were large , ranging from 2.86 to 5.24 cm for fasting scores , 1.36 to 1.88 cm for mean scores , 2.98 to 5.42 cm for delta-mean scores , and 3.16 to 6.44 cm for peak and delta-peak scores . For palatability ratings the CR values varied more , ranging from 2.38 ( taste ) to 8.70 cm ( aftertaste ) . Part of the difference in satiety ratings could be explained by the differences in palatability ratings . However , the low reproducibility may also be caused by a conditioned satiation or hunger due to the subjects ' prior experience of the meals and therefore not just be a reflection of r and om noise . It is likely , however , that the variation in appetite ratings is due both to method ological day-to-day variation and to biological day-to-day variation in subjective appetite sensations BACKGROUND Cholecystokinin is associated with satiety . Fat stimulates cholecystokinin release , and fiber appears to prolong cholecystokinin elevation during the alimentary period . OBJECTIVE We tested whether adding fiber or fat to a low-fat , low-fiber meal increases cholecystokinin release and enhances subjective measures of satiety and whether the cholecystokinin response correlates with subjective measures of satiety . DESIGN Three isoenergetic breakfast meals were tested in a r and omized crossover design : low fiber , low fat ; high fiber , low fat ; and low fiber , high fat . Blood sample s were drawn from fasted subjects ( 7 men and 8 women ) before and at different time points after test meal consumption for 6 h. Plasma was analyzed for cholecystokinin , insulin , glucose , and triacylglycerols . Visual analogue scales were used to assess subjects ' hunger , desire to eat , fullness , and prospect i ve consumption . RESULTS In the women , the meals higher in fiber or in fat result ed in greater feelings of satiety and in significantly higher cholecystokinin responses than did the low-fat , low-fiber meal . In the men , the increase in cholecystokinin concentration did not differ between meals , but the 2 low-fat meals elicited a greater feeling of satiety than did the high-fat meal . The insulin response was significantly higher for the low-fiber , low-fat meal than for the other 2 meals , and the triacylglycerol response was greatest for the high-fat , low-fiber meal . CONCLUSION In women , the feeling of satiety caused by cholecystokinin release is enhanced by increasing either the fiber or fat content of a low-fat , low-fiber meal BACKGROUND Protein and fiber may be important determinants of satiety . Lupin kernel flour is a novel food ingredient that is rich in protein and fiber . OBJECTIVE The objective was to investigate the effects of lupin kernel flour-enriched bread ( LB ) on satiety and energy intake in humans . DESIGN Two r and omized controlled crossover trials were performed to compare the acute effects of LB with those of white bread ( WB ) . In study 1 , the subjects ( n = 16 ) completed 4 treatments 1 wk apart : WB breakfast ( as toast ) and WB lunch ( as s and wiches ) , WB breakfast and LB lunch , LB breakfast and WB lunch , and LB breakfast and LB lunch . Energy intake at all breakfast meals was matched ( 1655 kJ ) , and ad libitum energy intake at lunch , 3 h after breakfast , was measured . In study 2 , the subjects ( n = 17 ) completed 2 treatments 1 wk apart : WB breakfast and LB breakfast ( each 1655 kJ ) . Blood sample s were taken at baseline and at regular intervals for 3 h after breakfast . RESULTS In study 1 , the LB breakfast result ed in significantly higher self-reported satiety ( P < 0.001 ) and lower energy intake ( kJ ) at lunch ( -488 ; 95 % CI : -798 , -178 ) than did the WB breakfast . The LB lunch result ed in a significantly lower within-meal energy intake ( kJ ) at lunch ( -1028 ; 95 % CI : -1338 , -727 ) than did the WB lunch . In study 2 , compared with the WB breakfast , the LB breakfast significantly altered the 3-h postmeal plasma ghrelin response ( P = 0.04 ) and result ed in significantly lower mean 3-h plasma ghrelin concentrations ( P = 0.009 ) . CONCLUSION A novel food enriched in protein and fiber derived from lupin kernel flour significantly influences energy intake acutely BACKGROUND The pattern of substrate utilization with diets containing a high or a low proportion of unavailable and slowly digestible carbohydrates may constitute an important factor in the control , time course , and onset of hunger in humans . OBJECTIVE We tested the hypothesis that isoenergetic diets differing only in their content of unavailable carbohydrates would result in different time courses of total , endogenous , and exogenous carbohydrate oxidation rates . DESIGN Two diets with either a high ( H diet ) or a low ( L diet ) content of unavailable carbohydrates were fed to 14 healthy subjects studied during two 24-h periods in a metabolic chamber . Substrate utilization was assessed by whole-body indirect calorimetry . In a subgroup of 8 subjects , endogenous and exogenous carbohydrate oxidation were assessed by prelabeling the body glyc
Output:
| Most fibers do not reduce appetite or energy intake in acute study design s. KEY TEACHING POINTS : • Dietary fiber intake is associated with lower body weight in epidemiologic studies . •
Most acute fiber treatments ( 61 % ) did not enhance satiety . •
Most acute fiber treatments ( 78 % ) did not reduce food intake . •
Neither fiber type nor fiber dose were related to satiety response or food intake |
MS211721 | ***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: Postpr and ial hypotension is an important clinical condition that predisposes to syncope , falls , angina , and cerebrovascular events . The magnitude of the fall in blood pressure after meals depends on enteric glucose availability . We hypothesized that acarbose , an & agr;-glucosidase inhibitor that decreases glucose absorption in the small intestine , would attenuate postpr and ial hypotension . Acarbose or placebo was given 20 minutes before a st and ardized meal in 13 patients with postpr and ial hypotension in the setting of autonomic failure ( age : 65±2.64 years ; body mass index : 25±1.08 kg/m2 ; supine plasma norepinephrine : 110±26.6 pg/mL ) . Four patients were studied in a single-blind protocol and 9 patients in a double-blind , r and omized , crossover fashion . Patients were studied supine , and blood pressure , heart rate , and neuroendocrine parameters were obtained at baseline and for 90 minutes after meal intake . After adjusting for potential confounders , acarbose significantly attenuated the postpr and ial fall in systolic and diastolic blood pressures by 17 mm Hg ( 95 % CI : 7 to 28 ; P=0.003 ) and 9 mm Hg ( 95 % CI : 5 to 14 ; P=0.001 ) , respectively . Furthermore , acarbose effectively reduced plasma levels of insulin , a known vasodilator , by 11 & mgr;U/mL ( 95 % CI : 5 to 18 ; P=0.001 ) compared with placebo . After adjusting for insulin levels , the attenuation of postpr and ial hypotension by acarbose remained significant , indicating that additional mechanisms contribute to this effect . In conclusion , 100 mg of acarbose successfully improved postpr and ial hypotension in patients with severe autonomic failure . This effect is not explained solely by a reduction in insulin levels Postpr and ial hypotension occurs commonly in patients with autonomic failure and may be due to attenuation of the normal sympathetic nervous system activation in response to meal ingestion . In a r and omized , double-blind , placebo-controlled study , we investigated the therapeutic effect of the norepinephrine precursor 3,4-DL-threo-dihydroxyphenylserine ( DL-DOPS ) on this condition . We measured blood pressure , heart rate , forearm vascular resistance , and plasma DL-DOPS and norepinephrine in 11 patients with autonomic failure . DL-DOPS attenuated the postpr and ial fall in blood pressure . This was associated with an increase in plasma norepinephrine and forearm vascular resistance . DL-DOPS therapy did not change the postpr and ial increase in heart rate . There was a trend toward increased supine hypertension associated with DL-DOPS treatment . This study shows that DL-DOPS is a promising treatment for postpr and ial hypotension and provides support for the hypothesis that postpr and ial hypotension is , at least in part , due to decreased activation of the sympathetic nervous system . NEUROLOGY 1996;47 : 1414 - 1 . The aim of this study was to determine the effects of caffeine on haemodynamic and neurohumoral responses to meal ingestion in elderly patients with a history of symptomatic postpr and ial hypotension . 2 . Postpr and ial hypotension is a common disorder of blood pressure regulation in the elderly , associated with falls and syncope . The pathophysiological mechanism is thought to be related to impaired vascular compensation for splanchnic blood pooling after a meal . Since caffeine inhibits vasodilatory adenosine receptors in the splanchnic circulation , we postulated that caffeine would reduce splanchnic blood pooling and prevent the development of postpr and ial hypotension . 3 . We conducted a r and omized , double-blind , placebo-controlled , cross-over study in nine elderly patients [ age 76 + /- 9 ( SD ) years ] with histories of symptomatic postpr and ial hypotension . St and ardized 1674kJ liquid meals with 250 mg of caffeine or placebo were given on two occasions , at least 1 week apart . Blood pressure , heart rate , forearm vascular resistance ( by venous occlusion plethysmography ) , and plasma caffeine and catecholamine levels were measured . Cardiac and splanchnic blood volume were determined by radionuclide scans . 4 . By 30 min after both caffeine and placebo meal studies , supine mean arterial blood pressure fell significantly ( P = 0.006 ) by 31 + /- 7 and 19 + /- 6 mmHg , respectively ( mean + /- SEM , between group difference was not significant ) . Heart rate , cardiac output and splanchnic blood volume increased significantly , but to a similar extent , after caffeine and placebo . Forearm vascular resistance was unchanged after both meals . 5 . Oral caffeine given with a meal does not reduce splanchnic blood pooling nor prevent postpr and ial hypotension in symptomatic elderly patients Objective To investigate the effects of the somatostatin analogue octreotide , which inhibits the release of various peptides , on 24-h ambulatory blood pressure profiles in subjects with primary ( idiopathic ) autonomic failure due to sympathetic denervation , and in particular to determine whether octreotide reduces daytime hypotension and whether it causes or accentuates nocturnal hypertension . Subjects and methods Eighteen subjects with primary autonomic failure , confirmed by detailed physiological and biochemical autonomic tests , were studied in a r and omized manner on two occasions , with and without octreotide treatment ( 1 μg/kg body weight subcutaneously , twice a day at 0800 and 1800 h ) . Blood pressure was measured using the SpaceLabs 90207 system . This was connected at 0900 h with programmed recordings at 30-min intervals until 2300 h and at 60-min intervals until the next morning . There were additional subject-initiated recordings after 5 min each of lying , sitting and st and ing four times during the day , while sitting after lunch at noon and while st and ing following walking in the evening . Additional analyses included calculation of cumulative sum (cusum)-derived parameters and construction of cusum plots . Results After octreotide treatment , the overall mean daytime systolic/diastolic blood pressure ( mmHg ) was raised ( 123 ± 2/77 ± 1 without treatment versus 128 ± 2/79 ± 1 with treatment ) . There was a reduction in postural ( supine versus st and ing : from 96 ± 3/62 ± 3 without treatment to 106 ± 5/67 ± 4 with treatment ) , postpr and ial ( 107 ± 3/65 ± 2 to 122 ± 5/75 ± 4 ) and exertion-induced ( 96 ± 5/61 ± 5 to 113 ± 6/71 ± 5 ) hypotension . Symptoms of hypotension were reduced by octreotide . Nocturnal blood pressure was lower after octreotide ( 139 ± 3/84 ± 1 versus 129 ± 3/78 ± 2 ) . Analyses with the cusum technique further demonstrated blood pressure recovery during the day , with a reduction in the magnitude of change at night after octreotide treatment . Conclusions In primary autonomic failure , 24-h ambulatory blood pressure profiles and cusum analyses indicate that octreotide has beneficial effects in reducing postural , postpr and ial and exertion-induced hypotension , without causing or increasing nocturnal hypertension 1 . Postpr and ial hypotension is now recognized as an important clinical problem , particularly in the elderly and in patients with autonomic dysfunction . The mechanisms responsible are poorly understood ; however , impaired regulation of splanchnic blood flow and the release of gastrointestinal hormones appear to be important . The effect of gastric emptying on the magnitude of the postpr and ial fall in blood pressure has not been evaluated . 2 . The aim of this study was to determine whether there is a relationship between changes in blood pressure and the rate of gastric emptying after ingestion of 75 g of glucose in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) and both young and older normal subjects . Sixteen patients with recently diagnosed NIDDM , median age 57 ( 39 - 79 ) years , 10 ' young ' subjects with a median age of 23 ( 19 - 26 ) years and nine ' older ' subjects , median age 48 ( 40 - 68 ) years , were measured simultaneously for gastric emptying of 75 g of glucose in 350 ml of water blood pressure and blood glucose concentrations , commencing at approximately 10.00 hours after an overnight fast . Measurements of blood pressure were made in the sitting position immediately before glucose ingestion and at 15 min intervals up to 180 min . 3 . Gastric emptying of glucose was not significantly different between the three groups [ 50 % emptying time ( T50 ) : 95 + /- 7.3 min in patients with NIDDM compared with 120 + /- 13.2 min in the ' young ' group and 97 + /- 8.1 min in the ' older ' group ] . There was a significant fall in mean blood pressure after the glucose load in the patients with NIDDM ( P < 0.0001 ) and the ' older ' normal subjects ( P < 0.05 ) , but not the ' young ' normal subjects . Postpr and ial hypotension ( fall in systolic blood pressure > or = 20 mmHg ) was evident in seven ( 44 % ) patients with NIDDM and three ( 33 % ) ' older ' normal subjects . The area under the change in mean blood pressure curve was related significantly to the gastric emptying T50 ( r = 0.67 , P < 0.005 ) in the patients with NIDDM , but not in either control group . 4 . In conclusion , in patients with recently diagnosed NIDDM the fall in blood pressure after an oral glucose load is ( i ) greater than in both young and older normal subjects and ( ii ) related to the rate of gastric emptying In a double-blind placebo-controlled study , we examined the effect of caffeine pretreatment on the haemodynamic and humoral changes after a st and ardized breakfast in 15 healthy elderly subjects ( mean age 75.4 + /- 6.6 years ) . After placebo , the prepr and ial blood pressure did not change and the postpr and ial blood pressure declined by a maximum of 6.1 % . After oral ingestion of 250 mg caffeine , 60 min before breakfast , the prepr and ial blood pressure increased by 12.5 % . Although the decrease of the postpr and ial blood pressure was not altered , blood pressure remained above its basal value . The increase in plasma noradrenaline after the meal was similar in the placebo and the caffeine tests . Plasma adrenaline decreased after placebo ( -19 % ) but did not change after caffeine . Thus , despite the unchanged decrease of the postpr and ial blood pressure , the prepr and ial pressor effect of caffeine prevented the decline of the postpr and ial blood pressure below its baseline value . The clinical relevance of this finding has still to be determined 1 . A postpr and ial fall in blood pressure ( BP ) in older men and women increases the risks of falls and impaired cerebral perfusion . Postpr and ial hypotension has been suggested to be greater in hypertensive subjects , particularly in those on antihypertensive medication Postpr and ial hypotension occurs frequently in diabetes ; the fall in blood pressure is greatest after ingestion of carbohydrate , particularly glucose and , in type 2 diabetes , is related to the rate of gastric emptying . The aim of this study was to determine whether slowing of gastric emptying by guar gum reduces the fall in blood pressure after oral glucose in patients with type 2 diabetes . Eleven type 2 patients managed by diet alone , age 61.9 ± 1.3 years , had measurements of gastric emptying , blood pressure , blood glucose , and serum insulin on two occasions after ingestion of 300 ml water containing 50 g glucose , with or without 9 g guar gum . The magnitude of the fall in blood pressure was less ( P < 0.05 ) and gastric emptying slower ( P < 0.05 ) after guar . Blood glucose ( P < 0.05 ) and serum insulin ( P < 0.01 ) concentrations were lower after guar . The magnitude of the fall in systolic blood pressure was related to gastric emptying of glucose at 30 min on the control day ( r = 0.67 , P < 0.05 ) . We conclude that guar gum attenuates the fall in blood pressure after oral glucose in patients with type 2 diabetes mellitus , presumably by slowing glucose absorption OBJECTIVE To determine whether slowing of gastric emptying and glucose absorption with guar gum would reduce the fall in blood pressure after an oral glucose load in older subjects . DESIGN A r and omized , experimental , cross-over study . SETTING Department of Nuclear Medicine , Royal Adelaide Hospital , Adelaide , SA , Australia . PARTICIPANTS Ten healthy subjects ,
Output:
| RESULTS Thirteen articles reporting 12 studies ( 1 study was reported in 2 articles ) demonstrated that caffeine ( 5 studies ) ; acarbose ; 3,4-DL-threo-dihydroxyphenylserine ; guar gum ( 3 studies ) ; and octreotide ( 2 studies ) statistically attenuated the postpr and ial reduction in BP .
For symptomatic participants , there was improvement with acarbose but none with caffeine .
Drug interventions can attenuate postpr and ial reductions in BP , but they may not necessarily be effective in people with symptomatic PPH |
MS211722 | ***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 Optimal fluid management in patients with acute lung injury is unknown . Diuresis or fluid restriction may improve lung function but could jeopardize extrapulmonary-organ perfusion . METHODS In a r and omized study , we compared a conservative and a liberal strategy of fluid management using explicit protocol s applied for seven days in 1000 patients with acute lung injury . The primary end point was death at 60 days . Secondary end points included the number of ventilator-free days and organ-failure-free days and measures of lung physiology . RESULTS The rate of death at 60 days was 25.5 percent in the conservative- strategy group and 28.4 percent in the liberal- strategy group ( P=0.30 ; 95 percent confidence interval for the difference , -2.6 to 8.4 percent ) . The mean ( + /-SE ) cumulative fluid balance during the first seven days was -136+/-491 ml in the conservative- strategy group and 6992+/-502 ml in the liberal- strategy group ( P<0.001 ) . As compared with the liberal strategy , the conservative strategy improved the oxygenation index ( [ mean airway pressure x the ratio of the fraction of inspired oxygen to the partial pressure of arterial oxygen]x100 ) and the lung injury score and increased the number of ventilator-free days ( 14.6+/-0.5 vs. 12.1+/-0.5 , P<0.001 ) and days not spent in the intensive care unit ( 13.4+/-0.4 vs. 11.2+/-0.4 , P<0.001 ) during the first 28 days but did not increase the incidence or prevalence of shock during the study or the use of dialysis during the first 60 days ( 10 percent vs. 14 percent , P=0.06 ) . CONCLUSIONS Although there was no significant difference in the primary outcome of 60-day mortality , the conservative strategy of fluid management improved lung function and shortened the duration of mechanical ventilation and intensive care without increasing nonpulmonary-organ failures . These results support the use of a conservative strategy of fluid management in patients with acute lung injury . ( Clinical Trials.gov number , NCT00281268 [ Clinical Trials.gov ] . ) 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 : An individualized fluid optimization strategy , based on maximization of cardiac stroke volume ( SV ) with colloid boluses ( goal ‐directed therapy ) , improves outcome after surgery . Oesophageal Doppler ( OD ) is used for SV maximization in most r and omized studies , but evidence ‐based guidelines for the SV maximization procedure are lacking and variation in SV may influence the indication for fluid administration . We measured beat‐to‐beat OD SV before and after fluid optimization in order to estimate the number of heartbeats for which SV needs to be averaged to provide an acceptable accuracy for goal ‐directed therapy with this technology Objective To test whether fluid responsiveness can be predicted by the respiratory variation in aortic blood flow and /or the flow time corrected for heart rate monitored with esophageal Doppler . Design and setting Prospect i ve study in a 24-bed medical intensive care unit of a university hospital . Patients 38 mechanically ventilated patients with sinus rhythm and without spontaneous breathing activity in whom volume expansion was planned . Interventions The aortic blood flow was measured using an esophageal Doppler monitoring device before and after fluid infusion ( 500 ml NaCl 0.9 % over 10 min ) . The variation in aortic blood flow over a respiratory cycle between its minimal and maximal values was calculated . The flow time was also measured . Measurements and results Aortic blood flow increased by at least 15 % after volume expansion in 20 patients ( defined as responders ) . Before fluid infusion the respiratory variation in aortic flow was higher in responders than in nonresponders ( 28±12 % vs. 12±5 % ) . It significantly decreased after volume expansion ( 18±11 % ) in responders only . A respiratory variation in aortic flow before volume expansion of at least 18 % predicted fluid responsiveness with a sensitivity of 90 % and a specificity of 94 % . Flow time increased with fluid infusion in responders and nonresponders . A flow time corrected for heart rate below 277 ms predicted fluid responsiveness with a sensitivity of 55 % and a specificity of 94 % . The area under the ROC curve generated for variation in aortic blood flow ABF was greater than that generated for flow time . Conclusions The respiratory variation in aortic blood flow reliably predicts fluid responsiveness in patients with sinus rhythm and without breathing activity Introduction Total hip replacement is one of the most commonly performed major orthopaedic operations . Goal -directed therapy ( GDT ) using haemodynamic monitoring has previously demonstrated outcome benefits in high-risk surgical patients under general anaesthesia . GDT has never been formally assessed during regional anaesthesia . Methods Patients undergoing total hip replacement while under regional anaesthesia were r and omised to either the control group ( CTRL ) or the protocol group ( GDT ) . Patients in the GDT group , in addition to st and ard monitoring , were connected to the FloTrac sensor/Vigileo monitor haemodynamic monitoring system , and a GDT protocol was used to maximise the stroke volume and target the oxygen delivery index to > 600 mL/minute/m2 . Results Patients r and omised to the GDT group were given a greater volume of intravenous fluids during the intraoperative period ( means ± st and ard deviation ( SD ) : 6,032 ± 1,388 mL vs. 2,635 ± 346 mL ; P < 0.0001 ) , and more of the GDT patients received dobutamine ( 0 of 20 CTRL patients vs. 11 of 20 GDT patients ; P < 0.0003 ) . The GDT patients also received more blood transfused during the intraoperative period ( means ± SD : 595 ± 316 mL vs. 0 ± 0 mL ; P < 0.0001 ) , although the CTRL group received greater volumes of blood replacement postoperatively ( CTRL patients 658 ± 68 mL vs. GDT patients 198 ± 292 mL ; P < 0.001 ) . Overall blood consumption ( intraoperatively and postoperatively ) was not different between the two groups . There were an increased number of complications in the CTRL group ( 20 of 20 CTRL patients ( 100 % ) vs. 16 of 20 GDT patients ( 80 % ) ; P = 0.05 ) . These outcomes were predominantly due to a difference in minor complications ( 20 of 20 CTRL patients ( 100 % ) vs. 15 of 20 GDT patients ( 75 % ) ; P = 0.047 ) . Conclusions GDT applied during regional anaesthesia in patients undergoing elective total hip replacement changes intraoperative fluid management and may improve patient outcomes by decreasing postoperative complications . Larger trials are required to confirm our findings .Trial registration S RCT Objective To test the hypothesis that , in resuscitated septic shock patients , central venous-to-arterial carbon dioxide difference [ P(cv-a)CO2 ] may serve as a global index of tissue perfusion when the central venous oxygen saturation ( ScvO2 ) goal value has already been reached . Design Prospect i ve observational study . Setting A 22-bed intensive care unit ( ICU ) . Patients After early resuscitation in the emergency unit , 50 consecutive septic shock patients with ScvO2 > 70 % were included immediately after their admission into the ICU ( T0 ) . Patients were separated in Low P(cv-a)CO2 group ( Low gap ; n = 26 ) and High P(cv-a)CO2 group ( High gap ; n = 24 ) according to a threshold of 6 mmHg at T0 . Measurements Measurements were performed every 6 h over 12 h ( T0 , T6 , T12 ) . Results At T0 , there was a significant difference between Low gap patients and High gap patients for cardiac index ( CI ) ( 4.3 ± 1.6 vs. 2.7 ± 0.8 l/min/m² , P < 0.0001 ) but not for ScvO2 values ( 78 ± 5 vs. 75 ± 5 % , P = 0.07 ) . From T0 to T12 , the clearance of lactate was significantly larger for the Low gap group than for the High gap group ( P < 0.05 ) as well as the decrease of SOFA score at T24 ( P < 0.01 ) . At T0 , T6 and T12 , CI and P(cv-a)CO2 values were inversely correlated ( P < 0.0001 ) . Conclusion In ICU-resuscitated patients , targeting only ScvO2 may not be sufficient to guide therapy . When the 70 % ScvO2 goal -value is reached , the presence of a P(cv-a)CO2 larger than 6 mmHg might be a useful tool to identify patients who still remain inadequately resuscitated Organ dysfunction and multiple organ failure are the main causes of prolonged hospital stay after cardiac surgery , which increases re source use and health care costs . Increased levels of oxygen delivery and consumption are associated with improved outcome in different groups of postoperative patients . Cardiac surgical patients are at risk of inadequate perioperative oxygen delivery caused by extracorporeal circulation and limited cardiovascular reserves . The purpose of our study was to test whether increasing oxygen delivery immediately after cardiac surgery would shorten hospital and intensive care unit ( ICU ) stay . Four hundred three elective cardiac surgical patients were enrolled in the study and r and omly assigned to either the control or the protocol group . Goals of the protocol group were to maintain Svo2 >
Output:
| Goals with moderate quality evidence were sublingual microcirculation flow , the oxygen extraction ratio , cardiac index , cardiac output , and SVC collapsibility index . |
MS211723 | ***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: Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic population s. Using a combination , such as albendazole ( ALB ) to diethylcarbamazine ( DEC ) gives both macrofilaricidal and anti-helmintic activity . However , the safety of the combination versus DEC alone should be established in field studies in large population s prior to incorporation into national programmes . The present study compared the safety , tolerability , and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in population s living in two filariasis endemic villages in the district of Wardha in western India . The study was double blind , parallel group , and r and omized . Safety and tolerability study were studied in males and females older than 5 years . Safety was assessed by monitoring if adverse events ( AEs ) over 5 days affected daily acivities . Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe . Efficacy was evaluated by microfilaraemia ( Mf ) , immunochromatographic test ( ICT ) and ultrasonography ( USG ) at 0 , 3 , 6 , and 12 months of follow up . The efficacy study enrolled 103 male patients ( aged 18 - 50 years ) in microfilariae positive , clinical disease and asymptomatic , amicrofilaremic groups . There was no significant difference in efficacy between groups at 12 months . Within the Mf positive group , significant differences were seen in microfilaraemia ( P < 0.001 ) with both treatments , and in USG ( P < 0.001 and P < 0.004 respectively ) , at 12 months . The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes . Both drugs were adequately absorbed . The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up . While the safety of the combination has been ascertained , the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up This r and omized , placebo-controlled trial investigated the efficacy and nutritional benefit of combining chemotherapeutic treatment for intestinal helminths ( albendazole ) and lymphatic filariasis ( ivermectin ) . Children were infected with Ascaris ( 29.2 % ) , Trichuris ( 42.2 % ) , and hookworm ( 6.9 % ) , with 54.7 % of children having one or more of these parasites . Wuchereria bancrofti microfilaria were found in 13.3 % of the children . Children were r and omly assigned to treatment with placebo , albendazole , ivermectin , or combined therapy . Combination treatment reduced the prevalence of Trichuris infections significantly more than either drug alone . Combination therapy also significantly reduced the prevalence and density of W. bancrofti microfilaremia compared with placebo or ivermectin alone . Only combination therapy result ed in significantly greater gains in height ( hookworm-infected children ) or weight ( Trichuris-infected children ) compared with the placebo group . Combined albendazole and ivermectin was a more efficacious treatment for intestinal helminth and W. bancrofti infections in children and result ed in nutritional benefits not found with either drug alone The efficacy of two strategies for control of Bancroftian filariasis using selective rather than community-wide diethylcarbamazine ( DEC ) chemotherapy was evaluated and compared in two endemic communities of north-eastern Tanzania , with pretreatment microfilariae ( mf ) prevalences of 22 % and 38 % , and geometric mean intensities ( GMIs ) of 668 mf/ml and 735 mf/ml of blood . All mf-positive cases in the first community were offered treatment with 6 mg of DEC/kg of body weight a day for 12 days ( group 1 ) , and those in the second community were offered treatment with two doses of 6 mg of DEC/kg of body weight at an interval of six months ( group 2 ) . The effect of treatment was followed both among those treated and at the community level . In treated individuals , there was a rapid decrease in the mf load that was significantly greater among those receiving the 12-day st and ard dose . One year after the start of treatment , the mf clearance rates were 59 % and 39 % and the GMIs were reduced by 99 % and 97 % among treated individuals in groups 1 and 2 , respectively . However , at the community level , the mf prevalences were 16.3 % and 27.9 % ( reduced by 27 % and 26 % ) and the GMIs were 129 mf/ml and 224 mf/ml ( reduced by 81 % and 70 % ) one year after the start of treatment with the two regimens , respectively , suggesting that transmission continued at a significant level in the villages after treatment . The limitations of selective chemotherapy are discussed , and it is argued that strategies based on mass DEC chemotherapy would be more effective in reducing the microfilarial load in the community and thereby in reducing transmission Forty male Polynesian W. bancrofti carriers with mf counts greater than or equal to 20/ml were treated with a single ivermectin 50 , 100 , 150 or 200 mcg/kg dose . Following therapy , mf levels fell to less than 1 % of pretreatment levels in the carriers treated with the 3 highest doses . After one month , negativation rate was 40 % in patients treated with a 50 mcg/kg dose , significantly lower than in patients treated with higher doses . Recurrence of microfilaremia was observed by 3 months , mf recurrence percentages were significantly lower in patients treated with the 3 highest doses than in patients treated with a 50 mcg/kg dose . At 6 months , mf recurrence percentages reached 49.8 , 12.6 , 14 and 5.4 % of pretreatment levels in carriers treated with 50 , 100 , 150 and 200 mcg/kg , respectively . No significant difference was observed between mf levels by group at 6 and 12 months . With respect to efficacy , a dose greater than or equal to 100 mcg/kg appeared superior to 50 mcg/kg dose ; no significant difference between the 3 highest doses was observed . Some patients developed headache , myalgia and fever within 24 hours following therapy , none of adverse reactions were considered serious . In vector Ae . polynesiensis fed on carriers 6 months after treatment , average numbers of mf ingested and average numbers of L3 cephalic larvae were lower than those observed in mosquitoes fed on non-treated carriers with comparable mf counts . ( ABSTRACT TRUNCATED AT 250 WORDS In a ' blinded ' trial ( in Sri Lanka , 1996 - 98 ) of 47 male asymptomatic microfilaraemic subjects with Wuchereria bancrofti infection , the safety , tolerability and filaricidal efficacy of 3 single-dose combination regimens were compared : albendazole 400 mg with ivermectin 200 micrograms/kg , albendazole 400 mg with diethylcarbamazine citrate ( DEC ) 6 mg/kg or albendazole 600 mg with ivermectin 400 micrograms/kg . Treated subjects were followed-up for 24 months . This represents the first long-term study using combinations of albendazole with DEC or ivermectin in the above doses against bancroftian filariasis . All subjects had pre-treatment microfilaria ( mf ) counts over 100/mL. All 3 treatments significantly reduced mf counts , with the albendazole-DEC-treated group showing the lowest mf levels at 18 and 24 months post-treatment . Filarial antigen tests suggested that all 3 treatments had significant activity against adult W. bancrofti ; albendazole-DEC combination had the greatest activity according to this test , with antigen levels decreasing to 30.5 % of pre-treatment antigen levels , 24 months after therapy . All 3 treatments were clinical ly safe and well tolerated . These results suggest that a single dose of albendazole 400 mg together with DEC 6 mg/kg is a safe and effective combination for suppression of microfilaraemia of bancroftian filariasis that could be considered for use in filariasis control programmes based on mass treatment of endemic population This r and omized , placebo-controlled trial investigated the tolerance , efficacy , and nutritional benefit of combining chemotherapeutic treatment of intestinal helminths and lymphatic filariasis . Children were infected with Ascaris ( 30.7 % ) , Trichuris ( 53.4 % ) , and hookworm ( 9.7 % ) with 69.9 % having more than one of these parasites . A total of 15.8 % of the children had Wuchereria bancrofti microfilariae . Children were r and omly assigned treatment with placebo , albendazole ( ALB ) , diethylcarbamazine ( DEC ) , or combined therapy . The combination of DEC/ALB reduced microfilarial density compared with placebo , ALB , or DEC ( P < or = 0.03 ) . Albendazole and DEC/ALB reduced the prevalence of Ascaris , Trichuris , and hookworm more than placebo or DEC ( P < or = 0.03 ) . Among Trichuris-infected children , those receiving ALB and DEC/ALB demonstrated greater gains in weight compared with placebo ( P < or = 0.05 ) . Albendazole and DEC/ALB were equally efficacious in treating intestinal helminths and for children with W. bancrofti microfilaremia , DEC/ALB was more effective than DEC , with no increase in severity of adverse reactions Several new chemotherapeutic tools are now available for the control of lymphatic filariasis . Combinations of single doses of antifilarial drugs are generally superior to single drugs . The efficacy and safety of albendazole in combination with diethylcarbamazine ( DEC ) or ivermectin , for the treatment of Brugia malayi infection , were investigated , for the first time , in an open , hospital-based study . Fifty-one asymptomatic microfilaraemics ( with 108 - 4034 microfilariae/ml ; median = 531 ) of both sexes and aged 14 - 70 years were r and omly allocated to receive single-dose treatments of ivermectin ( 200 micrograms/kg ) with diethylcarbamazine ( DEC ; 6 mg/kg ) , ivermectin ( 200 micrograms/kg ) with albendazole ( 400 mg ) , DEC ( 6 mg/kg ) with albendazole ( 400 mg ) , or albendazole ( 400 mg ) alone . Albendazole alone had no effect on the microfilarial levels at the 1-year follow-up but both groups given DEC had significantly lower microfilaraemias ( P < 0.015 and P < 0.02 ) than that given ivermectin with albendazole . Overall , 47%-64 % of those given DEC but only 14 % of those given ivermectin with albendazole appeared to be amicrofilaraemic 1 year post-treatment . The adverse reactions seen in the study were mild , transient and qualitatively similar to those seen earlier with ivermectin and DEC . The combination of DEC and albendazole , both well tested drugs , offers a new option for countries such as India where there is no onchocerciasis or loiasis and where ivermectin may not be immediately available . The direct and indirect effects of albendazole on intestinal helminths would be additional benefits The efficacy of re-treatment with the combination of ivermectin ( 150 - 200 micrograms/kg bodyweight ) and albendazole ( 400 mg ) on Wuchereria bancrofti microfilaraemia was assessed in 1997 - 99 in 4 groups of individuals from coastal Ghana , which 1 year previously had received a primary treatment with placebo ( n = 38 ) , albendazole ( n = 39 ) , ivermectin ( n = 34 ) or combination of albendazole and ivermectin ( n = 42 ) , respectively . One year after the re-treatment , an overall mean reduction in microfilarial intensity of 76.2 % in relation to the intensity before re-treatment was observed , with no statistical significant difference between the 4 groups . The groups given primary treatment with placebo or the drug combination showed re-treatment reductions which were lower ( 72.5 % and 69.8 % , respectively ) but not statistically significantly different from the reduction observed 1 year after the primary treatment with the combination ( 86.7 % ) . The efficacy of the combination treatment thus appeared to be largely independent of the type of primary treatment given and multiplicative when used repeatedly To assess the efficacy of diethylcarbamazine ( DEC ) in clearing Wuchereria bancrofti microfilariae ( mf ) from the circulation , we conducted a single blind hospital-based therapeutic trial of 3 DEC regimens . All patients were assessed by filtration of 1 mL of venous blood taken before and 1 , 3 , 6 and
Output:
| AUTHORS ' CONCLUSIONS There is insufficient evidence to confirm or refute that albendazole co-administered with DEC or ivermectin is more effective than DEC or ivermectin alone in clearing microfilariae or killing adult worms .
Albendazole combined with ivermectin appears to have a small effect on microfilaraemia , but this was not consistently demonstrated . |
MS211724 | ***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 reduction in salt intake lowers blood pressure . However , most previous trials were in whites with few in blacks and Asians . Salt reduction may also reduce other cardiovascular risk factors ( eg , urinary albumin excretion , arterial stiffness ) . However , few well-controlled trials have studied these effects . We carried out a r and omized double-blind crossover trial of salt restriction with slow sodium or placebo , each for 6 weeks , in 71 whites , 69 blacks , and 29 Asians with untreated mildly raised blood pressure . From slow sodium to placebo , urinary sodium was reduced from 165±58 ( ±SD ) to 110±49 mmol/24 hours ( 9.7 to 6.5 g/d salt ) . With this reduction in salt intake , there was a significant decrease in blood pressure from 146±13/91±8 to 141±12/88±9 mm Hg ( P<0.001 ) , urinary albumin from 10.2 ( IQR : 6.8 to 18.9 ) to 9.1 ( 6.6 to 14.0 ) mg/24 hours ( P<0.001 ) , albumin/creatinine ratio from 0.81 ( 0.47 to 1.43 ) to 0.66 ( 0.44 to 1.22 ) mg/mmol ( P<0.001 ) , and carotid-femoral pulse wave velocity from 11.5±2.3 to 11.1±1.9 m/s ( P<0.01 ) . Subgroup analysis showed that the reductions in blood pressure and urinary albumin/creatinine ratio were significant in all groups , and the decrease in pulse wave velocity was significant in blacks only . These results demonstrate that a modest reduction in salt intake , approximately the amount of the current public health recommendations , causes significant falls in blood pressure in all 3 ethnic groups . Furthermore , it reduces urinary albumin and improves large artery compliance . Although both could be attributable to the falls in blood pressure , they may carry additional benefits on reducing cardiovascular disease above that obtained from the blood pressure falls alone Sodium restriction can reduce blood pressure in hypertensive patients . The present study indicates that if hypertension is well controlled then the reemergence of hypertension can be decreased by the use of a reduced sodium intake . The present paper demonstrates that in such patients on a normal salt diet , 90 % become hypertensive within 6 months while only 40 % of people on a reduced sodium diet become hypertensive . It is proposed that a high sodium intake activates a number of amplifiers that causes a shift of the dose-response curve to sodium to the left and if not prevented or interrupted leads to the development of hypertension BACKGROUND Few trials have evaluated the effects of reduced sodium intake in older individuals , and no trial has examined the effects in relevant subgroups such as African Americans . PATIENTS AND METHODS The effects of sodium reduction on blood pressure ( BP ) and hypertension control were evaluated in 681 patients with hypertension , aged 60 to 80 years , r and omly assigned to a reduced sodium intervention or control group . Participants ( 47 % women , 23 % African Americans ) had systolic BP less than 145 mm Hg and diastolic BP less than 85 mm Hg while taking 1 antihypertensive medication . Three months after the start of intervention , medication was withdrawn . The primary end point was occurrence of an average systolic BP of 150 mm Hg or more , an average diastolic BP of 90 mm Hg or more , the resumption of medication , or a cardiovascular event during follow-up ( mean , 27.8 months ) . RESULTS Compared with control , mean urinary sodium excretion was 40 mmol/d less in the reduced sodium intervention group ( P<.001 ) ; significant reductions in sodium excretion occurred in subgroups defined by sex , race , age , and obesity . Prior to medication withdrawal , mean reductions in systolic and diastolic BPs from the reduced sodium intervention , net of control , were 4.3 mm Hg ( P<.001 ) and 2.0 mm Hg ( P = .001 ) . During follow-up , an end point occurred in 59 % of reduced sodium and 73 % of control group participants ( relative hazard ratio = 0.68 , P<.001 ) . In African Americans , the corresponding relative hazard ratio was 0.56 ( P = .005 ) ; results were similar in other subgroups . In dose-response analyses , end points were progressively less frequent with greater sodium reduction ( P for trend = .002 ) . CONCLUSION A reduced sodium intake is a broadly effective , nonpharmacologic therapy that can lower BP and control hypertension in older individuals BACKGROUND The effect of dietary composition on blood pressure is a subject of public health importance . We studied the effect of different levels of dietary sodium , in conjunction with the Dietary Approaches to Stop Hypertension ( DASH ) diet , which is rich in vegetables , fruits , and low-fat dairy products , in persons with and in those without hypertension . METHODS A total of 412 participants were r and omly assigned to eat either a control diet typical of intake in the United States or the DASH diet . Within the assigned diet , participants ate foods with high , intermediate , and low levels of sodium for 30 consecutive days each , in r and om order . RESULTS Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg ( P<0.001 ) during the control diet and by 1.3 mm Hg ( P=0.03 ) during the DASH diet . Reducing the sodium intake from the intermediate to the low level caused additional reductions of 4.6 mm Hg during the control diet ( P<0.001 ) and 1.7 mm Hg during the DASH diet ( P<0.01 ) . The effects of sodium were observed in participants with and in those without hypertension , blacks and those of other races , and women and men . The DASH diet was associated with a significantly lower systolic blood pressure at each sodium level ; and the difference was greater with high sodium levels than with low ones . As compared with the control diet with a high sodium level , the DASH diet with a low sodium level led to a mean systolic blood pressure that was 7.1 mm Hg lower in participants without hypertension , and 11.5 mm Hg lower in participants with hypertension . CONCLUSIONS The reduction of sodium intake to levels below the current recommendation of 100 mmol per day and the DASH diet both lower blood pressure substantially , with greater effects in combination than singly . Long-term health benefits will depend on the ability of people to make long-lasting dietary changes and the increased availability of lower-sodium foods 31 patients with a diastolic blood-pressure between 95 and 109 mm Hg have been treated for two years with a regimen involving a moderate restriction of salt in the diet . The results are compared with those in a control group and in a drug-treated group . Salt restriction has reduced the diastolic blood-pressure by 7.3+/-1.6 mm Hg , a result similar to that in patients treated with antihypertensive drugs . In the untreated group the diastolic blood-pressure rose by 1.8+/-1.1 mm Hg . Most patients did not achieve the desired amount of salt restriction and a stricter adherence to the diet might have caused further falls in blood-pressure . Excessive salt intake is probably a major cause of the epidemic of hypertension in " civilised " countries and a reduction in salt intake may help to control the epidemic . In persons with a diastolic blood-pressure between 90 and 105 mm Hg salt restriction should be tried before drugs OBJECTIVE The aim of this study was to describe the effect of intensified antihypertensive therapy based on a structured teaching and treatment programme on the prognosis of hypertensive type 1 ( insulin-dependent ) diabetic patients with kidney disease . DESIGN The study was a controlled , prospect i ve , parallel , 10-year follow-up trial . PATIENTS AND INTERVENTIONS A sequential sample of 91 hypertensive type 1 diabetic patients with overt diabetic nephropathy was prospect ively followed for 10 years . Forty-five patients ( intensified antihypertensive therapy ; IT group ) participated in an intensified antihypertensive therapy programme and 46 patients received routine antihypertensive treatment as provided by family physicians , consultants and local hospitals ( routine antihypertensive therapy ; RT group ) . OUTCOME MEASURES The main endpoint was death ; secondary endpoints were renal replacement therapy , blindness and amputation . RESULTS Blood pressure was reduced in the IT group and increased in the RT group . During the follow-up period , 29 patients died , seven in the IT group and 22 in the RT group . The survival curves were significantly different ( P = 0.0008 ) . The main causes of death were cardiac . In a multiple Cox proportional hazards model , allocation to the IT group reduced the mortality risk [ relative risk ( RR ) = 0.213 ; 95 % confidence interval 0.089 - 0.509 , P = 0.00051 , while age ( P = 0.0039 ) and mean blood pressure ( P= 0.0113 ) increased this risk . In multiple Cox or multiple logistic regression models , the risks of dialysis ( RR = 0.269 , 95 % confidence interval 0.110 - 0.656 , P = 0.0039 ) , blindness ( odds ratio = 0.158 , 95 % confidence interval 0.037 - 0.684 , P= 0.0136 ) , and amputation ( RR = 0.181 , 95 % confidence interval 0.047 - 0.703 , P= 0.0135 ) were significantly lower in the IT group compared with the RT group ( log rank P = 0.0008 ) . CONCLUSION We conclude that intensified antihypertensive treatment , based on a hypertension teaching and treatment programme , reduces long-term morbidity and mortality in patients with diabetic nephropathy BACKGROUND Although the DASH ( Dietary Approaches to Stop Hypertension ) diet has been shown to lower blood pressure ( BP ) in short-term feeding studies , it has not been shown to lower BP among free-living individuals , nor has it been shown to alter cardiovascular biomarkers of risk . OBJECTIVE To compare the DASH diet alone or combined with a weight management program with usual diet controls among participants with prehypertension or stage 1 hypertension ( systolic BP , 130 - 159 mm Hg ; or diastolic BP , 85 - 99 mm Hg ) . DESIGN AND SETTING R and omized , controlled trial in a tertiary care medical center with assessment s at baseline and 4 months . Enrollment began October 29 , 2003 , and ended July 28 , 2008 . PARTICIPANTS Overweight or obese , unmedicated out patients with high BP ( N = 144 ) . INTERVENTIONS Usual diet controls , DASH diet alone , and DASH diet plus weight management . OUTCOME MEASURES The main outcome measure is BP measured in the clinic and by ambulatory BP monitoring . Secondary outcomes included pulse wave velocity , flow-mediated dilation of the brachial artery , baroreflex sensitivity , and left ventricular mass . RESULTS Clinic-measured BP was reduced by 16.1/9.9 mm Hg ( DASH plus weight management ) ; 11.2/7.5 mm ( DASH alone ) ; and 3.4/3.8 mm ( usual diet controls ) ( P < .001 ) . A similar pattern was observed for ambulatory BP ( P < .05 ) . Greater improvement was noted for DASH plus weight management compared with DASH alone for pulse wave velocity , baroreflex sensitivity , and left ventricular mass ( all P < .05 ) . CONCLUSION For overweight or obese persons with above-normal BP , the addition of exercise and weight loss to the DASH diet result ed in even larger BP reductions , greater improvements in vascular and autonomic function , and reduced left ventricular mass . CLINICAL TRIAL REGISTRATION clinical trials.gov Identifier : NCT00571844 AIM To determine the effect on blood pressure from brisk walking with or without salt restriction in a community based sample of treated hypertensives . METHODS The intervention was undertaken in a community setting with a factorial r and omised controlled trial and blinded assessment of blood pressure . One hundred and eighty one healthy adult volunteers with a sedentary lifestyle and on pharmacological therapy for hypertension briskly walked for 40 minutes three times per week with or without salt restriction . Systolic and diastolic blood pressure were assessed at three and six months . RESULTS Of the original 208 participants 181 ( 87 % ) completed the study . significant reductions of up to 7 mm Hg were found in systolic blood pressure at 3 months for brisk walking alone ( p = 0.04 ) and salt restriction alone ( p = 0.03 ) but not for the combined intervention ( p = 0.17 ) . No significant change was found for diastolic blood pressure . There was no significant change in blood pressure at 6 months . CONCLUSIONS Simple advice on exercise and sodium restriction in a community setting can significantly lower systolic blood pressure at least for 3 months . The combination of the two intervent
Output:
| A benefit from a salt-reduced diet in patients with high blood pressure is not proven with regard to patient-relevant outcomes based on systematic review s and RCTs published up to 2010 .
The results indicate a blood pressure-lowering effect through reduced salt intake in hypertensive patients |
MS211725 | ***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: Using data collected as a follow-up to a r and omized trial , Melissa Gladstone and colleagues show that during the first two years of life , infants born preterm in southern Malawi are disadvantaged in terms of mortality , growth , and development The effectivity of Partusisten or ethanol long term respectively short term tocolysis by combination of a retrospective and a prospect ive-r and omised study has been compared . Long term tocolysis was better than short term tocolysis . Partusisten was more effective than ethanol . Partusisten long term tocolysis was different to other forms or treatment with a high significance . 70 % of newborns after Partusisten long term tocolysis had a birth weight of 2500 g or more Abstract . In this study , 194 imminent premature deliveries were treated . The pregnancies were in the 28th to 36th week . Uterine contractions were demonstrable in all patients and amniotic membranes were intact . All patients were treated with bedrest . Two betasympathomimetics were used in a double‐blind study : Nylidrin hydrochloride ( 43 cases ) and Isoxuprine hydrochloride ( 60 cases ) . A placebo was given to 41 patients , and ethyl alcohol to 50 patients . Intravenous and intramuscular treatment given in the hospital was continued with oral administration ' at home , and follow‐up examinations were repeated at short intervals . Taking a minimum birth weight of 2 500 g as the criteria of successful treatment , the success rate in the placebo group was 71 % , in the Nylidrin hydrochloride group 86 % , the Isoxuprine hydrochloride group 75 % and the alcohol group 70 % . When premature delivery was postponed 7 days , the pregnancy advanced , to the 37th week or later in 73 , 77 , 62 and 56 % in their respective groups . The betasympathomimetics , especially the Nylidrin hydrochloride , were in every respect more efficient than placebo or alcohol . The therapeutic effect of alcohol was no better than that obtained with placebo . From the fetal point of view , the drugs used in the present study showed no adverse effects Ninety-two women in preterm labor were r and omly assigned to either terbutaline or ethanol . In women with intact membranes , terbutaline was significantly more effective than ethanol in preventing progressive cervical dilation during the first 36 hours of treatment while betamethasone was given to the mother . Additionally , pregnancy was maintained significantly longer in women with intact membranes who were treated with terbutaline ( 15 + /- 4 days ) rather than with ethanol ( 10 + /- 3 days ) . However , only 18 % of women in each treatment group maintained their pregnancy beyond 36 weeks ' gestation . In women with ruptured membranes and cervical dilation less than 4 cm , terbutaline was significantly better than ethanol in maintaining pregnancy for a minimum of 36 hours . Serious maternal side effects were not observed with terbutaline or ethanol , although a majority of women also received betamethasone . Neither drug caused serious adverse neonatal effects Intravenous salbutamol and ethanol were compared as treatments for preterm labour , 42 patients being assigned r and omly to salbutamol and 46 to ethanol . There was no statistically significant difference in outcome between patients in the two groups , the mean delay in delivery achieved being 15 days with salbutamol and 20 days with ethanol . Neither treatment was very effective since only 10 patients given salbutamol and 14 given ethanol had their delivery postponed to 37 weeks or later . Salbutamol was more rapidly acting than ethanol but produced more cardiovascular side effects Abstract Ethanol was administered intravenously to 26 near-term and term pregnant patients before labour and during early labour in various doses to determine the effect on bilirubin levels in the newborn . 18 patients at term , free from obstetric complications , were r and omly selected as controls . A statistically significant reduction of serum-bilirubin levels in infants in the third , fourth , and fifth days of life was observed in the group whose mothers were treated with more than 100 g. of ethanol prior to delivery . The findings suggest a simple , safe , and expedient agent which may be used to prevent raised levels of bilirubin in the newborn — levels which may affect mental and motor development in the first year of the infant 's life The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating Abstract A controlled study , design ed to permit sequential analysis , of the use of ethanol to inhibit premature labor was carried out . Only a total of 42 patients was required to prove the efficacy of the ethanol treatment statistically In travenous magnesium sulfate and alcohol were compared as treatments for premature labor . A successful treatment was the absence of contractions for a 24 hour interval . Early treatment was found to be essential for successful management of premature labor . There is a significant correlation of cervical dilatation at the onset of treatment to success at controlling premature labor . There was no statistically significant relation to weeks of gestation or parity to success at controlling premature labor . In this study magnesium sulfate was the better agent for controlling premature labor A r and omized controlled study was carried out at three medical centers to compare the efficacy and side effects of ethanol and ritodrine in the treatment of threatened premature labor . One hundred and thirty-five patients judged to be between the twentieth and thirty-sixth week of gestation and presenting with clinical symptoms of premature labor were included . Sixty-seven patients were treated with intravenous infusion of 10 per cent ethanol . Sixty-eight patients were treated with intravenous infusion of ritodrine for 12 hours followed by oral ritodrine . If labor recurred prematurely , up to two additional courses of ethanol or ritodrine were given . Delivery was postponed for more than 72 hours in 49 of 67 patients ( 73 per cent ) with ethanol and in 61 of 68 patients ( 90 per cent ) with ritodrine ; this difference was significant . Patients in the ethanol group gained a mean of 27.6 days while patients in the ritodrine group gained a mean of 44.0 days . Fifty-four per cent of the ethanol group and 72 per cent of the ritodrine group carried their infants to 36 weeks of gestation . Five infants in the ethanol group and one infant in the ritodrine group died from respiratory distress syndrome . The most frequent side effect of ethanol were nausea and vomiting . The most frequent side effects of ritodrine were tachycardia and blood pressure changes which were easily controlled by lowering the infusion rate . Ethanol and ritodrine were both found to be effective inhibitors of premature labor with ritodrine giving the most favorable results
Output:
| These outcomes are likely all related to the lower incidence of preterm birth seen with other tocolytics , which for all these comparisons were betamimetics .
There is no evidence that to suggest that ethanol is an effective tocolytic compared to placebo .
Ethanol appears to be inferior to betamimetics for preventing preterm birth in threatened preterm labor .
Ethanol is generally no longer used in current practice due to safety concerns for the mother and her baby . |
MS211726 | ***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 evaluate the effectiveness of radio-frequency ( RF ) ablation and percutaneous microwave coagulation ( PMC ) for treatment of hepatocellular carcinoma ( HCC ) . MATERIAL S AND METHODS Seventy-two patients with 94 HCC nodules were r and omly assigned to RF ablation and PMC groups . Thirty-six patients with 48 nodules were treated with RF ablation , and 36 patients with 46 nodules were treated with PMC . Therapeutic effect , residual foci of untreated disease , and complications of RF ablation and PMC were prospect ively evaluated with statistical analyses . RESULTS The number of treatment sessions per nodule was significantly lower in the RF ablation group than in the PMC group ( 1.1 vs 2.4 ; P < .001 ) . Complete therapeutic effect was achieved in 46 ( 96 % ) of 48 nodules treated with RF ablation and in 41 ( 89 % ) of 46 nodules treated with PMC ( P = .26 ) . Major complications occurred in one patient treated with RF ablation and in four patients treated with PMC ( P = .36 ) . During follow-up ( range , 6 - 27 months ) , residual foci of untreated disease were seen in four of 48 nodules treated with RF ablation and in eight of 46 nodules treated with PMC . No significant difference in rates of residual foci of untreated disease was noted ( P = .20 , log-rank test ) . CONCLUSION RF ablation and PMC thus far have had equivalent therapeutic effects , complication rates , and rates of residual foci of untreated disease . However , RF tumor ablation can be achieved with fewer sessions BACKGROUND Radiofrequency ablation ( RFA ) is emerging as a new therapeutic method for management of solid tumors . We report here our experience in the use of this technique for management of primary and secondary unresectable liver cancers . METHODS Thirty-five patients with liver cancers were considered not suitable for curative resection at presentation : 8 with primary hepatocellular carcinoma ( [ HCC ] 6 HCC and 2 fibrolamellar ) ; 27 with metastatic liver cancer ( 17 colorectal carcinoma and 10 others ) . They were treated either with radiofrequency heat ablation ( Radionics Europe N.V. , Wettdren , Belgium ) alone percutaneously and /or intraoperatively or in conjunction with surgical resections . The quality of RFA was based on the subjective feeling of whether the tumor was completely destroyed or not . The effectiveness of RFA was assessed according to clinical findings , radiographic images , and tumor markers at follow-up . RESULTS In 8 primary liver cases , 4 patients with a high level of alpha fetoprotein ( AFP ) benefited from the RFA with a 83.3 % to 99.7 % reduction of AFP . One with fibrolamellar hepatocellular carcinoma died 2 months after an incomplete percutaneous RFA from recurrence . The rest all had stable disease at the time of follow-up ( mean 10.4 months ) . In patients with colorectal liver metastases , there were 4 deaths : 1 patient died postoperatively on the 30th day from a severe chest infection having shown a considerable reduction of carcinoembryonic antigen level ( CEA , 8 versus 36 microg/L ) ; 3 died from local and systemic disease , 1 at 12 months and 2 at 1 month , having had an incomplete RFA . The others had stable disease at follow-up ( mean 7.6 months ) . Five patients underwent liver resections successfully with the application of RFA for residual lesions in the remaining contralateral lobe . In 10 patients with other liver tumors , 7 patients had stable disease at follow-up ( mean 13.4 months ) ; 1 patient had evidence of local and systemic recurrence 10 months after surgical resections with the intraoperative RFA and 2 patients died of systemic recurrence of disease 3 and 6 months after RFA alone . Two patients had liver resections in conjunction with the intraoperative RFA . The mean follow-up in our series was 8.5 months . CONCLUSION Radiofrequency heat ablation is useful as a primary treatment for unresectable liver cancers . The procedure can be used to treat the small residual tumor load in the contralateral lobe following liver resection in those considered unresectable at the first presentation . This new therapeutic strategy seems to increase surgical resectability in patients judged unresectable BACKGROUND AND STUDY AIMS Radiofrequency ( RF ) thermal ablation has been applied almost exclusively through the percutaneous approach under radiological/external ultrasound guidance . We have embarked on a programme of laparoscopic ultrasound-guided RF ablation of hepatic tumours in view of the potential advantages of this approach , i. e. reduced heat sink effect , greater precision and improved assessment of the thermal ablative zone . PATIENTS AND METHODS RF thermal ablation using the Zomed International generator and multielectrode probes in two patients with hepatoma arising on a background of cirrhosis and in eight patients with multiple deposits from primary colorectal cancer . RESULTS Total ablation was performed in two patients with hepatoma and 7/8 patients with secondary deposits . Total ablation with a minimum of 0.5-cm margin was achieved in 32 lesions . No complications were encountered postoperatively and all patients were discharged within 2 days of the intervention . One patient in whom thermal ablation was not completed has since died of progressive disease , eight appear to be free of tumour ( follow-up 6 - 20 months ) but one patient has developed further secondary hepatic deposits . CONCLUSIONS The initial experience with laparoscopic ultrasound-guided RF ablation of hepatic tumours indicates its safety and therapeutic potential in patients with inoperable hepatic tumours PURPOSE To compare the effectiveness of radio-frequency ( RF ) thermal ablation with that of percutaneous ethanol injection ( PEI ) for the treatment of small hepatocellular carcinoma ( HCC ) in patients with cirrhosis . MATERIAL S AND METHODS A series of 102 patients with hepatic cirrhosis and either single HCC 5 cm in diameter or smaller or as many as three HCCs each 3 cm or smaller ( overall number of lesions , 142 ) r and omly received either RF ablation ( n = 52 ) or PEI ( n = 50 ) as the sole first-line anticancer treatment . Mean follow-up was 22.9 months + /- 9.4 ( SD ) in the RF group and 22.4 months + /- 8.6 in the PEI group . Prognostic value of treatment techniques was assessed with univariate and multivariate Cox proportional hazards regression models . RESULTS One- and 2-year survival rates were 100 % and 98 % in the RF group and 96 % and 88 % in the PEI group , respectively ( univariate relative risk [ RR ] = 0.20 ; 95 % CI : 0.02 , 1.69 ; P = .138 ) . One- and 2-year local recurrence-free survival rates were 98 % and 96 % in the RF group and 83 % and 62 % in the PEI group , respectively ( univariate RR = 0.17 ; 95 % CI : 0.06 , 0.51 ; P = .002 ) . One- and 2-year event-free survival rates were 86 % and 64 % for the RF group and 77 % and 43 % for the PEI group , respectively ( univariate RR = 0.48 ; 95 % CI : 0.27 , 0.85 ; P = .012 ) . RF treatment was confirmed as an independent prognostic factor for local recurrence-free survival rates with multivariate analysis ( adjusted RR = 0.20 ; 95 % CI : 0.05 , 0.73 ; P = .015 ) . CONCLUSION RF ablation is superior to PEI with respect to local recurrence-free survival rates In two consecutive series of patients with hepatocellular carcinoma ( HCC ) , we compared clinico-laboratory and ultrasonographic characteristics , diagnostic work-up , survival of untreated patients and , finally , therapeutic choices . In addition of the clinical examination , we tested for blood serum alpha-fetoprotein levels , HBsAg and anti-HCV antibodies . Ultrasonography was performed in all the patients . In most cases , a pathologic diagnosis was obtained by ultrasound-guided fine-needle biopsy . As curative treatment we considered open surgery , percutaneous alcohol injection and radio frequency thermal ablation . In the second series , we observed an increased number of patients with compensated cirrhosis and with small HCCs , therefore the number of patients undergoing a potentially curative treatment was higher . The percentage of multiple tumours was comparable in two series implying the presence of two kinds of HCC , different ¿ ab initio ' . The survival rate of untreated patients was better in the second series
Output:
| REVIEW ER 'S CONCLUSIONS At present , radiofrequency thermal ablation is an insufficiently studied intervention for HCC |
MS211727 | ***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 effects on morbidity were examined of providing an educational intervention and a written guided self-management plan to the parents of pre-school children following a recent attendance at hospital for asthma or wheeze . Methods : A prospect i ve , r and omised , partially blinded , controlled trial was design ed at two secondary care centres . Over a 13 month period 200 children aged 18 months to 5 years at the time of admission to a children 's ward or attendance at an accident and emergency department or children 's ( emergency ) assessment unit ( A&E/CAU ) with a primary diagnosis of acute severe asthma or wheezing were recruited . 101 children were r and omised into the control group and received usual care and 99 were assigned to the intervention group and received : ( 1 ) a pre-school asthma booklet ; ( 2 ) a written guided self-management plan ; and ( 3 ) two 20 minute structured educational sessions between a specialist respiratory nurse and the parent(s ) and child . Subjects were assessed at 3 , 6 , and 12 months . The main outcomes were GP consultation rates , hospital re-admissions , and attendances at A&E/CAU . Secondary outcomes included disability score , caregivers ' quality of life , and parental knowledge of asthma . Results : There were no statistically significant differences between the two groups during the 12 month follow up period for any of the main or secondary outcome measures . Conclusions : These results do not support the hypothesis that the introduction of an educational package and a written guided self-management plan to the parents of pre-school children with asthma who had recently attended hospital for troublesome asthma or wheeze reduces morbidity over the subsequent 12 months Context Research on patient safety has focused on adverse events in hospitalized patients . Adverse events following hospitalization have received little attention . Contribution Among 400 consecutive patients discharged from the general medical service of an academic hospital , 76 had adverse events during the 2 weeks following hospital discharge . Of the adverse events , the research ers categorized 23 as preventable , 24 as ameliorable , and the remainder as neither . Adverse drug events were the most frequent occurrence . Implication s Interventions to maximize patient safety should consider the vulnerable transition from hospital to home . The Editors Patient safety is a public concern that has received substantial attention , especially since the release of two reports from the U.S. Institute of Medicine . The first of these , To Err Is Human , review ed the literature on adverse events , or injuries result ing from medical care ( 1 ) . On the basis of data from two large population -based chart review studies , the report estimated that adverse events occur in 2.9 % ( 2 ) to 3.7 % ( 3 ) of hospitalizations . The first of these studies ( 2 ) found that although most injuries are minor , approximately 1 in 10 results in death . The research ers determined that approximately half of the adverse events were caused by errors ( 1 , 3 , 4 ) . The second report , Crossing the Quality Chasm , which proposes strategies for improving the health system , declared patient safety a fundamental component of care quality ( 5 ) . However , the estimated incidence of adverse events quoted in To Err Is Human may underestimate the overall safety problem , since injuries occurring after discharge were not included in the evaluation . Patients may be especially vulnerable to injuries during this period because they may still have functional impairments and because discontinuities may occur at the interface of acute and ambulatory care ( 6 ) . These discontinuities may be worsened by the current health care environment , in which patients are leaving the hospital quicker and sicker ( 7 ) and may receive care from hospitalists rather than their primary care physicians ( 8) . Despite these theoretical concerns , few studies are available to estimate the extent of the problem . Several studies have determined the risk for postdischarge wound infections in surgical patients ( 9 , 10 ) , but this is a specific type of safety problem and the risk can not be generalized . Other studies have used readmission rates to identify poor- quality hospital care ( 11 ) . However , this outcome is an insensitive and nonspecific marker of quality in general ( 11 ) and safety in particular . Information on the incidence and type of adverse events is vital for improving postdischarge safety . We wanted to determine the incidence and severity of adverse events affecting patients after discharge from the hospital to home . In addition , we wanted to identify the incidence of preventable and ameliorable adverse events , classify types of adverse events , and identify system improvements to reduce the incidence and severity of adverse events after discharge . Methods Overview To determine the rate of adverse events , we first created a case summary of every patient 's posthospital course by performing a medical record review and a telephone interview approximately 3 weeks after discharge . Using this information , we created event summaries , which two board-certified internists independently review ed to determine whether medical management caused an injury and , if so , whether it was preventable or ameliorable . The institutional review board at the study hospital approved the protocol . Definitions Adverse outcomes were any of the following patient experiences after discharge : new or worsening symptoms , unanticipated visits to health facilities for tests or treatments , or death . An adverse event was an injury result ing from medical management rather than the underlying disease . We evaluated all injuries result ing in symptoms after discharge , regardless of when the events occurred . Thus , we included adverse events that occurred in the hospital and after discharge as long as symptoms persisted until the patient went home . A preventable adverse event was an injury that could have been avoided , that is , an injury judged to probably be the result of an error or a system design flaw . An ameliorable adverse event was an injury whose severity could have been substantially reduced if different actions or procedures had been performed or followed . Patient Sample We used a prospect i ve cohort design to study adult medical patients at an 800-bed urban academic teaching hospital . Patients were included if they went home from the general medical service during a sequential 81-day period , had telephone service , and could complete a telephone interview in English . Patient surrogates were permitted to complete the interview if the patient could not . Telephone Interview A board-certified internist contacted patients by telephone within 2 to 5 weeks of discharge . If the patient was eligible and consented , he or she underwent a semi-structured interview over the telephone . If the patient was not available , we made up to 20 attempts to contact him or her at different times of the day and week . If the patient declined to participate or we were unable to contact him or her after 5 weeks , we rated the patient as a nonresponder . Responders underwent a telephone interview that had several components ( Appendix Figure ) . The principal component assessed the patient 's condition since discharge by using a full review of organ systems . If patients answered yes to any question , the interviewer asked them to elaborate about the symptom 's severity , timing in relation to hospitalization and treatments , and resolution . The survey also determined patients ' use of health services since discharge , including home care services , physician services , visits to laboratories , and readmissions to the hospital . Preparation of Case Summaries To create a case summary , the internist combined the information from the telephone interview with information obtained from a review of the patient 's electronic medical record . This computerized clinical record contains h and over notes from the hospitalization ; discharge summaries ; previous orders and written instructions ; emergency department and clinic notes ; operative and procedure notes ; and all laboratory results , including results of radiography , electrocardiography , and pathologic examination . If necessary , the paper chart was also review ed to clarify information that was in the discharge summary or h and over notes . If patients returned to the study hospital after discharge , we were able to vali date their history by review ing their records . However , for patients receiving care elsewhere , we had to rely on firsth and accounts . Preparation of Event Summaries The internist review ed every patient 's case summary for adverse outcomes . If any were found , an event summary that consisted of a detailed description of each outcome , including its onset , its severity , the health services used during its treatment , and its resolution , was created for each one . If there were no adverse outcomes , then the event summary consisted of the case summary . Determination of Adverse Events Two other board-certified internists independently rated each event summary by using st and ard techniques as described elsewhere ( 3 ) . Each event summary was evaluated separately . Review ers first rated on a scale of 1 to 6 their confidence that medical management caused an injury . If their rating was 5 or 6 , indicating that the injury was probably or definitely caused by management , the event was considered an adverse event . For adverse events , the internists used implicit criteria to determine their preventability and ameliorability . The two review ers ' assessment s were then compared for causality , preventability , and ameliorability . If there was disagreement , the two review ers discussed the case to attempt to come to consensus . If they did not agree , a third board-certified internist rated the event independently . Next , review ers rated injury severity , health services used , type of injury , and location . Injury severity was categorized as serious laboratory abnormality only , one day of symptoms , several days of symptoms , nonpermanent disability , permanent disability , or death . Differentiation between several days of symptoms and nonpermanent disability relied on evidence that symptoms interfered with patients ' activities of daily living . We categorized health services used as none , additional visit to a physician , additional visit for laboratory testing in addition to a physician visit , visit to an emergency department , readmission to the hospital , or death . We were able to determine whether health services were additional because during the interview we asked whether the health service was arranged before discharge or specifically for the particular symptom . We used a st and ard approach to classify the type of injury ( 2 , 3 ) , categorizing each as an adverse drug event , a procedure-related injury , a nosocomial infection , a fall , or other . We also classified the location of adverse events . Our primary objective was to evaluate adverse events affecting patients after discharge from the hospital to home . We felt that most of these events would occur after the patient went home , but we recognized a priori that some adverse events could occur in the hospital but lead to morbidity after discharge because of the severity of the injury or because health providers did not recognize the problem at discharge . Examples of injuries occurring in the hospital but affecting patients after discharge include pressure ulcers , missed diagnoses , and erroneous drug prescriptions . If it was determined that the adverse event occurred in the hospital , we examined whether the injury was recognized before discharge and , if so , whether definitive management was instituted at that time . To develop strategies CONTEXT Inner-city high-risk infants often receive limited and fragmented care , a problem that may increase serious illness . OBJECTIVE To assess whether access to comprehensive care in a follow-up clinic is cost-effective in reducing life-threatening illnesses among high-risk , inner-city infants . DESIGN R and omized controlled trial . SETTING AND PARTICIPANTS A total of 887 very-low-birth-weight infants born in a Texas county hospital between January 1988 and March 1996 and followed up in a children 's hospital clinic . One hundred four infants who became ineligible or died after r and omization but before nursery discharge were excluded from the analysis . INTERVENTIONS Infants were r and omly assigned to receive routine follow-up care ( well-baby care and care for chronic illnesses ; n = 441 ) or comprehensive care ( which included the components of routine care plus care for acute illnesses , with 24-hour access to a primary caregiver ; n = 446 ) . MAIN OUTCOME MEASURES Life-threatening illnesses ( ie , causing death or hospital admission for pediatric intensive care ) occurring between nursery discharge and age 1 year , assessed by blinded evaluators from inpatient charts and state Medicaid and vital statistics records ; and hospital costs ( estimated from department-specific cost-to-charge ratios ) . RESULTS Comprehensive care result ed in a mean of 3.1 more clinic visits and 6.7 more telephone conversations with clinic staff ( P<.001 for both ) . One-year outcomes were unknown for fewer comprehensive-care infants than routine-care infants ( 9 vs 28 ; P = .001 ) . Identified deaths were similar ( 11 in comprehensive care vs 13 in routine care ; P = .68 ) . The comprehensive-care group had 48 % fewer life-threatening illnesses ( 33 vs 63 ; P<.001 ) , 57 % fewer intensive care admissions ( 23 vs 53 ; P = .003 ) , and 42 % fewer intensive care days ( 254 vs 440 ; P = .003 ) . Comprehensive care did not increase the mean estimated cost per infant for all care ( $ 6265 with comprehensive care and $ 9913 with routine care ) . CONCLUSION Comprehensive follow-up care by experienced caregivers can be highly effective in reducing life-threatening illness without increasing costs among high-risk inner-city infants . JAMA . 2000;284:2070 - 2076 A r and omised controlled study of an educational programme for children with asthma and their families was carried out by community child health nurses . Three hundred and sixty eight children aged 2 to 14 years were enrolled in the study after admission to hospital for asthma . The intervention group was visited monthly by a nurse for six months . The subjects were assessed six months later by a postal , self administered question naire . European children in the intervention group were taking significantly more drugs for the treatment of asthma six months after the index admission to hospital than those in the control group ( mean ( SD ) intake 2.7 ( 1.1 ) v 2.1 ( 1.0 ) , respectively ) . In particular , they were using more theophylline ( 56.6 % v 37.0 % ) and inhaled steroids ( 34.9 % v 21.0 % ) . There was no difference between the groups for parental reports of improvement , of missed schooling , and in severe attacks of asthma of not responding to the usual treatment at home . European children in the
Output:
| Interventions that demonstrated reductions in subsequent utilization targeted children with specific chronic conditions , providing enhanced inpatient feedback and education reinforced with postdischarge support . |
MS211728 | ***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 Colonoscopy insertion is difficult to teach due to the inability of current training models to provide realistic tactile sensation with simultaneous three-dimensional ( 3D ) colonoscope display . Aims To assess the influence of a simulator consisting of a colon model coupled with 3D instrument visualization on trainee colonoscopy performance . Methods Pilot study using the simulator model with three trainees who were not proficient in colonoscopy . At r and om times over a 6-week period , trainees participated in an individualized half-day session using the Colonoscope Training Model and a colonoscope equipped with a 3D magnetic probe imaging system ( ScopeGuide ) in six st and ardized cases . A blinded supervising instructor grade d patient-based colonoscopy performance over the 6-week period , and we independently analyzed the 2-week period before and after the intervention . We also measured cecal intubation and withdrawal times and medication requirements . Results Trainees performed 86 patient-based colonoscopies . Following the intervention , the colonoscopy performance score improved from 4.4 ± 2.3 to 5.9 ± 2.4 ( p = 0.005 ) . Trainees had a 76 % cecal intubation rate following the session as compared to 43 % before training ( p = 0.004 ) , while utilizing less time , 14 ± 7 versus 18 ± 11 min ( p = 0.056 ) and less medication ( p > 0.05 ) . Conclusions Colonoscopy simulation using the Colonoscope Training Model and the ScopeGuide produced an immediate and large effect on trainee colonoscopy performance BACKGROUND Little is known regarding the value of esophagogastroduodenoscopy ( EGD ) simulators in education . The purpose of the present paper was to vali date the use of computer simulation in novice EGD training . METHODS In phase 1 , expert endoscopists evaluated various aspects of simulation fidelity as compared to live endoscopy . Additionally , computer-recorded performance metrics were assessed by comparing the recorded scores from users of three different experience levels . In phase 2 , the transfer of simulation-acquired skills to the clinical setting was assessed in a two-group , r and omized pilot study . The setting was a large gastroenterology ( GI ) Fellowship training program ; in phase 1 , 21 subjects ( seven expert , intermediate and novice endoscopist ) , made up the three experience groups . In phase 2 , eight novice GI fellows were involved in the two-group , r and omized portion of the study examining the transfer of simulation skills to the clinical setting . During the initial validation phase , each of the 21 subjects completed two st and ardized EDG scenarios on a computer simulator and their performance scores were recorded for seven parameters . Following this , staff participants completed a question naire evaluating various aspects of the simulator 's fidelity . Finally , four novice GI fellows were r and omly assigned to receive 6 h of simulator-augmented training ( SAT group ) in EGD prior to beginning 1 month of patient-based EGD training . The remaining fellows experienced 1 month of patient-based training alone ( PBT group ) . Results of the seven measured performance parameters were compared between three groups of varying experience using a Wilcoxon ranked sum test . The staffs ' simulator fidelity survey used a 7-point Likert scale ( 1 , very unrealistic ; 4 , neutral ; 7 , very realistic ) for each of the parameters examined . During the second phase of this study , supervising staff rated both SAT and PBT fellows ' patient-based performance daily . Scoring in each skill was completed using a 7-point Likert scale ( 1 , strongly disagree ; 4 , neutral ; 7 , strongly agree ) . Median scores were compared between groups using the Wilcoxon ranked sum test . RESULTS Staff evaluations of fidelity found that only two of the parameters examined ( anatomy and scope maneuverability ) had a significant degree of realism . The remaining areas were felt to be limited in their fidelity . Of the computer-recorded performance scores , only the novice group could be reliably identified from the other two experience groups . In the clinical application phase , the median Patient Discomfort ratings were superior in the PBT group ( 6 ; interquartile range [ IQR ] , 5 - 6 ) as compared to the SAT group ( 5 ; IQR , 4 - 6 ; P = 0.015 ) . PBT fellows ' ratings were also superior in Sedation , Patient Discomfort , Independence and Competence during various phases of the evaluation . At no point were SAT fellows rated higher than the PBT group in any of the parameters examined . CONCLUSION This EGD simulator has limitations to the degree of fidelity and can differentiate only novice endoscopists from other levels of experience . Finally , skills learned during EGD simulation training do not appear to translate well into patient-based endoscopy skills . These findings suggest against a key element of validity for the use of this computer simulator in novice EGD training BACKGROUND AND AIMS The advantages of using a computer-based simulator during colonoscopy training are debated . We aim ed to explore its usefulness in objective ly measuring trainees ' competence in colonoscopy . METHODS Twelve colonoscopy trainees ( fully trained in upper GI endoscopy ) were evaluated using a computer-based simulator ( GI-Mentor , Symbionix ) before and during h and s-on training ( i.e. after 60 colonoscopies ) ; the controls were 15 experts ( > 90 % of caecal intubation ) . Both trainees and experts performed two " screening " simulations ( easy and difficult ) in a r and omised order , and the time to reach the caecum and withdrawal time was assessed . RESULTS The percentage of caecal intubation progressively increased during h and s-on training . All of the trainees intubated the caecum during the easy and difficult simulations , both before and during h and s-on training . The median time ( interquartile range ) to reach the caecum upon easy simulation was the only variable influenced by h and s-on training : 2.7 min ( 2.1 - 3.2 ) before and 1.9 min ( 1.6 - 2 ) during training ( p<0.01 ) . Withdrawal time was ≥6 min in the case of five trainees before training , and three during h and s-on training . Computer-based simulator performance did not correlate with h and s-on training performance . CONCLUSIONS The computer-based simulator was not found to be useful in evaluating competence during h and s-on training in colonoscopy Background Virtual reality ( VR ) simulators and Web-based instructional videos are valuable supplemental training re sources in surgical programs , but it is unclear how to optimally integrate them into minimally invasive surgical training . Methods Medical students were r and omized to proficiency-based training on VR laparoscopy and endoscopy simulators by two different methods : proctored training ( automated simulator feedback plus human expert feedback ) or independent training ( simulator feedback alone ) . After achieving simulator proficiency , trainees performed a series of laparoscopic and endoscopic tasks in a live porcine model . Prior to their entry into the animal lab , all trainees watched an instructional video of the procedure and were r and omly assigned to either observe or not observe the actual procedure before performing it themselves . The joint effects of VR training method and procedure observation on time to successful task completion were evaluated with Cox regression models . Results Thirty-two students ( 16 proctored , 16 independent ) completed VR training . Cox regression modeling with adjustment for relevant covariates demonstrated no significant difference in the likelihood of successful task completion for independent versus proctored training [ Hazard Ratio ( HR ) 1.28 ; 95 % Confidence Interval ( CI ) 0.96–1.72 ; p = 0.09 ] . Trainees who observed the actual procedure were more likely to be successful than those who watched the instructional video alone ( HR 1.47 ; 95 % CI 1.09–1.98 ; p = 0.01 ) . Conclusions Proctored VR training is no more effective than independent training with respect to surgical performance . Therefore , time-consuming human expert feedback during VR training may be unnecessary . Instructional videos , while useful , may not be adequate substitutes for actual observation when trainees are learning minimally invasive surgical procedures Background The hypothesis of this study is that working on the simulator without a structured feedback does not change performance ; hence , any effects shown after structured feedback would amount to useful learning of the procedure . The aim was to investigate the learning curve for the HT Immersion Medical Colonoscopy Simulator without any structured feedback . This could then be potentially applied to vali date the learning curve on the simulator when structured feedback is provided . There are no previous studies on this matter . Methods C and i date s were asked to perform colonoscopy on the HT Immersion Medical Colonoscopy Simulator . Modules 3 and 4 were used at r and om . In total , each c and i date was asked to perform five consecutive virtual colonoscopies on the same module . These five episodes were collectively referred to as one trial . A time result of 3,600 sec ( 1 h ) was used to denote perforation . No guidance or feedback was given to c and i date s before , during , or after each procedure . A total of 26 postgraduate doctors were recruited , including nine research fellows , five pre registration house officers , six specialist registrars , and six consultants . Fourteen c and i date s recorded five attempts each ( i.e. , one trial each ) on the same module of the colonoscopy simulator ( 14 trials over 70 episodes ) . Another 12 c and i date s recorded five attempts ( i.e. , one trial each ) on two modules of the colonoscopy simulator ( 24 trials over 120 episodes ) . Hence , 190 episodes were recorded in total , representing 38 trials . Results There was no improvement in performance on the simulator from first attempt to the fifth in the absence of feedback . If there was any initial gain in any measurable outcome , this was lost in subsequent attempts indicating lack of learning . The outcomes measured included time taken to complete the test , percentage of the mucosa visualized , depth of the instrument inserted , and the path length used . The results were statistically significant for all outcomes . Conclusions This study demonstrates that in the absence of feedback , it is not possible to improve performance on the HT Immersion Medical Colonoscopy Simulator . Thus , there is no learning curve for the machine . The information from this study is vital for using the simulators in training and assessment because any improvement in learning curves shown after training on simulators can be presumed to be due to learning the procedure and not the Background The Erlangen Active Simulator for Interventional Endoscopy ( EASIE ) using ex-vivo porcine organs was introduced in 1997 . The present study should analyze whether repeated EASIE simulator training in endoscopic hemostasis led to superior performance compared with a traditionally educated group . The results were compared with a similar project in New York . Methods Thirty-five French GI fellows were enrolled . Baseline skills evaluation was performed in four disciplines ( manual skills , injection/coagulation , clip application and variceal ligation ) using the compactEASIE-simulator equipped with an upper gastrointestinal organ package for bleeding simulation . The same , translated evaluation forms ( from the prior New York project ) were used . Subsequently , fellows were r and omized into group A ( n=17 , only clinical education ) and group B ( n=18 , additional three simulator trainings ) . Group B was trained the next day and after 4 and 7 months by experts of the French Society of Gastrointestinal Endoscopy . Both groups performed routine and emergency endoscopies at their home hospitals during the study period . Both groups were re-evaluated blindly after 9 months . Results The learning curve for group B showed a significant improvement in all disciplines ( P<0.004 ) whereas group A improved significantly in only two of four disciplines at blinded final evaluation ( manual skills P=0.02 , injection/coagulation P=0.013 ) . The direct comparison of groups B and A at blinded final evaluation showed significantly superior ratings for group B in all disciplines ( P<0.006 ) and significantly shorter performance times in two disciplines ( P=0.016 each ) . The comparison with the similar ‘ New York project ’ revealed that preexisting differences in skills were adjusted by the training . Conclusion Complementary trainings ( three workshops in 7 months ) in endoscopic hemostasis using the compactEASIE improved skills compared with a solely clinical education . The results of the ‘ New York project ’ were confirmed and benefits were independent from the medical educational system INTRODUCTION Colonoscopic simulators offer the opportunity for skill acquisition in the pre clinical setting . Currently available simulators vary widely with respect to level of fidelity and technological sophistication . Despite the belief that more realistic is better , there is a paucity of evidence regarding the relative effectiveness of simulator fidelity ( high vs low ) on the acquisition of basic colonoscopic skills . We hypothesized that novice learners can acquire basic colonoscopic skills using simulators , however fidelity of the simulator does not make a difference . METHODS We r and omly assigned novice third-year and fourth-year medical students to practice on either a low-fidelity or high-fidelity colonoscopy model . The low-fidelity model used is described in the module 16 of the American College of Surgeons/Association of Program Directors in Surgery surgical skills curriculum for residents , Phase 1 : basic or core skills and tasks < http://elearning.facs.org/mod/re source /view.php?1d=450 > . The high-fidelity model was the AccuTouch colonoscopy simulator , Immersion Medical ( AccuTouch CS ) that has 6 different simulated scenarios for diagnostic colonoscopy ( level 1 - 6 ) . Both groups had 16 students and were given st and ard instruction by an expert with respect to the procedure and instrument h and ling on both models . Both groups were pretested and posttested on level 1 of the AccuTouch CS . The high-fidelity group practice d on level 2 and 4 of the Accu
Output:
| Simulation-based training , as compared with no training , generally appears to provide participants with some advantage over their untrained peers as measured by composite score of competency , independent procedure completion , performance time , independent insertion depth , overall rating of performance or competency error rate and mucosal visualization .
Alternatively , there was no conclusive evidence that simulation-based training was superior to conventional patient-based training , although data were limited .
The results of this systematic review indicate that virtual reality endoscopy training can be used to effectively supplement early conventional endoscopy training ( apprenticeship model ) in diagnostic oesophagogastroduodenoscopy , colonoscopy and /or sigmoidoscopy for health professions trainees with limited or no prior endoscopic experience . |
MS211729 | ***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 Disruption of gut microbiota may exacerbate severity of cystic fibrosis ( CF ) . Vitamin D deficiency is a common comorbidity in patients with CF that may influence composition of the gut microbiota . Objectives Compare microbiota of vitamin D-sufficient and -insufficient CF patients and assess impact of a weekly high-dose vitamin D3 bolus regimen on gut and airway microbiome in adults with CF and vitamin D insufficiency ( 25-hydroxyvitamin D < 30 ng/mL ) . Design Forty-one subjects with CF were classified into two groups : vitamin D insufficient ( n = 23 ) and vitamin D sufficient ( n = 18 ) . Subjects with vitamin D insufficiency were r and omized to receive 50,000 IU of oral vitamin D3 or placebo weekly for 12 weeks . Sputum and stool sample s were obtained pre- and postintervention and 16S ribosomal RNA genes sequenced using Illumina MiSeq technology . Results Gut microbiota differed significantly based on vitamin D status with Gammaproteobacteria , which contain numerous , potentially pathogenic species enriched in the vitamin D-insufficient group . Principal coordinates analysis showed differential gut microbiota composition within the vitamin D-insufficient patients following 12 weeks treatment with placebo or vitamin D3 ( permutation multivariate analysis of variance = 0.024 ) , with Lactococcus significantly enriched in subjects treated with vitamin D3 , whereas Veillonella and Erysipelotrichaceae were significantly enriched in patients treated with placebo . Conclusion This exploratory study suggests that vitamin D insufficiency is associated with alterations in microbiota composition that may promote inflammation and that supplementation with vitamin D has the potential to impact microbiota composition . Additional studies to determine the impact of vitamin D on microbiota benefit clinical outcomes in CF are warranted The importance of gut microbiota in pathogenesis of diabetes remains unknown . This study investigated the relationship between microbiota and metabolic markers in African American men ( AAM ) with prediabetes and hypovitaminosis D. The study was ancillary to a r and omized trial of vitamin D supplementation with weekly ergocalciferol ( 50,000 IU ) conducted in AAM veterans over 12 months ( D Intervention in Veterans Affairs ) . Glycemic groups ( Gr ) were characterized based on changes in oral glucose tolerance between baseline and exit . Subjects with stable normal glucose tolerance were assigned to Gr-1 and those with stable prediabetes ( impaired glucose tolerance and impaired fasting glucose ) to Gr-2 . Microbiota composition was analyzed in stool collected at the exit ( n = 115 ) and compared between Gr-1 and Gr-2 , as well as between the lowest and highest quartiles of dietary intake of energy and fat , hemoglobin A1c , and serum 25-hydroxyvitamin D ( 25[OH]D ) level . Differences between Gr-1 and Gr-2 included the Bacteroidetes/Firmicutes and Bacteroidales/Clostridia ratios and differences in genera such as Ruminococcus and Dialister . Changes in specific taxa associated with the lowest and highest quartiles of 25(OH)D ( eg , Ruminococcus , Roseburia , Blautia , Dorea ) were clearly distinct from those of dietary intake ( eg , Bacteroides , Bacteroides/Prevotella ratio ) or A1c ( eg , Faecalibacterium , Catenibacterium , Streptococcus ) . These findings suggest a novel interaction between microbiota and vitamin D and a role for microbiota in early stages of diabetes development . Although results suggest that specific taxa are associated with glycemic stability over time , a causative relationship between microbiota makeup and dysglycemia is still to be demonstrated Vitamin D has immunomodulatory properties giving it the potential to affect microbial colonization of the intestinal tract . We investigated whether maternal vitamin D supplemention , maternal plasma 25-hydroxyvitamin D concentration , or direct supplementation of the infant influences key bacterial taxa within microbiota of one month old infants . Infant and maternal vitamin D supplement use was ascertained via question naires . Maternal plasma 25-hydroxyvitamin D was determined at approximately the 36th week of pregnancy . In 913 one month old infants in the prospect i ve KOALA Birth Cohort Study , fecal Bifidobacterium spp . , Escherichia coli , Clostridium difficile , Bacteroides fragilis group , Lactobacillus spp . and total bacteria were quantified with real-time polymerase chain reaction assays targeting 16S rRNA gene sequences . The association between vitamin D exposure and prevalence or abundance of a specific bacterial group or species was analyzed using logistic or linear regression , respectively . There was a statistically significant negative linear trend between counts of Bifidobacterium spp . and levels of maternal vitamin D supplementation and maternal 25-hydroxyvitamin D quintiles , respectively . In addition , a positive linear trend between quintile groups and B. fragilis group counts was observed . Lower counts of C. difficile were associated with vitamin D supplementation of breast fed infants whose mothers were more likely to adhere to an alternative lifestyle in terms of , e.g. , dietary habits . These data suggest that vitamin D influences the abundance of several key bacterial taxa within the infant microbiota . Given that intestinal microbiotic homeostasis may be an important factor in the prevention of immune mediated diseases and that vitamin D status is a modifiable factor , further investigation of the impact of postnatal vitamin D supplementation should be conducted in older infants Background : The gut microbiome in infancy influences immune system maturation , and may have an important impact on allergic disease risk . Objective : We sought to determine how prenatal and early life factors impact the gut microbiome in a relatively large , ethnically diverse study population of infants at age 3 to 6 months , who were enrolled in Vitamin D Antenatal Asthma Reduction Trial , a clinical trial of vitamin D supplementation in pregnancy to prevent asthma and allergies in offspring . Methods : We performed 16S rRNA gene sequencing on 333 infants ' stool sample s. Microbial diversity was computed using the Shannon index . Factor analysis applied to the top 25 most abundant taxa revealed 4 underlying bacterial coabundance groups ; the first dominated by Firmicutes ( Lachnospiraceae/Clostridiales ) , the second by Proteobacteria ( Klebsiella/Enterobacter ) , the third by Bacteriodetes , and the fourth by Veillonella . Scores for coabundance groups were used as outcomes in regression models , with prenatal/birth and demographic characteristics as independent predictors . Multivariate analysis , using all microbial community members , was also conducted . Results : White race/ethnicity was associated with lower diversity but higher Bacteroidetes coabundance scores . C‐section birth was associated with higher diversity , but decreased Bacteroidetes coabundance scores . Firmicutes scores were higher for infants born by C‐section . Breast‐fed infants had lower proportions of Clostridiales . Cord blood vitamin D was linked to increased Lachnobacterium , but decreased Lactococcus . Conclusions : The findings presented here suggest that race , mode of delivery , breast‐feeding , and cord blood vitamin D levels are associated with infant gut microbiome composition , with possible long‐term implication s for immune system modulation and asthma/allergic disease incidence
Output:
| Conclusions Despite substantial heterogeneity , we found evidence to support the hypothesis that vitamin D influences the composition of the gastrointestinal microbiome . |
MS211730 | ***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 investigate if cognitive behavior therapy ( CBT ) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome ( IBS ) . Participants were recruited through self-referral . Eighty-six participants were included in the study and r and omized to treatment or control condition ( an online discussion forum ) . One participant was excluded after r and omization . The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life , GI-specific anxiety , depression and general functioning . Participants were assessed at pre-treatment , post-treatment and 3 month follow-up ( treatment condition only ) . Four participants ( 5 % of total sample ) in the treatment condition did not participate in post-treatment assessment . Participants in the treatment condition reported a 42 % decrease and participants in the control group reported a 12 % increase in primary IBS-symptoms . Compared to the control condition , participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life ( Cohen 's d = 1.21 ) . We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating IBS- patients , alleviating the total burden of symptoms and increasing quality of life Twenty patients with irritable bowel syndrome ( IBS ) were r and omly assigned either to intensive , individualized cognitive therapy ( 10 sessions over 8 weeks ) or to 8 weeks of daily gastrointestinal ( GI ) symptom monitoring . Pre- to posttreatment evaluations showed significantly ( p = .005 ) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring . At posttreatment , 80 % of the cognitive therapy group showed clinical ly significant improvement , whereas only 10 % of the monitoring group showed this . Results held up well at a 3-month follow-up . Within the cognitive therapy group , GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts OBJECTIVES : Psychological treatments are considered to be useful in the irritable bowel syndrome ( IBS ) , although the evidence is based on small , often flawed trials . Although cognitive behavior therapy ( CBT ) and relaxation therapy have both been promising , we hypothesized that CBT would be superior to relaxation and st and ard care alone in IBS patients . The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS . METHODS : Patients ( n = 105 ) with Rome I criteria for IBS were recruited from advertisement ( n = 51 ) and outpatient clinics ( n = 54 ) ; those patients with resistant IBS were not included . A r and omized controlled trial with three arms ( st and ard care for all groups plus either CBT or relaxation ) for 8 wk was conducted , which applied blinded outcome assessment s using vali date d measures with 1 yr of follow-up . The primary outcome for this study was bowel symptom severity . RESULTS : Of 105 patients at the commencement of treatment , the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1 ; this persisted at the 52-wk follow-up , with a significant linear trend for scores to change over time ( F= 39.57 p < 0.001 ) . However , there were no significant differences among the three treatment conditions . Significant changes over time were found for physical functioning ( F= 4.37 , p < 0.001 ) , pain ( F= 3.12 , p < 0.05 ) , general health ( F= 2.71 , p < 0.05 ) , vitality ( F= 2.94 , p < 0.05 ) , and the social functioning scales on the Medical Outcomes Study Short Form 36 ( F= 4.08 , p < 0.05 ) ; however , all three arms showed similar improvement . There were significant reductions in anxiety , depression , and locus of control scales , but no significant differences among the treatment groups were detected . CONCLUSION : Cognitive behavior and relaxation therapy seem not to be superior to st and ard care alone in IBS CONTEXT Chronic tension-type headaches are characterized by near-daily headaches and often are difficult to manage in primary practice . Behavioral and pharmacological therapies each appear modestly effective , but data are lacking on their separate and combined effects . OBJECTIVE To evaluate the clinical efficacy of behavioral and pharmacological therapies , singly and combined , for chronic tension-type headaches . DESIGN AND SETTING R and omized placebo-controlled trial conducted from August 1995 to January 1998 at 2 outpatient sites in Ohio . PARTICIPANTS Two hundred three adults ( mean age , 37 years ; 76 % women ) with diagnosis of chronic tension-type headaches ( mean , 26 headache d/mo ) . INTERVENTIONS Participants were r and omly assigned to receive tricyclic antidepressant ( amitriptyline hydrochloride , up to 100 mg/d , or nortriptyline hydrochloride , up to 75 mg/d ) medication ( n = 53 ) , placebo ( n = 48 ) , stress management ( eg , relaxation , cognitive coping ) therapy ( 3 sessions and 2 telephone contacts ) plus placebo ( n = 49 ) , or stress management therapy plus antidepressant medication ( n = 53 ) . MAIN OUTCOME MEASURES Monthly headache index scores calculated as the mean of pain ratings ( 0 - 10 scale ) recorded by participants in a daily diary 4 times per day ; number of days per month with at least moderate pain ( pain rating > /=5 ) , analgesic medication use , and Headache Disability Inventory scores , compared by intervention group . RESULTS Tricyclic antidepressant medication and stress management therapy each produced larger reductions in headache activity , analgesic medication use , and headache-related disability than placebo , but antidepressant medication yielded more rapid improvements in headache activity . Combined therapy was more likely to produce clinical ly significant ( > /=50 % ) reductions in headache index scores ( 64 % of participants ) than antidepressant medication ( 38 % of participants ; P = .006 ) , stress management therapy ( 35 % ; P = .003 ) , or placebo ( 29 % ; P = .001 ) . On other measures the combined therapy and its 2 component therapies produced similar outcomes . CONCLUSIONS Our results indicate that antidepressant medication and stress management therapy are each modestly effective in treating chronic tension-type headaches . Combined therapy may improve outcome relative to monotherapy Study Design . A 14-week , r and omized , double-blind , multicenter , placebo-controlled study of Japanese patients with chronic low back pain ( CLBP ) who were r and omized to either duloxetine 60 mg once daily or placebo . Objective . This study aim ed to assess the efficacy and safety of duloxetine monotherapy in Japanese patients with CLBP . Summary of Background Data . In Japan , duloxetine is approved for the treatment of depression , diabetic neuropathic pain , and pain associated with fibromyalgia ; however , no clinical study of duloxetine has been conducted for CLBP . Methods . The primary efficacy measure was the change in the Brief Pain Inventory ( BPI ) average pain score from baseline to Week 14 . Secondary efficacy measures included BPI pain ( worst pain , least pain , pain right now ) , Patient 's Global Impression of Improvement , Clinical Global Impressions of Severity , and Rol and -Morris Disability Question naire , among other measures , and safety and tolerability . Results . In total , 458 patients were r and omized to receive either duloxetine ( n = 232 ) or placebo ( n = 226 ) . The BPI average pain score improved significantly in the duloxetine group compared with that in the placebo group at Week 14 [ −2.43 ± 0.11 vs. −1.96 ± 0.11 , respectively ; between-group difference ( 95 % confidence interval ) , − 0.46 [ −0.77 to−0.16 ] ; P = 0.0026 ] . The duloxetine group showed significant improvement in many secondary measures compared with the placebo group , including BPI pain ( least pain , pain right now ) ( between-group difference : −1.69 ± 0.10 , P = 0.0009 ; −2.42 ± 0.12 , P P = 0.0230 , respectively ) , Patient 's Global Impression of Improvement ( 2.46 ± 0.07 , P = 0.0026 ) , Clinical Global Impressions of Severity ( −1.46 ± 0.06 , P = 0.0019 ) , and Rol and -Morris Disability Question naire ( −3.86 ± 0.22 , P = 0.0439 ) . Adverse events occurring at a significantly higher incidence in the duloxetine group were somnolence , constipation , nausea , dizziness , and dry mouth , most of which were mild or moderate in severity and were resolved or improved . Conclusion . Duloxetine 60 mg was effective and well tolerated in Japanese CLBP patients . Level of Evidence : BACKGROUND Recent guidelines for the treatment of irritable bowel syndrome ( IBS ) emphasize the need for research to facilitate home-based self-management for these patients in primary care . The aim of the current study was to test the efficacy of a manualized cognitive behavioural therapy (CBT)-based self-management programme for IBS in a pilot r and omized controlled trial ( RCT ) . METHOD Sixty-four primary -care patients meeting Rome criteria for IBS were r and omized into either self-management plus treatment as usual ( TAU ) ( n=31 ) or a TAU control condition ( n=33 ) . The self-management condition included a structured 7-week manualized programme that was self-administered in conjunction with a 1-hour face-to-face therapy session and two 1-hour telephone sessions . The primary outcome measures were the Subject 's Global Assessment ( SGA ) of Relief and the Irritable Bowel Syndrome Severity Scoring System ( IBS-SSS ) assessed at baseline , end of treatment ( 2 months ) , and 3 and 6 months post-treatment . RESULTS Analysis was by intention-to-treat . Twenty-three ( 76.7 % ) of the self-management group rated themselves as experiencing symptom relief across all three time periods compared to seven ( 21.2 % ) of the TAU controls [ odds ratio ( OR ) 12.2 , 95 % confidence interval ( CI ) 3.72 - 40.1 ] . At 8 months , 25 ( 83 % ) of the self-management group showed a clinical ly significant change on the IBS-SSS compared to 16 ( 49 % ) of the control group ( OR 5.3 , 95 % CI 1.64 - 17.26 ) . CONCLUSIONS This study provides preliminary evidence that CBT-based self-management in the form of a structured manual and minimal therapist contact is an effective and acceptable form of treatment for primary -care IBS patients OBJECTIVES : Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome ( IBS ) . However , r and omized , controlled studies are rare and few have been performed outside highly specialized research centers . The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical setting s outside the traditional research units . METHODS : The study population included IBS patients refractory to st and ard management . In study 1 , patients were r and omized to receive gut-directed hypnotherapy ( 12 sessions , 1 h/week ) in psychology private practice s or supportive therapy , whereas patients were r and omized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2 . Gastrointestinal symptom severity and quality of life were evaluated at baseline , at 3 months follow-up and after 1 year . RESULTS : We r and omized 138 IBS patients refractory to st and ard management , 90 in study 1 and 48 in study 2 . In both the studies , IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups ( P<0.05 ) , but not in the control groups ( ns ) . In study 1 , a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group ( P<0.05 ) , and a trend in the same direction was seen in study 2 ( P=0.17 ) . The results seen at 3 months were sustained up to 1 year . CONCLUSIONS : Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS , but the effectiveness is lower when the therapy is given outside the highly specialized research centers Background Irritable bowel syndrome is the most common disorder diagnosed by gastroenterologists . Although several r and omized‐controlled trials have assessed the therapeutic role of antidepressant drugs , there is insufficient evidence to support their use One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy , relaxation , and st and ard medical treatment compared with st and ard medical treatment alone . Patients were only selected if their symptoms had not improved with st and ard medical treatment over the previous 6 months
Output:
| Cognitive behavioral therapy , relaxation therapy , multi-component psychological therapy , hypnotherapy , and dynamic psychotherapy were all beneficial when data from two or more RCTs were pooled .
: Antidepressants are efficacious in reducing symptoms in IBS patients . |
MS211731 | ***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: AIM This paper reports a study to examine the effectiveness of a 6-month dementia care programme for Chinese families living with and caring for a relative with dementia , compared with routine family support services in Hong Kong . BACKGROUND Recognizing the adverse psychosocial health effects inherent in dementia care , different psychosocial interventions provided preliminary evidence of their effectiveness in improving family members ' knowledge and skills in caregiving and delaying dementia sufferers ' illness deterioration and institutionalization . Little is known about the effects of such interventions for family caregivers ' psychosocial health conditions , particularly in non-Western population s. METHODS A r and omized controlled trial was conducted with 92 Chinese families of a relative with dementia in two dementia care centres in Hong Kong . They were r and omly selected from a dementia client list and then r and omly assigned to receive either the dementia family care programme ( n=46 ) , or routine care only ( n=46 ) . Clients ' symptoms and institutionalization , and caregivers ' quality of life , burden and social support at recruitment , 1 week , and 12 and 18 months following intervention were measured and compared between the study groups using repeated measures MANOVAS followed by Helmert 's contrast tests . Data was collected over a period of 24 months , between September 2007 and August 2009 . RESULTS Results of the MANOVAS and contrast tests indicated that at 18-month follow-up , participants in the family programme reported significantly greater improvements in clients ' symptoms and institutionalization rates , and caregivers ' quality of life and burden , when compared with their counterparts in the routine care group . CONCLUSION These findings provide evidence that the dementia care family programme can improve the psychosocial functioning of both clients with dementia and their family caregivers in a Chinese population . Further research is recommended to investigate whether this intervention can also apply to families with different socio-economic background s and across cultures 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 of dementia as measured by the total NPI score at 12 months ( mean difference , -5.6 ; P = .01 ) and at 18 months ( mean difference , -5.4 ; P = .01 ) . Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months ; at 18 months , caregivers showed improvement in depression as measured by the Patient Health Question naire-9 . No group differences were found on the CSDD , cognition , activities of daily living , or on rates of hospitalization , nursing home placement , or death . CONCLUSIONS Collaborative care for the treatment of Alzheimer disease result ed in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers . These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00246896 BACKGROUND It is believed that timely recognition and diagnosis of dementia is a pre-condition for improving care for both older adults with dementia and their informal caregivers . However , diagnosing dementia often occurs late in the disease . This means that a significant number of patients with early symptoms of dementia and their informal caregivers may lack appropriate care . OBJECTIVES To compare the effects of case management and usual care among community-dwelling older adults with early symptoms of dementia and their primary informal caregivers . DESIGN R and omized controlled trial with measurements at baseline and after 6 and 12 months . SETTING Primary care in West-Friesl and , the Netherl and s. PARTICIPANTS 99 pairs of community-dwelling older adults with dementia symptoms ( defined as abnormal screening for symptoms of dementia ) and their primary informal caregivers . INTERVENTION 12 months of case management by district nurses for both older adults and informal caregivers versus usual care . MEASUREMENTS PRIMARY OUTCOME informal caregiver 's sense of competence . SECONDARY OUTCOMES caregiver 's quality of life , depressive symptoms , and burden , and patient 's quality of life . Process measurements : intervention fidelity and caregiver 's satisfaction with the quality of case management . RESULTS Linear mixed model analyses showed no statistically significant and clinical ly relevant differences over time between the two groups . The process evaluation revealed that intervention fidelity could have been better . Meanwhile , informal caregivers were satisfied with the quality of case management . CONCLUSION This study shows no benefits of case management for older adults with dementia symptoms and their primary informal caregivers . One possible explanation is that case management , which has been recommended among diagnosed dementia patients , may not be beneficial if offered too early . However , on the other h and , it is possible that : ( 1 ) case management will be effective in this group if more fully implemented and adapted or aim ed at informal caregivers who experience more severe distress and problems ; ( 2 ) case management is beneficial but that it is not seen in the timeframe studied ; ( 3 ) case management might have undetected small benefits . This has to be established . Trial registration ISCRTN83135728 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 Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field BACKGROUND Care for elderly persons with disabilities is usually characterized by fragmentation , often leading to more intrusive and expensive forms of care such as hospitalization and institutionalization . There has been increasing interest in the ability of integrated models to improve health , satisfaction , and service utilization outcomes . METHODS A program of integrated care for vulnerable community-dwelling elderly persons ( SIPA [ French acronym for System of Integrated Care for Older Persons ] ) was compared to usual care with a r and omized control trial . SIPA offered community-based care with local agencies responsible for the full range and coordination of community and institutional ( acute and long-term ) health and social services . Primary outcomes were utilization and public costs of institutional and community care . Secondary outcomes included health status , satisfaction with care , caregiver burden , and out-of-pocket expenses . RESULTS Accessibility was increased for health and social home care with increased intensification of home health care . There was a 50 % reduction in hospital alternate level inpatient stays ( " bed blockers " ) but no significant differences in utilization and costs of emergency department , hospital acute inpatient , and nursing home stays . For all study participants , average community costs per person were C dollar 3390 higher in the SIPA group but institutional costs were C dollar 3770 lower with , as hypothesized , no difference in total overall costs per person in the two groups . Satisfaction was increased for SIPA caregivers with no increase in caregiver burden or out-of-pocket costs . As expected , there was no difference in health outcomes . CONCLUSIONS Integrated systems appear to be feasible and have the potential to reduce hospital and nursing home utilization without increasing costs Background Dem and for home care services has increased considerably , along with the growing complexity of cases and variability among re sources and providers . Design ing services that guarantee co-ordination and integration for providers and levels of care is of paramount importance . The aim of this study is to determine the effectiveness of a new case-management based , home care delivery model which has been implemented in And alusia ( Spain ) . Methods Quasi-experimental , controlled , non-r and omised , multi-centre study on the population receiving home care services comparing the outcomes of the new model , which included nurse-led case management , versus the conventional one . Primary endpoints : functional status , satisfaction and use of healthcare re sources . Secondary endpoints : recruitment and caregiver burden , mortality , institutionalisation , quality of life and family function . Analyses were performed at base-line , and at two , six and twelve months . A bivariate analysis was conducted with the Student 's t-test , Mann-Whitney 's U , and the chi squared test . Kaplan-Meier and log-rank tests were performed to compare survival and institutionalisation . A multivariate analysis was performed to pinpoint factors that impact on improvement of functional ability . Results Base-line differences in functional capacity – significantly lower in the intervention group ( RR : 1.52 95%CI : 1.05–2.21 ; p = 0.0016 ) – disappeared at six months ( RR : 1.31 95%CI : 0.87–1.98 ; p = 0.178 ) . At six months , caregiver burden showed a slight reduction in the intervention group , whereas it increased notably in the control group ( base-line Zarit Test : 57.06 95%CI : 54.77–59.34 vs. 60.50 95%CI : 53.63–67.37 ; p = 0.264 ) , ( Zarit Test at six months : 53.79 95%CI : 49.67–57.92 vs. 66.26 95%CI : 60.66–71.86 p = 0.002 ) . Patients in the intervention group received more physiotherapy ( 7.92 CI95 % : 5.22–10.62 vs. 3.24 95%CI : 1.37–5.310 ; p = 0.0001 ) and , on average , required fewer home care visits ( 9.40 95%CI : 7.89–10.92 vs.11.30 95%CI : 9.10–14.54 ) . No differences were found in terms of frequency of visits to A&E or hospital re-admissions . Furthermore , patients in the control group perceived higher levels of satisfaction ( 16.88 ; 95%CI : 16.32–17.43 ; range : 0–21 , vs. 14.65 95%CI : 13.61–15.68 ; p = 0,001 ) . Conclusion A home care service model that includes nurse-led case management streamlines access to healthcare services and re sources , while impacting positively on patients ' functional ability and caregiver burden , with increased levels of satisfaction . Trial registration IS RCT Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clin
Output:
| Characteristics associated with positive results for caregivers were a high intensity of case management and programs specifically addressed to dementia patients .
Despite the numerous method ological challenges in the assessment of such complex social interventions , our results show that case management programs can be beneficial for caregivers of dementia patients and that positive results for patients are achieved without increasing caregivers ' burden .
Copyright © 2017 John Wiley & Sons , |
MS211732 | ***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: Much research on visual function in migraine has examined early aspects of visual processing , often using detection or discrimination measures and stimuli reported to trigger an attack , e.g. striped patterns or flickering lights . Differences between people with and without migraine have been attributed to abnormal cortical processing in migraine , variously described by interictal hyperexcitability , heightened responsiveness , a lack of habituation and /or a lack of intra-cortical inhibition . Here , two experiments are presented that explore a uniquely cortical phenomenon , pattern or contrast adaptation , one using the motion after-effect , one the tilt after-effect . Pattern adaptation reflects specific interactions between groups of neurones and is therefore ideally suited to address proposed models of cortical function in migraine . These models lead to specific predictions in an adaptation study : there should be smaller effects in people with migraine than in people without . The results from both adaptation experiments , however , revealed larger effects in migraine sufferers than in headache-free control subjects . There were no differences between migraine subgroups classified according to the presence or absence of aura . These results are discussed in terms of models of cortical function in migraine Between attacks , migraine patients are characterized by potentiation instead of habituation of stimulation-evoked cortical responses . It is debated whether this is due to increased or decreased cortical excitability . We have studied the changes in visual cortex excitability by recording pattern-reversal visual evoked potentials ( PR-VEP ) after low- and high-frequency repetitive transcranial magnetic stimulation ( rTMS ) , known respectively for their inhibitory and excitatory effect on the cortex . In 30 patients ( 20 migraine without , 10 with aura ) and 24 healthy volunteers , rTMS of the occipital cortex was performed with a focal figure-of-eight magnetic coil ( Magstim ) . Nine hundred pulses were delivered r and omly at 1 or 10 Hz in two separate sessions . Stimulus intensity was set to the phosphene threshold or to 110 % of the motor threshold if no phosphenes were elicited . Before and after rTMS , PR-VEP were averaged sequentially in six blocks of 100zztieresponses during uninterrupted 3.1 Hz stimulation . In healthy volunteers , PR-VEP amplitude was significantly decreased in the first block after 1 Hz rTMS and the habituation normally found in successive blocks after sustained stimulation was significantly attenuated . In migraine patients , 10 Hz rTMS was followed by a significant increase of first block PR-VEP amplitude and by a reversal to normal habituation of the potentiation ( or dishabituation ) characteristic of the disorder . This effect was similar in both forms of migraine and lasted for at least 9 min . There were no significant changes of PR-VEP amplitudes after 1 Hz rTMS in migraineurs and after 10 Hz rTMS in healthy volunteers , nor after sham stimulation . The recovery of a normal PR-VEP habituation pattern after high-frequency rTMS is probably due to activation of the visual cortex and the dishabituation in healthy volunteers to cortical inhibition . We conclude , therefore , that the deficient interictal PR-VEP habituation in migraine is due to a reduced , and not to an increased , pre-activation excitability level of the visual cortex The aim of this study was to characterize the temporal course of phosphene thresholds ( PT ) using transcranial magnetic stimulation ( TMS ) in control subjects and in subjects with migraine and to observe whether changes in PT over time can predict a subsequent migraine attack . PTs were measured in 16 migraineurs [ nine with aura ( MA ) and seven without aura ( MoA ) ] and nine controls five times over an approximately 10-week period . Mean PTs were not significantly different between migraineurs and controls ; however , there was a trend in MA showing lower thresholds . The minimum threshold values were also smaller in MA subjects than in MoA or control subjects . Generally , PTs had higher variance in migraineurs than in controls , revealing a significant increase in st and ard deviation of PTs in MA subjects . There was no significant difference of thresholds from the first to the last stimulation in controls and in MoA subjects , but the 3rd , 4th and 5th measurements of MA subjects were significantly lower than their first measurements . Four migraineurs experienced headache within 1 day after one of the measurements . They had either very low or very high PTs compared with the PT values which were not followed by a migraine attack . Our results imply that migraineurs show a higher variability among PT measurements over time than controls , revealing unstable excitability levels in these patients . Additionally , both particularly high and low PTs might predict a subsequent headache in some individuals OBJECTIVE To determine the excitability of the visual cortex by phosphene thresholds ( PT ) in patients with migraine using transcranial magnetic stimulation ( TMS ) with single- and paired-pulses . METHODS Nineteen patients with migraine with aura ( MWA ) , 19 patients with migraine without aura ( MWoA ) , and 22 control subjects were included . Patients were free from preventive anti-migraine treatment and were investigated within 3 days before or after an acute migraine attack . In each subject , PT were assessed by single-pulse and paired-pulse TMS with an interstimulus interval of 50 ms . RESULTS The main effect of diagnosis indicated that mean PT were significantly lower in migraine patients than in control subjects ( P = .001 ) . Using single-pulse TMS , mean PT tended to be lower in MWoA- patients ( 57.7 + /- 11.8 % ) compared with control subjects ( 64.4 + /- 10.5 % ) ( P = .064 ) . In MWA- patients , mean PT ( 53.1 + /- 5.7 % ) were significantly lower compared with controls ( P < .001 ) . Using TMS with paired pulses , mean PT were significantly reduced in MWoA- patients ( 40.3 + /- 4.9 % , P = .017 ) as well as in MWA- patients ( 39.6 + /- 4.2 % , P = .005 ) compared with controls ( 44.6 + /- 6.0 % ) . The main effect of stimulation type indicated that mean PT were lower determined with paired-pulse stimulation than with single pulses ( P < .001 ) . CONCLUSIONS PT are reduced in patients with migraine in the interictal state suggesting an increased excitability of visual cortical areas . Compared with single-pulse TMS , paired-pulse magnetic stimulation is more efficient to elicit phosphenes . This technique provides the opportunity to evaluate visual cortex excitability with lower stimulus intensities and less discomfort The present study used recordings of visual potentials evoked by pattern reversal ( VEPs ) to investigate the central effects of three drugs used in migraine prophylaxis : the calcium channel blocker nifedipine , the beta‐1‐selective blocker metoprolol , and the nonselective beta adrenoreceptor blocker propranolol . The study involved 58 patients with common or classical migraine who were treated in a double‐blind r and omized study over a period of 7 months , while the effectiveness of prophylactic treatment was recorded in headache diaries that were subjected to time series analysis . VEPs were recorded at the beginning of a 2‐month baseline period without treatment , after 4 months of treatment , and at the end of a 3‐month washout period . At baseline , migraine patients had significantly higher VEP amplitudes and longer latencies than did a group of 87 healthy control subjects . Patients were separated by statistical analysis into responders and nonresponders to each prophylactic treatment . Nifedipine had no effects on the frequency , intensity , and duration of migraine attacks , nor on amplitude and latency of the VEPs . In contrast , the use of beta blockers result ed in a significant decrease in VEP amplitude , both in responders and nonresponders , whereas VEP latency remained unchanged . VEP amplitudes returned to the initial values at follow‐up in the nonresponders , but stayed at lower levels in responders . Beta blockers thus appear to have a significant effect on the increased excitability of the visual system in patients with migraine , although their action is not directly related to their reduction of migraine frequency We performed transcranial magnetic stimulations of the motor and visual cortices in healthy controls ( n = 27 ) and in patients suffering from migraine without ( n = 33 ) or with ( n = 25 ) aura between attacks . By using a 13‐cm circular coil placed over the vertex and recordings of the first dorsal interosseus muscle , we measured thresholds ( at rest and during contraction ) , amplitudes of motor evoked potentials and cortical silent periods . Paired stimulations with short ( 1–20 msec ) interstimulus intervals were performed to assess intracortical inhibition . The visual cortex was stimulated with the same coil placed over the occipital scalp ( 7 cm above the inion ) and the prevalence and threshold of phosphene production was determined . In patients with migraine with aura , motor thresholds during isometric contraction were significantly higher , whereas the prevalence of stimulation‐induced phosphene production was lower compared with healthy controls . These changes were not correlated with attack frequency or disease duration . No differences were found between subject groups in thresholds at rest , motor evoked potential amplitudes , cortical silent periods , or response curves after paired stimuli . These results are in favor of cortical hypoexcitability rather than hyperexcitability in patients with migraine with aura between attacks Magnetic coil ( MC ) stimulation percutaneously of human occipital cortex was tested on perception of 3 briefly presented , r and omly generated alphabetical characters . When the visual stimulus-MC pulse interval was less than 40 - 60 msec , or more than 120 - 140 msec , letters were correctly reported ; at test intervals of 80 - 100 msec , a blur or nothing was seen . Shifting the MC location in the transverse and rostro-caudal axes had effects consistent with the topographical representation in visual cortex , but incompatible with an effect on attention or suppression from an eyeblink . The MC pulse probably acts by eliciting IPSPs in visual cortex . The neural activity subserving letter recognition is probably transmitted from visual cortex within 140 msec of the visual stimulus
Output:
| Overall considered , these results support the hypothesis of a primary visual cortex hyper-excitability in MA , providing not enough evidence for MwA. A significant statistical heterogeneity reflects clinical and method ological differences across studies , and higher temporal variabilities among PT measurements over time , related to unstable excitability levels . |
MS211733 | ***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 At present , 7.2 % of the population in Singapore is in the geriatric age group , which will increase to 18.4 % in the year 2030 . The frailest segment of the geriatric population live in nursing homes . They suffer from multiple co-morbidities requiring multiple medication use . Polypharmacy and inappropriate medication use have been considered as quality indicators for nursing home care . As no data of these indicators are available in Singapore , this study was planned to assess the prevalence of polypharmacy and inappropriate medication use in Singapore nursing homes . MATERIAL S AND METHODS A total of 454 residents in the geriatric age group residing in 3 r and omly selected nursing homes were involved in the study . Case notes were review ed for demographic information , clinical history and medication use . The data were analysed for polypharmacy ( 5 or more medication orders ) and inappropriate medication use ( based on established criteria ) . RESULTS Residents were on an average of 5.32 medications . Polypharmacy and inappropriate medication use were seen in 266 ( 58.6 % ) and 318 ( 70.0 % ) residents , respectively . There was significant association between polypharmacy and inappropriate medication use [ P < 0.001 , chi2 = 82.56 at 95 % confidence interval ( CI ) ] . The most common medication-related problems were the use of medication without proper indication ( n = 302 ) , significant potential for adverse drug reactions ( n = 281 ) and drug interactions ( n = 141 ) . CONCLUSION The prevalence of polypharmacy and inappropriate medication use is high in Singapore nursing homes . Current practice of medication use in the nursing homes may lead to significant adverse drug reactions and drug interactions . A multidisciplinary approach involving geriatricians , nursing home physicians , nurses and pharmacists may potentially reduce polypharmacy and inappropriate medication use in Singapore nursing homes Background Nursing home residents are mainly older people with multiple diseases and taking multiple medications . The quality use of medication and its association with health related quality of life ( HRQoL ) have not been reported in Malaysia . This study aims to investigate the association between the use of potentially inappropriate medications ( PIMs ) and the changes observed in the HRQoL among older nursing home residents . Methods A prospect i ve follow up study was conducted at four nongovernmental organization nursing homes in Penang , Malaysia . Older residents ( ≥65 years old ) taking at least one prescribed medication were included . Residents with PIMs were identified by using Screening Tool of Older Person ’s potentially inappropriate Prescriptions ( STOPP ) criteria . HRQoL was assessed using EuroQol-5 dimension ( EQ-5D ) and EuroQol-visual analog scale ( EQ-VAS ) at baseline and after a 3-month follow up . The association of PIMs with HRQoL was analyzed using Mann-Whitney U test . Results The median age of the 211 participants was 77 years ( interquartile range 72–82 years ) and the median number of prescription medicines was four ( interquartile range three to six ) . The prevalence of PIMs was 23.7 % and 18.6 % at baseline and 3 months later , respectively . The most commonly prescribed PIMs in decreasing order were first generation antihistamine , prescriptions of duplicate drug class , glibenclamide with type 2 diabetes mellitus , and anticholinergic to treat extrapyramidal side effects of neuroleptic medications . At baseline , there was no significant difference among residents with or without PIMs in each bracket of EQ-5D , EQ-5D index , or EQ-VAS scores . Comparison of the differences in the mean score index of EQ-5D between baseline and after 3 months also showed no statistically significant differences . Conclusion PIMs were found to be relatively common among older nursing home residents . However , no significant changes were observed in HRQoL among these residents . Further studies with a bigger sample size and longer follow up period are required to establish this association PURPOSE To develop a simple screen based on easily collectable measures to identify older people living in residential care facilities at high risk of falls . METHODS This prospect i ve study was conducted in seven residential care facilities in the U.K. Residents aged>60 years who were not bedbound or terminally ill participated . Demographics , medical history , medication use , cognition ( mini mental state examination ( MMSE ) ) , function ( Barthel , balance and sit-to-st and ability ) and behavior ( neuro-psychiatric inventory ( NPI ) and impulsivity ) were recorded at baseline . Falls and injuries were prospect ively recorded over 6 months . Data were analyzed for differences between fallers and non-fallers and significant variables entered into logistic regression analysis . RESULTS Two hundred and forty residents completed the study . In the follow-up period , 50 % fell ≥1 times . Fallers had worse function , cognition , behavior and balance and took more medications . Falling in the past year , walking frame and hypnotic/anxiolytic and anti-depressant medication use were also associated with increased likelihood of falling . Logistic regression identified MMSE<17 , impulsivity score ≥ 2 , st and ing balance score<6 , requiring a walking frame , falling in the previous year and use of antidepressants and hypnotics/anxiolytics as independent and significant predictors of falls . The area under the receiver operating curve ( ROC ) for this model was 0.79 ( 95 % CI 0.73 - 0.84 ) . CONCLUSIONS This tool comprising multi-factorial measures provides a simple way of quantifying the probability with which a care home resident will fall over a 6-month period . The tool may also assist in guiding the development and targeting of interventions to prevent falls in this group BACKGROUND In a prospect i ve study of nursing home residents , we found adverse drug events ( ADEs ) to be common , serious , and often preventable . To direct prevention efforts at high-risk residents , information is needed on resident-level risk factors . METHODS Case-control study nested within a prospect i ve study of ADEs among residents in 18 nursing homes . For each ADE , we r and omly selected a control from the same home . Data were abstract ed from medical records on functional status , medical conditions , and medication use . RESULTS Adverse drug events were identified in 410 nursing home residents . Independent risk factors included being a new resident ( odds ratio [ OR ] , 2.8 ; 95 % confidence interval [ CI ] , 1.5 - 5.2 ) and taking anti-infective medications ( OR , 4.0 ; CI , 2.5 - 6.2 ) , antipsychotics ( OR , 3.2 ; CI , 2.1 - 4.9 ) , or antidepressants ( OR , 1.5 ; CI , 1.1 - 2.3 ) . The number of regularly scheduled medications was associated with increased risk of ADEs ; the OR associated with taking 5 to 6 medications was 2.0 ( CI , 1.2 - 3.2 ) ; 7 to 8 medications , 2.8 ( CI , 1.7 - 4.7 ) ; and 9 or more , 3.3 ( CI , 1.9 - 5.6 ) . Taking supplements or nutrients was associated with lower risk ( OR , 0.42 ; CI , 0.27 - 0.63 ) . Preventable ADEs occurred in 226 residents . Independent risk factors included taking opioid medications ( OR , 6.6 ; CI , 2.3 - 19.3 ) , antipsychotics ( OR , 4.0 ; CI , 2.2 - 7.3 ) , anti-infectives ( OR , 3.0 ; CI , 1.6 - 5.8 ) , antiepileptics ( OR , 2.2 ; CI , 1.1 - 4.5 ) , or antidepressants ( OR , 2.0 ; CI , 1.1 - 3.5 ) . Scores of 5 or higher on the Charlson Comorbidity Index were associated with increased risk of ADEs ( OR , 2.6 ; CI , 1.1 - 6.0 ) . The number of regularly scheduled medications was also a risk factor : the OR for 7 to 8 medications was 3.2 ( CI , 1.4 - 6.9 ) and for 9 or more , 2.9 ( CI , 1.3 - 6.8 ) . Residents taking nutrients or supplements were at lower risk ( OR , 0.27 ; CI , 0.14 - 0.50 ) . CONCLUSIONS It is possible to identify nursing home residents at high risk of having an ADE . Particular attention should be directed at new residents , those with multiple medical conditions , those taking multiple medications , and those taking psychoactive medications , opioids , or anti-infective drugs Objective : To study changes in drug use after admission to Dutch nursing homes . Setting . Six nursing homes near the city of Nijmegen , The Netherl and s. Design . Prospect i ve longitudinal study . Methods . All patients who had been newly admitted to the nursing home were included in the study . Age , gender , residence of the patients before admission , and indication were registered . All prescriptions were registered with start‐ date and end‐ date . The nomenclature and subcategory definitions used were those of the World Health Organisation Nordic Anatomical Therapeutic Chemical classification index ( ATC ) codes . Patients had a follow‐up of six weeks . Results . There was a minor , but statistically significant , increase in the mean number of drugs from 5.6 on admission to 5.8 six weeks later . Patients referred from a hospital and patients with a somatic indication were prescribed the highest number of drugs . On admission 5.5 % of the patients were not on medication at all , 48%were using 1‐2 drugs , and 46 % had been prescribed 6 or more drugs . Six weeks after admission , a significant increase in drug use was found in drugs for the nervous system , and drugs for the sensory organs . Conclusion . Increase in drug use does not necessarily have to reflect bad prescribing practice s. However , in this frail population , continuous drug review is needed to guarantee quality of prescribing and reduce unnecessary polypharmacy OBJECTIVES To evaluate the association between the Drug Burden Index ( DBI ) , a measure of a person 's total exposure to anticholinergic and sedative medications that includes principles of dose-response and maximal effect and is associated with impaired physical function in community-dwelling older people , and falls in residents of residential aged care facilities ( RACFs ) . DESIGN Data were drawn from participants in a r and omized controlled trial that investigated falls and fractures . SETTING RACFs in Sydney , Australia . PARTICIPANTS Study participants ( N=602 ; 70.9 % female ) were recruited from 51 RACFs . Mean age was 85.7 ± 6.4 , and mean DBI was 0.60 ± 0.66 . MEASUREMENTS Medication history was obtained on each participant . Drugs were classified as anticholinergic or sedative and a DBI was calculated . Falls were measured over a 12-month period . Comorbidity , cognitive impairment ( Mini-Mental State Examination ) and depression ( Geriatric Depression Scale ) were determined . RESULTS There were 998 falls in 330 individuals during a follow-up period of 574.2 person-years , equating to an average rate of 1.74 falls per person-year . The univariate negative binomial regression model for falls showed incidence rate ratios of 1.69 ( 95 % confidence interval (CI)=1.22 - 2.34 ) for low DBI ( < 1 ) and 2.11 ( 95 % CI=1.47 - 3.04 ) for high DBI ( ≥1 ) when compared with those who had a DBI of 0 . After adjusting for age , sex , history of falling , cognitive impairment , depression , use of a walking aid , comorbidities , polypharmacy , and incontinence , incident rate ratios of 1.61 ( 95 % CI=1.17 - 2.23 ) for low DBI and 1.90 ( 95 % CI=1.30 - 2.78 ) for high DBI were obtained . CONCLUSION DBI is significantly and independently associated with falls in older people living in RACFs . Interventional studies design ed for this population are needed to determine whether reducing DBI , through dose reduction or cessation of anticholinergic and sedative drugs , can prevent falls OBJECTIVES To evaluate the feasibility of developing consensus recommendations for appropriate prescribing for patients with advanced dementia using a new conceptual framework and to determine the frequency of inappropriate medication use based on these recommendations in a small sample of patients with advanced dementia . DESIGN Medication data were obtained using chart review . Recommendations for appropriate prescribing were achieved using a modified Delphi consensus panel . SETTING Three long-term care facilities . PARTICIPANTS Thirty-four patients with advanced dementia enrolled in the Palliative Excellence in Alzheimer Care Efforts Program were selected to evaluate medication use . Twelve geriatricians at the University of Chicago participated in the modified Delphi consensus panel . MEASUREMENTS Prescription and over-the-counter medications were recorded for the 34 patients . Following the modified Delphi process , medications were characterized into one of four categories for use in palliative care patients with advanced dementia : never appropriate , rarely appropriate , sometimes appropriate , or always appropriate . RESULTS Patients were taking an average of 6.5 medications at enrollment . Six patients were taking 10 or more medications daily . Consensus was reached ranking the appropriateness of 69 of 81 medic
Output:
| The prevalence of polypharmacy in LTCFs is high , varying widely between facilities , geographical locations and the definitions used . |
MS211734 | ***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 : Excluding pulmonary embolism , anastomotic leak is the leading cause of death and major morbidity in patients undergoing open or laparoscopic gastric bypass operations . We observed a number of these leaks ( 11 out of 1,120 MicropouchSM gastric bypass [ MGB ] patients ; 0.9 % ) . The majority ( 80 % ) required emergency laparotomy and drainage , massive fluid resuscitation , and aggressive nutritional support . Therefore , we design ed a 2-year , prospect i ve study to determine the therapeutic efficacy of vapor-heated fibrin sealant to prevent anastomotic leaks at the gastro-jejunostomy ( GJS ) site . Methods : Between April , 2000 and March , 2002 , 738 patients underwent a primary ( n=671 ) or revisionary ( n=67 ) MGB procedure . The gastric reservoir was limited to the cardia of the stomach . Vapor-heated fibrin glue 1 cc was applied circumferentially to a 12-mm , non-b and ed GJS anastomosis . Once activated , fibrin sealant polymerized into a soft , closely adherent gel . No omental patch was used to cover the fibrin-sealed anastomosis . Results : Of 738 patients , 2 required emergency laparotomy for leaks and 2 for adhesive b and s that contributed to a distal small bowel obstruction . There were no anastomotic leaks at the fibrin-sealed GJS sites . No gastro-gastric or gastro-enteric fistulas were recorded . Conclusion . Fibrin sealant applied to the GJS site appears to have eliminated anastomotic leaks in our MicropouchSM gastric bypass patients . These results suggest that fibrin glue application may contribute to " leak prophylaxis " in patients undergoing open Rouxen-Y gastric bypass . Glue placements may also benefit patients undergoing a laparoscopic Roux-en-Y procedure , wherein anastomotic leaks have been reported early in the learning curve PURPOSE : The aim of this study was to investigate the role of omentoplasty , by means of intact omentum , in preventing anastomotic leakages after rectal resection . METHODS : Between 1992 and 1997 a total of 112 patients ( 64 males ) with a mean age of 64.7 ( range , 39–83 ) years were r and omly assigned to undergo omentoplasty ( Group A ) or not ( Group B ) to reinforce the colorectal anastomosis after anterior resection for rectal cancer . The primary end point was anastomotic leakage ; the secondary end point included morbility and mortality related to omentoplasty . RESULTS : The two groups were comparable in terms of preoperative and intraoperative characteristics . Staple-ring disruption at plain abdominal radiographs was detected in seven instances in Group A and in ten in Group B patients ( P = not significant ) . Two leakages were evident clinical ly in Group A and seven in Group B ( P<0.05 ) . Three leaks were documented radiologically in Group A and eight in Group B ( P = not significant ) . No complications related to omentoplasty were observed in Group A. There were two repeat operations for anastomotic leakage in Group B. At follow-up , one stricture developed in Group A and three in Group B ( P = not significant ) CONCLUSIONS : Despite a similar incidence of staple-ring defects , a strikingly lower rate of clinical ly and radiologically detected leaks developed in patients su bmi tted to omentoplasty . Although not affecting the incidence of anastomotic disruption , omentoplasty seems to contain the severity of anastomotic leakage BACKGROUND Despite improved surgical techniques , anastomotic leakage remains as a serious complication in colorectal surgery , producing increased morbidity and mortality . This prospect i ve study was initiated to test the hypothesis that preexisting disorders in the extracellular matrix ( ECM ) may be a factor influencing the onset of anastomotic wound healing complications . METHODS In this prospect i ve study of 119 patients with colorectal anastomoses , 30 clinical parameters with possible influence on anastomotic complications were evaluated . From all patients , sample s of macroscopically intact colonic tissue were obtained at the index operation . Crosspolarization microscopy was performed to analyze the collagen type I/III ratio , and immunohistochemical studies were done to determine the expression of matrix metalloproteinase ( MMP ) 1 , 2 , 9 , and 13 . The patients with uncomplicated postoperative healing were compared with those developing anastomotic leakage . RESULTS Patients with impaired anastomotic healing exhibited a significantly lower collagen type I/III ratio compared with the controls . Significantly higher expression of MMP-1 and MMP-2 in the mucosal layers and of MMP-2 and MMP-9 in the submucosal layers was found in the normal bowel wall of the leakage group . These findings were statistically independent from the clinical parameters . CONCLUSION The present study confirms the hypothesis that disturbances of the ECM play a role in the pathogenesis of anastomotic leakage after large bowel surgery A left-sided colon obstruction was produced with a polypropylene sling in 65 rats . Colon resection and primary anastomosis were performed three days later . The animals were then r and omly allocated to the FG ( fibrin glue ) group receiving sealing of the anastomosis with 0.4 ml of fibrin glue ( Beriplast R ) , or to the NG ( non-glue ) group . The anastomoses were assessed 30 min , two days and four days later . Adhesion formation was similar in both groups . The number of macroscopic or radiological leakages did not differ either . At 30 min the mean bursting pressure was 74.6 + /- 8.6 ( SD ) mmHg in the FG group and 58.3 + /- 21.6 mmHg in NG ( non-glue ) group ( p less than 0.05 , Mann-Whitney test ) . Later on the strength of the anastomoses was equal in both groups . We conclude that the initial sealing of weak points in the anastomoses was beneficial but the inherent strength per se could not be enhanced Purpose To investigate whether a collagen fleece kept in place by fibrin glue might seal off a colorectal anastomosis , provide reinforcement , and subsequently improve anastomotic healing . Methods Wistar rats underwent a 1-cm left-sided colonic resection followed by a 4-suture end-to-end anastomosis . They were then r and omly assigned to one of three treatment groups : no additional intervention ( control , n = 20 ) , the anastomosis covered with fibrin glue ( fibrin glue , n = 20 ) , the anastomosis covered with a collagen fleece , kept in place with fibrin glue ( collagen fleece , n = 21 ) . At either 3 or 7 days follow-up , anastomotic bursting pressure was measured and tissue was obtained for histology and collagen content assessment after which animals were sacrificed . Results Three rats in the control ( 15 % ) , three in the fibrin glue ( 15 % ) , and one in the collagen group ( 4.8 % ) died due to anastomotic complications ( P = 0.497 ) . Anastomotic bursting pressures were not significantly different between groups at 3 and 7 days follow-up ( P = 0.659 and P = 0.427 , respectively ) . However , bowel obstructions occurred significantly more often in the collagen group compared to the control group ( 14/21 vs. 3/20 , P = 0.003 ) . Collagen contents were not different between groups , but histology showed a more severe inflammation in the collagen group compared to the other groups at both 3 and 7 days follow-up . Conclusions A collagen fleece kept in place by fibrin glue does not improve healing of colonic anastomoses in rats . Moreover , this technique induces significantly more bowel obstructions in rats , warranting further study before being translated to a clinical setting Objective The aim of this study was to characterize a successful approach for the management of infants with long-gap esophageal atresia ( EA ) with tracheoesophageal fistula ( TEF ) . The goal was to preserve the native esophagus and minimize the incidence of esophageal anastomotic leaks using fibrin glue as a sealant over the esophageal anastomosis . Method A total of 52 patients were evaluated in this study . Only patients in whom , gap between the two ends of the esophagus was ≥ 2 cm were selected during January 2005 to January 2007 . Patients were divided in two groups on the basis of block r and omization . Group A comprised the patients in whom fibrin sealant was used as reinforcement on a primary end-to-end esophageal anastomosis ; in group B , fibrin glue was not used . The two groups were compared in terms of esophageal anastomotic leak ( EL ) , postoperative esophageal stricture ( ES ) , and mortality . The statistical analysis was done using Fisher ’s exact test and the chi-squared test . Result The number of anastomotic leaks in group A ( glue group ) was about one-fifth that in group B ( no glue group ) . The incidence of ES was almost twice as high in group B as in group A. The mortality rate was almost threefold higher in group B ( no-glue group ) . The higher incidence of EL and ES in group B compared to group A was statistically significant . Conclusion Thus , fibrin glue when used as an adjunct to esophageal anastomosis for primary repair of long-gap EA with TEF appears safe in the clinical setting and may lower the chances of esophageal leak and anastomosis-site strictures . Hence , it can diminish the mortality and morbidity of these patients Abstract Background After colon resection for colonic cancer , the administration of antineoplastic agents may prolong survival by killing residual cancer calls and preventing metastasis , but may also slow anastomotic healing . This study was design ed to determine the effects of 5-fluorouracil ( 5-FU ) and leucovorin ( LEV ) , injected intraperitoneally , on the healing of colonic anastomoses with or without fibrin glue ( FG ) covering . Methods Sixty rats were r and omized to one of four groups . After resection of a transverse colon segment , an end-to-end sutured anastomosis was performed . Rats in the 5-FU+LEV and the 5- FU+LEV+FG groups received 5-FU+LEV intraperitoneally . The colonic anastomoses of the rats in the FG group and in the 5-FU+LEV+FG group were covered with fibrin glue . All rats were killed on postoperative day 8 . Bursting pressure measurements were recorded and the anastomoses were examined macroscopically and histologically . Results The leakage rate of the anastomoses was significantly different among groups . Specifically , the leakage rate was significantly higher in the 5-FU+LEV group ( 40 % ) than in the FG and in the 5-FU+LEV+FG groups where there were no leakages ( p=0.017 ) . The mean adhesion formation score was significantly higher in rats of the 5-FU+LEV group , compared to the control ( p=0.023 ) , the FG ( p=0.006 ) and the 5-FU+LEV+FG ( p=0.006 ) groups . Bursting pressures were significantly lower in the 5-FU+LEV group than in the other groups ( p<0.001 ) . Also , bursting pressures were significantly lower in the control group compared to the FG and 5-FU+LEV+FG groups ( p<0.001 ) . Rats in the 5-FU+LEV+FG group had significantly greater neoangiogenesis and fibroblast activity than those in the 5-FU+LEV group ( p=0.025 ) . Conclusion The early intraperitoneal postoperative administration of 5-fluorouracil plus leucovorin impaired colonic wound healing . However , the application of fibrin glue prevented the deleterious effect of chemotherapy OBJECTIVE To investigate the role of omentoplasty ( OP ) in the prevention of anastomotic leakage after colonic or rectal resection . SUMMARY BACKGROUND DATA It has been proposed that OP -- wrapping the omentum around the colonic or rectal anastomosis -- reinforces intestinal sutures with the expectation of lowering the rate of anastomotic leakage . However , there are no prospect i ve , r and omized trials to date to prove this . METHODS Between September 1989 and March 1994 , a total of 705 patients ( 347 males and 358 females ) with a mean age of 66 + /- 15 years ( range , 15 - 101 ) originating from 20 centers were r and omized to undergo either OP ( n = 341 ) or not ( NO , n = 364 ) to reinforce the colonic anastomosis after colectomy . Patients had carcinoma , benign tumor , colonic Crohn 's disease , diverticular disease of the sigmoid colon , or another affliction located anywhere from the right colon to and including the midrectum . Patients undergoing emergency surgery were not included . R and om allotment took place once the resection and anastomosis had been performed
Output:
| Conclusion : In the available studies , FG did not consistently have a positive influence on the healing of gastrointestinal anastomoses .
It is consequently plausible that the positive effect of FG sealing of gastrointestinal anastomoses , if there is any , may be due to a mechanical sealing effect rather than due to improved healing per se |
MS211735 | ***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 We previously reported that monthly telephone contact by lay personnel , to promote self-care for patients with osteoarthritis ( OA ) , was associated with improved joint pain and physical function after 1 year of followup . The present study was a secondary analysis to determine whether improvement was contingent on intensified medical treatment . METHODS We reanalyzed control/treatment group differences in all 40 subjects with radiographically confirmed knee OA who had had no changes in antirheumatic drug therapy or institution of physical therapy during the period of observation . RESULTS Group differences in measured pain remained significant ( effect size [ ES ] = 0.65 SD , P less than 0.01 ) . The same trend was observed for physical function ( ES = 0.53 SD , P not significant ) . CONCLUSION The findings in this re analysis suggest that periodic telephone support interventions are effective enough to be regarded as an adjunctive treatment for OA OBJECTIVE The purpose of this study was to investigate the efficacy of acupuncture as an adjunctive therapy to st and ard care for the relief of pain and dysfunction in elderly patients with osteoarthritis ( OA ) of the knee . METHODS Seventy-three patients with symptomatic OA of the knee were r and omly assigned to treatment ( acupuncture ) or st and ard care ( control ) . Analysis was performed on last score carried forward to account for patients who dropped out before completion . Patients self-scored Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and Lequesne indices at baseline and at 4 , 8 and 12 weeks . Patients in the control group were offered acupuncture treatment after 12 weeks . The data for these patients are pooled with those from the original acupuncture group for within-group analysis . RESULTS Patients r and omized to acupuncture improved on both WOMAC and Lequesne indices compared to those who received st and ard treatment alone . Significant differences on total WOMAC Scale were seen at 4 and 8 weeks . There appears to be a slight decline in effect at 4 weeks after cessation of treatment ( 12 weeks after first treatment ) . No adverse effects of acupuncture were reported . CONCLUSION These data suggest that acupuncture is an effective and safe adjunctive therapy to conventional care for patients with OA of the knee OBJECTIVE To evaluate the cost-effectiveness of telephone intervention for patients with osteoarthritis . METHODS R and omized , controlled trial . RESULTS The intervention did not significantly increase health care costs . The annual costs for a 1-unit improvement in physical functioning and in pain , as measured by the Arthritis Impact Measurement Scales , were $ 70.86 and $ 31.00 , respectively . CONCLUSION Telephone contact is a potentially cost-effective intervention in osteoarthritis OBJECTIVE The effects of treatment counseling or symptom monitoring telephone intervention strategies on the health outcomes of patients with rheumatoid arthritis ( RA ) or osteoarthritis ( OA ) , compared with usual care , were assessed . METHODS A 3-group , r and omized , controlled 9-month trial was conducted incorporating 405 patients with RA or OA and using the Arthritis Impact Measurement Scales ( AIMS 2 ) as the outcome measure . RESULTS Analyses of covariance showed that the AIMS 2 total health status of the treatment counseling group ( effect size = 33 , P < 0.01 ) , but not the symptom monitoring group ( effect size = 0.21 , P = 0.10 ) , was significantly improved , compared with usual care , for both RA and OA patients . The specific types of benefits differed significantly between RA and OA patients . The mean number of medical visits by OA patients in the treatment counseling group was also significantly reduced ( P < 0.01 ) . CONCLUSION Telephone contact using the treatment counseling strategy produced significant , but different , health status benefits for RA and OA patients . The symptom monitoring strategy produced modest benefits Approximately 14 million patients in the United States regularly take nonsteroidal anti-inflammatory drugs(NSAIDs ) for various types of arthritis [ 1 ] for relief of pain , stiffness , and other symptoms . However , these benefits are obtained at a price . Use of NSAIDs is associated with various gastrointestinal side effects . Minor side effects such as nausea , dyspepsia , anorexia , abdominal pain , flatulence , and diarrhea may affect 10 % to 60 % of patients [ 2 ] . Symptomatic ulcers and potentially life-threatening ulcer complications such as upper gastrointestinal bleeding , perforation , and gastric outlet obstruction are reported in 2 % to 4 % of patients who take NSAIDs for a year [ 3 ] . The chance of hospitalization or death from a gastrointestinal adverse event is 1.3 % to 1.6 % per year in patients with rheumatoid arthritis [ 4 ] . These infrequent but potentially serious gastrointestinal side effects of NSAIDs have become a major health care problem because of the many patients at risk [ 5 ] . General physicians and rheumatologists caring for patients with symptoms of chronic arthritis may be reluctant to ab and on using NSAIDs , which help most of these patients , in order to protect the few who may develop serious complications from use of these drugs . On the other h and , gastroenterologists see fewer patients for arthritis but many with serious gastrointestinal complications . Life-threatening events such as perforation or serious hemorrhage from NSAID-induced ulcers , which often develop with little or no warning [ 6 ] , are a real problem because of the many patients at risk . Various agents have been used in attempts to reduce the incidence of NSAID-induced gastrointestinal lesions . In one endoscopic study , cimetidine at a dose of 300 mg four times a day showed no benefit in healing NSAID-related lesions compared with placebo , and 400 mg at bedtime provided no benefit in preventing these lesions compared with placebo [ 7 ] . Antacids ( magnesium-aluminum hydroxide , 10 to 20 mL as needed to a dose as high as 60 mL daily ) and sucralfate have recently been reported to reduce dyspeptic symptoms in arthritic patients receiving NSAIDs in whom gastropathic lesions ( but not ulcers ) were shown endoscopically [ 8 , 9 ] . The surface-active antiulcer drug sucralfate was ineffective in preventing ulcers in persons receiving NSAIDs [ 10 , 11 ] , and the histamine-2-receptor antagonist ranitidine did not prevent gastric ulcers but did reduce the frequency of duodenal ulcers [ 12 , 13 ] . Results of preliminary studies indicate that the effects of omeprazole parallel those of ranitidine [ 14 ] . A recent study [ 15 ] in achlorhydric patients showed that NSAID-induced ulcers develop in the absence of gastric acid . In contrast , several clinical trials have shown that the incidence of endoscopically visible erosions and ulcers associated with NSAID use can be reduced by cotherapy with the synthetic prostagl and in misoprostol [ 16 - 19 ] . However , it was not proved that preventing endoscopic lesions would prevent clinical ly serious complications of NSAID-induced gastrointestinal ulcers [ 20 ] . Our objective was to determine whether concurrent therapy with misoprostol reduces the incidence of serious upper gastrointestinal complications in older patients with chronic rheumatoid arthritis who are taking NSAIDs . Because most patients taking NSAIDs do not routinely have endoscopy , we investigated the incidence of these complications during clinical care as actually practice d. A second goal was to better define which patients were at increased risk for development of serious NSAID-induced upper gastrointestinal complications . Methods Patients Ambulatory patients at least 52 years of age who had chronic rheumatoid arthritis , defined by American College of Rheumatology criteria [ 21 ] , and who were expected to be taking 1 of 10 specified NSAIDs at predefined minimum doses for 6 months were sought from practice s of family medicine , internal medicine , or rheumatology . Of these practice s , 661 in the United States and 3 in Canada enrolled at least one patient between July 1991 and August 1993 . For all patients , a medical history was elicited , a physical examination was done , and a modified Health Assessment Question naire that included eight items on activities of daily living was administered [ 22 ] . Patients were excluded if they had had active peptic ulcer disease within 30 days of study enrollment ; were taking or expected to need antiulcer medication ( histamine-2 blockers , sucralfate , omeprazole ) or any experimental medication during the study ; had the Zollinger-Ellison syndrome , pyloric or duodenal obstruction , previous gastric resection or vagotomy , gastroesophageal reflux disease , varices , or cirrhosis ; had a history of inflammatory bowel disease , upper gastrointestinal tract malignancies , hepatitis , alcoholism , or bleeding diathesis ; were estimated to have a life expectancy of less than 8 months or had do-not-resuscitate status ; were women of child-bearing potential ; or could not tolerate misoprostol or any prostagl and in . The following were the minimum NSAID doses ( mg/d ) allowed : aspirin , 2000 ; diclofenac , 100 ; flurbiprofen , 200 ; ibuprofen , 1200 ; indomethacin , 75 ; ketoprofen , 150 ; naproxen , 750 ; piroxicam , 20 ; sulindac , 200 ; or tolmetin , 1200 . Patients were allowed to receive more than one NSAID . Intervention Eligible patients were r and omly assigned to receive either misoprostol or placebo in the form of 200- micrograms tablets from coded bottles supplied by the manufacturer . Patients were r and omly assigned in blocks of four , so that in each block , half the patients would receive misoprostol and half would receive placebo . Because blocks were assigned to investigators , patients were r and omly assigned within the individual centers . Investigators were not informed about the r and omization procedure but were told only that the study was r and omized and double-blind . Patients were instructed to begin taking half a tablet with meals and at bedtime each day for 10 days and then , if the drug was tolerated , to increase the dose to a whole tablet four times a day for the rest of the study . If the drug was not tolerated , the patients were instructed to reduce the dose back to half a tablet four times a day . Patients could continue therapy with arthritis disease-modifying agents ( such as gold or corticosteroids ) and were allowed to take antacids that did not contain magnesium . Patients purchased their own arthritis medications or antacids and reported their consumption when seen monthly for examination and counts of study medication tablets . Physicians were instructed to watch closely for clinical signs of gastrointestinal bleeding or other possible gastrointestinal complications , to inquire about symptoms , and to investigate suspicious episodes by appropriate clinical procedures . Outcome Measures All suspicious events , regardless of presumed cause , were to be reported , along with all available patient data , to the study medical officer ( HWD ) and then to an external review committee . This committee consisted of a gastroenterologist ( FS ) , a rheumatologist ( Kenneth Br and t , MD , Indiana University ) , and an epidemiologist ( Marie Griffin , MD , MPH , V and erbilt University ) . The committee determined , without unblinding the r and omization code , whether the patient had upper gastrointestinal bleeding ; other ulcer complications ; or a problem such as hemorrhoids , diverticulitis , colon polyps , or cancer . It developed definitions of what were considered to be complications related to NSAID use and categories of such complications . The committee reached consensus and assigned such events to one of the following categories of definite upper gastrointestinal complications : 1 . perforated ulcer , proved at surgery ; 2 . gastric outlet obstruction caused by proven ulceration and stricture , proved by endoscopy ; 3 . hematemesis , with endoscopically proven gastric or duodenal ulceration or erosion ; 4 . active or recent visualized bleeding from endoscopically proven ulceration or erosion ; 5 . melena , with endoscopically proven ulceration or erosion ; 6 . heme-positive stool , with endoscopically proven ulceration or erosion , plus either a ) a decrease in hematocrit of at least 0.05 or b ) orthostatic change in the pulse rate ( from sitting to st and ing ) of at least 20 beats per minute or decrease in systolic blood pressure of at least 20 mm Hg and a decrease in diastolic blood pressure of 10 mm Hg ; 7 . hematemesis , without endoscopically proven ulceration or erosion ; and 8 . melena , with heme-positive stool and without endoscopically proven ulceration or erosion . The committee also defined categories of events not involving clinical ly significant bleeding : 9 . report of melena with no other data ; 10 . heme-positive stools , with endoscopically proven ulceration or erosion and without active bleeding ; and 11 . report of melena and heme-negative stools when the stools were tested . Sample Size Calculation and Statistical Methods The placebo group was expected to have an incidence of serious NSAID-induced upper gastrointestinal complications of about 2 % per
Output:
| Furthermore , the risk for a catastrophic gastrointestinal event in elderly patients taking NSAIDs is dose dependent ( 18 ) .
Celecoxib has been found to be more effective than placebo and as effective as naproxen for symptoms in patients with hip or knee osteoarthritis ( 27 - 29 ) .
Rofecoxib has also been found to be more effective than placebo and is comparable in efficacy to both ibuprofen and diclofenac in patients with hip or knee osteoarthritis ( 30 , 31 ) .
A further advantage of COX-2specific inhibitors with respect to upper gastrointestinal bleeding is that celecoxib and rofecoxib do not have a clinical ly significant effect on platelet aggregation or bleeding time .
In addition , at doses recommended for treatment of osteoarthritis , these drugs appear to be better tolerated than comparator nonselective NSAIDs , with a lower incidence of dyspepsia and other gastrointestinal side effects .
As with nonselective NSAIDs , however , COX-2specific inhibitors can cause renal toxicity .
Histamine-2 blockers in usual doses , however , have not been found to be as effective as misoprostol ( 36 ) , whereas omeprazole ( 20 mg/d or 40 mg/d ) was as effective as misoprostol ( 200 g twice daily ) in treatment of existing ulcers and was better tolerated and associated with a lower rate of relapse ( 37 ) . |
MS211736 | ***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 AIM : To establish the prevalence of anthelmintic resistance in parasitic nematodes on sheep farms in New Zeal and . METHODS : A cross-sectional prevalence study was conducted , using a st and ardised faecal nematode egg count ( FEC ) reduction ( FECR ) test ( FECRT ) for ivermectin , at a full ( 0.2 mg/kg ) and half ( 0.1 mg/kg ) dose rate , and albendazole , levamisole and albendazole-levamisole in combination , on 60 lambs ( n=10 per group ) on farms selected from throughout New Zeal and . Farms that conformed with selection criteria were chosen at r and om ( n=80 ) or with a history of suspected resistance to macrocy- clic lactone ( ML ) anthelmintics ( n=32 ) . Resistance to an an- thelmintic was inferred when there was < 95 % reduction in FEC 7 - 10 days after treatment . Larval cultures were performed for all control groups and for treated groups for which resistance was evident . RESULTS : Of the farms r and omly selected , 36 % showed ≥95 % FECR for all anthelmintics tested ; resistance to ivermectin at 0.1 and 0.2 mg/kg liveweight was evident on 36 % and 25 % of these farms , respectively . Resistance to both ivermectin ( 0.2 mg/kg ) and levamisole was evident on 8/80 ( 10 % ) farms , to ivermectin and albendazole on 10/80 ( 13 % ) farms , and to iver- mectin , levamisole and albendazole on 6/80 ( 8 % ) farms . The prevalence of resistance to a half dose of ivermectin tended to be more prevalent on farms with a history of suspected ML resistance ( p=0.06 ) . Resistance to albendazole was seen across all the main parasite genera , and to levamisole in Nematodirus , Ostertagia (= Teladorsagia ) and Trichostrongylus species . Resistance to ivermectin was dominated by Ostertagia spp , although Cooperia , Nematodirus and Trichostrongylus species were also implicated . CONCLUSION : Anthelmintic resistance in parasitic nema-todes of sheep is common in New Zeal and . Not only was resistance to albendazole and levamisole common , but resistance to the ML , ivermectin , was at a higher prevalence than expected . Sheep farmers and advisors in New Zeal and need to re-evaluate the way they manage parasites , and more research is urgently needed if the steady decline in anthelmintic susceptibility is to be halted Abstract AIM : To test the theory that creating a reservoir of unselected worms by leaving a proportion of lambs in a flock untreated with anthelmintic , i.e. in refugia , will slow the development of anthelmintic resistance in nematode parasite population s. METHODS : Newly weaned Romney lambs ( n=180 ) were infected with two nematode parasite species , Teladorsagia ( = Ostertagia ) circumcincta and Trichostrongylus colubriformis . For each species , the challenge doses contained a mixture of infective larvae from benzimidazole-resistant and -susceptible isolates calculated to yield , from the combined population , a 95 % reduction in faecal nematode egg counts ( FEC ) following treatment with albendazole . Once the infections were patent , the lambs were divided into nine groups of 20 animals , and each group was allocated to one of three treatments . In Treatments 1 , 2 and 3 , 100 % , 90 % and 80 % of animals were treated with an anthelmintic , respectively . For treatments 2 and 3 , the heaviest animals remained untreated . Following treatment , each group was moved to its own previously prepared low-contamination pasture . Lambs grazed this pasture for 7 weeks before again being treated and moved to new low-contamination pastures ( Shift 1 and Shift 2 ) . The parasite population s on pasture result ing from the different treatments were subsequently sample d using tracer lambs , and worm eggs derived from these were used in both egg-hatch assays ( EHA ) and larval development assays ( LDA ) , to measure albendazole-resistance status . RESULTS : Treating all animals each time the groups were moved to new low-contamination pastures result ed in higher levels of albendazole resistance ( p<0.05 ) , measured using EHA and LDA , in subsequent parasite generations than when either 10 or 20 % of animals were left untreated . However , higher FEC in the tracer lambs grazed on pastures in Treatments 2 and 3 , compared with Treatment 1 , indicated an increased level of pasture contamination as a result of leaving some animals untreated . CONCLUSIONS : The results demonstrate that creating a reservoir of unselected parasites slows the development of anthelmintic resistance , and emphasises the risk of treating all animals prior to a shift on to low-contamination pasture . However , higher levels of pasture contamination , result ing from untreated animals , indicate the difficulty in managing both worm control and resistance Objective To investigate the effect of an additional review based on reporting guidelines such as STROBE and CONSORT on quality of manuscripts . Design Masked r and omised trial . Population Original research manuscripts su bmi tted to the Medicina Clínica journal from May 2008 to April 2009 and considered suitable for publication . Intervention Control group : conventional peer review s alone . Intervention group : conventional review plus an additional review looking for missing items from reporting guidelines . Outcomes Manuscript quality , assessed with a 5 point Likert scale ( primary : overall quality ; secondary : average quality of specific items in paper ) . Main analysis compared groups as allocated , after adjustment for baseline factors ( analysis of covariance ) ; sensitivity analysis compared groups as review ed . Adherence to review er suggestions assessed with Likert scale . Results Of 126 consecutive papers receiving conventional review , 34 were not suitable for publication . The remaining 92 papers were allocated to receive conventional review s alone ( n=41 ) or additional review s ( n=51 ) . Four papers assigned to the conventional review group deviated from protocol ; they received an additional review based on reporting guidelines . We saw an improvement in manuscript quality in favour of the additional review group ( comparison as allocated , 0.25 , 95 % confidence interval –0.05 to 0.54 ; as review ed , 0.33 , 0.03 to 0.63 ) . More papers with additional review s than with conventional review s alone improved from baseline ( 22 ( 43 % ) v eight ( 20 % ) , difference 23.6 % ( 3.2 % to 44.0 % ) , number needed to treat 4.2 ( from 2.3 to 31.2 ) , relative risk 2.21 ( 1.10 to 4.44 ) ) . Authors in the additional review group adhered more to suggestions from conventional review s than to those from additional review s ( average increase 0.43 Likert points ( 0.19 to 0.67 ) ) . Conclusions Additional review s based on reporting guidelines improve manuscript quality , although the observed effect was smaller than hypothesised and not definitively demonstrated . Authors adhere more to suggestions from conventional review s than to those from additional review s , showing difficulties in adhering to high method ological st and ards at the latest research phases . To boost paper quality and impact , authors should be aware of future requirements of reporting guidelines at the very beginning of their study . Trial registration and protocol Although registries do not include trials of peer review , the protocol design was su bmi tted to sponsored research projects ( Instituto de Salud Carlos III , PI081903 ) Abstract Fifty four r and omly selected farms , located throughout the North Isl and and the Nelson region of South Isl and , were surveyed for anthelmintic usage and for sheep nematodes resistant to anthelmintics . Information on anthelmintic usage was recorded on a st and ardized question naire . Most fanners had used both benzimidazole and non- benzimidazole broad spectrum drenches on their properties in previous years . Sheep were being drenched , on average , 7 times within their first year of life but much less frequently thereafter . Commercial interests played the dominant role in helping farmers formulate their drenching policies . On each farm 24 numbered ewe replacement lambs were sample d for faeces at the beginning of the trial to provide material for egg counts and larval cultures . The lambs were weighed and divided into three groups of eight . One group received thiabendazole ( TBZ ) at 66 mg/kg , the second levamisole ( LEV ) at 8mg/kg while the third remained untreated as controls . All were re sample d 4 to 10 da Forty-three r and omly selected farms located throughout South Isl and , excluding the Nelson region , were surveyed for anthelmintic usage and for sheep nematodes resistant to anthelmintics . Most farmers had used both benzimidazole and non-benzimidazole broad-spectrum drenches on their properties in previous years . Sheep were being drenched , on average , 5.6 times within their first year of life but much less frequently thereafter . Commercial interests played the dominant role in helping farmers formulate their drenching policies . On each farm 24 numbered ewe replacement lambs , born during the spring of 1980 , were sample d for faeces at the beginning of the trial to provide material for egg counts and larval cultures . The lambs were weighed and divided into three groups of eight . One group received thiabendazole ( TBZ ) at 66 mg/kg , the second levamisole ( LEV ) at 8 mg/kg while the third remained untreated as controls . All were re sample d 4 to 10 days later . On 32 ( 88 % ) of the 40 farms where drenching trials were successfully carried out during autumn 1981 , the faecal egg count depression ( FECD ) following treatment with either drench was 100 % . On one farm TBZ was less than 100 % effective as gauged by FECD . LEV proved to be less than 100 % effective on 7 farms . On one farm the FECD was less than 80 % , on 2 between 90 % and 95 % and on 4 between 95 % and 99 % OBJECTIVES To develop and vali date a new risk-of-bias tool for nonr and omized studies ( NRSs ) . STUDY DESIGN AND SETTING We developed the Risk of Bias Assessment Tool for Nonr and omized Studies ( RoBANS ) . A validation process with 39 NRSs examined the reliability ( interrater agreement ) , validity ( the degree of correlation between the overall assessment s of RoBANS and Method ological Index for Nonr and omized Studies [ MINORS ] , obtained by plotting the overall risk of bias relative to effect size and funding source ) , face validity with eight experts , and completion time for the RoBANS approach . RESULTS RoBANS contains six domains : the selection of participants , confounding variables , the measurement of exposure , the blinding of the outcome assessment s , incomplete outcome data , and selective outcome reporting . The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial . There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS . The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies . The mean time required to complete RoBANS was approximately 10 min . The external experts who were interviewed evaluated RoBANS as a " fair " assessment tool . CONCLUSIONS RoBANS shows moderate reliability , promising feasibility , and validity . The further refinement of this tool and larger validation studies are required This survey was conducted on 252 farms r and omly distributed over all the sheep raising areas in Uruguay . The study involved farms with more than 600 sheep , which represented 80 % of the total sheep population of the country . Three anthelmintic groups were assessed , namely , benzimidazoles , levamisole and avermectins . Overall , the results showed 80 % of sheep flocks had benzimidazole resistance , 71 % had resistance to levamisole , and 1.2 % of flocks showed resistance to avermectins . Approximately 28 % of farms had resistance to one anthelmintic group , 64 % to two anthelmintic groups , and 1 % resistance to all three groups . Only 7.5 % of farms had no detectable levels of anthelmintic resistance . More than 80 % of farms had Trichostrongylus population s resistant to both benzimidazoles and levamisole . Resistance was recorded in all three anthelmintic groups for Haemonchus and resistance also occurred to benzimidazoles and levamisole in Ostertagia Abstract AIM : To examine the effect of an anthelmintic treatment to lambs , followed immediately by a shift onto pastures with differing levels of larval contamination , on the development of anthelmintic resistance , in order to support recommendations to farmers regarding drench- and -shift practice s for sustainable worm control . METHODS : Newly weaned Romney lambs ( n=72 ) were dosed with third-stage infective larvae ( L3 ) of two nematode parasite species , Teladorsagia ( = Ostertagia ) circumcincta and Trichostrongylus colubriformis , comprising benzimidazole-resistant and -susceptible isolates , calculated to yield , after treatment with albendazole
Output:
| While there is abundant literature on the topic of AHR in sheep GINs , few studies have explicitly investigated the association between putative risk or protective factors and AHR . |
MS211737 | ***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 Female athletes have a higher risk of anterior cruciate ligament injury than their male counterparts who play at similar levels in sports involving pivoting and l and ing . Hypothesis The competitive female basketball players who participated in a sports injury prevention training program would show better muscle strength and flexibility and improved biomechanical properties associated with anterior cruciate ligament injury than during the pretraining period and than posttraining parameters in a control group . Study Design Controlled laboratory study . Methods A total of 22 high school female basketball players were recruited and r and omly divided into 2 groups ( the experimental group and the control group , 11 participants each ) . The experimental group was instructed in the 6 parts of the sports injury prevention training program and performed it during the first 20 minutes of team practice for the next 8 weeks , while the control group performed their regular training program . Both groups were tested with a rebound-jump task before and after the 8-week period . A total of 21 reflective markers were placed in preassigned positions . In this controlled laboratory study , a 2-way analysis of variance ( 2 × 2 ) experimental design was used for the statistical analysis ( P < .05 ) using the experimental group and a testing session as within and between factors , respectively . Post hoc tests with Sidak correction were used when significant factor effects and /or interactions were observed . Results A comparison of the experimental group 's pretraining and posttraining results identified training effects on all strength parameters ( P = .004 to .043 ) and on knee flexion , which reflects increased flexibility ( P = .022 ) . The experimental group showed higher knee flexion angles ( P = .024 ) , greater interknee distances ( P = .004 ) , lower hamstring-quadriceps ratios ( P = .023 ) , and lower maximum knee extension torques ( P = .043 ) after training . In the control group , no statistical differences were observed between pretraining and posttraining findings ( P = .084 to .873 ) . At pretraining , no significant differences were observed between the 2 groups for any parameter ( P = .067 to .784 ) . However , a comparison of the 2 groups after training revealed that the experimental group had significantly higher knee flexion angles ( P = .023 ) , greater knee distances ( P = .005 ) , lower hamstring-quadriceps ratios ( P = .021 ) , lower maximum knee extension torques ( P = .124 ) , and higher maximum knee abduction torques ( P = .043 ) than the control group . Conclusion The sports injury prevention training program improved the strength and flexibility of the competitive female basketball players tested and biomechanical properties associated with anterior cruciate ligament injury as compared with pretraining parameters and with posttraining parameters in the control group . Clinical Relevance This injury prevention program could potentially modify the flexibility , strength , and biomechanical properties associated with ACL injury and lower the athlete 's risk for injury Background : The causes of noncontact anterior cruciate ligament injury remain an enigma . Purpose : To prospect ively evaluate risk factors for noncontact anterior cruciate ligament injuries in a large population of young athletic people . Study Design : Prospect i ve cohort study . Methods : In 1995 , 1198 new United States Military Academy cadets underwent detailed testing and many parameters were documented . During their 4-year tenure , all anterior cruciate ligament injuries that occurred were identified . Statistical analyses were used to identify the factors that may have predisposed the cadets to noncontact anterior cruciate ligament injuries . Results : Among the 895 cadets who completed the entire 4-year study , there were 24 noncontact anterior cruciate ligament tears ( 16 in men , 8 in women ) . Significant risk factors included small femoral notch width , generalized joint laxity , and , in women , higher than normal body mass index and KT-2000 arthrometer values that were 1 st and ard deviation or more above the mean . The presence of more than one of these risk factors greatly increased the relative risk of injury . All female cadets who had some combination of risk factors sustained noncontact anterior cruciate ligament injuries , indicating that some combinations of factors are especially perilous to the female knee . Conclusion : Several risk factors may predispose young athletes to noncontact anterior cruciate ligament injury CONTEXT Improving neuromuscular control of hamstrings muscles might have implication s for decreasing anterior cruciate ligament injuries in females . OBJECTIVE To examine the effects of a 6-week agility training program on quadriceps and hamstrings muscle activation , knee flexion angles , and peak vertical ground reaction force . DESIGN Prospect i ve , r and omized clinical research trial . SETTING Sports medicine research laboratory . PATIENTS OR OTHER PARTICIPANTS Thirty female intramural basketball players with no history of knee injury ( age = 21.07 + /- 2.82 years , height = 171.27 + /- 4.66 cm , mass = 66.36 + /- 7.41 kg ) . INTERVENTION(S ) Participants were assigned to an agility training group or a control group that did not participate in agility training . Participants in the agility training group trained 4 times per week for 6 weeks . MAIN OUTCOME MEASURE(S ) We used surface electromyography to assess muscle activation for the rectus femoris , vastus medialis oblique , medial hamstrings , and lateral hamstrings for 50 milliseconds before initial ground contact and while the foot was in contact with the ground during a side-step pivot maneuver . Knee flexion angles ( at initial ground contact , maximum knee flexion , knee flexion displacement ) and peak vertical ground reaction force also were assessed during this maneuver . RESULTS Participants in the training group increased medial hamstrings activation during ground contact after the 6-week agility training program . Both groups decreased their vastus medialis oblique muscle activation during ground contact . Knee flexion angles and peak vertical ground reaction force did not change for either group . CONCLUSIONS Agility training improved medial hamstrings activity in female intramural basketball players during a side-step pivot maneuver . Agility training that improves hamstrings activity might have implication s for reducing anterior cruciate ligament sprain injury associated with side-step pivots Background : Anterior cruciate ligament ( ACL ) injuries are immediately disabling , costly , take a significant amount of time to rehabilitate , and are associated with an increased risk of developing posttraumatic osteoarthritis of the knee . Specific multiplanar movement patterns of the lower extremity , such as those associated with the drop vertical jump ( DVJ ) test , have been shown to be associated with an increased risk of suffering noncontact ACL injuries . The L and ing Error Scoring System ( LESS ) has been developed as a tool that can be applied to identify individuals who display at-risk movement patterns during the DVJ . Hypothesis : An increase in LESS score is associated with an increased risk of noncontact ACL injury . Study Design : Case-control study ; Level of evidence , 3 . Methods : Over a 3-year interval , 5047 high school and college participants performed preseason DVJ tests that were recorded using commercial video cameras . All participants were followed for ACL injury during their sports season , and video data from injured participants and matched controls were then assessed with the LESS . Conditional logistic regression analysis was used to examine the association between LESS score and ACL injury risk in all participants as well as subgroups of female , male , high school , and college participants . Results : There was no relationship between the risk of suffering ACL injury and LESS score whether measured as a continuous or a categorical variable . This was the case for all participants combined ( odds ratio , 1.04 per unit increase in LESS score ; 95 % confidence interval , 0.80 - 1.35 ) as well as within each subgroup ( odds ratio range , 0.99 - 1.14 ) . Conclusion : The LESS did not predict ACL injury in our cohort of high school and college athletes CONTEXT Anterior tibial shear force and knee valgus moment increase anterior cruciate ligament ( ACL ) loading . Muscle coactivation of the quadriceps and hamstrings influences anterior tibial shear force and knee valgus moment , thus potentially influencing ACL loading and injury risk . Therefore , identifying exercises that facilitate balanced activation of the quadriceps and hamstrings might be beneficial in ACL injury rehabilitation and prevention . OBJECTIVE To quantify and compare quadriceps with hamstrings coactivation electromyographic ( EMG ) ratios during commonly used closed kinetic chain exercises . DESIGN Cross-sectional study . SETTING Research laboratory . PATIENTS OR OTHER PARTICIPANTS Twenty-seven healthy , physically active volunteers ( 12 men , 15 women ; age = 22.1 ± 3.1 years , height = 171.4 ± 10 cm , mass = 72.4 ± 16.7 kg ) . INTERVENTION(S ) Participants completed 9 separate closed chain therapeutic exercises in a r and omized order . MAIN OUTCOME MEASURE(S ) Surface electromyography quantified the activity level of the vastus medialis ( VM ) , vastus lateralis ( VL ) , medial hamstrings ( MH ) , and biceps femoris ( BF ) muscles . The quadriceps-to-hamstrings ( Q : H ) coactivation ratio was computed as the sum of average quadriceps ( VM , VL ) EMG amplitude divided by the sum of average hamstrings ( MH , BF ) EMG amplitude for each trial . We used repeated- measures analyses of variance to compare Q : H ratios and individual muscle contributions across exercises ( α = .05 ) , then used post hoc Tukey analyses . RESULTS We observed a main effect for exercise ( F(3,79 ) = 22.6 , P < .001 ) . The post hoc Tukey analyses revealed smaller Q : H ratios during the single-limb dead lift ( 2.87 ± 1.77 ) than the single-limb squat ( 5.52 ± 2.89 ) exercise . The largest Q : H ratios were observed during the transverse-lunge ( 7.78 ± 5.51 , P < .001 ) , lateral-lunge ( 9.30 ± 5.53 , P < .001 ) , and forward-lunge ( 9.70 ± 5.90 , P < .001 ) exercises . CONCLUSIONS The most balanced ( smallest ) coactivation ratios were observed during the single-limb dead-lift , lateral-hop , transverse-hop , and lateral b and -walk exercises . These exercises potentially could facilitate balanced activation in ACL rehabilitation and injury-prevention programs . They also could be used in postinjury rehabilitation programs in a safe and progressive manner BACKGROUND The purpose of this study was to determine whether current post-operative rehabilitation protocol s return the strength of the contralateral uninjured limb knee flexors and extensors after an anterior cruciate ligament ( ACL ) reconstruction to those of an uninjured control group . METHODS Subjects with a hamstring tendon ACL reconstruction ( n=12 ) were compared to an active control group ( n=30 ) . Comprehensive bilateral knee flexor and extensor isovelocity strength testing was performed ( five speeds , 5 - 95 degrees , concentric and eccentric contractions ) . FINDINGS After hamstring tendon ACL reconstruction and rehabilitation , bilateral strength normalization ( within 10 % of the contralateral limb ) is achieved by the knee extensors but not the knee flexors . When compared to the uninjured control group , large and statistically significant strength deficits were demonstrated in the knee extensors and knee flexors of both the anterior cruciate ligament reconstructed ( extensors 24.8 % ; flexors 26.8 % ) and the contralateral uninjured ( extensors 21 % ; flexors 13.5 % ) limbs . INTERPRETATION These findings suggest that improvement can be made in knee flexor rehabilitation after ACL reconstruction and limit the validity of the use of a contralateral leg as a rehabilitation endpoint or as a control in the ACL reconstructed population Objective : To determine the association of quadriceps and hamstrings strength to anterior cruciate ligament ( ACL ) injury risk in female athletes . The primary hypothesis was that there would be decreased knee flexor and increased knee extensor strength in female athletes who went on to ACL injured status ( FACL ) compared to uninjured female ( FC ) and male ( MC ) control subjects . Study Design : Matched case control . Setting : Institutional Biomechanics Laboratory . Participants : Prospect ively measured FACL ( n = 22 ) female athletes who subsequently suffered confirmed noncontact ACL ruptures ( 16 during soccer and 6 during basketball play ) were matched ( 1:4 ratio ) to female controls ( FC ; n = 88 ) using limb ( dominant or nondominant ) , pubertal status , sport , and nearest height and mass . In addition , male controls ( MC ) were matched ( 1:1 ratio ) to FACL to serve as a secondary comparative control . Assessment of Risk Factors : Isokinetic ( concentric ) knee extension/flexion strength ( 300 degrees/s ) . Results : FACL subjects had decreased hamstrings strength compared to MC ( 15 % ; 95 % CI , 1 to 27 % ; P = 0.04 ) . FC were not different from MC in hamstrings strength . Conversely , FACL subjects did not differ compared to the MC in quadriceps strength , and the FC demonstrated decreased quadriceps strength relative to MC ( 10 % ; 95 % CI , 3 to 18 % ; P = 0.01 ) . Conclusions : The results of this investigation indicate that female athletes who suffered ACL injury subsequent to strength testing had a combination of decreased hamstrings strength but not quadriceps strength compared to males . In direct contrast , female athletes who did not go on
Output:
| Three of which looked into muscular capacity and one looked into muscular activation patterns but none of the studies found strong evidence of how muscular capacity or muscular activation deficits are a risk factor for a primary non-contact ACL injury . |
MS211738 | ***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 This pivotal phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting ( CINV ) following highly emetogenic chemotherapy ( HEC ) . PATIENTS AND METHODS Patients were r and omized to a single intravenous dose of palonosetron 0.25 mg or 0.75 mg , or ondansetron 32 mg prior to HEC . Dexamethasone pre-treatment ( with stratification ) was used at investigator discretion . The primary efficacy endpoint was the proportion of patients with complete response ( CR ) during the first 24 h post-chemotherapy ( acute phase ) . RESULTS In the intent-to-treat analysis ( n = 667 ) , palonosetron 0.25 mg and 0.75 mg were at least as effective as ondansetron in preventing acute CINV ( 59.2 % , 65.5 % , and 57.0 % CR rates , respectively ) ; CR rates were slightly higher with palonosetron than ondansetron during the delayed ( 24 - 120 h ) and overall ( 0 - 120 h ) phases . Two thirds of patients ( n = 447 ) received concomitant dexamethasone . Patients pre-treated with palonosetron 0.25 mg plus dexamethasone had significantly higher CR rates than those receiving ondansetron plus dexamethasone during the delayed ( 42.0 % versus 28.6 % ) and overall ( 40.7 % versus 25.2 % ) phases . Palonosetron and ondansetron were well tolerated . CONCLUSIONS Single-dose palonosetron was as effective as ondansetron in preventing acute CINV following HEC , and with dexamethasone pre-treatment , its effectiveness was significantly increased over ondansetron throughout the 5-day post-chemotherapy period Although elderly patients have been reported to be less prone to chemotherapy-induced nausea and vomiting ( CINV ) , its management is complicated by a high frequency of comorbidities and polypharmacy and an increased risk of dehydration and impaired cognition . The comparative efficacy and tolerability of palonosetron and ondansetron/dolasetron were assessed in a retrospective post hoc analysis using pooled data from 171 elderly patients ( age > or = 65 years ) with cancer enrolled in two r and omized , double-blind , phase III clinical studies comparing single IV doses of these antiemetic agents given prior to receipt of moderately emetogenic chemotherapy . The complete response rate during the postchemotherapy period was significantly higher in the palonosetron group than in the ondansetron/dolasetron group in the 5 days following chemotherapy . The proportion of patients who were nausea-free on the problematic days 2 and 3 post chemotherapy and the time to treatment failure also significantly favored palonosetron . In this population that included patients with pre-existing comorbidities , palonosetron was well tolerated , with similar or fewer adverse events than the comparators . Comparisons in electrocardiogram parameters revealed that the mean postdose change from baseline in QTc interval was 3 ms for palonosetron 0.25 mg and 5 ms for ondansetron/dolasetron . In this retrospective analysis , palonosetron provided superior efficacy to ondansetron/dolasetron for the treatment of CINV in elderly patients receiving moderately emetogenic chemotherapy . Based on its safety profile , antiemetic control , and convenient dosing , palonosetron can be recommended for use in elderly patients with cancer receiving emetogenic chemotherapy BACKGROUND The localization of substance P in brain-stem regions associated with vomiting , and the results of studies in ferrets , led us to postulate that a neurokinin-1-receptor antagonist would be an antiemetic in patients receiving anticancer chemotherapy . METHODS In a multicenter , double-blind , placebo-controlled trial involving 159 patients who had not previously received cisplatin , we evaluated the prevention of acute emesis ( occurring within 24 hours ) and delayed emesis ( on days 2 to 5 ) after a single dose of cisplatin therapy ( 70 mg or more per square meter of body-surface area ) . Before receiving cisplatin , all the patients received granisetron ( 10 microg per kilogram of body weight intravenously ) and dexamethasone ( 20 mg orally ) . The patients were r and omly assigned to one of three treatments in addition to granisetron and dexamethasone : 400 mg of an oral trisubstituted morpholine acetal ( also known as L-754,030 ) before cisplatin and 300 mg on days 2 to 5 ( group 1 ) , 400 mg of L-754,030 before cisplatin and placebo on days 2 to 5 ( group 2 ) , or placebo before cisplatin and placebo on days 2 to 5 ( group 3 ) . Additional medication was available at any time to treat occurrences of vomiting or nausea . RESULTS In the acute-emesis phase , 93 percent of the patients in groups 1 and 2 combined and 67 percent of those in group 3 had no vomiting ( P<0.001 ) . In the delayed-emesis phase , 82 percent of the patients in group 1 , 78 percent of those in group 2 , and 33 percent of those in group 3 had no vomiting ( P<0.001 for the comparison between group 1 or 2 and group 3 ) . The median nausea score in the delayed-emesis phase was significantly lower in group 1 than in group 3 ( P=0.003 ) . No serious adverse events were attributed to L-754,030 . CONCLUSIONS The neurokinin-1-receptor antagonist L-754,030 prevents delayed emesis after treatment with cisplatin . Moreover , combining L-754,030 with granisetron plus dexamethasone improves the prevention of acute emesis Palonosetron , a highly selective and potent 5‐HT3 receptor antagonist with a strong binding affinity and a long plasma elimination half‐life ( approximately 40 hours ) , has shown efficacy in Phase II trials in preventing chemotherapy‐induced nausea and vomiting ( CINV ) result ing from highly emetogenic chemotherapy . The current Phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed CINV after moderately emetogenic chemotherapy As professionals , we want to use the best treatments ; as patients , we want to be given them . Knowing whether an intervention works ( or does not work ) is fundamental to clinical decision making . However , clinical decision making involves more than simply taking published results of research directly to the bedside . Physicians need to consider how similar their patients are to those in the published studies , to take the values and preferences of their patients into account , and to consider their own experience with a given test or treatment . Evidence from clinical research is becoming increasingly important in medical- practice decisions as more and better evidence is published . But when is the evidence strong enough to justify changing a practice ? Individual studies that involve only small numbers of patients may have results that are distorted by the r and om play of chance and thus lead to less than optimal decisions . As is clear from other papers in this series , systematic review s identify , critically appraise , and review all the relevant studies on a clinical question and are more likely to give a valid answer . They use explicit methods and quality st and ards to reduce bias . Their results are the closest we can come to reaching the truth given our current state of knowledge . The questions about an intervention that a systematic review should answer are the following : 1 . Does it work ? 2 . If it works , how well does it work in general and compared with placebo , no treatment , or other interventions that are currently in use ? 3 . Is it safe ? 4 . Will it be safe and effective for my patients ? Whereas the critical appraisal and qualitative synthesis provided by review articles can be interpreted directly , the numerical products of quantitative review s can be more difficult to underst and and apply in daily clinical practice . This paper provides guidance on how to interpret the numerical and statistical results of systematic review s , translate these results into more underst and able terms , and apply them directly to individual patients . Many of these principles can also be used to interpret the numerical results of individual clinical studies . They are particularly relevant to systematic review s , however , because such review s contain more information than do primary studies and often exert greater influence than do individual studies . Making Sense of the Numerical Results of Clinical Studies Although the results of clinical studies can be expressed in intuitively meaningful ways , such results do not always easily translate into clinical decision making . For example , results are frequently expressed in terms of risk , which is an expression of the frequency of a given outcome . ( Risks are probabilities , which can vary between 0.0 and 1.0 . A probability of 0.0 means that the event will never happen , and a probability of 1.0 means that it always happens . ) Consider a hypothetical study of the recurrence of migraine headaches in a control group receiving placebo and a treatment group receiving a new antimigraine preparation , drug M ( a secondary prevention trial ) . Suppose that at the end of the trial , migraines recurred in 30 % of the control group ( the risk for recurrence was 0.30 ) but in only 5 % of the drug M group ( risk of 0.05 ) ( Table 1 ) . Table 1 . Numerical Expression of Hypothetical Clinical Trial Results The outcomes of the study are clear enough for the two groups when they are examined separately . But clinicians and patients are more interested in the comparative results , that is , the outcome in one group relative to the outcome in the other group . This overall ( comparative ) result can be expressed in various ways . For example , the relative risk , which is the risk in the treatment group relative to that in the control group , is simply the ratio of the risks in the two groups . In other words , relative risk is the risk in the treatment group divided by that in the control group , 0.05 0.30 , or 0.17 . The comparison can also be expressed as the reduction in relative risk , which is the ratio between the decrease in risk ( in the treatment group ) and the risk in the control group , 0.25 0.30 , or 0.83 ( Table 1 ) . ( The relative risk reduction can also be calculated as 1 relative risk ) . Although the clinical meaning of relative risk ( and relative risk reduction ) is reasonably clear , relative risk has the distinct disadvantage that a given value ( for example , 0.17 ) is the same whether the risk with treatment decreases from 0.80 to 0.14 , from 0.30 to 0.05 , from 0.001 to 0.00017 , and so forth . The clinical implication s of these changes clearly differ from one another enormously and depend on the specific disease and intervention . An important alternate expression of comparative results , therefore , is the absolute risk reduction . Absolute risk reduction is determined by subtracting the risk in one group from the risk in the other ( for example , the risk in the treatment group is subtracted from the risk in the placebo group ) . In the case of our migraine study , the absolute risk reduction would be 0.30 0.05 , which equals 0.25 , or 25 percentage points . In contrast , for a study in which the risk decreased from 0.001 to 0.00017 , the absolute risk reduction would be only 0.00083 , or 0.083 percentage points , which is a trivial change in comparison ( Table 1 ) . This arithmetic emphasizes the difficulty of expressing the results of clinical studies in meaningful ways . Relative risk and relative risk reduction clearly give a quantitative sense of the effects of an intervention in proportional terms but provide no clue about the size of an effect on an absolute scale . In contrast , although it tells less about proportional effects , absolute risk says a great deal about whether an effect is likely to be clinical ly meaningful . Despite this benefit , even absolute risk is problematic because it is a dimensionless , abstract number ; that is , it lacks a direct connection with the clinical situation in which the patient and physician exist . However , another way of expressing clinical research results can provide that clinical link : the number needed to treat ( NNT ) . Number Needed To Treat The NNT for a given therapy is simply the reciprocal of the absolute risk reduction for that treatment [ 1 , 2 ] . In the case of our hypothetical migraine study ( in which risk decreased from 0.30 without treatment with drug M to 0.05 with treatment with drug M , for a relative risk of 0.17 , a relative risk reduction of 0.83 , and an absolute risk reduction of 0.25 ) , the NNT would be 1 0.25 , or 4 . In concrete clinical terms , an NNT of 4 means that you would need to treat four patients with drug M to prevent migraine from recurring in one patient . To emphasize the difference between the concepts embodied in NNT and relative risk , recall the various situations mentioned above , in all of which the relative risk was 0.17 but in which the absolute risk decreased from 0.80 to 0.14 in one case and from 0.001 to 0.00017 in another . Note that the corresponding NNTs in these two other cases are 1.5 and 1204 , respectively : that is , you would need to treat 1.5 and 1204 patients to obtain a therapeutic result in these two situations compared with 4 patients with drug M ( Table 1 ) . The NNT can be calculated easily and kept as a single numerical reminder of the effectiveness ( or , as we will see , the potential for harm ) of a particular therapy . As we suggested , the NNT has the crucial advantage of direct applicability to clinical practice because it shows the effort that is required to achieve a particular
Output:
| Patients receiving PAL presented less nausea and vomiting regardless of the use of corticoids .
Conclusion PAL was more effective than the other 5-HT3R in preventing acute and delayed CINV in patients receiving MoHE treatments , regardless of the use of concomitant corticosteroids |
MS211739 | ***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 This paper aims to describe factors associated with HIV sero-status in young , rural South African women and the relationship between intimate partner violence ( IPV ) and HIV . METHODS A total of 1295 sexually active female volunteers , aged 15 - 26 , from 70 villages were recruited to participate in a cluster r and omized controlled trial of an HIV behavioural intervention . The main measures were HIV sero-status , and IPV and sexual practice s measured using a question naire administered during baseline interviews . RESULTS About 12.4 % of women had HIV and 26.6 % had experienced more than one episode of physical or sexual IPV . After adjusting for age , HIV infection was associated with having three or more past year partners [ odds ratio ( OR ) 2.39 ; 95 % confidence interval ( 95 % CI ) 1.48 - 3.85 ] , sex in past 3 months ( OR 3.33 ; 95 % CI 1.87 - 5.94 ) , a partner three or more years older ( OR 1.69 ; 95 % CI 1.16 - 2.48 ) , and a more educated partner ( OR 1.91 ; 95 % CI 1.30 - 2.78 ) . IPV was associated with HIV in two-way analyses ( OR 1.56 ; 95 % CI 1.08 - 2.23 ) , but the effect was non-significant after adjusting for HIV risk behaviours . The experience of IPV was strongly associated with past year partner numbers , time of last sex , and partner 's education ; it was also marginally associated with partner age difference . Adverse experiences in childhood , including sexual abuse , increased the likelihood of having more past year partners ( OR 1.43 ; 95 % CI 1.21 - 1.69 ) . CONCLUSIONS IPV was strongly associated with most of the identified HIV risk factors . Our findings provide further evidence of links between IPV and HIV among women and the importance of joint prevention Objective To assess the impact of Stepping Stones , a HIV prevention programme , on incidence of HIV and herpes simplex type 2 ( HSV-2 ) and sexual behaviour . Design Cluster r and omised controlled trial . Setting 70 villages ( clusters ) in the Eastern Cape province of South Africa . Participants 1360 men and 1416 women aged 15 - 26 years , who were mostly attending schools . Intervention Stepping Stones , a 50 hour programme , aims to improve sexual health by using participatory learning approaches to build knowledge , risk awareness , and communication skills and to stimulate critical reflection . Villages were r and omised to receive either this or a three hour intervention on HIV and safer sex . Interviewers administered question naires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2 . Main outcome measures Primary outcome measure : incidence of HIV . Other outcomes : incidence of HSV-2 , unwanted pregnancy , reported sexual practice s , depression , and substance misuse . Results There was no evidence that Stepping Stones lowered the incidence of HIV ( adjusted incidence rate ratio 0.95 , 95 % confidence interval 0.67 to 1.35 ) . The programme was associated with a reduction of about 33 % in the incidence of HSV-2 ( 0.67 , 0.46 to 0.97 ; P=0.036)—that is , Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 ( 1.6 to 68.2 ) per 1000 people exposed . Stepping Stones significantly improved a number of reported risk behaviours in men , with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months . In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months . Conclusion Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV — notably , HSV-2 and perpetration of intimate partner violence . Trial Registration Clinical Trials NCT00332878 OBJECTIVE To describe factors associated with HIV infection in men aged 15 - 26 years . SETTING Rural Eastern Cape Province , South Africa . SAMPLE A total of 1277 sexually experienced Xhosa male volunteers from 70 villages participating in a cluster r and omized controlled trial of an HIV behavioural intervention . Xhosas circumcise during manhood initiation rituals . DESIGN Cross-sectional , analysis of the study 's baseline interviews . MAIN MEASURE HIV sero-status , sexual practice s measured with an interviewer-administered question naire . RESULTS About 2 % of the men were HIV positive . A logistic regression model showed HIV positivity to be associated with age ( OR 1.55 ; 95%CI 1.22 - 1.95 ) , having made a woman pregnant ( OR 2.93 ; 95 % CI 1.28 - 6.68 ) , having been circumcised ( OR 0.40 ; 95 % CI 0.16 - 0.98 ) , and having had sex with a man ( OR 3.61 ; 95 % CI 1.0 - 13.0 ) . CONCLUSIONS Our findings provide further evidence to suggest that circumcision is protective . There was much heterosexual risk taking among men but only pregnancy ( with its association with sexual frequency ) predicted HIV sero-positivity . Although relatively rare , same-sex sexual experiences were a risk factor . Male-male sexual contact is rarely assessed in HIV research in Africa and almost never addressed in general HIV prevention programming . Our findings suggest that it should be given more attention BACKGROUND Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women . We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women . METHODS In this cluster r and omised trial , never-married women aged 13 - 22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and r and omly assigned with computer-generated r and om numbers by enumeration area ( 1:1 ) to receive cash payments ( intervention group ) or nothing ( control group ) . Intervention enumeration areas were further r and omly assigned with computer-generated r and om numbers to conditional ( school attendance required to receive payment ) and unconditional ( no requirements to receive payment ) groups . Participants in both intervention groups were r and omly assigned by a lottery to receive monthly payments ranging from US$ 1 to $ 5 , while their parents were independently assigned with computer-generated r and om numbers to receive $ 4 - 10 . Behavioural risk assessment s were done at baseline and 12 months ; serology was tested at 18 months . Participants were not masked to treatment status but counsellors doing the serologic testing were . The primary outcomes were prevalence of HIV and herpes simplex virus 2 ( HSV-2 ) at 18 months and were assessed by intention-to-treat analyses . The trial is registered , number NCT01333826 . FINDINGS 88 enumeration areas were assigned to receive the intervention and 88 as controls . For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data , weighted HIV prevalence at 18 month follow-up was 1·2 % ( seven of 490 participants ) in the combined intervention group versus 3·0 % ( 17 of 799 participants ) in the control group ( adjusted odds ratio [ OR ] 0·36 , 95 % CI 0·14 - 0·91 ) ; weighted HSV-2 prevalence was 0·7 % ( five of 488 participants ) versus 3·0 % ( 27 of 796 participants ; adjusted OR 0·24 , 0·09 - 0·65 ) . In the intervention group , we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence ( 3/235 [ 1 % ] vs 4/255 [ 2 % ] ) or weighted HSV-2 prevalence ( 4/233 [ 1 % ] vs 1/255 [ < 1 % ] ) . For individuals who had already dropped out of school at baseline , we detected no significant difference between intervention and control groups for weighted HIV prevalence ( 23/210 [ 10 % ] vs 17/207 [ 8 % ] ) or weighted HSV-2 prevalence ( 17/211 [ 8 % ] vs 17/208 [ 8 % ] ) . INTERPRETATION Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income setting s. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies . FUNDING Global Development Network , Bill & Melinda Gates Foundation , National Bureau of Economic Research Africa Project , World Bank 's Research Support Budget , and several World Bank trust funds ( Gender Action Plan , Knowledge for Change Program , and Spanish Impact Evaluation fund ) Background : Incidence data from prospect i ve cohort studies using rigorous laboratory methods are important in design ing and evaluating HIV vaccine and therapeutic clinical trials and health care programs . We report 36-month HIV-1 incidence rates and demographic and psychosocial risks from the Kericho cohort in rural Kenya 's southern Rift Valley Province . Methods : Thirty-six month , prospect i ve , closed , observational cohort study of adult plantation workers and dependents followed biannually . HIV-1 incidence rates per 100 person-years ( py ) were calculated , and Cox regression analyses were used to estimate hazards ratios ( HR ) associated with seroconversion . Results : Two thous and four hundred volunteers ( mean age ± SD = 30.1 ± 8.5 years ; 36.5 % women ) participated . Twenty-nine new HIV cases were identified in year 1 of follow-up , which increased to cumulative totals of 49 and 63 cases in years 2 and 3 , respectively . The corresponding 1- , 2- , and 3-year incidence rates were 1.41 [ 95 % confidence interval ( CI ) = 0.95 - 2.02 ] , 1.16 ( 95 % CI = 0.86 - 1.54 ) , and 1.00 ( 95 % CI = 0.77 - 1.28 ) per 100 py . Risk factors associated with HIV seroconversion included the following : of the Luo tribe ( HR = 3.31 ; 95 % CI = 1.65 - 6.63 ) , marriage more than once ( HR = 2.83 ; 95 % CI = 1.20 - 6.69 ) , self-reported male circumcision ( HR = 0.32 ; 95 % CI = 0.17 - 0.60 ) , history of sexually transmitted infection ( HR = 2.40 ; 95 % CI = 1.09 - 5.26 ) , history of substance abuse during sex ( HR = 2.44 ; 95 % CI = 1.16 - 5.13 ) , and history of transactional sex ( HR = 3.30 ; 95 % CI = 1.79 - 6.09 ) . Conclusions : HIV-1 incidence rates were relatively low in adult plantation workers and dependents in rural Kenya . Cohorts including higher risk population s ( eg , commercial sex workers ) warrant consideration for regional HIV preventive vaccine trials . Even low incidence , well-described cohorts generate valuable epidemiological clinical trial data Objective : To identify and describe population s at risk for HIV in 3 clinical research centers in Kenya and South Africa . Design : Prospect i ve cohort study . Methods : Volunteers reporting recent sexual activity , multiple partners , transactional sex , sex with an HIV-positive partner , or , if male , sex with men ( MSM ; in Kenya only ) were enrolled . Sexually active minors were enrolled in South Africa only . Risk behavior , HIV testing , and clinical data were obtained at follow-up visits . Results : From 2005 to 2008 , 3023 volunteers were screened , 2113 enrolled , and 1834 contributed data on HIV incidence . MSM had the highest HIV incidence rate of 6.8 cases per 100 person-years [ 95 % confidence interval ( CI ) : 4.9 to 9.2 ] followed by women in Kilifi and Cape Town ( 2.7 cases per 100 person-years , 95 % CI : 1.7 to 4.2 ) . No seroconversions were observed in Nairobi women or men in Nairobi or Cape Town who were not MSM . In 327 MSM , predictors of HIV acquisition included report of genital ulcer ( Hazard Ratio : 4.5 , 95 % CI : 1.7 to 11.6 ) , not completing secondary school education ( HR : 3.4 , 95 % CI : 1.6 to 7.2 ) and reporting receptive anal intercourse ( HR : 8.2 , 95 % CI : 2.7 to 25.0 ) . Paying for sex was inversely associated with HIV infection ( HR : 0.2 , 95 % CI : 0.04 to 0.8 ) . 279 ( 13.0 % ) volunteers did not return after the first visit ; subsequent attrition rates ranged from 10.4 to 21.8 volunteers per 10
Output:
| Conclusions Transactional sex is associated with HIV among women , whereas findings for men were inconclusive . |
MS211740 | ***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: Sixty patients with moderate and severe burns were r and omly assigned to receive topical silver sulfadiazine ( SSD ) alone ( n=30 ) or SSD combined with cerium nitrate ( SSD-CN ) ( n=30 ) . There were four deaths in the SSD group and one in the SSD-CN group ; more patients with higher risk severity survived in the SSD-CN group . Wound infection did not differ significantly between the groups . The rate of re-epithelialization of partial thickness burns was faster by 8 days in the SSD-CN group . The relatively dry shell-like eschar of the SSD-CN-treated burn allowed planned excisions with immediate autologous grafting and the tissue beneath was ready to accept grafting 11 days earlier than in the SSD group ( p=0.03 ) . This result ed in a significantly shorter hospital stay for those in the SSD-CN group than in the SSD group ( 23.3 vs. 30.7 days ; p=0.03 ) with consequent cost savings . A higher incidence of transient stinging pain was reported with application of SSD-CN , but this was effectively managed with analgesics where necessary . The results of this study confirm the greater efficacy of SSD-CN in the treatment of burns patients Burn injury is associated with a high incidence of death and disability ; yet , its management remains problematic and costly . We conducted this clinical study to evaluate the efficacy of honey in the treatment of superficial and partial-thickness burns covering less than 40 % of body surface area and compared its results with those of silver sulphadiazine ( SSD ) . In this r and omised comparative clinical trial , carried out Burn Center of POF Hospital , Wah Cantt , Pakistan , from May 2007 to February 2008 , 150 patients of all ages having similar types of superficial and partial-thickness burns at two sites on different parts of body were included . Each patient had one burn site treated with honey and one treated with topical SSD , r and omly . The rate of re-epithelialization and healing of superficial and partial-thickness burns was significantly faster in the sites treated with honey than in the sites treated with SSD ( 13·47 ± 4·06 versus 15·62 ± 4·40 days , respectively : P < 0·0001 ) . The site treated with honey healed completely in less than 21 days versus 24 days for the site treated with SSD . Six patients had positive culture for Pseudomonas aeroginsa in honey-treated site , whereas 27 patients had positive culture in SSD-treated site . The results clearly showed greater efficacy of honey over SSD cream for treating superficial and partial-thickness burns The present paper reports the results of clinical and laboratory tests carried out on two homogeneous groups of ten burn patients subjected to local therapy , either with isotonic chloroxidating solution Amuchina * or with 1 % silver sulfadiazine cream at the Burns Centre of the Pisa University Dermatological Clinic . The local systemic behaviour of the patients examined was evaluated for the containment of septic complications at the burn site . In the group subjected to treatment with chloroxidating solution , sepsis appeared to have a lower incidence in the evolution of dermatitis in the phase of escharolysis , in the formation of granulation tissue , and in the attachment of cutaneous grafts . The systemic involvement ( temperature curve , etc . ) appeared to be more marked for some patients treated with silver sulfadiazine in response to septic aggression of the burn wounds . On the basis of data referring to the development of the wound granulation and the temperature curve , as well as the microbial presence and the subjective tolerance of the medication , the comparison was favourable , making all necessary allowances , to topical treatment with electrolytic chloroxidating solution ; other comparative data were at the limit of significance OBJECTIVE To evaluate the therapeutic effect of silver nitrate ointment on partial-thickness burn wounds , and observe its side-effects . METHODS Multi-center , r and omized , positive drug paralleled self-controlled trial was carried out . Eighty patients with superficial partial-thickness burns , and 40 with deep-partial thickness burns were r and omized into AgNO3 group and SD-Ag group according to drug topically applied to the wounds . The wound healing time , wound healing rate and bacterial culture of the wound , the effect and safety of the drug , as well as drug irritation to the wounds were studied in these two groups . RESULTS For the patients with superficial partial-thickness burn wounds , the wound healing time in silver nitrate group was ( 9.5 + /- 2.7 ) days , which was obviously shorter than that in SD-Ag group [ ( 10.8 + /- 3.4 ) days , P < 0.01 ] . The wound healing rate in silver nitrate group on 7 post-burn day ( PBD ) was ( 77.9 + /- 20.5)% , which was obviously higher than that in SD-Ag group [ ( 67.3 + /- 22.6 ) % , P < 0.01 ] . For those with deep-partial thickness burn wounds , the wound healing time in silver nitrate group was ( 21.5 + /- 4.8 ) days , which was evidently shorter than that in SD-Ag group [ ( 23.3 + /- 6.4 ) days , P < 0.01 ] . The wound healing rate in silver nitrate group on 20 PBD was ( 86.6 + /- 15.9)% , which was evidently higher than that in SD-Ag group [ ( 78.5 + /- 17.7)% , P < 0.01 ] . Silver nitrate ointment has the same antibacterial effect as 1 % SD-Ag cream , but it was less painful when applied to the open wounds . CONCLUSION Silver nitrate ointment is an effective and safe medicament for the clinical management of partial-thickness burn wounds Due to the limited re sources for the management of burns in most regions of Africa there is a significant role for many aspects of traditional African medicine . The active component of many traditional preparations is often of plant origin and more than 25 plants have been described as useful in relations to burns and wound healing . Carica papaya is currently used in The Gambia at the Royal Victoria Hospital , Banjul in the Paediatric Unit as the major component of burns dressings , where it is well tolerated by the children . Cheap and widely available , the pulp of the papaya fruit is mashed and applied daily to full thickness and infected burns . It appears to be effective in desloughing necrotic tissue , preventing burn wound infection , and providing a granulating wound suitable for the application of a split thickness skin graft . Possible mechanisms of action include the activity of proteolytic enzymes chymopapain and papain , as well as an antimicrobial activity , although further studies are required We prospect ively studied 52 consecutive patients who were treated by early tangential excision and grafting following thermal injury . The usefulness of two topical antimicrobial agents—0.5 % silver nitrate ( Ag ) and neomycin ( 1 gm/liter ) plus bacitracin ( 50,000 units/liter ) (NB)—was compared with the effectiveness of Ringer 's lactate ( RL ) for prevention of autogenous skin-graft loss due to infection . Graft loss of 10 percent or more occurred in 17 patients ( 33 percent)—due to infection in 16 . Skin-graft loss was a minor problem in patients with less than 20 percent total body surface area ( TBSA ) burn ( Ag : 0 of 6 , NB : 1 of 6 , RL : 1 of 5 ) . The use of either antimicrobial ( Ag or NB ) result ed in less graft loss ( 1 of 14 ) than RL ( 4 of 6 ; p < 0.05 ) in the 20 to 40 percent TBSA burn group . Large burns ( > 40 percent ) had a very high incidence of at least 10 percent graft loss ( 67 percent ) regardless of treatment . Infection in the area of graft loss was caused by antibiotic-resistant organisms or yeast in 50 percent of the Ringer 's lactate group and the entire neomycin plus bacitracin group . No graft infections were caused by resistant organisms or yeast in the silver nitrate group . This study demonstrates that topical antimicrobial agents reduce infection-related skin-graft loss in patients with medium-sized ( 20 to 40 percent TBSA ) burns and that neomycin plus bacitracin is associated with rapid emergence of drug-resistant organisms whereas silver nitrate is not
Output:
| The evidence found in our review does not support differences in efficacy of topical agents to reduce sepsis and /or local infections in burn patients |
MS211741 | ***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 short-term and long-term beneficial effects of early coronary revascularization by primary PTCA or thrombolytic therapy have been established for acute myocardial infa rct ion , thrombolytic therapy > 24 hours after the onset of acute myocardial infa rct ion has not been shown to improve clinical outcome . The purpose of this study was to assess the effect of late revascularization by primary PTCA over a 5-year period . METHODS AND RESULTS Eighty-three patients with initial Q-wave anterior myocardial infa rct ion > 24 hours after onset were r and omized into a PTCA group ( n=44 ) and a no-PTCA group ( n=39 ) . Long-term follow-up was conducted with regard to end points , which included cardiac death , nonfatal recurrence of myocardial infa rct ion , and development of congestive heart failure . Left ventricular ejection fraction and regional wall motion at 6 months after myocardial infa rct ion were similar in the 2 groups . Left ventricular end-diastolic and end-systolic volume indexes were significantly smaller in the PTCA group than in the no-PTCA group ( P<0.0001 ) . With cardiac events as end points , a 5-year Kaplan-Meier event-free survival analysis revealed that the no-PTCA group had a worse prognosis than the PTCA group ( P<0.0001 ) . Patency of the infa rct -related artery , left ventricular ejection fraction , end-diastolic volume index , and end-systolic volume index were significantly associated with cardiac events by a Cox proportional hazards analysis ( hazard ratios 0.120 , 0.845 , 1.065 , and 1.164 , respectively ) . CONCLUSIONS In initial Q-wave anterior myocardial infa rct ion , we conclude that even with late reperfusion , PTCA had beneficial effects on cardiac events over the 5-year period after myocardial infa rct ion , with the prevention of left ventricular dilation after myocardial infa rct ion being a possible mechanism Background After thrombolytic therapy for patients with acute myocardial infa rct ion ( MI ) , percutaneous transluminal coronary angioplasty ( PTCA ) is frequently performed because of the presence of a “ significant ” infa rct vessel stenosis demonstrated at predischarge coronary angiography . Several studies have shown PTCA performed early after thrombolysis to be unnecessary or even harmful . However , PTCA in these trials was generally performed 1–3 days after MI , when the milieu in the infa rct artery may be unsuited for PTCA , and the incidence of major ischemic complications was high . To date , no trial has assessed whether delayed PTCA ( 4–14 days ) should be performed in patients without evidence of ischemia on stress testing . Methods and Results To test the hypothesis that delayed PTCA might provide clinical benefit compared with medical therapy alone , 87 patients treated within 6 hours of chest pain onset with thrombolytic therapy and with negative functional test were r and omized between PTCA to be performed 4–14 days after MI versus no PTCA . Both groups received medical therapy . Patients with postinfa rct angina or prior Q wave infa rct ion in the infa rct distribution were excluded . The primary study end point was increase in left ventricular ejection fraction with exercise measured by radionuclide studies 6 weeks after MI , a parameter known from other studies to correlate inversely with future ischemic events . Clinical outcome was also monitored for 12 months . There were no differences between the study groups for any prer and omization variable recorded . Mean age was 57± 10 years , 84 % of patients were male , 21 % had prior MI , 36 % had anterior MI , 7 % had multivessel disease , and the infa rct stenosis measured 70±17 % before r and omization . PTCA was successful in 38 of 42 patients ( 88 % ) but result ed in non-Q wave MI due to acute closure of the treated site in three of 42 ( 9.5 % ) . There was no difference in 6-week resting ejection fraction or increase in ejection fraction with exercise between the two groups ( 47±12 % and 6±8 % , respectively , in the PICA group ; 49±10 % and 5±9%o in the no-PTCA group ; p = NS for both . ) There were no deaths in either group . Actuarial 12-month infa rct -free survival was 97.8 % in the no-PTCA group and 90.5 % in the PTCA group ( p=0.07 ) . Conclusions There was no functional or clinical benefit from routine late PTCA after MI treated with thrombolytic therapy in this relatively low-risk cohort of patients . These data strongly suggest that patients with an uncomplicated MI after thrombolytic therapy , even if they have a “ significant ” residual stenosis of the infa rct vessel , should be treated medically if they are without evidence of ischemia on stress testing before hospital discharge Background Experimental and observational clinical studies of acute coronary occlusion have suggested that late reperfusion prevents infa rct expansion and facilitates myocardial healing . The purpose of this trial was to assess whether infa rct vessel patency could be achieved in late-entry patients and what benefit , if any , can be demonstrated . Methods and Results In a double-blind fashion , 197 patients with 6 to 24 hours of symptoms and ECG ST elevation were r and omly assigned to tissue-type plasminogen activator ( 100 mg over 2 hours ) or placebo . Coronary angiography within 24 hours was used to determine infa rct vessel patency status . Patients with infa rct -related occluded arteries were then eligible for a second r and omization to either angioplasty ( 34 patients ) or no angioplasty ( 37 patients ) . Ventricular function and cavity size were reassessed at 1 month by gated blood pool scintigraphy and at 6 months by repeat cardiac catheterization . The primary end point , infa rct vessel patency , was 65 % for plasminogen activator patients compared with 27 % in the placebo group ( p<0.0001 ) . There were no differences between these groups in ejection fraction or infa rct zone regional wall motion at 1 or 6 months . At 6 months , infa rct vessel patency was 59 % in both groups . In the placebo group , there was a significant increase in end-diastolic volume from acute phase of 127 ml to 159 ml at 6-month follow-up ( p=0.006 ) but no increase in cavity size for the plasminogen activator group patients . Coronary angioplasty was associated with an initial 81 % recanalization success and improved ventricular function at 1 month , but by late follow-up no advantage could be demonstrated for this procedure , and there was a 38 % spontaneous recanalization rate in the patients assigned to no angioplasty . Conclusions The study demonstrates that it is possible to achieve infa rct vessel recanalization in the majority of late-entry patients with either thrombolytic therapy or angioplasty . Thrombolytic intervention had a favorable effect on prevention of cavity dilatation and left ventricular remodeling , but there are no late benefits on systolic function after thrombolysis or coronary angioplasty . The conclusions concerning overall potential benefit of applying late reperfusion therapy will require data from large-scale trials design ed to assess mortality reduction For nearly a decade , it has been appreciated that 1 ) thrombotic occlusion of an epicardial coronary artery is usually the proximate cause of acute myocardial infa rct ion ; 2 ) after sudden and sustained total occlusion of such a vessel , the course of myocardial necrosis is generally rapid and relentless ( in most cases , the process is completed within 3 or 4 hours of the coronary occlusion , in 6 hours at a maximum ) ; 3 ) infa rct size is a critical determinant of left ventricular function ; and 4 ) left ventricular function , in turn , is the most important determinant of early ( in-hospital ) and long-term ( postdischarge ) survival . Major efforts have been devoted to the development of techniques design ed to interfere with the sequence of events summarized above . Considerable attention has been directed to achieving timely reperfusion of occluded coronary arteries to interrupt the infa rct ion with the hope that the result ant limitation of infa rct size will improve ventricular function and thereby patient survival.1 Many techniques to achieve reperfusion have been used , including emergency coronary artery bypass surgery , emergency percutaneous transluminal coronary angioplasty ( PTCA ) , and the intracoronary and intravenous administration of a variety of thrombolytic agents ; the last of these approaches is particularly attractive because its simplicity makes it applicable to a large proportion of patients with acute myocardial infa rct ion . In some instances , combinations of these techniques , such as intravenous thrombolytic therapy followed by PTCA , have been used . These efforts to treat acute myocardial infa rct ion have been notably successful , as reflected in an improvement in survival noted in controlled r and omized trials.2 - 6 Also , the absolute mortality rates achieved in some recent trials of reperfusion therapy ( 3 - 5 % ) are far lower than those noted The TAMI-6 trial has demonstrated that coronary reperfusion > 6h after onset ( ie , late reperfusion ) in patients with acute myocardial infa rct ion ( AMI ) does not improve left ventricular ( LV ) function during the chronic phase of infa rct ion . However , the low patency rate ( only 60 % ) of the infa rct -related artery ( IRA ) during the chronic phase in the TAMI-6 trial raises a new hypothesis that late reperfusion with a higher patency rate may improve LV function during the chronic phase . Forty-four patients with AMI , who were admitted to hospital 6 - 24h after the symptom onset and in whom emergency coronary angiography revealed a total occlusion of the IRA , were r and omly assigned to either the late reperfusion group ( n=22 ) or the non-reperfusion group ( n=22 ) . The initial success rate of reperfusion therapy in the late reperfusion group was 86 % and the chronic patency rate of the IRA was 91 % . The improvements in ejection fraction and chord shortening in the infa rct region from the acute phase to the chronic phase were significantly greater in the late reperfusion group than in the non-reperfusion group . Late reperfusion with a high patency rate of the IRA significantly improves LV global and regional function in patients with AMI Background —A recent l and mark report has demonstrated that plasma B-type natriuretic peptide ( BNP ) measured in acute coronary syndromes independently predicts mortality , heart failure , and new myocardial infa rct ion . After acute cardiac injury , left ventricular ejection fraction ( LVEF ) is also of prognostic significance and plays a major role in determining the therapeutic response . Methods and Results —The present report is the first from a substantial ( n=666 ) cohort of patients with acute myocardial infa rct ion to test the prognostic utility of concurrent measurements of BNP , amino-terminal BNP ( N-BNP ) , norepinephrine , and radionuclide LVEF . The B-type peptides and LVEF were predictors of death , heart failure , and new myocardial infa rct ion ( all P < 0.001 ) independent of patient age , gender , previous myocardial infa rct ion , antecedent hypertension or diabetes , previous heart failure , plasma norepinephrine , creatinine , cholesterol , drug therapy , and coronary revascularization procedures . The combination of N-BNP ( or BNP ) with LVEF substantially improved risk stratification beyond that provided by either alone . Elevated N-BNP ( or BNP ) predicted new myocardial infa rct ion only in patients with LVEF < 40 % . LVEF < 40 % coupled to N-BNP over the group median conferred substantial 3-year risks of death , heart failure , and new myocardial infa rct ion of 37 % , 18 % , and 26 % , respectively . N-BNP and BNP were equivalent prognostic markers for these clinical outcomes . Conclusions —Plasma N-BNP ( or BNP ) and LVEF are complementary independent predictors of major adverse events on follow-up after myocardial infa rct ion . Combined measurement provides risk stratification substantially better than that provided by either alone Experimental and clinical studies have suggested that late opening of an infa rct -related artery ( IRA ) after myocardial infa rct ion ( MI ) could improve clinical outcome . However , the suggestive observational data are limited by selection biases . Indeed , most small r and omized studies have not demonstrated benefit . Thus , there is no recommendation for routine late opening of the IRA in current national guidelines for management of stable post-MI patients . The OAT is design ed to test the hypothesis that opening a totally occluded IRA 3 to 28 days after MI in high-risk asymptomatic patients will improve clinical outcome and be cost-effective . The primary end point is the first occurrence of recurrent MI , hospitalization/treatment of New York Heart Association class IV congestive heart failure , or death . Trial background , design , and preliminary baseline characteristics of 2027 r and omized patients are presented . Eligible patients are r and omly assigned in equal proportions to optimal evidence -
Output:
| This meta- analysis suggests that late revascularization of an occluded IRA may improve left ventricular systolic function and remodeling , supporting the " open artery hypothesis . " |
MS211742 | ***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 Patients with atrial flutter are believed to be at lower risk of thromboembolism than patients with atrial fibrillation . However , the incidence of atrial thrombi and the need for anticoagulation in patients with atrial flutter is not well established . METHODS AND RESULTS A prospect i ve observational multicentre study was undertaken to assess the frequency of atrial thrombi and spontaneous echocontrast and the prevalence for aortic complex atherosclerotic lesions in a cohort of unselected patients with atrial flutter . We evaluated 134 patients ( 102 male , aged 70+/-9 years ) ; exclusion criteria were history of atrial fibrillation , rheumatic mitral valve disease and mitral mechanical prosthesis . The median of atrial flutter duration was 33 days . Twelve patients had been taking warfarin for more than 7 days . One hundred and twenty-four patients ( 94 % ) underwent a transoesophageal echocardiogram , which revealed left atrial appendage thrombi in two patients ( 1.6 % ) and right atrial thrombi in one patient ( 1 % ) . At least moderate left atrial echocontrast was found in 16/124 patients ( 13 % ) . Complex atherosclerotic aortic plaques were detected in 10 patients ( 8 % ) . Atrial flutter conversion was attempted in 93/134 patients ( 69 % ) . At the 1-month follow-up , two patients experienced a thromboembolic event following restoration of sinus rhythm . CONCLUSIONS Atrial thrombi and echocontrast , and complex aortic atherosclerotic plaques are relatively uncommon in patients with atrial flutter . Post-cardioversion embolism was observed in two patients in our study population ACCF : American College of Cardiology Foundation ACCP : American College of Chest Physicians ACS : acute coronary syndrome ACT : Atrial arrhythmia Conversion Trial ADONIS : American – Australian – African trial with DronedarONe In atrial fibrillation or flutter for the maintenance of Sinus rhythm AF : atrial fibrillation AHA : American Heart Association AND ROMEDA : ANtiarrhythmic trial with DROnedarone in Moderate-to-severe congestive heart failure Evaluating morbidity DecreAse APHRS : Asia Pacific Heart Rhythm Society aPTT : activated partial thromboplastin time ARB : angiotensin-receptor blocker ARISTOTLE : Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation ATHENA : A placebo-controlled , double-blind , parallel arm Trial to assess the efficacy of dronedarone 400 mg b.i.d . for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter ATRIA : AnTicoagulation and Risk factors In Atrial fibrillation AVERROES : Apixaban VErsus acetylsalicylic acid ( ASA ) to Reduce the Rate Of Embolic Stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment AVRO : A prospect i ve , r and omized , double-blind , Active-controlled , superiority study of Vernakalant vs. amiodarone in Recent Onset atrial fibrillation b.i.d : bis in die ( twice daily ) b.p.m . : beats per minute CABANA : Catheter ABlation vs . ANtiarrhythmic drug therapy for Atrial fibrillation CABG : coronary artery bypass graft CAP : Continued Access to Protect AF CHA2DS2-VASc : Congestive heart failure or left ventricular dysfunction Hypertension , Age ≥75 ( doubled ) , Diabetes , Stroke (doubled)-Vascular disease , Age 65–74 , Sex category ( female ) CHADS2 : Congestive heart failure , Hypertension , Age ≥75 , Diabetes , Stroke ( doubled ) CI : confidence interval CRAFT : Controlled R and omized Atrial Fibrillation Trial CrCl : creatinine clearance DAFNE : Dronedarone Atrial FibrillatioN study after Electrical cardioversion DIONYSOS : R and omized Double blind trIal to evaluate efficacy and safety of drOnedarone ( 400 mg b.i.d . ) vs . amiodaroNe ( 600 mg q.d . for 28 daYS , then 200 mg qd thereafter ) for at least 6 mOnths for the maintenance of Sinus rhythm in patients with atrial fibrillation EAST : Early treatment of Atrial fibrillation for Stroke prevention Trial EHRA : European Heart Rhythm Association ECG : electrocardiogram EMA : European Medicines Agency ERATO : Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation EURIDIS : EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm FAST : atrial Fibrillation catheter Ablation vs . Surgical ablation Treatment FDA : Food and Drug Administration Flec-SL : Flecainide Short-Long trial HAS-BLED : Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly HF-PEF : heart failure with preserved ejection fraction HF-REF : heart failure with reduced ejection fraction HR : hazard ratio HRS : Heart Rhythm Society ICH : intracranial haemorrhage INR : international normalized ratio i.v . : intravenous J-RHYTHM : Japanese RHYTHM management trial for atrial fibrillation LAA : left atrial appendage LoE : level of evidence LVEF : left ventricular ejection fraction MANTRA-PAF : Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation NICE : National Institute for Health and Clinical Excellence NOAC : novel oral anticoagulant NSAID : non-steroidal anti-inflammatory drug NYHA : New York Heart Association OAC : oral anticoagulant or oral anticoagulation o.d . : omni die ( every day ) PALLAS : Permanent Atrial fibriLLAtion outcome Study using dronedarone on top of st and ard therapy PCI : percutaneous coronary intervention PREVAIL : Prospect i ve R and omized EVAluation of the LAA closure device In patients with atrial fibrillation v s. Long-term warfarin therapy PROTECT AF : WATCHMAN LAA system for embolic PROTECTion in patients with Atrial Fibrillation PT : prothrombin time RAAFT : Radio frequency Ablation Atrial Fibrillation Trial RE-LY : R and omized Evaluation of Long-term anticoagulant therapY with dabigatran etexilate ROCKET-AF : Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in atrial fibrillation RRR : relative risk reduction TE : thromboembolism TIA : transient ischaemic attack t.i.d . : ter in die ( three times daily ) TOE : transoesophageal echocardiogram TTR : time in therapeutic range VKA : vitamin K antagonist Guidelines summarize and evaluate all currently available evidence on a particular issue with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition , taking into account the impact on AIMS We investigated the temporal changes in circulating levels of markers of extracellular cardiac matrix ( ECCM ) turnover and their relationship with infa rct size ( IS ) , ejection fraction ( EF ) , and left ventricular ( LV ) volumes , determined by serial cardiac magnetic resonance ( CMR ) imaging in patients with first-time ST-elevation myocardial infa rct ion ( STEMI ) . METHODS AND RESULTS Forty-two patients with a first-time STEMI , successfully revascularized by primary percutaneous coronary intervention ( pPCI ) had serum sample s taken prior to pPCI , 2 , 7 days , 2 months , and 1 year following STEMI for the analysis of the markers of collagen synthesis , and collagen degradation . Late enhancement and cine CMR was performed on Days 2 , 7 , 2 months , and 1-year post-STEMI . There was a significant increase in type I collagen degradation following STEMI that was not accompanied by an increase in collagen type I synthesis until 2 months and 1 year . In contrast to the delay in type I collagen synthesis , there was an immediate increase in type III collagen synthesis that was sustained for 1 year . N-terminal procollagen type I levels assessed prior to pPCI were predictive of adverse LV remodelling at all CMR time-points . CONCLUSIONS Our findings indicate a net type I collagen breakdown in the first week following STEMI compensated by an early increase in collagen type III synthesis . There is an increase in both type I and III collagen synthesis markers at 2 months and 1 year , indicating a persistent increase in collagen turnover even in these apparently successfully treated patients AIMS Primary percutaneous coronary intervention ( PCI ) is the preferred treatment for ST-elevation myocardial infa rct ion ( STEMI ) . The distance to primary PCI centres and the inherent time delay in delivering primary PCI , however , limit widespread use of this treatment . This study aim ed to evaluate the impact of pre-hospital diagnosis on time from emergency medical services contact to balloon inflation ( system delay ) in an unselected cohort of patients with STEMI recruited from a large geographical area comprising both urban and rural districts . METHODS AND RESULTS From February 2004 until January 2007 , data on pre-hospital timing and transport distance were prospect ively recorded . Patients were divided into groups depending on achievement of pre-hospital diagnosis and /or direct referral to a primary PCI centre . Seven hundred and fifty-nine consecutive STEMI patients were included . In patients with a pre-hospital diagnosis and direct referral , the system delay was 92 vs. 153 min in patients without pre-hospital diagnosis ( P < 0.001 ) . Patients from rural areas were transported a median of 30 km longer than patients from urban areas ; however , this prolonged the system delay by only 9 min . CONCLUSION Pre-hospital electrocardiographic ( ECG ) diagnosis and direct referral for primary PCI enables STEMI patients living far from a PCI centre to achieve a system delay comparable with patients living in close vicinity of a PCI centre AIMS TOTAL ( N = 10 732 ) , a r and omized trial of routine manual thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infa rct ion , showed no difference in the primary efficacy outcome but a significant increase in stroke . We sought to underst and these findings . METHODS AND RESULTS A detailed analysis of stroke timing , stroke severity , and stroke subtype was performed . Strokes were adjudicated by neurologists blinded to treatment assignment . Stroke within 30 days , the primary safety outcome , was increased [ 33 ( 0.7 % ) vs. 16 ( 0.3 % ) , hazard ratio ( HR ) 2.06 ; 95 % confidence interval ( CI ) 1.13 - 3.75 ] . The difference in stroke was apparent within 48 h [ 15 ( 0.3 % ) vs. 5 ( 0.1 % ) , HR 3.00 ; 95 % CI 1.09 - 8.25 ] . There was an increase in strokes within 180 days with minor or no disability ( Rankin 0 - 2 ) [ 18 ( 0.4 % ) vs. 13 ( 0.3 % ) HR 1.38 ; 95 % CI 0.68 - 2.82 ] and in strokes with major disability or fatal ( Rankin 3 - 6 ) [ 35 ( 0.7 % ) vs. 13 ( 0.3 % ) , HR 2.69 ; 95 % CI 1.42 - 5.08 ] . Most of the absolute difference was due to an increase in ischaemic strokes within 180 days [ 37 ( 0.7 % ) vs. 21 ( 0.4 % ) , HR 1.71 ; 95 % CI 1.03 - 3.00 ] , but there was also an increase in haemorrhagic strokes [ 10 ( 0.2 % ) vs. 2 ( 0.04 % ) , HR 4.98 ; 95 % CI 1.09 - 22.7 ] . Patients that had a stroke had a mortality of 30.8 % within 180 days vs. 3.4 % without a stroke ( P < 0.001 ) . A meta- analysis of r and omized trials ( N = 21 173 ) showed an increase in risk of stroke ( odds ratio 1.59 ; 95 % CI 1.11 - 2.27 ) but a trend towards reduction in mortality odds ratio ( odds ratio 0.87 ; 95 % CI 0.76 - 1.00 ) . CONCLUSION Thrombectomy was associated with a significant increase in stroke . Based on these findings , future trials must carefully collect stroke to determine safety in addition to efficacy The prevalence of left ventricular ( LV ) thrombosis and incidence of arterial embolism after acute anterior myocardial infa rct ion ( AAMI ) treated with streptokinase 1.5
Output:
| Surprisingly , TOTAL showed no difference in the primary efficacy outcome between the two approaches , but a significant increase in stroke .
Thus thrombectomy is associated with an increase in stroke , but , based on a meta- analysis of all trials , possibly with a trend towards reduced mortality .
Endovascular therapy significantly improved the rate of functional independence compared with fibrinolysis alone |
MS211743 | ***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 long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown . Methods and Results — The effects of a nurse-led , multidisciplinary , home-based intervention ( HBI ) in a typically elderly cohort of patients with chronic heart failure initially r and omized to either HBI ( n=149 ) or usual postdischarge care ( UC ) ( n=148 ) after a short-term hospitalization were studied for up to 10 years of follow-up ( minimum 7.5 years of follow-up ) . Study end points were all-cause mortality , event-free survival ( event was defined as death or unplanned hospitalization ) , recurrent hospital stay , and cost per life-year gained . Median survival in the HBI cohort was almost twice that of UC ( 40 versus 22 months ; P<0.001 ) , with fewer deaths overall ( HBI , 77 % versus 89 % ; adjusted relative risk , 0.74 ; 95 % CI , 0.53 to 0.80 ; P<0.001 ) . HBI was associated with prolonged event-free survival ( median , 7 versus 4 months ; P<0.01 ) . HBI patients had more unplanned readmissions ( 560 versus 550 ) but took 7 years to overtake UC ; the rates of readmission ( 2.04±3.23 versus 3.66±7.62 admissions ; P<0.05 ) and related hospital stay ( 14.8±23.0 versus 28.4±53.4 days per patient per year ; P<0.05 ) were significantly lower in the HBI group . HBI was associated with 120 more life-years per 100 patients treated compared with UC ( 405 versus 285 years ) at a cost of $ 1729 per additional life-year gained when we accounted for healthcare costs including the HBI . Conclusions — In altering the natural history of chronic heart failure relative to UC ( via prolonged survival and reduced frequency of recurrent hospitalization ) , HBI is a remarkably cost- and time-effective strategy over the longer term Systemic arterial compliance ( SAC ) makes an important contribution to cardiac afterload , and thus is a significant determinant of left ventricular work . Previous studies have suggested that arterial compliance may be reduced in patients with congestive heart failure ( CHF ) , and that SAC is increased after a 4-week exercise training programme in healthy , sedentary individuals . The present study aim ed to investigate the effects of an 8-week exercise training programme on arterial mechanical properties , left ventricular performance and quality of life in CHF patients . A total of 21 patients with NYHA class II or III CHF ( mean+/-S.D. age 55+/-13 years ) were r and omly allocated to either an 8-week exercise training group or a " usual lifestyle " control group . SAC , as determined non-invasively using applanation tonometry and Doppler aortic velocimetry , increased from 0.57+/-0.11 to 0.77+/-0.14 arbitrary compliance units ( mean+/-S.E.M. ; P=0.01 ) in the exercise group , while no change occurred in the control group . Left ventricular structure and function was assessed by echocardiography , and these parameters were unchanged over the 8-week study period . Exercise training significantly increased exercise capacity , measured by a 6-min walking test ( 474+/-27 to 547+/-34 m ; P=0.008 ) . Quality of life , as assessed using the Minnesota Living with Heart Failure Evaluation , demonstrated a decrease in heart failure symptoms from 46+/-7 to 24+/-5 units ( P=0.01 ) following the exercise training programme . These data show that exercise training improves SAC in patients with CHF . The accompanying improvement in exercise capacity may be due , in part , to an improvement in arterial function BACKGROUND The time required for oxygen uptake ( O(2 ) ) to return to baseline level ( recovery kinetics ) is prolonged in patients with reduced ventricular function , and the degree to which it is prolonged is related to the severity of heart failure , markers of abnormal ventilation , and prognosis . In the present study , we sought to determine the effect of exercise training on O(2 ) recovery kinetics in patients with reduced ventricular function . METHODS Twenty-four male patients with reduced ventricular function after a myocardial infa rct ion were r and omized to either a 2-month high-intensity residential exercise training program or to a control group . O(2 ) kinetics in recovery from maximal exercise were calculated before and after the study period and expressed as the slope of a single exponential relation between O(2 ) and time during the first 3 min of recovery . RESULTS Peak O(2 ) increased significantly in the exercise group ( 19.4 + /- 3.0 mL/kg/min vs 25.1 + /- 4.7 mL/kg/min , p < 0.05 ) , whereas no change was observed in control subjects . The O(2 ) half-time in recovery was reduced slightly after the study period in both groups ( 108.7 + /- 33.1 to 102.1 + /- 50.5 s in the exercise group and 122.3 + /- 68.7 to 107.5 + /- 36.0 s in the control group ) ; neither the change within or between groups was significant . The degree to which O(2 ) was prolonged in recovery was inversely related to measures of exercise capacity ( peak O(2 ) , watts achieved , and exercise time ; r = - 0.48 to - 0.57 ; p < 0.01 ) and directly related to the peak ventilatory equivalents for oxygen ( r = 0.59 , p < 0.01 ) and carbon dioxide ( r = 0.57 , p < 0.01 ) . CONCLUSION Two months of high-intensity training did not result in a faster recovery of O(2 ) in patients with reduced ventricular function . This suggests that adaptations to exercise training manifest themselves only during , but not in , recovery from exercise AIM To assess changes in quality of life ( QoL ) and oxygen consumption produced by two different patterns of physical training in patients with congestive heart failure ( CHF ) . MATERIAL AND METHODS 42 men ( mean age 55.9+/-8.1 years ) with ischaemic CHF lasting 3.1+/-1.0 years . Patients were r and omised into three groups each consisting of 14 men : group A -- with constant workload , group B-with progressive/increasing workload , each trained up to 6 months and group C -- not trained . QoL was assessed at baseline and at 6 months by means of the Psychological General Well-being Index ( PGWB ) and the Subjective Symptoms Assessment Profile ( SSA-P ) . Cardiopulmonary exercise test and echocardiography were performed twice . RESULTS At 6 months improvement in PGWB total index was observed , both in groups A and B ( p<0.01 ) . Men from groups A and B reported less cardiac symptoms ( p<0.01 ) , emotional distress ( p<0.01 ) , peripheral circulatory symptoms ( p<0.01 ) and dizziness ( p<0.01 ) in SSA-P. Improvement in sexual life was observed only in group B ( p<0.01 ) . Overall improvement of QoL was greater in group B than in group A as well as oxygen uptake ( p<0.01 ) . Higher QoL correlated positively with peak VO2 only in group B ( r=0.56 , p<0.05 ) . CONCLUSIONS Physical training improves QoL in men with CHF , but only progressive/increasing workload seems to markedly improve oxygen uptake . Improvement of QoL is related to psychological well-being and physical complaints associated with CHF BACKGROUND We aim ed to determine the role of skeletal muscle mitochondrial ATP production rate ( MAPR ) in relation to exercise tolerance after resistance training ( RT ) in chronic heart failure ( CHF ) . METHODS AND RESULTS Thirteen CHF patients ( New York Heart Association functional class 2.3 + /- 0.5 ; Left ventricular ejection fraction 26 + /- 8 % ; age 70 + /- 8 years ) underwent testing for peak total body oxygen consumption ( VO(2peak ) ) , and resting vastus lateralis muscle biopsy . Patients were then r and omly allocated to 11 weeks of RT ( n = 7 ) , or continuance of usual care ( C ; n = 6 ) , after which testing was repeated . Muscle sample s were analyzed for MAPR , metabolic enzyme activity , and capillary density . VO(2peak ) and MAPR in the presence of the pyruvate and malate ( P+M ) substrate combination , representing carbohydrate metabolism , increased in RT ( P < .05 ) and decreased in C ( P < .05 ) , with a significant difference between groups ( VO(2peak ) , P = .005 ; MAPR , P = .03 ) . There was a strong correlation between the change in MAPR and the change in peak total body oxygen consumption ( VO(2peak ) ) over the study ( r = 0.875 ; P < .0001 ) , the change in MAPR accounting for 70 % of the change in VO(2peak ) . CONCLUSIONS These findings suggest that mitochondrial ATP production is a major determinant of aerobic capacity in CHF patients and can be favorably altered by muscle strengthening exercise BACKGROUND Current guidelines broadly recommend comprehensive cardiac rehabilitation ( CR ) , although evidence for this is still limited . It is not known whether evidence from before 1995 is still valid . STUDY DESIGN The DANish Cardiac ReHABilitation ( DANREHAB ) trial was design ed as a central ly r and omized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure , ischemic heart disease , or high risk for ischemic heart disease . A combined primary outcome measure included total mortality , myocardial infa rct ion , or readmissions due to heart disease based on linkage to public registries . The CR was an individually tailored , multidisciplinary program ( 6 weeks of intensive CR and 12 months of follow-up ) including patient education , exercise training , dietary counseling , smoking cessation , psychosocial support , risk factor management , and clinical assessment . STUDY POPULATION Of 5060 discharged patients , 1614 ( 32 % ) were eligible for the trial and 770 patients were r and omized ( 47 % of those eligible ) . Participants were younger ( P < .001 ) and had less comorbidity than non participants ( P < .03 ) . CONCLUSION Our trial shows that a large-scale , central ly r and omized clinical trial on comprehensive CR can be conducted among a broadly defined patient group , but reaching the stipulated number of 1800 patients was difficult . Although the study included relatively many women and older people , elderly patients and patients with high comorbidity were underrepresented , which may influence the external validity BACKGROUND Preliminary evidence suggests that meditative exercise may have benefits for patients with chronic systolic heart failure ( HF ) ; this has not been rigorously tested in a large clinical sample . We sought to investigate whether tai chi , as an adjunct to st and ard care , improves functional capacity and quality of life in patients with HF . METHODS A single-blind , multisite , parallel-group , r and omized controlled trial evaluated 100 out patients with systolic HF ( New York Heart Association class I-III , left ventricular ejection fraction ≤40 % ) who were recruited between May 1 , 2005 , and September 30 , 2008 . A group-based 12-week tai chi exercise program ( n = 50 ) or time-matched education ( n = 50 , control group ) was conducted . Outcome measures included exercise capacity ( 6- minute walk test and peak oxygen uptake ) and disease-specific quality of life ( Minnesota Living With Heart Failure Question naire ) . RESULTS Mean ( SD ) age of patients was 67 ( 11 ) years ; baseline values were left ventricular ejection fraction , 29 % ( 8 % ) and peak oxygen uptake , 13.5 mL/kg/min ; the median New York Heart Association class of HF was class II . At completion of the study , there were no significant differences in change in 6-minute walk distance and peak oxygen uptake ( median change [ first quartile , third quartile ] , 35 [ -2 , 51 ] vs 2 [ -7 , 54 ] meters , P = .95 ; and 1.1 [ -1.1 , 1.5 ] vs -0.5 [ -1.2 , 1.8 ] mL/kg/min , P = .81 ) when comparing tai chi and control groups ; however , patients in the tai chi group had greater improvements in quality of life ( Minnesota Living With Heart Failure Question naire , -19 [ -23 , -3 ] vs 1 [ -16 , 3 ] , P = .02 ) . Improvements with tai chi were also seen in exercise self-efficacy ( Cardiac Exercise Self-efficacy Instrument , 0.1 [ 0.1 , 0.6 ] vs -0.3 [ -0.5 , 0.2 ] , P < .001 ) and mood ( Profile of Mood States total mood disturbance , -6 [ -17 , 1 ] vs -1 [ -13 , 10 ] , P = .01 ) . CONCLUSION Tai chi exercise may improve quality of life , mood , and exercise self-
Output:
| AUTHORS ' CONCLUSIONS This up date d Cochrane review supports the conclusions of the previous version of this review that , compared with no exercise control , exercise-based rehabilitation does not increase or decrease the risk of all-cause mortality in the short term ( up to 12-months ' follow-up ) but reduces the risk of hospital admissions and confers important improvements in health-related quality of life .
This up date provides further evidence that exercise training may reduce mortality in the longer term and that the benefits of exercise training on appear to be consistent across participant characteristics including age , gender and HF severity . |
MS211744 | ***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 Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time Objective : Since peers have such an important influence on adolescents , we evaluated the efficacy of adding peer-based ‘ adventure therapy ’ to a st and ard cognitive-behavioral weight control program for overweight adolescents . Methods : Adolescents ( N=76 ) aged 13–16 years and 20 to 80 % overweight ( M=60.56 % , s.d.=15.17 % ) , were r and omly assigned to one of two treatment conditions : cognitive-behavioral group treatment with ‘ adventure therapy ’ similar to Outward Bound ® ( cognitive-behavioral treatment with peer-enhanced adventure therapy ( CBT+PEAT ) ) or cognitive-behavioral group treatment with aerobic exercise ( CBT+EXER ) . Anthropometric and psychosocial measures were obtained at baseline , at the end of the 16-week intervention , and at 10 months following r and omization . Results : Adolescents assigned to both treatment conditions demonstrated significant weight loss over time , F=29.06 , df=2 , 53 , P<0.01 . Average weight loss did not differ significantly between groups ( −5.31 kg for CBT+PEAT and −3.20 kg for CBT+EXER ) at the end of treatment . There was a significant difference in the percentage of participants maintaining a minimum 4.5 kg ( 10 pounds ) weight loss ( 35 % in the CBT+PEAT condition vs 12 % in the CBT+EXER condition , P=0.042 ) 10 months from r and omization . We also observed a significant age by treatment group interaction , such that older adolescents r and omized to CBT+PEAT demonstrated more than four times the weight loss of older adolescents assigned to CBT+EXER ( M=−7.86 kg vs M=−1.72 kg ) at the end of treatment . Conclusions : Peer-based ‘ adventure therapy ’ is a promising adjunct to st and ard cognitive-behavioral weight control intervention for adolescents , and may be most effective for older adolescents OBJECTIVES The primary goals were to underst and the relationship among the inflammatory factors , C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and fibrinogen , and indices of obesity in normoglycemic , insulin-resistant adolescents and to investigate the impact of a lifestyle-only intervention on these nontraditional risk factors for cardiovascular disease ( CVD ) . STUDY DESIGN R and omized controlled lifestyle-only intervention study in adolescents . Of the 21 adolescents studied , 15 obese subjects ( body mass index [ BMI ] = 37.6 + /- 3.3 kg/m 2 ) were r and omized to either a lifestyle intervention program or usual care . The lean controls were studied only at baseline . Analysis of variance ( ANOVA ) for repeated measures was used to study intervention effect and t test , one-way ANOVA , and discriminant function analysis for baseline comparisons . RESULTS The intervention group maintained weight , whereas the control group gained weight ( P = .02 ) . A redistribution of body composition and a decrease in insulin resistance were observed . Elevated circulating concentrations of CRP , fibrinogen , and IL-6 were significantly reduced ( all P < or=.02 ) in response to intervention , but not in controls . CONCLUSIONS Modest lifestyle-only change in previously sedentary obese adolescents redistributes the parameters of body composition in the absence of weight loss and reverses , at least in part , the inflammatory state in association with an improvement of insulin resistance The leisure-time physical activity of 13-year-old Finnish adolescents was assessed in the prospect i ve STRIP study . A self-administered question naire ( N=565 ) was used . The leisure-time physical activity index ( PAI ; MET h/week ) was calculated on the basis of reported exercise intensity , duration and frequency ( N=558 ; 53 % boys ) . The participants were divided into Sedentary , Moderately Active and Active groups by PAI tertiles . A sub population ( N=197 ) also used a heart rate monitor ( 3 days , > /=8 h/day ) to assess the time spent on different activity intensities . The median male PAI was 31.3 ( inter-quartile range ( IQR ) 44.2 ) MET h/week and female 19.5 ( IQR 26.3 ) MET h/week ( P=0.0002 ) . The cutoff points of the PAI tertiles were similar for the Active girls ( 31.3 MET h/week ) and boys ( 32.6 MET h/week ) , but for the Sedentary boys it was 19.5 MET h/week and only 5.0 MET h/week for the Sedentary girls . High self-reported leisure-time physical activity associated poorly with time spent on moderate or vigorous exercise measured by heart rate monitoring . Active mothers had more often Active daughters or sons . In conclusion , the amount of leisure-time physical activity of one-third of 13-year-old girls is extremely low . Sedentary adolescents , especially girls , should therefore be put into focus for active efforts to increase their leisure-time physical activity . Parental models may be important Background : Childhood obesity has become a nutritional problem in China since the 1990s . Aims : A family based behavioural treatment was developed and tested , to see if its use was feasible in China and to evaluate its impact on obese schoolchildren . Methods : In a single school in Beijing , 33 obese children were r and omly assigned to a treatment group and 35 to a control group . The treatment group participated in a family based behavioural treatment programme for two years . Height and weight were measured every six months for all participants . Blood pressure , cholesterol , and triglyceride levels were measured at baseline and after two years of programme implementation . Results : Body mass index ( BMI , kg/m2 ) was significantly reduced in the treatment group ( from 26.6 ( 1.7 ) to 24.0 ( 0.9 ) , 95 % CI 2.06 to 3.18 ) but not in the control group ( from 26.1 ( 1.5 ) to 26.0 ( 1.6 ) ) . Total cholesterol decreased 5.5 % and triglycerides 9.7 % in the treatment group . There was a significant correlation between change in BMI and change in triglycerides . There were no significant changes in plasma lipids in the controls . Blood pressure values also decreased significantly in the treatment , but not the control group . Conclusions : A family based behavioural intervention was feasible to use in treating obesity in schoolchildren in Beijing , China . After two years of implementation , it successfully decreased the degree of obesity , reduced levels of blood pressure , and decreased serum lipids in treatment ; there were no significant changes among control children The purpose s of this article are to present an overview of r and omized clinical trials ( RCTs ) and describe some of the method ological problems inherent in using RCTs in nursing research . Many nursing intervention studies are fraught with problems that defy the stringent control criteria required for RCTs , leading to biased estimates of intervention efficacy . Five threats to validity in RCTs are presented , including problems related to ( a ) differential dropout , ( b ) r and om assignment , ( c ) identifying and maintaining an adequate control condition , ( d ) nonadherence to research protocol s , and ( e ) assessment of clinical ly meaningful change . Three strategies are recommended for addressing some of the problems posed by RCTs and improving inference Recent findings indicate that nearly 50 % of black American women are obese and that adolescence is a critical period for the development of their obesity . This study investigated the efficacy of a behavioral weight control program in 36 black female adolescents with a mean age of 14.0 years , weight of 95.0 kg , and height of 163.2 cm . All subjects participated in the same 16-week program but had different levels of parent participation : ( 1 ) child alone with no parent participation ; ( 2 ) mother and child treated in the same session ; and ( 3 ) mother and child treated in separate but concurrent session . At the end of the 16-week program , children in the three conditions lost 1.6 , 3.7 , and 3.1 kg , respectively . Differences among conditions were not statistically significant ; however , a secondary analysis revealed that the greater the number of sessions attended by mothers , the greater their daughters ' weight losses . Weight reduction was associated with significant improvements in body composition , serum total cholesterol concentrations , and psychological status . Results are discussed in terms of the need to improve the maintenance of weight loss in adolescents and to explore possible differences between black and white females in their preferred body types The effectiveness of the adolescent obesity intervention SHAPEDOWN was evaluated for 15 months through a r and omized experimental design study . Test groups ( no. = 37 ) participating in the intervention were compared with a no-treatment control group ( no. = 29 ) at four sites in northern California . The program employs a variety of cognitive , behavioral , and affective techniques adapted to make successive small modifications in diet , exercise , communication , and affect that are sustainable . Very-low-calorie or restrictive diets are avoided in the program . Parents are instructed on strategies for supporting their adolescents ' weight-loss efforts . Participation in the group application of the program was associated with significant improvement in relative weight , weight-related behavior , depression , and knowledge of weight management concepts at post-treatment and at 1-year follow-up . Self-esteem increased significantly regardless of condition . Change in relative weight for the test group was -9.9 + /- 14.9 % ( mean + /- st and ard deviation ) and for the control group was -0.10 + /- 13.2 % . At month 15 of the study period , weight change in the test group
Output:
| RESULTS Due to a lack of consistency among the studies regarding methods and rigor of the studies , the evidence is not entirely clear on the best multicomponent program for addressing overweight in middle adolescents .
The success of an intervention was associated with the dose of the intervention received by the adolescent and parent .
A structured program addressing nutrition , physical activity , and behavioral skills appears to be efficacious in reducing weight and cardiovascular risk factors . |
MS211745 | ***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: Patients with malignant endocrine pancreatic tumors ( EPTs ) are responsive to combinations of chemotherapy with streptozotocin and 5‐fluorouracil/doxorubicin , whereas patients with malignant carcinoids are not . For both categories of patients , α‐interferon and /or somatostatin analogs can produce long‐lasting responses . Cisplatin in combination with etoposide has been suggested to be effective in patients with malignant neuroendocrine carcinomas . The authors used this therapy as second‐line or third‐line treatment in patients with poorly differentiated and /or rapidly progressing disease BACKGROUND Mutational inactivation in cancer of key apoptotic pathway components , such as TP53/p53 , undermines cytotoxic therapies that aim to increase apoptosis . Accordingly , TP53 mutations are reproducibly associated with poor treatment outcomes . Moreover , cytotoxic treatments destroy normal stem cells with intact p53 systems , a problem especially for myeloid neoplasms , as these cells reverse the low blood counts that cause morbidity and death . Pre clinical studies suggest that noncytotoxic concentrations of the DNA methyltransferase 1 ( DNMT1 ) inhibitor decitabine produce p53-independent cell-cycle exits by reversing aberrant epigenetic repression of proliferation-terminating ( MYC-antagonizing ) differentiation genes in cancer cells . METHODS In this clinical trial , patients with myelodysplastic syndrome ( n=25 ) received reduced decitabine dosages ( 0.1 - 0.2 mg/kg/day compared with the FDA -approved 20 - 45 mg/m2/day dosage , a 75%-90 % reduction ) to avoid cytotoxicity . These well-tolerated doses were frequently administered 1 - 3 days per week , instead of pulse cycled for 3 to 5 days over a 4- to 6-week period , to increase the probability that cancer S-phase entries would coincide with drug exposure , which is required for S-phase-dependent DNMT1 depletion . RESULTS The median subject age was 73 years ( range , 46 - 85 years ) , 9 subjects had relapsed disease or were refractory to 5-azacytidine and /or lenalidomide , and 3 had received intensive chemoradiation to treat other cancers . Adverse events were related to neutropenia present at baseline : neutropenic fever ( 13 of 25 subjects ) and septic death ( 1 of 25 subjects ) . Blood count improvements meeting the International Working Group criteria for response occurred in 11 of 25 ( 44 % ) subjects and were highly durable . Treatment-induced freedom from transfusion lasted a median of 1,025 days ( range , 186 - 1,152 days ; 3 ongoing ) , and 20 % of subjects were treated for more than 3 years . Mutations and /or deletions of key apoptosis genes were frequent ( present in 55 % of responders and in 36 % of nonresponders ) . Noncytotoxic DNMT1 depletion was confirmed by serial BM γ-H2AX ( DNA repair/damage marker ) and DNMT1 analyses . MYC master oncoprotein levels were markedly decreased . CONCLUSION Decitabine regimens can be re design ed to minimize cytotoxicity and increase exposure time for DNMT1 depletion , to safely and effectively circumvent mutational apoptotic defects . TRIAL REGISTRATION Clinical trials.gov NCT01165996 . FUNDING NIH ( R01CA138858 , CA043703 ) ; Department of Defense ( PR081404 ) ; Clinical and Translational Science Award ( CTSA ) ( UL1RR024989 ) ; and the Leukemia and Lymphoma Society ( Translational Research Program ) BACKGROUND The molecular determinants of clinical responses to decitabine therapy in patients with acute myeloid leukemia ( AML ) or myelodysplastic syndromes ( MDS ) are unclear . METHODS We enrolled 84 adult patients with AML or MDS in a single-institution trial of decitabine to identify somatic mutations and their relationships to clinical responses . Decitabine was administered at a dose of 20 mg per square meter of body-surface area per day for 10 consecutive days in monthly cycles . We performed enhanced exome or gene-panel sequencing in 67 of these patients and serial sequencing at multiple time points to evaluate patterns of mutation clearance in 54 patients . An extension cohort included 32 additional patients who received decitabine in different protocol s. RESULTS Of the 116 patients , 53 ( 46 % ) had bone marrow blast clearance ( < 5 % blasts ) . Response rates were higher among patients with an unfavorable-risk cytogenetic profile than among patients with an intermediate-risk or favorable-risk cytogenetic profile ( 29 of 43 patients [ 67 % ] vs. 24 of 71 patients [ 34 % ] , P<0.001 ) and among patients with TP53 mutations than among patients with wild-type TP53 ( 21 of 21 [ 100 % ] vs. 32 of 78 [ 41 % ] , P<0.001 ) . Previous studies have consistently shown that patients with an unfavorable-risk cytogenetic profile and TP53 mutations who receive conventional chemotherapy have poor outcomes . However , in this study of 10-day courses of decitabine , neither of these risk factors was associated with a lower rate of overall survival than the rate of survival among study patients with intermediate-risk cytogenetic profiles . CONCLUSIONS Patients with AML and MDS who had cytogenetic abnormalities associated with unfavorable risk , TP53 mutations , or both had favorable clinical responses and robust ( but incomplete ) mutation clearance after receiving serial 10-day courses of decitabine . Although these responses were not durable , they result ed in rates of overall survival that were similar to those among patients with AML who had an intermediate-risk cytogenetic profile and who also received serial 10-day courses of decitabine . ( Funded by the National Cancer Institute and others ; Clinical Trials.gov number , NCT01687400 . ) This report investigated in vivo turnover kinetics of marrow hematopoietic progenitors and precursors using a recently developed stable isotope-mass spectrometric technique ( SIMST ) . Human subjects were administered a 2-day infusion of 6,6-[2H2]-glucose , a nontoxic stable isotope-labeled form of glucose , which becomes incorporated into DNA of all S-phase cells . The percent [2H2]-glucose incorporated into DNA in the form of [2H2]-deoxyadenosine ( % [2H2]-dA enrichment ) was determined by gas chromatography-mass spectrometry . The rate constant of replacement of unlabeled by labeled DNA str and s ( labeling kinetics ) was used to calculate population turnover kinetics of CD34 + cells , CD133 + cells , and CD133-CD34 + cells . The observed mean replacement half-life ( t1/2 ) was 2.6 days for CD34 + cells , 2.5 days for CD133-CD34 + cells , and 6.2 days for CD133 + cells . Results from the estimated rate constant of replacement of labeled by unlabeled DNA ( delabeling kinetics ) also demonstrated slower turnover rates for CD133 + cells than for CD133-CD34 + cells . Although there was a relatively rapid initial decrease in the % [2H2]-dA enrichment , low levels of labeled DNA persisted in CD34 + cells for at least 4 weeks . The results indicate the presence of sub population s of CD34 + cells with relatively rapid turnover rates and sub population s with a slower t1/2 of 28 days . Results also demonstrate that in vivo [2H2]-glucose-SIMST is sensitive enough to detect differences in turnover kinetics between erythroid and megakaryocyte lineage cells . These studies are the first to demonstrate the use of in vivo [2H2]-glucose-SIMST to measure in vivo turnover kinetics of sub population s of CD34 + cells and precursors in healthy human subjects Primary myelofibrosis ( PMF ) and overlap myelodysplastic/myeloproliferative neoplasms ( MDS/MPN ) are clonal hematopoietic disorders that share similar clinical features and molecular abnormalities , such as the Janus kinase 2 ( JAK2 ) valine to phenylalanine mutation at codon 617 ( V617F ) and the tet methylcytosine dioxygenase 2 ( TET2 ) mutation . There are limited therapeutic options available for these diseases , and single agents have only modest efficacy . In this phase 2 study , the authors combined multiple active agents ( thalidomide , arsenic trioxide , dexamethasone , and ascorbic acid [ TADA ] ) to treat patients with these disorders PURPOSE This study was design ed to assess the effectiveness of vinblastine , ifosfamide , and cisplatin ( VeIP ) as second-line therapy in patients with recurrent germ cell tumors with previous treatment with cisplatin plus etoposide , usually in combination with bleomycin . PATIENTS AND METHODS From July 1984 through December 1989 , 135 patients with progressive , disseminated germ cell tumors after cisplatin-etoposide-based combination therapy induction chemotherapy were treated with VeIP . Patients who progressed within 3 weeks of previous cisplatin therapy were not eligible . Progression was documented by biopsy or increasing serum markers . No exclusion was made on the basis of metastatic site or performance status . The dosages were vinblastine 0.11 mg/kg/d ( days 1 and 2 ) , ifosfamide 1.2 gm/m2/d ( days 1 through 5 ) , and cisplatin 20 mg/m2/d ( days 1 through 5 ) , with courses repeated every 21 days for four cycles . RESULTS Sixty-seven ( 49.6 % ) patients achieved a disease-free status after chemotherapy with or without surgical resection of residual carcinoma or teratoma . Overall , 42 ( 32 % ) patients are alive and 32 ( 23.7 % ) are continuously free of disease . None of the 32 patients with nonseminomatous extragonadal tumors are disease-free compared with 30 of 100 patients with gonadal primaries . Two of three extragonadal seminomas are continuously disease-free . CONCLUSION VeIP is capable of producing durable complete remissions in patients with disseminated germ cell cancer who relapse after cisplatin-etoposide-based induction therapy . Long-term disease-free survival is not seen in those patients with extragonadal nonseminomatous germ cell tumors BACKGROUND All-trans retinoic acid ( ATRA ) with chemotherapy is the st and ard of care for acute promyelocytic leukemia ( APL ) , result ing in cure rates exceeding 80 % . Pilot studies of treatment with arsenic trioxide with or without ATRA have shown high efficacy and reduced hematologic toxicity . METHODS We conducted a phase 3 , multicenter trial comparing ATRA plus chemotherapy with ATRA plus arsenic trioxide in patients with APL classified as low-to-intermediate risk ( white-cell count , ≤10 × 10(9 ) per liter ) . Patients were r and omly assigned to receive either ATRA plus arsenic trioxide for induction and consolidation therapy or st and ard ATRA-idarubicin induction therapy followed by three cycles of consolidation therapy with ATRA plus chemotherapy and maintenance therapy with low-dose chemotherapy and ATRA . The study was design ed as a noninferiority trial to show that the difference between the rates of event-free survival at 2 years in the two groups was not greater than 5 % . RESULTS Complete remission was achieved in all 77 patients in the ATRA-arsenic trioxide group who could be evaluated ( 100 % ) and in 75 of 79 patients in the ATRA-chemotherapy group ( 95 % ) ( P=0.12 ) . The median follow-up was 34.4 months . Two-year event-free survival rates were 97 % in the ATRA-arsenic trioxide group and 86 % in the ATRA-chemotherapy group ( 95 % confidence interval for the difference , 2 to 22 percentage points ; P<0.001 for noninferiority and P=0.02 for superiority of ATRA-arsenic trioxide ) . Overall survival was also better with ATRA-arsenic trioxide ( P=0.02 ) . As compared with ATRA-chemotherapy , ATRA-arsenic trioxide was associated with less hematologic toxicity and fewer infections but with more hepatic toxicity . CONCLUSIONS ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with low-to-intermediate-risk APL . ( Funded by Associazione Italiana contro le Leucemie and others ; Clinical Trials.gov number , NCT00482833 . )
Output:
| Our analyses suggested loss-of-function events to master TF drivers of lineage-fates and their cofactors as being linked to differentiation-failure : genomic data in TCGA and ICGC data bases demonstrated frequent haploinsufficiency of lineage master TFs ( e.g. , GATA4/6 ) in poorly differentiated tumors ; the coactivators that these TFs use to activate genes ( e.g. ARID1A , PBRM1 ) were also frequently inactivated by genetic mutation and /or deletion .
By contrast , corepressor components ( e.g. , DNMT1 , EED , UHRF1 , and BAZ1A/B ) , that oppose coactivators to repress or turn off genes , were frequently amplified instead , and the level of amplification was highest in poorly differentiated lesions .
This selection by neoplastic evolution towards unbalanced activity of transcriptional corepressors suggests these enzymes as c and i date targets for inhibition aim ing to re-engage forward-differentiation . |
MS211746 | ***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 This pilot r and omized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise , spinal manipulation , and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain , a common morbidity of pregnancy . Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy . Once enrolled , they remained in the study until they had their babies . Women were r and omly allocated into one of three treatment groups using opaque envelopes . The treatment schedule paralleled the prenatal care schedule and women received individualized intervention . Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain . Our primary outcome measure was the Rol and Morris Disability Question naire and our secondary outcome measure was the Numeric Pain Rating Scale . Intention to treat analysis was conducted . For the primary analysis , regression was conducted to compare groups on the outcome measure scores . In a secondary responder analysis , difference in proportions of participants in attaining 30 % and 50 % improvement were calculated . Feasibility factors for conducting a future larger trial were also evaluated such as recruitment , compliance to study protocol s , cost , and adverse events . Results Fifty-seven participants were r and omized into the exercise ( n = 22 ) , spinal manipulation ( n = 15 ) , and Neuro Emotional Technique ( n = 20 ) treatment arms . At least 50 % of participants in each treatment group experienced clinical ly meaningful improvement in symptoms for the Rol and Morris Disability Question naire . At least 50 % of the exercise and spinal manipulation participants also experienced clinical ly meaningful improvement for the Numeric Pain Rating Scale . There were no clinical ly meaningful or statistically significant differences between groups in any analysis . Conclusions This pilot study demonstrated feasibility for recruitment , compliance , safety , and affordability for conducting a larger study in the future . Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain , but the study was not powered to detect the between-group differences as statistically significant . Trial registration Clinical Trials.gov ( Identifier : NCT00937365 ) OBJECTIVE Pregnancy-related lumbopelvic pain is a major problem for the majority of pregnant women . Complementary medicine has been used to alleviate pain , and yoga is one of the most commonly chosen alternative methods . The objective of this study was to assess the effectiveness of Hatha yoga in the reduction of lumbopelvic pain in pregnancy . METHODS A r and omized controlled trial with 60 pregnant women ( age range , 14 - 40 years ) who reported lumbopelvic pain at 12 to 32 weeks of gestation was conducted from June 2009 to June 2011 . Pregnant women who had twin pregnancies , had medical restrictions for exercise , used analgesics , and participated in physical therapy were excluded from the study . Pregnant women were divided into two groups : the yoga group , practicing exercises guided by this method , and the postural orientation group , performing st and ardized posture orientation according to instructions provided in a pamphlet . Treatment in each group lasted 10 weeks . A visual analog scale ( VAS ) was used to measure pain intensity . Lumbar pain and posterior pelvic pain provocation tests were used to confirm the presence of pain . Statistical analysis included the Mann-Whitney test , the McNemar test , a paired Wilcoxon test , and analysis of covariance . RESULTS The median pain score was lower in the yoga group ( p<.0058 ) than the postural orientation group . Lumbar pain provocation tests showed a decreased response in relation to posterior pelvic pain provocation tests and a gradual reduction in pain intensity during 10 yoga sessions ( p<.024 ) . CONCLUSIONS The yoga method was more effective at reducing lumbopelvic pain intensity compared with postural orientation OBJECTIVE To investigate the effect of an exercise program , including specific stabilizing exercises , on pain intensity and functional ability in women with pregnancy-related low back pain . METHODS Fifty women between 16 and 24 weeks of pregnancy were recruited at Tygerberg and Paarl Hospitals , Western Cape , South Africa . Twenty-six women were r and omized to a 10-week exercise program and 24 were r and omized as controls . RESULTS Overall , the most frequent type of back pain experienced was lumbar pain ( 36 [ 72.0 % ] ) . Pain intensity ( P=0.76 ) and functional ability ( P=0.29 ) were comparable between the groups on study entry . In the study group , there was a significant improvement in pain intensity ( P<0.01 ) and an improvement in functional ability ( P=0.06 ) at the end of the study . In the control group , there were no significant changes in pain intensity ( P=0.89 ) or functional ability ( P=0.70 ) at the end of the study . CONCLUSION A specific exercise program decreased back pain intensity and increased functional ability during pregnancy in South African women with lumbar and pelvic girdle pain In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias INTRODUCTION Pelvic girdle pain ( PGP ) is a universally disabling condition affecting three of 10 pregnant women . Qualitative studies on the subject are lacking . OBJECTIVE To describe pregnant women 's experiences of PGP as related to daily life . METHODS In all , 27 women with PGP participating in a r and omised controlled study were interviewed during 2010 - 2011 . Qualitative content analysis was used . RESULTS Five main categories emerged : PGP affects the ability to cope with everyday life ; Coping with motherhood ; Relationships between partners often reached the breaking point ; Question ing one 's identity as defined by profession and work , and Lessons learned from living with PGP . The categories illustrate how women 's everyday lives were interrupted . Their inability to meet their own and others ' expectations put a strain on their lives causing disappointment , sadness and frustration . It made them question and doubt their roles and identities as mothers , partners and professionals , and kept them from looking forward to future pregnancies , in the absence of effective treatment for PGP . Knowledge gained was that women with PGP should seek help immediately , listen to their bodies , and acknowledge their limitations . CONCLUSION PGP severely affects pregnant women 's everyday lives . There appears to be a lack of knowledge and awareness in general , as well as among caregivers and employers of PGP that needs to be highlighted and rectified . There is also a great need to learn how to support those suffering from it . Appropriate support during this important and rare phase in a woman 's life is highly warranted OBJECTIVE To investigate the association of muscle function and subgroups of low back pain ( no low back pain , pelvic girdle pain , lumbar pain and combined pelvic girdle pain and lumbar pain ) in relation to pregnancy . DESIGN Prospect i ve cohort study . SUBJECTS Consecutively enrolled pregnant women seen in gestational weeks 12 - 18 ( n = 301 ) and 3 months postpartum ( n = 262 ) . METHODS Classification into subgroups by means of mechanical assessment of the lumbar spine , pelvic pain provocation tests , st and ard history and a pain drawing . Trunk muscle endurance , hip muscle strength ( dynamometer ) and gait speed were investigated . RESULTS In pregnancy 116 women had no low back pain , 33 % ( n = 99 ) had pelvic girdle pain , 11 % ( n = 32 ) had lumbar pain and 18 % ( n = 54 ) had combined pelvic girdle pain and lumbar pain . The prevalence of pelvic girdle pain/combined pelvic girdle pain and lumbar pain decreased postpartum , whereas the prevalence of lumbar pain remained stable . Women with pelvic girdle pain and /or combined pelvic girdle pain and lumbar pain had lower values for trunk muscle endurance , hip extension and gait speed as compared to women without low back pain in pregnancy and postpartum ( p < 0.001 - 0.04 ) . Women with pelvic girdle pain throughout the study had lower values of back flexor endurance compared with women without low back pain . CONCLUSION Muscle dysfunction was associated with pelvic girdle pain , which should be taken into consideration when developing treatment strategies and preventive measures Objective . To study lumbopelvic pain in women r and omized to a regular exercise program during pregnancy in comparison to women receiving st and ard antenatal care . Design . A two‐armed , two‐center , r and omized controlled trial . Setting . St Olavs Hospital , Trondheim University Hospital and Stavanger University Hospital . Population . A total of 855 pregnant women were r and omized to intervention or control groups . Methods . The intervention was a 12 week exercise program , including aerobic and strengthening exercises , conducted between 20 and 36 weeks of pregnancy . One weekly group session was led by physiotherapists , and home exercises were encouraged twice a week . The control group received st and ard antenatal care . Main outcome measures . Self‐reports of lumbopelvic pain and sick leave due to lumbopelvic pain . The data were analysed according to the “ intention‐to‐treat ” principle . Results . There were no significant differences between groups of women reporting lumbopelvic pain at 36 weeks ( 74 vs. 75 % , p=0.76 ) . The proportion of women on sick leave due to lumbopelvic pain was lower in the intervention group ( 22 % vs 31 % , p=0.01 ) . Conclusions . Exercise during pregnancy does not influence the prevalence of lumbopelvic pain , but women offered a regular exercise course seem to h and le the disorder better Background Antenatal preparation programmes are recommended worldwide to promote a healthy pregnancy and greater autonomy during labor and delivery , prevent physical discomfort and high levels of anxiety . The objective of this study was to evaluate effectiveness and safety of a birth preparation programme to minimize lumbopelvic pain , urinary incontinence , anxiety , and increase physical activity during pregnancy as well as to compare its effects on perinatal outcomes comparing two groups of nulliparous women . Methods A r and omized controlled trial was conducted with 197 low risk nulliparous women aged 16 to 40 years , with gestational age ≥ 18 weeks . Participants were r and omly allocated to participate in a birth preparation programme ( BPP ; n=97 ) or a control group ( CG ; n=100 ) . The intervention was performed on the days of prenatal visits , and consisted of physical exercises , educational activities and instructions on exercises to be performed at home . The control group followed a routine of prenatal care . Primary outcomes were urinary incontinence , lumbopelvic pain , physical activity , and anxiety . Secondary outcomes were perinatal variables . Results The risk of urinary incontinence in BPP participants was significantly lower at 30 weeks of pregnancy ( BPP 42.7 % , CG 62.2 % ; relative risk [ RR ] 0.69 ; 95 % confidence interval [ CI ] 0.51 - 0.93 ) and at 36 weeks of pregnancy ( BPP 41.2 % , CG 68.4 % ; RR 0.60 ; 95%CI 0.45 - 0.81 ) . Participation in the BPP encouraged women to exercise during pregnancy ( p=0.009 ) . No difference was found between the groups regarding to anxiety level , lumbopelvic pain , type or duration of delivery and weight or vitality of the newborn infant . Conclusions The BPP was effective in controlling urinary incontinence and to encourage the women to exercise during pregnancy with no adverse effects to pregnant women or the fetuses . Trial registration Clinical trials.gov , ( NCT01155804 OBJECTIVE To investigate if water-gymnastics during pregnancy may reduce the intensity of back/low back pain and the number of days on sick-leave . METHODS A prospect i ve , r and omized study . One hundred and twenty-nine women were r and omized to participate in water-gymnastics once a week during the second half of pregnancy and 129 were r and omized to a control group . The women in both groups filled in question naires in gestational weeks 18 , 34 and within the first postpartum week . Every day from week 18 to labor they assessed the intensity of back/low back pain . RESULTS Back pain intensity increased during pregnancy . No excess risk for the pregnancy associated with water-gymnastics was observed . The women participating in water-gymnastics recorded a lower intensity of back/low back pain . The total number of days on sick-leave because of back/low back pain was 982 in
Output:
| ‘ Very low ’ to ‘ moderate ’ quality evidence from 13 r and omised controlled trials ( RCTs ) showed prenatal exercise did not reduce the odds of suffering from LBP , PGP and LBPP either in pregnancy or the postpartum period .
These findings were supported by ‘ very low ’ quality evidence from other study design s. Conclusion Compared with not exercising , prenatal exercise decreased the severity of LBP , PGP or LBPP during and following pregnancy but did not decrease the odds of any of these conditions at any time point |
MS211747 | ***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 range of patient-oriented and practitioner-oriented outcomes were used to evaluate the efficacy of " gait plate " shoe inlays in controlling symptoms associated with in-toeing in otherwise healthy children . For 18 in-toeing children , parents completed a preintervention question naire . Then , during r and omized trials , foot placement angle was measured both with and without gait plate inlays in the children 's footwear . After the children had worn the gait plates for 1 month , a simple question naire was used to rate parental satisfaction with a range of factors associated with control of symptoms . The use of gait plate inlays result ed in a small but statistically significant reduction in the amount of in-toeing as measured by foot placement angle . Gait plates reduced the reported frequency of tripping in 14 of the 18 cases . The reported parental satisfaction was high or very high in all but one case , suggesting that this intervention warrants further investigation as an alternative to " observational management " for symptomatic in-toeing OBJECTIVE . To compare the clinical efficacy of custom foot orthotics , prefabricated " off-the-shelf " shoe inserts , and supportive athletic shoes worn alone , on reducing pain and improving function for children with juvenile idiopathic arthritis ( JIA ) . METHODS Children with JIA and foot pain ( n = 40 ) were r and omized to one of 3 groups receiving : ( 1 ) custom-made semirigid foot orthotics with shock absorbing posts ( n = 15 ) , ( 2 ) off-the-shelf flat neoprene shoe inserts ( n = 12 ) , or ( 3 ) supportive athletic shoes with a medial longitudinal arch support and shock absorbing soles worn alone ( n = 13 ) . Foot pain and functional limitations were measured using the Pediatric Pain Question naire-visual analog scale ( VAS ) , Timed Walking , Foot Function Index ( FFI ) , and the Physical Functioning Subscale of the Pediatric Quality of Life Inventory ( PedsQL ) . Measures were administered by personnel blinded to group status at baseline ( before wearing the assigned intervention ) and at 3 months ' followup . RESULTS Children in the orthotics group showed significantly greater improvements in overall pain ( p = 0.009 ) , speed of ambulation ( p = 0.013 ) , activity limitations ( p = 0.002 ) , foot pain ( p = 0.019 ) , and level of disability ( p = 0.024 ) when compared with the other 2 groups . Both children and parents in the orthotics group reported clinical ly meaningful improvement in child health-related quality of life , although the group by time interaction did not show statistical significance . Except for a reduction in pain for supportive athletic shoes ( paired t test , p = 0.011 ) , neither the off-the-shelf shoe inserts nor the supportive athletic shoes worn alone showed significant effect on any of the evaluation measures . CONCLUSION In children with JIA , custom-made semirigid foot orthotics with shock-absorbing posts significantly improve pain , speed of ambulation , and self-rated activity and functional ability levels compared with prefabricated off-the-shelf shoe inserts or supportive athletic shoes worn alone Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Background : Orthoses for children with flexible excess pronation are estimated to cost Australian parents millions of dollars per year ; however , there is no high-level evidence that orthoses improve function or reduce pain . Methods : A r and omized parallel , single-blinded , controlled trial of custom-made and ready-made orthoses was conducted in children between the ages of 7 and 11 years with bilateral flexible excess pronation . The diagnosis was based on calcaneal eversion and navicular drop . Outcomes included gross motor proficiency , self-perception , exercise efficiency , and pain . Measurements were taken at baseline , and at 3 and 12 months . Of the 178 children who participated at baseline , 160 continued to the end of the trial . Results : After r and omization , baseline characteristics were similar between the three treatment groups ( custom-made , ready-made , and control ) . Statistical modeling demonstrated that although for most outcome measures there were statistically significant trends over time , none of the group comparisons were statistically significant . A sub-group analysis of those presenting with pain found no significant differences at 3 or 12 months . Conclusions : This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children In a survey of 6000 children between 9 and 10 years of age , 122 were found to have unilateral or bilateral hallux valgus . These children were r and omly assigned to no treatment or to the use of a foot orthosis . About three years later 93 again had radiography . The metatarsophalangeal joint angle had increased in both groups but more so in the treated group . During the study , hallux valgus developed in the unaffected feet of children with unilateral deformity , despite the use of the orthosis A Foot Function Index ( FFI ) was developed to measure the impact of foot pathology on function in terms of pain , disability and activity restriction . The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales . Both total and sub-scale scores are produced . The FFI was examined for test-retest reliability , internal consistency , and construct and criterion validity . A total of 87 patients with rheumatoid arthritis were used in the study . Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69 . Internal consistency ranged from 0.96 to 0.73 . With the exception of two items , factor analysis supported the construct validity of the total index and the sub-scales . Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index . The FFI should prove useful for both clinical and research purpose Pes planovalgus is an extremely common deformity and still not completely understood . Its pathogenesis and the possibilities for treating it with shoe inserts are still under debate . While the controversy between abstentionists and interventionists remains a fact , since a certain number of flat feet persist into adult age and cause disability , a new type of orthosis is proposed . This has been tested on children affected with grade III pes planovalgus and with all the worst clinical , objective and prognostic parameters . The study was carried out with a control group using traditional Lelièvre insoles . The results were extremely good and correction was achieved in a significantly higher number of patients than in the control group OBJECTIVE To assess the method ologic quality of approaches used to allocate participants to comparison groups in r and omized controlled trials from one medical specialty . DESIGN Survey of published , parallel group r and omized controlled trials . DATA SOURCES All 206 reports with allocation described as r and omized from the 1990 and 1991 volumes of four journals of obstetrics and gynecology . MAIN OUTCOME MEASURES Direct and indirect measures of the adequacy of r and omization and baseline comparisons . RESULTS Only 32 % of the reports described an adequate method for generating a sequence of r and om numbers , and only 23 % contained information showing that steps had been taken to conceal assignment until the point of treatment allocation . A mere 9 % described both sequence generation and allocation concealment . In reports of trials that had apparently used unrestricted r and omization , the differences in sample sizes between treatment and control groups were much smaller than would be expected due to chance . In reports of trials in which hypothesis tests had been used to compare baseline characteristics , only 2 % of reported test results were statistically significant , lower than the expected rate of 5 % . CONCLUSIONS Proper r and omization is required to generate unbiased comparison groups in controlled trials , yet the reports in these journals usually provided inadequate or unacceptable information on treatment allocation . Additional analyses suggest that nonr and om manipulation of comparison groups and selective reporting of baseline comparisons may have occurred
Output:
| The evidence from r and omised controlled trials is currently too limited to draw definitive conclusions about the use of non-surgical interventions for paediatric pes planus .
Only limited interventions commonly used in practice have been studied and there is much debate over the treatment of symptomatic and asymptomatic pes planus |
MS211748 | ***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 Sodium bicarbonate ( NaHCO₃ ) is often ingested at a dose of 0.3 g/kg body mass ( BM ) , but ingestion protocol s are inconsistent in terms of using solution or capsules , ingestion period , combining NaHCO₃ with sodium citrate ( Na₃C₆H₅O₇ ) , and coingested food and fluid . PURPOSE To quantify the effect of ingesting 0.3 g/kg NaHCO₃ on blood pH , [ HCO₃- ] , and gastrointestinal ( GI ) symptoms over the subsequent 3 hr using a range of ingestion protocol s and , thus , to determine an optimal protocol . METHODS In a crossover design , 13 physically active subjects undertook 8 NaHCO₃ experimental ingestion protocol s and 1 placebo protocol . Capillary blood was taken every 30 min and analyzed for pH and [ HCO₃- ] . GI symptoms were quantified every 30 min via question naire . Statistics used were pairwise comparisons between protocol s ; differences were interpreted in relation to smallest worthwhile changes for each variable . A likelihood of > 75 % was a substantial change . RESULTS [ HCO₃- ] and pH were substantially greater than in placebo for all other ingestion protocol s at almost all time points . When NaHCO3 was coingested with food , the greatest [ HCO₃- ] ( 30.9 mmol/kg ) and pH ( 7.49 ) and lowest incidence of GI symptoms were observed . The greatest incidence of GI side effects was observed 90 min after ingestion of 0.3 g/kg NaHCO₃ solution . CONCLUSIONS The changes in pH and [ HCO₃- ] for the 8 NaHCO₃-ingestion protocol s were similar , so an optimal protocol can not be recommended . However , the results suggest that NaHCO₃ coingested with a high-carbohydrate meal should be taken 120 - 150 min before exercise to induce substantial blood alkalosis and reduce GI symptoms ABSTRACT The aim of this study was to investigate the effects of sodium bicarbonate ( NaHCO3 ) on 4 km cycling time trial ( TT ) performance when individualised to a predetermined time to peak blood bicarbonate ( HCO3− ) . Eleven male trained cyclists volunteered for this study ( height 1.82 ± 0.80 m , body mass ( BM ) 86.4 ± 12.9 kg , age 32 ± 9 years , peak power output ( PPO ) 382 ± 22 W ) . Two trials were initially conducted to identify time to peak HCO3− following both 0.2 g.kg−1 BM ( SBC2 ) and 0.3 g.kg−1 BM ( SBC3 ) NaHCO3 . Thereafter , on three separate occasions using a r and omised , double-blind , crossover design , participants completed a 4 km TT following ingestion of either SBC2 , SBC3 , or a taste-matched placebo ( PLA ) containing 0.07 g.kg−1 BM sodium chloride ( NaCl ) at the predetermined individual time to peak HCO3−. Both SBC2 ( −8.3 ± 3.5 s ; p < 0.001 , d = 0.64 ) and SBC3 ( −8.6 ± 5.4 s ; p = 0.003 , d = 0.66 ) reduced the time to complete the 4 km TT , with no difference between SBC conditions ( mean difference = 0.2 ± 0.2 s ; p = 0.87 , d = 0.02 ) . These findings suggest trained cyclists may benefit from individualising NaHCO3 ingestion to time to peak HCO3− to enhance 4 km TT performance The aim of the present study was to examine the effects of sodium bicarbonate ( NaHCO3 ) administration on lower-body , hypertrophy-type resistance exercise ( HRE ) . Using a double-blind r and omized counterbalanced design , 12 resistance-trained male participants ( mean ± SD ; age = 20.3 ± 2 years , mass = 88.3 ± 13.2 kg , height = 1.80 ± 0.07 m ) ingested 0.3 g kg−1 of NaHCO3 or placebo 60 min before initiation of an HRE regimen . The protocol employed multiple exercises : squat , leg press , and knee extension , utilizing four sets each , with 10–12 repetition-maximum loads and short rest periods between sets . Exercise performance was determined by total repetitions generated during each exercise , total accumulated repetitions , and a performance test involving a fifth set of knee extensions to failure . Arterialized capillary blood was collected via fingertip puncture at four time points and analyzed for pH , [ HCO3− ] , base excess ( BE ) , and lactate [ Lac− ] . NaHCO3 supplementation induced a significant alkaline state ( pH : NaHCO3 : 7.49 ± 0.02 , placebo : 7.42 ± 0.02 , P < 0.05 ; [ HCO3− ] : NaHCO3 : 31.50 ± 2.59 , placebo : 25.38 ± 1.78 mEq L−1 , P < 0.05 ; BE : NaHCO3 : 7.92 ± 2.57 , placebo : 1.08 ± 2.11 mEq L−1 , P < 0.05 ) . NaHCO3 administration result ed in significantly more total repetitions than placebo ( NaHCO3 : 139.8 ± 13.2 , placebo : 134.4 ± 13.5 ) , as well as significantly greater blood [ Lac− ] after the exercise protocol ( NaHCO3 : 17.92 ± 2.08 , placebo : 15.55 ± 2.50 mM , P < 0.05 ) . These findings demonstrate ergogenic efficacy for NaHCO3 during HRE and warrant further investigation into chronic training applications Sodium bicarbonate ingestion has been shown to improve performance in single-bout , high intensity events , probably due to an increase in buffering capacity , but its influence on single-bout swimming performance has not been investigated . The effects of sodium bicarbonate supplementation on 200 m freestyle swimming performance were investigated in elite male competitors . Following a r and omised , double blind counterbalanced design , 9 swimmers completed maximal effort swims on 3 separate occasions : a control trial ( C ) ; after ingestion of sodium bicarbonate ( SB : NaHCO3 300 mg . kg ( -1 ) body mass ) ; and after ingestion of a placebo ( P : CaCO3 200 mg . kg ( -1 ) body mass ) . The SB and P agents were packed in gelatine capsules and ingested 90 - 60 min prior to each 200 m swim . Mean 200 m performance times were significantly faster for SB than C or P ( 1 : 52.2 + /- 4.7 ; 1 : 53.7 + /- 3.8 ; 1 : 54.0 + /- 3.6 min : ss ; p < 0.05 ) . Base excess , pH and blood bicarbonate were all elevated pre-exercise in the SB compared to C and P trials ( p < 0.05 ) . Post-200 m blood lactate concentrations were significantly higher following the SB trial compared with P and C ( p < 0.05 ) . It was concluded that SB supplementation can improve 200 m freestyle performance time in elite male competitors , most likely by increasing buffering capacity We tested the hypothesis that reducing hydrogen ion accumulation during training would result in greater improvements in muscle oxidative capacity and time to exhaustion ( TTE ) . Male Wistar rats were r and omly assigned to one of three groups ( CON , PLA , and BIC ) . CON served as a sedentary control , whereas PLA ingested water and BIC ingested sodium bicarbonate 30 min prior to every training session . Training consisted of seven to twelve 2-min intervals performed five times/wk for 5 wk . Following training , TTE was significantly greater in BIC ( 81.2 + /- 24.7 min ) compared with PLA ( 53.5 + /- 30.4 min ) , and TTE for both groups was greater than CON ( 6.5 + /- 2.5 min ) . Fiber respiration was determined in the soleus ( SOL ) and extensor digitorum longus ( EDL ) , with either pyruvate ( Pyr ) or palmitoyl carnitine ( PC ) as substrates . Compared with CON ( 14.3 + /- 2.6 nmol O(2).min(-1).mg dry wt(-1 ) ) , there was a significantly greater SOL-Pyr state 3 respiration in both PLA ( 19.6 + /- 3.0 nmol O(2).min(-1).mg dry wt(-1 ) ) and BIC ( 24.4 + /- 2.8 nmol O(2).min(-1).mg dry wt(-1 ) ) , with a significantly greater value in BIC . However , state 3 respiration was significantly lower in the EDL from both trained groups compared with CON . These differences remained significant in the SOL , but not the EDL , when respiration was corrected for citrate synthase activity ( an indicator of mitochondrial mass ) . These novel findings suggest that reducing muscle hydrogen ion accumulation during running training is associated with greater improvements in both mitochondrial mass and mitochondrial respiration in the soleus PURPOSE Fifteen males were studied before , during , and in recovery from exhaustive resistance exercise 105 min after ingesting 0.3 g.kg-1 of either a placebo ( white flour ) or sodium bicarbonate ( NaHCO3 ) . METHODS The exercise consisted of five maximal sets on a leg press machine , The load was adjusted to maintain the number of repetitions per set for each subject at approximately 12 repetitions . A significant ( P < 0.05 ) increase in pH ( 7.40 to 7.47 ) , oxygenated base excess ( OxyBE ) ( -1.3 to 4.0 mEq . L-1 ) , and bicarbonate concentration ( [ HCO3- ] ) ( 22.8 to 27.4 mM ) was achieved before exercise with the ingestion of NaHCO3 . RESULTS The exercise protocol produced significant changes in acid base status consistent with metabolic acidosis for both trials ( pH sets 1 - 5 : placebo , 7.4 to 7.26 ; NaHCO3 , 7.47 to 7.33 ) , ( OxyBE sets 1 - 5 : placebo , -1.3 to -12.3 mEq . L-1 ; NaHCO3 , 4.0 to -6.9 mEq . L-1 ) and ( [ HCO3- ] sets 1 - 5 : placebo , 22.9 to 14.0 mM ; NaHCO3 , 27.4 to 17.6 mM ) . After every set ; pH , OxyBE , and [ HCO3- ] were significantly higher in the NaHCO3 trial . Blood lactate concentration ( [ La- ] ) significantly increased throughout exercise for both trials ( [ La- ] sets 1 - 5 : placebo , 4.6 to 11.3 mM ; NaHCO3 , 4.8 to 13.4 mM ) . After sets 4 and 5 , blood [ La- ] was significantly higher in the NaHCO3 trial . Bicarbonate ingestion did not improve performance ( total repetitions : NaHCO3 = 59 + /- 3 ; placebo = 60 + /- 2 ) . CONCLUSIONS This may be a result of a lower dem and on the whole body metabolic system in comparison with that for other modes of exercise in which ergogenic effects have been found Alkalosis enhances human exercise performance , and reduces K+ loss in contracting rat muscle . We investigated alkalosis effects on K+ regulation , ionic regulation and fatigue during intense exercise in nine untrained volunteers . Concentric finger flexions were conducted at 75 % peak work rate ( 3 W ) until fatigue , under alkalosis ( Alk , NaHCO3 , 0.3 g kg(-1 ) ) and control ( Con , CaCO3 ) conditions , 1 month apart in a r and omised , double-blind , crossover design . Deep antecubital venous ( v ) and radial arterial ( a ) blood was drawn at rest , during exercise and recovery , to determine arterio-venous differences for electrolytes , fluid shifts , acid-base and gas exchange . Finger flexion exercise barely perturbed arterial plasma ions and acid-base status , but induced marked arterio-venous changes . Alk elevated [ HCO3- ] and PCO2 , and lowered [ H+ ] ( P < 0.05 ) . Time to fatigue increased substantially during Alk ( 25 + /- 8 % , P < 0.05 ) , whilst both [K+]a and [K+]v were reduced ( P < 0.01 ) and [K+]a-v during exercise tended to be greater ( P= 0.056 , n= 8) . Muscle K+ efflux at fatigue was greater in Alk ( 21.2+/- 7.6 micromol min(-1 ) , 32 + /- 7 % , P < 0.05 , n= 6 ) , but peak K+ uptake rate was elevated during recovery ( 15 + /- 7 % , P < 0.05 ) suggesting increased muscle Na+,K+-ATPase activity . Alk induced greater [Na+]a , [Cl-]v , muscle Cl- influx and muscle lactate concentration ( [ Lac-
Output:
| No significant linear trends in the effects of timing of sodium bicarbonate ingestion or acute increase in blood bicarbonate concentrations on muscular endurance or muscular strength were found .
Overall , sodium bicarbonate supplementation acutely improves muscular endurance of small and large muscle groups , but no significant ergogenic effect on muscular strength was found |
MS211749 | ***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 pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer OBJECTIVE The present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation ( TENS ) is more effective than acupuncture or TENS alone for treating chronic low back pain ( LBP ) . METHODS Thirty-two patients with chronic LBP were r and omly allocated to four groups . The acupuncture group ( ACP ) received only acupuncture treatment at selected acupoints for low back pain ; the TENS group ( TENS ) received only TENS treatment at pain areas ; the acupuncture and TENS group ( A&T ) received both acupuncture and TENS treatments ; the control group ( CT ) received topical poultice ( only when necessary ) . Each group received specific weekly treatment five times during the study . Outcome measures were pain intensity in terms of visual analogue scale ( VAS ) and QOL of low back in terms of Rol and -Morris Disability Question naire ( RDQ ) . RESULTS The ACP , TENS and A&T groups all reported lower VAS and RDQ scores . Significant reduction in pain intensity ( P<0.008 ) and significant improvement in QOL ( P<0.008 ) were shown in the A&T group . CONCLUSION Combined acupuncture and TENS treatment is effective in pain relief and QOL of low back improvement for the sample d patients suffering from chronic LBP Our aim is to investigate the effects of three therapeutic approaches in the chronic low back pain on pain , spinal mobility , disability , psychological state , and aerobic capacity . Sixty patients with chronic low back pain were r and omized to three groups : group 1 , aerobic exercise + home exercise ; group 2 , physical therapy ( hot pack , ultrasound , TENS ) + home exercise ; group 3 , home exercise only . Spinal mobility , pain severity , disability , and psychological disturbance of the patients were assessed before and after the treatment and at 1-month follow-up . Aerobic capacities of the patients were measured before and after treatment . All of the groups showed similar decrease in pain after the treatment and at 1-month follow-up , and there was no significant difference between the groups . In group 2 , a significant decrease in Beck Depression Inventory scores was observed with treatment . At 1-month follow-up , group 1 and 2 showed significant decreases in General Health Assessment Question naire scores . In group 2 , there was also a significant improvement in Rol and Morris Disability scores . There were similar improvements in exercise test duration and the MET levels in all the three groups . All of the three therapeutic approaches were found to be effective in diminishing pain and thus increasing aerobic capacity in patients with chronic low back pain . On the other h and , physical therapy + home exercise was found to be more effective regarding disability and psychological disturbance 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 UNLABELLED Transcutaneous electrical nerve stimulation ( TENS ) is an electrophysical modality used for pain management . This study investigated the dose response of different TENS intensities on experimentally induced pressure pain . One hundred and thirty TENS naïve healthy individuals ( 18 - 64 years old ; 65 males , 65 females ) were r and omly allocated to 5 groups ( n = 26 per group ) : Strong Non Painful TENS ; Sensory Threshold TENS ; Below Sensory Threshold TENS ; No Current Placebo TENS ; and Transient Placebo TENS . Active TENS ( 80 Hz ) was applied to the forearm for 30 minutes . Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds ( PPT ) were recorded from 2 points on the h and and forearm before and after TENS to measure hypoalgesia . There were significant differences between groups at both the h and and forearm ( ANOVA ; P = .005 and .002 ) . At 30 minutes , there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to : Below Sensory Threshold TENS , No Current Placebo TENS and Transient Placebo TENS groups ( P < .0001 ) at the forearm ; Transient Placebo TENS and No Current Placebo TENS groups at the h and ( P = .001 ) . There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups . The area under the curve for the changes in PPT significantly correlated with the current amplitude ( r(2 ) = .33 , P = .003 ) . These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes . PERSPECTIVE This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect ; thus , we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief CONTEXT AND OBJECTIVE Transcutaneous electrical nerve stimulation ( TENS ) and interferential current are the most used electrotherapy methods , although there is little scientific evidence to support their use . The aim of this study was to compare the effects of TENS and interferential current among patients with nonspecific chronic low back pain . DESIGN AND SETTING Single-blind r and omized controlled trial in the Department of Physiotherapy , Centro Universitário de Maringá . METHODS One hundred and fifty patients were r and omly divided into three groups : TENS ( group 1 ) , interferential current ( group 2 ) and controls ( group 3 ) . The patients design ated for electrotherapy received ten 30-minute sessions , while the control group remained untreated . All patients and controls were evaluated before and after treatment using a visual analog scale and the McGill Pain and Rol and Morris question naires , and regarding their use of additional medications . RESULTS There was a mean reduction on the visual analog scale of 39.18 mm with TENS , 44.86 mm with interferential current and 8.53 mm among the controls . In the Rol and Morris question naire , group 1 had a mean reduction of 6.59 ; group 2 , 7.20 ; and group 3 , 0.70 points . In group 1 , 84 % of the patients stopped using medications after the treatment ; in group 2 , 75 % ; and in group 3 , 34 % . There was no statistically significant difference between the TENS and interferential current groups ( P > 0.05 ) ; a difference was only found between these groups and the controls ( P < 0.0001 ) . CONCLUSION There was no difference between TENS and interferential current for chronic low back pain treatment . CLINICAL TRIAL REGISTRATION NCT01017913 This study tested the effectiveness of episodic transcutaneous electrical nerve stimulation ( TENS ) as a supplement to pharmacologic analgesia on pain with movement and at rest after abdominal surgery and evaluated whether its use during walking and vital capacity maneuvers enhances performance of these activities . TENS , with a modulated frequency , intensity as high as the subject could tolerate , and electrodes placed on either side and parallel to the incision , was compared to placebo TENS and pharmacologic analgesia alone ( control ) by using a crossover design . Self-report of pain intensity , walking function , and vital capacity were assessed on 33 subjects . TENS result ed in significantly less pain than the control during both walking ( P < .5 ) and vital capacity activities ( P < .1 ) and significantly less pain than placebo TENS during vital capacity ( P < .01 ) . TENS also produced significantly better gait speeds than the control ( P < .05 ) and greater gait distances ( P < .01 ) than the control and placebo TENS . Vital capacity and pain intensity at rest were not significantly different among the 3 treatments . These results suggest TENS reduces pain intensity during walking and deep breathing and increases walking function postoperatively when used as a supplement to pharmacologic analgesia . The lack of effect on pain at rest supports the hypothesis that TENS works through reducing hyperalgesia OBJECTIVE To investigate to what extent a single 60-minute session of transcutaneous electrical nerve stimulation ( TENS ) would modify chronic clinical pain , acute experimental pain , and the flexion reflex evoked in chronic low back pain patients . STUDY DESIGN Thirty young subjects with chronic low back pain were r and omly allocated to two groups , receiving either TENS or placebo stimulation to the lumbosacral region for 60 minutes . The flexion reflex was elicited by an electrical stimulation applied to the subject 's right sole and recorded electromyographically from the biceps femoris and the tibialis anterior muscles . MAIN OUTCOME MEASURES Subjective sensation of low back pain and the electrically induced pain were measured by two separate visual analog scales , termed VAS(LBP ) and VAS(FR ) , respectively . Data obtained before , during , and 60 minutes after TENS and placebo stimulations were analyzed using repeated measures ANOVA . RESULTS The VAS(LBP ) score was significantly reduced to 63.1 % of the prestimulation value after TENS ( p<.001 ) , but the reduction was negligible after placebo stimulation ( to 96.7 % , p = .786 ) . In contrast , no significant change was found in the VASFR score ( p = .666 ) and the flexion reflex area ( p = .062 ) during and after stimulation within each group and between the two groups ( p = .133 for VASFR and p = .215 for flexion reflex area ) . CONCLUSIONS The same TENS protocol had different degrees of antinociceptive influence on chronic and acute pain in chronic low back pain patients OBJECTIVE This study examined the optimal stimulation duration of transcutaneous electrical nerve stimulation ( TENS ) for relieving osteoarthritic knee pain and the duration ( as measured by half-life ) of post-stimulation analgesia . SUBJECTS Thirty-eight patients received either : ( i ) 20 minutes ( TENS20 ) ; ( ii ) 40 minutes ( TENS40 ) ; ( iii ) 60 minutes ( TENS60 ) of TENS ; or ( iv ) 60 minutes of placebo TENS ( TENS(PL ) ) 5 days a week for 2 weeks . METHODS A visual analogue scale recorded the magnitude and pain relief period for up to 10 hours after stimulation . RESULTS By Day10 , a significantly greater cumulative reduction in the visual analogue scale scores was found in the TENS40 ( 83.40 % ) and TENS60 ( 68.37 % ) groups than in the TENS20 ( 54.59 % ) and TENS(PL ) ( 6.14 % ) groups ( p < 0.000 ) , such a group difference was maintained in the 2-week follow-up session ( p < 0.000 ) . In terms of the duration of post-stimulation analgesia period , the duration for the TENS40 ( 256 minutes ) and TENS60 ( 258 minutes ) groups was more prolonged than in the other 2 groups ( TENS20 = 168 minutes , TENS(PL ) = 35 minutes ) by Day10 ( p < 0.000 ) . However , the TENS40 group produced the longest pain relief period by the follow-up session . CONCLUSION 40 minutes is the optimal treatment duration of TENS , in terms of both the magnitude ( VAS scores ) of pain reduction and the duration of post-stimulation analgesia for knee osetoarthritis BACKGROUND AND PURPOSE It is not fully understood how transcutaneous electrical nerve stimulation ( TENS ) intensity affects mechanical pain threshold . METHOD Sixty-six healthy volunteers ( 13 male , 53 female ; 132 h and s ) without prior experience of TENS participated in the study , which comprised a r and omized single-blind controlled trial . TENS was administered for 20 minutes through electrodes ( 25 x 25 mm ) placed on the h and s and forearms with a fixed frequency of 100 Hz and pulse duration of 150 micros . TENS intensity was r and omized and allocated in a concealed manner so that one arm received TENS with stimulation intensity set at participants ' subjective sensory threshold and the other received TENS with stimulation intensity continuously adjusted by physiotherapists to a strong but comfortable non-painful stimulation . Observers were blinded to stimulation intensity levels . RESULTS Mechanical pain threshold increased significantly , by a mean total of 0.79 kg/cm2 ( 95 % confidence interval [ 95 % CI ] : 0.54 - 1.04 ) ( p < 0.001 ) on the strong but comfortable non-painful stimulation side .
Output:
| Analysis for adequate stimulation parameters was not significantly different , and there was no effect on disability . |
MS211750 | ***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 interactive CD-ROM program design ed to reduce adolescent substance use was developed and evaluated . The program uses video vignettes to teach refusal skills and socially acceptable responses to substance use situations , specifically offers of marijuana . In a r and omized pretest-to-posttest experiment with 74 public school students from six classes in three high schools , significant changes were observed at posttest on ( 1 ) the adolescent 's personal efficacy to refuse the offer of marijuana , ( 2 ) the adolescent 's intention to refuse marijuana if offered , and ( 3 ) the adolescent 's perceptions of the social norms associated with substance use and the importance of respecting another 's decision to refuse a drug offer . In addition , adolescents in the treatment condition were able to recall approximately 50 % of the portrayed refusal strategies . Findings are discussed with regard to the potential benefits of an interactive multimedia approach for conducting substance use interventions We sought to characterize attrition-related characteristics of three subgroups of adults ( i.e. early dropouts , late dropouts , treatment completers ) who had participated in a marijuana-dependence treatment outcome study involving two alternative forms of outpatient group counseling . Early dropouts were younger , earned less income , were more likely to rent rather than own their domiciles , were less able to pay bills , and had a higher level of psychological distress than was the case with treatment completers . Late dropouts and completers were quite similar on a number of measures ( e.g. , age , income , home ownership , ability to pay bills , psychological stress level , confidence in being abstinent in the future ) , yet the lower rates of abstinence in the late dropouts largely resembled the treatment outcomes of early dropouts . The findings suggest that attrition prevention in the early phase of counseling ought to focus on motivational ambivalence as well as assisting the client in dealing with schedule conflicts or financial impediments to continued involvement . In the later stage of counseling , attrition reduction is more likely to be accomplished through efforts to better underst and and address the client 's dissatisfaction with treatment components delivered at that stage AIMS Our objective was to identify client characteristics and other factors associated with pre-treatment drop-out by people with marijuana dependence . DESIGN AND PARTICIPANTS Data from the Marijuana Treatment Project 's screening assessment were used to examine correlates of pre-treatment drop-out . Information from all eligible study participants ( n = 813 ) ( i.e. those who were interested in receiving treatment for their marijuana dependence and were determined to be eligible for the r and omized treatment efficacy trial ) was used to examine differences between the 450 participants who initiated treatment ( by enrolling in the trial ) and the 363 individuals who declined enrollment . SETTING The study was conducted at three community-based outpatient treatment facilities in Farmington , CT , Seattle , WA and Miami , FL . MEASUREMENTS The information gathered in the screening interview included demographic characteristics , residential stability variables , employment and education history and referral source . Substance use variables included the number of days and the number of times per day marijuana was used , self-perceived dependence on marijuana , alcohol or other drugs , other drug use history and current treatment ( i.e. substance abuse , medical , psychiatric ) situation . FINDINGS Stepwise logistic regression was conducted to confirm variables associated with treatment initiation in bivariate analyses . Pre-treatment drop-out was associated with being younger , unmarried , unemployed , less educated and Asian American or Native American . It was also associated with self-perceived dependence on marijuana and use of other drugs . CONCLUSIONS By recognizing demographic and substance use factors that may serve as barriers for individuals accessing treatment for marijuana dependence , clinicians may target clients with these characteristics proactively to encourage treatment initiation and subsequent attendance The effects of fasting on the intake and subjective effects of marijuana were studied in five marijuana smokers . A within-subjects design was used in which subjects smoked either active ( 0.8 and 3.6 % THC ) or placebo ( 0.0 % THC ) marijuana after eating normally or after fasting for 24 hr . Six experimental sessions were conducted in a r and omized order . Each 3-hr . session consisted of two periods : a sampling period in which subjects took 4 controlled puffs from a cigarette of a given potency , followed about one hour later by a 30-min . self-administration period , in which subjects could smoke as much or as little of the sample d marijuana as desired . Subjective and physiological measures ( i.e. , carbon monoxide level and heart rate ) were assessed before and 5 , 20 , and 60 min . after the four puffs during the sampling period . During the self-administration period , the number of puffs taken was recorded . Dose-dependent effects of marijuana , such as elevated heart rate and “ high ” ratings , were observed during the sampling period , but these effects of marijuana were not affected by the feeding manipulation . Subjects varied widely in their marijuana self-administration , but self-administration was not systematic ally affected by fasting . We conclude that an acute period of food deprivation does not affect the mood-altering effects of different potencies of marijuana . We could not adequately demonstrate whether fasting increases the reinforcing efficacy of marijuana , since self-administration rate of active marijuana did not exceed that of placebo marijuana self-administration One hundred and fifty five drug-dependent women in an urban hospital emergency room in Detroit , Michigan , were the subjects for this 3-year exploratory field study . Subjects were women who told the emergency room staff that while they wanted assistance with their presenting health problems , they wanted no assistance with their drug addiction . The women were r and omly assigned to either the experimental or control study group . Both groups received a pretest in the emergency room , a posttest between 8 and 12 weeks after their emergency room visit , and a follow-up test 6 months after the posttest . In addition , the experimental women were seen by project nurses , primarily in their homes , for a maximum of eight visits on a once-a-week basis . The experimental women were treated using " Personalized Nursing , " a nursing intervention model , which focused on providing assistance for client-identified concerns . It was hypothesized that interaction with the Personalized Nursing Intervention Model would be associated with : a decrease in daily drug cost and a decrease in perceived stress . Results show that while there were no differences between the study groups at the pretest interview , the experimental group reported a lower daily drug cost ( F(1 , 95 ) = 2.90 ; p = 0.09 ) , a lower daily heroin cost ( U = 165 ; p = .01 ) , less perceived stress ( F(1 , 84 ) = 3.00 ; p = .09 ) and emotional distress ( F(1 , 83 ) = 3.70 ; p = .06 ) than control subjects at the 8-week posttest . The experimental subjects also reported less perceived stress ( t(65 ) = -2.35 ; p = .02 ) at 6-month follow-up than control subjects . It was found that results could be improved if members of the experimental clients ' social networks were treated simultaneously and if project nurses were correctly utilizing the model . Implication s for substance abuse treatment programs are discussed . The encouraging results of this exploratory study warrant follow-up and replication This study investigated the efficacy of brief strategic family therapy ( BSFT ) with Hispanic behavior problem and drug using youth , an underrepresented population in the family therapy research literature . One hundred twenty-six Hispanic families with a behavior problem adolescent were r and omly assigned to 1 of 2 conditions : BSFT or group treatment control ( GC ) . Results showed that , compared to GC cases , BSFT cases showed significantly greater pre- to post-intervention improvement in parent reports of adolescent conduct problems and delinquency , adolescent reports of marijuana use , and observer ratings and self reports of family functioning . These results extend prior findings on the efficacy of family interventions to a difficult to treat Hispanic adolescent sample BACKGROUND The present study addresses diffusion of a psychosocial-based substance abuse prevention program , including : ( a ) teacher adoption , implementation , and maintenance ; ( b ) teacher characteristics associated with implementation ; ( c ) the relationship between integrity of program delivery and program outcomes ; and ( d ) the effectiveness of teacher training and school principal involvement in increasing implementation . METHODS Participants were teachers ( n = 60 ) , school principals ( n = 25 ) , and fifth- grade students ( n = 1147 ) from four Los Angeles area school districts . Districts were r and omly assigned to an intensive or brief teacher training condition . Schools were r and omly assigned to a principal-intervention or a no-principal-intervention condition . Assessment s included teacher and principal self-reports , classroom observations of program delivery , and evaluation of immediate program outcomes . RESULTS During the first year , 78 % of trained teachers implemented one or more program lessons . During the second year , only 25 % maintained implementation of the program . Implementors reported fewer years of teaching experience and stronger self-efficacy , enthusiasm , preparedness , teaching methods compatibility , and principal encouragement than did nonimplementors . The principal intervention increased rates of implementation , but the intensive teacher training did not . Integrity of program delivery was positively associated with immediate program outcomes . CONCLUSIONS Program implementation was highly variable , suggesting that widespread teacher use of psychosocial-based programs can not be taken for granted . Strategies for increasing implementation and maintenance need to be developed R and om assignment was made of 182 clinical ly referred marijuana- and alcohol-abusing adolescents to one of three treatments : multidimensional family therapy ( MDFT ) , adolescent group therapy ( AGT ) , and multifamily educational intervention ( MEI ) . Each treatment represented a different theory base and treatment format . All treatments were based on a manual and were delivered on a once-a-week outpatient basis . The therapists were experienced community clinicians trained to model-specific competence prior to the study and then supervised throughout the clinical trial . A theory-based multimodal assessment strategy measured symptom changes and prosocial functioning at intake , termination , and 6 and 12 months following termination . Results indicate improvement among youths in all three treatments , with MDFT showing superior improvement overall . MDFT participants also demonstrated change at the 1-year follow-up period in the important prosocial factors of school/academic performance and family functioning as measured by behavioral ratings . Results support the efficacy of MDFT , a relatively short-term , multicomponent , multitarget , family-based intervention in significantly reducing adolescent drug abuse and facilitating adaptive and protective developmental processes The increasing dem and for cannabis dependence treatment has led to the identification of significant gaps in the knowledge of effective interventions . A r and omized controlled trial of brief cognitive-behavioral interventions ( CBT ) for cannabis dependence was undertaken to address this issue . A total of 229 participants were assessed and allocated to either a 6-session CBT program , a single-session brief intervention , or a delayed-treatment control group . This paper demonstrates that individuals with cannabis use disorder will present for a brief intervention program . While they report similar patterns of cannabis use to nontreatment sample s , they report a range of serious health and psychosocial consequences . While they appear relatively socially stable , they typically demonstrated severe cannabis dependence and significantly elevated levels of psychological distress , with the most commonly cited reason for cannabis use being stress relief . There were clinical ly relevant gender differences among the sample . This study provides more evidence of the dem and for , and nature of issues relevant to , interventions for cannabis use disorders , and supports the need for further research into how best to assist individuals with these disorders We have examined whether practitioner ratings ( immediately post-intervention ) or other recorded characteristics of a single-session 1-hour motivational intervention were predictive of 3-month cannabis use outcome . In the context of a cluster r and omized trial involving 200 non help-seeking illegal drug users ( age range 16 - 20 ) , 105 were r and omized to the intervention , of whom 97 ( 92 % ) were interviewed for followup at 3 months , 96 of whom were current cannabis users at study entry . Six intervention characteristics and seven practitioner ratings as well as patterns of self-motivational statements were investigated in relation to substantial change in use , ( which was defined as cessation or reduction by more than 50 % ) . Both practitioner ratings post-session , and also the subject 's own elicited self-motivational statements , were found to be predictive of outcome 3 months later . The strongest predictor of substantial change , however , was simply whether change had been discussed during the session . On the basis of the above findings , it does indeed appear possible for outcome to be predicted by the motivational interviewing practitioner immediately following delivery of the intervention , on the basis of simple observations and ratings . This area warrants more specific study This study presents one-year follow-up data from an evaluation study testing the effectiveness of a cognitive-behavioral substance abuse prevention approach which emphasizes the teaching of social resistance skills within the larger context of an intervention design ed to enhance general social and personal competence . The follow-up study involved 998 eighth grade rs from 10 suburban New York junior high schools . Two schools were assigned to each of the following conditions ( a ) peer-led intervention , ( b ) peer-led intervention with booster sessions , ( c ) teacher-led intervention , ( d ) teacher-led intervention with booster sessions , and ( e ) control . The original intervention was implemented in the seventh grade ; the booster intervention was implemented during the eighth grade . Results indicate that this type of prevention strategy , when implemented by peer leaders in the seventh grade and when additional booster sessions are provided during the eighth grade , can reduce tobacco , alcohol , and marijuana use . Similar effects are evident for females when the prevention program is implemented with fidelity by classroom teachers . Moreover , the prevention program is also capable of producing a significant impact on several hypothesized mediating variables OBJECTIVE To evaluate the long-term efficacy of a school-based approach to drug abuse prevention . DESIGN R and omized trial involving 56 public schools that received the prevention program with annual
Output:
| The six included studies suggested that counseling approaches might have beneficial effects for the treatment of cannabis dependence .
Group and individual sessions of cognitive behavioral therapy ( CBT ) had both efficacy for the treatment of cannabis dependence and associated problems , CBT produced better outcomes than a brief intervention when CBT was delivered in individual sessions .
Abstinence rates were relatively small overall but favored the individual CBT 9-session ( or more ) condition .
All included trials reported a statistically significant reductions in frequency of cannabis use and dependence symptoms .
But other measures of problems related to cannabis use were not consistently different .
The studies comparing different therapeutic modalities raise important questions about the duration , intensity and type of treatment .
However , the low abstinence rate indicated that cannabis dependence is not easily treated by psychotherapies in outpatient setting |
MS211751 | ***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 There has been considerable interest recently in developing and evaluating interventions to increase research use by clinicians . However , most work has focused on medical practice s ; and nursing is not well represented in existing systematic review s. The purpose of this article is to report findings from a systematic review of interventions aim ed at increasing research use in nursing . Objective To assess the evidence on interventions aim ed at increasing research use in nursing . Methods A systematic review of research use in nursing was conducted using data bases ( Medline , CINAHL , Healthstar , ERIC , Cochrane Central Register of Controlled Trials , and Psychinfo ) , grey literature , ancestry search ing ( Cochrane Data base of Systematic Review s ) , key informants , and manual search ing of journals . R and omized controlled trials and controlled before- and after- studies were included if they included nurses , if the intervention was explicitly aim ed at increasing research use or evidence -based practice , and if there was an explicit outcome to research use . Method ological quality was assessed using pre-existing tools . Data on interventions and outcomes were extracted and categorized using a pre-established taxonomy . Results Over 8,000 titles were screened . Three r and omized controlled trials and one controlled before- and after- study met the inclusion criteria . The method ological quality of included studies was generally low . Three investigators evaluated single interventions . The most common intervention was education . Investigators measured research use using a combination of surveys ( three studies ) and compliance with guidelines ( one study ) . Research er-led educational meetings were ineffective in two studies . Educational meetings led by a local opinion leader ( one study ) and the formation of multidisciplinary committees ( one study ) were both effective at increasing research use . Conclusion Little is known about how to increase research use in nursing , and the evidence to support or refute specific interventions is inconclusive . To advance the field , we recommend that investigators : ( 1 ) use theoretically informed interventions to increase research use , ( 2 ) measure research use longitudinally using theoretically informed and psychometrically sound measures of research use , as well as , measuring patient outcomes relevant to the intervention , and ( 3 ) use more robust and method ologically sound study design s to evaluate interventions . If investigators aim to establish a link between using research and improved patient outcomes they must first identify those interventions that are effective at increasing research use BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved & NA ; This paper presents the results of a detailed study of the pain epidemiology and health related quality of life ( HRQL ) in 150 chronic non‐malignant pain patients consecutively referred to a Danish multidisciplinary pain center . Mean pain severity was 71.6 ( SD=18.5 ) on the VAS scale . Forty‐two percent reported poor quality of sleep . HRQL was evaluated with the Medical Outcome Study ‐Short Form ( SF‐36 ) , the Hospital Anxiety and Depression scale ( HAD ) and the Psychological General Well‐Being Scale ( PGWB ) . Compared with the normal population ( NP ) both SF‐36 scores and PGWB scores were significantly reduced ( P<0.001 ) indicating that physical , psychological and social well‐being were severely reduced . On the HAD scale 58 % were found to have a depressive or anxiety disorder . Statistically significant but modest correlations were found between pain severity and HRQL . Psychological and social well‐being was closely correlated . Sixty‐three percent of the referred patients had neurogenic pain conditions . Of these , only 25 % were treated with antidepressants or anticonvulsants at referral . Seventy‐three percent were treated with opioids at referral . Mean opioid consumption was 64 mg of morphine per day ( range 1–280 mg ) . Compared with the NP the chronic pain patients had used the health care system five times more often in the years prior to referral ( P<0.001 ) . The study confirms the severe multidimensional impact of chronic pain and demonstrates that HRQL of chronic non‐malignant pain patients is among the lowest observed for any medical condition Purpose The Canadian STOP-PAIN Project was design ed to document the human and economic burden of chronic pain in individuals on waitlists of Multidisciplinary Pain Treatment Facilities ( MPTF ) . This paper describes the societal costs of their pain . Methods A subgroup of 370 patients was selected r and omly from The Canadian STOP-PAIN Project . Participants completed a self-administered costing tool ( the Ambulatory and Home Care Record ) on a daily basis for three months . They provided information about publicly financed re sources , such as health care professional consultations and diagnostic tests as well as privately financed costs , including out-of-pocket expenditures and time devoted to seeking , receiving , and providing care . To determine the cost of care , re sources were valued using various costing methods , and multivariate linear regression was used to predict total cost . Results Overall , the median monthly cost of care was $ 1,462 ( CDN ) per study participant . Ninety-five percent of the total expenditures were privately financed . The final regression model consisted of the following determinants : educational level , employment status , province , pain duration , depression , and health-related quality of life . This model accounted for 35 % of the variance in total expenditure ( P < 0.001 ) . Conclusion The economic burden of chronic pain is substantial in patients on waitlists of MPTFs . Consequently , it is essential to consider this burden when making decisions regarding re source allocation and waitlist assignment for a MPTF . Re source allocation decision-making should include the economic implication s of having patients wait for an assessment and for care . RésuméObjectifLe projet canadien STOP-PAIN a été élaboré afin de documenter le fardeau humain et économique que représentait la douleur chronique pour les personnes se trouvant sur les listes d’attente des établissements pluridisciplinaires de traitement de la douleur ( MPTF – Multidisciplinary Pain Treatment Facilities ) . Cet article décrit les coûts sociétaux de leur douleur . MéthodeUn sous-groupe de 370 patients a été aléatoirement choisi parmi les participants au projet canadien STOP-PAIN . Les participants ont rempli quotidiennement un outil auto-administré de calcul des coûts ( le fichier de soins ambulatoires et à domicile - Ambulatory and Home Care Record ) pendant trois mois . Ils ont fourni des renseignements concernant les res sources financées par le secteur public , comme par exemple les consultations auprès de professionnels de la santé et les tests diagnostiques , ainsi que les coûts privés , notamment les sorties effectives d’argent et le temps consacré à chercher , recevoir et fournir des soins . Afin de déterminer le coût des soins , les res sources ont été estimées à l’aide de plusieurs méthodes de calcul des coûts , et une analyse par régression linéaire multivariée a été appliquée afin d’estimer le coût total . RésultatsGlobalement , le coût mensuel moyen des soins était de 1462 $ ( CDN ) par participant à l’étude . Quatre-vingt-quinze pour cent des dépenses totales étaient prises en charge de façon privée . Le modèle de régression final était composé des déterminantes suivantes : niveau d’éducation , situation d’emploi , province , durée de la douleur , dépression , et qualité de vie par rapport à la santé . Ce modèle a justifié 35 % de la variance des dépenses totales ( P < 0,001 ) . Conclusion Le fardeau économique que représente la douleur chronique est substantiel pour les patients sur les listes d’attente des MPTF . Pour cette raison , il est nécessaire de tenir compte de ce fardeau lors de la prise de décision concernant l’attribution des res sources et l’affectation à la liste d’attente d’un MPTF . La prise de décision concernant l’attribution des res sources devrait inclure les implication s économiques liées à l’attente des patients pour une évaluation de leur état et pour les soins Study Design . A r and omized clinical trial . Objectives . To evaluate long-term clinical and economical effects of a light mobilization program on the duration of sick leave for patients with subacute low back pain . Summary of Background Data . Twelve-month follow-up results from a previous study showed that early intervention with examination at a spine clinic , giving the patients information , reassurance , and encouragement to engage in physical activity as normal as possible had significant effect in reducing sick leave . At 12-month follow-up , 68.4 % in the intervention group were off sick leave , as compared with 56.4 % in the control group . Patients in this study were followed-up for a period of 3 years to investigate possible long-term effects . Material s and Methods . Four hundred fifty-seven patients placed on a sick list for 8 to 12 weeks for low back pain were r and omized into two groups : an intervention group ( n = 237 ) and a control group ( n = 220 ) . The intervention group was examined at a spine clinic and given information and advice to stay active . The control group was not examined at the clinic but was treated within the primary health care . Results . Over the 3 years of observation , the intervention group had significantly fewer days of sickness compensation ( average 125.7 d/person ) than the control group ( 169.6 d/person ) . This difference is mainly caused by a more rapid return to work during the first year . There was no significant difference for the second or third year . In particular , there is no increased risk for reoccurrence of illness from early return to work . At 6-month follow-up , patients in the intervention group were less likely to use bed rest and more likely to use stretching and walking to cope with their back pain compared with the control group . This effect diminished . At 12-month follow-up , the only significant difference between the groups was in the use of stretching . Economic returns of the intervention were calculated in terms of increases in the net present value of production for the society because of the reduction in number of days on sick leave . Net benefits accumulated over 3 years of treating the 237 patients in the intervention group amount to approximately $ 2,822 per person . Conclusions . For patients with subacute low back pain , a brief and simple early intervention with examination , information , reassurance , and encouragement to engage in physical activity as normal as possible had economic gains for the society . The effect occurred during the first year after intervention . There were no significant long-term effects of the intervention . The initial gain obtained during the first year does not lead to any increased costs or increased risks for reoccurrence of illness over the next 2 years OBJECTIVE To assess the prevalence , treatment and impact of chronic pain in Canada . METHODS A stratified r and om sample of 2012 adult Canadians ( weighted by sex , age and region according to 1996 census data ) was surveyed by telephone in 2001 to determine the prevalence of chronic pain , defined as continuous or intermittent pain for at least six months . A second sample of 340 chronic pain sufferers who were taking prescription medication for their pain was studied in detail to determine current therapeutic approaches and to assess the social and economic impact of chronic pain . RESULTS Chronic noncancer pain was reported by 29 % of the respondents , with increased frequency in women and older age groups . The average duration of pain was 10.7 years and the average intensity was 6.3 ( on a scale from 1 to 10 ) , with 80 % reporting moderate or severe pain . Anti-inflammatory agents were prescribed for 49 % of respondents and opioid analgesics were prescribed for 22 % ( two-thirds of these were codeine ) . Almost 70 % were worried about addiction potential , and one-third felt that strong analgesics should be reserved for terminal illnesses . Almost one-half were unable to attend social and family events , and the mean number of days absent from work in the past year due to chronic pain was 9.3 . INTERPRETATION Chronic noncancer pain is common in Canadian adults and has a major social and economic impact . Despite growing evidence supporting the efficacy and safety of major opioid analgesics for chronic noncancer pain , less than 10 % of chronic pain patients taking prescription medication were treated with a major opioid . Chronic pain is undertreated in Canada , and major opioid analgesics are probably underutilized in the management of moderate to severe pain as part of a multidisciplinary treatment program BACKGROUND Similar to other countries worldwide , Scotl and lacked a national view of whether the quality of the physiotherapy management of low back pain was compliant with national guidelines . Anecdotal evidence suggested that st and ards of care varied considerably despite the wide availability of clinical guidelines to clinicians . AIM To develop a framework that supports National Health Service ( NHS ) Scotl and in providing consist
Output:
| Interactive KT education for health care providers has a positive effect on patients ' function , but its benefits for other health provider- and patient-related outcomes are inconsistent .
Interactive education for patients leads to improvements in knowledge and function .
Little research evidence supports the effectiveness of structural changes in health systems and quality improvement processes or coordination of care .
CONCLUSIONS KT interventions incorporating interactive education in chronic noncancer pain led to positive effects on patients ' function and knowledge about pain . |
MS211752 | ***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 Collaboration between physicians and pharmacists is one approach to address drug-related morbidity and achieve therapeutic goals . A collaborative practice of pharmaceutical care has been used in the Fairview Clinics System of Minneapolis-St Paul since 1999 . METHODS The quality of therapeutic determinations made by pharmacists within this collaborative practice of pharmaceutical care was studied by a 12-member panel of physicians and pharmacists who used r and omly selected patient records . This was a quality improvement and care process validation component of a study evaluating the effects of drug therapy management in patients receiving prepaid medical assistance . An implicit review process was used to evaluate the clinical credibility of therapeutic determinations made by pharmaceutical care practitioners . RESULTS A total of 5780 drug therapy problems were resolved for 2524 patients receiving pharmaceutical care . The rate of therapeutic goals achieved increased from 74 % at the time of patients ' initial pharmaceutical care encounters to 89 % at patients ' latest encounters . In this quality assessment analysis panel members performed a total of 4779 evaluations of clinical decisions . Panelists indicated agreement with the evaluations in 94.2 % of cases , expressed a neutral opinion in 3.6 % of cases , and disagreed in 2.2 % of cases . Intraclass correlation coefficients ranged from 0.73 to 0.85 . CONCLUSIONS The decisions made by pharmaceutical care practitioners working in collaboration with physicians to provide drug therapy management services are clinical ly credible based on the evaluations and comments of a peer review panel . This study provides information on the quality of care provided by pharmacists when collaborating with physicians to provide drug therapy management services OBJECTIVES to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients . DESIGN r and omized controlled trial . SUBJECTS AND SETTING S we r and omized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care . INTERVENTIONS the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient . A copy was given to the patient and to all relevant professionals and carers . This was followed by a domiciliary assessment by a community pharmacist . In the control group , patients were discharged from hospital following st and ard procedures that included a discharge letter to the general practitioner listing current medications . OUTCOMES the primary outcome was re-admission to hospital within 6 months . Secondary outcomes included the number of deaths , attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period , together with patients ' general well-being , satisfaction with the service and knowledge of and adherence to prescribed medication . RESULTS we recruited 362 patients , of whom 181 were r and omized to each group . We collected hospital and general practice data on at least 91 and 72 % of patients respectively at each follow-up point and interviewed between 43 and 90 % of the study subjects . There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months . There were no significant differences in any of the secondary outcomes . CONCLUSIONS we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes The effect of clinical pharmacy services on prescribing patterns and drug costs for nonsteroidal anti-inflammatory drugs ( NSAIDs ) and salicylates in a primary -care clinic operated by a health-maintenance organization ( HMO ) was studied . Two pharmacists provided clinical services to a r and omly selected cluster of family practice physicians in the HMO for six months . A second family practice cluster served as a control group . The pharmacists alerted prescribers to the availability of low-cost alternatives ( such as ibuprofen and salicylates ) and review ed the medication profiles of patients receiving high-cost NSAIDs . Data were collected for both physician clusters for nine months before and six months after the pharmacists ' intervention . Changes in the mean numbers of prescriptions for ibuprofen and piroxicam per 1000 enrollees per physician in the baseline and evaluation periods were not significantly different between the two groups . Significantly more prescriptions for salicylates were written by physicians in the intervention group than in the control group during the evaluation period . Annualized mean drug ingredient costs per enrollee and per prescription for NSAIDS and salicylates decreased during the evaluation period in both groups , but these differences were not significant . In relatively unstructured interactions with physicians and nurses , clinical pharmacists were not able to reduce the costs associated with NSAIDs but did have a modest effect on altering salicylate prescribing patterns . This clinical pharmacy program was not economically self-sustaining during the first six months of operation , since operating costs exceeded anticipated savings Purpose To examine the impact of systematic medication reconciliations upon hospital admission and of a medication review while in hospital on the number of inappropriate medications and unscheduled drug-related hospital revisits in elderly patients . Methods This was a prospect i ve , controlled study in 210 patients , aged 65 years or older , who were admitted to one of three internal medicine wards at a University Hospital in Sweden . Intervention patients received the complete Lund Integrated Medicines Management model ( medication reconciliation upon admission and discharge , and medication review and monitoring ) provided by a multi-professional team , including a clinical pharmacist . Control patients received st and ard care and medication reconciliation upon discharge . Blinded review ers evaluated the appropriateness of the prescribing ( using the Medication Appropriateness Index ) on admission and discharge , and assessed the probability that a drug-related problem was the reason for any patient readmitted to hospital or visiting the emergency department within 3 months of discharge ( using World Health Organisation causality criteria ) . Results There was a greater decrease in the number of inappropriate drugs in the intervention group than in the control group for both the intention-to-treat population { 51 % [ 95 % confidence interval ( CI ) 43–58 % ] vs. 39 % ( 95 % CI 30–48 % ) ; p = 0.0446 } and the per- protocol population [ 60 % ( 95 % CI 51–67 % ) vs. 44 % ( 95 % CI 34–52 % ) ; p = 0.0106 ) ] . There were six revisits to hospital in the intervention group which were judged as ‘ possibly , probably or certainly drug-related ’ , compared with 12 in the control group ( p = 0.0469 ) . Conclusions In this study , medication reconciliation and review provided by a clinical pharmacist in a multi-professional team significantly reduced the number of inappropriate drugs and unscheduled drug-related hospital revisits among elderly patients BACKGROUND The pharmaceutical care approach serves as a model for medication review , involving collaboration between GPs , pharmacists , patients , and carers . Its use is advocated with older patients who are typically prescribed several drugs . However , it has yet to be thoroughly evaluated . AIM To estimate the effectiveness of pharmaceutical care for older people , shared between GPs and community pharmacists in the UK , relative to usual care . DESIGN OF STUDY Multiple interrupted time-series design in five primary care trusts which implemented pharmaceutical care at 2-month intervals in r and om order . Patients acted as their own controls , and were followed over 3 years including their 12 months ' participation in pharmaceutical care . SETTING In 2002 , 760 patients , aged > or = 75 years , were recruited from 24 general practice s in East and North Yorkshire . Sixty-two community pharmacies also took part . A total of 551 participants completed the study . METHOD Pharmaceutical care was undertaken by community pharmacists who interviewed patients , developed and implemented pharmaceutical care plans together with patients ' GPs , and thereafter undertook monthly medication review s. Pharmacists and GPs attended training before the intervention . Outcome measures were the UK Medication Appropriateness Index , the Short Form-36 Health Survey ( SF-36 ) , and serious adverse events . RESULTS The intervention did not lead to any statistically significant change in the appropriateness of prescribing or health outcomes . Although the mental component of the SF-36 decreased as study participants become older , this trend was not affected by pharmaceutical care . CONCLUSION The RESPECT model of pharmaceutical care ( R and omised Evaluation of Shared Prescribing for Elderly people in the Community over Time ) shared between community pharmacists and GPs did not significantly change the appropriateness of prescribing or quality of life in older patients BACKGROUND Studies have demonstrated that blood pressure ( BP ) control can be improved when clinical pharmacists assist with patient management . The objective of this study was to evaluate if a physician and pharmacist collaborative model in community-based medical offices could improve BP control . METHODS This was a prospect i ve , cluster r and omized , controlled clinical trial with clinics r and omized to a control group ( n = 3 ) or to an intervention group ( n = 3 ) . The study enrolled 402 patients ( mean age , 58.3 years ) with uncontrolled hypertension . Clinical pharmacists made drug therapy recommendations to physicians based on national guidelines . Research nurses performed BP measurements and 24-hour BP monitoring . RESULTS The mean ( SD ) guideline adherence scores increased from 49.4 ( 19.3 ) at baseline to 53.4 ( 18.1 ) at 6 months ( 8.1 % increase ) in the control group and from 40.4 ( 22.6 ) at baseline to 62.8 ( 13.5 ) at 6 months ( 55.4 % increase ) in the intervention group ( P = .09 for adjusted between-group comparison ) . The mean BP decreased 6.8/4.5 mm Hg in the control group and 20.7/9.7 mm Hg in the intervention group ( P < .05 for between-group systolic BP comparison ) . The adjusted difference in systolic BP was -12.0 ( 95 % confidence interval [ CI ] , -24.0 to 0.0 ) mm Hg , while the adjusted difference in diastolic BP was -1.8 ( 95 % CI , -11.9 to 8.3 ) mm Hg . The 24-hour BP levels showed similar effect sizes . Blood pressure was controlled in 29.9 % of patients in the control group and in 63.9 % of patients in the intervention group ( adjusted odds ratio , 3.2 ; 95 % CI , 2.0 - 5.1 ; P < .001 ) . CONCLUSIONS A physician and pharmacist collaborative intervention achieved significantly better mean BP and overall BP control rates compared with a control group . Additional research should be conducted to evaluate efficient strategies to implement team-based chronic disease management . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00201019 Abstract Objective : To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice . Design : R and omised controlled trial of clinical medication review by a pharmacist against normal general practice review . Setting : Four general practice s. Participants : 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community . Intervention : Patients were invited to a consultation at which the pharmacist review ed their medical conditions and current treatment . Main outcome measures : Number of changes to repeat prescriptions over one year , drug costs , and use of healthcare services . Results : 590 ( 97 % ) patients in the intervention group were review ed compared with 233 ( 44 % ) in the control group . Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions ( mean number of changes per patient 2.2 v 1.9 ; difference=0.31 , 95 % confidence interval 0.06 to 0.57 ; P=0.02 ) . Monthly drug costs rose in both groups over the year , but the rise was less in the intervention group ( mean difference £ 4.72 per 28 days , −£7.04 to -£2.41 ) ; equivalent to £ 61 per patient a year . Intervention patients had a smaller rise in the number of drugs prescribed ( 0.2 v 0.4 ; mean difference −0.2 , −0.4 to −0.1 ) . There was no evidence that review of treatment by the pharmacist affected practice consultation rates , outpatient consultations , hospital admissions , or death rate . Conclusions : A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs . Such review results in significant changes in patients ' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners . What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by review ing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of review ing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not Background —R and omized controlled trials have demonstrated that collaborative medication review s can improve outcomes for patients with heart failure . We aim ed to determine whether these results translated into Australian practice , where collaborative review s are nationally funded . Methods and Results —This retrospective cohort study using administrative cl aims data included veterans 65 years and older receiving bis
Output:
| Patient involvement is important for long-term success |
MS211753 | ***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 With an average incidence rate of 11 % , chronic pain is considered the most serious complication of inguinal hernioplasty after surgical site infection . One of the proposed solutions to this problem is to use tissue adhesive for mesh fixation , which helps prevent nerve and tissue damage . Aim The goal of this study was to compare mesh fixation with the use of sutures vs. adhesive in Lichtenstein 's inguinal hernia repair in a r and omized , double-blind one-center study . Material and methods The study group consisted of 41 males with primary inguinal hernia undergoing Lichtenstein 's repair ( 20 – adhesive ; 21 – suture ) and remaining in follow-up from July 2008 to November 2010 . R and omization took place during the operation . The follow-up was performed by one surgeon ( blinded ) according to a pre-agreed schedule ; the end-of- study unblinding was performed during the last follow-up visit , usually 16 months postoperatively . Results In 1 patient from the “ adhesive ” group , a recurrence was observed one year after the initial repair . The early postoperative pain was less intense in this group . In later postoperative periods the method of mesh fixation had no influence on the pain experienced by the patient . Other complications were not correlated with the method of mesh fixation . Conclusions In this r and omized , one-center double-blind clinical study of males with primary inguinal hernia it has been show during follow-up that the use of Glubran 2 cyanoacrylate adhesive for mesh implant fixation yields similar recurrence and chronic pain rates as the classical suture technique . In the early postoperative period , the pain reported by these patients was relatively weaker ; patients undergoing adhesive mesh fixation experienced a quicker return to daily household activities BACKGROUND We compared the effectiveness of n-butyl-2-cyanoacrylate ( NBCA ) and traditional suture for patch fixation in Lichtenstein tension-free herniorrhaphy for inguinal hernias . METHODS A total of 110 patients with primary unilateral inguinal hernia were assigned r and omly to either experimental or control groups . In the experimental group , NBCA adhesive was used during Lichtenstein herniorrhaphy ; traditional suture was used in the control group . We evaluated operation time , postoperative duration of stay , visual analogue scale ( VAS ) pain score , incidence of chronic pain and hematoma formation , and hernia recurrence . RESULTS There was no hernia recurrence or wound infection in either group . In the experimental group , 2 local hematomas occurred while no patients experienced chronic postoperative pain ; in the control group , 10 hematomas occurred , and 6 patients experienced chronic pain . There was no difference in postoperative duration of stay between the groups ( P > .05 ) , but the experimental group had a lesser operation time and postoperative VAS score ( P < .05 ) . CONCLUSION The use of NBCA medical adhesive in tension-free inguinal herniorrhaphy is effective and safe The Lichtenstein hernioplasty has become a popular method in inguinal hernia repair . This study compared two methods of mesh fixation and wound closure . Forty-six men with unilateral inguinal hernia were r and omized into two groups . In the control group polypropylene mesh was anchored with 3/0 Dexon sutures , fascia and skin were closed with sutures 3/0 Dexon and 3/0 Monosof . In the study group , the mesh was secured with butyl-2-cyanoacrylate adhesive and the fascia and skin were also glued with the adhesive . The costs of material s , duration of the operation , amount of postoperative analgesic doses , pain score after the first and the 7th postoperative day and return to daily activity were recorded . No recurrences during the mean follow-up of 4.7 months were observed and the cosmetic effect was very good . In the study group with tissue adhesive the patients had significantly lower pain score after the first postoperative day and had a tendency to require less analgetic doses and to return earlier to their daily activity . Duration of the operation was similar in both groups . The cost of sutures and tissue adhesive used in both procedures was comparable . The use of tissue adhesive in mesh fixation and wound closure seems to be a promising technique in Lichtenstein hernia repair Introduction : This was a prospect i ve , r and omised study undertaken from January 2001 to July 2003 firstly to assess the possibility of using glues to fix meshes , secondly to verify whether or not this leads to a higher hernia recurrence rate , and thirdly to assess post-operative pain . Methods : This study covered a total of 55 patients with bilateral hernias who presented similar characteristics on both sides and on whom fixation of the mesh was undertaken differently , depending on the side . On the right side polypropylene sutures were used ( prolene 2/0 ) , while on the left , attachment was done using glue ( Tissucol ) . Results and conclusions : Results were similar in both inguinal regions , although there was less post-operative pain and less inflammatory reaction on the left side . There was no hernia recurrence in the follow-up at the end of 1 Purpose The aim of the present r and omised study was to find out whether usage of lightweight mesh in inguinal hernia repair , compared with heavyweight mesh , results in decreased incidence of chronic groin pain and foreign body feeling , as well as to evaluate the risk factors for chronic pain development and hernia recurrences . Methods The patients were r and omised into the heavyweight mesh ( HW ) group and lightweight mesh ( LW ) group . A tension-free mesh repair using the Lichtenstein technique was performed on all patients . Pain scores during different activities were measured on visual analogue scale . All patients underwent a clinical examination for any evidence of hernia recurrence . Results Of the patients , 17.2 % in the HW group and 29.3 % in the LW group reported that they experienced pain at 3-year follow-up ( P = 0.1323 ) . Pain was most often reported during physical activity . The median VAS score of all studied activities was 30.5 in the HW group and 30.0 in the LW group . There were more patients in the HW group than in the LW group who stated that they could feel the mesh in the groin ( 27.6 vs. 20.7 % , P = 0.3967 ) . Among all patients , 42.9 % who had severe pain preoperatively also reported pain during different activities and 19.6 % of the patients who did not have severe pain preoperatively reported pain during different activities ( P = 0.0481 ) . At 3-year follow-up , there was 1 hernia recurrence in the HW group and 1 hernia recurrence in the LW group . Conclusions Our study shows that compared with HW mesh , LW mesh has no advantage in reducing chronic groin pain and foreign body feeling at the operation site after inguinal hernioplasty at 3-year follow-up . Severe preoperative pain was correlated with the development of chronic pain . There was no difference between the two study groups in the recurrence rates A pre-trial was conducted to investigate the reliability of using the surgical adhesive , BioGlue ™ ( CryoLife ® , Inc. , Kennesaw , Georgia , USA ) for mesh fixation in Lichtenstein repair of inguinal hernia . From February to August 2008 , 60 patients with unilateral inguinal hernia underwent a Lichtenstein repair . In 30 of the patients , BioGlue ™ was used for mesh fixation and in the other 30 cases a conventional suture was used . The patients were sorted into two groups ( BioGlue ™ -group and suture-group ) . No differences were noted in demographic characteristics . The main criteria for dropout were incarceration , relapse , operation , and /or scrotal hernia . Twenty-four hours postoperative , pain intensity was measured with a numeric analogous scale ( NAS ) that reached from 0 ( no pain ) to 10 ( heavy pain ) . The pain intensity in the BioGlue ™ -group was 2.4 points and 4.3 points in the suture-group . The cut-suture time was 30 minutes in the BioGlue ™ -group and 56 minutes in the suture-group . In the first nine months , no relapses , no mesh infections , nor serom-formations were reported ; however , one superficial wound infection did occur in the BioGlue ™ -group . Lichtenstein-repair using BioGlue ™ for mesh-fixation is a safe , new method without early recurrences and less pain-intensity in relation to suture-supported Lichtenstein repair OBJECTIVE Three different mesh fixation techniques were compared to find out how to perform a safe and cost-effective open inguinal hernioplasty in day-case setting with the best outcomes with regard to chronic pain . SUMMARY BACKGROUND DATA Mesh fixation method may influence on the incidence of chronic pain after Lichtenstein hernioplasty . METHODS Lichtenstein hernioplasty was performed under local anesthesia in 625 patients as day-case surgery in 8 Finnish hospitals . The patients were r and omized to receive either a cyanoacrylate glue ( Histoacryl , n = 216 ) , self-gripping mesh ( Parietex ProGrip , n = 202 ) , or conventional nonabsorbable sutures ( Prolene 2 - 0 , n = 207 ) for mesh fixation . The incidence of wound complications , pain , recurrences , and patients discomfort was recorded on days 1 , 7 , 30 , and 1 year after surgery . The primary endpoint was the sensation of pain measured by pain scores and the need of analgesics after 1 year of surgery . RESULTS The type and size of inguinal hernias were similar in the 3 study groups . The duration of operation was 34 ± 13 , 32 ± 9 , and 38 ± 9 minutes in the glue , self-gripping , and suture groups , respectively ( P < 0.001 ) . There were no significant differences postoperatively in pain response or need for analgesics between the study groups . Two superficial infections ( 0.3 % ) , 31 wound seromas ( 5.0 % ) , and 4 recurrent hernias ( 0.6 % ) were recorded during a 1-year follow-up . Some 25 patients ( 4.2 % ) needed occasionally analgesics for chronic groin pain . A feeling of a foreign object and quality of life were similar in all study groups . CONCLUSIONS This r and omized trial failed to prove that mesh fixation without sutures causes less inguinodynia than suture fixation in Lichtenstein hernioplasty . Mesh fixation without sutures is feasible without compromising postoperative outcome Background Complications associated with sutured mesh fixation following open groin hernia repair have prompted surgeons to evaluate methods of atraumatic fixation such as the use of human fibrin glue . Small trials with Tissucol/Tisseel fibrin glue ( Baxter Healthcare , Deerfield , IL , USA ) have shown promising results that warrant further investigation . Methods TIMELI ( Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair ) is an international , controlled , r and omized , patient- and evaluator-blinded study that is comparing mesh fixation with Tissucol or sutures in patients with inguinal hernia . The primary endpoint evaluates the incidence of disabling complications ( chronic pain and /or numbness and /or groin discomfort ) at 12 months post-surgery . Results Patient enrolment started in February 2006 and ended on 19 April 2007 , with a total of 325 patients recruited . Initial results are expected in early 2008 . Conclusions TIMELI is a major international trial that will provide important information on the efficacy and safety of Tissucol , compared with sutures , for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair Background Early post-operative pain after inguinal hernia repair delays management in ambulatory setting . The type of mesh used for repair appears to influence their incidence . Aims The aim of this r and omized , prospect i ve study using the alternation principle was to compare post-operative early pain and the quality of life of patients operated on for inguinal hernia depending on the type of mesh used and their impact on management in ambulatory setting . Patients and methods Fifty successive patients were included prospect ively . Hernia repair was performed using the Lichtenstein procedure with two types of mesh , namely st and ard polypropylene 100 g/m2 ( Prolène ® ) or light polypropylene ( 55 g/m2 ) with a natural beta-d-glucan coating ( Glucamesh ® ) . The main assessment criterion was post-operative pain evaluated twice daily by the patient for 7 days , using the visual analogue scale ( VAS ) and their use of analgesics . The secondary assessment criteria were the rate of unscheduled admissions the evening of the intervention and the hospital length of stay and the quality of life evaluated by the SF12 question naire at pre-operative stage and on days 7 and 30 . Results The two groups were comparable . The operative duration s were identical ( 38.8 ± 10.2 vs 48 ± 15.4 min ) . On the evening of the intervention before discharge , the pain was less intense in the Glucamesh ® group ( mean VAS score 21.6 ± 2.4 vs 31.7 ± 6.2 , p = 0.02 ) . On day 4 , 20 % of patients from the Glucamesh ® group and none of the patients from the Prolène ® group had a VAS score of 0 ( p = 0.02
Output:
| Based on the short-term results , glue may reduce postoperative chronic pain and not simultaneously increase the recurrence rate , compared with sutures for mesh fixation in Lichtenstein hernia repair .
Glue may therefore be a sensible alternative to suture for mesh fixation in Lichtenstein repair . |
MS211754 | ***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 pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer In 2007 , the International Agency for Research on Cancer declared shift work that involved circadian disruption to be a " probable " carcinogen ( group 2A ) , noting that human evidence was limited . Using data from 2 prospect i ve cohort studies , the Nurses ' Health Study ( 1988 - 2012 ; n = 78,516 ) and Nurses ' Health Study II ( 1989 - 2013 ; n = 114,559 ) , we examined associations between rotating night-shift work and breast cancer risk . In the 2 cohorts , there were a total of 9,541 incident invasive breast malignancies and 24 years of follow-up . In the Nurses ' Health Study , women with 30 years or more of shift work did not have a higher risk of breast cancer ( hazard ratio ( HR ) = 0.95 , 95 % confidence interval ( 95 % CI ) : 0.77 , 1.17 ; P for trend = 0.63 ) compared with those who never did shift work , although follow-up occurred primarily after retirement from shift work . Among participants in the Nurses ' Health Study II , who were younger than participants in the other cohort , the risk of breast cancer was significantly higher in women with 20 years or more of shift work at baseline , reflecting young-adult exposure ( HR = 2.15 , 95 % CI : 1.23 , 3.73 ; P for trend = 0.23 ) , and was marginally significantly higher for women with 20 years or more of cumulative shift work when we used up date d exposure information ( HR = 1.40 , 95 % CI : 1.00 , 1.97 ; P for trend = 0.74 ) . In conclusion , long-term rotating night-shift work was associated with a higher risk of breast cancer , particularly among women who performed shift work during young adulthood . Further studies should explore the role of shift work timing on breast cancer risk CONTEXT Neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep . OBJECTIVES Despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown . DESIGN This study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , r and omized design in continuously polysomnography-monitored subjects . SETTING The study was conducted in a laboratory-based study . PARTICIPANTS The subjects were 11 healthy young men . INTERVENTION We investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to 2 h followed by a day without naps or with 30 minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at 20:00 . MAIN OUTCOME MEASURES Salivary interleukin-6 and urinary catecholamines were assessed throughout the daytime study periods . RESULTS The increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps . Interleukin-6 changes observed after sleep deprivation were also normalized after napping . During the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition . A recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition . CONCLUSIONS Our data suggest that napping has stress-releasing and immune effects . Napping could be easily applied in real setting s as a countermeasure to the detrimental health consequences of sleep debt 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 Shift work has been hypothesized as a risk factor for obesity . In this study , we investigated the association between current shift work and body mass index ( BMI ) among female nurses in Korea . The relationship between duration of shift work and BMI of the participants was also evaluated . Methods This cross-sectional survey evaluated participants in the Korean Nurses ’ Survey , conducted from October to December 2011 , using web-based self-administered question naires . A total of 9,989 nurses were included among 10,000 who registered on the survey web site ( 5,287 shift workers and 4,702 non-shift workers ) . Current shift workers were divided into tertiles of shift work duration ( 0.08–3.00 years , n = 1,732 ; 3.08–6.75 years , n = 1,731 ; and 6.83–38.00 years , n = 1,686 ) . The BMI thresholds of overweight and obesity were ≥23 kg/m2 and ≥25 kg/m2 , respectively . Data were analyzed using SPSS software . Results Mean participant age was 33.2 ± 8.6 years and the mean BMI was 20.9 ± 2.5 kg/m2 . There were statistically significant differences in current smoking status , regular drinking habit , dietary habits , regular exercise , sleep problems and self-perceived health status according to duration of shift work . The overall prevalence of overweight/obesity ( 18.6 % ) and obesity ( 7.4 % ) increased significantly as shift work duration increased from the lowest to highest tertile ( P for trend < 0.001 ) . Multivariate logistic regression analysis revealed no association between current shift work and BMI . However , after adjusting for potential confounders , the participants with the longest duration of shift work were 1.63 ( 95 % CI , 1.22–2.17 ) times more likely to be overweight or obese than those with the shortest duration . There was a significant positive association between obesity and shift work duration in the unadjusted analysis ; however , it was attenuated and no longer significant in the multivariate model . Conclusions The duration of shift work was positively associated with prevalence of overweight/obesity in nurses in Korea . Although these findings need to be confirmed in prospect i ve studies , they suggest that special attention should be paid to female nurses with a long duration of shift work STUDY OBJECTIVES To assess sleep inertia following 10-min and 30-min naps during a simulated night shift . METHODS Thirty-one healthy adults ( aged 21 - 35 y ; 18 females ) participated in a 3-day laboratory study that included one baseline ( BL ) sleep ( 22:00 - 07:00 ) and one experimental night involving r and omization to either : total sleep deprivation ( NO-NAP ) , a 10-min nap ( 10-NAP ) or a 30-min nap ( 30-NAP ) . Nap opportunities ended at 04:00 . A 3-min psychomotor vigilance task ( PVT-B ) , digit-symbol substitution task ( DSST ) , fatigue scale , sleepiness scale , and self-rated performance scale were undertaken pre-nap ( 03:00 ) and at 2 , 17 , 32 , and 47 min post-nap . RESULTS The 30-NAP ( 14.7 ± 5.7 min ) had more slow wave sleep than the 10-NAP ( 0.8 ± 1.5 min ; P < 0.001 ) condition . In the NO-NAP condition , PVT-B performance was worse than pre-nap ( 4.6 ± 0.3 1/sec ) at 47 min post-nap ( 4.1 ± 0.4 1/sec ; P < 0.001 ) . There was no change across time in the 10-NAP condition . In the 30-NAP condition , performance immediately deteriorated from pre-nap ( 4.3 ± 0.3 1/sec ) and was still worse at 47 min post-nap ( 4.0 ± 0.5 1/sec ; P < 0.015 ) . DSST performance deteriorated in the NO-NAP ( worse than pre-nap from 17 to 47 min ; P < 0.008 ) , did not change in the 10-NAP , and was impaired 2 min post-nap in the 30-NAP condition ( P = 0.028 ) . All conditions self-rated performance as better than pre-nap for all post-nap test points ( P < 0.001 ) . CONCLUSIONS This study is the first to show that a 10-min ( but not a 30-min ) nighttime nap had minimal sleep inertia and helped to mitigate short-term performance impairment during a simulated night shift . Self-rated performance did not reflect objective performance following a nap OBJECTIVES To evaluate the effectiveness of a broad , literature -based night shiftwork intervention for enhancement of emergency physicians ' ( EPs ' ) adaptation to night rotations . METHODS A prospect i ve , double-blind , active placebo-controlled study was conducted on 6 attending physicians in a university hospital ED . Three data sets were collected under the following conditions : baseline , after active placebo intervention , and after experimental intervention . In each condition , data were collected when the physicians worked both night and day shifts . Measurements included ambulatory polysomnographic recordings of the main sleep periods , objective performance tests administered several times during the subjects ' shifts , and daily subjective ratings of the subjects ' sleep , moods , and intervention use . RESULTS The subjects slept an average of 5 hr 42 min across all conditions . After night shifts , the subjects slept significantly less than they did after day shifts ( 5 hr 13 min vs 6 hr 20 min ; p < 0.05 ) . The physicians ' vigilance reaction times and times for intubation of a mannequin were significantly slower during night shifts than they were during day shifts ( p = 0.007 and p < 0.04 , respectively ) , but performances on ECG analysis did not significantly differ between night and day shifts . Mood ratings were significantly more negative during night shifts than they were during day shifts ( more sluggish p < 0.04 , less motivated p < 0.03 , and less clear thinking p < 0.04 ) . The strategies in the experimental intervention were used 85 % of the time according to logbook entries . The experimental and active placebo interventions did not significantly improve the physician 's performance , or mood on the night shift , although the subjects slept more after both interventions . CONCLUSIONS Although the experimental intervention was successfully implemented , it failed to significantly improve attending physicians ' sleep , performance , or mood on night shifts . A decrease in speed of intubation , vigilance reaction times , and subjective alertness was evident each time the physicians rotated through the night shift . These findings plus the limited sleep across all conditions and shifts suggest that circadian-mediated disruptions of waking neurobehavioral functions and sleep deprivation are problems in EPs IMPORTANCE Prospect i ve studies linking shift work to coronary heart disease ( CHD ) have been inconsistent and limited by short follow-up . OBJECTIVE To determine whether rotating night shift work is associated with CHD risk . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 189,158 initially healthy women followed up over 24 years in the Nurses ' Health Studies ( NHS [ 1988 - 2012 ] : N = 73,623 and NHS2 [ 1989 - 2013 ] : N = 115,535 ) . EXPOSURES Lifetime history of rotating night shift work ( ≥3 night shifts per month in addition to day and evening shifts ) at baseline ( up date d every 2 to 4 years in the NHS2 ) . MAIN OUTCOMES AND MEASURES Incident CHD ; ie , nonfatal myocardial infa rct ion , CHD death , angiogram-confirmed angina pectoris , coronary artery bypass graft surgery , stents , and angioplasty . RESULTS During follow-up , 7303 incident CHD cases occurred in the NHS ( mean age at baseline , 54.5 years ) and 3519 in the NHS2 ( mean age , 34.8 years ) . In multivariable-adjusted Cox proportional hazards models , increasing years of baseline rotating night shift work was associated with significantly higher CHD risk in both cohorts . In the NHS , the association between duration of shift work and CHD was stronger in the first half of follow-up than in the second half ( P=.02 for interaction ) , suggesting waning risk after cessation of shift work . Longer time since quitting shift work was associated with decreased CHD risk among ever shift workers in the NHS2 ( P<.00
Output:
| Many nurses experienced napping during their night-shift although no clear policy emerged .
Napping is beneficial to the well-being of nurses and could improve their psychomotor vigilance and performance .
The evidence on reducing sleepiness and fatigue was also insufficient and napping in nursing still faces challenges .
Although research on this topic has just started , napping during night-shift is beneficial to nurses ' health and performance . |
MS211755 | ***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: Obesity worsens and modest weight loss improves female fertility . Overweight women were r and omised to lifestyle or st and ard treatment pre‐in vitro fertilisation with treatment cessation at embryo transfer . There was a greater reduction in weight ( P < 0.001 ) for lifestyle treatment ( −3.8 ± 3.0 kg , P < 0.001 ) compared with no changes for st and ard treatment ( −0.5 ± 1.2 kg , P = 0.092 ) . Both the intervention ( −5.3 ± 4.6 cm ) and control ( −3.5 ± 3.5 cm ) group had reductions in waist circumference ( P < 0.001 ) with no differences between the two groups ( P = 0.215 ) . The overall pregnancy rate was 53 % ( 20/38 ) for the intervention and control group combined INTRODUCTION The aims of this prospect i ve cohort study were to examine 16-year trajectories of weight and BMI in young adult women who had a healthy BMI in 1996 and determinants of remaining in the healthy BMI category . METHODS A total of 4,881 women with healthy BMI at baseline and either healthy , overweight , or obese BMI at 16-year follow-up reported their weight , height , health , and health behaviors in six surveys of the Australian Longitudinal Study on Women 's Health between 1996 ( aged 18 - 23 years ) and 2012 ( aged 34 - 39 years ) . Determinants of BMI maintenance were estimated using binary logistic regression and generalized estimating equations in 2015 . RESULTS Almost 60 % remained in the healthy BMI category from 1996 to 2012 , ( mean weight gain , 0.19 kg/year ) , 29 % transitioned to overweight BMI ( 0.83 kg/year ) , and 11.6 % transitioned to obese ( 1.73 kg/year ) . The mean rates of annual weight gain in each group were consistent over time . Only three factors ( low alcohol , moderate/high physical activity , having a university degree ) were positively associated with maintaining a healthy BMI . Additional behavioral factors ( smoking , high sitting time , energy intake , dieting , takeaway food , and use of oral contraceptives ) , as well as blue collar occupation , separation/divorce/widowhood , and major illness were negatively associated with BMI maintenance . CONCLUSIONS To prevent the transition from healthy to overweight/obese BMI , weight gain must be limited to < 0.5 kg/year . Women with healthy BMI , but with higher rates of weight gain in their early 20s , could be identified by health professionals for assistance with prevention of becoming overweight/obese Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials OBJECTIVE To investigate whether r and omized diet and /or physical exercise influence serum levels of antimüllerian hormone ( AMH ) in obese women with polycystic ovary syndrome ( PCOS ) . DESIGN R and omized , 4-month trial with three interventions . SETTING Women 's health clinical research unit at a university hospital . PATIENT(S ) Fifty-seven overweight/obese women with PCOS . INTERVENTION(S ) Diet , physical exercise , or both , using programs individually adapted and supervised by a dietician and /or a physiotherapist . MAIN OUTCOME MEASURE(S ) Serum AMH levels before and after the interventions and correlations to reproductive function , body composition , and endocrine and metabolic variables . RESULT ( S ) After intervention , serum levels of AMH were significantly decreased only in the diet group , and the levels were significantly lower than in the exercise group . The strongest predictor of decreased AMH was a decrease in free T , whereas weight loss had no significant influence . Normalized levels of AMH were associated with improvements in menstrual cyclicity and hyper and rogenism but not in metabolic variables . CONCLUSION ( S ) This r and omized study supports that diet reduces serum AMH in association with decreased and rogen levels in obese women with PCOS . Increased serum AMH may be used as a marker of ovulatory dysfunction and hyper and rogenism but not as a marker of insulin resistance . CLINICAL TRIAL REGISTRY NUMBER IS RCT N48342048 This pilot study assessed the effects of exercise and nutritional counseling on hormonal , menstrual , and reproductive function in women with polycystic ovary syndrome ( PCOS ) . Twelve females with a clinical , biochemical , and ultrasonographic diagnosis of PCOS were r and omly assigned to endurance and resistance exercise plus nutritional counseling ( EN ) or nutritional counseling only ( N ) for a period of 12 weeks . Anthropometry , resting metabolic rate ( RMR ) , selected hormones , and ovarian follicle population were measured pre and post-intervention . Following the 12 week intervention , greater decreases in sum of 2 skinfolds ( p = 0.002 ) and a greater increase in estimated VO2 max ( p = 0.017 ) occurred in the exercise group . Significant decreases in waist girth ( p = 0.001 ) and insulin levels ( p = 0.03 ) occurred in both groups . Hormonal changes were not statistically significant ; however , a trend towards an improved hormonal profile , specifically sex-hormone binding globulin ( EN , 39 % increase ; N , 8 % increase ) and lutenizing hormone : follicle-stimulating hormone ( LH : FSH ) ( EN , 9 % decrease ; N , 27 % decrease ) occurred in the absence of weight loss . These findings suggest exercise and nutritional counseling may benefit the metabolic and reproductive abnormalities associated with PCOS Aim of this study was to compare the effects of metformin and a body weight reduction regimen using sibutramine on insulinemia , insulin sensitivity , and ovarian function in women with anovulatory cycles or infertility . 30 women with anovulatory cycles and hyperinsulinemia were treated with metformin and 15 anovulating women with obesity were treated with sibutramine in combination with a caloric restriction diet and physical exercise . In the metformin group there was a mild decrease of the body mass index ( BMI ) , a decrease of fasting and stimulated insulinemia ( I0 , p < 0.05 , I120 , p < 0.01 ) , a significant reduction of insulin resistance calculated as index FIRI ( p < 0.05 ) , serum LH ( p < 0.05 ) and testosterone levels ( p < 0.05 ) . There was an improvement of menstrual cycles in 21 ( 70 % ) of women , and 6 of them became pregnant . In the sibutramine group we found a significant decrease of BMI ( p < 0.01 ) , waist circumference ( p < 0.01 ) , fasting and stimulated insulinemia ( p < 0.05 , p < 0.01 ) and a significant improvement of insulin sensitivity ( FIRI , p < 0.01 ) . However , the levels of FSH , LH , and testosterone were not significantly changed . There was a significantly greater reduction of insulin levels and FIRI after sibutramine treatment compared with metformin treatment , while the changes of LH were not signifcantly different . Testosterone was changed more after metformin therapy . We conclude that although the body weight reduction using sibutramine has a more pronounced effect on insulinemia and insulin sensitivity , metformin may be more effective in the prompt restoration of ovarian function . ( Tab . 3 , Ref . 24 . ) CONTEXT Polycystic ovary syndrome ( PCOS ) is an insulin-resistant ( IR ) state . Visceral fat ( VF ) is independently associated with IR . OBJECTIVES The objectives of the study were to explore mechanisms underpinning IR by assessing the effect of exercise training on IR and body composition in overweight PCOS and non-PCOS women . DESIGN This was a prospect i ve exercise intervention study . SETTING AND PARTICIPANTS The study was conducted at an academic medical center . Participants included 20 overweight PCOS and 14 overweight non-PCOS women . INTERVENTION The intervention included 12 wk of intensified aerobic exercise ( 3 h/wk ) . MAIN OUTCOME MEASURES IR on euglycemic hyperinsulinemic clamp , body composition including abdominal visceral and sc fat distribution by computer tomography and lipids was measured . RESULTS PCOS subjects were more IR ( P = 0.02 ) and had more VF ( P = 0.04 age adjusted ) than non-PCOS women . In PCOS women , IR correlated with VF ( r = -0.78 , P < 0.01 ) . With exercise training , both groups maintained weight but within PCOS , VF ( -12.0 cm(2 ) , P = 0.03 ) and within non-PCOS abdominal sc fat ( -40.2 cm(2 ) , P = 0.02 ) decreased . Despite exercise-induced improvement in IR within PCOS ( + 27.9 mg · m(-2 ) · min(-1 ) , P = 0.03 ) , no relationship with decreased VF ( r = -0.08 , P = 0.84 ) and no differential changes in IR and VF between groups were noted . Triglycerides decreased within PCOS ( -0.27 mmol/liter , P = 0.02 ) and decreased differentially between groups ( P < 0.01 ) . CONCLUSIONS Higher IR was related to increased VF in PCOS , suggesting an etiological role for VF in intrinsic IR in PCOS ; however , changes with exercise intervention did not support a causal relationship . Triglycerides were modulated more by exercise training in PCOS than non-PCOS women . Within-group exercise-induced reductions in cardiometabolic risk factors including IR , triglycerides , and VF in PCOS were observed without significant weight loss and if confirmed in future controlled trials , suggest weight loss should not be the sole focus of exercise programs CONTEXT Lifestyle modification is recommended in women with polycystic ovary syndrome ( PCOS ) prior to conception but there are few r and omized trials to support its implementation or benefit . OBJECTIVE This study aim ed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS . DESIGN , SETTING , AND PARTICIPANTS This was a r and omized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS , age 18 - 40 y and body mass index 27 - 42 kg/m(2 ) . INTERVENTION Women were r and omly assigned to receive either 16 weeks of 1 ) continuous oral contraceptive pills ( OCPs ) ( ethinyl estradiol 20 mcg/1 mg norethindrone acetate ) ( " OCP " ) ; 2 ) lifestyle modification consisting of caloric restriction with meal replacements , weight loss medication ( either sibutramine , or orlistat ) , and increased physical activity to promote a 7 % weight loss ( " Lifestyle " ) ; or 3 ) combined treatment with both OCP and lifestyle modification ( " Combined " ) . After preconception intervention , women underwent st and ardized ovulation induction with clomiphene citrate and timed intercourse for four cycles . Pregnancies were followed with trimester visits until delivery . MAIN OUTCOME MEASURES Weight , ovulation , and live birth were measured . RESULTS We consented 216 and r and omly assigned 149 women ( Lifestyle : n = 50 ; OCP : n = 49 ; Combined : n = 50 ) . We achieved significant weight loss with both Lifestyle ( mean weight loss , -6.2 % ; 95 % confidence interval ( CI ) , -7.4 - -5.0 ; and Combined ( mean weight loss , -6.4 % ; 95 % CI , -7.6 - -5.2 ) compared with baseline and OCP ( both P < .001 ) . There
Output:
| WIDER IMPLICATION S There is emerging evidence from RCT that PA may improve pregnancy rates in women with reproductive health problems .
Comparative studies indicate that PA intervention may be as effective as other commonly used clinical intervention strategies for improving reproductive health outcomes .
While the type , intensity , frequency , and duration of optimal PA intervention , and the role of PA independent of weight loss , remain unclear , these preliminary findings suggest that PA may be an affordable and feasible alternative or complementary therapy to fertility treatments |
MS211756 | ***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 minimum local analgesic concentration ( MLAC ) has been defined as the median effective local analgesic concentration ( EC50 ) in a 20-ml volume for epidural analgesia in the first stage of labor . The aim of this study was to determine the relative local anesthetic sparing efficacies of intravenous and epidural fentanyl by comparison of their effects on the MLAC of bupivacaine . Methods In this double-blind , r and omized , prospect i ve study , 84 parturients at ≤ 7-cm cervical dilation who requested epidural analgesia were allocated to one of two groups . After lumbar epidural catheter placement , 20 ml bupivacaine ( n = 44 ) or bupivacaine with 3 & mgr;g/ml ( 60 & mgr;g ) fentanyl ( n = 40 ) was administered . The plain bupivacaine group then received 60 & mgr;g intravenous fentanyl . The bupivacaine – fentanyl group received intravenous saline . The concentration of bupivacaine was determined by the response of the previous patient in that group to a higher or lower concentration using up – down sequential allocation . Analgesic efficacy was assessed using 100-mm visual analog pain scores , with ≤ 10 mm within 30 min defined as effective . Results The MLAC of bupivacaine – intravenous fentanyl was 0.064 % wt/vol ( 95 % confidence interval , 0.049–0.080 ) , and the MLAC of bupivacaine – epidural fentanyl was 0.034 % wt/vol ( 95 % confidence interval , 0.017–0.050 ) . Epidural fentanyl significantly increased the analgesic potency of bupivacaine by a factor of 1.88 ( 95 % confidence interval , 1.09–3.67 ) compared with intravenous fentanyl . The epidural fentanyl group demonstrated significantly higher dermatomal spread ( P = 0.0064 ) and increased pruritus ( P = 0.01 ) . Conclusions Epidural fentanyl significantly reduced the MLAC of bupivacaine when compared with intravenous fentanyl for the parturients in this study . The significantly enhanced local anesthetic sparing , dermatomal level , and pruritus with epidural fentanyl suggest a primarily spinal site of action OBJECTIVE To evaluate the effects of epidural analgesia using 0.2 % Ropivacaine on the mother , newborn and during labor . METHODS This study was conducted at the Zeynep Kamil Obstetric , Gynecology , and Pediatric Research and Training Hospital in Istanbul , Turkey , between July 2003 and April 2004 . Eighty pregnant women of 37 - 41 weeks ' gestation were enrolled in the study . Forty cases received epidural analgesia ( group 1 ) and the control group composed 40 cases ( group 2 ) . Duration of labor , systolic and diastolic blood pressures at initial , 15th , 30th , 45th and 60th minutes , and number of breathing per minute , pulse rates , fetal heart rates and presence of motor block were recorded . Blood gas assessment s from the umbilical cord , 1st and 5th minute Apgar scores were noted following the delivery . Way of delivery , adverse effects and complications of the epidural analgesia were recorded . RESULTS Mean age of the cases was 24.79 + /- 4.72 years . Duration between full cervical dilation and delivery ( phase 2 ) was significantly longer in group 1 ( p<0.01 ) . Sixty minutes systolic arterial pressure was significantly lower in group 1 ( p<0.05 ) . In group 1 , diastolic arterial pressures at 15th , 45th , 60th minutes ( p<0.01 ) and 30th minute ( p<0.05 ) were significantly lower when compared to the initial values . No significant differences were recorded in terms of breathing rates , umbilical cord CO2 , O2 , pH levels and Apgar scores between the 2 groups . The most common adverse effect of epidural analgesia was sedation ( 59 % ) . The second dose of Ropivacaine was needed in 24 ( 61.5 % ) cases in group 1 . In group 1 , 29 ( 74.4 % ) patients expressed their pleasure as very good regarding the epidural analgesia . CONCLUSION Epidural analgesia , if administered by a specialist to a properly selected patient at proper time , leads to a comfortable delivery by relieving the pain . It can be performed safely after taking an informed consent Purpose Epidural analgesia is associated with hyperthermia during labor and presumably causes it , although no convincing mechanism has been postulated . It seems likely that fever associated with pyrogenic factors related to labor is suppressed by opioids , whereas it is expressed normally in patients given epidural analgesia . We examined this hypothesis and the possible etiology of temperature elevation in labor . Methods In this prospect i ve , r and omized , controlled study , we assessed 201 parturients during spontaneous labor . Analgesia was r and omly provided with one of four treatment groups : ( 1 ) epidural ropivacaine alone , ( 2 ) IV remifentanil alone , ( 3 ) epidural ropivacaine plus IV remifentanil , and ( 4 ) epidural ropivacaine plus IV acetaminophen . At r and omization , patients were normothermic . Intrapartum hyperthermia ( ≥38 ° C ) was correlated to the analgesic technique . Results The maximum increase in oral temperature was greatest in the ropivacaine group ( 0.7 ± 0.6 ° C ) and least in the remifentanil group ( 0.3 ± 0.4 ° C ; P = 0.013 ) . The percentage of patients who became hyperthermic ( ≥38 ° C ) during the first 6 h of labor was greatest in the ropivacaine group ( 14 % ) and least in the remifentanil-alone group ( 2 % ) , but the difference was not statistically significant . The maximum forearm-finger gradients were lower ( less vasoconstriction ) in the remifentanil group when compared to the gradients in patients with epidural analgesia ( 1.4 ± 1.8 vs 3.0 ± 1.7 , respectively ; P < 0.001 ) . Conclusion Our results are consistent with the theory that low-dose opioids inhibit fever in patients not given epidural analgesia . However , in view of the negative results , the hypothesis of epidural-induced hyperthermia may be question able Background Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries . However , only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery . The authors ' primary purpose in this r and omized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative : patient-controlled intravenous analgesia . Methods Seven hundred fifteen women of mixed parity in spontaneous labor at full term were r and omly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia . Epidural analgesia was maintained with a continuous epidural infusion of 0.125 % bupivacaine with 2 micro gram/ml fentanyl . Patient-controlled analgesia was maintained with 10 - 15 mg meperidine given every 10 min as needed using a patient-controlled pump . Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman r and omized in the study . Results A total of 358 women were r and omized to receive epidural analgesia , and 243 ( 68 % ) of these women complied with the epidural analgesia protocol . Similarly , 357 women were r and omized to receive patient-controlled intravenous meperidine analgesia , and 259 ( 73 % ) of these women complied with the patient-controlled intravenous analgesia protocol . Only five women who were r and omized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief . There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original r and omization ( epidural analgesia , 4 % [ 95 % CI : 1.9 - 6.2 % ] compared with patient-controlled intravenous analgesia , 5 % [ 95 % CI : 2.6 - 7.2 % ] ) . Similar results were observed for the analysis of the protocol -compliant groups ( epidural analgesia , 5 % [ 95 % CI : 2.6 - 8.5 % ] compared with patient-controlled intravenous analgesia , 6 % [ 95 % CI : 3 - 8.9 % ] ) . Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia . Conclusions Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia OBJECTIVE To estimate the effect of epidural analgesia on the Friedman labor curve . METHODS This study was a secondary analysis of a previously reported r and omized trial of the effects of patient‐controlled epidural analgesia during labor compared with patient‐controlled meperidine on cesarean delivery rate . All subjects had a singleton , cephalic , nonanomalous fetus at or beyond 37 weeks ' gestation . This secondary analysis was limited to women who had cervical dilatation commencing of at least 3 cm ( ie , active phase of labor ) . RESULTS A total of 459 women were r and omized . Twenty‐five women were excluded for a cervix less than 3 cm dilated , leaving 220 women allocated to patient‐controlled epidural analgesia and 214 to patient‐controlled intravenous meperidine available for analysis . There were no significant demographic differences between the two groups , including age , race , gestational age , and cervix on admission . The active phase of labor was 1 hour longer in the epidural‐treated group ( 6.0 ± 3.2 hours versus 5.0 ± 3.2 hours , P < .001 ) . The rate of cervical dilation was significantly less with epidural analgesia ( 1.4 cm/h versus 1.6 cm/h , P < .002 ) . The duration of the second stage tended to be longer in the epidural group ( 1.1 ± 1.5 hours versus 0.9 ± 1.0 hours , P = .079 ) . CONCLUSION Epidural analgesia prolonged the active phase of labor by 1 hour compared with Friedman 's original criteria Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic . Our study was conducted to answer the question : does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population ? Method 395 healthy , nulliparous women , at term , presented in spontaneous labor with a singleton vertex presentation . These patients were r and omized to receive analgesia either , epidural with bolus doses of 1 % lidocaine or intravenous , with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters . The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded , in each patient . The total number of vacuum-assisted and cesarean deliveries were also measured . Results 197 women were r and omized to the epidural group . 198 women were r and omized to the single-dose intravenous meperidine group . There was no statistical difference in rates of vacuum-assisted delivery rate . Cesarean deliveries , as a consequence of fetal bradycardia or dystocia , did not differ significantly between the groups . Differences in the duration of the active-first and the second stages of labor were not statistically significant . The number of newborns with 1-min and 5-min Apgar scores less than 7 , did not differ significantly between both analgesia groups . Conclusion Epidural analgesia with 1 % lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate BACKGROUND Epidural analgesia initiated early in labor ( when the cervix is less than 4.0 cm dilated ) has been associated with an increased risk of cesarean delivery . It is unclear , however , whether this increase in risk is due to the analgesia or is attributable to other factors . METHODS We conducted a r and omized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm . Women were r and omly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia . Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia . The primary outcome was the rate of cesarean delivery . RESULTS The rate of cesarean delivery was not significantly different between the groups ( 17.8 percent after intrathecal analgesia vs.
Output:
| No studies reported on rare but potentially serious adverse effects of epidural analgesia .
Epidural analgesia appears to be effective in reducing pain during labour .
However , women who use this form of pain relief are at increased risk of having an instrumental delivery .
Epidural analgesia had no statistically significant impact on the risk of caesarean section , maternal satisfaction with pain relief and long-term backache and did not appear to have an immediate effect on neonatal status as determined by Apgar scores . |
MS211757 | ***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: Contractile force is transmitted to the skeleton through tendons and aponeuroses , and , although it is appreciated that the mechanocharacteristics of these tissues play an important role for movement performance with respect to energy storage , the association between tendon mechanical properties and the contractile muscle output during high-force movement tasks remains elusive . The purpose of the study was to investigate the relation between the mechanical properties of the connective tissue and muscle performance in maximal isometric and dynamic muscle actions . Sixteen trained men participated in the study . The mechanical properties of the vastus lateralis tendon-aponeurosis complex were assessed by ultrasonography . Maximal isometric knee extensor force and rate of torque development ( RTD ) were determined . Dynamic performance was assessed by maximal squat jumps and countermovement jumps on a force plate . From the vertical ground reaction force , maximal jump height , jump power , and force-/velocity-related determinants of jump performance were obtained . RTD was positively related to the stiffness of the tendinous structures ( r = 0.55 , P < 0.05 ) , indicating that tendon mechanical properties may account for up to 30 % of the variance in RTD . A correlation was observed between stiffness and maximal jump height in squat jumps and countermovement jumps ( r = 0.64 , P < 0.05 and r = 0.55 , P < 0.05 ) . Power , force , and velocity parameters obtained during the jumps were significantly correlated to tendon stiffness . These data indicate that muscle output in high-force isometric and dynamic muscle actions is positively related to the stiffness of the tendinous structures , possibly by means of a more effective force transmission from the contractile elements to the bone The aim of this study was to measure if passive stretching would influence delayed onset muscle soreness ( DOMS ) , dynamic muscle strength , plasma creatine kinase concentration ( CK ) and the ratio of phosphocreatine to inorganic phosphate ( PCr/P(i ) ) following eccentric exercise . Seven healthy untrained women , 28 - 46 years old , performed eccentric exercise with the right m. quadriceps in an isokinetic dynamometer ( Biodex , angle velocity : 60 degrees.s-1 ) until exhaustion , in two different experiments , with an interval of 13 - 23 months . In both experiments the PCr/P(i ) ratio , dynamic muscle strength , CK and muscle pain were measured before the eccentric exercise ( day 0 ) and the following 7 d. In the second experiment daily passive stretching ( 3 times of 30 s duration , with a pause of 30 s in between ) of m. quadriceps was included in the protocol . The stretching was performed before and immediately after the eccentric exercise at day 0 , and before measurements of the dependent variables daily for the following 7 d. The eccentric exercise alone led to significant decreases in PCr/P(i ) ratio ( P < 0.001 ) and muscle strength ( P < 0.001 ) , and an increase in CK concentration ( P < 0.01 ) . All subjects reported pain in the right m. quadriceps with a peak 48 h after exercise . There was no difference in the reported variables between experiments one and two . It is concluded that passive stretching did not have any significant influence on increased plasma-CK , muscle pain , muscle strength and the PCr/P(i ) ratio , indicating that passive stretching after eccentric exercise can not prevent secondary pathological alterations To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries PURPOSE To analyze the effectiveness in reducing the number of sport injuries after application of different strategies of preventive physiotherapy during competition periods in an America 's Cup yachting crew . METHODS A prospect i ve physiotherapy intervention study during competition periods for three seasons was conducted on an America 's Cup yachting race crew of 30 professional sailors . In the first two acts ( 2004 ) , athletes did not receive any preventive physiotherapy . In the two acts celebrated in 2005 , preventive intervention ( phase 1 ) consisted of stretching exercises before the yacht race and preventative taping . During the four acts corresponding to the 2006 season , the physiotherapy program was implemented adding articular mobilization before competition , ice baths after competition , and kinesiotaping ( phase 2 ) . In the last act and the Louis Vuitton Cup ( 2007 ) , a recovery program with " core stability " exercises , postcompetition stretching exercises , and 12 h of compressive clothing were added ( phase 3 ) . RESULTS In the preintervention phase ( 2004 ) , the rate of injured sailors/competition day was 1.66 , decreasing to 0.60 in 2007 ( phase 3 ) . The number of athletes with more than one injury was significantly reduced from 53 % ( 8 of 15 ) to 6.5 % ( 2 of 12 ) . In the preintervention period , mastmen , grinders , and bowmen showed a rate of 2.88 injuries per competition day . After phase 3 , this group only suffered 0.35 injuries per competition day . CONCLUSIONS The implementation of a program of preventive physiotherapy decreased the risk of injuries suffered during competition by an America 's Cup yacht crew CONTEXT Some research ers have suggested that an alteration of stretch perception could be responsible for the success of the contract-relax ( CR ) stretch , a stretch technique derived from proprioceptive neuromuscular facilitation ( PNF ) . OBJECTIVE This study was conducted to determine if the alteration of the stretch perception is a possible explanation for the range of motion ( ROM ) gains of the CR stretch . PARTICIPANTS Eighteen subjects performed two stretches in r and omized order : the slow stretch and the CR stretch . MAIN OUTCOME MEASURE The stretch intensity was controlled . The stretch force was measured and compared between the slow stretch and CR stretch . RESULTS There was a significant difference between the stretch force that could be applied in the PNF stretch ( 126.0 N ) and the slow stretch ( 108.4 N ) ; P = 0.00086 . The average stretch tolerance progressively increased with successive trials from 120.6 N in the first trial to 132.4 N in the fourth trial . CONCLUSION The alteration of stretch perception plays a role in the success of the CR form of PNF stretching . At least four repetitions of the CR stretch are recommended to get the greatest ROM gain The purpose of this study was to determine the effect of different static and dynamic stretch protocol s on 20-m sprint performance . The 97 male rugby union players were assigned r and omly to 4 groups : passive static stretch ( PSS ; n = 28 ) , active dynamic stretch ( ADS ; n = 22 ) , active static stretch ( ASST ; n = 24 ) , and static dynamic stretch ( SDS ; n = 23 ) . All groups performed a st and ard 10-minute jog warm-up , followed by two 20-m sprints . The 20-m sprints were then repeated after subjects had performed different stretch protocol s. The PSS and ASST groups had a significant increase in sprint time ( p ≤ 0.05 ) , while the ADS group had a significant decrease in sprint time ( p ≤ 0.05 ) . The decrease in sprint time , observed in the SDS group , was found to be nonsignificant ( p ≥ 0.05 ) . The decrease in performance for the 2 static stretch groups was attributed to an increase in the musculotendinous unit ( MTU ) compliance , leading to a decrease in the MTU ability to store elastic energy in its eccentric phase . The reason why the ADS group improved performance is less clear , but could be linked to the rehearsal of specific movement patterns , which may help increase coordination of subsequent movement . It was concluded that static stretching as part of a warm-up may decrease short sprint performance , whereas active dynamic stretching seems to increase 20-m sprint performance Abstract Maddigan , ME , Peach , AA , and Behm , DG . A comparison of assisted and unassisted proprioceptive neuromuscular facilitation techniques and static stretching . J Strength Cond Res 26(5 ) : 1238–1244 , 2012—Proprioceptive neuromuscular facilitation ( PNF ) stretching often requires a partner . Straps are available allowing an individual to perform PNF stretching alone . It is not known if a strap provides similar improvements in the range of motion ( ROM ) as partner-assisted PNF or static stretching . The purpose of this study was to compare assisted and unassisted ( with a strap ) PNF stretching and static stretching . Hip joint ROM , reaction time ( RT ) , and movement time ( MT ) were measured prestretching and poststretching . Thirteen recreationally active adults participated in this study . The participants were subjected to 5 different stretch interventions in a r and om order on separate days . Stretch conditions included unassisted PNF stretching using ( a ) isometric , ( b ) concentric , and ( c ) eccentric contractions with a stretch strap , ( d ) partner-assisted isometric PNF , and ( e ) static stretching . The RT , MT , dynamic , active , passive hip flexion angle , and angular velocity with dynamic hip flexion were measured before and after the intervention . The ROM improved ( p < 0.05 ) 2.6 , 2.7 , and 5.4 % , respectively , with dynamic , active static , and passive static ROM , but there was no significant difference between the stretching protocol s. There was a main effect for time ( p < 0.05 ) with all stretching conditions negatively impacting dynamic angular velocity ( 9.2 % ) . Although there was no significant effect on RT , MT showed a negative main effect for time ( p < 0.05 ) slowing 3.4 % . In conclusion , it was found that all 3 forms of active stretching provided similar improvements in the ROM and poststretching performance decrements in MT and angular velocity . Thus , individuals can implement PNF stretching techniques with a partner or alone with a strap to improve ROM , but athletes should not use these techniques before important competitions or training because of the impairment of limb velocity and MT Curry , BS , Chengkalath , D , Crouch , GJ , Romance , M , and Manns , PJ . Acute effects of dynamic stretching , static stretching and light aerobic activity on muscular performance in women . J Strength Cond Res 23(6 ) : 1811 - 1819 , 2009-The purpose of this study was to compare three warm-up protocol s-static stretching , dynamic stretching , and light aerobic activity-on selected measures of range of motion and power in untrained females and to investigate the sustained effects at 5 and 30 minutes after warm-up . A total of 24 healthy females ( ages 23 - 29 years ) attended one familiarization session and three test sessions on nonconsecutive days within 2 weeks . A within-subject design protocol with the testing investigators blinded to the subjects ' warm-up was followed . Each session started with 5 minutes of light aerobic cycling followed by pretest baseline measures . Another 5 minutes of light aerobic cycling was completed and followed by one of the three r and omly selected warm-up interventions ( static stretching , dynamic stretching , or light aerobic activity ) . The following posttest outcome measures were collected 5 and 30 minutes following the intervention : modified Thomas test , countermovement jump , and isometric time to peak force knee extension measured by dynamometer . Analysis of the data revealed significant time effects on range of motion and countermovement jump changes . No significant differences ( p > 0.05 ) were found between the warm-up conditions on any of the variables . The variation in responses to warm-up conditions emphasizes the unique nature of individual reactions to different warm-ups ; however , there was a tendency for warm-ups with an active component to have beneficial effects . The data suggests dynamic stretching has greater applicability to enhance performance on power outcomes compared to static stretching AIM The interaction between running , stretching and practice jumps during warm-up for jumping tests has not been investigated . The purpose of the present study was to compare the effects of running , static stretching of the leg extensors and practice jumps on explosive force production and jumping performance . METHODS Sixteen volunteers ( 13 male and 3 female ) participated in five different warm-ups in a r and omised order prior to the performance of two jumping tests . The warm-ups were control , 4 min run , static stretch , run + stretch , and run + stretch + practice jumps . After a 2 min rest , a concentric jump and a drop jump were performed , which yielded 6 variables expressing fast force production and jumping performance of the leg extensor muscles ( concentric jump height , peak force , rate of force developed , drop jump height , contact time and height/time ) . RESULTS Generally the stretching warm-up produced the lowest values and the run or run + stretch + jumps warm-ups produced the highest values of explosive force production . There were no significant differences ( p<0.05 ) between the control and run + stretch warm-ups , whereas the run yielded significantly better scores than the run + stretch warm-up for
Output:
| Testing was performed on average 3 - 5 min after stretching , and most studies did not include poststretching dynamic activities ; when these activities were included , no clear performance effect was observed .
DS produced small-to-moderate performance improvements when completed within minutes of physical activity .
SS and PNF stretching had no clear effect on all-cause or overuse injuries ; no data are available for DS .
All forms of training induced ROM improvements , typically lasting < 30 min .
Changes may result from acute reductions in muscle and tendon stiffness or from neural adaptations causing an improved stretch tolerance .
Considering the small-to-moderate changes immediately after stretching and the study limitations , stretching within a warm-up that includes additional poststretching dynamic activity is recommended for reducing muscle injuries and increasing joint ROM with inconsequential effects on subsequent athletic performance |
MS211758 | ***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 purpose of this pilot study was to evaluate the effectiveness of whole body vibration ( WBV ) training as a modality for inducing changes in body composition , cardiovascular condition , and muscular strength in sedentary postmenopausal women . WBV training was compared with other training regimens , ie , aerobic training and circuit resistance training , commonly used to promote weight loss , cardiovascular conditioning , and muscular strength . Postmenopausal women ( aged 48–60 years ) were r and omly assigned to WBV training , circuit resistance training , or aerobic training . Participants trained three times per week for 8 weeks . The training regimens were progressive in nature , with increases in training intensity and duration occurring throughout the 8-week period . Body composition was assessed using dual-energy X-ray absorptiometry analyses . A modified Bruce treadmill protocol was used to assess aerobic capacity ( VO2peak ) and time to peak exhaustion . Upper and lower body strengths were determined by one repetition maximum ( 1-RM ) chest and leg presses , respectively . Variables were analyzed using separate 3 ( exercise mode ) × 2 ( time ) repeated- measures analysis of variance with effect sizes due to the small sample size . No significant main effects or interactions were seen for any body composition variable ; however , moderate to large effect sizes ( η2=0.243 and η2=0.257 ) were detected regarding interactions for percent body fat and lean body mass favoring aerobic training and circuit resistance training . For VO2peak , no significant main effects or interactions were detected ( time , η2=0.150 ; P=0.11 ; time × group , η2=0.139 ; P=0.30 ) ; but a significant time effect was observed for time to peak exhaustion ( η2=0.307 ; P=0.017 ) . A significant interaction for upper body strength ( η2=0.464 ; P=0.007 ) , and main effect for time in lower body strength ( η2=0.663 ; P=0.0001 ) was detected . Post hoc analysis indicated a significant increase in upper body strength for circuit resistance training ( P=0.023 ) and a decrease for WBV training ( P=0.015 ) . Our results indicate that WBV may not be an effective alternative to traditional training with regard to body composition or aerobic capacity , but could have a positive impact on lower body strength Abstract The aim of the study was to compare the effect of an unsupervised whole body vibration ( WBV ) training and two different supervised multi- purpose exercise programmes , with and without WBV , on body composition , functional fitness and self-reported well-being in middle-aged adults . Fifty-four healthy participants ( age 48.6 ± 6.7 years ) were r and omly assigned to a vibration group ( VG ) , a multi- purpose exercise group ( MG ) and a multi- purpose exercise with vibration group ( VMG ) and trained 3 days a week for 4 months . VG performed a st and ardised unsupervised WBV protocol , MG a supervised multi- purpose exercise and VMG a multi- purpose exercise including vibration . After training , drop out was significantly higher in VG group ( P = 0.016 ) when compared to VMG group . In both MG and VMG , body composition , sit-up , push-up , sit and reach , agility test , hopping test and self-reported general health significantly improved ( P < 0.05 ) . No additive effects were generated by the vibration stimulus . Percentage of body fat and agility test in VG had a significant opposite trend compared to VMG group ( P < 0.05 ) . In summary , an unsupervised WBV training should not be chosen for training protocol . However , positive effects on physical fitness and the best results in adherence could be achieved integrating WBV practice into a multi- purpose exercise training Lamont , HS , Cramer , JT , Bemben , DA , Shehab , RL , And erson , MA , and Bemben , MG . Effects of 6 weeks periodized squat training with or without whole-body vibration upon short-term adaptations in squat strength and body composition . J Strength Cond Res 25(7 ) : 1839 - 1848 , 2011—The purpose of this study was to examine the effects of a 6-week , periodized squat training program , with or without whole-body low-frequency vibration ( WBLFV ) , applied before and between sets to 1RM squat strength and body composition . Thirty men aged between 20 and 30 years with at least 6 months of recreational weight training experience completed the study . Subjects were r and omly assigned to either 1 of 2 training groups or to an active control group ( CON ) . Group 1 ( CON ; n = 6 ) did not participate in the training protocol but participated only in testing sessions . Group 2 ( SQTV , n = 13 ) performed 6 weeks of squat training while receiving WBLFV ( 50 Hz ) , before , and in-between sets . The third group ( SQT , n = 11 ) performed 6 weeks of squat training only . Subjects completed 12 workouts with variable loads ( 55 - 90 % one repetition maximum [ 1RM ] ) and sets ( 3 - 5 ) , performing squats twice weekly separated by 72 hours . The RM measures were recorded on weeks ( W ) 1 , 3 , and 7 . During the second workout of a week , the load was reduced by 10 - 15 % , with “ speed squats ” performed during the final 3 weeks . Rest periods in between sets were set at 240 seconds . The WBLFV was applied while subjects stood on a WBLFV platform holding an isometric quarter squat position ( knee angle 135 ± 5 ° ) . Initially , WBLFV was applied at 50 Hz for 30 seconds at low amplitude ( peak-peak 2 - 4 mm ) . A rest period of 180 seconds followed WBLFV exposure before the first set of squats . The WBLFV was then applied intermittently ( 3 × 10 seconds ) at 50 Hz , high amplitude ( peak-peak , 4 - 6 mm ) at time points , 60 , 120 , and 180 seconds into the 240-second rest period . Total body dual x-ray absorptiometry scans were performed at W0 ( week before training ) and W7 ( week after training ) . Measures recorded included total body mass ( kg ) , total body lean mass ( TLBM , kg ) , trunk lean mass ( kg ) , leg lean mass ( kg ) , total body fat percentage , trunk fat percentage , and leg fat percentage ( LF% ) . Repeated- measures analysis of variance and analysis of covariance revealed 1RM increased significantly between W1-W3 , W3-W7 , and W1-W7 for both experimental groups but not for control ( p = 0.001 , effect size [ ES ] = 0.237 , 1 − β = 0.947 ) . No significant differences were seen for % Δ ( p > 0.05 ) . Significant group by trial and group effects were seen for TLBM , SQTV > CON at W7 ( p = 0.044 ) . A significant main effect for time was seen for LF% , W0 vs. W7 ( p = 0.047 ) . No other significant differences were seen ( p > 0.05 ) . “ Practical trends ” were seen favoring “ short-term ” neuromuscular adaptations for the SQTV group during the first 3 weeks ( p = 0.10 , ES = 0.157 , 1 − β = 0.443 , mean diff ; SQTV week 3 4.72 kg > CON and 2.53 kg > SQT ) . Differences in motor unit activation patterns , hypertrophic responses , and dietary intake during the training period could account for the trends seen Aim : To determine the effect of whole body vibration ( WBV ) , combined with caloric restriction , on weight , body composition and metabolic risk factors in overweight and obese adults . Methods : A r and omized , controlled study with a 6-month intervention period and a 6-month ‘ no intervention ’ follow-up . 61 of the 79 participants completed the study . Data were collected at baseline and at 3 , 6 and 12 months in the control group ( CONTROL ) , the diet only group ( DIET ) , the diet plus fitness group ( FITNESS ) and the diet plus WBV group ( VIBRATION ) . Results : Weight decreased significantly in all three intervention groups . Only FITNESS and VIBRATION managed to maintain a weight loss of 5 % or more in the long term . Visceral adipose tissue ( VAT ) changed most in VIBRATION : –47.8 ± 41.2 and –47.7 ± 45.7 cm2 after 6 and 12 months respectively compared to CONTROL ( –3.6 ± 20.5 or + 26.3 ± 30.6 cm2 ) , DIET ( –24.3 ± 29.8 or –7.5 ± 28.3 cm2 ) and FITNESS ( –17.6 ± 36.6 or –1.6 ± 33.3 cm2 ) ( p < 0.001 ) . Conclusions : Combining aerobic exercise or WBV training with caloric restriction can help to achieve a sustained long-term weight loss of 5–10 % . These preliminary data show that WBV training may have the potential to reduce VAT more than aerobic exercise in obese adults , possibly making it a meaningful addition to future weight loss programs Whole-body vibration ( WBV ) is being promoted as an efficient complement to resistance training . The aim of this study was to investigate the effects of an 8-week program of WBV in combination with resistance training on knee extensors muscular performance . A group of 29 young adults ( 25 men , 4 women ; age 21.8 ± 1.5 ) performed a WBV plus resistance training program ( WBV + RES ) or an identical exercise program in absence of vibration ( placebo plus resistance training , PL + RES ) . Participants were evaluated for anthropometry , muscle strength ( half-squat three repetition maximum , 3RM ) , knee extensors isokinetic dynamometry ( 180 ° and 60 ° s−1 ) and counter-movement jump ( CMJ ) . After the intervention , percent body fat significantly decreased 2.1 % only in WBV + RES ( P < 0.001 ) , while muscle mass significantly increased in both groups ( P < 0.01 ) : 2.2 and 2.8 kg in PL + RES and WBV + RES , respectively . No significant differences were observed in isokinetic strength or CMJ , and 3RM significantly increased in both groups ( P < 0.001 ) : 64.2 kg ( 52 % of baseline ) in PL + RES , and 46.9 kg ( 43 % ) in WBV + RES . The addition of WBV to resistance training during 8 weeks , in recreationally active young adults , did not result in a larger muscular performance improvement compared to an identical exercise program in absence of vibration . Muscle mass also seemed to be equally affected with or without vibration , yet body fat could be exclusively decreased by WBV . Further research is required to clarify whether WBV , as a complement to resistance training , produces additional specific benefits Objective ( i ) to determine the outcomes of whole-body vibration training ( WBVT ) on obese individuals , and the intervention setting s producing such effects ; ( ii ) identify potential improper or harmful use of WBVT . Design Systematic review . Data sources Medline , Scopus , Web of Science , PEDro and Scielo until July 2018 . Eligibility criteria Full papers evaluating the effect of WBVT on body composition , cardiovascular status and functional performance in obese adults . Papers with PEDro score<4 were excluded . Study appraisal and synthesis Risk of bias and quality of WBVT reporting were assessed with PEDro scale ( r and omized controlled trials ) or TREND checklist ( non-r and omized studies ) and a 14-items checklist , respectively . Weighted acceleration , daily exposure and Hedges ’ adjusted g were computed . Results We included 18 papers published 2010–2017 . Typical interventions consisted in three sessions/week of exercises ( squats , calf-raises ) performed on platforms vibrating at 25–40 Hz ( amplitude : 1–2 mm ) ; according to ISO 2631–1:1997 , daily exposure was “ unsafe ” in 7/18 studies . Interventions lasting ≥6 weeks improved cardiac autonomic function and reduced central /peripheral arterial stiffness in obese women ; 10 weeks of WBVT produced significant weight/fat mass reduction , leg strength improvements as resistance training , and enhanced glucose regulation when added to hypocaloric diet . No paper evidence d losses of lean mass . Isolated cases of adverse effects were reported . Summary To date , WBVT is a promising adjuvant intervention therapy for obese women ; long-term studies involving larger cohorts and male participants are required to demonstrate the associated safety and health benefits . The therapeutic use of WBVT in the management of obese patients is still not st and ardised and should be supported by an extensive knowledge on the causality between vibration parameters and outcomes The applied use of new technologies to enhance performance and improve health has been increasing . Initially , whole body vibration training ( WBVT ) was used as system to improve elite athlete performance . However , this is also used to improve body composition , especially there is a great attention on the effectiveness of WBVT to reduce fat and body weight , with a potential increase in muscle tissue . The aim of this study was to investigate the effects of a 6-week vibration-training program on total and segmental body composition in a group of physically healthy participants . The final study sample included 64 health
Output:
| This systematic review and meta-analyses showed a significant effect of WBV on total fat mass ( kg ) , however clinical ly insignificant effects of 6 - 24 weeks of WBV therapy on % body fat . |
MS211759 | ***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 —In 3 r and omized controlled trials in heart failure ( HF ) , mineralocorticoid receptor antagonists reduced mortality . The net benefit from r and omized controlled trials may not be generalizable , and eplerenone was , but spironolactone was not , studied in mild HF . We tested the hypothesis that spironolactone is associated with reduced mortality also in a broad unselected contemporary population with HF and reduced ejection fraction , in particular New York Heart Association ( NYHA ) I – II . Methods and Results —We prospect ively studied 18 852 patients ( age 71±12 years ; 28 % women ) with NYHA I – IV and ejection fraction < 40 % who were registered in the Swedish Heart Failure Registry between 2000 and 2012 and who were ( n=6551 ) or were not ( n=12 301 ) treated with spironolactone . We derived propensity scores for spironolactone treatment based on 41 covariates . We assessed survival by Cox regression with adjustment for propensity scores and with matching based on propensity score . We performed sensitivity and residual confounding analyses and analyzed the NYHA I – II and III – IV subgroups separately . One-year survival was 83 % versus 84 % in treated versus untreated patients ( log rank P<0.001 ) . After adjustment for propensity scores , the hazard ratio for spironolactone was 1.05 ( 95 % confidence interval , 1.00–1.11 ; P=0.054 ) . Spironolactone interacted with NYHA ( P<0.001 ) . In the NYHA I – II subgroup , after adjustment for propensity scores , the hazard ratio for spironolactone was 1.11 ( 95 % confidence interval , 1.02–1.21 ; P=0.019 ) . Conclusions —In an unselected contemporary population of HF with reduced ejection fraction , spironolactone was not associated with reduced mortality . The net benefits of spironolactone may be lower outside the clinical trial setting and in milder HF Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items AIMS Hospitalizations for heart failure ( HF ) are common and are associated with significant morbidity , mortality and cost . However , precipitating factors leading to HF hospitalization and their importance with respect to subsequent outcomes are not well understood . METHODS AND RESULTS The symptoms and signs present at admission and investigator-identified factors thought to have contributed to the first adjudicated HF hospitalization in the C and esartan in Heart Failure : Assessment of Reduction in Mortality and Morbidity ( CHARM ) programme were prospect ively collected and stratified by ejection fraction ( EF ) . Potential precipitants were collected using a specifically design ed case report form and categorized according to the presence of cardiovascular ( CV ) , non-CV and unknown factors . Associations between these factors and subsequent rehospitalization and mortality rates were examined . Of 1668 patients who experienced HF hospitalization , 1152 had reduced EF ( ≤40 % , HFrEF ) and 516 had preserved EF ( HFpEF ) . Overall , 54 % had CV , 32 % had non-CV and 14 % had unknown factors thought to have precipitated HF , with similar proportions in the HFrEF and HFpEF groups . The most common precipitants were arrhythmia ( 15 % ) , other non-CV factors ( 11 % ) and respiratory infection ( 10 % ) . Subsequent CV readmission rates were highest in those whose initial HF hospitalization was precipitated by CV factors . However , mortality rates were similar among patients with any of the three categories of precipitating factors . Results were similar in HFrEF and HFpEF . CONCLUSIONS Among chronic HF patients hospitalized for decompensation , the investigator-reported precipitating factor was not associated with the subsequent mortality rate , but was associated with type of readmission : readmissions for CV reasons were more likely when the index precipitant was CV AIMS Many patients who receive a diagnosis of heart failure have neither a low left ventricular ( LV ) ejection fraction nor valve disease . Few substantial r and omized controlled trials have been conducted in this population , none has focussed on patients with evidence of diastolic dysfunction and none has shown clear benefit on symptoms , morbidity , or mortality . METHODS AND RESULTS This was a r and omized double-blind trial , comparing placebo with perindopril , 4 mg/day in patients aged > or = 70 years with a diagnosis of heart failure , treated with diuretics and an echocardiogram suggesting diastolic dysfunction and excluding substantial LV systolic dysfunction or valve disease . The primary endpoint was a composite of all-cause mortality and unplanned heart failure related hospitalization with a minimum follow-up of 1 year . A total of 850 patients were r and omized . Their mean age was 76 ( SD 5 ) years and 55 % were women . Median follow-up was 2.1 ( IQR 1.5 - 2.8 ) years . Enrollment and event rates were lower than anticipated , reducing the power of the study to show a difference in the primary endpoint to 35 % . Many patients withdrew from perindopril ( 28 % ) and placebo ( 26 % ) after 1 year and started taking open-label ACE-inhibitors . Overall , 107 patients
Output:
| By contrast , dispensing β-blockers at discharge was associated with 35 % lower risk of all-cause deaths in HFrEF and has a weak association with borderline statistical significance on improving overall survival in HFpEF . |
MS211760 | ***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 Background : Systematic evaluation and validation of new prognostic and predictive markers , technologies and interventions for colorectal cancer ( CRC ) is crucial for optimizing patients ’ outcomes . With only 5–15 % of patients participating in clinical trials , generalizability of results is poor . Moreover , current trials often lack the capacity for post-hoc subgroup analyses . For this purpose , a large observational cohort study , serving as a multiple trial and biobanking facility , was set up by the Dutch Colorectal Cancer Group ( DCCG ) . Methods / design : The Prospect i ve Dutch ColoRectal Cancer cohort is a prospect i ve multidisciplinary nationwide observational cohort study in the Netherl and s ( yearly CRC incidence of 15 500 ) . All CRC patients ( stage I – IV ) are eligible for inclusion , and longitudinal clinical data are registered . Patients give separate consent for the collection of blood and tumor tissue , filling out question naires , and broad r and omization for studies according to the innovative cohort multiple r and omized controlled trial design ( cm RCT ) , serving as an alternative study design for the classic RCT . Objectives of the study include : 1 ) systematic ally collected long-term clinical data , patient-reported outcomes and bio material s from daily CRC practice ; and 2 ) to facilitate future basic , translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods , even for studies with stringent inclusion criteria . Results : Seven months after initiation 650 patients have been enrolled , eight centers participate , 15 centers await IRB approval and nine embedded cohort- or cm RCT - design ed studies are currently recruiting patients . Conclusion : This cohort provides a unique multidisciplinary data , biobank , and patient-reported outcomes collection initiative , serving as an infrastructure for various kinds of research aim ing to improve treatment outcomes in CRC patients . This comprehensive design may serve as an example for other tumor types PURPOSE Fluoropyrimidines are frequently prescribed anticancer drugs . A polymorphism in the fluoropyrimidine metabolizing enzyme dihydropyrimidine dehydrogenase ( DPD ; ie , DPYD*2A ) is strongly associated with fluoropyrimidine-induced severe and life-threatening toxicity . This study determined the feasibility , safety , and cost of DPYD*2A genotype-guided dosing . PATIENTS AND METHODS Patients intended to be treated with fluoropyrimidine-based chemotherapy were prospect ively genotyped for DPYD*2A before start of therapy . Variant allele carriers received an initial dose reduction of ≥ 50 % followed by dose titration based on tolerance . Toxicity was the primary end point and was compared with historical controls ( ie , DPYD*2A variant allele carriers receiving st and ard dose described in literature ) and with DPYD*2A wild-type patients treated with the st and ard dose in this study . Secondary end points included a model-based cost analysis , as well as pharmacokinetic and DPD enzyme activity analyses . RESULTS A total of 2,038 patients were prospect ively screened for DPYD*2A , of whom 22 ( 1.1 % ) were heterozygous polymorphic . DPYD*2A variant allele carriers were treated with a median dose-intensity of 48 % ( range , 17 % to 91 % ) . The risk of grade ≥ 3 toxicity was thereby significantly reduced from 73 % ( 95 % CI , 58 % to 85 % ) in historical controls ( n = 48 ) to 28 % ( 95 % CI , 10 % to 53 % ) by genotype-guided dosing ( P < .001 ) ; drug-induced death was reduced from 10 % to 0 % . Adequate treatment of genotype-guided dosing was further demonstrated by a similar incidence of grade ≥ 3 toxicity compared with wild-type patients receiving the st and ard dose ( 23 % ; P = .64 ) and by similar systemic fluorouracil ( active drug ) exposure . Furthermore , average total treatment cost per patient was lower for screening ( € 2,772 [ $ 3,767 ] ) than for nonscreening ( € 2,817 [ $ 3,828 ] ) , outweighing screening costs . CONCLUSION DPYD*2A is strongly associated with fluoropyrimidine-induced severe and life-threatening toxicity . DPYD*2A genotype-guided dosing results in adequate systemic drug exposure and significantly improves safety of fluoropyrimidine therapy for the individual patient . On a population level , upfront genotyping seemed cost saving UNLABELLED In February 2010 , the Medical Advisory Secretariat ( MAS ) began work on evidence -based review s of the literature surrounding three pharmacogenomic tests . This project came about when Cancer Care Ontario ( CCO ) asked MAS to provide evidence -based analyses on the effectiveness and cost-effectiveness of three oncology pharmacogenomic tests currently in use in Ontario . Evidence -based analyses have been prepared for each of these technologies . These have been completed in conjunction with internal and external stakeholders , including a Provincial Expert Panel on Pharmacogenomics ( PEPP ) . Within the PEPP , subgroup committees were developed for each disease area . For each technology , an economic analysis was also completed by the Toronto Health Economics and Technology Assessment Collaborative ( THETA ) and is summarized within the reports . THE FOLLOWING REPORTS CAN BE PUBLICLY ACCESSED AT THE MAS WEBSITE AT : www.health.gov.on.ca/mas or at www.health.gov.on.ca/english/providers/program/mas/mas_about.htmlGENE EXPRESSION PROFILING FOR GUIDING ADJUVANT CHEMOTHERAPY DECISIONS IN WOMEN WITH EARLY BREAST CANCER : An Evidence -Based and Economic Analysis Epidermal Growth Factor Receptor Mutation ( EGFR ) Testing for Prediction of Response to EGFR-Targeting Tyrosine Kinase Inhibitor ( TKI ) Drugs in Patients with Advanced Non-Small-Cell Lung Cancer : an Evidence -Based and Economic Analysis K-RAS testing in Treatment Decisions for Advanced Colorectal Cancer : an Evidence -Based and Economic Analysis . OBJECTIVE The objective of this systematic review is to determine the predictive value of KRAS testing in the treatment of metastatic colorectal cancer ( mCRC ) with two anti-EGFR agents , cetuximab and panitumumab . Economic analyses are also being conducted to evaluate the cost-effectiveness of KRAS testing . CLINICAL NEED CONDITION AND TARGET POPULATION Metastatic colorectal cancer ( mCRC ) is usually defined as stage IV disease according to the American Joint Committee on Cancer tumour node metastasis ( TNM ) system or stage D in the Duke 's classification system . Patients with advanced colorectal cancer ( mCRC ) either present with metastatic disease or develop it through disease progression . KRAS ( Kristen-RAS , a member of the rat sarcoma virus ( ras ) gene family of oncogenes ) is frequently mutated in epithelial cancers such as colorectal cancer , with mutations occurring in mutational hotspots ( codons 12 and 13 ) of the KRAS protein . Involved in EGFR-mediated signalling of cellular processes such as cell proliferation , resistance to apoptosis , enhanced cell motility and neoangiogenesis , a mutation in the KRAS gene is believed to be involved in cancer pathogenesis . Such a mutation is also hypothesized to be involved in resistance to targeted anti-EGFR ( epidermal growth factor receptor with tyrosine kinase activity ) treatments such as cetuximab and panitumumab , hence , the important in evaluating the evidence on the predictive value of KRAS testing in this context . KRAS MUTATION TESTING IN ADVANCED COLORECTAL CANCER : Both cetuximab and panitumumab are indicated by Health Canada in the treatment of patients with metastatic colorectal cancer whose tumours are WT for the KRAS gene . Cetuximab may be offered as monotherapy in patients intolerant to irinotecan-based chemotherapy or in patients who have failed both irinotecan and oxaliplatin-based regimens and who received a fluoropyrimidine . It can also be administered in combination with irinotecan in patients refractory to other irinotecan-based chemotherapy regimens . Panitumumab is only indicated as a single agent after failure of fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens . In Ontario , patients with advanced colorectal cancer who are refractory to chemotherapy may be offered the targeted anti-EGFR treatments cetuximab or panitumumab . Eligibility for these treatments is based on the KRAS status of their tumour , derived from tissue collected from surgical or biopsy specimens . It is believed that KRAS status is not affected by treatments , therefore , for patients for whom surgical tissue is available for KRAS testing , additional biopsies prior to treatment with these targeted agents is not necessary . For patients that have not undergone surgery or for whom surgical tissue is not available , a biopsy of either the primary or metastatic site is required to determine their KRAS status . This is possible as status at the metastatic and primary tumour sites is considered to be similar . RESEARCH QUESTION To determine if there is predictive value of KRAS testing in guiding treatment decisions with anti-EGFR targeted therapies in advanced colorectal cancer patients refractory to chemotherapy . RESEARCH METHODS LITERATURE SEARCH The Medical Advisory Secretariat followed its st and ard procedures and on May 18 , 2010 , search ed the following electronic data bases : Ovid MEDLINE , EMBASE , Ovid MEDLINE In-Process & Other Non-Indexed Citations , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s and The International Network of Agencies for Health Technology Assessment data base . The subject headings and keywords search ed included colorectal cancer , cetuximab , panitumumab , and KRAS testing . The search was further restricted to English- language articles published between January 1 , 2009 and May 18 , 2010 result ing in 1335 articles for review . Excluded were case reports , comments , editorials , non systematic review s , and letters . Studies published from January 1 , 2005 to December 31 , 2008 were identified in a health technology assessment conducted by the Agency for Healthcare Research and Quality ( AHRQ ) , published in 2010 . In total , 14 observational studies were identified for inclusion in this EBA : 4 for cetuximab monotherapy , 7 for the cetuximab-irinotecan combination therapy , and 3 to be included in the review for panitumumab monotherapy INCLUSION CRITERIA English- language articles , and English or French- language HTAs published from January 2005 to May 2010 , inclusive . R and omized controlled trials ( RCTs ) or observational studies , including single arm treatment studies that include KRAS testing . Studies with data on main outcomes of interest , overall and progression-free survival . Studies of third line treatment with cetuximab or panitumumab in patients with advanced colorectal cancer refractory to chemotherapy . For the cetuximab-irinotecan evaluation , studies in which at least 70 % of patients in the study received this combination therapy . EXCLUSION CRITERIA Studies whose entire sample was included in subsequent publications which have been included in this EBA . Studies in pediatric population s . Case reports , comments , editorials , or letters . OUTCOMES OF INTEREST Overall survival ( OS ) , medianProgression-free-survival ( PFS ) , median . Response rates . Adverse event rates . Quality of life ( QOL ) . SUMMARY OF FINDINGS OF SYSTEMATIC REVIEW : CETUXIMAB OR PANITUMUMAB MONOTHERAPY : Based on moderate GRADE observational evidence , there is improvement in PFS and OS favouring patients without the KRAS mutation ( KRAS wildtype , or KRAS WT ) compared to those with the mutation . CETUXIMAB-IRINOTECAN COMBINATION THERAPY : There is low GRADE evidence that testing for KRAS may optimize survival benefits in patients without the KRAS mutation ( KRAS wildtype , or KRAS WT ) compared to those with the mutation . However , cetuximab-irinotecan combination treatments based on KRAS status discount any effect of cetuximab in possibly reversing resistance to irinotecan in patients with the mutation , as observed effects were lower than for patients without the mutation . Clinical experts have raised concerns about the biological plausibility of this observation and this conclusion would , therefore , be regarded as hypothesis generating . ECONOMIC ANALYSIS Cost-effectiveness and budget impact analyses were conducted incorporating estimates of effectiveness from this systematic review . Evaluation of relative cost-effectiveness , based on a decision-analytic cost-utility analysis , assessed testing for KRAS genetic mutations versus no testing in the context of treatment with cetuximab monotherapy , panitumumab monotherapy , cetuximab in combination with irinotecan , and best supportive care . Of importance to note is that the cost-effectiveness analysis focused on the impact of testing for KRAS mutations compared to no testing in the context of different treatment options , and does not assess the cost-effectiveness of the drug treatments alone . CONCLUSIONS KRAS status is predict
Output:
| Model-based cost-effectiveness analyses of systemic mCRC treatments have adopted varied modelling methods and structures , result ing in substantially different outcomes .
As models generally focus on first-line treatment without consideration of downstream treatments , there is a profound source of structural uncertainty implying that the cost-effectiveness of treatments across the mCRC pathway remains uncertain |
MS211761 | ***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 : This phase II study was conducted to assess the efficacy of temozolomide in patients with relapsed small cell lung cancer ( SCLC ) . Experimental Design : Patients with disease progression after one or two prior chemotherapy regimens received temozolomide at 75 mg/m2/d for 21 days of a 28-day cycle . The primary endpoint was the overall response rate [ ORR ; complete response ( CR ) plus partial response ( PR ) ] , which was evaluated separately in sensitive and refractory cohorts . In the available tissue , we assessed O6-methylguanine-DNA methyltransferase ( MGMT ) promoter methylation status by PCR and MGMT expression by immunohistochemistry . Results : Sixty-four patients were accrued : 48 patients in the sensitive cohort and 16 in the refractory group . One CR and 10 PRs were noted in sensitive patients [ ORR , 23 % ; 95 % confidence interval ( CI ) , 12%–37 % ] . Two PRs were seen in the refractory cohort ( ORR , 13 % ; 95 % CI , 2%–38 % ) . As second- and third-line treatment , the ORR was 22 % ( 95 % CI , 9%–40 % ) and 19 % ( 95 % CI , 7%–36 % ) , respectively . Among patients with target brain lesions , 38 % had a CR or PR ( 95 % CI , 14%–68 % ) . Grade ≥3 thrombocytopenia and neutropenia were observed in nine patients ( 14 % ) . A greater number of cases with methylated MGMT had a response compared to those with unmethylated MGMT ( 38 % vs. 7 % ; P = 0.08 ) . Conclusion : Temozolomide has activity in relapsed SCLC , particularly for brain metastases . Response to temozolomide may correlate with MGMT methylation in SCLC . Clin Cancer Res ; 18(4 ) ; 1138–45 . © 2012 AACR BACKGROUND AND METHODS Cisplatin ( cis-diamminedichloroplatinum ) has been reported to enhance the cell-killing effect of radiation , an effect whose intensity varies with the schedule of administration . We r and omly assigned 331 patients with nonmetastatic inoperable non-small-cell lung cancer to one of three treatments : radiotherapy for two weeks ( 3 Gy given 10 times , in five fractions a week ) , followed by a three-week rest period and then radiotherapy for two more weeks ( 2.5 Gy given 10 times , five fractions a week ) ; radiotherapy on the same schedule , combined with 30 mg of cisplatin per square meter of body-surface area , given on the first day of each treatment week ; or radiotherapy on the same schedule , combined with 6 mg of cisplatin per square meter , given daily before radiotherapy . RESULTS Survival was significantly improved in the radiotherapy-daily-cisplatin group as compared with the radiotherapy group ( P = 0.009 ) : survival in the radiotherapy-daily-cisplatin group was 54 percent at one year , 26 percent at two years , and 16 percent at three years , as compared with 46 percent , 13 percent , and 2 percent , respectively , in the radiotherapy group . Survival in the radiotherapy-weekly-cisplatin group was intermediate ( 44 percent , 19 percent , and 13 percent ) and not significantly different from survival in either of the other two groups . The survival benefit of daily combined treatment was due to improved control of local disease ( P = 0.003 ) . Survival without local recurrence was 59 percent at one year and 31 percent at two years in the radiotherapy-daily-cisplatin group ; 42 percent and 30 percent , respectively , in the radiotherapy-weekly-cisplatin group ; and 41 percent and 19 percent , respectively , in the radiotherapy group . Cisplatin induced nausea and vomiting in 86 percent of the patients given it weekly and in 78 percent of those given it daily ; these effects were severe in 26 percent and 28 percent , respectively . CONCLUSIONS Cisplatin , given daily in combination with the radiotherapy described here to patients with nonmetastatic but inoperable non-small-cell lung cancer , improved rates of survival and control of local disease at the price of substantial side effects
Output:
| OS and PFS did not significantly differ between combination therapy and WBRT alone .
No advantages of concurrent WBRT and TMZ were observed in breast cancer patients with brain metastases .
Combination therapy was associated with improved ORR in NSCLC patients , especially in Chinese patients .
As a “ surrogate endpoint ” for OS , ORR may allow a conclusion to be made about the management of NSCLC with brain metastases with the combination of WBRT and TMZ . |
MS211762 | ***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 No quantitative data on glenohumeral translation exist allowing one to distinguish insufficiency of the active or passive stabilizers in different forms of shoulder instability . Hypothesis To determine whether 1 ) in traumatic or atraumatic shoulder instability an increase of glenohumeral translation can be observed in specific relevant arm positions , 2 ) muscle activity leads to recentering of the humeral head , and 3 ) there exist differences between traumatic and atraumatic instability . Study Design Prospect i ve clinical trial . Methods In 12 patients with traumatic and 10 patients with atraumatic instability , both shoulders were examined in different arm positions — with and without muscle activity — by using open magnetic resonance imaging and a three-dimensional postprocessing technique . Results At 90 ° of abduction and external rotation , translation ( anterior-inferior ) was significantly higher in patients with traumatic unstable shoulders compared with their contralateral side ( 3.6 ± 1.5 versus 0.7 ± 1.6 mm ) . In patients with atraumatic instability , significantly increased translation ( 4.7 ± 2.0 mm ) was observed , with the direction being nonuniform . Muscle activity led to significant recentering in traumatic but not in atraumatic instability . Conclusions In traumatic instability , increased translation was observed only in functionally important arm positions , whereas intact active stabilizers demonstrate sufficient recentering . In atraumatic instability , a de central ized head position was recorded also during muscle activity , suggesting alterations of the active stabilizers . Clinical Relevance Clinical Relevance : These data are relevant for optimizing diagnostics and therapeutic strategies Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists 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 . Descriptive studies have shown that shoulder complaints can be persistent and recurrent , requiring long term evaluation of treatment.1 Unfortunately , in most r and omised studies comparing treatments for shoulder complaints the study period varies from a few weeks ( trials of non-steroidal anti-inflammatory drugs ) to 3 - 6 months ( injection therapy and physiotherapy trials).2–4 ) In a trial in 1994 - 5 of treatment of shoulder complaints in general practice we showed that in a study period of 11 weeks , injection therapy with a corticosteroid was superior to physiotherapy and manipulative therapy in the patients whose complaints originated from the structures of the glenohumeral joint , the subacromial space , or the acromioclavicular joint ( synovial group).5 In the patients whose complaints related to functional disorders of the cervical spine , the upper thoracic spine , or the adjoining ribs ( shoulder girdle group ) , manipulation was superior to physiotherapy . To assess the various treatments in A method for directly measuring the position of the humeral head on the face of the glenoid in different positions of abduction of the arm was developed . We studied three subject groups : 12 patients with normal shoulders ( group 1 ) , 15 patients with stage II impingement syndrome ( group 2 ) , and 20 patients with rotator cuff tears or stage III impingement ( group 3 ) . The study consisted of a series of anteroposterior roentgenograms in the plane of the scapula with the arm in neutral rotation . Roentgenograms were obtained at 20 degrees intervals as the arm was elevated in the plane of the scapula from 0 degree to 120 degrees . Patients held a weight equal to 2 1/2 % of body weight in the h and . The parameters measured were excursion of the humeral head on the glenoid face , expressed as the distance that the center of the head lies above or below the center of the glenoid , arm angle , scapulothoracic angle , and glenohumeral angle . For patients with normal shoulders ( group 1 ) , there was no significant change in position of the humeral head with arm elevation . In contrast , those with stage II impingement ( group 2 ) had significant ( p < 0.05 ) superior displacement of the center of the humeral head with arm elevation . Patients with rotator cuff tears ( group 3 ) demonstrated a significant rise ( p < 0.05 ) during the first 40 degrees of abduction . The average position of the humeral head in the two pathologic patient groups was superior ( p < 0.05 ) to the average head position in the normal patient group . There was no significant difference in head position between patients with stage II impingement and patients with rotator cuff tear . The ratio of the glenohumeral angle to the scapulothoracic angle during abduction was calculated for our patient groups . In both patient groups , arm abduction had a larger scapulothoracic component than for normal shoulders . The superior migration of the humeral head is a probable result of cuff failure , either partial or complete
Output:
| Evidence , however , indicated that not only the passive , but also the active and control subsystems of the shoulder may need to be considered when determining the direction of the translational gliding of the HOH . |
MS211763 | ***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 : Routine deep venous thrombosis prophylaxis is controversial in Asian patients , because deep venous thrombosis incidence was considered negligible . Because of recent reports of significantly higher incidences , a r and omized , controlled trial was conducted to assess the effectiveness and complications of enoxaparin prophylaxis ( low molecular weight heparins ) in major colorectal surgery . METHODS : Three hundred twenty consecutive patients were r and omly assigned to control or low molecular weight heparins groups . Patients in the low molecular weight heparins group were given perioperative enoxaparin starting 12 hours before surgery . The surgeon ( blinded ) assessed for difficulties related to possible enoxaparin administration . Independent blinded observers performed daily clinical assessment s and Doppler studies ( at the 3rd and 5th postoperative day ) . Deep venous thrombosis was confirmed by duplex ultrasound , and pulmonary embolism was confirmed by lung scans or postmortem examinations . RESULTS : Deep venous thrombosis developed in 5 of 169 ( 3 percent ) controls and 0 of 134 low molecular weight heparins patients ( P=0.045 ) . Three of the deep venous thrombosis patients had pulmonary embolism , which was fatal in one patient . The surgeons were unable to perceive any increased surgical difficulties in the low molecular weight heparins group . The bleeding-related complications were significantly higher in the low molecular weight heparins patients ( controls , n=3 ( 1.8 percent ) ; low molecular weight heparins , n=9 ( 6.7 percent ) ) . However , apart from one subdural hematoma and two abdominal hemorrhages needing re-exploration , which also occurred in one of the controls , these complications were minor bruises at the wounds , drains , or injection sites . CONCLUSION : Deep venous thrombosis prophylaxis is needed in Asian patients undergoing major colorectal surgery In a r and omized , prospect i ve , double‐blind multicentre trial , the effect of conventional low‐dose heparin 5000 units twice daily , was compared with that of a low molecular weight heparin fragment ( 4000–5000 ) 5000 anti‐factor Xa units once daily . Four hundred and thirty‐two patients fulfilled the inclusion criteria and were analysed for development of deep vein thrombosis ( 125I‐labelled fibrinogen test ) and haemorrhagic complications . Thrombosis occurred in a 4.3 per cent of patients in the low‐dose heparin group and in 6.4 per cent of patients in the heparin fragment group , a difference which is not significant . There was a significant delay in the onset of thrombosis in the heparin fragment group . Mortality did not differ between the groups , nor did peroperative blood loss or transfusion requirements or infectious complications . Haemorrhagic complications occurred significantly more often in the fragment group ( 11.6 per cent ) than in the conventional heparin group ( 4.6 per cent ) . Patients in the heparin fragment group experienced local pain following the subcutaneous injection significantly less often Abstract Heparin ( 1 IU kg -1 h -1 ) given intravenously for 3 - 5 days during and after operation in a double-blind r and omised study , significantly reduced the frequency of deep-vein thrombosis detected by 125 I-fibrinogen uptake , and pulmonary embolism . 22 % ( 11/50 ) control patients and 4 % ( 2/45 ) patients receiving heparin had deep-vein thrombosis or pulmonary embolism . Heparin administration was not associated with any increase in preoperative or postoperative bleeding In a prospect i ve , r and omized multicentre trial the efficacy and safety of the low molecular weight heparin ( LMWH ) fraction Fraxiparin ® and unfractionated calcium heparin ( Calciparin ® ) were compared for the prevention of postoperative deep vein thrombosis . Of 1909 patients included in the trial 1896 underwent abdominal surgery and received either one daily subcutaneous injection of 7500 anti‐X a units Fraxiparin or 5000 units calcium heparin three times a day subcutaneously . Elastic compression stockings were worn by both groups of patients in the postoperative period . Before r and omization the patients were stratified in two subgroups with or without malignant disease . To assess the rate of deep vein thrombosis ( DVT ) , 125I‐labelled fibrinogen leg scanning was performed daily for 7 postoperative days . Positive results were confirmed by phlebography whenever possible . Venous thrombosis occurred in 27 of 960 patients ( 2.8 per cent ) given Fraxiparin and in 42 of 936 patients ( 4.5 per cent ) given calcium heparin ( P = 0.034 ) . The rates of proximal vein thrombosis were 0.4 per cent ( 4 patients ) and 1.4 per cent ( 13 patients ) respectively ( P<0.05 ) . Pulmonary embolism occurred in 2 of 960 patients ( 0.2 per cent ) treated with Fraxiparin and in 5 of 936 patients ( 0.5 per cent ) treated with calcium heparin . The two treatments were equally well tolerated . Intra‐ and postoperative blood loss , the number of wound haematomas as well as frequency and volume of transfusions were similar in both groups . The present trial demonstrates that a single daily subcutaneous injection of Fraxiparin is more effective than the established low dose subcutaneous heparin prophylaxis with 5000 units three times per day in preventing postoperative DVT after abdominal surgery in patients wearing compression stockings In a prospect i ve , double-blind , r and omized multicenter trial the efficacy and safety of low molecular weight heparin and unfractionated heparin were compared for the prevention of postoperative deep vein thrombosis in patients undergoing abdominal surgery . Six hundred and seventy-three patients were r and omly allocated to the two prophylaxis groups ; 20 of these , however , did not undergo surgery and did not receive any prophylaxis . Of the remaining 653 patients 323 received one subcutaneous injection of 3,000 anti-Xa units of low molecular weight heparin and 330 received subcutaneously 5,000 U heparin three times a day . Treatment was initiated 2 h preoperatively and continued for 7 to 10 days . The occurrence of DVT was determined by the 125I-labelled fibrinogen uptake test and phlebography . Venous thrombosis was diagnosed in 24 of 323 patients ( 7.4 % ) treated with low molecular weight heparin and in 26 of 330 patients ( 7.9 % ) treated with low-dose heparin . DVT of proximal veins was detected in four patients of the low molecular weight heparin group and in three patients of the low-dose heparin group . During the observation period three pulmonary emboli - one fatal and two non-fatal - occurred in patients receiving prophylaxis with low-dose heparin . No pulmonary embolism was found in patients treated with low molecular weight heparin . Both prophylactic schemes were well tolerated . Intra- and postoperative blood loss , incidence of wound hematoma , frequency and volume of intra- and postoperative blood transfusion were similar in both groups with a slight advantage for the low molecular weight heparin group . ( ABSTRACT TRUNCATED AT 250 WORDS The effect of low-dose heparin prophylaxis on venous thrombosis and bleeding after major elective surgery was studied in a prospect i ve controlled study of 820 patients . The total incidence of venous thrombosis detected with leg-scanning using fibrinogen labeled with radioactive iodine ( 125I ) was reduced from 16.0 % in the control group to 4.2 % in treated patients . More important , the incidence of popliteal or femoral vein thrombosis was reduced from 2.9 % to 1.0 % . Prophylaxis result ed in a slight increase in bleeding-minor wound hematoma , mean volume of blood transfused , and a post-operative hematocrit fall in treated patients . However , increased bleeding was clinical ly minor , and prophylaxis was well tolerated Fourty patients who underwent general surgery have been enrolled in a double-blind controlled trial which evaluated the efficacy and safety of Fragmin , a new low molecular weight heparin , chosen to be the 1st OMS International St and ard for LMWH . Fragmin 2500 UI anti-Xa once daily and unfractionated heparin 5000 UI twice daily were administered to prevent postoperative deep venous thrombosis . Prophylaxis began two hours before surgery and continued for the next 5 postoperative days . The incidence of isotopic venous thrombosis , thromboembolic disorders and bleeding complications have been evaluated . Results have shown a similar efficacy and safety profile of the two drugs , although Fragmin doses are markedly inferior to unfractionated heparin 's . Moreover , Fragmin has the advantage of a single daily administration , with a better patients ' compliance and an easier and less expensive nursing care The potential antithrombotic effect of a new low molecular weight heparinoid , Org 10172 , was examined in a r and omized , double-blind , placebo-controlled , dose-ranging pilot study of the prevention of deep venous thrombosis ( DVT ) in 45 high-risk patients having major thoracic or abdominal surgery for cancer . Org 10172 was given in doses of 500 , 750 or 1000 U bd subcutaneously . DVT occurred in 9 of 14 patients given placebo and in 4 of 11 patients given 500 U bd but in none of the 20 patients given 750 or 1000 U bd . Operative blood loss and post-operative bleeding were not significantly different between the groups but one patient given 1000 U bd had major post-operative bleeding . Average mid-interval and trough plasma anti-Xa levels reached 0.26 and 0.20 U/ml respectively following the highest dose . It is concluded that Org 10172 is a potentially useful antithrombotic agent and that the effective and safe dose appears to be between 500 and 1000 U bd for prevention of DVT in high-risk patients The prophylactic effect of a semisynthetic heparin analogue ( SSHA ) on deep vein thrombosis was investigated in a prospect i ve double‐blind multicentre trial . 440 major general surgical and gynaecological patients were r and omized to one of three treatment groups : 50 mg SSHA , 37.5 mg SSHA and 5000 units sodium heparin subcutaneously 12‐hourly . Deep venous thrombosis ( DVT ) was diagnosed with the fibrinogen uptake test and verified with phlebography . Bleeding complications and other side‐effects were carefully monitored . There were no significant differences between the three treatment groups of patients in age , sex , type of operation or risk factors . A DVT was diagnosed in 16 patients ( 12 per cent ) in the SSHA 50 mg group , in 21 patients ( 15 per cent ) in the SSHA 37.5 mg group and 21 patients ( 14 per cent ) in the heparin‐treated group . No significant differences were found in the number of patients who bled unexpectedly in the postoperative period , required transfusion or developed wound haematomas . Blood loss at operation was similar in all three groups . Three pulmonary emboli were diagnosed by pulmonary scintigraphy , one in each group Objective To compare the effectiveness and safety of low-dose unfractionated heparin and a low-molecular-weight heparin as prophylaxis against venous thromboembolism after colorectal surgery . Methods In a multicenter , double-blind trial , patients undergoing resection of part or all of the colon or rectum were r and omized to receive , by subcutaneous injection , either calcium heparin 5,000 units every 8 hours or enoxaparin 40 mg once daily ( plus two additional saline injections ) . Deep vein thrombosis was assessed by routine bilateral contrast venography performed between postoperative day 5 and 9 , or earlier if clinical ly suspected . Results Nine hundred thirty-six r and omized patients completed the protocol and had an adequate outcome assessment . The venous thromboembolism rates were the same in both groups . There were no deaths from pulmonary embolism or bleeding complications . Although the proportion of all bleeding events in the enoxaparin group was significantly greater than in the low-dose heparin group , the rates of major bleeding and reoperation for bleeding were not significantly different . Conclusions Both heparin 5,000 units subcutaneously every 8 hours and enoxaparin 40 mg subcutaneously once daily provide highly effective and safe prophylaxis for patients undergoing colorectal surgery . However , given the current differences in cost , prophylaxis with low-dose heparin remains the preferred method at present Deep vein thrombosis and its sequel , pulmonary embolus , are possibly the greatest threats to recovery after surgical operation . In a r and omized , controlled clinical trial in which the 125I-fibrinogen uptake test , Doppler ultrasound , and phlebography were used for diagnosis , it was found that low doses of calcium heparinate administered subcutaneously and sodium pentosan polysulf
Output:
| Studies of general surgery contain considerable numbers of colorectal patients . |
MS211764 | ***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 This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft . STUDY DESIGN A total of 162 women were enrolled in a prospect i ve , r and omized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse . Subjects were r and omly assigned to st and ard colporrhaphy with or without a patch . Before and after surgery , subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems . " Failure " was defined as stage II anterior wall prolapse or worse . RESULTS Of 154 women r and omly assigned ( 76 patch : 78 no patch ) , all underwent surgery and 153 ( 99 % ) returned for follow-up . Sixteen women ( 21 % ) in the patch group and 23 ( 29 % ) in the control group experienced recurrent anterior vaginal wall prolapse ( P = .229 ) . Only 26 % of all recurrences were symptomatic . Concomitant transvaginal Cooper 's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse ( odds ratio [ OR ] 0.105 , P < .0001 ) . CONCLUSION Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy . Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse Introduction and hypothesisThe objective of this study was to assess the effect of the tension-free vaginal mesh ( Prolift ™ ) procedure on the non-treated and initially unaffected vaginal compartments . Methods This prospect i ve observational cohort study involved 150 patients who underwent a Prolift ™ procedure . Pelvic organ prolapse ( POP ) quantification and evaluation of prolapse symptoms with vali date d question naires was performed pre-operatively and 6 and 12 months postoperatively . Primary outcome was the rate of POP stage ≥II in the non-treated vaginal compartments . Results Twenty-three percent of all patients developed a de novo POP stage ≥II in the untreated compartment . This occurred in 46 % and 25 % of patients after an isolated anterior and isolated posterior Prolift ™ , respectively . Conclusion Tension-free vaginal mesh treatment of one vaginal compartment seems to provoke the development of vaginal prolapse in initially unaffected vaginal compartments , particularly after an isolated anterior Prolift ™ procedure OBJECTIVES This prospect i ve , r and omised study investigated whether a prophylactic procedure , performed during colposacropexy for prolapse repair , prevents ex novo postoperative incontinence . Sixty-six consecutive continent patients with advanced prolapse were r and omised into two groups : group A underwent sacropexy combined with a Burch colposuspension ; no anti-incontinence procedure was performed in group B patients . METHODS Work-up included clinical assessment ( Halfway System and International Continence Society [ ICS ] classification for prolapse and Ingelman Sunderberg scale for incontinence ) , the Urogenital Distress Inventory and Impact Incontinence Quality of Life question naires , urogynaecologic ultrasound scans , and complete urodynamic testing that included the urethral pressure profile and Valsalva leak point pressure with reduced prolapse . Check-ups were done at 3 , 6 , 12 mo postoperatively and then yearly . Mean follow-up time was 39.5 mo . RESULTS The mean age ( + /- st and ard deviation ) was 62+/-9 yr . All patients presented with grade ( G ) 3 - 4 prolapse . Postoperative incontinence was present in 12 of the 34 patients in group A : 7 G1 ; 4 G2 , and 1 G3 . Postoperative incontinence was present in 3 of the 32 patients in group B : 2 G1 , 1 G3 . The frequency of postoperative incontinence was significantly greater in patients who had undergone colposuspension ( p<0.05 ) . CONCLUSIONS These preliminary data cast doubt on whether colposuspension should be performed during sacropexy for severe urogenital prolapse as prophylaxis for postoperative incontinence because it seems to emerge as overtreatment . Incontinence developed ex novo in 35 % of continent patients treated with colposuspension combined with sacropexy Introduction and hypothesisThe surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques . This study evaluates anterior vaginal mesh repair , sacrospinous hysteropexy and posterior fascial plication in women with anterior compartment dominated uterovaginal prolapse . Methods Consecutive women who underwent the aforementioned surgery were prospect ively evaluated . Main outcome measures included objective ( pelvic organ prolapse quantification stage < 2 ) and subjective success rates , patient satisfaction , functional outcomes and complications . Results One hundred and seventeen women were eligible , and 100 agreed to participate . At 12 months , objective success rate at the anterior compartment was 87 % and at all compartments , 75 % . Subjective success was 84 % , and mean patient satisfaction was 8.5/10 . There were no stage 3 or 4 recurrences at any site . Conclusions The combination of anterior vaginal mesh , sacrospinous hysteropexy and posterior fascial plication is reasonably effective in restoring the anatomy and achieving favourable bladder , bowel and sexual function OBJECTIVE To compare changes in urinary symptoms before and after pelvic organ prolapse ( POP ) surgery , using either laparoscopic sacrocolpopexy ( LSC ) or transvaginal porcine dermis hammock placement with sacrospinous ligament suspension ( VS ) . MATERIAL S AND METHODS Data were prospect ively collected from all women undergoing POP surgery between May 2001 and October 2009 . Pre- and postoperative urinary symptoms , Urinary Distress Inventory ( UDI ) , and Urinary Impact Question naires ( UIQ ) scores were compared within and between groups . A generalized linear model was used for multivariate analysis . RESULTS Out of the 151 patients included , 87 patients underwent LSC , and 64 VS . Overall , after a median follow-up of 32.4 months , POP surgery improved urinary frequency ( P = 0.006 ) , voiding difficulty ( P = 0.001 ) , stress urinary incontinence ( SUI ) ( P = 0.001 ) , but not urgency ( P = 0.29 ) . VS was more effective in treating SUI ( P < 0.001 vs. 0.52 ) while LSC more effective on voiding difficulty ( P = 0.01 vs. 0.08 ) . Postoperative de novo symptoms were observed in 35.8 % of patients with no difference between the groups ( P = 0.06 ) . UDI ( P = 0.04 ) and UIQ ( P = 0.01 ) scores were significantly lower after surgery . However , LSC significantly improved UDI ( P = 0.03 ) with no effect on UIQ ( P = 0.29 ) scores while VS significantly improved both scores ( P = 0.02 and 0.001 , respectively ) . Upon multivariate analysis , only the improvement in the impact of urinary symptoms on daily living was independently associated to VS ( OR = 5.45 [ 95 % confidence interval 2.20 - 13.44 ] , P = 0.01 ) . CONCLUSION Most preoperative urinary symptoms decreased after POP surgery with equivalent proportion of de novo symptoms after vaginal and laparoscopic approaches OBJECTIVE The purpose of this study was to compare 2 anti-incontinence procedures in women who had severe genital prolapse and potential stress incontinence . STUDY DESIGN In addition to vaginal reconstructive surgery , 50 patients with stage II or higher anterior defect and a positive stress test result with prolapse reduction received either tension-free vaginal tape or plication of the endopelvic fascia . Preoperative evaluation included history , physical examination , stress test , and urodynamic assessment . Data were analyzed with the Student t test , the Fisher 's exact test , and the Wilcoxon signed-rank test . RESULTS The median follow-up time was similar for both groups , 26 and 24 months . Subjective ( 96 % vs 64 % ; P=.01 ) and objective ( 92 % vs 56 % ; P<.01 ) continence rates were higher after the tension-free vaginal tape procedure . Time for the resumption of spontaneous voiding , rates of urinary retention , or de novo urge incontinence were similar in the 2 groups . CONCLUSION Tension-free vaginal tape can be recommended for patients with prolapse and occult stress incontinence OBJECTIVE Polypropylene mesh in the treatment of genital prolapse in women was introduced at the turn of the millennium with the rationale of decreasing surgical invasiveness , reinforcing weak tissues and to possibly complement insufficient surgical techniques . Prospect i ve r and omized studies comparing traditional and modern operations are lacking . SUBJECT Prospect i ve multicentre r and omized study . SETTING Department of Obstetrics and Gynaecology , The First Faculty of Medicine , Charles University in Prague . SUBJECT AND METHOD A prospect i ve multicentre trial was approved by the Ministry of Health of the Czech Republic and registered with the FDA planning to recruit 500 patients with vaginal prolapse , 18 years of age and over , undergoing surgery at 5 major urogynaecologic centres . The patients were divided into three groups according to prolapse predominance . The surgical techniques used were : anterior and posterior prolift , and r and omly allocated total prolift or sacrospinous fixation . The examination setup included lower urinary tract ultrasound , MRI , POP-Q assessment and QoL question naires before surgery and six and 24 month after the surgery . CONCLUSION Preliminary analysis of partial data of 225 women showed an acceptable rate of complications and a better success rate in the mesh groups , whereas operation time and blood loss was lower in the classical operation group . Quality of life question naires documented that all the methods used have comparably good results . The surgical techniques used are acceptable methods for pelvic organ prolapse repair with low complication rates and excellent impact on the subjective perception of the patient 's quality of life Introduction and hypothesisEndoFast Reliant ™ system is a novel technology for pelvic organ prolapse ( POP ) repair that attaches mesh directly with metal fasteners . Methods This was a prospect i ve multicenter study in 20 women who underwent vaginal POP repair to evaluate safety and efficacy . The patients were followed for 12 months , using POP-Q measures , question naires on symptoms ( PFDI ) , and sexual function ( FSFI ) . Results No intraoperative complications occurred . Prolapse has been anatomically resolved ( < stage 2 ) in 85 % at 1-year follow-up ( 17/20 patients ) . Pelvic Floor Distress Inventory ( PFDI ) scores showed significant improvement for 1 year in symptoms related to prolapse ( 4.1–0.7 , p < 0.001 ) and bladder ( 1.4–0.7 , p = 0.06 ) but not to rectum . Female Sexual Function Index ( FSFI ) scores did not change significantly . One case of mesh exposure was found ( 5 % ) and treated conservatively . No migration of fasteners was observed on X-ray . Conclusions The EndoFast Reliant ™ system was found safe and efficacious . Future studies are needed to evaluate its advantages over techniques using trocars Introduction and hypothesisThe optimal duration of urethral catheterization during and after pelvic reconstructive surgery is not established . This study investigated the optimal duration of urinary catheterization in patients undergoing anterior vaginal repair with or without other vaginal surgeries . Methods A total of 90 patients were included from April 2007 to March 2008 . They were r and omly divided into 2 , 3 , and 4 days urinary catheterization groups based on the color of the question naire papers they blindly chose . After catheter removal , the amount of post-void residual urine was used to measure the efficacy of bladder emptying . Differences between groups were determined using Chi-square test , Fisher 's exact test , or Kruskal – Wallis test , as appropriate . Results No significant differences were found in the amount of post-void residual urine between the three catheterization groups . Conclusions Our findings suggest that the duration of urethral catheterization after anterior colporrhaphy need not exceed 2 days Introduction and hypothesisVaginal mesh kits are increasingly used in the management of pelvic organ prolapse . This study aim ed to determine similarity of outcomes of the Anterior Prolift ® with Perigee ® systems for anterior compartment prolapse . Methods Consecutive women undergoing Perigee ® or Anterior Prolift ® for symptomatic stage 2 or greater anterior vaginal prolapse were prospect ively evaluated . Main outcome measures included objective and subjective success rates , perioperative outcomes , patient satisfaction , and complications . Results One hundred and six women ( Prolift , 52 ; Perigee , 54 ) completed question naires , and 91 ( Prolift , 46 ; Perigee , 45 ) were examined postoperatively . At follow-up ( Prolift : median , 11.0 ; range , 5–23 months ; Perigee : median , 11.5 ; range , 6–23 months ) , objective success rates ( Prolift , 89 % ; Perigee , 80 % ; p = 0.23 ) , subjective success rates ( Prolift , 94 % ; Perigee , 96 % ;
Output:
| Results Continent women undergoing anterior compartment prolapse surgery have a lower rate of de novo stress urinary incontinence ( SUI ) after anterior repair than armed mesh procedures ( grade A ) .
Data are conflicting on whether colposuspension should be performed prophylactically in continent women undergoing sacral colpopexy ( grade C ) .
No clear conclusion can be made regarding the management of continent women undergoing prolapse surgery without occult SUI .
In continent women undergoing POP surgery with occult SUI the addition of continence surgery reduces the rate of postoperative SUI ( grade A ) .
In women with prolapse and SUI symptoms prolapse procedures alone ( transobturator mesh and anterior repair ) are associated with low success rates for SUI .
Concomitant continence procedures reduce the risk of postoperative SUI ( grade B ) . |
MS211765 | ***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 Team-based learning ( TBL ) has been successfully used in non-medical curricula , but its effectiveness in medical education has not been studied extensively . We evaluated the impact of TBL on the academic performance of Year 2 medical students at Wright State University by comparing this active learning strategy against a traditional method of case-based group discussion ( CBGD ) . METHODS A prospect i ve crossover design assigned 83 Year 2 medical students to either CBGD or TBL for 8 pathology modules in the systems-based curriculum . The effectiveness of both learning methods was assessed by performance on pathology-based examination questions contained in end-of-course examinations . The highest and lowest academic quartiles of students were evaluated separately . Students ' opinions of both methods were surveyed . RESULTS No significant differences in whole group performance on pathology-based examination questions were observed as a consequence of experiencing TBL versus CBGD . However , students in the lowest academic quartile showed better examination performance after experiencing TBL than CBGD in 4 of 8 modules ( P = 0.035 ) . Students perceived that the contributions of peers to learning were more helpful during TBL than CBGD ( P = 0.003 ) . CONCLUSION This study demonstrates that TBL and CBGD are equally effective active learning strategies when employed in a systems-based pre- clinical pathology curriculum , but students with lower academic performance may benefit more from TBL than CBGD
Output:
| The majority of the articles , however , reported that TBL provided a positive learning experience for students . |
MS211766 | ***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: Nalorphine and naloxone were compared as to their effectiveness as pethidine antagonists . 85 infants were divided into a control group containing 19 newborn babies whose mothers did not receive pethidine and the babies received no antagonist , and three groups in which the mothers all received pethidine and the babies had either no antagonist ( 24 ) , nalorphine IV ( 16 ) , or naloxone IV ( 26 ) . All the babies were assessed by measuring their neurobehavioural states and respiratory functions . A further 12 newborn babies had naloxone plasma levels measured by radioimmunoassay . Although st and ard doses of nalorphine effectively antagonised the depressive effect on respiration induced by pethidine , there was a pronounced and undesirable excitatory agonist action . Naloxone was not observed to have any agonist activity , but the recommended IV dose ( 0.01 mg/kg ) had only a slight and delayed antagonist action as measured by respiratory function tests . A more rapid and improved antagonism was noted after this dose was doubled ( 0.02 mg/kg ) . The plasma elimination-phase half-life of naloxone after intravenous cord injection was about 3 To investigate the presence of subtle narcotic depression following maternal narcotic analgesia , we have evaluated the effects of naloxone versus placebo in a double-blind parallel group study in 43 normal term newborn infants whose mothers had received routine narcotic analgesia within six hours prior to delivery . Infants were given either an intramuscular injection of 20 microgram/kg naloxone or 0.20 ml/kg placebo after determination of the one-minute Apgar score , and the following measurements were compared : Apgar scores at one and five minutes , capillary blood gas values at one , 60 , 120 , and 240 minutes , and neurobehavioral assessment s at one , 4 , and 24 hours . No adverse effects from naloxone were observed . Neither Apgar scores nor capillary blood gas determinations differed significantly between the two groups . Response to sound was significantly higher in the naloxone group at 24 hours . The alertness score was significantly higher for the naloxone group at one and four hours ; the general assessment score for the naloxone group was significantly higher at four and 24 hours . Average scores of naloxone and placebo groups were also different at four and 24 hours of age . These data demonstrate that maternal narcotic analgesia may produce subtle changes in alertness and general behavior not reflected by Apgar scores or respiratory status , potentially reversible by administration of naloxone shortly following delivery Abstract . Infants born to mothers receiving 100 mg of pethidine during labor , were r and omly given either 100 μg of naloxone ( n = 14 ) or 0.25 ml 0.9 % NaCl ( n = 13 ) one hour post partum . Infant behavior was assessed with the Brazelton Neonatal Behavioral Assessment Scale ( BNBAS ) and the Broussard Neonatal Perception Inventory ( NPI ) . No differences in cluster scores on the BNBAS were found between the two groups . Both groups improved scores over time in 4 out of 7 clusters . On the NPI , mothers assessed naloxone infants as having less optimal behavior than did the control mothers . The results of this study on the effects of naloxone on infant behavior and maternal perception of newborn behavior do not warrant administration of naloxone after maternal analgesia with pethidine in the absence of clinical evidence of respiratory depression in the newborn The effects on mature newborn have been compared at 0.5 , 4 , 8 12 24 and 48 hr after birth , of maternally administered epidural bupivacaine ( 11 babies ) or pethidine ( 18 babies ) or pethidine reversed by naloxone administered intramuscularly to the newborn ( 15 babies ) . Bupivacaine ( mean dose 130 mg ) had less effect that pethidine ( mean dose 183.3 mg ) on alveolar carbon dioxide tension ( PACO2 ) at 0.5 hr after birth , but had a similar effect to pethidine on feeding , elicited reflexes and produced more depression of muscle tone up to 48 hr . Bupivacaine had more effect on PACO2 feeding measures , elicited reflexes and muscle tone at almost all examination periods than pethidine ( mean dose 157.0 mg ) reversed by naloxone ( 200 micrograms intramuscularly ) . Except at delivery , the effects of bupivacaine or pethidine on respiration and feeding up to 48 hr after birth were similar . There were more signs of depression with both drugs than when pethidine had been reversed by naloxone Twenty neonates whose mothers had received meperidine ( 1.0 to 1.5 mg/kg ) intravenously within three hours of delivery were studied to determine the effectiveness of naloxone in reversing neonatal respiratory depression . The following measurements were carried out within 20 to 30 minutes after delivery : minute ventilation , end tidal CO2 , and ventilatory response to CO2 . These determinations were repeated after administration of either placebo or naloxone , 0.01 mg/kg intramuscularly . Minute ventilation and PAco were within a normal range before medication in both groups , but the slope of the CO2 response curve was decreased , indicating mild-to-moderate respiratory depression . After administration of placebo the test results did not change significantly . After administration of naloxone , VE increased significantly ( P less than 0.05 ) and the slope of the CO2 response curve doubled ( P less than 0.001 ) . Naloxone effectively reverses narcotic depression of the respiratory center in the newborn infant
Output:
| Although there was evidence that naloxone increased alveolar ventilation , no data were found on the specified primary outcomes of this review : the need for assisted ventilation or admission to a neonatal unit .
CONCLUSIONS There is a need for a r and omised controlled trial to determine if naloxone confers any clinical ly important benefits on newborn infants with respiratory depression that may be due to transplacentally acquired narcotic |
MS211767 | ***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: Surgical therapy for stage III non-small cell lung cancer ( NSCLC ) has not result ed in substantial long-term survival . Neoadjuvant treatment programs that could down-stage the tumor and achieve increased long-term survival would be of obvious benefit . We have used preoperative simultaneous chemotherapy and irradiation in 85 patients with clinical stage III non-small cell lung cancer considered c and i date s for surgical resection . One group of 56 patients was treated with cisplatin , 5-fluorouracil , and simultaneous irradiation for five days every other week for a total of four cycles . After treatment , 39 patients underwent resection , and the operative mortality was 2 ( 5 % ) of 39 . A second trial was undertaken in which etoposide ( VP-16 ) was added because of its synergism with cisplatin . In this group , 29 patients were considered to have potentially resectable disease , and 23 underwent thoracotomy with 1 operative death ( 4 % ) . Of the total of 62 patients having thoracotomy , 60 underwent resection ( 97 % ) . Complications were major , and there were four bronchopleural fistulas . For the 85 patients eligible for surgical intervention in these two groups of patients , the Kaplan-Meier median survival estimate is 40 % at 3 years . The median survival of the 62 patients having thoracotomy is 36.6 months . Combination preoperative chemotherapy and irradiation is feasible with acceptable toxicity and operative mortality in patients with clinical stage III non-small cell lung cancer . Prospect i ve r and omized studies are suggested for further evaluation of this treatment program OBJECTIVES Surgical resection after preoperative chemotherapy in patients with non-small cell lung cancer might only be best for patients who are responders . We compared positron emission tomographic scanning with 2-fluoro-2-deoxy-d-glucose ( FDP-PET scanning ) with computed tomographic scanning to evaluate their ability to predict this response for the primary tumor , N1 and N2 lymph nodes . METHODS All patients with non-small cell lung cancer who had an initial FDP-PET scan staging with tissue biopsy , neoadjuvant chemotherapy , repeat FDP-PET scanning , and repeat biopsies were prospect ively studied . RESULTS There were 34 patients ( 24 men ; median age , 64 years ) . Eleven patients had N2 disease , and 7 had N1 disease . Twenty-seven patients received chemotherapy , and 7 patients received chemotherapy and radiation . All but 9 patients underwent resection . Statistical analysis showed FDP-PET scanning to be more specific ( P < .0001 ) , to have a higher positive predictive value ( P = .0018 ) , and to have a higher negative predictive value ( P < .0001 ) than computed tomographic scanning for predicting residual tumor at the primary site . FDP-PET scanning was more sensitive ( P < .0001 ) and more accurate ( P < .0001 ) , had a higher positive predictive value ( P < .0001 ) , and had a higher negative predictive value ( P = .0002 ) than computed tomographic scanning for paratracheal nodes ( number 2 and 4 lymph nodes ) . FDP-PET scanning had a higher positive predictive value ( P < .0001 ) than computed tomographic scanning for the other N2 ( numbers 5 , 6 , 7 , 8 , and 9 ) lymph nodes . CONCLUSIONS Repeat FDP-PET scanning is more specific and has a higher positive predictive value and negative predictive value than computed tomographic scanning for detecting residual tumor in the lung in patients with non-small cell lung cancer who have received preoperative chemotherapy . It is more sensitive and accurate for paratracheal N2 nodes as well . However , there is no significant difference in its detection of N1 lymph nodes PURPOSE A number of studies have demonstrated that 18F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) is effective for staging of lung cancer . However , the efficacy of FDG-PET for staging lung cancer after neoadjuvant treatment is still controversial . This study compared FDG-PET and computed tomography ( CT ) for lung cancer staging , and evaluated the ability of the two methods to predict the pathologic response of the primary tumor to neoadjuvant treatment . PATIENTS AND METHODS Twenty-two patients who underwent neoadjuvant treatment followed by surgery were investigated . Eighteen patients received chemoradiotherapy and four patients received chemotherapy only . One hundred and three lymph node stations in the 22 patients were evaluated by FDG-PET and CT . The pathologic responses of the tumors were compared by FDG-uptake and tumor size on CT for the 15 patients who underwent FDG-PET and CT both before and after neoadjuvant treatment . RESULTS There was no significant difference in the ability of FDG-PET or CT to predict residual viable tumor . Although positive predictive value by FDG-PET ( 0.29 ) was lower than that by CT ( 0.64 ) ( p=0.04 ) in the mediastinal lymph nodes , there were no statistically significant differences in the other results of lymph nodes by FDG-PET and CT . Both decrease in FDG-uptake and decrease in tumor size by CT after neoadjuvant treatment correlated significantly with pathologic response in the 15 patients ( p=0.003 and 0.009 , respectively ) . CONCLUSION FDG-PET did not appear to offer any advantages over CT for lymph node staging or for predicting the pathologic response after neoadjuvant treatment of non-small cell lung cancer PURPOSE This phase II trial was design ed to evaluate the feasibility , toxicity , response rates , and survival for neoadjuvant chemotherapy and radiotherapy ( RT ) followed by surgical resection in newly diagnosed patients with surgically staged IIIA non-small-cell lung carcinoma ( NSCLC ) . PATIENTS AND METHODS Previously untreated patients with NSCLC underwent bronchoscopy , chest and abdominal computed tomography ( CT ) , bone scan , and surgical staging of the mediastinum . Neoadjuvant treatment consisted of concurrent chemotherapy and RT . Patients then underwent surgical resection , which was followed in turn by additional chemotherapy and RT . Chemotherapy included cisplatin 100 mg/m2 on days 1 and 29 , vinblastine 3 mg/m2 on days 1 and 3 and 29 and 31 , and fluorouracil ( 5-FU ) 30 mg/kg/d by infusion on days 1 to 3 and 29 to 31 ( FVP ) . RT began on day 1 and included 3,000 cGy in 15 fractions . Surgery took place on day 55 , and one more cycle of chemotherapy and an additional 3,000 cGy of RT began on day 85 . RESULTS Forty-one eligible patients ( median follow-up , 53 months ) were studied . N2 disease was present in 80 % , whereas 20 % had T3N0 or T3N1 lesions . Response to neoadjuvant chemotherapy and RT included no complete responses ( CR ) , 21 ( 51 % ) partial responses ( PR ) or regressions , 19 ( 46 % ) stable disease ( SD ) , and one ( 2 % ) progressive disease ( PD ) . Thirty-one patients underwent surgery , and 25 were resected . In four of the 25 resection specimens , no viable tumor was present , whereas in three of the six unresectable patients , extensive biopsy results demonstrated only necrotic tumor . The maximum response achieved using all protocol treatment was 27 ( 66 % ) CRs , seven ( 17 % ) PRs or regression , six ( 15 % ) SDs , and one ( 2 % ) PD . Toxicity was substantial and primarily hematologic . There were six ( 15 % ) treatment-related deaths , which included three perioperative deaths and three chemotherapy-related toxicity deaths . The Kaplan-Meier curve indicated a 1-year survival of 58 % and a median survival of 15.5 months . Nine patients ( 22 % ) remain disease-free . CONCLUSIONS There was a reasonably high rate of PR associated with concurrent neoadjuvant chemotherapy and RT , and a high percentage of patients who ultimately were rendered completely disease-free . However , treatment-related morbidity and mortality was common . Median survival seemed to be only modestly improved beyond that achieved with less intensive means of treatment . However , a group has emerged of patients who enjoy prolonged disease-free survival and possible cure To evaluate the usefulness of transbronchial needle aspiration biopsy ( TBNA ) for the diagnosis of mediastinal involvement , we have prospect ively examined 316 patients with morphologically verified bronchogenic carcinoma . The percentage of positive aspirations ( 149 of 316 ) from the three basic lymph node groups in the mediastinum was not significantly different . Tumor cells were aspirated from the mediastinum in 75 of 112 patients with radiologically positive findings and in patients with 74 of 204 radiologically negative findings . Mediastinal involvement was verified even in 61 of 196 patients with a normal endoscopic picture . Metastases were proved in 14 of 39 patients with peripheral versus 135 of 277 patients with central carcinoma . Tumor cells were aspirated in 47 of 76 patients with undifferentiated small cell carcinoma , 92 of 227 patients with squamous cell carcinoma , and 10 of 13 patients with adenocarcinoma . Our results suggest that TBNA being a highly diagnostic and less invasive method , will prove its clinical importance BACKGROUND Results from phase II studies in patients with stage IIIA non-small-cell lung cancer with ipsilateral mediastinal nodal metastases ( N2 ) have shown the feasibility of resection after concurrent chemotherapy and radiotherapy with promising rates of survival . We therefore did this phase III trial to compare concurrent chemotherapy and radiotherapy followed by resection with st and ard concurrent chemotherapy and definitive radiotherapy without resection . METHODS Patients with stage T1 - 3pN2M0 non-small-cell lung cancer were r and omly assigned in a 1:1 ratio to concurrent induction chemotherapy ( two cycles of cisplatin [ 50 mg/m(2 ) on days 1 , 8 , 29 , and 36 ] and etoposide [ 50 mg/m(2 ) on days 1 - 5 and 29 - 33 ] ) plus radiotherapy ( 45 Gy ) in multiple academic and community hospitals . If no progression , patients in group 1 underwent resection and those in group 2 continued radiotherapy uninterrupted up to 61 Gy . Two additional cycles of cisplatin and etoposide were given in both groups . The primary endpoint was overall survival ( OS ) . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00002550 . FINDINGS 202 patients ( median age 59 years , range 31 - 77 ) were assigned to group 1 and 194 ( 61 years , 32 - 78 ) to group 2 . Median OS was 23.6 months ( IQR 9.0-not reached ) in group 1 versus 22.2 months ( 9.4 - 52.7 ) in group 2 ( hazard ratio [ HR ] 0.87 [ 0.70 - 1.10 ] ; p=0.24 ) . Number of patients alive at 5 years was 37 ( point estimate 27 % ) in group 1 and 24 ( point estimate 20 % ) in group 2 ( odds ratio 0.63 [ 0.36 - 1.10 ] ; p=0.10 ) . With N0 status at thoracotomy , the median OS was 34.4 months ( IQR 15.7-not reached ; 19 [ point estimate 41 % ] patients alive at 5 years ) . Progression-free survival ( PFS ) was better in group 1 than in group 2 , median 12.8 months ( 5.3 - 42.2 ) vs 10.5 months ( 4.8 - 20.6 ) , HR 0.77 [ 0.62 - 0.96 ] ; p=0.017 ) ; the number of patients without disease progression at 5 years was 32 ( point estimate 22 % ) versus 13 ( point estimate 11 % ) , respectively . Neutropenia and oesophagitis were the main grade 3 or 4 toxicities associated with chemotherapy plus radiotherapy in group 1 ( 77 [ 38 % ] and 20 [ 10 % ] , respectively ) and group 2 ( 80 [ 41 % ] and 44 [ 23 % ] , respectively ) . In group 1 , 16 ( 8 % ) deaths were treatment related versus four ( 2 % ) in group 2 . In an exploratory analysis , OS was improved for patients who underwent lobectomy , but not pneumonectomy , versus chemotherapy plus radiotherapy . INTERPRETATION Chemotherapy plus radiotherapy with or without resection ( preferably lobectomy ) are options for patients with stage IIIA(N2 ) non-small-cell lung cancer . FUNDING National Cancer Institute , Canadian Cancer Society , and National Cancer Institute of Canada Thirty-three patients with T3,N2,M0 or T4,N
Output:
| These results are not significantly affected by the type of induction therapy or the timing of restaging .
The ability to identify patients who have achieved mediastinal downstaging other than by a careful primary mediastinoscopy is poor |
MS211768 | ***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 describe fluorescein angiographic guidelines for the use of verteporfin therapy in patients with subfoveal choroidal neovascularization ( CNV ) secondary to age-related macular degeneration ( AMD ) or other conditions based on 2-year vision outcomes from the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy ( TAP ) Investigation and Verteporfin in Photodynamic Therapy ( VIP ) Trial . METHODS Three multicenter , double-masked , placebo-controlled r and omized clinical trials at 28 ophthalmology clinical centers in Europe and North America involving prospect ively identified patients with best-corrected visual acuity ( Snellen equivalent ) of approximately 20/20 to 20/200 , subfoveal CNV secondary to AMD or pathologic myopia with evidence of CNV , and a lesion greatest linear dimension of 5400 micro m or less . Fluorescein angiography was to be performed on all patients at enrollment and at regular 3-month follow-up visits through 2 years . The initial treatment laser spot size and all subsequent treatment decisions were based on the investigator 's interpretation of these fluorescein angiograms . Photographic material s forwarded to the Wilmer Photograph Reading Center were review ed by masked grade rs . MAIN OUTCOME MEASURES Baseline angiographic features , including lesion composition and size , morphologic response to treatment during follow-up ( eg , absence of leakage ) , and reliability ( kappa values ) of grading selected characteristics based on a 10 % regrading of baseline visits . RESULTS Terms and examples of different lesions and lesion components are provided to assist recognition of fluorescein angiographic characteristics of choroidal neovascular lesions that were important in determining when and where to apply verteporfin therapy . The kappa statistics for agreement of identification of lesion characteristics by the Wilmer Photograph Reading Center for these trials ranged from 0.70 to 0.85 . CONCLUSIONS Ophthalmologists should consider interpreting fluorescein angiographic images of subfoveal lesions with terms provided to follow recommendations regarding which patients are most likely to benefit from verteporfin therapy based on results from the TAP Investigation and VIP Trial PURPOSE To determine if photodynamic therapy with verteporfin ( Visudyne ; Novartis AG , Bülach , Switzerl and ) , termed verteporfin therapy , can safely reduce the risk of vision loss compared with a placebo ( with sham treatment ) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration who were identified with a lesion composed of occult with no classic choroidal neovascularization , or with presumed early onset classic choroidal neovascularization with good visual acuity letter score . METHODS This was a double-masked , placebo-controlled ( sham treatment ) , r and omized , multicenter clinical trial involving 28 ophthalmology practice s in Europe and North America . The study population was patients with age-related macular degeneration , with subfoveal choroidal neovascularization lesions measuring no greater than 5400 microm in greatest linear dimension with either 1 ) occult with no classic choroidal neovascularization , best-corrected visual acuity score of at least 50 ( Snellen equivalent approximately 20/100 ) , and evidence of hemorrhage or recent disease progression ; or 2 ) evidence of classic choroidal neovascularization with a best-corrected visual acuity score of at least 70 ( better than a Snellen equivalent of approximately 20/40 ) ; assigned r and omly ( 2:1 ) to verteporfin therapy or placebo therapy . Verteporfin ( 6 mg per square meter of body surface area ) or placebo ( 5 % dextrose in water ) was administered by means of intravenous infusion of 30 ml over 10 minutes . Fifteen minutes after the start of the infusion , a laser light at 689 nm delivered 50 J/cm(2 ) by application of an intensity of 600 mW/cm(2 ) over 83 seconds using a spot size with a diameter 1000 microm larger than the greatest linear dimension of the choroidal neovascularization lesion on the retina . At follow-up examinations every 3 months , retreatment with the same regimen was applied if angiography showed fluorescein leakage . The main outcome measure was at least moderate vision loss , that is , a loss of at least 15 letters ( approximately 3 lines ) , adhering to an intent-to-treat analysis with the last observation carried forward to impute for missing data . RESULTS Two hundred ten ( 93 % ) and 193 ( 86 % ) of the 225 patients in the verteporfin group compared with 104 ( 91 % ) and 99 ( 87 % ) of the 114 patients in the placebo group completed the month 12 and 24 examinations , respectively . On average , verteporfin-treated patients received five treatments over the 24 months of follow-up . The primary outcome was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination , although a number of secondary visual and angiographic outcomes significantly favored the verteporfin-treated group . Between the month 12 and 24 examinations , the treatment benefit grew so that by the month 24 examination , the verteporfin-treated eyes were less likely to have moderate or severe vision loss . Of the 225 verteporfin-treated patients , 121 ( 54 % ) compared with 76 ( 67 % ) of 114 placebo-treated patients lost at least 15 letters ( P = .023 ) . Likewise , 67 of the verteporfin-treated patients ( 30 % ) compared with 54 of the placebo-treated patients ( 47 % ) lost at least 30 letters ( P = .001 ) . Statistically significant results favoring verteporfin therapy at the month 24 examination were consistent between the total population and the subgroup of patients with a baseline lesion composition identified as occult choroidal neovascularization with no classic choroidal neovascularization . This subgroup included 166 of the 225 verteporfin-treated patients ( 74 % ) and 92 of the 114 placebo-treated patients ( 81 % ) . In these patients , 91 of the verteporfin-treated group ( 55 % ) compared with 63 of the placebo-treated group ( 68 % ) lost at least 15 letters ( P = .032 ) , whereas 48 of the verteporfin-treated group ( 29 % ) and 43 of the placebo-treated group ( 47 % ) lost at least 30 letters ( P = .004 ) . Other secondary outcomes , including visual acuity letter score worse than 34 ( approximate Snellen equivalent of 20/200 or worse ) , mean change in visual acuity letter score , development of classic choroidal neovascularization , progression of classic choroidal neovascularization and size of lesion , favored the verteporfin-treated group at both the month 12 and month 24 examination for both the entire study group and the subgroup of cases with occult with no classic choroidal neovascularization at baseline . Subgroup analyses of lesions composed of occult with no classic choroidal neovascularization at baseline suggested that the treatment benefit was greater for patients with either smaller lesions ( 4 disc areas or less ) or lower levels of visual acuity ( letter score less than 65 , an approximate Snellen equivalent of 20/50(-1 ) or worse ) at baseline . Prospect ively planned multivariable analyses confirmed that these two baseline variables affected the magnitude of treatment benefit . ( ABSTRACT TRUNCATED Aims : ( 1 ) A prospect i ve study to assess visual function measures and quality of life ( QoL ) in patients with wet age related macular degeneration ( AMD ) treated with photodynamic therapy ( PDT ) . ( 2 ) To assess if PDT prevents severe visual loss ( loss of six or more lines of distance visual acuity ) in the treated eye . Methods : 48 of 51 recruited patients with predominantly classic subfoveal choroidal neovascularisation ( CNV ) secondary AMD who were treated with PDT were followed up for 1 year . Assessment included distance and near visual acuity , contrast sensitivity , vision related quality of life and fluorescein angiography . Photodynamic therapy using Visudyne was carried out according to st and ard protocol . Patients were followed up every 3 months and treatment repeated if there was significant leakage from CNV . Results : At the 12 month follow up , 71 % ( n = 34 ) of the patients lost less than three lines of best corrected distance visual acuity . Although there were significant decreases in some of the QoL items tested , patients were significantly less anxious and more independent outdoors at the 12 month follow up . Conclusion : This study is in keeping with published literature with PDT preventing severe visual loss in two thirds of treated patients with predominantly classic CNV Purpose : To provide broad clinical experience and to gather safety data on photodynamic therapy with verteporfin ( Visudyne , Novartis AG , Basel , Switzerl and ) , also termed verteporfin therapy , in patients with predominantly classic subfoveal choroidal neovascularization ( CNV ) secondary to age-related macular degeneration ( AMD ) . The Verteporfin in Age-related Macular Degeneration ( VAM ) Study was design ed to provide exp and ed access to verteporfin therapy after beneficial results for these cases were reported but before regulatory approval in North America . Methods : This open-label multicenter study from September 1999 through June 2000 enrolled among 222 centers patients 50 years or older in the United States , or 40 years or older in Canada , with age-related macular degeneration and subfoveal CNV with a lesion composition that was predominantly classic CNV on fluorescein angiography . Corrected visual acuity with habitual eyewear in the office setting was 20/40 to 20/200 , inclusive . All patients received verteporfin therapy and returned for follow-up every 3 months . At those follow-up examinations , additional courses of treatment were recommended if any fluorescein leakage from CNV was identified . Safety information was collected from patient self-reporting , question ing ( in person and by telephone ) , and physician evaluation . Safety was assessed by evaluating the effect of treatment on corrected distance visual acuity and by evaluating adverse events . Results : A total of 4,435 patients were enrolled of whom 4,051 ( 91 % ) completed the study after receiving 6,701 treatments . Most patients received only one treatment in VAM before regulatory approval of verteporfin in the United States and Canada . Three hundred patients ( 6.8 % ) experienced an adverse event considered by the treating ophthalmologist to be associated with treatment , including 115 ( 2.6 % ) with abnormal or decreased vision , of whom 25 ( 0.6 % ) experienced acute severe visual acuity decrease , and 14 ( 0.3 % ) with transient infusion-related back pain . Patients were advised to avoid exposure to direct sunlight for 24 hours ; however , after verteporfin administration only 2 ( 0.05 % ) reported a photosensitivity reaction . An additional course of verteporfin therapy was administered to 1,739 of 2,314 patients ( 75.2 % ) who had a month 3 examination that was not their close-out visit and 177 of 266 ( 66.5 % ) who had a month 6 examination that was not their close-out visit . Conclusions : Verteporfin therapy exhibited no additional or new safety concerns . The therapy associated with a low incidence of adverse events when exp and ed access was provided in a large , open-label , multicenter study , including a low incidence ( 0.05 % ) of reported photosensitivity reactions despite a short photosensitivity protection period ( 24 hours ) following verteporfin administration PURPOSE To evaluate vascular changes documented by confocal indocyanine green angiography ( ICGA ) through 2 years after photodynamic therapy ( PDT ) with verteporfin of neovascular age-related macular degeneration ( AMD ) . DESIGN Single-center , 2-year , r and omized , double-masked , interventional , placebo-controlled trial ( subset from Treatment of AMD with PDT Study [ TAP ] ) . PARTICIPANTS Sixty patients with subfoveal choroidal neovascularization ( CNV ) result ing from AMD . INTERVENTION Patients were r and omized in a ratio of 2:1 to a st and ard regimen using verteporfin therapy at a drug dose of 6 mg/m(2 ) body surface area and a light dose of 50 J/cm(2 ) or a sham treatment with placebo infusion and light exposure . Retreatments , if persistent fluorescein leakage from CNV was documented , were scheduled at 3-month intervals for up to 2 years . Confocal ICGA with tomographic sections was performed at baseline and continuously at the month 3 , 6 , 12 , and 24 examinations using a st and ardized protocol . MAIN OUTCOME MEASURES Analysis included the size of the neovascular net , the area of late hyperfluorescence , and choroidal hypofluorescence during early- and late-phase imaging . RESULTS In the verteporfin-treated group , the mean size of the CNV and the mean area of late leakage consistent with active leakage or staining showed no further enlargement at month 12 and were reduced at month 24 . In the
Output:
| Photodynamic therapy in people with choroidal neovascularisation due to AMD is probably effective in preventing visual loss though there is doubt about the size of the effect . |
MS211769 | ***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 effect of support with human chorionic gonadotrophin in the luteal phase in women taking part in an in vitro fertilisation programme after buserelin and human menopausal gonadotrophin were used to hyperstimulate their ovaries . DESIGN --Controlled group comparison . SETTING --Outpatient department of a private hospital . PATIENTS --115 Women with indications for in vitro fertilisation , all of whom had at least one embryo transferred . INTERVENTIONS --After suppression of the pituitary with buserelin the ovaries of all the women were stimulated with human menopausal gonadotrophin on day 4 of the luteal phase . Human chorionic gonadotrophin ( 10,000 IU ) was given to induce ovulation , and oocytes were recovered 34 hours later . Embryos were transferred 46 to 48 hours after insemination . Women who had received the 10,000 IU of human chorionic gonadotrophin on a date that was an uneven number ( n = 61 ) were allocated to receive support doses of 2500 IU human chorionic gonadotrophin three and six days after that date . The remaining 54 women did not receive hormonal support . END POINT -- Determination of the rates of pregnancy . MEASUREMENTS and main results --Support with human chorionic gonadotrophin did not significantly alter the progesterone or oestradiol concentrations in the early or mid-luteal phase . The mean ( range ) progesterone concentrations in the late luteal phase in women who did not become pregnant were , however , significantly higher in those who received support ( 16(9 - 110 ) nmol/l nu 8(4 - 46 ) nmol/l ) , and the luteal phase was significantly longer in this group ( 14 days nu 12 days ) . The rate of pregnancy was significantly higher in the women who received support than in those who did not ( 25/61 nu 8/54 ) . CONCLUSIONS --When buserelin and human menopausal gonadotrophin are used to hyperstimulate ovaries support with human chorionic gonadotrophin in the luteal phase has a beneficial effect on in vitro fertilisation This study aim ed to compare the efficacy of micronized progesterone administered as luteal support following ovulation induction for in-vitro fertilization (IVF)- embryo transfer in cycles using gonadotrophin-releasing hormone agonist , either orally ( 200 mgx4/day ) or vaginally ( 100 mgx2/day ) and to characterize the luteal phase hormonal profile during such treatments . A total of 64 high responder patients requiring intracytoplasmic sperm injection due to male factor infertility were prospect ively r and omized into two treatment groups . Patients treated orally or vaginally were comparable in age ( 31.9 + /- 6.1 versus 30.6 + /- 5.2 ; mean + /- SD ) , number of oocytes retrieved ( 17 + /- 8.2 versus 18 + /- 7.0 ) , and number of embryos transferred ( 3.1 + /- 1.2 versus 2.7 + /- 0.9 ) per cycle . Following low dose vaginal treatment , a significantly higher implantation rate ( 30.7 versus 10.7 % , P < 0.01 ) , but similar clinical pregnancy rate ( 47.0 versus 33.3 % ) and ongoing pregnancy rate ( 41.1 versus 20.0 % ) was observed , compared with oral treatment . In conception cycles , luteal serum progesterone and oestrogen concentrations did not differ between the treatment groups . In non-conception cycles , late luteal progesterone concentrations were significantly lower following vaginal treatment . As low dose micronized progesterone administered vaginally is simple , easy and well tolerated , it could be recommended as the method of choice for luteal support , especially for high responder patients at risk for ovarian hyperstimulation syndrome Background . A prospect i ve study was done to compare the efficacy of luteal phase support ( LPS ) using either three times hCG ( group I , n=77 ) , hCG on the day of embryo transfer ( ET ) in combination with daily vaginal progesterone ( group II , n=62 ) or vaginal progesterone only ( group III , n=70 ) A total of 156 patients were r and omly treated with exogenous natural progesterone ( intramuscularly , 50 mg/day ) and vaginal gel ( 90 mg/day ) P or nothing ( Controls ) from the day before embryo transfer ( ET ) for two weeks . In case of positive beta-HCG , the treatment was continued for 12 weeks . Plasma P and 17 beta-Estradiol concentrations were estimated and compared with the control not supplemented group . Both treatments were able to increase significantly the luteal plasmatic values of P versus controls . The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel P. The intramuscular natural P appears the most suitable route of administration for luteal phase support in IVF-ET procedures In an attempt to determine the best luteal support in in-vitro fertilization ( IVF ) cycles treated with gonadotrophin-releasing hormone agonist ( GnRHa ) and human menopausal gonadotrophin ( HMG ) by the ultrashort protocol , 60 patients were prospect ively r and omized for either i.m . progesterone or human chorionic gonadotrophin ( HCG ) luteal support . The two groups did not differ in the mean number of oocytes retrieved and embryos replaced , nor in the mean age of the patients and the amount of HMG used . HCG maintained higher levels of oestradiol and progesterone during the luteal phase . Conception rate was significantly higher in the HCG group . We conclude that HCG is superior to i.m . progesterone as luteal support in IVF cycles in which GnRHa is used in the ultrashort protocol Gonadotrophin-releasing hormone agonists ( GnRHa ) are widely used in in-vitro fertilization ( IVF ) for the prevention of a premature rise in luteinizing hormone ( LH ) concentrations . However , the administration of GnRHa during the follicular phase may also impair subsequent luteal function due to retarded recovery of pituitary gonadotrophin secretion . Therefore , luteal supplementation is generally applied . The present study was design ed to determine whether a premature LH surge would still be prevented after early cessation of GnRHa during ovarian stimulation and whether subsequent luteal phase LH production would be sufficient to support progesterone synthesis by the corpus luteum . Sixty patients were r and omized for three groups : ( i ) A long GnRHa/human menopausal gonadotrophin ( HMG ) protocol with luteal support by repeated human chorionic gonadotrophin ( HCG ) ( n = 20 ) , ( ii ) early follicular phase cessation of GnRHa without luteal support ( n = 20 ) , and ( iii ) a long GnRHa protocol without luteal support ( n = 20 ) . Frequent ultrasound and blood sampling was performed during the entire IVF cycle . Forty normo-ovulatory women served as controls . No premature LH surges were found after early cessation of GnRHa . In this group , some pituitary recovery occurred during the late luteal phase , but this did not affect corpus luteum function . Progesterone concentrations were shown to be dependent on disappearance of the pre-ovulatory bolus of HCG . Pregnancies occurred in all three groups . In conclusion , early follicular phase cessation of GnRHa is still effective in the prevention of a premature rise in LH . Although some pituitary recovery was observed thereafter , corpus luteum function is still abnormal due to early luteolysis This study was conducted to compare the endocrine milieu and pregnancy rates in an in-vitro fertilization and embryo transfer ( IVF-ET ) programme employing a gonadotrophin-releasing hormone agonist ( GnRHa ) and human menopausal gonadotrophin ( HMG ) when either human chorionic gonadotrophin ( HCG ) or progesterone were used for luteal phase support . A total of 121 IVF-ET treatment cycles were prospect ively studied . All patients started leuprolide acetate in the midluteal phase and it was continued for at least 10 days . When oestradiol levels were less than 150 pmol/l , HMG was started . When at least three follicles were greater than or equal to 17 mm in diameter , HCG 5000 IU i.m . was given . Oocytes were retrieved using transvaginal ultrasound and embryos were transferred 48 h later . The patients ' cycles were prospect ively r and omized to receive HCG ( 72 cycles ) or progesterone ( 49 cycles ) luteal support . The HCG group received 1500 IU i.m . on days 3 , 6 and 9 after the initial trigger . The progesterone group received 12.5 mg i.m . q.d . starting from the day after the HCG trigger . The dose of progesterone was increased to 25 mg i.m . q.d . starting on the day of embryo transfer and continued for 17 - 21 days . If the patient became pregnant , this dose of progesterone was continued until fetal heart activity was visualized by ultrasound . Mean ages , number of eggs retrieved , embryos transferred , oestradiol levels on the day of the HCG trigger , oestradiol and progesterone at the time of embryo transfer were the same in both groups . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To evaluate the possible role for estrogen supplementation to the P luteal phase support of GnRH agonists (GnRH-a)- and hMG-induced IVF-ET cycles . SETTING In vitro fertilization unit in a tertiary care university hospital . DESIGN A prospect ively r and omized study . PATIENTS One hundred consecutive patients undergoing ET after IVF were assigned into one of two luteal supplementation regimens . INTERVENTIONS In all patients enrolled in the study , ovulation was induced using the midluteal regimen for pituitary down regulation with GnRH-a followed by follicular stimulation with hMG . The first group received IM P 50 mg/d , as luteal phase support , starting the day of ET . The second group received the same dosage of P , combined with oral E2 valerate , 2 mg/d . Serum levels of P and E2 were monitored every 4 days for 16 days after ET . MAIN OUTCOME MEASURES Pregnancy rates ( PRs ) and live birth rates per ET . RESULTS No significant difference in E2 or P levels throughout the cycle was observed between groups . Similar PRs per ET and the live birth rates were also observed between group A and B ( 28 % versus 26.5 % and 78.6 % versus 76.1 % , respectively ) . CONCLUSION No advantage was found in the addition of E2 valerate to P luteal phase support of GnRH-a- and hMG-induced IVF-ET cycles The luteal phase hormone profiles of two groups participating in the Yale in vitro fertilization ( IVF ) program were compared . A control group ( group I ) consisted of 28 women ( 28 cycles ) who received our st and ard ovulation induction regimen ( no luteal phase support ) . The treatment group ( group II ) consisted of 40 women ( 42 cycles ) who were prospect ively studied after receiving luteal phase support with 10,000 IU human chorionic gonadotropin ( hCG ) 5 days after the initial hCG dose . The groups were matched for age and cause of infertility . Estradiol ( E2 ) and progesterone ( P ) were measured on the day of embryo transfer and every 3 to 4 days thereafter . Luteal phase hCG support significantly augmented ( 1 ) E2 and P levels in the conception cycles of group II compared with group I and ( 2 ) P levels in the nonconception cycles of group II compared with group I. The midluteal decline in E2 and P that was observed in group I was minimized or prevented in group II . An ongoing pregnancy rate of 19 % was achieved in group II . This was not statistically different from the 13 % ongoing pregnancy rate noted in a separate group of 163 tubal factor couples undergoing IVF after our st and ard ovulation induction regimen during the period of the study . In summary , the luteal phase hormone profiles of IVF cycles were improved by supplementation with hCG . It is concluded that this type of intervention may serve to rescue potentially failing corpora lutea and thereby optimize the peri-implantation hormonal milieu Two progesterone presentations , a vaginal application of 90 mg progesterone per day ( Crinone ) or 300 mg progesterone administered orally ( Utrogestan ) , were compared for luteal phase support of patients undergoing an in-vitro fertilization ( IVF ) procedure . A total of 283 patients were r and omly allocated to either treatment . The treatment started within 24 h after the embryo transfer procedure and continued until day 30 in cases of implantation . Efficacy was assessed using the pregnancy and delivery rates . Safety was assessed through specific
Output:
| RESULTS Luteal supplementation with either i.m .
hCG or i.m .
progesterone significantly improved fertility outcomes compared with no treatment .
When comparing i.m .
progesterone with i.m .
hCG , no fertility differences were found .
Intramuscular progesterone conferred the most benefit compared with oral or vaginal use .
Addition of oral estrogen to progesterone also improved implantation rates .
CONCLUSION Given the increased risk of ovarian hyperstimulation syndrome associated with hCG use , i.m .
progesterone is favoured for luteal phase supplementation with the addition of estrogen |
MS211770 | ***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: CARET is a multicenter , two-armed , double-masked r and omized chemoprevention trial in Seattle , Portl and , San Francisco , Baltimore , Connecticut , and Irvine , to test whether oral administration of beta-carotene ( 30 mg/day ) plus retinyl palmitate ( 25,000 IU/day ) can decrease the incidence of lung cancer in high risk population s , namely , heavy smokers and asbestos-exposed workers . The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30 , 1993 , CARET had r and omized 1,845 participants in the 1985 - 1988 pilot phase plus 13,260 " efficacy " participants since 1989 ; of these , 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers ( 44 % female ) . Accrual is complete everywhere except Irvine , which was the last center added ( 1991 ) , and the safety profile of the regimen to date has been excellent . With 14,420 smokers , 4,010 asbestos-exposed participants , and 114,100 person-years through February 1998 , we expect CARET to be capable of detecting a 23 % reduction in lung cancer incidence in the two population s combined and 27 , 49 , 32 , and 35 % reductions in the smokers , female smokers , male smokers , and asbestos-exposed subgroups , respectively . CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finl and and the Harvard Physicians Health Study ( beta-carotene alone ) in the National Cancer Institute portfolio of major cancer chemoprevention trials BACKGROUND : In observational studies , individuals with high intakes of fruits and vegetables containing beta-carotene experience lower risks of developing cancer . However , the few r and omized trials of beta-carotene supplementation show no overall benefits ; some even suggest harm . This trial was design ed to test the effects of beta-carotene supplementation in women . METHODS : The Women 's Health Study is a r and omized , double-blind , placebo-controlled trial originally testing aspirin , vitamin E , and beta-carotene in the prevention of cancer and cardiovascular disease among 39 876 women aged 45 years or older . The beta-carotene component was terminated early after a median treatment duration of 2.1 years ( range = 0.00 - 2 . 72 years ) . Statistical tests were two-sided . RESULTS : Among women r and omly assigned to receive beta-carotene ( 50 mg on alternate days ; n = 19 939 ) or placebo ( n = 19 937 ) , there were no statistically significant differences in incidence of cancer , cardiovascular disease , or total mortality after a median of 4.1 years ( 2.1 years ' treatment plus another 2.0 years ' follow-up ) . There were 378 cancers in the beta-carotene group and 369 cancers in the placebo group ( relative risk [ RR ] = 1.03 ; 95 % confidence interval [ CI ] = 0.89 - 1 . 18 ) . There were no statistically significant differences for any site-specific cancer or during years 1 and 2 combined and years 3 and up combined . For cardiovascular disease , there were no statistically significant differences for myocardial infa rct ion ( 42 in the beta-carotene group versus 50 in the placebo group ) , stroke ( 61 versus 43 ) , deaths from cardiovascular causes ( 14 versus 12 ) , or the combined end point of these three events ( 116 versus 102 ; among women with more than one event , only the first was counted ) . Deaths from any cause were similar in the two groups ( 59 versus 55 ) . Among smokers at baseline ( 13 % of all women ) , there were no statistically significant differences in overall incidence of cancer ( RR = 1.11 ; 95 % CI = 0.78 - 1.58 ) or cardiovascular disease ( RR = 1.01 ; 95 % CI = 0 . 62 - 1.63 ) . CONCLUSION : Among apparently healthy women , there was no benefit or harm from beta-carotene supplementation for a limited period on the incidence of cancer and of cardiovascular disease BACKGROUND Evidence has accumulated from observational studies that people eating more fruits and vegetables , which are rich in beta-carotene ( a violet to yellow plant pigment that acts as an antioxidant and can be converted to vitamin A by enzymes in the intestinal wall and liver ) and retinol ( an alcohol chemical form of vitamin A ) , and people having higher serum beta-carotene concentrations had lower rates of lung cancer . The Beta-Carotene and Retinol Efficacy Trial ( CARET ) tested the combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate ( vitamin A ) taken daily against placebo in 18314 men and women at high risk of developing lung cancer . The CARET intervention was stopped 21 months early because of clear evidence of no benefit and substantial evidence of possible harm ; there were 28 % more lung cancers and 17 % more deaths in the active intervention group ( active = the daily combination of 30 mg beta-carotene and 25,000 IU retinyl palmitate ) . Promptly after the January 18 , 1996 , announcement that the CARET active intervention had been stopped , we published preliminary findings from CARET regarding cancer , heart disease , and total mortality . PURPOSE We present for the first time results based on the pre-specified analytic method , details about risk factors for lung cancer , and analyses of subgroups and of factors that possibly influence response to the intervention . METHODS CARET was a r and omized , double-blinded , placebo-controlled chemoprevention trial , initiated with a pilot phase and then exp and ed 10-fold at six study centers . Cigarette smoking history and status and alcohol intake were assessed through participant self-report . Serum was collected from the participants at base line and periodically after r and omization and was analyzed for beta-carotene concentration . An Endpoints Review Committee evaluated endpoint reports , including pathologic review of tissue specimens . The primary analysis is a stratified logrank test for intervention arm differences in lung cancer incidence , with weighting linearly to hypothesized full effect at 24 months after r and omization . Relative risks ( RRs ) were estimated by use of Cox regression models ; tests were performed for quantitative and qualitative interactions between the intervention and smoking status or alcohol intake . O'Brien-Fleming boundaries were used for stopping criteria at interim analyses . Statistical significance was set at the .05 alpha value , and all P values were derived from two-sided statistical tests . RESULTS According to CARET 's pre-specified analysis , there was an RR of 1.36 ( 95 % confidence interval [ CI ] = 1.07 - 1.73 ; P = .01 ) for weighted lung cancer incidence for the active intervention group compared with the placebo group , and RR = 1.59 ( 95 % CI = 1.13 - 2.23 ; P = .01 ) for weighted lung cancer mortality . All subgroups , except former smokers , had a point estimate of RR of 1.10 or greater for lung cancer . There are suggestions of associations of the excess lung cancer incidence with the highest quartile of alcohol intake ( RR = 1.99 ; 95 % CI = 1.28 - 3.09 ; test for heterogeneity of RR among quartiles of alcohol intake has P = .01 , unadjusted for multiple comparisons ) and with large-cell histology ( RR = 1.89 ; 95 % CI = 1.09 - 3.26 ; test for heterogeneity among histologic categories has P = .35 ) , but not with base-line serum beta-carotene concentrations . CONCLUSIONS CARET participants receiving the combination of beta-carotene and vitamin A had no chemopreventive benefit and had excess lung cancer incidence and mortality . The results are highly consistent with those found for beta-carotene in the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study in 29133 male smokers in Finl and CARET is a chemoprevention trial of beta-carotene and vitamin A with lung cancer as the primary outcome . Participants at high risk for lung cancer are drawn from two population s : asbestos-exposed workers and heavy smokers . The intervention is a daily combination of 30 mg beta-carotene and 25,000 IU vitamin A as retinyl palmitate . Nearly 18,000 participants will be followed for a mean 6 years , yielding over 100,000 person-years of follow-up . We project that this sample size will have 80 % power to detect a 23 % decrease in the incidence of lung cancer cases . The purpose of this paper is to present the values of the key sample size parameters of CARET ; our schemes for monitoring CARET for sample size adequacy , incidence of side effects , and efficacy of the study vitamins ; an overview of the data collected ; and plans for the primary , secondary , and ancillary analyses to be performed at the end of the trial . These approaches to the design , monitoring , and analysis of CARET are applicable for many other prevention trials Despite numerous published studies , debate continues regarding the risk of developing lung cancer among men exposed occupationally to asbestos , particularly those without radiographic or functional evidence of asbestosis . The beta-Carotene and Retinol Efficacy Trial ( CARET ) , a study of vitamin supplementation for chemoprevention of lung cancer , has followed 4,060 heavily exposed US men for 9 - 17 years . Lung cancer incidence for 1989 - 2002 was analyzed using a stratified proportional hazards model . The study confirmed excessive rates of lung cancer among men with radiographic asbestosis . Comparison of study arms revealed a strong , unanticipated synergy between radiographic profusion category and the active intervention . In the large subgroup of men with normal lung parenchyma on chest radiograph at baseline , there was evidence of exposure-related lung cancer risk : Men with more than 40 years ' exposure in high-risk trades had a risk approximately fivefold higher than men with 5 - 10 years , after adjustment for covariates . The effect in these men was independent of study intervention arm , but pleural plaques on the baseline radiograph and abnormal baseline flow rate were strong independent predictors of subsequent lung cancer . Residual confounding by sub clinical asbestosis , exposure to unmeasured lung carcinogens , or differences in smoking are unlikely to explain these observations better than a carcinogenic effect of asbestos per se BACKGROUND The Beta-Carotene and Retinol Efficacy Trial ( CARET ) tested the effect of daily beta-carotene ( 30 mg ) and retinyl palmitate ( 25,000 IU ) on the incidence of lung cancer , other cancers , and death in 18,314 participants who were at high risk for lung cancer because of a history of smoking or asbestos exposure . CARET was stopped ahead of schedule in January 1996 because participants who were r and omly assigned to receive the active intervention were found to have a 28 % increase in incidence of lung cancer , a 17 % increase in incidence of death and a higher rate of cardiovascular disease mortality compared with participants in the placebo group . METHODS After the intervention ended , CARET participants returned the study vitamins to their study center and provided a final blood sample . They continue to be followed annually by telephone and mail self-report . Self-reported cancer endpoints were confirmed by review of pathology reports , and death endpoints were confirmed by review of death certificates . All statistical tests were two-sided . RESULTS With follow-up through December 31 , 2001 , the post-intervention relative risks of lung cancer and all-cause mortality for the active intervention group compared with the placebo group were 1.12 ( 95 % confidence interval [ CI ] = 0.97 to 1.31 ) and 1.08 ( 95 % CI = 0.99 to 1.17 ) , respectively . Smoothed relative risk curves for lung cancer incidence and all-cause mortality indicated that relative risks remained above 1.0 throughout the post-intervention follow-up . By contrast , the relative risk of cardiovascular disease mortality decreased rapidly to 1.0 after the intervention was stopped . During the post-intervention phase , females had larger relative risks of lung cancer mortality ( 1.33 versus 1.14 ; P = .36 ) , cardiovascular disease mortality ( 1.44 versus 0.93 ; P = .03 ) , and all-cause mortality ( 1.37 versus 0.98 ; P = .001 ) than males . CONCLUSIONS The previously reported adverse effects of beta-carotene and retinyl palmitate on lung cancer incidence and all-cause mortality in cigarette smokers and individuals with occupational exposure to asbestos persisted after drug administration was stopped although they are no longer statistically significant . Planned subgroup analyses suggest that the excess risks of lung cancer were restricted primarily to females , and cardiovascular disease mortality primarily to females and to former smokers Our aim was to describe a vitamin A-based cancer prevention program for former asbestos workers and to check for possible harmful effects by comparing rates of disease and death in study subjects with subjects who chose not to join . All subjects
Output:
| REVIEW ER 'S CONCLUSIONS There is currently no evidence to support recommending vitamins such as alpha-tocopherol , beta-carotene or retinol , alone or in combination , to prevent lung cancer .
A harmful effect was found for beta-carotene with retinol at pharmacological doses in people with risk factors for lung cancer ( smoking and /or occupational exposure to asbestos ) . |
MS211771 | ***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 : This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention . Subjects/ methods : In this multicenter , r and omized , open-label clinical trial , 255 adults with a body mass index of 30–40 kg m−2 were treated and outcomes were assessed up to 12 months . Participants were r and omized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone . Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months . At 9 months , co primary end points were two measures of weight loss . Results : At 6 months , weight loss was −3.3 % of total body weight ( −3.2 kg ) in the lifestyle arm vs −10.2 % ( −9.9 kg ) in the balloon plus lifestyle arm ( P<0.001 ) ; at 9 months ( 3 months postballoon removal ) , weight loss was −3.4 % ( −3.2 kg ) vs −9.1 % ( −8.8 kg , P⩽0.001 ) ; and at 12 months , −3.1 % ( −2.9 kg ) vs −7.6 % ( −7.4 kg , P⩽0.001 ) . For the primary end points , at 9 months , mean percent loss of weight in excess of ideal body weight ( s.d . ) at 9 months was 26.5 % ( 20.7 ) ( P=0.32 ) and 9.7 % ( 15.1 ) in the balloon and control groups , respectively . Also , 45.6 % ( 36.7 , 54.8 ) of the subjects r and omized to the balloon achieved at least 15 % loss of weight in excess of ideal body weight greater than the control group ( P<0.001 ) . The majority of balloon subjects experienced adverse events ; 86.9 % nausea , 75.6 % vomiting , 57.5 % abdominal pain and 18.8 % had their device removed before 6 months because of an adverse event or subject request . Five subjects ( 3.1 % ) in the balloon group had a gastric abnormality at the time of device removal , and no ulcers were found . Conclusions and relevance : Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone . Adverse gastrointestinal events were common Objectives : The AspireAssist System ( AspireAssist ) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30 % of the calories consumed in a meal , in conjunction with lifestyle ( diet and exercise ) counseling . Methods : In this 52-week clinical trial , 207 participants with a body-mass index ( BMI ) of 35.0–55.0 kg/m2 were r and omly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling ( n=137 ; mean BMI was 42.2±5.1 kg/m2 ) or Lifestyle Counseling alone ( n=70 ; mean BMI was 40.9±3.9 kg/m2 ) . The co- primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25 % excess weight loss . Results : At 52 weeks , participants in the AspireAssist group , on a modified intent-to-treat basis , had lost a mean ( ±s.d . ) of 31.5±26.7 % of their excess body weight ( 12.1±9.6 % total body weight ) , whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5 % of their excess body weight ( 3.5±6.0 % total body weight ) ( P<0.001 ) . A total of 58.6 % of participants in the AspireAssist group and 15.3 % of participants in the Lifestyle Counseling group lost at least 25 % of their excess body weight ( P<0.001 ) . The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period . Serious adverse events were reported in 3.6 % of participants in the AspireAssist group . Conclusions : The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone Background We would expect information on adverse drug reactions in r and omised clinical trials to be easily retrievable from specific search es of electronic data bases . However , complete retrieval of such information may not be straightforward , for two reasons . First , not all clinical drug trials provide data on the frequency of adverse effects . Secondly , not all electronic records of trials include terms in the abstract or indexing fields that enable us to select those with adverse effects data . We have determined how often automated search methods , using indexing terms and /or textwords in the title or abstract , would fail to retrieve trials with adverse effects data . Methods We used a sample set of 107 trials known to report frequencies of adverse drug effects , and measured the proportion that ( i ) were not assigned the appropriate adverse effects indexing terms in the electronic data bases , and ( ii ) did not contain identifiable adverse effects textwords in the title or abstract . Results Of the 81 trials with records on both MEDLINE and EMBASE , 25 were not indexed for adverse effects in either data base . Twenty-six trials were indexed in one data base but not the other . Only 66 of the 107 trials reporting adverse effects data mentioned this in the abstract or title of the paper . Simultaneous use of textword and indexing terms retrieved only 82/107 ( 77 % ) papers . Conclusions Specific search strategies based on adverse effects textwords and indexing terms will fail to identify nearly a quarter of trials that report on the rate of drug adverse effects BACKGROUND & AIMS The effects of bariatric surgery in patients with nonalcoholic fatty liver disease ( NASH ) are not well established . We performed a prospect i ve study to determine the biological and clinical effects of bariatric surgery in patients with NASH . METHODS From May 1994 through May 2013 , one hundred and nine morbidly obese patients with biopsy-proven NASH underwent bariatric surgery at the University Hospital of Lille , France ( the Lille Bariatric Cohort ) . Clinical , biological , and histologic data were collected before and 1 year after surgery . RESULTS One year after surgery , NASH had disappeared from 85 % of the patients ( 95 % confidence interval [ CI ] : 75.8%-92.2 % ) . Compared with before surgery , patients had significant reductions in mean ± SD body mass index ( BMI , from 49.3 ± 8.2 to 37.4 ± 7 ) and level of alanine aminotransferase ( from 52.1 ± 25.7 IU/L to 25.1 ± 20 IU/L ) ; mean levels of γ-glutamyltransferases were reduced from 51 IU/L before surgery ( interquartile range [ IQR ] , 34 - 87 IU/L ) to 23 IU/L afterward ( IQR , 14 - 33 IU/L ) and mean insulin resistance index values were reduced from 3.6 ± 0.5 to 2.9 ± 0.5 ( P < .01 for each comparison ) . NASH disappeared from a higher proportion of patients with mild NASH before surgery ( 94 % ) than severe NASH ( 70 % ) ( P < .05 ) according to Brunt score . In histologic analysis , steatosis was detected in 60 % of the tissue before surgery ( IQR , 40%-80 % ) but only 10 % 1 year after surgery ( IQR , 2.5%-21.3 % ) ; the mean nonalcoholic fatty liver disease score was reduced from 5 ( IQR , 4 - 5 ) to 1 ( IQR , 1 - 2 ) ( each P < .001 ) . Hepatocellular ballooning was reduced in 84.2 % of sample s ( n = 69 ; 95 % CI : 74.4 - 91.3 ) and lobular inflammation in 67.1 % ( n = 55 ; 95 % CI : 55.8 - 77.1 ) . According to Metavir scores , fibrosis was reduced in 33.8 % of patients ( 95 % CI : 23.6%-45.2 % ) . Patients whose NASH persisted 1 year after surgery ( n = 12 ) had lost significantly less weight ( change in BMI , 9.1 ± 1.5 ) than those without NASH ( change in BMI , 12.3 ± 0.6 ) ( P = .005 ) . Patients who underwent laparoscopic gastric b and ing lost less weight ( change in BMI , 6.4 ± 0.7 ) than those who underwent gastric bypass ( change in BMI , 14.0 ± 0.5 ) ( P < .0001 ) , and a higher proportion had persistent NASH ( 30.4 % vs 7.6 % of those with gastric bypass ; P = .015 ) . CONCLUSIONS Bariatric surgery induced the disappearance of NASH from nearly 85 % of patients and reduced the pathologic features of the disease after 1 year of follow-up . It could be a therapeutic option for appropriate morbidly obese patients with NASH who do not respond to lifestyle modifications . More studies are needed to determine the long-term effects of bariatric surgery in morbidly obese patients with NASH ABSTRACT Background : Bariatric endoscopic techniques are minimally invasive and induce gastric volume reduction to treat obesity . Aim : To evaluate endoscopic sleeve gastroplasty ( Apollo method ) using a suturing method directed at the greater curvature , as well as the perioperative care , two year safety and weight loss . Method : Prospect i ve single-center study over 154 patients ( 108 females ) using the endoscopic sleeve gastroplasty procedure under general anesthesia with overnight inpatient observation . Of the154 initial patients , 143 were available for 1-month of follow-up , 133 for 6-month , 64 for 12-month and 28 completed the 24 month assessment . Follow-up was carried out by a multidisciplinary team ( nutritionist and psychologist ) . Outcomes evaluated were : change in BMI ; change in body weight ( TBWL ) ; % of loss of initial body weight ( % TBWL ) ; % of excess body weight loss ( % EWL ) ( segregated in > or < 25 % and adverse effects . Voluntary oral contrasted radiological examinations were scheduled to assess the gastroplasty at different times post-procedure . Results : Mean age was 44.9 ( 23 - 69 ) years . At 24 months after the procedure baseline mean BMI change from 38.3 to 30.8 kg/m2 . TBWL , % TBWL and % EWL were of 21.3 kg , 19.5 % and 60.4 % respectively . 85.7 % of patients achieve the goal of > 25 % % EWL . There were no mayor adverse events intraprocedure or during the 24 months of follow-up . Conclusion : Endoscopic sleeve gastroplasty with regular monitoring by a multidisciplinary team can be considered an effective , safe and well tolerated procedure for obesity treatment , at least for two years of follow-up BACKGROUND & AIMS : Although bariatric surgery is the most effective therapy for obesity , only a small proportion of c and i date s undergo this surgery . Endoscopic sleeve gastroplasty ( ESG ) is a minimally invasive procedure that reduces the size of the gastric reservoir . We investigated its durability and effects on body weight and gastrointestinal function in a prospect i ve study of obese individuals . METHODS : Twenty‐five obese individuals ( 21 female ; mean body mass index , 35.5 ± 2.6 kg/m2 ; mean age , 47.6 ± 10 years ) underwent ESG with endoluminal creation of a sleeve along the gastric lesser curve from September 2012 through March 2015 at the Mayo Clinic in Rochester , Minnesota . Subjects were followed for a median period of 9 months . We measured changes in body weight and recorded adverse events ; patients were assessed by endoscopy after 3 months . Four participants underwent pre‐ESG and post‐ESG analyses to measure solid and liquid gastric emptying , satiation ( meal tolerance ) , and fasting and postpr and ial levels of insulin , glucose , and gut hormones . RESULTS : Subjects had lost 53 % ± 17 % , 56 % ± 23 % , 54 % ± 40 % , and 45 % ± 41 % of excess body weight at 6 , 9 , 12 , and 20 months , respectively , after the procedure ( P < .01 ) . Endoscopy at 3 months showed intact gastroplasty in all subjects . After ESG , physiological analyses of 4 participants showed a decrease by 59 % in caloric consumption to reach maximum fullness ( P = .003 ) , slowing of gastric emptying of solids ( P = .03 ) , and a trend toward increased insulin sensitivity ( P =
Output:
| In a systematic review and meta- analysis , we found ESG to produce clinical ly significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events . |
MS211772 | ***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 system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials Systematic Review Series Series Editors : Cynthia Mulrow , MD , MSc Deborah Cook , MD , MSc The last article in this series outlined methods with which to search the literature for studies on the clinical question that generates a systematic review [ 1 ] . Herein , we discuss the subsequent steps of selecting and appraising studies for a review . Both of these steps involve important judgments that can influence the results of a review . In selecting studies , review ers judge the relevance of the studies to the review question . In appraising studies , review ers judge numerous features of design and analysis . Some of these judgments are easy to make ; others are more difficult and prone to error . To be confident in their decisions , review ers should use methods that are reliable ( the results do not change if the procedure is repeated ) , impartial ( not influenced by the study results ) , and explicit ( unambiguous ) [ 2 ] . These strategies for selection and appraisal are sensible , and they distinguish most systematic review s from most narrative review s. However , evidence to support the importance of some of the methods we suggest is either scant or conflicting ; readers are referred to the original research on these approaches for more details . Selecting Studies for Systematic Review s If review ers perform a comprehensive search of the literature using the methods described previously in this series [ 1 ] , they will probably have assembled a large sample of articles . This sample will include most ( ideally , all ) studies that are relevant to the review question ( that is , the sensitivity of the search will be high ) . Inevitably , because such a wide net is cast , articles not pertinent to the clinical question will be retrieved ( that is , the specificity of the search will be modest ) . Thus , the review ers ' next task is to sort through all of the potentially relevant articles and select those that will be included in the review . To do so , review ers adopt several of the tactics listed in Table 1 and Table 2 for planning and executing the selection process ( in effect , improving the specificity of the search ) ; these tactics are described below . Table 1 . Planning Study Selection Table 2 . Strategies for Selecting and Appraising Studies Begin with a Well-Built Clinical Question Review ers should ensure that the question for review includes the four elements of a well-built clinical question [ 3 , 4 ] : the patients of interest , the main interventions under investigation , the comparison interventions , and the clinical outcomes of interest . By including these four elements , review ers can better focus the selection process . Choose Selection Criteria That Fit the Clinical Question Consider a systematic review of the effectiveness of a drug treatment ( for example , a proton-pump inhibitor ) for patients with a particular disorder ( such as esophageal reflux ) . Review ers need to decide whether to include studies of patients with any symptoms of reflux , only those with classic symptoms , or only those in whom definitive diagnostic tests have confirmed the presence of reflux . In addition , review ers might choose to include studies of patients with different comorbid conditions ; patients from different demographic or geographic or cultural background s ; or patients from different health systems , such as inpatient or community population s. Similarly , review ers should use selection criteria that reflect the main and comparison interventions of interest . In our esophageal reflux example , review ers would need to decide whether to include studies of a particular drug or studies of all agents in that drug 's class and whether to include studies of any dose and regimen or only studies with a specific regimen . For the comparison interventions , the review ers would decide whether to include studies that compare the experimental drug with alternate treatments ( such as antacids or histamine-2-receptor antagonists ) , with placebo , or with both . For the clinical outcomes , review ers have analogous tasks of defining the outcomes and translating them into criteria . In our example , the review ers would start by listing each clinical outcome ( for example , whether the outcome was endoscopic or clinical and whether it focused on cure or persistence ) and then decide whether to include studies that reported any outcome or only those with certain clinical ly important outcomes ( such as improvement in symptoms at 1 year ) . After thoroughly considering each element of the review question , review ers compile a set of explicit selection criteria . When these criteria are not explicit , the results of the review are more prone to error [ 5 , 6 ] . Reporting the selection criteria used in a review is extremely important to readers because the criteria indicate the relevance of the review to the readers ' clinical practice . Specify the Types of Study Design To Be Included After creating selection criteria that appropriately reflect the review question , review ers should consider which study design s to include . Ideally , review ers choose study design s that are most likely to produce valid results . For example , to answer questions about therapy or harm , review ers may want to include r and omized trials [ 7 ] because they provide more accurate estimates of benefit or harm than do cohort studies , casecontrol studies , and case series [ 8 ] . In reality , however , r and omized trials may not be conducted to address questions of harm [ 9 ] . Therefore , review ers need to consider which study design s are likely to be available to answer their question ; this information may necessitate modification of originally conceptualized selection criteria to incorporate observational ( nonexperimental ) studies . Specify Criteria Related to Type and Form of Publication Review ers also need to consider issues related to type and form of publication . Ideally , all of the relevant studies would be published as peer- review ed journal articles . However , some completed studies may be published only as abstract s , in non-peer- review ed form , or not at all . Review ers decide whether to include these incompletely reported studies when planning their literature search . By including all articles in various stages of publication and subjecting them to rigorous critical appraisal , review ers minimize the threat of publication bias ( the preferential reporting of studies with positive results ) [ 10 - 12 ] , which could generate misleading review s. Other studies may be reported more than once . To avoid over-representing duplicate studies in the review , investigators should plan to look for and exclude duplicate publications [ 13 ] . Finally , because studies may be published in different language s and because excluding studies published in different language s may bias the results of review s [ 14 , 15 ] , articles should be included , as appropriate , regardless of the language of publication ( translating as necessary ) . Limited time and re sources , however , may preclude such an approach . Construct and Pretest Selection Forms After deciding on selection criteria , review ers can prepare customized forms that contain checklists of the selection criteria ( Figure 1 ) . Using these forms can simplify the selection process , increase reliability , and provide a record of the judgments made about each study . After drafting form prototypes , review ers pretest these forms for clarity , ease of application , and reliability . To pretest the forms , two or more independent review ers typically apply them to a r and om sample of studies identified by the literature search . Review ers compare their results to identify sources of ambiguity and then revise the forms accordingly . If the revisions are substantial , this process may need to be repeated before the forms can be used . Figure 1 . Example of a form that might be developed for the selection of studies for a systematic review evaluating the efficacy of -blockers for secondary prevention of variceal bleeding . Write a Detailed Protocol Having a selection protocol as part of a larger protocol for the entire review helps review ers in two ways . First , it provides a document that explicitly states the review question and the selection criteria , making the process accountable . Review ers can later return to the protocol for guidance in resolving disagreements about article selection . Second , the selection protocol identifies what work will be done , by whom , in what manner , when , and for what reason ; thus , it provides a mode of communication within the review team . When review ers have a very large sample of studies from which to select , they can simplify this task by review ing all of the titles , then the abstract s , and then the full articles , excluding studies that do not meet one or more selection criteria at each step . In doing so , review ers should record ( on the selection forms ) the reasons for exclusion . After review ers have selected studies for the systematic review , they will move to the next task of critical appraisal . This procedure also requires careful planning . Appraising Studies for Systematic Review s Review ers appraise the studies selected for review with three objectives in mind : 1 ) to underst and the validity of the studies , 2 ) to uncover reasons for differences among study results other than chance , and 3 ) to provide readers with sufficient information with which to judge for themselves the applicability of the systematic review to their clinical practice . To achieve these goals , review ers use the strategies outlined in Table 2 and Table 3 to carefully reexamine many important features of the primary studies . Table 3 . Planning Study Appraisal Examine Important Clinical Features Although the selection criteria for a systematic review define the population , interventions , and outcomes of interest , the appraisal process involves a detailed assessment of the patients ( for example , high , medium , or low risk ) , the study interventions ( for example , frequency , degree , and duration ) , and the outcome measurements ( for example , definitions and degree of surveillance ) In a r and omized , prospect i ve , multicenter trial , 227 children ranging in age from 3 to 17 years who had tonsillopharyngitis and a throat culture positive for group A beta-hemolytic streptococci ( GABHS ) were treated with erythromycin estolate ( 40 mg/kg/d in two divided doses for five days ) or penicillin V ( 30 mg/kg/d in three divided doses for ten days ) . Clinical signs and symptoms of tonsillopharyngitis were recorded , and throat cultures were obtained before treatment as well as one to three days and six weeks after treatment . Clinical success ( cure and improvement ) was observed on days 6 to 8 in 100 of 102 ( 98 % ) assessable children treated with erythromycin estolate and on days 11 to 13 in 97 of 99 ( 98 % ) assessable children treated with penicillin V. Of all patients showing clinical success , 11 were rated as improved , all of whom were treated with erythromycin estolate . There was a trend towards increased use of analgesic treatment in the erythromycin estolate group ( 41 % vs 33 % ) . On completion of treatment , the rate of eradication of GABHS was 83.3 % in the erythromycin estolate group compared with 87.9 % in the penicillin V group . The difference is not significant but does not take into account patients excluded because of erythromycin resistance ( 3.7 % ) . Clinical recurrence was observed in 11 ( 10.8 % ) patients treated with erythromycin estolate and in 6 ( 6.1 % ) patients treated with penicillin V ( non-significant difference ) . Compliance in the erythromycin estolate group was statistically superior to that in the penicillin V group . The incidence and nature of adverse events were similar in both treatment groups Objective . To compare a 3-day azithromycin vs. a 10-day penicillin V regimen for treatment of acute group A streptococcal ( GAS ) pharyngitis in children and to determine whether viral infection and /or pharyngeal GAS carriage in patients and adult contacts affect clinical and bacteriologic efficacy . Methods . This multicenter , r and omized , comparative , open label study compared 3-day , once daily 10 mg/kg azithromycin oral suspension with a 10-day regimen of 100 000 IU/kg/day penicillin V oral suspension in three divided doses in children with acute GAS pharyngitis . Clinical and bacteriologic efficacy and tolerability of the antibiotics were evaluated . Recurrence of symptoms and infection was monitored for 6 months . Results . In total , 292 children ( age range , 2 to 12 years ) received at least one dose of study medication . Clinical success ( cure/improvement ) with either antibiotic was similar at the end of therapy ( Day 14 ; azithromycin , 95 % ; penicillin V , 97 % ) and at Day 28 ( azithromycin , 94 % ; penicillin V , 95 % ) . Bacteriologic eradication was significantly less with azithromycin than with penicillin V at Day 14 ( azithromycin , 38 % ; penicillin V , 81%;P < 0.001 ) and at Day 28 ( azithromycin , 31 % ; penicillin V , 68%;P < 0.001 ) . There was no associated increase in GAS-related sequelae . The lower incidence of bacteriologic eradication with azithromycin was not the result of possible concomitant viral infections in the patients , GAS carriage in one parent/guardian or any reduced susceptibility in pretreatment GAS isolates . Both antibiotics were equally well-tolerated . Conclusions . Treatment with 3-day , once daily 10 mg/kg azithromycin for GAS pharyngitis is associated with similar high levels of clinical efficacy , but lower levels of bacteriologic eradication , than with 10-day 100 000 IU/kg/day penicillin OBJECTIVE To estimate the incidence and risk factors of group A streptococcus ( GAS ) sore throat among school-aged children living in a periurban slum area of Ch and igarh , North India . METHODS A total of 536 children aged 5 - 15 years from 261 families identified by a
Output:
| Three to six days of oral antibiotics had comparable efficacy compared to the st and ard duration 10-day course of oral penicillin in treating children with acute GABHS pharyngitis .
. |
MS211773 | ***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 Patients with chronic obstructive pulmonary disease ( COPD ) exhibit aerobic function , autonomic nervous system , and mucociliary clearance alterations . These parameters can be attenuated by aerobic training , which can be applied with continuous or interval efforts . However , the possible effects of aerobic training , using progressively both continuous and interval sessions ( ie , linear periodization ) , require further investigation . Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation , mucociliary clearance , and aerobic function in patients with COPD . Methods Sixteen patients with COPD were divided into an aerobic ( continuous and interval ) training group ( AT ) ( n=10 ) and a control group ( CG ) ( n=6 ) . An incremental test ( initial speed of 2.0 km·h−1 , constant slope of 3 % , and increments of 0.5 km·h−1 every 2 minutes ) was performed . The training group underwent training for 4 weeks at 60 % of the peak velocity reached in the incremental test ( vVO2peak ) ( 50 minutes of continuous effort ) , followed by 4 weeks of sessions at 75 % of vVO2peak ( 30 minutes of continuous effort ) , and 4 weeks of interval training ( 5 × 3-minute effort at vVO2peak , separated by 1 minute of passive recovery ) . Intensities were adjusted through an incremental test performed at the end of each period . Results The AT presented an increase in the high frequency index ( ms2 ) ( P=0.04 ) , peak oxygen uptake ( VO2peak ) ( P=0.01 ) , vVO2peak ( P=0.04 ) , and anaerobic threshold ( P=0.02 ) . No significant changes were observed in the CG ( P>0.21 ) group . Neither of the groups presented changes in mucociliary clearance after 12 weeks ( AT : P=0.94 and CG : P=0.69 ) . Conclusion Twelve weeks of aerobic training ( continuous and interval sessions ) positively influenced the autonomic modulation and aerobic parameters in patients with COPD . However , mucociliary clearance was not affected by aerobic training In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Abstract Objective : The aim of this study was to investigate the effects of moderate continuous training ( MCT ) and high intensity aerobic interval training ( AIT ) on systolic ventricular function and aerobic capacity in COPD patients . Methods : Seventeen patients with COPD ( 64 ± 8 years , 12 men ) with FEV1 of 52.8 ± 11 % of predicted , were r and omly assigned to isocaloric programs of MCT at 70 % of max heart rate ( HR ) for 47 minutes ) or AIT ( ∼90 % of max HR for 4 × 4 minutes ) three times per week for 10 weeks . Baseline cardiac function was compared with 17 age- and sex-matched healthy individuals . Peak oxygen uptake ( VO2-peak ) and left ( LV ) and right ventricular ( RV ) function examined by echocardiography , were measured at baseline and after 10 weeks of training . Results : At baseline , the COPD patients had reduced systolic function compared to healthy controls ( p < 0.05 ) . After the training , AIT and MCT increased VO2-peak by 8 % and 9 % and work economy by 7 % and 10 % , respectively ( all p < 0.05 ) . LV and RV systolic function both improved ( p < 0.05 ) , with no difference between the groups after the two modes of exercise training . Stroke volume increased by 17 % and 20 % , LV systolic tissue Doppler velocity ( S ’ ) by 18 % and 17 % and RV S ’ by 15 % after AIT and MCT , respectively ( p < 0.05 ) . Conclusion : Systolic cardiac function is reduced in COPD . Both AIT and MCT improved systolic cardiac function . In contrast to other patient groups studied , higher exercise intensity does not seem to have additional effects on cardiac function or aerobic capacity in COPD patients Objectives Chronic obstructive pulmonary disease ( COPD ) is associated with cardiac autonomic nervous system dysregulation . This study evaluates the effects of interval hypoxic training on cardiovascular and respiratory control in patients with mild COPD . Methods In 18 eucapnic normoxic mild COPD patients ( age 51.7 ± 2.4 years , mean ± SEM ) , r and omly assigned to either training or placebo group , and 14 age-matched healthy controls ( 47.7 ± 2.8 years ) , we monitored end-tidal carbon dioxide , airway flow , arterial oxygen saturation , electrocardiogram , and continuous noninvasive blood pressure at rest , during progressive hypercapnic hyperoxia and isocapnic hypoxia to compare baroreflex sensitivity to hypoxia and hypercapnia before and after 3 weeks of hypoxic training . In double-blind fashion , both groups received 15 sessions of passive intermittent hypoxia ( training group ) or normoxia ( placebo group ) . For the hypoxia group , each session consisted of three to five hypoxic ( 15–12 % oxygen ) periods ( 3–5 min ) with 3-min normoxic intervals . The placebo group inhaled normoxic air . Results Before training , COPD patients showed depressed baroreflex sensitivity , as compared with healthy individuals , without evident chemoreflex abnormalities . After training , in contrast to placebo group , the training group showed increased ( P < 0.05 ) baroreflex sensitivity up to normal levels and selectively increased hypercapnic ventilatory response ( P < 0.05 ) , without changes in hypoxic ventilatory response . Conclusion Eucapnic normoxic mild COPD patients already showed signs of cardiovascular autonomic abnormalities at baseline , which normalized with hypoxic training . If confirmed in more severe patients , interval hypoxic training may be a therapeutic strategy to rebalance early autonomic dysfunction in COPD patients BACKGROUND The chronic obstructive pulmonary disease ( COPD ) is associated with the strength and resistance decreasing in addition to the dysfunction on autonomic nervous system ( ANS ) . The aerobic training isolated or in association with the resistance training showed evidence of beneficial effects on an autonomic modulation of COPD ; however , there are no studies addressing the effect of isolated resistance training . AIMS This study aims at investigating the influence of resistance training on an autonomic modulation through heart rate variability ( HRV ) , functional capacity and muscle strength in individuals with COPD . DESIGN Clinical series study . SETTING Out patients . POPULATION The study involved 13 individuals with COPD . METHODS The experimental protocol was composed by an initial and final evaluation that consisted in autonomic evaluations ( HRV ) , cardiopulmonary functional capacity evaluation ( 6-minute walk test ) and strength evaluation ( dynamometry ) in addition by the resistance training performed by 24 sessions lasted 60 minutes each one and on a frequency of three times a week . The intensity was determined initially with 60 % of one maximum repetition and was progressively increased in each five sessions until 80 % . RESULTS The HRV temporal and spectral indexes analysis demonstrates improvement of autonomic modulation , with significant statistical increases to sympathetic and parasympathetic components of ANS representing by SDNN , LF and HF . In addition , it was observed significant statistical increases to shoulder abduction and knee flexion strength and functional capacity . CONCLUSION The exclusive resistance training performed was able to positively influence the autonomic modulation ; in addition it promoted benefits on cardiorespiratory functional capacity and strength benefits in individuals with COPD . CLINICAL REHABILITATION IMPACT This study could contribute to clinical and professionals research ers that act with COPD , even though the resistance component of pulmonary rehabilitation presents consensual benefits on several healthy indicators parameters . There is no evidence about the effects on HRV before . Moreover , this study showed , on clinical practice , the HRV uses as an ANS activity on sinus node evaluation and highlights further importance on scientific context Background : Pulmonary rehabilitation ( PR ) has emerged as a recommended st and ard of care in symptomatic COPD . Objectives : We now studied whether PR may affect cardiovascular response to exercise in these patients . Methods : Twenty-seven patients ( 9 females aged 69 ± 8 years ) with moderate-to-severe airflow obstruction admitted to a 9-week PR course performed a pre-to-post evaluation of lung function test and symptom-limited cardiopulmonary exercise test ( CPET ) . Oxygen uptake ( VO2 ) , tidal volume ( VT ) , dyspnea and leg fatigue scores were measured during CPET . Cardiovas-cular response was assessed by means of oxygen pulse ( O2Pulse ) , the oxygen uptake efficiency slope and heart rate recovery at the 1st min . Results : A significant increase in peak VO2 and in all cardiovascular parameters ( p < 0.05 ) was found following PR when compared to baseline . Leg fatigue ( p < 0.05 ) , but not dyspnea , was significantly reduced after PR . When assessed at metabolic and ventilatory iso levels [ % VCO2max and % minute ventilation ( VEmax ) ] , O2Pulse and VT were significantly higher ( p < 0.05 ) at submaximal exercise ( 75 and 50 % of VCO2max and VEmax ) after PR when compared to baseline . VT percent changes at 75 % VCO2max and 75 % VEmax after PR significantly correlated with corresponding changes in O2Pulse ( p < 0.01 ) . Conclusions : In COPD patients , a PR training program improved the cardiovascular response during exercise at submaximal exercise independent of the external workload . This change was associated with an enhanced ventilatory function during exercise BACKGROUND Current literature lacks solid evidence on the improvement of heart rate variability ( HRV ) after exercise training in patients with COPD . OBJECTIVES We aim ed to investigate changes in HRV after two exercise training programs in patients with COPD and to investigate the determinants of these eventual changes . METHODS Forty patients with COPD ( FEV(1 ) 39 ± 13%pred ) were r and omized into high ( n = 20 ) or low ( n = 20 ) intensity exercise training ( 3-month duration ) , and had their HRV assessed by the head-up tilt test before and after either protocol s. Baseline spirometry , level of daily physical activity , exercise capacity , body composition , functional status , health-related quality of life and muscle force were also assessed to investigate the determinants of improvement in HRV after the training program . RESULTS There was a significant improvement in HRV only after the high-intensity protocol ( pre versus post ; SDNN 29 ± 15 ms versus 36 ± 19 ms ; rMSSD 22 ± 14 ms versus 28 ± 22 ms ; p < 0.05 for both ) . Higher values of biceps brachialis strength , time spent walking in daily life and SDNN at baseline were determinants of improvement in HRV after the training program . CONCLUSIONS High-intensity exercise training improves HRV at rest and during orthostatic stimulus in patients with COPD . Better baseline total HRV , muscle force and daily physical activity level are predictors of HRV improvements after the training program BACKGROUND AND OBJECTIVES The present pilot study was undertaken to evaluate the efficacy of an aerobic exercise training ( AET ) program alone or combined with an antihypertensive agent ( irbesartan ) to reduce blood pressure ( BP ) and enhance heart rate variability ( HRV ) in chronic obstructive pulmonary disease patients . METHODS Twenty-one patients were r and omly assigned to a double-blind treatment with exercise and placebo ( n=11 ) or exercise and irbesartan ( n=10 ) . Subjects underwent 24 h BP monitoring and 24 h electrocardiographic recording before and after the 12-week AET . HRV was investigated using three indexes from the power spectral analysis and three indexes calculated from the time domain . The AET program consisted of exercising on a calibrated ergocycle for 30 min three times per week . Five patients in the placebo group were excluded during follow-up because they were not compliant . RESULTS There was no change in 24 h systolic and diastolic BP before ( 130+/-14 mmHg and 70+/-3 mmHg , respectively ) and after ( 128+/-8 mmHg and 70+/-8 mmHg , respectively ) exercise training in the placebo group , whereas in the irbesartan group systolic and diastolic B
Output:
| Evidence synthesis of studies with high method ological quality revealed that a high quality evidence level supported a significant increase for time-domain heart rate variability ( HRV ) analyses and the heart rate recovery ( HRR ) following AET .
The review also found that frequency domain HRV analyses were not significantly affected by AET .
CONCLUSION Aerobic exercise training demonstrated beneficial but limited effects on the AF in COPD .
Presently , it is not clear whether these effects are sustained in the long term . |
MS211774 | ***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 OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review 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 OBJECTIVES This study aim ed to assess analgesia provided by acupuncture , alone or in combination with pharmacotherapy , to patients presenting to emergency departments with acute low back pain , migraine or ankle sprain . DESIGN A pragmatic , multicentre , r and omised , assessor-blinded , equivalence and non-inferiority trial of analgesia , comparing acupuncture alone , acupuncture plus pharmacotherapy , and pharmacotherapy alone for alleviating pain in the emergency department . Setting , participants : Patients presenting to emergency departments in one of four tertiary hospitals in Melbourne with acute low back pain , migraine , or ankle sprain , and with a pain score on a 10-point verbal numerical rating scale ( VNRS ) of at least 4 . MAIN OUTCOME MEASURES The primary outcome measure was pain at one hour ( T1 ) . Clinical ly relevant pain relief was defined as achieving a VNRS score below 4 , and statistically relevant pain relief as a reduction in VNRS score of greater than 2 units . RESULTS 1964 patients were assessed between January 2010 and December 2011 ; 528 patients with acute low back pain ( 270 patients ) , migraine ( 92 ) or ankle sprain ( 166 ) were r and omised to acupuncture alone ( 177 patients ) , acupuncture plus pharmacotherapy ( 178 ) or pharmacotherapy alone ( 173 ) . Equivalence and non-inferiority of treatment groups was found overall and for the low back pain and ankle sprain groups in both intention-to-treat and per protocol ( PP ) analyses , except in the PP equivalence testing of the ankle sprain group . 15.6 % of patients had clinical ly relevant pain relief and 36.9 % had statistically relevant pain relief at T1 ; there were no between-group differences . CONCLUSION The effectiveness of acupuncture in providing acute analgesia for patients with back pain and ankle sprain was comparable with that of pharmacotherapy . Acupuncture is a safe and acceptable form of analgesia , but none of the examined therapies provided optimal acute analgesia . More effective options are needed . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry , ACTRN12609000989246 A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects , particularly in the elderly . Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs ( NSAIDs ) and corticosteroids in patients with acute low back pain . Eighty-four patients were r and omized to receive anti-inflammatory therapy according to the following protocol s : ( a ) mesotherapy group received the 1st and 4th day 2 % lidocaine ( 1 mL ) + ketoprofen 160 mg ( 1 mL ) + methylprednisolone 40 mg ( 1 mL ) , then on 7th , 10th , and 13th day , 2 % lidocaine ( 1 mL ) + ketoprofen 160 mg ( 1 mL ) + methylprednisolone 20 mg ( 1 mL ) ( b ) conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days , methylprednisolone 40 mg/die intramuscularly for 4 days , followed by methylprednisolone 20 mg/die for 3 days , and thereafter , methylprednisolone 20 mg/die at alternate days . Pain intensity and functional disability were assessed at baseline ( T0 ) , at the end of treatment ( T1 ) , and 6 months thereafter ( T2 ) by using visual analogic scale ( VAS ) and Rol and -Morris disability question naire ( RMDQ ) . In both groups , VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months , in comparison with baseline . No significant differences were found between the two groups . This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs Study objective : In US emergency departments ( EDs ) , patients with low back pain are often treated with nonsteroidal anti‐inflammatory drugs and muscle relaxants . We compare functional outcomes among patients r and omized to a 1‐week course of naproxen+placebo versus naproxen+orphenadrine or naproxen+methocarbamol . Methods : This was a r and omized , double‐blind , comparative effectiveness trial conducted in 2 urban EDs . Patients presenting with acute , nontraumatic , nonradicular low back pain were enrolled . The primary outcome was improvement on the Rol and ‐Morris Disability Question naire ( RMDQ ) between ED discharge and 1 week later . All patients were given 14 tablets of naproxen 500 mg , to be used twice a day , as needed for low back pain . Additionally , patients were r and omized to receive a 1‐week supply of orphenadrine 100 mg , to be used twice a day as needed , methocarbamol 750 mg , to be used as 1 or 2 tablets 3 times per day as needed , or placebo . All patients received a st and ardized 10‐minute low back pain educational session before discharge . Results : Two hundred forty patients were r and omized . Baseline demographic characteristics were comparable . The mean RMDQ score of patients r and omized to naproxen+placebo improved by 10.9 points ( 95 % confidence interval [ CI ] 8.9 to 12.9 ) . The mean RMDQ score of patients r and omized to naproxen+orphenadrine improved by 9.4 points ( 95 % CI 7.4 to 11.5 ) . The mean RMDQ score of patients r and omized to naproxen+methocarbamol improved by 8.1 points ( 95 % CI 6.1 to 10.1 ) . None of the between‐group differences surpassed our threshold for clinical significance . Adverse events were reported by 17 % ( 95 % CI 10 % to 28 % ) of placebo patients , 9 % ( 95 % CI 4 % to 19 % ) of orphenadrine patients , and 19 % ( 95 % CI 11 % to 29 % ) of methocarbamol patients . Conclusion : Among ED patients with acute , nontraumatic , nonradicular low back pain , combining naproxen with either orphenadrine or methocarbamol did not improve functional outcomes compared with naproxen+placebo BACKGROUND Current worldwide clinical practice guidelines recommend acetaminophen as the first option for the treatment of acute low back pain . However , there is no concrete evidence regarding whether acetaminophen or nonsteroidal anti-inflammatory drugs ( NSAIDs ) is more effective for treating acute low back pain ( LBP ) in Japan . The present study aim ed to investigate whether acetaminophen treatment for acute musculoskeletal pain was comparable with loxoprofen ( a traditional NSAID in Japan ) treatment . METHODS Of the 140 patients with acute LBP who visited out-patient hospitals , 127 were considered eligible and were r and omly allocated to a group taking acetaminophen or one taking loxoprofen . As primary outcome measure , pain intensity was measured using a 0 - 10-numeric rating scale ( NRS ) . Moreover , pain disability , pain catastrophizing , anxiety , depression , and quality of life , as well as adverse events , were assessed as secondary outcomes . The primary outcome was tested with a noninferiority margin ( 0.84 on changes in pain-NRS ) , and the secondary outcomes were compared using conventional statistical methods at week 2 and week 4 . RESULTS Seventy patients completed the study ( acetaminophen : 35 , loxoprofen : 35 ) . The dropout rates showed no significant difference between the two medication-groups . We found that the mean differences of changes in pain-NRS from baseline to week 2 or 4 between the two medication groups were not statistically beyond the noninferiority margin ( mean [ 95 % confidence interval ] : -0.51 [ -1.70 , 0.67 ] , at week 2 and -0.80 [ -2.08 , 0.48 ] at week 4 ) . There were no consistent differences between the two medication groups in terms of secondary outcomes . CONCLUSIONS The results suggest that acetaminophen has comparable analgesic effects on acute LBP , based on at least a noninferiority margin , compared with loxoprofen at 4 weeks . Acetaminophen seems to be a reasonable first-line
Output:
| NSAIDs seemed slightly more effective than placebo for short-term pain reduction ( moderate certainty ) , disability ( high certainty ) , and global improvement ( low certainty ) , but the magnitude of the effects is small and probably not clinical ly relevant .
There was no clear difference in short-term pain reduction ( low certainty ) when comparing selective COX-2 inhibitors to non-selective NSAIDs .
We found very low evidence of no clear difference in the proportion of participants experiencing adverse events in both the comparison of NSAIDs versus placebo and selective COX-2 inhibitors versus non-selective NSAIDs . |
MS211775 | ***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 effect of support with human chorionic gonadotrophin in the luteal phase in women taking part in an in vitro fertilisation programme after buserelin and human menopausal gonadotrophin were used to hyperstimulate their ovaries . DESIGN --Controlled group comparison . SETTING --Outpatient department of a private hospital . PATIENTS --115 Women with indications for in vitro fertilisation , all of whom had at least one embryo transferred . INTERVENTIONS --After suppression of the pituitary with buserelin the ovaries of all the women were stimulated with human menopausal gonadotrophin on day 4 of the luteal phase . Human chorionic gonadotrophin ( 10,000 IU ) was given to induce ovulation , and oocytes were recovered 34 hours later . Embryos were transferred 46 to 48 hours after insemination . Women who had received the 10,000 IU of human chorionic gonadotrophin on a date that was an uneven number ( n = 61 ) were allocated to receive support doses of 2500 IU human chorionic gonadotrophin three and six days after that date . The remaining 54 women did not receive hormonal support . END POINT -- Determination of the rates of pregnancy . MEASUREMENTS and main results --Support with human chorionic gonadotrophin did not significantly alter the progesterone or oestradiol concentrations in the early or mid-luteal phase . The mean ( range ) progesterone concentrations in the late luteal phase in women who did not become pregnant were , however , significantly higher in those who received support ( 16(9 - 110 ) nmol/l nu 8(4 - 46 ) nmol/l ) , and the luteal phase was significantly longer in this group ( 14 days nu 12 days ) . The rate of pregnancy was significantly higher in the women who received support than in those who did not ( 25/61 nu 8/54 ) . CONCLUSIONS --When buserelin and human menopausal gonadotrophin are used to hyperstimulate ovaries support with human chorionic gonadotrophin in the luteal phase has a beneficial effect on in vitro fertilisation This study aim ed to compare the efficacy of micronized progesterone administered as luteal support following ovulation induction for in-vitro fertilization (IVF)- embryo transfer in cycles using gonadotrophin-releasing hormone agonist , either orally ( 200 mgx4/day ) or vaginally ( 100 mgx2/day ) and to characterize the luteal phase hormonal profile during such treatments . A total of 64 high responder patients requiring intracytoplasmic sperm injection due to male factor infertility were prospect ively r and omized into two treatment groups . Patients treated orally or vaginally were comparable in age ( 31.9 + /- 6.1 versus 30.6 + /- 5.2 ; mean + /- SD ) , number of oocytes retrieved ( 17 + /- 8.2 versus 18 + /- 7.0 ) , and number of embryos transferred ( 3.1 + /- 1.2 versus 2.7 + /- 0.9 ) per cycle . Following low dose vaginal treatment , a significantly higher implantation rate ( 30.7 versus 10.7 % , P < 0.01 ) , but similar clinical pregnancy rate ( 47.0 versus 33.3 % ) and ongoing pregnancy rate ( 41.1 versus 20.0 % ) was observed , compared with oral treatment . In conception cycles , luteal serum progesterone and oestrogen concentrations did not differ between the treatment groups . In non-conception cycles , late luteal progesterone concentrations were significantly lower following vaginal treatment . As low dose micronized progesterone administered vaginally is simple , easy and well tolerated , it could be recommended as the method of choice for luteal support , especially for high responder patients at risk for ovarian hyperstimulation syndrome There is disagreement among in vitro fertilization ( IVF ) programs as to the need to administer exogenous progesterone to support the luteal phase of patients undergoing embryo transfer after IVF . We examined the effect on pregnancy rates of Prolution , 50-mg daily injections given on days 7–16 following oocyte recovery , in 186 women undergoing IVF treatment using a combined stimulation regime of clomiphene and human menopausal gonadotropin ( hMG ) . One group was deliberately selected for treatment on the possible criterion of lutealphase deficiency and two other groups were r and omly selected into a treatment and a control group . No effect on pregnancy rate was noted in any of these groups . These results indicate that extension of the luteal phase with exogenous progesterone is unlikely to have a significant effect on increasing the pregnancy rate in IVF programs using similar treatment regimes Background . A prospect i ve study was done to compare the efficacy of luteal phase support ( LPS ) using either three times hCG ( group I , n=77 ) , hCG on the day of embryo transfer ( ET ) in combination with daily vaginal progesterone ( group II , n=62 ) or vaginal progesterone only ( group III , n=70 ) BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences A total of 156 patients were r and omly treated with exogenous natural progesterone ( intramuscularly , 50 mg/day ) and vaginal gel ( 90 mg/day ) P or nothing ( Controls ) from the day before embryo transfer ( ET ) for two weeks . In case of positive beta-HCG , the treatment was continued for 12 weeks . Plasma P and 17 beta-Estradiol concentrations were estimated and compared with the control not supplemented group . Both treatments were able to increase significantly the luteal plasmatic values of P versus controls . The ongoing pregnancy and the living birth rates per transfer were significantly higher in the patients supplemented with intramuscular P than in those treated with vaginal gel P. The intramuscular natural P appears the most suitable route of administration for luteal phase support in IVF-ET procedures In a consecutive series of 167 patients reaching the stage of embryo transfer after in vitro fertilization and embryo transfer , 19 clinical pregnancies ensued . The serum progesterone ( P ) levels were significantly greater on the first and second ( P less than 0.01 ) and third ( P less than 0.05 ) postaspiration days for those who conceived . Higher circulating levels of P were achieved on days 1 , 2 , and 3 ( P less than 0.05 ) by the daily injection of P , 50 mg in oil , given for 5 consecutive days , beginning immediately after follicle aspiration . Both pregnancy and nonpregnancy cycles demonstrated high circulating P levels , but the study implies that relatively higher levels are required for conception , and such levels can be achieved by the use of intramuscular Fifty-two women , who had 62 ovum aspiration cycles , received a progesterone ( P ) supplementation of 100 mg/day that was initiated 10 hours before human chorionic gonadotropin ( hCG ) administration and was continued over the following 6 days . Forty-eight women who had 74 ovum pick-ups , but did not get P , served as controls . Forty-four ( 84.6 % ) women of the treatment group , and 40 ( 83.3 % ) of the controls had ovum fertilization and embryo replacement . The fertilization and cleavage rates and the mean number of replaced embryos per embryo transfer ( ET ) cycle did not differ between the groups . Endometrial biopsies , from treatment group women with no fertilized eggs , which were taken 48 hours after ovum pick-up , mostly revealed an " advanced endometrial dating , " in relation to the " day of hCG . " Pregnancy rate per ET cycle for the treatment group was significantly higher than that of the controls ; 41.2 % versus 23.3 % , respectively . It is concluded that the higher pregnancy rate result ed from an improvement in uterine receptivity Replacing GnRH agonist cotreatment for the prevention of a premature rise in LH during ovarian stimulation for in vitro fertilization ( IVF ) by the late follicular phase administration of GnRH antagonist may render supplementation of the luteal phase redundant , because of the known rapid recovery of pituitary function after antagonist cessation . This r and omized two-center study was performed to compare nonsupplemented luteal phase characteristics after three different strategies for inducing final oocyte maturation . Forty patients underwent ovarian stimulation using recombinant (r-)FSH ( 150 IU/d , fixed ) combined with a GnRH antagonist ( antide ; 1 mg/d ) during the late follicular phase . When at least one follicle above 18 mm was observed , patients were r and omized to induce oocyte maturation by a single injection of either r-human (h)CG ( 250 microg ) ( n = 11 ) , r-LH ( 1 mg ) ( n = 13 ) , or GnRH agonist ( triptorelin ; 0.2 mg ) ( n = 15 ) . Retrieved oocytes were fertilized by either IVF or intracytoplasmatic sperm injection , depending on sperm quality . Embryo transfer was performed 3 - 4 d after oocyte retrieval . No luteal support was provided . Serum concentrations of FSH , LH , estradiol ( E(2 ) ) , progesterone ( P ) , and hCG were assessed at fixed intervals during the follicular and luteal phase . The median duration of the luteal phase was 13 , 10 , and 9 d for the r-hCG , the r-LH , and the GnRH agonist group , respectively ( P = 0.005 ) . The median area under the curve per day ( from 4 d post r and omization until the onset of menses ) for LH was 0.50 , 2.34 , and 1.07 for the r-hCG , the r-LH , and the GnRH agonist group , respectively ( P = 0.001 ) . The median area under the curve per day for P was 269 vs. 41 and 16 for the r-hCG , the r-LH , and the GnRH agonist group , respectively ( P < 0.001 ) . Low pregnancy rates ( overall , 7.5 % ; range , 0 - 18 % per started cycle ) were observed in all groups . In conclusion , the nonsupplemented luteal phase was insufficient in all three groups . In the patients receiving r-hCG , the luteal phase was less disturbed , compared with both other groups , presumably because of prolonged clearance of hCG from the circulation and the result ing extended support of the corpus luteum . Despite high P and E(2 ) concentrations during the early luteal phase in all three groups , luteolysis started prematurely , presumably because of excessive negative steroid feedback result ing in suppressed pituitary LH release . Hence , support of corpus luteum function remains m and atory after ovarian stimulation for IVF with GnRH antagonist cotreatment A polysyloxane vaginal ring containing 1 g of natural progesterone was developed as luteal supplementation for women treated with IVF-embryo transfer and for agonadal women participating in an oocyte donation programme . The ring provides continuous release of progesterone ( 10 - 20 nmol/l ) for 90 days . The efficacy of this form of progesterone supplementation was evaluated in two multicentre prospect i ve r and omized trials . IVF-embryo transfer trial : After oocyte aspiration , 505 women were r and omly allocated to progesterone supplementation with vaginal ring or i.m . progesterone ( 50 mg/day ) . The clinical pregnancy rate was 36.6 % in both groups . Implantation rate was 15.9 % in the vaginal ring and 16.0 % in i.m . progesterone . Oocyte donation trial : After endometrial proliferation with micronized
Output:
| Comparing routes of progesterone administration , reductions in clinical pregnancy rate with the oral route , compared to the intramuscular or vaginal routes , did not reach statistical significance , but there was evidence of benefit of the intramuscular over the vaginal route for the outcomes of ongoing pregnancy and live birth .
No significant difference in pregnancy rate was observed between vaginal progesterone gel and other types of vaginal progesterone .
REVIEW ERS ' CONCLUSIONS Luteal phase support with hCG or progesterone after assisted reproduction results in an increased pregnancy rate .
hCG does not provide better results than progesterone , and is associated with a greater risk of OHSS when used with GnRHa . |
MS211776 | ***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 : An imbalance between Th1 and Th2 cells is involved in allergic rhinitis ( AR ) that may be improved by probiotics . To test the efficacy of the probiotic Lactobacillus paracasei subsp . paracasei LP-33 , a double-blind , placebo-controlled , r and omized trial was carried out in patients with AR to grass pollen treated with loratadine and presenting altered quality of life . Subjects/ methods : Subjects with persistent AR , symptomatic during the grass pollen season , and a positive skin test or specific immunoglobulin E to grass pollens were included by general practitioners ( GPs ) . All received loratadine for 5 weeks . The primary end point was the improvement in Rhinitis Quality of Life ( RQLQ ) global score at the fifth week of LP-33 consumption compared with placebo ( in addition to loratadine ) . Secondary end points included nasal and ocular symptoms ( individual and total symptom scores ) , visual analogue scale and time of first exacerbation of the symptoms when loratadine was stopped . Results : A total of 425 subjects were included . Using intent-to-treat analysis , the RQLQ global score decreased significantly more in the LP-33 group than in the placebo group ( P=0.0255 , difference=−0.286 ( 95 % confidence interval ( CI ) : −0.536 ; −0.035 ) ) . No significant differences were noted for the change of the rhinitis total symptom score 5 global score between groups ( P=0.1288 , difference=−0.452 ( 95 % CI : −1.036 ; 0.132 ) ) . Significant differences in ocular symptoms ( RQLQ ) were observed between groups ( P=0.0029 , difference=−0.4087 ( 95 % CI : −0.6768 ; −0.1407 ) ) . Conclusions : This study performed by GPs shows that LP-33 improves the quality of life of subjects with persistent AR who are currently being treated with an oral H1-antihistamine . Whereas nasal symptoms had not changed , ocular symptoms had consistently improved Background : A prospect i ve , cross‐sectional , international survey was conducted among patients and physicians to identify symptom perception and the impact of allergic rhinitis ( AR ) on health‐related quality of life ( HRQoL ) . This paper presents the results from the USA BACKGROUND The gastrointestinal microflora is an important constituent of the gut mucosal defense barrier . We have previously shown that a human intestinal floral strain , Lactobacillus GG ( ATCC 53103 ) , promotes local antigen-specific immune responses ( particularly in the IgA class ) , prevents permeability defects , and confers controlled antigen absorption . OBJECTIVE The aim of this study was to evaluate the clinical and immunologic effects of cow 's milk elimination without ( n = 14 ) and with ( n = 13 ) the addition of Lactobacillus GG ( 5 x 10(8 ) colony-forming units/gm formula ) in an extensively hydrolyzed whey formula in infants with atopic eczema and cow 's milk allergy . The second part of the study involved 10 breast-fed infants who had atopic eczema and cow 's milk allergy . In this group Lactobacillus GG was given to nursing mothers . METHODS The severity of atopic eczema was assessed by clinical scoring . The concentrations of fecal alpha 1- antitrypsin , tumor necrosis factor-alpha , and eosinophil cationic protein were determined as markers of intestinal inflammation before and after dietary intervention . RESULTS The clinical score of atopic dermatitis improved significantly during the 1-month study period in infants treated with the extensively hydrolyzed whey formula fortified with Lactobacillus GG . The concentration of alpha 1-antitrypsin decreased significantly in this group ( p = 0.03 ) but not in the group receiving the whey formula without Lactobacillus GG ( p = 0.68 ) . In parallel , the median ( lower quartile to upper quartile ) concentration of fecal tumor necrosis factor-alpha decreased significantly in this group , from 709 pg/gm ( 91 to 1131 pg/gm ) to 34 pg/gm ( 19 to 103 pg/gm ) ( p = 0.003 ) , but not in those receiving the extensively hydrolyzed whey formula only ( p = 0.38 ) . The concentration of fecal eosinophil cationic protein remained unaltered during therapy . CONCLUSION These results suggest that probiotic bacteria may promote endogenous barrier mechanisms in patients with atopic dermatitis and food allergy , and by alleviating intestinal inflammation , may act as a useful tool in the treatment of food allergy Background : Oral probiotic bacteriotherapy with Lactobacillus rhamnosus has given promising results in small children with food allergy . We studied the effects of similar therapy in teenagers and young adults , who were allergic to birch pollen and apple food and had intermittent symptoms of atopic allergy and /or mild asthma BACKGROUND Japanese cedar pollinosis ( JCPsis ) affects nearly one in six Japanese . Oral administration of Bifidobacterium longum BB536 has been shown to be effective in relieving JCPsis symptoms during the pollen season . METHODS This double- two-way crossover study was design ed to evaluate the efficacy of BB536 on reducing symptoms in JCPsis patients exposed to Japanese cedar pollen ( JCP ) in an environmental exposure unit ( EEU ) outside of the normal JCP season . After a 1-week run-in period , subjects ( n=24 ) were r and omly allocated to receive BB536 powder ( approximately 5x1010 ) or placebo twice a day for 4 weeks . After a 2-week washout period , subjects were crossed over to another 4 weeks of intake . At the end of each intake period , subjects received controlled JCP exposure for 4 hours in the EEU . Symptoms were self-rated 30 minutes before and every 30 minutes during the exposures . From the first day of exposure through the next 5 successive days , participants self-rated their delayed symptoms and medication uses . Blood sample s were taken before the exposures . The mean JCP levels for exposures were 6500 to 7000 grains/m3 air . RESULTS In comparison with placebo , BB536 intake significantly reduced the ocular symptom scores during JCP exposures . Evaluating delayed symptoms after exposures indicated that scores for disruption of normal activities were significantly lower in the BB536 group compared with the placebo group . Prevalence of medication use was markedly reduced by BB536 intake . CONCLUSIONS These results suggest the potential beneficial effect of BB536 in relieving symptoms of JCP allergy Live Lactobacillus paracasi 33 ( LP33 ) may effectively improve the quality of life for patients with perennial allergic rhinitis . It has been demonstrated that heat-killed lactic acid bacteria ( LAB ) suppress specific immunoglobulin E synthesis and stimulate interleukin-12 production in animals . The aim of this study was , therefore , to evaluate the efficacy of heat-killed LP33 in the treatment of allergic rhinitis induced by house-dust-mite in human subjects . A total of 90 patients were enrolled in a r and omized , double blind , placebo-controlled trial and assigned to three treatment groups . Patients in groups A and B received two capsules per day of live or heat-killed LAB ( 5 x 10(9 ) colony-forming units/capsule ) , respectively , over a period of 30 days while those in Group C received placebo capsules . A modified question naire on pediatric rhinoconjunctivitis-related quality of life was administered to all subjects or their parents during each clinical visit . The overall quality of life score decreased for groups A and B , as compared with the placebo group , in terms of both frequency ( 9.47 + /- 2.89 , 6.30 + /- 2.19 , vs. -3.47 + /- 1.53 , respectively ; p < 0.0001 ) and level of bother ( 5.91 + /- 3.21 , 6.04 + /- 2.44 , vs. -2.80 + /- 1.64 , respectively ; p = 0.004 ) after the 30-day treatment . The efficacy of the heat-killed LP33 was not inferior to the live variant . No obvious side effects were reported for either active treatment group during the study period . Our results suggest that heat-killed LP33 can effectively improve the overall quality of life for patients with allergic rhinitis , and that it may be efficacious as an alternative treatment Japanese cedar pollinosis is an important contributor to allergic rhinitis in Japan . Lactobacillus may be useful as an immunomodulator and is used widely as a foodstuff . The purpose of the study was to examine the effects of daily intake of the Lactobacillus paracasei strain KW3110 in patients with cedar pollinosis . The effects of daily intake of KW3110 in patients with cedar pollinosis were investigated in 126 patients who received KW3110 or a placebo in a double-blind study . The study began 1 month before the start of the pollen season and lasted for 3 months . A significant reduction of nasal symptoms and the serum level of eosinophil cationic protein and improvement of quality of life scores occurred in the patients who received KW3110 when pollen scattering was low . However , the effects were limited during the peak period of pollen scattering . Intake of KW3110 may reduce allergic inflammation , but the effect is limited tion of both CP and cisplatin . Hypersensitivity to mannitol was reported as a cause of apparent hypersensitivity to cisplatin . 6 In case 2 the result of a skin test with mannitol was negative , whereas the result of a skin test with the commercial formulation containing CP and mannitol was positive , suggesting that CP was solely responsible for the hypersensitivity reaction . In addition to the clinical tolerance induced by the desensitization protocol , skin responses to intradermal CP diminished . As shown in Table I , the ratio between wheal sizes of CP and histamine decreased more than 3.5 times after the desensitization . The observation of wheal- and -flare responses becoming negative has already been described in penicillin desensitization . 7 This phenomenon supports an antigen-specific desensitization . The rate at which the drug concentration increases in the extracellular fluid seems to be the most important factor in a successful outcome of desensitization . As suggested by our two patients , this rate can differ in each individual case . We conclude that the 4-hour desensitization protocol may not be suitable for all patients allergic to CP , whereas a modified prolonged protocol seems to be more tolerable . Until further data have been accumulated , the short protocol may be at tempted initially but should be replaced by the prolonged protocol if adverse effects appear . The prolonged protocol seems to be both safe and efficacious with regard to anti tumor activity To examine whether long-term consumption of fermented milk containing a specific Lactobacillus casei may improve the health status of preschool children suffering from allergic asthma and /or rhinitis a r and omized , prospect i ve , double blind , controlled trial was conducted in 187 children 2–5 y of age . The children received for 12 mo either fermented milk ( 100 mL ) containing Lactobacillus casei ( 108 cfu/mL ) or placebo . The time free from and the number of episodes of asthma/rhinitis after starting intervention were the outcome measures . The number of fever or diarrhea episodes and the change in serum immunoglobulin were further assessed . No statistical difference between intervention and control group occurred in asthmatic children . In children with rhinitis , the annual number of rhinitis episodes was lower in the intervention group , mean difference ( 95 % CI ) , −1.6 ( −3.15 to −0.05 ) ; the mean duration of an episode of diarrhea was lower in the intervention group , mean difference −0.81 ( −1.52 to −0.10 ) days . While long-term consumption of fermented milk containing Lactobacillus casei may improve the health status of children with allergic rhinitis no effect was found in asthmatic children Objective To study , we examined the effect of Lactobacillus salivarius on the clinical symptoms and medication use among children with established allergic rhinitis ( AR ) . Design Double blind , r and omized , controlled trial . Setting Hualien Tzu-Chi General Hospital . Methods Atopic children with current allergic rhinitis received 4 × 109 colony forming units/g of Lactobacillus salivarius ( n=99 ) or placebo ( n=100 ) daily as a powder mixed with food or water for 12 weeks . The SCORing Allergic rhinitis index ( specific symptoms scores [ SSS ] and symptom medication scores [ SMS ] ) , which measures the extent and severity of AR , was assessed in each subject at each of the visits — 2 weeks prior to treatment initiation ( visit 0 ) , at the beginning of the treatment ( visit 1 ) , then at 4 ( visit 2 ) , 8 ( visit 3 ) and 12 weeks ( visit 4 ) after starting treatment . The WBC , RBC , platelet and , eosinophil counts as well as the IgE antibody levels of the individuals were evaluated before and after 3 months of treatment . Results The major outcome , indicating the efficacy of Lactobacillus salivarius treatment ,
Output:
| Probiotics may be beneficial in improving symptoms and quality of life in patients with allergic rhinitis ; however , current evidence remains limited due to study heterogeneity and variable outcome measures . |
MS211777 | ***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 : Though the greatest proportion of irritable bowel syndrome ( IBS ) patients report a mixed bowel pattern ( IBS-Mixed ) , no available therapies have been rigorously evaluated in this subgroup . This study aim ed to evaluate the efficacy and safety of the 5-HT4 agonist tegaserod in women with IBS-Mixed and IBS with constipation ( IBS-C ) . METHODS : This prospect i ve , double-blind , r and omized , placebo-controlled , multicenter study was conducted in 100 centers in North America , South America , and Europe . Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily . The primary efficacy variable was the patient 's assessment of satisfactory relief over the 4-wk treatment period . The proportion of patients reporting satisfactory relief for ≥3 of 4 treatment weeks ( 75 % rule ) and individual IBS symptoms were assessed . RESULTS : In total , 661 women were r and omized ( IBS-Mixed 324 , IBS-C 337 ) . Baseline symptom assessment s identified clear differences between the two cohorts . Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk ( OR 1.75 , 95 % CI 1.35–2.25 , P < 0.001 ) in both IBS-Mixed and IBS-C patients . Using the 75 % rule , 52.3 % of tegaserod-receiving IBS-M patients and 43.3 % of IBS-C patients were responders ( vs 36.3 , OR 1.88 , 95 % CI 1.16–3.04 , P < 0.010 ; and 28.9 , OR 1.90 , 95 % CI 1.19–3.05 , P < 0.008 for placebo , respectively ) . The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea ( 1.5 % ) and abdominal pain ( 0.9 % ) . Overall 7 % of IBS-C patients reported diarrhea compared to 12 % of IBS-Mixed ( placebo 2.4 % , 1.8 % , respectively ) . CONCLUSIONS : Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and OBJECTIVES : To assess long-term safety and efficacy of alosetron in women with severe , chronic diarrhea-predominant IBS and in a subset having more frequent urgency ( i.e. , bowel urgency at least 10 of 14 days during screening ) . METHODS : R and omized patients received either alosetron 1 mg ( n = 351 ) or placebo ( n = 363 ) twice daily during a 48-wk , double-blind study . The primary endpoint was the 48-wk average rate of adequate relief of IBS pain and discomfort . Secondary endpoints included 48-wk average satisfactory control rates of urgency , stool frequency , stool consistency , and bloating . Other efficacy endpoints were average monthly adequate relief and urgency control rates and impact of provided rescue medication . RESULTS : Alosetron-treated patients had significantly greater 48-wk average adequate relief ( p = 0.01 ) and urgency control ( p < 0.001 ) rates , regardless of rescue medication use , compared with placebo . Results in subjects with more frequent urgency were more robust than those in the overall population ( p = 0.005 ) . In weeks without rescue medication use , satisfactory control rates for stool frequency and stool consistency were significantly greater in alosetron-treated patients than placebo . Alosetron-treated patients had significantly greater adequate relief than placebo-treated patients ( p < 0.05 ) in 9 of 12 months and significantly greater urgency control ( p < 0.001 ) in all months . Adequate relief and urgency control were maintained throughout the treatment . Adverse events and serious adverse events were similar between treatment groups , except for constipation . Neither ischemic colitis nor serious events related to bowel motor dysfunction was reported . CONCLUSIONS : Long-term use of alosetron is effective and well-tolerated in women with chronic , diarrhea-predominant IBS , including those with more frequent urgency : No currently available treatment provides consistent relief of irritable bowel syndrome . Colonic sensory and motor function are modulated partly through 5HT3‐receptors Herbal remedies , particularly peppermint , have been reported to be helpful in controlling symptoms of irritable bowel syndrome ( IBS ) . We conducted a r and omized double-blind placebo-controlled study on 90 out patients with IBS . Subjects took one capsule of enteric-coated , delayed-release peppermint oil ( Colpermin ) or placebo three times daily for 8 weeks . We visited patients after the first , fourth , and eighth weeks and evaluated their symptoms and quality of life . The number of subjects free from abdominal pain or discomfort changed from 0 at week 0 to 14 at week 8 in the Colpermin group and from 0 to 6 in controls ( P < 0.001 ) . The severity of abdominal pain was also reduced significantly in the Colpermin group as compared to controls . Furthermore , Colpermin significantly improved the quality of life . There was no significant adverse reaction . Colpermin is effective and safe as a therapeutic agent in patients with IBS suffering from abdominal pain or discomfort OBJECTIVES : Bowel urgency is one of the most bothersome symptoms for nonconstipated IBS patients . The efficacy of alosetron in control of bowel urgency and Global Improvement of IBS symptoms were evaluated in a multicenter double-blind , r and omized , placebo-controlled study . METHODS : Female IBS patients with lack of satisfactory control of bowel urgency were r and omized 2:1 to alosetron 1 mg twice daily or placebo treatment groups . The primary endpoint was the proportion of days with satisfactory control of bowel urgency during the 12-wk treatment period and 2-wk follow-up period . Secondary endpoints included IBS Global Improvement ( responder defined as patient-reported moderate or substantial improvement in IBS symptoms ) and improvements in bowel function ( stool frequency , consistency , and sensation of incomplete evacuation ) . RESULTS : A total of 801 women were r and omized to the alosetron ( n = 532 ) or placebo groups ( n = 269 ) . Physicians classified 98 % of patients with diarrhea-predominant IBS . Patients treated with alosetron had a significantly greater proportion of days with satisfactory control of urgency compared to placebo for the treatment period ( 73 % vs 57 % , p < 0.001 ) . A significantly greater number of patients treated with alosetron were IBS Global Improvement responders compared to placebo at week 12 ( 76 % vs 44 % , p < 0.001 ) . IBS Global Improvement responders had more days with satisfactory control of urgency at week 12 ( 88 % vs 48 % ) as well as firmer stools , fewer stools/day , and fewer days with incomplete evacuation compared with nonresponders . Alosetron-treated patients showed improvements in bowel functions compared to placebo-treated patients . Constipation was the most commonly reported adverse event . CONCLUSIONS : Alosetron is effective at managing bowel urgency in women with diarrhea-predominant IBS . The IBS Global Improvement assessment correlated with improvements in bowel function and may be a useful tool in future IBS clinical trials Are meta-analyses the brave new world , or are the critics of such combined analyses right to say that the biases inherent in clinical trials make them uncombinable ? Negative trials are often unreported , and hence can be missed by meta-analysts . And how much heterogeneity between trials is acceptable ? A recent major criticism is that large r and omised trials do not always agree with a prior meta- analysis . Neither individual trials nor meta-analyses , reporting as they do on population effects , tell how to treat the individual patient . Here we take a more rounded approach to meta-analyses , arguing that their strengths outweigh their weaknesses , although the latter must not be brushed aside A double-blind controlled therapeutic trial of factorial design was used to study the therapeutic effects of lorazepam , hyoscine butylbromide , and ispaghula husk in 12 r and omised blocks of eight patients with the irritable bowel syndrome ( IBS ) . Each of the three agents caused a sustained symptomatic improvement in some of the patients , although only with ispaghula was the difference between the real and dummy preparation statistically significant . When the eight possible combinations of treatment were analysed none of the 12 patients who received only dummy preparations of the three agents had maintained any improvement over the three months of the trial . Seven patients improved among the 12 who received potent preparations of all three agents , and between four and six patients improved in the groups receiving one or two of the potent preparations . These therapeutic results , though far from perfect , show that the types of drug commonly used to treat IBS are of some value and may be additive in their effects . Similar combinations of other therapeutic agents may be more effective , but it will be possible to determine this only by carrying out factorial therapeutic trials Background / objective In order to follow the most recent developments and recommendations in trial methodology for drug evaluation in patients with irritable bowel syndrome , we performed an extended analysis of a large clinical trial from a previously published study of otilonium bromide , using an assessment that integrates the key symptoms of irritable bowel syndrome . Material s and methods A large-scale clinical trial with a double-blind , placebo-controlled , parallel-group study design was conducted in 378 patients , treated for 15 weeks with the recommended st and ard dose of 40 mg otilonium bromide or placebo three times daily . The study was based on the collection of 12 single efficacy endpoints . The new efficacy assessment was based on the data reported by the patients . Rather than demonstrating score differences between the treatment groups of the study , we carried out an assessment that integrates the most frequent symptoms reported ( pain frequency and intensity , presence of meteorism and distension ) by the patient . Results The rate of response to treatment within 2–4 months ( the primary efficacy outcome measure ) was significantly higher in the otilonium bromide group ( 36.9 % ) than in the placebo group ( 22.5 % ; P = 0.007 ) . In each month of treatment , the rate of monthly response was higher in the otilonium bromide group as compared to the placebo group ( P < 0.05 ) . The total monthly and weekly responses to the single endpoints ( intensity and frequency of pain and discomfort , meteorism/abdominal distension , severity of diarrhoea or constipation and mucus in the stool ) were significantly more frequent in the group treated with otilonium bromide than in the placebo-treated group , with differences ranging from 10 % to 20 % . The subgroup analysis of the intestinal habits endpoint indicates that patients with diarrhoea have an additional benefit . Conclusion The present re-evaluation of a previously published study confirms that otilonium bromide is more effective than placebo for the treatment of irritable bowel syndrome , being very efficient in relieving pain and discomfort BACKGROUND AND AIM Previous studies with cisapride reported conflicting results in patients with constipation-predominant irritable bowel syndrome ( IBS ) . To gain further evidence , this r and omized double-blind study was carried out . METHODS Eighty-two symptomatic out patients were r and omized to receive either 5 mg oral cisapride or placebo three times daily for a period of 12 weeks . In patients without satisfactory improvement after 4 weeks , the dose was doubled . Symptom evaluation used visual analog scales ( VAS ) and the investigators ' global assessment . RESULTS After 4 weeks , in 18 ( 45 % ) cisapride and 24 ( 57 % ) placebo patients the dose was doubled because of insufficient improvement of symptoms . The mean VAS score for patients ' global rating of IBS symptoms at baseline was 67.5 mm for cisapride versus 70.7 mm for placebo , and improved to 38.4 mm versus 44.5 mm after 12 weeks of treatment . Investigators rated the overall effect of therapy as good or excellent in 70 % of the cisapride and 50 % of the placebo group . Neither these nor further efficacy parameter differences reached statistical significance . CONCLUSIONS These results indicate that the effect of 15 - 30 mg cisapride daily on symptoms of constipation-predominant IBS is not significantly superior to placebo . During the 12 week treatment of this trial cisapride proved to be safe and tolerable BACKGROUND : A r and omized , double blind , placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome ( IBS ) . METHODS : Six hundred and sixty-two men were r and omized to treatment with alosetron 0.5 , 1.0 , 2.0 , 4.0 mg , or placebo twice daily for 12 wk , followed by a 4-wk posttreatment period . Adequate relief of IBS pain and discomfort during week 5–12 of the treatment phase was the primary endpoint ; secondary endpoints included bowel urgency , stool frequency , and consistency , incomplete evacuation , bloating , and abdominal pain or discomfort . RESULTS : Subjects ranked urgency and abdominal pain as their most bothersome IBS symptoms .
Output:
| Placebo response rates across RCTs of pharmacological therapies in IBS were high . |
MS211778 | ***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 efficacy of proteasome inhibition for myeloma is limited by therapeutic resistance , which may be mediated by activation of the autophagy pathway as an alternative mechanism of protein degradation . Pre clinical studies demonstrate that autophagy inhibition with hydroxychloroquine augments the antimyeloma efficacy of the proteasome inhibitor bortezomib . We conducted a phase I trial combining bortezomib and hydroxychloroquine for relapsed or refractory myeloma . We enrolled 25 patients , including 11 ( 44 % ) refractory to prior bortezomib . No protocol -defined dose-limiting toxicities occurred , and we identified a recommended phase 2 dose of hydroxychloroquine 600 mg twice daily with st and ard doses of bortezomib , at which we observed dose-related gastrointestinal toxicity and cytopenias . Of 22 patients evaluable for response , 3 ( 14 % ) had very good partial responses , 3 ( 14 % ) had minor responses , and 10 ( 45 % ) had a period of stable disease . Electron micrographs of bone marrow plasma cells collected at baseline , after a hydroxychloroquine run-in , and after combined therapy showed therapy-associated increases in autophagic vacuoles , consistent with the combined effects of increased trafficking of misfolded proteins to autophagic vacuoles and inhibition of their degradative capacity . Combined targeting of proteasomal and autophagic protein degradation using bortezomib and hydroxychloroquine is therefore feasible and a potentially useful strategy for improving outcomes in myeloma therapy Pre clinical studies indicate autophagy inhibition with hydroxychloroquine ( HCQ ) can augment the efficacy of DNA-damaging therapy . The primary objective of this trial was to determine the maximum tolerated dose ( MTD ) and efficacy of HCQ in combination with radiation therapy ( RT ) and temozolomide ( TMZ ) for newly diagnosed glioblastoma ( GB ) . A 3 + 3 phase I trial design followed by a noncomparative phase II study was conducted in GB patients after initial resection . Patients received HCQ ( 200 to 800 mg oral daily ) with RT and concurrent and adjuvant TMZ . Quantitative electron microscopy and immunoblotting were used to assess changes in autophagic vacuoles ( AVs ) in peripheral blood mononuclear cells ( P BMC ) . Population pharmacokinetic ( PK ) modeling enabled PK-pharmacodynamic correlations . Sixteen phase I subjects were evaluable for dose-limiting toxicities . At 800 mg HCQ/d , 3/3 subjects experienced Grade 3 and 4 neutropenia and thrombocytopenia , 1 with sepsis . HCQ 600 mg/d was found to be the MTD in this combination . The phase II cohort ( n = 76 ) had a median survival of 15.6 mos with survival rates at 12 , 18 , and 24 mo of 70 % , 36 % , and 25 % . PK analysis indicated dose-proportional exposure for HCQ . Significant therapy-associated increases in AV and LC3-II were observed in P BMC and correlated with higher HCQ exposure . These data establish that autophagy inhibition is achievable with HCQ , but dose-limiting toxicity prevented escalation to higher doses of HCQ . At HCQ 600 mg/d , autophagy inhibition was not consistently achieved in patients treated with this regimen , and no significant improvement in overall survival was observed . Therefore , a definitive test of the role of autophagy inhibition in the adjuvant setting for glioma patients awaits the development of lower-toxicity compounds that can achieve more consistent inhibition of autophagy than HCQ Blocking autophagy with hydroxychloroquine ( HCQ ) augments cell death associated with alkylating chemotherapy in pre clinical models . This phase I study evaluated the maximum tolerated dose ( MTD ) , safety , preliminary activity , pharmacokinetics , and pharmacodynamics of HCQ in combination with dose-intense temozolomide ( TMZ ) in patients with advanced solid malignancies . Forty patients ( 73 % metastatic melanoma ) were treated with oral HCQ 200 to 1200 mg daily with dose-intense oral TMZ 150 mg/m2 daily for 7/14 d. This combination was well tolerated with no recurrent dose-limiting toxicities observed . An MTD was not reached for HCQ and the recommended phase II dose was HCQ 600 mg twice daily combined with dose-intense TMZ . Common toxicities included grade 2 fatigue ( 55 % ) , anorexia ( 28 % ) , nausea ( 48 % ) , constipation ( 20 % ) , and diarrhea ( 20 % ) . Partial responses and stable disease were observed in 3/22 ( 14 % ) and 6/22 ( 27 % ) patients with metastatic melanoma . In the final dose cohort 2/6 patients with refractory BRAF wild-type melanoma had a near complete response , and prolonged stable disease , respectively . A significant accumulation in autophagic vacuoles ( AV ) in peripheral blood mononuclear cells was observed in response to combined therapy . Population pharmacokinetics ( PK ) modeling , individual PK simulations , and PK-pharmacodynamics ( PD ) analysis identified a threshold HCQ peak concentration that predicts therapy-associated AV accumulation . This study indicates that the combination of high-dose HCQ and dose-intense TMZ is safe and tolerable , and is associated with autophagy modulation in patients . Prolonged stable disease and responses suggest antitumor activity in melanoma patients , warranting further studies of this combination , or combinations of more potent autophagy inhibitors and chemotherapy in melanoma Introduction : This investigator-initiated study explores the safety , maximum tolerated dose , clinical response , and pharmacokinetics of hydroxychloroquine ( HCQ ) with and without erlotinib in patients with advanced non – small-cell lung cancer . Methods : Patients with prior clinical benefit from an epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitor were r and omized to HCQ or HCQ plus erlotinib in a 3 + 3 dose-escalation schema . Results : Twenty-seven patients were treated , eight with HCQ ( arm A ) and 19 with HCQ plus erlotinib ( arm B ) . EGFR mutations were detected in 74 % of the patients and 85 % had received two or more prior therapies . Arm A had no dose-limiting toxicities , but the maximum tolerated dose was not reached as this arm closed early to increase overall study accrual . In arm B , one patient each experienced grade 3 rash , nail changes , skin changes , nausea , dehydration , and neutropenia ; one had grade 4 anemia ; and one developed fatal pneumonitis , all considered unrelated to HCQ . There were no dose-limiting toxicities , therefore the highest tested dose for HCQ with erlotinib 150 mg was 1000 mg daily . One patient had a partial response to erlotinib/HCQ , for an overall response rate of 5 % ( 95 % confidence interval , 1–25 ) . This patient had an EGFR mutation and remained on therapy for 20 months . Administration of HCQ did not alter the pharmacokinetics of erlotinib . Conclusions : HCQ with or without erlotinib was safe and well tolerated . The recommended phase 2 dose of HCQ was 1000 mg when given in combination with erlotinib 150 mg Autophagy enables cells to de grade and recycle cytoplasmic material s both as a housekeeping mechanism and in response to extracellular stress such as nutrient deprivation . Recent studies indicate that autophagy also functions as a protective mechanism in response to several cancer therapy agents , making it a prospect i ve therapeutic target . Few pharmacological inhibitors suitable for testing the therapeutic potential of autophagy inhibition in vivo are known . An automated microscopy assay was used to screen > 3,500 drugs and pharmacological agents and identified one drug , verteporfin , as an inhibitor of autophagosome accumulation . Verteporfin is a benzoporphyrin derivative used in photodynamic therapy , but it inhibits autophagy without light activation . Verteporfin did not inhibit LC3/Atg8 processing or membrane recruitment in response to autophagic stimuli , but it inhibited drug- and starvation-induced autophagic degradation and the sequestration of cytoplasmic material s into autophagosomes . Transient exposure to verteporfin in starvation conditions reduced cell viability whereas cells in nutrient-rich medium were unaffected by drug treatment . Analysis of structural analogs indicated that the activity of verteporfin requires the presence of a substituted cyclohexadiene at ring A of the porphyrin core but that it can tolerate a number of large substituents at rings C and D. The existence of an autophagy inhibitor among FDA -approved drugs should facilitate the investigation of the therapeutic potential of autophagy inhibition in vivo Autophagy is a lysosomal degradation process that may act as a mechanism of survival in a variety of cancers . While pharmacologic inhibition of autophagy with hydroxychloroquine ( HCQ ) is currently being explored in human clinical trials , it has never been evaluated in canine cancers . Non-Hodgkin lymphoma ( NHL ) is one of the most prevalent tumor types in dogs and has similar pathogenesis and response to treatment as human NHL . Clinical trials in canine patients are conducted in the same way as in human patients , thus , to determine a maximum dose of HCQ that can be combined with a st and ard chemotherapy , a Phase I , single arm , dose escalation trial was conducted in dogs with spontaneous NHL presenting as patients to an academic , tertiary-care veterinary teaching hospital . HCQ was administered daily by mouth throughout the trial , beginning 72 h prior to doxorubicin ( DOX ) , which was given intravenously on a 21-d cycle . Peripheral blood mononuclear cells and biopsies were collected before and 3 d after HCQ treatment and assessed for autophagy inhibition and HCQ concentration . A total of 30 patients were enrolled in the trial . HCQ alone was well tolerated with only mild lethargy and gastrointestinal-related adverse events . The overall response rate ( ORR ) for dogs with lymphoma was 93.3 % , with median progression-free interval ( PFI ) of 5 mo . Pharmacokinetic analysis revealed a 100-fold increase in HCQ in tumors compared with plasma . There was a trend that supported therapy-induced increase in LC3-II ( the cleaved and lipi date d form of microtubule-associated protein 1 light chain 3/LC3 , which serves as a maker for autophagosomes ) and SQSTM1/p62 ( sequestosome 1 ) after treatment . The superior ORR and comparable PFI to single-agent DOX provide strong support for further evaluation via r and omized , placebo-controlled trials in canine and human NHL We previously reported that inhibition of autophagy significantly augmented the anticancer activity of the histone deacetylase ( HDAC ) inhibitor vorinostat ( VOR ) through a cathepsin D-mediated mechanism . We thus conducted a first-in-human study to investigate the safety , preliminary efficacy , pharmacokinetics ( PK ) , and pharmacodynamics ( PD ) of the combination of the autophagy inhibitor hydroxychloroquine ( HCQ ) and VOR in patients with advanced solid tumors . Of 27 patients treated in the study , 24 were considered fully evaluable for study assessment s and toxicity . Patients were treated orally with escalating doses of HCQ daily ( QD ) ( d 2 to 21 of a 21-d cycle ) in combination with 400 mg VOR QD ( d one to 21 ) . Treatment-related adverse events ( AE ) included grade 1 to 2 nausea , diarrhea , fatigue , weight loss , anemia , and elevated creatinine . Grade 3 fatigue and /or myelosuppression were observed in a minority of patients . Fatigue and gastrointestinal AE were dose-limiting toxicities . Six-hundred milligrams HCQ and 400 mg VOR was established as the maximum tolerated dose and recommended phase II regimen . One patient with renal cell carcinoma had a confirmed durable partial response and 2 patients with colorectal cancer had prolonged stable disease . The addition of HCQ did not significantly impact the PK profile of VOR . Treatment-related increases in the expression of CDKN1A and CTSD were more pronounced in tumor biopsies than peripheral blood mononuclear cells . Based on the safety and preliminary efficacy of this combination , additional clinical studies are currently being planned to further investigate autophagy inhibition as a new approach to increase the efficacy of HDAC inhibitors
Output:
| Pre clinical trials have shown that HCQ alone and in combination therapy leads to enhancement of tumor shrinkage . |
MS211779 | ***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 determine the prevalence of refractive errors and their distribution according to age and sex in a Brazilian population . METHODS This population -based cross-sectional study involved 7654 Brazilian inhabitants of nine municipalities of Sao Paulo State , Brazil , between March 2004 and July 2005 . Participants aged > 1 year were selected using a r and om , stratified , household cluster sampling technique , excluding individuals with previous refractive or cataract surgery . Myopia was defined as spherical equivalent ( SE ) ≤-0.5D , high myopia as SE ≤-3.0D , hyperopia as SE ≥+0.5D , high hyperopia as SE ≥+3D , astigmatism as ≤-0.5DC and anisometropia as ≥1.0D difference between eyes . Age , sex , complaints and a comprehensive eye examination including cycloplegic refraction test were collected and analysed using descriptive analysis , univariate and multivariate methods . RESULTS The prevalence of astigmatism was 59.7 % , hyperopia 33.8 % and myopia was 25.3 % . Astigmatism had a progressive increase with age . With-the-rule ( WTR ) axes of astigmatism were more frequently observed in the young participants and the against-the-rule ( ATR ) axes were more frequent in the older subjects . The onset of myopia occurred more frequently between the 2nd and 3rd decades of life . Anisometropia showed a prevalence of 13.2 % ( 95 % CI 12.4 - 13.9 ; p < 0.001 ) . There was an association between age and all types of refractive error and hyperopia was also associated with sex . Hyperopia was associated with WTR axes ( odds ratio 0.73 ; 95 % CI : 0.6 - 0.8 ; p < 0.001 ) and myopia with ATR axes ( odds ratio 0.66 ; 95 % CI : 0.6 - 0.8 ; p < 0.001 ) . CONCLUSIONS Astigmatism was the most prevalent refractive error in a Brazilian population . There was a strong relationship between age and all refractive errors and between hyperopia and sex . WTR astigmatism was more frequently associated with hyperopia and ATR astigmatism with myopia . The vast majority of participants had low- grade refractive error , which favours planning aim ed at correction of refractive error in the population PURPOSE To describe the prevalence of hyperopia and associated factors in a representative sample of Australian schoolchildren 6 and 12 years old . DESIGN Population -based cross-sectional study . PARTICIPANTS Schoolchildren ages 6 ( n = 1765 ) and 12 ( n = 2353 ) from 55 r and omly selected schools across Sydney . METHODS Detailed eye examinations included cycloplegic autorefraction , ocular biometry , cover testing , and dilated fundus examination . Information on birth and medical history were obtained from a parent question naire . MAIN OUTCOME MEASURES Moderate hyperopia defined as spherical equivalent ( SE ) refraction of > or = + 2.00 diopters ( D ) , and eye conditions including amblyopia , strabismus , astigmatism , and anisometropia . RESULTS Prevalences of moderate hyperopia among children ages 6 and 12 were 13.2 % and 5.0 % , respectively ; it was more frequent in children of Caucasian ethnicity ( 15.7 % and 6.8 % , respectively ) than in children of other ethnic groups . Compared with children without significant ametropia ( -0.49 < or = SE refraction < or = + 1.99 D ) , the prevalence of eye conditions including amblyopia , strabismus , abnormal convergence , and reduced stereoacuity was significantly greater in children with moderate hyperopia ( all Ps < 0.01 ) . Maternal smoking was significantly associated with moderate hyperopia among 6-year-olds ( P = 0.03 ) , but this association was borderline among 12-year-olds ( P = 0.055 ) . Early gestational age ( < 37 weeks ) and low birth weight ( < 2500 g ) were not statistically significant predictors of moderate hyperopia in childhood . CONCLUSIONS Moderate hyperopia was strongly associated with many common eye conditions , particularly amblyopia and strabismus , in older children . Birth parameters did not predict moderate hyperopia PURPOSE To determine the prevalence of refractive error types in Singaporean Chinese children aged 6 to 72 months . METHODS The Strabismus , Amblyopia and Refractive Error in Singaporean Children ( STARS ) is a population -based study in southwest Singapore . Door-to-door recruitment of participants was used , with disproportionate r and om sampling in 6-month increments . Parental question naires were administered . Participant eye examinations included logMAR visual acuity , cycloplegic autorefraction , and ocular biometry . Overall and age-specific prevalences of myopia ( spherical equivalence [ SE ] < or= -0.50 D ) , high myopia ( SE < or= -6.00 D ) , hyperopia ( SE > or= + 3.00 D ) , astigmatism ( cylinder > or= + 1.50 D ) , and anisometropia ( SE difference between each eye > or=2.00 D ) were calculated . RESULTS A total of 3009 children were examined ( participation rate , 72.3 % ) . Right eye ( OD ) cycloplegia data were available for 1375 boys and 1264 girls ( mean age , 41 months ) . Mean OD SE was + 0.69 D ( SD 1.15 ) . Overall myopia prevalence was 11.0 % with no variance between the sexes ( P = 0.91 ) . The prevalence of high myopia ( at least -6.00 D ) was 0.2 % . The prevalences of hyperopia , astigmatism , and anisometropia were 1.4 % , 8.6 % , and 0.6 % , respectively . Most astigmatism ( > 95 % ) was with-the-rule ( cylinder axes between 1 degrees and 15 degrees or 165 degrees and 180 degrees ) . Myopia was present in 15.8 % , 14.9 % , 20.2 % , 8.6 % , 7.6 % , and 6.4 % of children aged 6 to 11 , 12 to 23 , 24 to 35 , 36 to 47 , 48 to 59 , and 60 to 72 months , respectively . Prevalence increased with age for astigmatism ( P < 0.001 ) , but not for hyperopia or anisometropia ( P = 0.55 and P = 0.37 ) , respectively . CONCLUSIONS The prevalences of myopia and astigmatism in young Singaporean Chinese children are high , but that of hyperopia is low . Age effects were observed for each refractive error category , but differences between the sexes were not significant . Age-related variation in myopia prevalence may be influenced by ocular development , environment , and /or testability Background Due to its high prevalence and associated sight-threatening pathologies , myopia has emerged as a major health issue in East Asia . The purpose was to test the impact on myopia development of a school-based intervention program aim ed at increasing the time student spent outdoors . Methods A total of 3051 students of two primary ( grade s 1 - 5 , aged 6 - 11 ) and two junior high schools ( grade s 7 - 8 , aged 12 - 14 ) in both urban and rural Northeast China were enrolled . The intervention group ( n = 1735 ) unlike the control group ( n = 1316 ) was allowed two additional 20-min recess programs outside the classroom . A detailed question naire was administered to parents and children . Uncorrected visual acuity ( UCVA ) was measured using an E St and ard Logarithm Vision Acuity Chart ( GB11533 - 2011 ) at baseline , 6-month and 1-year intervals . A r and om sub sample ( n = 391 ) participated in the clinic visits and underwent cycloplegia at the beginning and after 1 year . Results The mean UCVA for the entire intervention group was significantly better than the entire control group after 1 year ( P < 0.001 ) . In the subgroup study , new onset of myopia and changes in refractive error towards myopia were direction during the study period was significantly lower in the intervention group than in the control group ( 3.70 % vs. 8.50 % , P = 0.048 ; -0.10 ± 0.65 D/year vs. -0.27 ± 0.52 D/year , P = 0.005 ) . Changes in axial length and IOP were also significantly lower following the intervention group ( 0.16 ± 0.30 mm/year vs. 0.21 ± 0.21 mm/year , P = 0.034 ; -0.05 ± 2.78 mmHg/year vs. 0.67 ± 2.21 mmHg/year , P = 0.006 ) . Conclusions Increasing outdoor activities prevented myopia onset and development , as well as axial growth and elevated IOP in children . Trial registration Current controlled trials NCT02271373 Purpose : To determine the prevalence of amblyopia and refractive errors among 7 to 12-year-old primary school children in Tehran , Iran . Methods : This population -based cross-sectional study included 2,410 r and omly selected students . Visual acuity was tested using an E-chart on Yang vision tester . Refractive errors were measured by photorefractometry and cycloautorefraction . Strabismus was checked using cover test . Direct ophthalmoscopy was used to assess the anterior segment , lens opacities , red reflex and fundus . Functional amblyopia was defined as best corrected visual acuity ≤20/40 in one or both eyes with no anatomical problems . Results : Amblyopia was present in 2.3 % ( 95 % CI : 1.8 % to 2.9 % ) of participants with no difference between the genders . Amblyopic subjects were significantly younger than non-amblyopic children ( P=0.004 ) . Overall , 15.9 % of hyperopic and 5.9 % of myopic cases had amblyopia . The prevalence of hyperopia ≥+2.00D , myopia ≤-0.50D , astigmatism ≥0.75D , and anisometropia ( ≥1.00D ) was 3.5 % , 4.9 % , 22.6 % , and 3.9 % , respectively . With increasing age , the prevalence of myopia increased ( P<0.001 ) , that of hyperopia decreased ( P=0.007 ) , but astigmatism showed no change . Strabismus was found in 2.3 % of cases . Strabismus ( OR=17.9 ) and refractive errors , especially anisometropia ( OR=12.87 ) and hyperopia ( OR=11.87 ) , were important amblyogenic risk factors . Conclusion : The high prevalence of amblyopia in our subjects in comparison to developed countries reveals the necessity of timely and sensitive screening methods . Due to the high prevalence of amblyopia among children with refractive errors , particularly high hyperopia and anisometropia , provision of glasses should be specifically attended by parents and supported by the Ministry of Health and insurance organizations INTRODUCTION Refractive error remains one of the primary causes of visual impairment in children worldwide , and the prevalence of refractive error varies widely . The objective of this study was to determine the prevalence of refractive error and study the possible associated factors inducing refractive error among primary school children of Malay ethnicity in the suburban area of Kota Bharu , Kelantan , Malaysia . MATERIAL S AND METHODS A school-based cross-sectional study was performed from January to July 2006 by r and om selection on St and ard 1 to St and ard 6 students of 10 primary schools in the Kota Bharu district . Visual acuity assessment was measured using logMAR ETDRS chart . Positive predictive value of uncorrected visual acuity equal or worse than 20/40 , was used as a cut-off point for further evaluation by automated refraction and retinoscopic refraction . RESULTS A total of 840 students were enumerated but only 705 were examined . The prevalence of uncorrected visual impairment was seen in 54 ( 7.7 % ) children . The main cause of the uncorrected visual impairment was refractive error which contributed to 90.7 % of the total , and with 7.0 % prevalence for the studied population . Myopia is the most common type of refractive error among children aged 6 to 12 years with prevalence of 5.4 % , followed by hyperopia at 1.0 % and astigmatism at 0.6 % . A significant positive correlation was noted between myopia development with increasing age ( P < 0.005 ) , more hours spent on reading books ( P < 0.005 ) and background history of siblings with glasses ( P < 0.005 ) and whose parents are of higher educational level ( P < 0.005 ) . Malays in suburban Kelantan ( 5.4 % ) have the lowest prevalence of myop
Output:
| Conclusion This report showed that astigmatism was the most common refractive errors in children and adults followed by hyperopia and myopia .
The highest prevalence of myopia and astigmatism was seen in South-East Asian adults . |
MS211780 | ***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 set out to determine whether screening can be psychologically harmful to healthy adults . A prospect i ve controlled study was carried out on 215 healthy adults attending a by-invitation coronary heart disease screening clinic in general practice . The general health question naire was used as an indicator of recent psychological distress . Patients attending the screening clinic had significantly lower subjective psychological distress than an unscreened group of 225 age-matched controls , indicating that we may well be screening an already psychologically healthy sub-group . The main finding was that patients ' own assessment of their psychological distress was significantly increased three months after screening compared with that of controls , who showed a non-significant decrease . It is concluded that there is a real risk of causing distress by screening healthy adults and that this possibility has largely been ignored by previous studies . Possible explanations and implication s of these findings are discussed , particularly in the light of increased pressure from many quarters for more screening services to be set up in general practice A total of 96 patients with moderate elevations of low-density lipoprotein ( LDL ) cholesterol were r and omly assigned to 4 different double-blind treatment regimens : placebo ; colestipol 5 g and lovastatin 20 mg/day ( C5 + L20 ) ; colestipol 10 g and lovastatin 20 mg/day ( C10 + L20 ) ; and lovastatin 40 mg/day ( L40 ) . During 12 weeks of therapy , C10 + L20 achieved the greatest reduction in total cholesterol ( -32 % ) and LDL cholesterol ( -48 % ) levels from baseline . This combination also exhibited significantly greater reductions in LDL cholesterol levels than the C5 + L20 and L40 groups ( p < 0.01 ) . The differences in total and LDL cholesterol reduction between the C5 + L20 and L40 groups were not significant . Similar changes and differences between treatments were seen in apolipoprotein B levels . Whereas mean total apolipoprotein A-I levels increased with all treatments ( p < 0.05 ) , lipoprotein particles A-I were significantly increased in the C10 + L20 group ( p < 0.01 ) only . Results demonstrate that the combination of low-dose lovastatin ( 20 mg/day ) with low-dose colestipol ( 5 or 10 g/day ) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin ( 40 mg/day ) . In addition , low-dose combinations are > 25 % more cost-effective than high-dose monotherapy The cost of screening for hypercholesterolaemia in a clinical trial was investigated at a primary health care centre . A convenience sample of the population was screened for inclusion in a study of the effectiveness of a lipid lowering programme . Included in the study were adults 30 - 59 years of age with a S-Cholesterol of 6.50 - 7.79 mmol l-1 at r and omization , plus two previous values > or = 6.50 mmol l-1 at screening and selection , with at least two other cardiovascular risk factors . In total 447 persons were screened and 37 were r and omized into the lipid lowering programme . The mean cost per r and omized person was estimated at about SEK 7500 ( Swedish Crowns ) . An analysis of different inclusion criteria for treatment was also carried out . The cost of finding a patient to treat in the clinical trial was estimated to be more than three times as high with a total cholesterol cut-off point of 7.80 mmol l-1 compared with a cut-off point of 5.20 mmol l-1 This cost-benefit analysis attempts to translate the clinical findings of the Helsinki Heart Study ( HHS ) and published results regarding additional cardiovascular conditions into economic terms meaningful to US managed care providers . The study has the following 3 key objectives : to define the cost effectiveness of gemfibrozil in the prevention of coronary heart disease ( CHD ) ; to assess the net impact of gemfibrozil on total treatment costs for CHD ; and to identify those patient groups for whom gemfibrozil therapy is most cost effective . In order to reach these findings a cost-effectiveness model was constructed based on original clinical data provided by the HHS , published findings for CHD risk and cost of treatment in the US , expert opinion and extension of HHS to other cardiovascular conditions , and documented costs and treatment protocol s of US Medicaid and privately managed health care programmes . The model was applied to the California Medicaid ( Medi-Cal ) programme to estimate costs of hyperlipidaemia therapy using gemfibrozil . In parallel , savings to Medi-Cal from averted coronary events were estimated . From these data , the net expected savings to Medi-Cal were calculated . The probability of experiencing CHD varies with cholesterol level , age , sex and risk factors such as smoking , hypertension and diabetes . Therefore , it is possible to use risk-factor profiles to define groups of individuals with low , moderate or high risk of experiencing acute myocardial infa rct ion ( AMI ) or sudden cardiac death . The probability of a cardiac event within 5 years ranges from 1.1 % in a 45-year-old low risk male to over 36 % in a 55-year-old high risk male . The average total cost of CHD care was found to be US$ 22,271 within 5 years . Using the probability of a CHD event to calculate the expected 5-year cost of CHD care produces a range from US$ 242 in the 45-year-old low risk male to US$ 8084 in the 55-year-old high risk male . Treatment with gemfibrozil reduces the probability of AMI and sudden cardiac death events by 34 % , as demonstrated in the HHS . Therefore , the corresponding probability ranges are reduced to 0.7 % in the 45-year-old low risk male and 27.3 % in the 55-year-old high risk male after treatment with gemfibrozil . The expected cost of a coronary event is reduced by US$ 82 and US$ 1997 , respectively . ( ABSTRACT TRUNCATED AT 400 WORDS Over the past decade the efficacy and cost of medical interventions have been subject to increasing scrutiny with quantitative techniques , such as the r and omized controlled trial and cost-effectiveness analysis . Such studies provide invaluable guidance for the clinician choosing from a limited range of options in caring for an individual patient . However , in the field of health policy myriad competing programs , services , institutions , and interests must be weighed . Unfortunately , quantitative methods are virtually always used to compare two , or at most a few , alternative strategies . Since the relative cost effectiveness of an intervention may appear radically different depending on the alternative . . Twenty-four factories or other occupational groups , employing 18 210 men aged 40 to 59 , were formed into matched pairs . One of each pair was allocated r and omly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors . Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations , stopping or reducing cigarette smoking , regular exercies for the sedentary and reduced energy intake for the overweight , and hypertension was treated . The programme was delivered mainly through existing occupational medical services , helped by a small central staff . Personal consultations were largely confined to men with a high risk of developing coronary heart disease . Changes in risk factors were assessed by regular st and ardised examinations of r and om sample s of men . The spread of information by general propag and a proved easy , but a change in habits seemed to require personal contact . Small but significant reductions occurred , mainly in the high-risk group , but these were not sustained when pressure was relaxed STUDY OBJECTIVE : To evaluate the cost effectiveness and equity of a community based cardiovascular disease prevention programme . DESIGN : A prospect i ve cross sectional design . SETTING : A community based intervention to reduce cardiovascular disease in the district of Norsjö ( n = 5500 ) , Sweden . The intervention was aim ed at both the general population and at individuals thought to be at special risk , the emphasis being on changing dietary habits and reducing cholesterol concentrations . PARTICIPANTS : The participants were men and women aged 30 - 60 years . MAIN RESULTS : The mean serum cholesterol concentration in the Norsjö population was reduced by nearly 20 % during the first six years of intervention . It was estimated that the programme 's overall total societal costs were 363,000 pounds and estimates of the cost per year of life saved ranged from 14,900 pounds to net savings , according to different assumptions . Taking only health care costs and savings into account , the cost per year of life saved ranged from 1100 pounds to 4050 pounds . The results varied between different sex and age groups , but not between social classes . Even if a causal relationship exists between low cholesterol concentrations and excess mortality , the estimated side effects of lowering cholesterol values in Norsjö were negligible in comparison with the expected benefits . CONCLUSIONS : The community based intervention in Norsjö seems to be cost effective even under conservative assumptions . The approach used seems to have benefited all social classes . Cost effectiveness analyses that take consequences for equity into account are valuable tools in decision making BACKGROUND Advances in the treatment of cardiovascular disease have increased costs ; annual cardiovascular healthcare expenditure in the United States currently exceeds $ 100 billion . Physicians and third-party payers need to assess the economic impact of treatments that reduce cardiovascular morbidity and mortality . METHODS AND RESULTS The Sc and inavian Simvastatin Survival Study is a r and omized , double-blind , placebo-controlled trial in which simvastatin reduced the risk of death by 30 % ( P=.0003 ) over the median follow-up period of 5.4 years in patients with previous myocardial infa rct ion or stable angina pectoris as a result of a 42 % reduction in the risk of coronary deaths ( P=.00001 ) . In the present report , data prospect ively collected from hospital admissions were analyzed to evaluate the impact of simvastatin on healthcare re source use and perform a cost-minimization analysis . In the placebo group ( n=2223 ) , there were 1905 hospitalizations ( average duration , 7.9 days ) for acute cardiovascular events or coronary revascularization procedures among 937 patients , whereas in the simvastatin group ( n=2221 ) , there were 1403 such hospitalizations ( average duration , 7.1 days ) among 720 patients ( all differences , P<.0001 ) . The corresponding number of hospital days was 15089 and 9951 in the two groups , respectively ( 34 % reduction , P<.0001 ) . In the United States , the result ing reduction in hospitalization costs over the 5.4 years of the trial would be $ 3872 per patient , reducing the effective cost of simvastatin by 88 % to $ 0.28 per day . CONCLUSIONS In addition to reducing mortality and morbidity in coronary heart disease patients , simvastatin markedly reduces use of hospital services , thus off setting most of its cost Abstract Objective : To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme . Design : Cost effectiveness analysis of a r and omised controlled trial using clinical and economc data taken from the trial . Setting : Five general practice s in Luton and Dunstable , Engl and . Subjects : 2205 patients who attended a health check in 1989 - 90 and were scheduled for re-examination in 1992 - 3 ( intervention group ) ; 1916 patients who attended their initial health check in 1992 - 3 ( control group ) . Participants were men and women aged 35 - 64years . Intervention : Health check conducted by nurse , with health education and follow up according to degree of risk . Main outcome measures : Cost of health check programme ; cost per 1 % reduction in coronary risk . Results : Health check and follow up cost £ 29.27 per patient . Estimated programme cost per 1 % reduction in coronary risk per participant was between £ 1.46 and £ 2.25 ; it was nearly twice as much for men as women . Conclusions : The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , a proportion of which could be paid for through staff pay reimbursements and B and Three health promotion target payments . This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme . Economic evaluations should be integrated into the protocol s of r and omised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies . Key messages Research was undertaken to estimate the cost of the health checks and relate the cost to changes in the relative risk of cardiovascular disease The immediate cost of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , which is comparable with the immediate cost of a cervical screening programme The actual costs to the practice would be substantially reduced by staff pay reimbursements and health promotion target payments Further research is required to estimate the wider costs of health checks result ing from the additional use of health care BACKGROUND The National Cholesterol Education Program recommends achievement of a defined target level of low-density lipoprotein cholesterol ( LDL-C ) for the treatment of hypercholesterolemia . They endorse the use of niacin and /or sequestrants as the first line of therapy to achieve such target LDL-C level . This recommendation has not been compared with the use of lovastatin as initial therapy if multidrug regimens are required to achieve goal LDL-C. METHODS Pro
Output:
| CONCLUSIONS : There is lack of data on cost effectiveness of cholesterol lowering interventions in the general practice setting .
The cost effectiveness of cholesterol lowering in general practice deteriorates when all relevant costs are taken into account and when efficacy is corrected for community effectiveness .
Cholesterol lowering intervention is more cost effective in men compared with women and in patients with coronary heart disease compared with persons without coronary heart disease . |
MS211781 | ***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 , r and omized , single‐dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 × 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P < 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo One hundred sixty-one patients with postoperative pain were treated at a single center in a double-blind , r and omized , parallel study design ed to compare the efficacy and safety of single oral doses of ketoprofen ( 50 and 150 mg ) , an acetaminophen ( 650 mg ) plus codeine ( 60 mg ) combination , and placebo . From 1 through 4 hours after administration of the study drugs , the mean summed pain intensity difference ( SPID ) and time-weighted total pain relief ( TOPAR ) scores for the three active treatments generally were significantly ( P less than 0.05 ) higher than those for placebo but not significantly different from each other . At the 6-hour evaluation , the ketoprofen groups , but not the acetaminophen-codeine group , had higher ( P less than 0.05 ) mean SPID and TOPAR scores than the placebo group , as a result of a shorter duration of pain relief in the acetaminophen-codeine group . The 6-hour TOPAR scores were significantly ( P less than 0.05 ) higher for both ketoprofen groups than for the acetaminophen-codeine group ; the ketoprofen 150 mg group also had significantly ( P less than 0.05 ) higher mean 6-hour SPID and global subjective assessment scores . As a result of a higher frequency of somnolence , there was a significantly ( P less than 0.05 ) greater incidence of central nervous system adverse drug reactions among patients treated with acetaminophen plus codeine than among those treated with 150 mg of ketoprofen . These results indicate that the analgesic efficacy of both 50 and 150 mg doses of ketoprofen equals that of acetaminophen 650 mg plus codeine 60 mg and the duration of the analgesic effect of ketoprofen is significantly longer & NA ; The objective was to investigate the relationship between pain relief scores produced by placebo and by active interventions in r and omised controlled trials ( RCTs ) . Individual patient categorical pain relief scores from 5 placebo‐controlled single‐dose parallel‐group RCTs in acute postoperative pain were used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) for the different treatments . One hundred and thirty of the 525 patients in the 5 trials had a placebo . Individual patients ' scores with placebo varied from 0 to 100 % of the maximum possible pain relief . The proportion who obtained more than 50 % of the maximum possible pain relief with placebo varied from 7 % to 37 % across the trials ; with the active drugs the variation was from 5 to 63 % . Mean placebo scores were related to the mean score for the active treatments in each study ; the higher the mean active score , the higher the mean placebo score . This relationship disappeared when median values were used . Medical folklore has it that the amount of relief obtained with placebo is one‐third of the maximum possible ( and does not vary ) , and that one‐third of patients respond to placebo . The results show that the amount of relief obtained with placebo varies considerably between patients , that 38 % of patients obtained more than 10 % of the maximum possible relief , and 16 % obtained greater than 50 % . In double‐blind , r and omised parallel‐group studies of high quality placebo scores should not vary . Despite these conditions being met the placebo scores did vary . The previous explanation , of a relationship between the mean placebo scores and the mean scores for the active treatments was not supported The analgesic efficacy of single 500 and 1,000 mg doses of diflunisal , a new nonsteroidal antiinflammatory analgesic , was compared in a double-blind study with acetaminophen 600 mg , the combination of acetaminophen 600 mg with codeine 60 mg , and placebo in 132 in patients with postoperative pain . Using a self-rating record , patients rated their pain and its relief hourly for up to 12 hours after medication . Diflunisal 500 and 1,000 mg were significantly superior to placebo for every measure of total and peak analgesia , and a significant analgesic effect persisted for 8 hours . Acetaminophen alone and the acetaminophen-codeine combination were significantly superior to placebo for most measures of analgesia , and their effects were significant for 4 and 5 hours respectively . Differences among the active medications were not statistically significant for measures of total or peak analgesia Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form Two-hundred six out patients with postoperative pain after the surgical removal of impacted third molars were r and omly assigned on a double-blind basis to receive oral doses of ketorolac tromethamine 10 and 20 mg , ibuprofen 400 mg , acetaminophen 600 mg , a combination of acetaminophen 600 mg plus codeine 60 mg , or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 6 hours after medicating . All active medications were significantly superior to placebo . Analgesia was similar for ketorolac 10 and 20 mg and ibuprofen 400 mg ; however , these treatments were superior to acetaminophen alone and the acetaminophen-codeine combination . The analgesic effect of each active medication was significant by hour 1 and persisted for 5 - 6 hours . The data suggest a plateau in ketorolac 's analgesic efficacy at the 10-mg level . Repeat-dose data indicated that on the day of surgery ketorolac 10 and 20 mg and ibuprofen 400 mg were superior to acetaminophen 600 mg ; ketorolac 20 mg was also superior to acetaminophen-codeine . Differences among active medications were not significant when data for the entire postoperative period ( days 0 - 6 ) were evaluated . The frequency of adverse effects was similar for the active medications A double-blind , r and omized , single-dose study was performed to compare the efficacy and safety of two commonly prescribed combination analgesic products to placebo . The combinations were acetaminophen 300 mg/codeine 30 mg(† ) , and aspirin 325 mg/butalbital 50 mg/caffeine 40 mg/codeine 30 mg(†† ) . One hundred twenty-three ( 123 ) oral surgery out patients took study medications when their pain became moderate to severe and recorded the levels of pain intensity , pain relief , anxiety and relaxation at 30 minutes and hourly for 6 hours after dosing . Remedication was permitted if study medications did not provide adequate pain relief . Time to remedication , and the number of observations with 50 % or better relief , were noted as were any side effects . An overall evaluation was obtained from each patient . Results of the study showed that the aspirin/butalbital/caffeine/codeine combination was significantly more effective than placebo for total pain relief , peak relief and global evaluation . While the acetaminophen/codeine combination was numerically superior to placebo , it achieved statistical significance only for global evaluation . The aspirin/butalbital/caffeine/codeine combination was numerically superior to acetaminophen/codeine for every measure of analgesic efficacy but the differences did not achieve statistical significance . Both active treatment groups experienced significantly less total anxiety than did the placebo group . Only 11 patients reported mild , transient adverse effects ; the most common was drowsiness . The adverse effects occurred equally among the three treatment groups . In this study , the aspirin/butalbital/caffeine/codeine combination was significantly superior to placebo and somewhat better than acetaminophen/codeine & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data The analgesic efficacy of single 500- and 1,000-mg doses of diflunisal ( Dolobid ) , a new nonsteroidal anti-inflammatory analgesic , was compared in a double-blind study with that of acetaminophen , 600 mg , the combination of acetaminophen , 600 mg , with codeine phosphate , 60 mg , and placebo in 159 oral surgery out patients . Using a self-rating record , patients rated their pain and its relief hourly for 12 hours after medication . Both doses of diflunisal were significantly more effective than acetaminophen alone and produced peak analgesia comparable to that of the acetaminophen-codeine combination . Diflunisal proved to have an unusually long duration of analgesic action . Acetaminophen and the combination were significantly superior to placebo through hours 2 and 5 , respectively ; both doses of diflunisal were significantly superior through the end of the 12-hour observation period . None of the active treatments produced more side effects than the placebo The analgesic efficacy and duration of action of naproxen sodium 440 mg ( n = 92 ) , acetaminophen 1000 mg ( n = 89 ) , and placebo ( n = 45 ) were compared in a single-dose , r and omized , double-blind , 12-hour study of patients with at least moderate pain secondary to extraction of three or four third molars . Time to remedication , a measure of duration of analgesic effect , was significantly longer ( P < 0.001 ) with naproxen sodium ( median , 9.9 hours ) than with either acetaminophen ( median , 3.1 hours ) or placebo ( median , 2.0 hours ) . Naproxen sodium was also superior to acetaminophen for peak pain intensity difference ( visual analog scale ) , summed pain intensity differences , total pain relief , peak pain relief , time to reduction
Output:
| The results confirm that paracetamol is an effective analgesic , and that codeine 60 mg added to paracetamol produces worthwhile additional pain relief even in single oral doses |
MS211782 | ***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 This study examined effectiveness of a theoretically based education programme in reducing inappropriate antipyretic use in fever management . BACKGROUND Paediatric nurses ' inconsistent , ritualistic antipyretic use in fever management is influenced by many factors including inconsistent beliefs and parental requests . Determinants of antipyretic administration , identified by the theory of planned behaviour , were belief-based attitudes and subjective norms . DESIGN A quasi-experiment explored group effects of a peer education programme , based on the theory of planned behaviour , on factors influencing paediatric nurses ' antipyretic administration . Surveys and chart audits collected data from medical wards at experimental and control hospitals one month pre and one and four months postpeer education programme . METHODS All nurses employed in targeted wards were eligible to participate in surveys and all eligible charts were audited . The peer education programme consisted of four one-hour sessions targeting evidence -based knowledge , myths and misconceptions , normative , attitudinal and control influences over and rehearsal of evidence -based fever management . All nurses in experimental hospital targeted wards were eligible to attend . Peer education and support facilitated session information reaching those unable to attend sessions . RESULTS Two-way univariate anovas explored between subject , experimental and control group and within subject factors , pre , post and latency data . Significant interactions in normative influence ( p = 0.01 ) and intentions ( p = 0.01 ) , a significant main group effect in control influence ( p = 0.01 ) and a significant main effect between audit data across time points ( p = 0.03 ) highlight peer education programme effectiveness in behaviour change . Normative , control and intention changes postpeer education programme were maintained in latency data ; mean temperature was not . CONCLUSION The peer education programme , based on a behaviour change theory , initiated and maintained evidence -based intentions for antipyretics use in fever management . RELEVANCE TO CLINICAL PRACTICE The promotion of evidence -based change in organizational unit intentions and behaviour highlights the crucial role peer support and education can play in continuing educational programmes OBJECTIVE To compare the effectiveness of tepid sponging and antipyretic drug versus only antipyretic drug among febrile children . DESIGN R and omized controlled trial . SETTING Tertiary care hospital . PARTICIPANTS 150 children 6 mo - 12 yr age with axillary temperature 101F . INTERVENTION Tepid sponging and antipyretic drug ( Paracetamol ) ( n=73 ) or only antipyretic drug ( Paracetamol ) ( n=77 ) . MAIN OUTCOME MEASURES Reduction of body temperature and level of comfort . RESULTS The reduction of body temperature in the tepid sponging and antipyretic drug group was significantly faster than only antipyretic group ; however , by the end of 2 hours both groups had reached the same degree of temperature . The children in tepid sponging and antipyretic drug had significantly higher discomfort than only antipyretic group , but the discomfort was mostly mild . CONCLUSION Apart from the initial rapid temperature reduction , addition of tepid sponging to antipyretic administration does not offer any advantage in ultimate reduction of temperature ; moreover it may result in additional discomfort A controlled clinical study compared the antipyretic effectiveness of acetaminophen administered at regular 4 h intervals ( group 1,n=53 ) versus sproadic usage contingent upon a body temperature above 37.9 ° C ( group 2,n=51 ) in 104 children presenting with simple febrile convulsions . The incidence of febrile episodes or temperature values were similar in spite of significantly larger amounts of acetaminophen administered to patients in group 1 . Four and 4 children in groups 1 and 2 , respectively , had a second episode of febrile seizures , in all of them within the first 24 h of admission . We conclude that the prophylactic administration of acetaminophen in children with febrile seizures is not effective in the prevention of fever , the reduction of its degree , or in preventing the early recurrence of febrile seizures A controlled clinical study compared the effectiveness of sponging with tepid water , ice water , and equal parts of 70 per cent isopropyl alcohol and water in addition to orally administered acetaminophen to reduce fever in children . More rapid reduction of fever was demonstrated when sponging was combined with the oral antipyretic drug . Sponging with ice water or with alcohol in water were equally effective and significantly superior to sponging with tepid water ; however , sponging with tepid water afforded significantly better comfort during the sponging procedure OBJECTIVES --To compare the acceptability and effects on temperature of advice to unwrap children and give paracetamol or warm sponging treatments in the management of feverish illness at home . DESIGN --A r and omised , open , parallel group study using factorial design comparison of unwrapping , warm sponging plus unwrapping , paracetamol plus unwrapping , and paracetamol and warm sponging plus unwrapping . SETTING --Homes of willing families with a feverish child recruited after consulting one of 21 participating general practitioners in Southampton . SUBJECTS--52 children aged from 3 months to 5 years with axillary temperatures before treatment of > or = 37.8 degrees C and < 40 degrees C. MAIN OUTCOME MEASURES --Response to advice assessed over four hours ; temperature assessed by continuous data logging from an axillary thermistor ; acceptability of treatment to child and parent scored on Likert scales immediately after treatment and on return to health . RESULTS --Response to treatment advice varied ; unwrapping alone had little effect on temperature . Paracetamol increased the time below 37.2 degrees C in four hours by 109 ( 95 % confidence interval 74 to 145 ) minutes compared with unwrapping ; warm sponging caused the fastest reduction in temperature . Parents discriminated between treatments , preferring paracetamol . CONCLUSION --Advice to give paracetamol is more effective than sponging or unwrapping in controlling temperature in children at home and is more acceptable to parents . Warm sponging has an additive effect and reduces fever more quickly than paracetamol BACKGROUND Routine antipyretic therapy in children with infectious diseases has long been the source of controversy . Each year , in addition to antimalarial medication , millions of children with Plasmodium falciparum malaria receive paracetamol to reduce fever . However , the usefulness of this practice has not been proven . METHODS In a r and omised trial in Lambaréné , Gabon , 50 children with P falciparum malaria were treated with intravenous quinine , and received either mechanical antipyresis alone , or in combination with paracetamol . Rectal body temperature and parasitaemia were recorded every 6 h for 4 days . Plasma concentrations and inducible concentrations of tumour necrosis factor ( TNF ) and interleukin-6 were measured every 24 h. In addition , production of oxygen radicals was measured in both groups . FINDINGS The mean fever clearance time was 32 h for children treated with paracetamol and 43 h for those who received mechanical antipyresis alone ; however , this 11 h difference was not significant ( 95 % CI -2 to 24 h ; p = 0.176 ) . Parasite clearance time was significantly prolonged in patients who received paracetamol with a difference of 16 h ( 8 - 24 h ; p = 0.004 ) . Plasma concentrations of TNF and interleukin-6 were similar in both groups during the study . However , the induced concentrations of TNF , and the production of oxygen radicals , were significantly lower in children treated with paracetamol than those who received mechanical antipyresis alone . INTERPRETATION These data suggest that paracetamol has no antipyretic benefits over mechanical antipyresis alone in P falciparum malaria . Moreover , paracetamol prolongs parasite clearance time , possibly by decreased production of TNF and oxygen radicals CONTEXT AND OBJECTIVE The role of tepid sponging to promote fever control in children is controversial . We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone . The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever . DESIGN AND SETTING A r and omized clinical trial was undertaken at Instituto Materno-Infantil Professor Fern and o Figueira , Recife , Pernambuco . METHODS Children from six months to five years old with axillary temperature greater than 38 masculineC in the emergency ward between January and July 2006 were eligible . One hundred and twenty children were r and omly assigned to receive oral dipyrone ( 20 mg/kg ) or oral dipyrone and tepid sponging for 15 minutes . The primary outcome was mean temperature reduction after 15 , 30 , 60 , 90 and 120 minutes . Secondary outcomes were crying and irritability . RESULTS 106 children finished the study . After the first 15 minutes , the fall in axillary temperature was significantly greater in the sponged group than in the control group ( p < 0.001 ) . From 30 to 120 minutes , better fever control was observed in the control group . Crying and irritability were observed respectively in 52 % and 36 % of the sponged children and in none and only two of the controls . CONCLUSIONS Tepid sponging plus dipyrone cooled faster during the first 15 minutes , but dipyrone alone presented better fever control over the two-hour period . Tepid sponging caused mild discomfort , crying and irritability for most of the children . CLINICAL TRIAL REGISTRATION NUMBER ACTRN12608000083392 Tepid sponge baths distress febrile children , and their efficacy at reducing fever has not been established . This study compared fever reduction and with ( 1 ) acetaminophen alone and ( 2 ) acetaminophen plus a 15-minute tepid sponge bath . Twenty children , ages 5 to 68 months , who presented to the emergency department or urgent care center with fever of > or = 38.9 degrees C were r and omized to receive ( 1 ) acetaminophen alone or ( 2 ) acetaminophen plus a 15-minute tepid sponge bath . All subjects received a 15-mg/kg dose of acetaminophen . Tympanic temperature was monitored every 30 minutes for 2 hours . Subjects were monitored for signs of discomfort ( crying , shivering , goosebumps ) . Sponge-bathed subjects cooled faster during the first hour but there was no significant temperature difference between the groups over the 2-hour study period ( P = .871 ) . Subjects in the sponge bath group had significantly higher discomfort scores ( P = .009 ) Two hundred and twenty-four children aged 6 months to 5 years , with rectal temperatures greater than or equal to 30 degrees ( 104 degrees F ) , were r and omly treated with sponging alone or with medication including a single oral dose of aspirin 15 mg/kg , or paracetamol 15 mg/kg , or ibuprofen 8 mg/kg . Twenty-three children were excluded from the final analysis because they did not complete the study . Demographic characteristics of the patients were found to be comparable in all groups . Rectal temperatures were recorded every 30 min for a 3 h period . During the first 30 min of intervention , sponging was found to be more effective than all of the three medications . After 60 min , the effects of each medication became superior to sponging with tepid water in reducing body temperature . Twenty-three children were excluded from the final analysis because they did not complete the study . Comparing the effect of the three different medications , it was seen that the antipyretic efficacy of aspirin and ibuprofen were significantly more than paracetamol 3 h after intervention ( P < 0.05 ) . For the management of fever over 39 degrees C , it is therefore recommended to give children an antipyretic drug , preferably ibuprofen , and at the same time to begin sponging to provide a rapid and sustained Several commonly used antipyretic therapies were compared in a series of 67 children . All regimens were more effective than exposure alone . Paracetamol and aspirin were comparable in antipyretic effect and superior to tepid sponging alone . The addition of tepid sponging to paracetamol therapy did not further improve the antipyretic response A block r and omized clinical trial to compare the efficacy of tepid sponging with the use of paracetamol in febrile children was undertaken at the Queen Elizabeth Central Hospital , Blantyre . Eighty children aged between 6 and 54 months with axillary temperatures of between > or = 38.5 degrees C and < or = 40 degrees C and a clinical diagnosis consistent with upper respiratory tract infection and /or malaria were block r and omized to receive either oral paracetamol ( 15 mg/kg ) or tepid sponging . Children receiving tepid sponging were sponged from head to toe ( except the scalp ) by leaving a thin layer of water on the body . If the body became dry it was repeated and continued until the axillary temperature fell to < 38.5 degrees C. Axillary temperature and assessment of discomfort ( convulsions , crying , irritability , vomiting and shivering ) were recorded every 30 minutes for 2 hours . A significantly greater and more
Output:
| RESULTS This study review ed mainly the effect of tepid massage on temperature compared with the use of antipyretics , along with other adverse effects in relation with fever management .
The results revealed no significant effect of tepid massage on temperature in febrile children .
In addition , incidence rates of adverse effects including chills , goose pimples , and discomfort were higher in tepid massage groups . |
MS211783 | ***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 and compare the effects of activator and Twin Block ( TB ) appliances on the soft tissue profile . The study included 50 skeletal Class II patients ( 25 girls and 25 boys , mean age : 11.9 + /- 0.16 years ) who were r and omly allocated to one of two functional appliance treatment groups . The control group included 25 untreated skeletal Class II patients ( 13 boys and 12 girls , mean age : 10.11 + /- 0.91 years ) . Data were obtained from st and ardized lateral cephalograms taken at the beginning ( T0 ) and end ( T1 ) of appliance wear . The mean treatment time was 9 months for the activator group and 8 months for the TB group . The observation period of the control group was 8 months . Soft tissue profile changes were evaluated by means of 12 linear and five angular measurements . The groups were compared at T0 and T1 using analysis of variance , and treatment/observation differences ( T1-T0 ) were evaluated with the Kruskal-Wallis test . Treatment changes in both appliance groups differed significantly ( P < or = 0.001 ) from those in the control group , except for Ss-y , Ls-y , Li-E , and A-y measurements in the TB group and Ls-y , Li-E , nasolabial angle , and A-y measurements in the activator group . When the effects of the two appliances were compared , significant differences were observed only for SS-y ( P < or = 0.05 ) , Ss-E ( P < or = 0.05 ) , Si-E ( P < or = 0.05 ) , and nasolabial angle ( P < or = 0.01 ) . The effects of the activator and TB appliances on the soft tissue profile were similar ; both significantly changed the soft tissue profile This study evaluated the effectiveness of early orthodontic treatment with the Twin-block appliance for the developing Class II Division 1 malocclusion . This multicenter trial was carried out in the United Kingdom . A total of 174 children , aged 8 to 10 years old , with Class II Division 1 malocclusion were r and omly allocated to receive treatment with a Twin-block appliance or to an untreated , control group . Data were collected at the start of the study and 15 months later . Results showed that early treatment with Twin-block appliances result ed in reduction of overjet , correction of molar relationships , and reduction in severity of malocclusion . Most of this correction was due to dentoalveolar change , but some was due to favorable skeletal change . Early treatment with the Twin-block appliance is effective in reducing overjet and severity of malocclusion . The small change in the skeletal relationship might not be considered clinical ly significant A prospect i ve clinical study with a r and om allocation of 47 adolescent patients to three different functional appliance groups was established and compared with an untreated control group over a 9-month period . Treatment was undertaken with either a Bionator , Twin Block , or Bass appliance . Pre- and post-treatment cephalograms were used to quantify the skeletal and dentoalveolar changes produced by the appliances and compared with those observed in the control group as a result of growth . Both the Bionator and Twin Block appliances demonstrated a statistically significant increase in m and ibular length ( 3.9 + /- 2.7 mm ; 3.7 + /- 2.1 mm , respectively ) compared with the control group ( P < 0.05 ) , with an anterior movement of pogonion and point B. Highly statistically significant increases ( P < 0.01 ) were seen in lower face heights for all the appliance groups compared with the control group . The Twin Block group showed the least forward movement of point A due to a change in the inclination of the maxillary plane . The Bionator and Twin Block groups showed statistically significant reductions in the inclination of the upper incisors to the maxillary plane ( P < 0.05 ) . The Bass group showed minimal change in the inclination of the lower labial segment to the m and ibular plane . The Bionator group demonstrated the greatest proclination of the lower labial segment ( 4.0 + /- 3.6 degrees ) . Clinical ly important changes were measured in all the appliance groups when compared with the control group . Differences were also identified between the functional appliance groups . The Twin Block appliance and , to a lesser extent , the Bionator appeared the most effective in producing sagittal and vertical changes A prospect i ve clinical study with a r and om allocation of 47 patients to three different functional appliance groups was established and compared with a slightly younger control group over a 9-month period . The cephalometric hard tissue changes were assessed in relation to the soft tissue changes produced and the patients were also assessed by three-dimensional ( 3D ) laser scanning of the facial soft tissues . Each ' averaged ' appliance group scan was compared with the ' averaged ' control group face . Statistically and clinical ly significant changes occurred in the group treated with the Twin Block appliance , and to a lesser extent in the group treated with the Bionator appliance . No statistically significant facial soft tissue changes could be demonstrated in the Bass appliance group . Upper lip position remained stable despite the significant overjet reduction attained in the three appliance groups . Lower lip protrusion ( up to 3.8 mm ) , lower lip length ( up to 4.0 mm ) , and soft tissue lower and total face height increased significantly in all appliance groups by varying amounts . The long-term effect of these changes needs to be fully evaluated . The laser scanning system was found to be a sensitive and accurate method of quantitatively assessing small changes in the soft tissue facial form . Significant changes of the facial tissues in the transverse plane were highlighted by this technique INTRODUCTION The purpose of this study was to evaluate the skeletal and dentoalveolar effects of the Twin-block and bionator appliances in the treatment of Class II Division 1 malocclusions . METHODS Fifty-five girls from North India with Class II Division 1 malocclusion and the same physical growth maturation status were selected for the study . The subjects were divided among a Twin-block group ( n = 25 ) , a bionator group ( n = 20 ) , and a control group ( n = 10 ) . Pretreatment and posttreatment lateral cephalometric radiographs of the treatment group subjects , and prefollow-up and postfollow-up radiographs of the control group subjects , were traced manually and subjected to the pitchfork analysis . RESULTS Statistical software was used for 1-way analysis of variance and multiple comparisons ( post-hoc test , Bonferroni ) . A P value of .05 was considered statistically significant . Neither the Twin-block nor the bionator appliance significantly restricted forward growth of the maxilla ( P = .476 ) . M and ibular growth in the Twin-block subjects was significantly greater than in controls ( P = .005 ) . M and ibular growth was comparable in the control and the bionator subjects . Molar correction , overjet reduction , and proclination of the m and ibular incisors were significantly greater ( P = .000 ) in the treated subjects compared with the controls . CONCLUSIONS Both the Twin-block and bionator appliances were effective in correcting molar relationships and reducing overjets in Class II Division 1 malocclusion subjects . However , the Twin-block was more efficient than the bionator in the treatment of Class II Division 1 malocclusion This prospect i ve controlled study investigated the net effects of the Twin Block functional appliance taking into account the effects of normal growth in an untreated control group . The treatment group consisted of 36 subjects , mean age of 12.4 years , consecutively treated with Twin Block appliances for an average period of 0.9 years . Each subject had immediate pre- and posttreatment lateral cephalograms . The control group consisted of 27 subjects with a mean age of 12.1 years . These patients were observed for a mean time of 1.2 years and had radiographic investigation at the initial consultation and immediately before the start of Twin Block therapy . The data were then annualized and subjected to multiple regression analysis . In the treatment group , a reduction in ANB of 2.0 degrees ( p < 0.001 ) was observed largely because of an increase in SNB of 1.9 degrees ( p < 0.001 ) . No statistically significant restraint in the maxillary growth was observed . Treatment result ed in an increase in Ar-Pog of 5.1 mm ( p < 0.001 ) compared with the control group increase in Ar-Pog of 2.7 mm , result ing in a net gain of 2.4 mm . The overjet was reduced by combination of a net maxillary incisor retroclination of 10.8 degrees ( p < 0.001 ) , net m and ibular incisor proclination of 7.9 degrees ( p < 0.001 ) and forward movement of the m and ible . Buccal segment relationships were corrected by means of lower molar eruption , restraint in the eruption of the upper molars and forward growth or repositioning of the m and ible . Any possible fossa adaption was not assessed
Output:
| Clinical ly significant restraint of maxillary growth was not found .
Although the m and ibular body length is increased , the facial impact of it is reduced by the simultaneous increment of the face height .
Changes of lower face height and occlusal plane inclination varied , suggesting that vertical dimension can be manipulated in patients who would benefit from lower molar extrusion .
As for lip position , there is not enough evidence to suggest clear lip position changes .
Changes associated with a Class II correction were identified .
Most of the changes individually were of limited clinical significance , but when combined reached clinical importance . |
MS211784 | ***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 Disease prevention and health promotion are important tasks in the daily practice of all general practitioners ( GPs ) . The objective of this study was to explore the knowledge and attitudes of European GPs in implementing evidence -based health promotion and disease prevention recommendations in primary care , to describe GPs ' perceived barriers to implementing these recommendations and to assess how GPs ' own health behaviors affect their work with their patients . METHODS A postal multinational survey was carried out from June to December 2000 in a r and om sample of GPs listed from national colleges of each country . RESULTS Eleven European countries participated in the study , giving a total of 2082 GPs . Although GPs believe they should advise preventive and health promotion activities , in practice , they are less likely to do so . About 56.02 % of the GPs answered that carrying-out prevention and health promotion activities are difficult . The two most important barriers reported were heavy workload/lack of time and no reimbursement . Associations between personal health behaviour and attitudes to health promotion or activities in prevention were found . GPs who smoked felt less effective in helping patients to reduce tobacco consumption than non-smoking GPs ( 39.34 % versus 48.18 % , P < 0.01 ) . GPs who exercised felt that they were more effective in helping patients to practice regular physical exercise than sedentary GPs ( 59.14 % versus 49.70 % , P < 0.01 ) . CONCLUSIONS Significant gaps between GP 's knowledge and practice s persist in the use of evidence -based recommendations for health promotion and disease prevention in primary care INTRODUCTION Smoking cessation counseling by health professionals is an effective approach to increase cessation rates among smokers . To guide the development of training and educational interventions , we surveyed six health professional groups including general practitioners ( GPs ) , pharmacists , dentists , dental hygienists , nurses , and respiratory therapists , in order to describe current practice s and identify the correlates of smoking cessation counseling . METHODS Self-administered question naires were mailed to 500 persons r and omly selected from the membership lists of active licensed professionals in each health professional group in Québec . RESULTS Response proportions ranged from 52 % ( nurses ) to 70 % ( dental hygienists ) . Compared with other groups , GPs and pharmacists undertook more counseling with patients ready to quit . GPs and respiratory therapists undertook more counseling with patients not ready to quit . Three factors emerged consistently across most groups as positively associated with counseling , including the belief that counseling is the role of health professionals , perceived self-efficacy to engage in effective counseling , and knowledge of community cessation re sources . DISCUSSION The correlates of cessation counseling are similar across health professional groups . Interventions that address beliefs that cessation counseling is the role of health professionals , self-efficacy to provide effective counseling , and knowledge of community re sources may result in improved cessation counseling practice s among health professionals Over the years we have been working to develop , test , and implement tobacco control interventions as a part of routine care within Kaiser Permanente . Most of our work has been in Kaiser Permanente 's northwest division , based in Portl and , Oregon , but we have also implemented similar approaches in several other divisions , including Ohio , Hawaii , and Georgia . I will first describe our general approach , which we call the TRAC model ( “ tobacco reduction , assessment , and care ” ) , and then share both our progress and some very real difficulties we have encountered in trying to implement the program throughout the health care system . The rationale for delivering brief tobacco intervention during routine care is familiar to those who work in cessation.1 Tobacco remains the most important cause of preventable disease . We know that most smokers see clinicians frequently , and that these visits create teachable moments when patients are receptive to advice and intervention . When we routinely ignore these intervention opportunities , we are , in effect , failing our patients . Indeed , meta-analyses from the Agency for Health Care Policy and Research ( AHCPR ) clinical guideline 2 show that brief advice and support lead to modest but consistent long term effects on smoking cessation . We also know that brief tobacco interventions are among the most cost effective of all medical care procedures we routinely offer.3 4 It is for these reasons that the Health Plan Employer Data Information Set ( HEDIS ) and other quality monitoring groups are holding health care systems accountable for addressing tobacco during clinical care . For me , however , the most important reasons to offer cessation advice and assistance are that our patients want , need , and expect this kind of support . How are we doing as a nation in delivering cessation advice during medical care visits ? Figure 1 displays time trend data 5 from the National Household BACKGROUND China has the most smokers among the world 's nations . Physicians play a key role in smoking cessation , but little is known about Chinese physicians and smoking . METHODS This 2004 clustered r and omized survey of 3552 hospital-based physicians from six Chinese cities measured smoking attitudes , knowledge , personal behavior , and cessation practice s for patients . Descriptive statistics and multivariate analysis of factors associated with asking about or advising against smoking were conducted in 2005 and 2006 . RESULTS Smoking prevalence was 23 % among all Chinese physicians , 41 % for men and 1 % for women . Only 30 % report good implementation of smoke-free workplace policies and 37 % of current smokers have smoked in front of their patients . Although 64 % usually advise smokers to quit , only 48 % usually ask about smoking status , and 29 % believe most smokers will follow their cessation advice . Less than 7 % set quit date s or use pharmacotherapy when helping smokers quit . Although 95 % and 89 % , respectively , know that active or passive smoking causes lung cancer , only 66 % and 53 % , respectively , know that active or passive smoking causes heart disease . Physicians were significantly more likely to ask about or advise against smoking if they believed that counseling about health harms helps smokers quit and that most smokers would follow smoking-cessation advice . CONCLUSIONS Physician smoking cessation , smoke-free workplaces , and education on smoking-cessation techniques need to be increased among Chinese physicians . Strengthening counseling skills may result in more Chinese physicians helping smoking patients to quit . These improvements can help reduce the Chinese and worldwide health burden from smoking OBJECTIVE To investigate the smoking habits and associated risk factors among Greek physicians . STUDY DESIGN Cross-sectional survey of a r and omly selected sample of Greek physicians . METHODS A national sample of 1284 physicians ( 718 men , 566 women ) participated in the study , which was conducted between September 2003 and June 2005 . Data were collected through an anonymous self-completed question naire . Logistic regression was used to analyse the influence of different factors on the probability of a physician being a current or former smoker . RESULTS Overall , 38.6 % of the physicians ( 40 % of men ; 37 % of women ) currently smoked , 13.8 % were former smokers , and 47.6 % had never smoked . Eighty-three per cent of smokers reported starting smoking before the age of 25 years , with half of them during medical school ( aged 19 - 24 years ) . Multivariate analyses revealed that physicians who were male , unmarried , divorced or widowed , surgeons or anaesthetists , and residents were more likely to be current smokers . Former smokers were more likely to be older , male and born in a rural area . Moreover , the odds of being a current or former smoker were significantly higher among physicians with a history of parents who smoked . The proportion of physicians who reported counselling patients ( often or always ) to stop smoking was lower among current smokers compared with those who never smoked or those who were former smokers ( 74.4 % vs. 85.3 % vs. 84.7 % , P<0.0001 ) . CONCLUSIONS The prevalence of smoking among Greek physicians is exceedingly high and similar to that of the general population . More effective interventions that reduce smoking in the medical community should be implemented immediately so that physicians will be better able to fulfil their function as role models for the general population BACKGROUND While cardiologists are very active in the prevention of cardiovascular disease , their attitudes towards patients ' smoking habits are poorly studied . AIMS In a nationwide French survey , we assessed cardiologists ' levels of knowledge and management of smoking cessation . METHODS We sent out a question naire to a r and om sample of 1000 cardiologists . RESULTS A total of 371cardiologists agreed to participate in the survey ; 8.1 % were current smokers and 32.4 % were past smokers . Most classified smoking cessation as the top priority for patients with coronary artery disease ( 56.5 % ) and peripheral arterial disease ( 88.5 % ) . Cardiologists routinely assessed active and passive smoking in 96.2 % and 43 % of their patients , respectively . Only 29.2 % considered themselves well informed about smoking-cessation management . While 39.9 % declared they knew about the minimal counselling 7.3 % described it correctly . Only 17.5 % used the Fagerström question naire . Smoking cessation was advised systematic ally by 85 % but only 5.4 % of cardiologists followed up their patients specifically on this issue . They referred smokers to either their general practitioner or to smoking-cessation centres and /or quitlines in 16.0 % and 67.0 % of cases , respectively ; 31.8 % never referred their patients to a smoking-cessation centre , and 25 % declared being unaware of any such centre in their area . Cardiologists who smoked were less likely to ask about patients ' smoking status than non-smokers ( 90 % vs 98.2 % , p=0.039 ) . Similarly , they were more passive in offering smoking-cessation counselling ( 23 % vs 7 % , p=0.011 ) , and referred less frequently their patients to a smoking-cessation centre ( 37 % vs 64 % , p=0.028 ) . CONCLUSION French cardiologists are rarely involved in the management of smoking cessation . Their own smoking status influences their attitudes towards the management of smoking cessation CONTEXT The World Health Organization has advocated that physicians should not smoke cigarettes and surveys on this issue should be conducted among medical professionals . However , no nationally representative surveys of smoking among physicians in Japan have been reported . OBJECTIVES To estimate the nationwide prevalence of smoking and determine the attitudes toward smoking among Japanese physicians . DESIGN , SETTING , AND PARTICIPANTS Descriptive study in which anonymous question naires were mailed to 4500 r and omly selected physician members of the Japan Medical Association in the year 2000 , which represents 63 % of all Japanese physicians ; 3771 ( 84 % ) respondents were included in the analysis . MAIN OUTCOME MEASURES Smoking prevalence among physicians , history of smoking , and attitudes toward smoking . RESULTS The prevalence of cigarette smoking among physicians was 27.1 % for men and 6.8 % for women , about half the age-adjusted prevalences among the general Japanese population . Smoking prevalence was higher among male physicians in Japan than those in the United States ( 3%-10 % ) and the United Kingdom ( 4%-5 % ) . Smoking prevalence differed by age , with the highest prevalence among male past smokers aged 70 years or older ( 51.8 % ; 95 % confidence interval [ CI ] , 47.4%-56.2 % ) . Among male current smokers , the highest rates were for those aged 40 to 49 years ( 31 % ; 95 % CI , 27.5%-34.5 % ) ; rates for female past smokers were highest among those aged 50 to 59 years ( 10.7 % ; 95 % CI , 6.6%-14.8 % ) and for female current smokers were highest among those aged 70 years or older ( 8.2 % ; 95 % CI , 4.8%-11.6 % ) . Nonsmoking physicians had more unfavorable views toward smoking and were more active in encouraging patients not to smoke than those physicians who smoked . CONCLUSION Smoking cessation programs should be introduced among Japanese physicians to reduce the number of smoking physicians . Also , a continuing education program should be instituted to motivate physicians about their role in society OBJECTIVES Several countries have followed the US example in publishing national guidelines on smoking cessation interventions . Gauging responses to these guidelines can provide important lessons for future implementation and revision internationally . This study sought to assess General Practitioners ' ( GPs ' ) views on recently published English smoking cessation guidelines that form the foundation of the UK National Health Service 's smoking cessation strategy . DESIGN Postal survey in which GPs were asked to judge the appropriateness , effectiveness and practicability of key recommendations for primary care in recent national smoking cessation guidelines . SETTING General practice , Engl and and Wales . SUBJECTS R and om national sample of GPs ; 236 GPs completed the question naire ; effective response rate : 62 % . RESULTS Only 16 % of GPs accepted that all the recommendations in the guidelines were appropriate ; 43 % accepted that it was appropriate to check the smoking status of known smokers when they visit the surgery and only 30 % thought it was practicable to advise smokers to stop at every opportunity . However , 77 % of GP
Output:
| However , high levels of heterogeneity were found that were not explained by the meta-regression .
Smoking status of doctors may affect their delivery of smoking cessation treatments to patients , with smokers being less likely than non-smokers or ex-smokers to advise and counsel their patients to quit but more likely to refer them to smoking cessation programmes |
MS211785 | ***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 outcomes between robotic versus laparoscopic hysterectomy and lymphadenectomy in patients with endometrial cancer . METHODS A cohort study was performed by prospect ively identifying all patients with clinical stage I or occult stage II endometrial cancer who underwent robotic hysterectomy and lymphadenectomy from 2006 - 2008 and retrospectively comparing data using the same surgeons ' laparoscopic hysterectomy and lymphadenectomy cases from 1998 - 2005 , prior to our robotic experience . Patient demographics , operative times , complications , conversion rates , pathologic results , and length of stay were analyzed . RESULTS 181 patients ( 105 robotic and 76 laparoscopic ) met inclusion criteria . There was no significant difference between the two groups in median age , uterine weight , bilateral pelvic or aortic lymph node counts , or complication rates in patients whose surgeries were completed minimally invasively . Despite a higher BMI ( 34 vs. 29 , P<0.001 ) , the estimated blood loss ( 100 vs. 250 mL , P<0.001 ) , transfusion rate ( 3 % vs. 18 % , RR 0.18 , 95%CI 0.05 - 0.64 , P=0.002 ) , laparotomy conversion rate ( 12 % vs. 26 % , RR 0.47 , 95%CI 0.25 - 0.89 , P=0.017 ) , and length of stay ( median : 1 vs. 2 nights , P<0.001 ) were lower in the robotic patients compared to the laparoscopic cohort . The odds ratio of conversion to laparotomy based on BMI for robotics compared to laparoscopy is 0.20 ( 95 % CI 0.08 - 0.56 , P=0.002 ) . The mean skin to skin time ( 242 vs. 287 min , P<0.001 ) and total room time ( 305 vs. 336 min , P<0.001 ) was shorter for the robotic cohort . CONCLUSION Robotic hysterectomy and lymphadenectomy for endometrial carcinoma can be accomplished in heavier patients and results in shorter operating times and hospital length of stay , a lower transfusion rate , and less frequent conversion to laparotomy when compared to laparoscopic hysterectomy and lymphadenectomy PURPOSE To demonstrate the feasibility of robot-assisted staging surgery using three arms in patients with endometrial cancer . METHODS One hundred nine patients with clinical stage I endometrial cancer who underwent staging surgery at Yonsei University Health System were enrolled from May 2006 to January 2009 . Patient demographics and operative outcomes were prospect ively collected . RESULTS Robotic surgery using three arms was performed in 28 patients , laparoscopy in 25 , and laparotomy in 56 . There were no differences among the three groups in terms of patient demographics . The number of harvested pelvic lymph nodes was lower in the laparoscopy group than in the laparotomy group ( 18.36 + /- 7.25 vs. 24.39 + /- 10.08 , respectively , P = 0.025 ) , but there was no difference between the robot and laparotomy groups . The number of resected para-aortic lymph nodes and operative time did not differ among the three groups . The average hospital stay was longer for the laparotomy group than the robot and laparoscopy groups ( 10.78 days vs. 7.92 days vs. 7.67 days , respectively , P < 0.001 ) . Operative complications and transfusions developed more frequently in the laparotomy group than in the robot and laparoscopy groups ( 25.0 % vs. 7.1 % vs. 8.0 % , respectively , P = 0.049 ; 42.9 % vs. 14.3 % vs. 16.0 % , respectively , P = 0.006 ) . CONCLUSION Robot-assisted surgery using three arms is a feasible method for surgical staging in patients with clinical stage I endometrial cancer OBJECTIVE : To evaluate the effect of introducing a robotic program on cost and patient outcome . METHODS : This was a prospect i ve evaluation of clinical outcome and cost after introducing a robotics program for the treatment of endometrial cancer and a retrospective comparison to the entire historical cohort . RESULTS : Consecutive patients with endometrial cancer who underwent robotic surgery ( n=143 ) were compared with all consecutive patients who underwent surgery ( n=160 ) before robotics . The rate of minimally invasive surgery increased from 17 % performed by laparoscopy to 98 % performed by robotics in 2 years . The patient characteristics were comparable in both eras , except for a higher body mass index in the robotics era ( median 29.8 compared with 27.6 ; P<.005 ) . Patients undergoing robotics had longer operating times ( 233 compared with 206 minutes ) , but fewer adverse events ( 13 % compared with 42 % ; P<.001 ) , lower estimated median blood loss ( 50 compared with 200 mL ; P<.001 ) , and shorter median hospital stay ( 1 compared with 5 days ; P<.001 ) . The overall hospital costs were significantly lower for robotics compared with the historical group ( Can$7,644 compared with Can$10,368 [ Canadian dollars ] ; P<.001 ) even when acquisition and maintenance cost were included ( Can$8,370 compared with Can$10,368 ; P=.001 ) . Within 2 years after surgery , the short-term recurrence rate appeared lower in the robotics group compared with the historic cohort ( 11 recurrences compared with 19 recurrences ; P<.001 ) . CONCLUSION : Introduction of robotics for endometrial cancer surgery increased the proportion of patients benefitting from minimally invasive surgery , improved short-term outcomes , and result ed in lower hospital costs . LEVEL OF EVIDENCE : Purpose Laparoscopy ( LSC ) offers superior patient outcomes compared to laparotomy . Small retrospective/ prospect i ve series have suggested robotics offers further reduction in postoperative pain and pain medication use compared to st and ard LSC . Our objective was to compare postoperative pain in patients undergoing robotically assisted ( RBT ) versus st and ard LSC for newly diagnosed endometrial cancer . Methods All preoperative endometrial cancer cases scheduled for RBT and LSC from May 1 , 2007 to June 9 , 2010 were identified . For this analysis , we only included cases not requiring conversion to laparotomy . All patients were offered intravenous ( IV ) patient-controlled analgesia ( PCA ) postoperatively . Intraoperative equivalent fentanyl doses ( IEFDs ) and pain scores in the postanesthesia care unit ( PACU ) were assessed . Results IV PCA was used in 206 RBTs ( 86 % ) and 208 LSCs ( 88 % ) . Median IEFD was 425 μg for LSCs and 500 μg for RBTs ( P = 0.03 ) . Median pain scores on PACU arrival were similar in both groups . Median highest pain score was 5 for LSCs and 4 for RBTs ( P = 0.007 ) . Linear regression demonstrated that the IEFD was not correlated with the highest pain score ( R = 0.09 ; P = 0.07 ) . Fentanyl was used postoperatively in 196 of 206 RBTs ( 95 % ) and 187 of 208 LSCs ( 90 % ) . The total fentanyl doses were 242.5 ( range 0–2705 ) μg and 380 ( range 0–2625 ) μg , respectively ( P < 0.001 ) . The median hourly fentanyl doses were 16.7 ( range 0–122.5 ) μg and 23.5 ( range 0–132.4 ) μg , respectively ( P = 0.005 ) . Simultaneous multiple regression analysis further demonstrated RBT was independently associated with a lower total fentanyl dose compared to LSC ( P = 0.02 ) . Conclusions RBT is independently associated with significantly lower postoperative pain and pain medication requirements compared to LSC . The amount of intraoperative fentanyl analgesia does not appear to correlate with postoperative pain BACKGROUND Evaluation of the impact of a new robotic surgery programme on perioperative outcomes for endometrial cancer METHODS A prospect i ve data base of all patients undergoing staging for endometrial cancer during July 2007-July 2008 was collected and analysed . Demographic data and perioperative outcomes were compared between cases performed via laparotomy , laparoscopy and robotics . RESULTS Sixty-five patients underwent staging during the time of data collection ( LAP-26 , LSC-7 , ROB-32 ) . No difference in surgical volume in the year before vs. after robotics was identified . Median operative time for robotics and laparotomy was significantly less than for laparoscopy ( p = 0.023 ) . There was no significant difference in lymph node yields between the three groups ( p = 0.92 ) . Robotics was associated with significantly less blood loss ( p < 0.0001 ) . Complication rates were significantly lower in the robotic group compared to the laparotomy group ( p = 0.05 ) . Median hospital stay was 1 day for the minimally invasive groups . Total number of perioperative inpatient days decreased from 331 to 150 in one year . Practice management of endometrial cancer transitioned from a predominantly open approach ( 5.6 % LSC ) to robotics ( 11 % LSC , 49 % ROB ) within 12 months . CONCLUSIONS Robotic surgery dramatically altered our management of endometrial cancer and was associated with a significant improvement in several perioperative outcomes when compared to laparotomy and laparoscopy INTRODUCTION Comparison of perioperative outcomes and recurrence in patients undergoing primary surgical treatment for endometrial cancer by robotics , laparoscopy , vaginal/laparoscopy , or laparotomy approaches . METHODS Prospect i ve analysis of 67 patients undergoing robotic surgery for endometrial cancer between March 2004 and December 2007 . Comparison was made with similar patients operated between November 1999 and December 2006 by laparoscopy ( 37 cases ) , laparotomy ( 99 cases ) and vaginal/laparoscopy approach ( vaginal hysterectomy , bilateral adnexectomy/laparoscopic lymphadenectomy ) ( 47 cases ) and matched by age , body mass index ( BMI ) , histological type and International Federation of Gynecologists and Obstetricians ( FIGO ) staging . RESULTS Mean operating times for patients undergoing robotic , laparoscopy , vaginal/laparoscopy or laparotomy approach were 181.9 , 189.5 , 202.7 and 162.7 min , respectively ( p = 0.006 ) ; mean blood loss was 141.4 , 300.8 , 300.0 and 472.6 ml , respectively ( p < 0.001 ) ; mean number of nodes was 24.7 , 27.1 , 28.6 , and 30.9 , respectively ( p = 0.008 ) ; mean length of hospital stay was 1.9 , 3.4 , 3.5 and 5.6 days , respectively ( p < 0.001 ) . There were no significant differences in intra- or postoperative complications among the four groups . The conversion rate was 2.9 % for robotics and 10.8 % for the laparoscopy group ( 0.001 ) . There were no differences relative to recurrence rates among the four groups : 9 % , 14 % , 11 % and 15 % for robotics , laparoscopy , vaginal/laparoscopy , and laparotomy , respectively . CONCLUSION Robotics , laparoscopy and vaginal/laparoscopy techniques are preferable to laparotomy for suitable patients with endometrial cancer . Robotics is preferable to laparoscopy due to a shorter hospital stay and lower conversion rate and preferable to vaginal/laparoscopy due to a reduced hospitalization BACKGROUND Previous studies comparing robotic-assisted laparoscopic surgery to traditional laparoscopic or open surgery in gynecologic oncology have been retrospective . To our knowledge , no prospect i ve r and omized trials have thus far been performed on endometrial cancer . OBJECTIVE We sought to prospect ively compare traditional and robotic-assisted laparoscopic surgery for endometrial cancer . STUDY DESIGN This was a r and omized controlled trial . From December 2010 through October 2013 , 101 endometrial cancer patients were r and omized to hysterectomy , bilateral salpingo-oophorectomy , and pelvic lymphadenectomy either by robotic-assisted laparoscopic surgery or by traditional laparoscopy . The primary outcome measure was overall operation time . The secondary outcome measures included total time spent in the operating room , and surgical outcome ( number of lymph nodes harvested , complications , and recovery ) . The study was powered to show at least a
Output:
| A robotic approach has favourable clinical outcomes but is more expensive |
MS211786 | ***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 The purpose of this study was to compare the effects of N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided therapy with those of intensive clinical management and with usual care ( UC ) on clinical outcomes in chronic symptomatic heart failure . BACKGROUND Initial trial results suggest titration of therapy guided by serial plasma B-type natriuretic peptide levels improves outcomes in patients with chronic heart failure , but the concept has not received widespread acceptance . Accordingly , we conducted a longer-term study comparing the effects of NT-proBNP-guided therapy with those of intensive clinical management and with UC of patients with heart failure . METHODS Three hundred sixty-four patients admitted to a single hospital with heart failure were r and omly allocated 1:1:1 ( stratified by age ) to therapy guided by NT-proBNP levels or by intensive clinical management , or according to UC . Treatment strategies were applied for 2 years with follow-up to 3 years . RESULTS One-year mortality was less in both the hormone- ( 9.1 % ) and clinical ly-guided ( 9.1 % ) groups compared with UC ( 18.9 % ; p = 0.03 ) . Three-year mortality was selectively reduced in patients < or=75 years of age receiving hormone-guided treatment ( 15.5 % ) compared with their peers receiving either clinical ly managed treatment ( 30.9 % ; p = 0.048 ) or UC ( 31.3 % ; p = 0.021 ) . CONCLUSIONS Intensive management of chronic heart failure improves 1-year mortality compared with UC . Compared with clinical ly guided treatment and UC , hormone-guided treatment selectively improves longer-term mortality in patients < or=75 years of age . ( NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death [ BATTLESCARRED ] ; Australian New Zeal and Clinical Trials Registry 12605000735651 ) OBJECTIVES The aim of this multicenter study was to evaluate the prognostic impact of a therapeutic strategy using plasma brain natriuretic peptide ( BNP ) levels . BACKGROUND The prognosis of chronic heart failure ( CHF ) remains poor , even among patients treated in specialized departments . METHODS A total of 220 New York Heart Association functional class II to III patients considered optimally treated with angiotensin-converting enzyme inhibitors ( ACEIs ) , beta-blockers , and diuretics by CHF specialists were r and omized to medical treatment according to either current guidelines ( clinical group ) or a goal of decreasing BNP plasma levels < 100 pg/ml ( BNP group ) . Outpatient visits were scheduled every month for 3 months , then every 3 months . The primary combined end point was CHF-related death or hospital stay for CHF . RESULTS Both groups were similar for baseline clinical and biological characteristics . Left ventricular ejection fraction was slightly lower in the BNP group than in the clinical group ( 29.9 + /- 7.7 % vs. 31.8 + /- 8.4 % , p = 0.05 ) . At the end of the first 3 months , all types of drugs were changed more frequently in the BNP group . Mean dosages of ACEIs and beta-blockers were significantly higher in the BNP group ( p < 0.05 ) , whereas the mean increase in furosemide dosage was similar in both groups . During follow-up ( median 15 months ) , significantly fewer patients reached the combined end point in the BNP group ( 24 % vs. 52 % , p < 0.001 ) . CONCLUSIONS In optimally treated CHF patients , a BNP-guided strategy reduced the risk of CHF-related death or hospital stay for CHF . The result was mainly obtained through an increase in ACEI and beta-blocker dosages BACKGROUND Heart failure ( HF ) treatment guided by amino-terminal pro-B type natriuretic peptide ( NT-proBNP ) may reduce cardiovascular event rates compared to st and ard-of-care ( SOC ) management . Comprehensive underst and ing regarding effect of NT-proBNP guided care on patient-reported quality of life ( QOL ) remains unknown . METHODS One hundred fifty-one subjects with HF due to left ventricular systolic dysfunction were r and omized to either SOC HF management or care with a goal to reduce NT-proBNP values ≤1000 pg/mL. Effects of HF on QOL were assessed using the Minnesota Living with HF Question naire ( MLHFQ ) quarterly , with change ( Δ ) in score assessed across study procedures and as a function of outcome . RESULTS Overall , baseline MLHFQ score was 30 . Across study visits , QOL improved in both arms , but was more improved and sustained in the NT-proBNP arm ( repeated measures P = .01 ) ; NT-proBNP patients showing greater reduction in MLHFQ score ( -10.0 vs -5.0 ; P = .05 ) , particularly in the physical scale of the question naire . Baseline MLHFQ scores did not correlate with NT-proBNP ; in contrast , ∆MLHFQ scores modestly correlated with ∆NT-proBNP values ( ρ = .234 ; P = .006 ) as did relative ∆ in MLHFQ score and NT-proBNP ( ρ = .253 ; P = .003 ) . Considered in tertiles , less improvement in MLHFQ scores was associated with a higher rate of HF hospitalization , worsening HF , and cardiovascular death ( P = .001 ) . CONCLUSIONS We describe novel associations between NT-proBNP concentrations and QOL scores among patients treated with biomarker guided care . Compared to SOC HF management , NT-proBNP guided care was associated with greater and more sustained improvement in QOL ( Clinical Trial Registration : www . clinical trials.govNCT00351390 ) Heart failure has been named “ the growing epidemic . ” Over the last decade , the annual number of heart failure hospitalizations has almost doubled with approximately 50 % of patients being rehospitalized within 6 months of discharge [ 1 ] . The complex array of physiologic , psychological , social , and health care delivery issues makes it a challenging chronic disease to manage . Underst and ing the epidemiology and pathophysiology of the syndrome , identifying the predictors and their strength of association with outcomes , and using the available diagnostic modalities cost-effectively are essential in order to devise effective prevention interventions and implement novel therapeutic approaches to curb this epidemic . In this special issue , we have invited a few papers that address such issues and explain why despite the emergence of novel therapeutic approaches , that promise life prolongation and hospital length reduction , this patient population will still be needing rehospitalization and will often have a poor prognosis . This special issue is the extension of an effort that was initiated in 2011 with the first heart-failure-focused issue [ 2 ] . In the pathophysiology section , S. M. R. Kazemi-Bajestani et al. describe the opportunities and challenges of targeting the angiotensin converting enzyme 2 (ACE2)/Ang II/Ang1–7 and apelin/APJ pathways as novel therapeutic modalities in heart failure [ 3 ] . ACE2 and the apelin/APJ are two important peptide systems which exert diverse effects on the cardiovascular system . Dysregulation of such systems may be involved in the predisposition to cardiovascular diseases whereas enhancing their action may have important therapeutic effects . In the same section , D. Lindner et al. provide a comprehensive review on the protective function of signal transducer and activator of transcription 3 ( STAT3 ) in CVB3-induced myocarditis [ 4 ] . The transcription factor ( STAT3 ) is an important mediator of the inflammatory process , and in this original research the investigators examine the role of STAT3 in viral myocarditis and its possible role in the development to dilated cardiomyopathy . Considering the high mortality rate and the availability of life-saving therapies like transplantation and left ventricular assist devices , accurate prognosis determination in HF is clinical ly important . Taking into account the mediocre performance of current established prediction models , such as the Seattle Heart Failure Model [ 5–7 ] , the work by H. Fukuta et al. [ 8 ] on the prognostic value of left ventricular diastolic dysfunction in patients undergoing cardiac catheterization for coronary artery disease sheds light on this extremely important topic . A shared underst and ing of medical conditions between patients and their health care providers has been shown to improve self-care and outcomes [ 9 ] . In the comorbidity section , we demonstrate how certain comorbid conditions may affect patients ' decision-making capacity and interfere with their ability to comply with treatment requirements , recognize and self-manage disease worsening symptoms . Among others , cognitive impairment is increasingly recognized as a common adverse consequence of HF , whereby phenomena such as microembolism , chronic or intermittent cerebral hypoperfusion , and /or impaired cerebral vessel reactivity may lead to cerebral hypoxia and ischemic brain damage . Cognitive decline in HF is characterized by deficits in one or more cognition domains , including attention , memory , executive function , and psychomotor speed . E. Dardiotis et al. [ 10 ] , in a comprehensive review , underscore the importance for healthcare professionals to become familiar with assessment of cognitive performance using st and ardized screening instruments in their routine evaluations of HF patients . Another comorbidity gaining increasing attention in HF patients is depression . There are several pathophysiological mechanisms as well as behavioral processes linking depression and HF . Equally important is screening for depression and there are several valid and reliable screening tools to identify patients at greater risk . Consultation should be provided by a multidisciplinary team , consisting of cardiologists , psychiatrists , and hospital or community nurses so as to carefully plan , execute , and evaluate medical intervention and implement lifestyle changes . D. Mastrogiannis et al. [ 11 ] systematic ally review the existing knowledge regarding current definitions , prognostic implication s , pathophysiological mechanisms , and current and future treatment options in patients with depression and HF . Evidence from the literature supports the possibility of a pathophysiological relationship between cognitive impairment , depression , and HF . Yet , very few studies have sought to investigate this relationship . The paper by Z. N. Sohani and Z. Samaan review s current literature on the association between depression and cognitive impairment in persons with HF and explores possible mechanisms explaining this complex triad [ 12 ] . Heart failure through neurohumoral activation induces alterations of cardiac metabolism , such as insulin resistance , and promotes increased utilization of noncarbohydrate substrates for energy production [ 13 , 14 ] . Fasting blood ketone bodies as well as fat oxidation have been shown to be increased in this patient population . The result is depletion of myocardial ATP , phosphocreatine , and creatine kinase , leading to decreased efficiency of mechanical work . A direct approach to manipulate cardiac energy metabolism consists in modifying substrate utilization by the failing heart . Trimetazidine , perhexiline , and ranolazine directly inhibit fatty acid oxidation and have been used to increase the ischemic threshold in patients with effort angina . Current research is supporting the concept that shifting the energy substrate preference away from fatty acid metabolism and toward glucose metabolism could be an effective adjunctive treatment in patients with HF . These agents have been shown to improve both glucose metabolism and left ventricular function in diabetic patients with left ventricular dysfunction . In the pharmacotherapy section , we provide a systematic review , in which N. Signoretta et al. [ 15 ] discuss the beneficial therapeutic effects of modulation of cardiac metabolic substrates utilization in patients with HF . In the advanced heart failure section , we provide a thorough review on the current status of mechanical circulatory support in patients with advanced HF . Management of the advanced HF patients with the numerous comorbidities [ 16 , 17 ] requires a significant amount of health care re sources and is becoming a major public health problem . As therapeutical strategies for HF have been refined , the number of patients suffering from the end-stage disease has exp and ed dramatically . Although heart transplantation still represents the gold st and ard therapeutical approach , the shortage of donors universally has made the implantation of mechanical circulatory support devices a well-established management for this disease . The systematic review by K. Spiliopoulos et al. [ 18 ] , outlines the current status of mechanical circulatory support in this patient population . In the chronic follow-up section , we deal with telemonitoring , a novel diagnostic modality that has been suggested to be beneficial for HF patients , targeting optimization of their chronic followup . Telemonitoring is viewed as a means of recording physiological data ( such as body weight , heart rate , arterial blood pressure electrocardiogram recordings , and other data ) by portable devices and transmitting these data remotely ( via a telephone line , a mobile phone , or a computer ) to a server where they can be stored , review ed , and analyzed by the research team . In a systematic review of all r and omized clinical trials evaluating telemonitoring in chronic HF , G. Giamouzis et al. [ 19 ] assess whether telemonitoring provides any substantial benefit in this patient population . We hope that the readers of the journal will find the topics as interesting and important as we did . Gregory Giamouzis George Giannakoulas Javed Butler John A. Ele
Output:
| Authors ' conclusions In patients with heart failure low‐ quality evidence showed a reduction in heart failure admission with NP‐guided treatment while low‐ quality evidence showed uncertainty in the effect of NP‐guided treatment for all‐cause mortality , heart failure mortality , and all‐cause admission .
Uncertainty in the effect was further shown by very low‐ quality evidence for patient 's quality of life . |
MS211787 | ***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 Lymphedema is a potentially debilitating condition that occurs among breast cancer survivors . This study examines the incidence of self-reported lymphedema , timing of lymphedema onset , and associations between sociodemographic , clinical and lifestyle factors and lymphedema risk across racial-ethnic groups using data from a multicenter , multiethnic prospect i ve cohort study of breast cancer survivors , the Health , Eating , Activity and Lifestyle Study . Methods A total of 666 women diagnosed with breast cancer staged as in situ , localized or regional disease at ages 35 to 64 years were recruited through the Surveillance , Epidemiology , and End Results registries in New Mexico ( non-Hispanic white and Hispanic white ) , Los Angeles County ( black ) , and Western Washington ( non-Hispanic white ) and followed for a median of 10.2 years . We evaluated sociodemographic factors , breast cancer- and treatment-related factors , comorbidities , body mass index ( BMI ) , hormonal factors , and lifestyle factors in relation to self-reported lymphedema by fitting Cox proportional hazards models , estimating hazard ratios ( HR ) and 95 % confidence intervals ( CI ) . Results Over the follow-up period , 190 women ( 29 % ) reported lymphedema . The median time from breast cancer diagnosis to onset of lymphedema was 10.5 months ( range : 0.5 to 134.9 months ) . Factors independently associated with lymphedema were total/modified radical mastectomy ( versus partial/less than total mastectomy ; HR = 1.37 , 95 % CI : 1.01 to 1.85 ) , chemotherapy ( versus no chemotherapy ; HR = 1.48 , 95 % CI : 1.09 to 2.02 ) , no lymph nodes removed ( versus ≥10 lymph nodes removed ; HR = 0.17 , 95 % CI : 0.08 to 0.33 ) , pre-diagnostic BMI ≥30 kg/m2 ( versus BMI < 25 kg/m2 ; HR = 1.59 , 95 % CI : 1.09 to 2.31 ) , and hypertension ( versus no hypertension ; HR = 1.49 , 95 % CI : 1.06 to 2.10 ) . After adjusting for demographics and breast cancer- and treatment-related factors , no significant difference in lymphedema risk was observed across racial/ethnic groups . Analyses stratified by race/ethnicity showed that hypertension and chemotherapy were lymphedema risk factors only for black women . Conclusions Breast cancer patients who have undergone extensive surgery or extensive lymph node dissection , or who have a higher BMI should be closely monitored for detection and treatment of lymphedema . Further studies are needed to underst and the roles of chemotherapy and hypertension in the development of lymphedema Goals of workOur aim was to compare the effects of l and versus water multimodal exercise programs on body composition and breast cancer-specific quality of life in breast cancer survivors . Patients and methods Ninety-eight breast cancer survivors were assigned to three groups : control , l and exercise , and water exercise . Both exercise groups participated in an 8-week multimodal program . Adiposity was measured by anthropometry ( body mass index , waist circumference ) and bioelectrical impedance ( body fat and muscle lean body mass ) . Incidence of clinical ly significant secondary lymphedema was also assessed . Finally , specific quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life BR-23.Main Results Using ANCOVA , significant group × time interactions for body fat percentage ( F = 3.376 ; P = 0.011 ) and lean body mass ( F = 3.566 ; P = 0.008 ) were found . Breast cancer survivors in the l and exercise group exhibited a greater decrease in percentage of body fat than those in the water exercise ( P < 0.001 ) and control ( P = 0.002 ) groups . The ANCOVA revealed a significant group × time interaction for waist circumference ( F = 4.553 ; P = 0.002 ) : breast cancer survivors in the control group showed a greater waist circumference when compared to water ( P = 0.003 ) and l and ( P < 0.001 ) exercise groups . A significant group × time interaction was also found for breast symptoms ( F = 9.048 ; P < 0.001 ) : participants in the water exercise group experienced a greater decrease of breast symptoms than those in the l and exercise ( P < 0.01 ) and control ( P < 0.05 ) groups . Conclusion L and exercise produced a greater decrease in body fat and an increase in lean body mass , whereas water exercise was better for improving breast symptoms Objective The aim of this study was to evaluate the feasibility and effect of a water-based exercise program on lymphedema status and shoulder range of motion among women with breast cancer – related lymphedema . Design This was a single-blinded , r and omized controlled pilot trial . Twenty-nine eligible breast cancer survivors ( median , 10 yrs after surgery ) with arm lymphedema ( median , 21 % interlimb difference ) were included and r and omized into the intervention ( n = 15 ) or control ( n = 14 ) group . Twenty-five participants completed the study . The intervention was at least twice-weekly water-based exercise for 8 wks , initially supervised but performed independently during the study period . Outcomes of interest were feasibility as measured by retention and adherence ; lymphedema status as measured by optoelectronic perometry , bioimpedance spectroscopy , and tissue dielectric constant ; and shoulder range of motion as measured by goniometer . Results Four participants were not measured at postintervention and were not included in the analysis ( retention ) . Four participants in the intervention group did not perform the minimum water-based exercise criteria set ( adherence ) . No effect was found on lymphedema status . Compared with the control group , median range of motion change for flexion was 6 ( 1–10 ) degrees ( P < 0.001 ) and 6 ( 0–15.5 ) degrees ( P = 0.07 ) for external rotation . A clinical ly relevant increase in the intervention group was found for 36 % in flexion ( P ⩽ 0.05 ) and 57 % in external rotation ( P ⩽ 0.05 ) compared with controls . Conclusions This study shows that water-based exercise is feasible for breast cancer survivors with arm lymphedema and that shoulder range of motion can be improved years after cancer treatment has been completed The aim of this study was to determine whether an exercise program , commencing 4–6 weeks post-operatively , reduces upper limb impairments in women treated for early breast cancer . Women ( n = 160 ) were r and omized to either an 8-week exercise program ( n = 81 ) or to a control group ( n = 79 ) following stratification for axillary surgery . The exercise program comprised a weekly session and home program of passive stretching and progressive resistance training for shoulder muscles . The control group attended fortnightly assessment s but no exercises were provided . The primary outcome was self-reported arm symptoms derived from the EORTC breast cancer-specific question naire ( BR23 ) , scored out of 100 with a low score indicative of fewer symptoms . The secondary outcomes included physical measures of shoulder range of motion , strength , and swelling ( i.e. , lymphedema ) . Women were assessed immediately following the intervention and at 6 months post-intervention . The change in symptoms from baseline was not significantly different between groups immediately following the intervention or at 6 m post-intervention . The between group difference immediately following the intervention was 4 ( 95 % CI −1 to 9 ) and 6 months post-intervention was 4 ( −2 to 10 ) . However , the change in range of motion for flexion and abduction was significantly greater in the exercise group immediately following the intervention , as was change in shoulder abductor strength . In conclusion , a supervised exercise program provided some , albeit small , additional benefit at 6 months post-intervention to women who had been provided with written information and reminders to use their arm . Both the groups reported few impairments including swelling immediately following the intervention and 6 months post-intervention . Notably , resistance training in the post-operative period did not precipitate lymphedema BACKGROUND Weight lifting has generally been proscribed for women with breast-cancer-related lymphedema , preventing them from obtaining the well-established health benefits of weight lifting , including increases in bone density . METHODS We performed a r and omized , controlled trial of twice-weekly progressive weight lifting involving 141 breast-cancer survivors with stable lymphedema of the arm . The primary outcome was the change in arm and h and swelling at 1 year , as measured through displaced water volume of the affected and unaffected limbs . Secondary outcomes included the incidence of exacerbations of lymphedema , number and severity of lymphedema symptoms , and muscle strength . Participants were required to wear a well-fitted compression garment while weight lifting . RESULTS The proportion of women who had an increase of 5 % or more in limb swelling was similar in the weight-lifting group ( 11 % ) and the control group ( 12 % ) ( cumulative incidence ratio , 1.00 ; 95 % confidence interval , 0.88 to 1.13 ) . As compared with the control group , the weight-lifting group had greater improvements in self-reported severity of lymphedema symptoms ( P=0.03 ) and upper- and lower-body strength ( P<0.001 for both comparisons ) and a lower incidence of lymphedema exacerbations as assessed by a certified lymphedema specialist ( 14 % vs. 29 % , P=0.04 ) . There were no serious adverse events related to the intervention . CONCLUSIONS In breast-cancer survivors with lymphedema , slowly progressive weight lifting had no significant effect on limb swelling and result ed in a decreased incidence of exacerbations of lymphedema , reduced symptoms , and increased strength . ( Clinical Trials.gov number , NCT00194363 . Background This study was to investigate the effects of complex exercise on shoulder range of motion and pain for women with breast cancer-related lymphedema . Methods 69 women participated in this study and then they were r and omly allocated to complex exercise group ( n = 35 ) or the conventional decongestive therapy group ( n = 34 ) . All subjects received 8 sessions for 4 weeks . To identify the effects on shoulder range of motion and pain , goniometer and visual analog scale were used , respectively . The outcome measurements were performed before and after the 4 week intervention . Results After 4 weeks , complex exercise group had greater improvements in shoulder range of motion and pain compared with the conventional decongestive therapy group ( p < 0.05 ) . Conclusion These results suggest that complex exercise is beneficial to improve shoulder range of motion as well as pain of the women with breast cancer-related lymphedema . Complex exercise would be useful to improve shoulder range of motion and pain of the women with breast cancer-related lymphedema Background We aim ed to evaluate the effect of an 8-week yoga intervention on the shoulder and spinal actions of women with breast cancer-related arm lymphoedema . Method A r and omised controlled pilot trial . The intervention group ( n = 12 ) completed eight weeks of daily yoga sessions while the control group ( n = 11 ) continued with best current care including information on compression sleeves , skin care , risks of temperature variations and recommended safe use of affected arm . Lumbo-pelvic posture , range of motion ( ROM ) in the shoulder and spine , and strength in shoulder and pectoral major and minor , and serratus anterior were taken at baseline , week 8 and after a 4-week follow-up . Outcome assessors were blinded to allocation . Results At week eight the intervention group had an improvement in lumbo-pelvic posture , as indicated by a reduction in pelvic obliquity compared to the control group ( mean difference = −8.39 ° , 95 % CI : −15.64 to −1.13 ° , p = 0.023 ) . A secondary finding was that strength in shoulder abduction significantly increased following the yoga intervention in both the affected ( 9.5 kg ; CI : 0.34 to 18.66 , p = 0.042 ) and non-affected arm ( 11.58 kg ; CI : 0.25 to 22.91 ; p = 0.045 ) . There were no significant between group changes in any ROM measures as a result of the yoga intervention . Conclusion This pilot study demonstrates that participation in yoga may provide benefits for posture and strength in women with Breast Cancer Related Lymphoedema . The improvements may be attributed to the focus of yoga on overall postural and functional movement patterns . Further trials with longer intervention that follow this methodology are warranted . Trial registration The Australian New Zeal and Clinical Trials Registry ACTRN12611000202965 Exercise for Health was a r and omized , controlled trial design ed to evaluate two modes of delivering ( face-to-face [ FtF ] and over-the-telephone [ Tel ] ) an 8-month translational exercise intervention , commencing 6-weeks post-breast cancer surgery ( PS ) . Outcomes included quality of life ( QoL ) , function ( fitness and upper body ) and treatment-related side effects ( fatigue , lymphoedema , body mass index , menopausal symptoms , anxiety , depression and pain ) . Generalised estimating equation modelling determined time ( baseline [ 5 weeks PS ] , mid-intervention [ 6 months PS ] , post-intervention [ 12
Output:
| Results have indicated aerobic exercise , resistance exercise , stretching , yoga , qigong , and pilates can be safe and effective in the management of symptoms for those with , or at risk for , BCRL .
Conclusion Several forms of exercise appear to be safe interventions for clinicians to use when treating this population and offer benefits such as improved quality of life , strength , body mass index , and mental health and decreased pain and lymphatic swelling . |
MS211788 | ***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 : Elevated levels or increases in circulating tumor cells ( CTC ) portend poor prognosis in patients with epithelial cancers . Less is known about CTCs as surrogate endpoints or their use for predictive biomarker evaluation . This study investigated the utility of CTC enumeration and characterization using the Cell Search platform , as well as mutation detection in circulating tumor DNA ( ctDNA ) , in patients with advanced non – small cell lung cancer ( NSCLC ) . Experimental Design : Forty-one patients were enrolled in a single-arm phase II clinical trial of erlotinib and pertuzumab . Peripheral blood was analyzed for CTC enumeration , EGFR expression in CTCs , and detection of oncogenic mutations in CTCs and ctDNA . Changes in CTC levels were correlated with 2[18F]fluoro-2-deoxy-d-glucose – positron emission tomographic ( FDG-PET ) and computed tomographic ( CT ) imaging and survival endpoints . Results : CTCs were detected ( ≥1 CTC ) at baseline in 78 % of patients . Greater sensitivity for mutation detection was observed in ctDNA than in CTCs and detected mutations were strongly concordant with mutation status in matched tumor . Higher baseline CTC counts were associated with response to treatment by Response Evaluation Criteria in Solid Tumors ( RECIST , P = 0.009 ) and decreased CTC counts upon treatment were associated with FDG-PET and RECIST response ( P = 0.014 and P = 0.019 ) and longer progression-free survival ( P = 0.050 ) . Conclusion : These data provide evidence of a correlation between decreases in CTC counts and radiographic response by either FDG-PET or RECIST in patients with advanced NSCLC . These findings require prospect i ve validation but suggest a potential role for using CTC decreases as an early indication of response to therapy and ctDNA for real-time assessment of mutation status from blood . Clin Cancer Res ; 18(8 ) ; 2391–401 . © 2012 AACR Purpose : Activating mutations in the epidermal growth factor receptor ( EGFR ) are associated with enhanced response to EGFR tyrosine kinase inhibitors in non-small cell lung cancer ( NSCLC ) , whereas KRAS mutations translate into poor patient outcomes . We hypothesized that analysis of plasma for EGFR and KRAS mutations from shed tumor DNA would have clinical utility . Methods : An allele-specific polymerase chain reaction assay using Scorpion-amplification refractory mutation system ( DxS , Ltd ) was used to detect mutations in plasma DNA from patients with advanced stage NSCLC treated as second- or third-line therapy on a phase I/II trial of docetaxel plus intercalated erlotinib . Results : EGFR mutations were detected in 10 of 49 patients ( 20 % ) . Six ( 12 % ) had single activating mutations in EGFR , associated with improved progression-free survival ( median , 18.3 months ) , compared with all other patients ( median , 3.9 months ; p = 0.008 ) , or those with wild-type EGFR ( median , 4.0 months ; p = 0.012 ) . Four of 49 patients harbored a de novo T790 M resistance mutation ( median progression-free survival , 3.9 months ) . EGFR mutational status was associated with clinical response ( 45 assessable , p = 0.0001 ) ; in the six patients with activating mutations , all achieved complete ( 33 % ) or partial ( 67 % ) response . All CR patients had E19del detectable in both tumor and plasma . KRAS mutations were detected in two of 49 ( 4 % ) patients , both of whom had rapid progressive disease . Conclusions : Activating EGFR mutations detected in shed DNA in plasma are significantly associated with favorable outcomes in patients with advanced NSCLC receiving docetaxel plus intercalated erlotinib . The addition of docetaxel in this schedule did not diminish the efficacy of erlotinib against patients with EGFR activating mutations BACKGROUND Lung cancer is one of the most common malignant diseases worldwide and associated with considerable morbidity and mortality . New agents targeting the epidermal growth factor system are emerging , but only a subgroup of the patients will benefit from the therapy . Cell free DNA ( cfDNA ) in the blood allows for tumour specific analyses , including KRAS-mutations , and the aim of the study was to investigate the possible prognostic value of plasma mutated KRAS ( pmKRAS ) in patients with non-small cell lung cancer ( NSCLC ) . MATERIAL AND METHODS Patients with newly diagnosed , advanced NSCLC eligible for chemotherapy were enrolled in a prospect i ve biomarker trial . A pre-treatment blood sample was drawn and subsequently DNA was extracted and pmKRAS analysed . The patients received carboplatin ( AUC5 ) i.v . day 1 and vinorelbine ( 30mg/m(2 ) i.v . day 1 and 60mg/m(2 ) p.o . day 8) for a maximum of six cycles . Response to chemotherapy was evaluated according to RECIST v.1.0 by CT scans of the chest and upper abdomen . The presence of pmKRAS at baseline was assessed by an in-house qPCR method . The primary endpoint was overall survival ( OS ) . Secondary end-points were progression free survival ( PFS ) and overall response rate . RESULTS The study included 246 patients receiving a minimum of 1 treatment cycle , and all but four were evaluable for response according to RECIST . Forty-three patients ( 17.5 % ) presented with a KRAS mutation . OS was 8.9 months and PFS by intention to treat 5.4 months . Patients with a detectable plasma-KRAS mutation had a significantly shorter OS and PFS compared to the wild type ( WT ) patients ( median OS 4.8 months versus 9.5 months , HR 1.87 , 95 % CI 1.23 - 2.84 , p=0.0002 and median PFS 3.0 months versus 5.6 months , HR 1.60 , 95 % CI 1.09 - 2.37 , p=0.0043 ) . A multivariate Cox regression analysis confirmed the independent prognostic value of pmKRAS in OS but not in PFS . The response rate to chemotherapy was significantly lower in the group of patients with a mutation compared to WT ( p<0.0001 ) . CONCLUSION The presence of KRAS mutations in plasma may be a marker of poor prognosis and may also hold predictive value . Further validation in an independent cohort is highly needed PURPOSE Mutations in the epidermal growth factor receptor ( EGFR ) kinase domain can predict tumor response to tyrosine kinase inhibitors ( TKIs ) in non-small-cell lung cancer ( NSCLC ) . However , obtaining tumor tissues for mutation analysis is challenging . We hypothesized that plasma-based EGFR mutation analysis is feasible and has value in predicting tumor response in patients with NSCLC . PATIENTS AND METHODS Plasma DNA sample s and matched tumors from 230 patients with stages IIIB to IV NSCLC were analyzed for EGFR mutations in exons 19 and 21 by using denaturing high-performance liquid chromatography . We compared the mutations in the plasma sample s and the matched tumors and determined an association between EGFR mutation status and the patients ' clinical outcomes prospect ively . RESULTS In 230 patients , we detected 81 EGFR mutations in 79 ( 34.3 % ) of the patients ' plasma sample s. We detected the same mutations in 63 ( 79.7 % ) of the matched tumors . Sixteen plasma ( 7.0 % ) and fourteen tumor ( 6.1 % ) sample s showed unique mutations . The mutation frequencies were significantly higher in never-smokers and in patients with adenocarcinomas ( P = .012 and P = .009 , respectively ) . In the 102 patients who failed platinum-based treatment and who were treated with gefitinib , 22 ( 59.5 % ) of the 37 with EGFR mutations in the plasma sample s , whereas only 15 ( 23.1 % ) of the 65 without EGFR mutations , achieved an objective response ( P = .002 ) . Patients with EGFR mutations had a significantly longer progression-free survival time than those without mutations ( P = .044 ) in plasma . CONCLUSION EGFR mutations can be reliably detected in plasma DNA of patients with stages IIIB to IV NSCLC and can be used as a biomarker to predict tumor response to TKIs
Output:
| Sensitivity analyses and subgroup analyses demonstrated the stability of our conclusion .Our analysis showed that EGFR mutations in ctDNA predicted a better PFS , in particular in advanced NSCLC patients treated by EGFR-TKIs .
KRAS mutations in ctDNA indicated a worse PFS and OS in patients treated by chemotherapy |
MS211789 | ***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 Treatment with low-dose amphotericin B ( 0.4 mg per kilogram of body weight per day ) or oral azole therapy in patients with the acquired immunodeficiency syndrome ( AIDS ) and cryptococcal meningitis has been associated with high mortality and low rates of cerebrospinal fluid sterilization . METHODS In a double-blind multicenter trial we r and omly assigned patients with a first episode of AIDS-associated cryptococcal meningitis to treatment with higher-dose amphotericin B ( 0.7 mg per kilogram per day ) with or without flucytosine ( 100 mg per kilogram per day ) for two weeks ( step one ) , followed by eight weeks of treatment with itraconazole ( 400 mg per day ) or fluconazole ( 400 mg per day ) ( step two ) . Treatment was considered successful if cerebrospinal fluid cultures were negative at 2 and 10 weeks or if the patient was clinical ly stable at 2 weeks and asymptomatic at 10 weeks . RESULTS At two weeks , the cerebrospinal fluid cultures were negative in 60 percent of the 202 patients receiving amphotericin B plus flucytosine and in 51 percent of the 179 receiving amphotericin B alone ( P=0.06 ) . Elevated intracranial pressure was associated with death in 13 of 14 patients during step one . The clinical outcome did not differ significantly between the two groups . Seventy-two percent of the 151 fluconazole recipients and 60 percent of the 155 itraconazole recipients had negative cultures at 10 weeks ( 95 percent confidence interval for the difference in percentages , -100 to 21 ) . The proportion of patients who had clinical responses was similar with fluconazole ( 68 percent ) and itraconazole ( 70 percent ) . Overall mortality was 5.5 percent in the first two weeks and 3.9 percent in the next eight weeks , with no significant difference between the groups . In a multivariate analysis , the addition of flucytosine during the initial two weeks and treatment with fluconazole for the next eight weeks were independently associated with cerebrospinal fluid sterilization . CONCLUSIONS For the initial treatment of AIDS-associated cryptococcal meningitis , the use of higher-dose amphotericin B plus flucytosine is associated with an increased rate of cerebrospinal fluid sterilization and decreased mortality at two weeks , as compared with regimens used in previous studies . Although consolidation therapy with fluconazole is associated with a higher rate of cerebrospinal fluid sterilization , itraconazole may be a suitable alternative for patients unable to take fluconazole BACKGROUND HIV-associated cryptococcal meningitis is associated with an estimated 600 000 deaths worldwide per year . Current st and ard initial therapy consists of amphotericin B ( AmB ) plus flucytosine ( 5-FC ) , but 5-FC remains largely unavailable in Asia and Africa . Alternative , more widely available , and /or more effective antifungal combination treatment regimens are urgently needed . METHODS Eighty HIV-seropositive , antiretroviral naive patients presenting with cryptococcal meningitis were r and omized to 4 treatment arms of 2 weeks duration : group 1 , AmB ( 0.7 - 1 mg/kg ) and 5-FC ( 25 mg/kg 4 times daily ) ; group 2 , AmB ( 0.7 - 1 mg/kg ) and fluconazole ( 800 mg daily ) ; group 3 , AmB ( 0.7 - 1 mg/kg ) and fluconazole ( 600 mg twice daily ) ; and group 4 , AmB ( 0.7 - 1 mg/kg ) and voriconazole ( 300 mg twice daily ) . The primary end point was the rate of clearance of infection from the cerebrospinal fluid ( CSF ) or early fungicidal activity ( EFA ) , as determined by results of serial , quantitative CSF cryptococcal cultures . RESULTS There were no statistically significant differences in the rate of clearance of cryptococcal colony-forming units ( CFU ) in CSF sample s among the 4 treatment groups ; the mean ( ±st and ard deviation ) EFA for treatment groups 1 , 2 , 3 , and 4 were -0.41 ± 0.22 log CFU/mL CSF/day , -0.38 ± 0.18 log CFU/mL CSF/day , -0.41 ± 0.35 log CFU/mL CSF/day , and -0.44 ± 0.20 log CFU/mL CSF/day , respectively . Overall mortality was 12 % ( 9 of 78 patients died ) at 2 weeks and 29 % ( 22 of 75 patients died ) at 10 weeks , with no statistically significant differences among groups . There were few laboratory abnormalities related to the second agents given ; in particular , there were no statistically significant ( ≥ grade 3 ) increases in alanine transaminase level or decreases in neutrophil count . CONCLUSIONS There was no statistically significant difference in EFA between AmB in combination with fluconazole and AmB plus 5-FC for the treatment of HIV-associated cryptococcal meningitis . AmB plus fluconazole ( 800 - 1200 mg/day ) represents an immediately implementable alternative to AmB plus 5-FC . AmB plus voriconazole is an effective alternative combination in patients not receiving interacting medications In a prospect i ve observational study of 54 patients with human immunodeficiency virus-associated cryptococcal meningitis , the early fungicidal activity of amphotericin B ( 1 mg/kg/day ) was significantly greater than that of fluconazole ( 400 mg/day ) . Compared with antiretroviral therapy-naive patients , patients developing cryptococcal meningitis while already receiving antiretroviral therapy had lower baseline fungal burdens and a longer median duration of survival , but there were no differences observed in fungal clearance , cerebrospinal fluid proinflammatory cytokines , or 10-week mortality BACKGROUND The st and ard therapy for human immunodeficiency virus (HIV)-associated cryptococcal meningitis of amphotericin B ( AmB ; 0.7 mg/kg per day ) plus flucytosine frequently takes > 2 weeks to sterilize the cerebral spinal fluid , and acute mortality remains high . A dosage range for AmB of 0.7 - 1 mg/kg per day is noted in current guidelines , but there are no data comparing 0.7 mg/kg per day with 1 mg/kg per day . METHODS Sixty-four HIV-seropositive , antiretroviral therapy-naive patients in Cape Town , South Africa , who experienced their first episode of cryptococcal meningitis during the period May 2005-June 2006 were r and omized to receive either ( 1 ) AmB , 0.7 mg/kg per day , plus flucytosine , 25 mg/kg 4 times per day ( group 1 ; 30 patients ) ; or ( 2 ) AmB , 1 mg/kg per day , plus flucytosine , 25 mg/kg 4 times per day ( group 2 ; 34 patients ) . Regimens were given for 2 weeks , followed by treatment with oral fluconazole . The primary outcome measure was early fungicidal activity , as determined by results of serial , quantitative cerebral spinal fluid cryptococcal cultures . Secondary outcome measures were safety and mortality . The median duration of follow-up was 1 year . RESULTS Early fungicidal activity was significantly greater for group 2 than for group 1 ( mean + /- SD , -0.56 + /- 0.24 vs. -0.45 + /- 0.16 log cfu/mL of cerebral spinal fluid per day ; P = .02 ) . The incidence of renal impairment did not significantly differ between the 2 groups . Anemia was associated with female sex and , less strongly , with membership in group 2 . Renal impairment and anemia reversed after the regimen was switched to fluconazole . Two- and 10-week mortality rates were 6 % and 24 % , respectively , with no difference between groups . CONCLUSIONS AmB , 1 mg/kg per day , plus flucytosine is more rapidly fungicidal than is st and ard-dose AmB plus flucytosine . Because of its size , this study provides limited data on any difference in toxicity between the regimens , but toxicities were manageable and reversible . CLINICAL TRIALS REGISTRATION NUMBER IS RCT N68133435 ( http://www.controlled-trials.com ) The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B ( AmB ) lipid complex ( ABLC ) in the treatment of AIDS-associated cryptococcal meningitis . Of 55 patients r and omly assigned to 6 weeks of therapy with ABLC ( 1.2 - 5.0 mg/[kg.d ] , with ascending doses for three sequential cohorts ) or AmB ( 0.7 - 1.2 mg/[kg.d ] ) , 46 received > or = 12 doses . Transfusion requirements , mean decreases in hemoglobin level , and mean increases in creatinine level were significantly greater with AmB than with ABLC . The total number of adverse events , infusion-related events , and occurrences of hypomagnesemia and hypokalemia associated with each form of therapy were similar . Among 21 recipients of ABLC at a dosage of 5 mg/kg ( daily for 2 weeks and then thrice weekly for 4 weeks ) , symptoms and signs resolved for 18 ( 86 % ) . Of those receiving > or = 12 doses of ABLC , cultures converted to negative for 8 ( 42 % ) , were undeterminable for 3 ( 16 % ) , and remained positive for 8 ( 42 % ) despite resolution of symptoms . Although preliminary , these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis . Because this formulation has less hematologic and renal toxicity than does AmB , further evaluation of ABLC is warranted Background : Cryptococcal meningitis in Africa is associated with up to 70 % mortality at 3 months and 500 000 deaths annually . We examined strategies to improve on fluconazole ( FLU ) monotherapy : addition of flucytosine ( 5-FC ) and /or addition of short-course amphotericin B ( AmB ) . Methods : In step 1 , previously reported , patients were r and omized to receive FLU 1200 mg per day with or without 5-FC 100 mg/kg per day for 14 days . In step 2 , 43 patients were similarly r and omized , with addition of AmB 1 mg/kg per day for 7 days to both arms . After 2 weeks , patients received FLU monotherapy and were followed to 10 weeks . The primary endpoint was rate of clearance of infection ( early fungicidal activity , EFA ) . Secondary endpoints related to safety and mortality . Results : Forty patients ( 25 % with Glasgow Coma Scale < 15 ) were analyzed . EFA for the triple combination arm was greater than that for AmB – FLU : −0.50 ± 0.15 log CFU/day vs. −0.38 ± 0.19 log colony forming units per day ( P = 0.03 ) ; and greater than that for step 1 with FLU–5-FC ( −0.28 ± 0.17 ) or FLU alone ( −0.11 ± 0.09 ) . Combined analysis across steps revealed that addition of 5-FC and AmB had significant , independent additive effects on EFA , with trends toward fewer early deaths with addition of 5-FC ( 4/41 vs. 11/39 , P = 0.05 ) and fewer deaths overall with addition of AmB ( 13/39 vs. 20/40 , P = 0.1 ) . Conclusion : Addition of 5-FC and short-course AmB to high-dose FLU significantly enhanced EFA and may be associated with favorable trends in survival . Both these strategies should be tested in a larger phase III study 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 . It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis . However , administration of this drug is accompanied by substantial adverse effects . This double-blind study , performed before the routine availability of highly active antiretroviral therapy , was design ed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome ( AIDS ) and acute cryptococcal meningitis . METHODS . Patients were r and omized ( ratio , 1:1:1 ) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day ( n = 87 ) , liposomal amphotericin B at 3 mg/kg/day ( n = 86 ) , or liposomal amphotericin B at 6 mg/kg/
Output:
| A statistically significant trial-level correlation was identified between EFA slope and ACM at 2 weeks , but is likely misleading , as there was no treatment effect on ACM .
CONCLUSIONS Mortality remains high in short time periods in CM clinical trials . |
MS211790 | ***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: Recent studies suggest that months to years of intensive and systematic meditation training can improve attention . However , the lengthy training required has made it difficult to use r and om assignment of participants to conditions to confirm these findings . This article shows that a group r and omly assigned to 5 days of meditation practice with the integrative body – mind training method shows significantly better attention and control of stress than a similarly chosen control group given relaxation training . The training method comes from traditional Chinese medicine and incorporates aspects of other meditation and mindfulness training . Compared with the control group , the experimental group of 40 undergraduate Chinese students given 5 days of 20-min integrative training showed greater improvement in conflict scores on the Attention Network Test , lower anxiety , depression , anger , and fatigue , and higher vigor on the Profile of Mood States scale , a significant decrease in stress-related cortisol , and an increase in immunoreactivity . These results provide a convenient method for study ing the influence of meditation training by using experimental and control methods similar to those used to test drugs or other interventions BACKGROUND Yoga and meditation have been shown to be effective in alleviating symptoms of depression and anxiety in healthy volunteers and psychiatric population s. Recent work has also indicated that yoga can improve cognitive-behavioural performance and control . Although there have been no controlled studies of the effects of yoga in a prison population , we reasoned that yoga could have beneficial effects in a setting where psychosocial functioning is often low , and the frequency of impulsive behaviours is high . METHODS Participants were recruited from 7 British prisons and r and omly allocated to either a 10-week yoga programme ( yoga group ; 1 class per week ; N = 45 ) or a control group ( N = 55 ) . Self-report measures of mood , stress , and psychological distress were collected before and after the intervention period . Participants completed a cognitive-behavioural task ( Go/No-Go ) at the end of the study , which assessed behavioural response inhibition and sustained attention . RESULTS Participants in the yoga group showed increased self-reported positive affect , and reduced stress and psychological distress , compared to participants in the control group . Participants who completed the yoga course also showed better performance in the cognitive-behavioural task , making significantly fewer errors of omission in Go trials and fewer errors of commission on No-Go trials , compared to control participants . CONCLUSIONS Yoga may be effective in improving subjective wellbeing , mental health , and executive functioning within prison population s. This is an important consideration given the consistently high rates of psychological morbidity in this group and the need for effective and economical intervention programmes Background : The dem and for clinical ly efficacious , safe , patient acceptable , and cost-effective forms of treatment for mental illness is growing . Several studies have demonstrated benefit from yoga in specific psychiatric symptoms and a general sense of well-being . Objective : To systematic ally examine the evidence for efficacy of yoga in the treatment of selected major psychiatric disorders . Methods : Electronic search es of The Cochrane Central Register of Controlled Trials and the st and ard bibliographic data bases , MEDLINE , EMBASE , and PsycINFO , were performed through April 2011 and an up date d in June 2011 using the keywords yoga AND psychiatry OR depression OR anxiety OR schizophrenia OR cognition OR memory OR attention AND r and omized controlled trial ( RCT ) . Studies with yoga as the independent variable and one of the above mentioned terms as the dependent variable were included and exclusion criteria were applied . Results : The search yielded a total of 124 trials , of which 16 met rigorous criteria for the final review . Grade B evidence supporting a potential acute benefit for yoga exists in depression ( four RCTs ) , as an adjunct to pharmacotherapy in schizophrenia ( three RCTs ) , in children with ADHD ( two RCTs ) , and Grade C evidence in sleep complaints ( three RCTs ) . RCTs in cognitive disorders and eating disorders yielded conflicting results . No studies looked at primary prevention , relapse prevention , or comparative effectiveness versus pharmacotherapy . Conclusion : There is emerging evidence from r and omized trials to support popular beliefs about yoga for depression , sleep disorders , and as an augmentation therapy . Limitations of literature include inability to do double-blind studies , multiplicity of comparisons within small studies , and lack of replication . Biomarker and neuroimaging studies , those comparing yoga with st and ard pharmaco- and psychotherapies , and studies of long-term efficacy are needed to fully translate the promise of yoga for enhancing mental health The present study evaluated whether Posttraumatic Stress Disorder ( PTSD ) symptom severity was associated with participation and treatment outcomes comparing a Vipassana meditation course to treatment as usual in an incarcerated sample . This study utilizes secondary data . The original study demonstrated that Vipassana meditation is associated with reductions in substance use . The present study found that PTSD symptom severity did not differ significantly between those who did and did not volunteer to take the course . Participation in the Vipassana course was associated with significantly greater reductions in substance use than treatment as usual , regardless of PTSD symptom severity levels . These results suggest that Vipassana meditation is worthy of further study for those with comorbid PTSD and substance use problems BACKGROUND Emotional distress is an increasing public health problem and Hatha yoga has been cl aim ed to induce stress reduction and empowerment in practicing subjects . We aim ed to evaluate potential effects of Iyengar Hatha yoga on perceived stress and associated psychological outcomes in mentally distressed women . MATERIAL / METHODS A controlled prospect i ve non-r and omized study was conducted in 24 self-referred female subjects ( mean age 37.9+/-7.3 years ) who perceived themselves as emotionally distressed . Subjects were offered participation in one of two subsequential 3-months yoga programs . Group 1 ( n=16 ) participated in the first class , group 2 ( n=8 ) served as a waiting list control . During the yoga course , subjects attended two-weekly 90-min Iyengar yoga classes . Outcome was assessed on entry and after 3 months by Cohen Perceived Stress Scale , State-Trait Anxiety Inventory , Profile of Mood States , CESD-Depression Scale , Bf-S/Bf-S ' Well-Being Scales , Freiburg Complaint List and ratings of physical well-being . Salivary cortisol levels were measured before and after an evening yoga class in a second sample . RESULTS Compared to waiting-list , women who participated in the yoga-training demonstrated pronounced and significant improvements in perceived stress ( P<0.02 ) , State and Trait Anxiety ( P<0.02 and P<0.01 , respectively ) , well-being ( P<0.01 ) , vigor ( P<0.02 ) , fatigue ( P<0.02 ) and depression ( P<0.05 ) . Physical well-being also increased ( P<0.01 ) , and those subjects suffering from headache or back pain reported marked pain relief . Salivary cortisol decreased significantly after participation in a yoga class ( P<0.05 ) . CONCLUSIONS Women suffering from mental distress participating in a 3-month Iyengar yoga class show significant improvements on measures of stress and psychological outcomes . Further investigation of yoga with respect to prevention and treatment of stress-related disease and of underlying mechanism is warranted BACKGROUND This report presents the results of confirmatory factor analyses of patterns of comorbidity among 10 common mental disorders in the National Comorbidity Survey , a national probability sample of US civilians who completed structured diagnostic interviews . METHODS Patterns of comorbidity among DSM-III-R mental disorders were analyzed via confirmatory factor analyses for the entire National Comorbidity Survey sample ( N = 8098 ; age range , 15 - 54 years ) , for r and om halves of the sample , for men and women separately , and for a sub sample of participants who were seeing a professional about their mental health problems . Four models were compared : a 1-factor model , a 2-factor model in which some disorders represented internalizing problems and others represented externalizing problems , a 3-factor variant of the 2-factor model in which internalizing was modeled as having 2 subfactors ( anxious-misery and fear ) , and a 4-factor model in which the disorders represented separate affective , anxiety , substance dependence , and antisocial factors . RESULTS The 3-factor model provided the best fit in the entire sample . This result was replicated across r and om halves of the sample as well as across women and men . The substantial empirical intercorrelation between anxious-misery and fear ( 0.73 ) suggested that these factors were most appropriately conceived as subfactors of a higher-order internalizing factor . In the treatment sample , the 2-factor model fit best . CONCLUSIONS The results offer a novel perspective on comorbidity , suggesting that comorbidity results from common , underlying core psychopathological processes . The results thereby argue for focusing research on these core processes themselves , rather than on their varied manifestations as separate disorders Psychological distress among college students represents a serious health concern . The aim of this research was to investigate , for the first time , whether interactions between rumination and different measures of stress could differentially predict components of psychological distress , within a diathesis-stress framework . This self-report study employed a longitudinal design , spanning a period of 6 months . One hundred sixty-one undergraduate college students completed selected measures of psychological distress , rumination , and stress at two time points 6 months apart . Both independent and interaction effects were examined through hierarchical regression analyses . Rumination and stress were found to interact significantly to predict the social dysfunction components of psychological distress . Other main effects are reported . The evidence supported the proposed diathesis-stress model and extended previous research by relating rumination to different components of psychological distress prospect ively PURPOSE This study examines the impact of yoga , including physical poses , breathing , and meditation exercises , on quality of life ( QOL ) , fatigue , distressed mood , and spiritual well-being among a multiethnic sample of breast cancer patients . PATIENTS AND METHODS One hundred twenty-eight patients ( 42 % African American , 31 % Hispanic ) recruited from an urban cancer center were r and omly assigned ( 2:1 ratio ) to a 12-week yoga intervention ( n = 84 ) or a 12-week waitlist control group ( n = 44 ) . Changes in QOL ( eg , Functional Assessment of Cancer Therapy ) from before r and om assignment ( T1 ) to the 3-month follow-up ( T3 ) were examined ; predictors of adherence were also assessed . Nearly half of all patients were receiving medical treatment . RESULTS Regression analyses indicated that the control group had a greater decrease in social well-being compared with the intervention group after controlling for baseline social well-being and covariates ( P < .0001 ) . Secondary analyses of 71 patients not receiving chemotherapy during the intervention period indicated favorable outcomes for the intervention group compared with the control group in overall QOL ( P < .008 ) , emotional well-being ( P < .015 ) , social well-being ( P < .004 ) , spiritual well-being ( P < .009 ) , and distressed mood ( P < .031 ) . Sixty-nine percent of intervention participants attended classes ( mean number of classes attended by active class participants = 7.00 + /- 3.80 ) , with lower adherence associated with increased fatigue ( P < .001 ) , radiotherapy ( P < .0001 ) , younger age ( P < .008 ) , and no antiestrogen therapy ( P < .02 ) . CONCLUSION Despite limited adherence , this intent-to-treat analysis suggests that yoga is associated with beneficial effects on social functioning among a medically diverse sample of breast cancer survivors . Among patients not receiving chemotherapy , yoga appears to enhance emotional well-being and mood and may serve to buffer deterioration in both overall and specific domains of QOL
Output:
| Overall , the evidence suggests that yoga and meditation have favourable effects on prisoners |
MS211791 | ***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 Activation of the phosphatidylinositol-3-kinase ( PI3 K ) and /or mitogen-activated protein kinase ( MAPK ) pathways results in anti-estrogen resistance in vitro , but a biomarker with clinical validity to predict intrinsic resistance has not been identified . In metastatic breast cancer patients with previous exposure to endocrine therapy , the addition of a mammalian target of rapamycine ( mTOR ) inhibitor has been shown to be beneficial . Whether or not patients on adjuvant endocrine treatment might benefit from these drugs is currently unclear . A biomarker that predicts intrinsic resistance could potentially be used as companion diagnostic in this setting . We tested the clinical validity of different downstream-activated proteins in the PI3 K and /or MAPK pathways to predict intrinsic tamoxifen resistance in postmenopausal primary breast cancer patients . Methods We recollected primary tumor tissue from patients who participated in a r and omized trial of adjuvant tamoxifen ( 1–3 years ) versus observation . After constructing a tissue micro-array , cores from 563 estrogen receptor α positive were immunostained for p-AKT(Thr308 ) , p-AKT(Ser473 ) , p-mTOR , p-p706SK and p-ERK1/2 . Cox proportional hazard models for recurrence free interval were used to assess hazard ratios and interactions between these markers and tamoxifen treatment efficacy . Results Interactions were identified between tamoxifen and p-AKT(Thr308 ) , p-mTOR , p-p70S6 K and p-ERK1/2 . Applying a conservative level of significance , p-p70S6 K remained significantly associated with tamoxifen resistance . Patients with p-p70S6 K negative tumors derived significant benefit from tamoxifen ( HR 0.24 , P < 0.0001 ) , while patients whose tumor did express p-p70S6 K did not ( HR = 1.02 , P = 0.95 ) , P for interaction 0.004 . In systemically untreated breast cancer patients , p-p70S6 K was associated with a decreased risk for recurrence . Conclusions Patients whose tumor expresses p-p70S6 K , as a marker of downstream PI3 K and /or MAPK pathway activation , have a favorable prognosis , but do not benefit from adjuvant tamoxifen . A potential benefit from inhibitors of the PI3K/Akt/mTOR pathway in these patients needs to be further explored Background and purpose There are scarce data available on the prognostic/predictive value of p-Akt and p-mTOR protein expression in patients with high-risk early breast cancer . Patients and methods Formalin-fixed paraffin-embedded ( FFPE ) tumor tissue sample s from 997 patients participating in two adjuvant phase III trials were assessed for EGFR , PTEN , p-Akt , p-mTOR protein expression , and PIK3CA mutational status . These markers were evaluated for associations with each other and with selected patient and tumor characteristics , immunohistochemical subtypes , disease-free survival ( DFS ) , and overall survival ( OS ) . Results p-mTOR protein expression was negatively associated with EGFR and positively associated with PTEN , with p-Akt473 , and with the presence of PIK3CA mutations . EGFR expression was positively associated with p-Akt473 , p-Akt308 , and PIK3CA wild-type tumors . Finally , p-Akt308 was positively associated with p-Akt473 expression . In univariate analysis , EGFR ( p = 0.016 ) and the coexpression of EGFR and p-mTOR ( p = 0.015 ) were associated with poor OS . Among patients with p-Akt308-negative or low-expressing tumors , those treated with hormonal therapy were associated with decreased risk for both relapse and death ( p = 0.013 and p < 0.001 , respectively ) . In the subgroup of patients with locoregional relapse , positive EGFR and mTOR protein expression was found to be associated with increased ( p = 0.034 ) and decreased ( p < 0.001 ) risk for earlier relapse , respectively . In multivariate analysis , low levels of p-Akt308 and the coexpression of EGFR and p-mTOR retained their prognostic value . Conclusion Low protein expression of p-Akt308 was associated with improved DFS and OS among patients treated with hormonal therapy following adjuvant chemotherapy . Coexpression of EGFR and p-mTOR was associated with worse OS.ZusammenfassungHintergrundGeringe Date n existieren über den prognostischen/prädiktiven Wert der p-Akt- und p-mTOR-Proteinexpression bei Patienten mit “ High-risk”-Mammakarzinom i m Frühstadium . Patienten und Method enFormalinfixierte und in Paraffin eingebettete ( FFPE ) Tumorgewebeproben von 997 Patienten , welche i m Rahmen von 2 adjuvanten Phase-III-Studien zytostatisch beh and elt wurden , wurden auf EGFR , PTEN , p-Akt , pmTOR und PIK3CA-Mutationsstatus untersucht . Diese Marker wurden in Assoziation mit ausgewählten Patienten- und Tumorcharakteristika , immunhistochemischen Mammakarzinomsubtypen , dem krankheitsfreien Überleben ( DFS ) sowie dem Gesamtüberleben ( OS ) evaluiert . ErgebnisseDie Expression von p-mTOR war negativ mit der Expression von EGFR , jedoch signifikant positiv mit PTEN und p-Akt473 sowie dem Nachweis von PIK3CA-Mutationen assoziiert . Die EGFR-Expression war signifikant positiv mit der Proteinexpression von p-Akt473 und p-Akt308 sowie PIK3CA-Wildtyp-Tumoren assoziiert . Die p-Akt308-Expression war ebenfalls signifikant positiv mit der Expression von p-Akt473 assoziiert . In der univariaten Analyse war sowohl die EGFR ( p = 0,016 ) , als auch die Koexpression von EGFR und p-mTOR ( p = 0,015 ) mit einem schlechteren OS assoziiert . Unter den Patienten mit p-Akt308-negativen oder gering exprimierenden Tumoren konnte bei denjenigen , die mit einer Hormontherapie beh and elt wurden , ein signifikant vermindertes Risiko für ein Rezidiv als auch für den Tod ( jeweils p = 0,013 und p < 0,001 ) nachgewiesen werden . In der Subgruppenanalyse von Patienten mit lokoregionärem Rezidiv konnte eine Assoziation von positivem EGFR-Status sowie mTOR-Expression mit einem jeweils erhöhten ( p = 0,034 ) bzw . verminderten ( p < 0,001 ) Risiko für das Auftreten von Frührezidiven nachgewiesen werden . In der multivariaten Analyse behielten die niedrigen p-Akt308-Werte und die Koexpression von EGFR und p-mTOR ihren prognostischen Wert . FazitEine niedrige Expression von p-Akt308 bei Patienten , die eine Hormontherapie nach einer adjuvanten Chemotherapie erhielten , war mit einem verbesserten DFS und OS assoziiert . Die Koexpression von EGFR und p-mTOR war mit einem schlechteren OS assoziiert In a phase 3 , double-blind , r and omized , international study ( the BOLERO-2 ) , the addition of mTOR inhibitor everolimus to exemestane was evaluated in postmenopausal women with estrogen-receptor-positive ( ER⁺ ) advanced/recurrent breast cancer that was refractory to any nonsteroidal aromatase inhibitor ( NSAI ) . This report presents the safety and up date d ( 18- month ) efficacy results from the Japanese subset ( n=106 ) of BOLERO-2 . After a median follow-up of 18 months , the median progression-free survival time was 8.5 months with everolimus plus exemestane compared to 4.2 months with placebo plus exemestane . The most common adverse events ( AEs ) with everolimus plus exemestane were stomatitis , rash , dysgeusia , and non-infectious lung disease . The AEs reported with the combination therapy were mostly of grade 1 or 2 and manageable with appropriate intervention . In conclusion , this combination could be a useful addition to the armamentarium of treatments for Japanese postmenopausal women with ER⁺ advanced/recurrent breast cancer progressing on NSAIs BACKGROUND Resistance to endocrine therapy in breast cancer is associated with activation of the mammalian target of rapamycin ( mTOR ) intracellular signaling pathway . In early studies , the mTOR inhibitor everolimus added to endocrine therapy showed antitumor activity . METHODS In this phase 3 , r and omized trial , we compared everolimus and exemestane versus exemestane and placebo ( r and omly assigned in a 2:1 ratio ) in 724 patients with hormone-receptor-positive advanced breast cancer who had recurrence or progression while receiving previous therapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat advanced disease ( or both ) . The primary end point was progression-free survival . Secondary end points included survival , response rate , and safety . A preplanned interim analysis was performed by an independent data and safety monitoring committee after 359 progression-free survival events were observed . RESULTS Baseline characteristics were well balanced between the two study groups . The median age was 62 years , 56 % had visceral involvement , and 84 % had hormone-sensitive disease . Previous therapy included letrozole or anastrozole ( 100 % ) , tamoxifen ( 48 % ) , fulvestrant ( 16 % ) , and chemotherapy ( 68 % ) . The most common grade 3 or 4 adverse events were stomatitis ( 8 % in the everolimus-plus-exemestane group vs. 1 % in the placebo-plus-exemestane group ) , anemia ( 6 % vs. < 1 % ) , dyspnea ( 4 % vs. 1 % ) , hyperglycemia ( 4 % vs. < 1 % ) , fatigue ( 4 % vs. 1 % ) , and pneumonitis ( 3 % vs. 0 % ) . At the interim analysis , median progression-free survival was 6.9 months with everolimus plus exemestane and 2.8 months with placebo plus exemestane , according to assessment s by local investigators ( hazard ratio for progression or death , 0.43 ; 95 % confidence interval [ CI ] , 0.35 to 0.54 ; P<0.001 ) . Median progression-free survival was 10.6 months and 4.1 months , respectively , according to central assessment ( hazard ratio , 0.36 ; 95 % CI , 0.27 to 0.47 ; P<0.001 ) . CONCLUSIONS Everolimus combined with an aromatase inhibitor improved progression-free survival in patients with hormone-receptor-positive advanced breast cancer previously treated with nonsteroidal aromatase inhibitors . ( Funded by Novartis ; BOLERO-2 Clinical Trials.gov number , NCT00863655 . ) BACKGROUND Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway . We aim ed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab . METHODS In this r and omised , double-blind , placebo-controlled , phase 3 trial , we recruited women with HER2-positive , trastuzumab-resistant , advanced breast carcinoma who had previously received taxane therapy . Eligible patients were r and omly assigned ( 1:1 ) using a central patient screening and r and omisation system to daily everolimus ( 5 mg/day ) plus weekly trastuzumab ( 2 mg/kg ) and vinorelbine ( 25 mg/m(2 ) ) or to placebo plus trastuzumab plus vinorelbine , in 3-week cycles , stratified by previous lapatinib use . The primary endpoint was progression-free survival ( PFS ) by local assessment in the intention-to-treat population . We report the final analysis for PFS ; overall survival follow-up is still in progress . This trial is registered with Clinical Trials.gov , number NCT01007942 . FINDINGS Between Oct 26 , 2009 , and May 23 , 2012 , 569 patients were r and omly assigned to everolimus ( n=284 ) or placebo ( n=285 ) . Median follow-up at the time of analysis was 20.2 months ( IQR 15.0 - 27.1 ) . Median PFS was 7.00 months ( 95 % CI 6.74 - 8.18 ) with everolimus and 5.78 months ( 5.49 - 6.90 ) with placebo ( hazard ratio 0.78 [ 95 % CI 0.65 - 0.95 ] ; p=0.0067 ) . The
Output:
| Our findings suggested that p-mTOR overexpression was not significantly related to prognosis in breast carcinoma regarding OS and disease recurrence . |
MS211792 | ***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 Since inflammation is believed to have a role in the pathogenesis of cardiovascular events , measurement of markers of inflammation has been proposed as a method to improve the prediction of the risk of these events . METHODS We conducted a prospect i ve , nested case-control study among 28,263 apparently healthy postmenopausal women over a mean follow-up period of three years to assess the risk of cardiovascular events associated with base-line levels of markers of inflammation . The markers included high-sensitivity C-reactive protein ( hs-CRP ) , serum amyloid A , interleukin-6 , and soluble intercellular adhesion molecule type 1 ( sICAM-1 ) . We also studied homocysteine and a variety of lipid and lipoprotein measurements . Cardiovascular events were defined as death from coronary heart disease , nonfatal myocardial infa rct ion or stroke , or the need for coronary-revascularization procedures . RESULTS Of the 12 markers measured , hs-CRP was the strongest univariate predictor of the risk of cardiovascular events ; the relative risk of events for women in the highest as compared with the lowest quartile for this marker was 4.4 ( 95 percent confidence interval , 2.2 to 8.9 ) . Other markers significantly associated with the risk of cardiovascular events were serum amyloid A ( relative risk for the highest as compared with the lowest quartile , 3.0 ) , sICAM-1 ( 2.6 ) , interleukin-6 ( 2.2 ) , homocysteine ( 2.0 ) , total cholesterol ( 2.4 ) , LDL cholesterol ( 2.4 ) , apolipoprotein B-100 ( 3.4 ) , HDL cholesterol ( 0.3 ) , and the ratio of total cholesterol to HDL cholesterol ( 3.4 ) . Prediction models that incorporated markers of inflammation in addition to lipids were significantly better at predicting risk than models based on lipid levels alone ( P<0.001 ) . The levels of hs-CRP and serum amyloid A were significant predictors of risk even in the subgroup of women with LDL cholesterol levels below 130 mg per deciliter ( 3.4 mmol per liter ) , the target for primary prevention established by the National Cholesterol Education Program . In multivariate analyses , the only plasma markers that independently predicted risk were hs-CRP ( relative risk for the highest as compared with the lowest quartile , 1.5 ; 95 percent confidence interval , 1.1 to 2.1 ) and the ratio of total cholesterol to HDL cholesterol ( relative risk , 1.4 ; 95 percent confidence interval , 1.1 to 1.9 ) . CONCLUSIONS The addition of the measurement of C-reactive protein to screening based on lipid levels may provide an improved method of identifying persons at risk for cardiovascular events Increased cardiovascular mortality has been associated with rheumatoid arthritis ( RA ) . There have been reports indicating that tumor necrosis factor blockers may exert favorable but transient effects on lipid profile , flow-mediated vasodilation ( FMD ) of the brachial artery , and common carotid intima – media thickness ( ccIMT ) in RA . In this study , we assessed the effects of rituximab on FMD , ccIMT , and lipid profile . Five female RA patients received two infusions of 1000 mg rituximab i.v . High-resolution B-mode ultrasound was used to assess brachial FMD and ccIMT . We also determined plasma total cholesterol ( TC ) , HDL-C , LDL-C , and triglyceride ( Tg ) levels . Assessment s were performed at baseline , as well as at weeks 2 , 6 , and 16 after the first infusion . Rituximab ( RTX ) treatment result ed in a rapid and sustained improvement in FMD . The mean improvement was 30 % , 22 % , and 81 % at weeks 2 , 6 , and 16 , respectively . RTX had little effect on atherosclerosis within this short period of time ; however , we observed 10 % , 9 % , and 2 % decreases in ccIMT at weeks 2 , 6 , and 16 , respectively . RTX therapy result ed in 3–11 % decrease in TC , as well as 14–35 % increase in HDL-C levels . Two infusions of RTX exerted early and sustained favorable effects on endothelial dysfunction , as well as plasma TC and HDL-C levels . RTX may also decrease ccIMT ; however , longer follow-up is needed to assess the prolonged effects of RTX on vascular function and lipid profile in RA patients Objectives : Rheumatoid arthritis ( RA ) is associated with increased cardiovascular disease ( CVD ) risk that has been attributed to endothelial dysfunction and inflammation . Non‐steroidal anti‐inflammatory drugs ( NSAIDs ) and cyclo‐oxygenase (COX)‐2 inhibitors have been shown in some studies to improve endothelial function in subjects without RA . The aim of this study was to investigate the effects of COX inhibition on endothelial function in patients with RA . Methods : Patients with RA ( n = 37 ) were r and omized to receive a 2‐week course of either indomethacin ( 75 mg bd ) , rofecoxib ( 12.5 mg bd ) , or placebo in a double‐blind study . Endothelial function was measured using flow‐mediated dilation ( FMD ) of the brachial artery in response to reactive hyperaemia . Arterial stiffness was also assessed using pulse wave analysis ( PWA ) through the measurement of the aortic augmentation index ( AIx ) . Measurements of vascular function and inflammatory markers were taken before and at the end of the treatment period . Results : There were no significant differences in changes in FMD , AIx , blood pressure ( BP ) , serum creatinine , erythrocyte sedimentation rate ( ESR ) , or high‐sensitivity C‐reactive protein ( hsCRP ) between groups . However , compared with the other treatment groups , there was a tendency for systolic BP to decrease in the placebo group ( p = 0.063 ) and for creatinine to increase in the indomethacin and rofecoxib groups after treatment ( p = 0.054 ) . Conclusions : This study suggests that COX inhibition by indomethacin or rofecoxib do not improve endothelial function in patients with RA BACKGROUND Endothelial vasodilator dysfunction is a characteristic feature of patients at risk for coronary atherosclerosis . Therefore , we prospect ively investigated whether coronary endothelial dysfunction predicts disease progression and cardiovascular event rates . METHODS AND RESULTS Coronary vasoreactivity was assessed in 147 patients using the endothelium-dependent dilator acetylcholine , sympathetic activation by cold pressor testing , dilator responses to increased blood flow , and dilation in response to nitroglycerin . Cardiovascular events ( cardiovascular death , unstable angina , myocardial infa rct ion , percutaneous transluminal coronary angioplasty , coronary bypass grafting , ischemic stroke , or peripheral artery revascularization ) served as outcome variables over a median follow-up period of 7.7 years . Patients suffering from cardiovascular events during follow-up ( n=16 ) had significantly increased vasoconstrictor responses to acetylcholine infusion ( P=0 . 009 ) and cold pressor testing ( P=0.002 ) , as well as significantly blunted vasodilator responses to increased blood flow ( P<0.001 ) and the intracoronary injection of nitroglycerin ( P=0.001 ) . Impaired endothelial and endothelium-independent coronary vasoreactivity were associated with a significantly higher incidence of cardiovascular events by Kaplan-Meier analysis . By multivariate analysis , all tests of coronary vasoreactivity were significant , independent predictors of a poor prognosis , even after adjustment for traditional cardiovascular risk factors or the presence of atherosclerosis itself . CONCLUSIONS Coronary endothelial vasodilator dysfunction predicts long-term atherosclerotic disease progression and cardiovascular event rates . Thus , the assessment of coronary endothelial vasoreactivity can provide pivotal information as both a diagnostic and prognostic tool in patients at risk for coronary heart disease Objectives : Vascular endothelial function and common carotid artery intima – medial thickness ( CCA‐IMT ) are well‐established surrogate markers for early atherosclerotic disease , which accounts for 30–40 % of excess mortality in rheumatoid arthritis ( RA ) patients . Our aim was to investigate whether long‐term treatment with anti‐tumour necrosis factor (TNF)α agents can modulate endothelial function and CCA‐IMT . Methods : Twelve patients with RA ( mean age 54.8±15 years ) on anti‐TNFα treatment ( seven adalimumab , five infliximab ) due to uncontrolled disease activity , with mean Disease Activity Score ( DAS28 ) 5.7 ( range 4.6–6.9 ) despite disease‐modifying anti‐rheumatic drugs ( DMARDs ) , were studied prospect ively . Patients were assessed at baseline and after 3 and 18 months for endothelial‐dependent vasodilatation , assessed by flow‐mediated vasodilatation ( FMD ) , endothelial‐independent vasodilatation and CCA‐IMT . RA disease activity and response to therapy were assessed by the DAS28 index . Results : After 18 months of treatment , 67 % of the patients were responders according to European League Against Rheumatism ( EULAR ) response criteria . Anti‐TNFα treatment improved FMD ( from 7±4.3 % to 11.1±3.8 % , p = 0.026 ) whereas CCA‐IMT did not change significantly [ from 0.67 ( 0.4–1 ) to 0.68 ( 0.39–1.2 ) mm ; mean change 0.01 ( −0.06 to 0.08 ) mm ] . Endothelial‐independent vasodilatation remained stable ( 20.4±7.3 % to 22.9±6.5 % , p = 0.4 ) . Conclusions : In this small cohort of patients with RA and no clinical ly overt cardiovascular disease ( CVD ) , after 18 months of treatment with anti‐TNFα agents , endothelial function improved significantly while CCA‐IMT remained stable . Longitudinal studies using more patients are needed to determine the clinical significance of these findings in relation to the risk of atherosclerosis OBJECTIVE To vali date the European League Against Rheumatism ( EULAR ) , the American College of Rheumatology ( ACR ) , and the World Health Organization (WHO)/International League Against Rheumatism ( ILAR ) response criteria for rheumatoid arthritis ( RA ) . METHODS EULAR response criteria were developed combining change from baseline and level of disease activity attained during follow up . In a trial comparing hydroxychloroquine and sulfasalazine , we studied construct ( radiographic progression ) , criterion ( functional capacity ) , and discriminant validity . RESULTS EULAR response criteria had good construct , criterion , and discriminant validity , ACR and WHO/ILAR criteria showed only good criterion validity . CONCLUSION EULAR response criteria showed better construct and discriminant validity than did the ACR and the WHO/ILAR response criteria for RA NG monomethyl-L-arginine ( L-NMMA ) , a specific inhibitor of the synthesis of endothelium-derived nitric oxide ( NO ) , was infused into the brachial arteries of healthy volunteers to study the role of NO in the control of forearm blood flow . L-NMMA caused a 50 % fall in basal blood flow and attenuated the dilator response to infused acetylcholine but not that to glyceryl trinitrate . These results indicate that the dilator action of endothelium-derived NO contributes to the control of basal and stimulated regional blood flow in man . Impairment of production of NO might account for the abnormalities in vascular reactivity that characterise a wide variety of disease states Introduction In this study we aim ed to investigate whether there are indications of premature atherosclerosis , as measured by endothelial dependent flow-mediated dilation ( ED-FMD ) and intima media thickness ( IMT ) , in patients with very early RA , and to analyze its relation to biomarkers of endothelial dysfunction , taking inflammation and traditional cardiovascular disease ( CVD ) risk factors into account . Methods Patients from the three northern counties of Sweden diagnosed with early RA are followed in an ongoing prospect i ve study of CVD co-morbidity . Of these , all patients aged ≤60 years were consecutively included in this survey of CVD risk factors ( n = 79 ) . Forty-four age and sex matched controls were included . IMT of common carotid artery and ED-FMD of brachial artery were measured using ultrasonography . Blood was drawn for analysis of lipids , erythrocyte sedimentation rate ( ESR ) , C-reactive protein ( CRP ) , plasminogen activator inhibitor-1 ( PAI-1 ) , tissue plasminogen activator (tPA)-mass , VonWillebr and factor ( VWF ) , soluble intercellular adhesion molecule-1 ( sICAM ) , soluble vasc
Output:
| RESULTS Vascular function and morphology was impaired in RA relative to healthy controls .
The majority of studies reported no associations between systemic inflammation and vascular function .
CONCLUSION The link between systemic inflammation and vascular function and morphology is not wholly supported by the available literature . |
MS211793 | ***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 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 The association between long-term use of depot-medroxyprogesterone acetate ( DMPA ) and bone mineral density ( BMD ) has been controversial , as seen in three case-control studies in New Zeal and , Thail and , and the United Kingdom . In the present case-controlled study of BMD , a group of 67 Chinese women who had used DMPA from 5 - 15 years was compared with 218 women of the same age range who had not used any steroidal hormones . DMPA users were found to have a significantly lower BMD at lumbar vertebra ( L2 - 4 ) ( 0.93 g/cm2 ) , neck of femur ( 0.69 g/cm2 ) , trochanter ( 0.59 g/cm2 ) , and Ward 's triangle ( 0.58 g/cm2 ) , as compared with the control group , whose corresponding BMD values were 1.03 g/cm2 , 0.83 g/cm2 , 0.71 g/cm2 , and 0.78 g/cm2 , respectively ( p < 0.001 ) . The average percentage of bone loss per year was estimated to be 1.1 % in L2 - 4 , 2.3 % in neck of femur , 2.4 % in trochanter , and 3.5 % in Ward 's triangle . The percentage of bone loss in L2 - 4 was found to be more pronounced with age . This study provided information that the use of DMPA in a Chinese group for > 5 years in associated with bone loss , and a prospect i ve study is needed to confirm these data , which are different from two case-control studies The calcium requirement for prolonged lactation was investigated in a r and omized supplementation study of Gambian mothers consuming a low-calcium diet ( 7.1 mmol/d , or 283 mg/d ) . Sixty women were studied from 10 d to 78 wk of lactation , receiving calcium or placebo for the first 12 mo . The supplement increased average calcium intake by 17.9 mmol/d ( 714 mg/d ) . Supplementation had no effect on breast-milk calcium concentration or on maternal bone mineral content . Urinary calcium output was higher in supplemented than in unsupplemented mothers by 1.18 mmol/d ( 47 mg/d ) , P < or = 0.005 . Longitudinal changes in urinary calcium output and bone mineral content made a substantial contribution to calcium requirements for lactation . This study suggests that , in women with low calcium intakes , there is no direct benefit from increasing calcium intake during lactation , and that physiological mechanisms operate to furnish calcium for breast-milk production BACKGROUND Several studies report an association between depot medroxyprogesterone acetate ( DMPA ) injectable contraception and decreased bone mineral density . Adolescents , who are still gaining bone , may be particularly affected , but there has been little study of the association in adolescent users and none following discontinuation . OBJECTIVE To evaluate bone mineral density changes in adolescents using and discontinuing use of DMPA contraception . DESIGN A population -based prospect i ve cohort study . PARTICIPANTS One hundred seventy adolescent women , aged 14 to 18 years ; 80 baseline DMPA users and 90 age-similar , unexposed comparison women . Sixty-one participants discontinued DMPA use during follow-up . MAIN OUTCOME MEASURE Bone mineral density , measured every 6 months for 24 to 36 months at the hip , spine , and whole body , comparing mean bone mineral density changes in DMPA users and discontinuers with nonusers . RESULTS Among DMPA users , bone mineral density declined significantly relative to nonusers at the hip and spine but not the whole body . Annualized mean percentage changes , adjusted for covariates , were hip , -1.81 % vs -0.19 % ; P<.001 ; spine , -0.97 % vs 1.32 % ; P<.001 , and whole body , 0.73 % vs 0.88 % ; P = .78 for DMPA users vs nonusers , respectively . New users lost bone mineral density more rapidly than prevalent users . Discontinuers experienced significantly increased bone mineral density relative to nonusers at all anatomical sites ; annualized mean percentage changes were hip , 1.34 % vs -0.19 % ; P = .004 ; spine , 2.86 % vs 1.32 % ; P = .004 ; and whole body , 3.56 % vs 0.88 % ; P<.001 . CONCLUSIONS Use of DMPA contraception in adolescents was associated with significant continuous losses of bone mineral density at the hip and spine . However , significant gains postdiscontinuation provide evidence that the loss of bone mass is apparently reversed OBJECTIVE The purpose of this clinical trial was to evaluate the effect of estrogen supplementation on bone mineral density in adolescent girls who received depot medroxyprogesterone acetate for contraception . STUDY DESIGN One hundred twenty-three adolescents who began receiving depot medroxyprogesterone acetate injections every 12 weeks were assigned r and omly to receive monthly injections of estradiol cypionate or placebo . The main outcome was bone mineral density that was measured by dual energy x-ray absorptiometry for 12 ( n = 69 ) to 24 ( n = 36 ) months . Participants , technicians , and physicians were blinded to estrogen treatment . RESULTS Over the 24-month period , the percentage of change from baseline bone mineral density at the lumbar spine was 2.8 % in the estradiol cypionate group versus -1.8 % in the placebo group ( P < .001 ) . At the femoral neck , the percentage of change from baseline bone mineral density was 4.7 % in the estradiol cypionate group versus -5.1 % in the placebo group ( P < .001 ) . CONCLUSION Our results suggest that estrogen supplementation is protective of bone in adolescent girls who receive depot medroxyprogesterone acetate injections Several studies indicate that parity and lactation are associated with modest , short-term bone loss , but the long-term effect on osteoporotic fracture risk is uncertain . The authors therefore analyzed data from a population -based case-control study among Swedish postmenopausal women aged 50 - 81 years between October 1993 and February 1995 . Mailed question naires and telephone interviews were used to collect data on 1,328 incident cases with hip fracture and 3,312 r and omly selected controls . In age-adjusted analyses , the risk of hip fracture among all women was reduced by 10 % per child ( 95 % confidence interval ( CI ) : 5 , 14 ) . After multivariate adjustment including body mass index as a covariate , the risk reduction was 5 % per child ( 95 % CI : 0 , 10 ) . Oral contraceptive use modified the association of parity with hip fracture risk . Among never users of oral contraceptives , the risk of hip fracture was reduced by 8 % per child ( 95 % CI : 2 , 13 ) , whereas among ever users of oral contraceptives , the risk was in the opposite direction , with an increase in risk by 19 % per child ( 95 % CI : 0 , 41 ) . After parity was considered , there was no association of duration of lactation period with fracture risk . The authors conclude that parity is modestly associated with a reduced hip fracture risk among women who had not used oral contraceptives previously The primary aim of this prospect i ve 2-year follow-up study was to investigate the effect of depot medroxyprogesterone acetate ( DMPA ) on the maintenance of bone mass in women aged 30 - 45 years . The effects of estrogen or calcium substitution during the second year of follow-up was investigated in seven DMPA users with a high annual bone loss during the first year . The bone mass of 35 users of DMPA and 10 women without hormonal contraception was investigated using peripheral quantitative computed tomography . The baseline cortical and trabecular bone mass ( TBM ) and the annual change was not different in DMPA users and controls . Over 24 months we measured an increase in TBM of 0.6 % and a decrease in cortical bone mass of 0.1 % in exposed women . Some but not all of the DMPA users with a bone loss during the first year could be successfully treated with estradiol or calcium . In conclusion , we did not observe an accelerated bone loss in DMPA users aged 30 - 45 years A cross-sectional study was design ed to determine trabecular bone density in 75 long-term depot-medroxyprogesterone acetate ( DMPA ) users ( > 3 yr ) matched with non-DMPA users by age , body mass index ( 18 - 25 ) , limitation of age ( < 45 yr ) , and body weight ( < 60 kg ) . The long-term DMPA cases were divided into 3 groups according to duration of injectable contraceptive use . Neither cases nor controls had a smoking or chronic alcohol consumption history . Cases and controls were matched by age . Trabecular bone of the femoral neck were assessed by X-ray and interpreted by a single-blinded radiologist . Trabecular bone patterns were grade d according to Singh 's Index . Blood collection for determination of estradiol , prolactin , calcium , phosphorus , and medroxyprogesterone acetate were performed in cases and controls . Venous blood was taken at twelfth week of injection of DMPA and within 5 days after menstrual bleeding cessation in the controls . Mean trabecular bone in the cases was 5.5 + /- 0.6 ( range 4 - 6 ) . It was not statistically different from that in the controls ( mean 5.5 + /- 0.6 , range 2 - 6 ) . No statistically significant difference of serum , calcium , phosphorus , prolactin , and estradiol was seen in the cases when compared to controls at mid follicular phase of normal menstrual cycle . Serum MPA of individual case at twelfth week of injection was 4.1 + /- 1.1 nmol/l . In conclusion , trabecular bone density in long-term DMPA users were not statistically different from normal menstruating women who have not received injectable DMPA The question of differential effects on bone density by two different types of progestogen-only methods for contraception in premenopausal women was addressed . Data from a prospect i ve r and omized clinical trial among 22 premenopausal women , age 32.6 ( range 20 - 45 years ) , who were r and omly assigned to either of two treatments with continuous progestogens for contraception were analyzed ; depot-medroxyprogesterone acetate ( DMPA ) or continuous levonorgestrel treatment with subdermal implants ( Norplant ) , respectively . Forearm bone density ( BMDprox ) increased with 2.94 % ( p = 0.006 ) in women who were prescribed levonorgestrel , which was in contrast to stable values in those prescribed depot-medroxy-progesterone acetate ; group difference at 6 months for BMDprox 3.4 % ( 95 % CI 1.3 , 5.5 ; p = 0.025 ) and BMDdist 4.1 % ( 95 % CI - 1.3 , 9.6 ; p = 0.077 ) . The changes in bone density were consistent with the changes in biochemical indices for bone metabolism ; DMPA users showed signs of increased bone turnover and users of levonorgestrel showed increased
Output:
| RESULTS BMD consistently returned toward or to baseline values following DMPA discontinuation in women of all ages . |
MS211794 | ***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 a single high dose of vitamin A given to all children in communities with high mortality and malnutrition could affect mortality and to assess whether periodic community wide supplementation could be readily incorporated into an ongoing primary health programme . DESIGN --Opportunistic controlled trial . SETTING --Jumla district , Nepal . SUBJECTS -- All children aged under 5 years ; 3786 in eight subdistricts given single dose of vitamin A and 3411 in remaining eight subdistricts given no supplementation . MAIN OUTCOME MEASURES --Mortality and cause of death in the five months after supplementation . RESULTS --Risk of death for children aged 1 - 59 months in supplemented communities was 26 % lower ( relative risk 0.74 , 95 % confidence interval 0.55 to 0.99 ) than in unsupplemented communities . The reduction in mortality was greatest among children aged 6 - 11 months : death rate ( deaths/1000 child years at risk ) was 133.8 in supplemented children and 260.8 in unsupplemented children ( relative risk 0.51 , 0.30 to 0.89 ) . The death rate from diarrhoea was also reduced ( 63.5 supplemented v 97.5 unsupplemented ; relative risk 0.65 , 0.44 to 0.95 ) . The extra cost per death averted was about $ 11 . CONCLUSION --The results support a role for Vitamin A in increasing child survival . The supplementation programme was readily integrated with the ongoing community health programme at little extra cost A prospect i ve study was conducted in slum children to determine the incidence of post-measles corneal disease and to clarify its relationship with nutritional status . A total of 318 cases of measles were identified over a period of 15 mo ; maximum incidence was observed for children between 1 - 2 yr . Most of the children showed weight loss and serum proteins decrease during the acute stage of measles . Corneal lesions were observed in 3 % of the children , and the lesions responded well to treatment . Serum vitamin A and RBP levels were significantly depressed during the acute stage of measles but were restored to normal 8 wk after recovery . There were no significant differences in the serum levels for those with and without eye lesions , which suggests that these lesions may not be mediated simply through the effect of infection on serum concentration of vitamin A cross-sectional study , a follow-up study , and an intervention trial were carried out to investigate the association between mild vitamin A deficiency and the occurrence of diarrhea and respiratory diseases . Cross-sectional analysis was performed among 1,772 children , aged 1 - 8 years , in the Sakon Nakhon province of northeastern Thail and . Children with a history of diarrhea or respiratory disease had lower levels of serum retinol and retinol-binding protein . Adjusted for age , sex , nutritional status , and level of urbanization , logistic regression using data for 877 children showed a negative association between serum retinol and both diarrhea and respiratory diseases . A follow-up three months later ( n = 146 children ) showed that children with deficient serum retinol ( less than 0.35 mumol/liter ) had a fourfold greater risk of respiratory disease ( p less than 0.01 ) . No relation was found for diarrhea . An intervention trial ( n = 166 children aged 1 - 5 years ) showed that , during 2 months of follow-up after administration of oral vitamin A ( 200,000 IU ) , the control group ( aged 3 - 5 years ) had a higher incidence of respiratory disease ( 2.9 times ) as well as diarrhea ( 3.1 times ) . Between 2 and 4 months , a significantly ( p less than 0.025 ) higher incidence of respiratory diseases ( 2.5 times ) could be observed in children aged 1 - 2 years . This study supports earlier reports on a greater risk of respiratory diseases and of diarrhea in mild vitamin A deficiency . Supplementation reduced the incidence of both diarrhea and respiratory disease for a period of at least 2 months Community trials of the efficacy of vitamin A supplementation in reducing preschool childhood mortality have produced conflicting results . To resolve the question , a r and omised , double-masked , placebo-controlled community trial of 28,630 children aged 6 - 72 months was carried out in rural Nepal , an area representative of the Gangetic flood plain of South Asia . R and omisation was carried out by administrative ward ; the vitamin-A-supplemented children received 60,000 retinol equivalents every 4 months and placebo-treated children received identical capsules containing 300 retinol equivalents . After 12 months , the relative risk of death in the vitamin-A-supplemented compared with the control group was 0.70 ( 95 % confidence interval 0.56 - 0.88 ) , equivalent to a 30 % reduction in mortality . The trial , which had been planned to last 2 years , was discontinued . The reduction in mortality was present in both sexes ( relative risk for boys 0.77 ; for girls 0.65 ) , at all ages ( range of relative risks 0.83 - 0.50 ) , and throughout the year ( 0.76 - 0.67 ) . The reduction in mortality risk was not affected by acute nutritional status , as measured by arm circumference . Thus , periodic vitamin A delivery in the community can greatly reduce child mortality in developing countries
Output:
| There was no evidence that vitamin A in a single dose was associated with a reduced risk of mortality among children with measles .
Although we found no overall significant reduction in mortality with vitamin A therapy for children with measles there was evidence that two doses were associated with a reduced risk of mortality and pneumonia-specific mortality in children under the age of two years . |
MS211795 | ***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: Two hundred ears with otosclerosis have been operated upon using a 0.4-mm diameter Teflon platinum piston in 100 ears and a 0.6-mm diameter Teflon piston in the other 100 ears . The postoperative air-bone gap , calculated as the difference between the postoperative air and bone conduction levels , was smaller in the 0.6 mm group for all frequencies except at 2000 Hz , the differences were statistically insignificant except at 4000 Hz . The mean postoperative air-bone gap was 8.6 dB and 7.4 dB for the 0.4 and 0.6 mm groups , respectively , which is statistically insignificant . We found no postoperative loss of bone conduction exceeding 15 dB , there was a deterioration of more than 10 dB in three ears , one in the 0.4 mm group and two in the 0.6 mm group . According to our results , we conclude that the 0.4 mm and the 0.6 mm Teflon prostheses produce the same hearing improvement in stapes surgery for otosclerosis Tight fixation of stapes prostheses yields better functional results because sound transmission from the incus to the prosthesis is improved . Background : The optimal prosthesis to use for otosclerosis surgery is still a matter of debate . It has been proposed that using prostheses made of Nitinol , a shape-memory metal , produces better functional results with less variability and reduced risk for middle and inner ear damage . This is thought to be because heat activation rather than manual crimping of the prosthesis loop forms a tighter fixation . Methods : Functional results of two groups were compared 1 year after surgery . In one group were 75 cases of stapedotomy performed using Nitinol prostheses . Results were analyzed prospect ively and compared with 75 retrospectively analyzed matched controls with conventional stapes prostheses . Crimping quality was measured in 23 patients by intraoperative laser Doppler interferometry ( LDI ) . Causality was assessed by correlating results of intraoperative LDI and postoperative pure-tone thresholds . Results : Nitinol and conventional prostheses yielded postoperative air-bone gaps ( ABGs ) of 8.0 and 11.6 dB with 71 and 43 % ABG closure within 10 dB , respectively . Intraoperatively , sound transmission was improved by 2.5 dB with the Nitinol prostheses as compared with conventional prostheses . These differences were statistically significant . Intraoperative fixation quality was positively correlated to functional outcome , but results were not statistically significant . Conclusion : Tight fixation , as provided by Nitinol prostheses leads to improved functional results because of better sound transmission properties at the incus-prosthesis interface . The improvement in ABG closure is in the range of 3 dB pure-tone average and more pronounced at higher frequencies . Nitinol prostheses provide an effective treatment option in otosclerosis surgery Objectives : This is the first clinical trial to evaluate the suitability of a new titanium stapes prosthesis , which we developed jointly with the Kurz Company ( Dußlingen ) This study compares hearing results after stapedotomy by 0.6 mm and 0.8 mm teflon pistons . Retrospective analysis studied 100 patients r and omly selected who underwent stapedotomy for otosclerosis with insertion of 0.8 mm teflon piston prosthesis and 100 patients with 0.6 mm teflon piston prosthesis . Air-conduction hearing level in both groups were measured before and after the procedure and the gain of the air conduction between the 2 groups at different frequencies were compared statistically . The group with the 0.8 mm prosthesis had better results that were statistically significant and more pronounced at lower frequencies The early and long-term hearing results of 1,681 primary otosclerosis operations performed by the same surgeon , Jean Marquet , were review ed retrospectively and analyzed with very strict statistical st and ards . Significantly better short- and long-term results were achieved with the stapedotomy technique compared to total stapedectomy , mainly at the higher frequencies ( 4 and 8 kHz ) important for speech discrimination . Whatever technique was used to open the footplate ( micropick , microdrill , or laser ) , no statistical audiometric difference could be found . The results were equal whether or not the stapedial tendon was preserved . Perioperative problems like pronounced oozing , difficult anatomic relationships , and accidental perilymph aspiration could affect hearing at higher frequencies . The calibrated hole technique was equally as good as conventional oval window sealing in sealing of the fenestra to prevent fistula . The stapedotomy technique was found the safest , having fewer complications This study reports the evaluation of hearing results after implantation of a Teflon piston of a different diameter in cases of otosclerosis requiring stapedotomy . By r and om selection , a Teflon piston with a shaft diameter of 0.3 mm was inserted in 34 cases and a piston with a shaft diameter of 0.4 mm in 26 cases . A retrospective analysis of the pre- and postsurgery audiological results of these two patient groups was carried out by microcomputer . A repeated statistical measures analysis of variance was used to test and estimate the air-conduction frequency-specific differences between the two prostheses with respect to changes in pre- and postoperative healing . The results of this comparative study of the two Teflon pistons with different diameters indicate statistically a greater hearing gain for the 0.4-mm prosthesis , especially in the lower frequencies Over the last 10 years , lasers have evolved to become an integral part of stapes surgery . Argon , KTP , and CO2 lasers have all been tested for their improved accuracy and safety in the middle ear . Because of the difference in optical properties between visible light ( argon , KTP ) and infrared ( CO2 ) lasers , discussion s have evolved around which laser is better and safer . In an effort to clarify the issues , a prospect i ve comparison was made of 100 consecutive primary stapedotomies by using either the CO2 or KTP laser From 1975 to 1992 , a total of 1459 primary stapedoplasty operations ( i.e. , stapedectomy , stapedotomy with tendon section , and stapedotomy with tendon preservation ) were performed in 1323 subjects at the Ear , Nose , and Throat Department of the University of Verona . Pure-tone audiometry was carried out in all subjects who were operated on and who underwent 6-month and 10-year follow-ups . To evaluate the influence of stapedius tendon preservation on functional outcome , we r and omly selected subgroups of patients using the three different stapedoplasty techniques and tested them by multiple-frequency tympanometry , psychoacoustic tuning curves , and speech discrimination in noise . Finally , to assess the effect of prosthesis diameter on middle ear transfer function , we used the electrocochleographic technique and examined the threshold and latency of cochlear nerve compound action potentials recorded during surgery from the round window . The results of this study show that the best auditory performance in otosclerotic subjects is achieved by performing a stapedotomy of 0.7 mm diameter , using a 0.6 wire-Teflon piston , and preserving the stapedius tendon Thirty-four ears with conductive hearing loss due to otosclerosis were operated upon using the laser stapedotomy technique . Audiological results were compared with the results of 316 non-laser stapedotomies . The post-operative air-bone gap , calculated as the difference between the post-operative air and bone conduction levels , was smaller with the laser stapedotomy group . Also , the bone conduction showed significant improvement with the use of laser . Significant sensorineural hearing loss was not found in any of the laser-treated patients . According to our results , we concluded that laser is of benefit in stapes surgery for improving the hearing results and minimizing the inner ear trauma BACKGROUND The first hearing results with a new stapes prosthesis with clip function ( Soft-CliP(R ) piston ) are presented . PATIENTS AND METHODS This new prosthesis was used in 15 patients ( mean age 45.2 years ; range 21 - 63 years ) undergoing routine stapes surgery . Soft-CliP(R ) piston prostheses with a shaft diameter of 0.4 mm and a length ranging from 4.25 mm to 5.5 mm were used . Postoperative audiological testing and measurement of the air-bone gap were performed after an average of 47.3 days and compared with the preoperative values . RESULTS The median observed postoperative air-bone gap ( ABG ) was 8.33 dB + /-4.16 dB. All patients had less than 20 dB ABG and in 53.3 % of cases was less than 10 dB. The operating time showed a clear difference between the left ( 66.5 min + /-37.79 min ) and right ears ( 47.2 min + /-11.08 min ) . DISCUSSION This new prosthesis design greatly facilitates a very difficult step in stapes surgery , the prosthesis fixation to the incus . The first postoperative hearing results are very promising but long-term results in a larger group of patients are still pending
Output:
| The frequency-specific analysis of the postoperative ABG showed no advantage for the small prosthesis in the high frequencies .
There was no difference in postoperative change of bone conduction in the 0.6- and 0.4-mm groups . |
MS211796 | ***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: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain OBJECTIVE Fat oxidation during exercise depends on nutritional state , and exercise performed in the post-absorptive state oxidizes more fat than that performed in the postpr and ial state . However , the effects of exercise on energy metabolism continue during the post-exercise period , and the difference in fat oxidation during exercise may be compensated for during the post-exercise period . The present study compared the effects of an acute exercise bout in the post-absorptive or postpr and ial state on 24 h fat oxidation . METHODS Twelve young male athletes stayed twice in a room-size metabolic chamber for 24 h indirect calorimetry in a r and omized repeated-measure design . Before or after breakfast , i.e. in the post-absorptive or postpr and ial state , subjects exercised at 50 % VO(2)max for 60 min . RESULTS During the 60 min of exercise , energy expenditure in the two exercise trials were equivalent , but exercise in the post-absorptive state was performed with lower RQ compared with that in the postpr and ial state ( P<0.01 ) . The time of exercise relative to breakfast did not affect 24 h energy expenditure ( P>0.5 ) . However , accumulated 24 h fat oxidation was higher ( P<0.05 ) and that of carbohydrate oxidation was lower ( P<0.05 ) when exercise was performed in the post-absorptive state . CONCLUSIONS Compared with exercise performed in the postpr and ial state , exercise performed in the post-absorptive state oxidized more fat and saved more carbohydrate in the body , without affecting 24 h energy expenditure The glycaemic index ( GI ) concept was originally introduced to classify different sources of carbohydrate (CHO)-rich foods , usually having an energy content of > 80 % from CHO , to their effect on post-meal glycaemia . It was assumed to apply to foods that primarily deliver available CHO , causing hyperglycaemia . Low-GI foods were classified as being digested and absorbed slowly and high-GI foods as being rapidly digested and absorbed , result ing in different glycaemic responses . Low-GI foods were found to induce benefits on certain risk factors for CVD and diabetes . Accordingly it has been proposed that GI classification of foods and drinks could be useful to help consumers make ' healthy food choices ' within specific food groups . Classification of foods according to their impact on blood glucose responses requires a st and ardised way of measuring such responses . The present review discusses the most relevant method ological considerations and highlights specific recommendations regarding number of subjects , sex , subject status , inclusion and exclusion criteria , pre-test conditions , CHO test dose , blood sampling procedures , sampling times , test r and omisation and calculation of glycaemic response area under the curve . All together , these technical recommendations will help to implement or reinforce measurement of GI in laboratories and help to ensure quality of results . Since there is current international interest in alternative ways of expressing glycaemic responses to foods , some of these methods are discussed The purpose of this study was to determine the effects of a pre-exercise meal on the plasma human growth hormone ( hGH ) response and fat oxidation during walking . Subjects ( n=8 ) were r and omly provided with either 1 g/kg body weight of glucose in 200 mL water ( CHO ) or 200 mL water alone ( CON ) 30 min prior to exercise and subsequently walked on a treadmill at 50 % of VO2max for 60 min . Plasma hGH concentrations were significantly higher in subjects who received CHO compared to those who received CON at 15 and 30 min . The fat oxidation rate in the CHO was significantly lower than the CON while walking for 5~15 , 25~35 and 45~55 min . Plasma FFA levels were also significantly lower in the CHO compared to the CON at 30 , 45 and 60 min . Plasma glucose levels in the CHO were significantly lower while plasma insulin levels were significantly higher than in the CON at 15 and 30 min . Therefore , the results of this study suggest that the elevation of plasma hGH levels due to the intake of a pre-exercise meal may not be strongly related to fat oxidation and plasma free fatty acid ( FFA ) levels during low-intensity exercise The present study was undertaken to examine the effects of glucose ingestion before exercise on liver glucose output and muscle glucose uptake during exercise . On two occasions , at least 1 wk apart , six trained men ( peak pulmonary O2 uptake = 5.11 + /- 0.17 l/min ) ingested 400 ml of a solution containing either 75 g glucose [ carbohydrate ( CHO ) ] or a sweet placebo [ control ( Con ) ] 30 min before 60 min of exercise at 71 + /- 1 % peak pulmonary O2 uptake . Glucose kinetics ( rates of appearance and disappearance ) were measured by a primed continuous infusion of [6,6 - 2H2]glucose . Liver glucose output was derived from total glucose appearance and the appearance of ingested glucose from the gut . After glucose ingestion , plasma glucose increased to 6.4 + /- 0.4 mmol/l immediately before exercise , fell to 4.2 + /- 0.5 mmol/l after 20 min of exercise , and then increased to a higher value than in the Con group ( 5.4 + /- 0.3 vs. 4.7 + /- 0.1 mmol/l ; P < 0.05 ) after 60 min of exercise . In the CHO group , plasma insulin was higher immediately before exercise ( P < 0.05 ) and , despite falling during exercise , remained higher than in the Con group after 60 min of exercise ( 57.0 + /- 11.4 vs. 24.8 + /- 1.7 pmol/l ; P < 0.05 ) . The rapid fall in plasma glucose in the CHO group was the result of a higher muscle glucose uptake with the onset of exercise ( P < 0.05 ) , which could not be matched by the glucose rate of appearance . Liver glucose output was decreased by glucose ingestion , and although it increased during the early stages of exercise in the CHO group , it did not rise above the basal values and was reduced by 62 % over the 60 min of exercise compared with the Con group . In summary , preexercise glucose ingestion results in increased muscle glucose uptake and reduced liver glucose output during exercise BACKGROUND Obesity is a major health problem due , in part , to physical inactivity . The amount of activity needed to prevent weight gain is unknown . OBJECTIVE To determine the effects of different amounts and intensities of exercise training . DESIGN R and omized controlled trial ( February 1999-July 2002 ) . SETTING AND PARTICIPANTS Sedentary , overweight men and women ( aged 40 - 65 years ) with mild to moderate dyslipidemia were recruited from Durham , NC , and surrounding communities . INTERVENTIONS Eight-month exercise program with 3 groups : ( 1 ) high amount/vigorous intensity ( calorically equivalent to approximately 20 miles [ 32.0 km ] of jogging per week at 65%-80 % peak oxygen consumption ) ; ( 2 ) low amount/vigorous intensity ( equivalent to approximately 12 miles [ 19.2 km ] of jogging per week at 65%-80 % ) , and ( 3 ) low amount/moderate intensity ( equivalent to approximately 12 miles [ 19.2 km ] of walking per week at 40%-55 % ) . Subjects were counseled not to change their diet and were encouraged to maintain body weight . MAIN OUTCOME MEASURES Body weight , body composition ( via skinfolds ) , and waist circumference . RESULTS Of 302 subjects screened , 182 met criteria and were r and omized and 120 completed the study . There was a significant ( P<.05 ) dose-response relationship between amount of exercise and amount of weight loss and fat mass loss . The high-amount/vigorous-intensity group lost significantly more body mass ( in mean [ SD ] kilograms ) and fat mass ( in mean [ SD ] kilograms ) ( -2.9 [ 2.8 ] and -4.8 [ 3.0 ] , respectively ) than the low-amount/moderate-intensity group ( -0.9 [ 1.8 ] and -2.0 [ 2.6 ] , respectively ) , the low-amount/vigorous-intensity group ( -0.6 [ 2.0 ] and -2.5 [ 3.4 ] , respectively ) , and the controls ( + 1.0 [ 2.1 ] and + 0.4 [ 3.0 ] , respectively ) . Both low-amount groups had significantly greater improvements than controls but were not different from each other . Compared with controls , all exercise groups significantly decreased abdominal , minimal waist , and hip circumference measurements . There were no significant changes in dietary intake for any group . CONCLUSIONS In nondieting , overweight subjects , the controls gained weight , both low-amount exercise groups lost weight and fat , and the high-amount group lost more of each in a dose-response manner . These findings strongly suggest that , absent changes in diet , a higher amount of activity is necessary for weight maintenance and that the positive caloric imbalance observed in the overweight controls is small and can be reversed by a modest amount of exercise . Most individuals can accomplish this by walking 30 minutes every day The oxidation of glucose and fructose ingested during moderate exercise performed on a cycle ergometer ( 120 min , 52 % VO2max ) was compared in ten young males fasted ( n = 5 ) or fed ( n = 5 ) before exercise . The subjects ingested r and omly 1.33 g/kg body weight ( approximately 96 + /- 9 g ) of either enriched 13C-glucose ( G ) , 13C-fructose ( F ) , or water only ( W ) ; the solutions were evenly distributed over the exercise period . The fasted subjects began the three exercises with a lower blood glucose ( P less than or equal to 0.05 for F only ) and insulin ( P less than or equal to 0.05 ) levels and a higher free fatty acid ( FFA ) concentration ( P less than or equal to 0.05 ) than the fed ones . Throughout the exercise period , blood glucose level was maintained in fasted as well as in fed group for G and F ingestions , while it decreased ( P less than or equal to 0.05 at the 100th min in fasted subjects ) with water ingestion . Insulin level was similar in both fed and fasted conditions with F and W ingestions and lower than G trials for the fed subjects . For the three ingestions , FFA was lower ( P less than or equal to 0.05 ) in the fasted than in the fed group over the exercise period . Over the 2-h period of exercise , a greater ( P less than or equal to 0.05 ) amount of exogenous F was oxidized in the fasted ( 49 + /- 6 g ) than in the fed ( 36 + /- 5 g ) group , which represent 31 % and 20 % of the total carbohydrate energy supply , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS Skeletal muscle insulin resistance entails dysregulation of both glucose and fatty acid metabolism . This study examined whether a
Output:
| We conclude that aerobic exercise performed in the fasted state induces higher fat oxidation than exercise performed in the fed state |
MS211797 | ***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 : Mutations in PIK3CA [ the gene encoding the p110α catalytic subunit of phosphatidylinositide-3-kinase ( PI3 K ) ] play an important role in colorectal carcinogenesis . Experimental evidence suggests that PIK3CA exon 9 and exon 20 mutations trigger different biologic effects , and that concomitant mutations in both exons 9 and 20 synergistically enhance tumorigenic effects . Thus , we hypothesized that PIK3CA exon 9 and exon 20 mutations might have differential effects on clinical outcome in colorectal cancer , and that concomitant PIK3CA exon 9 and 20 mutations might confer aggressive tumor behavior . Experimental Design : We sequenced PIK3CA by pyrosequencing in 1,170 rectal and colon cancers in two prospect i ve cohort studies , and found 189 ( 16 % ) PIK3CA mutated tumors . Mortality HR according to PIK3CA status was computed using Cox proportional hazards model , adjusting for clinical and molecular features , including microsatellite instability , CpG isl and methylator phenotype , LINE-1 methylation , and BRAF and KRAS mutations . Results : Compared with PIK3CA wild-type cases , patients with concomitant PIK3CA mutations in exons 9 and 20 experienced significantly worse cancer-specific survival [ log-rank P = 0.031 ; multivariate HR = 3.51 ; 95 % confidence interval ( CI ) : 1.28–9.62 ] and overall survival ( log-rank P = 0.0008 ; multivariate HR = 2.68 ; 95 % CI : 1.24–5.77 ) . PIK3CA mutation in either exon 9 or 20 alone was not significantly associated with patient survival . No significant interaction of PIK3CA mutation with BRAF or KRAS mutation was observed in survival analysis . Conclusion : Coexistence of PIK3CA ( the PI3 K p110α subunit ) exon 9 and 20 mutations , but not PIK3CA mutation in either exon 9 or 20 alone , is associated with poor prognosis of colorectal cancer patients . Clin Cancer Res ; 18(8 ) ; 2257–68 . © 2012 AACR CONTEXT The fraction of malignant cells in tumor tissue su bmi tted for tests of genetic alterations is a critical variable in testing accuracy . That fraction is currently determined by pathologist visual estimation of the percentage of malignant cells . Inaccuracy could lead to a false-negative test result . OBJECTIVE To describe a prospect i ve , multi-institutional study to determine pathologist estimation accuracy . DESIGN Ten ×20 magnification images of hematoxylin-eosin-stained colon tissue specimens were sent as an educational component of the College of American Pathologists KRAS-B 2011 Survey . Data from 194 labs were analyzed and compared to a criterion st and ard with comprehensive manual nuclear counts . RESULTS Survey responses indicated low interlaboratory precision of pathologist estimation , but mean estimates were fairly accurate . A total of 5 of the 10 cases assessed showed more than 10 % of respondents overestimating in a manner that could lead to false-negative test results . CONCLUSIONS The significance of estimation errors result ing in molecular testing failures with implication s for patient care is unknown , but the current study suggests false-negative test results may occur Lynch syndrome ( LS ) is characterised by the development of colorectal cancer , endometrial cancer and various other cancers , and is caused by a mutation in one of the mismatch repair genes : MLH1 , MSH2 , MSH6 or PMS2 . In 2007 , a group of European experts ( the Mallorca group ) published guidelines for the clinical management of LS . Since then substantial new information has become available necessitating an up date of the guidelines . In 2011 and 2012 workshops were organised in Palma de Mallorca . A total of 35 specialists from 13 countries participated in the meetings . The first step was to formulate important clinical questions . Then a systematic literature search was performed using the Pubmed data base and manual search es of relevant articles . During the workshops the outcome of the literature search was discussed in detail . The guidelines described in this paper may be helpful for the appropriate management of families with LS . Prospect i ve controlled studies should be undertaken to improve further the care of these families Purpose : Cetuximab improves survival in patients with K-ras wild-type advanced colorectal cancer . We examined the predictive and prognostic significance of additional biomarkers in this setting , in particular BRAF , PIK3CA , and PTEN . Experimental Design : Available colorectal tumor sample s were analyzed from the CO.17 study . BRAF mutations were identified in tumor-derived DNA by direct sequencing and PIK3CA mutations were identified using a high-resolution melting screen with confirmation by sequencing . PTEN expression by immunohistochemistry ( IHC ) was performed on tissue microarrays . For each biomarker , prognostic and predictive effects were examined using a Cox model with tests for treatment – biomarker interaction . Results : A total of 572 patients with pretreated colorectal cancer were r and omly assigned to receive cetuximab or best supportive care ( BSC ) . Of 401 patients assessed for BRAF status , 13 ( 3.2 % ) had mutations . Of 407 patients assessed for PIK3CA status , 61 ( 15 % ) had mutations . Of 205 patients assessed for PTEN , 148 ( 72 % ) were negative for IHC expression . None of BRAF , PIK3CA , or PTEN was prognostic for overall or progression-free survival in the BSC arm . None was predictive of benefit from cetuximab , either in the whole study population or the K-ras wild-type subset . In the K-ras wild-type subgroup , the overall survival adjusted HR according to BRAF mutation status was 1.39 ( interaction P = 0.69 ) , PIK3CA mutation status HR = 0.79 ( interaction P = 0.63 ) , and PTEN expression HR = 0.75 ( interaction P = 0.61 ) . Conclusions : In chemotherapy-refractory colorectal cancer , neither PIK3CA mutation status nor PTEN expression were prognostic , nor were they predictive of benefit from cetuximab . Evaluation of predictive significance of BRAF mutations requires a larger sample size . Clin Cancer Res ; 20(3 ) ; 744–53 . © 2013 AACR BACKGROUND Treatment with cetuximab , a monoclonal antibody directed against the epidermal growth factor receptor , improves overall and progression-free survival and preserves the quality of life in patients with colorectal cancer that has not responded to chemotherapy . The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment-independent prognostic value . METHODS We analyzed tumor sample s , obtained from 394 of 572 patients ( 68.9 % ) with colorectal cancer who were r and omly assigned to receive cetuximab plus best supportive care or best supportive care alone , to look for activating mutations in exon 2 of the K-ras gene . We assessed whether the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups . RESULTS Of the tumors evaluated for K-ras mutations , 42.3 % had at least one mutation in exon 2 of the gene . The effectiveness of cetuximab was significantly associated with K-ras mutation status ( P=0.01 and P<0.001 for the interaction of K-ras mutation status with overall survival and progression-free survival , respectively ) . In patients with wild-type K-ras tumors , treatment with cetuximab as compared with supportive care alone significantly improved overall survival ( median , 9.5 vs. 4.8 months ; hazard ratio for death , 0.55 ; 95 % confidence interval [ CI ] , 0.41 to 0.74 ; P<0.001 ) and progression-free survival ( median , 3.7 months vs. 1.9 months ; hazard ratio for progression or death , 0.40 ; 95 % CI , 0.30 to 0.54 ; P<0.001 ) . Among patients with mutated K-ras tumors , there was no significant difference between those who were treated with cetuximab and those who received supportive care alone with respect to overall survival ( hazard ratio , 0.98 ; P=0.89 ) or progression-free survival ( hazard ratio , 0.99 ; P=0.96 ) . In the group of patients receiving best supportive care alone , the mutation status of the K-ras gene was not significantly associated with overall survival ( hazard ratio for death , 1.01 ; P=0.97 ) . CONCLUSIONS Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab , whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab . The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone . ( Clinical Trials.gov number , NCT00079066 . Background : To test the prognostic value of tumour protein and genetic markers in colorectal cancer ( CRC ) and examine whether deficient mismatch repair ( dMMR ) tumours had a distinct profile relative to proficient mismatch repair ( pMMR ) tumours . Methods : This prospect i ve multicentric study involved 251 stage I – III CRC patients . Analysed biomarkers were EGFR ( binding assay ) , VEGFA , thymidylate synthase ( TS ) , thymidine phosphorylase ( TP ) and dihydropyrimidine dehydrogenase ( DPD ) expressions , MMR status , mutations of KRAS ( codons 12–13 ) , BRAF ( V600E ) , PIK3CA ( exons 9 and 20 ) , APC ( exon 15 ) and P53 ( exons 4–9 ) , CpG isl and methylation phenotype status , ploidy , S-phase , LOH . Results : The only significant predictor of relapse-free survival ( RFS ) was tumour staging . Analyses restricted to stage III showed a trend towards a shorter RFS in KRAS-mutated ( P=0.005 ) , BRAF wt ( P=0.009 ) and pMMR tumours ( P=0.036 ) . Deficient mismatch repair tumours significantly demonstrated higher TS ( median 3.1 vs 1.4 ) and TP ( median 5.8 vs 3.5 ) expression relative to pMMR ( P<0.001 ) and show higher DPD expression ( median 14.9 vs 7.9 , P=0.027 ) and EGFR content ( median 69 vs 38 , P=0.037 ) relative to pMMR . Conclusions : Present data suggesting that both TS and DPD are overexpressed in dMMR tumours as compared with pMMR tumours provide a strong rationale that may explain the resistance of dMMR tumours to 5FU-based therapy BACKGROUND Patients with metastatic colorectal cancer that harbors KRAS mutations in exon 2 do not benefit from anti-epidermal growth factor receptor ( EGFR ) therapy . Other activating RAS mutations may also be negative predictive biomarkers for anti-EGFR therapy . METHODS In this prospect ive-retrospective analysis , we assessed the efficacy and safety of panitumumab plus oxaliplatin , fluorouracil , and leucovorin ( FOLFOX4 ) as compared with FOLFOX4 alone , according to RAS ( KRAS or NRAS ) or BRAF mutation status . A total of 639 patients who had metastatic colorectal cancer without KRAS mutations in exon 2 had results for at least one of the following : KRAS exon 3 or 4 ; NRAS exon 2 , 3 , or 4 ; or BRAF exon 15 . The overall rate of ascertainment of RAS status was 90 % . RESULTS Among 512 patients without RAS mutations , progression-free survival was 10.1 months with panitumumab-FOLFOX4 versus 7.9 months with FOLFOX4 alone ( hazard ratio for progression or death with combination therapy , 0.72 ; 95 % confidence interval [ CI ] , 0.58 to 0.90 ; P=0.004 ) . Overall survival was 26.0 months in the panitumumab-FOLFOX4 group versus 20.2 months in the FOLFOX4-alone group ( hazard ratio for death , 0.78 ; 95 % CI , 0.62 to 0.99 ; P=0.04 ) . A total of 108 patients ( 17 % ) with nonmutated KRAS exon 2 had other RAS mutations . These mutations were associated with inferior progression-free survival and overall survival with panitumumab-FOLFOX4 treatment , which was consistent with the findings in patients with KRAS mutations in exon 2 . BRAF mutations were a negative prognostic factor . No new safety signals were identified . CONCLUSIONS Additional RAS mutations predicted a lack of response in patients who received panitumumab-FOLFOX4 . In
Output:
| Evidence supports mutational testing for EGFR signaling pathway genes , since they provide clinical ly actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC .
Mutations in several of the biomarkers have clear prognostic value . |
MS211798 | ***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 —Tai Chi Chuan ( TTC ) exercise has beneficial effects on the components of physical condition and can produce a substantial reduction in the risk of multiple falls . Previous studies have shown that short term TCC exercise did not improve the scores in the single leg stance test with eyes closed and the sit and reach test . There has apparently been no research into the effects of TCC on total body rotation flexibility and heart rate responses at rest and after a three minute step test . Methods —In this cross sectional study , 28 male TCC practitioners with an average age of 67.5 years old and 13.2 years of TCC exercise experience were recruited to form the TCC group . Another 30 sedentary men aged 66.2 were selected to serve as the control group . Measurements included resting heart rate , left and right single leg stance with eyes closed , modified sit and reach test , total body rotation test ( left and right ) , and a three minute step test . Results —Compared with the sedentary group , the TCC group had significantly better scores in resting heart rate , three minute step test heart rate , modified sit and reach , total body rotation test on both right and left side ( p<0.01 ) , and both right and left leg st and ing with eyes closed ( p<0.05 ) . According to the American Fitness St and ards , the TCC group attained the 90th percentile rank for sit and reach and total body rotation test , right and left . Conclusion —Long term regular TCC exercise has favourable effects on the promotion of balance control , flexibility , and cardiovascular fitness in older adults BACKGROUND Studies of the cardioprotective effects of exercise training in patients with coronary artery disease have yielded contradictory results . Exercise training has been associated with improvement in myocardial perfusion even in patients who have progression of coronary atherosclerosis . We therefore conducted a prospect i ve study of the effect of exercise training on endothelial function in patients with coronary artery disease . METHODS We r and omly assigned 19 patients with coronary endothelial dysfunction , indicated by abnormal acetylcholine-induced vasoconstriction , to an exercise-training group ( 10 patients ) or a control group ( 9 patients ) . To reduce confounding , patients with coronary risk factors that could be influenced by exercise training ( such as diabetes , hypertension , hypercholesterolemia , and smoking ) were excluded . In an initial study and after four weeks , the changes in vascular diameter in response to the intracoronary infusion of increasing doses of acetylcholine ( 0.072 , 0.72 , and 7.2 microg per minute ) were assessed . The mean peak flow velocity was measured by Doppler velocimetry , and the diameter of epicardial coronary vessels was measured by quantitative coronary angiography . RESULTS In the initial study , the two groups had similar vasoconstrictive responses to acetylcholine . After four weeks of exercise training , coronary-artery constriction in response to acetylcholine at a dose of 7.2 microg per minute was reduced by 54 percent ( from a mean [ + /-SE ] decrease in the luminal diameter of 0.41+/-0.05 mm in the initial study to a decrease of 0.19+/-0.07 mm at four weeks ; P<0.05 for the comparison with the change in the control group ) . In the exercise-training group , the increases in mean peak flow velocity in response to 0.072 , 0.72 , and 7.2 microg of acetylcholine per minute were 12+/-7 , 36+/-11 , and 78+/-16 percent , respectively , in the initial study . After four weeks of exercise , the increases in response to acetylcholine were 27+/-7 , 73+/-19 , and 142+/-28 percent ( P<0.01 for the comparison with the control group ) . Coronary blood-flow reserve ( the ratio of the mean peak flow velocity after adenosine infusion to the resting velocity ) increased by 29 percent after four weeks of exercise ( from 2.8+/-0.2 in the initial study to 3.6+/-0.2 after four weeks ; P<0.01 for the comparison with the control group ) . CONCLUSIONS Exercise training improves endothelium-dependent vasodilatation both in epicardial coronary vessels and in resistance vessels in patients with coronary artery disease INTRODUCTION In patients with cardiac diseases , lifestyle changes such as an increase in physical activity are recommended to prevent further cardiac events . In Germany this is possible by attending outpatient heart groups . A problem inherent in these programs is the lack of adherence since more than two thirds of patients stop attending cardiac rehabilitation programs after six months . An alternative to the conventional implementation of heart groups is Tai Chi , which was found to improve adherence to cardiac rehabilitation programs in international studies . METHODS Patients were r and omly assigned to a conventional heart group or a heart group with Tai Chi exercises . At the beginning of the study , a medical history was taken and physical and instrumental tests were carried out , including an assessment of anxiety/depression ( HADS question naire ) and physical well-being ( SD-12 ) . Follow-up tests were performed every three months . RESULTS Patients were 62.6 ± 8.5 years old , the mean BMI was 28.6 ± 62 kg/m(2 ) , and the proportion of women was 29.8 % . The groups were different in terms of age ( conventional heart group : 65.0 ± 7.5 ; Tai Chi group : 59.9 ± 8.9 years ) . Therefore , age-adjusted analyses were performed in addition to the planned analyses . Regarding the primary endpoint of the study , there was no difference between the groups . After twelve months , 50 % of subjects were active in the Tai Chi group and 48 % in the conventional heart group ( odds ratio 0.92 , p = 0.891 ) . After adjustment for age by logistic regression , the odds ratio was 0.47 ( p = 0.285 ) . Furthermore , both the participation period in weeks ( Tai Chi group : 43.3 ± 26.0 ; conventional group : 45.5 ± 24.2 , p = 0.766 ) and the participation rate ( Tai Chi group : 66.8 ± 19.2 % Tai Chi , conventional group : 76.3 ± 16.5 % , p = 0.074 ) did not differ between the two groups . A further analysis showed a non-significant trend for improvement of anxiety , depression and physical well-being in the Tai Chi group compared with the conventional group . CONCLUSION The insight gained in international studies regarding a better adherence to Tai Chi-guided prevention programs was not transferable to heart group participants from Germany . However , there was a trend regarding a better mental condition in the Tai Chi group PURPOSE This study prospect ively evaluated the training effect of a 1-yr Tai Chi Chuan ( TCC ) program for low-risk patients with coronary artery bypass surgery ( CABS ) after a postoperative outpatient ( phase II ) cardiac rehabilitation program . METHODS Twenty patients with mean age of 56.5+/-7.4 yr completed this study . The TCC group included nine men who practice d classical Yang TCC with an exercise intensity of 48 - 57 % heart rate range ( HRR ) . The control group included 11 men whom were recommended to do a home-based self-adjusted exercise program with similar intensity of phase II cardiac rehabilitation . Grade d exercise tests were performed before and after 1 yr of training for all subjects . RESULTS Mean attendance of the TCC group was 3.8+/-1.5 times weekly in contrast to 1.7+/-1.1 times for the control group . During the follow-up examination , the TCC group increased 10.3 % in VO2peak ( from 26.2+/-4.4 to 28.9+/-5.0 mL x kg(-1 ) min(-1 ) , P<0.01 ) and increased 11.9 % in peak work rate ( from 135+/-26 W to 151+/-28 W , P<0.01 ) . However , the control group showed slight decrease in VO2peak from 26.0+/-3.9 to 25.6+/-4.6 mL x kg(-1 ) x min(-1 ) and in peak work rate from 131+/-23 W to 128+/-32 W. At the ventilatory threshold , the TCC group also showed significant increase in VO2 and work rate ( P<0.05 ) . The control group did not significantly change in these variables . CONCLUSIONS The study demonstrated that a 1-yr TCC program for low-risk patients with CABS could favorably enhance cardiorespiratory function BACKGROUND Patients with a recent myocardial infa rct ion ( MI ) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption ( Vo2 peak ) . The impact of a Tai Chi Chuan ( TCC ) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed . Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI . METHODS A single-blind r and omized clinical trial was conducted . The research ers who performed the tests were blinded to group allocation . Between the 14th and 21st days after hospital discharge , all patients performed a cardiopulmonary exercise testing and a laboratory blood workup . Mean age was similar ( 56±9 years in the TCC group and 60±9 years in the control group ) . Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks ( n=31 ) . The control group participated in 3 weekly sessions of full-body stretching exercises ( n=30 ) . RESULTS After the 12-week study period , participants in the TCC group experienced a significant 14 % increase in Vo2 peak from baseline ( 21.6 ± 5.2 to 24.6 ± 5.2 mL/kg per minute ) , whereas control participants had a nonsignificant 5 % decline in Vo2 peak ( 20.4 ± 5.1 to 19.4 ± 4.4 mL/kg per minute ) . There was a significant difference between the 2 groups ( P<.0001 ) . CONCLUSIONS Tai Chi Chuan practice was associated with an increase in Vo2 peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population Tai chi -- moving for better balance , a falls-prevention program developed from a r and omized controlled trial for community-based use , was evaluated with the re- aim framework in 6 community centers . The program had a 100 % adoption rate and 87 % reach into the target older adult population . All centers implemented the intervention with good fidelity , and participants showed significant improvements in health-related outcome measures . This evidence -based tai chi program is practical to disseminate and can be effectively implemented and maintained in community setting
Output:
| Conclusion : Compared to no exercise or other types of exercise with low-to-moderate intensity , Tai Chi seems a good choice for coronary disease rehabilitation in improving cardiorespiratory fitness . |
MS211799 | ***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 examined the effectiveness of the universal component of the Fast Track prevention model : the PATHS ( Promoting Alternative THinking Strategies ) curriculum and teacher consultation . This r and omized clinical trial involved 198 intervention and 180 comparison classrooms from neighborhoods with greater than average crime in 4 U.S. locations . In the intervention schools , Grade 1 teachers delivered a 57-lesson social competence intervention focused on self-control , emotional awareness , peer relations , and problem solving . Findings indicated significant effects on peer ratings of aggression and hyperactive-disruptive behavior and observer ratings of classroom atmosphere . Quality of implementation predicted variation in assessment s of classroom functioning . The results are discussed in terms of both the efficacy of universal , school-based prevention models and the need to examine comprehensive , multiyear programs The influence of cognitive self-instructional training on the impulsive-aggressive behavior of 16 third- grade boys was examined . Children were equated by ranks on the frequency of their aggressive and motor behavior in the classroom and r and omly assigned to the cognitive self-instruction or an attention-control group . The instruction condition employed a training procedure which required the child to talk to himself , initially overtly and then covertly , to increase self-control . Posttreatment classroom observations and teachers ' ratings showed that the instruction group exhibited fewer deviant behaviors compared to controls although the differences were non-significant . Daring a staged problematic situation the instruction condition showed somewhat fewer deviant responses than controls and the number of prosocial responses differed only slightly . However , there was a significant difference between groups in the frequency of waiting and verbal aggressive behaviors . Results suggest that the instruction group may have used covert speech for controlling deviant responses to frustration rather than generating prosocial approach behavior This study tested the hypothesis that both aggressive and withdrawn children would benefit from participating in brief daily learning sessions with peers having similar behavioral problems . In particular the study looked for gains in self-concept and in the children 's behavioral difficulties . Sixty children from a Buffalo public school were r and omly placed into three groups : tutors , tutees , and control subjects . After r and om assignments were made , I met with the tutors for two training sessions in which they learned how to correct and reinforce their students in an easygoing , nonhostile manner . Tutors were given freedom to manipulate content material s of each session and were allowed to meet with their tutees as often as they wanted . After the five weeks of peer tutoring , almost all children who actively participated in the program showed higher gains than the control subjects . They had higher self-concepts and made greater behavioral improvements . In addition they demonstrated a renewed interest in school and in the learning process . A significant correlation was found between gain scores and the number of times of participation in the peer-tutoring sessions . Teachers and administrators were in favor of continuing the project with some modification . They felt that the sessions should be more structured and more under a teacher 's control A multiyear , multi context aggression prevention intervention was provided during the early or late elementary school years in an inner-city and an urban poor community . Sixteen schools were r and omly assigned to 1 of 4 conditions : ( a ) no-treatment control , ( b ) general enhancement classroom program , ( c ) general enhancement plus small-group peer-skills training , or ( d ) general enhancement plus small-group peer-skills training plus family intervention . This article reports on results for the high-risk sub sample of 1,500 children . Results from hierarchical linear modeling indicate that comprehensive interventions , if provided in early grade s , can be effective for children in schools in setting s with re sources adequate to support learning and development , but some unintended effects can occur in schools in the most distressed communities when delivered too late in development Annual screenings of preschool children at kindergarten registration identified 158 children having high levels of aggressive , hyperactive , impulsive , and inattentive behavior . These " disruptive " children were r and omly assigned to four treatment conditions lasting the kindergarten school year : no treatment , parent training only , full-day treatment classroom only , and the combination of parent training with the classroom treatment . Results showed that parent training produced no significant treatment effects , probably owing largely to poor attendance . The classroom treatment produced improvement in multiple domains : parent ratings of adaptive behavior , teacher ratings of attention , aggression , self-control , and social skills , as well as direct observations of externalizing behavior in the classroom . Neither treatment improved academic achievement skills or parent ratings of home behavior problems , nor were effects evident on any lab measures of attention , impulse control , or mother-child interactions . It is concluded that when parent training is offered at school registration to parents of disruptive children identified through a brief school registration screening , it may not be a useful approach to treating the home and community behavioral problems of such children . The kindergarten classroom intervention was far more effective in reducing the perceived behavioral problems and impaired social skills of these children . Even so , most treatment effects were specific to the school environment and did not affect achievement skills . These findings must be viewed as tentative until follow-up evaluations can be done to determine the long-term outcomes of these interventions First through fourth grade rs from 22 suburban elementary schools were screened for cross- setting disruptive behavior as eligibility criteria for participation in a longitudinal secondary prevention study aim ed at reducing the risk for serious externalizing behavioral disorders . Three hundred nine subjects participated in either a multicomponent competence enhancement intervention ( MCEI ) or an information/attention control ( IAC ) condition over a 2-year period . Following baseline measurements , initial intervention effects were assessed at the end of intervention Year 1 , at the beginning of intervention Year 2 ( fall of the next school year ) , and at the end of intervention Year 2 . Multi source assessment s were not supportive of the efficacy of the MCEI over the IAC condition . Children in both groups rated themselves as improved over time in terms of increased adaptive skills and decreased school problems and internalizing symptoms . Teacher and parent ratings of externalizing behavior did not yield evidence of positive change , but teachers noted improved problem solving and observers noted a decrease in behavioral interference in both groups over time , possibly as a result of maturation OBJECTIVE To compare the effectiveness of the Violence Prevention Curriculum for Adolescents to the Conflict Resolution : A Curriculum for Youth Providers among middle school students . METHODS A sample ( N = 225 ) of adolescents ( males = 48 % ) representing 20 % of the student population in two middle schools were administered a pretest question naire . Of these students , 89 % were African-American , 10 % were white , and 1 % were Native-American and lived in public housing ( 40 % ) or in neighborhoods adjacent to public housing ( 60 % ) . Each school was r and omly assigned to one of the curricula . Each curriculum was administered during 10 50-min sessions held twice a week over 5 weeks . One week later , 209 students who completed the 10 sessions were tested with the same question naire . The data were analyzed with a repeated- measures analysis of variance . RESULTS Students who received either curriculum reported significant decreases in their self-reported use of violence in hypothetical conflict situations , frequency of use of violence in the previous 30 days , and frequency of physical fights in the previous 30 days . The conflict resolution curriculum was more effective in reducing the frequency of fights result ing in an injury requiring medical treatment in the previous 30 days . CONCLUSIONS Both curricula were successful in reducing three indicators of violence . However , the conflict resolution approach was more successful in reducing the frequency of more severe physical fights requiring medical treatment . The latter finding is of particular importance , because that physical fighting is the form of violence behavior in which young adolescents most often engage An attributional intervention was design ed to reduce aggressive males ' tendency to attribute hostile intentions to peers following ambiguously caused peer provocations . African-American elementary school boys ( N = 101 ) , aggressive and nonaggressive , were r and omly assigned to the attributional intervention , an attention training program , or a no-treatment control group . Data were collected on subjects ' attributions about hypothetical and laboratory simulations of peer provocation , disciplinary referrals to the school office , and teacher ratings of aggressive behavior . Aggressive subjects in the attributional intervention were less likely to presume hostile intent by peers in hypothetical and laboratory simulations of ambiguous provocation . They were also less likely to endorse hostile retaliation on judgment measures and to engage in verbally hostile behaviors in the laboratory task . Further , intervention subjects were rated as less aggressive by their teachers following the treatment . Both the benefits of attributional change and its limitations in the African-American population are discussed From a school population of normal children third through fifth grade s ) , thirty children initially identified as “ angry”were r and omly assigned to either an affective imagery training group , an attention group , or a control group . The treatment group received three sessions of affective imagery in which they focused on physiological changes and on their thoughts associated with prior emotional experiences . Teachers recorded pre- , post- , and short term follow-up aggressive behaviors for all thirty children . Cognitive perceptions and attributions were recorded at the same three occasions on the Affect Question naire . Results suggested that , as a result of affective imagery training , angry children 's perceptions and cognitions shifted from “ angry ” towards “ sad , ” and there was a concomitant decrease in observed aggressive classroom behavior Fast Track is a multisite , multicomponent preventive intervention for young children at high risk for long-term antisocial behavior . Based on a comprehensive developmental model , intervention included a universal-level classroom program plus social skills training , academic tutoring , parent training , and home visiting to improve competencies and reduce problems in a high-risk group of children selected in kindergarten . At the end of Grade 1 , there were moderate positive effects on children 's social , emotional , and academic skills ; peer interactions and social status ; and conduct problems and special-education use . Parents reported less physical discipline and greater parenting satisfaction/ease of parenting and engaged in more appropriate/consistent discipline , warmth/positive involvement , and involvement with the school . Evidence of differential intervention effects across child gender , race , site , and cohort was minimal This paper describes a preventive intervention trial called EARLY ALLIANCE which is aim ed at reducing risk for three adverse outcomes in childhood and adolescence : conduct problems , substance abuse , and school failure . The structure of the prevention trial is unique because two linked design s are being implemented concurrently . The primary design focuses on children at elevated risk for adverse outcomes , and compares a targeted , multi context ual preventive intervention with family , classroom , peer relational , and academic components to a universal , schoolwide preventive intervention that emphasizes peaceful conflict management and serves as a " usual care " control condition . The secondary design focuses on children at lower risk for adverse outcomes and compares a universally administered classroom program to the control condition . The paper describes the theoretical foundation for EARLY ALLIANCE , the goals of the prevention trial , the rationale for design choices , and the methods employed The Montréal Longitudinal Study of Disruptive Boys , an experimental study , was design ed to underst and boys who were considered disruptive in kindergarten . One part of the study involved assessing effects of a preventive treatment program carried out during the boys ' early years in primary school . This paper reports on the outcome of the r and omized treatment experiment 3 years after treatments ended . Disruptive boys were r and omly allocated to a treated group and two nontreated groups . Treatment consisted of parent training and training of boys for social skills , fantasy play and television viewing . Results suggest that the treatment program had some positive effects . Some of the improvements were not evident immediately after treatment ended The purpose s of this study were to examine the type of response to different situations displayed by children with or without conduct disorders and to assess the efficacy of the social skills training program herein proposed for modifying styles of interpersonal relationship in children . The sample included 315 children , 8 to 12 years of age . Those exhibiting conduct problems were 164 boys , and those having no conduct problems were 151 boys . All participants shared a low socioeconomic and cultural status and attended schools located in poor districts of Mendoza City in Argentina . Analysis showed that the groups trained in social skills improved in social interaction by reducing disruptive behaviors , whereas the groups without social skills training showed no behavioral changes . These data were confirmed by the teachers ' assessment s. These results suggest social skills training seems an efficient therapeutic approach to the attenuation of behavior disorders of boys V and alism is a major problem facing educators and taxpayers alike . The present investigation analyzed how v and alism costs and student disruption were related to the implementation of a training and consultation package design ed to increase the reinforcing ambience of the school . A positive environment , it was posited , would displace previous events that may have set the occasion for v and alism , with cues to promote productive school performance . Eighteen elementary and junior high schools were involved over a 3-year period . Using a delayed treatment control design , treatment was delivered following either 4 or 13 months of baseline . During treatment , teams of school personnel attended training workshops in behavioral strategies for reducing v and alism and disruption by students in school . Each team also met regularly on its campus to plan and implement programs on a schoolwide basis . To demonstrate that reinforcing procedures were actually implemented and accompanied by change in student performance , these variables were periodically probed throughout the study . Project staff also provided consultation . V and alism costs decreased significantly ( p less than .05 ) more in treatment than control schools , with an average reduction of 78.5 % for all project schools . Rates of praise delivered by project teachers and other r and omly selected teachers in the school increased significantly ( p less than .05 ) , and rates of off-task behavior by students decreased significantly ( p less than .05 ) following treatment . The staff development model used in this study appeared to be both feasible and economical Thirty-two boys who were rejected by their peers in Grade s 1 - 3 were identified on the basis of negative sociometric nominations and negative social behavior . They were r and omly assigned to one of four treatment conditions : ( a ) instructions to promote positive social behavior , ( b ) prohibitions to reduce negative social behavior , ( c ) a combination of instructions and prohibitions , or ( d ) no treatment . Interventions were applied during 10 half-hour school play sessions . Behavioral observations and peer and teacher ratings were collected
Output:
| School-based secondary prevention programmes to reduce aggressive behaviour appear to produce improvements in behaviour greater than would have been expected by chance .
Benefits can be achieved in both primary and secondary school age groups and in both mixed sex groups and boys-only groups . |
Subsets and Splits