***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: One hundred and forty-three patients presenting with ankle sprains within 24 h of injury were entered into a double blind study . Treatment consisted of a st and ardized regime of high dose non-steroidal anti-inflammatory medication and an elastic support for all patients , who were then r and omly allocated to two groups . One group received immediate cold therapy , the other received simulated therapy . Assessment s made at 7 days showed a trend in favour of the group receiving cold therapy , although this did not reach significance . It is concluded that cold therapy together with compression may have a beneficial effect but that a single application in the accident and emergency department is not justified when a background therapy of non-steroidal anti-inflammatory medication is given Meta-analytic investigations sometimes use assessment s of research quality according to a formal protocol as a tool for improving research synthesis . We asked whether a particular  quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference . In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled r and omized clinical trials comprising 107 primary studies , we found no relation between treatment difference and overall quality score . We also found no relation between quality score and variation in treatment difference . The level of quality scores has increased at a rate of 9 % per decade for three decades , averaging 0.51 on a scale of 0 to 1 for the 1980s , and leaving much room for improvement . Nevertheless , attention to quality of studies by editors , review ers , and authors may be raising both the level of research done and quality of the reports A r and omized , controlled parallel-group trial has assessed 14 days ' use of a new ankle support ( Malleotrain , Bauerfeind , Aldershot , UK ) in 220 patients ( 118 Malleotrain , 102 control group ) with acute ankle injuries .  Self-assessed pain levels were significantly lower in the group using Malleotrain at the end of the trial ( P less than 0.05 ) , as were median times taken for reduction of symptom scores to 10 % ( P less than 0.05 ) and total analgesic consumption during the trial ( P less than 0.05 ) . Overall clinical assessment scores were significantly superior in the Malleotrain group ( P less than 0.02 ) . Of those patients who received Malleotrain , 112 of 116 patients who commented ( 95 % of all Malleotrain-treated patients ) did so positively and only one patient stopped wearing the support during the trial . Malleotrain is acceptable to patients with acute ankle injuries and its use increases the rate of alleviation of symptoms . Its use should therefore be considered in the management of all such patients We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 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 Abstract Objective : To assess the method ological quality of approaches to blinding and to h and ling of exclusions as reported in r and omised trials from one medical specialty . Design : Survey of published , parallel group r and omised controlled trials . Data sources : A r and om sample of 110 reports in which allocation was described as r and omised from the 1990 and 1991 volumes of four journals of obstetrics and gynaecology . Main outcome measures : The adequacy of the descriptions of double blinding and exclusions after r and omisation . Results : Though 31 trials reported being double blind , about twice as many could have been . Of the 31 trials only eight ( 26 % ) provided information on the protection of the allocation schedule and only five ( 16 % ) provided some written assurance of successful implemention of double blinding . Of 38 trials in which the authors provided sufficient information for readers to infer that no exclusions after r and omisation had occurred , six ( 16 % ) reported adequate allocation concealment and none stated that an intention to treat analysis had been performed . That compared with 14 ( 27 % ) and six ( 12 % ) , respectively , for the 52 trials that reported exclusions . Conclusions : Investigators could have double blinded more often . When they did double blind , they reported poorly and rarely evaluated it . Paradoxically , trials that reported exclusions seemed generally of a higher method ological st and ard than those that had no apparent exclusions . Exclusions from analysis may have been made in some of the trials in which no exclusions were reported . Editors and readers of reports of r and omised trials should underst and that flawed reporting of exclusions may often provide a misleading impression of the quality of the trial . Key messages Key messages Poor reporting of methods used for double blinding raises concerns about how effective blinding was in many of the studies Some investigators may have excluded some patients from the analysis but not reported these exclusions in their published paper Given the apparent failure to report exclusions , some of the more biased trials may be mistaken as unbiased and vice versa Investigators must pay more attention to executing and reporting their approaches to blinding and the h and ling of Eighty patients with grade III lateral ligament ruptures were treated either with total immobilization in a walking plaster cast or early mobilization in a stabilizing orthosis . The criterion for entrance was a talar tilt of more than 9 ° and an anterior translation of more than 10 mm at stress radiography , a previously stable ankle , and a contralateral ankle showing normal stress radiographic values . Ninety-one percent of the patients were evaluated at 7 weeks , 3 months , and 1 year postinjury . While functionally treated patients reached normal mobility and resumed work and sports earlier than immobilized patients there were no differences between the treatment groups in ankle stability or symptoms during activity after 1 year . Ninety-five percent of the ankles in either group were mechanically stable after treatment . Residual symptoms were present 1 year postinjury in 13 % of the functionally treated ankles and in 9 % of the cast-mobilized ankles . In lateral ankle ligament ruptures causing gross mechanical instability early mobilization results in a better early functional result ; however , at 1 year postinjury there was no statistically significant difference in outcome as compared to cast-immobilized ankles We analysed the results of 221 comparisons of an innovation with a st and ard treatment in surgery published in six leading surgery journals in 1983 to relate features of study design to the magnitude of gain . For each comparison we measured the gain attributed to the innovation over the st and ard therapy by the Mann-Whitney statistic and the difference in proportion of treatment successes . For primary treatments ( aim ed at curing or ameliorating a patient 's principal disease ) , an average gain of 0.56 was produced by 20 r and omized controlled trials . This was less than the 0.62 average for four non-r and omized controlled trials , 0.63 for 19 externally controlled trials , and 0.57 for 73 record review s ( 0.50 represents a toss-up between innovation and st and ard ) . For secondary therapies ( used to prevent or treat complications of therapy ) , the average gain was 0.53 for 61 r and omized controlled trials , 0.58 for eleven non-r and omized controlled trials , 0.54 for eight externally controlled trials , and 0.55 for 18 record review s. Readers of studies evaluating new treatments , particularly for primary treatments , may consider adjustment of the gain according to the study type A support for the treatment of stable injuries of the lateral ligament of the ankle has been design ed . One hundred and seventy-five consecutive patients with acute injuries were studied . Unstable injuries were excluded by the use of the radiological anterior stress test . One hundred and forty-four patients with stable injuries were r and omly allocated to three treatment groups : double Tubigrip , eversion strapping and the new support . The change in the range of movement was used as an objective measure of improvement . The new support was noticeably better than Tubigrip and eversion strapping Acutely sprained ankles represent a frequent and common injury among active duty troops in training , and are a significant source of morbidity with respect to days lost to training . Swelling in the form of periarticular edema limits motion , causes pain , prevents wearing of normal foot gear , and slows the healing process . Reduction of edema was attempted in acutely sprained ankles by the use of pulsed electromagnetic energy ( Diapulse ) . In a r and omized , prospect i ve , double blind study of 50 grade I and II ( no gross instability ) sprained ankles , a statistically significant ( p < 0.01 ) decrease in edema was noted following one treatment with Diapulse . The application of this modality in acutely sprained ankles could result in significant decreases in time lost to military training The purpose of this study was to compare the effects of three treatment protocol s on pitting edema in patients with first- and second-degree sprained ankles . Thirty subjects with postacute ( greater than 24 hours postinjury ) ankle sprains and pitting edema but not requiring cast immobilization were r and omly assigned to an elastic wrap group ( N = 10 ) , an intermittent compression group ( N = 10 ) , or an elevated control group ( N = 10 ) . Pretreatment and posttreatment volumetric measurements of the subjects ' ankles were obtained by the water displacement method . After the pretreatment measurement , the groups were treated for 30 minutes . All subjects ' ankles were elevated by raising the foot section of an adjustable table to a 45 degrees angle during treatment . For the first treatment group , the intermittent compression device was set at 40 - 50 mm Hg , with a 60-second on time and a 15-second off time . For the second treatment group , an elastic wrap was applied from the heads of the metatarsals to 12.7 centimeters above the malleoli . Control group subjects received only the elevated position as their treatment . A three by two repeated measures ANOVA with a follow-up post hoc test revealed that the elevated control group subjects had the least amount of edema ( p < .0006 ) . The two compression protocol s produced increased edema in the subjects ' sprained ankles following treatment . In conclusion , elevation is the most appropriate of the three treatment protocol s if the major therapeutic objective is to minimize edema in the postacute phase of rehabilitation . J Orthop Sports Phys Ther 1991;14(2):65 - 69 
    Output:
    
Previous research has suggested that method ologically poorly design ed studies tend to over-estimate the effect estimate .
Our study does not confirm these conclusions