***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results W hat n ~ les of evidence should apply when evpert committees meet to generate recommendations for the clinical management of patients ? Should only the thoroughly vali date d results of r and omized clinical trials be admissible to avoid or minimize the application of useless or harmful therapy ? Or , to maximize the potential benefits to patients ( inclr ~ ding those possible from unproved remedies ) , should a synthesis of the experiences of experienced clinicians form the basis for such recommendations ? Ample precedent exists for the latter approach even when attempts are made to replace it . ' However , for the following reasons , the nonexperimental evidence that forms the recalled experiences of seasoned clinicians will tend to overestimate efficacy : Objective : To determine the efficacy of a fixed dose of ultrasound energy to treat acute lateral ligament sprains of the ankle joint . Study design : Double-blind r and omised controlled trial . Setting : Accident and Emergency department of University Teaching Hospital . Subjects : Patients presenting at Accident and Emergency with ankle injuries . Intervention : Ultrasound or placebo , and Tubigrip . Outcome measures : Pain measured with visual analogue scales , swelling using a tape measure , range of movement using a fluid-filled goniometer , and weight bearing using two scales simultaneously . Results : Patients in both groups improved symptomatically . There were no statistically significant differences between groups in any outcome measure . Within groups , statistically significant differences were detected in pain perceived , and range of movement ( dorsiflexion ) . Conclusion : At the dose and duration used , ultrasound therapy is no better than placebo in the management of lateral ligament injuries Ultrasound is commonly used in association with other forms of treatment in the management of sprains of the lateral ligament of the ankle . Despite its widespread use there is little scientific evidence to support its role in the management of sprained ankles . We have conducted a prospect i ve , r and omized , double-blind trial to compare the results of physiotherapy for sprains of the lateral ligament of the ankle  without the use of ultrasound with physiotherapy which included ultrasound . The results in the 154 patients who entered the trial demonstrate that there was no significant difference between the results achieved by the group treated with ultrasound and by those managed without Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration OBJECTIVE The purpose of this study was to determine the efficacy of adjusting the ankle in the treatment of subacute and chronic grade I and grade II ankle inversion sprains . DESIGN A single-blind , comparative , controlled pilot study . SETTING Technikon Natal Chiropractic Day Clinic . PARTICIPANTS Thirty patients with subacute and chronic grade I and grade II ankle inversion sprains . Patients were recruited from the public ; they responded to advertisements placed in newspapers and on notice boards around the campus and local sports clubs . INTERVENTION Each of the 15 patients in the treatment group received the ankle mortise separation adjustment . Each of the 15 patients in the placebo group received 5 minutes of detuned ultrasound treatment . Each participant received a maximum of 8 treatment sessions spread over a period of 4 weeks . MAIN OUTCOME MEASURE Patients were evaluated at the first treatment , at the final treatment , and at a 1-month follow-up consultation . Subjective scores were obtained by means of the short-form McGill Pain Question naire and the Numerical Pain Rating Scale 101 . Objective measurements were obtained from goniometer readings measuring ankle dorsiflexion range of motion and algometer readings measuring pain threshold over the ankle lateral ligaments . A functional evaluation of ankle function was also used . RESULTS Although both groups showed improvement , statistically significant differences in favor of the adjustment group were noted with respect to reduction in pain , increased ankle range of motion , and ankle function . CONCLUSIONS This study appears to indicate that the mortise separation adjustment may be superior to detuned ultrasound therapy in the management of subacute and chronic grade I and grade II inversion ankle sprains Eighty-six patients with acute ( < 24 h ) grade II or III lateral ligament ruptures were r and omized into two different non-surgical treatment groups . The main difference in treatment protocol s between the two groups was during the first week after injury . Group I ( n = 46 ) was to receive functional treatment using specially design ed compression pads , elevation of the injured foot ( 24 h ) , repeated elastic wrapping ( compression b and age followed by ankle tape ) , early full weight-bearing and proprioceptive range-of-motion training . Group II ( n = 40 ) was to receive conventional treatment with an elastic b and age , partial weight bearing and crutches until the pain subsided . One week after the injury , patients from both groups were given identical rehabilitation instructions . No early surgery was performed . The mean follow-up period was 18 months . The functional results were satisfactory in 91 % of the patients in group I and in 87 % of the patients in group II ( NS ) . Five patients had been operated on due to recurrent instability , two in group I and three in group II ( NS ) . The mean sick leave was significantly shorter in group I ; 5.6 + /- 4.2 days compared with 10.2 + /- 6.8 days in group II . Return to sports activities was also significantly earlier in group I , 9.6 + /- 4.8 days compared with 19.2 + /- 9.5 days in group II . In this study , non-surgical treatment of acute grade II and III ligament injuries of the ankle produced satisfactory results in the majority of patients . Early functional treatment result ed in shorter sick leave and facilitated an earlier return to sports , but it did not influence the final results Assessing the quality of r and omized controlled trials ( RCTs ) is important and relatively new . Quality gives us an estimate of the likelihood that the results are a valid estimate of the truth . We present an annotated bibliography of scales and checklists developed to assess quality . Twenty-five scales and nine checklists have been developed to assess quality . The checklists are most useful in providing investigators with guidelines as to what information should be included in reporting RCTs . The scales give readers a quantitative index of the likelihood that the reported methodology and results are free of bias . There are several shortcomings with these scales . Future scale development is likely to be most beneficial if questions common to all trials are assessed , if the scale is easy to use , and if it is developed with sufficient rigor OBJECTIVE --To determine the quality of r and omised controlled trials of exercise therapy for back pain . DESIGN --Computer aided search of published papers and blinded assessment of the methods of studies . SUBJECTS--23 r and omised controlled trials , of which 16 studied exercise therapy given by physiotherapists to individual patients with back pain . Other conservative treatments could be included . MAIN OUTCOME MEASURES --Score for quality of methods ( based on four main categories : study population , interventions , measurement of effect , and data presentation and analysis ) and main conclusion of author(s ) with regard to exercise therapy . RESULTS --Only four studies scored more than 50 points ( maximum 100 ) , indicating that most were of poor quality . Six studies found that exercise was better than reference treatments and 10 reported it to be no better or worse than the reference treatment . Those reporting positive results tended to have higher methods scores ( 4/6 positive v 4/10 negative scored greater than or equal to 42 ) . CONCLUSIONS --No conclusion can be drawn about whether exercise therapy is better than other conservative treatments for back pain or whether a specific type of exercise is more effective . Further trials are needed in which greater attention is paid to methods of study R and omised controlled trials are the best way to compare the effectiveness of different interventions . Only r and omised trials allow valid inferences of cause and effect . Only r and omised trials have the potential directly to affect patient care — occasionally as single trials but more often as the body of evidence from several trials , whether or not combined formally by meta- analysis . It is thus entirely reasonable to require higher st and ards for papers reporting r and omised trials than those describing other types of study . Like all studies , r and omised trials are open to bias if done badly.1 It is thus essential that r and omised trials are done well and reported adequately . Readers should not have to infer what was probably done , they should be told explicitly . Proper methodology should be used and be seen to have been used . Yet review s of published trials have consistently found major deficiencies in reporting,2 3 4 making the task OBJECTIVE To further the development of criteria for clinical ly important changes in outcomes seen in rheumatoid arthritis ( RA ) patients and trials . METHODS Small group discussion s and voting on specially design ed profiles based on a 6 factor 2 level factorial design for changes seen in patients and trials . The purpose was to bring out the implicit opinions of participants on these issues , to complement the explicit opinions expressed in the OMERACT question naire . This took place at a conference of rheumatologists , method ologists , biostatisticians , regulatory , pharmaceutical and biotechnology industry personnel with an interest in therapies for patients with RA . Data from patients with RA and r and omized clinical trials of second line drugs in patients with RA formed the basis to create 64 patient profiles and 64 trial profiles . The profiles contained information on changes in 6 measures : swollen joint count , tender joint count , pain , patient global assessment , physician global assessment and physical disability . The profiles were prepared on 4 " x 5 " cards and presented to the participants in packages of 64 in r and om order , in 2 different group sessions . Participants were assigned to 8 groups that contained a mix of all types of participants , with a majority of clinicians in each group . In the patient profile session , individual participants scored whether the profile represented important improvement . In the trial profile session , participants did likewise for important difference between the drugs . After structured discussion the group then voted : consensus was defined as agreement by at least 70 % of the group . We decided that an important improvement or difference was present in the profiles on which at least 6 of the 8 groups had achieved consensus . The changes in the profiles showing important improvement or difference can be used to suggest minimum criteria for each of the 6 measures . RESULTS The lower quartile of the change present in the patient profiles with important improvement varied from 17 % ( swollen joints ) to 49 % ( disability ) ; the median of these quartiles was 36 % . The lower quartile of the differences present in the trial profiles with important differences varied from 13 % ( tender joints ) to 26 % ( physician global ) ; the median of these quartiles was 18 % . CONCLUSIONS This approach has provided a beginning for less arbitrary definition of criteria for important change in patients and trials . It might be suggested that for patients , an improvement of at least 36 % should be clinical ly important , while an active drug needs to be at least 18 % better than placebo to be clinical ly important To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential 
    Output:
    
The evidence from the five small placebo-controlled trials included in this review does not support the use of ultrasound in the treatment of acute ankle sprains .
The potential treatment effects of ultrasound appear to be generally small and of probably of limited clinical importance , especially in the context of the usually short-term recovery period for these injuries .
However , the available evidence is insufficient to rule out the possibility that there is an optimal dosage schedule for ultrasound therapy that may be of benefit