***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 In a prospect i ve , r and om study carried out at the Casualty Clinic of the University Hospital of Hannover from 15 April 1986 to 31 July 1986 , 200 patients were r and omly selected from four treatment groups , according to treatment : operative-immobilized ( group A , n = 52 ) , operative-functional ( group B , n = 50 ) , conservative-immobilized ( group C , n = 48 ) and conservative-functional ( group D , n = 50 ) . Follow-up examinations were made in 92.5 % of patients after 3 months and 64 % after 12 months . At the 3-month and 1-year follow-ups , no statistically significant differences were found in the total evaluation ( 100-point checklist ) Moderately significant instability ( 6 degrees -10 degrees talar tilt and 6 - 10 mm anterior talar dislocation ) in the conservative groups C and D was observed only in the clinical -radiological instability test . This statistically significant difference is , however , only evident in stress tenographically confirmed dual-ligament lesions . No functional physiological differences can be found after 12 months ; on average , the period of incapacitation is 3 weeks shorter than with primary functional treatment , but so far there are no long-term results . Until late results are available , we conclude that conservative treatment , even for professional athletes , can be recommended as the procedure most free of risk and most economical ; if at all , operative therapy should only be carried out when the instability is very serious Two hundred consecutive patients with arthrographically verified rupture of one or both of the lateral ankle ligaments were allocated to treatment with either an operation and a walking cast , walking cast alone , or strapping with an inelastic tape - all for 5 weeks . Eighty-seven percent of the patients attended follow-up after 1 year . Only 5 percent in each treatment group were unsatisfied with the result . There were no differences between the treatment groups in ankle stability or symptoms during different activities , regardless of rupture of the anterior talofibular ligament alone or combined with rupture of the calcaneofibular ligament . However , the patients treated with tape had fewer symptoms , fewer complaints when running , and more ankles recovered to the preinjury state . Therefore , in lateral ankle ligament rupture , tape b and ages seem preferable The results of a study after 1 and 2 years of a prospect i ve r and omised trial of operative versus conservative treatment of ankle ligament rupture , demonstrate that purely functional orthotic therapy is the method of choice . This relates both to patient need and economical considerations . The trial demonstrated that without an operation it was possible to achieve a high degree of mechanical stability , a reduction of work disability time down to 3 weeks and full sports capability within 3 months . Consequently , and as a result of the trial , the only remaining surgical indications would seem to be  dislocations of the foot and ankle , ankle ligament rupture with additional intra-articular pathology , and second-stage injuries or re-ruptures . The joint-stabilising function of the prototype splint developed in this study was improved on the basis of experimental investigations , using a Y-shaped leather b and ( design ated CALIGAMED ) , which is available in 6 sizes for right and left ankle Good results have been reported after both primary repair and conservative management of grade III ankle sprains . This prospect i ve study found no advantage of operative treatment compared to taping ; no significant differences were found between the groups with regard to objective or subjective stability , functional scores , or the overall result Summary A prospect i ve r and omized clinical study was undertaken to compare b and aging , plaster cast immobilisation and operative treatment for recent tears of the lateral ligament of the ankle . The follow-up period was two years . Subjectively , only the fear of giving-way showed a clear difference in favour of operative repair . Objective evaluation , including stress radiographs , demonstrated no statistical differences between the three methods of treatment . Although b and aging appeared somewhat less satisfactory with respect to the result ing stability of the ankle , the differences were not statistically significant . The lateral ligament in patients over 40 years of age showed a statistically significant tendency to heal less well than that of younger patients .Severe ankle sprains in patients under 40 years of age should preferably be treated by operation , especially in younger patients and if the person is physically active . Lateral ligament tears in patients over 40 years of age should be treated conservatively and a secondary reconstruction carried out later , if necessary . RésuméUne recherche prospect i ve r and omisée a été réalisée pour comparer les traitements par b and age adhésif , par immobilisation plâtrée et par opération conjuguée au plâtre dans les lésions récentes du ligament latéral externe de la cheville . Le recul est de deux ans . Sur le plan subjectif la sensation d'instabilité de la cheville était le seul paramètre qui plaidait clairement en faveur de l'opération . L'examen objectif comportant notamment des clichés sous deux incidences en vue d ' objective r des mouvements anormaux de la tibiotarsienne n'a cependant pas fait apparaître de différences statistiques entre les trois modes de traitement . Après traitement par b and age l'instabilité était un peu plus fréquente qu'après les autres traitements mais toutefois sans nette différence statistique . Enfin les entorses des sujets de plus de 40 ans ont guéri nettement moins bien que celles des patients plus jeunes . Les entorses graves du cou de pied devraient donc être traitées opératoirement chez les sujets physiquement actifs et de moins de 40 ans . Pour les lésions des patients plus âgés on recomm and era un traitement conservateur que l'on pourra compléter ultérieurement par une reconstruction , si cela s'avère nécessaire Summary A prospect i ve r and omised study was undertaken to compare the results of functional and operative treatment of recent ruptures of the fibular ligament of the ankle in 80 patients , aged from 18 to 45 years , with similar injuries . The best results were obtained from functional treatment and it is to be hoped that early movement and a stable ankle will avoid later osteoarthritis . RésuméLes auteurs ont réalisé , chez 80 sujets , âgés de 18 à 45 ans et présentant des lésions comparables , une étude prospect i ve r and omisée afin de comparer les résultats du traitement fonctionnel et opératoire des entorses fraîches du ligament latéral externe de la cheville . Les résultats les meilleurs ont été obtenus par le traitement fonctionnel et l'on peut espérer que la mobilisation précoce et la stabilité de la tibio-tarsienne permettront d'éviter l'arthrose post-traumatique One hundred and forty-six adults who had an isolated injury of the fibular collateral ligaments of the ankle were r and omized to be managed operatively or non-operatively . Disruption of the ligaments was diagnosed by means of a physical examination and on the basis of stress radiographs of the ankle made with use of a specially design ed device to hold the leg . Operative treatment , performed in seventy-three patients , consisted of suture repair of the disrupted ligaments within seventy-two hours after the injury , followed by immobilization of the ankle in a below-the-knee plaster cast for six weeks . Non-operative treatment , used for seventy-three patients , consisted of the use of an ankle orthosis for six weeks . After a minimum of two years of follow-up , we could detect no significant differences , with the numbers available , between the two groups with regard to the functional result or the degree of joint laxity that was evident on stress radiographs . The non-operative group lost a mean of 1.6 weeks from work , and the operative group lost a mean of 7.0 weeks . We concluded that non-operative treatment of an injury of the fibular collateral ligaments of the ankle yields results that are comparable with those of operative repair and is associated with a shorter period of recovery The results of a r and omized study comparing three different principles of treatment for  rupture of the lateral ligaments of the ankle are presented . A total of 95 patients was treated and followed up for 17 months . In this series , 32 patients were treated with primary suture and plaster-of-Paris , 33 patients with plaster-of-Paris only and 30 patients with strapping . In all , 31 patients ( 97 % ) were completely free of symptoms in the operation group , 22 ( 67 % ) in the plaster-of-Paris group and 23 ( 77 % ) in the strapping group One hundred patients with acute ruptures of the lateral ligaments of the ankle were r and omly allocated either to conservative treatment in a plaster cast or to operative repair . With the aid of stress tenography , the extent of the injury was established . There were 30 patients with isolated anterior talofibular ruptures and 20 with additional calcaneofibular ligament ruptures in each treatment group . Operative repair was associated with a higher incidence of complications in the first weeks , and slightly delayed the patients ' return to work . At an independent two-year review there was no evidence that operative repair offered improved symptomatic or functional benefit Consecutive patients with a confirmed rupture of at least one of the lateral ligaments of the ankle were r and omly assigned to receive either operative or functional treatment . They were evaluated at a median of 8 years ( 6 to 11 ) . In total , 370 patients were included . Follow-up was available for 317 ( 86 % ) . Fewer patients allocated to operative treatment reported residual pain compared with those who had been allocated to functional treatment ( 16 % versus 25 % , RR 0.64 , CI 041 to 1.0 ) . Fewer surgically-treated patients reported symptoms of giving way ( 20 % versus 32 % , RR 0.62 , CI 0.42 to 0.92 ) and recurrent sprains ( 22 % versus 34 % , RR 0.66 , CI 0.45 to 0.94 ) . The anterior drawer test was less frequently positive in surgically-treated patients ( 30 % versus 54 % , RR 0.54 , CI 0.41 to 0.72 ) . The median Povacz score was significantly higher in the operative group ( 26 versus 22 , p < 0.001 ) . Compared with functional treatment , operative treatment gives a better long-term outcome in terms of residual pain , recurrent sprains and stability Summary In a series of 921 patients with acute inversion trauma of the ankle joint , the diagnostic features of lateral ligamentous ruptures were evaluated . Patients with proven lateral ligamentous rupture ( 150 patients in this series ) were su bmi tted to a prospect i ve trial to compare three methods of treatment . In the 50 patients operated upon , the results of  clinical diagnosis , stress radiography , and ankle arthrography were compared with surgical findings . Clinical diagnosis proved to be of very little value . The positive signs of ankle arthrography showed a reliability of 96 % in predicting ligamentous rupture . Inversion stress radiography  under full anesthesia showed a reliability of 92 % , but the same investigation under local anesthesia , however , was only 68%.ZusammenfassungIn einer Serie von 921 Patienten mit einem akuten Inversionstrauma des oberen Sprunggelenkes werden die diagnostischen Merkmale der lateralen Ligamentrupturen erforscht . Von diesen Patienten mit einer bewiesenen Ligamentruptur wurden 150 einer prospektiven Studie unterzogen , um drei Beh and lungs method en zu vergeichen . Bei 50 operierten Patienten konnten die Result ate der klinischen Diagnose , gehaltenen Röntgenaufnahmen und Arthrographien des oberen Sprunggelenkes mit den chirurgischen Befunden verglichen werden . Es hat sich herausgestellt , daß die klinische Diagnose nicht sehr wertvoll ist . Mit Hilfe der Arthrographie des oberen Sprunggelenkes konnte in 96 % der Fälle eine Ligamentruptur zuverlässig vorhergesagt werden . Eine gehaltene Röntgenaufnahme in Narkose ergab eine Zuverlässigkeit in 92 % der Fälle , jedoch eine gleiche Untersuchung in Lokalanästhesie nur in 68 % der Fälle OBJECTIVE To assess the impact on clinical practice of implementing the Ottawa ankle rules . DESIGN Nonr and omized , controlled trial with before-after and concurrent controls . SETTING Emergency departments of a university ( intervention ) hospital and a community ( control ) hospital . PATIENTS 
    Output:
    
While there were statistically significant differences for three primary outcomes ( non-return to pre-injury level of sports ; undefined pain or pain on activity ; and subjective or functional instability ) in favour of the surgical treatment group using the fixed effects model , these findings failed to demonstrate robustness in sensitivity analyses .
There was no statistically significant difference in ankle sprain recurrence , the other primary outcome measure .
Though there was a statistically significantly higher incidence of objective instability in conservatively treated patients , the functional implication s of this are uncertain .
There was some evidence for a lower incidence of long-term ankle swelling in surgically treated patients .
REVIEW ER 'S CONCLUSIONS There is insufficient evidence available from r and omised controlled trials to determine the relative effectiveness of surgical and conservative treatment for acute injuries of the lateral ligament complex of the ankle .