The quality of reporting and outcome measures in randomized clinical trials related to upper-extremity disorders

Purpose: Randomized clinical trials can provide strong evidence regarding effective treatment options. The quality of reporting and the type of outcome measures used are important when judging whether results justify change in clinical practice. The aim of this study was to assess the quality of reporting of randomized clinical trials related to treatment of upper-extremity disorders, published in 4 hand surgical and orthopedic journals during an 11-year period, and assess the type of outcome measures used in the trials. Methods: Eligible articles were identified by reviewing all abstracts published in the 4 journals from 1992 through 2002. The quality of reporting was assessed by a modified Jadad scale that consisted of 3 items (randomization, blinding, and withdrawals/dropouts). A higher score (0-5) indicated higher quality. The outcome measures were classified according to the International Classification of Functioning, Disability and Health into the levels of body function and structure, activity, and participation. Results: Of 92 articles reporting randomized clinical trials, 40 articles described appropriate randomization method that implied they were truly randomized studies, 31 articles did not describe the randomization method, and 21 articles (23%) described inappropriate randomization methods. Double or single blinding was reported in 33 articles. Absence or description of withdrawals/dropouts was shown in 77 articles. The median quality score calculated for all 92 articles was 2 (range, 0-5) points. The median score for the 28 articles published 1992 through 1996 was 1 (range, 0-5) points and for the 64 articles published from 1997 through 2002 was 3 (range, 0-5) points. All trials used outcome measures on body function and structure level; 41% used measures of activity and/or participation. Conclusions: There is a need to improve the quality of reporting of upper-extremity randomized clinical trials and to increase the use of outcome measures covering different aspects of disability. Copyright (C) 2004 by the American Society for Surgery of the Hand.