Original Articles: Reporting Upper Extremity Outcome Measures
The quality of reporting and outcome measures in randomized clinical trials related to upper-extremity disorders1 ,

https://doi.org/10.1016/j.jhsa.2004.04.003Get rights and content

Abstract

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.

Section snippets

Materials and methods

Studies were included if they were randomized trials comparing treatment methods for upper-extremity disorders among an adult patient population and were published from 1992 through 2002 in one of the following 4 journals: Journal of Hand Surgery (American volume), Journal of Hand Surgery (British and European volume), Journal of Bone and Joint Surgery (American volume), and Journal of Bone and Joint Surgery (British volume). Of these 4 journals only Journal of Bone and Joint Surgery (American

Results

The review of all abstracts of articles published in the 4 journals during the 11-year period identified 88 potentially eligible articles reporting RCTs related to the treatment of upper-extremity disorders. The advanced PubMed search identified 7 additional articles. Of these 95 articles 3 were excluded from further assessment because the terms “randomized,” “random,” or “randomly” were not mentioned in the description of the study except in the abstract.

Of the 92 articles included Journal of

Discussion

This systematic assessment revealed that only 43% of the studies reported to be RCTs that were related to treatment of upper-extremity disorders truly were randomized studies, based on the description of the randomization method. Twenty-three percent of the studies were described as randomized but the randomization method described was inappropriate. These studies should therefore not have been considered randomized studies. The randomization method was not described in 34% of the studies,

References (19)

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Supported by grants from the Vardal Foundation and the Skane County Council.

1

No benefits in any form have been received or will be received by a commercial party related directly or indirectly to the subject of this article.

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