The quality of randomised controlled trials involving surgery from the hand to the elbow: a critical analysis of the literature

Abstract

Aims: Our purpose was to determine the quality of current randomised controlled trials (RCTs) in hand surgery using standardised metrics.

Materials and methods: Based on five-year mean impact factors, we selected the six journals that routinely publish studies of upper extremity surgery. Using a journal-specific search query, 62 RCTs met our inclusion criteria. Then three blinded reviewers used the Jadad and revised Coleman Methodology Score (RCMS) to assess the quality of the manuscripts.

Results: Based on the Jadad scale, 28 studies were of high quality and 34 were of low quality. Methodological deficiencies in poorly scoring trials included the absence of rate of enrolment, no power analysis, no description of withdrawal or dropout, and a failure to use validated outcomes assessments with an independent investigator.

Conclusion: A large number of RCTs in hand, wrist, and elbow surgery were of suboptimal quality when judged against the RCMS and Jadad scales. Even with a high level of evidence, study design and execution of RCTs should be critically assessed. Methodological deficiencies may introduce bias and lead to statistically underpowered studies. Cite this article: Bone Joint J 2017;99-B:94-9.

Keywords: Consolidated Standards of Reporting Trials; Jadad scale; Randomised controlled trials; Upper extremity.