Clinical Trial Registry Use in Orthopaedic Surgery Systematic Reviews

Abstract

Background: Results from systematic reviews and meta-analyses, which have the highest level of evidence (Level I), often drive clinical decision-making and health policy. Often, unpublished trial data are omitted from systematic reviews, raising concerns about the extent of the reliability and validity of results that have been drawn from systematic reviews. We aimed to determine the extent to which systematic review authors include searches of clinical trial registries for unpublished data when conducting systematic reviews in orthopaedic surgery.

Methods: Systematic reviews and/or meta-analyses were gathered from the top 5 orthopaedic surgery journals based on the h5-index from Google Scholar Metrics. Systematic reviews that had been published in the Cochrane Database of Systematic Reviews, which requires the inclusion of a clinical trial registry search, served as controls. For the primary outcome, each systematic review from the top 5 orthopaedic journals was screened to determine whether the authors of each study searched for unpublished data in clinical trial registries. We then compared the rate of registry searches with those in the control group. For the secondary analysis, a search of ClinicalTrials.gov was performed for unpublished trial data for 100 randomized systematic reviews.

Results: All 38 of the Cochrane systematic reviews (100%) included clinical trial registry searches, while the top 5 orthopaedic journals had only 31 of 480 studies (6.5%) that looked at clinical trial registries. The secondary analysis yielded 59 of 100 systematic review articles (59.0%) that could have included unpublished clinical trial data from ≥1 studies to their sample.

Conclusions: Systematic reviews that have been published in the top orthopaedic surgery journals seldom included a search for unpublished clinical trial data.

Clinical relevance: The exclusion of clinical trial registry searches potentially contributes to publication bias within the orthopaedic literature. Moving forward, systematic review authors should include clinical trial registry searches for unpublished clinical trial data to provide the most accurate representation of the available evidence for systematic reviews and meta-analyses.