Statistical Fragility of Surgical Clinical Trials in Orthopaedic Trauma.

Abstract

The Fragility Index (FI) and the Fragility Quotient (FQ) are powerful statistical tools that can aid clinicians in assessing clinical trial results. The purpose of this study was to use the FI and FQ to evaluate the statistical robustness of widely cited surgical clinical trials in orthopaedic trauma. We performed a PubMed search for orthopaedic trauma clinical trials in high-impact orthopaedics-focused journals and calculated the FI and FQ for all identified dichotomous, categorical outcomes. We identified 128 studies with 545 outcomes. The median FI was 5, and the median FQ was 0.0482. For statistically significant and not statistically significant outcomes, the median FIs were 3 and 5, and the mean FQs were 0.0323 and 0.0526, respectively. The FI was greater than the number of patients lost to follow-up in most outcomes. The orthopaedic trauma literature is of equal or higher quality than research in other orthopaedic subspecialties, suggesting that other orthopaedic subspecialties may benefit from modeling their clinical trials after those in orthopaedic trauma.