The application of the reverse fragility index to randomized controlled trials in hand surgery.

Abstract

The reverse fragility index (RFI) is a tool used to measure the robustness of statistically non-significant outcomes by quantifying the minimum event changes required to achieve significance. This study applies the RFI and reverse fragility quotient (RFQ) to hand surgery randomized control trials (RCTs). A systematic review of 15 journals yielded 25 RCTs with 43 non-significant, dichotomous outcomes published from 2000 to 2024. The RFI was calculated using Fisher's exact test and the RFQ was calculated by dividing the RFI by the sample size. The median RFI was 4 and the median RFQ was 0.056. Loss to follow-up was not clearly reported in 24% of studies and loss to follow-up exceeded the RFI in 56% of outcomes. Hand surgery RCTs demonstrate fragility in non-significant findings, with a small number of event changes potentially altering conclusions. The RFI and RFQ are useful measures that complement traditional p-values, offering more context in interpreting clinical trial results.