Randomized Controlled Trials Evaluating Carpal Tunnel Release Are Statistically Fragile: A Systematic Review.

Abstract

Randomized controlled trials (RCTs) that assess carpal tunnel release (CTR) approaches often only report <i>P</i>-values for data that substantially influence surgical decision-making. This study employs fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) metrics to assess the statistical stability of RCTs assessing CTR. Randomized controlled trials from January 1, 2000, to January 31, 2024, were queried from PubMed, Embase, and Medline. Fragility index is defined as the amount of outcomes required to alter significant <i>P</i>-value to nonsignificant <i>P</i>-value; and rFI is the amount necessary to alter nonsignificant to significant <i>P</i>-value. The 12 included studies yielded a total of 43 outcomes that resulted in a pooled median FI of 5 (interquartile range 4-6.5). Thus, the statistical significance of outcomes relating to CTR may be reversed by a median of 5 patients. Overall, statistical outcomes in RCTs analyzing CTR approaches were fragile and should be interpreted cautiously. To allow surgeons to make better-informed decisions, we recommend RCTs co-report FI, rFI, and FQ alongside <i>P</i>-values to provide a comprehensive reliability assessment.