Javier Julian V, Corvi Michaela, Sabo Graham, Chari Rohit, Yendluri Avanish, Corvi John, Ferlauto Harrison R, Rhee Hannah, Parisien Robert L
Department of Orthopedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Royal College of Surgeons in Ireland, Dublin, Ireland.
Hand (N Y). 2025 Jun 27:15589447251348505. doi: 10.1177/15589447251348505.
Randomized controlled trials (RCTs) that assess carpal tunnel release (CTR) approaches often only report -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 -value to nonsignificant -value; and rFI is the amount necessary to alter nonsignificant to significant -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 -values to provide a comprehensive reliability assessment.
评估腕管松解术（CTR）方法的随机对照试验（RCT）通常仅报告对手术决策有重大影响的数据的P值。本研究采用脆弱性指数（FI）、反向脆弱性指数（rFI）和脆弱性商数（FQ）指标来评估评估CTR的RCT的统计稳定性。从2000年1月1日至2024年1月31日的随机对照试验从PubMed、Embase和Medline中检索。脆弱性指数定义为将显著P值改变为非显著P值所需的结果数量；rFI是将非显著P值改变为显著P值所需的数量。纳入的12项研究共产生了43个结果，汇总后的中位FI为5（四分位间距4 - 6.5）。因此，与CTR相关的结果的统计学显著性可能会因中位数为5名患者而逆转。总体而言，分析CTR方法的RCT中的统计结果是脆弱的，应谨慎解释。为了让外科医生做出更明智的决策，我们建议RCT在报告P值的同时共同报告FI、rFI和FQ，以提供全面的可靠性评估。
