Ahdoot Rodney, Benítez Trista M, Wang Chien-Wei, Chung Kevin C
From the University of Michigan Medical School, Ann Arbor, MI.
Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI.
Plast Reconstr Surg Glob Open. 2025 Jan 23;13(1):e6456. doi: 10.1097/GOX.0000000000006456. eCollection 2025 Jan.
The reverse fragility index (RFI) is a measure used to evaluate the neutrality of statistically nonsignificant findings in randomized controlled trials (RCTs). The RFI represents the minimum number of events needed to reverse a statistically nonsignificant result into a significant one. This study applied the RFI to examine the robustness of statistically nonsignificant RCTs in plastic surgery.
A systematic literature search of the 10 highest impact journals covering plastic and reconstructive surgery topics was conducted to identify RCTs published between January 2000 and March 2023. The Fisher exact test was used to calculate the RFI for each primary outcome. Bivariate analysis was performed to investigate the association of trial characteristics with the RFI.
Forty RCTs that yielded 65 primary outcomes were included in the analysis with a median sample size of 76 participants (interquartile range [IQR], 49-129) and a median of 10 events (IQR, 3-22). The median RFI was 4 (IQR, 3-5), indicating that statistical significance would have been achieved if 4 participants had a change in event status. The median RFQ was 0.053 (IQR, 0.038-0.08). Most studies (21 of 40) did not perform statistical power analysis. Twelve of 40 RCTs did not report or clearly indicate loss to follow-up.
The findings of RCTs in the plastic surgery literature demonstrate fragility as the preservation of nonsignificant results rested on a small number of events. The RFI is a useful measure to complement the value and examine the neutrality of null clinical trials.
反向脆弱性指数（RFI）是一种用于评估随机对照试验（RCT）中统计学无显著性结果的中立性的指标。RFI代表将统计学无显著性结果转变为显著性结果所需的最小事件数。本研究应用RFI来检验整形外科中统计学无显著性RCT的稳健性。
对涵盖整形与重建外科主题的10种影响因子最高的期刊进行系统文献检索，以确定2000年1月至2023年3月发表的RCT。采用Fisher精确检验计算每个主要结局的RFI。进行双变量分析以研究试验特征与RFI之间的关联。
分析纳入了产生65个主要结局的40项RCT，样本量中位数为76名参与者（四分位间距[IQR]，49 - 129），事件中位数为10个（IQR，3 - 22）。RFI中位数为4（IQR，3 - 5），表明如果有4名参与者的事件状态发生变化，就会达到统计学显著性。RFQ中位数为0.053（IQR，0.038 - 0.08）。大多数研究（40项中的21项）未进行统计效能分析。40项RCT中有12项未报告或未明确说明失访情况。
整形外科学文献中RCT的结果显示出脆弱性，因为无显著性结果的维持依赖于少数事件。RFI是一种有用的指标，可补充P值并检验无效临床试验的中立性。
