Vivekanantha Prushoth, Shah Ajay, Hoit Graeme, Ayeni Olufemi, Whelan Daniel
Michael DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada.
Division of Orthopaedic Surgery, Postgraduate Medical Education, University of Toronto, Toronto, ON, Canada.
World J Surg. 2023 May;47(5):1163-1173. doi: 10.1007/s00268-023-06928-3. Epub 2023 Jan 31.
The fragility index (FI) is defined as the minimum number of patients or subjects needed to switch experimental groups for statistical significance to be lost in a randomized control trial (RCT). This index is used to determine the robustness of a study's findings and recently as a measure of evaluating RCT quality. The objective of this review was to identify and describe published systematic reviews utilizing FI to evaluate surgical RCTs and to determine if there were common factors associated with higher FI values.
Three databases (PubMed, MEDLINE [Ovid], Embase) were searched, followed by a subsequent abstract/title and full-text screening to yield 50 reviews of surgical RCTs. Authors, year of publication, name of journal, study design, number of RCTs, subspecialty, sample size, median FI, patients lost to follow-up, and associations between variables and FI scores were collected.
Among 1007 of 2214 RCTs in 50 reviews reporting FI (median sample size 100), the pooled median FI was 3 (IQR: 1-7). Most reviews investigated orthopaedic surgery RCTs (n = 32). There was a moderate correlation between FI and p value (r = 0.-413), a mild correlation between FI and sample size (r = 0.188), and a mild correlation between FI and event number (r = 0.129).
Based on a limited sample of systematic reviews, surgical RCT FI values are still low (2-5). Future RCTs in surgery require improvement to study design in order to increase the robustness of statistically significant findings.
脆弱性指数（FI）定义为在随机对照试验（RCT）中为使统计学显著性丧失而需要转换实验组的患者或受试者的最小数量。该指数用于确定研究结果的稳健性，最近还用作评估RCT质量的一种手段。本综述的目的是识别和描述利用FI评估外科RCT的已发表系统评价，并确定是否存在与较高FI值相关的共同因素。
检索了三个数据库（PubMed、MEDLINE [Ovid]、Embase），随后进行摘要/标题和全文筛选，以获得50篇外科RCT的综述。收集作者、发表年份、期刊名称、研究设计、RCT数量、亚专业、样本量、FI中位数、失访患者以及变量与FI评分之间的关联。
在50篇报告FI的综述中的2214项RCT中的1007项（样本量中位数为100）中，汇总的FI中位数为3（IQR：1-7）。大多数综述调查了骨科手术RCT（n = 32）。FI与p值之间存在中度相关性（r = 0.-413），FI与样本量之间存在轻度相关性（r = 0.188），FI与事件数量之间存在轻度相关性（r = 0.129）。
基于有限的系统评价样本，外科RCT的FI值仍然较低（2-5）。未来的外科RCT需要改进研究设计，以提高具有统计学显著性结果的稳健性。
