Department of Epidemiology and Biostatistics, University of Arizona, Tucson, AZ; Department of Statistics, Florida State University, Tallahassee, FL.
Department of Statistics, Florida State University, Tallahassee, FL.
Am J Obstet Gynecol. 2023 Mar;228(3):276-282. doi: 10.1016/j.ajog.2022.08.053. Epub 2022 Sep 6.
The fragility index has been increasingly used to assess the robustness of the results of clinical trials since 2014. It aims at finding the smallest number of event changes that could alter originally statistically significant results. Despite its popularity, some researchers have expressed several concerns about the validity and usefulness of the fragility index. It offers a comprehensive review of the fragility index's rationale, calculation, software, and interpretation, with emphasis on application to studies in obstetrics and gynecology. This article presents the fragility index in the settings of individual clinical trials, standard pairwise meta-analyses, and network meta-analyses. Moreover, this article provides worked examples to demonstrate how the fragility index can be appropriately calculated and interpreted. In addition, the limitations of the traditional fragility index and some solutions proposed in the literature to address these limitations were reviewed. In summary, the fragility index is recommended to be used as a supplemental measure in the reporting of clinical trials and a tool to communicate the robustness of trial results to clinicians. Other considerations that can aid in the fragility index's interpretation include the loss to follow-up and the likelihood of data modifications that achieve the loss of statistical significance.
自 2014 年以来，脆弱指数越来越多地被用于评估临床试验结果的稳健性。它旨在找到最小数量的事件变化，这些变化可能会改变最初具有统计学意义的结果。尽管它很受欢迎，但一些研究人员对脆弱指数的有效性和有用性表示了一些担忧。本文全面回顾了脆弱指数的原理、计算、软件和解释，重点介绍了在妇产科研究中的应用。本文还介绍了脆弱指数在个体临床试验、标准成对荟萃分析和网络荟萃分析中的应用。此外，本文还提供了示例来说明如何正确计算和解释脆弱指数。此外，还回顾了传统脆弱指数的局限性以及文献中提出的一些解决这些局限性的方法。总之，建议在临床试验报告中使用脆弱指数作为补充措施，并将其作为向临床医生传达试验结果稳健性的工具。其他有助于解释脆弱指数的考虑因素包括随访损失和数据修改的可能性，这些修改可能会导致失去统计学意义。
