Department of Anesthesiology and Pain Medicine, Toronto General Hospital, University Health Network, University of Toronto, Toronto, ON, Canada.
Department of Clinical Epidemiology and Biostatistics, School of Medicine, Pontificia Universidad Javeriana, Bogotá D.C, Colombia.
PLoS One. 2024 Sep 12;19(9):e0310092. doi: 10.1371/journal.pone.0310092. eCollection 2024.
The Fragility Index (FI) and the FI family are statistical tools that measure the robustness of randomized controlled trials (RCT) by examining how many patients would need a different outcome to change the statistical significance of the main results of a trial. These tools have recently gained popularity in assessing the robustness or fragility of clinical trials in many clinical areas and analyzing the strength of the trial outcomes underpinning guideline recommendations. However, it has not been applied to perioperative care Clinical Practice Guidelines (CPG).
This study aims to survey clinical practice guidelines in anesthesiology to determine the Fragility Index of RCTs supporting the recommendations, and to explore trial characteristics associated with fragility.
A methodological survey will be conducted using the targeted population of RCT referenced in the recommendations of the CPG of the North American and European societies from 2012 to 2022. FI will be assessed for statistically significant and non-significant trial results. A Poisson regression analysis will be used to explore factors associated with fragility.
This methodological survey aims to estimate the Fragility Index of RCTs supporting perioperative care guidelines published by North American and European societies of anesthesiology between 2012 and 2022. The results of this study will inform the methodological quality of RCTs included in perioperative care guidelines and identify areas for improvement.
脆弱指数（FI）及其家族是统计学工具，通过检查需要多少患者出现不同的结果才能改变试验主要结果的统计学意义，来衡量随机对照试验（RCT）的稳健性。这些工具最近在许多临床领域评估临床试验的稳健性或脆弱性以及分析支持指南建议的试验结果的强度方面变得越来越受欢迎。然而，它尚未应用于围手术期护理临床实践指南（CPG）。
本研究旨在调查麻醉学中的临床实践指南，以确定支持建议的 RCT 的脆弱指数，并探讨与脆弱性相关的试验特征。
将对 2012 年至 2022 年北美和欧洲社会的 CPG 建议中引用的 RCT 进行目标人群的方法学调查。将评估 FI 对统计学上显著和非显著试验结果的影响。将使用泊松回归分析来探讨与脆弱性相关的因素。
本方法学调查旨在估计 2012 年至 2022 年北美和欧洲麻醉学会发布的围手术期护理指南所支持的 RCT 的脆弱指数。该研究的结果将告知围手术期护理指南中包含的 RCT 的方法学质量，并确定需要改进的领域。
