University of California, Irvine, CA, USA.
Georgetown University School of Medicine, Washington, DC, USA.
Foot Ankle Int. 2022 Oct;43(10):1331-1339. doi: 10.1177/10711007221108078. Epub 2022 Aug 24.
The statistical significance of randomized controlled trials (RCTs) and comparative studies is often conveyed utilizing the value. However, values are an imperfect measure and may be vulnerable to a small number of outcome reversals to alter statistical significance. The interpretation of the statistical strength of these studies may be aided by the inclusion of a Fragility Index (FI) and Fragility Quotient (FQ). This study examines the statistical stability of studies comparing operative vs nonoperative management for Achilles tendon rupture.
A systematic search was performed of 10 orthopaedic journals between 2000 and 2021 for comparative studies focusing on management of Achilles tendon rupture reporting dichotomous outcome measures. FI for each outcome was determined by the number of event reversals necessary to alter significance ( < .05). FQ was calculated by dividing the FI by the respective sample size. Additional subgroup analyses were performed.
Of 8020 studies screened, 1062 met initial search criteria with 17 comparative studies ultimately included for analysis, 10 of which were RCTs. A total of 40 outcomes were examined. Overall, the median FI was 2.5 (interquartile range [IQR] 2-4), the mean FI was 2.90 (±1.58), the median FQ was 0.032 (IQR 0.012-0.069), and the mean FQ was 0.049 (±0.062). The FI was less than the number of patients lost to follow-up for 78% of outcomes.
Studies examining the efficacy of operative vs nonoperative management of Achilles tendon rupture may not be as statistically stable as previously thought. The average number of outcome reversals needed to alter the significance of a given study was 2.90. Future analyses may benefit from the inclusion of a fragility index and a fragility quotient in their statistical analyses.
随机对照试验（RCT）和对比研究的统计学意义通常通过 值来传达。然而， 值是一种不完美的衡量标准，可能容易受到少数结果逆转的影响，从而改变统计学意义。通过纳入脆弱指数（FI）和脆弱性分数（FQ），可以帮助解释这些研究的统计学强度。本研究检查了比较手术与非手术治疗跟腱断裂的研究的统计学稳定性。
系统检索了 2000 年至 2021 年 10 种骨科期刊中关于报告二分类结局指标的跟腱断裂管理的对比研究，确定 FI 为每个结局需要改变显著性（ <.05）的事件逆转数量。FQ 通过将 FI 除以相应的样本量来计算。进行了额外的亚组分析。
在筛选的 8020 项研究中，有 1062 项符合初始检索标准，最终有 17 项对比研究纳入分析，其中 10 项为 RCT。共检查了 40 个结局。总体而言，中位数 FI 为 2.5（四分位距[IQR]2-4），均值 FI 为 2.90（±1.58），中位数 FQ 为 0.032（IQR 0.012-0.069），均值 FQ 为 0.049（±0.062）。78%的结局的 FI 小于失访病例数。
检查手术与非手术治疗跟腱断裂疗效的研究可能不像之前认为的那样具有统计学稳定性。改变给定研究显著性所需的平均结果逆转数量为 2.90。未来的分析可能受益于在其统计分析中纳入脆弱指数和脆弱性分数。
