Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada.
Am J Sports Med. 2024 Aug;52(10):2667-2675. doi: 10.1177/03635465231202522. Epub 2024 Jan 23.
Evidence-based care relies on robust research. The fragility index (FI) is used to assess the robustness of statistically significant findings in randomized controlled trials (RCTs). While the traditional FI is limited to dichotomous outcomes, a novel tool, the continuous fragility index (CFI), allows for the assessment of the robustness of continuous outcomes.
To calculate the CFI of statistically significant continuous outcomes in RCTs evaluating interventions for managing anterior shoulder instability (ASI).
Meta-analysis; Level of evidence, 2.
A search was conducted across the MEDLINE, Embase, and CENTRAL databases for RCTs assessing management strategies for ASI from inception to October 6, 2022. Studies that reported a statistically significant difference between study groups in ≥1 continuous outcome were included. The CFI was calculated and applied to all available RCTs reporting interventions for ASI. Multivariable linear regression was performed between the CFI and various study characteristics as predictors.
There were 27 RCTs, with a total of 1846 shoulders, included. The median sample size was 61 shoulders (IQR, 43). The median CFI across 27 RCTs was 8.2 (IQR, 17.2; 95% CI, 3.6-15.4). The median CFI was 7.9 (IQR, 21; 95% CI, 1-22) for 11 studies comparing surgical methods, 22.6 (IQR, 16; 95% CI, 8.2-30.4) for 6 studies comparing nonsurgical reduction interventions, 2.8 for 3 studies comparing immobilization methods, and 2.4 for 3 studies comparing surgical versus nonsurgical interventions. Significantly, 22 of 57 included outcomes (38.6%) from studies with completed follow-up data had a loss to follow-up exceeding their CFI. Multivariable regression demonstrated that there was a statistically significant positive correlation between a trial's sample size and the CFI of its outcomes ( = 0.23 [95% CI, 0.13-0.33]; < .001).
More than a third of continuous outcomes in ASI trials had a CFI less than the reported loss to follow-up. This carries the significant risk of reversing trial findings and should be considered when evaluating available RCT data. We recommend including the FI, CFI, and loss to follow-up in the abstracts of future RCTs.
循证护理依赖于强有力的研究。脆弱指数（FI）用于评估随机对照试验（RCT）中统计学显著发现的稳健性。虽然传统的 FI 仅限于二分类结局，但一种新工具，即连续脆弱指数（CFI），允许评估连续结局的稳健性。
计算评估管理肩前不稳定（ASI）干预措施的 RCT 中统计学显著的连续结局的 CFI。
荟萃分析；证据水平，2 级。
对 MEDLINE、Embase 和 CENTRAL 数据库进行了检索，以评估从开始到 2022 年 10 月 6 日 ASI 管理策略的 RCT。纳入报告研究组间在至少 1 个连续结局存在统计学显著差异的研究。计算了 CFI，并将其应用于所有报告用于治疗 ASI 的 RCT。多元线性回归分析了 CFI 与各种研究特征作为预测因子之间的关系。
纳入了 27 项 RCT，共 1846 个肩部。中位样本量为 61 个（IQR，43）。27 项 RCT 的中位 CFI 为 8.2（IQR，17.2；95%CI，3.6-15.4）。11 项比较手术方法的研究的中位 CFI 为 7.9（IQR，21；95%CI，1-22），6 项比较非手术复位干预的研究的中位 CFI 为 22.6（IQR，16；95%CI，8.2-30.4），3 项比较固定方法的研究的中位 CFI 为 2.8，3 项比较手术与非手术干预的研究的中位 CFI 为 2.4。值得注意的是，57 项纳入的结局中有 22 项（38.6%）来自完成随访数据的研究，其失访率超过了 CFI。多变量回归表明，试验的样本量与结局的 CFI 之间存在统计学显著的正相关（ = 0.23 [95%CI，0.13-0.33]；<.001）。
ASI 试验中超过三分之一的连续结局的 CFI 低于报告的失访率。这存在逆转试验结果的显著风险，在评估现有 RCT 数据时应予以考虑。我们建议在未来 RCT 的摘要中纳入 FI、CFI 和失访率。
