Abstract：
UNASSIGNED: 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.
UNASSIGNED: To calculate the CFI of statistically significant continuous outcomes in RCTs evaluating interventions for managing anterior shoulder instability (ASI).
UNASSIGNED: Meta-analysis; Level of evidence, 2.
UNASSIGNED: 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.
UNASSIGNED: 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 (r = 0.23 [95% CI, 0.13-0.33]; P < .001).
UNASSIGNED: 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.
UNASSIGNED: To calculate the CFI of statistically significant continuous outcomes in RCTs evaluating interventions for managing anterior shoulder instability (ASI).
UNASSIGNED: Meta-analysis; Level of evidence, 2.
UNASSIGNED: 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.
UNASSIGNED: 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 (r = 0.23 [95% CI, 0.13-0.33]; P < .001).
UNASSIGNED: 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.
摘要：
■循证护理依赖于强有力的研究。脆弱性指数（FI）用于评估随机对照试验（RCT）中具有统计学意义的结果的稳健性。虽然传统的FI仅限于二分结果，一个新颖的工具，连续脆弱性指数(CFI)，允许评估连续结果的稳健性。
■计算RCT中具有统计学意义的连续结果的CFI，以评估治疗肩关节前不稳定（ASI）的干预措施。
■荟萃分析；证据水平，2.
■在MEDLINE进行了搜索，Embase,和CENTRAL数据库，用于评估ASI从成立到2022年10月6日的管理策略。包括报告研究组之间在≥1个连续结局方面有统计学意义差异的研究。计算CFI并将其应用于所有可用的报告ASI干预措施的RCT。在CFI和各种研究特征之间进行多变量线性回归作为预测因子。
■有27个随机对照试验,总共有1846个肩膀，包括。样本量中位数为61肩(IQR，43).27个随机对照试验的CFI中位数为8.2(IQR，17.2；95%CI，3.6-15.4）。CFI中位数为7.9（IQR，21；95%CI，1-22)，用于11项比较手术方法的研究，22.6(IQR，16；95%CI，8.2-30.4)，用于6项比较非手术复位干预措施的研究，2.8为3项比较固定方法的研究，和2.4的3项研究比较了手术干预和非手术干预。重要的是,57项纳入研究的结果中有22项（38.6％）来自完成随访数据的研究，其随访损失超过其CFI。多因素回归分析显示，一项试验的样本量与其结果的CFI之间存在统计学显著正相关（r=0.23[95%CI，0.13-0.33]；P<.001）。
在ASI试验中，超过三分之一的连续结局的CFI低于报告的随访损失。这具有逆转试验结果的重大风险，在评估可用的RCT数据时应予以考虑。我们建议包括FI，CFI,以及未来随机对照试验摘要中的后续损失。
■计算RCT中具有统计学意义的连续结果的CFI，以评估治疗肩关节前不稳定（ASI）的干预措施。
■荟萃分析；证据水平，2.
■在MEDLINE进行了搜索，Embase,和CENTRAL数据库，用于评估ASI从成立到2022年10月6日的管理策略。包括报告研究组之间在≥1个连续结局方面有统计学意义差异的研究。计算CFI并将其应用于所有可用的报告ASI干预措施的RCT。在CFI和各种研究特征之间进行多变量线性回归作为预测因子。
■有27个随机对照试验,总共有1846个肩膀，包括。样本量中位数为61肩(IQR，43).27个随机对照试验的CFI中位数为8.2(IQR，17.2；95%CI，3.6-15.4）。CFI中位数为7.9（IQR，21；95%CI，1-22)，用于11项比较手术方法的研究，22.6(IQR，16；95%CI，8.2-30.4)，用于6项比较非手术复位干预措施的研究，2.8为3项比较固定方法的研究，和2.4的3项研究比较了手术干预和非手术干预。重要的是,57项纳入研究的结果中有22项（38.6％）来自完成随访数据的研究，其随访损失超过其CFI。多因素回归分析显示，一项试验的样本量与其结果的CFI之间存在统计学显著正相关（r=0.23[95%CI，0.13-0.33]；P<.001）。
在ASI试验中，超过三分之一的连续结局的CFI低于报告的随访损失。这具有逆转试验结果的重大风险，在评估可用的RCT数据时应予以考虑。我们建议包括FI，CFI,以及未来随机对照试验摘要中的后续损失。
