A.T. Still University, Kirksville College of Osteopathic Medicine, Kirksville, Missouri, U.S.A..
Geisinger Commonwealth School of Medicine, Scranton, Pennsylvania, U.S.A.
Arthroscopy. 2024 Mar;40(3):1009-1018. doi: 10.1016/j.arthro.2023.07.055. Epub 2023 Aug 12.
To analyze the statistical stability of randomized controlled trials (RCTs) evaluating the surgical management of autografts versus allografts in the anterior cruciate ligament reconstruction (ACLR) literature and calculate the fragility index (FI) and fragility quotient and explore a subgroup analysis by calculating the proportion of outcome events where the FI was less than the number of patients lost to follow-up.
Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic search in the PubMed and Cochrane databases to identify RCTs published between 2000 and 2022 that investigated the use of autografts versus allografts in ACLR literature and reported dichotomous data. The fragility index of each dichotomous variable was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient was calculated by dividing each fragility index by the study sample size. The interquartile range also was calculated.
Of the 4407 articles screened, 23 met the search criteria, with 11 RCTs evaluating ALCR using autografts and allografts included for analysis. Two hundred and 18 outcome events with 32 significant (P < .05) outcomes and 186 nonsignificant (P ≥ .05) outcomes were identified. The overall fragility index and fragility quotient for all 218 outcomes were 6 subjects (interquartile range 5-8) and 0.058 (interquartile range 0.039-0.077). Fragility analysis of statistically significant outcomes and nonsignificant outcomes had a fragility index of 3.5 (interquartile range 1-5.5) and 6 (interquartile range 5-8), respectively. All of the studies reported a loss to follow-up where 45.5% (5) reported a loss to follow-up greater or equal to 6.
The RCTs in the ACLR peer-reviewed literature evaluating autograft versus allograft use are vulnerable to a small number of outcome event reversals and exemplify significant statistical fragility in statistically significant findings.
Level I, systematic review of Level I studies.
分析评价前交叉韧带重建（ACLR）文献中自体移植物与同种异体移植物手术治疗的随机对照试验（RCT）的统计稳定性，并计算脆弱指数（FI）和脆弱性比，并通过计算 FI 小于失随访患者数的结局事件比例进行亚组分析。
使用系统评价和荟萃分析的首选报告项目指南，我们在 PubMed 和 Cochrane 数据库中进行了系统搜索，以确定 2000 年至 2022 年期间发表的、调查 ACLR 文献中自体移植物与同种异体移植物使用的 RCT，并报告二分类数据。通过逆转单个结局事件来计算每个二分类变量的脆弱指数，直到结果发生逆转。脆弱性比通过将每个脆弱性指数除以研究样本量来计算。还计算了四分位距。
在筛选的 4407 篇文章中，有 23 篇符合搜索标准，其中 11 项 RCT 评估了 ACLR 使用自体移植物和同种异体移植物进行分析。共确定了 218 个有 32 个有统计学意义（P<0.05）的结局事件和 186 个无统计学意义（P≥0.05）的结局事件。所有 218 个结局事件的总体脆弱指数和脆弱性比分别为 6 例（四分位距 5-8）和 0.058（四分位距 0.039-0.077）。对有统计学意义和无统计学意义的结局进行脆弱性分析，其脆弱指数分别为 3.5（四分位距 1-5.5）和 6（四分位距 5-8）。所有研究均报告了失随访情况，其中 45.5%（5 项）报告失随访人数≥6。
评估 ACLR 文献中自体移植物与同种异体移植物使用的 RCT 易受少数结局事件逆转的影响，并且在有统计学意义的发现中存在显著的统计脆弱性。
一级，一级研究的系统评价。
