Byrne Rory, Ahn Benjamin, Zhao Leon, Quinn Matthew, Naphade Om, Owens Brett D
Department of Orthopaedic Surgery, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Orthop J Sports Med. 2024 Aug 28;12(8):23259671241266329. doi: 10.1177/23259671241266329. eCollection 2024 Aug.
A value of <.05 is often used to denote statistical significance; however, in many scenarios, this threshold is vulnerable to a small number of outcome reversals. This study joins a body of studies within the orthopaedic literature that evaluate the statistical fragility of existing research via metrics such as fragility index (FI) and fragility quotient (FQ).
PURPOSE/HYPOTHESIS: The purpose of this study was to investigate the statistical fragility of randomized controlled trials (RCTs) and comparative studies on the topic, given the resurgent interest in lateral extra-articular tenodesis (LET) to augment primary or revision anterior cruciate ligament reconstruction (ACLR). It was hypothesized that the outcomes reported in these studies would be statistically fragile.
Systematic review; Level of evidence, 4.
Comparative studies and RCTs regarding LET as an adjunct procedure to ACLR published between 2000 and 2022 were analyzed. Descriptive characteristics, dichotomous outcomes, and continuous outcomes were extracted. The FI and continuous FI (CFI) were calculated by the number of event reversals to change significance; the FQ and continuous FQ (CFQ) were calculated to normalize the fragility metrics per sample size.
Of 455 studies screened, 29 studies were included (9 RCTs, 20 comparative); 79.3% of included studies were published after 2020. A total of 48 dichotomous and 265 continuous outcomes were analyzed. The median FI was 9.0 (IQR, 7.0-13.3), with FQ of 0.1 (IQR, 0.04-0.17); the median CFI was 7.8 (IQR, 4.2-19.6), with CFQ of 0.12 (IQR, 0.08-0.19). The FQ and CFQ for studies on LET with revision ACLR were larger (0.117 and 0.113, respectively) than those focused on primary ACLR (0.042 and 0.095, respectively).
Studies focused on LET with primary ACLR were more fragile than those on LET with revision, which suggests that further research on the indications for LET with primary ACLR is necessary. Future orthopaedic comparative research should include fragility metrics alongside traditional values.
小于.05 的值通常用于表示统计学显著性；然而，在许多情况下，这个阈值容易受到少数结果反转的影响。本研究加入了骨科文献中的一系列研究，这些研究通过诸如脆弱性指数（FI）和脆弱性商数（FQ）等指标来评估现有研究的统计学脆弱性。
目的/假设：鉴于对外侧关节外肌腱固定术（LET）以增强初次或翻修前交叉韧带重建（ACLR）的兴趣再度兴起，本研究的目的是调查关于该主题的随机对照试验（RCT）和比较研究的统计学脆弱性。研究假设这些研究报告的结果在统计学上是脆弱的。
系统评价；证据等级，4 级。
分析了 2000 年至 2022 年间发表的关于 LET 作为 ACLR 辅助手术的比较研究和 RCT。提取描述性特征、二分法结果和连续性结果。通过事件反转次数来计算 FI 和连续 FI（CFI）以改变显著性；计算 FQ 和连续 FQ（CFQ）以根据样本量对脆弱性指标进行标准化。
在筛选的 455 项研究中，纳入了 29 项研究（9 项 RCT，20 项比较研究）；79.3%的纳入研究发表于 2020 年之后。共分析了 48 个二分法结果和 265 个连续性结果。FI 的中位数为 9.0（四分位间距，7. – 13.3），FQ 为 0.1（四分位间距，0.04 – 0.17）；CFI 的中位数为 7.8（四分位间距，4.2 – 19.6），CFQ 为 0.12（四分位间距，0.08 – 0.19）。关于翻修 ACLR 的 LET 研究的 FQ 和 CFQ 更大（分别为 0.117 和 0.113），高于专注于初次 ACLR 的研究（分别为 0.042 和 0.095）。
专注于初次 ACLR 的 LET 研究比翻修的 LET 研究更脆弱，这表明有必要对初次 ACLR 的 LET 适应证进行进一步研究。未来的骨科比较研究应在传统值之外纳入脆弱性指标。
