大多数报道无显著性结果的运动医学和关节镜相关随机对照试验在统计学上是脆弱的。
The Majority of Sports Medicine and Arthroscopy-Related Randomized Controlled Trials Reporting Nonsignificant Results Are Statistically Fragile.
机构信息
Department of Orthopedics, Monmouth Medical Center, Long Branch, New Jersey.
Department of Orthopaedic Surgery, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts.
出版信息
Arthroscopy. 2023 Sep;39(9):2071-2083.e1. doi: 10.1016/j.arthro.2023.02.022. Epub 2023 Mar 2.
PURPOSE
To evaluate the robustness of sports medicine and arthroscopy related randomized controlled trials (RCTs) reporting nonsignificant results by calculating the reverse fragility index (RFI) and reverse fragility quotient (RFQ).
METHODS
All sports medicine and arthroscopic-related RCTs from January 1, 2010, through August 3, 2021, were identified. Randomized-controlled trials comparing dichotomous variables with a reported P value ≥ .05 were included. Study characteristics, such as publication year and sample size, as well as loss to follow-up and number of outcome events were recorded. The RFI at a threshold of P < .05 and respective RFQ were calculated for each study. Coefficients of determination were calculated to determine the relationships between RFI and the number of outcome events, sample size, and number of patients lost to follow-up. The number of RCTs in which the loss to follow-up was greater than the RFI was determined.
RESULTS
Fifty-four studies and 4,638 patients were included in this analysis. The mean sample size and loss to follow-up were 85.9 patients and 12.5 patients, respectively. The mean RFI was 3.7, signifying that a change of 3.7 events in one arm was needed to flip the results of the study from non-significant to significant (P < .05). Of the 54 studies investigated, 33 (61%) had a loss to follow-up greater than their calculated RFI. The mean RFQ was 0.05. A significant correlation between RFI with sample size (R = 0.10, P = .02) and the total number of observed events (R = 0.13, P < .01) was found. No significant correlation existed between RFI and loss to follow-up in the lesser arm (R = 0.01, P = .41).
CONCLUSIONS
The RFI and RFQ are statistical tools that allow the fragility of studies reporting nonsignificant results to be appraised. Using this methodology, we found that the majority of sports medicine and arthroscopy-related RCTs reporting nonsignificant results are fragile.
CLINICAL RELEVANCE
RFI and RFQ serve as tools that can be used to assess the validity of RCT results and provide additional context for appropriate conclusions.
目的
通过计算反向脆弱指数（RFI）和反向脆弱性比值（RFQ），评估运动医学和关节镜相关随机对照试验（RCT）报告无显著结果的稳健性。
方法
检索 2010 年 1 月 1 日至 2021 年 8 月 3 日期间发表的所有运动医学和关节镜相关 RCT。纳入比较二分类变量、报告 P 值≥0.05 的 RCT。记录研究特征，如发表年份和样本量，以及失访和结局事件数量。计算每个研究在 P<0.05 阈值下的 RFI 和相应的 RFQ。计算决定系数以确定 RFI 与结局事件数量、样本量和失访人数之间的关系。确定失访人数大于 RFI 的 RCT 数量。
结果
本研究共纳入 54 项研究和 4638 例患者。平均样本量和失访人数分别为 85.9 例和 12.5 例。平均 RFI 为 3.7，这意味着研究结果从无显著意义到显著意义的转变需要在一个臂中发生 3.7 个事件（P<0.05）。在 54 项研究中，有 33 项（61%）失访人数大于计算出的 RFI。平均 RFQ 为 0.05。RFI 与样本量（R=0.10，P=0.02）和总观察事件数量（R=0.13，P<0.01）之间存在显著相关性。RFI 与较小手臂的失访人数之间无显著相关性（R=0.01，P=0.41）。
结论
RFI 和 RFQ 是评估报告无显著结果研究稳定性的统计学工具。使用该方法，我们发现大多数报告无显著结果的运动医学和关节镜相关 RCT 是脆弱的。
临床意义
RFI 和 RFQ 可作为评估 RCT 结果有效性的工具，并为得出适当结论提供额外的背景信息。
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