Poursalehian Mohammad, Sahebi Mahdi, Tajvidi Mahboobeh, Sabaghian Amirhosein, Asgari Amir-Mohammad, Tabaie Sean A, Bhandari Mohit, Hoveidaei Amir Human
From the Joint Reconstruction Research Center, Tehran University of Medical Sciences, Tehran, Iran (Poursalehian, Sahebi, Tajvidi, and Sabaghian), the Students' Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran (Sahebi), the Student Research Committee, Faculty of Medicine, Abadan University of Medical Sciences, Abadan, Iran (Tajvidi), the School of Medicine, Iran University of Medical sciences, Tehran, Iran (Sabaghian), the Orthopedic Surgery Research Center (OSRC), Sina University Hospital, Tehran University of Medical Sciences, Tehran, Iran (Asgari), the Department of Orthopaedic Surgery, Nationwide Children's Hospital, Columbus, OH (Tabaie), the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (Bhandari), the Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada (Bhandari), and the International Center for Limb Lengthening, Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, MD (Hoveidaei).
J Am Acad Orthop Surg. 2025 Mar 15;33(6):e340-e347. doi: 10.5435/JAAOS-D-24-00691. Epub 2024 Dec 19.
Understanding the reliability of outcomes in randomized controlled trials (RCTs) is crucial, as standard metrics, such as P- value do not fully capture result fragility. This led to the adoption of specific indices: the fragility index (FI), which measures the strength of trial through significant results by calculating the minimum number of patient status changes from nonevent to event required to make the results statistically insignificant; reverse fragility index (RFI), used for insignificant results; and continuous fragility index (CFI), which acts similar to FI for significant continuous outcomes. The objective is to assess the robustness of orthopaedics RCTs using these indices across leading orthopaedic journals.
A systematic review of RCTs published between 2019 and 2023 in the top five general orthopaedic journals, identified through Scientific Journal Rankings, was done. Data extraction focused on FI, RFI, and CFI and related measures for 160 RCTs. The indices were calculated using established methodologies, with sample size adjustments.
22 RCTs had statistically significant dichotomous primary outcomes and 17 studies had notable dichotomous secondary outcomes. Twenty-nine had negligible (insignificant) dichotomous primary outcomes, and 92 reported notable continuous outcomes. Only one RCT reported a FI in the article. The median FI was 5 with a median sample size of 142 for dichotomous outcomes. The median RFI was 3 with a median sample size of 100 for negligible outcomes, and the median CFI was 13 with a median sample size of 86.5 for continuous outcomes, showing dichotomous outcomes to be more fragile than continuous ones.
Continuous outcomes are less fragile than dichotomous outcomes, with negligible dichotomous outcomes being particularly more fragile. This fragility stems from small sample sizes and limited outcome events. Using these indices, especially when considering patient loss to follow-up, can improve the reliability of findings.
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了解随机对照试验（RCT）结果的可靠性至关重要，因为诸如P值等标准指标并不能完全体现结果的脆弱性。这促使人们采用了特定的指标：脆弱性指数（FI），通过计算使结果在统计学上无显著性所需的从非事件到事件的患者状态变化的最小数量，来衡量试验结果的显著性；反向脆弱性指数（RFI），用于无显著性结果；以及连续脆弱性指数（CFI），对于显著的连续结果，其作用类似于FI。目的是使用这些指标评估领先骨科期刊上骨科RCT的稳健性。
对2019年至2023年在通过科学期刊排名确定的前五名普通骨科期刊上发表的RCT进行了系统评价。数据提取集中在160项RCT的FI、RFI和CFI及相关指标上。使用既定方法并进行样本量调整来计算这些指标。
22项RCT有统计学显著的二分法主要结局，17项研究有显著的二分法次要结局。29项有可忽略不计（无显著性）的二分法主要结局，92项报告了显著的连续结局。只有一项RCT在文章中报告了FI。二分法结局的FI中位数为5，样本量中位数为142。可忽略不计结局的RFI中位数为3，样本量中位数为100，连续结局的CFI中位数为13，样本量中位数为86.5, 表明二分法结局比连续结局更脆弱。
连续结局比二分法结局更不容易脆弱，可忽略不计的二分法结局尤其更脆弱。这种脆弱性源于样本量小和结局事件有限。使用这些指标，尤其是在考虑患者失访时，可以提高研究结果的可靠性。
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