骨科创伤外科临床试验的统计学脆弱性。
Statistical Fragility of Surgical Clinical Trials in Orthopaedic Trauma.
机构信息
From the Department of Orthopedic Surgery (Dr. Forrester, Dr. Tedesco, Dr. Baranek, Dr. Jang, and Dr. Tyler), Columbia University Irving Medical Center and the Columbia University Vagelos College of Physicians and Surgeons (Dr. McCormick and Bonsignore-Opp), New York, NY.
出版信息
J Am Acad Orthop Surg Glob Res Rev. 2021 Nov 19;5(11):e20.00197. doi: 10.5435/JAAOSGlobal-D-20-00197.
INTRODUCTION
The Fragility Index (FI) and the Fragility Quotient (FQ) are powerful statistical tools that can aid clinicians in assessing clinical trial results. The purpose of this study was to use the FI and FQ to evaluate the statistical robustness of widely cited surgical clinical trials in orthopaedic trauma.
METHODS
We performed a PubMed search for orthopaedic trauma clinical trials in high-impact orthopaedics-focused journals and calculated the FI and FQ for all identified dichotomous, categorical outcomes.
RESULTS
We identified 128 studies with 545 outcomes. The median FI was 5, and the median FQ was 0.0482. For statistically significant and not statistically significant outcomes, the median FIs were 3 and 5, and the mean FQs were 0.0323 and 0.0526, respectively. The FI was greater than the number of patients lost to follow-up in most outcomes.
CONCLUSIONS
The orthopaedic trauma literature is of equal or higher quality than research in other orthopaedic subspecialties, suggesting that other orthopaedic subspecialties may benefit from modeling their clinical trials after those in orthopaedic trauma.
简介
脆弱指数（FI）和脆弱分数（FQ）是强大的统计工具，可以帮助临床医生评估临床试验结果。本研究的目的是使用 FI 和 FQ 评估骨科创伤领域广泛引用的外科临床试验的统计稳健性。
方法
我们在高影响力的骨科专业期刊上进行了骨科创伤临床试验的 PubMed 检索，并为所有确定的二分类、分类结果计算了 FI 和 FQ。
结果
我们确定了 128 项研究，涉及 545 项结果。FI 的中位数为 5，FQ 的中位数为 0.0482。对于有统计学意义和无统计学意义的结果，FI 的中位数分别为 3 和 5，FQ 的平均值分别为 0.0323 和 0.0526。在大多数结果中，FI 大于失访患者的数量。
结论
骨科创伤文献的质量与其他骨科亚专业的研究相当或更高，这表明其他骨科亚专业可能会受益于模仿骨科创伤的临床试验。
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