Department of Orthopedic Surgery, Columbia University Medical Center, New York, NY (Dr. Forrester, Dr. Jang, Ms. Capi, and Dr. Tyler) and the Department of Orthopaedics, University of Rochester, Rochester, NY (Ms. Lawson).
J Am Acad Orthop Surg Glob Res Rev. 2020 Jun 1;4(6). doi: 10.5435/JAAOSGlobal-D-19-00152. eCollection 2020 Jun.
The fragility index (FI) is a powerful tool that can be used to assess the statistical strength of a study outcome. This metric is defined as the number of patients who would need to have an alternative outcome to convert a clinical trial result from statistically significant to not statistically significant, or vice versa. No studies to date have used the FI to evaluate surgical and procedural clinical trials in the orthopaedic oncology literature. The primary purpose of this study was to use the FI to evaluate the statistical strength of widely cited surgical and procedural clinical trials in orthopaedic oncology.
We performed a PubMed search for orthopaedic oncology clinical trials in high impact orthopaedics-focused, oncology-focused, and general medicine journals. For each study included in this analysis, we calculated the FI for all identified dichotomous, categorical outcomes.
We identified 23 studies with 48 outcomes. Twelve of these outcomes were statistically significant, with a median FI of two. Nine studies addressed the number of patients lost to follow up, and the FI was less than the number of patients lost to follow up for most outcomes (60%) in these studies.
The orthopaedic oncology literature has substantial statistical fragility, likely explained by a high number of patients lost to follow up and small sample sizes. More multicenter, cooperative studies are necessary to increases the robustness of clinical research in orthopaedic oncology.
脆弱指数（FI）是一种强大的工具，可用于评估研究结果的统计学强度。该指标定义为需要多少患者出现替代结果才能将临床试验结果从统计学上显著转变为不显著，或者反之亦然。迄今为止，尚无研究使用 FI 来评估骨科肿瘤学文献中的手术和程序临床试验。本研究的主要目的是使用 FI 来评估骨科肿瘤学中广泛引用的手术和程序临床试验的统计学强度。
我们在高影响力骨科、肿瘤学和普通医学期刊上进行了骨科肿瘤学临床试验的 PubMed 搜索。对于本分析中包含的每项研究，我们计算了所有确定的二分、分类结局的 FI。
我们确定了 23 项研究，涉及 48 项结果。其中 12 项结果具有统计学意义，中位数 FI 为 2。9 项研究涉及失访患者的数量，对于这些研究中的大多数结果（60%），FI 小于失访患者的数量。
骨科肿瘤学文献具有较大的统计学脆弱性，这可能是由于失访患者数量较多和样本量较小所致。需要更多的多中心、合作研究来提高骨科肿瘤学临床研究的稳健性。
