A.T. Still University Kirksville College of Osteopathic Medicine, Kirksville, MO, USA.
Geisinger Commonwealth School of Medicine, Scranton, PA, USA.
Foot (Edinb). 2023 Dec;57:102047. doi: 10.1016/j.foot.2023.102047. Epub 2023 Aug 24.
The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties.
We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.
Of the 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively.
The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.
本研究旨在利用脆弱指数评估评估跟骨骨折治疗的随机对照试验（RCT）的稳健性。我们假设跟骨骨折文献中的二分类结局在统计学上是脆弱的，且与其他骨科专业相似。
我们使用系统评价和荟萃分析的首选报告项目（PRISMA）对 2000 年至 2022 年的跟骨骨折 RCT 进行了 PubMed 检索。通过逆转单个结局事件来计算每个结局的脆弱指数（FI），直到结果发生逆转。通过将每个脆弱指数除以研究样本量来计算脆弱商数（FQ）。还计算了 FI 和 FQ 的四分位距（IQR）。
在筛选的 3003 项研究中，有 97 项符合检索标准，其中有 19 项 RCT 评估了跟骨骨折，包括在分析中。确定了 79 个二分类结局，其中 30 个具有显著（P<0.05）结局，49 个具有非显著（P>0.05）结局。所有结局的总体 FI 和 FQ 分别为 6（IQR 3-8）和 0.067（IQR 0.032-0.100）。
围绕跟骨骨折的文献可能不如以前认为的那样具有统计学稳定性。仅仅依赖 P 值可能会描绘出误导性的结果。因此，我们建议在报告 P 值的同时报告 FI 和 FQ，以在跟骨骨折文献中对临床发现进行稳健的上下文分析。
