Today, well-designed randomized clinical trials (RCTs) are considered the pinnacle of clinical research, and they inform many practices in orthopaedics. When designing these studies, researchers conduct a power analysis, which allows researchers to strike a balance between (1) enrolling enough patients to detect a clinically important treatment effect (i.e., researchers can be confident that the effect is unlikely due to chance) and (2) cost, time, and risk to patients, which come with enrolling an excessive number of patients. Because researchers will have a desire to conduct resource-efficient RCTs and protect patients from harm, many studies report a p value that is close to the threshold for significance. The concept of the fragility index (FI) was introduced as a simple way to interpret RCT findings, but it does not account for RCT design. The adoption of the FI conflicts with researchers' goals of designing efficient RCTs that conserve resources and limit ineffective or harmful treatments to patients. The use of the FI may reflect many clinicians' lack of familiarity with interpreting p values beyond "significant" or "nonsignificant." Instead of inventing new metrics to convey the same information provided by the p value, greater emphasis should be placed on educating clinicians on how to interpret p values and, more broadly, statistics, when reading scientific studies.

中文翻译：

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挑战统计脆弱性的概念：有任何附加值吗？


如今，精心设计的随机临床试验 (RCT) 被认为是临床研究的巅峰，它们为骨科的许多实践提供了信息。在设计这些研究时，研究人员进行功效分析，使研究人员能够在以下两者之间取得平衡：(1) 招募足够多的患者来检测临床上重要的治疗效果（即，研究人员可以确信该效果不太可能是偶然造成的）和（ 2) 招募过多患者会带来成本、时间和风险。由于研究人员希望进行资源节约型随机对照试验并保护患者免受伤害，因此许多研究报告的 p 值接近显着性阈值。脆弱性指数（FI）的概念是作为解释随机对照试验结果的简单方法而引入的，但它并没有考虑随机对照试验的设计。 FI 的采用与研究人员设计有效 RCT 的目标相冲突，该 RCT 旨在节省资源并限制对患者无效或有害的治疗。 FI 的使用可能反映出许多临床医生不熟悉解释“显着”或“不显着”之外的 p 值。不应发明新的指标来传达 p 值提供的相同信息，而应更加重视教育临床医生在阅读科学研究时如何解释 p 值，以及更广泛的统计数据。