Proceedings of the National Academy of Sciences of the United States of America ( IF 9.4 ) Pub Date : 2021-12-07 , DOI: 10.1073/pnas.2105254118 Benjamin R Baer 1 , Mario Gaudino 2 , Mary Charlson 3 , Stephen E Fremes 4, 5 , Martin T Wells 3, 6
The fragility index is a clinically meaningful metric based on modifying patient outcomes that is increasingly used to interpret the robustness of clinical trial results. The fragility index relies on a concept that explores alternative realizations of the same clinical trial by modifying patient measurements. In this article, we propose to generalize the fragility index to a family of fragility indices called the incidence fragility indices that permit only outcome modifications that are sufficiently likely and provide an exact algorithm to calculate the incidence fragility indices. Additionally, we introduce a far-reaching generalization of the fragility index to any data type and explain how to permit only sufficiently likely modifications for nondichotomous outcomes. All of the proposed methodologies follow the fragility index concept.
中文翻译:
仅针对足够可能的修改的脆弱性指数 [医学]
脆弱性指数是一种基于改变患者结果的具有临床意义的指标,越来越多地用于解释临床试验结果的稳健性。脆弱性指数依赖于一个概念,该概念通过修改患者测量值来探索同一临床试验的替代实现。在本文中,我们建议将脆弱性指数推广到称为发生率脆弱性指数的一系列脆弱性指数,它只允许对足够可能的结果进行修改,并提供一种精确的算法来计算发生率脆弱性指数。此外,我们将脆弱性指数广泛推广到任何数据类型,并解释如何只允许对非二分结果进行足够可能的修改。所有提议的方法都遵循脆弱性指数概念。