The fragility index can be used for sample size calculations in clinical trials.
The fragility index can be used for sample size calculations in clinical trials.
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DOI：
10.1016/j.jclinepi.2021.08.010
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发表时间：
2021-11
影响因子：
7.2
通讯作者：
Wells MT
中科院分区：
文献类型：
--
作者：
Baer BR;Gaudino M;Fremes SE;Charlson M;Wells MT
The fragility index is a clinically interpretable metric increasingly used to interpret the robustness of clinical trials results that is generally not incorporated in sample size calculation and applied post-hoc. In this manuscript, we propose to base the sample size calculation on the fragility index in a way that supplements the classical pre-fixed alpha and power cutoffs and we provide a dedicated R software package for the design and analysis tools. This approach follows from a novel hypothesis testing framework that is based on the fragility index and builds on the classical testing approach. As case studies, we re-analyse the design of two important trials in cardiovascular medicine, the FAME and FAMOUS-NSTEMI trials. The analyses show that approach returns sample sizes which results in a higher power for the p value based test and most importantly a lower and context dependent Type I error rate for the fragility index based test compared to standard tests. Our method allows clinicians to control for the fragility index during clinical trial design.
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