On clinical trial fragility due to patients lost to follow up.

ABSTRACT:

Background

Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification.

Methods

We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial's statistical results with respect to patients lost to follow up.

Results

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SUBMITTER: Baer BR 

PROVIDER: S-EPMC8606097 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature