Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.

ABSTRACT:

Objectives

Recurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects.

Design, setting, and patients

Secondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality ri

SUBMITTER: Abrams D 

PROVIDER: S-EPMC7708428 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature