Sample size estimation in clinical trials using ventilator-free days as the primary outcome: a systematic review.

ABSTRACT:

Background

Ventilator-free days (VFDs) are a composite endpoint increasingly used as the primary outcome in critical care trials. However, because of the skewed distribution and competitive risk between components, sample size estimation remains challenging. This systematic review was conducted to systematically assess whether the sample size was congruent, as calculated to evaluate VFDs in trials, with VFDs' distribution and the impact of alternative methods on sample size estimation.

Methods

A systematic literature search was conducted within the PubMed and Embase databases for randomized clinical trials in adults with VFDs as the primary outcome until December 2021. We focused on peer-reviewed journals with 2021 impact factors greater than five. After reviewing definition

SUBMITTER: Renard Triche L 

PROVIDER: S-EPMC10394791 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature