Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data.

ABSTRACT:

Background

Ventilator-associated pneumonia (VAP) is an important healthcare acquired infection, which is associated with high morbidity and mortality. Conducting conventional randomised controlled trials (RCTs) on VAP prevention is often challenging, due to low numbers of eligible patients and events per site, especially for pathogen-specific interventions. We explored how group sequential designs (GSD) and sample size re-estimation (SSR) trial designs could improve RCT efficiency in simulated superiority trials to prevent VAP.

Methods

Simulations were informed using data from the prospective observational Hospital Network Study - Preparation for a Randomised Evaluation of anti-Pneumonia Strategies (HONEST-PREPS). We tested the impact of different GSD and SSR designs on expe

SUBMITTER: Jackson H 

PROVIDER: S-EPMC12613641 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature