Coenrollment of critically ill patients in PROSPECT: characteristics and association with treatment efficacy and safety.

ABSTRACT:

Introduction

Coenrollment is the enrollment of one participant into more than one study. While coenrollment can enhance research efficiency, it theoretically may result in treatment interactions that distort effect estimates. This study aimed to explore the sensitivity of safety and efficacy outcomes to coenrollment in an international, blinded randomized controlled trial evaluating probiotic use in critically ill patients (PROSPECT: Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial; [NCT02462590]).

Methods

In this planned secondary analysis of PROSPECT, we performed Cox proportional hazards analyses to assess the sensitivity of the treatment effect of probiotics to coenrollment on the primary outcome of ventilator-associated pneumonia. Secondari

SUBMITTER: Thabane A 

PROVIDER: S-EPMC12465574 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature