Research without prior consent procedure and intervention effect on mortality in critical care: a meta-epidemiological study of randomized controlled trials.

ABSTRACT:

Background

In critical care randomized controlled trials (RCTs), obtaining informed consent from patients or proxies can be challenging and may delay randomization, potentially affecting intervention efficacy. Research without prior consent (RWPC) procedures are increasingly used to facilitate timely inclusion but their impact on trial outcomes remains uncertain. We aimed to assess whether RWPC procedures are associated with differences in intervention effects on mortality in critical care RCTs.

Methods

We searched PubMed and the Cochrane Database of Systematic Reviews from inception to August 1, 2024. We included meta-analyses of RCTs evaluating therapeutic interventions in critically ill adults, reporting mortality as a primary or secondary outcome. We conducted a meta-epi

SUBMITTER: Hariri G 

PROVIDER: S-EPMC12291516 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature