The influence of consent models on recruitment rates in randomised trials in critical care: A systematic review.

ABSTRACT:

Objectives

To determine whether type of consent model was associated with recruitment rate in critical care randomised clinical trials (RCT).

Data sources

PubMed was searched for relevant articles.

Study selection

Individual patient RCTs in critical care with a primary outcome of mortality published between 1990 and 2020 were included.

Data extraction

Two authors independently reviewed titles, abstracts, and full-text articles for eligibility, and data was entered into a structured custom database.

Data synthesis

186 RCTs were included, of which 141(75.8%) used a priori consent, while 45 (24.2%) used alternative consent models, including consent waiver and consent-to-continue. The alternate consent RCTs recruited significantly larger sample sizes

SUBMITTER: Ramanan M 

PROVIDER: S-EPMC12554108 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature