Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study)

Area of Science:

• Critical care medicine
• Clinical research methodology
• Patient recruitment strategies

Background:

• Limited data exist on challenges enrolling critically ill patients in research.
• Understanding recruitment barriers is crucial for advancing critical care studies.

Purpose of the Study:

• To characterize intensive care unit (ICU) recruitment practices.
• To identify factors influencing recruitment success and feasibility.
• To inform strategies for enhancing future research enrollment.

Main Methods:

• Prospective observational study across 23 Canadian ICUs.
• Characterized 452 eligibility events by consent outcome.
• Documented reasons for missed/infeasible recruitment and decision-maker rationale.

Main Results:

• Over 57% of recruitment opportunities were missed or infeasible.
• Key barriers included research team workload, narrow inclusion windows, and SDM (substitute decision maker) availability.
• Patient vs. SDM consent rationale differed; coordinator experience and site volume predicted fewer declines.

Conclusions:

• Significant gap between ICU patient eligibility and consent encounters.
• Recruitment is hindered by operational inefficiencies and personnel factors.
• Current practices may lead to underrepresentation in critical care research populations.