Research Recruitment Practices of Critically Ill Patients: A Multicenter, Cross-Sectional Study (The Consent Study)

Abstract
Critical Care Medicine, St. Michael's Hospital, Toronto, Canada, Toronto, Canada.

RATIONALE:

Limited cross-sectional data exist to characterize the challenges of enrolling critically ill patients into research studies.

OBJECTIVES:

We aimed to describe recruitment practices, document factors that impact recruitment, and identify factors that may enhance future research feasibility.

METHODS:

We conducted a prospective, observational study of all critically ill adults eligible to participate in research studies at 23 Canadian intensive care units (ICUs). We characterized eligibility events into one of five consent outcomes, identified reasons why opportunities to recruit were missed or infeasible, and documented decision-maker's rationale for providing or declining consent.

MEASUREMENTS AND MAIN RESULTS:

Only 8.9% of eligible patients made decisions for themselves.
In 453 eligibility events, consent was not required in 14 (3.1%), missed in 131 (28.9%), infeasible due to operational reasons in 129 (28.5%), obtained in 140 (30.9%) and declined in 39 (8.6%). Over half (57%) of all opportunities to recruit patients were missed or infeasible largely due to research team workload, limited availability, narrow time windows for inclusion, difficulties in contacting families, non-existent substitute decision makers (SDMs), physician refusals and protocols prohibiting co-enrollment. The rationale for providing consent differed between patients and SDMs. Greater research coordinator experience and site research volume were significant predictors of fewer declined consents.

CONCLUSIONS:

A large gap exists between eligibility and the frequency with which consent encounters occur in ICU research. Recruitment is susceptible to personnel availability, given the need to interact with SDMs, and to design and procedural inefficiencies that hinder recruitment. Current enrolment practices under-represent study populations.