Barriers to enrollment in a pediatric critical care biorepository

Abstract

Background: Individuals of minority race/ethnicity have lower rates of participation in genomic research. This study evaluated sociodemographic characteristics associated with decisions to enroll in a pediatric critical care biorepository.

Methods: Parents of children admitted to the PICU between November 2014 and May 2017 were offered to enroll their child in a biorepository using a single-page opt-in consent. Missed enrollment was assessed by failure to complete the form or declining consent on the form. We conducted a retrospective chart review for sociodemographic and clinical information. Bivariate and multivariable regression analyses were performed.

Results: In 4055 encounters, representing 2910 patients with complete data, 1480 (50%) completed the consent form and 1223 (83%) enrolled. We found higher odds of incomplete consent for non-English-speaking parents (OR = 2.1, p < 0.0001) and parents of children of all races except non-Hispanic white (OR = 1.27-1.99, p < 0.0001). We found higher odds of declined consent in patients with Medicaid (OR = 1.67, p = 0.003) and parents of children of all races except non-Hispanic white (OR = 1.32-2.9, p < 0.0001).

Conclusion: Inability to enroll patients in a critical care biorepository may be associated with several sociodemographic factors at various points in recruitment/enrollment.

Impact: Individuals of minority race/ethnicity are less likely to enroll in genomic research and in critical care research. This study evaluated sociodemographic characteristics associated with decisions to enroll a child in a pediatric critical care biorepository. Sociodemographic factors including race/ethnicity, primary language, and insurance status and patient clinical characteristics are associated with differential enrollment into a pediatric critical care biorepository. More research is needed to understand how study team-participant interactions may play a role in differential enrollment. Barriers to enrollment occur both at the time of approaching and consenting for enrollment.