Long-Term Engagement of Diverse Study Cohorts in Decentralized Research: Longitudinal Analysis of "All of Us" Research Program Data.

Abstract

Background: The generalizability of clinical research hinges on robust study designs, which include the recruitment and maintenance of a representative study population. This study examines the evolution of the demographic characteristics of 329,038 participants who enrolled and participated in The All of Us Research Program (AoURP), a decentralized study aimed at representing the diversity of the United States.

Objective: The primary objectives of this study were to assess alterations in the demographic composition of the cohort at different protocol stages within AoURP, while analyzing completion rates and timeframes for survey and substudy completion. Additionally, we examined how participant interactions with the program impacted engagement and survey responses.

Methods: We conducted a longitudinal analysis of the AoURP data, tracking changes in demographic composition, completion rates, and completion times for surveys and substudies. Comparative analyses were performed to assess differences in engagement and survey completion based on sociodemographic characteristics of participants involved in postenrollment study components.

Results: The sociodemographic composition of the cohort that participated in the postenrollment study (eg, optional components) differed significantly from that of the recruited population. The proportion of self-identified White participants increased by 21.2%, whereas the proportion of Black or African American participants decreased by 12.18% (P=.02). Participants who identified as White (n=93,614, 52.7%) and NonHispanic (n=109,279, 42.21%) were more engaged compared to those identifying as Black or African American (n=10,887, 15.76%), Asian (n=4274, 38.72%), or Hispanic (n=12,530, 20.7%; P=.006). Participants' response times to study surveys and completeness varied across all demographic groups (P<.001). Furthermore, those identifying as White skipped fewer survey questions (1.19) compared to those identifying as Black or African American (1.40) or other racial and ethnic identities (P<.001).

Conclusions: The AoURP dataset serves as an exceptional resource for investigating diverse public health concerns. However, the longitudinal analysis of participant-level data underscores a significant skew in population diversity, suggesting the need for targeted strategies to enhance engagement and retention across all groups. Ensuring diversity in the cohort is essential for maintaining the study's representativeness and the broad applicability of its findings.