Increasing Equity Within Randomized Control Trials: A Qualitative Analysis of Focus Groups From a Multi-Site, Pragmatic Clinical Trial.

Background: Underrepresentation of diverse populations in clinical trials poses challenges to equity and external validity in health care research. To successfully recruit underrepresented participants in pragmatic clinical trials, researchers must understand the perspectives and needs of individuals from diverse backgrounds who participate in research.

Objective: The purpose of this qualitative study was to gain an understanding of the needs and perspectives of participants of the OPTIMUM trial -- a pragmatic trial evaluating mindfulness-based stress reduction for chronic low back pain.

Methods: This qualitative study employed focus groups with participants from 3 clinical sites: Boston Medical Center, the University of North Carolina at Chapel Hill, and the University of Pittsburgh. Focus group discussions centered on participants' experiences, barriers, and facilitators to engagement in the OPTIMUM trial. Data were analyzed using thematic content analysis and the rapid qualitative analysis method, Lightning Reports, for real-time feedback integration into the trial process.

Results: Six focus groups were conducted with 46 participants, of whom 39.1% were first-time research participants and 56.5% identified as Black or African American. Qualitative analysis identified five key themes:1) The importance of providers in the recruitment of cLBP patients, (2) Motivators to participate and stay engaged in clinical research, (3) Participant lack of understanding of randomized control trials (RCTs) and general research processes, (4) Desire for social connection and community-building among participants, and (5) the Positive impact of regular study staff interaction.

Conclusion: Equity in RCTs requires intentional strategies to address barriers to participation and engagement faced by historically underrepresented populations. Engaging health care providers in recruitment, fostering positive interactions with study staff, and creating opportunities for social connection can improve recruitment, retention, and engagement. Incorporating community-engaged research methods and real-time feedback mechanisms can further support inclusivity and equity in pragmatic clinical trials.