Optimizing diversity, equity and inclusion in pragmatic clinical trials: Findings from the Pain Management Collaboratory.

The National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs established a Pain Management Collaboratory (PMC) in 2017, with the purpose of implementing and evaluating nonpharmacological approaches for management of pain and co-occurring conditions in military and veteran healthcare systems through the execution of pragmatic clinical trials. The purpose of the current study is to detail and critically examine recruitment and retention procedures across the PMC's large-scale multi-site pragmatic clinical trials, with attention to efforts made by trialists to diversify their study samples. Team members from 11 pragmatic clinical trials completed semi-structured interviews that focused on the meaning of diversity to the trial teams when planning the composition of their samples, methods used to recruit and retain diverse samples of patients, and planned analyses that take into consideration diverse subgroups of patients. Nearly 18,000 patients have been enrolled across trials, 22 % of whom were assigned female sex at birth and 34 % of whom identify with a marginalized race or ethnicity. Respondents highlighted study site selection, formation of partnerships with patient groups, and leveraging of data informatics as strategies that aided in the recruitment of patients diverse in terms of birth sex, race, and ethnicity. Notably, trialists adopted a narrow definition of diversity that did not take into consideration multiple intersecting identities of trial participants. Based on experiences of the PMC, we provide 14 recommendations on ways to diversify patient samples in clinical pain research. PERSPECTIVE: This article describes challenges posed, and opportunities provided, with pain pragmatic clinical trial designs, emphasizing approaches that optimize the inclusion of social identity groups that have historically been under-represented in pain research.