An Analysis of the Inclusion of Women, Older Individuals, and Racial/Ethnic Minorities in Rehabilitation Clinical Trials

Abstract

Objective: Our objective was to investigate whether women, people 65 yrs and older, or individuals who identify with racial and/or ethnic minority groups, were underrepresented among participants in rehabilitation clinical trials.

Design: This is a cross-sectional study of completed rehabilitation clinical trials investigating the number and percentage of women, older adults, and racial and/or ethnic minorities enrolled in rehabilitation clinical trials between January 1, 2011, and January 1, 2020. Secondary outcome measures were inclusion by diagnostic group, as well as International Classification of Functioning, Disability and Health category, and intervention by diagnostic group.

Results: Of the 108 studies meeting inclusion criteria, a majority (69%) were based in the United States. Stroke was the most frequent diagnostic group, followed by musculoskeletal conditions. Ninety-six percent of the United States-based trials included at least one female participant in their study, but among specific diagnostic groups, this ranged from 5% to 73%. Age information was reported inconsistently; however, of the trials reporting age, 100% of cardiac trials included older adults, whereas no spinal cord injury (SCI) trials included them. Among trials based in the United States reporting race, 70% of participants were White, followed by 20% Black or African American and 1% Asian. Among trials based in the United States reporting ethnicity, Hispanic or Latino participants were underrepresented overall and among each diagnostic group.

Conclusions: In this study, we found that among participants of rehabilitation clinical trials women, older individuals, and racial/ethnic minorities were generally underrepresented. In contrast, Black or African American participants were overrepresented with the exception of cardiac trials. An important finding was that many trials did not report age and/or race/ethnicity. Investigators should aim to include underrepresented populations and improve reporting.