Abstract
Purpose :
Prospective clinical trials in ophthalmology have historically struggled to enroll underrepresented racial and ethnic groups. In this study, we reviewed screening logs documenting consent or refusal to participate in prospective clinical studies. The purpose was to determine if specific patient and research personnel characteristics, such as demographics and languages spoken, influenced recruitment.
Methods :
Retrospective cohort study at an urban academic hospital. Screening logs from 8 prospective clinical studies between 2015-2021 with a total of 1290 patients were included; demographics (age, gender, race/ethnicity, primary language, insurance status) were collected via electronic medical record, socioeconomic status (SES) was determined via area-deprivation index scores. Research staff demographics were collected via survey. Variables were analyzed using chi-square tests and odds ratios were calculated by multivariate logistic regressions.
Results :
Black patients (OR=0.32, 95% CI 0.24-0.44; p<0.001) and Hispanic/Latino patients (OR=0.30, 95% CI 0.20-0.46; p<0.001) were significantly less likely to consent compared to White patients, even after adjusting for gender, language, SES, and insurance status. Males (OR=1.30, 95% CI 1.01-1.68; p=0.04) and those insured through Medicaid compared to Medicare (OR=1.6, 95% CI 1.30-2.16; p<0.001) were significantly more likely to consent, and patients with lower SES were significantly less likely to consent (OR=0.43, 95% CI 0.33-0.55; p<0.001). Concordance between patient and research staff gender decreased odds of enrollment (OR=0.71, 95% CI 0.54-0.93; p=0.014), while concordance in race and ethnicity (OR=2.98, 95% CI 2.14-4.16; p<0.001) significantly increased odds of enrollment. Patient’s primary language, concordance between patient and research staff language, and study design (interventional vs non-interventional) did not significantly influence the odds of participation.
Conclusions :
Patients from racial and ethnic minority groups and low socioeconomic backgrounds were significantly less likely to participate in ophthalmic clinical studies. Notably, concordance of race/ethnicity and gender discordance between patients and research staff significantly increased patient enrollment, despite controlling for language. This study underscores the necessity of diversity in clinical research teams to decrease disparities amongst study subject populations.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.