RESUMO
Historically marginalized populations are disproportionately affected by many diseases that commonly affect the retina, yet they have been traditionally underrepresented in prospective clinical trials. This study explores whether this disparity affects the clinical trial enrollment process in the retina field and aims to inform future trial recruitment and enrollment. Age, gender, race, ethnicity, preferred language, insurance status, social security number (SSN) status, and median household income (estimated using street address and zip code) for patients referred to at least one prospective, retina-focused clinical trial at a large, urban, retina-based practice were retrospectively extracted using electronic medical records. Data were collected for the 12-month period from 1 January 2022, through 31 December 2022. Recruitment status was categorized as Enrolled, Declined, Communication (defined as patients who were not contacted, were contacted with no response, were waiting for a follow-up, or were scheduled for screening following a clinical trial referral.), and Did Not Qualify (DNQ). Univariable and multivariable analyses were used to determine significant relationships between the Enrolled and Declined groups. Among the 1477 patients, the mean age was 68.5 years old, 647 (43.9%) were male, 900 (61.7%) were White, 139 (9.5%) were Black, and 275 (18.7%) were Hispanic. The distribution of recruitment status was: 635 (43.0%) Enrolled, 232 (15.7%) Declined, 290 (19.6%) Communication, and 320 (21.7%) DNQ. In comparing socioeconomic factors between the Enrolled and Declined groups, significant odds ratios were observed for age (p < 0.02, odds ratio (OR) = 0.98, 95% confidence interval (CI) [0.97, 1.00]), and between patients who preferred English versus Spanish (p = 0.004, OR = 0.35, 95% CI [0.17, 0.72]. Significant differences between the Enrolled and Declined groups were also observed for age (p < 0.05), ethnicity (p = 0.01), preferred language (p < 0.05), insurance status (p = 0.001), and SSN status (p < 0.001). These factors may contribute to patient participation in retina-focused clinical trials. An awareness of these demographic and socioeconomic disparities may be valuable to consider when attempting to make clinical trial enrollment an equitable process for all patients, and strategies may be useful to help address these challenges.
RESUMO
PURPOSE: To determine the proportion of patients with proliferative diabetic retinopathy (PDR) who were counted as loss to follow-up (LTFU) patients and to investigate predictive factors. DESIGN: Retrospective cohort study. METHODS: Information was collected for 4,423 patients with PDR between April 30, 2012, and April 30, 2017. Two definitions of LTFU were used. Complete LTFU referred to the population who never returned to care within the study period. Interval LTFU referred to the population who did not adhere to clinical recommendations and missed scheduled appointments, resulting in intervals longer than 6 months or 1 year between 2 appointments. Age, average gross income, and insurance were assessed as potential predictors of interval LTFU. RESULTS: Among 4,423 patients with PDR, 2,407 (54.4%) and 2,320 (52.4%) were complete LTFU at 6 months and 1 year, respectively; 782 (17.7%) and 468 (10.6%) patients were interval LTFU for 6 months and 1 year, respectively. Age and average gross income were not found to be significant predictors of interval LTFU. Compared to self-pay, government and private insurance patients were more likely to be interval LTFU at 6 months (government, P = .035; private, P = .005). Private insurance patients were also more likely to be interval LTFU at 1 year (P = .003). CONCLUSIONS: The identified complete LTFU rates were notably high and warrant further study. More than 1 of 6 patients were interval LTFU for at least 6 months, and 1 of 10 patients was interval LTFU for more than 1 year. Insurance status was significant in determining interval LTFU status. Consistent with other analyses, these results indicate that compliance with clinical appointments among patients with PDR is a substantial clinical challenge.