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
OBJECTIVES: The aim of this work was to assess the current state of baseline knowledge of diabetes and diabetic retinopathy (DR) in new patients referred to a tertiary retina service from their primary eye care provider. METHODS: This single-centre, prospective, observational study included patients presenting to the retina clinic at the Hamilton Regional Eye Institute, a major tertiary referral centre, for their initial consultation for diabetes- or DR-associated complications. Upon recruitment into the study, patients were asked to complete a 35-item questionnaire regarding diabetes and associated complications. All data were coded and analyzed using statistical software. RESULTS: A total of 98 patients participated in the study, which included 50 men and 48 women. Seventy-eight patients (79.6%) were Caucasian. We found that 56.1% (n=55) of the patients did not know the meaning of "HbA1C" (glycated hemoglobin) and only 26.5% of patients sampled were aware of their DR status. Bivariate analysis revealed that patients who had postsecondary education (p<0.001) or those who had education on complications of diabetes (p<0.05) were more likely to know their DR status. More importantly, it was found that 56.1% of patients expressed interest in a future diabetes seminar. CONCLUSIONS: It is evident that a significant proportion of patients do not have adequate knowledge of diabetes or DR, and this is related to their level of education and lack of being taught about diabetes complications. Our findings may guide prevention initiatives by primary eye care providers and promote increased awareness about diabetes and DR for prevention of disease complications, including blindness.