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David Weiss, Ann Murchison, Lisa Hark, Bianca Collymore, Robin Casten, Rickie Brawer, James Plumb, Barry Rovner, Jeffrey Henderer, Julia Haller; Comparing Opt-in Versus Opt-out Recruitment Strategies for Ophthalmology Research. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2438.
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Research recruitment, particularly among African Americans (AAs), can be difficult. Given the different requirements of IRBs, both opt-in and opt-out recruitment methods were used for a single ophthalmic study involving AAs with diabetes. The success of the two methods as well as their characteristics are compared.
A prospective, multi-site clinical trial was designed to test the efficacy of a culturally-relevant, home-based behavioral intervention to improve the rates of annual dilated fundus examinations in older AAs with diabetes. Patients were recruited from clinical practices at two academic medical centers. Depending on the medical center affiliation, patients were sent either opt-out or opt-in recruitment letters. Opt-out letters instructed patients to decline study participation via mail or telephone. Patients who did not opt out were called by study personnel. Opt-in letters directed patients to contact study personnel if they were interested in being screened for enrollment. Baseline measures included various cognitive assessments, the Diabetes Self-Care Inventory, Risk Perception Survey - Diabetes Mellitus, Cultural Relevancy Scale, and Visual Functioning Questionnaire-25. The number of recruitment letters mailed, recruitment calls made, enrollment, and all baseline measures were tracked and compared between the two sites.
A total of 2730 opt-in letters and 879 opt-out letters were mailed and 107 subjects enrolled in the trial. Enrollment rates were higher with opt-out recruitment (7.0% vs. 4.0%, p=0.01) but required more staff time (1271 telephone calls vs. 283 telephone calls). Participants recruited with an opt-out letter had better cognitive function (p=0.01), were less likely to be dependent on others due to their vision (p=0.04), and were more likely to have higher perceived personal control over their health (p=0.03). There were no significant differences between the groups in age, gender, education, hemoglobin A1C, diabetes self-care behaviors, or ratings of cultural characteristics.
In the current study, opt-out recruitment resulted in improved enrollment but required more staff time. Rising rates of diabetes and diabetic retinopathy will increase the need for ophthalmology research. To optimize recruitment of older and minority patients, researchers should be aware of optimal methods in their population.
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