Abstract
BackgroundEHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. Even so, stakeholders in the process must still contend with the practical and ethical challenges associated with research recruitment. Patient perspectives on these matters are particularly important given that the success of research recruitment depends on patients’ willingness to participate.MethodsWe conducted 15 focus groups (n = 110 participants) in four counties in diverse regions of the southeastern US: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. Based on a hypothetical study of a behavioral intervention for type 2 diabetes, we asked about the acceptability and appropriateness of direct investigator versus physician-mediated contact with patients for research recruitment, and whether patients should be asked to opt in or opt out of further contact in response to recruitment letters.ResultsFor initial contact, nearly all participants said it would be acceptable for researchers to contact patients directly and three-fourths said that it would be acceptable for researchers to contact patients through their physicians. When we asked which would be most appropriate, a substantial majority chose direct contact. Themes that arose in the discussion included trust and transparency, decision-making power, the effect on research, and the effect on patient care. For response expectations, the vast majority of participants said both opt-in and opt-out would be acceptable—typically finding neither especially problematic and noting that both afford patients the opportunity to make their own decisions.ConclusionsExternal validity relies heavily on researchers’ success enrolling eligible patients and failure to reach accrual targets is a costly and common barrier to advancing scientific knowledge. Our results suggest that patients recognize multiple advantages and disadvantages of different research recruitment strategies and place value on the implications not just for themselves, but also for researchers and healthcare providers. Our findings, including rich qualitative detail, contribute to the body of empirical and ethical literature on improving research recruitment and suggest specific ways forward as well as important areas for future research.
Highlights
electronic health records (EHRs) phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research
Many characteristics varied by study location, statistically significant differences were found only in self-reported race and having a regular healthcare provider. (See Additional file 2: Table S2–1 for data on trust and attitudes toward research.)
Initial contact with prospective participants: Cross-cutting themes We asked focus group participants their opinions about different ways researchers conducting a hypothetical study (Table 1) could contact potentially eligible patients—directly or through their physicians (Table 2)—
Summary
EHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. The widespread adoption and use of electronic health records (EHRs) [1, 2], together with the development of “big data” tools to mine, assimilate, and analyze information [3], has led to the ability to identify cohorts of patients with precise attributes This process, known as EHR phenotyping, applies algorithms to electronic data to classify patients based on exact constellations of information, such as demographics, diagnoses, procedures, lab values, vital signs, medications, and environmental and behavioral factors [4,5,6,7]. Beskow et al BMC Medical Research Methodology (2019) 19:42 or through their physicians, asking for either an opt-in or opt-out response regarding further recruitment communication Each of these strategies raises both ethical and practical challenges [14, 15] and studies suggest that institutional policies vary considerably [16,17,18]. Their perspectives are important given that the ultimate success of recruitment endeavors depends on building and maintaining patients’ trust and willingness to participate in research
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