Patient perspectives on use of electronic health records for research recruitment

Abstract

Background: EHR 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. Methods: We 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. Results: For 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. Conclusions: External 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.

EHR phenotyping for research recruitment: Researcher, IRB, and physician perspectives on approaches to contacting patients

“…In our previously-reported research [15], we explored patient perspectives on initial recruitment contact and similar qualitative themes emerged (see Introduction)-but patients seemed to weigh the tradeoffs differently compared to the professional stakeholder groups in the present study. Most participants in both studies found both approaches to initial contact acceptable; however, 100% of professionals said contact through physicians was acceptable compared to 75% of patients, and 66% of professionals said direct contact was acceptable compared to 95% of patients.…”

“…To resolve potential differences in perspectives reported here among professional stakeholder groups (physicians less often favored initial direct contact between researchers and patients, researchers less often favored opt in approaches, and IRBs less often favored opt out approaches) and between professionals and patients, we concur with McHugh and colleagues [9] that, "In light of how healthcare delivery has evolved toward providing more collaborative, patient-centered, and data-driven care, individual IRBs and institutions must reconsider existing policies so that recruitment can similarly evolve" (p.384). Steps toward a patient-centered approach-one that addresses stakeholder concerns about privacy and research quality while also promoting fair access to research and decisional autonomy-could include [15]: A strength of our interview design was asking participants about acceptable as well as most appropriate actions, after considering advantages and disadvantages of competing strategies from multiple viewpoints. However, interpretation of our findings is subject to some limitations.…”

“…We previously asked patients about these issues in mixed methods research conducted in diverse regions of the southeastern US [15]. Nearly all said it would be acceptable for researchers to contact patients directly and three-fourths said it would be acceptable for researchers to contact patients through their physicians.…”

The Competing Demands of Patient Privacy and Clinical Research

“…In a series of focus groups about research recruitment using electronic health records data, Beskow and colleagues report, trust and transparency were critical to the respondents' reactions to recruitment queries. The respondents thought that direct contact by either a researcher or their own physician was acceptable, although most thought that direct contact by the researcher would give them more control over their decision 24 …”

Electronic Medical Records and Machine Learning in Approaches to Drug Development

“…These implementations are dependent on the patient's consent to partake in the trials and there are studies that investigate the process and ethics of such consent [52]. Beskow et al identified patient informed consent as a bottleneck in using EHR for randomized clinical trials.…”