Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies.

OBJECTIVE To evaluate the effect of opt-in compared with opt-out recruitment strategies on response rate and selection bias. DESIGN Double blind randomised controlled trial. SETTING Two general practices in England. PARTICIPANTS 510 patients with angina. INTERVENTION Patients were randomly allocated to an opt-in (asked to actively signal willingness to participate in research) or opt-out (contacted repeatedly unless they signalled unwillingness to participate) approach for recruitment to an observational prognostic study of patients with angina. MAIN OUTCOME MEASURES Recruitment rate and clinical characteristics of patients. RESULTS The recruitment rate, defined by clinic attendance, was 38% (96/252) in the opt-in arm and 50% (128/258) in the opt-out arm (P = 0.014). Once an appointment had been made, non-attendance at the clinic was similar (20% opt-in arm v 17% opt-out arm; P = 0.86). Patients in the opt-in arm had fewer risk factors (44% v 60%; P = 0.053), less treatment for angina (69% v 82%; P = 0.010), and less functional impairment (9% v 20%; P = 0.023) than patients in the opt-out arm. CONCLUSIONS The opt-in approach to participant recruitment, increasingly required by ethics committees, resulted in lower response rates and a biased sample. We propose that the opt-out approach should be the default recruitment strategy for studies with low risk to participants.