The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Recruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategies
Open accessAbstract
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.
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Competing interests: none declared.
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Metadata
- Authors
- Junghans, C., Feder, G., Hemingway, H., Timmis, A., & Jones, M.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2005-09-12
- Volume
- 331
- Issue
- 7522
- Pages
- 940
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- OpenAlex
- W2049188870
- Cited by
- 255
- References
- 9
- FWCI
- 14.23
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Junghans, C., Feder, G., Hemingway, H., Timmis, A., & Jones, M. (2005). Recruiting patients to medical research: double blind randomised trial of “opt-in” versus “opt-out” strategies. BMJ. https://doi.org/10.1136/bmj.38583.625613.ae
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