The use of Zelen's design in randomised trials
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Zelen's design may bias results if participants in one arm disproportionately refuse consent or only consent when allowed to cross over to active treatment.
“This design may lead to bias if, for example, participants allocated to one particular arm of the trial disproportionally refuse to provide consent for participation or, alternatively, if participants only provide consent provided they are allowed to cross-over to the active treatment arm (Torgerson 2004).”
From Interventions for self-harm in children and adolescents (2021) · cites this paper as Torgerson 2004
Cites
O’Rourke, P. P., Crone, R. K., Vacanti, J. P., Ware, J. H., Lillehei, C. W., Parad, R. B., & Epstein, M. F. (1989) · PEDIATRICS · doi:10.1542/peds.84.6.957 · Cited by 493 · see citing works
Atkin, W. S., Cook, C., Cuzick, J. M., Edwards, R. P., Northover, J. M. A., & Wardle, J. (2002) · The Lancet · doi:10.1016/s0140-6736(02)08268-5 · Cited by 489 · see citing works
Randomized consent designs for clinical trials: An update
Zelen, M. (1990) · Statistics in Medicine · doi:10.1002/sim.4780090611 · Cited by 289 · see citing works
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Interventions for self-harm in children and adolescents
Hawton, K., Witt, K. G., Taylor Salisbury, T. L., Arensman, E., Gunnell, D., Townsend, E., van Heeringen, K., & Hazell, P. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd012013 · Cited by 261 · see citing works
Interventions for self-harm in children and adolescents
Witt, K. G., Hetrick, S. E., Rajaram, G., Hazell, P., Taylor Salisbury, T. L., Townsend, E., & Hawton, K. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013667.pub2 · Cited by 149 · see citing works
- Authors
- Torgerson, D.
- Affiliations
- University of York (GB)
- Corresponding author
- Torgerson, David
- ORCID
- Torgerson, David
- Venue
- BJOG: An International Journal of Obstetrics & Gynaecology
- Publisher
- Wiley
- Published
- 2003-12-15
- Volume
- 111
- Issue
- 1
- Pages
- 2-2
- ISSN
- 0306-5456 (ISSN-L)
- 1470-0328
- 1471-0528
- OpenAlex
- W1963790016
- Cited by
- 21
- References
- 3
- Citations by year
- 2022: 3 · 2021: 3 · 2020: 4 · 2019: 1 · 2017: 3 · 2016: 2 · 2015: 2 · 2013: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- BJOG An International Journal of Obstetrics & Gynaecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Management Science and Operations Research › Optimal Experimental Design Methods
- Keywords
- randomised trials, sequential assignment, randomization, trial design
- MeSH terms
- Humans, Informed Consent, Randomized Controlled Trials as Topic
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