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An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
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(2018) An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. Journal of Clinical Epidemiology, 99 . pp. 75-83. doi:10.1016/j.jclinepi.2018.02.018 Research output not available from this repository, contact author.
Official URL: http://dx.doi.org/10.1016/j.jclinepi.2018.02.018
Abstract
Objectives
To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment.
Study Design and Setting
Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties.
Results
One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was “best for them”. Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation.
Conclusions
The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation.
| Item Type: | Journal Article | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Journal or Publication Title: | Journal of Clinical Epidemiology | ||||||||
| Publisher: | Elsevier Inc. | ||||||||
| ISSN: | 0895-4356 | ||||||||
| Official Date: | July 2018 | ||||||||
| Dates: |
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| Volume: | 99 | ||||||||
| Page Range: | pp. 75-83 | ||||||||
| DOI: | 10.1016/j.jclinepi.2018.02.018 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access |
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