Journal
JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 99, Issue -, Pages 75-83Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2018.02.018
Keywords
Randomized controlled trials; Recruitment; Randomization; Qualitative research; Recruitment to RCTs; Patient information
Funding
- Medical Research Council (MRC) [MR/K025643/1]
- RCT: RCT 1 Arthritis Research UK [19707]
- RCT 2 National Institute for Health Research (NIHR) Health Technology Assessment (HTA) [HTA 06/301/233]
- Bupa Foundation
- RCT 3-Cancer Research UK (CRUK) [CRUK/11/027]
- RCT 4 NIHR Research for Patient Benefit (RfPB) [PB-PG-0807-14131]
- POUT Cancer Research UK (CRUK) [CRUK/11/027]
- RCT 5 NIHR HTA [HTA 10/34/01]
- NIHR HTA program [HTA 96/20/06, HTA 96/20/99, ISRCTN20141297]
- NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West at University Hospitals Bristol NHS Foundation Trust
- NIHR Senior Investigator award
- MRC [MR/K025643/1] Funding Source: UKRI
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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. (C) 2018 University of Bristol. Published by Elsevier Inc.
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