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An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)75-83
Number of pages9
JournalJournal of Clinical Epidemiology
Volume99
Early online date2 Mar 2018
DOIs
DateAccepted/In press - 26 Feb 2018
DateE-pub ahead of print - 2 Mar 2018
DatePublished (current) - 1 Jul 2018

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.

    Structured keywords

  • Centre for Surgical Research

    Research areas

  • Patient information, Qualitative research, Randomization, Randomized controlled trials, Recruitment, Recruitment to RCTs

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