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

Marcus Jepson*, Daisy Elliott, Carmel Conefrey, Julia Wade, Leila Rooshenas, Caroline Wilson, David Beard, Jane M. Blazeby, Alison Birtle, Alison Halliday, Rob Stein, Jenny L. Donovan, CSAW study group, Chemorad Study Group, POUT study group, ACST-2 study group, OPTIMA prelim study group

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

9 Citations (Scopus)
245 Downloads (Pure)

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.

Original languageEnglish
Pages (from-to)75-83
Number of pages9
JournalJournal of Clinical Epidemiology
Volume99
Early online date2 Mar 2018
DOIs
Publication statusPublished - 1 Jul 2018

Structured keywords

  • Centre for Surgical Research

Keywords

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

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