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

TLDR

Recruiters often use gambling metaphors or computer agency to explain randomization, which can confuse patients. This study explores how clinicians describe randomization and how patients understand it, aiming to assess its impact on recruitment. The authors conducted a qualitative analysis of 73 audio recordings from five UK RCTs facing recruitment challenges. Only 10 % of consultations omitted any mention of randomization; most included a description, frequently using gambling metaphors or computer references, yet the rationale was rarely provided, leading to potential misunderstandings.

Abstract

<h2>Abstract</h2><h3>Objectives</h3> 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. <h3>Study Design and Setting</h3> Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. <h3>Results</h3> 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. <h3>Conclusions</h3> 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 andusions 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.