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.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Jepson M,Elliott D,Conefrey C,Wade J,Rooshenas L,Wilson C,Beard D,Blazeby JM,Birtle A,Halliday A,Stein R,Donovan JL,CSAW study group.,Chemorad study group.,POUT study group.,ACST-2 study group.,OPTIMA prelim study group.doi
10.1016/j.jclinepi.2018.02.018subject
Has Abstractpub_date
2018-07-01 00:00:00pages
75-83eissn
0895-4356issn
1878-5921pii
S0895-4356(17)31278-7journal_volume
99pub_type
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journal_title:Journal of clinical epidemiology
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