TY - JOUR
T1 - An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
AU - OPTIMA prelim study group
AU - CSAW study group
AU - Chemorad study group
AU - POUT study group
AU - ACST-2 study group
AU - Jepson, Marcus
AU - Elliott, Daisy
AU - Conefrey, Carmel
AU - Wade, Julia
AU - Rooshenas, Leila
AU - Wilson, Caroline
AU - Beard, David
AU - Blazeby, Jane M.
AU - Birtle, Alison
AU - Halliday, Alison
AU - Stein, Rob
AU - Donovan, Jenny L.
AU - Beard, David
AU - Carr, Andrew
AU - Cook, Jonathan
AU - Cooper, Cushla
AU - Dean, Benjamin
AU - Donovan, Jenny L.
AU - Gray, Alastair
AU - Gwilym, Stephen
AU - Judge, Andrew
AU - Merritt, Naomi
AU - Moser, Jane
AU - Rees, Jonathan
AU - Rombach, Ines
AU - Savulescu, Julian
AU - Tracey, Irene
AU - Wartolowska, Karolina
AU - Blazeby, Jane M.
AU - Barham, Paul
AU - Brookes, Sara T.
AU - Williams, Geraint
AU - Bryan, Rik
AU - Hall, Emma
AU - Johnson, Mark
AU - Lewis, Rebecca
AU - Belli, Anna
AU - Gough, Michael
AU - Bartlett, John
AU - Canney, Peter
AU - Dunn, Janet
AU - Earl, Helena
AU - Francis, Adele
AU - Hall, Peter
AU - Higgins, Helen
AU - Hiller, Louise
AU - Marshall, Andrea
AU - McCabe, Christopher
AU - Poole, Christopher
AU - Rea, Daniel
PY - 2018/7/1
Y1 - 2018/7/1
N2 - 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.
AB - 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.
KW - Patient information
KW - Qualitative research
KW - Randomization
KW - Randomized controlled trials
KW - Recruitment
KW - Recruitment to RCTs
UR - http://www.scopus.com/inward/record.url?scp=85044974698&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2018.02.018
DO - 10.1016/j.jclinepi.2018.02.018
M3 - Article
AN - SCOPUS:85044974698
SN - 0895-4356
VL - 99
SP - 75
EP - 83
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -