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

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 c...

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Autores principales: Jepson, Marcus, Elliott, Daisy, Conefrey, Carmel, Wade, Julia, Rooshenas, Leila, Wilson, Caroline, Beard, David, Blazeby, Jane M., Birtle, Alison, Halliday, Alison, Stein, Rob, Donovan, Jenny L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015122/
https://www.ncbi.nlm.nih.gov/pubmed/29505860
http://dx.doi.org/10.1016/j.jclinepi.2018.02.018
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author Jepson, Marcus
Elliott, Daisy
Conefrey, Carmel
Wade, Julia
Rooshenas, Leila
Wilson, Caroline
Beard, David
Blazeby, Jane M.
Birtle, Alison
Halliday, Alison
Stein, Rob
Donovan, Jenny L.
author_facet Jepson, Marcus
Elliott, Daisy
Conefrey, Carmel
Wade, Julia
Rooshenas, Leila
Wilson, Caroline
Beard, David
Blazeby, Jane M.
Birtle, Alison
Halliday, Alison
Stein, Rob
Donovan, Jenny L.
author_sort Jepson, Marcus
collection PubMed
description 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.
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spelling pubmed-60151222018-07-01 An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment Jepson, Marcus Elliott, Daisy Conefrey, Carmel Wade, Julia Rooshenas, Leila Wilson, Caroline Beard, David Blazeby, Jane M. Birtle, Alison Halliday, Alison Stein, Rob Donovan, Jenny L. J Clin Epidemiol Article 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. Elsevier 2018-07 /pmc/articles/PMC6015122/ /pubmed/29505860 http://dx.doi.org/10.1016/j.jclinepi.2018.02.018 Text en © 2018 University of Bristol http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Jepson, Marcus
Elliott, Daisy
Conefrey, Carmel
Wade, Julia
Rooshenas, Leila
Wilson, Caroline
Beard, David
Blazeby, Jane M.
Birtle, Alison
Halliday, Alison
Stein, Rob
Donovan, Jenny L.
An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title_full An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title_fullStr An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title_full_unstemmed An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title_short An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
title_sort observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6015122/
https://www.ncbi.nlm.nih.gov/pubmed/29505860
http://dx.doi.org/10.1016/j.jclinepi.2018.02.018
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