The People's Trial: supporting the public's understanding of randomised trials.
Methodology
Online
Public engagement
Randomised trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
09 Mar 2022
09 Mar 2022
Historique:
received:
26
04
2021
accepted:
26
12
2021
entrez:
10
3
2022
pubmed:
11
3
2022
medline:
12
3
2022
Statut:
epublish
Résumé
Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial. Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial. Over 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned. The People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims. ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People's Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial.
METHODS
METHODS
Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial.
RESULTS
RESULTS
Over 3000 members of the public, from 72 countries, participated in The People's Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. 'Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?' We report the processes of The People's Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned.
CONCLUSION
CONCLUSIONS
The People's Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.
Identifiants
pubmed: 35264220
doi: 10.1186/s13063-021-05984-1
pii: 10.1186/s13063-021-05984-1
pmc: PMC8905031
doi:
Banques de données
ClinicalTrials.gov
['NCT04185818']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
205Subventions
Organisme : Health Research Board
ID : KEDS-2018-012
Pays : Ireland
Informations de copyright
© 2022. The Author(s).
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