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Research
Elaine Finucane
National University of Ireland Galway
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6052-7205
License:
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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.
Methods
Using a reflexive approach, we describe the processes of development, conduct and dissemination of The People’s Trial.
Results
Over 3000 members of the public, from 72 countries, participated in The People’s Trial. Through a series of online surveys, the public chose the question The People’s 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 to not reading a book in bed?’ We called this trial The Reading Trial.
We report 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
The People’s trial engaged members of 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
The Reading Trial was registered 4th December 2019 on ClinicalTrials.gov, ID: NCT04185818.
Keywords
Randomised trial, public engagement, online, methodology
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CURRENT STATUS: Under Review
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Major revision
On 28 Jun, 2021
Review #2 received
Received 27 Jun, 2021
Review #3 received
Received 22 Jun, 2021
Review #1 received
Received 16 Jun, 2021
Reviewer #3 agreed
On 14 Jun, 2021
Reviews received
Received 13 Jun, 2021
Reviewer #2 agreed
On 13 Jun, 2021
Reviewer #1 agreed
On 12 Jun, 2021
Reviewers invited
Invitations sent on 11 Jun, 2021
Editor assigned
On 26 May, 2021
Submission checks complete
On 25 May, 2021
First submitted
On 13 Feb, 2021
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Elaine Finucane
National University of Ireland Galway
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6052-7205
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Major revision
On 28 Jun, 2021
Review #2 received
Received 27 Jun, 2021
Review #3 received
Received 22 Jun, 2021
Review #1 received
Received 16 Jun, 2021
Reviewer #3 agreed
On 14 Jun, 2021
Reviews received
Received 13 Jun, 2021
Reviewer #2 agreed
On 13 Jun, 2021
Reviewer #1 agreed
On 12 Jun, 2021
Reviewers invited
Invitations sent on 11 Jun, 2021
Editor assigned
On 26 May, 2021
Submission checks complete
On 25 May, 2021
First submitted
On 13 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Methods
Using a reflexive approach, we describe the processes of development, conduct and dissemination of The People’s Trial.
Results
Over 3000 members of the public, from 72 countries, participated in The People’s Trial. Through a series of online surveys, the public chose the question The People’s 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 to not reading a book in bed?’ We called this trial The Reading Trial.
We report 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
The People’s trial engaged members of 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
The Reading Trial was registered 4th December 2019 on ClinicalTrials.gov, ID: NCT04185818.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
This is a list of supplementary files associated with this preprint. Click to download.
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