The People's Trial: supporting the public's understanding of randomised trials

Elaine Finucane; Ann O'Brien; Shaun Treweek; John Newell; Kishor Das; Sarah Chapman; Paul Wicks; Sandra Galvin; Patricia Healy; Linda Biesty; Katie Gillies; Anna Noel-Storr; Heidi Gardner; Mary Frances O'Reilly; Declan Devane

doi:10.1186/s13063-021-05984-1

The People's Trial: supporting the public's understanding of randomised trials

Elaine Finucane^* (Corresponding Author), Ann O'Brien, Shaun Treweek, John Newell, Kishor Das, Sarah Chapman, Paul Wicks, Sandra Galvin, Patricia Healy, Linda Biesty, Katie Gillies, Anna Noel-Storr, Heidi Gardner, Mary Frances O'Reilly, Declan Devane

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

3 Downloads (Pure)

Abstract

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: 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 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: 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: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

Original language	English
Article number	205
Number of pages	12
Journal	Trials
Volume	23
Issue number	1
Early online date	9 Mar 2022
DOIs	https://doi.org/10.1186/s13063-021-05984-1
Publication status	Published - 9 Mar 2022

Bibliographical note

Acknowledgements
The People’s Trial team members acknowledge with gratitude the study participants. We would also like to acknowledge and thank Simone Lepage, Aoife O’Shaughnessy, and Louise Foley for their support with the research project. We would also like to thank Rob & Paul Digital Design™, Galway, Ireland. In addition, we would like to thank Marina Zaki for her support of The People’s Trial, in particular her expertise in promoting The People’s Trial through social media channels.
Funding
This research was funded by the Health Research Board in Ireland, through the Health Research Board – Trials Methodology Research Network as part of a Knowledge Exchange and Dissemination Scheme Award (grant reference KEDS-2018-012) 2018. The funder of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit.

Keywords

Randomised trial
Public engagement
Online
Methodology

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Data from: The People’s Trial: supporting the public’s understanding of randomised trials
Finucane, E. (Creator), O’Brien, A. (Creator), Treweek, S. (Creator), Newell, J. (Creator), Das, K. (Creator), Chapman, S. (Creator), Wicks, P. (Creator), Galvin, S. (Creator), Healy, P. (Creator), Biesty, L. (Creator), Gillies, K. (Creator), Noel-Storr, A. (Creator), Gardner, H. (Creator), O’Reilly, M. F. (Creator) & Devane, D. (Creator), Figshare, 2022
DOI: 10.6084/m9.figshare.c.5886782.v1, https://springernature.figshare.com/collections/The_People_s_Trial_supporting_the_public_s_understanding_of_randomised_trials/5886782/1
Dataset

Cite this

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abstract = "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: 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 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: 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: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.",

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author = "Elaine Finucane and Ann O'Brien and Shaun Treweek and John Newell and Kishor Das and Sarah Chapman and Paul Wicks and Sandra Galvin and Patricia Healy and Linda Biesty and Katie Gillies and Anna Noel-Storr and Heidi Gardner and O'Reilly, {Mary Frances} and Declan Devane",

note = "Acknowledgements The People{\textquoteright}s Trial team members acknowledge with gratitude the study participants. We would also like to acknowledge and thank Simone Lepage, Aoife O{\textquoteright}Shaughnessy, and Louise Foley for their support with the research project. We would also like to thank Rob & Paul Digital Design{\texttrademark}, Galway, Ireland. In addition, we would like to thank Marina Zaki for her support of The People{\textquoteright}s Trial, in particular her expertise in promoting The People{\textquoteright}s Trial through social media channels. Funding This research was funded by the Health Research Board in Ireland, through the Health Research Board – Trials Methodology Research Network as part of a Knowledge Exchange and Dissemination Scheme Award (grant reference KEDS-2018-012) 2018. The funder of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit.",

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doi = "10.1186/s13063-021-05984-1",

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T2 - supporting the public's understanding of randomised trials

AU - Finucane, Elaine

AU - O'Brien, Ann

AU - Treweek, Shaun

AU - Newell, John

AU - Das, Kishor

AU - Chapman, Sarah

AU - Wicks, Paul

AU - Galvin, Sandra

AU - Healy, Patricia

AU - Biesty, Linda

AU - Gillies, Katie

AU - Noel-Storr, Anna

AU - Gardner, Heidi

AU - O'Reilly, Mary Frances

AU - Devane, Declan

N1 - Acknowledgements The People’s Trial team members acknowledge with gratitude the study participants. We would also like to acknowledge and thank Simone Lepage, Aoife O’Shaughnessy, and Louise Foley for their support with the research project. We would also like to thank Rob & Paul Digital Design™, Galway, Ireland. In addition, we would like to thank Marina Zaki for her support of The People’s Trial, in particular her expertise in promoting The People’s Trial through social media channels. Funding This research was funded by the Health Research Board in Ireland, through the Health Research Board – Trials Methodology Research Network as part of a Knowledge Exchange and Dissemination Scheme Award (grant reference KEDS-2018-012) 2018. The funder of the study had no role in the study design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit.

PY - 2022/3/9

Y1 - 2022/3/9

N2 - 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: 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 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: 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: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

AB - 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: 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 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: 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: ClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

KW - Randomised trial

KW - Public engagement

KW - Online

KW - Methodology

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VL - 23

JO - Trials

JF - Trials

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M1 - 205

ER -

The People's Trial: supporting the public's understanding of randomised trials

Abstract

Bibliographical note

Keywords

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Data from: The People’s Trial: supporting the public’s understanding of randomised trials

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