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

• DOI: 10.1186/s13063-021-05984-1
• Publication Date: 2022-03-09T09:02:47Z
• Authors: 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’Re...; Declan Devane
• Keywords: Randomised trial; Medicine (General); Health Knowledge, Attitudes, Practice; Research; R; Methodology; R Medicine; 551; 16. Peace & justice; Public engagement; 3. Good health; 03 medical and health sciences; R5-920; 0302 clinical medicine; Surveys and Questionnaires; Humans; Online; Randomized Controlled Trials as Topic

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.govNCT04185818. Registered on 4 December 2019