Evidence map›Paper›PMID 35264220›Full record

ArticleTrials2022

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 and 5 more

Registry-linked trialAbstract read
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04185818 (Citizen Science), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04185818 naunknown statusnot on this map

Citizen Science: The People's Trial: A Randomised Controlled Trial

TypeinterventionalSponsorNational University of Ireland, Galway, IrelandRan2019 to 2020Enrolled500ConditionsSleepArmsReading a book
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Elaine FinucaneSchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland. elainemay.finucane@nuigalway.ie.ORCID http://orcid.org/0000-0002-6052-7205
Ann O'BrienSchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Shaun TreweekHealth Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
John NewellSchool of Mathematics, Statistics and Applied Mathematics, National University of Ireland Galway, Galway, Ireland.
Kishor DasSchool of Mathematics, Statistics and Applied Mathematics, National University of Ireland Galway, Galway, Ireland.
Sarah ChapmanCochrane UK, hosted by Oxford University Hospitals NHS Foundation Trust and funded by the National Institute for Health Research, Oxford, UK.
Paul WicksWicks Digital Health, Lichfield, England, UK.
Sandra GalvinSchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Patricia HealySchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Linda BiestySchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
Katie GilliesHealth Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Anna Noel-StorrRadcliffe Department of Medicine, University of Oxford, Oxford, UK.
Heidi GardnerHealth Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Mary Frances O'ReillyFormerly - Nursing and Midwifery Planning and Development Unit, West Mid-West, Merlin Park University Hospital, Galway, Ireland.
Declan DevaneSchool of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.

Funding

Health Research Board KEDS-2018-012
6 · The paper itself

Abstract

backgroundRandomised 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.

methodsUsing a reflexive approach, we describe the processes of development, conduct, and dissemination of The People's Trial.

resultsOver 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.

conclusionThe 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 registrationClinicalTrials.gov NCT04185818 . Registered on 4 December 2019.

Indexed as

Health Knowledge, Attitudes, PracticeRandomized Controlled Trials as TopicHumansSurveys and QuestionnairesMethodologyOnlinePublic engagementRandomised trial

Identifiers

PMID35264220
PMCPMC8905031

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.