Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

Humans Odds Ratio Patient Selection Research Design
Information Randomised controlled trial Recruitment Research methodology SWATs User-testing

Journal

BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723

Informations de publication

Date de publication:
23 09 2021
Historique:
received: 30 06 2021
accepted: 04 08 2021
entrez: 23 9 2021
pubmed: 24 9 2021
medline: 16 10 2021
Statut: epublish

Résumé

The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment. Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part. Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies. Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Sections du résumé

BACKGROUND
The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment.
METHODS
Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part.
RESULTS
Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I
CONCLUSIONS
Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies.
TRIAL REGISTRATION
Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Identifiants

DOI: 10.1186/s12916-021-02086-2 PMID: 34551765 PMC: PMC8459527
pubmed: 34551765
doi: 10.1186/s12916-021-02086-2
pii: 10.1186/s12916-021-02086-2
pmc: PMC8459527
doi:

Banques de données

ClinicalTrials.gov
['NCT01925625']

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

218

Subventions

Organisme : Medical Research Council
ID : G1002325
Pays : United Kingdom

Informations de copyright

© 2021. The Author(s).

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Auteurs

Vichithranie W Madurasinghe (VW)

Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7L, UK.

Peter Bower (P)

NIHR School for Primary Care Research, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK. peter.bower@manchester.ac.uk.
ORCID: 0000-0001-9558-3349

Sandra Eldridge (S)

Centre for Clinical Trials and Methodology, Institute of Population Health Sciences, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.

David Collier (D)

Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, EC1M 6BQ, UK.

Jonathan Graffy (J)

Arbury Road Surgery 114, Arbury Road, Cambridge, CB4 2JG, UK.

Shaun Treweek (S)

Health Services Research Unit, University of Aberdeen, Room 306, 3rd Floor, Health Sciences Building Foresterhill, Aberdeen, AB25 2ZD, UK.

Peter Knapp (P)

Department of Health Sciences, University of York & the Hull York Medical School, York, UK.

Adwoa Parker (A)

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Jo Rick (J)

National Institute of Health Research School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.

Chris Salisbury (C)

Centre for Academic Primary Care, Department of Population Health Sciences, Bristol Medical School University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.

Mei See Man (MS)

Norwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.

David Torgerson (D)

Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

Rebecca Sheridan (R)

Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

Frank Sullivan (F)

University of St. Andrews North Haugh, St. Andrews, Fife, KY16 9T, UK.

Sarah Cockayne (S)

Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

Charlotte Dack (C)

Department of Psychology, University of Bath, Bath, BA2 7AY, UK.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Can we achieve better recruitment by providing...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Probabilité › Odds ratio › Can we achieve better recruitment by providing...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Sélection de patients › Can we achieve better recruitment by providing...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Can we achieve better recruitment by providing...