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

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Date
23/09/2021
Author
Madurasinghe, Vichithranie W.
Bower, Peter
Eldridge, Sandra
Collier, David
Graffy, Jonathan
Treweek, Shaun
Knapp, Peter
Parker, Adwoa
Rick, Jo
Salisbury, Chris
Man, Mei See
Torgerson, David
Sheridan, Rebecca
Sullivan, Frank
Cockayne, Sarah
Dack, Charlotte
Keywords
Recruitment
Information
User-testing
Research methodology
Randomised controlled trial
SWATs
RM Therapeutics. Pharmacology
Medicine(all)
3rd-NDAS
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Abstract
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, I2 = 0%). 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.
Citation
Madurasinghe , V W , Bower , P , Eldridge , S , Collier , D , Graffy , J , Treweek , S , Knapp , P , Parker , A , Rick , J , Salisbury , C , Man , M S , Torgerson , D , Sheridan , R , Sullivan , F , Cockayne , S & Dack , C 2021 , ' Can we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets ' , BMC Medicine , vol. 19 , 218 . https://doi.org/10.1186/s12916-021-02086-2
Publication
BMC Medicine
Status
Peer reviewed
DOI
https://doi.org/10.1186/s12916-021-02086-2
ISSN
1741-7015
Type
Journal article
Rights
Copyright © The Author(s). 2021. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
Description
Funding: The authors wish to acknowledge the MRC Methodology Research Programme which funds this research (MRC grant reference: G1002325).
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  • University of St Andrews Research
URI
http://hdl.handle.net/10023/24010

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