Madurasinghe, Vichithranie W, Bower, Peter, Eldridge, Sandra et al. (13 more authors) (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. pp. 1-8. ISSN 1741-7015
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. TRIAL REGISTRATION: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2021. The Author(s). |
Keywords: | Humans,Odds Ratio,Patient Selection,Research Design |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Social Sciences (York) > Centre for Reviews and Dissemination (York) The University of York > Faculty of Sciences (York) > Hull York Medical School (York) The University of York > Faculty of Sciences (York) > Health Sciences (York) The University of York > Faculty of Sciences (York) > Psychology (York) > York Neuroimaging Centre |
Depositing User: | Pure (York) |
Date Deposited: | 18 Oct 2021 11:30 |
Last Modified: | 07 Dec 2024 00:21 |
Published Version: | https://doi.org/10.1186/s12916-021-02086-2 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1186/s12916-021-02086-2 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:179354 |