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

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 and Dack, Charlotte (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, 19 (1). ISSN 1741-7015

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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, I 2 = 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).

Item Type: Article
Additional Information: Funding Information: The authors wish to acknowledge the MRC Methodology Research Programme which funds this research (MRC grant reference: G1002325). The MRC has no role in the study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication. As part of the START programme, chief investigators on trials recently funded by the National Institute of Health Research (NIHR) Health Technology Assessment Programme or on the Primary Care Research Network portfolio were invited to participate in START.
Uncontrolled Keywords: information,randomised controlled trial,recruitment,research methodology,swats,user-testing,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
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Depositing User: LivePure Connector
Date Deposited: 05 Oct 2021 01:21
Last Modified: 25 Oct 2021 00:41
URI: https://ueaeprints.uea.ac.uk/id/eprint/81543
DOI: 10.1186/s12916-021-02086-2

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