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dc.contributor.authorMadurasinghe, Vichithranie W.
dc.contributor.authorBower, Peter; orcid: 0000-0001-9558-3349; email: peter.bower@manchester.ac.uk
dc.contributor.authorEldridge, Sandra
dc.contributor.authorCollier, David
dc.contributor.authorGraffy, Jonathan
dc.contributor.authorTreweek, Shaun
dc.contributor.authorKnapp, Peter
dc.contributor.authorParker, Adwoa
dc.contributor.authorRick, Jo
dc.contributor.authorSalisbury, Chris
dc.contributor.authorMan, Mei See
dc.contributor.authorTorgerson, David
dc.contributor.authorSheridan, Rebecca
dc.contributor.authorSullivan, Frank
dc.contributor.authorCockayne, Sarah
dc.contributor.authorDack, Charlotte
dc.date.accessioned2021-09-23T15:36:50Z
dc.date.available2021-09-23T15:36:50Z
dc.date.issued2021-09-23
dc.date.submitted2021-06-30
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/625919/additional-files.zip?sequence=2
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/625919/12916_2021_Article_2086.pdf?sequence=3
dc.identifierhttps://chesterrep.openrepository.com/bitstream/handle/10034/625919/12916_2021_Article_2086_nlm.xml?sequence=4
dc.identifier.citationBMC Medicine, volume 19, issue 1, page 218
dc.identifier.urihttp://hdl.handle.net/10034/625919
dc.descriptionFrom Springer Nature via Jisc Publications Router
dc.descriptionHistory: received 2021-06-30, registration 2021-08-04, accepted 2021-08-04, pub-electronic 2021-09-23, online 2021-09-23, collection 2021-12
dc.descriptionPublication status: Published
dc.descriptionFunder: Medical Research Council; doi: http://dx.doi.org/10.13039/501100000265; Grant(s): G1002325
dc.description.abstractAbstract: 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)
dc.languageen
dc.publisherBioMed Central
dc.rightsLicence for this article: http://creativecommons.org/licenses/by/4.0/
dc.sourceeissn: 1741-7015
dc.subjectResearch Article
dc.subjectRecruitment
dc.subjectInformation
dc.subjectUser-testing
dc.subjectResearch methodology
dc.subjectRandomised controlled trial
dc.subjectSWATs
dc.titleCan we achieve better recruitment by providing better information? Meta-analysis of ‘studies within a trial’ (SWATs) of optimised participant information sheets
dc.typearticle
dc.date.updated2021-09-23T15:36:49Z
dc.date.accepted2021-08-04


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