• Peter Knapp, Thirimon Moe-Byrne, Jacqueline Martin-Kerry, Rebecca Sheridan, Jenny Roche, Elizabeth Coleman, Peter Bower, Steven Higgins, Catherine Stones, Jonathan Graffy, Jenny Preston, Carrol Gamble, Bridget Young, Daniel Perry, Annegret Dahlmann-Noor, Mohamed Abbas, Payal Khandelwal, Siobhan Ludden, Augusto Azuara-Blanco, Emma McConnell, Nicky Mandall, Anna Lawson, Chris A Rogers, SmarttHelena J MHJMTrials Unit, University of Bristol, Bristol, UK., Rachael Heys, Simon R Stones, Danielle Horton Taylor, Sophie Ainsworth, and Jenny Ainsworth.
• Department of Health Sciences & the Hull York Medical School, University of York, York, UK. peter.knapp@york.ac.uk.
• Bmc Med. 2023 Jul 4; 21 (1): 244244.

BackgroundRandomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making.MethodsWe undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis.ResultsData from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation.ConclusionsProviding MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.© 2023. The Author(s).

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