Journal Article

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs

Ainsworth, Sophie, Ludden, Siobhan, Stones, Simon R., Ainsworth, Jenny, Lawson, Anna, Perry, Daniel, Rogers, Chris A., Roche, Jenny, Young, Bridget, Graffy, Jonathan, Sheridan, Rebecca, Heys, Rachael, Dahlmann-Noor, Annegret, Bower, Peter, Smartt, Helena J. M., Knapp, Peter, Gamble, Carrol, Moe-Byrne, Thirimon, Mandall, Nicky, McConnell, Emma, Abbas, Mohamed, Higgins, Steven, Khandelwal, Payal, Azuara-Blanco, Augusto, Preston, Jenny, Martin-Kerry, Jacqueline, Coleman, Elizabeth, Stones, Catherine, Taylor, Danielle Horton

2023

Overview

Background Randomised 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. Methods We 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. Results Data 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. Conclusions Providing 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adolescents / Biomedicine / Child / Child health services / Children / Children & youth / Clinical trials / Consent / Decision making / Health aspects / Humans / Management / Medical research / Medicine / Medicine & Public Health / Meta-analysis / Multimedia / Multimedia information / Parents & parenting / Participant observation / Patient Selection / Randomization / Randomized Controlled Trials as Topic / Recruiting / Recruitment / Research Article / Retention / Surveys and Questionnaires / Trial / Young adults