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.
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 6-26 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.
Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n=1,758). 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. Among children and young people recruited to host trials, trial retention rates did not differ according to intervention allocation.
Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores or trial retention. Combined MMI+PIS instead of PIS had no effect on recruitment or retention rates. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.