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

Abstract

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.

Reasons for unsuccessful recruitment of children with atopic dermatitis in primary care in the Netherlands to a cohort study with an embedded pragmatic, randomised controlled open-label trial: a survey

“…A recent study by Knapp et al found that multimedia information only (eg, animations and videos) increased the trial recruitment rate in children and young people compared with participant information sheets for trial recruitment. 12 We used printed participant information only. However, the children in our study were already participating in a cohort study but maybe would have been more able and more willing to participate in the trial if multimedia information had been given.…”

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK

“…That study showed that EAs improved participants’ knowledge about and attitudes toward clinical trials and were more effective than any of the brochures, especially for those individuals with low motivation and low literacy to comprehend health-related information. Small standalone and embedded trials and a meta-analysis have also shown that the use of multimedia information can make information about trials easier to understand and may increase trial recruitment rates [ 12 – 15 ]. However, a recent meta-analysis of 5 studies within a trial (SWATs) showed that multimedia alongside written information did not improve trial recruitment rates [ 16 ].…”