The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs

• Published in: Health and social care delivery research 2023-11, Vol.11 (24), p.1-112
• Main Authors: Knapp, Peter, Martin-Kerry, Jacqueline, Moe-Byrne, Thirimon, Sheridan, Rebecca, Coleman, Elizabeth, Roche, Jenny, Young, Bridget, Higgins, Steven, Preston, Jennifer, Bower, Peter, Gamble, Carrol, Stones, Catherine
• Format: Article
• Language: English
• Subjects: adolescents; assent; children; co-design; consent; decision-making; multimedia information; participant information sheet; research ethics; trial; video
• ISSN: 2755-0060; 2755-0079
• DOI: 10.3310/HTPM3841

Background The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives The study objectives were as follows: to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets. Design Two-phase study: multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people. Setting United Kingdom trials involving patients aged under 18. Participants Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials). Interventions Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets. Main outcome measures Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis. Results Phase 1 generated two multimedia information resource