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

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: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. 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: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. 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: = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: = 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 templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; = 0.03; = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of 'information was easy to understand' ( = 3.03; = 0.003) and 'I had confidence in decision-making' ( = 2.00; = 0.044) than printed participant information sheet-only provision.

Limitations: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.

Conclusions: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.

Future Work: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.

Study Registration: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).

Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in ; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.