Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

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Moe-Byrne, Thirimon, Knapp, Peter, Perry, Daniel, Achten, Juul, Spoors, Louise, Appelbe, Duncan, Roche, Jenny, Martin-Kerry, Jacqueline M., Sheridan, Rebecca and Higgins, Steven (2022) Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT). BMJ Open, 12 (7). ISSN 2044-6055

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Abstract

Objectives: To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.  Design: Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study. Setting: Emergency departments in 23 UK hospitals. Participants 1409 children aged 4-16 years attending with a torus (buckle) fracture, and their parents/guardian. Children's mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language. Interventions Participants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728). Outcome measures: Primary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three free text' questions (deriving subjective evaluations) and trial retention.  Results: MMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI-1.23 to 1.32, p=0.94). The MMI group was more likely to report the information € very easy' to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks' timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).  Conclusions: MMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively. Trial registration number ISRCTN73136092 and ISRCTN13955395.

Item Type: Article
Uncontrolled Keywords: hand & wrist,medical ethics,paediatric a&e and ambulatory care,statistics & research methods,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
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Depositing User: LivePure Connector
Date Deposited: 26 Jan 2026 17:30
Last Modified: 27 Jan 2026 13:30
URI: https://ueaeprints.uea.ac.uk/id/eprint/101733
DOI: 10.1136/bmjopen-2021-057508

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