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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)

Moe-Byrne, Thirimon; Knapp, Peter; Perry, Daniel; Achten, Juul; Spoors, Louise; Appelbe, Duncan; Roche, Jenny; Martin-Kerry, Jacqueline M; Sheridan, Rebecca; Higgins, Steven

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) Thumbnail


Authors

Thirimon Moe-Byrne

Peter Knapp

Daniel Perry

Juul Achten

Louise Spoors

Duncan Appelbe

Jenny Roche

Jacqueline M Martin-Kerry

Rebecca Sheridan



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%).

Citation

Moe-Byrne, T., Knapp, P., Perry, D., Achten, J., Spoors, L., Appelbe, D., …Higgins, S. (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), Article e057508. https://doi.org/10.1136/bmjopen-2021-057508

Journal Article Type Article
Acceptance Date Jun 17, 2022
Online Publication Date Jul 13, 2022
Publication Date 2022
Deposit Date Aug 2, 2022
Publicly Available Date Aug 2, 2022
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 12
Issue 7
Article Number e057508
DOI https://doi.org/10.1136/bmjopen-2021-057508

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Publisher Licence URL
http://creativecommons.org/licenses/by-nc/4.0/

Copyright Statement
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.







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