Health Sciences, University of York, York, UK.
Health Sciences and the Hull York Medical School, University of York, York, UK
BMJ Open. 2022 Jul 13;12(7):e057508. doi: 10.1136/bmjopen-2021-057508.
To evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.
Study Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.
Emergency departments in 23 UK hospitals.
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.
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).
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.
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%).
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.
ISRCTN73136092 and ISRCTN13955395.
评估数字多媒体信息（MMI）对试验招募、保留、患者参与决策和可接受性的影响，与印刷信息相比。
在儿童前臂骨折恢复评估（FORCE）研究中，采用随机聚类分配的试验内研究。
英国 23 家医院的急诊部门。
1409 名年龄在 4-16 岁的患有环状（扣状）骨折的儿童及其父母/监护人。儿童平均年龄为 9.2 岁，41.0%为女性，77.4%为白种人，90.0%以英语为第一语言。
参与者及其父母/监护人通过平板电脑上的多媒体（包括动画视频、头部视频和文本（在需要时为可读性和年龄适宜性进行修订））（MMI 组，n=681）或印刷的参与者信息表（PIS 组，n=728）接受试验信息。
主要结局指标为 FORCE 的招募率。次要结局指标为决策问卷调查（九个李克特量表项目，综合和个别分析）、三个“自由文本”问题（得出主观评价）和试验保留率。
MMI 略微增加了招募率，但无统计学意义：MMI 组招募 475 名（69.8%）参与者；PIS 组招募 484 名（66.5%）（OR=1.35；95%CI 0.76-2.40，p=0.31）。共回收并分析了 324 份问卷。总决策问卷评分无差异：调整后的平均差异为 0.05（95%CI-1.23 至 1.32，p=0.94）。MMI 组更有可能报告信息“非常容易理解”（89 名，57.8% vs 67 名，39.4%；Z=2.60，p=0.01），并能识别解释得很好的信息（96 名，62.3% vs 71 名，41.8%）。FORCE 的几乎所有招募者在 6 周时都保留了下来，两组信息的保留率无差异：MMI（473；99.6%）；PIS（481；99.4%）。
MMI 并未增加 FORCE 试验的招募或保留率，但参与者认为多媒体更容易理解，并且更有可能给予积极评价。
ISRCTN73136092 和 ISRCTN13955395。
