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)

TY - JOUR

T1 - Does digital, multimedia information increase recruitment and retention in a children's wrist fracture treatment trial, and what do people think of it?

T2 - A randomised controlled Study Within A Trial (SWAT)

AU - Moe-Byrne, Thirimon

AU - Knapp, Peter

AU - Perry, Daniel

AU - Achten, Juul

AU - Spoors, Louise

AU - Appelbe, Duncan

AU - Roche, Jenny

AU - Martin-Kerry, Jacqueline M

AU - Sheridan, Rebecca

AU - Higgins, Steven

N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/7/13

Y1 - 2022/7/13

N2 - 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.

AB - 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.

KW - Child

KW - Cost-Benefit Analysis

KW - Female

KW - Humans

KW - Male

KW - Multimedia

KW - Parents

KW - Radius Fractures

KW - Research Design

KW - Surveys and Questionnaires

KW - Wrist

U2 - 10.1136/bmjopen-2021-057508

DO - 10.1136/bmjopen-2021-057508

M3 - Article

C2 - 35831055

SN - 2044-6055

VL - 12

JO - BMJ Open

JF - BMJ Open

IS - 7

M1 - e057508

ER -