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)
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 Recover...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e057508.full |
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| author | Jacqueline M Martin-Kerry Peter Knapp Steven Higgins Rebecca Sheridan Juul Achten Duncan Appelbe Louise Spoors Thirimon Moe-Byrne Daniel Perry Jenny Roche |
| author_facet | Jacqueline M Martin-Kerry Peter Knapp Steven Higgins Rebecca Sheridan Juul Achten Duncan Appelbe Louise Spoors Thirimon Moe-Byrne Daniel Perry Jenny Roche |
| author_sort | Jacqueline M Martin-Kerry |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-eca2d66ae54d4f26b645a152e4b3d2fc |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-eca2d66ae54d4f26b645a152e4b3d2fc2025-01-31T15:30:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-057508Does 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)Jacqueline M Martin-Kerry0Peter Knapp1Steven Higgins2Rebecca Sheridan3Juul Achten4Duncan Appelbe5Louise Spoors6Thirimon Moe-Byrne7Daniel Perry8Jenny Roche9Health Sciences, University of York, York, UKHealth Sciences and the Hull York Medical School, University of York, York, UKSchool of Education, University of Durham, Durham, UKDepartment of Health Sciences, University of York, York, North Yorkshire, UKNDORMS, University of Oxford, Oxford, UKNDORMS, University of Oxford, Oxford, UKNDORMS, University of Oxford, Oxford, UKHealth Sciences, University of York, York, UKNDORMS, University of Oxford, Oxford, UKHealth Sciences, University of York, York, UKObjectives 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.https://bmjopen.bmj.com/content/12/7/e057508.full |
| spellingShingle | Jacqueline M Martin-Kerry Peter Knapp Steven Higgins Rebecca Sheridan Juul Achten Duncan Appelbe Louise Spoors Thirimon Moe-Byrne Daniel Perry Jenny Roche 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/7/e057508.full |
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