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Investigating the use of a one-page infographic to improve recruitment and retention to the BASIL+ randomised controlled trial: A Study Within a Trial (SWAT).

作者信息

Atha Lucy, Ryde Eloise, Burke Lauren, Brady Samantha, Baird Kalpita, Shearsmith Leanne, Peck Charlie, Henry Andrew, Fairhurst Caroline, Wang Han-I, Bailey Della, Woodhouse Rebecca, McMillan Dean, Gilbody Simon, Ekers David, Littlewood Elizabeth

机构信息

Department of Health Sciences, University of York, York, United Kingdom.

Tees, Esk and Wear Valleys NHS FT, Research & Development, Flatts Lane Centre, Middlesbrough, United Kingdom.

出版信息

PLoS One. 2025 Sep 3;20(9):e0320821. doi: 10.1371/journal.pone.0320821. eCollection 2025.


DOI:10.1371/journal.pone.0320821
PMID:40901811
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12407392/
Abstract

BACKGROUND: Low participant recruitment and retention rates are a significant barrier to successful Randomised Controlled Trials (RCTs). A Study Within A Trial (SWAT) is an effective way to explore which trial delivery methods may be useful for improving participant recruitment and retention rates. Infographics are a useful information delivery tool that may improve participants' understanding of the trial and thus improve recruitment or retention rates. This SWAT was embedded within the Behavioural Activation in Social Isolation (BASIL+) RCT. BASIL+ was delivered during the Covid-19 pandemic and evaluated the clinical and cost-effectiveness of a brief psychological intervention (Behavioural Activation) to mitigate depression and loneliness in older adults with multiple long-term health conditions. METHODS: Twelve research sites were randomly allocated 1:1 to either the SWAT intervention group (participant information included a one-page infographic) or the SWAT control group (participant information did not include a one-page infographic). The primary outcome was the recruitment rate to the BASIL+ trial. The secondary outcomes were the number of expressions of interest in the trial and the follow-up retention rate at 3 months post-randomisation. Results were compared for each group using a mixed-effect logistic regression model with trial site as a random effect. The cost-effectiveness of the SWAT intervention was also evaluated. RESULTS: Despite a small additional cost (£0.13) per participant, there was no evidence that participant recruitment, expressions of interest or retention was significantly affected by the inclusion of the one-page infographic. CONCLUSION: Our results suggest that the inclusion of an infographic alongside the participant information sheet may not be the best way to improve recruitment and retention rates for RCTs. However, infographics continue to be effective tools for information delivery in healthcare settings, and further research is needed to explore their use in RCTs.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b8ec/12407392/ec684a735099/pone.0320821.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b8ec/12407392/ec684a735099/pone.0320821.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b8ec/12407392/ec684a735099/pone.0320821.g001.jpg

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本文引用的文献

[1]
Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.

Lancet Healthy Longev. 2024-2

[2]
Can we mitigate the psychological impacts of social isolation using behavioural activation? Long-term results of the UK BASIL urgent public health COVID-19 pilot randomised controlled trial and living systematic review.

Evid Based Ment Health. 2022-12

[3]
Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial.

Contemp Clin Trials Commun. 2022-6-2

[4]
Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.

PLoS One. 2022-3-24

[5]
Non-randomised evaluations of strategies to increase participant retention in randomised controlled trials: a systematic review.

Syst Rev. 2020-9-29

[6]
Investigating modifications to participant information materials to improve recruitment into a large randomized trial.

Trials. 2019-12-5

[7]
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study.

Trials. 2019-10-15

[8]
Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study.

Trials. 2018-3-1

[9]
No difference in knowledge obtained from infographic or plain language summary of a Cochrane systematic review: three randomized controlled trials.

J Clin Epidemiol. 2017-12-18

[10]
An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.

Trials. 2017-3-28

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