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调查使用单页信息图来提高BASIL+随机对照试验的招募率和留存率:一项试验中的研究(SWAT)。

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.

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

背景

低参与者招募率和保留率是成功进行随机对照试验(RCT)的重大障碍。试验中的研究(SWAT)是一种有效的方法,可用于探索哪些试验实施方法可能有助于提高参与者招募率和保留率。信息图表是一种有用的信息传递工具,可能会提高参与者对试验的理解,从而提高招募率或保留率。这项SWAT嵌入在社交隔离中的行为激活(BASIL+)随机对照试验中。BASIL+在新冠疫情期间实施,评估了一种简短心理干预(行为激活)对减轻患有多种长期健康状况的老年人的抑郁和孤独感的临床效果和成本效益。

方法

12个研究地点被随机1:1分配到SWAT干预组(参与者信息包括一页信息图表)或SWAT对照组(参与者信息不包括一页信息图表)。主要结果是BASIL+试验的招募率。次要结果是对试验感兴趣的表达数量以及随机分组后3个月的随访保留率。使用以试验地点为随机效应的混合效应逻辑回归模型对每组结果进行比较。还评估了SWAT干预的成本效益。

结果

尽管每位参与者有少量额外成本(0.13英镑),但没有证据表明包含一页信息图表会对参与者招募、感兴趣的表达或保留率产生显著影响。

结论

我们的结果表明,在参与者信息表旁边包含信息图表可能不是提高随机对照试验招募率和保留率的最佳方法。然而,信息图表仍然是医疗环境中有效的信息传递工具,需要进一步研究以探索它们在随机对照试验中的应用。

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

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