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Background <p>Randomised controlled trial recruitment is challenging. Recruitment and informed consent processes require provision of a participant information sheet (PIS). Visual presentation of information, in the form of an infographic, is increasingly utilised, despite limited effectiveness evidence. This Study Within A Trial (SWAT) assessed if a PIS plus an infographic increases recruitment relative to PIS alone.</p> Methods <p>A two-arm cluster randomised SWAT (1:1 allocation ratio at the site level), embedded within the SWHSI-2 trial. The primary outcome was recruitment rate analysed via mixed effects logistic regression using minimisation factors as fixed effects and site as a random effect. Secondary outcomes were the proportion of participants screened but not recruited, retention rate, and cost.</p> Results <p>All 29 SWHSI-2 sites were randomised to the SWAT (14 intervention; 15 control). Following SWAT implementation, 1634 patients were screened, with 1068 patients eligible (PIS plus infographic, 662/1008 [65.7%]; PIS only, 406/626 [64.9%]) and 585 randomised into the SWHSI-2 trial (PIS plus infographic, 342/662 [51.7%]; PIS only, 243/406 [59.9%]; (OR 0.61, 95% CI 0.23 to 1.62, <i>p</i> = 0.32). More patients were screened but not randomised in the intervention group compared to the control group (<i>n</i> = 666, 66.1% vs <i>n</i> = 383, 61.2%). Meta-analysis of two studies found the infographic intervention reduced participant recruitment (OR = 0.61, 95% CI 0.31 to 1.23).</p> Conclusion <p>Two SWAT replications have found that including an infographic alongside a PIS does not increase participant recruitment, but estimates were imprecise. Replications in other populations and exploration of infographic content and design remain warranted.</p>

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SWAT 116: the effectiveness of an infographic to improve trial recruitment—a randomised study within a trial (SWAT)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月7日

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  • C. E. Arundel,
  • F. Wiggins,
  • K. Baird,
  • C. Fairhurst,
  • A. Mott,
  • S. Swan,
  • J. Wilkinson,
  • S. Zahra,
  • I. Chetter

摘要

Background

Randomised controlled trial recruitment is challenging. Recruitment and informed consent processes require provision of a participant information sheet (PIS). Visual presentation of information, in the form of an infographic, is increasingly utilised, despite limited effectiveness evidence. This Study Within A Trial (SWAT) assessed if a PIS plus an infographic increases recruitment relative to PIS alone.

Methods

A two-arm cluster randomised SWAT (1:1 allocation ratio at the site level), embedded within the SWHSI-2 trial. The primary outcome was recruitment rate analysed via mixed effects logistic regression using minimisation factors as fixed effects and site as a random effect. Secondary outcomes were the proportion of participants screened but not recruited, retention rate, and cost.

Results

All 29 SWHSI-2 sites were randomised to the SWAT (14 intervention; 15 control). Following SWAT implementation, 1634 patients were screened, with 1068 patients eligible (PIS plus infographic, 662/1008 [65.7%]; PIS only, 406/626 [64.9%]) and 585 randomised into the SWHSI-2 trial (PIS plus infographic, 342/662 [51.7%]; PIS only, 243/406 [59.9%]; (OR 0.61, 95% CI 0.23 to 1.62, p = 0.32). More patients were screened but not randomised in the intervention group compared to the control group (n = 666, 66.1% vs n = 383, 61.2%). Meta-analysis of two studies found the infographic intervention reduced participant recruitment (OR = 0.61, 95% CI 0.31 to 1.23).

Conclusion

Two SWAT replications have found that including an infographic alongside a PIS does not increase participant recruitment, but estimates were imprecise. Replications in other populations and exploration of infographic content and design remain warranted.