Trial reportTrials2026
SWAT 116: the effectiveness of an infographic to improve trial recruitment-a randomised study within a trial (SWAT).
Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
9 authors.
Funding
Abstract
backgroundRandomised 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.
methodsA 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.
resultsAll 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).
conclusionTwo 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.
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