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Background:   Digital multimedia information (MMI) has potential for use in trial recruitment but there is little formal evaluation. The objectives were to evaluate digital MMI about a trial for its effects on recruitment, retention, participation decisions, and patients’ acceptability, compared with printed information (PIS) alone and when combined with PIS.   Methods:   SWAT (study within a trial) using random parallel-group individual allocation within the Thermic-3 trial evaluating warm versus cold cardioplegia solution during cardiac surgery.   Set in one UK hospital, participants were 147 children (0-16 years) awaiting surgery for congenital heart defects; 38% were female.     Participants and their parents/guardian received trial information via multimedia (including text, animated videos and talking-head videos) for viewing at home (MMI group; n=49), or PIS (PIS group; n=47), or both (PIS&amp;MMI group; n=51).   Primary outcome was recruitment rate to the Thermic-3 trial comparing PIS-alone and MMI-alone. Secondary outcomes were recruitment rate comparing PIS-alone and combined PIS&amp;MMI; Decision-Making Questionnaire; 3 ‘free-text’ questions (deriving subjective evaluations); trial retention.    Results:   MMI produced a 14.2% absolute increase in recruitment, which was not statistically significant: 32 (65.3%) participants were recruited from the MMI group; 24 (51.1%) from the PIS group (OR 1.80; 95% CI 0.79 to 4.10, p = 0.16); and 22 from the PIS&amp;MMI group. There was no difference in recruitment through combined PIS&amp;MMI (43.1% vs 51.1%; OR 0.73; 95% CI 0.33 to 1.61; p= 0.43). Questionnaires were returned by 17 (12%) participants and analysed descriptively. Trial retention (at 3 months) was high in all groups (72/77; 93.5% overall) and there was no difference due to information format received before participating.   Conclusions:   MMI increased recruitment to the Thermic-3 trial but the difference was not statistically significant, and the SWAT was small.   Trial registration: TRECA  ISRCTN73136092  and NI Hub for Trials Methodology Research SWAT Repository (SWAT 97). Thermic-3:  ISRCTN13467772 .

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The effects of multimedia information on recruitment and retention in a children’s cardiac surgery trial: a randomised controlled SWAT (study within a trial)