Long-term participant-reported outcomes after the GeneRAtiNg StUdent recruiters for randomised triaLs (GRANULE) course: a longitudinal, survey-based, international cohort study

Abstract Background Patient recruitment into clinical trials remains a major challenge and recruitment consultations play a key role in a patient’s decision to provide their informed consent. Currently, training in this important skill is absent from medical school and training curricula. This study aimed to evaluate the long-term participant-reported outcomes of a training course for medical students and junior doctors to provide information and informed consent for trial randomisation and recruitment. Methods The ‘GeneRAtiNg StUdent recruiters for randomised triaLs’ (GRANULE) course provides practical, evidence-based skills in conveying equipoise, balancing treatment options, and explaining randomisation during a trial recruitment consultation. Attendees were asked to complete a survey about their understanding of key concepts and experience in trial recruitment at two timepoints: (1) immediately after the course and (2) greater than 1 year after course completion. The survey asked for views about attendees’ confidence in communicating equipoise, randomisation, exploring patient preferences, and gaining consent in clinical trials. Response categories utilised five-point Likert scales. Paired t -tests were used to explore associations between survey responses. We also explored participants’ reported perceptions of the course’s relevance to their personal and professional development using open-ended questions. Data were coded and interpreted through thematic content analysis. Results Between 2016 and 2020, eight face-to-face courses were delivered in four countries to 98 medical students and junior doctors from 11 countries. The questionnaire response rate on long-term follow-up was 59.1% ( n = 58/98); median follow-up of 3.0 years (IQR: 2.0 to 4.0). Confidence in gaining (mean difference: −0.19, 95% CI: −0.45 to 0.078, p = 0.16) and documenting valid consent for trial involvement (mean difference: −0.063, 95% CI: −0.46 to 0.34, p = 0.75) was maintained on follow-up, while there were small reductions in respondents’ reported confidence in conveying clinical equipoise (mean difference: −0.53, 95% CI: −0.83 to −0.23, p = 0.001) over time. Over a third of respondents (36.2%, n = 21/58) had been involved in clinical trials since attending the course, 81.0% ( n = 17/21) of whom had experience of recruitment (median: 10.0 patients recruited, IQR: 3.0 to 24.0). Conclusions Among follow-up respondents, the GRANULE course was associated with sustained participant-reported confidence in several trial recruitment domains and substantial subsequent involvement in clinical trials. Structured recruiter training may help address an important gap in medical curricula, although comparator-based studies are needed to determine causal effects.