{
  "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.\n\nMethods: 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.\n\nResults: 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).\n\nConclusions: 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.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 20,
  "authors": [
    {
      "name": "Omar Kouli"
    },
    {
      "name": "Jane M. Blazeby"
    },
    {
      "name": "Nicola Mills"
    },
    {
      "name": "Kenneth A. McLean"
    },
    {
      "name": "Sivesh K. Kamarajah"
    },
    {
      "name": "Rohan R. Gujjuri"
    },
    {
      "name": "Simon Bach"
    },
    {
      "name": "Daniel M. Baker"
    },
    {
      "name": "Aneel Bhangu"
    },
    {
      "name": "Ruth Blanco-Colino"
    },
    {
      "name": "Afsana Elanko"
    },
    {
      "name": "Marcus Jepson"
    },
    {
      "name": "Emily C. Mills"
    },
    {
      "name": "Victoria Murray"
    },
    {
      "name": "Dmitri Nepogodiev"
    },
    {
      "name": "Francesco Pata"
    },
    {
      "name": "Peter Pockney"
    },
    {
      "name": "Leila Rooshenas"
    },
    {
      "name": "Alessandro Sgrò"
    },
    {
      "name": "James C. Glasbey"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/aw36as5e6cvpe.bib",
  "cited_by": 0,
  "doi": "10.1186/s13063-026-09863-5",
  "fulltext_url": null,
  "id": "aw36as5e6cvpe",
  "issns": [
    "1745-6215"
  ],
  "landing_url": "https://link.springer.com/article/10.1186/s13063-026-09863-5",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2739|Ethics in Clinical Research"
    ]
  ],
  "openalex": "W7221809289",
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-14",
  "publisher": "Springer Science and Business Media LLC",
  "ris": "https://research.draconitic.com/paper/aw36as5e6cvpe.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:20:30Z",
      "native_id": "10.1186/s13063-026-09863-5",
      "source": "crossref",
      "url": "https://link.springer.com/article/10.1186/s13063-026-09863-5"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2739|Ethics in Clinical Research",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Long-term participant-reported outcomes after the GeneRAtiNg StUdent recruiters for randomised triaLs (GRANULE) course: a longitudinal, survey-based, international cohort study",
  "title_text": "Long-term participant-reported outcomes after the GeneRAtiNg StUdent recruiters for randomised triaLs (GRANULE) course: a longitudinal, survey-based, international cohort study",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:20:30Z",
  "url": "https://research.draconitic.com/paper/aw36as5e6cvpe",
  "venue": "Trials",
  "versions": []
}