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“The Truth Is, We Must Miss Some”: A Qualitative Study of the Patient Eligibility Screening Process, and Automation Perspectives, for Cancer Clinical Trials

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  • Additional Information
    • Contributors:
      Laboratoire d'Informatique Médicale et Ingénierie des Connaissances en e-Santé (LIMICS); Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Sorbonne Paris Nord; Laboratoire Traitement du Signal et de l'Image (LTSI); Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM); Hôpital Henri Mondor; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12); CHU Tenon AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Laboratoire Génie Industriel (LGI); CentraleSupélec-Université Paris-Saclay; ALR was supported by a grant ‘Bourse de La Société Française d’Oto-Rhino-Laryngologie et de Chirurgie de la Face et du Cou, année 2022’
    • Publication Information:
      CCSD
      Wiley
    • Publication Date:
      2024
    • Collection:
      Université Paris 13: HAL
    • Abstract:
      International audience ; Background: Recruitment of cancer patients into clinical trials (CTs) is a challenge. We aimed to explore how patient eligibility assessment is conducted in practice, what factors support or hinder this process, and to assess the potential usefulness of Clinical Trial Recruitment Support Systems (CTRSS) for patient-to-trial matching.Methods: We conducted semi-structured interviews in France with healthcare professionals involved in cancer CTs and experts on trial recruitment. We focused on the stages in-between trial feasibility, and patient information and consent. Interviews were recorded, and the transcripts were analyzed thematically. We used the Systems Engineering Initiative for Patient Safety (SEIPS) 2.0 framework to organize our results.Results: We interviewed 25 participants. We identified common steps for cancer patient eligibility assessment: prescreening under medical supervision, followed by the validation of patient-trial matching based on manual chart review. This process built on rich interactions between clinicians, other professionals (clinical research assistants, data scientists, medical coding experts), and patients. Technological factors, mainly related to data infrastructure (both for patient data and trial data), and organizational factors (research culture, incentives, formal and informal research networks) mediated the performance of the recruitment process. Participants had mixed feelings towards CTRSSs; they welcomed automated pre-screening but insisted on manual verification. Given the necessary collaborative nature of multisite trials, coordinated efforts to support a common data infrastructure could be helpful.Conclusions: Material, organizational, and human factors affect cancer patient eligibility assessment for CTs. Patient-to-trial matching tools bear potential, but good understanding of the ecosystem, including stakeholders' motivations, is a prerequisite.
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/39624972; PUBMED: 39624972
    • Accession Number:
      10.1002/cam4.70466
    • Online Access:
      https://hal.science/hal-04816308
      https://hal.science/hal-04816308v1/document
      https://hal.science/hal-04816308v1/file/Cancer%20Medicine%20-%202024%20-%20La%20Rosa%20-%20The%20Truth%20Is%20We%20Must%20Miss%20Some%20A%20Qualitative%20Study%20of%20the%20Patient%20Eligibility.pdf
      https://doi.org/10.1002/cam4.70466
    • Rights:
      http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess
    • Accession Number:
      edsbas.76E5138B