Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens' Jury for an 'Informed Opt-Out' Approach.

An emerging approach to complement randomised controlled trial (RCT) data in the development of radiotherapy treatments is to use routinely collected 'real-world' data (RWD). RWD is the data collected as standard-of-care about all patients during their usual cancer care pathway. Given the nature of...

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Publicado en:Health Care Analysis Vol. 33; no. 2; pp. 192 - 214
Autores principales: Kapadi, Arbaz, Turner-Uaandja, Hannah, Holley, Rebecca, Wicks, Kate, Hamrang, Leila, Turner, Brian, van Staa, Tjeerd, Bowden, Catherine, Keane, Annie, Price, Gareth, Faivre-Finn, Corinne, French, David, Sanders, Caroline, Holm, Søren, Devaney, Sarah
Formato: Artículo
Publicado: Springer Nature Jun2025
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Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jun2025
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      pub: Springer Nature
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        10.1007/s10728-025-00510-9
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        atl: Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens' Jury for an 'Informed Opt-Out' Approach.
      aug:
        au:
          Kapadi, Arbaz
          Turner-Uaandja, Hannah
          Holley, Rebecca
          Wicks, Kate
          Hamrang, Leila
          Turner, Brian
          van Staa, Tjeerd
          Bowden, Catherine
          Keane, Annie
          Price, Gareth
          Faivre-Finn, Corinne
          French, David
          Sanders, Caroline
          Holm, Søren
          Devaney, Sarah
        affil:
          https://ror.org/027m9bs27 Manchester Centre for Health Psychology, Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
          https://ror.org/00he80998 Vocal, Research and Innovation Division, Manchester University NHS Foundation Trust, Manchester, UK
          https://ror.org/027m9bs27 Department of Radiotherapy Related Research, Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
          RAPID-RT PPI Advisory Group, Manchester, UK
          https://ror.org/027m9bs27 Centre for Health Informatics and Health Data Research UK North, Division of Informatics, Imaging and Data Science, School of Health Sciences, The University of Manchester, Manchester, UK
          https://ror.org/027m9bs27 Centre for Social Ethics and Policy, Division of Law, School of Social Sciences, The Faculty of Humanities, The University of Manchester, Manchester, UK
          https://ror.org/03v9efr22 Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK
          https://ror.org/027m9bs27 Centre for Primary Care and Health Services Research, NIHR Greater Manchester Patient Safety Research Collaboration, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK
      su:
        England
        Decision making
        Informed consent (Medical law)
        Communication
        Descriptive statistics
        Lung tumors
      sug:
        subj:
          Decision making
          Informed consent (Medical law)
          Communication
          England
          Descriptive statistics
          Lung tumors
      keyword:
        Citizens' jury
        Informed opt-out
        Patient consent
        Real-world data
        Citizens' jury
        Informed opt-out
        Patient consent
        Real-world data
      ab: An emerging approach to complement randomised controlled trial (RCT) data in the development of radiotherapy treatments is to use routinely collected 'real-world' data (RWD). RWD is the data collected as standard-of-care about all patients during their usual cancer care pathway. Given the nature of this data, important questions remain about the permissibility and acceptability of using RWD in routine practice. We involved and engaged with patients, carers and the public in a two-day citizens' jury to understand their views and obtain decisions regarding two key issues: (1) preferred approaches to consent for the use of RWD within the context of patients receiving radiotherapy for lung cancer in RAPID-RT and (2) how RWD use should be best communicated to patients. Individual views were polled using questionnaires at various stages of the jury, whilst group discussion activities prompted further dialogue about the rationale behind choices of consent. Key decisions obtained from the jury include: (1) an opt-out approach to consent for the use of RWD; (2) the opt-out approach to consent should be informed. Furthermore, it was advised that information and communication regarding the consent process and use of RWD should be accessible, clear and available in a variety of formats. It is important that the consent process for patient data use is underpinned by principles of autonomy and transparency with clear channels of communication between those asking for and giving consent. Moreover, the process of seeking consent from patients should be proportionate to the risks presented from their participation.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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