Finding the Ethical Path Forward: A Bioethical and Stakeholder-driven Investigation on the Sharing of Palliative-related Survey Results with Patients, Caregivers and Community Clinicians

项目摘要/摘要 尽管越来越多的人倡导将健康数据提供给患者作为临床护理的标准，但临床 研究数据通常不会与参与者共享，尽管这些数据有可能改善医疗保健和实时- 世界结果。文献表明，大多数参与者都希望收到研究成果。然而，还有 对于如何在道德上和有效地返回个人非基因研究，没有明确的指导或共识 结果(IRR)。值得注意的是，提高临床研究透明度的努力在很大程度上限于 基因组学，很少有研究关注更常见的，也是潜在的可操作的，患者报告 临床研究过程中收集的结果(PRO)。在本增刊中，我们重点介绍这些产品的退货 患者从以下角度向患者、家庭护理伙伴和社区临床医生报告的结果 这些关键利益攸关方，以及研究人员和生物伦理学。建议的项目是为期一年的生命伦理学 利用R01资助的正在进行的社区姑息治疗的务实试验的补充 患有帕金森氏病(PD)和路易体痴呆(NIH指定的阿尔茨海默病)的人 相关障碍；ADRD)。本补充的利益相关者参与者将包括我们的社区临床医生 合作伙伴，以及已完成最终数据收集的患者和家庭护理合作伙伴 亲子审判。通过提供专业人员，研究人员可能会增加对 参与者，表达对参与者自主性的尊重，赋予参与者个人决策权力 流程。也有风险，例如增加焦虑或痛苦，提供不是 可采取行动，干预患者与社区提供者的关系，并污染研究 结果如果这些信息导致健康行为的改变。还有一些隐私方面的问题，比如 信息在患者和家庭护理伙伴之间以及临床医生和护理伙伴之间共享。 因此，了解什么、何时以及如何共享内部收益率是至关重要的。本补充文件的具体目的是 要：1)征求关键利益相关者(患者、护理人员、社区临床医生和调查人员)的意见，以 了解对返回患者和护理者报告的结果的看法、担忧和偏好 混合方法；以及，2)聘请一个由生物伦理学家、姑息治疗研究人员组成的跨学科委员会， 社区临床医生、护理伙伴和帕金森病患者在回顾关键发现方面取得进展 关于职业球员回归的初步建议。通过这项研究获得的经验教训将为我们的 未来在PD和姑息治疗研究方面的工作，包括建设纳入回归患者的能力 以合乎道德的方式向参与者报告结果。我们预计这项工作将会有 对姑息治疗和神经学以外的临床研究的影响，并可能为未来奠定基础 希望在伦理上将专业人士的返还和其他非基因组IRR纳入试验设计的研究。

PROJECT SUMMARY/ABSTRACT Despite growing advocacy to make health data available to patients a standard in clinical care, clinical research data are often not shared with participants despite the potential for this data to improve care and real- world outcomes. The literature shows that most participants want to receive research results. However, there is no clear guidance or consensus on how to ethically and effectively return individual non-genetic research results (IRR). Notably, efforts for increasing transparency in clinical research have been largely limited to genomics with few studies looking at the much more common, and potentially actionable, patient reported outcomes (PRO) collected in the course of clinical research. In this supplement, we focus on return of these patient-reported outcomes to patients, family carepartners, and community clinicians from the perspectives of these key stakeholders, as well as researchers and bioethics. The proposed project is a one-year Bioethics Supplement that leverages an ongoing R01-funded pragmatic trial of community-based palliative care for people living with Parkinson's disease (PD) and Lewy Body Dementia (an NIH-designated Alzheimer Disease Related Disorder; ADRD). Stakeholder participants for this supplement will include our community clinician partners, as well as patients and family carepartners who have completed their final data collection for the parent trial. By making available PROs, it is possible that researchers may increase engagement of participants, convey respect for participants' autonomy, and empower participants' personal decision-making processes. There are also risks, such as increasing anxiety or distress, providing information that is not actionable, interfering in the patient's relationship with their community provider, and contaminating research results if this information leads to changes in health behaviors. There are also privacy concerns regarding what information is shared between patients and family carepartners and between the clinician and the carepartner. It is thus critical to understand what, when, and how to share IRRs. The Specific Aims of this supplement are to: 1) Elicit input from key stakeholders (patients, caregivers, community clinicians, and investigators) to understand views, concerns, and preferences on returning patient- and caregiver-reported outcomes using mixed methods; and, 2) Engage an interdisciplinary committee of bioethicists, palliative care researchers, community clinicians, carepartners, and individuals with PD in a review of the key findings to develop preliminary recommendations about the return of PROs. Lessons learned through this research will inform our future work in PD and palliative care research, including building capacity to incorporate returning patient reported outcome (PRO) results to participants in an ethically sound manner. We anticipate this work will have implications for clinical research outside of palliative care and neurology and may set a foundation for future studies looking to ethically integrate return of PROs and other non-genomic IRRs into trial design.