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

项目概要/摘要 尽管越来越多的人主张将健康数据提供给患者作为临床护理的标准， 研究数据通常不与参与者共享，尽管这些数据有可能改善护理和真实的- 世界成果。文献表明，大多数参与者希望获得研究成果。不过有 关于如何在道德上和有效地返还个人非遗传研究，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主要限于 基因组学，很少有研究着眼于更常见的，潜在的可操作性，患者报告 在临床研究过程中收集的结果（PRO）。在这篇补充文章中，我们重点关注这些 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。拟议的项目是为期一年的生物伦理学 补充，利用正在进行的R 01资助的基于社区的姑息治疗的务实试验， 患有帕金森病（PD）和路易体痴呆（一种NIH指定的阿尔茨海默病）的人 相关疾病; ADRD）。该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，以及完成最终数据收集的患者和家庭护理合作伙伴， 父母审判通过提供专业人员，研究人员可能会增加参与 参与者，传达对参与者自主权的尊重，并赋予参与者个人决策权 流程.也有风险，如增加焦虑或痛苦，提供信息， 可诉，干扰患者与社区提供者的关系，污染研究 如果这些信息导致健康行为的变化，结果会如何。还有隐私方面的问题， 病人和家庭护理伙伴之间以及临床医生和护理伙伴之间共享信息。 因此，了解什么、何时以及如何分享内部回报率至关重要。该补充的具体目标是 目的：1）从关键利益相关者（患者、护理人员、社区临床医生和研究者）那里获取信息， 了解关于返回患者和患者报告结局的观点、顾虑和偏好， 混合方法;以及，2）让生物伦理学家，姑息治疗研究人员， 社区临床医生、护理伙伴和PD患者，对关键发现进行回顾， 关于专业人员返回的初步建议。通过这项研究吸取的经验教训将告知我们 PD和姑息治疗研究的未来工作，包括建立纳入返回患者的能力 以符合伦理的方式向参与者报告结局（PRO）结果。我们预计这项工作将有 对姑息治疗和神经病学以外的临床研究的影响，并可能为未来的研究奠定基础。 希望在伦理上将PRO和其他非基因组IRR的回报整合到试验设计中的研究。

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.