Patient Perspectives on the Ethical Implementation of an Oncology Learning System

翻译后摘要：学习健康系统的发展正在引起环境的根本转变 NCI在其中追求其使命;理解这些变化的伦理和社会影响是 至关重要在快速学习系统（RLS）中，常规收集的患者数据驱动了 发现，这反过来又成为临床护理的自然产物。正如医学研究所所指出的， 这样的系统对于提高医疗和研究的质量，以及最终的价值， 医疗保健。随着这些系统的发展，目前临床实践、质量 护理和研究需要仔细考虑伦理影响。由于RLS还处于起步阶段， 进行研究以产生知情和考虑的患者对伦理 实施这些制度，特别是确保尊重病人自主权的方法， 隐私，包括告知参与者和数据使用治理的最佳方法， 这些系统的潜在好处。因此，我们提出了一项创新的研究， 协商民主的方法，以产生考虑和知情的意见，癌症患者， 利用一个独特的机会，在现实世界的RLS推出过程中评估患者的经验。 具体来说，美国临床肿瘤学会（ASCO）已经开发了一个真实世界的肿瘤学RLS 被称为CancerLinQ。CancerLinQ将在明年的15个先锋实践中实施， 该系统中的患者通知/同意和数据管理方法正在积极发展。我们提出 与ASCO及其先锋合作，采用两种不同的方法和目标进行实证调查 实践首先，我们将使用协商民主的方法来确定知情和 考虑了癌症患者的个人和团体对最佳治疗方法的意见和建议， 获得同意和适当使用在医疗护理过程中常规收集的信息， 一个旨在提高质量和推进研究的RLS。其次，在CancerLinQ推出后，我们将 调查经历真实世界实施该RLS的患者，以评估他们的知识 和对这个系统的看法。开展拟议工作的同时， RLS提供了一个机会，可以直接为国家学习计划的制定和实施提供信息。 系统，最终将影响成千上万的病人，它也允许考虑真实的- 生活，而不是纯粹假设的情况，以增加这些调查将 产生直接适用于其他环境的见解。调查结果将与 NCI的研究使命，因为肿瘤学学习系统正在从根本上改变研究的背景 在癌症病因、诊断、预防、治疗和生存护理的范围内。

Abstract: The development of learning health systems is causing radical transformation of the environment within which the NCI pursues its mission; understanding the ethical and social implications of these changes is of paramount importance. In rapid learning systems (RLS), routinely collected patient data drive the process of discovery, which in turn becomes a natural outgrowth of clinical care. As the Institute of Medicine has noted, such systems have substantial promise for improving the quality of care and research, and ultimately the value of health care. As such systems develop, the blurring of the current distinction between clinical practice, quality of care, and research necessitates careful consideration of ethical implications. As RLSs are in their infancy, it is critical to conduct research to generate informed and considered patient perceptions of the ethical implementation of such systems, particularly regarding ways to ensure respect for patient autonomy and privacy, including best approaches for informing participants and governance of data use, in order to realize the potential benefits of these systems. Therefore, we propose an innovative study that uses cutting edge methods of deliberative democracy to generate considered and informed opinions of cancer patients, leveraging a unique opportunity to evaluate patient experiences during the roll-out of a real-world RLS. Specifically, the American Society of Clinical Oncology (ASCO) has developed a real-world oncology RLS known as CancerLinQ. CancerLinQ is being implemented in 15 vanguard practices over the next year, and the approach to patient notification/consent and data governance in this system is actively evolving. We propose an empirical investigation with two distinct approaches and aims, in collaboration with ASCO and its vanguard practices. First, we will use a deliberative democracy approach to determine the range of informed and considered individual and group opinions and recommendations of cancer patients on the optimal approach for obtaining consent and appropriate uses of information routinely collected in the course of medical care as part of a RLS that seeks to improve quality and advance research. Second, following CancerLinQ roll-out, we will survey patients experiencing the real-world implementation of this RLS in order to evaluate their knowledge and perceptions of that system. Conducting the proposed work in parallel with the development of a real-world RLS provides an opportunity to directly inform the development and implementation of a national learning system that will ultimately impact tens of thousands of patients, and it also allows for the consideration of real- life rather than purely hypothetical scenarios in ways that increase the likelihood that these investigations will yield insights that are directly applicable in other settings. The findings will have substantial relevance to the research mission of the NCI, as oncology learning systems are fundamentally altering the context for research across the spectrum of cancer causation, diagnosis, prevention, treatment, and survivorship care.