ADVancing Innovative Comparative Effectiveness research-cancer diagnostics ADVICE

描述(由申请人提供)：科学争议和美国FDA灵活的监管要求相结合，导致用于癌症诊断和治疗后监测的技术的证据基础存在重大差距。这一问题已成为所有卫生保健付款人、提供护理的临床医生以及试图在相互竞争的护理替代方案中进行选择的患者的主要关切。由于诊断和监测疾病的现代测试具有巨大的经济影响，缺乏使用这些测试的证据也是医疗改革辩论的一个重要部分。该项目建议建立一个独特的资源，旨在进行癌症诊断的比较有效性研究，以填补这一证据空白。通过这样做，我们相信这将使癌症护理服务更有效率、更有效、更科学。 在两年的资助期间，我们将在华盛顿州西部建立一个多学科和跨机构的健康服务系统和研究人员网络(建议)，以评估癌症诊断在现实世界中的相对有效性。这一组织伙伴关系不仅提供基于人口的区域数据，而且代表了各种医疗保健提供系统，包括按服务收费的私人计划、公共机构和大型管理保健系统。我们的合作伙伴致力于实施研究结果，这使这项工作真正成为一种翻译性和变革性的努力，使用真实世界的例子和来自受诊断实践中这些差异影响的人群的数据。 为了证明我们有能力进行这类以社区为基础的回溯性和前瞻性研究，我们将进行两项回溯性比较有效性研究，作为“原则证明”。我们将进行的第一项研究是对用于确定新诊断的I-III期乳腺癌的疾病程度的诊断工具进行比较有效性评估。我们的第二个原则证明研究将通过采用一个过程来确定我们利益相关者关于体外诊断和成像模式及其临床应用的后续优先主题。 从长远来看，我们计划使用Puget Sound咨询网络进行回溯性和前瞻性的基于社区的比较有效性研究，重点是快速扭亏为盈、务实的观察性和随机性研究。研究优先事项将通过以下方式提供信息：系统审查；与主要利益攸关方，包括付款人和社区团体进行讨论，以确定研究和政策优先事项；以及评估开展研究的可行性。 公共卫生相关性：医疗器械行业开发了新的检测方法，用于发现癌症、评估疾病在人体内的传播情况，以及监测治疗后的病程。一般来说，到产品批准时，这些测试还没有经过全面的评估，很少进行比较有效性分析。该项目建议建立一个由研究人员和医疗保健提供组织组成的联盟，他们将致力于了解这些测试的优点和缺点，并进行研究，以产生这些测试的使用指南和未来的研究计划，以严格评估这些测试。

DESCRIPTION (Provided by the applicant): A combination of scientific controversies and flexible regulatory requirements at the US FDA have led to significant gaps in the evidence base for technologies used in diagnosis and post treatment monitoring of cancer. This issue has become of principal concern to all health care payers, to clinicians providing care, and to patients trying to choose among competing alternatives for care. Because of the large economic impact of modern tests to diagnose and monitor disease, the lack of evidence for the use of these tests is also a significant part of the debate on health care reform. This project proposes to establish a unique resource designed to perform comparative effectiveness research on cancer diagnostics to fill this evidence gap. In so doing, we believe this will make cancer care delivery more efficient, more effective, and more scientifically sound. During the two years of funding, we will establish a multi-disciplinary and cross-institutional network of health delivery systems and researchers in Western Washington State (ADVICE) for evaluating the comparative effectiveness of cancer diagnostics in real-world settings. This partnership of organizations not only provides regional population-based data but also represents a variety of health care delivery systems, including fee-for-service private plans, public agencies, and a large managed care system. Our partners' commitment to implementing the research findings make this truly a translational and transformative effort using real world examples and data from populations that are affected by these variations in diagnostic practices. To demonstrate our ability to conduct these types of community-based retrospective and prospective studies, we will conduct two retrospective comparative effectiveness studies as "proof of principle." The first study we will undertake is a comparative effectiveness assessment of diagnostic tools used for establishing extent of disease among newly diagnosed Stage I - III breast cancer. Our second proof of principle study will be identified by employing a process for identifying subsequent priority topics around in vitro diagnostic and imaging modalities and their clinical applications from our stakeholders. Over the long-term we plan to use the Puget Sound ADVICE network to conduct retrospective and prospective community based comparative effectiveness research with a focus on rapid turnaround, pragmatic observational and randomized studies. The research priorities will be informed by: systematic reviews; discussions with key stakeholders, including payers and community groups to establish research and policy priorities; and assessment of feasibility to perform studies. PUBLIC HEALTH RELEVANCE: The medical device industry has developed new tests for finding cancer, evaluating the spread of disease in a person, and for monitoring the course of disease after treatment. In general, these tests have not undergone complete evaluation by the time of product approval, and rarely have been subjected to a comparative effectiveness analysis. This project proposes to establish a consortium of researchers and health care providing organizations that will devote their expertise to understanding the strengths and weaknesses of these tests and to produce research that will result in guidelines for the use of these tests and a future program of studies to rigorously evaluate these tests.