ADVancing Innovative Comparative Effectiveness research-cancer diagnostics ADVICE

推进创新比较有效性研究-癌症诊断建议

• 批准号: 7944081
• 负责人: LARRY G KESSLER
• 金额: $ 199.04万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-29 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944081
• 关键词: Affect; Aftercare; Agreement; American College of Radiology Imaging Network; Biological Markers; Blood; Blue Cross; Blue Shield; Cancer Diagnostics; Caring; Clinical; Clinical and Translational Science Awards; Communities; Data; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic tests; Disease; Distant; Evaluation; Fee-for-Service Plans; Fred Hutchinson Cancer Research Center; Funding; Future; Guidelines; Health; Health Alliance; Health Care Reform; Healthcare; In Vitro; Industry; International; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Managed Care; Medicaid; Medical Device; Methods; Monitor; Newly Diagnosed; Patients; Pattern; Persons; Policy Research; Population; Positron-Emission Tomography; Process; Product Approvals; Prospective Studies; Provider; Randomized; Research; Research Infrastructure; Research Personnel; Research Priority; Resources; Staging; System; Technology; Testing; Time; Tissues; Ultrasonography; United States Department of Veterans Affairs; United States National Institutes of Health; Universities; Variant; Washington; Work; authority; base; cancer care; care delivery; care systems; clinical application; comparative effectiveness; compare effectiveness; design; economic impact; effectiveness research; evidence base; flexibility; health care delivery; imaging modality; improved; innovation; malignant breast neoplasm; population based; programs; prospective; public health relevance; sound; systematic review; tool; tumor

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.

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，导致癌症诊断和治疗后监测技术的证据基础存在巨大差距。这个问题已成为所有医疗保健支付者、提供护理的临床医生以及试图在竞争性护理替代方案中进行选择的患者的主要关注点。由于诊断和监测疾病的现代检测对经济产生巨大影响，缺乏使用这些检测的证据也是医疗改革辩论的一个重要组成部分。该项目建议建立一个独特的资源，旨在对癌症诊断进行比较有效性研究，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加高效、有效且更加科学合理。 在两年的资助期间，我们将在华盛顿州西部建立一个由卫生服务系统和研究人员组成的多学科、跨机构网络（ADVICE），以评估现实世界中癌症诊断的相对有效性。这种组织伙伴关系不仅提供基于区域人口的数据，还代表了各种医疗保健提供系统，包括按服务付费的私人计划、公共机构和大型管理式医疗系统。我们的合作伙伴致力于实施研究结果，利用来自受诊断实践变化影响的人群的真实例子和数据，使这真正成为一项转化和变革性的努力。 为了证明我们进行此类基于社区的回顾性和前瞻性研究的能力，我们将进行两项回顾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 期乳腺癌疾病范围的诊断工具进行比较有效性评估。我们的第二个原理研究证明将通过采用一个流程来确定我们的利益相关者围绕体外诊断和成像方式及其临床应用的后续优先主题。 从长远来看，我们计划利用普吉特湾 ADVICE 网络进行基于社区的回顾性和前瞻性比较有效性研究，重点是快速周转、务实的观察性和随机研究。研究重点将通过以下方式确定： 系统评价；与主要利益相关者（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；和评估进行研究的可行性。 公共健康相关性：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，这些测试在产品批准时尚未经过完整的评估，并且很少进行比较效果分析。该项目提议建立一个由研究人员和医疗保健提供组织组成的联盟，他们将利用其专业知识来了解这些测试的优点和缺点，并进行研究，从而制定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。