Economic Consequences of Advanced Testing for Subclinical Cardiovascular Disease

描述（由申请人提供）：目前的申请是对NIH健康与科学研究挑战基金（RC1）领域申请的回应，该领域属于（04）临床研究的广泛挑战领域，具体挑战领域：04- hl -104 -对现有数据进行二次分析，以回答重要的临床和预防医学研究问题，特别是确定预防干预的成本效益。该次要数据分析：亚临床心血管疾病（CVD）高级检测的经济后果建议在NIH- nhlbi赞助的多种族动脉粥样硬化研究（MESA）中完成。尽管心血管疾病带来了负担，但除了测量胆固醇之外的常规检测并不被认为是医疗必要性，也没有得到国家卫生保健覆盖决定的支持。美国预防服务工作组（US Preventive Services Taskforce）和其他机构最近的技术评估对额外的心血管疾病检测（胆固醇测量之外）的不良后果表示了强烈的担忧，包括可能出现不合理的、诱导的检测，以及在诊断为亚临床动脉粥样硬化后终生的耻辱和焦虑。由于缺乏提高风险检测的高质量证据，过去的争论对开展全国性心血管疾病筛查提出了警告。最近来自大型患者登记和人群系列的数据报告了CAC、Hs-CRP和C-IMT的高度预后准确性；包括最近由nih - nhlbi赞助的MESA的结果，揭示了这个国家不同地理区域的不同种族的女性和男性的有效风险分层。然而，人们仍然担心检测会引发更多的检测，并且开始检测亚临床动脉粥样硬化标志物的策略可能会导致早期和终身更高的资源消耗模式，如果没有可测量的亚临床CVD的初始文件，这是不可能实现的。因此，揭示心血管疾病检测成本影响的高质量证据是必要的，以便在检测的潜在不良后遗症（过高的成本超过任何可衍生的收益）的背景下，构建经常报告的改进的风险检测。然而，对无症状个体进行亚临床CVD检测后的“真实世界”资源消耗模式和医疗成本的有意义数据有限；主要由决策模型或小病人系列组成。在无症状测试的成本效益领域面临的挑战包括依赖决策模型，缺乏来自“现实世界”资源利用的输入；使建模结果难以解释。例如，模型表明，以Hs-CRP或CAC结果为指导的策略可以节省相当大的成本，这可能是乐观的，没有考虑到检测的不良后果，也没有考虑到不太广泛的异常或检测分层可能导致的成本。MESA提供的数据代表了我们的知识库在大量中老年成人诱导检测和治疗模式方面向前迈出了相当大的一步。我们建议在MESA登记的大量成年人队列中使用基于资源的方法来检查下游成本。我们的应用程序包括一个系统的方法，成本分析基于医疗保险报销率估计4-5年心血管疾病的成本。我们的分析方法是比较先进的心血管疾病检测所带来的额外好处的成本，包括改进的风险重新分类以及累积成本（包括与偶然发现和预期的辐射诱发癌症相关的成本）。我们提出了一种分析方法，该方法模拟了风险检测中的迭代步骤，最初基于FRS对结果进行分类，然后是给定的高级测试选项。因此，考虑到与改进风险分类或风险重新分类的附加效益有关的增量成本的计算；使用彭西纳和威尔逊最近描述的方法。我们提出了一种新的、疾病特异性的CVD事件净重分类成本效益指标（即，与FRS相比，采用先进的CVD测试检测到的每1个新CVD事件的成本）。我们的分析方法是迭代和基于策略的与FRS策略相关的成本与我们的一个或多个高级测试（CAC评分、C-IMT或Hs-CRP）的策略相比较。我们认为，这种新颖的成本效益指标更接近于最新的风险分类方法，并与标准FRS相比，区分了高级检测的额外成本和收益。关于亚临床CVD高级检测的经济后果，公共政策可获得的信息有限，这些检测随后使用实验室（如Hs-CRP）或成像生物标志物（如CAC评分）进行指数检测。鉴于现有数据的缺乏，目前在MESA中应用二级数据分析，确定资源消耗模式和估计下游护理成本，可以在现有证据的质量方面向前迈出一大步。目前的评估使MESA具有无与伦比的潜力，可以确定无症状个体中最有效和准确的CVD检测方法。目前的应用结合了卓越的临床结果、影像学和经济专业知识，提出了现有MESA数据的评估，以提高我们对无症状个体CVD检测的临床和经济效益和风险的理解。目前的研究旨在评估超过6000人的5年心脏病护理成本。我们进一步建议比较具有低风险和高风险心脏生物标志物的成人亚组的心脏病护理费用。我们将比较成本以及使用几种心脏生物标志物改进心脏病风险检测的额外好处。

DESCRIPTION (provided by applicant): The current application is written as a response to requests for applications in the area of NIH Challenge Grants in Health and Science Research (RC1) in the Broad Challenge Area of (04) CLINICAL RESEARCH, Specific Challenge Area: 04-HL-104 - To perform secondary analyses of existing data to answer important clinical and preventive medicine research questions, specifically to determine the cost effectiveness of preventive interventions. This Secondary Data Analysis: The Economic Consequences of Advanced Testing for Subclinical Cardiovascular Disease (CVD) is proposed to be completed in the NIH- NHLBI-sponsored Multi-Ethnic Study of Atherosclerosis (MESA). Despite the burden of CVD, routine testing beyond measurement of cholesterol, is not considered of medical necessity and supported by national healthcare coverage decisions. Recent technology evaluations by the US Preventive Services Taskforce and others have voiced strong concerns over the untoward consequences of additional CVD testing (beyond measurement of cholesterol) including the potential for unwarranted, induced testing and a lifelong stigma and anxiety following a diagnosis of subclinical atherosclerosis. Past arguments have cautioned over embarking on nationwide screening for CVD due to a lack of high quality evidence on improved risk detection. Recent data from large patient registries and population series report a high degree of prognostic accuracy for CAC, Hs-CRP, and C-IMT; including the recently results from the NIH-NHLBI-sponsored MESA revealing effective risk stratification of women and men of diverse ethnicity from geographically-diverse regions of this country. Yet, concerns remain that testing will beget more testing and initiation of a strategy for detection of markers for subclinical atherosclerosis may result in early and lifelong higher patterns of resource consumption that would not have been realized without the initial documentation of measureable subclinical CVD. Accordingly, high quality evidence unfolding the cost implications of CVD testing is necessary in order to frame the frequently reported improved detection of risk within the context of the potential untoward sequelae of testing where excessive costs exceed any derivable benefit. However, meaningful data on "real world" resource consumption patterns and healthcare costs following subclinical CVD testing in asymptomatic individuals is limited; principally comprised of decision models or small patient series. Challenges within the field of cost effectiveness of testing in asymptomatics include reliance upon decision modeling lacking input from "real world" resource utilization; rendering the modeling results difficult to interpret. For example, models that indicate a sizeable cost savings for strategies guided by Hs-CRP or CAC results may be optimistic and fail to consider the untoward consequences of testing or costs which may ensue for less extensive abnormalities or from test layering. The data available in MESA represents a sizeable step forward in our knowledge base of induced patterns of testing and treatment from a large cohort of middle-aged and elderly adults. We propose to examine downstream costs using a resource-based methodology in a large population cohort of adults enrolled in the MESA. Our application includes a systematic approach to cost analysis based on Medicare reimbursement rates for estimating 4-5 year CVD costs. Our analytical approach will be to compare costs within the context of the added benefit of advanced CVD testing including improved risk re-classification as well as the cumulative costs (including those associated with incidental findings and expected radiation- induced cancers). We propose that an analytic approach that emulates iterative steps in risk detection initially classifying outcome based on the FRS followed by a given advanced testing option. Thus, allowing for calculation of the incremental costs in relation to the added benefit of improved classification of risk or risk re- classification; using recent approaches described by Pencina and Wilson. We propose a novel, disease- specific cost effectiveness metric of cost per net reclassification of CVD events (i.e., the cost per 1 new CVD event detected with advanced CVD testing when compared to the FRS). Our analytical approach is both iterative and strategy based examining costs associated with an FRS strategy compared with a strategy with one or more of our advanced tests (CAC scoring, C-IMT, or Hs-CRP). We believe that this novel cost effectiveness metric more closely corresponds to more recent risk classification approaches and distinguishes the added cost and benefit of advanced testing compared with the standard FRS. Limited information is available to inform public policy with regards to the economic consequences of advanced testing for subclinical CVD ensuing following index testing using either laboratory, such as Hs-CRP, or imaging biomarkers, such as CAC scoring. Given the paucity of available data, the current application of secondary data analysis in MESA identifying resource consumption patterns and estimating downstream costs of care can provide a tremendous step forward in the quality of available evidence. This current evaluation empowers MESA with an unparalleled potential to identify the most efficient and accurate methods for CVD testing in asymptomatic individuals. The current application combines exceptional clinical outcomes, imaging, and economic expertise put forth in the evaluation of available MESA data to advance our understanding of the clinical and economic benefits and risk associated with CVD testing in asymptomatic individuals. The current study aims to evaluate 5-year cost for heart disease care in over 6 thousand individuals. We further propose to compare costs of heart disease care in subgroups of adults with low to high risk cardiac biomarkers. We will compare costs in addition to the added benefit of improved detection of heart disease risk using several cardiac biomarkers.