Economic Consequences of Advanced Testing for Subclinical Cardiovascular Disease

亚临床心血管疾病先进检测的经济后果

• 批准号: 7936322
• 负责人: Leslee J Shaw
• 金额: $ 49.8万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936322
• 关键词: Adult; Anxiety; Area; Atherosclerosis; Benefits and Risks; Biological Markers; C-reactive protein; Calcium; Cardiac; Cardiac Death; Cardiovascular Diseases; Caring; Chest; Cholesterol; Classification; Clinical; Clinical Research; Consumption; Coronary; Coronary artery; Cost Analysis; Cost Savings; Cost of Illness; Costs and Benefits; Country; Data; Data Analyses; Decision Modeling; Detection; Diagnosis; Disease; Documentation; Economics; Effectiveness; Elderly; Enrollment; Ethnic Origin; Evaluation; Event; Frequencies; Grant; Hand; Health Care Costs; Health Policy; Healthcare; Heart Diseases; Hospitalization; Image; Incidental Findings; Individual; Intervention; Laboratories; Lung nodule; Measurement; Medical; Medicare; Methodology; Methods; Metric; Modeling; Myocardial Infarction; Nodule; Outcome; Patients; Pattern; Pharmaceutical Preparations; Population; Preventive; Preventive Intervention; Preventive Medicine; Public Policy; Radiation; Radiation-Induced Cancer; Reliance; Reporting; Request for Applications; Research; Resources; Risk; Risk Estimate; Risk Marker; Screening procedure; Series; Services; Smoker; Stigmata; Stratification; Subgroup; Technology; Test Result; Testing; Thick; Treatment Cost; United States National Institutes of Health; Voice; Woman; Writing; base; cardiovascular disorder risk; cohort; cost; cost effectiveness; empowered; follow-up; health science research; heart disease risk; high risk; improved; indexing; intima media; knowledge base; life time cost; lifetime risk; men; middle age; non-smoker; novel; patient registry; prognostic; response; social stigma

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.

描述（由申请人提供）：当前申请是对 NIH 健康和科学研究挑战资助 (RC1) 领域申请请求的回应，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措施的成本效益。此二次数据分析：亚临床心血管疾病 (CVD) 高级检测的经济后果拟在 NIH-NHLBI 资助的动脉粥样硬化多种族研究 (MESA) 中完成。尽管有心血管疾病的负担，但胆固醇测量以外的常规检测并不被认为具有医疗必要性，也没有得到国家医疗保健覆盖决策的支持。美国预防服务工作组和其他机构最近进行的技术评估对额外的 CVD 检测（超出胆固醇测量）的不良后果表示强烈担忧，包括可能进行不必要的诱导检测以及亚临床动脉粥样硬化诊断后的终生耻辱和焦虑。由于缺乏改进风险检测的高质量证据，过去的争论对在全国范围内开展心血管疾病筛查提出了警告。来自大型患者登记和人群系列的最新数据报告了 CAC、Hs-CRP 和 C-IMT 的高度预后准确性；其中包括 NIH-NHLBI 资助的 MESA 最近的结果，该结果揭示了来自该国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，测试将导致更多的测试，并且启动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生更高的资源消耗模式，如果没有可测量的亚临床 CVD 的初始记录，这种情况就不会实现。因此，有必要提供高质量的证据来揭示 CVD 检测的成本影响，以便在检测的潜在不良后遗症（过度成本超过任何可带来的收益）的背景下，构建经常报告的改进的风险检测方法。然而，对无症状个体进行亚临床 CVD 检测后，有关“现实世界”资源消耗模式和医疗保健成本的有意义的数据有限；主要由决策模型或小型患者系列组成。无症状检测成本效益领域的挑战包括依赖决策模型，缺乏“现实世界”资源利用的输入；使得建模结果难以解释。例如，表明由 Hs-CRP 或 CAC 结果指导的策略可节省大量成本的模型可能是乐观的，并且未能考虑测试或成本的不良后果，这些后果可能会因不太广泛的异常或测试分层而产生。 MESA 中提供的数据代表了我们在一大群中老年人诱发的检测和治疗模式的知识库中向前迈出了一大步。我们建议使用基于资源的方法在 MESA 注册的大量成年人中检查下游成本。我们的应用程序包括基于 Medicare 报销率的系统成本分析方法，用于估算 4-5 年 CVD 成本。我们的分析方法将是在先进CVD检测的附加益处的背景下比较成本，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，该方法模拟风险检测中的迭代步骤，最初根据 FRS 对结果进行分类，然后是给定的高级测试选项。因此，允许计算与改进风险分类或风险重新分类的附加收益相关的增量成本；使用 Pencina 和 Wilson 描述的最新方法。我们提出了一种新颖的、特定于疾病的成本效益指标，用于衡量每次 CVD 事件重新分类的成本（即与 FRS 相比，通过先进 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，检查与 FRS 策略相关的成本，并与采用我们的一项或多项高级测试（CAC 评分、C-IMT 或 Hs-CRP）的策略进行比较。我们认为，这种新颖的成本效益指标更符合最新的风险分类方法，并区分了高级测试与标准 FRS 相比的额外成本和收益。在使用实验室（如 Hs-CRP）或成像生物标志物（如 CAC 评分）进行指数测试后，可用于告知公共政策的亚临床 CVD 高级测试的经济后果的信息有限。鉴于可用数据的缺乏，当前在 MESA 中应用二次数据分析来识别资源消耗模式并估计下游护理成本可以在可用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，可以确定对无症状个体进行 CVD 检测的最有效和最准确的方法。当前的应用程序结合了在评估可用 MESA 数据时提出的出色的临床结果、影像学和经济专业知识，以增进我们对无症状个体 CVD 检测相关的临床和经济效益和风险的理解。目前的研究旨在评估 6,000 多人的 5 年心脏病护理费用。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成本。除了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之外，我们还将比较成本。