Comparative Effectiveness of Treatment Combinations Post MI in the Elderly

老年人心梗后治疗组合的疗效比较

• 批准号: 7985693
• 负责人: JOHN M BROOKS
• 金额: $ 44.02万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7985693
• 关键词: Comparative; Effectiveness; Treatment; Combinations; Post

DESCRIPTION (provided by applicant): Based on randomized controlled trial (RCT) evidence establishing the individual benefit of beta- blockers, renin-angiotensin system antagonists (ACE/ARBs),, HMG-CoA reductase inhibitors (statins), and antiplatelets, clinical guidelines recommend using each of these treatments indefinitely for secondary acute myocardial infarction (AMI) prevention. However, the benefits and risks of these treatments in combination are unclear and evidence describing the effects of these treatments for the elderly patients and patients with multiple comorbidities is sketchy. Wide treatment variation and the observed "treatment risk paradox" suggests that clinicians are hesitant to follow guidelines for many of their patients. Given the barriers to conducting additional RCTs, the analysis of observational data has been suggested to fill this evidence gap. Different estimation methods are available to analyze observational data that are derived from distinct assumptions and yield estimates with distinct interpretations. Making proper inferences from analysis of observational data requires an analytical framework that enables validation of the assumptions underlying these methods and recognizes the proper inferential context of estimates across estimation methods. The AHRQ Comparative Effectiveness Portfolio, as described in PA-09-070, has both clinical and methodological goals. Our proposed research uses an advanced study design to estimate the comparative effectiveness of alterative treatment combinations post-AMI. Our estimates will fill knowledge gaps in the care of post-AMI patients that will probably never be filled using RCT methods. The study design applies innovative methodological approaches to Medicare Part D data along with the use of primary data collection via chart abstraction to validate estimation assumptions. We will estimate the comparative treatment effectiveness of treatment combinations for secondary prevention post-AMI using both risk-adjustment and instrumental variable approaches in light of recent methodological insights into the correct interpretations of estimates from these methods. We will exploit the large number of Medicare patients from the CMS Chronic Condition Data Warehouse (CCW) to estimate the effects of specific treatments within treatment combinations, as well as estimating these effects in important patient subgroups. In addition, using chart abstraction data we will interpret our estimates in light of potential biases and provide "bounds" of treatment effects. This research will give clinicians estimates of the benefits and risks associated with each treatment combination by patient age and comorbidity status, and will also provide evidence for policy-makers to assess whether changes in treatment rates across treatment combinations are warranted. PUBLIC HEALTH RELEVANCE: It is estimated that each year more than 610,000 Americans have new acute myocardial infarctions (AMIs) and 325,000 have a recurrent AMI. The results of this study will help clinicians, guideline-makers, and policy-makers understand the benefits, risks, and costs associated with post-MI secondary prevention treatment combinations.

描述（由申请人提供）：基于随机对照试验（RCT）证据，确立了β受体阻滞剂、肾素-血管紧张素系统拮抗剂（ACE/ARB）、HMG-CoA还原酶抑制剂（他汀类药物）和抗血小板药物的个体获益，临床指南建议无限期使用这些治疗方法预防继发性急性心肌梗死（AMI）。然而，这些联合治疗的获益和风险尚不清楚，描述这些治疗对老年患者和患有多种合并症的患者的影响的证据也很粗略。广泛的治疗差异和观察到的“治疗风险悖论”表明，临床医生对许多患者是否遵循指南犹豫不决。考虑到进行额外RCT的障碍，建议对观察性数据进行分析以填补这一证据缺口。不同的估计方法可用于分析来自不同假设的观测数据和具有不同解释的产量估计。从观测数据的分析中做出正确的推断需要一个分析框架，该框架能够验证这些方法的假设，并识别各种估计方法中估计值的正确推断背景。 如PA-09-070所述，AHRQ比较有效性组合具有临床和方法学目标。我们提出的研究采用先进的研究设计来评估AMI后替代治疗组合的比较有效性。我们的估计将填补知识空白，在照顾后AMI患者，可能永远不会填补使用随机对照试验方法。研究设计将创新的方法学方法应用于医疗保险D部分数据沿着，并通过图表抽象使用原始数据收集来验证估计假设。我们将根据最近对这些方法估计值的正确解释的方法学见解，使用风险调整和工具变量方法来估计AMI后二级预防治疗组合的比较治疗有效性。我们将利用CMS慢性病数据仓库（CCW）中的大量医疗保险患者来估计治疗组合中特定治疗的效果，以及估计重要患者亚组中的这些效果。此外，使用图表抽象数据，我们将根据潜在的偏倚解释我们的估计，并提供治疗效果的“界限”。这项研究将为临床医生提供按患者年龄和合并症状态评估每种治疗组合相关的获益和风险，并为政策制定者提供证据，以评估是否有必要改变治疗组合的治疗率。 公共卫生相关性：据估计，每年有超过610，000的美国人患有新的急性心肌梗死（AMI），并且325，000人患有复发性AMI。这项研究的结果将帮助临床医生，指南制定者和政策制定者了解MI后二级预防治疗组合的益处，风险和成本。