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: 8118253
• 负责人: JOHN M BROOKS
• 金额: $ 39.53万
• 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/8118253
• 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，证实了 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益处，临床指南建议无限期地使用每种治疗方法来预防继发性急性心肌梗死 (AMI)。然而，这些治疗组合的益处和风险尚不清楚，并且描述这些治疗对老年患者和患有多种合并症的患者的效果的证据也很粗略。广泛的治疗差异和观察到的“治疗风险悖论”表明临床医生对于遵循许多患者的指南犹豫不决。鉴于进行额外随机对照试验的障碍，建议对观察数据进行分析来填补这一证据空白。不同的估计方法可用于分析源自不同假设的观测数据以及具有不同解释的产量估计。从观测数据分析中做出正确的推论需要一个分析框架，该框架能够验证这些方法背后的假设，并识别跨估计方法的估计的正确推论背景。 如 PA-09-070 中所述，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 AMI 后患者护理方面的知识空白，而使用随机对照试验方法可能永远无法填补这些空白。研究设计对 Medicare D 部分数据应用创新方法，并通过图表抽象收集主要数据来验证估计假设。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效果。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，我们将根据潜在偏差解释我们的估计，并提供治疗效果的“界限”。这项研究将为临床医生根据患者年龄和合并症状况估计每种治疗组合的获益和风险，还将为政策制定者评估是否有必要改变治疗组合的治疗率提供证据。 公共卫生相关性：据估计，每年有超过 610,000 名美国人患有新发急性心肌梗塞 (AMI)，325,000 名美国人患有复发性 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与心肌梗死后二级预防治疗组合相关的益处、风险和成本。