Comparative Effectiveness of Treatment Combinations Post MI in the Elderly

描述(申请人提供)：根据随机对照试验(RCT)的证据，确定了β-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)和抗血小板的个体益处，临床指南建议无限期地使用这些治疗方法中的每一种来预防继发性急性心肌梗死(AMI)。然而，这些联合治疗的益处和风险尚不清楚，描述这些治疗对老年患者和多发性合并症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，临床医生对许多患者是否遵循指南犹豫不决。考虑到进行更多随机对照试验的障碍，有人建议对观测数据进行分析以填补这一证据空白。有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。要从观测数据的分析中做出适当的推论，需要一个分析框架，该框架能够验证这些方法所依据的假设，并认识到不同估计方法的估计的适当推理背景。 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。我们建议的研究使用一种先进的研究设计来评估急性心肌梗死后交替治疗组合的比较有效性。我们的估计将填补急性心肌梗死后患者护理方面的知识空白，而这些空白可能永远无法通过随机对照试验方法来填补。研究设计将创新的方法论方法应用于联邦医疗保险D部分数据，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评估用于急性心肌梗死后二级预防的联合治疗的比较治疗效果。我们将利用CMS慢性疾病数据仓库(CCW)中的大量Medicare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影响。此外，使用图表摘要数据，我们将根据潜在的偏差来解释我们的估计，并提供治疗效果的“界限”。这项研究将根据患者的年龄和合并症状况为临床医生提供与每种治疗组合相关的益处和风险的估计，并将为政策制定者提供证据，以评估是否有理由改变不同治疗组合的治疗率。 公共卫生相关性：据估计，每年有超过610,000名美国人患有新的急性心肌梗死(AMI)，325,000人有复发的急性心肌梗死。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好处、风险和成本。

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.