Comparative Effectiveness of Treatment Combinations Post MI in the Elderly

描述（由申请人提供）：基于随机对照试验（RCT）证据，确定了-受体阻滞剂、肾素-血管紧张素系统拮抗剂（ACE/ARBs）、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，这些联合治疗的益处和风险尚不清楚，描述这些治疗对老年患者和多重合并症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，临床医生在为许多患者遵循指导方针方面犹豫不决。鉴于进行额外随机对照试验的障碍，已建议对观测数据进行分析以填补这一证据空白。不同的估计方法可用于分析观测数据，这些观测数据来源于不同的假设和具有不同解释的产量估计。从观测数据的分析中做出适当的推断需要一个分析框架，该框架能够验证这些方法背后的假设，并认识到各种估计方法之间估计的适当推断背景。

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.