Can Administrative Data Match Clinical Trial Results?

描述（由申请人提供）：心脏结局预防评价（HOPE）试验证明了血管紧张素转换酶（ACE）抑制剂雷米普利在减缓糖尿病患者心血管疾病进展和降低具有其他心血管危险因素的患者糖尿病发病率方面的疗效。尽管这项随机对照试验的结果令人信服，但仍存在一些问题，包括HOPE研究中未包括的与雷米普利具有相似药效学特性的药物的疗效，以及这些药物在临床试验中代表性不足的患者中的疗效。 本研究的目的是测试使用医疗保险和医疗补助管理数据结合HOPE试验的结果来解决这些问题的可行性。我们建议： 1.使用因果统计模型，估计ACE抑制剂雷米普利对高血压和糖尿病患者心血管疾病或其他冠状动脉危险因素的影响，使用医疗补助和医疗保险管理数据库。 2.将该模型的结果与参加HOPE试验的临床相似患者的结果进行比较。如果结果比较有利，我们将 3.使用相同的统计技术分析与雷米普利具有相似药效学特性的药物的有效性，例如其他ACE抑制剂和血管紧张素受体阻滞剂（ARB），并 4.分析雷米普利和其他ACE抑制剂和ARB在HOPE和其他试验中代表性不足的非洲裔美国患者中的有效性。拟议的研究将作出两项重要贡献。首先，我们将为糖尿病患者提供药物治疗的证据，这些证据可以塑造一种高度流行和负担沉重的疾病的临床护理。第二，我们将开发和测试一个方法框架，可以在许多情况下复制，并可能显着提高行政和其他二级数据源的健康结果研究的效用。

DESCRIPTION (provided by applicant): The Heart Outcome Prevention Evaluation (HOPE) trial demonstrated the efficacy of the angiotensin converting enzyme (ACE) inhibitor ramipril in slowing the progression of cardiovascular disease for persons with diabetes and reducing the incidence of diabetes in persons with other cardiovascular risk factors. Despite compelling findings from this randomized controlled trial, some questions remain, including the efficacy of medications with similar pharmacodynamic properties to ramipril that were not included in the HOPE study, and the efficacy of these drugs in patients who have been under-represented in clinical trials. The purpose of this study is to test the feasibility of using Medicare and Medicaid administrative data in conjunction with results from the HOPE trial to address these questions. We propose to: 1. Use causal statistical models to estimate the impact of the ACE-inhibitor ramipril on cardiovascular disease in persons with hypertension and diabetes or other coronary risk factors using Medicaid and Medicare administrative databases. 2. Compare the results of this model with the results for clinically similar patients who participated in the HOPE trial. If the results compare favorably, we will 3. Use the same statistical techniques to analyze the effectiveness of medications with similar pharmacodynamic properties to ramipril, such as other ACE-inhibitors and Angiotensin Receptor Blockers (ARBs), and to 4. Analyze the effectiveness of ramipril and other ACE-inhibitors and ARBs in African-American patients who were under-represented in the HOPE and other trials. The proposed study will make two important contributions. First, we will provide evidence on pharmacological therapy for persons with diabetes that can shape clinical care for a highly prevalent and burdensome disease. Second, we will develop and test a methodological framework that can be duplicated in numerous situations and may significantly enhance the utility of administrative and other secondary data sources for health outcomes research.