Can Administrative Data Match Clinical Trial Results?

管理数据可以匹配临床试验结果吗？

• 批准号: 6752778
• 负责人: PAUL L. HEBERT
• 金额: $ 16.95万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-06-01 至 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6752778
• 关键词: ACE inhibitors; African American; Medicare /Medicaid; cardiovascular disorder risk; clinical research; data collection methodology /evaluation; diabetes mellitus; drug screening /evaluation; human data; hypertension; medical records; method development; outcomes research; pathologic process; pharmacokinetics; statistics /biometry

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.

描述（由申请人提供）：心脏预防预防评估（HOPE）试验证明了血管紧张素转化酶（ACE）抑制剂Ramipril在减缓糖尿病患者心血管疾病的进展方面的疗效，并降低了其他心血管风险风险因素的糖尿病患者的发生率。尽管这项随机对照试验的发现令人信服，但仍然存在一些问题，包括与Ramipril具有相似药效特性的药物的功效，这些药物与Hope研究未包括的药物学特性的功效，以及这些药物在临床试验中占代表性不足的患者的疗效。 这项研究的目的是测试使用Medicare和Medicaid行政数据与Hope试验的结果一起解决这些问题的可行性。我们建议： 1。使用因果统计模型来估计ACE抑制剂Ramipril对使用Medicaid和Medicare行政数据库患有高血压和糖尿病或其他冠心病风险因素的患者的心血管疾病的影响。 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来分析具有与Ramipril相似的药效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（ARBS），以及 4。分析雷米普利和其他ACE抑制剂和ARB在希望和其他试验中代表不足的非裔美国人患者中的有效性。拟议的研究将做出两个重要的贡献。首先，我们将为糖尿病患者的药理疗法提供证据，这些糖尿病患者可以为高度普遍且繁重的疾病塑造临床护理。其次，我们将开发和测试一个可以在多种情况下重复的方法学框架，并可能会大大增强行政和其他二级数据源用于健康结果研究的实用性。