Comparative effectiveness of dabigatran and warfarin for stroke prevention in atr

描述（由申请人提供）：15年多来，我一直致力于通过分析大型行政数据库来更好地定义医疗保健的成本和质量。我曾担任过一系列基于索赔的研究项目的首席研究员，导师和合作者，探索心血管疾病领域的风险调整，种族差异和健康结果的新方法。本申请描述了我的计划，通过调查房颤（AF）的结局和治疗，扩展与以患者为中心的比较有效性研究相关的方法学技能。与其他心血管疾病相比，AF的研究远未发展。特别是，在当代临床实践中，很少有研究使用管理数据来研究AF治疗和结局。医学研究所已将AF列为全国25个比较有效性研究重点之一。当心脏电活动的干扰导致心脏泵血无效时，就会发生AF，最终导致疲劳、生活质量降低和预期寿命缩短。AF的一个特别严重的并发症是缺血性卒中。抗凝治疗可以降低中风的风险（例如，华法林），尽管中风风险的降低往往伴随着出血风险的增加。近年来，新的抗凝药物（达比加群）已被引入，但这些新药在临床试验之外的有效性相对未知。在本提案中，我描述了我的计划，即在以患者为中心的比较有效性研究中开发关键的新专业知识，并运用我的技能调查华法林和达比加群在新诊断AF的医疗保险受益人中的有效性。我将使用一种新的定性方法评估患者和家属在互联网论坛上发布的关于抗凝治疗的安全性和有效性问题。然后，我将使用管理数据进行严格的统计调查，以解决华法林或达比加群抗凝相关的有效性和不良反应。我将由一组经验丰富的研究人员指导，他们在四个关键领域具有专业知识：定性研究方法，药房索赔数据分析，观察数据中的混淆调整以及AF的临床管理。

DESCRIPTION (provided by applicant): For more than 15 years I have worked to better define the cost and quality of healthcare through analysis of large administrative databases. I have worked as a principal investigator, mentor, and collaborator on a wide array of claims-based research projects exploring novel methods for risk adjustment, racial disparities, and health outcomes in the area of cardiovascular disease. This application describes my plan to expand my methodological skills related to patient-centered comparative effectiveness research by investigating outcomes and treatment of atrial fibrillation (AF). Compared to other cardiovascular conditions, research in AF is far less developed. In particular, there is a paucity of studies that have used administrative data to investigate AF treatment and outcomes in contemporary clinical practice. The Institute of Medicine has listed AF as one of the nation's top 25 comparative effectiveness research priorities. AF occurs when disturbances in cardiac electrical activity causes the heart to pump blood ineffectively, ultimately leading to fatigue, lower quality of life, and lower life expectancy. A particularly serious complication of AF is ischemic stroke. The risk of stroke may be lowered with anticoagulation therapy (e.g., warfarin), although the reduction in stroke risk is often accompanied by an increase in the risk of bleeding. In recent years new anticoagulation medications (dabigatran) have been introduced but the effectiveness of these new medications outside of clinical trials is relatively unknown. In this proposal I describe my plan to develop critical new expertise in patient-centered comparative effectiveness research and apply my skills to investigate the effectiveness of warfarin and dabigatran among Medicare beneficiaries with newly diagnosed AF. I will use a novel qualitative method to assess safety and effectiveness concerns regarding anticoagulation therapy posted by patients and families on internet discussion forums. I will then use administrative data to conduct rigorous statistical inquiry to address the effectiveness and adverse effects associated with anticoagulation by warfarin or dabigatran. I will be mentored by a team of experienced researchers with expertise in four critical areas: qualitative research methods, analysis of pharmacy claims data, adjustment for confounding in observational data, and clinical management of AF.