The Comparative Effectiveness of Single versus Dual Chamber Cardioverter Defibril

单室心脏复律除颤器与双室心脏复律除颤器的效果比较

• 批准号: 8031421
• 负责人: PAMELA N PETERSON
• 金额: $ 14.86万
• 依托单位: DENVER HEALTH AND HOSPITAL AUTHORITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8031421
• 关键词: Comparative; Effectiveness; Single; versus; Dual

DESCRIPTION (provided by applicant): Dr. Peterson is an Assistant Professor of Medicine in the Division of Cardiology at Denver Health Medical Center and the University of Colorado Denver (UCD). She has completed a master's in public health and conducted multiple observational studies focused on quality of care and outcomes for patients with heart failure (HF). Dr. Peterson's career goal is to improve the care and outcomes of patients with heart failure by conducting comparative effectiveness research (CER) in HF. Career Development Goals and Training: The proposed K08 career development plan builds on her prior training and experiences in observational research and addresses critical areas for performing robust observational CER. The three principal developmental goals of the application are to acquire: 1) expertise in combining data sources and analytic strategies for accounting for data structure; 2) advanced training in statistical methods for causal inference in observational studies; specifically, methods for addressing confounding, including propensity scores, instrumental variables, and sensitivity analysis; and 3) advanced training in statistical methods for analyzing longitudinal data and methods for handling missing data. Accordingly, Dr. Peterson proposes focused coursework and seminars, contextual learning through the proposed research and mentorship from a team of experts. These training activities will provide experience and skills to perform CER and advance the understanding of the comparative effectiveness of therapies for patients with HF. Mentors/Environment: The primary mentor, Frederick Masoudi, MD, MSPH, is Co-PI of the AHRQ- sponsored multicenter Longitudinal Studies of ICDs (LSICDs) which will provide the data and research infrastructure for this K08. Co-mentor David Magid, MD, MPH is Co-PI of the Cardiovascular Research Network (CVRN) and is Director of Research for the Colorado Permanente Medical Group. Co-mentor Sharon-Lise Normand, PhD is a Professor of Health Care Policy (biostatistics) at Harvard Medical School and Professor in the Department of Biostatistics at the Harvard School of Public Health and an internationally recognized expert in observational CER methods. This mentorship team is highly capable of guaranteeing the completion of Dr. Peterson's proposed research and training activities. A key aspect of Dr. Peterson's research environment is the nationally recognized Colorado Cardiovascular Outcomes Research (CCOR) group. CCOR is a multi-institutional and multidisciplinary group of established cardiovascular outcomes researchers which brings together methodological and content expertise to conduct cutting-edge cardiovascular outcomes research. Another key aspect of the research environment is the Kaiser Permanente Colorado Institute for Health Research (KPCO-IHR) which will serve as the data coordination and analytic center for this proposal. The KPCO-IHR includes 116 investigators supported by research nurses, project managers, research assistants, statisticians, analysis, programmers, IT support and administrative staff. Dr. Peterson has been an Affiliate Investigator since 2005. Dr. Masoudi (primary mentor) is also an Affiliate Investigator and Dr. Magid, a Co-Mentor for this proposal, is a senior investigator at IHR. Research: With the publication of landmark clinical efficacy trials, the use of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death in patients with HF and reduced left ventricular function has increased. However, these trials leave many questions, including optimal device selection, unanswered. More complex dual chamber devices offer theoretical benefits beyond simpler single chamber devices. However, the benefits of dual chamber devices in those without a clear indication (i.e. "discretionary" dual chamber devices) are not established. The research objectives of this multi-center cohort study are to identify the patient and physician factors associated with the use of discretionary dual chamber device and to compare a) peri-procedural and longitudinal complications, b) hospitalizations, c) mortality, and d) inappropriate shocks among those receiving single chamber ICDs and similar patients receiving discretionary dual chamber devices in a large, broadly representative community-based HF population. Summary: This mentored research and training proposal is also directly responsive to AHRQ's mission to improve the quality, safety efficiency and effectiveness of health care, and is specifically responsive to the comparative effectiveness priority area by proposing to 1) understand the patterns of appropriate and "discretionary" use of dual chamber ICDs in community-based populations and identify the demographic and clinical factors associated with the discretionary use of a dual chamber device; 2) determine the comparative safety of single and dual chamber ICDs; 3) generate critical insights on the clinical comparative effectiveness of single and dual chamber ICDs; and 4) evaluate outcomes important to stakeholders. Further, this award will facilitate Dr. Peterson's development into a nationally-recognized independent comparative effectiveness investigator in cardiovascular disease. PUBLIC HEALTH RELEVANCE: Many patients with heart failure are at high risk for sudden death due to abnormal heart rhythms. Implantable cardioverter defibrillators (ICDs) are devices designed to treat those rhythms and prevent sudden death. This study will provide information about the risks and benefits of the different types of ICD devices in real-world settings and therefore inform the best use of this invasive therapy in broad patient populations that were not studied in the randomized trials that currently guide practice.

简介（由申请人提供）：Peterson博士是丹佛健康医学中心和科罗拉多大学丹佛分校（UCD）心脏病科的医学助理教授。她完成了公共卫生硕士学位，并开展了多项观察性研究，重点关注心力衰竭（HF）患者的护理质量和结果。彼得森博士的职业目标是通过开展心衰患者的比较有效性研究（CER）来改善心衰患者的护理和预后。职业发展目标和培训：K08的职业发展计划建立在她之前的培训和观察研究经验的基础上，并解决了执行稳健的观察性CER的关键领域。该应用程序的三个主要发展目标是获得：1)结合数据源和分析策略以计算数据结构的专业知识；2)观察性研究中因果推理统计方法的高级培训；具体来说，解决混淆的方法，包括倾向评分、工具变量和敏感性分析；3)纵向数据分析的统计方法和缺失数据处理方法的高级培训。因此，彼得森博士建议重点课程和研讨会，通过拟议的研究和专家团队的指导进行情境学习。这些培训活动将提供执行CER的经验和技能，并促进对心衰患者治疗相对有效性的理解。导师/环境：主要导师Frederick Masoudi， MD， MSPH，是AHRQ赞助的ICDs多中心纵向研究（LSICDs）的共同负责人，该研究将为本次K08提供数据和研究基础设施。共同导师David Magid，医学博士，公共卫生硕士是心血管研究网络（CVRN）的共同负责人，也是科罗拉多永久医疗集团的研究主任。共同导师Sharon-Lise Normand博士是哈佛医学院卫生保健政策（生物统计学）教授和哈佛公共卫生学院生物统计学教授，也是国际公认的观察性CER方法专家。这个导师团队有很强的能力保证完成Dr. Peterson提出的研究和培训活动。彼得森博士的研究环境的一个关键方面是国家认可的科罗拉多心血管结果研究（CCOR）组。CCOR是一个由成熟的心血管结局研究人员组成的多机构和多学科小组，汇集了方法学和内容专业知识，开展尖端的心血管结局研究。研究环境的另一个关键方面是凯泽永久科罗拉多健康研究所（KPCO-IHR），该研究所将作为本提案的数据协调和分析中心。KPCO-IHR包括116名调查员，由研究护士、项目经理、研究助理、统计学家、分析人员、编程人员、信息技术支持人员和行政人员提供支持。自2005年以来，Peterson博士一直担任联盟调查员。Masoudi博士（主要导师）也是一名附属研究员，该提案的联合导师Magid博士是《国际卫生条例》的一名高级研究员。研究：随着具有里程碑意义的临床疗效试验的发表，使用植入式心律转复除颤器（ICDs）对心力衰竭和左心室功能降低患者心源性猝死的一级预防有所增加。然而，这些试验留下了许多问题，包括最佳设备选择，没有答案。较复杂的双腔装置比较简单的单腔装置提供理论上的好处。然而，双腔装置的好处是在那些没有明确适应症的患者中。“任意”双腔装置)不成立。这项多中心队列研究的研究目的是确定与使用任意双室装置相关的患者和医生因素，并比较a)手术期间和纵向并发症，b)住院情况，c)死亡率，d)接受单室icd的患者和接受任意双室装置的类似患者在大型、具有广泛代表性的社区HF人群中的不适当电击。简介:这项指导研究和培训提案也直接响应了AHRQ提高卫生保健质量、安全、效率和有效性的使命，并特别响应了比较有效性优先领域，建议：1)了解社区人群中适当和“酌情”使用双腔icd的模式，并确定与酌情使用双腔icd相关的人口和临床因素；2)确定单腔和双腔icd的相对安全性；3)对单腔icd和双腔icd的临床比较效果产生重要见解；4)评估对利益相关者重要的结果。此外，该奖项将促进Peterson博士发展成为全国公认的心血管疾病独立比较有效性研究者。