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: 8319245
• 负责人: PAMELA N PETERSON
• 金额: $ 14.69万
• 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/8319245
• 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.

描述（由申请人提供）：彼得森博士是丹佛健康医疗中心和科罗拉多丹佛大学（UCD）心脏病学系的医学助理教授。她已经完成了公共卫生硕士学位，并进行了多项观察性研究，重点关注心力衰竭（HF）患者的护理质量和结局。Peterson博士的职业目标是通过开展HF的比较有效性研究（CER）来改善心力衰竭患者的护理和结局。职业发展目标和培训：拟议的K 08职业发展计划建立在她之前在观察性研究方面的培训和经验的基础上，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）结合数据源和数据结构分析策略的专业知识; 2）观察性研究中因果推断的统计方法的高级培训;具体而言，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，彼得森博士提出了重点课程和研讨会，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HF患者治疗的比较有效性的理解。导师/环境：主要导师Frederick Masoudi（医学博士，MSPH）是AHRQ申办的ICD（LSICD）多中心纵向研究的共同主要研究者，该研究将为本K 08提供数据和研究基础设施。共同导师大卫马吉德，医学博士，公共卫生硕士是共同PI的心血管研究网络（CVRN），是研究主任为科罗拉多永久医疗集团。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系教授，也是国际公认的观察性CER方法专家。这个指导团队非常有能力保证彼得森博士的研究和培训活动的完成。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局研究（CCOR）组。CCOR是一个由心血管结局研究人员组成的多机构和多学科小组，汇集了方法和内容专业知识，以进行尖端的心血管结局研究。研究环境的另一个关键方面是凯撒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、统计员、分析人员、程序员、IT支持人员和行政人员提供支持。Dr. Peterson自2005年以来一直担任附属研究者。Masoudi博士（主要导师）也是一名附属研究员，Magid博士是本提案的共同导师，是IHR的高级研究员。研究：随着具有里程碑意义的临床疗效试验的发表，植入式心律转复除颤器（ICD）用于HF和左心室功能降低患者心脏性猝死的一级预防的使用有所增加。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。更复杂的双腔室装置提供了超越更简单的单腔室装置的理论益处。然而，双腔器械在没有明确适应症的患者中的受益（即“自由裁量”双腔器械）尚未确定。本多中心队列研究的研究目的是确定与使用任意双腔器械相关的患者和医生因素，并在一项大型、具有广泛代表性的社区HF人群。总结：这一指导研究和培训建议也直接响应AHRQ的使命，即提高保健的质量、安全效率和效力，并通过建议1）了解社区中适当和“酌情”使用双腔ICD的模式，对相对有效性优先领域做出具体回应-基于人群，并识别与酌情使用双腔器械相关的人口统计学和临床因素; 2）确定单腔和双腔ICD的比较安全性; 3）对单腔和双腔ICD的临床比较有效性产生重要见解;以及4）评价对利益相关者重要的结局。此外，该奖项将促进彼得森博士发展成为国家认可的心血管疾病独立比较有效性研究者。 公共卫生相关性：许多心力衰竭患者因心律异常而猝死的风险很高。植入式心律转复除颤器（ICD）是设计用于治疗这些心律失常并预防猝死的设备。本研究将提供关于不同类型ICD器械在现实环境中的风险和受益的信息，从而为在目前指导实践的随机试验中未研究的广泛患者人群中最佳使用这种侵入性治疗提供信息。