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: 8508804
• 负责人: PAMELA N PETERSON
• 金额: $ 14.68万
• 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/8508804
• 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）：Peterson 博士是丹佛健康医疗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果。 Peterson 博士的职业目标是通过开展心力衰竭比较有效性研究 (CER) 来改善心力衰竭患者的护理和结果。职业发展目标和培训：拟议的 K08 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）结合数据源和分析策略以解释数据结构的专业知识； 2）观察研究中因果推理统计方法的高级培训；具体来说，解决混杂因素的方法，包括倾向评分、工具变量和敏感性分析； 3）分析纵向数据的统计方法和处理缺失数据的方法的高级培训。因此，彼得森博士提出了有针对性的课程和研讨会，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，并增进对心衰患者治疗相对有效性的了解。导师/环境：主要导师 Frederick Masoudi（医学博士、公共卫生硕士）是 AHRQ 赞助的 ICD 多中心纵向研究 (LSICD) 的联合 PI，该研究将为 K08 提供数据和研究基础设施。联合导师 David Magid，医学博士、公共卫生硕士，是心血管研究网络 (CVRN) 的联合 PI，也是科罗拉多永久医疗集团的研究总监。共同导师 Sharon-Lise Normand 博士是哈佛医学院医疗保健政策（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。这个导师团队非常有能力保证完成Peterson博士提出的研究和培训活动。 Peterson 博士研究环境的一个重要方面是全国公认的科罗拉多心血管结果研究 (CCOR) 小组。 CCOR 是一个由知名心血管结果研究人员组成的多机构、多学科小组，汇集了方法论和内容方面的专业知识，以开展前沿的心血管结果研究。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)，它将作为该提案的数据协调和分析中心。 KPCO-IHR 包括 116 名研究人员，由研究护士、项目经理、研究助理、统计学家、分析人员、程序员、IT 支持和行政人员提供支持。 Peterson 博士自 2005 年以来一直担任附属研究员。Masoudi 博士（主要导师）也是附属研究员，而 Magid 博士是该提案的共同导师，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) 用于一级预防心力衰竭和左心室功能下降患者心源性猝死的情况有所增加。然而，这些试验留下了许多问题，包括最佳设备选择，尚未得到解答。更复杂的双室装置比更简单的单室装置具有理论上的优势。然而，双室装置在没有明确指示的情况下（即“酌情”双室装置）的好处尚未确定。这项多中心队列研究的研究目标是确定与使用酌情双腔装置相关的患者和医生因素，并比较在大型、具有广泛代表性的社区心力衰竭人群中接受单腔 ICD 的患者和接受酌情双腔装置的类似患者的 a) 围手术期和纵向并发症、b) 住院情况、c) 死亡率和 d) 不当电击。摘要：这项指导研究和培训提案也直接响应 AHRQ 提高医疗保健质量、安全效率和有效性的使命，并且特别响应比较有效性优先领域，提出以下建议：1) 了解双腔 ICD 在社区人群中适当和“酌情”使用的模式，并确定与酌情使用双腔装置相关的人口和临床因素； 2) 确定单室ICD和双室ICD的相对安全性； 3) 对单室 ICD 和双室 ICD 的临床比较有效性产生重要见解； 4) 评估对利益相关者重要的结果。此外，该奖项将促进彼得森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。 公共卫生相关性：许多心力衰竭患者因心律异常而面临猝死的高风险。植入式心律转复除颤器 (ICD) 是专为治疗心律失常和预防猝死而设计的设备。这项研究将提供有关不同类型 ICD 设备在现实环境中的风险和益处的信息，从而为目前指导实践的随机试验中尚未研究的广大患者群体提供这种侵入性治疗的最佳使用方式。