Balancing the Risks of Ischemia and Bleeding in Percutaneous Coronary Interventio

平衡经皮冠状动脉介入治疗中的缺血和出血风险

• 批准号: 9216363
• 负责人: Robert Yeh
• 金额: $ 16.44万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9216363
• 关键词: Accounting; Adverse event; Age; Antiplatelet Drugs; Applications Grants; Area; Benefits and Risks; Bioinformatics; Blood Platelets; Cardiac Catheterization Procedures; Cardiology; Cardiovascular system; Catheterization; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Coagulation Process; Computer software; Conduct Clinical Trials; Coronary; Coronary Arteriosclerosis; Coronary artery; Data; Data Analyses; Decision Aid; Decision Analysis; Economics; Effectiveness; Electronic Health Record; Environment; Epidemiology; Equilibrium; Ethnic group; Event; Faculty; Feasibility Studies; Funding; General Hospitals; Goals; Health; Health Policy; Heart; Hemorrhage; Industry; Information Technology; Institution; Insurance; Internal Medicine; Intervention; Ischemia; K-Series Research Career Programs; Laboratories; Lead; Literature; Logistic Regressions; London; Manuals; Massachusetts; Medical; Medicine; Mentors; Methods; Modeling; Morbidity - disease rate; Natural Language Processing; Outcome; Outcomes Research; Patient Care; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Physicians; Population; Pragmatic clinical trial; Procedures; Randomized; Randomized Clinical Trials; Registries; Reporting; Research; Research Institute; Research Methodology; Research Personnel; Research Training; Resources; Risk; Safety; Schools; System; Testing; Time; Training; Training Programs; Translating; Uncertainty; United States National Institutes of Health; Variant; Weight; alternative treatment; career; career development; clinical decision-making; cohort; comparative effectiveness; coronary angioplasty; design; effectiveness research; experience; implementation research; improved; individual patient; innovation; interest; medical schools; meetings; member; mid-career faculty; mortality; new technology; novel; patient oriented; patient population; patient registry; percutaneous coronary intervention; point of care; population health; professor; prospective; racial and ethnic; routine care; routine practice; skills; study population; symposium; theories; tool; training opportunity; treatment effect; treatment strategy; usability

DESCRIPTION (provided by applicant): The overall objective of this grant proposal is to develop and assess a system to enhance the rational and personalized application of antiplatelet therapy for patients undergoing percutaneous coronary intervention (PCI, or coronary angioplasty and stenting). This proposal describes a 5 year research and training program designed to provide the candidate, Robert Yeh, the necessary skills and experience to develop an independent academic research career in the conduct of translational cardiovascular outcomes research. Candidate: Dr. Yeh received an MSc in health policy from the London School of Economics, an MD from Harvard Medical School, and has completed clinical training in internal medicine (MGH), cardiology (UCSF) and interventional cardiology (MGH). He is now a junior faculty member at the Massachusetts General Hospital with 75% protected time to conduct clinical research. While he has successfully been involved with epidemiologic and secondary data analysis, Dr. Yeh will pursue additional training in the areas of decision analysis, clinical trial conduct and implementation research, and bioinformatics - training which will allow him to translate outcomes research findings into novel interventions which improve patient health. The candidate's long-term goal is to become an R01-funded investigator in the applied outcomes research that has a broad impact on population health. Environment: The candidate will be mentored by Dr. Laura Mauri (Primary Mentor), Associate Professor of Medicine at HMS and chief scientific officer of the Harvard Clinical Research Institute (HCRI), and Dr. Sharon- Lise Normand (Co-Mentor), Professor of Health Care Policy at HMS and Vice Chair of the Patient-Centered Outcomes Research Institute's Methods Committee. Both are internationally recognized leaders in their respective fields, and provide complementary expertise relevant to the research and training of the candidate. Dr. Mauri has an established track record of successfully leading practice-changing multicenter clinical trials in interventional cardiology, including the NIH/FDA/Industry-sponsored Dual Antiplatelet Theray (DAPT) Study. She has mentored several cardiovascular clinical investigators, including those that have received K awards and R01 funding. Dr. Normand has successfully mentored a large number of successful academic investigators, and is an internationally recognized expert in outcomes and comparative effectiveness research methods used in this proposal. The combined resources of several Harvard Medical School institutions, including HCRI, the Department of Health Care Policy, and the MGH Heart Center will support a rich and productive environment for Dr. Yeh's career development through a combination of didactic training, seminars, weekly research meetings, and conference presentations. Research: In the current era of invasive management of coronary artery disease, balancing the tradeoff between ischemic events and bleeding complications has become integral to decisions regarding the type and duration of antiplatelet therapy in patients undergoing coronary intervention. In Aim 1, multivariable logistic regression will be used to develop models that can predict bleeding and ischemic events in patients after PCI depending on antiplatelet strategy, using data from the DAPT Study, the largest PCI clinical trial conducted to date, and the Massachusetts PCI Registry, a comprehensive longitudinal registry of patients undergoing coronary intervention. Models that can predict treatment benefit or harm associated with specific strategies will be developed. In Aim 2, decision analysis methods will be employed to enhance these models such that the treatment strategy which is predicted to maximize patient benefit can be identified for all patients, and associated uncertainty in this determination can be assessed. In Aim 3, these tools will be integrated into a novel software application that can execute multivariable risk predictions at the point of care within the MGH cardiac catheterization laboratory. These tools will be used as clinical decision aids, and tested in a prospective randomized clinical trial to determine whether such interventions can enhance clinical decision making. The research will demonstrate how the end products of outcomes research can be translated into innovative interventions that can "personalize" medical decisions and ultimately improve patient care.

描述（由申请人提供）：本拨款提案的总体目标是开发和评估一个系统，以增强接受经皮冠状动脉介入治疗（PCI，或冠状动脉成形术和支架置入术）患者抗血小板治疗的合理和个性化应用。该提案描述了一项为期 5 年的研究和培训计划，旨在为候选人 Robert Yeh 提供必要的技能和经验，以在转化心血管结果研究方面发展独立的学术研究生涯。候选人：叶博士获得伦敦经济学院卫生政策硕士学位、哈佛医学院医学博士学位，并完成了内科（MGH）、心脏病学（UCSF）和介入心脏病学（MGH）的临床培训。他现在是马萨诸塞州总医院的一名初级教员，有 75% 的受保护时间进行临床研究。虽然叶博士已成功参与流行病学和二级数据分析，但他还将在决策分析、 临床试验的实施和实施研究以及生物信息学培训，使他能够将结果研究结果转化为改善患者健康的新颖干预措施。候选人的长期目标是成为 R01 资助的应用结果研究领域的研究人员，该研究对人口健康产生广泛影响。环境：候选人将受到 HMS 医学副教授兼哈佛临床研究所 (HCRI) 首席科学官 Laura Mauri 博士（主要导师）和 HMS 医疗保健政策教授兼以患者为中心的结果研究所方法委员会副主席 Sharon-Lise Normand 博士（联合导师）的指导。两人都是各自领域国际公认的领导者，并提供与候选人的研究和培训相关的互补专业知识。 Mauri 博士在介入心脏病学方面拥有成功领导改变实践的多中心临床试验的良好记录，包括 NIH/FDA/行业赞助的双重抗血小板治疗 (DAPT) 研究。她指导过几位心血管临床研究人员，包括那些获得 K 奖和 R01 资助的研究人员。诺曼德博士成功指导了大量成功的学术研究人员，并且是本提案中使用的结果和比较有效性研究方法方面国际公认的专家。哈佛医学院多个机构（包括 HCRI、医疗保健政策系和 MGH 心脏中心）的综合资源将通过教学培训、研讨会、每周研究会议和会议演讲相结合，为叶博士的职业发展提供丰富而富有成效的环境。研究：在当今冠状动脉疾病侵入性治疗的时代，平衡缺血事件和出血并发症之间的权衡已成为接受冠状动脉介入治疗的患者抗血小板治疗类型和持续时间决策中不可或缺的一部分。在目标 1 中，将使用多变量逻辑回归开发模型，根据抗血小板策略预测 PCI 后患者的出血和缺血事件，使用的数据来自 DAPT 研究（迄今为止进行的最大的 PCI 临床试验）和马萨诸塞州 PCI 登记处（接受冠状动脉介入治疗的患者的综合纵向登记处）。将开发可以预测与特定策略相关的治疗益处或危害的模型。在目标 2 中，将采用决策分析方法来增强这些模型，以便可以为所有患者确定预计将患者利益最大化的治疗策略，并可以评估该决定中的相关不确定性。在目标 3 中，这些工具将集成到一个新颖的软件应用程序中，该应用程序可以在 MGH 心导管实验室的护理点执行多变量风险预测。这些工具将用作临床决策辅助工具，并在前瞻性随机临床试验中进行测试，以确定此类干预措施是否可以增强临床决策。该研究将展示如何将结果研究的最终产品转化为创新干预措施，从而“个性化”医疗决策并最终改善患者护理。