Individualizing Anticoagulant use in Older Adults with Atrial Fibrillation

患有房颤的老年人个体化抗凝药物的使用

• 批准号: 10669490
• 负责人: Sachin J Shah
• 金额: $ 24.3万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10669490
• 关键词: Activities of Daily Living; Address; Adverse event; Aging; Anticoagulant therapy; Anticoagulants; Atrial Fibrillation; Award; Benefits and Risks; California; Cardiovascular system; Clinical; Clinical Trials; Complement; Conflict (Psychology); Cryosurgery; Data; Data Collection; Decision Aid; Decision Making; Decision Modeling; Dependence; Development; Devices; Disease; Elderly; Enrollment; Epidemiologic Methods; Epidemiology; Event; Foundations; Future; Goals; Grant; Guidelines; Health; Health and Retirement Study; Heart Atrium; Hemorrhage; Heterogeneity; Hospitalization; Hospitals; Impairment; Individual; Internal Medicine; Intervention; Ischemic Stroke; K-Series Research Career Programs; Lead; Left; Life Expectancy; Measures; Medicine; Mentors; Mentorship; Methods; Modeling; Modernization; Outcome; Patients; Physicians; Placebo Control; Population; Procedures; Prospective cohort; Recommendation; Recovery of Function; Reporting; Research; Research Personnel; Research Training; Risk; San Francisco; Series; Specific qualifier value; Stream; Stroke; Stroke prevention; Syndrome; Testing; Therapeutic; Training; Universities; Validation; Voice; Work; barrier to care; base; career development; clinical epidemiology; clinical practice; cohort; data resource; design; disability; experience; falls; follow-up; forest; frailty; functional outcomes; functional status; heart rhythm; high risk; human centered design; improved; individualized medicine; investigator training; leadership development; machine learning method; machine learning model; multidisciplinary; novel; outcome prediction; professor; programs; side effect; stroke risk; tool; treatment effect; trend

Project Summary/Abstract This is a Beeson (K76) career development award for Sachin J Shah, MD, MPH, a physician-investigator trained in internal medicine, clinical epidemiology, and aging research. Dr. Shah is an Assistant Professor in the Division of Hospital Medicine at the University of California, San Francisco. Dr. Shah's long-term goal is to build evidence to individualize treatment recommendations for older adults facing high-risk, high-benefit therapeutic decisions using new epidemiologic methods and geriatric research principles. The decision to use anticoagulants in older adults with atrial fibrillation (AF) is the paradigm of a high-stakes therapeutic decision because while anticoagulants prevent stroke, they increase the risk of bleeding complications. Guidelines use a one-size-fits-all approach; for older adults, they recommend near-universal anticoagulant use. In numerous studies of clinical practice, physicians report concern with the current approach voicing the need to individualize treatment recommendations for older adults. This proposal addresses the pressing need to individualize anticoagulant treatment decisions in older adults with AF through two aims. Aim 1: Develop and validate individualized estimates of the treatment effect of anticoagulants for ischemic stroke prevention in older adults with AF. This aim will use clinical trial and observational data to develop and validate a treatment effect model that will estimate individual-level treatment benefit. Aim 2: Ascertain functional outcomes after major extracranial hemorrhage, both short-term and longer-term. The functional outcomes following major hemorrhage, a key adverse event of anticoagulant therapy, are unclear, especially in older adults. Through two studies, this proposal will determine the short- and long-term functional outcomes following major hemorrhage. Dr. Shah's exceptional, multidisciplinary mentoring team is led by Dr. Margaret Fang, nationally recognized for her work studying the clinical outcomes of anticoagulants in older adults and co-mentored by Dr. Kenneth Covinsky, whose nationally recognized research program has advanced our understanding of the predictors and outcomes of disability in older adults. This career development award will support Dr. Shah's transition to research independence through mentorship and focused training in (1) measuring heterogeneous treatment effects using novel epidemiologic tools, (2) primary data collection to build prospective cohorts of older adults, (3) designing decision aids and (4) leadership development to lead cross-disciplinary, multi-institutional research teams. This proposal will support a development grant to design and pilot a clinical decision tool for older adults considering anticoagulant and a project grant to measure heterogeneous treatment effects of procedural interventions in older adults with AF. The proposed research and training aims will provide Dr. Shah with the data, training, and experience to support competitive R-series applications.

项目总结/摘要 这是一个比森（K76）职业发展奖萨钦J沙阿，医学博士，公共卫生硕士，一名医生，调查员 接受过内科、临床流行病学和老龄化研究方面的培训。Shah博士是一名助理教授， 加州大学旧金山弗朗西斯科医院医学部。Shah博士的长期目标是 建立证据，为面临高风险、高收益的老年人提供个性化的治疗建议 使用新的流行病学方法和老年医学研究原则作出治疗决定。决定使用 抗凝剂在老年房颤（AF）患者中是高风险治疗决策的范例 因为虽然抗凝剂可以预防中风，但它们会增加出血并发症的风险。指南使用 一种适合所有人的方法;对于老年人，他们建议几乎普遍使用抗凝剂。在许多 临床实践的研究，医生报告关注目前的方法，需要 为老年人提供个性化的治疗建议。这项建议针对迫切需要， 通过两个目标，对老年房颤患者进行个体化抗凝治疗决策。目标1：发展和 验证抗凝剂预防缺血性卒中治疗效果的个体化评估， 这一目标将使用临床试验和观察数据来开发和验证一种治疗方法， 估计个体水平治疗获益的效应模型。目标2：确定术后功能结局 短期和长期的颅外大出血主要职能成果 出血是抗凝治疗关键不良事件，目前尚不清楚，尤其是在老年人中。通过两 研究，该建议将确定大出血后的短期和长期功能结局。 沙阿博士的特殊，多学科的指导团队是由玛格丽特方博士，国家承认， 她研究老年人抗凝剂的临床结果，并由Kenneth博士共同指导 Covinsky，他的国家认可的研究项目已经推进了我们对预测因子的理解， 和老年人残疾的后果。这个职业发展奖将支持沙阿博士的过渡， 通过导师制和重点培训实现研究独立性：（1）测量异质性治疗 使用新的流行病学工具的影响，（2）初步数据收集，以建立老年人的前瞻性队列， (3)设计决策辅助工具和（4）领导力发展，以领导跨学科，多机构 研究团队。该提案将支持开发赠款，以设计和试点临床决策工具， 考虑抗凝剂的老年人和项目补助金，以衡量 建议的研究和培训目标将提供沙阿博士 提供数据、培训和经验，以支持竞争对手的R系列应用。