Using Claims-Based Signatures of Frailty to Support Individualized Treatment of Aortic Valve Stenosis and Coronary Artery Disease

使用基于索赔的虚弱特征来支持主动脉瓣狭窄和冠状动脉疾病的个体化治疗

• 批准号: 10363612
• 负责人: Robert Yeh
• 金额: $ 12.03万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10363612
• 关键词: Accounting; Age; Aortic Valve Stenosis; Aspirin; Cardiovascular Diseases; Cardiovascular system; Caring; Characteristics; Clinical Trials; Communities; Complement; Coronary; Coronary Arteriosclerosis; Coronary artery; Data; Data Collection; Data Set; Data Sources; Decision Aid; Decision Making; Development; Enrollment; Evaluation; Faculty; Frail Elderly; Funding; Grant; Health; Health system; Heart Diseases; Hemorrhage; Heterogeneity; Hospitals; Individual; Knowledge; Laboratories; Life; Link; Measurement; Measures; Medical; Medicare claim; Mentors; Mid-Career Clinical Scientist Award (K24); Morbidity - disease rate; Myocardial Infarction; National Heart, Lung, and Blood Institute; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patients; Physiological; Population; Procedures; Public Health; Quality of life; Recommendation; Registries; Research; Research Personnel; Research Support; Research Training; Risk; Risk Estimate; Risk Factors; Source; Stents; Stroke; Subgroup; Talents; Translating; Treatment outcome; Work; adverse event risk; aggressive therapy; alternative treatment; aortic valve; aortic valve replacement; base; career; comorbidity; data registry; evidence base; frailty; hazard; high risk; improved; indexing; individual patient; individualized medicine; inhibitor; insight; minimally invasive; mortality; novel; older patient; patient oriented research; personalized approach; personalized decision; point of care; preference; prognostic; programs; prospective; randomized trial; research clinical testing; risk stratification; shared decision making; stent thrombosis; stressor; therapy duration; tool; treatment effect; treatment strategy

PROJECT SUMMARY/ABSTRACT Severe aortic valve stenosis and coronary artery disease afflict a large number of patients worldwide. Choosing the optimal management strategies among various alternatives requires accounting for the characteristics and comorbidities of individuals that best determine the potential benefits or harms from different treatment approaches. However, randomized trials often do not collect the information necessary to inform individualized treatment decisions – in particular, data on patient frailty is typically not captured. In this grant, we will take advantage of linkages between two trial programs, the Dual Antiplatelet Therapy Study (comparing shorter vs. longer duration of antiplatelet therapy after coronary stenting) and the US CoreValve Program (comparing surgical versus transcatheter aortic valve replacement), with data from Medicare claims as part of the NHLBI-sponsored Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study to answer these additional questions. First, we will identify variables available in administrative claims that correlate with frailty among individuals undergoing aortic valve replacement or coronary artery stenting and assess whether they predict long-term adverse cardiovascular outcomes above traditional risk factors ascertained in trials. Next, we will determine whether claims-based frailty indices derived from these non-trial data can identify heterogeneous treatment effects – i.e. treatment effects that differ between individuals based on their personal characteristics – within the trials' randomized populations. Based on these results, we will then create and pilot the implementation of quantitative decision tools to support individualized treatment approaches for patients with aortic stenosis requiring aortic valve replacement and those who require dual antiplatelet therapy after coronary stent procedures. The results of this research will greatly enhance our understanding of whether administrative claims data can be used to augment the evaluation of patient frailty within clinical trials, and determine whether frail patients with cardiovascular disease require different treatment strategies. The results may also greatly improve the ability to identify individual patients who have the most or least to gain from different treatment approaches for two common and highly morbid cardiovascular conditions. Finally, the proposed research will help create evidence- based decision tools that can be used to support shared decision making between clinicians and patients with aortic valve stenosis and coronary artery disease.

项目摘要/摘要 严重的主动脉瓣狭窄和冠状动脉疾病困扰着全球大量患者。 在各种替代方案之间选择最佳管理策略需要考虑 最能确定潜在利益或损害的个人的特征和合并症 不同的治疗方法。但是，随机试验通常不会收集所需的信息 告知个性化的治疗决策 - 特别是，通常不会捕获有关患者脆弱的数据。在这个 格兰特，我们将利用两个试验计划之间的联系，即双重抗血小板治疗研究 （比较冠状动脉支架后较短与持续时间的抗血小板疗法）和美国Corevalve 程序（比较手术与经导管主动脉瓣更换）和Medicare索赔的数据 作为NHLBI赞助的新型医疗疗法评估的一部分 数据源（扩展）研究以回答这些其他问题。首先，我们将确定变量 在经历主动脉瓣的个体中与脆弱相关的行政索赔可用 替代或冠状动脉支架和评估是否预测长期不良心血管 在试验中确定的高于传统风险因素的结果。接下来，我们将确定是否基于索赔 从这些非试验数据中得出的脆弱指数可以识别出异质的治疗效果 - 即治疗 基于个人的个人特征之间不同的效果 - 在试验的随机分析中 人群。基于这些结果，我们将创建和试行定量决策的实施 支持需要主动脉瓣的主动脉狭窄患者的个性化治疗方法 替代者和冠状动脉支架手术后需要双重抗血小板治疗的人。结果 这项研究将大大增强我们对行政索赔数据是否可以使用的理解 增强对临床试验中患者脆弱的评估，并确定是否脆弱 心血管疾病需要不同的治疗策略。结果也可能会大大提高 确定两个人从不同的治疗方法中获得最多或最少的患者 常见且高病态的心血管疾病。最后，拟议的研究将有助于创造证据 - 可用于支持临床医生和患者之间共同决策的基于决策工具 主动脉瓣狭窄和冠状动脉疾病。