Treatment Endpoints in Acute Decompensated Heart Failure

描述（由申请人提供）：医生在治疗急性失代偿性心力衰竭（ADHF）时面临的一个基本问题是“治疗何时足以安全出院，谁需要进一步治疗？”ADHF患者的发病率和死亡率都很高。目前急诊科（ED）和医院处理ADHF患者的指南是基于有限的经验证据。这造成了临床处置的不确定性，导致住院时间延长、费用增加和资源消耗增加。开展一个项目来回答这个问题，结合精心策划的教学和杰出研究人员的指导，将使我成为一名独立的临床研究者，主要关注ADHF患者的决策。ED是大多数ADHF入学的入口，为前瞻性研究决策提供了肥沃的土壤。我的具体目标是：1)进一步发展临床研究、高级建模和决策科学方面的知识，以促进我作为独立临床研究者的发展；2)从现成的临床数据中制定预测规则，帮助医生识别ADHF患者，这些患者在开始治疗后，从急诊科和医院提前出院是安全的。认识到ED在ADHF治疗中的重要性，NHLBI正在支持我们对1800名ED患者的观察性队列研究，以制定初始风险分层的预测规则（STRATIFY- 1R01HL088459）。为了完成我的目标，我将收集来自STRATIFY的500名患者的额外数据，这些患者的基线数据是在ED治疗后1小时内收集的。除了来自STRATIFY的基线数据外，目前的建议将收集治疗开始后2-4小时、12-24小时和96小时的临床和实验室数据。我们还将采访患者以测量社会和行为变量。我们将使用这些额外的数据来制定第二个预测规则，以帮助医生识别早期ED和治疗开始后出院的患者。该项目是实际应用所获得的教学知识的理想载体，提供了丰富的临床研究经验，并承诺产生广泛的初步数据，以充分扩展长期研究计划。我的临床研究、教学计划和高级生物统计学和建模课程将由一个高素质的、多学科的人才团队指导。基于我已经完成的成果研究奖学金和以前的研究经验，这个提案将使我成为一名成熟的临床研究者，为ADHF的决策制定预测规则。并在具有巨大医疗保健系统意义的疾病过程中产生基于证据的研究。（摘要结束）

DESCRIPTION (provided by applicant): A fundamental question faced by physicians treating acute decompensated heart failure (ADHF) is 'When has treatment worked sufficiently for safe discharge, and who requires further treatment?' Patients with ADHF have a high incidence of morbidity and mortality. Current guidelines for emergency department (ED) and hospital disposition of patients with ADHF are based on limited empirical evidence. This creates clinical uncertainty regarding disposition, leads to prolonged hospitalizations, higher costs and increased resource consumption. Conducting a project to answer this question, in combination with carefully planned didactics and mentoring from distinguished researchers, will allow me to develop as an independent clinical investigator with a primary focus on decision making in patients with ADHF. The ED is the portal of entry for the majority of ADHF admissions and presents fertile ground for prospectively studying decision making. My specific aims are: 1) to further develop knowledge in clinical research, advanced modeling, and decision sciences to advance my development as an independent clinical investigator and 2) to develop a prediction rule from readily available clinical data that helps physicians identify ADHF patients for whom early discharge from the ED and hospital is safe after treatment is initiated. In recognition of the importance of the ED in ADHF care, the NHLBI is supporting our observational cohort study of 1800 ED patients to develop a prediction rule for initial risk-stratification (STRATIFY- 1R01HL088459). To complete my aim, I will collect additional data on a subset of 500 patients from STRATIFY whose baseline data is collected within 1 hour of ED therapy. In addition to the baseline data from STRATIFY, the current proposal will collect clinical and laboratory data 2-4 hours, 12-24 hours and 96 hours after treatment is begun. We will also interview patients to measure social and behavioral variables. We will use this additional data to develop a second prediction rule to assist physicians in identifying patients safe for early ED and hospital discharge after therapy is begun. This project is an ideal vehicle for practical application of didactic knowledge gained, offers an intensive clinical research experience, and promises to generate extensive preliminary data to fully expand a long-term research program. My clinical research, didactic program and advanced biostatistical and modeling coursework will be supervised by a highly qualified, multi-disciplinary team of talented individuals, Building from my completed Outcomes Research fellowship and previous research experience, this proposal will allow me to mature as a clinical investigator, develop a prediction rule for decision making in ADHF, and engender evidence- based research in a disease process with tremendous healthcare system implications. (End of Abstract)