实用性心力衰竭试验中的临床终点:从数据收集到临床终点分类
Veraprapas Kittipibul1,2, Harriette G C Van Spall3,4, William Schuyler Jones1,2
1Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
ESC heart failure
|July 9, 2025
概括
临床终点分类 (CEC) 确保一致的试验数据. 本综述探讨了心力衰竭 (HF) 试验的 CEC 策略,包括传统方法,现实数据和大语言模型,以改进实用性试验设计.
科学领域:
- 临床试验方法论的方法论.
- 心血管研究的心血管研究.
- 医疗信息学 医疗信息学
背景情况:
- 临床终点分类 (CEC) 对于在临床试验中一致评估安全性和疗效至关重要.
- 心力衰竭 (HF) 试验面临挑战,因为主观事件评估和变量管理恶化的HF.
- 实用性临床试验需要有效的CEC策略来提高概括性和减少参与者的负担.
研究的目的:
- 审查和总结常见的临床终点分类 (CEC) 策略.
- 检查最近心力衰竭 (HF) 实用试验中使用的CEC方法.
- 确定在高频实用试验中实施CEC的挑战和考虑因素.
主要方法:
- 对共同的 CEC 战略进行文献综述.
- 在最近的心力衰竭实用试验中分析了CEC方法.
- 讨论从终点选择到数据收集和分类的挑战.
主要成果:
- 常见的CEC策略包括传统方法,研究者报告的终点,现实世界数据 (RWD) 和大语言模型 (LLM).
- 最近的高频实用试验采用了各种CEC策略来实现试验目标.
- 关键的考虑包括端点选择,数据收集方法,以及应用LLMs等先进技术.
结论:
- 存在多种CEC策略,为实用试验提供灵活性.
- 选择CEC策略会影响试验的概括性和效率.
- 解决终点定义,数据采集和分类方面的挑战对于成功的高频实用试验至关重要.
更多相关视频
相关概念视频
Heart Failure IV: Classification and Diagnostic Evaluation
38
Heart failure can be classified in various ways, with the most common classifications based on physical activity limitations, disease progression, severity, and treatment strategies.The Functional Classification of Heart Failure divides patients into four categories based on physical activity limitation due to symptom burden.Class I: Patients in this class have cardiac disease but no physical activity limitations. Ordinary activities like walking, climbing stairs, or routine tasks do not cause...
38
Pathophysiology of Heart Failure
1.9K
Heart failure (HF) is a progressive syndrome involving ventricles that leads to inadequate cardiac output. It can be classified based on location and output or ejection fraction. Ejection fraction (EF) is an essential measurement in the diagnosis and surveillance of HF. Reduced EF corresponds to systolic heart failure (HFrEF). However, HF with preserved ejection fraction (HFpEF) is becoming increasingly prevalent. Also known as diastolic HF, this form of HF is related to aging. The...
1.9K
Heart Failure V: Medical Management
29
Medical Management of Acute Decompensated Heart Failure (ADHF)The primary goals of therapy for patients hospitalized with acute decompensated heart failure (ADHF) include:Relieving symptomsOptimizing volume statusSupporting oxygenation and ventilationMaintaining cardiac output (CO) and end-organ perfusionIdentifying and addressing the cause of ADHFPreventing complicationsProviding patient education on factors precipitating HF exacerbationPlanning for dischargeOngoing monitoring and assessment...
29
Heart Failure III: Clinical Manifestations
52
Heart failure (HF) manifests primarily as dyspnea, fatigue, and fluid retention, resulting in peripheral and pulmonary edema. Symptoms may vary depending on which ventricle is more affected, left or right.Left-Sided Heart FailureAlso known as left ventricular failure, this condition results from the left ventricle's inability to fill or eject sufficient blood into the systemic circulation. It leads to pulmonary congestion, which occurs when the left ventricle fails to eject blood effectively...
52
Heart Failure VI: Adjunct Therapies
36
Additional therapies for treating patients with heart failure (HF) may include procedural interventions, supplemental oxygen, the management of sleep disorders, and nutritional therapy.Procedural InterventionsImplantable Cardioverter-Defibrillator: For patients at risk of life-threatening arrhythmias due to severe left ventricular dysfunction, an Implantable Cardioverter-Defibrillator (ICD) can detect and terminate these arrhythmias, preventing sudden cardiac death and improving survival rates.
36
Heart Failure VII: Nursing Interventions
145
The first step in nursing management of a patient with heart failure involves thoroughly assessing the patient's medical history.Subjective Data: Obtain the patient's medical history of coronary artery disease, hypertension, myocardial infarction, and symptoms like dyspnea, orthopnea, and paroxysmal nocturnal dyspnea.Objective Data: Conduct a physical examination to identify findings such as jugular vein distention, pulmonary crackles, tachycardia, murmurs, peripheral edema, and vital signs,...
145


