实用心力衰竭试验的临床终点:从数据收集到临床终点分类。

IF 3.7 2区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Veraprapas Kittipibul, Harriette G.C. Van Spall, William Schuyler Jones, Marat Fudim, Robert J. Mentz, Kevin Anstrom, Bertram Pitt, Patrice Desvigne-Nickens, Jerome L. Fleg, Camilla Hage, Stefan James, Claes Held, Lars Lund, Adam DeVore
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引用次数: 0

摘要

临床终点分类(CEC)-即使用预先定义的标准对临床事件进行评估-通常在临床试验操作中进行,以确保对评估干预安全性和有效性所需的终点进行系统和一致的评估。这与心力衰竭(HF)试验尤其相关,因为围绕住院的主观决策以及如何处理恶化的心力衰竭事件的差异(在医院和门诊环境中)。为了满足日益增长的对实用临床试验的需求,已采用了若干CEC战略,以增强可推广性,并尽量减少试验地点和患者的研究负担。本文总结了常见的CEC策略,包括传统方法、研究者报告的端点、使用真实数据的CEC和使用大型语言模型的CEC。我们总结了最近HF实用试验中使用的CEC策略,并从临床终点的选择和数据收集到CEC,提出了HF实用试验中CEC的挑战和考虑因素。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Clinical endpoints in pragmatic heart failure trials: From data collection to clinical endpoint classification

Clinical endpoints in pragmatic heart failure trials: From data collection to clinical endpoint classification

Clinical endpoint classification (CEC)—that is, evaluation of clinical events using pre-defined criteria—is commonly conducted in clinical trial operations to ensure systematic and consistent assessment of endpoints needed to assess the intervention's safety and efficacy. This is particularly relevant for heart failure (HF) trials given the subjective decision-making around hospitalizations and variation in how worsening HF events are managed (both in hospital and in ambulatory settings). Several CEC strategies have been adopted to address the growing need for pragmatic clinical trials that enhance generalizability and minimize research burden on trial sites and patients. This review summarizes common CEC strategies including the traditional approach, investigator-reported endpoints, CEC using real-world data and CEC utilizing large language models. We summarize CEC strategies used in recent HF pragmatic trials and present challenges and considerations for CEC in HF pragmatic trials from the selection of clinical endpoints and data collection to CEC.

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来源期刊
ESC Heart Failure
ESC Heart Failure Medicine-Cardiology and Cardiovascular Medicine
CiteScore
7.00
自引率
7.90%
发文量
461
审稿时长
12 weeks
期刊介绍: ESC Heart Failure is the open access journal of the Heart Failure Association of the European Society of Cardiology dedicated to the advancement of knowledge in the field of heart failure. The journal aims to improve the understanding, prevention, investigation and treatment of heart failure. Molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, as well as the clinical, social and population sciences all form part of the discipline that is heart failure. Accordingly, submission of manuscripts on basic, translational, clinical and population sciences is invited. Original contributions on nursing, care of the elderly, primary care, health economics and other specialist fields related to heart failure are also welcome, as are case reports that highlight interesting aspects of heart failure care and treatment.
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