Standardised and hierarchically classified heart failure and complementary disease monitoring outcome measures: european Unified Registries for heart Care evaluation and randomised trials (EuroHeart).

IF 4.8 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Quality of Care and Clinical Outcomes Pub Date : 2024-10-09 DOI:10.1093/ehjqcco/qcae086

Asad Bhatty, Chris Wilkinson, Gorav Batra, Suleman Aktaa, Adam B Smith, Ali Wahab, Sam Chappell, Joakim Alfredsson, David Erlinge, Jorge Ferreira, Ingibjörg J Guðmundsdóttir, Þórdís Jóna Hrafnkelsdóttir, Inga Jóna Ingimarsdóttir, Alar Irs, András Jánosi, Zoltán Járai, Manuel Oliveira-Santos, Bogdan A Popescu, Peter Vasko, Dragos Vinereanu, Jonathan Yap, Raffaele Bugiardini, Edina Cenko, Ramesh Nadarajah, Matthew R Sydes, Stefan James, Aldo P Maggioni, Lars Wallentin, Barbara Casadei, Chris P Gale

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引用次数: 0

Abstract

Aims: The lack of standardised definitions for heart failure outcome measures limits the ability to reliably assess effectiveness of heart failure therapies. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) aimed to produce a catalogue of internationally endorsed data definitions for heart failure outcome measures.

Methods: Following the EuroHeart methods for the development of cardiovascular data standards, a working group was formed of representatives from the European Society of Cardiology Heart Failure Association and other leading heart failure experts. A systematic review of observational and randomised clinical trials identified current outcome measures, which was supplemented by clinical practice guidelines and existing registries for contemporary definitions. A modified Delphi process was employed to gain consensus for variable inclusion and whether collection should be mandatory (Level 1) or optional (Level 2) within EuroHeart. In addition, a set of complementary outcome measures were identified by the Working Group as of scientific and clinical importance for longitudinal monitoring for people with heart failure.

Results: Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure.

Conclusion: We present a structured, hierarchical catalogue of internationally endorsed heart failure outcome measures. This will facilitate quality improvement, high quality observational research, registry-based trials, and post market surveillance of medical devices.

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标准化和分级分类的心力衰竭和辅助疾病监测结果测量方法：欧洲心脏护理评估和随机试验统一登记处（EuroHeart）。

目的：心力衰竭结果测量标准定义的缺乏限制了可靠评估心力衰竭治疗效果的能力。欧洲心脏护理评估和随机试验统一登记处（EuroHeart）的目标是为心力衰竭结果测量编制一份国际认可的数据定义目录：按照 EuroHeart 制定心血管数据标准的方法，由欧洲心脏病学会心力衰竭协会的代表和其他主要心力衰竭专家组成了一个工作组。通过对观察性临床试验和随机临床试验的系统回顾，确定了当前的结果测量方法，并通过临床实践指南和现有登记册对当代定义进行了补充。我们采用了一种改良的德尔菲流程，以便就变量的纳入以及在 EuroHeart 中应强制收集（1 级）还是选择收集（2 级）达成共识。此外，工作组还确定了一组补充性结果测量指标，认为它们对心衰患者的纵向监测具有重要的科学和临床意义：结果：选定并定义了五项一级和两项二级结果指标，以及五项针对心衰患者的补充监测结果：结论：我们提出了国际认可的心力衰竭结果测量的结构化分级目录。这将有助于质量改进、高质量的观察研究、以登记为基础的试验以及医疗设备的上市后监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Heart Journal - Quality of Care and Clinical Outcomes CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

9.40

自引率

3.80%

发文量

期刊介绍： European Heart Journal - Quality of Care & Clinical Outcomes is an English language, peer-reviewed journal dedicated to publishing cardiovascular outcomes research. It serves as an official journal of the European Society of Cardiology and maintains a close alliance with the European Heart Health Institute. The journal disseminates original research and topical reviews contributed by health scientists globally, with a focus on the quality of care and its impact on cardiovascular outcomes at the hospital, national, and international levels. It provides a platform for presenting the most outstanding cardiovascular outcomes research to influence cardiovascular public health policy on a global scale. Additionally, the journal aims to motivate young investigators and foster the growth of the outcomes research community.