Bhatty Asad, Wilkinson Chris, Batra Gorav, Aktaa Suleman, Smith Adam B, Wahab Ali, Chappell Sam, Alfredsson Joakim, Erlinge David, Ferreira Jorge, Guðmundsdóttir Ingibjörg J, Hrafnkelsdóttir Þórdís Jóna, Ingimarsdóttir Inga Jóna, Irs Alar, Jánosi András, Járai Zoltán, Oliveira-Santos Manuel, Popescu Bogdan A, Vasko Peter, Vinereanu Dragos, Yap Jonathan, Bugiardini Raffaele, Cenko Edina, Nadarajah Ramesh, Sydes Matthew R, James Stefan, Maggioni Aldo P, Wallentin Lars, Casadei Barbara, Gale Chris P
Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
Eur Heart J Qual Care Clin Outcomes. 2024 Oct 9. doi: 10.1093/ehjqcco/qcae086.
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.
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.
Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure.
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.
心力衰竭预后指标缺乏标准化定义，限制了可靠评估心力衰竭治疗效果的能力。欧洲心脏护理评估与随机试验统一注册中心（EuroHeart）旨在编制一份国际认可的心力衰竭预后指标数据定义目录。
按照EuroHeart制定心血管数据标准的方法，成立了一个由欧洲心脏病学会心力衰竭协会代表和其他主要心力衰竭专家组成的工作组。对观察性和随机临床试验进行系统综述，确定当前的预后指标，并辅以临床实践指南和现有注册中心提供的当代定义。采用改良的德尔菲法，就EuroHeart中变量纳入以及收集应为强制性（1级）还是可选性（2级）达成共识。此外，工作组还确定了一组对心力衰竭患者进行纵向监测具有科学和临床重要性的补充预后指标。
选择并定义了五项1级和两项2级预后指标，以及五项心力衰竭患者的补充监测指标。
我们提出了一份国际认可的心力衰竭预后指标的结构化分层目录。这将有助于质量改进、高质量观察性研究、基于注册中心的试验以及医疗器械上市后监测。
