Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).
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Wilkinson Chris, Bhatty Asad, Batra Gorav, Aktaa Suleman, Smith Adam B, Dwight Jeremy, Ruciński Marcin, 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, Global Cardiovascular Outcomes Consortium and in collaboration with ACNAP, ACVC, EACVI, EAPC, EAPCI, EHRA, ESC Committee for Young CV Professionals, ESC Registry Committee, HFA, ESC Patient Forum and these Working Groups: aorta and peripheral vascular diseases, atherosclerosis and vascular biology, cardiac cellular electrophysiology, cardiovascular pharmacotherapy, cardiovascular regenerative and restorative medicine, cardiovascular surgery, cellular biology of the heart, e-cardiology, myocardial function, pulmonary circulation and right ventricular function and thrombosis
Аннотация
METHODS: The EuroHeart methods for data standard development were used. From a Global Cardiovascular Outcomes Consortium of 82 experts, five Working Groups were formed to identify and define key outcome measures for: cardiovascular disease (generic outcomes), acute coronary syndrome and percutaneous coronary intervention (ACS/PCI), atrial fibrillation (AF), heart failure (HF) and transcatheter aortic valve implantation (TAVI). A systematic review of the literature informed a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition and categorized the variable as mandatory (Level 1) or optional (Level 2) based on its clinical importance and feasibility.
RESULTS: Across the five domains, 24 Level 1 (generic: 5, ACS/PCI: 8, AF: 2; HF: 5, TAVI: 4) and 48 Level 2 (generic: 18, ACS-PCI: 7, AF: 6, HF: 2, TAVI: 15) outcome measures were defined.
CONCLUSIONS: Internationally derived and endorsed definitions for outcome measures for a range of common cardiovascular diseases and interventions are presented. These may be used for data alignment to enable high-quality observational and randomized clinical research, audit, and quality improvement for patient benefit.