TY - JOUR
T1 - Definitions of clinical study outcome measures for cardiovascular diseases
T2 - the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)
AU - 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 dis
AU - Wilkinson, Chris
AU - Bhatty, Asad
AU - Batra, Gorav
AU - Aktaa, Suleman
AU - Smith, Adam B
AU - Dwight, Jeremy
AU - Ruciński, Marcin
AU - Chappell, Sam
AU - Alfredsson, Joakim
AU - Erlinge, David
AU - Ferreira, Jorge
AU - Guðmundsdóttir, Ingibjörg J
AU - Hrafnkelsdóttir, Þórdís Jóna
AU - Ingimarsdóttir, Inga Jóna
AU - Irs, Alar
AU - Jánosi, András
AU - Járai, Zoltán
AU - Oliveira-Santos, Manuel
AU - Popescu, Bogdan A
AU - Vasko, Peter
AU - Vinereanu, Dragos
AU - Yap, Jonathan
AU - Bugiardini, Raffaele
AU - Cenko, Edina
AU - Nadarajah, Ramesh
AU - Sydes, Matthew R
AU - James, Stefan
AU - Maggioni, Aldo P
AU - Wallentin, Lars
AU - Casadei, Barbara
AU - Gale, Chris P
N1 - © The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2024/11/15
Y1 - 2024/11/15
N2 - BACKGROUND AND AIMS: Standardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures.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.
AB - BACKGROUND AND AIMS: Standardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures.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.
U2 - 10.1093/eurheartj/ehae724
DO - 10.1093/eurheartj/ehae724
M3 - Article
C2 - 39545867
SN - 0195-668X
JO - European Heart Journal
JF - European Heart Journal
ER -