51. Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)
- Author
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Wilkinson, Chris, Bhatty, Asad, Batra, Gorav, Aktaa, Suleman, Smith, Adam B., Dwight, Jeremy, Rucinski, Marcin, Chappell, Sam, Alfredsson, Joakim, Erlinge, David, Ferreira, Jorge, Guomundsdottir, Ingibjorg J., Hrafnkelsdottir, Ordis Jona, Ingimarsdottir, Inga Jona, Irs, Alar, Janosi, Andras, Jarai, Zoltan, 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., Wilkinson, Chris, Bhatty, Asad, Batra, Gorav, Aktaa, Suleman, Smith, Adam B., Dwight, Jeremy, Rucinski, Marcin, Chappell, Sam, Alfredsson, Joakim, Erlinge, David, Ferreira, Jorge, Guomundsdottir, Ingibjorg J., Hrafnkelsdottir, Ordis Jona, Ingimarsdottir, Inga Jona, Irs, Alar, Janosi, Andras, Jarai, Zoltan, 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, and Gale, Chris P.
- Abstract
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., Funding Agencies|Daiichi Sankyo Europe GmbH, Amgen; Republic of Ireland, Romania, Singapore and Sweden; ESC Working Groups and Associations; Association for Acute CardioVascular Care; European Association of Percutaneous Cardiovascular Interventions (EAPCI); European Association of Preventive Cardiology (EAPC); European Heart Rhythm Association (EHRA); Heart Failure Association (HFA); EURObservational Research Programme; WG Cardiovascular Regenerative and Reparative Medicine, WG on Adult Congenital Heart Disease, WG on Aorta and Peripheral Vascular Diseases, WG on Atherosclerosis and Vascular Biology, WG on Cardiac Cellular Electrophysiology, WG on Cardiovascular Pharmacot; WG on Cardiovascular Surgery, WG on Cellular Biology of the Heart, WG on Coronary Pathophysiology; WG on Development Anatomy and Pathology; WG on Myocardial and Pericardial Diseases, WG on Myocardial Function, WG on Pulmonary Circulation; Committee for Young Cardiovascular Professionals
- Published
- 2024
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