Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)
European Heart Journal
Abstract
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.
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.
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.
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.
Contributors
Erik Lerkevang Grove
Author
Chris Wilkinson
Author
Hull York Medical School York , United Kingdom of Great Britain & Northern Ireland
Asad Bhatty
Author
Leeds Institute of Cardiovascular and Metabolic Medicine Leeds , United Kingdom of Great Britain & Northern Ireland
Luca Liberale
Author
Riccardo Liga
Author
Gorav Batra
Author
Suleman Aktaa
Author
Adam B Smith
Author
Jeremy Dwight
Author
Marcin Ruciński
Author
Sam Chappell
Author
Joakim Alfredsson
Author
David Erlinge
Author
Jorge Ferreira
Author
Ingibjörg J Guðmundsdóttir
Author
Þórdís Jóna Hrafnkelsdóttir
Author
Inga Jóna Ingimarsdóttir
Author
Alar Irs
Author
A Michael Lincoff
Author
András Jánosi
Author
Zoltán Járai
Author
Manuel Oliveira-Santos
Author
Peter Vasko
Author
Dragos Vinereanu
Author
Jonathan Yap
Author
Ramesh Nadarajah
Author
Leeds General Infirmary Leeds , United Kingdom of Great Britain & Northern Ireland
Matthew R Sydes
Author
Roberto Lorusso
Author
Aldo P Maggioni
Author
Stefan James
Author
Aldo P Maggioni
Author
Lars Wallentin
Author
Barbara Casadei
Author
National Heart and Lung Institute Imperial College London , United Kingdom of Great Britain & Northern Ireland
Mamas Mamas
Author
Olivia Manfrini
Author
Fabio Mangiacapra
Author
Chris P Gale
Author
Nina Ajmone Marsan
Author
María Martín-Fernandez
Author
Victor Aboyans
Author
Ana G Almeida
Author
Jose L Merino
Author
Dan Atar
Author
Gorav Batra
Author
Antoni Bayés-Genís
Author
Asad Bhatty
Author
Giuseppe Biondi-Zoccai
Author
Marco Metra
Author
Marc P Bonaca
Author
Alessandro Parolari
Author
Nikolaos Bonaros
Author
Bianca J J M Brundel
Author
Raffaele Bugiardini
Author
Cinzia Perrino
Author
Gianluca Campo
Author
Lorenz Räber
Author
Barbara Casadei
Author
Ruben Casado-Arroyo
Author
Benyamin Rahmani
Author
Claudio Ceconi
Author
Peter P Rainer
Author
Edina Cenko
Author
Giuseppe M C Rosano
Author
Ovidiu Chioncel
Author
Alexia Rossi
Author
Michele Ciccarelli
Author
Andrea Rubboli
Author
Louise Coats
Author
Tanja Rudolph
Author
Sigrid Sandner
Author
Gianluigi Savarese
Author
Jolanta Siller-Matula
Author
Samuel Sossalla
Author
Cristiano Spadaccio
Author
Jean-Philippe Collet
Author
Eugenio Stabile
Author
Gheorghe-Andrei Dan
Author
David Tanne
Author
Victoria Delgado
Author
Jurrien ten Berg
Author
Polychronis Dilaveris
Author
Matthias Thielmann
Author
Dobromir Dobrev
Author
Roderick W Treskes
Author
Erwan Donal
Author
Izabella Uchmanowicz
Author
David Duncker
Author
Sarah Moharem Elgamal
Author
Justin A Ezekowitz
Author
Jacob A Udell
Author
Gregg Fonarow
Author
Alan G Fraser
Author
Chris P Gale
Author
Roland R J van Kimmenade
Author
George Giannakoulas
Author
Lars Wallentin
Author
Bruna Gigante
Author
Massimiliano Gnecchi
Author
Chris Wilkinson
Author
Can Gollmann-Tepeköylü
Author
Marija Zdravkovic
Author
Stephen J Greene
Author
Jordi Heijman
Author
Jonathan Howes
Author
Bernard Iung
Author
Stefan James
Author
Magnus T Jensen
Author
Vijay Kunadian
Author
Malgorzata Lelonek
Author
Sergio Leonardi
Author
