Data standards for acute coronary syndrome and percutaneous coronary intervention: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Author:

,Batra Gorav1ORCID,Aktaa Suleman234ORCID,Wallentin Lars1ORCID,Maggioni Aldo P5ORCID,Ludman Peter6,Erlinge David7,Casadei Barbara8ORCID,Gale Chris P234ORCID, , , , ,

Affiliation:

1. Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University , Uppsala , Sweden

2. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds , Leeds , UK

3. Leeds Institute for Data Analytics, University of Leeds , Leeds , UK

4. Department of Cardiology, Leeds Teaching Hospitals NHS Trust , Leeds , UK

5. Italian Association of Hospital Cardiologists Research Center (ANMCO) , Florence , Italy

6. Institute of Cardiovascular Sciences, University of Birmingham , Birmingham , UK

7. Department of Cardiology, Skåne University Hospital, Lund University , Lund , Sweden

8. Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford , Oxford , UK

Abstract

Abstract Standardized data definitions are essential for monitoring and benchmarking the quality of care and patient outcomes in observational studies and randomized controlled trials. There are no contemporary pan-European data standards for the acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aimed to develop such data standards for ACS and PCI. Following a systematic review of the literature on ACS and PCI data standards and evaluation of contemporary ACS and PCI registries, we undertook a modified Delphi process involving clinical and registry experts from 11 European countries, as well as representatives from relevant ESC Associations, including the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and Acute CardioVascular Care (ACVC). This resulted in final sets of 68 and 84 ‘mandatory’ variables and several catalogues of optional variables for ACS and PCI, respectively. Data definitions were provided for these variables, which have been programmed as the basis for continuous registration of individual patient data in the online EuroHeart IT platform. By means of a structured process and the interaction with major stakeholders, internationally harmonized data standards for ACS and PCI have been developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based randomized trials, and post-marketing surveillance of devices and pharmacotherapies.

Funder

European Society of Cardiology

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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