Gorav Batra1, Suleman Aktaa2, Lars Wallentin1, Aldo P Maggioni3, Chris Wilkinson4, Barbara Casadei5, Chris P Gale2. 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 Institute for Data Analytics, University of Leeds and Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. 3. Italian Association of Hospital Cardiologists Research Center (ANMCO), Florence, Italy. 4. Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom. 5. Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
Abstract
AIMS: Data standards are consensual specifications for the representation of data arising from different sources. If provided with internationally harmonised variables, permissible values, and clinical definitions they have the potential to enable reliable between and within country analysis of care and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) is a European Society of Cardiology (ESC) project that allows participating countries to collect patient data to undertake quality improvement, observational studies, drug and device surveillance, and registry-based randomised controlled trials for cardiovascular conditions. This document describes the methodology for development of harmonised data standards for EuroHeart. METHODS AND RESULTS: We adopted a five-step process for the development of harmonised data standards. The process includes: (1) identification of clinical domains for data standard development by evaluating specific cardiovascular conditions with high prevalence and opportunities for quality improvement; (2) construction of data standard specifications by systematic review of the literature; (3) selection of variables by a domain specific Working Group using a modified Delphi method; (4) validation of data standards by a domain specific Reference Group; and (5) implementation of the developed data standards into an IT platform. CONCLUSION: This document describes the approach adopted by EuroHeart for the development of clinical data standards for cardiovascular disease. The methodology has been developed and is used by EuroHeart to create a suite of international data standards for cardiovascular diseases. The EuroHeart data standards may be used to systematically capture individual patient data about clinical care and for research.
AIMS: Data standards are consensual specifications for the representation of data arising from different sources. If provided with internationally harmonised variables, permissible values, and clinical definitions they have the potential to enable reliable between and within country analysis of care and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) is a European Society of Cardiology (ESC) project that allows participating countries to collect patient data to undertake quality improvement, observational studies, drug and device surveillance, and registry-based randomised controlled trials for cardiovascular conditions. This document describes the methodology for development of harmonised data standards for EuroHeart. METHODS AND RESULTS: We adopted a five-step process for the development of harmonised data standards. The process includes: (1) identification of clinical domains for data standard development by evaluating specific cardiovascular conditions with high prevalence and opportunities for quality improvement; (2) construction of data standard specifications by systematic review of the literature; (3) selection of variables by a domain specific Working Group using a modified Delphi method; (4) validation of data standards by a domain specific Reference Group; and (5) implementation of the developed data standards into an IT platform. CONCLUSION: This document describes the approach adopted by EuroHeart for the development of clinical data standards for cardiovascular disease. The methodology has been developed and is used by EuroHeart to create a suite of international data standards for cardiovascular diseases. The EuroHeart data standards may be used to systematically capture individual patient data about clinical care and for research.
Authors: Diego R Mazzotti; Melissa A Haendel; Julie A McMurry; Connor J Smith; Daniel J Buysse; Till Roenneberg; Thomas Penzel; Shaun Purcell; Susan Redline; Ying Zhang; Kathleen R Merikangas; Joseph P Menetski; Janet Mullington; Eilis Boudreau Journal: Sleep Date: 2022-06-13 Impact factor: 6.313
Authors: Gorav Batra; Suleman Aktaa; Lars Wallentin; Aldo P Maggioni; Peter Ludman; David Erlinge; Barbara Casadei; Chris P Gale Journal: Eur Heart J Date: 2022-06-21 Impact factor: 35.855
Authors: Suleman Aktaa; Gorav Batra; John G F Cleland; Andrew Coats; Lars H Lund; Theresa McDonagh; Giuseppe Rosano; Petar Seferovic; Peter Vasko; Lars Wallentin; Aldo P Maggioni; Barbara Casadei; Chris P Gale Journal: Eur Heart J Date: 2022-06-14 Impact factor: 35.855