CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research.

COVID-19 / epidemiology Delivery of Health Care Electronic Health Records Electronics Humans Pandemics / prevention & control

Journal

European heart journal
ISSN: 1522-9645
Titre abrégé: Eur Heart J
Pays: England
ID NLM: 8006263

Informations de publication

Date de publication:
07 10 2022
Historique:
accepted: 21 06 2022
entrez: 8 10 2022
pubmed: 9 10 2022
medline: 12 10 2022
Statut: ppublish

Résumé

Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls. Verification, validation, and data privacy, as well as the social mandate to undertake research are key challenges. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry. We propose the CODE-EHR Minimum Standards Framework as a means to improve the design of studies, enhance transparency and develop a roadmap towards more robust and effective utilisation of healthcare data for research purposes.

Identifiants

DOI: 10.1093/eurheartj/ehac426 PMID: 36208161 PMC: PMC9452067
pubmed: 36208161
pii: 6659884
doi: 10.1093/eurheartj/ehac426
pmc: PMC9452067
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

3578-3588

Subventions

Organisme : British Heart Foundation
ID : RG/13/13/30194
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_20051
Pays : United Kingdom
Organisme : British Heart Foundation
ID : CH/12/2/29428
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_20059
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S003754/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_PC_20030
Pays : United Kingdom
Organisme : British Heart Foundation
ID : RG/18/13/33946
Pays : United Kingdom

Investigateurs

Xavier Kurz (X)
John Concato (J)
Robert Kazmierski (R)
Jose Pablo Morales (JP)
Ileana Piña (I)
Wim Goettsch (W)
Adrian Jonas (A)
Niklas Hedberg (N)
Filippo Crea (F)
Thomas F Lüscher (TF)
Wim Weber (W)
Tiago Villanueva (T)
Stuart Spencer (S)
Rupa Sarkar (R)
Martin Fredriksson (M)
Mats Sundgren (M)
Andrea Derix (A)
Gunnar Brobert (G)
Lothar Roessig (L)
Benoit Tyl (B)
Kees van Bochove (K)
Maureen Cronin (M)
Colm Carroll (C)
Ceri Thompson (C)
Birgit Beger (B)
Susanne Løgstrup (S)
Marilena Vrana (M)
Paul McGreavy (P)
Barbara Casadei (B)
Stephan Achenbach (S)
Valentina Tursini (V)
Panos E Vardas (PE)
Dan Atar (D)
Colin Baigent (C)
Chris P Gale (CP)
Donna Fitzsimons (D)
Stephan Windecker (S)
Stefan D Anker (SD)
Martin Cowie (M)
Amitava Banerjee (A)
Harry Hemingway (H)
R Tom Lumbers (RT)
Spiros Denaxas (S)
Folkert W Asselbergs (FW)
Rick Grobbee (R)
Ghislaine Van Thiel (G)
Dipak Kotecha (D)
George V Gkoutos (GV)
Angela Wood (A)
Martin Ingvar (M)
Carl Steinbeisser (C)
Ana Petrova (A)
Cinzia Ceccarelli (C)
Katija Baljevic (K)
Polyxeni Vairami (P)
Jennifer Taylor (J)

Informations de copyright

This article has been co-published with permission in The BMJ, the Lancet Digital Health, and the European Heart Journal © the Authors 2022.

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Auteurs

Dipak Kotecha (D)

Institute of Cardiovascular Sciences, University of Birmingham, Medical School, Birmingham, UK.
University Hospitals Birmingham NHS Foundation Trust and Health Data Research UK Midlands, Birmingham, UK.
Department of Cardiology, Division of Heart and Lungs, University Medical Centre Utrecht, University of Utrecht, Utrecht, Netherlands.
ORCID: 0000-0002-2570-9812

Folkert W Asselbergs (FW)

Department of Cardiology, Division of Heart and Lungs, University Medical Centre Utrecht, University of Utrecht, Utrecht, Netherlands.
Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, UK.
Health Data Research UK and Institute of Health Informatics, University College London, London, UK.

Stephan Achenbach (S)

Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.

Stefan D Anker (SD)

Department of Cardiology and Berlin Institute of Health Centre for Regenerative Therapies, German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.

Dan Atar (D)

Department of Cardiology, Oslo University Hospital, Ulleval, Oslo, Norway.
University of Oslo, Institute of Clinical Medicine, Oslo, Norway.

Colin Baigent (C)

MRC Population Health Research Unit, Nuffield Department of Population Health, Oxford, UK.
Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.

Amitava Banerjee (A)

Health Data Research UK and Institute of Health Informatics, University College London, London, UK.
University College London Hospitals NHS Trust, London, UK.

Birgit Beger (B)

European Heart Network, Brussels, Belgium.

Gunnar Brobert (G)

Bayer AB, Stockholm, Sweden.

Barbara Casadei (B)

Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford NIHR Oxford Biomedical Research Centre, Oxford, UK.

Cinzia Ceccarelli (C)

European Society of Cardiology, Sophia Antipolis, France.

Martin R Cowie (MR)

Royal Brompton Hospital, Division of Guy's St Thomas' NHS Foundation Trust, London, UK.
School of Cardiovascular Medicine Sciences, King's College London, London, UK.

Filippo Crea (F)

Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy.
European Heart Journal, Oxford University Press, University of Oxford, Oxford, UK.

Maureen Cronin (M)

Vifor Pharma, Glattbrugg, Switzerland and Ava AG, Zurich, Switzerland.

Spiros Denaxas (S)

Health Data Research UK and Institute of Health Informatics, University College London, London, UK.
Alan Turing Institute, London, UK.
British Heart Foundation Data Science Centre, London, UK.

Andrea Derix (A)

Bayer AG, Leverkusen, Germany.

Donna Fitzsimons (D)

School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland.

Martin Fredriksson (M)

Late Clinical Development, Cardiovascular, Renal and Metabolism (CVRM), Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.

Chris P Gale (CP)

Leeds Institute of Cardiovascular and Metabolic Medicine and Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Georgios V Gkoutos (GV)

University Hospitals Birmingham NHS Foundation Trust and Health Data Research UK Midlands, Birmingham, UK.
College of Medical and Dental Sciences, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.

Wim Goettsch (W)

National Health Care Institute (ZIN), Diemen, Netherlands.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.

Harry Hemingway (H)

Health Data Research UK and Institute of Health Informatics, University College London, London, UK.

Martin Ingvar (M)

Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.
Department of Neuroradiology, Karolinska University Hospital Stockholm, Stockholm, Sweden.

Adrian Jonas (A)

Data and Analytics Group, National Institute for Health and Care Excellence, London, UK.

Robert Kazmierski (R)

Office of Cardiovascular Devices, US Food and Drug Administration, Silver Spring, MD, USA.

Susanne Løgstrup (S)

European Heart Network, Brussels, Belgium.

R Thomas Lumbers (R)

Health Data Research UK and Institute of Health Informatics, University College London, London, UK.
Barts Health NHS Trust and University College London Hospitals NHS Trust.

Thomas F Lüscher (TF)

Centre for Molecular Cardiology, University of Zurich, Zurich, Switzerland.
Research, Education & Development, Royal Brompton and Harefield Hospitals, London, UK.
Faculty of Medicine, Imperial College London, London, UK.

Paul McGreavy (P)

European Society of Cardiology Patient Forum, European Society of Cardiology, Brussels, Belgium.

Ileana L Piña (IL)

Central Michigan University College of Medicine, Midlands, MI, USA.
Centre for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.

Lothar Roessig (L)

Bayer AG, Leverkusen, Germany.

Carl Steinbeisser (C)

Bayer AG, Leverkusen, Germany.
Steinbeisser Project Management, Munich, Germany.

Mats Sundgren (M)

Data Science AI, Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.

Benoît Tyl (B)

Centre for Therapeutic Innovation, Cardiovascular and Metabolic Disease, Institut de Recherches Internationales Servier, Suresnes, France.

Ghislaine van Thiel (G)

Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands.

Kees van Bochove (K)

The Hyve, Utrecht, Netherlands.

Panos E Vardas (PE)

Hygeia, Mitera, Hospitals Hellenic Health Group, Athens, Greece.
European Heart Agency, European Society of Cardiology, Brussels, Belgium.

Tiago Villanueva (T)

The BMJ, London, UK.

Marilena Vrana (M)

European Heart Network, Brussels, Belgium.

Wim Weber (W)

The BMJ, London, UK.

Franz Weidinger (F)

Rudolfstiftung Hospital, Vienna, Austria.

Stephan Windecker (S)

Department of Cardiology, Inselspital, University Hospital Bern, Bern, Switzerland.

Angela Wood (A)

Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.

Diederick E Grobbee (DE)

Department of Epidemiology, University Medical Centre Utrecht, Division Julius Centrum, Utrecht, Netherlands.

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