. 2022 Oct 7;43(37):3578-3588.

doi: 10.1093/eurheartj/ehac426.

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

Dipak Kotecha^{1

2

3}, Folkert W Asselbergs^{3

4

5}, Stephan Achenbach⁶, Stefan D Anker⁷, Dan Atar^{8

9}, Colin Baigent^{10

11}, Amitava Banerjee^{5

12}, Birgit Beger¹³, Gunnar Brobert¹⁴, Barbara Casadei¹⁵, Cinzia Ceccarelli¹⁶, Martin R Cowie^{17

18}, Filippo Crea^{19

20}, Maureen Cronin²¹, Spiros Denaxas^{5

22

23}, Andrea Derix²⁴, Donna Fitzsimons²⁵, Martin Fredriksson²⁶, Chris P Gale^{27

28

29}, Georgios V Gkoutos^{2

30}, Wim Goettsch^{31

32}, Harry Hemingway⁵, Martin Ingvar^{33

34}, Adrian Jonas³⁵, Robert Kazmierski³⁶, Susanne Løgstrup¹³, R Thomas Lumbers^{5

37}, Thomas F Lüscher^{38

39

40}, Paul McGreavy⁴¹, Ileana L Piña^{42

43}, Lothar Roessig²⁴, Carl Steinbeisser^{24

44}, Mats Sundgren⁴⁵, Benoît Tyl⁴⁶, Ghislaine van Thiel⁴⁷, Kees van Bochove⁴⁸, Panos E Vardas^{49

50}, Tiago Villanueva⁵¹, Marilena Vrana¹³, Wim Weber⁵¹, Franz Weidinger⁵², Stephan Windecker⁵³, Angela Wood⁵⁴, Diederick E Grobbee⁵⁵; Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group

Collaborators, Affiliations

Collaborators

Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group:
Xavier Kurz, John Concato, Robert Kazmierski, Jose Pablo Morales, Ileana Piña, Wim Goettsch, Adrian Jonas, Niklas Hedberg, Filippo Crea, Thomas F Lüscher, Wim Weber, Tiago Villanueva, Stuart Spencer, Rupa Sarkar, Martin Fredriksson, Mats Sundgren, Andrea Derix, Gunnar Brobert, Lothar Roessig, Benoit Tyl, Kees van Bochove, Maureen Cronin, Colm Carroll, Ceri Thompson, Birgit Beger, Susanne Løgstrup, Marilena Vrana, Paul McGreavy, Barbara Casadei, Stephan Achenbach, Valentina Tursini, Panos E Vardas, Dan Atar, Colin Baigent, Chris P Gale, Donna Fitzsimons, Stephan Windecker, Stefan D Anker, Martin Cowie, Amitava Banerjee, Harry Hemingway, R Tom Lumbers, Spiros Denaxas, Folkert W Asselbergs, Rick Grobbee, Ghislaine Van Thiel, Dipak Kotecha, George V Gkoutos, Angela Wood, Martin Ingvar, Carl Steinbeisser, Ana Petrova, Cinzia Ceccarelli, Katija Baljevic, Polyxeni Vairami, Jennifer Taylor

Affiliations

¹ Institute of Cardiovascular Sciences, University of Birmingham, Medical School, Birmingham, UK.
² University Hospitals Birmingham NHS Foundation Trust and Health Data Research UK Midlands, Birmingham, UK.
³ Department of Cardiology, Division of Heart and Lungs, University Medical Centre Utrecht, University of Utrecht, Utrecht, Netherlands.
⁴ Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, UK.
⁵ Health Data Research UK and Institute of Health Informatics, University College London, London, UK.
⁶ Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
⁷ 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.
⁸ Department of Cardiology, Oslo University Hospital, Ulleval, Oslo, Norway.
⁹ University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
¹⁰ MRC Population Health Research Unit, Nuffield Department of Population Health, Oxford, UK.
¹¹ Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
¹² University College London Hospitals NHS Trust, London, UK.
¹³ European Heart Network, Brussels, Belgium.
¹⁴ Bayer AB, Stockholm, Sweden.
¹⁵ Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford NIHR Oxford Biomedical Research Centre, Oxford, UK.
¹⁶ European Society of Cardiology, Sophia Antipolis, France.
¹⁷ Royal Brompton Hospital, Division of Guy's St Thomas' NHS Foundation Trust, London, UK.
¹⁸ School of Cardiovascular Medicine Sciences, King's College London, London, UK.
¹⁹ Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy.
²⁰ European Heart Journal, Oxford University Press, University of Oxford, Oxford, UK.
²¹ Vifor Pharma, Glattbrugg, Switzerland and Ava AG, Zurich, Switzerland.
²² Alan Turing Institute, London, UK.
²³ British Heart Foundation Data Science Centre, London, UK.
²⁴ Bayer AG, Leverkusen, Germany.
²⁵ School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland.
²⁶ Late Clinical Development, Cardiovascular, Renal and Metabolism (CVRM), Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.
²⁷ Leeds Institute of Cardiovascular and Metabolic Medicine and Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
²⁸ Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
²⁹ Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³⁰ College of Medical and Dental Sciences, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
³¹ National Health Care Institute (ZIN), Diemen, Netherlands.
³² Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
³³ Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.
³⁴ Department of Neuroradiology, Karolinska University Hospital Stockholm, Stockholm, Sweden.
³⁵ Data and Analytics Group, National Institute for Health and Care Excellence, London, UK.
³⁶ Office of Cardiovascular Devices, US Food and Drug Administration, Silver Spring, MD, USA.
³⁷ Barts Health NHS Trust and University College London Hospitals NHS Trust.
³⁸ Centre for Molecular Cardiology, University of Zurich, Zurich, Switzerland.
³⁹ Research, Education & Development, Royal Brompton and Harefield Hospitals, London, UK.
⁴⁰ Faculty of Medicine, Imperial College London, London, UK.
⁴¹ European Society of Cardiology Patient Forum, European Society of Cardiology, Brussels, Belgium.
⁴² Central Michigan University College of Medicine, Midlands, MI, USA.
⁴³ Centre for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
⁴⁴ Steinbeisser Project Management, Munich, Germany.
⁴⁵ Data Science AI, Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.
⁴⁶ Centre for Therapeutic Innovation, Cardiovascular and Metabolic Disease, Institut de Recherches Internationales Servier, Suresnes, France.
⁴⁷ Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands.
⁴⁸ The Hyve, Utrecht, Netherlands.
⁴⁹ Hygeia, Mitera, Hospitals Hellenic Health Group, Athens, Greece.
⁵⁰ European Heart Agency, European Society of Cardiology, Brussels, Belgium.
⁵¹ The BMJ, London, UK.
⁵² Rudolfstiftung Hospital, Vienna, Austria.
⁵³ Department of Cardiology, Inselspital, University Hospital Bern, Bern, Switzerland.
⁵⁴ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
⁵⁵ Department of Epidemiology, University Medical Centre Utrecht, Division Julius Centrum, Utrecht, Netherlands.

PMID: 36208161
PMCID: PMC9452067
DOI: 10.1093/eurheartj/ehac426

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

Dipak Kotecha et al. Eur Heart J. 2022.

. 2022 Oct 7;43(37):3578-3588.

doi: 10.1093/eurheartj/ehac426.

Authors

Collaborators

Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group:
Xavier Kurz, John Concato, Robert Kazmierski, Jose Pablo Morales, Ileana Piña, Wim Goettsch, Adrian Jonas, Niklas Hedberg, Filippo Crea, Thomas F Lüscher, Wim Weber, Tiago Villanueva, Stuart Spencer, Rupa Sarkar, Martin Fredriksson, Mats Sundgren, Andrea Derix, Gunnar Brobert, Lothar Roessig, Benoit Tyl, Kees van Bochove, Maureen Cronin, Colm Carroll, Ceri Thompson, Birgit Beger, Susanne Løgstrup, Marilena Vrana, Paul McGreavy, Barbara Casadei, Stephan Achenbach, Valentina Tursini, Panos E Vardas, Dan Atar, Colin Baigent, Chris P Gale, Donna Fitzsimons, Stephan Windecker, Stefan D Anker, Martin Cowie, Amitava Banerjee, Harry Hemingway, R Tom Lumbers, Spiros Denaxas, Folkert W Asselbergs, Rick Grobbee, Ghislaine Van Thiel, Dipak Kotecha, George V Gkoutos, Angela Wood, Martin Ingvar, Carl Steinbeisser, Ana Petrova, Cinzia Ceccarelli, Katija Baljevic, Polyxeni Vairami, Jennifer Taylor

Affiliations

¹ Institute of Cardiovascular Sciences, University of Birmingham, Medical School, Birmingham, UK.
² University Hospitals Birmingham NHS Foundation Trust and Health Data Research UK Midlands, Birmingham, UK.
³ Department of Cardiology, Division of Heart and Lungs, University Medical Centre Utrecht, University of Utrecht, Utrecht, Netherlands.
⁴ Institute of Cardiovascular Science, Faculty of Population Health Sciences, University College London, London, UK.
⁵ Health Data Research UK and Institute of Health Informatics, University College London, London, UK.
⁶ Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
⁷ 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.
⁸ Department of Cardiology, Oslo University Hospital, Ulleval, Oslo, Norway.
⁹ University of Oslo, Institute of Clinical Medicine, Oslo, Norway.
¹⁰ MRC Population Health Research Unit, Nuffield Department of Population Health, Oxford, UK.
¹¹ Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
¹² University College London Hospitals NHS Trust, London, UK.
¹³ European Heart Network, Brussels, Belgium.
¹⁴ Bayer AB, Stockholm, Sweden.
¹⁵ Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford NIHR Oxford Biomedical Research Centre, Oxford, UK.
¹⁶ European Society of Cardiology, Sophia Antipolis, France.
¹⁷ Royal Brompton Hospital, Division of Guy's St Thomas' NHS Foundation Trust, London, UK.
¹⁸ School of Cardiovascular Medicine Sciences, King's College London, London, UK.
¹⁹ Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy.
²⁰ European Heart Journal, Oxford University Press, University of Oxford, Oxford, UK.
²¹ Vifor Pharma, Glattbrugg, Switzerland and Ava AG, Zurich, Switzerland.
²² Alan Turing Institute, London, UK.
²³ British Heart Foundation Data Science Centre, London, UK.
²⁴ Bayer AG, Leverkusen, Germany.
²⁵ School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland.
²⁶ Late Clinical Development, Cardiovascular, Renal and Metabolism (CVRM), Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.
²⁷ Leeds Institute of Cardiovascular and Metabolic Medicine and Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
²⁸ Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
²⁹ Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³⁰ College of Medical and Dental Sciences, Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
³¹ National Health Care Institute (ZIN), Diemen, Netherlands.
³² Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
³³ Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden.
³⁴ Department of Neuroradiology, Karolinska University Hospital Stockholm, Stockholm, Sweden.
³⁵ Data and Analytics Group, National Institute for Health and Care Excellence, London, UK.
³⁶ Office of Cardiovascular Devices, US Food and Drug Administration, Silver Spring, MD, USA.
³⁷ Barts Health NHS Trust and University College London Hospitals NHS Trust.
³⁸ Centre for Molecular Cardiology, University of Zurich, Zurich, Switzerland.
³⁹ Research, Education & Development, Royal Brompton and Harefield Hospitals, London, UK.
⁴⁰ Faculty of Medicine, Imperial College London, London, UK.
⁴¹ European Society of Cardiology Patient Forum, European Society of Cardiology, Brussels, Belgium.
⁴² Central Michigan University College of Medicine, Midlands, MI, USA.
⁴³ Centre for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
⁴⁴ Steinbeisser Project Management, Munich, Germany.
⁴⁵ Data Science AI, Biopharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.
⁴⁶ Centre for Therapeutic Innovation, Cardiovascular and Metabolic Disease, Institut de Recherches Internationales Servier, Suresnes, France.
⁴⁷ Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands.
⁴⁸ The Hyve, Utrecht, Netherlands.
⁴⁹ Hygeia, Mitera, Hospitals Hellenic Health Group, Athens, Greece.
⁵⁰ European Heart Agency, European Society of Cardiology, Brussels, Belgium.
⁵¹ The BMJ, London, UK.
⁵² Rudolfstiftung Hospital, Vienna, Austria.
⁵³ Department of Cardiology, Inselspital, University Hospital Bern, Bern, Switzerland.
⁵⁴ Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
⁵⁵ Department of Epidemiology, University Medical Centre Utrecht, Division Julius Centrum, Utrecht, Netherlands.

PMID: 36208161
PMCID: PMC9452067
DOI: 10.1093/eurheartj/ehac426

Abstract

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.

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

PubMed Disclaimer

Figures

**Figure 1**
From structured healthcare data to improved patient care. Key challenges and the paths to improvement leading to sustainable impact from EHR-based research studies. EHR=electronic healthcare record.

**Figure 2**
Patient and public engagement to improve clinical research. POSITIVE steps leading to co-creation with patients and the public, and better research using big data sources. Content adapted from the Consensus Statement on Public Involvement and Engagement with Data-Intensive Health Research as used in the DaRe2THINK trial programme. Adapted from Bunting et al. PPI=patient and public involvement.

See this image and copyright information in PMC

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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical