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

Author:

Kotecha Dipak123ORCID,Asselbergs Folkert W345,Achenbach Stephan6,Anker Stefan D7,Atar Dan89,Baigent Colin1011,Banerjee Amitava512,Beger Birgit13,Brobert Gunnar14,Casadei Barbara15,Ceccarelli Cinzia16,Cowie Martin R1718,Crea Filippo1920,Cronin Maureen21,Denaxas Spiros52223,Derix Andrea24,Fitzsimons Donna25,Fredriksson Martin26,Gale Chris P272829,Gkoutos Georgios V230,Goettsch Wim3132,Hemingway Harry5,Ingvar Martin3334,Jonas Adrian35,Kazmierski Robert36,Løgstrup Susanne13,Thomas Lumbers R537,Lüscher Thomas F383940,McGreavy Paul41,Piña Ileana L4243,Roessig Lothar24,Steinbeisser Carl2444,Sundgren Mats45,Tyl Benoît46,van Thiel Ghislaine47,van Bochove Kees48,Vardas Panos E4950,Villanueva Tiago51,Vrana Marilena13,Weber Wim51,Weidinger Franz52,Windecker Stephan53,Wood Angela54,Grobbee Diederick E55,Kurz Xavier,Concato John,Kazmierski Robert,Morales Jose Pablo,Piña Ileana,Goettsch Wim,Jonas Adrian,Hedberg Niklas,Crea Filippo,Lüscher Thomas F,Weber Wim,Villanueva Tiago,Spencer Stuart,Sarkar Rupa,Fredriksson Martin,Sundgren Mats,Derix Andrea,Brobert Gunnar,Roessig Lothar,Tyl Benoit,van Bochove Kees,Cronin Maureen,Carroll Colm,Thompson Ceri,Beger Birgit,Løgstrup Susanne,Vrana Marilena,McGreavy Paul,Casadei Barbara,Achenbach Stephan,Tursini Valentina,Vardas Panos E,Atar Dan,Baigent Colin,Gale Chris P,Fitzsimons Donna,Windecker Stephan,Anker Stefan D,Cowie Martin,Banerjee Amitava,Hemingway Harry,Lumbers R Tom,Denaxas Spiros,Asselbergs Folkert W,Grobbee Rick,Van Thiel Ghislaine,Kotecha Dipak,Gkoutos George V,Wood Angela,Ingvar Martin,Steinbeisser Carl,Petrova Ana,Ceccarelli Cinzia,Baljevic Katija,Vairami Polyxeni,Taylor Jennifer,

Affiliation:

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

Abstract

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.

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine

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