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CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research.
Kotecha, Dipak; Asselbergs, Folkert W; Achenbach, Stephan; Anker, Stefan D; Atar, Dan; Baigent, Colin; Banerjee, Amitava; Beger, Birgit; Brobert, Gunnar; Casadei, Barbara; Ceccarelli, Cinzia; Cowie, Martin R; Crea, Filippo; Cronin, Maureen; Denaxas, Spiros; Derix, Andrea; Fitzsimons, Donna; Fredriksson, Martin; Gale, Chris P; Gkoutos, Georgios V; Goettsch, Wim; Hemingway, Harry; Ingvar, Martin; Jonas, Adrian; Kazmierski, Robert; Løgstrup, Susanne; Lumbers, R Thomas; Lüscher, Thomas F; McGreavy, Paul; Piña, Ileana L; Roessig, Lothar; Steinbeisser, Carl; Sundgren, Mats; Tyl, Benoît; Thiel, Ghislaine van; Bochove, Kees van; Vardas, Panos E; Villanueva, Tiago; Vrana, Marilena; Weber, Wim; Weidinger, Franz; Windecker, Stephan; Wood, Angela; Grobbee, Diederick E.
  • Kotecha D; Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK; Health Data Research UK Midlands, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; Department of Cardiology, Division of Heart and Lungs, University of Utrecht, Utrecht, Netherlands. Electronic addre
  • Asselbergs FW; Health Data Research UK London, London, UK; Institute of Cardiovascular Science and Institute of Health Informatics, Faculty of Population Health Sciences, University College London, London, UK.
  • Achenbach S; Department of Cardiology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
  • Anker SD; Department of Cardiology and Berlin Institute of Health Centre for Regenerative Therapies, German Centre for Cardiovascular Research, Charité Universitätsmedizin, Berlin, Germany.
  • Atar D; Department of Cardiology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
  • Baigent C; Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, Oxford, UK; Clinical Trial Service Unit and Epidemiological Studies Unit, University of Oxford, Oxford, UK.
  • Banerjee A; Health Data Research UK London, London, UK; University College London Hospitals NHS Trust, London, UK.
  • Beger B; European Heart Network, Brussels, Belgium.
  • Brobert G; Bayer, Stockholm, Sweden.
  • Casadei B; Division of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford National Institute for Health and Care Research Oxford Biomedical Research Centre, Oxford, UK.
  • Ceccarelli C; European Society of Cardiology, Sophia Antipolis, France.
  • Cowie MR; Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK; School of Cardiovascular Medicine Sciences, King's College London, London, UK.
  • Crea F; European Heart Journal, Oxford University Press, University of Oxford, Oxford, UK; Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart, Rome, Italy.
  • Cronin M; Vifor Pharma, Glattbrugg, Switzerland; Ava, Zurich, Switzerland.
  • Denaxas S; Health Data Research UK London, London, UK; Alan Turing Institute, London, UK; British Heart Foundation Data Science Centre, London, UK.
  • Derix A; Bayer, Leverkusen, Germany.
  • Fitzsimons D; School of Nursing and Midwifery, Queen's University Belfast, Northern Ireland.
  • Fredriksson M; Late Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals, AstraZeneca, Gothenburg, Sweden.
  • Gale CP; Leeds Institute of Cardiovascular and Metabolic Medicine and Leeds Institute for Data Analytics, University of Leeds, Leeds, UK; Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
  • Gkoutos GV; Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK; Health Data Research UK Midlands, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Goettsch W; University Medical Centre Utrecht, and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Utrecht, Netherlands; National Health Care Institute, Diemen, Netherlands.
  • Hemingway H; Health Data Research UK London, London, UK.
  • Ingvar M; Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden; Department of Neuroradiology, Karolinska University Hospital Stockholm, Stockholm, Sweden.
  • Jonas A; Data and Analytics Group, National Institute for Health and Care Excellence, London, UK.
  • Kazmierski R; Office of Cardiovascular Devices, US Food and Drug Administration, Silver Spring, MD, USA.
  • Løgstrup S; European Heart Network, Brussels, Belgium.
  • Lumbers RT; Health Data Research UK London, London, UK; Institute of Health Informatics, Barts Health NHS Trust and University College London Hospitals NHS Trust, London, UK.
  • Lüscher TF; Centre for Molecular Cardiology, University of Zurich, Zurich, Switzerland; Research, Education and Development, Royal Brompton and Harefield Hospitals, London, UK; Faculty of Medicine, Imperial College London, London, UK.
  • McGreavy P; European Society of Cardiology Patient Forum, European Society of Cardiology, Brussels, Belgium.
  • Piña IL; Centre for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA; College of Medicine, Central Michigan University, Midlands MI, USA.
  • Roessig L; Bayer, Leverkusen, Germany.
  • Steinbeisser C; Bayer, Leverkusen, Germany; Steinbeisser Project Management, Munich, Germany.
  • Sundgren M; Data Science and Artificial Intelligence, Biopharmaceuticals, AstraZeneca, Gothenburg, Sweden.
  • Tyl B; Centre for Therapeutic Innovation, Cardiovascular and Metabolic Disease, Institut de Recherches Internationales Servier, Suresnes, France.
  • Thiel GV; Julius Center for Health Sciences and Primary Care, University of Utrecht, Utrecht, Netherlands.
  • Bochove KV; The Hyve, Utrecht, Netherlands.
  • Vardas PE; Hygeia, Mitera, Hospitals Hellenic Health Group, Athens, Greece; European Heart Agency, European Society of Cardiology, Brussels, Belgium.
  • Villanueva T; The British Medical Journal, London, UK.
  • Vrana M; European Heart Network, Brussels, Belgium.
  • Weber W; The British Medical Journal, London, UK.
  • Weidinger F; Rudolfstiftung Hospital, Vienna, Austria.
  • Windecker S; Department of Cardiology, Inselspital, University Hospital Bern, Bern, Switzerland.
  • Wood A; Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
  • Grobbee DE; Department of Epidemiology, University of Utrecht, Utrecht, Netherlands.
Lancet Digit Health ; 4(10): e757-e764, 2022 10.
Article in English | MEDLINE | ID: covidwho-2004683
ABSTRACT
Big data is important to new developments in global clinical science that aim to improve the lives of patients. Technological advances have led to the regular use of structured electronic health-care records with the potential to address key deficits in clinical evidence that could improve patient care. The COVID-19 pandemic has shown this potential in big data and related analytics but has also revealed important limitations. Data verification, data validation, data privacy, and a mandate from the public to conduct research are important challenges to effective use of routine health-care data. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including representation from patients, clinicians, scientists, regulators, journal editors, and industry members. In this Review, we propose the CODE-EHR minimum standards framework to be used by researchers and clinicians to improve the design of studies and enhance transparency of study methods. The CODE-EHR framework aims to develop robust and effective utilisation of health-care data for research purposes.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Type of study: Prognostic study Limits: Humans Language: English Journal: Lancet Digit Health Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pandemics / COVID-19 Type of study: Prognostic study Limits: Humans Language: English Journal: Lancet Digit Health Year: 2022 Document Type: Article