CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research
Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, and CODE-EHR International Consensus Group
(2022) The Lancet Digital Health, volume 4, issue 10, pp. E757 - E764
(Article)
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
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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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Keywords: Big Data, COVID-19, Electronic Health Records, Electronics, Humans, Pandemics, Decision Sciences (miscellaneous), Health Information Management, Health Informatics, Medicine (miscellaneous)
ISSN: 2589-7500
Publisher: Elsevier Ltd
Note: Funding Information: We are grateful for the work of the CODE-EHR international consensus. The following were delegates and attendees of the meetings. Regulatory agencies: European Medicines Agency, Netherlands (Xavier Kurz); US Food and Drug Administration, USA (John Concato, Robert Kazmierski, Jose Pablo Morales, and Ileana Piña). Reimbursement authorities: National Health Care Institute, Netherlands (Wim Goettsch); National Institute for Health and Care Excellence, UK (Adrian Jonas); Dental and Pharmaceutical Benefits Agency (TLV), Sweden (Niklas Hedberg). Medical Journal Editors: European Heart Journal, Switzerland (Filippo Crea and Thomas F Lüscher); The BMJ, UK (Wim Weber and Tiago Villanueva). Industry representatives: AstraZeneca (Martin Fredriksson and Mats Sundgren); Bayer (Andrea Derix, Gunnar Brobert, and Lothar Roessig); Servier (Benoit Tyl); The Hyve (Kees van Bochove); Vifor Pharma (Maureen Cronin). Funders: European Union and the European Federation of Pharmaceutical Industries and Associations Innovative Medicines Initiative, Belgium (Colm Carroll); European Commission, Belgium (Ceri Thompson). Patient Advocacy: European Heart Network, Belgium (Birgit Beger, Susanne Løgstrup, and Marilena Vrana); European Society of Cardiology Patient Forum, France (Paul McGreavy). Clinical Academic and Professional Societies: European Society of Cardiology, France (Barbara Casadei, Stephan Achenbach, and Valentina Tursini); European Heart Agency, Belgium (Panos E Vardas); Oslo University Hospital and University of Oslo, Norway (Dan Atar); University of Oxford, UK (Colin Baigent); University of Leeds, UK (Chris P Gale); Queen's University Belfast, UK (Donna Fitzsimons); University Hospital Bern, Switzerland (Stephan Windecker); Charité-Universitätsmedizin Berlin, Germany (Stefan D Anker); Royal Brompton Hospital and Imperial College London, UK (Martin Cowie); University College London, UK (Amitava Banerjee, Harry Hemingway, R Tom Lumbers, Spiros Denaxas); University Medical Centre Utrecht, Netherlands (Folkert W Asselbergs, Rick Grobbee, and Ghislaine Van Thiel); University of Birmingham and University Hospitals Birmingham NHS Trust, UK (Dipak Kotecha and George V Gkoutos); University of Cambridge, UK (Angela Wood); Karolinska Institutet and Karolinska University Hospital Stockholm, Sweden (Martin Ingvar). Administrative: BigData@Heart Project Management, Germany (Carl Steinbeisser and Ana Petrova); European Society of Cardiology Project Management, France (Cinzia Ceccarelli, Katija Baljevic, and Polyxeni Vairami); Medical Writer, UK (Jennifer Taylor). Funding Information: The BigData@Heart project has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking (grant 116074) which receives support from the Horizon 2020 research and innovation programme of the European Union and the European Federation of Pharmaceutical Industries and Associations. The funders had no role in considering the study design; in the collection, analysis, or interpretation of data; in the writing of the report; or in the decision to submit the Review for publication. DK reports grants from the European Union and the European Federation of Pharmaceutical Industries and Associations Innovative Medicines Initiative (116074), the National Institute for Health Research (NIHR CDF-2015-08-074 RATE-AF; NIHR130280 DaRe2THINK; and NIHR132974 D2T-NeuroVascular), the British Heart Foundation (PG/17/55/33087, AA/18/2/34218 and FS/CDRF/21/21032), and the ESC. DK is supported by educational grants from Boehringer Ingelheim, Bristol Myers Squibb (BMS)-Pfizer Alliance, Bayer, Daiichi Sankyo, Boston Scientific, the NIHR and University of Oxford Biomedical Research Centre, the British Heart Foundation and University of Birmingham Accelerator Award (STEEER-AF NCT04396418 ), Amomed Pharma, Istituto Di Ricovero e Cura a Carattere Scientifico San Raffaele, and Menarini ( NCT0083244 ). DK receives advisory board personal fees from Bayer, Amomed, Protherics Medicines Development, and Myokardia. FWA reports grants from IMI BigData@Heart. SDA reports grants and personal fees from Vifor Pharma, Abbott, and Abbott Vascular; and personal fees from Bayer, Boehringer Ingelheim, Servier, Cardiac Dimensions, Actimed, AstraZeneca, Amgen, Bioventrix, Janssen, Respicardia, V-Wave, Brahms, Cordio, and Occlutech. CB reports grants from Medical Research Council, Boehringer Ingelheim, and NIHR. AB reports grants from AstraZeneca. BB reports grants from the European Commission. GB reports grants from the European Commission (IMI project support) and Bayer. BC reports non-financial support from Roche Diagnostics and iRhythm. CC reports grants from the European Commission. MRC reports personal fees from AstraZeneca. FC reports personal fees from Amgen, AstraZeneca, Servier, and BMS; and advisory board fees from GlyCardial Diagnostics. MC reports personal fees from Vifor Pharma. AD reports salary from Bayer. MF reports salary from AstraZeneca. CPG reports personal fees from AstraZeneca, Amgen, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Vifor Pharma, Menarini, Wondr Medical, Raisio Group, and Oxford University Press; and grants from BMS, Abbott, British Heart Foundation, NIHR, and ESC. MI reports grants from World Economic Forum, Swedish Innovation Agency, and the European Commission; and collaboration with Frisq. SL reports grants from the European Commission. TFL reports grants from Abbott, Amgen, Novartis, Boehringer Ingelheim, Servier, Vifor Pharma, Sanofi, and AstraZeneca; and personal fees from Daichi Sankyo, Pfizer, and Menarini. LR reports salary from Bayer. CS reports personal fees from Bayer. BT reports personal fees from Servier. GvT reports grants from IMI. KvB reports grants from IMI BigData@Heart. PEV reports personal fees from Hygeia Hospitals Group, Hellenic Healthcare Group, ESC, and Servier. TV is working as an editor at The BMJ and Acta Médica Portuguesa and is Vice President of the European Union of General Practitioners. MV reports grants from the European Commission. SW reports grants from Abbott, Amgen, AstraZeneca, BMS, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-Wave. SW serves as an unpaid advisory board member or unpaid member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis. He has not received personal payments by pharmaceutical companies or device manufacturers. SW is a member of the steering or executive committee group of several investigator-initiated trials that receive funding by industry without effect on his personal remuneration. SW is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee. SW is a member of the Clinical Study Group of the Deutsches Zentrum für Herz Kreislauf-Forschung and of the Advisory Board of the Australian Victorian Heart Institute. He is Chairperson of the ESC Congress Program Committee, former Chairperson of the ESC Clinical Practice Guidelines Committee, and Deputy Editor of the Journal of the American College of Cardiology Cardiovascular Interventions. All other authors declare no competing interests. Funding Information: In observational and randomised clinical research that uses EHRs and other structured data, the source of data, its manipulation, and data governance are of crucial importance to extrapolating results. Clarity from the stakeholders is needed to provide a quality framework to enhance the design and application of clinical research that increasingly depends on these new sources of data. This Review shows the collaboration of a wide range of international stakeholders with the task of improving the use of routinely collected health-care data. The CODE-EHR framework was coordinated by the European Society of Cardiology (ESC), a non-profit organisation of health-care professionals, and the BigData@Heart consortium, a public–private partnership funded by the European Union Innovative Medicines Initiative. We aim to explain opportunities and limitations of using structured health-care data in research and develop a framework for a broad audience of global stakeholders across all disease areas. The CODE-EHR framework seeks to leverage the digitisation of health data to increase the efficiency of health-care systems and improve the lives and wellbeing of patients. Publisher Copyright: © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
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