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. 2022 Aug 29:378:e069048.
doi: 10.1136/bmj-2021-069048.

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

Dipak Kotecha  1   2 , Folkert W Asselbergs  2   3 , Stephan Achenbach  4 , Stefan D Anker  5 , Dan Atar  6   7 , Colin Baigent  8   9 , Amitava Banerjee  3   10 , Birgit Beger  11 , Gunnar Brobert  12 , Barbara Casadei  13 , Cinzia Ceccarelli  14 , Martin R Cowie  15   16 , Filippo Crea  17   18 , Maureen Cronin  19 , Spiros Denaxas  3   20   21 , Andrea Derix  22 , Donna Fitzsimons  23 , Martin Fredriksson  24 , Chris P Gale  25   26 , Georgios V Gkoutos  27   28 , Wim Goettsch  29   30 , Harry Hemingway  3 , Martin Ingvar  31   32 , Adrian Jonas  33 , Robert Kazmierski  34 , Susanne Løgstrup  11 , R Thomas Lumbers  3   35 , Thomas F Lüscher  36   37 , Paul McGreavy  38 , Ileana L Piña  39   40 , Lothar Roessig  22 , Carl Steinbeisser  22   41 , Mats Sundgren  42 , Benoît Tyl  43 , Ghislaine van Thiel  44 , Kees van Bochove  45 , Panos E Vardas  46   47 , Tiago Villanueva  48 , Marilena Vrana  11 , Wim Weber  48 , Franz Weidinger  49 , Stephan Windecker  50 , Angela Wood  51 , Diederick E Grobbee  52 ; Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group
Affiliations

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

Dipak Kotecha et al. BMJ. .

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.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form (www.icmje.org/coi_disclosure.pdf) and declare: DK reports grants from EU/EFPIA Innovative Medicines Initiative (BigData@Heart 116074), during the study; grants from National Institute for Health Research (NIHR CDF-2015-08-074 RATE-AF; NIHR130280 DaRe2THINK; NIHR132974 D2T-NeuroVascular); British Heart Foundation (PG/17/55/33087, AA/18/2/34218 and FS/CDRF/21/21032); and European Society of Cardiology supported by educational grants from Boehringer Ingelheim, BMS-Pfizer Alliance, Bayer, Daiichi Sankyo, Boston Scientific, the NIHR/University of Oxford Biomedical Research Centre, and British Heart Foundation/University of Birmingham Accelerator Award (STEEER-AF NCT04396418); Amomed Pharma and IRCCS San Raffaele/Menarini (Beta-blockers in Heart Failure Collaborative Group NCT0083244), outside of this work; and advisory board personal fees from Bayer, Amomed, Protherics Medicines Development and Myokardia, outside of this work. FWA reports grants from IMI BigData@Heart, during the study. SDA reports grants and personal fees from Vifor Int, Abbott, and Abbott Vascular; personal fees from Bayer, Boehringer Ingelheim, and Servier; personal fees from Cardiac Dimensions, Actimed, Astra Zeneca, Amgen, Bioventrix, Janssen, Respicardia, V-Wave, Brahms, Cordio, and Occlutech, outside of this work. CB reports grants from Medical Research Council, Boehringer Ingelheim, and NIHR, outside of this work. AB reports grants from Astra Zeneca, outside of this work. BB reports grants from European Commission, during the study. GB reports grants from European Commission (IMI project support), during the study; and other from Bayer AB, outside of this work. BC reports non-financial support from Roche Diagnostics and iRhythm, outside of this work. CC reports grants from European Commission, during the study. MRC reports personal fees from AstraZeneca, outside of this work. FC reports personal fees from Amgen, Astra Zeneca, Servier, and BMS; other from GlyCardial Diagnostics, outside of this work. MC reports personal fees from Vifor Pharma, during the study; and personal fees from Vifor Pharma, outside of this work. AD reports other from Bayer AG, outside of this work. MF reports other from AstraZeneca, during the study; other from AstraZeneca, outside of this work; and is employed by 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, outside of this work. MI reports grants from World Economic Forum, Swedish Innovation Agency, and European Commission, during the study; and other collaboration with Frisq AB, outside of this work. SL reports grants from European Commission, during the study. TFL reports grants from Abbott, Amgen, Novartis, Boehringer Ingelheim, Servier, Vifor, Sanofi, and AstraZeneca; and personal fees from Daichi Sankyo, Pfizer, and Menarini, outside of this work. LR reports other from Bayer AG, during the study and other from Bayer AG, outside this work. CS reports personal fees from Bayer AG, during the study and personal fees from Bayer AG, outside of this work. BT reports personal fees from Servier, outside of this work. GvT reports grants from IMI, during the study. KvB reports grants from IMI BigData@Heart, during the study. PEV reports personal fees from Hygeia Hospitals Group, HHG group, European Society of Cardiology, and Servier International, outside of this work. TV is working as an editor at TheBMJ and Acta Médica Portuguesa and is vice president of the European Union of General Practitioners (UEMO). MV reports grants from European Commission, during the study. SW reports grants from Abbott, Amgen, Astra Zeneca, 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, outside of this work; and SW serves as unpaid advisory board member or unpaid member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, Astra Zeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers. SW is also member of the steering or executive committee group of several investigator-initiated trials that receive funding by industry without impact 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 also 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 JACC CV Interventions. All other authors declare no competing interests.

Figures

Fig 1
Fig 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
Fig 2
Fig 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

References

    1. Conrad N, Judge A, Tran J, et al. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet 2018;391:572-80. 10.1016/S0140-6736(17)32520-5 - DOI - PMC - PubMed
    1. Hernández B, Reilly RB, Kenny RA. Investigation of multimorbidity and prevalent disease combinations in older Irish adults using network analysis and association rules. Sci Rep 2019;9:14567. 10.1038/s41598-019-51135-7 - DOI - PMC - PubMed
    1. Oni T, Youngblood E, Boulle A, McGrath N, Wilkinson RJ, Levitt NS. Patterns of HIV, TB, and non-communicable disease multi-morbidity in peri-urban South Africa- a cross sectional study. BMC Infect Dis 2015;15:20. 10.1186/s12879-015-0750-1 - DOI - PMC - PubMed
    1. Studer R, Sartini C, Suzart-Woischnik K, et al. Identification and mapping real-world data sources for heart failure, acute coronary syndrome, and atrial fibrillation. Cardiology 2022;147:98-106. 10.1159/000520674 - DOI - PMC - PubMed
    1. Wallentin L, Gale CP, Maggioni A, Bardinet I, Casadei B. EuroHeart: European Unified registries on heart care evaluation and randomized trials. Eur Heart J 2019;40:2745-9. 10.1093/eurheartj/ehz599 - DOI - PubMed