TY - JOUR
T1 - CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research
AU - Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, CODE-EHR international consensus group
AU - Kotecha, Dipak
AU - Asselbergs, Folkert W
AU - Achenbach, Stephan
AU - Anker, Stefan D
AU - Atar, Dan
AU - Baigent, Colin
AU - Banerjee, Amitava
AU - Beger, Birgit
AU - Brobert, Gunnar
AU - Casadei, Barbara
AU - Ceccarelli, Cinzia
AU - Cowie, Martin R
AU - Crea, Filippo
AU - Cronin, Maureen
AU - Denaxas, Spiros
AU - Derix, Andrea
AU - Fitzsimons, Donna
AU - Fredriksson, Martin
AU - Gale, Chris P
AU - Gkoutos, Georgios V
AU - Goettsch, Wim
AU - Hemingway, Harry
AU - Ingvar, Martin
AU - Jonas, Adrian
AU - Kazmierski, Robert
AU - Løgstrup, Susanne
AU - Thomas Lumbers, R
AU - Lüscher, Thomas F
AU - McGreavy, Paul
AU - Piña, Ileana L
AU - Roessig, Lothar
AU - Steinbeisser, Carl
AU - Sundgren, Mats
AU - Tyl, Benoît
AU - van Thiel, Ghislaine
AU - van Bochove, Kees
AU - Vardas, Panos E
AU - Villanueva, Tiago
AU - Vrana, Marilena
AU - Weber, Wim
AU - Weidinger, Franz
AU - Windecker, Stephan
AU - Wood, Angela
AU - Grobbee, Diederick E
N1 - This article has been co-published with permission in The BMJ, the Lancet Digital Health, and the European Heart Journal © the Authors 2022.
PY - 2022/10/7
Y1 - 2022/10/7
N2 - 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.
AB - 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.
KW - COVID-19/epidemiology
KW - Delivery of Health Care
KW - Electronic Health Records
KW - Electronics
KW - Humans
KW - Pandemics/prevention & control
UR - http://www.scopus.com/inward/record.url?scp=85139571140&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehac426
DO - 10.1093/eurheartj/ehac426
M3 - Article
C2 - 36208161
SN - 0195-668X
VL - 43
SP - 3578
EP - 3588
JO - European Heart Journal
JF - European Heart Journal
IS - 37
ER -