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

Dipak Kotecha; Folkert W. Asselbergs; Stephan Achenbach; Stefan D. Anker; Dan Atar; Colin Baigent; Amitava Banerjee; Birgit Beger; Gunnar Brobert; Barbara Casadei; Cinzia Ceccarelli; Martin R. Cowie; Filippo Crea; Maureen Cronin; Spiros Denaxas; Andrea Derix; Donna Fitzsimons; Martin Fredriksson; Chris P. Gale; Georgios, V Gkoutos; Wim Goettsch; Harry Hemingway; Martin Ingvar; Adrian Jonas; Robert Kazmierski; Susanne Logstrup; R. Thomas Lumbers; Thomas F. Luescher; Paul McGreavy; Ileana L. Pina; Lothar Roessig; Carl Steinbeisser; Mats Sundgren; Benoit Tyl; Ghislaine van Thiel; Kees van Bochove; Panos E. Vardas; Tiago Villanueva; Marilena Vrana; Wim Weber; Franz Weidinger; Stephan Windecker; Angela Wood; Diederick E. Grobbee

doi:10.1016/S2589-7500(22)00151-0

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

Dipak Kotecha, Folkert W. Asselbergs, Stephan Achenbach, Stefan D. Anker, Dan Atar, Colin Baigent, Amitava Banerjee, Birgit Beger, Gunnar Brobert, Barbara Casadei, Cinzia Ceccarelli, Martin R. Cowie, Filippo Crea, Maureen Cronin, Spiros Denaxas, Andrea Derix, Donna Fitzsimons, Martin Fredriksson, Chris P. Gale, Georgios, V GkoutosWim Goettsch, Harry Hemingway, Martin Ingvar, Adrian Jonas, Robert Kazmierski, Susanne Logstrup, R. Thomas Lumbers, Thomas F. Luescher, Paul McGreavy, Ileana L. Pina, Lothar Roessig, Carl Steinbeisser, Mats Sundgren, Benoit Tyl, Ghislaine van Thiel, Kees van Bochove, Panos E. Vardas, Tiago Villanueva, Marilena Vrana, Wim Weber, Franz Weidinger, Stephan Windecker, Angela Wood, Diederick E. Grobbee

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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.

Original language	English
Pages (from-to)	E757-E764
Journal	The Lancet Digital Health
Volume	4
Issue number	10
DOIs	https://doi.org/10.1016/S2589-7500(22)00151-0
Publication status	Published - Oct 2022

Keywords

Big Data
COVID-19
Electronic Health Records
Electronics
Humans
Pandemics

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10.1016/S2589-7500(22)00151-0Licence: CC BY

1-s2.0-S2589750022001510-mainFinal published version, 1.29 MBLicence: CC BY

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Kotecha, D., Asselbergs, F. W., Achenbach, S., Anker, S. D., Atar, D., Baigent, C., Banerjee, A., Beger, B., Brobert, G., Casadei, B., Ceccarelli, C., Cowie, M. R., Crea, F., Cronin, M., Denaxas, S., Derix, A., Fitzsimons, D., Fredriksson, M., Gale, C. P., ... Grobbee, D. E. (2022). CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research. The Lancet Digital Health, 4(10), E757-E764. https://doi.org/10.1016/S2589-7500(22)00151-0

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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.",

keywords = "Big Data, COVID-19, Electronic Health Records, Electronics, Humans, Pandemics",

author = "Dipak Kotecha and Asselbergs, {Folkert W.} and Stephan Achenbach and Anker, {Stefan D.} and Dan Atar and Colin Baigent and Amitava Banerjee and Birgit Beger and Gunnar Brobert and Barbara Casadei and Cinzia Ceccarelli and Cowie, {Martin R.} and Filippo Crea and Maureen Cronin and Spiros Denaxas and Andrea Derix and Donna Fitzsimons and Martin Fredriksson and Gale, {Chris P.} and Gkoutos, {Georgios, V} and Wim Goettsch and Harry Hemingway and Martin Ingvar and Adrian Jonas and Robert Kazmierski and Susanne Logstrup and Lumbers, {R. Thomas} and Luescher, {Thomas F.} and Paul McGreavy and Pina, {Ileana L.} and Lothar Roessig and Carl Steinbeisser and Mats Sundgren and Benoit Tyl and {van Thiel}, Ghislaine and {van Bochove}, Kees and Vardas, {Panos E.} and Tiago Villanueva and Marilena Vrana and Wim Weber and Franz Weidinger and Stephan Windecker and Angela Wood and Grobbee, {Diederick E.}",

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doi = "10.1016/S2589-7500(22)00151-0",

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Kotecha, D, Asselbergs, FW, Achenbach, S, Anker, SD, Atar, D, Baigent, C, Banerjee, A, Beger, B, Brobert, G, Casadei, B, Ceccarelli, C, Cowie, MR, Crea, F, Cronin, M, Denaxas, S, Derix, A, Fitzsimons, D, Fredriksson, M, Gale, CP, Gkoutos, GV, Goettsch, W, Hemingway, H, Ingvar, M, Jonas, A, Kazmierski, R, Logstrup, S, Lumbers, RT, Luescher, TF, McGreavy, P, Pina, IL, Roessig, L, Steinbeisser, C, Sundgren, M, Tyl, B, van Thiel, G, van Bochove, K, Vardas, PE, Villanueva, T, Vrana, M, Weber, W, Weidinger, F, Windecker, S, Wood, A & Grobbee, DE 2022, 'CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research', The Lancet Digital Health, vol. 4, no. 10, pp. E757-E764. https://doi.org/10.1016/S2589-7500(22)00151-0

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T1 - CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research

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 - Logstrup, Susanne

AU - Lumbers, R. Thomas

AU - Luescher, Thomas F.

AU - McGreavy, Paul

AU - Pina, Ileana L.

AU - Roessig, Lothar

AU - Steinbeisser, Carl

AU - Sundgren, Mats

AU - Tyl, Benoit

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.

PY - 2022/10

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N2 - 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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KW - Big Data

KW - COVID-19

KW - Electronic Health Records

KW - Electronics

KW - Humans

KW - Pandemics

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DO - 10.1016/S2589-7500(22)00151-0

M3 - Review article

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SP - E757-E764

JO - The Lancet Digital Health

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ER -

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

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