CODE-EHR best practice framework for the use of structured electronic healthcare 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 Løgstrup; R. Thomas Lumbers; Thomas F. Lüscher; Paul McGreavy; Ileana L. Piña; Lothar Roessig; Carl Steinbeisser; Mats Sundgren; Benoît 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:10.1136/bmj-2021-069048

CODE-EHR best practice framework for the use of structured electronic healthcare 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 Løgstrup, R. Thomas Lumbers, Thomas F. Lüscher, Paul McGreavy, Ileana L. Piña, Lothar Roessig, Carl Steinbeisser, Mats Sundgren, Benoît 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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Article number	069048
Journal	The BMJ
Volume	378
DOIs	https://doi.org/10.1136/bmj-2021-069048
Publication status	Published - 29 Aug 2022

Keywords

Humans
Software
Delivery of Health Care
Electronics
Electronic Health Records

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10.1136/bmj-2021-069048Licence: CC BY

bmj-2021-069048.fullFinal published version, 461 KBLicence: 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 healthcare records in clinical research. The BMJ, 378, Article 069048. https://doi.org/10.1136/bmj-2021-069048

@article{f82b66c7e8464f0fbec97606179d01b1,

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

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.",

keywords = "Humans, Software, Delivery of Health Care, Electronics, Electronic Health Records",

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 L{\o}gstrup and Lumbers, {R. Thomas} and L{\"u}scher, {Thomas F.} and Paul McGreavy and Pi{\~n}a, {Ileana L.} and Lothar Roessig and Carl Steinbeisser and Mats Sundgren and Beno{\^i}t 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.}",

note = "Funding Information: Funding: The BigData@Heart project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116074. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication. Funding Information: In the case of observational and randomised clinical research using EHRs and other structured data, the source of data, its manipulation, and underpinning governance are of critical importance to extrapolating results. Clarity is needed from a broad stakeholder perspective, providing a quality framework to enhance the design and application of clinical research that increasingly depends on these crucial new sources of data. This article reflects the joint work of a wide range of international stakeholders with a remit to improve the use of structured healthcare data. The programme was coordinated by the European Society of Cardiology, a non-profit organisation of healthcare professionals, and the BigData@Heart Consortium, a public-private partnership funded by the European Union Innovative Medicines Initiative. Our aim was to navigate opportunities and limitations, and to develop a framework for a broad audience of global stakeholders across all disease areas. The CODE-EHR framework seeks to realise the exciting opportunity that digitisation of health data affords to increase efficiency of healthcare systems, and improve the lives and wellbeing of patients. Funding Information: 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 M{\'e}dica 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 f{\"u}r 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. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2022",

month = aug,

day = "29",

doi = "10.1136/bmj-2021-069048",

language = "English",

volume = "378",

journal = "The BMJ",

issn = "0959-8146",

publisher = "BMJ Publishing Group",

}

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, Løgstrup, S, Lumbers, RT, Lüscher, TF, McGreavy, P, Piña, 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 healthcare records in clinical research', The BMJ, vol. 378, 069048. https://doi.org/10.1136/bmj-2021-069048

TY - JOUR

T1 - CODE-EHR best practice framework for the use of structured electronic healthcare 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 - Løgstrup, Susanne

AU - Lumbers, R. Thomas

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 - Funding Information: Funding: The BigData@Heart project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116074. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication. Funding Information: In the case of observational and randomised clinical research using EHRs and other structured data, the source of data, its manipulation, and underpinning governance are of critical importance to extrapolating results. Clarity is needed from a broad stakeholder perspective, providing a quality framework to enhance the design and application of clinical research that increasingly depends on these crucial new sources of data. This article reflects the joint work of a wide range of international stakeholders with a remit to improve the use of structured healthcare data. The programme was coordinated by the European Society of Cardiology, a non-profit organisation of healthcare professionals, and the BigData@Heart Consortium, a public-private partnership funded by the European Union Innovative Medicines Initiative. Our aim was to navigate opportunities and limitations, and to develop a framework for a broad audience of global stakeholders across all disease areas. The CODE-EHR framework seeks to realise the exciting opportunity that digitisation of health data affords to increase efficiency of healthcare systems, and improve the lives and wellbeing of patients. Funding Information: 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. Publisher Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/8/29

Y1 - 2022/8/29

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 - Humans

KW - Software

KW - Delivery of Health Care

KW - Electronics

KW - Electronic Health Records

UR - http://www.scopus.com/inward/record.url?scp=85137894428&partnerID=8YFLogxK

U2 - 10.1136/bmj-2021-069048

DO - 10.1136/bmj-2021-069048

M3 - Article

C2 - 36562446

AN - SCOPUS:85137894428

SN - 0959-8146

VL - 378

JO - The BMJ

JF - The BMJ

M1 - 069048

ER -

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

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