CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research
Dipak KotechaFolkert W. AsselbergsStephan AchenbachStefan D. AnkerDan AtarColin BaigentAmitava BanerjeeBirgit BegerGunnar BrobertBarbara CasadeiCinzia CeccarelliMartín CowieFilippo CreaMaureen CroninSpiros DenaxasAndrea DerixDonna FitzsimonsMartin FredrikssonChris P GaleGeorgios V. GkoutosWim GoettschHarry HemingwayMartin IngvarAdrian JonasRobert KazmierskiSusanne LøgstrupR Thomas LumbersThomas F. LüscherPaul McGreavyIleana L. PiñaLothar RoessigCarl SteinbeisserMats SundgrenBenoît TylGhislaine J. M. W. van ThielKees van BochovePanos VardasTiago VillanuevaMarilena VranaWim WeberFranz WeidingerStephan WindeckerAngela WoodDiederick E. GrobbeeXavier KurzJohn ConcatoRobert KazmierskiJose P. MoralesIleana L. PiñaWim GoettschAdrian JonasNiklas HedbergFilippo CreaThomas F. LüscherWim WeberTiago VillanuevaStuart SpencerRupa SarkarMartin FredrikssonMats SundgrenAndrea DerixGunnar BrobertLothar RoessigBenoît TylKees van BochoveMaureen CroninColm CarrollCeri ThompsonBirgit BegerSusanne LøgstrupMarilena VranaPaul McGreavyBarbara CasadeiStephan AchenbachValentina TursiniPanos VardasDan AtarColin BaigentChris P GaleDonna FitzsimonsStephan WindeckerStefan D. AnkerMartín CowieAmitava BanerjeeHarry HemingwayR Tom LumbersSpiros DenaxasFolkert W. AsselbergsRick GrobbeeGhislaine J. M. W. van ThielDipak KotechaAngela WoodMartin IngvarCarl SteinbeisserAnastasia PetrovaCinzia CeccarelliKatija BaljevicPolyxeni VairamiJennifer Taylor
Key Points
- To establish a minimum standards framework to guide study design, ensure data transparency, and promote robust utilization of structured electronic healthcare records in clinical research.
- Convened an international stakeholder initiative organized by the European Society of Cardiology and the BigData@Heart consortium.
- Engaged patient representatives, clinicians, scientists, regulators, journal editors, and industry representatives to identify critical challenges in big data research.
- Identified critical pitfalls in big data utilization, specifically data verification, validation, data privacy, and the social mandate for research.
- Formulated the CODE-EHR Minimum Standards Framework as a practical roadmap to enhance study design, transparency, and reliability when using routine healthcare data.
PICO
I
Intervention / Comparator
CODE-EHR Minimum Standards Framework
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“With the support of patients and the public, routinely collected healthcare information provides an exciting opportunity to answer important clinical questions in populations representative of our communities. Our ability to apply findings from studies that use these data sources is critically dependent on transparency at every stage. This international framework will enable robust and effective use of healthcare data for clinical research and provide those working in this field with guidance on how to design better studies for maximal benefit to patient care.”
“The use of real-world data in large-scale registries and randomised trials is ushering in a new era of clinical evidence generation. The CODE-EHR framework addresses public concerns about data sharing and provides greater clarity on the use of real-world healthcare data for a broad range of stakeholders to improve clinical care.”
Implication
The CODE-EHR framework establishes minimum standards for using structured electronic healthcare records in clinical research to ensure robust and transparent evidence generation.
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.
Discussion
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Cite This Study
Kotecha et al. (2022) studied this question. CODE-EHR Minimum Standards Framework was evaluated. The CODE-EHR Minimum Standards Framework was proposed to improve study design, enhance transparency, and develop a roadmap for robust utilization of healthcare data in research.