An international team of researchers have proposed a framework to improve the integrity and quality of studies using structured healthcare data from electronic health records, along with using the results for clinical decision support.
Published in The BMJ, Lancet Digital Health and European Heart Journal, the approach was coordinated by the BigData@Heart consortium and the European Society of Cardiology. It included patients, patient advocacy groups, regulators, government agencies, leading medical journals, and representatives from professional societies, academic institutions, the pharmaceutical industry and payers.
Participants gathered to review opportunities and challenges with the aim of developing pragmatic advice on how healthcare data can be applied to research across the spectrum of disease.
The CODE-EHR framework was developed to provide researchers with step-by-step guidance on how to achieve appropriate governance and transparency, whilst also enabling stakeholders to be confident in findings.
Minimum standards are outlined in five key areas: dataset construction and linkage, clarifying the source, completeness and linkage of any healthcare data used in the study; data fit for purpose, providing detail on coding systems, data manipulation and assessment of data quality; disease outcome and definitions, allowing other researchers to re-use and improve by sharing all codes and algorithms used; analysis, describing how outcome events were analysed to enable validation and replication; and ethnics and governance, communicating processes for consent, data privacy, and patient/public involvement.
“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,” commented Professor Dipak Kotecha of the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, author of the report. “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.”
Fellow author Professor Folkert Asselbergs from the University Medical Center Utrecht and University College London added: “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.”
Read the paper, CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research (August 29, 2022) here.
