Healthcare data research should follow a framework to ensure transparency at every stage, according to experts across research, regulation and patient advocacy.
Healthcare data records are a crucial aspect of future research, and the framework for transparent management will enable insights to be better adopted into clinical practice and regulation
Routinely-collected healthcare data has the potential to improve the lives and wellbeing of patients across the world, through better understanding of disease, and research on existing and new treatments.
Presented today at ESC Congress and simultaneously published in The BMJ, Lancet Digital Health and European Heart Journal, an international team propose a framework to improve the integrity and quality of studies using healthcare data, and boost confidence in using the results for clinical decision support.
The approach was compiled by a wide range of global stakeholders, coordinated by the BigData@Heart consortium and the European Society of Cardiology. This included patients and patient advocacy groups, regulators, government agencies and leading medical journals, plus representatives from professional societies, academic institutions, the pharmaceutical industry and payers.
Participants convened to review opportunities and challenges, and develop pragmatic advice on how healthcare data can be applied to research across the spectrum of disease.
...concerns over quality, data privacy, transparency and comparability have limited the use of evidence generated using structured healthcare data
“Health data science has undergone rapid development in recent years, including the common adoption of electronic healthcare record systems. However, concerns over quality, data privacy, transparency and comparability have limited the use of evidence generated using structured healthcare data. These issues have also restricted acceptance by regulators, reimbursement authorities and guideline task forces,” states the paper.
Professor Dipak Kotecha of the University of Birmingham and the University Hospitals Birmingham NHS Foundation Trust, and first author of the paper said:
“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 CODE-EHR framework was iteratively developed to provide researchers with step-by-step guidance on how to achieve appropriate governance and transparency, and for stakeholders to have confidence in the reported findings.
Professor Folkert Asselbergs from University Medical Center Utrecht in the Netherlands and University College London, UK said:
“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.”
For media enquiries please contact Tim Mayo, Press Office, University of Birmingham, tel: +44 (0)7920 405040: email: t.mayo@bham.ac.uk
The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
The University of Birmingham is a member of Birmingham Health Partners (BHP), a strategic alliance which transcends organisational boundaries to rapidly translate healthcare research findings into new diagnostics, drugs and devices for patients. Birmingham Health Partners is a strategic alliance between five organisations who collaborate to bring healthcare innovations through to clinical application:
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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.
About the European Society of Cardiology
The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.
Launched in March 2017, BigData@Heart is a six-year project of the Innovative Medicines Initiative (IMI), an EU public-private consortium consisting of patient networks, learned societies, small and medium-sized enterprises, pharmaceutical companies and academia.
Professor of Cardiology & Cardiac Imaging
Staff profile for Professor Dipak Kotecha, Professor of Cardiology, Institute of Cardiovascular Sciences, College of Medical and Dental Sciences, The University of Birmingham.
