An international team including UCL and UCLH researchers have set out a framework to improve the integrity and quality of research using healthcare data.
A key aim of the framework, presented over the weekend at the European Society of Cardiology Congress, is to boost confidence in using the results of studies using data in clinical decision making.
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.
The CODE-EHR framework was developed alongside a wide range of groups including patients and patient advocacy groups, regulators, government agencies, leading medical journals, professional societies, academic institutions, and the pharmaceutical industry.
The framework covers data quality, data privacy, transparency of processes and comparability of data. It outlines minimum standards around:
- Datasets construction and linkage
- How to ensure data is of high quality and fit for purpose
- Transparency around disease outcomes and definitions, and codes and algorithms used
- How data are analysed
- Ethics and governance, communicating processes for consent, data privacy and patient and public involvement
Report author Professor Folkert Asselbergs, Director of the UCLH BRC Clinical Research Informatics Unit, 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.”
The framework has been published in The BMJ, Lancet Digital Health and European Heart Journal.
