Berlin, 15/01/2021. Within the scope of the COVID-19 Data Exchange Platform (CODEX), the Medical Informatics Initiative (MII) of the German Federal Ministry of Education and Research (BMBF) makes up-to-date data available for COVID-19 research. This was underlined by a recently published MII study. MII’s distributed research infrastructure is being expanded to include a central data platform for CODEX, with the aim of enabling COVID-19 research to use real-world data on a broad scale, and to provide physicians and healthcare decision-makers with treatment and other relevant COVID-19 data on a daily basis. The CODEX project was launched in August 2020 and is a central element of the German Network of University Medicine (NUM), which is receiving 150 million euros of funding from the BMBF.
Under the aegis of the MII, 29 university hospitals across Germany have established data integration centres (DICs) since 2018. The centres collect data from routine healthcare and research, and make it available, in compliance with data protection requirements, for research purposes. With the onset of the pandemic, the DICs began to provide COVID-19-specific high-quality structured data for research activities. The establishment of this distributed infrastructure allowed the early commencement of work on the development of the CODEX platform in August 2020.
The goal is to create a repository of COVID-19-specific research data from all in-patient cases at university hospitals. This cross-site pool of data, based on international standards, will enable new types of scientific COVID-19 analytics, for example to examine the use and success of treatments and medication, or to identify patient demographics at university hospitals. To this end, efforts are being made to swiftly gather pseudonymised clinical data, as well as image data and biosample data, from all German university hospitals – while ensuring compliance with all corresponding ethical and data-protection requirements. Data usage is based on consent provided by the impacted patients.
“The MII’s comprehensive technological and legal preparatory work, especially the data integration centres, are an essential basis for the COVID-19 research data platform – and that although we are still in the middle of the MII’s development phase, which the BMBF slated for 2018-2022. It is important that we jointly use and evolve the research infrastructure publicly funded for multiple projects,” emphasises Sebastian C. Semler, TMF (Technology, Methods and Infrastructure for Networked Medical Research), head of the MII’s coordination office, who is joint CODEX project lead with Ralf Heyder, Charité – Universitätsmedizin Berlin, head of the NUM coordination office.
Study shows the potential of MII infrastructure for COVID-19 research
Initial COVID-19 scientific studies have already been published on this basis, aimed at addressing the challenges associated with the pandemic. A study published in January 2021 by an MII research team, led by Friedrich Alexander University (FAU) Erlangen-Nuremberg, for example, demonstrated how patient data from university hospitals could be analysed by means of distribution evaluation methods, enabled by MII’s DIC infrastructure. The study investigated the number of in-patient hospital admissions at 18 German university hospitals between 1 January and 31 May 2020 in comparison with the same period of 2018 and 2019.
Professor Hans-Ulrich Prokosch, FAU Erlangen-Nuremberg, who coordinated the development of the distributed components of the CODEX platform, summarised the outcome: "The number of in-patient admissions at German university hospitals fell in the first four weeks after the announcement of the COVID-19 lockdown on 16 March 2020 in comparison with 2018 by an average of 35 per cent. This also applies in part to emergency room (A&E) hospitalisations, for example due to a heart attack. For these admissions, there was a drop of 38.7 per cent in 2020 in comparison with the same period of 2018. The difference with regard to critical health conditions in cancer treatment was markedly less pronounced, with a decline in hospitalisations of just 13 per cent. The figures for hip replacements due to osteoarthritis and the treatment of acute fractures illustrate that there was a sharp fall in elective (i.e. non-urgent) operations, whereas there was no fundamental change in the number of emergency procedures performed."
CODEX platform consolidates COVID-19 data from multiple sources
“MII’s successfully implemented distributed research data infrastructure for CODEX is to be expanded to include a platform that allows central analysis of complex COVID-19 data sets from diverse sources, including data from the MII’s data integration centres, local community hospitals, general practitioners, and public health agencies. The platform will also enable these data to be combined with data provided directly via apps used by the general public,” explained Professor Roland Eils, Digital Health Center, Berlin Institute of Health (BIH) and Charité – Universitätsmedizin Berlin, who coordinated the development of the central CODEX platform. Both he and Professor Prokosch are members of the CODEX steering committee.
“The aim is for the data platform to help improve our understanding of COVID-19 and to be a basis for political decision-making. Plus, we hope that this pool of data will advance the introduction of new services and applications for healthcare facilities and citizens, and allow the development of evidence-based decision-support systems for doctors,” explained Professor Heyo K. Kroemer, Chief Executive Officer of Charité and co-initiator of NUM.
During the CODEX launch phase, use was made of the clinical research platform of the German Centre for Cardiovascular Research (DZHK). As the CODEX project progresses, additional functionality for COVID-19 research will be developed and put into operation.