The preliminary analysis started with the Cardiology Network because it already had a shared minimum dataset (MDS) of data collected for individual research projects, a Clinical Trial Management System (CTMS) and a single platform for trial management based on RedCap (Research Electronic Data Capture). In addition, the Cardiology Network has ongoing initiatives, also at an international level, in line with the HBD project (such as the European Health Data and Evidence Network, EHDEN) and, above all, it already has a research project suitable for this purpose, the VaVirimS Study.

    The Network defined a minimum data set of 167 variables, which contains the research data common to all studies together with some data collected specifically for the VaVirimS study (e.g. inclusion criteria). The project then analysed the Network’s minimum dataset based on the FHIR (Fast Health Interoperability Resource) and OMOP (Observational Medical Outcomes Partnership) standards in order to identify a common format and representation of the data collected by the Cardiology Network’s clinical trial management system and the clinical data in the electronic outpatient record.

    From this analysis, it emerged that a series of alignments were needed in order to be able to make the data interoperable and shareable. The first requirement for Big Data to be usable is that it speaks the same language.

    Data platform. Currently, there are 10 active scientific studies on the RedCap platform customised for the Cardiology Network, with more than 15,000 patients enrolled and a total of more than 230 CRFs (Case Report Forms or data collection forms) with more than 4,300 variables and an initial minimum dataset (MDS) of 174 variables, modified and optimised over time. The pathway for the creation and development of a data platform for the Cardiology Network started in 2017. Instead of developing ad hoc software (a tailor-made solution that would have been more costly and time-consuming), the Network Assembly decided to use an existing platform, the latter strategy requiring a much shorter implementation time. With the collaboration of the Bioengineering and Medical Informatics Consortium, a data platform was thus developed based on the RedCap platform. The platform is perfectly capable of: 1) to collect and share homogeneous data from the clinical-scientific research projects of the Network; 2) to be interoperable, capable not only of acquiring data or transmitting them to external platforms, but also of giving individual IRCCSs control of the data collected within the Network and of the information that has to ‘travel’ between different projects. This also allows the IRCCSs and the Network to collect much more extensive data than the individual studies.

    VaVirimS. Researchers from the Cardiology Network, with the prospective multi-centre VaVirimS study, aimed to identify adverse VS remodelling in 193 patients following their first infarction (revascularised within 12 hours) with a baseline measurement with contrast-enhanced CMR at one month after the acute event, and with follow-up at 6 months. This is because, when the assessment is made in the immediacy of the event, in the first week, oedema and the presence of stunning contribute to inaccurate definition of infarct size and also of the remodelling process.
    In the study, remodelling was defined as an increase in left ventricular volume of ≥12%, (and not ≥20%, which implies an advanced remodelling process), and also taking into account other factors, such as remodelling based on increased end-systolic volume.
    What also makes the VaVirimS Study particularly innovative, from a methodological point of view, is that the DICOM (Digital Imaging and COmmunications in Medicine) images for the study were collected and managed in a single centre, using a web-based software platform (electronic Care Report Form – eCRF) based on RedCap (Research Electronic Data Capture), hosted by the Cardiology Network.

    CV-PREVITAL. Among the studies of the Cardiology Network using the RedCap platform, besides the VaVirimS study, the CV-PREVITAL project is perhaps the most complex. The platform satisfies interoperability requirements, first of all by allowing the integration and centralisation of data from different platforms (that of the Network, that of the General Practitioners and that of the Lombardy pharmacies). Not only that: the RedCap platform, optimised for the Cardiology Network, also integrates a series of services. In fact, it implements:

    • a hash calculation algorithm, applied to the tax code, which makes it possible to assign a unique identifier to each patient, preserving their anonymity and preventing different enrolment centres from enrolling the same patient;
    • a randomisation algorithm used when enrolling patients;
    • risk algorithms (a very important step in the enrolment phase) with which the system processes the collected data and, through ad hoc developed routines, calculates the estimated cardiovascular risk and the development of hypertension and type 2 diabetes, which enrich the project dataset.

    The Cardiology Network has at its disposal the RedCap platform, managed by the Consortium of Bioengineering and Medical Informatics – CBIM, which is configured as a single Network system on which all the eCRFs of the research projects related to the cardiology field are created and managed. The use of a single platform has also enabled the definition of a single Network Minimum Data Set (MDS), which represents the minimum data set that each research project initiated by the IRCCSs and the Network must collect. All IRCCSs enter data manually on the RedCap platform, with no compulsory compiling requirement.