Breakthrough Project Spotlight

ISTH Common Data Elements for Venous Thromboembolism

Clinical research studies and registries are often built using project-specific clinical data elements, limiting the ability to combine and compare datasets to derive deep insights and answer complex questions. Common Data Elements (CDEs) are a way to harmonize definitions and standards across these programs, building more interoperable datasets, enabling apples-to-apples comparison of findings, and expediting the time to design and develop studies and registries.

In November 2018, Breakthrough Healthcare began working with the International Society on Thrombosis and Haemostasis to develop the first CDEs for venous thromboembolism (VTE). Working with over 50 exemplary VTE researchers across the globe, Breakthrough facilitated the process of identifying the key clinical data points to be included in the CDEs, co-developed clinical definitions, developed metadata standards to describe the CDEs, and co-authored a methods paper outlining the process and outcomes of this project.

Powered by Breakthrough Clinical Data Engine™

Collaboratively developing over 500 clinical data elements is a complex task, involving coordination across researchers, version control, and complex data relationship management. Breakthrough’s Clinical Data Engine (Breakthrough CDE) platform was used to manage this process, providing a cloud-based platform for collaboration, documentation, and publication of the final CDEs. In addition to documenting and maintaining the metadata behind the CDEs, Breakthrough CDE’s public comment management feature was used to collect comments from stakeholders around the globe, and integrate the comments into final revisions to the CDE library.

Now in their final first version, the ISTH VTE CDEs are hosted in Breakthrough CDE, with a custom website including educational content and project background information. The platform provides an easily navigable interface for researchers and registry developers to find relevant CDEs, and to also choose CDE specifications to download for incorporation in programs. As the VTE CDEs are updated over time, Breakthrough CDE will maintain previous versions to ensure that the correct iterations of CDEs are always referenced in publications and used for interoperability projects.

For More Information

Project Methods & Outcomes
Le Gal, G., Carrier, M., Castellucci, L.A., Cuker, A., Hansen, J.‐B., Klok, F.A., Langlois, N.J., Levy, J.H., Middeldorp, S., Righini, M., Walters, S. and (2020), Development and implementation of common data elements for venous thromboembolism research: Official Communication from the SSC of the ISTH. J Thromb Haemost. Accepted Author Manuscript. https://doi.org/10.1111/jth.15138

ISTH Press Release
ISTH Publishes Venous Thromboembolism Common Data Elements to Aid in Sharing Global Research Data