Project Background

The International Society on Thrombosis and Haemostasis (ISTH) Venous Thromboembolism (VTE) Common Data Elements (CDE) project's goal is to create common research data standards for VTE clinical research throughout the world. CDEs are structured data definitions that provide a consistent framework for clinical research data capture and analysis. CDEs include common clinical definitions, as well as technical metadata such as data type, measurement type, and permissible value lists.

A team of over 50 international experts in VTE were convened over 12 months to identify core data elements used in VTE research, and develop consensus definitions and coding standards. In addition to addressing core data elements including broad-based topics such as medical history and study variables, working groups also addressed subtopics including malignancy, predictors and diagnosis, anticoagulation, pregnancy and women's health, longitudinal outcomes, and perioperative risk.

The ISTH VTE CDE project seeks to meet the following goals:

  1. To establish a consistent, interoperable and universal vocabulary for clinical research that will enable accurate and reproducible capture of clinical concepts and research elements

  2. To facilitate the development of clinical research, by increasing opportunities for sharing data across disparate sources (pooled analyses, individual patient-data meta-analysis)

The methods and outcomes of this project have been published in the Journal of Thrombosis and Haemostasis:

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

When using the ISTH CDEs in your research, please include this reference in your citations.