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ISTH Seeks Public Comments on VTE Common Data Elements Project

Wednesday, December 11, 2019   (0 Comments)
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The International Society on Thrombosis and Haemostasis (ISTH) invites you to provide feedback on the new Venous Thromboembolism (VTE) Common Data Elements (CDE) project. The goal of the VTE CDE project 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.

Please submit your comments here by January 31.

The ISTH Common Data Elements (CDEs) for venous thromboembolism (VTE) project seeks to meet the following goals:

  • To establish a consistent, interoperable and universal vocabulary for clinical research that will enable accurate and reproducible capture of clinical concepts and research elements.
  • To facilitate the development of clinical research, by increasing opportunities for sharing data across disparate sources (pooled analyses, individual patient-data meta-analysis)

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.

Please visit the VTE CDE portal located at isth.breakthrough.healthcare to provide feedback.

To provide comments, you will need to register for an account using your email address, name, and organization. In addition to the CDE list and comment options, the site contains a User's Guide to CDEs that provides an overview of how CDEs are constructed, and how to combine them to create case review forms (CRFs) and databases for research.


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