Development and implementation of common data elements for venous thromboembolism research: on behalf of SSC Subcommittee on official Communication from the SSC of the ISTH

Abstract

Clinical research in venous thromboembolism (VTE) is hindered by variability in the collection and reporting of data and outcomes. A consistent data language facilitates efficiencies, leads to higher quality data, and permits between‐study comparisons and evidence synthesis. The International Society on Thrombosis and Haemostasis (ISTH) launched an international task force of more than 50 researchers to develop common data elements for clinical research in venous thromboembolism. The project was organized in seven working groups, each focusing on a topic area: General Core Data Elements; Anticoagulation and Other Therapies; Chronic VTE and Functional Outcomes; Diagnosis of VTE; Malignancy; Perioperative; and Predictors of VTE. The groups met via teleconference to collaboratively identify key data elements and develop definitions and data standards that were structured in a project‐specific taxonomy. A Steering Committee met by teleconference and in‐person to determine the overall scope of the project and resolve questions arising from the working groups. ISTH held an open public comment period to enable broader stakeholder involvement and feedback. The common data elements were then refined by the working groups to create a set of 512 unique data elements that are publicly available at http://isth.breakthrough.healthcare. The ISTH VTE Common Data Elements are intended to be a living project with ongoing curation, future expansion, and adaptation to meet the needs of the thrombosis and hemostasis research community.

Optimal follow-up after acute pulmonary embolism: a position paper of the European Society of Cardiology Working Group on Pulmonary Circulation and Right Ventricular Function, in collaboration with the European Society of Cardiology Working Group on Atherosclerosis and Vascular Biology, endorsed by the European Respiratory Society

“…Chronic thromboembolic pulmonary disease (CTEPD) is defined as chronic pulmonary vascular obstruction with normal mean pulmonary artery pressure at rest, but with limited exercise tolerance which is attributed, at least in part, to an increased slope of the pulmonary arterial pressure–flow relationship (>3 mmHg/L/min) during exercise or dead space ventilation. 41 , 42 Dead space fraction is decreased with exercise, while ventilatory efficiency, measured by the ventilatory equivalent for carbon dioxide slope, is decreased. 36 , 43–45 It is obvious today that the majority of patients diagnosed with CTEPH are derived from cohorts with acute PE.…”

Harmonization and standardization of data for a pan-European cohort on SARS- CoV-2 pandemic

“…The use of CDEs to harmonize data originating from different studies has already been described 35 , 36 as a method to merge data in different medical disciplines. In their work, Meeuws et al 37 show how the presence of CDEs on Traumatic Brain Injury has enabled a high level of harmonization in data from three different large multi-centric studies.…”

A toolkit for the collection of thrombosis-related data elements in COVID-19 clinical studies

“… 16 - 18 We also used common data elements from the ISTH Common Data Elements for VTE Research project and adapted other previously published common data elements. 15 , 19 , 20 …”

“…For VTE, bleeding, antithrombotic therapy, and laboratory data points, the writing panel selected and/or adapted data elements from the recently released ISTH Common Data Elements for VTE project, a large initiative aimed at harmonizing data elements collected and reported in VTE-related clinical trials. 15 A draft document including the sets of variables was reviewed by the members of the ASHRC COVID-19 Non-Malignant Hematology Task Force and the ISTH COVID-19 Task Force. All comments were considered by the group, and final decisions on data elements to be retained were made by consensus.…”