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.
Bibliographical noteFunding Information:
G. Le Gal's institution has received research funding from Pfizer, Bristol‐Myers Squibb, Bayer, and consultancy fees on his behalf from Bayer, Bristol‐Myers Squibb, Pfizer, LEO Pharma, and Sanofi outside the submitted work. A. Cuker serves as a consultant for Synergy. His institution has received research support on his behalf from Alexion, Bayer, Novartis, Novo Nordisk, Pfizer, Sanofi, and Spark. M. Carrier's institution has received research funding on his behalf from BMS, Pfizer, and Leo Pharma. His institution has also received consultancy fees on his behalf from Leo Pharma, Bayer, BMS, Sanofi, Servier, and Pfizer. L. A. Castellucci's institution has received consultancy fees on her behalf from Bayer, BMS, LEO Pharma, Pfizer, Sanofi, and Servier. F. A. Klok reports research grants from Bayer, Bristol‐Myers Squibb, Boehringer‐Ingelheim, Daiichi‐Sankyo, MSD and Actelion, the Dutch Heart foundation, the Netherlands Organisation for Health Research and Development and the Dutch Thrombosis association, all outside the submitted work. J. H. Levy serves on advisory committees for Haima, Instrumentation Laboratories, Janssen, Octapharma, Leading Biosciences, and Merck. S. Middeldorp's institution received grants and fees on her behalf from GSK, BMS/Pfizer, Aspen, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Sanofi, and Portola. S. Walters is president of Breakthrough Healthcare, and serves as a paid consultant to the ISTH and the American Society of Hematology.
L. A. Castellucci is supported by the Heart & Stroke Foundation of Canada National New Investigator and Ontario Clinician Scientist Phase I awards and holds a T2 Research Chair in Thrombosis and Anticoagulation Safety from the University of Ottawa. G. Le Gal holds an Early Researcher Award from the Province of Ontario; a mid‐career clinician scientist award from the Heart and Stroke Foundation of Ontario; and the Chair on the Diagnosis of Venous Thromboembolism, Department of Medicine, University of Ottawa. N. J. Langlois's contribution was supported by the CanVECTOR and INVENT research networks.
The project was supported from the ISTH and SSC general funds. We acknowledge the members of the VTE CDE Steering Committee and seven project working groups for their scientific and technical contributions to this project. SSC Subcommittees on Control of Anticoagulation, Hemostasis & Malignancy, Perioperative and Critical Care, and Predictive and Diagnostic Variables supported the project and subcommittee leadership participated as working group members. We would also like to thank Dr Nicola Mutch, SSC Chair, for her support, as well as Shannon Brooks, Lacey Schmeidler, and Cary Clark from ISTH headquarters.
© 2020 International Society on Thrombosis and Haemostasis
- clinical research
- common data elements
- venous thromboembolism