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.
analysis
clinical research
common data elements
data
standardization
venous thromboembolism
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
29
08
2020
revised:
12
10
2020
accepted:
14
10
2020
entrez:
6
1
2021
pubmed:
7
1
2021
medline:
15
5
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33405381
doi: 10.1111/jth.15138
pii: S1538-7836(22)00446-9
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
297-303Investigateurs
Erik Klok
(E)
Lisa Bauman Kreuziger
(L)
Sam Schulman
(S)
Leslie Skeith
(L)
Neil Zakai
(N)
Nicoletta Riva
(N)
Jonathan Douxfils
(J)
Susan Kahn
(S)
Arina Ten Cate-Hoek
(A)
Stavros Konstantinides
(S)
Waleed Ghanima
(W)
Irene Lang
(I)
Jean-Philippe Galanaud
(JP)
Thomas Moumneh
(T)
Esteban Gandara
(E)
Paolo Prandoni
(P)
Char Witmer
(C)
Alejandro Lazo-Langner
(A)
Helia Robert-Ebadi
(H)
Fionnuala Ní Áinle
(F)
Cynthia Wu
(C)
Tzu-Fei Wang
(TF)
Jeffrey Zwicker
(J)
Mandy Lauw
(M)
Cihan Ay
(C)
Gabriela Cesarman Maus
(GC)
Pantep Angchaisuksiri
(P)
Marie Steiner
(M)
Raquel Bartz
(R)
Jean Connors
(J)
Marc Samama
(M)
Alex Spyropoulos
(A)
David Faraoni
(D)
Toshiaki Iba
(T)
Clive Kearon
(C)
Suzanne Canniegeter
(S)
Pierre Morange
(P)
Sigrid Braekkan
(S)
Vania Morelli
(V)
Fernanda Orsi
(F)
Informations de copyright
© 2020 International Society on Thrombosis and Haemostasis.
Références
http://cdisc.org/standards/foundational/cdash
Grinnon ST, Miller K, Marler JR, et al. NINDS common data element project - approach and methods. Clin Trials. 2012;9(3):322-329.
https://breakthrough.healthcare/clinical-datasets-and-measures
https://www.nlm.nih.gov/cde/index.html
https://www.isth.org/page/redcap
Tritschler T, Kraaijpoel N, Girard P, et al. Definition of pulmonary embolism-related death and classification of the cause of death in venous thromboembolism studies: communication from the SSC of the ISTH. J Thromb Haemost. 2020;18(6):1495-1500.