Core Outcome Measures in Effectiveness Trials

Establishing an International Core Outcome Set for Clinical Trials of Interventions for Venous Thromboembolism in Adults (VTE-COS)

General Information

Summary:
Clinical trials of venous thromboembolism (VTE) treatment in adults suffer from inconsistent measurement of outcomes and they may not be measuring all outcomes that are important, especially to patients and stakeholders. A COS for VTE does not exist as a resource for investigators.

We propose a mixed-methods Core Outcome Set development study with the goal of defining a core set of valid, homogeneous and relevant outcomes for use in clinical trials of interventions for venous thromboembolism in adults, then promoting these outcomes internationally with researchers, knowledge users and all relevant stakeholders.

Contributors:
Gregoire Le Gal (principal investigator)
Nicole Langlois (project manager)

CanVECTOR investigators: Dr. Lisa Duffett, Dr. Alfonso Iorio, Dr. Leslie Skeith
CanVECTOR clinical and research fellow: Dr. Tobias Tritschler
CanVECTOR patient partners: Carol West, Suzanne Dubois
Methods experts: Dr. Bev Shea, Dr. Brian Hutton, Dr. Peter Tugwell

Further Study Information

Current Stage:
Planning
Date:
July 2019 - June 2022
Funding source(s):
Grant Application to be submitted to the Canadian Institutes of Health Research on March 6, 2019

Health Area

Disease Category
Blood disorders

Disease Name
Deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
Venous thromboembolism

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Systematic review

This mixed-methods study includes a systematic review, focus groups with patients, a Delphi consensus and in-person meeting to define the core set, followed by additional work (systematic review and consensus) to identify measurement instruments relevant to the developed COS.


Stakeholders Involved

Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Epidemiologists
Governmental agencies
Methodologists
Policy makers
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
Recommended outcome measures (measurement)

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