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

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.

The scoping review has been registered at the University of Ottawa: http://hdl.handle.net/10393/40459

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

Collaborators: Dr. Helia Robert-Ebadie (Switzerland), Dr. Esteban Gandara (Argentina), Dr. Zoubida Tazi (Morocco), Dr. Maeve Crowley (Ireland)

Further Study Information

Current Stage: Ongoing
Date: July 2019 - December 2023
Funding source(s): Canadian Institutes of Health Research (Reference Number: PJT – 165897)


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 of Intervention: Any

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
- Recommendations for outcome measures (measurement/how)

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.

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