Establishing an International Core Outcome Set for Clinical Trials of Interventions for Venous Thromboembolism in Adults

(VTE-COS)

Blood clots in the veins (called venous thromboembolism or VTE) are common and affect up to 70,000 Canadians per year. This condition can be fatal if a blood clot in the leg or arm travels to the lungs. Treatment mostly relies on anticoagulants (blood thinners), which are very effective but involve risks and inconvenience for patients. Clinical trials are vital for determining the effectiveness of new treatments.

About the Study

The purpose of the VTE-COS study is to identify the most important outcomes of treatments for VTE. In other words, we would like to know how you might decide if a treatment for VTE is an excellent one. This research is led by an international partnership of researchers and patients. It is being done in collaboration with The International Society on Thrombosis and Haemostatis (ISTH) and national research groups.

A short YouTube video explains the research and how the results will be used:

More about the VTE-COS Study

Researchers measure outcomes that they believe are important for decision-making. Two problems that we have identified in clinical trials of VTE treatment are:

  1. inconsistent measurement of outcomes, and
  2. they may not be measuring all outcomes that are important, especially to patients but also to other stakeholders such as policy makers.

The development of “core outcome sets” is gaining popularity as a strategy to address these problems. They are an agreed upon collection of standardized outcomes that should be measured and reported for a condition. A variety of perspectives are required to create a useful core outcome set. CanVECTOR, a national VTE research network, plans to involve researchers, clinicians, patients and other stakeholders to decide together on the best outcomes for VTE studies.

We will seek input from international groups to develop a core outcome set that is applicable worldwide.

Our VTE-COS project has several steps:

  1. Review VTE studies to create a comprehensive list of outcomes (completed);
  2. Hold individual or small group sessions with patients, caregivers, and other groups to identify outcomes that are meaningful to them; (completed)
  3. Survey a large group of clinicians, researchers, patients, caregivers and policy makers to prioritize the list of outcomes; (completed)
  4. Hold a consensus meeting with representatives of each group to decide on the final core outcome set; and
  5. Introduce and promote the core outcome set to Canadian and International researchers and stakeholders in our Canadian and global networks
CanVECTOR Investigators
  • Principal Investigator (Canada): Dr. Grégoire Le Gal
  • Investigator (Canada): Dr. Alfonso Iorio
  • Investigator (Canada): Dr. Leslie Skeith
  • Investigator (Canada): Dr. Lisa Duffett
Methods Experts
  • Brian Hutton
  • Beverley Shea
  • Peter Tugwell
International Collaborators
  • Lead Investigator (Argentina): Dr. Esteban Gandara
  • Lead Investigator (Ireland): Dr. Maeve Crowley
  • Lead Investigator (Singapore): Dr. Lai Heng Lee
  • Lead Investigator (Switzerland): Dr. Helia Robert-Ebadi
  • Lead Investigator (Switzerland): Dr. Tobias Tritschler
  • Lead Investigator (Oman): Dr. Bader Al Rawahi
  • Lead Investigator (Morocco): Dr. Zoubida Tazi Mezalek
  • Lead Investigator (the Netherlands): Dr. Erik Klok
  • Lead Investigator (USA): Dr. Rachel Rosovsky
Patient Partners
  • Carol West
  • Suzanne Dubois
Trainees
  • Ellen Cusano
  • Leanne Genge
  • Alexa Krala
  • Marie-Eve Mathieu
  • Sara Ng
  • Lbena T-Michael
  • Trinity Lowthian
Project Manager
  • Nicole Langlois

Funding

Registration

  • The study is registered in the COMET database (Core Outcome Measures in Effectiveness Trials): COS registration.

Publications

  • A scoping review on the Evaluation of patients’ experience and related qualitative outcomes in venous thromboembolism was completed. The publication can be found here.
  • A scoping review on the Identification of outcomes in clinical studies of interventions for venous thromboembolism in non-pregnant adults was completed. The publication can be found here.

Questions

If you have any questions, please contact CanVECTOR-COS@ohri.ca.