PB0463 - Outcomes in clinical studies of interventions for venous thromboembolism in non-pregnant adults: A scoping review

Sunday, July 10, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Tobias Tritschler, MD, MSc

MD, MSc
Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Bern, Bern, Switzerland

Co-Author(s)

EC

Ellen Cusano

Medical Student
University of Calgary
Calgary, Alberta, Canada
MM

Marie-Eve Mathieu

Medical Student
University of Ottawa
Ottawa, Ontario, Canada
BH

Brian Hutton

Senior Scientist & Associate Professor
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
BS

Beverley J. Shea

Senior Methodologist & Adjunct Professor
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
RS

Risa Shorr

Librarian
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
Leslie Skeith, MD

Associate Professor
University of Calgary
Calgary, Alberta, Canada
LD

Lisa Duffett

Assistant Professor
Department of Medicine, University of Ottawa, Ottawa, ON, Canada
Ottawa, Ontario, Canada
NL

Nicole J. Langlois

RN, MSc
Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
LC

Lindsay Cowley

Research Assistant
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
SN

Sara S. Ng, MBBS FRACP FRCPA

Haematologist
NSW Health, Liverpool Hospital
Liverpool, New South Wales, Australia
SD

Suzanne Dubois

Patient Partner
CanVECTOR
Brantford, Ontario, Canada
CW

Carol West

Patient Partner
CanVECTOR
Chelsea, Quebec, Canada
PT

Peter Tugwell

Senior Scientist & Professor
Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario, Canada
Gregoire Le Gal, MD PhD

MD, PhD
Ottawa Hospital Research Institute, University of Ottawa, Canada
Ottawa, Ontario, Canada

Background: The development of a core outcome set (COS), defined as an agreed minimum set of outcomes that should be measured and reported in trials of a specific disease, aims to increase the relevance of study findings to key stakeholder groups and improve standardization.

Aims: As the first step in developing a COS for venous thromboembolism (VTE) treatment studies, we aimed to generate an inclusive list of unique outcomes reported in previous VTE treatment studies and classify them in domains.

Methods: MEDLINE, Embase and CENTRAL were searched for prospective studies reporting on interventions for VTE in non-pregnant adults. Study selection and data extraction were performed in blocks based on publication date, starting with 2015-2020 and subsequent 1-year periods, until no new outcome was identified. Outcomes were classified in domains, which are groups of closely related outcomes, and domains were classified in four core areas including death, pathophysiological manifestations/abnormalities life impact and resource use.

Results: Of 7100 records identified, we included 240 publications, representing 165 (69%) distinct studies. We identified 205 unique outcomes that were grouped into 48 domains. A total of 30 (13%) studies covered ≥3 of the 4 core areas; death was included in 102 (43%), pathophysiological manifestations/abnormalities in 218 (91%), life impact in 41 (17%), and resource use in 25 (10%) studies.

Conclusion(s): Most VTE treatment studies evaluated pathophysiological features of VTE, but few studies reported outcomes that measure life impact or resource use. Our findings will inform next steps in the development of a COS for VTE treatment studies. (Funded by the Canadian Institutes of Health Research and supported by the Canadian Venous Thromboembolism Research Network.)