COMET Initiative | Identification of outcomes in clinical studies of interventions for venous thromboembolism in non-pregnant adults: A scoping review

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

Background: The development of a core outcome set (COS), defined as an agreed minimum set of outcome domains that should be measured and reported in all trials of a specific disease, aims to increase the relevance of study findings to stakeholder groups and improve standardization.
Objectives: 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 into domains and core areas.
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 into domains, which are groups of closely related outcomes, and do-mains into four core areas including death, pathophysiological manifestations/abnor-malities, life impact, and resource use.
Results: Of 7100 records identified, 240 publications were included, representing 165 distinct studies. A total of 205 unique outcomes were identified that were grouped into 48 domains; 30 (13%) studies covered at least three core areas; death was in-cluded in 102 (43%), pathophysiological manifestations/abnormalities in 218 (91%), life impact in 41 (17%), and resource use in 25 (10%) studies.
Conclusion: Most VTE treatment studies evaluated pathophysiological features of VTE, but few studies reported outcomes that measured life impact or resource use. The findings will inform next steps in the development of a COS for VTE treatment studies

Aim

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 into domains and core areas.

Contributors

Tobias Tritschler, Ellen Cusano, Nicole Langlois, Marie-Eve Mathieu, Brian Hutton, Beverley J. Shea, Risa Shorr, Leslie Skeith, Lisa Duffett, Lindsay Cowley, Sara Ng, Suzanne Dubois, Carol West, Peter Tugwell, Grégoire Le Gal

Publication

Journal: Journal of thrombosis and haemostasis : JTH
Volume: 20
Issue:
Pages: 2313 - 2322
Year: 2022
DOI: 10.1111/jth.15787

Further Study Information

Current Stage: Completed
Date:
Funding source(s): The VTE-COS project is funded by the Canadian Institutes of Health Research (PJT- 165897) and is supported by CanVECTOR; the Network receives grant funding from the Canadian Institutes of Health Research (CDT-142654). Grégoire Le Gal holds a clinician–scientist award from the Heart and Stroke Foundation of Ontario and the Chair on Diagnosis of Venous Thromboembolism at the Department of Medicine, University of Ottawa

Health Area

Disease Category: Blood disorders

Disease Name: Venous thromboembolism

Target Population

Age Range: 18

Sex: Either

Nature of Intervention:

Stakeholders Involved

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Systematic review

To identify potentially relevant publications, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched without language restrictions using a strategy developed by an experienced information specialist and reviewed by a second independent information specialist ac-cording to the Peer Review of Electronic Search Strategies (PRESS) guideline statement.18 The search for studies that were published between 2015 and 2020 (see “study selection and data extraction”) was performed on March 17, 2020. Gray literature was not searched