Reporting of D-dimer testing in venous thromboembolism diagnostic management studies: a scoping review

Robin V Hofstetter; Caterina E Marx; Noémie Kraaijpoel; Emmanuel J Favaloro; Patrick M Bossuyt; Piet Meijer; Steve Kitchen; Kerstin de Wit; Helia Robert-Ebadi; Grégoire Le Gal; Drahomir Aujesky; Rita Selby; Tobias Tritschler

doi:10.1016/j.jtha.2026.03.005

Reporting of D-dimer testing in venous thromboembolism diagnostic management studies: a scoping review

J Thromb Haemost. 2026 Mar 14:S1538-7836(26)00190-X. doi: 10.1016/j.jtha.2026.03.005. Online ahead of print.

Authors

Affiliations

¹ Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: robin.hofstetter@insel.ch.
² Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
³ Department of Internal Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.
⁴ Department of Haematology, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, New South Wales, Australia.
⁵ Department of Epidemiology & Data Science, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands.
⁶ External Quality Control of Diagnostic Assays and Tests Foundation, Voorschoten, the Netherlands.
⁷ Department of Coagulation, Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, UK.
⁸ Departments of Emergency Medicine and Medicine, Queen's University, Kingston, Ontario, Canada.
⁹ Division of Angiology and Hemostasis, Faculty of Medicine, Geneva University Hospitals, Geneva, Switzerland.
¹⁰ Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Inflammation and Chronic Disease Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
¹¹ Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
¹² Departments of Laboratory Medicine & Pathobiology and Medicine, University of Toronto, Toronto, Ontario, Canada.
¹³ Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Inflammation and Chronic Disease Program, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.

PMID: 41839295
DOI: 10.1016/j.jtha.2026.03.005

Abstract

Background: D-dimer testing is widely integrated into diagnostic algorithms for venous thromboembolism (VTE). However, the lack of standardization across D-dimer assays and reporting may limit the comparability of study findings.

Objectives: To summarize reporting of essential characteristics of D-dimer testing in VTE diagnostic management studies.

Methods: We systematically searched MEDLINE and Embase from January 1999 to August 2024 for VTE diagnostic management studies that evaluated diagnostic algorithms, including D-dimer testing, and followed patients for ≥ 4 weeks after VTE was excluded. The primary outcome was reporting of D-dimer assay characteristics. Secondary outcomes were reporting of patient numbers and failure rates per assay.

Results: Of 9670 articles screened, 58 studies were included: 36 (62%) enrolled patients with suspected pulmonary embolism, 21 (36%) with suspected deep vein thrombosis, and 1 with suspected VTE. Sample sizes ranged from 191 to 5400; follow-up was 1 to 6 months. Assay name was fully reported in 52 of 58 studies (90%), manufacturer in 49 of 58 (85%), unit magnitude in 42 of 46 (91%), and the unit type in 8/46 (17%). The detection limit was reported in 3 of 58 studies (5.2%); other analytical performance parameters were unreported. Nineteen quantitative assays were used across 19 combinations of thresholds and unit magnitudes. Of 17 studies using multiple assays, 9 reported patient numbers per assay, and 1 reported failure rate per assay.

Conclusion: Key characteristics of D-dimer testing were inconsistently reported in VTE diagnostic management studies. While assay name, manufacturer, unit magnitude, and thresholds were often included, unit type and assay-specific data were frequently omitted. Minimum reporting standards for D-dimer testing are needed for VTE diagnostic management studies.

Keywords: D-dimer; diagnosis; pulmonary embolism; venous thromboembolism.