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20 May 2003 | Volume 138 Issue 10 | Pages 787-794
Background: Because clinical diagnosis is inaccurate, objective testing is usually considered necessary when patients present with suspected deep venous thrombosis (DVT).
Objective: To determine whether a negative result on a quantitative latex D-dimer assay eliminates the need for further investigation in patients with a low or moderate pretest probability of DVT.
Design: Prospective cohort study.
Setting: Three tertiary care hospitals in Canada.
Patients: 556 consecutive outpatients with suspected first DVT.
Intervention: Patients were categorized as having a low, moderate, or high pretest probability of DVT and then underwent D-dimer testing. Patients with low or moderate pretest probability and a negative D-dimer result had no further diagnostic testing and received no anticoagulant therapy. Serial compression ultrasonography was performed in all other patients. Patients who did not receive a diagnosis of DVT were followed for symptomatic venous thromboembolism.
Measurements: Objectively confirmed symptomatic venous thromboembolic events during 3 months of follow-up.
Results: 283 patients (51%) had low or moderate pretest probability and a negative D-dimer result. One of these patients had DVT during follow-up (negative likelihood ratio, 0.05 [CI, 0.01 to 0.23]). The negative likelihood ratio of the D-dimer test in all patients was 0.03 (CI, 0.01 to 0.16).
Conclusion: A negative result on a quantitative latex D-dimer assay safely eliminates the need for further testing in patients with low or moderate pretest probability of DVT.
Editors' Notes
Context
Contribution
Implications
–The Editors
Author and Article Information
From McMaster University and Henderson Research Centre, Hamilton, Ontario, Canada.
Acknowledgments: The authors thank Jo-Ann Bennett, Sue Smale, Laurie Sardo, RN, Pam Stevens, RN, Terri Schnurr, RN, and Karen Woods, RN, for providing technological and nursing assistance and collecting the data and Sharon Hendershott for assisting in data management. They also thank Drs. Akbar Panju, Ameen Patel, and Stéphanie Cloutier for contributing patients.
Grant Support: By the Canadian Institutes of Health Research University–Industry (Organon Teknika Corp., now bioMérieux, Inc.) Program (grant UOP-42365). Dr. Bates is a recipient of a New Investigator Award from the Canadian Institutes of Health Research University–Industry (bioMérieux, Inc) Program. Drs. Kearon and Douketis are Research Scholars of the Heart and Stroke Foundation of Canada, and Dr. Crowther is a Research Scholar of the Medical Research Council of Canada. Dr. Linkins is a recipient of a Thrombosis Interest Group Research Fellowship. Dr. O'Donnell receives salary support from the Fraser Fellowship. Dr. Lee is a recipient of a New Investigator Award from the Canadian Institutes of Health Research/Rx & D Research Program. Drs. Weitz and Ginsberg are recipients of Career Investigator Awards from the Heart and Stroke Foundation of Ontario. Dr. Weitz also holds the Heart and Stroke Foundation of Ontario/J. Fraser Mustard chair in cardiovascular research and the Canada Research Chair in Thrombosis. Dr. Ginsberg is also a recipient of a Research Chair from the Canadian Institutes of Health Research.
Potential Financial Conflicts of Interest:Consultancies: J.S. Ginsberg (bioMérieux, Inc.); Honoraria: S.M. Bates (bioMérieux, Inc.); Grants received: S.M. Bates (Canadian Institutes of Health Research and bioMérieux, Inc.), C. Kearon (Canadian Institutes of Health Research and bioMérieux, Inc.), M. Crowther (Canadian Institutes of Health Research and bioMérieux, Inc.), J.S. Ginsberg (Canadian Institutes of Health Research and bioMérieux, Inc.).
Requests for Single Reprints: Shannon M. Bates, MDCM, McMaster University Medical Centre, HSC 3W11, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada; e-mail, batesm{at}mcmaster.ca.
Current Author Addresses: Drs. Bates and Ginsberg: McMaster University Medical Centre, HSC 3W11, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.
Drs. Kearon and Lee: Hamilton Health Sciences—Henderson General Hospital, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
Drs. Crowther and Douketis: St. Joseph's Hospital, L208-4, 50 Charleton Avenue East, Hamilton, Ontario L8N 4A6, Canada.
Drs. Linkins, O'Donnell, and Weitz: Henderson Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
Ms. Johnston: Hemostasis Reference Laboratory, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
Author Contributions: Conception and design: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, J.I. Weitz, M. Johnston, J.S. Ginsberg.
Analysis and interpretation of the data: S.M. Bates, J.S. Ginsberg.
Drafting of the article: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, J.I. Weitz, M. Johnston, J.S. Ginsberg.
Critical revision of the article for important intellectual content: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, J.I. Weitz, M. Johnston, J.S. Ginsberg.
Final approval of the article: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, J.I. Weitz, M. Johnston, J.S. Ginsberg.
Provision of study materials or patients: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, J.I. Weitz, J.S. Ginsberg.
Statistical expertise: S.M. Bates, J.S. Ginsberg.
Obtaining of funding: S.M. Bates, C. Kearon, M. Crowther, J.S. Ginsberg.
Administrative, technical, or logistic support: S.M. Bates, J.I. Weitz, M. Johnston.
Collection and assembly of data: S.M. Bates, C. Kearon, M. Crowther, L. Linkins, M. O'Donnell, J. Douketis, A.Y.Y. Lee, M. Johnston, J.S. Ginsberg. ARTICLE
A Diagnostic Strategy Involving a Quantitative Latex D-Dimer Assay Reliably Excludes Deep Venous Thrombosis
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