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Clinical Utility of a Rapid Whole-Blood D-Dimer Assay in Patients with Cancer Who Present with Suspected Acute Deep Venous Thrombosis

Agnes Y.Y. Lee, MD, FRCP(C); Jim A. Julian, MMath; Mark N. Levine, MD, FRCP(C); Jeffrey I. Weitz, MD, FRCP(C); Clive Kearon, MB, PhD, FRCP(C); Philip S. Wells, MD, FRCP(C); and Jeffrey S. Ginsberg, MD, FRCP(C)
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From McMaster University, Hamilton, and University of Ottawa, Ottawa, Ontario, Canada.

Acknowledgment: The authors thank Ms. Julie Anderson for assistance with the chart reviews and data collection.

Grant Support: Dr. Lee is a recipient of a Research Fellowship from the Heart and Stroke Foundation of Canada. Dr. Kearon is a recipient of a Research Scholarship from the Heart and Stroke Foundation of Ontario. Dr. Wells is a recipient of a Research Scholarship from the Heart and Stroke Foundation of Canada. Drs. Weitz and Ginsberg are recipients of Career Investigator Awards from the Heart and Stroke Foundation of Ontario.

Requests for Reprints: Agnes Y. Y. Lee, MD, FRCP(C), Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada; e-mail, alee@thrombosis.hhscr.org.

Current Author Addresses: Drs. Lee, Kearon, and Weitz and Mr. Julian: Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.

Dr. Levine: Hamilton Regional Cancer Centre, 699 Concession Street, Hamilton, Ontario L8V 5C2, Canada.

Dr. Wells: Ottawa Civic Hospital, Civic Parkdale Clinic, Room 467, 737 Parkdale Avenue, Ottawa, Ontario K1Y 1J8, Canada.

Dr. Ginsberg: McMaster University Medical Centre, 1200 Main Street West, Room 3X28, Hamilton, Ontario L8N 3Z5, Canada.

Ann Intern Med. 1999;131(6):417-423. doi:10.7326/0003-4819-131-6-199909210-00004
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Venous thromboembolism is a common complication that contributes to morbidity and mortality in patients with cancer (12). An accurate and efficient diagnostic approach for confirming or excluding venous thrombosis in this subgroup is needed because it represents approximately 20% of all patients in whom deep venous thrombosis or pulmonary embolism is diagnosed (35). Noninvasive studies are the diagnostic tools of choice for initial screening for deep venous thrombosis because clinical diagnosis of this condition is inaccurate and because contrast venography, the reference standard, has associated morbidity and is costly. Although studies evaluating the accuracy of noninvasive diagnostic methods have included patients with cancer, it is not known whether these tests are as accurate in this subgroup (67). Both the cancer and its treatments may reduce the accuracy of these tests. For example, extrinsic venous compression by tumor mass may cause false-positive results on impedance plethysmography and compression ultrasonography. In support of these concepts, the one study evaluating diagnostic tests for deep venous thrombosis in patients with cancer demonstrated that impedance plethysmography was less sensitive and specific in these patients than in patients without cancer (8).

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Figure 1.
Formulas for sensitivity, specificity, predictive values, and likelihood ratios.

The values for patients with cancer have been used here.

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Figure 2.
The influence of the prevalence of deep venous thrombosis (DVT) on the positive predictive value (PPV) and negative predictive value (NPV) of the SimpliREDD-dimer assay.

The changes in positive predictive value and negative predictive value with changes in prevalence at a sensitivity of 85% and a specificity of 48% are shown. As the prevalence of deep venous thrombosis increases, the positive predictive value increases but the negative predictive value decreases. A plus sign indicates a positive test result or positivity for deep venous thrombosis; a minus sign indicates a negative test result or negativity for deep venous thrombosis.

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