Table 6
Author, date and countryPatient groupStudy type (level of evidence)OutcomesKey resultsStudy weaknesses
NPV = Negative predictive value, NLR = Likelihood ratio for negative result.
Wells PS et al, 1995, Canada214 consecutive patients referred for investigation of ?DVT.Prospective cohortPrevalence25%No sample size calculation Excluded patients with inconclusive venograms or plethysmogram
Sensitivity88% (CI 77, 96)
Specificity77% (CI 63, 80)
NPV95% (CI 89, 98)
NLR0.16
Brenner B et al, 1995, Israel86 consecutive patients referred for investigation of ?DVTProspective cohortPrevalence58%Small patient numbers. No sample size calculation. No confidence intervals
Sensitivity94%
Specificity61%
NPV88%
NLR0.1
Turkstra F et al, 1996, Netherlands234 consecutive patients referred for ?DVT or ?PEProspective cohortPrevalence27%No sample size calculation (but good numbers)
Sensitivity100% (CI 95, 100)
Specificity58% (CI 50, 65)
NPV100% (CI 96, 100)
Janssen MC et al, 1997, Netherlands132 patients referred to ED or OPD for investigation of ?DVTProspective cohortPrevalence67%No sample size calculation. Technique of assay may have affected results. Reference standard not applied to all patients
Sensitivity61% (CI 51, 71)
Specificity90% (CI 81, 99)
NPV52% (CI 29, 75)
NLR0.43
Ginsberg FS et al, 1997, Canada398 consecutive patients referred to thromboembolic OPD as first episode of ?DVTProspective management studyNPV d-dimer alone97.1% (CI 94.5, 98.8)No sample size calculation. Reference standard not applied to all patients
NPV d-dimer and plethysmography together98.5% (CI 96.3, 99.6)
Mayer W et al, 1997, Austria108 consecutive patients referred to vascular laboratory as ?DVTProspective cohortPrevalence31%Small patient numbers. No sample size calculation. Used single ultrasound as reference standard
Sensitivity100% (CI 89, 100)
Specificity75% (CI 63, 84)
NPV100% (CI 94, 100)
Wildberger JE et al, 1998, Germany250 consecutive patients referred for venographyProspective cohortSensitivity96%No sample size calculation. Patient selection bias. No confidence intervals
Specificity59%
NPV97%
NLR0.06
Wells PS et al, 1998, Canada496 consecutive outpatients referred with ?DVTProspective cohortOverall sensitivity94%No sample size calculation. Patient selection bias. No confidence intervals
Overall specificity71%
NPV98% (CI 96, 99)
NLR0.08
Low pretest probability
Sensitivity87%
Specificity76%
NPV99% (CI 97, 100)
NLR0.17
Medium pretest probability
Sensitivity89%
Specificity64%
NPV97% (CI 90, 99)
NLR0.17
High pretest probability
Sensitivity98%
Specificity54%
NPV86% (CI 42, 97)
NLR0.04
Mauron T et al, 1998, Switzerland45 consecutive outpatients referred with ?DVT.Prospective cohortPrevalence33%Small patient numbers. No sample size calculation. Wide confidence intervals
Sensitivity 53% (CI 28, 78)
Specificity 70% (CI 54, 86)
NPV 75% (CI 59, 91)
NLR 0.67
Carter CJ et al, 1999, Canada200 consecutive patients referred to diagnostic radiology department with ?DVT. Inpatients and outpatientsProspective cohortPrevalence28%No sample size calculation. Used single ultrasound as reference standard. Wide confidence intervals
Sensitivity87% (CI 80, 96)
Specificity79%
NPV94%
NLR0.16
Lennox AF et al, 1999, UK200 consecutive patients referred to diagnostic radiology department with ?DVT. Inpatients and outpatientsProspective cohortPrevalence23%No sample size calculation. Incorrect test procedure likely to give falsely high sensitivities. No confidence intervals
Sensitivity91%
Specificity82%
NPV97%
NLR0.11
Farrell S et al, 2000, USA173 consecutive patients referred to ED with ?DVT (48) or ?PE (125)Prospective clinical trialPrevalence33%Did not recruit all patients required. Used single ultrasound as reference standard. Wide confidence intervals
Sensitivity56% (CI 32, 81)
NPV77% (CI 62, 92)
NLR0.61 (CI 0.34, 1.11)
Van der Graaf F et al, 2000, Netherlands112 outpatients referred to departmentProspective cohortPrevalence50%Small patient numbers. No sample size calculation. Wide confidence intervals
Sensitivity80% (CI 66, 90)
Specificity94% (CI 83, 99)
NPV82% (CI 70, 91)
Likelihood ratio for negative result (NLR)0.21