The clinical diagnosis of deep-vein thrombosis is generally thought to
be unreliable, From experience, we hypothesised that this widely held
view might be incorrect. We developed a clinical model and prospectiv
ely tested its ability in three tertiary care centres to stratify symp
tomatic outpatients with suspected deep-vein thrombosis into groups wi
th high, moderate, or low probability groups of deep-vein thrombosis.
We evaluated our clinical model in combination with venous ultrasonogr
aphy to determine the potential for an improved and simplified diagnos
tic approach in patients with suspected deep-vein thrombosis. All pati
ents were clinically assessed to determine the probability for deep-ve
in thrombosis before they had ultrasonography and venography. All test
s were performed and interpreted by independent observers, In 529 pati
ents, the clinical model predicted prevalence of deep-vein thrombosis
in the three categories: 85% in the high pretest probability category,
33% in the moderate, and 5% in the low category. There was no statist
ical difference in the performance of the model in the three centres.
The model demonstrated excellent interobserver reliability (Kappa=0.85
), There were important differences with ultrasonography between the h
igh and low pretest probability groups for both positive predictive va
lues (100% (95% CI, 94-100%) vs(63% [35-85%], respectively). Thus, use
of the clinical model combined with ultrasonography would decrease th
e number of false positive and negative diagnosis if venography were d
one when the ultrasound result and pretest probability were discordant
. The diagnostic process could be simplified by excluding those patien
ts with low pretest probability and normal ultrasound results from ser
ial testing.