Abstract

The Venous Clinical Severity Score (VCSS) was designed and validated as an objective measure of disease severity in patients with chronic venous disease (CVD). Recently, a revision of the VCSS (rVCSS) was performed to resolve ambiguity in the clinical descriptors and improve clarity and ease of use. This new revised VCSS requires validation to determine its repeatability and reproducibility in clinical evaluation of patients with varying levels of CVD. A prospective multicenter protocol was designed to enroll patients undergoing evaluation for CVD at venous practices with experience using the original VCSS. At the time of initial evaluation, two clinicians independently assessed both lower extremities to determine the rVCSS and the CEAP clinical score. Between 1 and 6 weeks, patients returned and received repeat assessment of the rVCSS by the same two clinicians independently. Patients were excluded if any venous intervention occurred between the two separate evaluation visits. Scores were compared to determine inter- and intra-observer variability overall and within each CEAP clinical class. Seven centers enrolled a total of 136 limbs yielding 248 paired evaluations for interobserver variability and 258 paired evaluations for intraobserver variability. The mean interobserver rVCSS difference was 1.4± 1.7 and the mean intraobserver variability was 1.3± 1.6. Statistical assessment with weighted kappa yielded good repeatability (κ= 0.68; P<.0001) and good reproducibility (κ= 0.72; P< .000001) for the rVCSS. The rVCSS correlated well with the CEAP clinical class with significant differences between rVCSS in increasing classes. (P< .0001). In this multicenter evaluation, the rVCSS was demonstrated to be a reliable and reproducible instrument for documentation of the severity of symptoms in patients with lower extremity venous insufficiency.

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