RESUMO
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
RESUMO
BACKGROUND: Several standard venous assessment tools have been used as independent determinants of venous disease severity, but correlation between these instruments as a global venous screening tool has not been tested. The scope of this study is to assess the validity of Venous Clinical Severity Scoring (VCSS) and its integration with other venous assessment tools as a global venous screening instrument. METHODS: The American Venous Forum (AVF), National Venous Screening Program (NVSP) data registry from 2007 to 2009 was queried for participants with complete datasets, including CEAP clinical staging, VCSS, modified Chronic Venous Insufficiency Quality of Life (CIVIQ) assessment, and venous ultrasound results. Statistical correlation trends were analyzed using Spearman's rank coefficient as related to VCSS. RESULTS: Five thousand eight hundred fourteen limbs in 2,907 participants were screened and included CEAP clinical stage C0: 26%; C1: 33%; C2: 24%; C3: 9%; C4: 7%; C5: 0.5%; C6: 0.2% (mean, 1.41 ± 1.22). VCSS mean score distribution (range, 0-3) for the entire cohort included: pain 1.01 ± 0.80, varicose veins 0.61 ± 0.84, edema 0.61 ± 0.81, pigmentation 0.15 ± 0.47, inflammation 0.07 ± 0.33, induration 0.04 ± 0.27, ulcer number 0.004 ± 0.081, ulcer size 0.007 ± 0.112, ulcer duration 0.007 ± 0.134, and compression 0.30 ± 0.81. Overall correlation between CEAP and VCSS was moderately strong (r(s) = 0.49; P < .0001), with highest correlation for attributes reflecting more advanced disease, including varicose vein (r(s) = 0.51; P < .0001), pigmentation (r(s) = 0.39; P < .0001), inflammation (r(s) = 0.28; P < .0001), induration (r(s) = 0.22; P < .0001), and edema (r(s) = 0.21; P < .0001). Based on the modified CIVIQ assessment, overall mean score for each general category included: Quality of Life (QoL)-Pain 6.04 ± 3.12 (range, 3-15), QoL-Functional 9.90 ± 5.32 (range, 5-25), and QoL-Social 5.41 ± 3.09 (range, 3-15). Overall correlation between CIVIQ and VCSS was moderately strong (r(s) = 0.43; P < .0001), with the highest correlation noted for pain (r(s) = 0.55; P < .0001) and edema (r(s) = 0.30; P < .0001). Based on screening venous ultrasound results, 38.1% of limbs had reflux and 1.5% obstruction in the femoral, saphenous, or popliteal vein segments. Correlation between overall venous ultrasound findings (reflux + obstruction) and VCSS was slightly positive (r(s) = 0.23; P < .0001) but was highest for varicose vein (r(s) = 0.32; P < .0001) and showed no correlation to swelling (r(s) = 0.06; P < .0001) and pain (r(s) = 0.003; P = .7947). CONCLUSIONS: While there is correlation between VCSS, CEAP, modified CIVIQ, and venous ultrasound findings, subgroup analysis indicates that this correlation is driven by different components of VCSS compared with the other venous assessment tools. This observation may reflect that VCSS has more global application in determining overall severity of venous disease, while at the same time highlighting the strengths of the other venous assessment tools.
Assuntos
Doenças Vasculares/diagnóstico , Veias , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de DoençaRESUMO
In response to the need for a disease severity measurement, the American Venous Forum committee on outcomes assessment developed the Venous Severity Scoring system in 2000. There are three components of this scoring system, the Venous Disability Score, the Venous Segmental Disease Score, and the Venous Clinical Severity Score (VCSS). The VCSS was developed from elements of the CEAP classification (clinical grade, etiology, anatomy, pathophysiology), which is the worldwide standard for describing the clinical features of chronic venous disease. However, as a descriptive instrument, the CEAP classification responds poorly to change. The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment. Based on initial experiences with the VCSS, an international ad hoc working group of the American Venous Forum was charged with updating the instrument. This revision of the VCSS is focused on clarifying ambiguities, updating terminology, and simplifying application. The specific language of proven quality-of-life instruments was used to better address the issues of patients at the lower end of the venous disease spectrum. Periodic review and revision are necessary for generating more universal applicability and for comparing treatment outcomes in a meaningful way.