John Kingsley1, Thomas King2, Elizabeth Orfe2, David Wright2
1Alabama Vascular and Vein Center, Vestavia Hills, AL; 2BTG International Inc., West Conshohocken, PA.
OBJECTIVES: Varicose vein (VV) patients suffer not only from their symptoms but also from appearance. A standardized method for assessing VV appearance from a patient and clinician perspective is lacking. A study was conducted to assess the performance of a clinician-reported outcome (ClinRO) instrument and a patient-reported outcome (PRO) instrument developed through qualitative patient interviews for the evaluation of VV appearance.
METHODS: To assess the patient visible VV appearance instrument (PA-V3) and an independent expert panel rating scale (IPR-V3) of standardized photographs, 40 patients with VVs were recruited at a single site, half of the patients had treated saphenofemoral junction (SFJ) incompetence; the remainder were awaiting treatment. Patients scored the appearance of their VV on a 0 to 4 “noticeability” scale (0 not noticeable to 4 extremely noticeable, PA-V3); this was repeated after 2 weeks. A physician scored the VV on a 0 to 4 severity scale at the same visits.
Standardized photographs of the patient’s VV were scored on a 0 to 4 severity scale (IPR-V3) by a panel of independent trained expert physicians blinded to treatment status.
Measures were compared for reliability and variability within and between each other and with other known assessment tools (VEINES-QOL, CIVIQ-2, and VCSS).
RESULTS: Most patients were female (72%); mean age was 50.7 years. Test/retest between assessments produced matches to within 1 score of 87.5% and 100% for PA-V3 and IPR-V3, respectively. Both measures were found to correlate well with each other (Pearson coefficient=0.793) and with the physician assessment and other standard assessment tools (ranges from 0.758 to 0.881). As expected, treated patients had notably lower scores for all instruments.
CONCLUSIONS: PA-V3 and IPR-V3 are sensitive and reproducible measures of VV appearance from the perspective of the clinician, the independent expert panel, and the patient. These tools are suitable for measuring change in appearance following VV intervention.
AUTHOR DISCLOSURES: T. King, BTG International Inc. Employment (full or part-time); J. Kingsley, Nothing to disclose; E. Orfe, BTG International Inc. Employment (full or part-time); D. Wright, BTG International Inc. Employment (full or part-time).
Posted April 2012