Andrew Bradbury1, Gareth Bate1, Emma Thomas2, Thomas King2, David Wright2
1College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom; 2BTG International Inc., West Conshohocken, PA.
OBJECTIVES: Instruments to evaluate outcomes post VV treatments mix symptoms/signs and health-related quality of life. In contrast, the VV Symptoms Questionnaire (VVSymQ™), a patient-reported outcome instrument developed using iterative qualitative interviews with patients, considers only symptoms. To evaluate feasibility, reliability and validity of the VVSymQ™ via a PDA for measure of VV symptoms before and after great saphenous vein (GSV) closure (immediately preceding wk 8 visit) and to estimate treatment effect size (ES), the VVSymQ™ was administered daily using a PDA 14 days pre+10 days post GSV closure.
METHODS: VVSymQ™ assessed duration and intensity (6 and 11 point scales) of the 5 most important VV symptoms. Feasibility was evaluated by compliance; reliability by agreement between 1st and 2nd 7-day pre-GSV closure scores; and validity by correlation with other instruments: PA-VA3, VCSS, VEINES QoL, CIVIQ-20.
RESULTS: 40 patients were recruited (mean age 49.7; 62% female). Compliance with daily diary completion was 97%. Symptom scores remained stable for 14 days pretreatment and symptom score fell by 80% post GSV closure. ES (mean change/SD) and correlations with other instruments are shown in Table.
CONCLUSIONS: VVSymQ™ is a simple patient-centered measure that can be administered daily via a PDA with very high compliance. It is sensitive to clinically important symptom improvements following GSV closure and correlates with existing instruments.
AUTHOR DISCLOSURES: G. Bate, Nothing to disclose; A. Bradbury, Nothing to disclose; T. King, BTG International Inc. Employment (full or part-time); E. Thomas, BTG International Inc. Employment (full or part-time); D. Wright, BTG International Inc. Employment (full or part-time).
ES and correlation between instruments pre and post GSV closure
|
VVSymQ |
PA-V3 |
VCSS |
VEINES-QoL |
CIVIQ-20 |
Effect Size (ES) |
2.0 (paper) 1.6 (electronic) |
1.5 |
3.4 |
1.8 |
1.2 |
Correlation pre GSV closure |
-- |
0.318* |
NS |
0.727*** |
0.518*** |
Correlation 8 wk post GSV closure |
-- |
NS |
0.456** |
0.755*** |
0.587*** |
*p≤0.05; **p≤0.01; ***p≤0.001; NS=not significant
Posted April 2012