title: Psychometric Evaluation of a New Patient-Reported Outcome (PRO) Symptom Diary for Varicose Veins: VVSymQ(®) Instrument.
abstract: To evaluate the psychometric properties of the VVSymQ(®) instrument, a new 5-item patient-reported outcome (PRO) measure for symptoms of varicose veins.
  
  
  
  The VVSymQ(®) electronic daily diary was administered to outpatients who received routine treatment for varicose veins (N = 40). Compliance with diary administration and item score variability, reliability, construct validity, sensitivity to change, and clinically meaningful change were evaluated.
  
  
  
  Patients completed >97 % of scheduled diary assessments (at screening, baseline, and week 8). The VVSymQ(®) instrument captured patients' pre-treatment symptoms (all VVSymQ(®) symptoms were endorsed by ≥75 % of patients at baseline), and the change post-treatment (mean change in score -6.1), with a large Cohen effect size (1.6). Test-retest reliability was high (intraclass correlation coefficient 0.96); internal consistency was good (Cronbach's alpha ≥0.76; baseline, week 8). VVSymQ(®) scores were more strongly associated with PRO scores that reflect symptoms and symptom impact (the Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms [VEINES-QOL/Sym] instrument and the Chronic Venous Insufficiency Quality-of-Life Questionnaire [CIVIQ-20]) than with PRO scores that reflect appearance (the Patient Self-Assessment of Appearance of Visible Varicose Veins [PA-V(3)]) or clinician-reported outcome scores (the Clinical-Etiology-Anatomy-Pathophysiology [CEAP] Classification of Venous Disorders and Venous Clinical Severity Score [VCSS]), demonstrating construct validity. Patients reporting that symptoms were "moderately" or "much improved" on the Patient Global Impression of Change (PGIC) anchor (i.e., >97 % of patients) had mean improvements of -6.3 VVSymQ(®) points, while a cumulative distribution curve showed that 50 % of patients improved by ≥-5.8 points; thus, a score change of approximately -6 demonstrated a clinically meaningful change in this study. The clinically meaningful change in the VVSymQ(®) score was greater in patients with a greater baseline VVSymQ(®) symptom burden, and the VVSymQ(®) instrument captured clinically meaningful treatment benefit even in patients with a low baseline symptom burden.
  
  
  
  The 5-item VVSymQ(®) instrument is a brief, psychometrically sound, useful tool for evaluating patient-reported varicose veins symptoms.
authors.affiliation: BTG International, Ltd., Lakeview, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK. david.wright@btgplc.com.
authors.forename: David D I
authors.initials: DD
authors.lastname: Wright
authors.affiliation: ERT, Pittsburgh, PA, USA.
authors.forename: Jean
authors.initials: J
authors.lastname: Paty
authors.affiliation: ERT, Pittsburgh, PA, USA.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Turner-Bowker
authors.affiliation: University of Birmingham, Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bradbury
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012501:Saphenous Vein; D015911:Sclerotherapy; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014648:Varicose Veins / Q000523:psychology* / Q000628:therapy*