title: The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms.
abstract: BACKGROUND
  No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients.
  
  
  METHODS
  The VVSymQ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins (heaviness, achiness, swelling, throbbing and itching). This paper describes how the VVSymQ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two randomized, controlled, phase 3 clinical trials.
  
  
  RESULTS
  Patients were highly compliant in completing the electronic daily diary, and the VVSymQ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients.
  
  
  CONCLUSIONS
  The VVSymQ® instrument is a reliable, valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention, and is uniquely focused on patient-reported symptoms compared with other widely used questionnaires completed by clinicians.
authors.affiliation: Quintiles, Hawthorne, NY, USA Jean.Paty@quintiles.com.
authors.forename: Jean
authors.initials: J
authors.lastname: Paty
authors.affiliation: Quintiles, Cambridge, MA, USA.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Turner-Bowker
authors.affiliation: ERT, Pittsburgh, PA, USA.
authors.forename: Celeste A
authors.initials: CA
authors.lastname: Elash
authors.affiliation: BTG International Ltd., West Conshohocken, USA.
authors.forename: David
authors.initials: D
authors.lastname: Wright
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D000073222:Patient Health Questionnaire; D057566:Self Report; D014648:Varicose Veins / Q000503:physiopathology* / Q000628:therapy
keywords: Patient-reported outcome (PRO); diary; self-report; symptom; varicose veins