• Jean Paty, Diane M Turner-Bowker, Celeste A Elash, and David Wright.
• Quintiles, Hawthorne, NY, USA Jean.Paty@quintiles.com.
• Phlebology. 2016 Aug 1; 31 (7): 481-8.

IntroductionNo existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients.MethodsThe 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.ResultsPatients 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.ConclusionThe 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.© The Author(s) 2015.

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