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The VVSymQ(R) instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms

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Phlebology: The Journal of Venous Disease

Published online on

Abstract

Introduction

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.

Conclusion

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.