Jean Paty1, Diane M Turner-Bowker2, Celeste A Elash3, David Wright4. 1. Quintiles, Hawthorne, NY, USA Jean.Paty@quintiles.com. 2. Quintiles, Cambridge, MA, USA. 3. ERT, Pittsburgh, PA, USA. 4. BTG International Ltd., West Conshohocken, USA.
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.
RCT Entities:
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.
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