VVSymQ®仪器：一种用于评估静脉曲张症状的新型患者报告结局测量工具的应用。
The VVSymQ® instrument: Use of a new patient-reported outcome measure for assessment of varicose vein symptoms.
作者信息
Paty Jean, Turner-Bowker Diane M, Elash Celeste A, Wright David
机构信息
Quintiles, Hawthorne, NY, USA
Quintiles, Cambridge, MA, USA.
出版信息
Phlebology. 2016 Aug;31(7):481-8. doi: 10.1177/0268355515595193. Epub 2015 Jul 15.
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.
摘要
引言
现有的患者报告结局工具均未专门聚焦于评估令患者困扰的静脉曲张症状。
方法
VVSymQ®工具是一项包含五个条目的患者报告结局，用于评估对静脉曲张患者最重要的症状（沉重感、疼痛、肿胀、搏动和瘙痒）。本文描述了VVSymQ®工具如何被纳入电子日常日记中，以长期监测关键结局，并在两项随机、对照、3期临床试验中获取治疗益处。
结果
患者在完成电子日常日记方面具有很高的依从性，VVSymQ®工具显示出能够检测总体变化以及检测对患者有意义的变化的能力。
结论
VVSymQ®工具是一种可靠、有效的工具，可用于测量干预前后患者静脉曲张症状体验的变化，并且与临床医生填写的其他广泛使用的问卷相比，它独特地聚焦于患者报告的症状。
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