Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
J Vasc Surg Venous Lymphat Disord. 2022 Jan;10(1):139-145.e1. doi: 10.1016/j.jvsv.2021.09.002. Epub 2021 Sep 14.
Chronic venous disease is a frequent vascular condition. International societies have recommended the use of health-related quality of life (HRQoL) instruments in the assessment of patients with vascular diseases. Thus, the Freiburg Life Quality Assessment for chronic venous disease, 10-item questionnaire (FLQA-VS-10) was developed. The aim of the present study was to validate the FLQA-VS-10 in a prospective study.
We recruited 100 patients with recurrent varicosis or incomplete or complete venous insufficiency undergoing interventional vein treatment (high ligation of the great or small saphenous vein or endovenous ablation therapy). These patients completed the FLQA-VS-10 and instruments assessing convergent validation criteria at four points: preoperatively (T1), postoperatively (T2) and twice 3 years later with a 1-week interval (T3 and T4).
The mean age was 56.0 ± 13.7 years, and 66.0% were women. The patients had presented with recurrent varicosis of the saphenofemoral junction (28.0%), recurrent varicosis of the saphenopopliteal junction (1.0%), incomplete or complete insufficiency of the great saphenous vein (69.0%), or complete insufficiency of the small saphenous vein (2.0%). The items showed few missing values. The FLQA-VS-10 global score showed no ceiling effect (patients reporting the highest possible impairments in HRQoL) but did show a floor effect (patients reporting the lowest possible impairments in HRQoL), which was highest at the postoperative assessments. The internal consistency of the global score was high at all measurement points. A convergent validity and responsiveness analysis revealed that the FLQA-VS-10 correlated in the expected direction with the convergent instruments, including the Freiburg Life Quality Assessment for venous diseases (venous disease-specific HRQoL) and the five-level EQ-5D (generic HRQoL). Data from T3 and T4 revealed high test-retest reliability (intraclass correlation, 0.92). Overall, the patients stated that the FLQA-VS-10 was comprehensible, comprehensive, and easy to complete.
Our data suggest that the FLQA-VS-10 is a reliable, valid, responsive, and feasible HRQoL questionnaire for patients with chronic venous diseases. This questionnaire can serve as short and easy-to-use instrument to assess patient-reported outcomes in the treatment of these patients.
慢性静脉疾病是一种常见的血管疾病。国际社会建议在评估血管疾病患者时使用健康相关生活质量（HRQoL）工具。因此，开发了弗赖堡静脉疾病生活质量评估 10 项问卷（FLQA-VS-10）。本研究的目的是在一项前瞻性研究中验证 FLQA-VS-10。
我们招募了 100 名接受介入静脉治疗（大隐静脉或小隐静脉高位结扎或腔内消融治疗）的复发性静脉曲张或不完全或完全静脉功能不全患者。这些患者在四个时间点完成了 FLQA-VS-10 和评估收敛验证标准的工具：术前（T1）、术后（T2）和 3 年后两次，间隔 1 周（T3 和 T4）。
平均年龄为 56.0±13.7 岁，66.0%为女性。患者表现为大隐静脉股隐交界处复发性静脉曲张（28.0%）、大隐静脉隐股交界处复发性静脉曲张（1.0%）、大隐静脉不完全或完全功能不全（69.0%）或小隐静脉完全功能不全（2.0%）。各项目缺失值较少。FLQA-VS-10 总体评分无天花板效应（报告 HRQoL 最高可能受损的患者），但有地板效应（报告 HRQoL 最低可能受损的患者），术后评估时最高。所有测量点的总体评分内部一致性均较高。收敛有效性和反应性分析显示，FLQA-VS-10 与预期方向的收敛工具相关，包括弗赖堡静脉疾病生活质量评估（静脉疾病特异性 HRQoL）和五水平 EQ-5D（通用 HRQoL）。T3 和 T4 的数据显示出较高的测试 - 重测可靠性（组内相关系数，0.92）。总体而言，患者认为 FLQA-VS-10 易于理解、全面且易于完成。
我们的数据表明，FLQA-VS-10 是一种可靠、有效、敏感且可行的慢性静脉疾病患者 HRQoL 问卷。该问卷可作为评估这些患者治疗后患者报告结果的简短易用工具。
