Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):416-422.e4. doi: 10.1016/j.jvsv.2020.07.005. Epub 2020 Jul 29.
Patient-reported outcome measures (PROMs) are increasingly used to measure symptoms and treatment effects, and a short PROM is more user friendly. The aim of this study was to test whether a Swedish seven-item version of the PROM used in the Vascular Quality Initiative Varicose Vein Registry can be used to measure quality of life in a Swedish cohort of patients with superficial venous insufficiency (SVI) equally well as the 26-item Swedish version of the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym-S) and measure treatment effect.
Consecutive patients with SVI and Clinical-Etiology-Anatomy-Pathophysiology (CEAP) clinical class ≥C2 were recruited at three private clinics and one county hospital between January 2018 and October 2019. The patients were asked to answer both the VEINES-QOL/Sym-S and the Swedish seven-item version, called VARIShort, at two assessment points, baseline (cohort 1, 252 patients) and 1 week later (cohort 2, 138 patients), and the VARIShort at baseline and 8 weeks after an endovenous procedure (cohort 3, 106 patients). The mean age was 58.3 years (range, 20-93 years), 61.4 years (range, 20-93 years), and 57.2 years (range, 20-89 years) in cohorts 1, 2, and 3, respectively; the majority were female (59%, 55%, and 64%), and most were CEAP C4 (39%, 46%, and 38%). The VARIShort was evaluated with regard to its validity, test-retest reliability, internal consistency reliability, sensitivity, and responsiveness.
There was a strong correlation between the VEINES-QOL-S and the VARIShort (r = -0.819; P < .001). The VARIShort showed both excellent internal consistency with Cronbach's α of 0.93 and a high response to clinical change as measured with Cohen's d, overall score of 1.17.
The Swedish seven-item PROM, the VARIShort, may be used for assessment of symptoms of SVI and outcome after treatment in Swedish SVI patients. The short PROM shows degree of SVI symptom impact on quality of life in the same manner as the 26-item VEINES-QOL/Sym-S.
患者报告的结局测量（PROMs）越来越多地用于测量症状和治疗效果，而简短的 PROM 更便于用户使用。本研究旨在测试瑞典静脉质量倡议静脉曲张登记处使用的七项 PROM 是否可以与 26 项瑞典静脉功能不全流行病学和经济研究生活质量/症状（VEINES-QOL/Sym-S）一样，同样可以测量患有浅表静脉功能不全（SVI）的瑞典患者队列的生活质量，并测量治疗效果。
连续招募了 2018 年 1 月至 2019 年 10 月在三家私人诊所和一家县医院就诊的 SVI 和临床病因解剖病理（CEAP）临床分级≥C2 的患者。患者被要求在两个评估点回答 VEINES-QOL/Sym-S 和瑞典的七项版本（称为 VARIShort），基线（队列 1，252 例患者）和 1 周后（队列 2，138 例患者），并在静脉内治疗后 8 周进行基线和 VARIShort（队列 3，106 例患者）。队列 1、2 和 3 的平均年龄分别为 58.3 岁（范围 20-93 岁）、61.4 岁（范围 20-93 岁）和 57.2 岁（范围 20-89 岁）；大多数是女性（59%、55%和 64%），大多数为 CEAP C4（39%、46%和 38%）。VARIShort 的有效性、测试重测可靠性、内部一致性可靠性、敏感性和反应性进行了评估。
VEINES-QOL-S 和 VARIShort 之间具有很强的相关性（r=-0.819；P<.001）。VARIShort 显示出极好的内部一致性，克朗巴赫的α为 0.93，并且具有很高的临床变化反应能力，总体得分为 1.17。
瑞典的七项 PROM，即 VARIShort，可用于评估瑞典 SVI 患者的 SVI 症状和治疗后的结果。短 PROM 以与 26 项 VEINES-QOL/Sym-S 相同的方式显示 SVI 症状对生活质量的影响程度。
