Validation of a Swedish version of a short patient-reported outcome measure for superficial venous insufficiency

Abstract

Objective: 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.

Methods: 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.

Results: There was a strong correlation between the VEINES-QOL-S and the VARIShort (r_s = -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.

Conclusions: 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.

Keywords: Patient-reported outcome measures (PROMs); Quality of life; Superficial venous insufficiency; Varicose veins; Vascular Quality Initiative Varicose Vein Registry (VQI VVR).