Clinical and linguistic validation of the Polish version of VascuQoL: a disease-specific quality- -of-life questionnaire assessing patients with chronic limb ischemia

INTRODUCTION Objective clinical assessments should include patient-reported outcome measures. VascuQoL is an established disease-specific questionnaire assessing the quality of life in patients with peripheral artery disease (PAD). Quality-of-life questionnaires require geographical localization and validation. OBJECTIVES The goal of this study was to validate the Polish version of the VascuQoL: a patient-reported health-related quality-of-life (HRQoL) instrument specific for PAD. PATIENTS AND METHODS The linguistic validation of VascuQoL followed Mapi Institute methodology. Clinical validation process compared VascuQoL, EQ-5D-3L, and SF-36 questionnaires in 100 patients with both intermittent claudication and critical limb-threatening ischemia. Cronbach a coefficients for reliability, receiver operating characteristic curves for clinical discriminative performance, standardized response means for responsiveness, and Pearson correlations for construct validity were evaluated. Additionally, in a separate cohort of 58 patients with stable disease, the test-retest was characterized with intraclass correlation, Bland-Altman analysis, and Pearson correlation coefficients. RESULT VascuQoL proved to perform better than SF-36 and E0.-5D-3L (area under the curve, 0.802). Cronbach a coefficients showed good internal consistency (a values >0.9 for all summary scores). All test-retest Pearson r values for VascuQoL were above 0.70. The intraclass correlation of absolute agreement consistency exceeded 0.8. The Bland-Altman 95% limits of agreement were between 2.72 and 4.87. There were strong and moderate correlations for total scores in all domains between Vasculaol and SF-36, and for most of the domains between VascuQoL and EQ-5D-3L. CONCLUSIONS The Polish version of VascuQoL is a sensitive, accurate, and reliable tool for assessing HRQoL in patients with PAD.