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

Abstract

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 α 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. RESULTS VascuQol proved to perform better than SF‑36 and EQ‑5D‑3L. Cronbach α coefficients showed good internal consistency (α 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 VascuQol 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.