Abstract
Venous leg ulcers are a common manifestation of chronic venous disease and are associated with substantial morbidity and impaired health-related quality of life (HRQoL). Patient-reported outcome measures are essential for capturing the patient perspective of disease burden and treatment outcomes in wound care management. The Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D) is a concise preference-based instrument designed to assess the quality of life in individuals with venous leg ulcers and to support health-economic evaluation. However, its measurement properties have not been extensively examined in different linguistic contexts. This study aimed to evaluate the psychometric properties of the Spanish version of the SPVU-5D in patients with venous leg ulcers. A methodological validation study was conducted involving 132 patients (264 observations from pre- and post-treatment assessments) with a mean age of 63.76 ± 10.02 years. Cross-cultural adaptation followed the established guidelines for translation and cultural equivalence. Content validity was assessed using Aiken's V coefficient. Structural validity and reliability were examined using multilevel confirmatory factor analysis and measurement performance was further evaluated using a multilevel graded response model based on item response theory. Floor and ceiling effects, minimum detectable change and convergent validity with the RESVECH 2.0 clinical scale were also evaluated. Confirmatory factor analysis supported a unidimensional structure with excellent fit indices and satisfactory internal consistency. Item response theory analyses showed high item discrimination and well-distributed difficulty thresholds for the items. The floor and ceiling effects were minimal, indicating adequate sensitivity across the latent trait continuum. The Spanish version of the SPVU-5D demonstrates satisfactory validity, reliability and measurement precision and represents a useful instrument for assessing the health-related quality of life in patients with venous leg ulcers.