Psychometric Validation of the Spanish Version of the Sheffield Preference-Based Venous Leg Ulcer Questionnaire (SPVU-5D) in Patients With Venous Leg Ulcers.

The Spanish version of the SPVU-5D showed excellent structural validity through confirmatory factor analysis supporting a unidimensional structure.

• A multilevel confirmatory factor analysis was conducted on 264 observations (pre- and post-treatment) from 132 patients
• The confirmatory factor analysis supported a unidimensional structure with 'excellent fit indices'
• Mean patient age was 63.76 ± 10.02 years
• Structural validity was evaluated using multilevel CFA to account for repeated measures design

Content validity of the Spanish SPVU-5D was assessed as acceptable using Aiken's V coefficient.

• Aiken's V coefficient was used to quantify content validity
• Cross-cultural adaptation followed established guidelines for translation and cultural equivalence
• Content validity assessment was part of the broader psychometric validation framework

Item response theory analyses demonstrated high item discrimination and well-distributed difficulty thresholds across the SPVU-5D items.

• A multilevel graded response model based on item response theory (IRT) was applied
• Items showed 'high item discrimination' parameters
• Difficulty thresholds were described as 'well-distributed' across items
• IRT analyses provided evaluation of measurement performance at the item level

Floor and ceiling effects were minimal in the Spanish SPVU-5D, indicating adequate sensitivity across the latent trait continuum.

• Floor and ceiling effects were explicitly evaluated as part of the psychometric validation
• Minimal floor and ceiling effects indicate the instrument can differentiate patients at both ends of the health-related quality of life spectrum
• Adequate sensitivity was observed 'across the latent trait continuum'

The Spanish SPVU-5D demonstrated satisfactory internal consistency reliability.

• Internal consistency was described as 'satisfactory' in the multilevel CFA framework
• Reliability was examined alongside structural validity using multilevel confirmatory factor analysis
• The instrument showed 'satisfactory validity, reliability and measurement precision' overall

Convergent validity of the Spanish SPVU-5D was evaluated against the RESVECH 2.0 clinical scale for venous leg ulcers.

• The RESVECH 2.0 was used as the comparator clinical scale for convergent validity assessment
• Convergent validity testing examined the relationship between the patient-reported SPVU-5D and the clinical wound assessment tool
• This analysis was part of the broader psychometric validation including minimum detectable change estimation

The study sample consisted of 132 patients with venous leg ulcers providing 264 total observations from pre- and post-treatment assessments.

• 132 patients participated in the methodological validation study
• 264 observations were generated from two time-point assessments (pre- and post-treatment)
• Mean patient age was 63.76 ± 10.02 years
• A multilevel analytical approach was used to account for the nested structure of repeated measurements within patients

Venous leg ulcers are associated with substantial morbidity and impaired health-related quality of life, necessitating validated patient-reported outcome measures.

• Venous leg ulcers are described as 'a common manifestation of chronic venous disease'
• The condition is associated with 'substantial morbidity and impaired health-related quality of life (HRQoL)'
• Patient-reported outcome measures are described as 'essential for capturing the patient perspective of disease burden and treatment outcomes in wound care management'
• The SPVU-5D is described as 'a concise preference-based instrument designed to assess quality of life in individuals with venous leg ulcers and to support health-economic evaluation'