The venous leg ulcer quality of life (VLU‐QoL) questionnaire: development and psychometric validation

ABSTRACT To develop and validate a disease‐specific quality of life (QoL) measure, based on the conceptual model of the SKINDEX‐29 for patients with a chronic venous leg ulcer (VLU), in‐depth interviews, and focus groups of patients ( n =36) with VLU were used to generate VLU‐specific items. These items were added to selected SKINDEX‐29 items that were adapted for use in VLU. Further samples of VLU patients were used for item reduction ( n =124) and to assess the psychometric properties of the new tool ( n =120). The final VLU‐QoL contained 34 items: 17 items adapted from the SKINDEX‐29 and 17 VLU‐specific items. Factor analysis of the items confirmed the existence of three hypothesized domains: Activities (12 items), Psychological (12 items), and Symptom Distress (10 items). Reliability in terms of internal consistency and test–retest reliability was found to be good. The measure was also found to be valid and responsive to clinical change. The VLU‐QoL has good psychometric properties. The instrument's sensitivity to differences in clinical outcome and responsiveness to change in clinical parameters makes it a useful tool to assess the outcomes of treatment from the patients' perspective.