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

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.