Purpose: This prospective study aimed to validate a newly designed specific measure of quality of life for patients with venous ulcers.
Methods: The study was set in a London teaching hospital and surrounding community clinics. Items for the questionnaire were selected by means of patient interviews, a literature review, and expert opinion. The questionnaire and the Short Form 36-item (SF-36) Health Survey were given to a prospective consecutive cohort of 98 patients with proven venous ulcers that were diagnosed by means of clinical and color duplex examination. Fifty-eight of the patients were women (60%), and the median age of patients was 76 years. The questionnaire was assessed for reliability, validity, and responsiveness.
Results: The ulcer-specific questionnaire showed good reliability, as assessed by means of the internal consistency (Cronbach alpha = 0.93) and test-retest analysis (r = 0.84). Factor analysis identified four important health factors: social function, domestic activities, cosmesis, and emotional status. Validity was demonstrated by means of a high correlation with all eight domains of the SF-36 general health measure (r > 0.55, P <.001). Responsiveness was demonstrated by means of a significant reduction in the score on the ulcer questionnaire as ulcers healed at 6 and 11 weeks (P <.05).
Conclusion: Good evidence exists that a clinically derived measure for patients with venous ulcers has validity to measure the quality of life.