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 co
mmunity clinics. Items for the questionnaire were selected by means of pati
ent interviews, a literature review, and expert opinion. The questionnaire
and the Short Form 36-item (SF-36) Health Survey were given to a prospectiv
e consecutive cohort of 98 patients with proven venous ulcers that were dia
gnosed by means of clinical and color duplex examination. Fifty-eight of th
e patients were women (60%), and the median age of patients was 76 years. T
he questionnaire was assessed for reliability, validity, and responsiveness
.
Results: The ulcer-specific questionnaire showed good reliability, as asses
sed by means of the internal consistency (Cronbach alpha = 0.93) and test-r
etest analysis (r = 0.84). Factor analysis identified four important health
factors: social function, domestic activities, cosmesis, and emotional sta
tus. Validity was demonstrated by means of a high correlation with all eigh
t domains of the SF-36 general health measure (r r 0.55, P <.001). Responsi
veness 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 pati
ents with venous ulcers has validity to measure the quality of life.