Pilot study investigating the feasibility of an ulcer-specific quality of life questionnaire

Abstract

Objective: This study explores the feasibility and reliability of a modified ulcer-specific quality of life (QOL) questionnaire on patients suffering from venous leg ulcers. Methods: A cross-sectional survey was conducted on a cohort of patients suffering from venous leg ulcers who had been registered at Rochdale Infirmary to participate in a clinical trial. A self-administered six-page questionnaire – Freiburger Lebensqualitäts Questionnaire Assessment (FLQA) – on the QOL along with a checklist was used to collect data from March 2002 to June 2003. The feasibility and reliability of the venous leg ulcer specific questionnaire, the patient-reported QOL and their perspective on compression therapy were chosen as the main outcomes of the study. Results: A response rate of 94% was obtained, of which 56% were women and 44% were men with an average age of 63 years. Approximately 72% of respondents reported that the questionnaire was suitable to reflect their perspectives on QOL and compression therapy. The questionnaire took an average of 20 minutes to complete. The average QOL score was 45.27 in all the eight domains, where 0 reflected good QOL and 100 reflected poor QOL, indicating that the respondents' QOL had been adversely affected due to venous leg ulcers. Men had an average score of 52.0 in all the eight domains and women scored 39.0 in a 0–100 scale. Hence, comparatively, men had poorer QOL than women. Reliability was assessed using measures of internal consistency and test–retest analysis. Cronbach's alpha, α = 0.934 indicated that the survey items were highly inter-correlated. Test–retest analysis indicated that there was moderate-to-strong correlation in seven out of eight domains, which meant that the reproducibility of the FLQA questionnaire was consistent. Conclusions: The pilot survey conducted on a representative sample of patients indicated that the questionnaire is suitable and has the potential to reflect the perspective on compression therapy and overall QOL of patients suffering from venous leg ulcers. The survey tool demonstrated the clinical and research utility as a QOL outcome measure for clinical trials evaluating wound care products on patients suffering from venous leg ulcers.