Quality of life of people with venous leg ulcers: a comparison of the discriminative and responsive characteristics of two generic and a disease specific instruments.

BACKGROUND: Venous leg ulcers are an important source of morbidity in society. Measuring the impact of leg ulcers on quality of life is important within clinical and economic evaluations. In this study we report a validation study of the leg ulcer disease specific Hyland questionnaire and compare its discriminative and responsive characteristics to general health quality of life measures: the SF-12 and EQ-5D.
METHODS: HRQoL of venous leg ulcer patients from 9 UK regions was measured using SF-12, EQ-5D and Hyland, at baseline and every three months for 1 year. Psychometric analysis was used to confirm the validity of the Hyland questionnaire. Quarterly scores for all instruments were calculated. Effect size and standardised mean difference were used to investigate the responsiveness to ulcer healing and discriminative abilities of the instruments.
RESULTS: Three hundred and eighty seven individuals were recruited into the VenUS I study. Baseline health related quality of life data from the study participants suggested a two factor solution for the Hyland. This questionnaire was associated with small and moderate ability to discriminate individuals according to age, mobility, initial ulcer size and ulcer duration. SF-12 and EQ-5D had good evaluative properties; both instruments were responsive to changes in HRQoL after ulcer healing. High levels of bodily pain were reported in the SF-12 questionnaire, whilst only minor ulcer related discomfort was reported in the Hyland. DISCUSSION: SF-12 and EQ-5D are suitable for exploring dimensions of health related quality of life in people with chronic venous leg ulceration. The responsiveness to healing of the Hyland questionnaire is unclear. We would recommend the use of generic instruments for the measurement of HRQoL in patients with venous leg ulcers.