Measuring health-related quality of life in patients with venous leg ulcers

Introduction: The effect on quality of life by healing leg ulcers is not kn own and no validated disease-specific tool is available for measuring healt h-related quality of life (HRQoL) for people with venous leg ulcers. The ob jective of this paper was to compare four generic instruments [MOS 36-Item Short-Form Health Survey (SF-36); EuroQol (EQ); McGill Short Form Pain Ques tionnaire (SF-MPQ) and the Frenchay Activities Index (FAI)] used for measur ing HRQoL in people with venous leg ulcers, and to offer guidance on the mo st appropriate tool for researchers. Methods: Two hundred and thirty-three patients with venous leg ulcers were recruited as part of a randomised cont rolled trial of the cost-effectiveness of community leg ulcer clinics. Subj ects completed questionnaires containing the four instruments on three occa sions (initial assessment, 3 and 12 months). The discriminative and evaluat ive properties of the four instruments were compared. Results: All four ins truments were acceptable to patients, taking a mean of 19.3 (SD 6.3) min to complete. At initial assessment, the SF-MPQ had poorer discriminative prop erties than the other three instruments and was not able to distinguish bet ween the different patient groups in relation to age and ulcer duration. Th e FAI was good at discriminating between the different patient groups (at i nitial assessment) in relation to age, mobility and ulcer size. At the thre e-month follow-up, the SF-MPQ was more responsive than the other measures a nd detected changes in HRQoL, whereas the EQ and SF-36 did not. At 12 month s, the SF-MPQ still identified differences and the SF-36 and EQ also did at this stage. Conclusion: In the absence of a validated condition-specific t ool for measuring changes in general health status for patients with venous leg ulcers, we make the following recommendations. For evaluating the outc ome of interventions with a short-term follow-up (three months) in a clinic al study we recommend the SF-MPQ and for 12-month follow-up in a clinical s tudy the SF-36, with or without the SF-MPQ.