QUALITY-OF-LIFE ANALYSIS IN PATIENTS WITH LOWER-LIMB ISCHEMIA - SUGGESTIONS FOR EUROPEAN STANDARDIZATION

Introduction and Objectives: In this era of evidence-based medicine an d limited resources we seem obliged, on clinical and economic grounds, to demonstrate that we improve not only patient survival but also the quality of patients' lives. This study aims to determine the impact o f increasing lower limb ischaemia on quality of life (QOL) and which o f three commonly used generic QOL instruments is the most valid, relia ble, and responsive to change in patients with lower limb ischaemia. P atients and Methods: Two hundred and thirty-five patients, 144 men and 91 women, median age 68 years (range 41-87 years) were graded accordi ng to ISCVS suggested reporting standards, i.e. 16 mild, 116 moderate and 26 severe claudicants; 33 patients had rest pain and 45 tissue los s. Patients completed Short Form 36 (SF36), EuroQol (EQ-5D) and Nottin gham Health Profile (NHP) questionnaires at interview. Additional copi es of questionnaires were posted to 80 patients prior to attendance. C orrelation between the two sets of responses reflects test-retest reli ability. Correlation between domains measured by the three instruments reflects convergent and divergent validity. Kruskal Wallis ANOVA dete cted QOL changes across the whole group. Spearman Rank was used to ana lyse validity and reliability. Responsiveness was analysed using the M ann-Whitney U-test. Results: Increasing lower limb ischaemia confers s ignificant (P < 0.04) deterioration in: SF36 measured: physical functi oning, physical role, pain, general health, vitality, social functioni ng and mental health. EQ-5D (rs = 0.37-0.7). SF36 & NHP are equally re sponsive to changes in physical activity and pain. SF36 and EQ-5D are most responsive to changes in social activity. SF36 is most responsive to changes in psychological status. Conclusion: QOL detriorates marke dly with increasing lower limb ischaemia. The SF36 would appear to be the most appropriate generic QOL analysis tool for these patients. We recommend its widespread adoption throughout Europe, thus providing a standardised tool for reporting generic QOL.