WHAT DOES THIS STUDY/REVIEW ADD TO THE EXISTING LITERATURE AND HOW WILL IT INFLUENCE FUTURE CLINICAL PRACTICEIn elderly patients with critical limb ischaemia (CLI), guidelines about the definition of quality of life and the instruments that measure quality of life are sparse. Often quality of life is confused with health status. This study provides evidence that there is a discrepancy between quality of life and health status in elderly CLI patients undergoing major amputation. This raises the question, which outcome measurement is the most relevant for elderly CLI patients. We advocate the use of distinctive and subjective QoL questionnaires, like the WHOQOL-BREF, in future research.Objectives: A patient-oriented appraisal of treatment has become extremely important, particularly in elderly patients with critical limb ischaemia (CLI). Quality of life (QoL) is an important patient-reported outcome in vascular surgery. Frequently, the physical domain of QoL questionnaires represents an 'objective' evaluation of performing activities, which is expected to be impaired after major limb amputation. However, an objective appraisal of physical function is an assessment of health status (HS) and not of QoL. Little is known about the subjective appraisal of physical health (QoL). The goal of this study was to evaluate, prospectively, QoL in relation to HS in elderly CLI patients undergoing major limb amputation. Methods: Patients suffering from CLI aged 70 years or older were included in a prospective observational cohort study with a follow-up period of 1 year. Patients were divided according to having had an amputation or not.The World Health Organization Quality Of Life-BREF (WHOQOL-BREF) was used to asses QoL.The 12-Item Short Form Health Survey (SF-12) was used to measure HS. These self-reported questionnaires were completed five times during follow-up. Results: Two-hundred patients were included of whom 46 underwent a major limb amputation within one year. Amputees had a statistically significant improvement of their physical QoL after six months (14.0 vs. 9.0 (95% CI -7.84;-1.45),p ¼ 0.005) and after a one-year follow-up (14.0 vs. 9.0 (95% CI -9.58;-1.46),p ¼ 0.008). They did not however show any statistically significant difference in HS. For non-amputees, both physical QoL and HS improved. An instant statistically significant improvement of the physical QoL appeared 1 week after inclusion (12.0 vs. 10.9 (95% CI -1.57;-0.63),p<0.001). Similarly, statistically significant improvement in the physical HS first occurred at 1 week follow-up (29.0 vs. 28.9 (95% CI -5.78; À2.23),p ¼ 0.003). Conclusions: There is a clear difference between patients' functioning (HS) and the patients' appraisal of functioning (QoL). In elderly CLI patients, this study clearly suggests a discrepancy between the physical QoL (WHOQOL-BREF) and HS (SF-12) measurements in vascular amputees. This raises the question, which outcome measurement is the most relevant for elderly CLI patients. Individual treatment goals should be kept in mind when as...