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Unformatted text preview: a. Page 1 of 11 (page number not for citation purposes) Health and Quality of Life Outcomes 2004, 2 Background During the past few decades quality of life assessment has become one central outcome in treatment of patients with chronic lower limb ischaemia. Different generic quality of life instruments such as the Nottingham Health Profile (NHP) and the Short Form 36 Health Survey (SF-36) [1,2] have previously been tested, revealing conflicting results in these patients according to psychometric attributes in short-term evaluations. The strengths and weakness of the NHP and the SF-36 scales are not extensively examined and further research is needed to establish which is the more appropriate and responsive quality of life instrument for patients with chronic lower limb ischaemia in the long term. The main goal of vascular surgical treatment is the relief of symptoms and improvement in patients quality of life. A majority of the patients are elderly and have generally widespread arterial disease with numbers of symptoms due to the chronic lower limb ischaemia, which may affect the patients' quality of life [35]. Intermittent claudication (IC) means leg pain constantly produced by walking or muscular activity and is relieved by rest, while critical leg ischaemia (CLI) means pain even at rest and problems with non-healing ulcers or gangrene [6]. It is important to identify dimensions which are influenced by the severity and nature of the disease when selecting a suitable quality of life instrument [7]. The World Health Organization QOL group [8] has identified and recommended five broad dimensions – physical and psychological health, social relationship perceptions, function and well-being – which should be included in a generic quality of life instrument. Generic instruments cover a broad range of dimensions and allow comparisons between different groups of patients. Disease-specific instruments, on the other hand, are specially designed for a particular disease, patient group or areas of function [9]. The functional scale, Walking Impairment Questionnaire (WIQ) [10] and quality of life instruments such as Intermittent Claudication Questionnaire (ICQ) [11] and Claudication Scale (CLAU-S) [12] are examples of disease-specific instruments which have been developed in recent years for patients with IC. However, at present there is no accepted disease-specific questionnaire for quality of life assessment in patients with CLI. Nevertheless, the TransAtlantic Inter-Society Consensus (TASC) [6] recommended that quality of life instruments should be used in all clinical trials and preferably include both generic and disease-specific quality of life measures. Outcome measures need to satisfy different criteria to be useful as a suitable health outcome instrument in clinical practice. Construct validity is one of the most important characteristics and is a lengthy and ongoing process [13]. An essential consideration is the instrument's ability to discriminate between different levels of the disease; http://...
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