DEVELOPMENT OF A DISEASE-SPECIFIC INSTRUM ENT FOR THE ASSESSMENT OF QUALITY-OF-LIFE IN PATIENTS WITH PERIPHERAL ARTERIAL OCCLUSIVE DISEASE

Impairment in health-related quality of life in patients with peripher al arterial occlusive disease (PAOD) are well-known to clinicians, but due to the lack of disease specific assessment instruments, have not been systematically investigated. We describe the development and psyc hometric testing of a 86-items patient-based questionnaire for the ass essment of the quality of life in PAOD containing 7 dimensions: functi onal status, pain, symptoms, mood, disease related anxiety, social lif e and treatment evaluation. The questionnaire was included along with standard questionnaires in a prospective study with 308 patients suffe ring from PAOD in Fontaine stages I to IV before and one week into tre atment. Psychometric testing pertained to reliability (internal consis tency, retest), validity (convergent, discriminant) and sensitivity (t reatment-related change over time). In addition patient acceptance of the questionnaire was assessed. Psychometric testing yield exellent re sults regarding scale structure and reliability of the newly developed questionnaire. Validity was reflected in high correlations with stand ard generic questionnaires and in discriminating in quality of life be tween patients according to disease severity. The sensitivity was refl ected in improved quality of life ratings in patients with improved tr eadmill performance. Patients needed 20 minutes for responding and rat ed the questionnaire to be easily understandable and not exhausting. T hese results show that the newly developed PAVK-86 questionnaire is a reliable, valid and sensitive instrument for the assessment of quality of life in patients with arterial occlusive disease which can be used in clinical studies, epidemiological research and quality assurance p rograms.