PERCEIVED HEALTH-RELATED QUALITY-OF-LIFE, FUNCTIONAL STATUS, AND MORTALITY IN DIABETIC-PATIENTS UNDER RENAL REPLACEMENT THERAPY - DESIGN OFTHE CALVIDIA STUDY

Objective: To study the predictive effect of functional status and per ceived health-related quality of life on both early and late mortality in diabetes patients starting renal replacement therapy, regardless o f clinical factors. Design: A prospective cohort study. A cohort of no n-diabetes patients at onset of renal replacement therapy will be comp ared concurrently. The overall follow-up time will be three years. Set ting: Population starting renal replacement therapy attended by each o f the participant centres. Subjects: Every new diabetic patient starti ng renal replacement therapy who consents to fill in the health-relate d quality of life questionnaire, up to a total of 230. We intend to de tect a two-fold greater relative risk for death in the half with worse scores compared with the half with better scores in the quality of li fe questionnaire. In 5 centres every new non-diabetic patient will be included, up to a total of 100. Interventions: The MOS-SF-36 will be a dministered to evaluate the health-related quality of life. The Karnof sky scale will be used to measure the functional status. The baseline measurements will be made within the first month of treatment. From th e third month the KDQOL(TM), a specific instrument for end-stage renal disease will be administered. Outcome variables: Mortality and its ca uses; cardiovascular and infectious morbidity and hospital admissions. Other predictive variables: Demographic features; associated cardiova scular peripheral and visual morbidity; associated stroke; serum album in; and type and adequacy of dialysis.