F Ortega

PUK13 EXPANDED CRITERIA DONORS IN RENAL TRANSPLANTATION: RESULTS OF ECONOMIC EVALUATION

ing the dialysis treatment. The cost of treatment of end-stage renal disease is high and increases with age. Therefore, delaying the start of renal replacement therapy with hemodialysis and improving the patient’s quality of life are two primary goals justifying the use of protein-restricted diets. The aim of the study was to evaluate the economic impact of a low-protein diet (0.6 gr proteins/kg, body weight/day) with the intent of delay the haemodialysis treatment in patients with advanced chronic-renalfailure. METHODS: The study was a naturalistic, longitudinal retrospective Cost of Treatment study. Patients were enrolled during the 2005 and followed up until 2007 or the beginning of haemodialysis treatment. Direct health care resources attributable to disease management (drugs, ambulatory care, day case treatments, hospitalizations, specialist visits, diagnostics and laboratory exams) were quantified using National Health Service (NHS) tariffs expressed in Euro 2008. NHS perspective was adopted. Health-related quality of life information were also collected using SF-36 questionnaire at the enrolment and at the end of the observation period. RESULTS: We enrolled 30 patients (males 60%, mean age of 56.5 13.9 y.o.) from the Nephrology Department of the University “Federico II” of Naples, with a mean follow-up of 12.7 7.5 months. The average monthly cost of care was €1075.6 925.2 per patient, mainly because of hospitalization which represented the 45.0% of the expenses. SF-36 results showed a quality of life stable during the observation period and quite similar to the general population. CONCLUSIONS: This is the first study evaluating the economic impact of law-protein diet in patients with CRF in Italy. The protein-restricted diets helps to delay initiation of hemodialysis sessions, which substantially increase treatment costs and negatively impacts quality of life.

PUK23 ILLNESS REPRESENTATIONS IN RENAL TRANSPLANT RECIPIENTS

were collected through the symptom bother subscale of the OAB-q questionnaire which was administered at three different time points: before (M0) and after 3 (M3) and 12 Months or more (M12) of TER treatment. Efficacy and tolerability of TER treatment were also investigated. RESULTS: A total of 168 patient questionnaires of M3 and 93 of M12 were compared to baseline questionnaires (M0). The average age ( SD) was 59 ( 16.9), patients were mainly female (70%). The mean total score ( SD) of the OAB-q subscale decreased from 29.13 ( 9.12) to 18.16 ( 7.53) at M3 and to 17.14 ( 7.01) at M12 (p < 0.001) compared to baseline oxybutinin treatment, exceeding the “Minimally Important Difference” of 10 points. All individual OAB-q symptom bother items showed an improvement with the highest impact on micturition frequency (27% at M3, 30% at M12) and uncomfortable/sudden urge to urinate (28% at M3, 30% at M12) (p < 0.001). The % of patients reporting improvement in the treatment related adverse events such as memory, vertigo, constipation and dry mouth further increased from M3 to M12 compared to baseline oxybutinin treatment, with the most pronounced improvement for dry mouth: 58% at M3, 61% at M12 (p < 0.001). CONCLUSION: The data presented in this real life study show that TER improved the Health Related Quality of Life of patients with a neurogenic OAB. Based upon these results the reimbursement of TER was maintained in Belgium.

PUK21 RESEARCH NETWORK ON TRANSPLANTATION: FEMALES ON THE WAITING LIST FOR RENAL TRANSPLANT SHOW A POORER PERCEIVED STATE OF HEALTH THAN DO MALES

PUK18 A MULTICENTRE STUDY OF RENAL TRANSPLANT PATIENTS USING THE SF-36 AND THE END STAGE RENAL DISEASE SYMPTOM CHECK-LIST (ESRD-SCL) Ortega T, Ortega F,Valdés C, Rearch Network on Transplantation FC Hospital Universitario Central de Asturias, Oviedo, Spain OBJECTIVES: The aim was to study the changes in the HRQOL during the first year following renal transplant. METHODS: A total of 508 patients from fifteen transplant centres in Spain were included in a kidney waiting list and 200 were prospectively studied. QoL over time (before, at three and six months after transplantation) was obtained using the SF-36 and the End-Stage Renal Disease Symptom Checklist (ESRD-scl). Clinical and socio-demographic records were searched. RESULTS: Some clinical variables (haemoglobin and serum creatinine) improved 3 months after transplantation. Comparison the SF-36 dimensions before and three months after transplantation, all domains, as well as physical (PCS) and mental component summaries (MCS) (p < 0.01), showed significant improvement except in Bodily Pain and Physical Functioning. Comparison of SF-36 between three and six months after transplantation, only role-physical showed significant improvement and the rest of physical dimensions showed similar scores, but mental functioning was a little worse than at three months post transplant. For ESRD-scl before and three months after transplantation, the symptoms were better (Limited Physical Capacity, Limited Cognitive Capacity, Cardiac and Renal Dysfunction and Transplantation-associated Psychological Distress, except for Increased Growth of Gum and Hair) (p < 0.01). Comparing three and six months post-tx, only Side Effects of Corticosteroids dimension showed significant improvement. Females significantly more often showed the worst HRQoL (MCS, Vitality, Mental Health and Role-emotional; p < 0.001). Age, educational level, dialysis modality before transplantation, time on dialysis and comorbidity index did not affect the HRQoL after transplantation. However, variables that were not significant in the overall score reached significance in some symptoms. CONCLUSIONS: The most important finding in this study is that all domains showed a significant improvement in HRQoL three months after transplantation, and at six months HRQoL was slightly improved, while mental domains remained the same with respect to measurements at three months.

PUK19 OPEN MULTICENTER STUDY OF HEALTH RE LATED QUALITY OF LIFE BEFORE AND AFTER SOLID ORGAN TRANSPLANTATION (KIDNEY, LIVER, HEART AND LUNG)

PUK18 A MULTICENTRE STUDY OF RENAL TRANSPLANT PATIENTS USING THE SF-36 AND THE END STAGE RENAL DISEASE SYMPTOM CHECK-LIST (ESRD-SCL) Ortega T, Ortega F,Valdés C, Rearch Network on Transplantation FC Hospital Universitario Central de Asturias, Oviedo, Spain OBJECTIVES: The aim was to study the changes in the HRQOL during the first year following renal transplant. METHODS: A total of 508 patients from fifteen transplant centres in Spain were included in a kidney waiting list and 200 were prospectively studied. QoL over time (before, at three and six months after transplantation) was obtained using the SF-36 and the End-Stage Renal Disease Symptom Checklist (ESRD-scl). Clinical and socio-demographic records were searched. RESULTS: Some clinical variables (haemoglobin and serum creatinine) improved 3 months after transplantation. Comparison the SF-36 dimensions before and three months after transplantation, all domains, as well as physical (PCS) and mental component summaries (MCS) (p < 0.01), showed significant improvement except in Bodily Pain and Physical Functioning. Comparison of SF-36 between three and six months after transplantation, only role-physical showed significant improvement and the rest of physical dimensions showed similar scores, but mental functioning was a little worse than at three months post transplant. For ESRD-scl before and three months after transplantation, the symptoms were better (Limited Physical Capacity, Limited Cognitive Capacity, Cardiac and Renal Dysfunction and Transplantation-associated Psychological Distress, except for Increased Growth of Gum and Hair) (p < 0.01). Comparing three and six months post-tx, only Side Effects of Corticosteroids dimension showed significant improvement. Females significantly more often showed the worst HRQoL (MCS, Vitality, Mental Health and Role-emotional; p < 0.001). Age, educational level, dialysis modality before transplantation, time on dialysis and comorbidity index did not affect the HRQoL after transplantation. However, variables that were not significant in the overall score reached significance in some symptoms. CONCLUSIONS: The most important finding in this study is that all domains showed a significant improvement in HRQoL three months after transplantation, and at six months HRQoL was slightly improved, while mental domains remained the same with respect to measurements at three months.

PR2 ESTIMATING UTILITY VALUES FOR HEALTH STATUS USING THE SPANISH VERSION OF THE SF-36. DATA OF VALIDITY OF THE SF-6D VS EQ-5D IN SPAIN

PR1 HEALTH RELATED QUALITY OF LIFE IN DIFFERENT STATES OF BREAST CANCER Lidgren M,Wilking N, Jönsson B, Rehnberg C Karolinska Institutet, Stockholm, Sweden, Stockholm School of Economics, Stockholm, Sweden OBJECTIVES: The aim of this study was to describe the health related quality of life (HRQoL) in different breast cancer disease states using preference-based measures. METHODS: A total of 361 consecutive breast cancer patients attending the breast cancer outpatient clinic at Karolinska University hospital Solna for outpatient visits between April and May 2005 were included in the study. The EQ-5D self classifier and a direct Time Trade Off (TTO) question was used to estimate the HRQoL in different breast cancer disease states. RESULTS: All of the different disease states had lower HRQoL compared to the general population. Patients in their first year after a primary breast cancer had a mean EQ-5D index value of 0.696 (95% confidence interval (CI): 0.634–0.747)). Patients in their first year after a recurrence had a mean EQ-5D index value of 0.779 (CI: 0.700–0.849). Patients whom had not had a primary breast cancer diagnosis or a recurrence during the previous year had a mean EQ-5D index value of 0.779 (CI: 0.745–0.811). Patients with metastatic disease reported the lowest HRQoL values, and had a mean EQ-5D index value of 0.685 (CI: 0.620–0.735). The main driver behind the reduction in HRQoL was pain and discomfort as well as anxiety and depression. TTO values were higher for all diseases states compared to the EQ-5D index values. CONCLUSION: This study shows that breast cancer is associated with a reduction in HRQoL. This effect is most pronounced for patients with metastatic disease. Our results also indicate that breast cancer has a permanent negative effect on HRQoL, even if the patient remains recurrence free.

PMC10 ESTIMATING UTILITY VALUES FOR HEALTH STATUS USING THE SPANISH VERSION OF THE SF-36. IS IT WORTHY TO CALCULATE WEIGHT VALUES FOR UTILITY MEASURES?

PMC10 ESTIMATING UTILITY VALUES FOR HEALTH STATUS USING THE SPANISH VERSION OF THE SF-36. IS IT WORTHY TO CALCULATE WEIGHT VALUES FOR UTILITY MEASURES? Rebollo P, Morís J, Prieto L, Ortega F, Ortega T BAP Health Outcomes, Oviedo, Spain, Madrid, San Agustín de Guadalíx, Madrid, Spain, Hospital Universitario Central de Asturias, Oviedo, Spain OBJECTIVES: A new utility index derived of the SF-36, the SF6D, was recently developed and has generated an increasing research in different groups of patients and has also been compared with other utility measures, as it is the EQ-5D. The purpose of present work was to evaluate the differences between the weighted and not weighted version of two utility measures: the Spanish SF-6D and EQ-5D. METHODS: A total of 1843 complete measures of the SF-36 and the EQ-5D (5 items and visual analogic scale-VAS) from 1283 patients who received a solid organ transplant (kidney, liver, heart or lung) were used. Data were collected at different moments during the first year after the surgery in the context of the Spanish Research Network on Transplantation. SF-6D values were calculated using the model proposed by its creator (weighted version) and without tariff values, as has been proposed by some authors (not weighted). EQ-5D values were calculated using Spanish VAS tariff (VAS-t), the time-trade off tariff (TTO-t) and also without tariff values (not weighted). Spearman correlation coefficients were calculated between SF-6D (weighted and not weighted) and EQ-5D values (VAS-t, TTO-t and not weighted). RESULTS: Mean value of weighted SF-6D was 0.67 (0.15) and not weighted, 0.72 (0.15). Mean values of EQ-5D VAS-t was 0.69 (0.24), of TTO-t, 0.70 (0.32) and of not weighted EQ-5D, 0.63 (0.33). SF-6D values had moderate correlation with EQ-5D VASt (r = 0.734) and EQ-5D TTO-t (r = 0.731) (both p < 0.001). Using the SF-6D index without tariff values, it had a high correlation with the weighted version of SF-6D (r = 0.969, p < 0.001), and moderate with the EQ-5D VAS-t (r = 0.754), EQ5D TTO-t (r = 0.750) and no weighted EQ-5D (r = 0.784) (p < 0.001). CONCLUSIONS: The efforts made to get the preferences values and calculate the weights in utility indexes do not seem to add enough information to make them worthy.

PUK1 THE TIMELY CONSTRUCTION OF AN ARTERIOVENOUS FISTULAE: A KEY FACTOR IN REDUCING MORBIDITY AND MORTALITY AND IMPROVING ECONOMIC EFFECTIVENESS

measurements like waist circumference (WC) may define obesity and explain its health consequences. The objective of this study was to determine if utility (EQ5Dindex) varied by BMI category, as WC varied. METHODS: This retrospective study used the latest data from the England Health Survey (2003). A general linear model (GLM) was developed that included factors associated with utility, standardising for age and sex to generate estimates of utility with relation to obesity (obesity categories: normal [Nl, BMI 18.5–24.9kg/m], overweight [Ov, 25.0–29.9 kg/m], obese [Ob, ≥30kg/m], and thirties of WC, L = low, M = medium, and H = high). RESULTS: The standardised mean utility by BMI category for men was: Nl = 0.877, Ov = 0.894, Ob = 0.858. Standardised mean utility by BMI category for women was: Nl = 0.879, Ov = 0.871, Ob = 0.812. Standardised mean utility by WC category for men was: L = 0.887, M = 0.877, H = 0.866. Standardised mean utility by WC category for women was: L = 0.872, M = 0.857, H = 0.833. BMI and WC were dependent and interacting determinants of utility. For females in the nine obesity groups, the standardised mean utility was as follows: Nl/L = 0.878, Nl/M = 0.877, Nl/H = 0.882, Ov/L = 0.896, Ov/M = 0.873, Ov/H = 0.844, Ob/L = 0.842, Ob/M = 0.822, Ob/H = 0.774. For men: Nl/L = 0.862, Nl/M = 0.882, Nl/H = 0.888, Ov/L = 0.907, Ov/M = 0.893, Ov/H = 0.883, Ob/L = 0.892, Ob/M = 0.856, Ob/H = 0.828. CONCLUSIONS: In both women and men, the highest EQ5Dindex values (best QoL) was evident in overweight people with a low WC. A reduction in WC in obese people resulted in a greater gain in utility than the same change in normal or overweight people. Use of both BMI and WC, rather than a single measure of obesity, provided a more precise prediction of health-related utility. Utility varied more widely as a function of waist circumference in higher BMI categories.

PUK16 LOWER IMPACT ON HEALTH RELATED QUALITY OF LIFE (HRQOL) IN ELDERLY PATIENS STARTING AND AFTER ONE YEAR OF HEMODIALYSIS (HD) THAN IN YOUNGER PATIENS:A PROSPECTIVE STUDY

OBJECTIVE: With the progression of the renal insufficiency (RI) produced in the chronic allograft nephropathy (CAN), the patients’ HRQoL worsens. The treatment of the anemia associated to the RI with rh-EPO improves the HRQoL. The objective of present study was to evaluate the HRQoL of kidney transplant patients with CAN and anemia associated to the RI, and the effect of the treatment with rh-EPO on the HRQoL. METHODS: Prospective study of 24 kidney transplant patients with RI caused by CAD and anemia who received rh-EPO to treated the anemia. The hemoglobin target was 12gr/dL. HRQoL was evaluated with the SF-36 Health Survey at start treatment, 3 months later and at the end of followup. SF-36 scores (8 dimensions, Physical-PCS and Mental Component Summary-MCS) were standardized by age and gender using the Spanish general population norms. The “Effect Size” was also calculated for each dimension and for summary scores. RESULTS: Hemoglobin statistically improved from start to third month (p < 0.01). SF36 scores of studied patients were worse than those of the general population and that those of a transversal sample of transplant patients with good renal function: PCS = 36.08 ± 12.83 vs. 48.68 ± 9.86; MCS = 47.16 ± 14.46 vs. 51.91 ± 10.25. Three SF-36 dimensions statistically improved with the correction of anemia with the rh-EPO treatment: Role Physical, Vitality and Mental Health. The “Effect Size” was very small for Physical Functioning and Social Functioning; small for General Health (0.28) and PCS (0.23); moderate for Pain (0.41), Role Emotional (0.39) and MCS (0.42); and large for Role Physical (0.65), Vitality (0.81) and Mental Health (0.74). CONCLUSIONS: The poor HRQoL of kidney transplant patients with CAN and anemia improves with the treatment of the anemia with rh-EPO. The “Effect Size” for this change in the HRQoL is moderate to large in majority of HRQoL areas.