Validation of the Spanish version of the liver disease quality of life instrument among candidates for liver transplant.

OBJECTIVE: To validate a Spanish version of the Liver Disease Quality of Life Questionnaire (LDQOL 1.0) among patients awaiting hepatic transplantation. METHODS: This observational, cross-sectional study was performed between May 2002 and June 2006. We included ambulatory or hospitalized patients aged 18 or over with chronic liver disease awaiting transplantation. Patients completed the LDQOL 1.0. The feasibility of the LDQOL for clinical use was tested by examining the administration time and values for the questionnaire's 12 disease-specific scales. Reliability was tested by examining the internal consistency of the scales (Cronbach's alpha). Known group validity was tested by examining the questionnaire's ability to discriminate between patients with hepatocellular (HCC), liver cirrhosis (CH), hepatitis C virus infection, and alcohol-induced CH. RESULTS: A total of 200 patients were included in the analysis. Their mean age (SD) was 52.6 (9.8) years; 73% of the sample were men. The most common indication for liver transplant was HCC (34%). The mean (SD) time to complete the LDQOL 1.0 was 35 minutes (21 minutes). Over 20% of patients scored at the ceiling (maximum possible score) on seven of the 12 disease-specific scales. Floor effects were less marked. All dimensions had Cronbach alpha coefficients over 0.60. The lowest value (0.64) was found in the sexual problems (women) dimension. Patients with HCC had significantly higher scores on several scales, including symptoms of liver disease (P = .000), effects of liver disease (P = .000), concentration (P = .002), memory (P = .015), quality of social interaction (P = .030), sleep (P = .000), loneliness (P = .043), and stigma (P = .028). Statistically significant differences were found between HCC patients and alcohol-induced CH patients in only two dimensions. CONCLUSIONS: Among pretransplant patients, the Spanish version of the LDQOL 1.0 showed substantial ceiling effects and the length of administration makes its application in clinical practice difficult. This preliminary analysis showed good internal consistency for the disease-specific scales and acceptable known group validity.

[Financial assessment of device for the preparation of intravenous mixtures in hospital pharmacy]. / Evaluación económica de un dispositivo para preparación de mezclas intravenosas en farmacia hospitalaria.

OBJECTIVE: To financially assess a device for the preparation of intravenous mixtures (DPIVM) --Grifill system-- such as IV gammaglobulin, salbutamol, ondansetron/dexametasone, cisplatin rehydrating solution and mesna. MATERIAL AND METHODS: The most relevant resources used in the preparation and rebottling of each of the above-mentioned intravenous mixtures (for both the DPIVM and the commonly used alternative system) are assessed, as well as unitary costs (obtained from six Spanish hospitals enrolled), and an approach to the real cost by system used is obtained. A sensitivity analysis is performed considering most influencing variables. Results are calculated for one month of system operation. RESULTS: For IV gammaglobulin, mesna, salbutamol, ondansetron/dexametasone and polyionic solutions DPIVM resulted in financial benefit, but it did not in the preparation of cisplatin rehydrating solution. CONCLUSIONS: An individualized study in each center is needed to achieve reliable financial data on the system's profitability at hospital pharmacy departments. DPIVM may allow significant financial savings in centers and hospital departments using high-cost pharmaceuticals susceptible of customized dosing --e. g., IV gammaglobulin, other blood derivatives, monoclonal antibodies and/or antibiotics-- or intravenous mixtures requiring pharmaceuticals usually purchased directly from the manufacturer that may be prepared from low-cost raw materials (for instance, salbutamol and polyionic solution) requiring high-quality manipulation (e. g., sterility and precision).

[Impact of an intravenous mixture preparation device in hospital Pharmacy Departments. Perceived healthcare quality and user satisfaction]. / Impacto de un dispositivo de preparación de mezclas intravenosas en farmacia hospitalaria. Percepción de calidad asistencial y satisfacción del usuario.

OBJECTIVE: To integrally assess an intravenous mixture preparation device (IMPD) from the point of view of perceived healthcare improvement in a center (operational and organizational changes of the hospitals pharmacy department, staff nurse satisfaction and end-user satisfaction). MATERIAL AND METHODS: An observational, multicenter and domestic healthcare technology assessment project (an analysis to estimate relative value and contribution of a specific healthcare technology to both individual and collective health) is under discussion. Data were obtained from 6 Spanish hospitals. RESULTS: In 3 out of 4 Pharmacy Departments surveyed, reports on the use of IMPD showed that this system contributed to time saving, as well as improved preparation quality and system safety. From a nursing standpoint, the use of IMPD was mostly considered satisfactory, whereas most patients (81%) reported increased satisfaction with care provided after IMPD was included in their medication process. CONCLUSIONS: IMPD demonstrated satisfactory characteristics that were deemed positive by hospital pharmacy departments, nursing departments and patients.

[Cost-effectiveness analysis of enoxaparin for the prophylaxis of venous thromboembolism in major orthopedic surgery patients]. / Análisis coste-efectividad de enoxaparina en la proxilaxis de la enfermedad tromboembólica venosa en pacientes sometidos a cirugía mayor ortopédica.

OBJECTIVES AND METHODS: A retrospective, modeled, cost-effectiveness analysis was conducted with enoxaparin versus non-prophylaxis, tinzaparin, and unfractionated heparin for venous thromboembolic disease in Spanish patients undergoing major orthopedic surgery from the standpoint of the Spanish national health system. Episodes avoided and life-years gained with each treatment were estimated by a meta-analysis of clinical trials. RESULTS: With enoxaparin fewer thromboembolic episodes and deaths occurred, when compared to the available alternative options. Enoxaparin was the dominant option (lower total cost and equal or greater effectiveness than any alternative option) in comparison with non-prophylaxis, tinzaparin, and unfractionated heparin. A sensitivity analysis confirmed the stability of these results. CONCLUSION: The administration of enoxaparin as a prophylactic treatment for venous thromboembolic disease in patients undergoing hip or knee surgery is a cost-effective intervention in every case, and less expensive than the alternative options used in Spain.

Análisis coste-efectividad de enoxaparina en la profilaxis de laenfermedad tromboembólica venosa en pacientes sometidos acirugía mayor ortopédica / Cost-effectiveness analysis of enoxaparin for the prophylaxis of venous thromboembolism in major orthopedic surgery patients

Objetivos y métodos: Se hizo un análisis coste-efectividad, retrospectivo y modelizado, de enoxaparina frente a la no profilaxis, tinzaparina y heparina no fraccionada de la enfermedad tromboembólica venosa, en pacientes españoles sometidos a cirugía mayor ortopédica, desde la perspectiva del Sistema Nacional de Salud. Los episodios evitados y años de vida ganados con cada tratamiento se estimaron mediante un metaanálisis de ensayos clínicos. Resultados: Con enoxaparina hubo un menor número de episodios tromboembólicos y muertes que con las opciones alternativas. Enoxaparina fue la opción dominante (costes totales menores y efectividad igual o mayor que la opción alternativa) en comparación con la no profilaxis, tinzaparina y las heparinas no fraccionadas. El análisis de sensibilidad confirmó la estabilidad de estos resultados. Conclusión: La administración de enoxaparina como profilaxis de la enfermedad tromboembólica venosa, en la cirugía de cadera o rodilla, es una intervención coste-efectiva en todos los casos, suponiendo un ahorro respecto a opciones alternativas utilizadas en nuestro país. (AU)