Paloma González

Cost-Effectiveness of Sacral Neuromodulation Compared to Botulinum Neurotoxin A or Continued Medical Management in Refractory Overactive Bladder

OBJECTIVES This study assessed the cost-effectiveness and health-care budget impact of sacral neuromodulation (SNM) in refractory idiopathic OAB-wet patients in Spain. METHODS A 10-year Markov analytic model was developed to estimate quality-adjusted life-years (QALYs) gained and incontinence episode avoided associated with SNM therapy compared with botulinum neurotoxin A (BoNT-A) or continued optimized medical treatment (OMT). RESULTS At 10 years, the cumulative costs of SNM, BoNT-A, and OMT were €29,166, €29,458, and €29,370, respectively, whereas the QALYs for SNM, BoNT-A, and OMT are 6.89, 6.38, and 5.12, respectively. Consequently, incremental cost-effectiveness ratios (ICERs) for SNM demonstrate that although the initial costs for SNM are higher than those for the other treatments, decreasing follow-up costs coupled with consistently greater effectiveness in the long term make SNM the economically dominant option at 10 years. Sensitivity analyses suggest that 99.7% and 99.9% (for SNM vs. BoNT-A and OMT, respectively) of the 1000 Monte Carlo iterations fall within the €30,000 cost-effectiveness threshold, considered to be acceptable in Spain. The 10-year incremental cost per incontinence episode avoided for SNM also makes this therapy the dominant option compared to BoNT-A or OMT. Additionally, the estimated budget impact of the gradually increased referral for SNM for the management of OAB patients in Spain is small. CONCLUSIONS As a treatment option for refractory idiopathic OAB, at 10 years, SNM provides a considerable possibility of symptom and quality-of-life improvement and is cost-effective compared to BoNT-A or continued OMT.

Adaptación cultural, validación y desarrollo de un cuestionario abreviado sobre el miedo a la inyección y al autoanálisis de glucosa para pacientes diabéticos

OBJECTIVE To develop and validate in Spain a test to measure fear of injecting and selftesting [HIAT-I](c) in diabetic patients by translating and adapting the original English version of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). PATIENTS AND METHOD Forward-backward translations in duplicate were carried out and were revised by an expert and a nonexpert panel. Men and women with type 1 and type 2 diabetes aged more than 18 years old were enrolled in three primary care centers. The Spanish version of the D-FISQ was administered on two separate occasions at a 15-day interval. The trait-anxiety scale of the Stait-Trait Anxiety Inventory (STAI) and five specific questions on glycemic control, insulin injection, pain and worry were administered. Sociodemographic and clinical data were also collected. Feasibility, construct validity, concept validity and reliability were assessed. RESULTS A 32-item version of the D-FISQ was developed by an expert panel and was administered to 93 (35 Type 1, 58 Type 2) insulin-treated diabetic patients. Ninetynine per cent of the patients answered all items in 5 minutes (median). Item-total correlation and factor analysis led to an abridged, 19-item version, maintaining the two original dimensions, and explaining 47.4% percent of the total variance: fear of self-injecting (FSI), accounting for 29.5% of the variance, and fear of self-testing (FST), accounting for 17.9%. Test-retest correlation coefficients were 0.85 (FSI) and 0.94 (FST). The correlations between STAI and FSI and FST were not statistically significant (p=0.771). The correlation coefficient between FSI and time under insulin treatment was -0.546 (p=0.023). CONCLUSIONS We developed a newrecalibrated version of the Spanish D-FISQ called the MIAT-D. The feasibility, dimensionality, construct validity and reliability of this questionnaire were accurate. The concept validity of this test should be explored in further studies.

OriginalesAdaptación cultural, validación y desarrollo de un cuestionario abreviado sobre el miedo a la inyección y al autoanálisis de glucosa para pacientes diabéticosCultural adaptation, validation and development of a spanish brief version of the diabetes fear of injecting and self-testing questionnaire

OBJECTIVE To develop and validate in Spain a test to measure fear of injecting and selftesting [HIAT-I](c) in diabetic patients by translating and adapting the original English version of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ). PATIENTS AND METHOD Forward-backward translations in duplicate were carried out and were revised by an expert and a nonexpert panel. Men and women with type 1 and type 2 diabetes aged more than 18 years old were enrolled in three primary care centers. The Spanish version of the D-FISQ was administered on two separate occasions at a 15-day interval. The trait-anxiety scale of the Stait-Trait Anxiety Inventory (STAI) and five specific questions on glycemic control, insulin injection, pain and worry were administered. Sociodemographic and clinical data were also collected. Feasibility, construct validity, concept validity and reliability were assessed. RESULTS A 32-item version of the D-FISQ was developed by an expert panel and was administered to 93 (35 Type 1, 58 Type 2) insulin-treated diabetic patients. Ninetynine per cent of the patients answered all items in 5 minutes (median). Item-total correlation and factor analysis led to an abridged, 19-item version, maintaining the two original dimensions, and explaining 47.4% percent of the total variance: fear of self-injecting (FSI), accounting for 29.5% of the variance, and fear of self-testing (FST), accounting for 17.9%. Test-retest correlation coefficients were 0.85 (FSI) and 0.94 (FST). The correlations between STAI and FSI and FST were not statistically significant (p=0.771). The correlation coefficient between FSI and time under insulin treatment was -0.546 (p=0.023). CONCLUSIONS We developed a newrecalibrated version of the Spanish D-FISQ called the MIAT-D. The feasibility, dimensionality, construct validity and reliability of this questionnaire were accurate. The concept validity of this test should be explored in further studies.

Evaluación farmacoeconómica de olmesartán en comparación con losartán en el tratamiento de la hipertensión arterial leve a moderada en España

ResumenObjetivo: Realizar una evaluación económica (EE) de olmesartán en comparación con losartán en el tratamiento de la hipertensión arterial leve a moderada. Material y métodos: La EE utilizó los resultados de un ensayo clínico que comparó la eficacia antihipertensiva de olmesartán (10, 20 mg/día o 20 mg más hidroclorotiazida, n = 160) con la de losartán (50, 100 mg/día o 100 mg más hidroclorotiazida, n = 156), durante 24 semanas. La perspectiva fue la del Sistema Nacional de Salud español, y se computan únicamente costes médicos directos, a precios de año 2004. La EE se realizó mediante un árbol de decisión. La medición de la efectividad fue la proporción de pacientes con presión arterial (PA) controlada (PA diastólica < 90 mm Hg o con una reducción ≥ 10 mm Hg con respecto a la PAD basal). Resultados: La EE reveló que olmesartán es una opción dominante sobre losartán; la proporción de pacientes con PA controlada fue numéricamente mayor con olmesartán [70,6% (IC del 95%: 62,9%–77,5%)] que con losartán [69,2% (61,4%–76,4%), diferencias no significativas], con un coste medio por paciente significativamente menor: [285,50 € (280,96 €–290,05 €) frente a 325,90 e (320,26 €–331,69 €), respectivamente]. El coste por paciente con PA controlada fue un 14,1% inferior con olmesartán: 404,45 € (368,57 €–454,13 €), frente a 470,72 € (426,54 €–530,75 €) con losartán. Los resultados de la EE fueron robustos a los análisis de sensibilidad. Conclusión: Olmesartán es una opción dominante sobre losartán en el tratamiento de la hipertensión arterial leve y moderada en España.AbstractObjective: To perform an economic evaluation (EE) of olmesartan versus losartan for the treatment of mild to moderate hypertension. Material and methods: The EE was performed using the results of a clinical trial that compares the antihypertensive efficacy of olmesartan (10, 20 mg/day or 20 mg+hidrochlorothiazide, n =160) vs. losartan (50, 100 mg/day or 100 mg+ hidrochlorothiazide, n =156), at week 24. This analysis was made from the Spanish NHS perspective computing only direct medical costs at their 2004 prices. This EE was made using a decision tree model. The measurement of effectiveness was the proportion of patients with controlled blood pressure (BP; diastolic BP < 90 mmHg or a reduction from baseline ≥ 10 mmHg). Results: This EE showed that olmesartan is a dominant option over losartan: patients with controlled BP proportion was higher with olmesartan although not statistically significant over losartan [70,6% (95% confidence intervals: 62,9%–77,5%) vs. 69,2% (61,4%–76,4%)], with a mean cost per patient significantly lower [285,50 € (280,96 €–290,05 €) versus 325,90 € (320,26 €–331,69 €), respectively]. Cost per patient with controlled BP was 14,1% lower with olmesartan; 404,45 € (368,57 €–454,13 €) versus 470,72 € (426,54 €–530,75 €) with losartan. Results were robust through the sensitivity analyses. Conclusion: Olmesartan is a dominant option over losartan for the treatment of mild to moderate hypertension in Spain.