Incidence and costs of cardiovascular events in Spanish patients with type 2 diabetes mellitus: a comparison with general population, 2015.

INTRODUCTION: Cardiovascular (CV) disease affects a high percentage of patients with type 2 diabetes mellitus (T2DM), especially in the hospital setting, impacting on mortality, complications, quality of life and use of health resources. The aim of this study was to estimate the incidence, mean length of hospital stay (LOHS) and costs attributable to hospital admissions due to CV events in patients with T2DM versus patients without diabetes mellitus (non-DM) in Spain. RESEARCH DESIGN AND METHODS: Retrospective observational study based on the Spanish National Hospital Discharge Database for 2015. Hospital admissions for patients aged ≥35 years with a diagnosis of CV death, non-fatal acute myocardial infarction (AMI), non-fatal stroke, unstable angina, heart failure and revascularization were evaluated. The International Classification of Diseases, Ninth Revision (250.x0 or 250.x2) coding was used to classify records of patients with T2DM. For each CV complication, the hospital discharges of the two groups, T2DM and non-DM, were precisely matched and the number of hospital discharges, patients, LOHS and mean cost were quantified. Additional analyses assessed the robustness of the results. RESULTS: Of the 276 925 hospital discharges analyzed, 34.71% corresponded to patients with T2DM. A higher incidence was observed in all the CV complications studied in the T2DM population, with a relative risk exceeding 2 in all cases. The mean LOHS (days) was longer in the T2DM versus the non-DM group for: non-fatal AMI (7.63 vs 7.02, p<0.001), unstable angina (5.11 vs 4.78, p=0.009) and revascularization (7.96 vs 7.57, p<0.001). The mean cost per hospital discharge was higher in the T2DM versus the non-DM group for non-fatal AMI (€6891 vs €6876, p=0.029) and unstable angina (€3386 vs €3304, p<0.001). CONCLUSIONS: Patients with T2DM had a higher incidence and number of hospital admissions per patient due to CV events versus the non-DM population. This generates a significant clinical and economic burden given the longer admission stay and higher costs associated with some of these complications.

Cost of early-stage mycosis fungoides treatments in Spain.

AIM: To identify the most common therapeutic options for the treatment of early-stage mycosis fungoides in Spain, quantify their associated healthcare resource use and costs. METHODS: After reviewing the literature, a panel of 6 Spanish clinical dermatologists validated the treatments and healthcare resource use through a structured questionnaire. Individual responses were collected, analyzed and presented into a face-to-face meeting in order to reach a consensus. Cost categories considered were: drug acquisition and administration, photo/radiotherapy session and maintenance, clinical follow-up visits and laboratory tests. Costs were expressed in euros from 2018. The Spanish National Health System perspective was considered, taking into account direct health costs and time horizons of 1, 3 and 6 months. RESULTS: Costs for the skin-directed treatments (SDT) assessed at 1, 3 and 6 months, were: Topical carmustine [€6,593.36, €19,780.09 and €27,592.78]; Phototherapy with psoralens and ultraviolet A light (PUVA) [€1,098.68, €2,999.99 and €3,187.60]; Narrow-band ultraviolet B phototherapy [€1,657.47, €4,842.10 and €4,842.10]; Total skin electron beam therapy (TSEBT) [€6,796.45, €7,913.34 and €7,913.34]. Cost for topical corticosteroids, being considered an adjuvant option, were €17.16, €51.49 and €102.97. Costs for the assessed systemic treatments alone or in combination with SDT at 1, 3 and 6 months, were: Systemic retinoids [€2,026.03, €5,206.63 and €7,426.42]; Systemic retinoids + PUVA phototherapy [€3,066.50, €8,271.26 and €10,046.58]; Interferon alfa + PUVA phototherapy [€1,541.09, €5,167.57 and €6,404.55]. CONCLUSION: According to the Spanish clinical practice, phototherapies in monotherapy were the treatments with the lowest associated costs regardless of the time horizon considered. TSEBT turned out as the treatment with the highest associated costs when considering 1 month. However, while considering 3 and 6 months the treatment with the highest associated costs was topical carmustine. The results of this analysis may provide critical information to measure the disease burden, to detect unmet medical needs and to advocate towards better treatments for this rare disease.

Impacto sobre entorno laboral de un proyecto de gestión de enfermería en el turno de noche / A Nursing Management Project's Impact on the Work Environment during the Night Shift

Introducción: Para garantizar los cuidados 24h en instituciones hospitalarias es esencial la existencia de Equipos de Enfermería cuya actividad se desarrolle en horario nocturno. Existen factores organizativos que provocan, entre los equipos nocturnos, la percepción de menos oportunidades de desarrollo profesional y menos atención institucional. Esto puede repercutir en la calidad de los cuidados e incluso en la salud de los profesionales. Las enfermeras líderes tienen la responsabilidad de crear y mantener un entorno laboral con influencia positiva. Objetivo: Evaluar un proyecto de gestión de enfermería mediante el impacto sobre la percepción del entorno laboral en el turno de noche. Métodos: Estudio casi-experimental pre-post, con intervención sobre la población. De una población de enfermeras del turno de noche n = 268 se obtuvo muestra n = 159. Se utilizó el instrumento "Practice Environment Scale of the Nursing Work Index", que permite evaluar y comparar factores del entorno de la práctica de enfermería. Se realizaron estadísticos univariables de tendencia central y dispersión, y estadísticos de contraste con significancia p < 0,05. Resultados: En el 41,94 por ciento de las cuestiones obtuvieron diferencias significativas, destacando el Factor 3 "Habilidad, liderazgo y apoyo a las enfermeras por parte de sus responsables". El valor medio global obtenido en la prueba PRE fue de 2,37 (IC95 por ciento 2,22 2,52) y la media global para el valor POST fue 2,49 (IC95 por ciento 2,34 2,95), con p = 0,0254. Conclusiones: La evaluación de un proyecto de gestión de enfermería mediante el impacto sobre la percepción del entorno laboral en turno de noche muestra mejoras con diferencias significativas(AU)

Introduction: To guarantee 24 hours of care in hospital institutions, the existence of nursing teams is essential whose activity is carried out at night. There are organizational factors that provoke, among night teams, the perception of fewer opportunities for professional development and less institutional attention. This can have an impact on the quality of care and even on the health of professionals. Leader nurses are responsible for creating and maintaining a positively influencing work environment. Objective: To evaluate a nursing management project through the impact on the perception about the work environment on the night shift. Methods: Pre-post quasi-experimental study carried out with intervention on the population. From a population of night-shift nurses (n=268), we obtained a sample of 268. The instrument "Practice Environment Scale of the Nursing Work Index" was used, which allows evaluating and comparing factors from the nursing practice setting. Univariate statistics of central tendency and dispersion were determined, as well as contrast statistics with significance p < 0.05. Results: In 41.94 percent of the questions, significant differences were obtained, highlighting factor 3 (nurses' skill, leadership and support by their heads). The global mean value obtained in the PRE test was 2.37 (95 percent CI, 2.22-2.52) and the global mean for the POST value was 2.49 (95 percent CI, 2.34-2.95), with p=0.0254. Conclusions: A nursing management project's evaluation through the impact on the perception about the work environment in the night shift shows improvements with significant differences(AU)

Comparative economic study of the use of corifollitropin alfa and daily rFSH for controlled ovarian stimulation in older patients: Cost-minimization analysis based on the PURSUE study.

This study presents an economic assessment of controlled ovarian stimulation in assisted reproductive technology procedures in Spain, comparing the use of corifollitropin alfa and various forms of recombinant follicle-stimulating hormone (rFSH) in women of advanced maternal age. A cost-minimization analysis (CMA) was performed to assess the cost per cycle of controlled controlled ovarian stimulation, including only direct costs associated with the stimulation phase. The CMA was based on the population characteristics, the protocol, and the results obtained from the PURSUE study, taking into account 9 days of controlled controlled ovarian stimulation and 300 IU rFSH/day. The primary analysis included pharmacological costs alone. Different scenarios were evaluated including various doses and possible additional days (0-5) for rFSH. For the alternative analyses, the total costs (direct pharmacological costs, costs of visits and follow-up tests, and any additional pharmacological costs) were considered in both the private and public sectors. Treatment with corifollitropin alfa resulted in a lower pharmacological cost compared with rFSH (€757.25 and €950.30, respectively), creating a saving of approximately -20%. The results of the scenario analyses showed that corifollitropin alfa reduced the pharmacological cost of controlled ovarian stimulation in comparison with daily administration of doses ≥ 250 IU rFSH (considering same daily dose for all days), regardless of the additional days required (7-12 days) (average -€223; range -€488 to -€44). In conclusion, in addition to the efficacy shown in the PURSUE study, the use of corifollitropin alfa results in a decrease in the direct costs associated with controlled ovarian stimulation in older women in Spain.

Cost-effectiveness analysis in the Spanish setting of the PEAK trial of panitumumab plus mFOLFOX6 compared with bevacizumab plus mFOLFOX6 for first-line treatment of patients with wild-type RAS metastatic colorectal cancer.

OBJECTIVE: To assess the cost-effectiveness of panitumumab in combination with mFOLFOX6 (oxaliplatin, 5-fluorouracil, and leucovorin) vs bevacizumab in combination with mFOLFOX6 as first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC) in Spain. METHODS: A semi-Markov model was developed including the following health states: Progression free; Progressive disease: Treat with best supportive care; Progressive disease: Treat with subsequent active therapy; Attempted resection of metastases; Disease free after metastases resection; Progressive disease: after resection and relapse; and Death. Parametric survival analyses of patient-level progression free survival and overall survival data from the PEAK Phase II clinical trial were used to estimate health state transitions. Additional data from the PEAK trial were considered for the dose and duration of therapy, the use of subsequent therapy, the occurrence of adverse events, and the incidence and probability of time to metastasis resection. Utility weightings were calculated from patient-level data from panitumumab trials evaluating first-, second-, and third-line treatments. The study was performed from the Spanish National Health System (NHS) perspective including only direct costs. A life-time horizon was applied. Probabilistic sensitivity analyses and scenario sensitivity analyses were performed to assess the robustness of the model. RESULTS: Based on the PEAK trial, which demonstrated greater efficacy of panitumumab vs bevacizumab, both in combination with mFOLFOX6 first-line in wild-type RAS mCRC patients, the estimated incremental cost per life-year gained was €16,567 and the estimated incremental cost per quality-adjusted life year gained was €22,794. The sensitivity analyses showed the model was robust to alternative parameters and assumptions. LIMITATIONS: The analysis was based on a simulation model and, therefore, the results should be interpreted cautiously. CONCLUSIONS: Based on the PEAK Phase II clinical trial and taking into account Spanish costs, the results of the analysis showed that first-line treatment of mCRC with panitumumab + mFOLFOX6 could be considered a cost-effective option compared with bevacizumab + mFOLFOX6 for the Spanish NHS.

Costes directos de la diabetes mellitus y de sus complicaciones en España (Estudio SECCAID: Spain estimated cost Ciberdem-Cabimer in Diabetes) / Direct cost of diabetes mellitus and its complications in Spain (SECCAID Study: Spain estimated cost Ciberdem-Cabimer in Diabetes)

OBJETIVO: Estimar los costes directos generados por la diabetes mellitus (DM), tanto tipo 1 como tipo 2, desde la perspectiva del Sistema Nacional de Salud. MATERIAL Y MÉTODO: Estudio del coste de la enfermedad mediante un enfoque de prevalencia, a través del análisis y la revisión de las bases de datos y de la literatura relacionada con el uso de recursos en la DM. Las categorías de costes directos anuales considerados fueron: hospitalarios (incluyendo la atención ambulatoria), atención primaria (incluyendo pruebas complementarias y tiras reactivas de automonitorización de glucemia capilar) y, fármacos. Para los costes no relacionados, solo se incorporó el sobrecoste. Adicionalmente, se analizó el coste de las complicaciones independientemente de la categoría de costes donde se hubieran originado. Todos los costes fueron actualizados a euros de 2012. RESULTADOS: El coste directo total anual de la DM ascendió a 5.809 millones de euros, que representó el 8,2% del gasto sanitario total. Los costes farmacológicos fueron la categoría con mayor peso sobre el coste directo total (38%), seguido por los costes hospitalarios (33%). El coste farmacológico fue de 2.232 millones de euros, donde los fármacos antidiabéticos aportaron 861 millones de euros (15%). Las tiras reactivas de automonitorización de glucemia capilar contribuyeron en 118 millones de euros (2%). El coste total de complicaciones en general fue de 2.143 millones de euros. CONCLUSIONES: Los costes de la DM representan una proporción muy elevada del total del gasto sanitario español, siendo imprescindible introducir estrategias y medidas para mejorar la eficiencia en el control y el tratamiento de la DM para reducir así sus complicaciones y los enormes costes humanos y económicos asociados a la enfermedad

OBJECTIVE: The aim of the study was to estimate the direct costs associated with type 1 and 2 diabetes mellitus in Spain taking into account a National Health Service perspective. METHOD: A costs of illness study was conducted using the prevalence approach and data from existing databases and bibliographic references related to the use of resources in the treatment of diabetes mellitus. The costs categories analysed were: hospital costs (including outpatient care), primary care costs (including additional tests cost and self monitoring blood glucose strips cost) and drug costs. In calculating the non-related cost, only the extra cost was taken into account. Additionally, we analysed the complications cost independently of where costs were originated. Costs were updated to 2012 euros. RESULTS: The total direct annual cost of diabetes mellitus was 5,809 million euros, representing 8.2% of the total Spanish health expenditure. Drug costs was the major component of total cost (38%), followed by hospital costs (33%). Drug costs accounted for 2,232 million euros, with antidiabetic drugs costs being 861 million euros (15%). Self monitoring blood glucose strips only contributed 118 million euros (2%) to the total cost. The cost of complications cost was 2,143 million euros, around 37% of the total. CONCLUSIONS: Total direct costs associated with diabetes mellitus represent a high proportion of total Spanish health expenditure. It is crucial to introduce measures and strategies to improve efficiency in the control and treatment of diabetes mellitus, with the final purpose of reducing its complications and the considerable economic impact generated