Nurses' preferences regarding MenACWY conjugate vaccines attributes: a discrete choice experiment in Spain.

OBJECTIVES: Immunisation against preventable diseases as meningitis is crucial from a public health perspective to face challenges posed by these infections. Nurses hold a great responsibility for these programs, which highlights the importance of understanding their preferences and needs to improve the success of campaigns. This study aimed to investigate nurses' preferences regarding Meningococcus A, C, W, and Y (MenACWY) conjugate vaccines commercialised in Spain. STUDY DESIGN: A national-level discrete choice experiment (DCE) was conducted. METHODS: A literature review and a focus group informed the DCE design. Six attributes were included: pharmaceutical form, coadministration evidence, shelf-life, package contents, single-doses per package, and package volume. Conditional logit models quantified preferences and relative importance (RI). RESULTS: Thirty experienced primary care nurses participated in this study. Evidence of coadministration with other vaccines was the most important attribute (RI = 43.78%), followed by package size (RI = 22.17%), pharmaceutical form (RI = 19.07%), and package content (RI = 11.80%). There was a preference for evidence of coadministration with routine vaccines (odds ratio [OR] = 2.579, 95% confidence interval [95%CI] = 2.210-3.002), smaller volumes (OR = 1.494, 95%CI = 1.264-1.767), liquid formulations (OR = 1.283, 95%CI = 1.108-1.486) and package contents including only vial/s (OR = 1.283, 95%CI = 1.108-1.486). No statistical evidence was found for the remaining attributes. CONCLUSIONS: Evidence of coadministration with routine vaccines, easy-to-store packages, and fully liquid formulations were drivers of nurses' preferences regarding MenACWY conjugate vaccines. These findings provide valuable insights for decision-makers to optimize current campaigns.

Cost-Analysis of Subcutaneous vs Intravenous Administration of Natalizumab Based on Patient Care Pathway in Multiple Sclerosis in Spain.

INTRODUCTION: A subcutaneous (SC) formulation of natalizumab has been recently authorised for multiple sclerosis patients. This study aimed to assess the implications of the new SC formulation, and to compare the annual treatment costs of SC versus intravenous (IV) natalizumab therapy from both the Spanish healthcare system (direct health cost) and the patient (indirect cost) perspectives. METHODS: A patient care pathway map and a cost-minimisation analysis were developed to estimate SC and IV natalizumab annual costs over a 2-year time horizon. Considering the patient care pathway and according to natalizumab experience (IV) or estimation (SC), a national expert panel involving neurologists, pharmacists, and nurses provided information/data regarding resource consumption for drug and patient preparation, administration, and documentation. One hour of observation was applied to the first six (SC) or 12 (IV) doses, and 5 min for successive doses. The Day hospital (infusion suite) facilities at a reference hospital were considered for IV administrations and the first six SC injections. For successive SC injections, either a reference hospital or regional hospital in a consulting room was considered. Productivity time associated with travel (56 min to reference hospital, 24 min to regional hospital) and waiting time pre- and post-treatment (SC 15 min, IV 25 min) were assessed for patients and caregivers (accompanying 20% of SC and 35% of IV administrations). National salaries for healthcare professionals were used for cost estimation (€, year 2021). RESULTS: At years 1 and 2, total time and cost savings (excluding drug acquisition cost) per patient, driven by saving on administration and patient and caregiver productivity for SC at a reference hospital versus IV at a reference hospital, were 116 h (a reduction of 54.6%) and €3682.82 (a reduction of 66.2%). In the case of natalizumab SC at a regional hospital, the total time and cost saving were 129 h (a reduction of 60.6%) and €3883.47 (a reduction of 69.8%). CONCLUSIONS: Besides the potential benefits of convenient administration and improving work-life balance, as suggested by the expert panel, natalizumab SC was associated with cost savings for the healthcare system by avoiding drug preparation, reducing administration time, and freeing up infusion suite capacity. Additional cost savings could be derived with regional hospital administration of natalizumab SC by reducing productivity loss.

Surgical management of complex perianal fistula revisited in a systematic review: a critical view of available scientific evidence.

BACKGROUND: Treating complex perianal fistulas in Crohn's disease patients remains a challenge. Classical surgical treatments for Crohn's disease fistulas have been extrapolated from cryptoglandular fistulas treatment, which have different etiology, and this might interfere with its effectiveness, in addition, they increase fecal incontinence risk. Recently, new surgical techniques with support from biological approaches, like stem cells, have been developed to preserve the function of the sphincter. We have performed a systematic literature review to compare the results of these different techniques in the treatment of Crohn's or Cryptoglandular fistula. METHODS: PubMed, EMBASE, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials were searched systematically for relevant articles. We included randomized controlled trials and observational studies that referred to humans, were written in English, included adults 18+ years old, and were published during the 10-year period from 2/01/2010 to 2/29/2020. Evidence level was assigned as designated by the Scottish Intercollegiate Guidelines Network. RESULTS: Of the 577 citations screened, a total of 79 were ultimately included in our review. In Crohn's disease patients, classical techniques such as primarily seton, Ligation of Intersphincteric Fistula Tracks, or lay open, healing rates were approximately 50-60%, while in cryptoglandular fistula were around, 70-80% for setons or flaps. In Crohn's disease patients, new surgical techniques using derivatives of adipose tissue reported healing rates exceeding 70%, stem cells-treated patients achieved higher combined remission versus controls (56.3% vs 38.6%, p = 0.010), mesenchymal cells reported a healing rate of 80% at week 12. In patients with cryptoglandular fistulas, a healing rate of 70% using derivatives of adipose tissue or platelets was achieved, and a healing rate of 80% was achieved using laser technology. Fecal incontinence was improved after the use of autologous platelet growth factors and Nitinol Clips. CONCLUSION: New surgical techniques showed better healing rates in Crohn's disease patients than classical techniques, which have better results in cryptoglandular fistula than in Crohn's disease. Healing rates for complex cryptoglandular fistulas were similar between the classic and new techniques, being the new techniques less invasive; the incontinence rate improved with the current techniques.

Estudio WAKE de vida real en pacientes con narcolepsia con cataplejía tratados con pitolisant no respondedores a tratamientos previos / Real-life WAKE study in narcolepsy patients with cataplexy treated with pitolisant and unresponsive to previous treatments

Introducción: La narcolepsia de tipo 1 es una enfermedad incapacitante que requiere tratamiento continuo, que no siempre es eficaz. El pitolisant es un nuevo fármaco con un mecanismo de acción diferente que ofrece una nueva opción de tratamiento. El objetivo del estudio fue analizar la efectividad y la seguridad del pitolisant en pacientes con narcolepsia de tipo 1 que no hubieran respondido o tolerado previamente los tratamientos habituales. Pacientes y métodos: Estudio observacional descriptivo multicéntrico de vida real que incluyó a pacientes diagnosticados de narcolepsia de tipo 1 no respondedores a tratamientos previos que iniciaron tratamiento con pitolisant. El estudio evaluó tres momentos: el inicio del tratamiento, la estabilización del tratamiento con pitolisant y los tres meses posteriores. Resultados: En 32 pacientes incluidos (media de edad, 44 años; 37,5% de mujeres), la media de la escala de somnolencia de Epworth se redujo de 17,1 a 13,5; un 47,8% de los pacientes mejoró subjetivamente de su cataplejía; un 65% de los pacientes mejoró su impresión clínica global a criterio médico y a criterio del paciente; y se redujo la media de medicamentos consumidos de 2,0 a 1,4. El efecto adverso más frecuente fue el insomnio, en un 43,8% de los pacientes. De los 32 pacientes, 23 mantuvieron el tratamiento durante los tres meses de seguimiento. Conclusiones: En pacientes con narcolepsia de tipo 1 que no responden a o no toleran los tratamientos disponibles, el pitolisant puede mejorar su situación clínica y reducir su consumo de medicamentos. Son necesarios estudios de mayor nivel de evidencia para confirmar estos resultados.(AU)

INTRODUCTION: Type 1 narcolepsy is a disabling disease that requires continuous treatment, which is not always effective. Pitolisant is a new drug with a different mechanism of action that offers a new treatment option. The objective of the study was to analyse the effectiveness and safety of pitolisant in patients with type 1 narcolepsy that did not respond to or tolerate previous standard treatments. PATIENTS AND METHODS: Real-life multicentre descriptive observational study that included patients diagnosed with type 1 narcolepsy who did not respond to or tolerate previous treatments and started treatment with pitolisant. The study evaluated three different moments: the start of treatment, the stabilization of treatment with pitolisant and the three months after. RESULTS: In 32 patients included (mean age, 44 years; 37.5% women) the mean of the Epworth Sleepiness Scale was reduced from 17.1 to 13.5; 47.8% of the patients improved from their cataplexy; 65% of the patients improved their clinical global impression at the physician’s and at the patient’s discretion and the mean number of medications consumed was reduced from 2.0 to 1.4. The most frequent adverse effect was insomnia in 43.8% of patients. Of the 32 patients, 23 continued with the treatment during the 3-month follow-up period. CONCLUSIONS: In patients with type I narcolepsy who do not respond to or do not tolerate the available treatments, pitolisant can improve their clinical situation and reduce their medication consumption. Studies with a higher level of evidence are needed to confirm these results.(AU)

[Real-life WAKE study in narcolepsy patients with cataplexy treated with pitolisant and unresponsive to previous treatments]. / Estudio WAKE de vida real en pacientes con narcolepsia con cataplejía tratados con pitolisant no respondedores a tratamientos previos.

INTRODUCTION: Type 1 narcolepsy is a disabling disease that requires continuous treatment, which is not always effective. Pitolisant is a new drug with a different mechanism of action that offers a new treatment option. The objective of the study was to analyse the effectiveness and safety of pitolisant in patients with type 1 narcolepsy that did not respond to or tolerate previous standard treatments. PATIENTS AND METHODS: Real-life multicentre descriptive observational study that included patients diagnosed with type 1 narcolepsy who did not respond to or tolerate previous treatments and started treatment with pitolisant. The study evaluated three different moments: the start of treatment, the stabilization of treatment with pitolisant and the three months after. RESULTS: In 32 patients included (mean age, 44 years; 37.5% women) the mean of the Epworth Sleepiness Scale was reduced from 17.1 to 13.5; 47.8% of the patients improved from their cataplexy; 65% of the patients improved their clinical global impression at the physician's and at the patient's discretion and the mean number of medications consumed was reduced from 2.0 to 1.4. The most frequent adverse effect was insomnia in 43.8% of patients. Of the 32 patients, 23 continued with the treatment during the 3-month follow-up period. CONCLUSIONS: In patients with type I narcolepsy who do not respond to or do not tolerate the available treatments, pitolisant can improve their clinical situation and reduce their medication consumption. Studies with a higher level of evidence are needed to confirm these results.

TITLE: Estudio WAKE de vida real en pacientes con narcolepsia con cataplejía tratados con pitolisant no respondedores a tratamientos previos.Introducción. La narcolepsia de tipo 1 es una enfermedad incapacitante que requiere tratamiento continuo, que no siempre es eficaz. El pitolisant es un nuevo fármaco con un mecanismo de acción diferente que ofrece una nueva opción de tratamiento. El objetivo del estudio fue analizar la efectividad y la seguridad del pitolisant en pacientes con narcolepsia de tipo 1 que no hubieran respondido o tolerado previamente los tratamientos habituales. Pacientes y métodos. Estudio observacional descriptivo multicéntrico de vida real que incluyó a pacientes diagnosticados de narcolepsia de tipo 1 no respondedores a tratamientos previos que iniciaron tratamiento con pitolisant. El estudio evaluó tres momentos: el inicio del tratamiento, la estabilización del tratamiento con pitolisant y los tres meses posteriores. Resultados. En 32 pacientes incluidos (media de edad, 44 años; 37,5% de mujeres), la media de la escala de somnolencia de Epworth se redujo de 17,1 a 13,5; un 47,8% de los pacientes mejoró subjetivamente de su cataplejía; un 65% de los pacientes mejoró su impresión clínica global a criterio médico y a criterio del paciente; y se redujo la media de medicamentos consumidos de 2,0 a 1,4. El efecto adverso más frecuente fue el insomnio, en un 43,8% de los pacientes. De los 32 pacientes, 23 mantuvieron el tratamiento durante los tres meses de seguimiento. Conclusiones. En pacientes con narcolepsia de tipo 1 que no responden a o no toleran los tratamientos disponibles, el pitolisant puede mejorar su situación clínica y reducir su consumo de medicamentos. Son necesarios estudios de mayor nivel de evidencia para confirmar estos resultados.

Optimal treatment sequencing of abiraterone acetate plus prednisone and enzalutamide in patients with castration-resistant metastatic prostate cancer: A systematic review and meta-analysis.

PURPOSE: To evaluate the impact of the hormonal treatment sequencing including abiraterone acetate plus prednisone (AAP) and enzalutamide (ENZ) in mCRPC, and determine which sequence provides more benefits for patients. METHODS: Studies published in English between 1 January 2013 and 30 September 2017 were identified in PubMed and EMBASE electronic databases. Studies assessing the efficacy of treatment sequences, based on AAP and ENZ, in mCRPC patients, were eligible for analysis. RESULTS: Seventeen studies met the inclusion criteria. Two assessed both treatment sequences AAP â†’ ENZ and ENZ â†’ AAP; it was found that sequence of AAP â†’ ENZ showed a statistically significantly longer PSA-PFS than the observed in ENZ â†’ AAP (pooled HR: 0,54; 95% CI; 0,36-0,82; p < 0,05). The nine studies analysing Doc â†’ AAP â†’ ENZ sequence, revealed favourable results in terms of PFS. The 5 studies which analysed AAP â†’ ENZ sequence, show a decrease in PSA levels ≥ 50% in 11-41% of patients treated with enzalutamide after previous treatment with AAP. In the two studies that analysed the Doc â†’ ENZ â†’ AAP sequence, PSA response rates were much lower than those reported with Doc â†’ AAP â†’ ENZ, with decreases in PSA ≥ 30 of 3-18% and PSA ≥ 50 of 8-11%. CONCLUSION: Significant clinical efficacy of AAP administered as the first-line treatment in mCRPC patients followed by enzalutamide, delaying disease progression, compared with the ENZ â†’ AAP sequence. However, more studies and randomized trials are needed, to validate the best treatment sequencing.

Desarrollo y validación preliminar del instrumento HSQoL-24 para evaluar calidad de vida en pacientes con hidradenitis supurativa / Development and Preliminary Validation of the HSQoL-24 Tool to Assess Quality of Life in Patients With Hidradenitis Suppurativa

Introducción y objetivos: La hidradenitis supurativa (HS) es una enfermedad inflamatoria crónica de la piel que influencia negativamente la calidad de vida. En la actualidad no existen escalas en español que la evalúen. El objetivo del presente estudio fue desarrollar y validar un cuestionario específico para evaluar la calidad de vida en pacientes con HS. Material y métodos: Se desarrolló un estudio multicéntrico en España entre 2016 y 2017 para elaborar un cuestionario. Para ello se consideró tanto el marco conceptual como el conocimiento de la situación del paciente mediante la revisión de la bibliografía, reuniones de profesionales de diferentes áreas y entrevistas con pacientes. El cuestionario resultante se pasó a un grupo de 30 pacientes con 30 ± 10 días de intervalo entre uno y otro. Resultados: El análisis de fiabilidad muestra una buena consistencia interna y reproductibilidad con puntuación alfa de Cronbach de 0,920 (test) y 0,917 (retest) y coeficiente de correlación intraclase con DLQI y Skindex-29 de 0,698 IC 95% (0,456-0,844) y 0,900 IC 95% (0,801-0,951) respectivamente. Se establecieron puntos de corte para su uso y se comprobó que el instrumento es sensible al cambio. Conclusiones: El cuestionario HSQoL-24 es la primera prueba autoadministrada específica para evaluar la calidad de vida en HS en español. Sencillo de usar y puntuar por los profesionales. Este estudio demuestra que el instrumento es fiable, válido y sensible al cambio, pendiente de realizar estudio confirmatorio con una muestra mayor con 100 pacientes con HS

Introduction and objectives: Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the skin with a negative impact on quality of life. Up to now, there are no disease specific instruments in Spanish to assess quality of life in HS. The objective of this study was to develop and validate a questionnaire to evaluate the quality of life in patients with HS. Material and methods: A multicentre study was carried out in Spain between 2016 and 2017 to develop the questionnaire. Both the conceptual framework and understanding of the patient's situation were considered through a review of the literature, consensus of professionals from different related health areas, and in-depth interviews with patients. The resulting questionnaire was passed to a group of 30 patients with 30±10 days of interval between both assessments. Results: The reliability analysis shows a good internal consistency and reproducibility with Cronbach's alpha score of 0.920 (test) and 0.917 (retest) and intraclass correlation coefficient with DLQI and Skindex-29 of 0.698 IC 95% (0.456-0.844) and 0.900 IC 95% (0.801-0.951) respectively. Cut-off points were established for its use and the instrument was found to be sensitive to change. Conclusions: The HSQoL-24 is the first disease-specific self-administered instrument to assess quality of life in patients with HS in Spanish. It is user friendly, and easy to score. This study shows that the instrument is reliable, valid and sensitive to change, pending confirmatory study with a larger sample of 100 patients with HS

Development and Preliminary Validation of the HSQoL-24 Tool to Assess Quality of Life in Patients With Hidradenitis Suppurativa. / Desarrollo y validación preliminar del instrumento HSQoL-24 para evaluar calidad de vida en pacientes con hidradenitis supurativa.

INTRODUCTION AND OBJECTIVES: Hidradenitis suppurativa (HS) is a chronic inflammatory disease of the skin with a negative impact on quality of life. Up to now, there are no disease specific instruments in Spanish to assess quality of life in HS. The objective of this study was to develop and validate a questionnaire to evaluate the quality of life in patients with HS. MATERIAL AND METHODS: A multicentre study was carried out in Spain between 2016 and 2017 to develop the questionnaire. Both the conceptual framework and understanding of the patient's situation were considered through a review of the literature, consensus of professionals from different related health areas, and in-depth interviews with patients. The resulting questionnaire was passed to a group of 30 patients with 30±10 days of interval between both assessments. RESULTS: The reliability analysis shows a good internal consistency and reproducibility with Cronbach's alpha score of 0.920 (test) and 0.917 (retest) and intraclass correlation coefficient with DLQI and Skindex-29 of 0.698 IC 95% (0.456-0.844) and 0.900 IC 95% (0.801-0.951) respectively. Cut-off points were established for its use and the instrument was found to be sensitive to change. CONCLUSIONS: The HSQoL-24 is the first disease-specific self-administered instrument to assess quality of life in patients with HS in Spanish. It is user friendly, and easy to score. This study shows that the instrument is reliable, valid and sensitive to change, pending confirmatory study with a larger sample of 100 patients with HS.

Plano de almohadas: valoración de su efectividad como sistema preventivo de las úlceras por presión en pacientes con lesión medular / The flat pillow: evaluation of its effectiveness in preventing pressure ulcers in patients with a spinal cord injury

Introducción. Este estudio analiza las diferencias de presión en la interfaz (manta de presiones) en las posiciones de decúbito supino y decúbito lateral sobre 2 planos de apoyo: una cama de hospital estándar y un plano de almohadas. Material y métodos. La presión de la interfaz se registró en 27 pacientes con lesión medular (22 hombres y 5 mujeres). Resultados. Se demuestran disminuciones significativas (p < 0,001) de las presiones máximas, presiones medias y superficies de contacto con riesgo de úlceras por presión (más de 32 mmHg) de las zonas de apoyo con el plano de almohadas para las posturas en decúbito supino. En decúbito lateral, estas diferencias son más pequeñas (p < 0,005). Conclusiones. El plano de almohadas se presenta como un medio alternativo y de bajo costo en la prevención de las úlceras por presión (AU)

Introduction. This study examines differences in interface pressure (rug pressure) in supine and lateral decubitus positions at two levels of support: standard hospital bed and flat pillow. Material and methods. Interface pressure was recorded in 27 patients with a spinal cord injury (22 men and 5 women). Results. Significant decreases (P<.001) were found in peak pressures, average pressures, and contact surfaces with a risk of producing pressure ulcer (more than 32 mmHg) in areas of flat pillow support for supine positions. These differences were smaller (P<.005) in lateral decubitus. Conclusions. The flat pillow is an inexpensive alternative in the prevention of pressure ulcers (AU)

[Adalimumab versus etanercept in the treatment of active rheumatoid arthritis: cost-effectiveness analysis]. / Adalimumab versus etanercept en el tratamiento de la artritis reumatoide: análisis coste-efectividad.

PURPOSE: To assess the effectiveness and efficiency of the two alternatives mainly used in our area, etanercept (ETN) and adalimumab (ADA), for the treatment of rheumatoid arthritis (RA) patients under real clinical practice. MATERIAL AND METHODS: We performed a retrospective observational study, where the time horizon was 12 months referred to the year 2012. We analyzed the characteristics of patients, and the effectiveness and efficiency of ETN and ADA in our study population. INCLUSION CRITERIA: patients over 18 years, diagnosed with RA treated at the outpatient clinic of the Rheumatology Health Sector of Teruel. We determined the mean decrease in DAS28 value (DAS28r) of each drug and we defined as a unit of effectiveness in pharmacoeconomic study, a DAS28 value at baseline (DAS28a) less than 3.2 points and DAS28r greater than 1.2 points. As parameter to determine the cost-effectiveness of both alternatives we used net health benefits (NHB). RESULTS: The average value of DAS28a was 2,25 and 2,72 points for ETN and ADA respectively, with a value of DAS28r 1,01 points higher for ETN, although not statistically significant (p> 0.05). NHB obtained a value of -0.121, 95% CI (-0.951 to 0.709). CONCLUSIONS: Both alternatives are effective in the treatment of RA, although it seems to be a trend in favor of ETN in cost-effectiveness degree.

Objetivo: Valorar el grado de efectividad y eficiencia de las dos alternativas principalmente utilizadas en nuestro ámbito, etanercept (ETN) y adalimumab (ADA), para el tratamiento de pacientes diagnosticados de artritis reumatoide (AR) en condiciones reales de la práctica clínica diaria. Material y método: Se realizó un estudio observacional retrospectivo, cuyo horizonte temporal fue de 12 meses referidos al año 2012, en el que se analizaron las características de los pacientes, así como la efectividad y eficiencia de ETN y ADA en la población de estudio. Se estudiaron todos los pacientes de ambos sexos mayores de 18 años, diagnosticados de AR, atendidos en las consultas externas del Servicio de Reumatología del Sector Sanitario de Teruel. Se determinó el descenso medio del valor de DAS28 (DAS28r) de cada fármaco y se definió como unidad de efectividad en el estudio farmacoeconómico un valor DAS28 al inicio (DAS28a) inferior a 3,2 puntos y DAS28r mayor a 1,2 puntos. Como parámetro del estudio para determinar el coste-efectividad de ambas alternativas se utilizó el beneficio neto sanitario (BNS). Resultados: El valor medio de DAS28a fue 2,25 y 2,72 puntos para ETN y ADA respectivamente, con un valor DAS28r de 1,01 puntos superior para ETN, aunque sin ser estadísticamente significativo (p > 0,05). El cálculo del parámetro BNS obtuvo un valor igual a -0,121; IC95% (-0,951 a 0,709), sin embargo la inclusión del valor 0 en el intervalo de confianza hizo que no se observaran diferencias de coste-efectividad. Conclusiones: Ambas alternativas son efectivas en el tratamiento de la AR, aunque parece existir una tendencia a favor de ETN en el grado coste-efectividad sin ser significativa.

Adalimumab versus etanercept en el tratamiento de la artritis reumatoide: análisis coste-efectividad / Adalimumab versus etanercept in the treatment of active rheumatoid arthritis: cost-effectiveness analysis

Objetivo: Valorar el grado de efectividad y eficiencia de las dos alternativas principalmente utilizadas en nuestro ámbito, etanercept (ETN) y adalimumab (ADA), para el tratamiento de pacientes diagnosticados de artritis reumatoide (AR) en condiciones reales de la práctica clínica diaria. Material y método: Se realizó un estudio observacional retrospectivo, cuyo horizonte temporal fue de 12 meses referidos al año 2012, en el que se analizaron las características de los pacientes, así como la efectividad y eficiencia de ETN y ADA en la población de estudio. Se estudiaron todos los pacientes de ambos sexos mayores de 18 años, diagnosticados de AR, atendidos en las consultas externas del Servicio de Reumatología del Sector Sanitario de Teruel. Se determinó el descenso medio del valor de DAS28 (DAS28r) de cada fármaco y se definió como unidad de efectividad en el estudio farmacoeconómico un valor DAS28 al inicio (DAS28a) inferior a 3,2 puntos y DAS28r mayor a 1,2 puntos. Como parámetro del estudio para determinar el coste-efectividad de ambas alternativas se utilizó el beneficio neto sanitario (BNS). Resultados: El valor medio de DAS28a fue 2,25 y 2,72 puntos para ETN y ADA respectivamente, con un valor DAS28r de 1,01 puntos superior para ETN, aunque sin ser estadísticamente significativo (p > 0,05). El cálculo del parámetro BNS obtuvo un valor igual a -0,121; IC95% (-0,951 a 0,709), sin embargo la inclusión del valor 0 en el intervalo de confianza hizo que no se observaran diferencias de coste-efectividad. Conclusiones: Ambas alternativas son efectivas en el tratamiento de la AR, aunque parece existir una tendencia a favor de ETN en el grado coste-efectividad sin ser significativa (AU)

Purpose: To assess the effectiveness and efficiency of the two alternatives mainly used in our area, etanercept (ETN) and adalimumab (ADA), for the treatment of rheumatoid arthritis (RA) patients under real clinical practice. Material and methods: We performed a retrospective observational study, where the time horizon was 12 months referred to the year 2012. We analyzed the characteristics of patients, and the effectiveness and efficiency of ETN and ADA in our study population. Inclusion criteria: patients over 18 years, diagnosed with RA treated at the outpatient clinic of the Rheumatology Health Sector of Teruel. We determined the mean decrease in DAS28 value (DAS28r) of each drug and we defined as a unit of effectiveness in pharmacoeconomic study, a DAS28 value at baseline (DAS28a) less than 3.2 points and DAS28r greater than 1.2 points. As parameter to determine the cost-effectiveness of both alternatives we used net health benefits (NHB). Results: The average value of DAS28a was 2,25 and 2,72 points for ETN and ADA respectively, with a value of DAS28r 1,01 points higher for ETN, although not statistically significant (p> 0.05). NHB obtained a value of -0.121, 95% CI (-0.951 to 0.709). Conclusions: Both alternatives are effective in the treatment of RA, although it seems to be a trend in favor of ETN in cost-effectiveness degree (AU)

[Analisis of the budget impact of adalimumab and etanercept in rheumatoid arthritis and spondyloarthropathies]. / Análisis del impacto presupuestario de adalimumab y etanercept en artritis reumatoide y espondiloartropatías.

PURPOSE: To assess the economic impact derived from the widening of the administration intervals of adalimumab (ADA) and etanercept (ETN) for the treatment of rheumatoid arthritis (RA) and spondyloarthropathies (SAP) at our working environment. MATERIAL AND METHODS: A budget impact model (BIM) was developed to estimate the economic impact that would have widening the usual administration intervals of ADA, 40 mg every 2 weeks and ETN, 50 mg weekly (scenario A), to ADA, 40 mg every 3 weeks, and ETN, 50 mg every 2 weeks (scenario B) according to the guidelines and recommendations applied to these studies, specifying the target population, the study perspective, the temporal horizon, and analysing the study robustness by a threshold univariate sensitivity analysis. RESULTS: 71 patients were included in the study. The application of the BIM showed yearly savings for ADA and ETN of 19.784 ??and 38.271 ?, respectively. The net cost, that is to say the saving that this would imply within the temporal horizon considered (2 years), was 116.110 ?. The sensitivity analysis showed that the estimated BIM for the study period was very robust since the net result in the different scenarios varied very little, being negative in the new scenarios. CONCLUSIONS: widening the administration intervals of ADA and ETN to every 3 weeks and 2 weeks respectively, would be a strategy that would allow generating savings in the hospital budget close to 116.110 ??for the temporal horizon considered, achieving this way optimization of the treatment with these two drugs.

Objetivo: Evaluar el impacto económico derivado de la ampliación de los intervalos de administración de adalimumab (ADA) y etanercept (ETN), en el tratamiento de la artritis reumatoide (AR) y espondiloartropatias (EAP) en nuestro ámbito de trabajo. Material y método: Se desarrolló un modelo de impacto presupuestario (MIP) para estimar la repercusión económica que tendría la ampliación en los intervalos habituales de administración de ADA 40 mg cada dos semanas y ETN 50 mg semanal (escenario A), por ADA 40 mg cada tres semanas y ETN 50 mg cada dos semanas (escenario B) de acuerdo a las guías y recomendaciones que se aplican a estos estudios, especificando la población diana, la perspectiva del estudio, el horizonte temporal y analizando la robustez del estudio a través de un análisis de sensibilidad univariante de tipo umbral. Resultados: Se incluyeron un total de 71 pacientes en el estudio. La aplicación del MIP mostró unos ahorros anuales para ADA y ETN de 19.784??y 38.271 ??respectivamente. El coste neto, es decir, el ahorro que esto supuso en el horizonte temporal considerado (dos años) ascendió a 116.110 ?. El análisis de sensibilidad realizado mostró que el MIP estimado para el periodo de estudio fue muy robusto ya que el resultado neto en diferentes escenarios apenas variaba, manteniéndose negativo en los nuevos escenarios. Conclusiones: La ampliación de los intervalos de administración de ADA y ETN cada tres semanas y dos semanas respectivamente, sería una estrategia que permitiría generar ahorros en el presupuesto hospitalario cercanos a los 116.110 ??en el horizonte temporal considerado, consiguiendo así una optimización del tratamiento con estos fármacos.

[Efficiency of oncologic treatments for solid tumours in Spain]. / Eficiencia de tratamientos oncológicos para tumores sólidos en España.

OBJECTIVE: To provide estimates of the efficiency for chemotherapy strategies used in Spain. METHODS: Published reports of the phase-III clinical trials for chemotherapies used for the most prevalent solid tumours in Spain were retrieved. The incremental cost-effectiveness ratio (ICER) was calculated for each strategy compared to the control group in the clinical trial, with the National Health System perspective. The total cost (?, 2012) including only drug cost (exfactory price) was estimated based on the total units of each drug required for administration (no vial wastage), with the dosification and number of cycles specified in the publication for each treatment arm. Effectiveness was measured as month of overall survival (OS) and/or month of progression free survival (PFS). RESULTS: A total of 40 chemotherapies for 13 different advanced or metastatic tumours were assessed. OS ranged from 5.3 to 33.3 months for the 34 therapies that included the information with hazard ratios (HR) values from 0.49 to 1.15 when compared with its control group. PFS ranged, from 39 therapies with these data, between 1.5 to 12.4 months, with HR from 0.33 to 1.52. ICERs were between ?2,142.57 and ?60,996.37 per each OS month gained, and from ?2,102.54 to ?661,845.27 per PFS month gained. CONCLUSION: The variety and heterogenicity of survival and ICERs results, suggest disparity of criteria in the price and reimbursement process of drugs in Spain. The continuous advances in oncology seem to require economic revaluations of drugs.

Objetivo: Proporcionar estimadores de la eficiencia de esquemas oncológicos empleados en España. Métodos: Se seleccionaron las publicaciones de ensayos clínicos en fase III usados para indicación de las terapias oncológicas de alto impacto empleadas para tratamiento de tumores sólidos en estadíos III-IV. Para cada esquema se calculó la relación costeeficacia incremental (RCEI) respecto al comparador del ensayo, con la perspectiva del Sistema Nacional de Salud. El coste (?, 2012) farmacológico, en PVL, de cada esquema y comparador se estimó con las unidades de medicamento requeridas en cada administración (aprovechamiento máximo de viales) considerando la posología y el número de ciclos especificado en el ensayo para cada una de las ramas. La efectividad se expresó en meses de supervivencia global (SG) y/o supervivencia libre de progresión (SLP). Resultados: Se analizaron 40 esquemas oncológicos para trece tumores metastásicos. La SG osciló entre 5,3 y 33,3 meses para las 34 terapias que incluían esa información, con valores de Hazard ratio (HR) respecto a sus comparadores de 0,49 a 1,15. La SLP osciló entre 1,5 y 12,4 meses para las 39 terapias con este dato, con HR de 0,33 a 1,52. Los valores de RCEI oscilaron entre 2.142,57 ?-60.996,37 ?/mes de SG adicional y entre 2.102,54 ?-661.845,27 ?/mes de SLP adicional. Conclusión: La dispersión y heterogeneidad de la supervivencia y RCEI estimadas, sugieren disparidad de criterios en la decisión de precio y financiación de las terapias, en España. Los continuos avances en terapias oncológicas parecen requerir reevaluaciones económicas de los medicamentos.

Análisis del impacto presupuestario de adalimumab y etanercept en artritis reumatoide y espondiloartropatías / Analisis of the budget impact of adalimumab and etanercept in rheumatoid arthritis and spondyloarthropathies

OBJETIVO: Evaluar el impacto económico derivado de la ampliación de los intervalos de administración de adalimumab (ADA) y etanercept (ETN), en el tratamiento de la artritis reumatoide (AR) y espondiloartropatias (EAP) en nuestro ámbito de trabajo. MATERIAL Y MÉTODO: Se desarrolló un modelo de impacto presupuestario (MIP) para estimar la repercusión económica que tendría la ampliación en los intervalos habituales de administración de ADA 40 mg cada dos semanas y ETN 50 mg semanal (escenario A), por ADA 40 mg cada tres semanas y ETN 50 mg cada dos semanas (escenario B) de acuerdo a las guías y recomendaciones que se aplican a estos estudios, especificando la población diana, la perspectiva del estudio, el horizonte temporal y analizando la robustez del estudio a través de un análisis de sensibilidad univariante de tipo umbral. RESULTADOS: Se incluyeron un total de 71 pacientes en el estudio. La aplicación del MIP mostró unos ahorros anuales para ADA y ETN de 19.784€ y 38.271 € respectivamente. El coste neto, es decir, el ahorro que esto supuso en el horizonte temporal considerado (dos años) ascendió a 116.110 €. El análisis de sensibilidad realizado mostró que el MIP estimado para el periodo de estudio fue muy robusto ya que el resultado neto en diferentes escenarios apenas variaba, manteniéndose negativo en los nuevos escenarios. CONCLUSIONES: La ampliación de los intervalos de administración de ADA y ETN cada tres semanas y dos semanas respectivamente, sería una estrategia que permitiría generar ahorros en el presupuesto hospitalario cercanos a los 116.110 € en el horizonte temporal considerado, consiguiendo así una optimización del tratamiento con estos fármacos

PURPOSE: To assess the economic impact derived from the widening of the administration intervals of adalimumab (ADA) and etanercept (ETN) for the treatment of rheumatoid arthritis (RA) and spondyloarthropathies (SAP) at our working environment. MATERIAL AND METHODS: A budget impact model (BIM) was developed to estimate the economic impact that would have widening the usual administration intervals of ADA, 40 mg every 2 weeks and ETN, 50 mg weekly (scenario A), to ADA, 40 mg every 3 weeks, and ETN, 50 mg every 2 weeks (scenario B) according to the guidelines and recommendations applied to these studies, specifying the target population, the study perspective, the temporal horizon, and analysing the study robustness by a threshold univariate sensitivity analysis. RESULTS: 71 patients were included in the study. The application of the BIM showed yearly savings for ADA and ETN of 19.784 € and 38.271 €, respectively. The net cost, that is to say the saving that this would imply within the temporal horizon considered (2 years), was 116.110 €. The sensitivity analysis showed that the estimated BIM for the study period was very robust since the net result in the different scenarios varied very little, being negative in the new scenarios. CONCLUSIONS: widening the administration intervals of ADA and ETN to every 3 weeks and 2 weeks respectively, would be a strategy that would allow generating savings in the hospital budget close to 116.110 € for the temporal horizon considered, achieving this way optimization of the treatment with these two drugs

Eficiencia de tratamientos oncológicos para tumores sólidos en España / Efficiency of oncologic treatments for solid tumours in Spain

OBJETIVO: Proporcionar estimadores de la eficiencia de esquemas oncológicos empleados en España. MÉTODOS: Se seleccionaron las publicaciones de ensayos clínicos en fase III usados para indicación de las terapias oncológicas de alto impacto empleadas para tratamiento de tumores sólidos en estadíos III-IV. Para cada esquema se calculó la relación coste-eficacia incremental (RCEI) respecto al comparador del ensayo, con la perspectiva del Sistema Nacional de Salud. El coste (€, 2012) farmacológico, en PVL, de cada esquema y comparador se estimó con las unidades de medicamento requeridas en cada administración (aprovechamiento máximo de viales) considerando la posología y el número de ciclos especificado en el ensayo para cada una de las ramas. La efectividad se expresó en meses de supervivencia global (SG) y/o supervivencia libre de progresión (SLP). RESULTADOS: Se analizaron 40 esquemas oncológicos para trece tumores metastásicos. La SG osciló entre 5,3 y 33,3 meses para las 34 terapias que incluían esa información, con valores de hazard ratio (HR) respecto a sus comparadores de 0,49 a 1,15. La SLP osciló entre 1,5 y 12,4 meses para las 39 terapias con este dato, con HR de 0,33 a 1,52. Los valores de RCEI oscilaron entre 2.142,57 €-60.996,37 €/mes de SG adicional y entre 2.102,54 €-661.845,27 €/mes de SLP adicional. CONCLUSIÓN: La dispersión y heterogeneidad de la supervivencia y RCEI estimadas, sugieren disparidad de criterios en la decisión de precio y financiación de las terapias, en España. Los continuos avances en terapias oncológicas parecen requerir reevaluaciones económicas de los medicamentos (AU)

OBJECTIVE: To provide estimates of the efficiency for chemotherapy strategies used in Spain. METHODS: Published reports of the phase-Ill clinical trials for chemotherapies used for the most prevalent solid tumours in Spain were retrieved. The incremental cost-effectiveness ratio (ICER) was calculated for each strategy compared to the control group in the clinical trial, with the National Health System perspective. The total cost (€, 2012) including only drug cost (ex-factory price) was estimated based on the total units of each drug required for administration (no vial wastage), with the dosification and number of cycles specified in the publication for each treatment arm. Effectiveness was measured as month of overall survival (OS) and/or month of progression free survival (PFS). RESULTS: A total of 40 chemotherapies for 13 different advanced or metastatic tumours were assessed. OS ranged from 5.3 to 33.3 months for the 34 therapies that included the information with hazard ratios (HR) values from 0.49 to 1.15 when compared with its control group. PFS ranged, from 39 therapies with these data, between 1.5 to 12.4 months, with HR from 0.33 to 1.52. ICERs were between €2,142.57 and €60,996.37 per each OS month gained, and from €2,102.54 to €661,845.27 per PFS month gained. CONCLUSION: The variety and heterogenicity of survival and ICERs results, suggest disparity of criteria in the price and reimbursement process of drugs in Spain. The continuous advances in oncology seem to require economic revaluations of drugs (AU)

[Perioperative anaemia in geriatric patients with hip fracture]. / Efectividad de distintas pautas de tratamiento de la anemia perioperatoria en pacientes ancianos con fractura de cadera.

OBJECTIVE: To describe and study the effectiveness of the perioperative anaemia treatment patterns for patients older than 64 with hip fracture. METHOD: Three groups of patients were compared: Group 1: Oral iron or without iron therapy. Group 2: low doses of intravenous iron. Group 3: treated according to a blood saving programme including intravenous iron, alpha epoetin and restrictive transfusional criteria. The homogeneity of gender, age, type of fracture, ASA, preoperative period and perisurgical bleeding affecting drug consumption within the groups was analyzed. The effectiveness of the treatments was determined by means of transfusional rate, postoperative haemoglobin levels, and postoperative length of stay and infection rate. RESULTS: 329 patients were checked. Patients were comparable. Patients included in Group 3 were transfused less than the rest (36.5 of patients in group 3 vs. 52.0% in group 1 and 67.6% in group 3, p = 0.002). Decreases in the infection rate and mean postoperative stay in group 3 were not significant. Haemoglobin levels at 48 hours post surgery were higher in group 1 but haemoglobin levels at the seventh day post surgery were similar for the three groups. CONCLUSIONS: The above mentioned blood saving programme has been observed to be effective in decreasing transfusional requirements without increasing morbidity. However, further prospective studies are needed in order to define the cost-effectiveness of this programme and to determine its role in the reduction of posttransfusional infections and postoperative length of stay.

Efectividad de distintas pautas de tratamiento de la anemia perioperatoria en pacientes ancianos con fractura de cadera / Perioperative anaemia in geriatric patients with hip fracture

Objetivo: Analizar la efectividad de distintas pautas de tratamientode la anemia perioperatoria en pacientes mayores de 64años con fractura de cadera.Método: Se compararon tres grupos de pacientes: Grupo 1:sin ferroterapia o con hierro oral. Grupo 2: con hierro intravenosoa bajas dosis. Grupo 3: tratados según protocolo de ahorro desangre con criterios transfusionales restrictivos, hierro intravenosoy epoetina alfa. Se estudió si los grupos eran homogéneos ensexo, edad, tipo de fractura, ASA, tiempo prequirúrgico y consumode fármacos que pueden afectar al sangrado. La efectividad delos tratamientos se determinó mediante el porcentaje de pacientestransfundidos, los valores de hemoglobina postoperatorios, laestancia postoperatoria y la presencia de infección hospitalaria.Resultados: Se estudiaron 329 pacientes, que se consideraroncomparables en las variables estudiadas. Los pacientes delgrupo 3 se transfundieron significativamente menos que el resto(el 36,5 de los pacientes frente al 52,0% de los del grupo 1 y el67,6% de los del grupo 2, p = 0,002). El porcentaje de pacientescon infección hospitalaria y la estancia postoperatoria media fuemenor en el grupo 3 que en el resto de grupos aunque no alcanzósignificación. Los valores de hemoglobina a las 48 h tras la intervenciónfueron mayores en el grupo 1 pero los niveles a los sietedías fueron similares en los tres grupos. Conclusiones: El protocolo de ahorro de sangre se ha mostradoefectivo en disminuir las necesidades transfusionales sinaumentar la morbilidad. Sin embargo son necesarios estudios másamplios, de carácter prospectivo, que establezcan su papel en ladisminución de las infecciones postransfusionales, en la disminuciónde la estancia hospitalaria y que definan el coste-efectividaddel programa

Objective: To describe and study the effectiveness of the perioperativeanaemia treatment patterns for patients older than 64with hip fracture.Method: Three groups of patients were compared: Group 1:Oral iron or without iron therapy. Group 2: low doses of intravenousiron. Group 3: treated according to a blood saving programmeincluding intravenous iron, alfa epoetin and restrictivetransfusional criteria. The homogeneity of gender, age, type offracture, ASA, preoperative period and perisurgical bleedingaffecting drug consumption within the groups was analyzed. Theeffectiveness of the treatments was determined by means of transfusionalrate, postoperative haemoglobin levels, and postoperativelength of stay and infection rate.Results: 329 patients were checked. Patients were comparable.Patients included in Group 3 were transfused less than the rest (36.5of patients in group 3 vs. 52.0% in group 1 and 67.6% in group 3, p= 0.002). Decreases in the infection rate and mean postoperativestay in group 3 were not significant. Haemoglobin levels at 48 hourspost surgery were higher in group 1 but haemoglobin levels at theseventh day post surgery were similar for the three groups.Conclusions: The above mentioned blood saving programmehas been observed to be effective in decreasing transfusionalrequirements without increasing morbidity. However, furtherprospective studies are needed in order to define the cost-effectivenessof this programme and to determine its role in the reduction ofpostransfusional infections and postoperative length of stay