Value contribution of cenobamate for the treatment of Focal-Onset Seizures (FOS) in patients with drug-resistant epilepsy (DRE) in Spain through reflective Multi-Criteria Decision Analysis (MCDA).

INTRODUCTION: Epilepsy is one of the most common neurological conditions worldwide. The main goal of its treatment is to achieve seizure freedom without intolerable adverse effects. However, despite the availability of many anti-seizure medications, including the latest options, called third-generation anti-seizure medications (ASMs), approximately 40% of people with epilepsy present drug-resistant epilepsy (DRE). Cenobamate is the first ASM approved in Spain for the adjunctive treatment of Focal-Onset Seizures (FOS) in adult patients with DRE. In a chronic disease with a portfolio of available ASMs, the decision to introduce a new therapeutic alternative must follow a holistic evaluation of value provided. Reflective Multi-Criteria Decision Analysis (MCDA) methodology allows to determine the value contribution of a treatment in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner from the perspective of relevant stakeholders. PURPOSE: The aim of this study was to determine the relative value contribution of cenobamate in the treatment of FOS in patients with DRE compared with third-generation ASMs using reflective MCDA-based methodology. METHODS: A systematic literature review (combining biomedical databases and grey literature sources) was performed to populate the Evidence and Value: Impact on DEcisionMaking (EVIDEM) MCDA framework adapted to determine what represents value in the management of FOS in patients with DRE in Spain. The study was conducted in two phases. The first took place in 2021 with a multi-stakeholder group of eight participants. The second phase was conducted in 2022 with a multi-stakeholder group of 32 participants. Participants were trained in MCDA methodology and scored four evidence matrices (cenobamate vs. brivaracetam, vs. perampanel, vs. lacosamide and vs. eslicarbazepine acetate). Results were analyzed and discussed in a group meeting through reflective MCDA discussion methodology. RESULTS: DRE is considered a very severe condition associated with many important unmet needs, mainly with regard to the lack of more effective treatments to achieve the ultimate goal of treatment. Compared to third-generation ASMs, cenobamate is perceived to have a better efficacy profile based on improvements in responder rate and seizure freedom. Regarding safety, it is considered to have a similar profile to alternatives and a positive quality-of-life profile. Cenobamate results in lower direct medical costs (excluding pharmacological) and indirect costs. Overall, cenobamate is regarded as providing a high therapeutic impact and supported by high-quality evidence. CONCLUSIONS: Based on reflective MCDA methodology and stakeholders' experience in clinical management of epilepsy in Spain, cenobamate is perceived as a value-added option for the treatment of patients with DRE when compared with third-generation ASMs.

The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.

INTRODUCTION: Dravet Syndrome (DS) is a severe, developmental epileptic encephalopathy (DEE) that begins in infancy and is characterized by pharmaco-resistant epilepsy and neurodevelopmental delay. Despite available antiseizure medications (ASMs), there is a need for new therapeutic options with greater efficacy in reducing seizure frequency and with adequate safety and tolerability profiles. Fenfluramine is a new ASM for the treatment of seizures associated with DS as add-on therapy to other ASMs for patients aged 2 years and older. Fenfluramine decreases seizure frequency, prolongs periods of seizure freedom potentially helping to reduce risk of Sudden Unexpected Death in Epilepsy (SUDEP) and improves patient cognitive abilities positively impacting on patients' Quality of Life (QoL). Reflective Multi-Criteria Decision Analysis (MCDA) methodology allows to determine what represents value in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner from the perspective of relevant stakeholders. The aim of this study was to determine the relative value contribution of fenfluramine for the treatment of DS in Spain using MCDA. METHOD: A literature review was performed to populate an adapted a MCDA framework for orphan-drug evaluation in Spain. A panel of ten Spanish experts, including neurologists, hospital pharmacists, patient representatives and decision-makers, scored four comparative evidence matrices. Results were analyzed and discussed in a group meeting through reflective MCDA discussion methodology. RESULTS: Dravet syndrome is considered a severe, rare disease with significant unmet needs. Fenfluramine is perceived to have a higher efficacy profile than all available alternatives, with a better safety profile than stiripentol and topiramate and to provide improved QoL versus studied alternatives. Fenfluramine results in lower other medical costs in comparison with stiripentol and clobazam. Participants perceived that fenfluramine could lead to indirect costs savings compared to available alternatives due to its efficacy in controlling seizures. Overall, fenfluramine's therapeutic impact on patients with DS is considered high and supported by high-quality evidence. CONCLUSIONS: Based on reflective MCDA, fenfluramine is considered to add greater benefit in terms of efficacy, safety and QoL when compared with available ASMs.

Prevalence of inappropriate prescribing in complex chronic patients: Time trends in a health department of Valencia, Spain (2015-2019).

BACKGROUND AND OBJECTIVE: Inappropriate prescribing (IP) is an important cause of health problems among elderly and complex chronic patients (CCPs). OBJECTIVE: Surveillance of IP prevalence among elderly and CCPs in a health department. IP time trends across the period 2015-2019. METHOD: Descriptive population-based study. SETTING: 'València-Clínic-Malvarrosa' Health Department, Valencia, Spain. PERIOD: 2015-2019. SUBJECTS: Complete set of CCPs in the department, defined by clinical risk groups. Number of CCPs (annual average in the period): 9102 (75% ≥65 years of age). IP was measured using an indicator consisting of 13 specific types of prescriptions defined as inappropriate. ANALYSES: frequencies and time trends, both overall and by specific type. RESULTS: Overall prevalence of IP ranged from 0.276 (2015) to 0.289 (2018) per patient, without time trend. The most frequent inappropriate prescription was type 1: "≥75 years of age with inappropriate medication", which showed a stable rate across the period. Some types of inappropriate prescriptions displayed favourable decreasing time trends, while others showed no change or an unfavourable trend (i.e., joint prescription of absorbents and urinary antispasmodics). CONCLUSIONS: IP prevalence is a serious and persistent problem among the elderly and CCPs, especially in the oldest. It is therefore necessary its continuous surveillance (overall and by specific types of prescription). As well as interventions to optimise prescribing, thus improving the quality and efficiency of care for the elderly and CCPs.

Prevalence of inappropriate prescribing in complex chronic patients: Time trends in a health department of Valencia, Spain (2015–2019) / Prevalencia de prescripción inapropiada en pacientes crónicos complejos: tendencias temporales en un departamento de salud de Valencia, España (2015-2019)

Background and objective: Inappropriate prescribing (IP) is an important cause of health problems among elderly and complex chronic patients (CCPs).Objective: Surveillance of IP prevalence among elderly and CCPs in a health department. IP time trends across the period 2015–2019.Method: Descriptive population-based study. Setting: ‘València-Clínic-Malvarrosa’ Health Department, Valencia, Spain. Period: 2015–2019. Subjects: Complete set of CCPs in the department, defined by clinical risk groups. Number of CCPs (annual average in the period): 9102 (75% ≥65 years of age). IP was measured using an indicator consisting of 13 specific types of prescriptions defined as inappropriate. Analyses: frequencies and time trends, both overall and by specific type.Results: Overall prevalence of IP ranged from 0.276 (2015) to 0.289 (2018) per patient, without time trend. The most frequent inappropriate prescription was type 1: “≥75 years of age with inappropriate medication”, which showed a stable rate across the period. Some types of inappropriate prescriptions displayed favourable decreasing time trends, while others showed no change or an unfavourable trend (i.e., joint prescription of absorbents and urinary antispasmodics).Conclusions: IP prevalence is a serious and persistent problem among the elderly and CCPs, especially in the oldest. It is therefore necessary its continuous surveillance (overall and by specific types of prescription). As well as interventions to optimise prescribing, thus improving the quality and efficiency of care for the elderly and CCPs. (AU)

Antecedentes y objetivo: La prescripción inapropiada (PI) es una importante causa de problemas de salud en las personas mayores y pacientes crónicos complejos (PCC). Objetivo: Monitorizar la prevalencia de PI en personas mayores y PCC, en un departamento de salud. Tendencias temporales de la PI durante 2015-2019.Método: Estudio descriptivo de base poblacional. Lugar: Departamento de Salud «València-Clínic-Malvarrosa», Valencia, España. Periodo: 2015-2019. Sujetos: Conjunto completo de PCC en el Departamento, definidos mediante Clinical Risk Groups. Número de PCC (valor promedio anual en el periodo): 9.102 (75% ≥65 años de edad). La PI se cuantificó mediante un indicador que comprende 13 tipos concretos de prescripciones definidas como inapropiadas. Análisis: frecuencias y tendencia temporal, global y por tipos.Resultados: La prevalencia global de PI osciló entre 0,276 (2015) y 0,289 (2018) por paciente, sin tendencia temporal. El tipo concreto de PI más frecuente fue el 1: «≥75 años con medicación inapropiada», y fue estable en el periodo. Algunos de los tipos inapropiados de prescripción mostraron evolución temporal favorable, descendente; pero en otros no hubo cambios o fue desfavorable (como la prescripción conjunta de absorbentes y antiespasmódicos urinarios).Conclusiones: La prevalencia de la PI constituye un problema importante y persistente en las personas mayores y PCC, especialmente en las de más edad. Es pues necesaria su monitorización continuada (global y por tipos de prescripción), así como intervenciones para optimizar la prescripción, mejorando la calidad y eficiencia de la asistencia a las personas mayores y PCC. (AU)

Cost of Type 2 Diabetes Patients with Chronic Kidney Disease Based on Real-World Data: An Observational Population-Based Study in Spain.

This study analyzed the prevalence, costs and economic impact of chronic kidney disease CKD in patients with T2D in a Spanish Health District using real-world data. Observational cross-sectional study in adult patients with T2D was through data extracted from the information systems of the Valencia Clínico-La Malvarrosa Health District in the year 2015. Patients were stratified with the KDIGO classification for CKD. Additionally, patients were assigned to Clinical Risk Groups (CRGs) according to multimorbidity. Direct costs of primary and specialized care, and medication were estimated. The prevalence of T2D in the database population (n = 28,345) was 10.8% (mean age (SD) = 67.8 years (13.9); 51.5% male). Up to 14.935 patients (52.6%) had data on kidney function. According to the KDIGO classification, 66.2% of the patients were at low risk of CKD, 20.6% at moderately increased risk, 7.9% at high risk, and 5.2% at very high risk. The average healthcare costs associated with these four risk groups were EUR 3437, EUR 4936, EUR 5899 and EUR 7389, respectively. The large number of T2D patients with CKD in the early stages of the disease generated a significant increase in direct healthcare costs. The economic impact could be mitigated by early and comprehensive therapeutic approaches.

[Analysis of potentially inappropriate prescriptions according to the START criteria in nursing homes]. / Análisis de las prescripciones potencialmente inadecuadas en centros sociosanitarios según los criterios START.

BACKGROUND AND OBJECTIVE: The potentially inappropriate prescription by omission of a drug is defined as the failure to prescribe drugs that are clinically indicated. The objective of this article is to describe and analyse the evolution of inappropriate prescriptions by omission in nursing homes of a health department. MATERIAL AND METHODS: Retrospective observational descriptive study carried out in nursing homes of the Valencia-Clínico-Malvarrosa health department during the period 2016-2018. All institutionalized patients during this period were included. The prevalence of potentially inappropriate prescriptions by omission was assessed based on version 2 of the START criteria. The variables came from the electronic medical records of ambulatory care of the Conselleria de Sanitat (Abucasis). RESULTS: 2251 different patients were selected, mean age of 79,53years, 69% women, and an average of 4,60 chronic drugs/resident. A total of 2647 inappropriate prescriptions by omission were identified during the study period, and the results were similar during these 3years. The most prevalent START criteria were those related to the musculoskeletal system and the cardiovascular system, and those related to analgesic consumption. The mean value of inappropriate prescriptions by omission prevalence for the period studied were 39.54%. CONCLUSION: The results of our study confirm a high prevalence of potentially inappropriate prescriptions by omission in residents of nursing homes, and the maintenance of this prevalence during the 3years of the study.

Determining the burden of infectious diseases caused by carbapenem-resistant gram-negative bacteria in Spain / Determinación de la carga de las infecciones causadas por bacterias gramnegativas resistentes a carbapenemas en España

Objective: To estimate the burden of nosocomial infections induced by carbapenem resistant Gram-negative (CRGN) pathogens in Spain, focusing on both the clinical and economic impact. Methods: The burden of disease was estimated using data from 2017 according to the availability of data sources. The impact, both clinical and economic, of the most frequent CRGN nosocomial infections (those produced by Klebsiella pneumoniae, Pseudomonasaeruginosa and Acinetobacter baumannii) was analysed. Incidence and mortality of CRGN nosocomial infections were estimated, as well as the direct and indirect costs produced by this health problem. Results: Approximately 376,346 patients are believed to have suffered a nosocomial infection in Spain in 2017; 3.2% of them due to CRGN bacilli. Infections by carbapenem-resistant P. aeruginosa produced the highest mortality rates (2578 deaths) when compared with A. baumannii (1571) and K. pneumoniae (415). Total economic costs of CRGN nosocomial infections in Spain were estimated to be €472 million in 2017, with 83% of the total cost caused by direct costs. Conclusion: CRGN nosocomial infections have a high clinical impact on patients’ lives, high mortality rates, and represent one of the hospitalisation episodes with the most associated costs. Efforts should be focussed to implement preventive policies in order to avoid infections due to CRGN pathogens and the resulting burden, and to reduce direct costs due to morbimortality, specifically in those infections produced by P. aeruginosa.(AU)

Objetivo: Estimar la carga de las infecciones nosocomiales inducidas por patógenos gramnegativos resistentes a carbapenemas (GNRC) en España, focalizada tanto en el impacto clínico como en el económico. Métodos: La carga de la enfermedad se estimó utilizando datos del año 2017, de acuerdo con la disponibilidad de los mismos en bases de datos. Se analizó el impacto, tanto clínico como económico, de las infecciones nosocomiales GNRC más habituales (causadas por Klebsiella pneumoniae, Pseudomonas aeruginosa y Acinetobacter baumannii). Se estimaron la incidencia y la mortalidad de las infecciones nosocomiales GNRC, así como los costes directos e indirectos derivados de este problema de salud. Resultados: Aproximadamente 376.346 pacientes podrían haber sufrido una infección nosocomial en España durante el año 2017; siendo el 3,2% de ellas producidas por bacilos GNRC. Las infecciones causadas por P. aeruginosa resistente a carbapenemas produjeron las mayores tasas de mortalidad (2.578 muertes) en comparación con A. baumannii (1.571) y K. pneumoniae (415). Los costes económicos totales de las infecciones nosocomiales producidas por GNRC en España se estimaron en 472 M€ en 2017, siendo el 83% del coste total representado por los costes directos. Conclusión: Las infecciones nosocomiales producidas por GNRC tienen un gran impacto en la vida de los pacientes, altas tasas de mortalidad y representan uno de los episodios de hospitalización con más costes hospitalarios asociados. Se deben focalizar los esfuerzos en políticas de prevención para evitar las infecciones por patógenos GNRC y su carga, así como para reducir los costes directos producidos por la morbimortalidad, concretamente en aquellas infecciones producidas por P. aeruginosa.(AU)

Determining the burden of infectious diseases caused by carbapenem-resistant gram-negative bacteria in Spain.

OBJECTIVE: To estimate the burden of nosocomial infections induced by carbapenem resistant Gram-negative (CRGN) pathogens in Spain, focusing on both the clinical and economic impact. METHODS: The burden of disease was estimated using data from 2017 according to the availability of data sources. The impact, both clinical and economic, of the most frequent CRGN nosocomial infections (those produced by Klebsiella pneumoniae, Pseudomonasaeruginosa and Acinetobacter baumannii) was analysed. Incidence and mortality of CRGN nosocomial infections were estimated, as well as the direct and indirect costs produced by this health problem. RESULTS: Approximately 376,346 patients are believed to have suffered a nosocomial infection in Spain in 2017; 3.2% of them due to CRGN bacilli. Infections by carbapenem-resistant P. aeruginosa produced the highest mortality rates (2578 deaths) when compared with A. baumannii (1571) and K. pneumoniae (415). Total economic costs of CRGN nosocomial infections in Spain were estimated to be €472 million in 2017, with 83% of the total cost caused by direct costs. CONCLUSION: CRGN nosocomial infections have a high clinical impact on patients' lives, high mortality rates, and represent one of the hospitalisation episodes with the most associated costs. Efforts should be focussed to implement preventive policies in order to avoid infections due to CRGN pathogens and the resulting burden, and to reduce direct costs due to morbimortality, specifically in those infections produced by P. aeruginosa.

[Epidemiology and sociodemographic characterization of the fibromyalgia in Comunidad Valenciana]. / Epidemiología y caracterización sociodemográfica de la fibromialgia en la Comunidad Valenciana.

OBJECTIVE: The elevated prevalence of the fibromyalgia and its polypathologic clinic suppose an important Public Health problem in Spain. The purpose of this study was to carry out an approach of the syndrome's epidemiology, with the finality of collaborate in the scientific knowledge progress of the people who suffer fibromyalgia, in this case, through the sociodemographic analysis of Comunidad Valenciana patients, in Spain. METHODS: It was done an epidemiologic descriptive transversal study, by extractions and analysis of epidemiological variables in official resources of health information of Comunidad Valenciana (Abucasis II, SIA, GAIA, SIP, SIE). The study presented two different analysis processes: the first one was the exam of the fibromyalgia prevalence evolution of the whole Comunidad Valenciana, considering the totality of diagnosed people between 2012 and 2016. The second one, supposed the sociodemographic characterization of people who are affected with fibromyalgia, using a sample of 9,267 people with active diagnostic of the disease in one of the 25 health department of the valencian public system, observing variables such as age, sex, origin, asistenciality, labour activity and economic level. The datum statistic treatment was descriptive univariable and it was made with percentage values of means, median and mode. The confidence interval for the average when required was set at 95 percent. RESULTS: Fibromyalgia was an elevated prevalence disease in Comunidad Valenciana (3.7%) in the study's period, establishing itself above the world media prevalence studied, Europe or Spain. What is more, it presented a special gravity in the male prevalence. Its evolution reflected a growth year-to-year of the order of 28 percent, with an average incidence rate of 5.39 new cases per thousand inhabitants / year. It specially affected women (it had it the 63% of the sample) and the average age of 54 years. Besides, people with fibromyalgia presented low economic levels and laboural difficulties defined by low employment rate, the elevated unemployment rate and the frequency and length of their work leaves. CONCLUSIONS: Fibromyalgia has a special epidemiological importance in Comunidad Valenciana, with a high prevalence and incidence. In its basic sociodemography we found an elevated percent of women with ages between 51 and 70 years, but also, we find a male prevalence of special consideration comparatively with other studies. We observe an important reduce of the socioeconomic and sociodemographic conditions between fibromyalgia diagnosed people.

OBJETIVO: La elevada prevalencia de la fibromialgia y su clínica polipatológica supone un importante problema de salud pública en España. El presente estudio tuvo por objeto realizar una aproximación a la epidemiología del síndrome, con la finalidad de colaborar en el avance del conocimiento científico de las personas que sufren fibromialgia, en este caso mediante el análisis sociodemográfico de los pacientes en la Comunidad Valenciana (España). METODOS: Se realizó un estudio epidemiológico descriptivo transversal, mediante extracción y análisis de variables epidemiológicas en fuentes oficiales de información sanitaria de la Comunidad Valenciana (Abucasis II, SIA, GAIA, SIP, SIE). El estudio presentó dos procesos de análisis diferenciados: el primero fue el examen de la evolución de la prevalencia de la fibromialgia en toda la Comunidad Valenciana, considerando a la totalidad de las personas diagnosticadas entre 2012 y 2016. El segundo supuso la caracterización sociodemográfica de las personas afectadas de fibromialgia, utilizando una muestra de 9.267 personas con diagnóstico activo de la enfermedad en uno de los 25 departamentos de salud del sistema público valenciano, observando variables tales como edad, sexo, procedencia, asistencialidad, actividad laboral y nivel económico. El tratamiento estadístico de los datos fue descriptivo univariable, y realizado con valores porcentuales, de media, mediana y moda. El intervalo de confianza para la media, cuando fue requerido, se estableció en el 95 por ciento. RESULTADOS: La fibromialgia fue una enfermedad de elevada prevalencia en la Comunidad Valenciana (3,7%) en el periodo de estudio, situándose por encima de las prevalencias medias estudiadas en el mundo, Europa o España. Presentó además una especial gravedad en la prevalencia masculina. Su evolución reflejó un crecimiento interanual del orden del 28 por ciento, con una tasa de incidencia media de 5,39 nuevos casos por cada mil habitantes/año. Afectó especialmente a las mujeres (63 por ciento de la muestra) y la edad media fue de 54 años. Además, las personas con fibromialgia presentaron bajos niveles económicos y dificultades laborales definidas por la baja tasa de empleo, la elevada tasa de paro y la frecuencia y duración de sus bajas laborales. CONCLUSIONES: La fibromialgia tiene una especial importancia epidemiológica en la Comunidad Valenciana, con alta prevalencia e incidencia. En su sociodemografía básica encontramos un porcentaje elevado de mujeres en edades comprendidas entre los 51 y los 70 años, pero también una prevalencia masculina de especial consideración comparativamente con otros estudios. Observamos un importante menoscabo de las condiciones socioeconómicas y sociolaborales entre las personas con diagnóstico de fibromialgia.

Epidemiología y caracterización sociodemográfica de la fibromialgia en la Comunidad Valenciana / Epidemiology and sociodemographic characterization of the fibromyalgia in Comunidad Valenciana

FUNDAMENTOS: La elevada prevalencia de la fibromialgia y su clínica polipatológica supone un importante problema de salud pública en España. El presente estudio tuvo por objeto realizar una aproximación a la epidemiología del síndrome, con la finalidad de colaborar en el avance del conocimiento científico de las personas que sufren fibromialgia, en este caso mediante el análisis sociodemográfico de los pacientes en la Comunidad Valenciana (España). MÉTODOS: Se realizó un estudio epidemiológico descriptivo transversal, mediante extracción y análisis de variables epidemiológicas en fuentes oficiales de información sanitaria de la Comunidad Valenciana (Abucasis II, SIA, GAIA, SIP, SIE). El estudio presentó dos procesos de análisis diferenciados: el primero fue el examen de la evolución de la prevalencia de la fibromialgia en toda la Comunidad Valenciana, considerando a la totalidad de las personas diagnosticadas entre 2012 y 2016. El segundo supuso la caracterización sociodemográfica de las personas afectadas de fibromialgia, utilizando una muestra de 9.267 personas con diagnóstico activo de la enfermedad en uno de los 25 departamentos de salud del sistema público valenciano, observando variables tales como edad, sexo, procedencia, asistencialidad, actividad laboral y nivel económico. El tratamiento estadístico de los datos fue descriptivo univariable, y realizado con valores porcentuales, de media, mediana y moda. El intervalo de confianza para la media, cuando fue requerido, se estableció en el 95 por ciento. RESULTADOS: La fibromialgia fue una enfermedad de elevada prevalencia en la Comunidad Valenciana (3,7%) en el periodo de estudio, situándose por encima de las prevalencias medias estudiadas en el mundo, Europa o España. Presentó además una especial gravedad en la prevalencia masculina. Su evolución reflejó un crecimiento interanual del orden del 28 por ciento, con una tasa de incidencia media de 5,39 nuevos casos por cada mil habitantes/año. Afectó especialmente a las mujeres (63 por ciento de la muestra) y la edad media fue de 54 años. Además, las personas con fibromialgia presentaron bajos niveles económicos y dificultades laborales definidas por la baja tasa de empleo, la elevada tasa de paro y la frecuencia y duración de sus bajas laborales. CONCLUSIONES: La fibromialgia tiene una especial importancia epidemiológica en la Comunidad Valenciana, con alta prevalencia e incidencia. En su sociodemografía básica encontramos un porcentaje elevado de mujeres en edades comprendidas entre los 51 y los 70 años, pero también una prevalencia masculina de especial consideración comparativamente con otros estudios. Observamos un importante menoscabo de las condiciones socioeconómicas y sociolaborales entre las personas con diagnóstico de fibromialgia

BACKGROUND: The elevated prevalence of the fibromyalgia and its polypathologic clinic suppose an important Public Health problem in Spain. The purpose of this study was to carry out an approach of the syndrome's epidemiology, with the finality of collaborate in the scientific knowledge progress of the people who suffer fibromyalgia, in this case, through the sociodemographic analysis of Comunidad Valenciana patients, in Spain. METHODS: It was done an epidemiologic descriptive transversal study, by extractions and analysis of epidemiological variables in official resources of health information of Comunidad Valenciana (Abucasis II, SIA, GAIA, SIP, SIE). The study presented two different analysis processes: the first one was the exam of the fibromyalgia prevalence evolution of the whole Comunidad Valenciana, considering the totality of diagnosed people between 2012 and 2016. The second one, supposed the sociodemographic characterization of people who are affected with fibromyalgia, using a sample of 9,267 people with active diagnostic of the disease in one of the 25 health department of the valencian public system, observing variables such as age, sex, origin, asistenciality, labour activity and economic level. The datum statistic treatment was descriptive univariable and it was made with percentage values of means, median and mode. The confidence interval for the average when required was set at 95 percent. RESULTS: Fibromyalgia was an elevated prevalence disease in Comunidad Valenciana (3.7%) in the study's period, establishing itself above the world media prevalence studied, Europe or Spain. What is more, it presented a special gravity in the male prevalence. Its evolution reflected a growth year-to-year of the order of 28 percent, with an average incidence rate of 5.39 new cases per thousand inhabitants / year. It specially affected women (it had it the 63% of the sample) and the average age of 54 years. Besides, people with fibromyalgia presented low economic levels and laboural difficulties defined by low employment rate, the elevated unemployment rate and the frequency and length of their work leaves. CONCLUSIONS: Fibromyalgia has a special epidemiological importance in Comunidad Valenciana, with a high prevalence and incidence. In its basic sociodemography we found an elevated percent of women with ages between 51 and 70 years, but also, we find a male prevalence of special consideration comparatively with other studies. We observe an important reduce of the socioeconomic and sociodemographic conditions between fibromyalgia diagnosed people

Fibromialgia: prevalencia, perfiles epidemiológicos y costes económicos / Fibromyalgia: Prevalence, epidemiologic profiles and economic costs

La fibromialgia es una enfermedad crónica idiopática que ocasiona dolor musculoesquelético generalizado, hiperalgesia y alodinia. La presente revisión pretende aproximarse a la epidemiología general de la fibromialgia de acuerdo con los más recientes estudios publicados, identificar la prevalencia general de la enfermedad a nivel mundial, sus perfiles epidemiológicos básicos y los costes económicos que ocasiona, con interés específico en el caso de España y de la Comunidad Valenciana. La fibromialgia afecta como promedio a un 2,10% de la población mundial; al 2,31% de la europea; al 2,40% en la población española y al 3,69% de la población en la Comunidad Autónoma Valenciana. Supone una dolorosa pérdida de la calidad de vida de las personas que la presentan y los costes económicos son enormes: en el caso español se han estimado en más de 12.993 millones de euros anuales (AU)

Fibromyalgia is an idiopathic chronic condition that causes widespread musculoskeletal pain, hyperalgesia and allodynia. This review aims to approach the general epidemiology of fibromyalgia according to the most recent published studies, identifying the general worldwide prevalence of the disease, its basic epidemiological profiles and its economic costs, with specific interest in the Spanish and Comunidad Valenciana cases. Fibromyalgia affects, on average, 2.10% of the world's population; 2.31% of the European population; 2.40% of the Spanish population; and 3.69% of the population in the Comunidad Valenciana. It supposes a painful loss of the quality of life of the people who suffer it and the economic costs are enormous: in Spain is has been estimated at more than 12,993 million euros annually (AU)

Fibromyalgia: Prevalence, epidemiologic profiles and economic costs. / Fibromialgia: prevalencia, perfiles epidemiológicos y costes económicos.

Fibromyalgia is an idiopathic chronic condition that causes widespread musculoskeletal pain, hyperalgesia and allodynia. This review aims to approach the general epidemiology of fibromyalgia according to the most recent published studies, identifying the general worldwide prevalence of the disease, its basic epidemiological profiles and its economic costs, with specific interest in the Spanish and Comunidad Valenciana cases. Fibromyalgia affects, on average, 2.10% of the world's population; 2.31% of the European population; 2.40% of the Spanish population; and 3.69% of the population in the Comunidad Valenciana. It supposes a painful loss of the quality of life of the people who suffer it and the economic costs are enormous: in Spain is has been estimated at more than 12,993 million euros annually.

Methods to control the pharmaceutical cost impact of chronic conditions in the elderly.

Multimorbidity is the main cause of polypharmacy in elderly people, with the consequent increment in cost and use of inappropriate medication. To control cost, specific strategies have been implemented in healthcare services to reduce potentially inappropriate prescription. Many interventions are applied online during the prescription process using computerized decision support systems, for example, therapeutic algorithms and alerts. Other interventions can be categorized as offline due to their application before or after the prescription process, the main strategies being financial incentives, medication reviews and organizational change. All these strategies are complementary and multifaceted. There is evidence that some of these interventions are effective, but further research should be directed in this field, including investigation of patient cost and outcomes.

Pharmaceutical cost management in an ambulatory setting using a risk adjustment tool.

BACKGROUND: Pharmaceutical expenditure is undergoing very high growth, and accounts for 30% of overall healthcare expenditure in Spain. In this paper we present a prediction model for primary health care pharmaceutical expenditure based on Clinical Risk Groups (CRG), a system that classifies individuals into mutually exclusive categories and assigns each person to a severity level if s/he has a chronic health condition. This model may be used to draw up budgets and control health spending. METHODS: Descriptive study, cross-sectional. The study used a database of 4,700,000 population, with the following information: age, gender, assigned CRG group, chronic conditions and pharmaceutical expenditure. The predictive model for pharmaceutical expenditure was developed using CRG with 9 core groups and estimated by means of ordinary least squares (OLS). The weights obtained in the regression model were used to establish a case mix system to assign a prospective budget to health districts. RESULTS: The risk adjustment tool proved to have an acceptable level of prediction (R2 ≥ 0.55) to explain pharmaceutical expenditure. Significant differences were observed between the predictive budget using the model developed and real spending in some health districts. For evaluation of pharmaceutical spending of pediatricians, other models have to be established. CONCLUSION: The model is a valid tool to implement rational measures of cost containment in pharmaceutical expenditure, though it requires specific weights to adjust and forecast budgets.

Predictability of pharmaceutical spending in primary health services using Clinical Risk Groups.

BACKGROUND: Risk adjustment instruments applied to existing electronic health records and administrative datasets may contribute to monitoring the correct prescribing of medicines. OBJECTIVE: We aim to test the suitability of the model based on the CRG system and obtain specific adjusted weights for determined health states through a predictive model of pharmaceutical expenditure in primary health care. METHODS: A database of 261,054 population in one health district of an Eastern region of Spain was used. The predictive power of two models was compared. The first model (ATC-model) used nine dummy variables: sex and 8 groups from 1 to 8 or more chronic conditions while in the second model (CRG-model) we include sex and 8 dummy variables for health core statuses 2-9. RESULTS: The two models achieved similar levels of explanation. However, the CRG system offers higher clinical significance and higher operational utility in a real context, as it offers richer and more updated information on patients. CONCLUSIONS: The potential of the CRG model developed compared to ATC codes lies in its capacity to stratify the population according to specific chronic conditions of the patients, allowing us to know the degree of severity of a patient or group of patients, predict their pharmaceutical cost and establish specific programmes for their treatment.

[A standardized amount indicator by equivalent patient to control outpatient pharmaceutical expenditure, Spain]. / Desarrollo del indicador Población Estandarizada Equivalente para el control del gasto farmacéutico ambulatorio.

BACKGROUND: The outpatient pharmaceutical expenditure in developed countries represents a huge percentage of the total health budget, because of that, it is necessary to use tools aimed to control and guarantee an efficient use of these resources. Improving the current construction of the indicator of pharmaceutical expenditure in order to have a more adjusted tool of pharmaceutical expenditure control. METHODS: We introduce the concept of "equivalent patient" in the standardization of outpatient pharmaceutical expenditure, considering in its design several socio demographic variables in order to supersede the previous model which just considered the "Co-payment status" for adjusting the outpatient pharmaceutical expenditure. We considered variables as age, sex, co-payment status and nationality to elaborate the concept of equivalent patient. RESULTS: By applying the standardization method we obtained 160 groups of consumption with weights from 0,10 to 4,39 equivalent patients. CONCLUSIONS: We obtained a tool capable of improving the construction of Pharmaceutical Expenditure Indicators, which are essential for the design of measures aimed to stimulate the rational use of drugs. In a micro level of analysis, the new indicator is useful to establish economic incentives aimed to encourage good performance from physicians in the prescription field.

Desarrollo del indicador población estandarizada equivalente para el control del gasto farmacéutico ambulatorio / A standardized amount indicator by equivalent patient to control outpatient pharmaceutical expenditure, Spain

Fundamentos: El gasto farmacéutico representa un elevado porcentaje del gasto sanitario total en la mayoría de los países desarrollados, por lo que es importante utilizar herramientas que permitan hacer un uso eficiente. El objetivo del presente trabajo es construir un indicador de gasto farmacéutico estandarizado con el fin de disponer de una herramienta objetiva de evaluación y control del gasto más precisa que el indicador utilizado hasta el momento en la Comunitat Valenciana. Métodos: Para la construcción de este indicador se introdujo el concepto de "paciente equivalente" en la estandarización de la población, lo que permitió discriminar pacientes con perfiles de consumo diferentes. Dicha estandarización tiene en cuenta una serie de variables sociodemográficas que ofrecen una estandarización de los pacientes más ajustada que la que ofrecía el modelo utilizado hasta 2011, sustituido ahora por este nuevo indicador: el anterior indicador de importe estandarizado solo consideraba como característica diferenciadora del gasto la condición de farmacia (prestación farmaceútica sin o con aportación del 40%). Las variables consideradas en el nuevo proceso de estandarización fueron, la edad, el género, la condición de prestación farmaceútica y la cobertura internacional. Resultados: Después de aplicar el método de estandarización de la población se obtuvieron 160 grupos de pacientes con consumos diferentes a los que se les adjudicó unos pesos de 0,10 a 4,39 pacientes equivalentes. Conclusiones: El indicador obtenido permite comparar poblaciones homogéneas a través del proceso de su estandarización, lo que facilita la evaluación y control del gasto farmacéutico ambulatorio considerando los patrones de consumo de cada estructura poblacional. El indicador se puede aplicar a cualquier nivel organizativo, desde departamentos de salud a facultativos, por lo que ofrece información necesaria para el establecimiento de incentivos encaminados a promover una prescripción más eficiente(AU)

Background: The outpatient pharmaceutical expenditure in developed countries represents a huge percentage of the total health budget, because of that, it is necessary to use tools aimed to control and guarantee an efficient use of these resources. Improving the current construction of the indicator of pharmaceutical expenditure in order to have a more adjusted tool of pharmaceutical expenditure control. Methods: We introduce the concept of "equivalent patient" in the standardization of outpatient pharmaceutical expenditure, considering in its design several socio demographic variables in order to supersede the previous model which just considered the "Co-payment status" for adjusting the outpatient pharmaceutical expenditure. We considered variables as age, sex, co-payment status and nationality to elaborate the concept of equivalent patient. Results: By applying the standardization method we obtained 160 groups of consumption with weights from 0,10 to 4,39 equivalent patients. Conclusions: We obtained a tool capable of improving the construction of Pharmaceutical Expenditure Indicators, which are essential for the design of measures aimed to stimulate the rational use of drugs. In a micro level of analysis, the new indicator is useful to establish economic incentives aimed to encourage good performance from physicians in the prescription fiel(AU)

Impact of a multifaceted intervention to improve the clinical management of osteoporosis. The ESOSVAL-F study.

BACKGROUND: A study to evaluate the impact of a combined intervention (in-class and on-line training courses, a practicum and economic incentives) to improve anti-osteoporosis treatment and to improve recordkeeping for specific information about osteoporosis. METHODS/DESIGN: A before/after study with a non-equivalent control group to evaluate the impact of the interventions associated with participation in the ESOSVAL-R cohort study (intervention group) compared to a group receiving no intervention (control group). The units of analysis are medical practices identified by a Healthcare Position Code (HPC) referring to a specific medical position in primary care general medicine in a Healthcare Department of the Region of Valencia, Spain. The subjects of the study are the 400 participating "practices" (population assigned to health care professionals, doctors and/or nurses) selected by the Healthcare Departments of the Valencia Healthcare Agency for participation as associate researchers in the ESOSVAL-R study (intervention group), compared to 400 participating "practices" assigned to primary care professionals NOT selected for participation as associate researchers in the ESOSVAL-R study, who are selected on the basis of their working in the same Healthcare Centers as the practices receiving the interventions (control group). The study's primary endpoint is the appropriateness of treatment according by the Spanish National Health System guide (2010) and the National Osteoporosis Foundation (NOF, 2008) and International Osteoporosis Foundation guidance (IOF, 2008).The study will also evaluate a series of secondary and tertiary endpoints. The former are the suitability of treatment and evaluation of the risk of fracture; and the latter are the volume of information registered in the electronic clinical records, and the evaluation of risks and the suitability of treatment.