The regulatory and Health Technology processes in Europe and drug market access. The case of cystic fibrosis

In order to reach the European market, a new drug needs to receive a positive evaluation regarding its quality, safety and efficacy by regulatory health authorities and also obtain a positive HTA appraisal regarding its cost-effectiveness by HTA bodies. Regulators and HTA bodies are collaborating in several projects at European level in order to harmonize the scientific requirements of both evaluations to the maximum extent possible. The comparison of the regulatory evaluation performed by EMA for Kalydeco and the HTA appraisals issued by several EU bodies exemplifies the dilemma between scientific evidence and local economic considerations and the difficulties in the achievement of harmonization and therefore equity in the access to drugs

Evaluating the Impact of the Diabetes Mellitus Strategy for the National Health System: An Interrupted Time Series Analysis

Background: Diabetes mellitus is a significant public health problem. Macrovascular complications (stroke, acute myocardial infarction (AMI) and lower limb amputations (LLAs) represent the leading cause of morbi-mortality in DM. This work aims to evaluate the impact of the approval of the Diabetes Mellitus Strategy of the National Health System (SDM-NHS) on hospitalizations for those macrovascular complications related to DM. Methods: Interrupted time series applying segmented regression models (Negative Binomial) adjusted for seasonality to data from hospital discharge records with a primary or secondary diagnosis of DM (code 250 ICD9MC). Results: Between 2001 and 2015, there have been 7,302,750 hospital discharges with a primary or secondary diagnosis of DM. After the approval of the SDM-NHS, all the indicators showed a downward trend, modifying the previous trend in the indicators of AMI and LLA. The indicators of stroke and AMI also showed an immediate reduction in their rates. Conclusions: After the approval of the SDM-NHS, an improvement has been observed in all the indicators of macrovascular complications of DM evaluated, although it is difficult to establish a causal relationship between the strategy and the effects observed. Interrupted time series is applicable for evaluating the impact of interventions in public health when experimental designs are not possible.This research was partially funded by the Nazarbayev University #080420FD1916.S

New approach to managing COVID-19 pandemic in a complex tertiary care medical centre in Madrid, Spain

The COVID-19 pandemic is putting healthcare systems under unprecedented stress to accommodate unexpected numbers of patients forcing a quick re-organization. This article describes the staff management experience of a third level referral hospital in the city of Madrid, Spain, one of the cities and hospitals with the largest number of COVID19 cases. A newly created COVID-19-specific Clinical Management Unit (CMU) coordinated all clinical departments and conducted real-time assessments of the availability and needs of medical staff, alongside the hospital's general management board. The Unit was able to (i) redeploy up to 285 physicians every week to bolster medical care in COVID-19 wards and forecast medical staff requirements for the upcoming week so all departments could organize their work while coping with COVID-19 needs, (ii) overview all clinical activities conducted in a medicalized hotel, and (iii) recruit a team of roughly 90 volunteer medical students to accelerate data collection and evidence generation. The main advantage of a clinical management unit composed by a member of every job category - its ability to generate rapid, locally-adapted responses to unexpected challenges - made it perfect for the unprecedented increase in healthcare need generated by the COVID-19 pandemic

Criterios de financiación y reembolso de los medicamentos huérfanos

Dado su elevado precio, los medicamentos huérfanos no suelen ser coste-efectivos bajo los umbrales estándares de aceptación de la evaluación económica. Sin embargo, la sociedad puede considerar relevante tener en cuenta otros criterios adicionales en su decisión de financiación y reembolso público. Este trabajo pretende identificar los criterios que podrían ser relevantes, y aquéllos que efectivamente imperan en la práctica real de los países desarrollados.RESUMEN 1. INTRODUCCIÓN Y OBJETIVO 2. METODOLOGÍA 3. CRITERIOS DE FINANCIACIÓN DE LOS MEDICAMENTOS HUÉRFANOS DESDE UNA PERSPECTIVA TEÓRICA 4. CRITERIOS DE FINANCIACIÓN DE LOS MEDICAMENTOS HUÉRFANOS EN DISTINTOS PAÍSES DESARROLLADOS 5. DISCUSIÓN 6. CONCLUSIONES REFERENCIAS BIBLIOGRÁFICA

Reproductive and Obstetric Outcomes after UAE, HIFU, and TFA of Uterine Fibroids: Systematic Review and Meta-Analysis

Novel treatment options for uterine fibroids, such as uterine artery embolization (UAE), ultrasound-guided and magnetic resonance-guided high-intensity focused ultrasound (USgHIFU and MRgHIFU), and transcervical radiofrequency ablation (TFA) methods, are widely used in clinical practice. This systematic review and meta-analysis (CRD42022297312) aims to assess and compare reproductive and obstetric outcomes in women who underwent these minimally invasive approaches for uterine fibroids. The search was performed in PubMed, Google Scholar, ScienceDirect, Cochrane Library, Scopus, Web of Science and Embase. Risk of bias was assessed using the Newcastle-Ottawa Scale (NOS) and Cochrane guidelines. The articles were selected to meet the following eligibility criteria: (1) research article, (2) human subject research, and (3) the study of pregnancy outcomes after the treatment of uterine fibroids by either one of three methods-UAE, HIFU, and TFA. The analysis of 25 eligible original articles shows a similar rate of live births for UAE, USgHIFU, MRgHIFU, and TFA (70.8%, 73.5%, 70%, and 75%, respectively). The number of pregnancies varied considerably among these studies, as well as the mean age of pregnant women. However, the results of pregnancy outcomes for TFA are insufficient to draw firm conclusions, since only 24 women became pregnant in these studies, resulting in three live births. The miscarriage rate was highest in the UAE group (19.2%). USgHIFU was associated with a higher rate of placental abnormalities compared to UAE (2.8% vs. 1.6%). The pooled estimate of pregnancies was 17.31% to 44.52% after UAE, 18.69% to 78.53% after HIFU, and 2.09% to 7.63% after TFA. The available evidence confirmed that these minimally invasive uterine-sparing treatment options for uterine fibroids are a good approach for patients wishing to preserve their fertility, with comparable reproductive and obstetric outcomes among the different techniques

Manejo hospitalario de la cardiopatía isquémica en España. Análisis de situación

La Enfermedad Isquémica del Corazón (EIC) representa un importante problema para los sistemas de salud pública y para los servicios de salud. La variabilidad en el manejo de estas patologías pone de manifiesto la existencia de incertidumbre en cuanto al valor de las tecnologías, tratamientos y procedimientos disponibles. La medida de la efectividad es imprescindible para mejorar la calidad asistencial. Las Bases de Datos Administrativas (BDA) y los estudios observacionales pueden aportar mucha información para mejorar la toma de decisiones. Los sistemas de ajuste por el riesgo son imprescindibles para poder comparar los resultados de las intervenciones sanitarias. Este trabajo pretende presentar una visión panorámica del manejo hospitalario de la EIC en España, investigando los ingresos hospitalarios y la utilización de procedimientos diagnósticos y de revascularización coronaria, y valorar las posibilidades de evaluar la calidad y efectividad asistencial en el tratamiento de dicha patología utilizando una base de datos administrativa.Introducción, Objetivos, Los estudios observacionales en evaluación de servicios salud, El impacto de la Enfermedad Isquémica del Corazón en España, La variabilidad en la práctica médica e investigación de resultados, Orígenes e implicaciones de la Variabilidad en la Práctica Médica, Variabilidad en el manejo del Infarto Agudo de Miocardio (IAM) y la Enfermedad Isquémica del Corazón (EIC), Investigación de resultados y evaluación de la calidad asistencial, La mortalidad intrahospitalaria como indicador de resultados, Sistema de información para la investigación y evaluación en servicós de salud, Bases de Datos Administrativas (BDA), Características del Conjunto Mínimo Básico de Datos (CMBD), El ajuste por el riesgo. Concepto, Sistemas de ajuste por el riesgo en EIC, Sujetos y métodos, Resultados, IAM: Características generales de los pacientes ingresados por IAM, Descripción de la mortalidad en pacientes ingresados por IAM, Validación de sistemas de ajuste por el riesgo para IAM, Modelos multivariables de ajuste por el riesgo y utilización de procedimientos; ACTP: Características generales de los pacientes ingresados con ACTP, Descripción de la mortalidad en pacientes ingresados con ACTP, Validación de sistemas de ajuste por el riesgo para ACTP; CRC: Características generales de los pacientes ingresados con CRC, Descripción de la mortalidad en pacientes ingresados con CRC, Validación de sistemas de ajuste por el riesgo para CRC, DISCUSIÓN: El manejo hospitalario del IAM en España, Utilización de procedimientos de revascularización en España, Validación de modelos de ajuste por el riesgo con el CMBD-AETS, Conclusiones y recomendaciones, Referencias bibliográficas, ANEXO: Tablas y figuras

Effectiveness of spinal manipulation in treating whiplash injuries.

[ES] Objetivo: Evaluar la eficacia de las manipulaciones espinales en pacientes con «síndrome del latigazo cervical» (whiplash) (SLC). Diseño: Revisión sistemática. Fuentes de datos: Búsqueda sistemática desde enero de 2000 hasta mayo de 2006 en: CINAHL, The Cochrane Library, EMBASE, MEDLINE, Centre for Reviews and Dissemination Index Medicus, PEDro y libros de ponencias de congresos de fisioterapia desde 2000 hasta 2005. Selección de estudios: Criterios de inclusión: estudios de pacientes con SLC y tratamiento basado en manipulaciones espinales exclusivas o combinadas con otras técnicas. Los resultados debían expresarse en al menos uno de los siguientes términos: dolor, efecto general percibido o amplitud de movimientos. Extracción de datos: Los artículos fueron seleccionados por 2 revisores de forma independiente. El análisis de la calidad metodológica se realizó siguiendo las recomendaciones de la Agencia de Evaluación de Tecnologías Sanitarias. La escasez y variedad de los datos encontrados imposibilitaron su análisis estadístico. Resultados: De 290 documentos encontrados se analizaron 9: 7 eran revisiones y 2, estudios primarios. En general, ninguna de las revisiones mostraba pruebas de que las técnicas manipulativas fueran más efectivas que otros tratamientos. La exposición de los resultados era en muchos casos vaga y defectuosa. Conclusiones: No se han encontrado pruebas suficiente de que las manipulaciones espinales sean un tratamiento efectivo del SLC. Aunque parece que a corto plazo produce una mejoría del dolor, no se puede confirmar su evolución a largo plazo, ni sus ventajas clínicas o económicas frente a los tratamientos convencionales. [EN] To assess the efficacy of spinal manipulation treatments in patients with whiplash injuries. Systematic review. A systematic search was conducted between January 2000 and May 2006 in CINAHL, the Cochrane Library, EMBASE, MEDLINE, CRD (Center for Reviews and Dissemination), Spanish Index Medicus, and PEDro. Reports of Physiotherapy congresses between 2000 and 2005 were reviewed. studies of patients with whiplash injuries who were treated with spinal manipulations, either exclusively or combined with other therapies. Outcomes were expressed in at least one of the following: pain, global perceived effect or range of movement (ROM). Only 9 of the first screening (290) were analyzed. The studies were independently selected by 2 reviewers. Methodological quality was assessed on the basis of the recommendations of the Agency for Health Technology Evaluation. The lack of data and their heterogeneity made any statistical analysis impossible. Of the 9 studies analyzed, 7 were systematic reviews and 2 were primary studies. No review showed evidence of the efficacy of spinal manipulations versus other therapies. The results were often explained vaguely and inadequately. There is not enough evidence to suggest that spinal manipulation is an effective treatment for whiplash. Though in the short term it seems to improve pain, any long-term benefit or clinical or economic advantages versus conventional therapies could not be determined.S

Health services utilization and the measures for the sostenibility of the Community of Madrid.

RETIC RD12/0001; FIS PI 06/1122 y PI09/1362.S

Factors associated with the use of Emergency Services by the Spanish population in 2017

[ES] Fundamentos: En los sistemas sanitarios modernos, los Servicios de Urgencias (SU) constituyen una de las piedras angulares de la atención sanitaria y tienen una importancia esencial en la concepción de los servicios sanitarios actuales. El objetivo de este trabajo fue analizar el efecto de las características sociodemográficas y los factores clínicos en la utilización de los SU en España. Métodos: Se realizó un estudio transversal con los datos de la Encuesta Nacional de Salud de España (2017), en el que participaron 23.089 personas adultas (15 años o más). Se definieron tres perfiles poblacionales para analizar las visitas a los SU (jóvenes entre 15 y 24 años; personas con 75 años o más y con pluripatología; población general). Se realizaron análisis descriptivos por perfil poblacional, y se aplicaron modelos de regresión logística por perfil poblacional y tipo de servicio (hospital público, centro público de Urgencias no hospitalario y centro sanitario privado) para evaluar la asociación entre la utilización de los SU y distintas variables clínicas y sociodemográficas. Resultados: El porcentaje de utilización de los SU fue mayor en población anciana con pluripatología (41,1%) en comparación con los jóvenes (35,7%) y la población en general (28,4%). Las personas jóvenes utilizaron más los SU en centros privados, y los factores asociados fueron el sexo femenino (OR=2,862; IC 95%=1,139-7,191), la realización de pruebas diagnósticas (OR=9,401; IC 95%=3,183-27,760), pertenecer a una clase social menos favorecida (OR=0,207; IC 95%=0,073-0,585) y residir en municipios de más de 50.000 habitantes y capitales (OR=5,985; IC 95%=1,143-31,330). La población anciana con pluripatología presentó un peor estado de salud que los otros dos grupos poblacionales y con mayor demanda de los SU en hospitales públicos. Además, en el grupo de población anciana, los factores asociados a la utilización de los SU en hospitales públicos fueron haber sido hospitalizado (OR=2,229; IC 95%=1,333-3,730), pertenecer a una clase social menos favorecida (clase social III: OR=2,794; IC 95%=1,154-6,768/clase social IV-V-VI: OR=3,767; IC 95%=2,236-6,344), residir en municipios de más de 50.000 habitantes y capitales (OR=1,679; IC 95%=1,042-2,704) y tener sólo una consulta al médico de Atención Primaria (AP) (OR=0,603; IC 95%=0,396-0,918). Finalmente, en la población general se observó que las variables asociadas con mayor utilización de los SU en hospitales públicos fueron la edad (OR=1,009; IC 95%=1,001-1,016), un mayor número de consultas al médico de Atención Primaria (OR=1,550; IC 95%=1,180-2,170), la realización de pruebas diagnósticas (OR=1,480; IC 95%=1,236-1,773) y pertenecer a la clase social menos favorecida (clase social IV-V-VI: OR=1,581; IC 95%=1,229-2,033). Conclusiones: Las características asociadas con la utilización de los SU, tanto públicos como privados, así como hospitalarios y extrahospitalarios, difieren según las características socioeconómicas y los factores clínicos. Los resultados de este estudio sugieren reconducir las intervenciones para mejorar los resultados de la atención, así como conseguir un uso más racional de los SU. [EN] Background: In modern health systems, emergency services (ES) constitute one of the cornerstones of health care, and they have an essential role in the conception of current health services. The objective of this work was to analyze the effect of sociodemographic characteristics and clinical factors in the use of ES. Methods: A cross-sectional study was carried out with data from the National Health Survey of Spain (2017) in which 23,089 adults (15 years or more) participated. Three population profiles were defined to analyze visits to ES (young people between 15 and 24 years of age; people aged 75 or over and with multiple pathologies; the general population). Descriptive analyses were performed by population profile, and logistic regression models by population profile and type of service (public hospital, public non-hospital emergency center, and private health center) were applied to evaluate the association between the use of ES and the independent variables. Results: The percentage of use of ES was higher in the elderly population with multiple pathologies (41.1%) compared to young people (35.7%) and the general population (28.4%). Young people between 15 and 24 years of age used ES more in private centers, and the associated factors were female sex (OR=2.862; 95% CI=1.139-7.191), the use of diagnostic tests (OR=9.401; 95% CI=3.183-27.760), belonging to the lowest social classes (OR=0.207; 95% CI=0.073-0.585) and residing in municipalities with more than 50,000 inhabitants and capitals (OR=5.985; 95% CI=1.143-31.330). The elderly population with multiple pathologies presented a worse state of health than the other two population groups and with a higher demand for ES in public hospitals. In addition, in the elderly population group, the factors associated with the use of ES in public hospitals were having been hospitalized (OR=2.229; 95% CI=1.333-3.730), belonging to the lowest social classes (social class III: OR=2.794; 95% CI=1.154-6.768/social class IV-V- VI: OR=3.767; 95% CI=2.236-6.344), residing in municipalities with more than 50,000 inhabitants and capitals (OR=1.679; 95% CI=1.042-2.704) and having had at least one visit to the PC doctor (OR=0.603; 95% CI=0.396-0.918). Finally, in the general population the variables associated with increased use of ES in public hospitals were age (OR=1.009; 95% CI=1.001-1.016), the highest number of visits to the PC doctor (OR=1.550; 95% CI=1.180-2.170), the use of diagnostic tests (OR=1.480; 95% CI=1.236-1.773) and belonging to the lowest social classes (social class IV-V-VI: OR=1.581; 95% CI=1.229-2.033). Conclusions: The characteristics associated with the use of ES, both public and private, as well as hospital and extra-hospital, differ according to socioeconomic characteristics and clinical factors. The results of this study suggest redirecting interventions to improve care outcomes, as well as achieving a more rational use of ES.S

Unveiling the Role of the Work Environment in the Quality of Life of Menopausal Physicians and Nurses

Background: There is a lack of scientific evidence regarding the specific challenges faced by menopausal medical professionals in different work settings. This study aims to investigate the relationship between work environment and the menopausal quality of life (QoL) in physicians and nurses. Methods: This survey was conducted using the Menopausal Quality of Life Questionnaire (MENQOL) with a sample of 35 menopausal physicians and 95 nurses employed in health facilities in Astana and Kyzylorda cities, Kazakhstan. Results: Physicians reported a higher frequency of menopausal symptoms compared to nurses. The difference was statistically significant (p < 0.05) for symptoms such as decreased productivity (60.00% vs. 38.20%), flatulence or gas pains (71.43% vs. 48.39%), weight gain (79.41% vs. 61.80%), changes in skin appearance (79.59% vs. 50.00%), and changes in sexual desire (58.82% vs. 33.70%). Physicians with managerial duties had a significantly higher occurrence of vasomotor symptoms compared to non-managerial physicians (mean 3.35 ± 2.14 vs. 1.69 ± 0.89) and also had a higher mean psychological score (mean 3.26 ± 1.28 vs. 2.29 ± 1.19). Conclusions: These findings reflect differences between the menopause effects related to work environment for doctors and nurses, and shed light on the specific challenges faced by them during menopause. In addition, it is important to consider socio-demographic and workplace-related factors in investigating their impact on the QoL