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OBJECTIVE: This research aims to develop a nursing assessment tool, based on Gordon's Health Functional Patterns, through a content validation by a committee of experts, applying a Delphi technique. DESIGN: An assessment instrument with 53 items has been designed. SITE: It is carried out within the framework of a doctoral thesis, for its implementation by midwives of Primary Health Care. PARTICIPANTS: The committee was made up of 16 professionals with a hide clinical, teaching and research experience who all participated in the entire validation process. INTERVENTION: It has been assessed as a whole and in each of the items through four rounds of consultations, establishing a positive assessment of more than 60% to accept each item, as well as incorporating the suggestions provided by the committee. The final version had to reach a unanimous consensus. MAIN MEASUREMENTS: All items were accepted with a score higher than 60%. RESULTS: There were no contradictions between the inputs provided by the experts, so all of them were integrated into the final version that has a 100% approval by the committee. CONCLUSION: After this process, a new assessment tool is presented to be applied by primary care midwives in the pregnancy monitoring. The questionnaire has been piloted with 50 pregnant women, determining the most prevalent nursing diagnoses, establishing the workload for the midwife of her implementation of individualized care plans to improve some health indicators of pregnant women.
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Evaluación en Enfermería , Atención Primaria de Salud , Humanos , Embarazo , Femenino , Evaluación en Enfermería/métodos , Técnica Delphi , Encuestas y Cuestionarios , Adulto , Atención Prenatal/normas , Atención Prenatal/métodosRESUMEN
Cell-to-cell metabolic interactions are crucial for the functioning of the nervous system and depend on the differential expression of glucose transporters (GLUTs) and monocarboxylate transporters (MCTs). The olfactory receptor neurons (ORNs) and supporting cells (SCs) of the olfactory epithelium exhibit a marked polarization and a tight morphological interrelationship, suggesting an active metabolic interaction. We examined the expression and localization of MCTs and GLUTs in the olfactory mucosa and found a stereotyped pattern of expression. ORNs exhibited GLUT1 labeling in soma, dendrites, and axon. SCs displayed GLUT1 labeling throughout their cell length, whereas MCT1 and GLUT3 localize to their apical portion, possibly including the microvilli. Additionally, GLUT1 and MCT1 were detected in endothelial cells and GLUT1, GLUT3, and MCT2 in the cells of the Bowman's gland. Our observations suggest an energetic coupling between SCs and Bowman's gland cells, where glucose crossing the blood-mucosa barrier through GLUT1 is incorporated by these epithelial cells. Once in the SCs, glucose can be metabolized to lactate, which could be transported by MCTs into the Bowman's gland duct, where it can be used as metabolic fuel. Furthermore, SCs may export glucose and lactate to the mucous layer, where they may serve as possible energy supply to the cilia.
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Regulación de la Expresión Génica , Proteínas Facilitadoras del Transporte de la Glucosa/genética , Proteínas Facilitadoras del Transporte de la Glucosa/metabolismo , Transportadores de Ácidos Monocarboxílicos/genética , Transportadores de Ácidos Monocarboxílicos/metabolismo , Mucosa Olfatoria/metabolismo , Animales , Immunoblotting , Masculino , ARN Mensajero/metabolismo , Ratas , Ratas Sprague-DawleyRESUMEN
Meteorological variables have a noticeable impact on pollutant concentrations. Among these variables, wind speed is typically measured, although research into how pollutants respond to it can be improved. This study considers nine years of hourly CO2 and CH4 measurements at a rural site, where wind speed values were calculated by the METEX model. Nine wind speed intervals are proposed where concentrations, distribution functions, and daily as well as annual cycles are calculated. Contrasts between local and transported concentrations are around 5 and 0.03 ppm for CO2 and CH4, respectively. Seven skewed distributions are applied, and five efficiency criteria are considered to test the goodness of fit, with the modified Nash-Sutcliffe efficiency proving to be the most sensitive statistic. The Gumbel distribution is seen to be the most suitable for CO2, whereas the Weibull distribution is chosen for CH4, with the exponential function being the worst. Finally, daily and annual cycles are analysed, where a gradual decrease in amplitude is observed, particularly for the daily cycle. Parametric and nonparametric procedures are used to fit both cycles. The latter gave the best fits, with the agreement being higher for the daily cycle, where evolution is smoother than for the annual cycle.
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Contaminantes Atmosféricos , Viento , Contaminantes Atmosféricos/análisis , Dióxido de Carbono/análisis , Monitoreo del Ambiente , Humanos , Población RuralRESUMEN
BACKGROUND: As a first step towards a vaccine protecting COVID-19 convalescents from reinfection, we evaluated FINLAY-FR-1A vaccine in a clinical trial. METHODS: Thirty COVID-19 convalescents aged 22-57 years were studied: convalescents of mild COVID-19, asymptomatic convalescents, both with PCR-positive at the moment of diagnosis; and individuals with subclinical infection detected by viral-specific IgG. They received a single intramuscular injection of the FINLAY-FR-1A vaccine (50 µg of the recombinant dimeric receptor binding domain). The primary outcomes were safety and reactogenicity, assessed over 28 days after vaccination. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following vaccination was evaluated by ELISA and live-virus neutralization test. The effector T cellular response was also assessed. Cuban Public Registry of Clinical Trials, WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000349-En. FINDINGS: No serious adverse events were reported. Minor adverse events were found, the most common, local pain: 3 (10%) and redness: 2 (6·7%). The vaccine elicited a >21 fold increase in IgG anti-RBD antibodies 28 days after vaccination. The median of inhibitory antibody titres (94·0%) was three times greater than that of the COVID-19 convalescent panel. Virus neutralization titres higher than 1:160 were found in 24 (80%) participants. There was also an increase in RBD-specific T cells producing IFN-γ and TNF-α. INTERPRETATION: A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 was an efficient booster of pre-existing natural immunity, with excellent safety profile. FUNDING: Partial funding for this study was received from the Project-2020-20, Fondo de Ciencia e Innovación (FONCI), Ministry of Science, Technology and the Environment, Cuba.â¯â¯â¯RESUMEN. ANTECEDENTES: Como un primer paso hacia una vacuna que proteja a los convalecientes de COVID-19 de la reinfección, evaluamos la vacuna FINLAY-FR-1A en un ensayo clínico. MÉTODOS: Se estudiaron treinta convalecientes de COVID-19 de 22 a 57 años: convalecientes de COVID-19 leve y convalecientes asintomáticos, ambos con prueba PCR positiva al momento del diagnóstico; e individuos con infección subclínica detectada por IgG específica viral. Los participantes recibieron una dosis única por vía intramuscular de la vacuna FINLAY-FR-1A (50 µg del dominio de unión al receptor recombinante dimérico del SARS CoV-2). Las variables de medida primarias fueron la seguridad y la reactogenicidad, evaluadas durante 28 días después de la vacunación. La variable secundaria, la inmunogenicidad. La respuesta humoral, al inicio del estudio y después de la vacunación, se evaluó por ELISA y mediante la prueba de neutralización del virus vivo. También se evaluó la respuesta de células T efectoras. Registro Público Cubano de Ensayos Clínicos, WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000349-En. RESULTADOS: No se reportaron eventos adversos graves. Se encontraron eventos adversos leves, los más comunes, dolor local: 3 (10%) y enrojecimiento: 2 (6·7%). La vacuna estimuló un incremento >21 veces de los anticuerpos IgG anti-RBD 28 días después de la vacunación. La mediana de los títulos de anticuerpos inhibidores (94·0%) fue aproximadamente tres veces mayor que la del panel de convalecientes de COVID-19. Se encontraron títulos de neutralización viral superiores a 1:160 en 24 (80%) de los participantes. También hubo un aumento en las células T específicas de RBD que producen IFN-γ y TNF-α. INTERPRETACIÓN: Una sola dosis de la vacuna FINLAY-FR-1A contra el SARS-CoV-2 reforzó eficazmente la inmunidad natural preexistente, con un excelente perfil de seguridad. FINANCIAMIENTO: Se recibió un financiamiento parcial del Proyecto-2020-20, Fondo de Ciencia e Innovación (FONCI), Ministerio de Ciencia, Tecnología y Medio Ambiente, Cuba.
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Objetivo. Comparar la estabilidad dimensional de un hidrocoloide irreversible de vaciado convencional con hidrocoloides irreversibles de vaciado extendido. Metodología. Fueron evaluados cuatro productos con indicación de vaciado extendido: Jeltrate Plus (Denstply Sirona), Hydrogum 5 (Zhermack SpA), Algimax (Major), Kromopan (Lascod) y un producto de vaciado convencional (Tropicalgin; Zhermack SpA). Con cada producto se realizaron 10 impresiones y se vaciaron en yeso tipo III en cinco tiempos de almacenamiento diferentes (0, 24, 96, 120 y 168 horas). Un escáner para modelos tridimensionales se utilizó para digitalizar los modelos de yeso y realizar las mediciones correspondientes: sumatoria de las longitudes, variabilidad dimensional, porcentaje de variabilidad. Resultados. Las cinco marcas comerciales presentaron una sumatoria de longitudes mayor al grupo control (p<0,033). A las 0, 24 y 96h Tropicalgin e Hydrogum 5 presentaron significativamente menor variación dimensional en comparación con el modelo maestro (p<0,001). Los porcentajes de variabilidad oscilaron entre un 0.24 a 0.91%. Conclusiones. La estabilidad dimensional depende del producto utilizado. Almacenado correctamente, el hidrocoloide irreversible de vaciado convencional parece no sufrir alteraciones significativas hasta 96h, mientras que en el caso de Hydrogum 5 parece mantener su estabilidad dimensional hasta 168h.
Objetivo. Comparar a estabilidade dimensional de um hidrocolóide irreversível de vazamento convencional com hidrocolóides irreversíveis de vazamento prolongado. Metodologia. Foram avaliados quatro produtos com indicação de vazamento estendido: Jeltrate Plus (Denstply Sirona), Hydrogum 5 (Zhermack SpA), Algimax (Major), Kromopan (Lascod) e um produto de vaziamento convencional (Tropicalgin; Zhermack SpA). Para cada produto foram feitas 10 impressões e vazadas em gesso tipo III em cinco tempos de armazenamento diferentes (0, 24, 96, 120 e 168 horas). Um scanner de modelos tridimensionais foi utilizado para digitalizar os modelos de gesso e fazer as medições correspondentes: soma dos comprimentos, variabilidade dimensional, percentagem de variabilidade. Resultados. As cinco marcas comerciais apresentaram somatório de comprimentos maior que o grupo controle (p<0,033). Nos tempos 0, 24 e 96h Tropicalgin e Hydrogum 5 apresentaram variação dimensional significativamente menor em comparação ao modelo Mestre (p<0,001). Os percentuais de variabilidade variaram de 0,24 a 0,91%. Conclusões. A estabilidade dimensional depende do produto utilizado. Armazenado corretamente, o hidrocolóide irreversível de vaziamento convencional convencionalmente parece não sofrer alterações significativas até 96h, enquanto no caso do Hydrogum 5 parece manter sua estabilidade dimensional até 168h.
Aim . Compare the dimensional stability of a conventional pouring irreversible hydrocolloid with extended pouring irreversible hydrocolloids. Methodology. Four products with extended emptying indication were evaluated: Jeltrate Plus (Denstply Sirona), Hydrogum 5 (Zhermack SpA), Algimax (Major), Kromopan (Lascod) and a conventional emptying product (Tropicalgin; Zhermack SpA). For each product, 10 impressions were made and cast in type III plaster at five different storage times (0, 24, 96, 120 and 168 hours). A three-dimensional model scanner was used to digitize the plaster models and make the corresponding measurements: sum of lengths, dimensional variability, percentage of variability. Results . The five commercial brands presented a greater sum of lengths than the control group (p<0,033). At 0, 24 and 96h Tropicalgin and Hydrogum 5 presented significantly less dimensional variation compared to the master model (p<0,001). The variability percentages ranged from 0.24 to 0.91%. Conclusions. Dimensional stability depends on the product used. Stored correctly, the conventionally cast irreversible hydrocolloid appears not to undergo significant alterations up to 96h, while in the case of Hydrogum 5 it appears to maintain its dimensional stability up to 168h.
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Increased glucose uptake as a principal energy source is a requirement for the continued survival of tumour cells. Facilitative glucose transporter-1 (GLUT1) and -3 (GLUT3) have been previously shown to be present and regulated in breast cancer cells and are associated with poor patient prognosis. In cancer cells, the cAMP secondary messenger pathway is known to potentiate described glucose transporter activators and regulate cell fate. However, no regulation of the glucose transporters in breast cancer cells by cAMP has previously been examined. Herein, we determined in the well-characterized breast cancer cell line ZR-75, if the cAMP analogue 8-br-cAMP was capable of regulating GLUT1 and GLUT3 expression and thus glucose uptake. We demonstrated that 8-br-cAMP transiently up-regulates GLUT3 mRNA levels. The use of actinomycin-D and the cloning of 1,200 bp upstream of the human GLUT3 promoter demonstrated that this regulation was transcriptional. Immunocytochemistry and Western blotting confirmed that the increase in mRNA was reflected by an increase in protein levels. No notable regulation of GLUT1 in the presence of 8-br-cAMP was detected. Finally, we determined using the non-metabolizable glucose analogue 2-DOG if this up-regulation in GLUT3 increased glucose uptake. We observed the presence of two uptake components, one corresponding to the Km of GLUT1/4 and the other to GLUT3. A doubling in the uptake velocity was observed only at the Km corresponding to GLUT3. In conclusion, we demonstrate and characterize for the first time, an up-regulation of GLUT3 mRNA, protein and glucose uptake by the cAMP pathway in breast cancer cells.
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Neoplasias de la Mama/metabolismo , AMP Cíclico/metabolismo , Regulación Neoplásica de la Expresión Génica , Transportador de Glucosa de Tipo 3/metabolismo , Glucosa/metabolismo , Transducción de Señal , 8-Bromo Monofosfato de Adenosina Cíclica/farmacología , Transporte Biológico/efectos de los fármacos , Neoplasias de la Mama/patología , Línea Celular Tumoral , Desoxiglucosa/farmacología , Relación Dosis-Respuesta a Droga , Femenino , Técnica del Anticuerpo Fluorescente Indirecta , Transportador de Glucosa de Tipo 3/genética , Humanos , Inmunohistoquímica , Progesterona/farmacología , ARN Mensajero/metabolismoRESUMEN
Fundamento: los riesgos que implica el quehacer de los profesionales de la salud en el ejercicio de su práctica cotidiana demandan incorporar los elementos concernientes a la bioseguridad a sus funciones. Objetivo: determinar el nivel de conocimiento y la aplicación de las normas de bioseguridad en estudiantes de enfermería ante la COVID-19. Métodos: se realizó un estudio descriptivo transversal durante el mes de octubre de 2020 en el Hospital Clínico-Quirúrgico "Comandante Faustino Pérez Hernández" y el Hospital Pediátrico "Eliseo Noel Camaño" de Matanzas. Se utilizaron métodos teóricos: histórico-lógico e inductivo-deductivo; y empíricos: cuestionario y el análisis documental. Resultados: a través de la aplicación del cuestionario se obtuvo que el 100 % de los estudiantes tienen un adecuado conocimiento sobre el lavado y secado de las manos, el 83,3 % mostró conocimientos adecuados sobre el uso de equipos de protección personal, mientras que el 100 % conoce el uso del nasobuco en la atención a pacientes con infección respiratoria, además se pudo conocer que el 55,5 % hacen uso de los medios de protección siempre, y el 45,5 % solo lo usan algunas veces. Conclusiones el nivel de conocimiento y la aplicación de las normas de bioseguridad en estudiantes de enfermería ante la COVID-19 fueron en su mayoría adecuados, lo que implica diseñar una capacitación sobre el tema dirigida a aquellos que la necesiten.
Background: the risks involved in the work of health professionals in the exercise of their daily practice demand the incorporation of elements concerning biosafety into their functions. Objective: to determine the level of knowledge and the application of biosafety standards in nursing students while facing COVID-19. Methods: a cross-sectional descriptive study was carried out during the month of October 2020 at the "Comandante Faustino Pérez Hernández" Clinical-Surgical Hospital and the "Eliseo Noel Camaño" Pediatric Hospital in Matanzas. Theoretical methods were used: historical-logical and inductive-deductive; and empirical ones: questionnaire and documentary analysis. Results: through the implentation of the questionnaire, it was obtained that 100% of the students have adequate knowledge about washing and drying their hands, 83.3% showed adequate knowledge about the use of personal protective equipment, while 100% know the use of the facemask in the care of patients with respiratory infection, in addition it was possible to know that 55.5% always use the means of protection, and 45.5% only use it sometimes. Conclusions: the level of knowledge and the application of biosafety standards in nursing students before COVID-19 was mostly adequate, which implies designing training on the subject aimed at those who need it.
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Estudiantes de Medicina , Infecciones por Coronavirus , Educación MédicaRESUMEN
Introducción: La satisfacción del paciente y el prestador de servicio asistencial de salud es una variable multidimensional de la calidad en la atención médica. La comunicación, la atención y cortesía, el tiempo de espera percibido, la aplicación de una tecnología de avanzada y una infraestructura idónea son los factores que se deben trabajar para incrementar dicha satisfacción. Objetivo: Identificar el nivel de satisfacción de pacientes, familiares y prestadores de servicios en el Instituto de Hematología e Inmunología. Métodos: Se realizó un estudio descriptivo de corte transversal, durante cinco años (2017-2021). El universo lo conformaron 1004 personas, seleccionados mediante un muestreo aleatorio simple. Se aplicaron para la evaluación de la satisfacción las técnicas de encuestas y entrevistas. Resultados: Se identificó el nivel de satisfacción de las personas respecto a las dimensiones evaluadas sobresaliendo en más del 90 por ciento el trato recibido, la eficiencia en los servicios prestados y la privacidad en salas de asistencia médica. Resultó ser de un 93 por ciento el compromiso y la entrega de los prestadores de servicios y más del 70 por ciento del personal se capacitó. Se analizaron varios indicadores a partir de encuestas de tipo cerradas, abiertas y entrevistas. Conclusiones: La identificación del nivel de satisfacción de pacientes, familiares y prestadores de servicios permite mitigar o eliminar la mayoría de las inconformidades lo que contribuye a la mejora en los servicios asistenciales, docentes e investigativos, que avalan los logros alcanzados por el instituto en la actualidad(AU)
Introduction: Patient and healthcare provider satisfaction is a multidimensional variable of healthcare quality. Communication, care and politeness, the perceived waiting time, the application of advanced technology, as well as an adequate infrastructure, are the factors that should be worked on to increase such satisfaction. Objective: To identify the level of satisfaction of patients, family members and service providers at the Institute of Hematology and Immunology. Methods: A descriptive and cross-sectional study was carried out during five years (2017-2021). The universe consisted of 1004 people, selected by simple random sampling. The survey and interview techniques were used to evaluate satisfaction. Results: The level of satisfaction of the people was identified, with respect to the evaluated dimensions; received treatment, efficiency of provided services and privacy in medical care rooms stood out in more than 90 percent. The commitment and dedication of the service providers was 93 percent, while more than 70 percent of the personnel received training. Several indicators were analyzed based on closed or open-ended surveys and interviews. Conclusions: The identification of the level of satisfaction among patients, family members and service providers allows mitigating or eliminating most of the nonconformities, contributing to the improvement in care, teaching and research services, which confirms the achievements attained by the institute nowadays(AU)
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Humanos , Masculino , Femenino , Calidad de la Atención de Salud , Encuestas y Cuestionarios , Satisfacción del Paciente , Personal de Salud/ética , Epidemiología Descriptiva , Estudios TransversalesRESUMEN
Introducción: Un sistema de gestión de calidad brinda la estructura organizativa, los procesos, los procedimientos y las herramientas para implementar las actividades y alcanzar los objetivos requeridos. Es un proceso en el que participan directivos, operativos y administrativos. Todos deben reconocer y asumir su responsabilidad para el éxito de la implementación o mejoramiento del sistema y deben esforzarse para alcanzarlo. Objetivo: Exponer el proceso de implementación del sistema de gestión de calidad del Instituto de Hematología e Inmunología. Métodos: Se realizó una investigación descriptiva. Se realizaron encuestas, entrevistas y auditorías para mostrar el desarrollo del sistema de gestión de calidad del Instituto de Hematología e Inmunología. El período de estudió fue de 2017-2020 e incluyó 32 áreas del instituto. Resultados: Se crearon los documentos del sistema de gestión de calidad y el plan de gestión. Se capacitó al personal. Se definieron las políticas, el objetivo y la proyección estratégica de la calidad. Se elaboró y se puso en ejecución todo el sistema documental, con un total de más de 590 documentos. Las tareas derivadas del plan de gestión de la calidad se cumplieron en un 81,25 por ciento, esto permitió identificar las áreas de mejoras Conclusiones: La implementación del sistema de gestión de calidad es trascendental para elevar el buen desempeño de una organización de salud y constituye el motor impulsor para lograr la calidad merecida en todos los servicios asistenciales que brinda, lo cual demuestra su importancia para alcanzar los resultados que espera y necesita el sistema de salud cubano(AU)
Introduction: A quality management system provides the organizational structure, processes, procedures and tools to implement activities and achieve the required objectives. It is a process with the participation of management, operational and administrative personnel. All of them must recognize and assume their responsibility for the successful implementation or improvement of the system and must strive to achieve it. Objective: To describe the implementation process of the quality management system in the Institute of Hematology and Immunology. Methods: A descriptive research was carried out. Surveys, interviews and audits were conducted to show the development of the quality management system in Institute of Hematology and Immunology. The study period was 2017-2020 and included 32 institutional areas. Results: The corresponding documents were created for the quality management system and the management plan. The personnel received training. Quality policies, objective and strategic projection were defined. The entire document system was developed and implemented, with a total of more than 590 documents. The tasks derived from the quality management plan were completed at 81.25 percent, which allowed the identification of areas for improvement. Conclusions: The implementation of the quality management system is transcendental to raise the good performance of a health organization, as well as the driving force to achieve the deserved quality in all the care services provided by any institution, which shows its importance to achieve the outcomes expected and needed by the Cuban health system(AU)
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Humanos , Masculino , Femenino , Gestión de la Calidad Total/organización & administración , Acreditación de Hospitales , Epidemiología DescriptivaRESUMEN
El objetivo de este trabajo es evaluar la actitud y satisfacción de 182 pacientes con trastorno mental grave alojados en pisos y residencias supervisadas, sus redes sociales, las necesidades de atención y los cambios clínicos. Se recogieron datos sociodemográficos y clínicos. Se aplicaron los cuestionarios de Actitudes del Usuario (CAU), de Red Social (CURES) y la Escala ENAR-CPB de Valoración de los Niveles de Atención Residencial, con repetición a los dos años. El 86% refirieron mejoría en su vida, 77% en su enfermedad y 50% en sus relaciones sociales. Se observó una reducción significativa en las necesidades de atención a los dos años. Un 86% no tuvo ingresos hospitalarios, frente al 99% del año previo. En general, encontramos una buena aceptación de los alojamientos, con mejoría en las relaciones sociales, la estabilidad clínica y hospitalizaciones. Gracias al tratamiento asertivo comunitario, la mayoría consideraba que había habido una mejoría en su enfermedad y en sus vidas. (AU)
The aim of this work was to evaluate the attitude and satisfaction of 182 patients with severe mental disorder in supervised accommodation, their social networks, their care needs and clinical changes. Sociodemographic and clinical data were collected. The User Attitudes Questionnaire (CAU), the Social Network Questionnaire (CURES) and the Scale of Assessment of the Levels of Residential Attention for people with Severe Mental Disorder (ENAR-CPB) were administered with repetition at two years. 86% of them reported improvement in their life, 77% in their illness, and 50% in their social relationships. There was a significant reduction in care needs at two years. 86% of the participants did not have hospital admissions, compared to 99% the previous year. In general, we found a good acceptance of the accommodations, as well as an improvement in their social relationships, clinical stability, and hospitalizations. Thanks to the assertive community treatment, the majority considered that there was an improvement both in their disease and in their lives. (AU)
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Humanos , Masculino , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Trastornos Mentales , Salud Mental , Rehabilitación Psiquiátrica , Epidemiología Descriptiva , Estudios Transversales , Encuestas y CuestionariosRESUMEN
Regulators and payers have contrasting priorities that can lead to divergent decisions and delays in patient access to new treatments. Those involved in coverage decisions have not routinely been integrated in the drug development process. Theoretically, inclusion of payer representatives early in development could help discern discordance among stakeholder priorities; facilitate cooperation to align objectives; foster agreement on the evidence required for approval and reimbursement; improve transparency, accountability, and consistency of payer decision making; and ideally, minimize delays in patient access to new therapies. However, early participation by payers may not provide these expected benefits if payers' decision-making processes are not evidence based or cannot be reliably predicted. This paper describes current interactions among regulatory agencies, payers, sponsors, and investigators and proposes collaboration among all stakeholders earlier in the development process. The premise that a priori discussions might facilitate the delivery of advances in cardiovascular care is a hypothesis worth testing.
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Fármacos Cardiovasculares/economía , Aprobación de Drogas/organización & administración , Control de Medicamentos y Narcóticos , Control de Medicamentos y Narcóticos/economía , Control de Medicamentos y Narcóticos/métodos , Accesibilidad a los Servicios de Salud/organización & administración , Accesibilidad a los Servicios de Salud/normas , Humanos , Mejoramiento de la Calidad , Mecanismo de ReembolsoRESUMEN
Introducción: El trasplante es la opción terapéutica más favorable para las personas con insuficiencia renal crónica. El donante puede ser cadavérico o donante vivo, emparentado o no. Los resultados del trasplante están en relación con varios factores inmunológicos y no inmunológicos. Objetivo: Caracterizar inmunogenéticamente a los donantes cadavéricos cubanos para trasplante renal. Métodos: Se realizó un estudio transversal y descriptivo de los donantes cadavéricos durante el año 2019. Se analizó la región de procedencia, sexo, color de la piel y rangos de edades de los donantes, así como, grupo sanguíneos ABO y Rhesus Rh; serología para VIH, Virus de hepatitis B(VHB) y Virus de hepatitis C (VHC); y hábitos tóxicos. Resultados: Se estudió un total de 95 donantes cadavéricos, 62 provenientes del occidente y 33 del centro del país. El 63,2 por ciento fueron masculinos y 36,8 por ciento femenino. El grupo de edad de mayor frecuencia fue 40 - 60 años y la edad media de 49,45 años. El 58,95 por ciento de los pacientes fueron de grupo sanguíneo O; 30,53 por ciento grupo A y los grupos B y AB tuvieron 5,26 por ciento de prevalencia; y solo 8 fueron Rh negativos. Todos tuvieron serología para VIH, VHB y VHC negativas. Las enfermedades asociadas más frecuentes fueron la hipertensión arterial y la diabetes mellitus. Conclusiones: Los donantes cadavéricos durante el año 2019 mostraron características similares a las reportadas por otros estudios. El aumento de las edades de los donantes incide en la aparición de enfermedades asociadas y esto pudiera repercutir en el resultado del trasplante(AU)
Introduction: Transplantation is the most favorable therapeutic option for people with chronic renal failure. The donor can be a cadaveric or living donor, related or not. Transplant outcomes are related to various immunological and non-immunological factors. Objective: To characterize Cuban cadaveric donors for renal transplantation Materials and methods: A cross-sectional and descriptive study of cadaveric donors was carried out during the year 2019. The region of origin, sex, skin color and age ranges of the donors were analyzed, as well as ABO and Rhesus Rh blood groups; serology for HIV, Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV), and toxic habits. Results: A total of 95 cadaveric donors were studied, 62 from the West and 33 from the Center of the country. 63.2 percent were male and 36.8 percent female due to the most frequent age group being 40-60 years and the mean age of 49.45 years. 58.95 percent of the patients were of blood group O, 30.53 percent group A and groups B and AB had 5.26 percent prevalence; and only 8 were Rh negative. All had negative serology for HIV, HBV and HCV. The most frequent associated diseases were arterial hypertension and diabetes mellitus. Conclusions: The cadaveric donors during the year 2019 showed characteristics similar to those reported by other studies. The increase in the age of the donors affects the appearance of associated diseases and this could affect the result of the transplant(AU)
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Humanos , Donantes de Tejidos , Antígenos de Grupos Sanguíneos , Pigmentación de la Piel , Sobrevivientes , Donadores Vivos , Insuficiencia Renal Crónica , Factores Inmunológicos , Fallo Renal Crónico , Epidemiología Descriptiva , Estudios Transversales , CubaRESUMEN
Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.
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Fármacos Cardiovasculares/uso terapéutico , Ensayos Clínicos como Asunto , Insuficiencia Cardíaca/tratamiento farmacológico , Evaluación de Resultado en la Atención de Salud , Consenso , Aprobación de Drogas , HumanosRESUMEN
RESUMEN Objetivo: Identificar la relación de los riesgos laborales de tipo psicosocial y el desgaste psíquico con respuestas de estrés en 985 trabajadores de una administración pública mexicana. Materiales y métodos: El diseño del estudio es no experimental, transversal y cuantitativo. Se aplicó la batería para el estudio de las condiciones de trabajo de carácter psicosocial CTCPSMAC, validada para población iberoamericana, con Alpha de Crombach 0.927 y población mexicana 0,931. Se realizó el análisis de datos a través del programa IBM SPSS Statistics 21 mediante un análisis bivariado y regresión logística binaria. Resultados: Características personales, relaciones interpersonales en el trabajo y carga y ritmo de trabajo están asociados a respuestas cognitivo-emocional, conductual y fisiológica. Ambientes laborales y amortiguadores del riesgo psíquico están asociados a las respuestas conductual y isiológica. Concepción de las tareas del puesto de trabajo está asociada a las respuestas cognitivo-emocional y fisiológicas. La exposición a una mala interrelación trabajo con problemas familiares o sociales y características de la empresa, está asociada a respuesta conductual. Conclusiones: La investigación mostró que en la organización pública objeto de estudio existe una relación signiicativa entre los factores de riesgo psicosocial del entorno laboral y las respuestas de estrés por parte de los trabajadores que integran la misma, poniendo en riesgo la salud de estos, por lo que es importante considerar el cumplimiento de la Norma Oficial Mexicana NOM-035-STPS-2018, que recién entró en vigencia.
ABSTRACT Objective: The purpose of the present study is to identify the relationship of occupational risks of psychosocial type and psychic attrition with stress responses in 985 Mexican public administration workers. Materials and methods: The study design is non-experimental, cross-sectional, and quantitative. The CTCPSMAC questionnaire, used to study the work conditions of a psychosocial nature, was applied, validated for an Ibero-American population, with a 0.927 Crombach's Alpha; and a 0.931 value for a Mexican population. Data analysis was performed through the IBM SPSS Statistics 21 program, using a bivariate analysis and binary logistic regression. Results: Personal characteristics, interpersonal relationships at work, and work load and rhythm are associated with cognitive-emotional, behavioral, and physiological responses. Work environments and psychic risk buffers are associated with behavioral and physiological responses. Conception of job duties is associated with cognitive-emotional and physiological responses. Exposure to a bad work interrelation with family or social problems, and company characteristics is associated with behavioral response. Conclusions: The research showed that, in the public organization under study, there is a significant relationship between the psychosocial risk factors of the work environment and the stress responses by the workers who integrate it, putting their health at risk,thus, it is important to consider compliance with the Official Mexican Standard NOM-035-STPS-2018, which has just been enacted.
RESUMEN
Hyperkalemia is a common clinical problem, especially in patients with chronic kidney disease, diabetes mellitus, or heart failure. Treatment with renin angiotensin aldosterone system inhibitors exacerbates the risk of hyperkalemia in these patients. Concern about hyperkalemia can result in the failure to initiate, suboptimal dosing, or discontinuation of renin angiotensin aldosterone system inhibitor therapy in patients; effective treatments for hyperkalemia might mitigate such undertreatment. New treatments for hyperkalemia in development may offer better efficacy, tolerability and safety profiles than do existing approved treatments. These compounds might enable more eligible patients to receive renin angiotensin aldosterone system inhibitor therapy or to receive renin angiotensin aldosterone system inhibitors at target doses. The evidence needed to support a treatment claim (reduction in serum potassium) differs from that needed to support a prevention claim (preventing hyperkalemia to allow renin angiotensin aldosterone system inhibitor treatment). Thus, several issues related to clinical trial design and drug development need to be considered. This paper summarizes and expands upon a discussion at the Global Cardiovascular Clinical Trialists 2014 Forum and examines methodologic considerations for trials of new potassium binders for the prevention and management of hyperkalemia in patients with renin angiotensin aldosterone system inhibitor indications.
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Inhibidores de la Enzima Convertidora de Angiotensina/efectos adversos , Hiperpotasemia/tratamiento farmacológico , Sistema Renina-Angiotensina/efectos de los fármacos , Ensayos Clínicos como Asunto , Comorbilidad , Humanos , Hiperpotasemia/metabolismo , Potasio/metabolismo , Guías de Práctica Clínica como Asunto , Proyectos de InvestigaciónRESUMEN
INTRODUCCIÓN: La región sudeste del Gran Buenos Aires (GBA) reformuló el sistema público de salud por la pandemia de COVID19. Entre las medidas que se tomaron, está la ampliación del número de camas mediante la construcción y puesta en marcha de tres hospitales. OBJETIVO: Evaluar el impacto de la ampliación del número de camas en los resultados de internación de los pacientes asistidos por los efectores públicos de salud durante el período de estudio (8 de abril de 2020 al 11 de septiembre de 2020). MÉTODOS: Estudio descriptivo a partir de información registrada en el Tablero COVID-19, software de gestión desarrollado por el equipo del Instituto del Cálculo de la Universidad de Buenos Aires, en el que se obtienen datos de cada paciente internado en la red de efectores de salud; se evalúan los resultados del efecto del aumento de la capacidad instalada. RESULTADOS: Se registraron 2 306 pacientes internados, de los cuales 266 (11,54%) requirieron internación en unidad de cuidados intensivos (UCO), 1 786 (77,4%) en cuidados intermedios y 254 (11%) pacientes en sala general. La media de edad fue de 50,63 y los pacientes de sexo masculino representaron el 55,5% del total. Se produjeron 253 muertes (10,97%), de las cuales el 64% fueron hombres. El 58,3% del total tenían enfermedades preexistentes, estos tienen un riesgo 90% más alto que quienes no las tenían. El promedio total de ocupación de camas en UCI fue del 40,7%, mientras que el de ocupación en cuidados intermedios fue de 61,5%. Sin los hospitales nuevos, 169 pacientes (9,46%) no hubieran tenido camas en cuidados intermedios y 31 pacientes (11,6%) no hubieran tenido cama en la UCI. DISCUSIÓN: El sistema de salud de la región sudeste del GBA se preparó de manera adecuada gracias a la ampliación del número de camas de internación.
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Mortalidad , Infecciones por Coronavirus , Sistemas Nacionales de SaludRESUMEN
The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus.
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Enfermedades Cardiovasculares/inducido químicamente , Enfermedades Cardiovasculares/epidemiología , Diabetes Mellitus/tratamiento farmacológico , Hipoglucemiantes/efectos adversos , Animales , Guías como Asunto , Humanos , Hipoglucemiantes/uso terapéutico , Medición de Riesgo , Gestión de Riesgos , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVES: The aim of this study was to assess prevalence, clinical characteristics, and prognosis in elderly patients with heart failure with preserved ejection fraction (HFPEF) compared to patients with heart failure with reduced ejection fraction (HFREF) who were followed in an internal medicine unit. METHODS: In this retrospective observational study, the sample consisted of 301 patients followed in an internal medicine referral unit between January 2007 and December 2010. All patients were checked to determine their vital status on 31 December 2012. Survival was analyzed using Kaplan-Meier curves, and compared using the log-rank test. RESULTS: Of the 301 patients, 165 (54.8%) were women. In the 263 cases (87.4%) who underwent echocardiographic assessment, 190 (72.2%) had HFPEF and 73 (27.8%) had HFREF. Mean age was similar in the two groups (80.1 and 79.9 years; p=0.905), with a predominance of women in the HFPEF group (60.5% women, 42.5% men; p=0.025). The main etiology was hypertensive heart disease in the HFPEF group. Regarding treatment, more beta-blockers were administered in the HFREF group. No statistically significant differences were observed between the groups in terms of cardiovascular risk factors, comorbidities, NYHA functional class, or mortality. CONCLUSION: Clinical characteristics were similar for both HFPEF and HFREF patients. Women were predominant in the HFPEF group, as was hypertensive etiology. No significant differences in mortality were observed between the groups.
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Insuficiencia Cardíaca/diagnóstico , Anciano , Anciano de 80 o más Años , Femenino , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Humanos , Masculino , Pronóstico , Estudios Retrospectivos , Volumen SistólicoRESUMEN
The assessment of the relationship between species diversity, species interactions and environmental characteristics is indispensable for understanding network architecture and ecological distribution in complex networks. Saproxylic insect communities inhabiting tree hollow microhabitats within Mediterranean woodlands are highly dependent on woodland configuration and on microhabitat supply they harbor, so can be studied under the network analysis perspective. We assessed the differences in interacting patterns according to woodland site, and analysed the importance of functional species in modelling network architecture. We then evaluated their implications for saproxylic assemblages' persistence, through simulations of three possible scenarios of loss of tree hollow microhabitat. Tree hollow-saproxylic insect networks per woodland site presented a significant nested pattern. Those woodlands with higher complexity of tree individuals and tree hollow microhabitats also housed higher species/interactions diversity and complexity of saproxylic networks, and exhibited a higher degree of nestedness, suggesting that a higher woodland complexity positively influences saproxylic diversity and interaction complexity, thus determining higher degree of nestedness. Moreover, the number of insects acting as key interconnectors (nodes falling into the core region, using core/periphery tests) was similar among woodland sites, but the species identity varied on each. Such differences in insect core composition among woodland sites suggest the functional role they depict at woodland scale. Tree hollows acting as core corresponded with large tree hollows near the ground and simultaneously housing various breeding microsites, whereas core insects were species mediating relevant ecological interactions within saproxylic communities, e.g. predation, competitive or facilitation interactions. Differences in network patterns and tree hollow characteristics among woodland sites clearly defined different sensitivity to microhabitat loss, and higher saproxylic diversity and woodland complexity showed positive relation with robustness. These results highlight that woodland complexity goes hand in hand with biotic and ecological complexity of saproxylic networks, and together exhibited positive effects on network robustness.
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Biodiversidad , Ecosistema , Bosques , Insectos , Animales , Insectos/clasificación , EspañaRESUMEN
The purpose of the following study is to characterize the variables, psychic attrition, and self-esteem, as well as explore their association and identify differences, in a group of working and non-working women in a socially vulnerable condition of Ciudad Guzmán, Jalisco. Exploratory, descriptive, correlational study; we applied the fourth dimension of the Battery for the study of psychosocial working conditions (CTCPS-MAC), which evaluates psychic attrite and three factors (cognitive-emotional response, behavioral response, and physiological response). As well as the Cooper and Smith test that assesses self-esteem in three dimensions (self, family and social), to 195 vulnerable women to whom the System of Integral Development of the Family (DIF because of its acronym in Spanish) grants monthly support in the form of provisions, of which 125 are housewives and 70 work outside their home. The results showed a tendency in the majority of the population to present optimal ratings regarding psychic wear and self-esteem. There was no significant difference in women who work outside the home and those who do not. The correlation we found between the factor 1 of psychic wear and self-esteem. It remains an assumption for future studies that women with high self-esteem will tend to manifest less mental weariness.
El propósito del siguiente estudio es caracterizar las variables desgaste psíquico y autoestima, así como explorar su asociación e identificar diferencias, en un grupo de mujeres trabajadoras y no trabajadoras en condición de vulnerabilidad social de Ciudad Guzmán, Jalisco. El estudio exploratorio, descriptivo, correlacional, se aplicó la dimensión número cuatro de la Batería para el estudio de las condiciones de trabajo de carácter psicosocial (CTCPSMAC), que evalúa desgaste psíquico y tres factores (respuesta cognitiva-emocional; respuesta conductual y respuesta fisiológica); así como el test de Cooper y Smith que evalúa autoestima en tres dimensiones (sí mismo, familiar y social) a 195 mujeres vulnerables, a quienes el Sistema de Desarrollo Integral de la Familia (DIF) otorga apoyo mensual en forma de despensa, y de las cuales 125 son amas de casa y 70 trabajan fuera de su hogar. Los resultados mostraron una tendencia, en la mayoría de la población, a presentar calificaciones óptimas en lo relativo al desgaste psíquico y la autoestima. No hubo diferencia significativa en las mujeres que trabajan fuera de casa y las que no lo hacen. Se encontró correlación entre el factor 1 de desgaste psíquico y la autoestima. Queda como un planteamiento supuesto para futuros estudios, que mujeres con una autoestima elevada tenderán a manifestar menos desgaste psíquico.