[Design of a nursing assessment instrument during pregnancy monitoring in Primary Health care and the validation of its content]. / Diseño de un instrumento de valoración enfermera para el seguimiento de embarazo en Atención Primaria de salud y la validación de su contenido.

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.

Conocimientos sobre medidas de bioseguridad ante la COVID-19 en estudiantes de Enfermería / Knowledge about biosecurity measures against COVID-19 in nursing students

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.

Satisfacción de pacientes y prestadores de servicios en el Instituto de Hematología e Inmunología / Satisfaction of Patients and Service Providers in the Institute of Hematology and Immunology

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)

Implementación del sistema de gestión de calidad en el Instituto de Hematología e Inmunología / Implementation of the Quality Management System in the Institute of Hematology and Immunology

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)

Las personas con trastorno mental grave en un programa de alojamiento supervisado por un Equipo Comunitario Asertivo / People with severe mental disorders in a housing program supervised by an Assertive Community Team

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)

Caracterización inmunogenética de donantes cadavéricos cubanos en el año 2019 / Immunogenetic characterization of Cuban cadaveric donors in 2019

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)

Riesgos laborales de tipo psicosocial y desgaste psíquico en trabajadores de una administración pública mexicana / Occupational Risks of the Psychosocial Type and Psychic Attrition in Mexican Public Administration Workers

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.

A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial.

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.   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.

Influence of Wind Speed on CO2 and CH4 Concentrations at a Rural Site.

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.

La región sudeste del Gran Buenos Aires frente a la pandemia Evaluación de la ampliación del sistema de salud en el marco de la COVID 19 / The Southeastern region of the Buenos Aires Province metropolitan area in the face of the pandemic: evaluation of the expansion of the health system in the framework of COVID-19

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.

Evaluación preliminar de estándares de calidad en el Instituto de Hematología e Inmunología / Preliminary evaluation of quality standards in the Institute of Hematology and Immunology

Introducción: El Instituto de Hematología e Inmunología (IHI), desde el año 2002 comenzó a capacitar a todo el personal en Sistema de Gestión de la Calidad y paulatinamente avanzó en la documentación requerida hasta lograr una política y un Programa de Garantía de la Calidad, basado en normativas nacionales, cumpliendo con el anexo Programa de Perfeccionamiento continuo de la calidad de los servicios hospitalarios. Objetivo: Realizar una evaluación preliminar de estándares de calidad en el IHI, aplicando la última versión del Manual de Acreditación, para solicitar la acreditación hospitalaria. Métodos: Se realizó una evaluación parcial mediante auditorías internas al 90 por ciento de las áreas y se desarrollaron actividades para cumplir con lo solicitado por la Junta Nacional de Acreditación en Salud. Se emplearon diversos métodos, como aplicación de listas de verificación, cursos de capacitación y superación, observación in situ de evidencias objetivas, entrevistas, encuestas y revisión de documentos. Resultados: De los 18 servicios auditados se obtuvo del Estándar Centrado en la Atención y Seguridad a Paciente el cumplimiento del 77 por ciento de los elementos a evaluar; dl Estándar Docencia e Investigación, se cumplió el 88 por ciento y del Estándar Gestión y Seguridad Hospitalaria se cumplió el 87 por ciento de los elementos auditados. Conclusiones: La aplicación preliminar de los estándares de calidad en el IHI ha generado más de 60 documentos, lo cual indica el desarrollo progresivo en esta actividad, además de capacitar al personal en temas de calidad y conocer el estado de satisfacción de pacientes y prestadores de servicios(AU)

Introduction: The Institute of Hematology and Immunology (IHI) had begun training all its personnel in the Quality Management System since 2002 and it gradually progressed in the required documentation until achieving a policy and a Quality Assurance Program, based on national regulations, complying with the annex Program of continuous improvement of the quality of hospital services. Objective: To carry out a preliminary evaluation of quality standards in the IHI, applying the latest version of the Accreditation Manual, in order to request hospital accreditation. Methods: A partial evaluation was carried out through internal audits to 90 percent of the areas and activities were developed to comply with the requirements of the National Health Accreditation Board. Various methods were used, such as: application of checklists, training and improvement courses, on-site observation of objective evidence, interviews, surveys and document review. Results: Of the 18 audited services, compliance with 77 percent of the elements to be evaluated was obtained from the Standard centered on Patient Care and Safety; 88 percent of the Standard related to Teaching and Research was fullfilled and the Hospital Management and Safety Standard achieved 87 percent of the audited elements. Conclusion: The preliminary application of the quality standards in the IHI has generated more than 60 documents. It indicates the progressive development of this activity and at the same time allows for the training of the staff on quality issues and gives us the possibility of knowing the satisfaction status of patients and service providers(AU)

Evaluación del riesgo biológico en laboratorios de Control de la Calidad del Instituto Finlay / Evaluation of biological risk in quality control laboratories of the Finlay Institute

El Instituto Finlay dedicado a producir vacunas empleando agentes biológicos, durante años, viene capacitando al personal de las áreas que presentan mayor potencial de riesgos, dada la importancia de proteger a sus trabajadores, instalaciones, equipos y producciones. Por ello se comenzaron a realizar evaluaciones de riesgos según métodos empleados por otros países, como España. Este trabajo tuvo como objetivo principal evaluar el riesgo biológico en laboratorios de Control de la Calidad, tales como el laboratorio de Bacteriología y el laboratorio de Pruebas Biológicas. Otros objetivos fueron, analizar la aplicación de la legislación nacional vigente de Bioseguridad y proponer un programa de acciones. El estudio se realizó en el último trimestre del año 2011 y primer semestre del año 2012. Se utilizaron como instrumentos de calidad, el método de la observación, listas de chequeo, entrevistas, tormentas de ideas y análisis documental. Los resultados mostraron que: ambos laboratorios cumplieron la legislación vigente de Bioseguridad, se identificaron los factores de riesgos más frecuentes, de ellos los de mayor nivel de riesgo y se obtuvo un programa de acciones correctivas encaminado a la solución de problemas detectados. Se demostró la posibilidad de la aplicación de un método cuantitativo, escogido para evaluar el riesgo y la implementación del programa de acciones correctivas con resultados satisfactorios(AU)

The Finlay Institute, dedicated to producing vaccines using biological agents, has for years been training personnel in the areas with the greatest risk potential, given the importance of protecting its workers, facilities, equipment and production. Therefore, risk assessments were started according to methods used by other countries, such as Spain. The main objective of this work was to evaluate the biological risk in Quality Control laboratories, such as the Bacteriology laboratory and the Biological Testing laboratory. Other objectives were to analyze the application of the current national Biosecurity legislation and propose a program of actions. The study was conducted in the last quarter of 2011 and the first semester of 2012. The observation method, checklists, interviews, storms of ideas and documentary analysis were used as quality instruments. The results showed that: both laboratories complied with the current Biosafety legislation, the most frequent risk factors were identified, including those with the highest level of risk and a program of corrective actions aimed at solving problems detected was obtained. The possibility of the application of a quantitative method, chosen to evaluate the risk and the implementation of the program of corrective actions with satisfactory results was demonstrated(AU)

Psychic attrition and self-esteem of women in a socially vulnerable condition in Ciudad Guzmán, Jalisco / Desgaste psíquico y autoestima de mujeres en condición de vulnerabilidad social de ciudad Guzmán, Jalisco

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.

Role of Payers in the Development of Cardiovascular Therapeutics: Misalignment Between Approval and Reimbursement.

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.

Desgaste psíquico y vulnerabilidad social de mujeres zapotlenses. Un estudio descriptivo / Psychic wear and social vulnerability of Zapotlenses women: A descriptive study

Resumen Introducción: Numerosos estudios han documentado la incidencia de los riesgos psicosociales, y particularmente, del desgaste psíquico en la salud de los trabajadores. No obstante, las mujeres en condición de vulnerabilidad social no han sido objeto de exploración. Objetivo: Caracterizar el desgaste psíquico de una muestra de mujeres vulnerables. Materiales y métodos: Estudio exploratorio, descriptivo, correlacional. Se aplicó la dimensión número 4 de la Batería para el estudio de las condiciones de trabajo de carácter psicosocial (CTCPS-MAC), que evalúa desgaste psíquico y 3 factores particulares (respuesta cognitiva-emocional; respuesta conductual y respuesta fisiológica), a 99 mujeres vulnerables de Zapotlán el Grande. Resultados: Un 75,8 % de las participantes presentaron condiciones óptimas con calificaciones entre bueno y muy bueno, el 24,2% entre normal y nocivo, lo cual indica que requieren ayuda inmediata. El factor más afectado fue el número 1, respuesta cognitivo-emocional, el 52,5% presentó sintomatología negativa. No se encontraron asociaciones significativas entre las variables sociodemográficas estudiadas y el desgaste psíquico. Conclusiones: Los resultados permiten abrir puertas para investigaciones más profundas con la población estudiada con el fin de garantizar salud mental, y calidad de vida en las mujeres en estado de vulnerabilidad social de Zapotlán el Grande.

Abstract Introduction: Numerous studies have documented the impact of psychosocial risks, and particularly the psychic wear on workers' health. However, women in a situation of social vulnerability have not been the subject of exploration. Objective: To characterize the psychic wear in a sample of vulnerable women. Materials and methods: An exploratory, descriptive and correlational study was conducted. The dimension number 4 from the Battery for the study of the working conditions of psychosocial character was applied (CTCPS-MAC), which evaluates psychological wear and 3 particular factors (cognitive-emotional response; behavioral response and physiological response) at 99 Vulnerable women of Zapotlán el Grande. Results: A 75.8 % of the participants presented optimal conditions with ratings between good and very good, 24.2% between normal and harmful, which indicates that they require immediate assistance. The most affected factor was number 1 (cognitive-emotional response), 52.5% presented negative symptomatology. There were no significant associations between the sociodemographic variables studied and the psychic wear. Conclusions: The results allow to open doors for deeper investigations with the population studied in order to guarantee mental health and quality of life for women with social vulnerability in Zapotlán el Grande.

New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

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.

Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

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.

New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.

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.

Clinical characteristics and prognosis of heart failure in elderly patients.

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.

Association patterns in saproxylic insect networks in three Iberian Mediterranean woodlands and their resistance to microhabitat loss.

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.