El puntaje de Framingham ayudaría en la estratificación del riesgo de pacientes con ergometría positiva y SPECT normal / The Framingham score could help in risk stratification of patients with positive ergometry and normal SPECT

Antecedentes. El valor pronóstico de una ergometría positiva en el contexto de imágenes tomográficas de perfusión miocárdica de estrés y reposo (SPECT) normales no está bien establecido. Objetivos. Documentar la incidencia de infarto, muerte y revascularización coronaria en pacientes con una ergometría positiva de riesgo intermedio e imágenes de perfusión SPECT normales, y explorar el potencial valor del puntaje de riesgo de Framingham en la estratificación pronóstica de estos pacientes. Métodos. Cohorte retrospectiva integrada por pacientes que habían presentado síntomas o hallazgos electrocardiográficos compatibles con enfermedad arterial coronaria durante la prueba de esfuerzo, con criterios de riesgo intermedio en la puntuación de Duke y perfusión miocárdica SPECT normal. Fueron identificados a partir de la base de datos del laboratorio de cardiología nuclear del Instituto de Cardiología y Cirugía Cardiovascular de la ciudad de Posadas, Argentina. Resultados. Fueron elegibles 217 pacientes. El seguimiento fue de 3 1,5 años. La sobrevida libre de eventos (muerte,infarto de miocardio no fatal, angioplastia coronaria o cirugía de bypass de arteria coronaria) a uno, tres y cinco años fue significativamente menor (Log-rank test, p= 0,001) en el grupo con puntaje de Framingham alto o muy alto (77, 71y 59 %, respectivamente) que en el grupo de puntaje bajo o intermedio (89, 87 y 83 %). Tomando como referencia a los pacientes con riesgo bajo en el puntaje de Framingham, luego de ajustar por edad, sexo y puntaje de Duke, los pacientes categorizados en los estratos alto y muy alto riesgo del puntaje de Framingham presentaron una incidencia del evento combinado cercana al triple (hazard ratio [HR] 2,81; intervalo de confianza [IC] del 95 % 0,91 a 8,72; p= 0,07 y HR 3,61;IC 95 % 1,23 a 10,56; p= 0,019 respectivamente). Conclusiones. La estimación de riesgo con el puntaje de Framingham sería de ayuda en la estratificación pronóstica de los pacientes con ergometría positiva y SPECT normal. (AU)

Background. The prognostic value of positive exercise testing with normal SPECT myocardial perfusion imaging is not well established. Objectives. To document the incidence of infarction, death, and coronary revascularization in patients with a positive intermediate-risk exercise test and normal SPECT perfusion images and to explore the potential value of the Framingham Risk Score in the prognostic stratification of these patients. Methods. A retrospective cohort comprised patients who presented symptoms or electrocardiographic findings compatible with coronary artery disease during the stress test, with intermediate risk criteria in the Duke score and normal SPECT myocardial perfusion. They were identified from the database of the nuclear cardiology laboratory of the Instituto de Cardiología y Cirugía Cardiovascular of Posadas, Argentina. Results. 217 patients were eligible. Follow-up was 3 1.5 years. Event-free survival (death, non-fatal myocardial infarction, coronary angioplasty, or coronary artery bypass surgery) at one, three, and five years was significantly lower (Log-ranktest, p: 0.001) in the group with a score of Framingham high or very high (77, 71 and 59 %, respectively) than in the lowor intermediate score group (89, 87 and 83 %). Taking as reference the low-risk patients in the Framingham score, after adjusting for age, sex, and Duke score, the patients categorized in the high-risk and very high-risk strata showed about three times higher incidence of the combined event (hazard ratio [HR] 2.81; 95 % confidence interval [CI] 0.91 to 8.72;p=0.07 and HR 3.61; 95 % CI 1.23 to 10.56; p=0.019 respectively). Conclusions. Risk estimation with the Framingham score would be helpful in the prognostic stratification of patients with positive exercise testing and normal SPECT. (AU)

El dilema clínico frente a los pacientes con ergometría positiva y prueba de perfusión miocárdica con SPECT normal / The clinical dilemma facing patients with positive stress test and normal SPECT myocardial perfusion imaging

La evaluación de la perfusión miocárdica con SPECT combina una prueba de esfuerzo (ergometría o estrés farmacológico) junto a imágenes de perfusión con radioisótopos. Este estudio es útil para establecer el diagnóstico de enfermedad arterial coronaria, estratificar el riesgo de infarto y tomar decisiones terapéuticas. Un resultado normal aporta un alto valor predictivo negativo, es decir, una muy baja probabilidad de que el paciente presente eventos cardiovasculares. El hallazgo de signos de isquemia en la ergometría podría poner en jaque el valor predictivo negativo de una perfusión normal. En presencia de este resultado, el paso siguiente es evaluar los predictores de riesgo en la ergometría, el riesgo propio del paciente en función de los antecedentes clínicos y el puntaje cálcico coronario, cuando este se encuentra disponible. Ante la presencia concomitante de otros marcadores de riesgo se sugiere completar la evaluación con un estudio anatómico.El uso de nuevas tecnologías podría mejorar la precisión en la predicción de eventos. (AU)

Assessment of myocardial perfusion with SPECT combines a stress test (ergometry or pharmacological stress) with radioisotope perfusion imaging. This test is helpful to diagnose coronary artery disease, stratify the risk of heart attack, and make therapeutic decisions. A normal result provides a high negative predictive value; therefore, the probability of cardiovascular events is very low. Signs of ischemia on an ergometry could jeopardize the negative predictive value of normal perfusion. In this clinical setting, the next step is to evaluate the risk predictors in the stress test, the individual risk based on the clinical history, and the coronary calcium score when available. Given the simultaneous presence of other risk markers,completing the evaluation with an anatomical study is suggested. The use of new technologies could improve the accuracy of event prediction. (AU)

Teleconsulta de enfermagem: desenvolvimento de plataforma para atendimento de casos de Covid-19 / Nursing teleconsultation: development of a platform for Covid-19 case management / Telecosulta en enfermería: desarrollo de una plataforma para el manejo de casos de Covid-19

Objetivo: Desenvolver uma plataforma virtual de Teleconsulta para atendimento a casos suspeitos de Síndromes Gripais e infecção por COVID-19. Metodologia: Trata-se de um estudo de natureza aplicada, com desenvolvimento de produção tecnológica e inovadora, prospectivo, ecológico, descritivo, de série temporal. A população do estudo foi formada por qualquer pessoa sintomática para Síndromes Gripais por COVID-19, suspeitos ou confirmados, de qualquer local do Brasil. Este estudo foi realizado em duas etapas, a saber: Etapa I: Desenvolvimento da Aplicação para Plataforma de Teleconsulta. Etapa II: atendimento por meio de Teleconsulta de Casos suspeitos de COVID-19 e Sindromes Gripais. A metodologia utilizada para o desenvolvimento da aplicação proposta foi a modelagem por prototipação evolucionária. Resultados: Foram realizados 209 atendimentos na Plataforma de Teleconsulta, sendo 151 (70%) do sexo feminino e 65 (30%) do sexo masculino, com prevalência de idade variando de 20 a 29 anos (41%). Quanto ao risco de infecção por COVID-19, 42 (20%) tinham alto risco, 75 (36%) médio risco e 92 (44%) baixo risco. Os sintomas mais prevalentes foram: secreção nasal ou espirros (53%), dores no corpo (49%), dor de cabeça (47%), dor de garganta (46%), tosse seca (35%), Febre (31%), falta de ar (25%) e diarreia (23%). Inicialmente o teleatendimento foi composto por teletriagem com classificação de risco com base na sintomatologia dos pacientes que foram codificados com pontuações conforme a gravidade do sintoma para formas graves de COVID-19. A classificação de risco categorizou os pacientes em risco baixo (1 a 9 pontos), risco médio (10 a 19 pontos) e risco alto (20 a 36 pontos). Em seguida, a teleconsulta foi agendada conforme disponibilidade do paciente por meio do método SBAR para comunicação efetiva e ao término do atendimento um plano de cuidados com Sistematização da Assistência de Enfermagem ­ SAE era encaminhado ao paciente por meio de WhatsApp ou e-mail. Conclusão: A plataforma de teleconsulta possibilitou a triagem dos pacientes, reduziu as visitas desnecessárias às unidades de emergência, permitiu a avaliação e monitoramento dos casos, bem como o acompanhamento de pacientes ambulatoriais que não necessitam de avaliação presencial.

Objective: To develop a virtual Teleconsultation platform for care of suspected cases of influenza syndromes and infection by COVID-19. Methodology: This is a study of applied nature, with development of technological and innovative production, prospective, ecological, descriptive, time series. The study population was made up of any person symptomatic for COVID-19 influenza syndromes, suspected or confirmed, from any location in Brazil. This study was conducted in two stages, namely: Stage I: Development of the Application for Teleconsultation Platform. Stage II: care through Teleconsultation of suspected cases of COVID-19 and influenza syndromes. The methodology used to develop the proposed application was evolutionary prototyping modeling. Results: There were 209 consultations in the Teleconsultation Platform, 151 (70%) were female and 65 (30%) were male, with prevalence of age ranging from 20 to 29 years (41%). As for the risk of infection by COVID-19, 42 (20%) had high risk, 75 (36%) medium risk and 92 (44%) low risk. The most prevalent symptoms were: nasal discharge or sneezing (53%), body aches (49%), headache (47%), sore throat (46%), dry cough (35%), fever (31%), shortness of breath (25%), and diarrhea (23%). Initially, the telecare was composed of teletry with risk classification based on the symptomatology of the patients who were coded with scores according to symptom severity for severe forms of COVID-19. The risk classification categorized patients into low risk (1 to 9 points), medium risk (10 to 19 points), and high risk (20 to 36 points). Then, the teleconsultation was scheduled according to the patient's availability through the SBAR method for effective communication and at the end of the service a care plan with Nursing Assistance Systematization - SAE was forwarded to the patient through WhatsApp or e-mail. Conclusion: Teleconsultation platform enabled patient triage, reduced unnecessary visits to emergency units, allowed the evaluation and monitoring of cases, as well as the follow- up of outpatients who do not need face-to-face evaluation.

Objetivo: Desarrollar una plataforma de Teleconsulta virtual para atender casos sospechosos de síndromes gripales e infección por COVID-19. Metodología: Se trata de un estudio aplicado, con desarrollo de producción tecnológica e innovadora, prospectivo, ecológico, descriptivo, con serie de tiempo. La población de estudio estuvo formada por cualquier persona sintomática de síndromes gripales por COVID-19, sospechada o confirmada, de cualquier localidad de Brasil. Este estudio se realizó en dos etapas, a saber: Etapa I: Desarrollo de Aplicaciones para la Plataforma de Teleconsulta. Etapa II: atención mediante teleconsulta de casos sospechosos de COVID-19 y síndromes gripales. La metodología utilizada para el desarrollo de la aplicación propuesta fue el modelado por prototipo evolutivo. Resultados: Se realizaron 209 consultas en la Plataforma de Teleconsulta, 151 (70%) del sexo femenino y 65 (30%) del masculino, con prevalencia de edades entre 20 a 29 años (41%). En cuanto al riesgo de infección por COVID-19, 42 (20%) fueron de alto riesgo, 75 (36%) de riesgo medio y 92 (44%) de bajo riesgo. Los síntomas más prevalentes fueron: secreción nasal o estornudos (53%), dolor de cuerpo (49%), dolor de cabeza (47%), dolor de garganta (46%), tos seca (35%), fiebre (31%), falta de aliento (25%) y diarrea (23%). Inicialmente, la teleasistencia consistía en teleselección con clasificación de riesgo en función de la sintomatología de los pacientes a los que se codificaba con puntuaciones según la gravedad del síntoma para formas graves de COVID-19. La clasificación de riesgo clasificó a los pacientes en riesgo bajo (1 a 9 puntos), riesgo medio (10 a 19 puntos) y riesgo alto (20 a 36 puntos). Luego, se programó la teleconsulta de acuerdo a la disponibilidad del paciente a través del método SBAR para una comunicación efectiva y al final de la atención se remitió al paciente un plan de cuidados con Sistematización de Atención de Enfermería - SAE vía WhatsApp o correo electrónico. Conclusión: La plataforma de teleconsulta posibilitó el triaje de pacientes, redujo las visitas innecesarias a las unidades de emergencia, permitió la evaluación y seguimiento de casos, así como el seguimiento de pacientes ambulatorios que no requieren evaluación presencial.

Instrumentos para la evaluación del riesgo de lesiones por presión en adultos en estado crítico: scoping review / Risk assessment instruments for pressure ulcer in adults in critical situation: a scoping review / Instrumentos para a avaliação do risco de lesões por pressão para adultos em situação crítica: scoping review*

Objetivo: mapear los instrumentos para la evaluación del riesgo de lesiones por presión en adultos en situación crítica en una unidad de terapia intensiva; identificar los indicadores de desempeño de los instrumentos y la apreciación de los usuarios con respecto al uso/limitaciones de los instrumentos. Método: scoping review. Para redactar el estudio se utilizó la extensión Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. La investigación se realizó mediante la herramienta de búsqueda EBSCOhost en 8 bases de datos, resultando 1846 estudios, de los cuales 22 conforman la muestra. Resultados: se identificaron dos grandes grupos de instrumentos: los generalistas [Braden, Braden (ALB), Emina, Norton-MI, RAPS y Waterlow]; y los específicos (CALCULATE, Cubbin & Jackson, EVARUCI, RAPS-ICU, Song & Choi, Suriaidi y Sanada y el índice COMHON). En cuanto al valor predictivo, EVARUCI y CALCULATE mostraron los mejores resultados de indicadores de desempeño. En cuanto a las apreciaciones/limitaciones señaladas por los usuarios, destaca la escala CALCULATE, seguida de la EVARUCI y la RAPS-ICU, aunque aún necesitan ajustes futuros. Conclusión: el mapeo mostró que las evidencias son suficientes para indicar uno o más instrumentos para la evaluación del riesgo de lesiones por presión en adultos críticos en una unidad de cuidados intensivos.

Objective: to map the instruments for risk assessment of pressure ulcers in adults in critical situation in intensive care units; identify performance indicators of the instrument, and the appreciation of users regarding the instruments' use/limitations. Method: a scoping review. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews in the writing of the study. We carried out the searches in the EBSCOhost search tool for 8 databases, resulting in 1846 studies, of which 22 studies compose the sample. Results: we identified two big instrument groups: generalist [Braden, Braden (ALB), Emina, Norton-MI, RAPS, and Waterlow]; and specific (CALCULATE, Cubbin & Jackson, EVARUCI, RAPS-ICU, Song & Choi, Suriaidi and Sanada, and COMHON index). Regarding the predictive value, EVARUCI and CALCULATE presented better results for performance indicators. Concerning appreciation/limitations indicated by users, we highlight the CALCULATE scale, followed by EVARUCI and RAPS-ICU, although they still need future adjustments. Conclusion: the mapping of the literature showed that the evidence is sufficient to indicate one or more instruments for the risk assessment of pressure ulcers for adults in critical situation in intensive care units.

Objetivo: mapear os instrumentos para avaliação do risco de lesões por pressão nos adultos em situação crítica em unidade de cuidados intensivos; identificar os indicadores de desempenho dos instrumentos e a apreciação dos utilizadores quanto ao uso/às limitações dos instrumentos. Método: scoping review. O Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews foi utilizado para a redação do estudo. A pesquisa foi realizada na ferramenta de busca EBSCOhost em oito bases de dados, resultando em 1846 estudos, dos quais 22 compõem a amostra. Resultados: identificaram-se dois grandes grupos de instrumentos: os genéricos [Braden, Braden (ALB), Emina, Norton-MI, RAPS e Waterlow]; e os específicos (CALCULATE, Cubbin & Jackson, EVARUCI, RAPS-ICU, Song & Choi, Suriaidi e Sanada e o índice de COMHON). Quanto ao valor preditivo, a EVARUCI e a CALCULATE apresentaram os melhores resultados de indicadores de desempenho. Em relação à apreciação/às limitações apontadas pelos utilizadores, destacam-se a escala CALCULATE, seguindo-se da EVARUCI e da RAPS-ICU, embora ainda necessitem de ajustes futuros. Conclusão: o mapeamento mostrou que as evidências são suficientes para indicar um ou mais instrumentos para avaliação do risco de lesões por pressão nos adultos em situação crítica em unidade de cuidados intensivos.

Consideraciones médico-legales laborales de la fórmula de Balthazard / Occupational medical-legal considerations of the Balthazard formula

La determinación del porcentaje de pérdida en pacientes lesionados con múltiples secuelas por riesgos de trabajo resulta un verdadero reto para el perito, esto adquiere mayor relevancia cuando en el fuero judicial se pueden presentar discrepancias en los criterios para el uso o no de fórmulas matemáticas para el cálculo. La fórmula de suma combinada, creada por el Médico Forense Víctor Balthazard, no es más que un ordenamiento de una regla de tres que ordena los porcentajes otorgados a cada secuela de mayor a menor para evitar que el porcentaje final sobrepase el 100%, o bien que resulte en un porcentaje mayor que una secuela única puntuada en el baremo y que por gravedad en la intensidad de la misma resulte con un porcentaje menor al calculado por la secuela múltiple y que se ha utilizado en fueros laborales y de seguridad social alrededor del mundo. El Baremo contenido en el Código de Trabajo no establece explícitamente la forma en que se calcula el porcentaje de pérdida por secuelas múltiples, lo cual brinda libertad al perito para utilizar fórmulas, como lo es la fórmula de suma combinada, que permite calcular de forma congruente las pérdidas sucesivas sin sobrepasar a la persona más allá de su capacidad general total del 100% o de otorgar porcentajes mayores a secuelas de mayor gravedad que la suma de las pérdidas por el evento que se está valorando.

The determination of the percentage of loss in injured patients with multiple sequelae due to occupational hazards is a real challenge for the expert, this becomes even more relevant when in the judicial system there may be discrepancies in the criteria for the use or not of mathematical formulas for the calculation. The combined sum formula, created by the Forensic Physician Victor Balthazard, is nothing more than an arrangement of a rule of three that orders the percentages given to each sequel from highest to lowest to avoid that the final percentage exceeds 100%, or that it results in a higher percentage than a single sequel scored in the scale and that due to the severity in the intensity of the same results in a lower percentage than that calculated for the multiple sequel and that has been used in labor and social security courts around the world. The Schedule contained in the Labor Code does not explicitly establish the way in which the percentage of loss for multiple sequelae is calculated, which gives the expert the freedom to use formulas, such as the combined sum formula, which allows a congruent calculation of the successive losses without exceeding the person's total general capacity of 100% or to grant higher percentages to sequelae of greater severity than the sum of the losses for the event being valued.

Análisis ajustado de la mortalidad operatoria en cirugía cardíaca de adultos en Uruguay; 14 años de aplicación y validación del EuroSCORE I ajustado por el Fondo Nacional de Recursos / Adjusted analysis of operative mortality in cardiac surgery of adults in Uruguay, 14 years of application and validation of EuroSCORE I by the Fondo Nacional de Recursos / Análise ajustada da mortalidade operatória em cirurgia cardíaca de adultos no Uruguai, 14 anos de aplicação e validação do EuroSCORE I pelo Fondo Nacional de Recursos

Introducción: la mortalidad posoperatoria ha sido el indicador principal de los resultados a corto y mediano plazo en la evaluación de la cirugía cardíaca. Una forma de analizar dicho evento es mediante los modelos de ajuste del riesgo que identifican variables que predicen su ocurrencia. Uno de los más utilizados es el EuroSCORE I que pro-porciona la probabilidad de morir de cada individuo y que está constituido por 18 variables de riesgo. Objetivos: presentar los resultados de la aplicación y la validación del modelo EuroSCORE I en Uruguay entre los años 2003 y 2020. Metodología: inicialmente se desarrolló una validación externa del EuroSCORE I en la población uruguaya adulta tomando como población de referencia la intervenida entre los años 2003 y 2006. Una vez que se validó el EuroSCORE I, este se aplicó prospectivamente durante los años 2007 al 2020 en su versión original y con el ajuste desarrollado con población del período 2003-2006. Resultados: la aplicación del modelo original encontró que hubo 5 años en los que la razón de mortalidad observada y esperada (MO/ME) fue significativamente mayor que 1. En el período 2007-2020 el EuroScore I no calibró en 6 oca-siones, y fue aplicada la versión ajustada en la evaluación de las instituciones de medicina altamente especializada. La aplicación del modelo ajustado mostró una buena calibración para el período 2007-2020, salvo en el año 2013, y mostró una buena discriminación (área bajo la curva ROC) en todo el período evaluado. Conclusiones: las escalas de riesgo son herramientas metodológicas y estadísticas que tienen gran utilidad para la toma de decisiones en salud. Este trabajo tiene como fortaleza el de presentar datos nacionales aplicando un modelo de riesgo ampliamente utilizado en todo el mundo, lo que nos permite comparar nuestros resultados con los obte-nidos a nivel internacional (EuroSCORE I logístico original) y, por otro lado, evaluar la performance comparativa interna a lo largo de un largo período de tiempo (EuroSCORE I logístico ajustado). Para el futuro resta el desafío de comparar estos resultados, ya sea con un modelo propio o con otros internacionales de elaboración más reciente.

Introduction: postoperative mortality has been the main indicator of short- and medium-term results in the eva luation of cardiac surgery. One way to analyze such outcomes is through risk adjustment models that identify varia bles that predict the occurrence. One of the most used is the EuroSCORE I, which provides the probability of death for each individual and is made up of 18 risk variables. Objectives: present the results of the application and validation of the EuroSCORE I model in Uruguay between 2003 and 2020. Methodology: initially, an external validation of the EuroSCORE I was developed in the Uruguayan adult popula tion, taking as reference population the intervened population between 2003 and 2006. Once the EuroSCORE I was validated, it was applied prospectively during the years 2007 to 2020 in its original version and with the adjustment developed with the population of the period 2003 to 2006. Results: the application of the original model found that there were 5 years during which the observed versus ex pected mortality ratio (OM/ME) was significantly greater than 1. In the period 2007 to 2020, the EuroScore I did not calibrate on 6 occasions, the adjusted version being applied in the evaluation of highly specialized medicine institu tions. The application of the adjusted model showed a good calibration for the period 2007-2020 except in the year 2013 and showed good discrimination (area under the ROC curve) throughout the evaluated period. Conclusions: risk scales are methodological and statistical tools that are very useful for decision-making in health care. This work has the strength of presenting national data applying a risk model widely used across the world, which allows it to be compare with results at an international level (original logistical Euroscore I) and, on the other hand, to evaluate the internal comparative performance over long period of time (adjusted logistic Euroscore I). Up next is the challenge of comparing these results either with our own model or with other more recent international ones.

Introdução: a mortalidade pós-operatória tem sido o principal indicador de resultados a curto e médio prazo na avaliação da cirurgia cardíaca. Uma forma de analisar esse evento é por meio de modelos de ajuste de risco que identificam variáveis que predizem a ocorrência do evento. Um dos mais utilizados é o EuroSCORE I, que fornece a probabilidade de morrer para cada indivíduo e é composto por 18 variáveis de risco. Objetivos: apresentar os resultados da aplicação e validação do modelo EuroSCORE I no Uruguai entre os anos de 2003 e 2020. Metodologia: inicialmente, foi realizada uma validação externa do EuroSCORE I na população uruguaia adulta, tomando como referência a população operada entre 2003 e 2006. Uma vez validado o EuroSCORE I, foi aplicado prospectivamente durante os anos de 2007 a 2020 em sua versão original e com o ajuste desenvolvido com a popu lação do período de 2003 a 2006. Resultados: a aplicação do modelo original constatou que houve 5 anos em que a razão de mortalidade observada versus esperada (MO/ME) foi significativamente maior que 1. No período de 2007 a 2020, o EuroScore I não calibrou em 6 ocasiões, sendo a versão ajustada aplicada na avaliação de instituições médicas altamente especializadas. A aplicação do modelo ajustado mostrou uma boa calibração para o período 2007-2020 exceto no ano de 2013 e apre sentou boa discriminação (área sob a curva ROC) em todo o período avaliado. Conclusões: as escalas de risco são ferramentas metodológicas e estatísticas muito úteis para a tomada de decisões em saúde. O ponto forte deste trabalho é apresentar dados nacionais aplicando um modelo de risco amplamente uti lizado em todo o mundo, que permite comparar com resultados a nível internacional (original Logistic Euroscore I) e, por outro lado, avaliar o comparativo interno desempenho durante um longo período de tempo (Euroscore Logístico I ajustado). Para o futuro, fica o desafio de comparar esses resultados, seja com um modelo próprio ou com outros internacionais de elaboração mais recente.

Evaluación de riesgo biológico en el control de calidad de vacunas virales / Biological risk evaluation in the quality control of viral vaccines

Las medidas de bioseguridad son el conjunto de conductas mínimas a ser adoptadas, a fin de reducir o eliminar los riesgos para el personal, la comunidad y el medio ambiente. Los laboratorios veterinarios manipulan materiales biológicos que pueden suponer riesgos biológicos tanto para los animales como para el hombre, por lo que los profesionales de estos laboratorios están expuestos a una variedad de riesgos relacionados con su trabajo que pueden afectar su salud. El objetivo de este trabajo fue evaluar el riesgo en el control de calidad de las vacunas virales mediante el uso del método BIOGAVAL, una forma cómoda y fiable de evaluar el riesgo de exposición a agentes biológicos. El estudio se realizó en la Unidad Empresarial de Base Control de la Calidad de la Empresa Productora de Vacunas Virales y Bacterianas el cual pertenece a LABIOFAM. La muestra de estudio estuvo conformada por 18 trabajadores, distribuidos en tres áreas. En los resultados obtenidos para valores superiores a 12 del nivel de acción biológica se requiere la adopción de medidas preventivas para reducir la exposición en el caso de Avulavirus, Pestivirus y Coronavirus, mientras que para Alphavirus se requieren acciones correctoras inmediatas ya que representa una situación de riesgo intolerable(AU)

Biosafety measures are the set of minimum behaviors to be adopted, in order to reduce or eliminate risks to personnel, the community and the environment. Veterinary laboratories handle biological materials that can pose biological risks for both animals and humans, so that professionals in these laboratories are exposed to a variety of risks to their health related to their work. The objective of this work was to evaluate the risk in the quality control of viral vaccines through the use of BIOGAVAL method, a convenient and reliable way to assess the risk of exposure to biological agents. The study was carried out in the Base Business Unit Quality Control of the Production Company of Viral and Bacterial Vaccines which belongs to LABIOFAM. The study sample consisted was 18 workers, dispersed in three areas. For values above 12 of the biological action level, preventive measures are required to reduce exposure to Avulavirus, Pestivirus and Coronavirus, while for Alphavirus immediate corrective measures actions are required as it represents an intolerable risk situation(AU)

Exploring the Feasibility of Machine Learning to Predict Risk Stratification Within 3 Months in Chest Pain Patients with Suspected NSTE-ACS / 生物医学与环境科学（英文）

OBJECTIVE@#We aimed to assess the feasibility and superiority of machine learning (ML) methods to predict the risk of Major Adverse Cardiovascular Events (MACEs) in chest pain patients with NSTE-ACS.@*METHODS@#Enrolled chest pain patients were from two centers, Beijing Anzhen Emergency Chest Pain Center Beijing Bo'ai Hospital, China Rehabilitation Research Center. Five classifiers were used to develop ML models. Accuracy, Precision, Recall, F-Measure and AUC were used to assess the model performance and prediction effect compared with HEART risk scoring system. Ultimately, ML model constructed by Naïve Bayes was employed to predict the occurrence of MACEs.@*RESULTS@#According to learning metrics, ML models constructed by different classifiers were superior over HEART (History, ECG, Age, Risk factors, & Troponin) scoring system when predicting acute myocardial infarction (AMI) and all-cause death. However, according to ROC curves and AUC, ML model constructed by different classifiers performed better than HEART scoring system only in prediction for AMI. Among the five ML algorithms, Linear support vector machine (SVC), Naïve Bayes and Logistic regression classifiers stood out with all Accuracy, Precision, Recall and F-Measure from 0.8 to 1.0 for predicting any event, AMI, revascularization and all-cause death ( vs. HEART ≤ 0.78), with AUC from 0.88 to 0.98 for predicting any event, AMI and revascularization ( vs. HEART ≤ 0.85). ML model developed by Naïve Bayes predicted that suspected acute coronary syndrome (ACS), abnormal electrocardiogram (ECG), elevated hs-cTn I, sex and smoking were risk factors of MACEs.@*CONCLUSION@#Compared with HEART risk scoring system, the superiority of ML method was demonstrated when employing Linear SVC classifier, Naïve Bayes and Logistic. ML method could be a promising method to predict MACEs in chest pain patients with NSTE-ACS.

Development and validation of ischemic heart disease and stroke prognostic models using large-scale real-world data from Japan

BACKGROUND@#Previous cardiovascular risk prediction models in Japan have utilized prospective cohort studies with concise data. As the health information including health check-up records and administrative claims becomes digitalized and publicly available, application of large datasets based on such real-world data can achieve prediction accuracy and support social implementation of cardiovascular disease risk prediction models in preventive and clinical practice. In this study, classical regression and machine learning methods were explored to develop ischemic heart disease (IHD) and stroke prognostic models using real-world data.@*METHODS@#IQVIA Japan Claims Database was searched to include 691,160 individuals (predominantly corporate employees and their families working in secondary and tertiary industries) with at least one annual health check-up record during the identification period (April 2013-December 2018). The primary outcome of the study was the first recorded IHD or stroke event. Predictors were annual health check-up records at the index year-month, comprising demographic characteristics, laboratory tests, and questionnaire features. Four prediction models (Cox, Elnet-Cox, XGBoost, and Ensemble) were assessed in the present study to develop a cardiovascular disease risk prediction model for Japan.@*RESULTS@#The analysis cohort consisted of 572,971 invididuals. All prediction models showed similarly good performance. The Harrell's C-index was close to 0.9 for all IHD models, and above 0.7 for stroke models. In IHD models, age, sex, high-density lipoprotein, low-density lipoprotein, cholesterol, and systolic blood pressure had higher importance, while in stroke models systolic blood pressure and age had higher importance.@*CONCLUSION@#Our study analyzed classical regression and machine learning algorithms to develop cardiovascular disease risk prediction models for IHD and stroke in Japan that can be applied to practical use in a large population with predictive accuracy.

Prescription of statins according to the ASCVD estimator at Pablo Arturo Suarez Hospital, March 2021 to February 2022 / Prescripción de estatinas según el estimador ASCVD en el Hospital Pablo Arturo Suárez, marzo 2021 a febrero 2022

Worldwide, the leading cause of death is cardiovascular disease. The study details the prescription of statins at the Pablo Arturo Suarez Hospital in Ecuador between March 2021 and February 2022 following the ASCVD risk scale of the American College of Cardiology and the American Heart Association. There are 563 people in this cross-sectional and retrospective study: 70% women, 30% men, 93.30% mestizos, 48.10% diabetics, 62.30% hypertensives, and 18.70% smokers. 26.10% of all patients received statins, with simvastatin being the most common (96.60%). The mean cardiovascular risk in the general population was 15.52 ± 14.51%, 44.99% of subjects had a risk lower than 7.50%, and 29% had a risk higher than 20%, with a statistically significant difference (p<0.001) according to sex. The study determined that 58.60% of the population received a statin or an inadequate dosage.

A nivel mundial, la principal causa de muerte es la enfermedad cardiovascular. El estudio detalla la prescripción de estatinas en el Hospital Pablo Arturo Suárez de Ecuador entre marzo de 2021 y febrero de 2022, siguiendo la escala de riesgo ASCVD del Colegio Americano de Cardiología y la Asociación Americana del Corazón. Son 563 personas en este estudio transversal y retrospectivo: 70% mujeres, 30% hombres, 93.30% mestizos, 48.10% diabéticos, 62.30% hipertensos y 18.70% fumadores. El 26.10% de los pacientes recibía estatinas, siendo la simvastatina la más frecuente (96.60%). El riesgo cardiovascular medio en la población general fue de 15.52 ± 14.51%, el 44.99% de los sujetos tenía un riesgo inferior al 7.50%, y el 29% tenía un riesgo superior al 20%, con una diferencia estadísticamente significativa (p<0.001) según el sexo. El estudio determinó que el 58.60% de la población recibía una estatina o una dosis inadecuada.

Validation of the Grace Risk Score to Predict In-Hospital and 6-Month Post-Discharge Mortality in Patients with Acute Coronary Syndrome

Abstract Background The wide range of clinical presentations of acute coronary syndrome (ACS) makes it indispensible to use tools for risk stratification and for appropriate risks management; thus, the use of prognosis scores is recommended in the immediat clinical decision-making. Objective To validate the Global Registry of Acute Coronary Events (GRACE) score as a predictor of in-hospital and 6-month post-discharge mortality in a population diagnosed with ACS. Methods This is a prospective cohort study of consecutive patients diagnosed with ACS between May and December 2018. GRACE scores were calculated, as well as their predictive value for in-hospital and 6-month post-discharge mortality. The validity of the model was assessed by two techniques: discriminative power using the area under the receiver operating characteristic curve (AUC) and goodness-of-fit, using the Hosmer-Lemeshow (HL) test, at the 5% level of significance. Results A total of 160 patients were included, mean age 64 (±10.9) years; of which 60% were men. The risk model showed to have satisfactory ability to predict both in-hospital mortality, with an area under the curve (AUC) of 0.76 (95% confidence interval [CI], 0.57-0.95; p = 0.014), and 6-month post-discharge mortality, with AUC of 0.78 (95%CI, 0.62-0.94), p = 0.002. The HL test indicated good-fit for both models of the GRACE score. Conclusion In this study, the GRACE risk score for predicting mortality was appropriately validated in patients with ACS, with good discriminative power and goodness-of-fit. The results suggest that the GRACE score is appropriate for clinical use in our setting.

Cardiovascular Risk Assessment after COVID-19 Infection before Resuming Sports Activities - Practical Flowchart and Meta-Analysis

Abstract Background: The risk of sports-related sudden cardiac arrest after COVID-19 infection can be a serious problem. There is an urgent need for evidence-based criteria to ensure patient safety before resuming exercise. Objective: To estimate the pooled prevalence of acute myocardial injury caused by COVID-19 and to provide an easy-to-use cardiovascular risk assessment toolkit prior to resuming sports activities after COVID-19 infection. Methods: We searched the Medline and Cochrane databases for articles on the prevalence of acute myocardial injury associated with COVID-19 infection. The pooled prevalence of acute myocardial injury was calculated for hospitalized patients treated in different settings (non-intensive care unit [ICU], ICU, overall hospitalization, and non-survivors). Statistical significance was accepted for p values <0.05. We propose a practical flowchart to assess the cardiovascular risk of individuals who recovered from COVID-19 before resuming sports activities. Results: A total of 20 studies (6,573 patients) were included. The overall pooled prevalence of acute myocardial injury in hospitalized patients was 21.7% (95% CI 17.3-26.5%). The non-ICU setting had the lowest prevalence (9.5%, 95% CI 1.5-23.4%), followed by the ICU setting (44.9%, 95% CI 27.7-62.8%), and the cohort of non-survivors (57.7% with 95% CI 38.5-75.7%). We provide an approach to assess cardiovascular risk based on the prevalence of acute myocardial injury in each setting. Conclusions: Acute myocardial injury is frequent and associated with more severe disease and hospital admissions. Cardiac involvement could be a potential trigger for exercise-induced clinical complications after COVID-19 infection. We created a toolkit to assist with clinical decision-making prior to resuming sports activities after COVID-19 infection.

Síndrome metabólico y su correlación con ecuaciones de predicción del riesgo global de enfermedad cardiovascular / Metabolic Syndrome and its Correlation with Prediction Equations of Global Risk for Cardiovascular Disease

Introducción: El síndrome metabólico constituye un hito en la investigación de evaluar mejor y de manera óptima el riesgo de enfermedad cardiovascular aterosclerótica. Objetivo: Analizar la correlación entre la capacidad predictiva del riesgo global de enfermedad cardiovascular aterosclerótica del síndrome metabólico y las tablas de riesgo: Framingham Risk Score, la tabla de la OMS/ISH y las de Gaziano, la ecuación PROCAM y el algoritmo QRISK2. Métodos: Se realizó una revisión documental, para lo cual se empleó la bibliografía nacional e internacional, especialmente la publicada en los últimos 5 años. Se utilizó el motor de búsqueda Google Académico y se consultaron artículos de libre acceso en las bases de datos Pubmed y SciELO desde marzo 2020 hasta el mes de enero 2021. Se emplearon como palabras clave: síndrome metabólico, riesgo cardiovascular global, método de estimación de riesgo y sus equivalentes en inglés. Las unidades de análisis fueron artículos originales, de revisión, incluyendo revisiones sistemáticas publicadas en los idiomas español e inglés. Fueron seleccionados 38 artículos (23 en idioma español, 15 en inglés) y 31 (81,5 por ciento) corresponden a los últimos 5 años. Conclusiones: El síndrome metabólico y los sistemas de estimación del riesgo global de enfermedad cardiovascular aterosclerótica no deben ser utilizados como equivalentes a causa de que su concordancia, en sentido general, es muy cuestionable. No obstante, se puede considerar como una herramienta útil en prevención primaria de la enfermedad cardiovascular aterosclerótica, siempre y cuando no sustituyan el juicio clínico y se contemplen todas las excepciones y precauciones posibles en el momento de su aplicación(AU)

Introduction: Metabolic syndrome is a milestone within the research to assess better and optimally the risk of atherosclerotic cardiovascular disease. Objective: To analyze the correlation between the predictive capacity for the global risk of atherosclerotic cardiovascular disease of metabolic syndrome and the risk tables: Framingham Risk Score, the WHO/ISH and Gaziano tables, the PROCAM equation, and the QRISK2 algorithm. Methods: A documentary review was carried out, using national and international literature, especially published within the last five years. The Google Scholar search engine was used and open-access articles were consulted in the Pubmed and SciELO databases, from March 2020 to January 2021. The keywords used were síndrome metabólico [metabolic syndrome], riesgo cardiovascular global [global cardiovascular risk], método de estimación de riesgo [risk estimation method] and their English equivalents. The units of analysis were original review articles, including systematic reviews published in Spanish and English. Thirty-eight articles were selected (23 in Spanish and fifteen in English), 31 (81.5 percent) of which correspond to the last five years. Conclusions: Metabolic syndrome and global risk estimation systems for atherosclerotic cardiovascular disease should not be used as equivalents because their concordance, in general, is very questionable. Nevertheless, they can be considered a useful tool in the primary prevention of atherosclerotic cardiovascular disease, as long as they do not replace clinical judgment and all possible exceptions or precautions are considered at the time of their application(AU)

Comparison of different neonatal illness severity scores in predicting mortality risk of extremely low birth weight infants / 浙江大学学报·医学版

To compare different illness severity scores in predicting mortality risk of extremely low birth weight infants (ELBWI). From January 1st, 2019 to January 1st, 2020, all ELBWI admitted in the Children's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital and the First Affiliated Hospital of Nanjing Medical University were included in the study. ELBWI with admission age ≥1 h, gestational age ≥37 weeks and incomplete data required for scoring were excluded. The clinical data were collected, neonatal critical illness score (NCIS), score for neonatal acute physiology version Ⅱ (SNAP-Ⅱ), simplified version of the score for neonatal acute physiology perinatal extension (SNAPPE-Ⅱ), clinical risk index for babies (CRIB) and CRIB-Ⅱ were calculated. The scores of the fatal group and the survival group were compared, and the receiver operating characteristic (ROC) curve was used to evaluate the predictive value of the above illness severity scores for the mortality risk of ELBWI. Pearson correlation analysis was used to analyze the correlation between illness scores and birth weight, illness scores and gestational age. A total of 192 ELBWI were finally included, of whom 114 cases survived (survival group) and 78 cases died (fatal group). There were significant differences in birth weight, gestational age and Apgar scores between fatal group and survival group (all <0.01). There were significant differences in NCIS, SNAP-Ⅱ, SNAPPE-Ⅱ, CRIB and CRIB-Ⅱ between fatal group and survival group (all <0.01). The CRIB had a relatively higher predictive value for the mortality risk. Its area under the ROC curve (AUC) was 0.787, the sensitivity was 0.678, the specificity was 0.804, and the Youden index was 0.482. The scores of NCIS, SNAP-Ⅱ, SNAPPE-Ⅱ, CRIB and CRIB-Ⅱ were significantly correlated with birth weight and gestational age (all <0.05). The correlation coefficients of CRIB-Ⅱ and CRIB with birth weight and gestational age were relatively large, and the correlations coefficients of NCIS with birth weight and gestational age were the smallest (0.191 and 0.244, respectively). Among these five illness severity scores, CRIB has better predictive value for the mortality risk in ELBWI. NCIS, which is widely used in China, has relatively lower sensitivity and specificity, and needs to be further revised.

Application of three risk assessment methods to noise risk assessment in an automobile foundry enterprise / 中华劳动卫生职业病杂志

Objective: To explore the applicability of three different kinds of noise occupational health risk assessment methods to the occupational health risk assessment of noise exposed positions in an automobile foundry enterprise. Methods: In July 2020, the occupational-health risk assessment of noise-exposed positions was conducted by using the Guidelines for risk management of occupational noise hazard (guideline method) , the International Commission on Mining and Metals Guidelines for Occupational Health Risk Assessment (ICMM) method and the Occupational-health risk index method (index method) respectively, and the results were analyzed and compared. Results: Through the occupational health field investigation, the noise exposure level of the enterprise's main workstations was between 80.3 and 94.8 dB (A) , among which the noise of the posts of shaking-sand, cleaning and modeling was greater than 85 dB (A) ; The noise risk of each position was evaluated by the three methods, and the adjustment risk level was between 2 and 5 assessed using the guideline method, between 2 and 3 assessed using the index method, and 5 evaluated using the ICMM model. Conclusion: Each of the three risk assessment methods has its own advantages and disadvantages. The ICMM model has a large difference in value assignment, and values in the results are larger than expected. The evaluation results of the guideline method and the index method are consistent in some positions, there is certain subjectivity in the evaluation using the index method, and the guideline method is more objective.

Application of fuzzy analytic hierarchy process in risk assessment in medicine related fields / 中华流行病学杂志

Risks exist in medicine related fields, which cannot be defined and quantified precisely. It is necessary to adopt a method for the risk assessment of uncertain and fuzzy phenomenon. This paper summarizes the thinking, procedure, advantage and application of fuzzy analytic hierarchy process in the risk assessment in medicine related fields for the purpose of providing reference for its further application.

Tools and scores for general and cardiovascular perioperative risk assessment: a narrative review / Ferramentas e escores para avaliação de risco perioperatório geral e cardiovascular: uma revisão narrativa

ABSTRACT The number of surgical procedures in the world is large and in Brazil it has been expressing a growth trend higher than the population growth. In this context, perioperative risk assessment safeguards the optimization of the outcomes sought by the procedures. For this evaluation, anamnesis and physical examination constitute an irreplaceable initial stage which may or may not be followed by complementary exams, interventions for clinical stabilization and application of risk estimation tools. The use of these tools can be very useful in order to obtain objective data for decision making by weighing surgical risk and benefit. Global and cardiovascular risk assessments are of greatest interest in the preoperative period, however information about their methods is scattered in the literature. Some tools such as the American Society of Anesthesiologists Physical Status (ASA PS) and the Revised Cardiac Risk Index (RCRI) are more widely known, while others are less known but can provide valuable information. Here, the main indices, scores and calculators that address general and cardiovascular perioperative risk were detailed.

RESUMO O número de procedimentos cirúrgicos no mundo é amplo e no Brasil vem expressando tendência de crescimento superior ao crescimento populacional. Nesse contexto, a avaliação de risco perioperatório resguarda a otimização dos desfechos buscados pelos procedimentos. Para a realização dessa avaliação, a anamnese e exame físico constituem etapa inicial insubstituível, a qual pode ou não ser seguida de exames complementares, intervenções para estabilização clínica e aplicação de ferramentas de estimativa de risco. A utilização destas ferramentas pode ser bastante útil a fim de se obter um dado objetivo para a tomada de decisão pesando-se risco e benefício cirúrgico. As avaliações de risco global e cardiovascular são as de maior interesse no pré-operatório, entretanto informações sobre seus métodos encontram-se dispersas na literatura. Algumas ferramentas como o American Society of Anesthesiologists Physical Status (ASA PS) e Índice de Risco Cardíaco Revisado (RCRI) são mais amplamente conhecidos, enquanto outros são menos conhecidos em nosso meio mas podem fornecer informações valiosas. Aqui detalhou-se os principais índices, escores e calculadoras que abordam risco perioperatório geral e cardiovascular.

QbD enabled Process Variable Study to Develop Sustained Release Chitosan-Alginate Embedded Delivery System for Improved Patient Compliance

Abstract The current investigation entail systematic Quality by Design (QbD)-enabled approach for the development of Sustained released embedded drug delivery systems of L-Arginine employing ionic gelation technique to attain improved patient compliance. Hence, in this QbD enabled systematic approach; quality target product profile (QTTP) was defined and critical quality attributes (CQAs) were identified. Further the risk assessment studies were undertaken through Ishikawa fish bone diagram to locate the critical material attributes (CMAs) and/or critical process parameters (CPPs) for the formulation of beads that may affect CQAs of drug product. A face centered central composite design (CCD) for two factors at three levels each with α =1 was employed for the optimization process to checkout the impact of concentration of sodium alginate and concentration of chitosan as CMAs which wereprior identified from risk assessment study and further evaluated for CQAs viz. bead size, swelling index and percent drug entrapment. The optimum formulation was embarked upon by using mathematical model being developed yielding desired CQAs. Thereby chitosan coated calcium-alginate delivery system was successfully developed by strategically employing QbD approach.In a nutshell, the presentinvestigation reports the successful development of optimized chitosan coated alginate beads employing QbD approach which can serve as a platform for other drugs too.