Exploration of Centralized Purchasing Management Platform for Research Reagent Supplies Based on One-stop Service / 中国医疗器械杂志

OBJECTIVE@#The national requirements for the fund management of scientific research projects are becoming more stringent, so that it is convenient to carry out scientific research work and can strengthen the regulation of scientific research reagent procurement, so this study explores the standardization of the whole process of the procurement of scientific research reagent supplies in hospitals and new modes of management.@*METHODS@#By exploring the implementation of the centralized procurement management platform, we engage in full process supervision before, during, and after the event.@*RESULTS@#Introduction of centralized procurement management platform for scientific research reagent supplies can normalize the procurement process, ensure the quality of procurement and improve the procurement efficiency on the basis of ensuring the quality of scientific research.@*CONCLUSIONS@#The new model of centralized procurement of full process management based on one-stop service for scientific research reagent supplies is an important part of improving the fine scale management of public hospitals, and it is of great significance in improving the level of scientific research in China and avoiding scientific research corruption.

Discussion on Key Control Points and Common Problems of Molecular Diagnostic Reagents in the Process of Design and Development / 中国医疗器械杂志

Design and development process of molecular diagnostic reagents is critical to quality management system of in vitro diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.

Leishmaniose visceral: aspectos epidemiológicos, espaciais e temporais no município de Sobral, nordeste do Brasil, 2007-2019 / Visceral leishmaniasis: epidemiological, spatial and temporality aspects in the municipality of Sobral, northeast Brazil, 2007-2019

Objetivos: descrever os aspectos epidemiológicos, espaciais e temporais da leishmaniose visceral humana, no município de Sobral, no período de 2007 a 2019. Métodos: foi realizado um estudo epidemiológico descritivo e ecológico de análise espacial e temporal, com uso dos programas Quantum-Gis e Joinpoint. Resultados: foram confirmados 316 casos novos, predominantemente, no sexo masculino, nas faixas etárias de 1 a 4 anos (26,3%) e de 20 a 39 anos (24,0%), na zona urbana. Febre (95,9%), fraqueza (85,1%), emagrecimento (80,1%), palidez (73,7%), esplenomegalia (75,6%) e hepatomegalia (69,3%) foram os sinais clínicos mais frequentes. A doença se concentrou em quatro bairros: Terrenos Novos, Centro, Expectativa e Sinhá Saboia, expressando áreas mais densas (quentes). A incidência e a letalidade foram crescentes no início do período e decrescentes no final, com uma inversão destes indicadores no ano de 2014. Conclusão: em Sobral, a leishmaniose visceral humana é um agravo considerado relevante para o serviço de vigilância em saúde com necessidade de intensificação das ações de controle entomológico, zoonótico e de manejo ambiental, principalmente nas áreas mais densas.

Objectives: the objective was to describe the epidemiological, spatial, and temporal aspects of human visceral leishmaniasis, in the municipality of Sobral, from 2007 to 2019. Methods: A descriptive, spatial and temporal ecological study was carried out using Quantum-Gis and Joinpoint programs. Results: 316 new cases were confirmed, predominantly in males, in the age groups of 1 to 4 years (26.3%) and 20 to 39 years (24.0%), mainly in the urban area. Fever (95.9%), weakness (85.1%), weight loss (80.1%), pallor (73.7%), splenomegaly (75.6%), and hepatomegaly (69.3%) were the most frequent clinical signs. The disease was concentrated in four neighborhoods (Terrenos Novos, Centro, Expectativa, and Sinhá Saboia), hot spots. The incidence and case-fatality increased at the beginning of the period but decreased at the end, with an inversion in these in the year 2014. Conclusion: In Sobral, human visceral leishmaniasis is a disease considered relevant to the health surveillance service, with the need to intensify entomological, zoonotic, and environmental management actions, especially in denser areas.

As diferentes fases, os seus impactos e os desafios da pandemia de covid-19 no Brasil / The different stages, its impacts, and the challenges of the covid-19 pandemic in Brazil / Las diferentes fases, sus impactos y los desafíos de la pandemia de covid-19 e Brasil

A dinâmica da pandemia de covid-19 vem evoluindo segundo fases marcadas por uma maior ou menor taxa de infecção, e diferentes impactos sobre o sistema de saúde e a mortalidade. Essas fases foram estudadas segundo quatro indicadores disponibilizados no sistema MonitoraCovid-19: positividade de testes de diagnóstico, número de casos, número de óbitos e o número de pessoas com ao menos duas doses de vacinas ­ padronizados numa série histórica para permitir sua comparação. São distinguidas cinco fases, marcadas pela circulação de diferentes variantes do vírus, estratégias de implementação ­ ou mesmo boicote ­ de medidas de controle e a vacinação gradativa da população. Esses indicadores podem ser usados no futuro para monitorar tendências e apontar políticas públicas adequadas.

The dynamics of the covid-19 pandemic has evolved according to phases marked by a higher or lower rate of infection, the different impacts on the health system and mortality. These phases were studied according to four indicators made available by the MonitoraCovid-19 system: positivity rates of diagnostic tests, number of cases, number of deaths and number of people who received at least two vaccine doses, standardized in a historical series to allow their comparison. Five phases are discerned, evidenced by the circulation of different virus variants, strategies employed to implement -or even undermine ­ disease control measures and the gradual vaccination of the population. These indicators can be used in the future to monitor trends and point out appropriate public policies.

La dinámica de la pandemia de covid-19 ha evolucionado según fases marcadas por una mayor o menor tasa de contagios, sus diferentes impactos en el sistema de salud y mortalidad. Estas fases se estudiaron según cuatro indicadores disponibles en el sistema MonitoraCovid-19: positividad de las pruebas diagnósticas, número de casos, número de defunciones y el número de personas vacunadas con al menos dos dosis, estandarizados en una serie histórica para permitir su comparación. Se distinguen cuatro fases, marcadas por la circulación de diferentes variantes del virus, las estrategias de implementación - o mismo el boicoteode medidas de control y la paulatina vacunación de la población. Estos indicadores pueden utilizarse en el futuro para monitorear tendencias y señalar políticas públicas apropiadas.

Adherencia terapéutica en hemofilia, adaptación lingüística del VERITAS-Pro en población mexicana / Therapeutic adherence in hemophilia, linguistic adaptation of the VERITAS-Pro to the Mexican population

Introducción: La hemofilia es una enfermedad hemorrágica caracterizada por la deficiencia de alguno de los factores de la coagulación VIII o IX. Actualmente el estándar de oro en el tratamiento consiste en la aplicación periódica del factor (profilaxis), por lo que se vuelve indispensable contar con instrumentos especializadas, estandarizados y válidos para evaluar el grado de adherencia a los tratamientos. Objetivo: Adaptar lingüística y culturalmente a población mexicana la escala de adherencia al tratamiento profiláctico (VERITAS-Pro). Métodos: La escala VERITAS-Pro fue traducida al castellano de México, adaptada y retraducida al idioma original. La equivalencia conceptual de las versiones fue comprada por la autora original, posteriormente se sometió a escrutinio de un grupo de expertos en el tratamiento de personas con hemofilia, la claridad y pertinencia de la versión adaptada, el grado de acuerdo entre los jueces se evalúo con el estadígrafo de Aiken. Resultados: Se encontró adecuada la equivalencia conceptual entre las versiones original y adaptada de la prueba. Los jueces calificaron como adecuada la claridad (V=0,93, IC10 por ciento=0,92-0,95) y pertinencia (V=0,89, IC10 por ciento=0,86-0,91) de los reactivos. Conclusiones: La escala VERITAS-Pro, versión al castellano de México, es una herramienta válida para evaluar los niveles de adherencia a la profilaxis en hemofilia(AU)

Introduction: Hemophilia is a hemorrhagic disease characterized by the deficiency of either coagulation factor VIII or IX. Nowadays, the gold standard in treatment is the periodic application of the factor (prophylaxis), so it is indispensable to have specialized, standardized and valid instruments to evaluate the degree of adherence to treatment. Objective: To adapt linguistically and culturally to the Mexican population the Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-Pro). Methods: The VERITAS-Pro scale was translated into Mexican Spanish, adapted, and re-translated into the original language. The conceptual equivalence of the versions was compared by the original author, subsequently, it was under scrutiny the clarity and relevance of the adapted version by a group of experts in the treatment of people with hemophilia, the degree of agreement between the judges was evaluated with the Aiken statistician. Results: The original and adapted versions of the test, show an adequate conceptual equivalence, judges were rated adequate clarity (V=0.93, IC10 percent=0.92-0.95) and relevance (V=0.89, CI10 percent=0.86-0.91) of the items. Conclusion: The scale Veritas-Pro, the Mexican Spanish version, is a valid tool to assess the levels of adherence to the prophylaxis in hemophilia(AU)

Análisis de la curva ROC en la evaluación de indicadores antropométricos / Analysis of the ROC curve in the evaluation ofanthropometric indicators

Evaluación del Índice Peso-Circunferencia de Cintura (IPCC) mediante Regresión Logística. Estudio descriptivo, prospectivo y transversal, muestra 1095 adultos y adultos mayores, edad entre 20 y 96 años. Métodos: variables: edad, peso, talla, Circunferencia de Cintura (CC), IMC, Índice Cintura-Talla (ICT). Resultados: IMC similar en los dos sexos; promedios de CC e ICT mayor en grupo ≥ 65 años; IPCC mayor en grupo 20-59 años; porcentaje de riesgo del IPCC(54,1%) mayor en CC (44,7%) menor en ICT (78,2%). IPCC significativamente asociado al IMC, CC e ICT (p<0,000); valor predictivo positivo 0,92 y valor predictivo negativo 0,70, indican capacidad discriminativa; Riesgo Relativo, 1,92; el estadístico de prueba Wald indica significancia estadística para los coeficientes de ecuaciones de probabilidad de riesgo; área bajo la curva ROC es 0,803 y 0,903 (P<0,000), alta sensibilidad y especificidad. Conclusión: el IPCC puede considerarse para evaluar sobrepeso y obesidad en adultos, dada su alta capacidad discriminativa(AU)

Evaluation of the Waist Weight-CircumferenceIndex (WWCI) using Logistic Regression. Descriptive, prospective and cross-sectional study shows 1095 adults andolder adults, aged between 20 and 96 years. Methods: variables: age, weight, size, Waist Circumference (WC), BMI, Waist-SizeIndex (WSI). Results: Similar BMI in both sexes; higher WCand WSI averages in a ≥ age of 65; major WWCI in group20-59 years; WWCI risk rate (54.1%) higher in WC (44.7%)WSI (78.2%). WWSI significantly associated with BMI, WCand WSI (p<0.000); positive predictive value 0.92 and negative predictive value 0.70, indicate discriminatory capacity; RelativeRisk, 1.92; Wald test statistic indicates statistical significance for the coefficients of risk probability equations; area under theROC curve is 0.803 and 0.903 (P<0.000), high sensitivity and specificity. Conclusion: WWCI can be considered to evaluate overweight and obesity in adults, given its high discriminatory capacity(AU)

Adaptation to university studies affects on functional state of freshmen

According to different researches, 30% of university graduates have a low level of health, and studying at university is one of the factors of its deterioration, besides the first year is considered critical. The purpose of research is to study the dynamics of physical development, physical fitness and functional state of young men during the first year of university studies. For the survey we used standard measurements and index calculations for 11 indicators of physical development, 9 indicators of physical fitness and 15 indicators of functional status. We calculated the arithmetic mean (M), the standard error of the mean (m), then evaluated differences by the Student criterion (t) for independent samples and considered them as reliable atр < 0.05. It is shown that during the first year of studies, young men have an increase in the Erismann index, the corpulence (Rohrer's) index, the body mass index and a decrease in the Pignet index. There is also an increase in the coefficient of endurance, adaptive capacity and diastolic pressure, while vital capacity of the lungs, the vital index, time of hanging on the bar and the speed of running 1000 m decrease. The dynamics of physical development is expressed in a change in mass-growth indices and indicates an increase in body weight. The dynamics of physical fitness is expressed in a decrease of the time of hanging on the bar and the speed of running 1000 m. The dynamics of the functional state is expressed in a decrease of vital capacity of the lungs, vital index, increase in the coefficient of endurance, adaptive capacity and diastolic blood pressure.

Discussion on Technical Evaluation Requirements of Allergen Detection Reagent Pre-marketing / 中国医疗器械杂志

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.

Practice of Refined Management of in Vitro Diagnostic Reagents Based on SPD in Hospital / 中国医疗器械杂志

The management of in vitro diagnostic reagents has always been a concern. This paper describes the application of SPD medical consumables fine management system in our hospital. Relying on the brand-new management mode, the whole process from supplier qualification certificate management, in vitro diagnostic reagent procurement management, secondary warehouse management, and then to the use process traceability was realized. The monthly cost of in vitro diagnostic reagents can be accurately counted, which effectively controls the cost of in vitro diagnostic reagents.

Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

¿Podría ser el maltrato animal un indicador policial de violencia de género? Análisis de casos en España / Could animal abuse be a police indicator of gender violence? Analysis of cases in Spain / O abuso de animais poderia ser um indicador policial da violência baseada no gênero? Análise de casos na Espanha

La concurrencia entre el maltrato animal y la violencia de género, cometidos por el mismo maltratador, ha sido señalada en los últimos años en diversas sociedades, principalmente en EE. UU., Reino Unido y Australia. En este estudio analizamos esta relación en España, con la idea de investigar la posible utilización del maltrato animal como indicador policial de violencia de género. Hemos vislumbrado la perpetración del maltrato animal, de forma instrumental, con el fin de controlar a la (ex)pareja, o de forma expresiva para causar daño de forma indirecta a la (ex)pareja. Creemos pertinente avanzar en esta clase de estudios mediante la recolección de más datos y la realización de análisis cualitativos.

The concurrence between animal abuse and gender violence, committed by the same abuser, has been reported in recent years in several societies, mainly in the USA, United Kingdom and Australia. In this study we analyze this relationship in Spain, with the idea of investigating the possible use of animal abuse as a police indicator of gender violence. We have glimpsed the perpetration of animal abuse, in an instrumental way, in order to control the (ex)partner, or in an expressive way to indirectly cause harm to the (ex)partner. We believe it is pertinent to advance in this kind of studies by collecting more data and conducting qualitative analyses.

A concorrência entre o abuso de animais e a violência de gênero, cometida pelo mesmo abusador, tem sido relatada nos últimos anos em várias sociedades, principalmente nos EUA, no Reino Unido e na Austrália. Neste estudo analisamos esta relação na Espanha, com a idéia de investigar o possível uso de abuso de animais como um indicador policial de violência de gênero. Vislumbramos a perpetração de abuso de animais, de forma instrumental, a fim de controlar o (ex)parceiro, ou de forma expressiva para causar indiretamente danos ao (ex)parceiro. Acreditamos que é pertinente avançar neste tipo de estudos, coletando mais dados e realizando análises qualitativas.

Geohelmintos y parámetros fisicoquímicos del suelo como indicadores de calidad ambiental en el distrito de José Crespo y Castillo, Huánuco / Geohelminths and physicochemical parameters of the soil as indicators of environmental quality in José Crespo y Castillo, Huánuco district

En la investigación se determinaron la presencia de geohelmintos y se evaluó la calidad ambiental del suelo mediante parámetros fisicoquímicos en el distrito de José Crespo y Castillo ­ Huánuco, Perú. Se detectaron y cuantificaron los geohelmintos, se caracterizó los perfiles modales y propiedades fisicoquímicas en función del Soil Taxonomy, y contraste con el estándar de calidad para el cadmio (Cd) y determinación del índice de calidad ambiental del suelo empleando el análisis de componentes principales. Los perfiles modales son Fluventic Eutrudepts, Lithic Udorthents, Typic Dystrudepts, Typic Dystrudepts - Lithic Udorthents, Typic Dystrudepts - Typic Endoaquents, Typic Endoaquents, Typic Eutrudepts - Typic Eutrudepts, Typic Udifluvents y Typic Udorthents; los parámetros fisicoquímicos textura, pH, materia orgánica, nitrógeno, fosforo disponible, potasio disponible, cadmio disponible, capacidad de intercambio catiónico efectivo, calcio, magnesio, aluminio, hidrogeno, bases y ácidos cambiables y porcentaje de saturación de aluminio, determinando que el cadmio disponible se encuentra dentro de los estándares de calidad ambiental del Perú; y el índice de calidad ambiental del suelo es de 41,48%, teniendo la calificación de un suelo regular de calidad ambiental. Y la contaminación por Ascaris lumbricoides fue en 25 de las calicatas (55,56%), presente en los 8 tipos de suelos catalogados, seguida de las unicinarias representadas por Necator americano y Ancylostoma duodenale en 14 calicatas (31,11%) de pH ligeramente a medianamente acido, y Taenias y Capilaria, ambos en el 8,29%; los geohelmintos como riesgo de salud pública, permanecen por largo de tiempo en el suelo, independientemente de la calidad y en amplios rangos de pH, favorecidos por niveles de sustratos orgánicos derivados de la antropogénesis(AU)

In the investigation, the presence of geohelminths was determined and the environmental quality of the soil was evaluated through physicochemical parameters in the district of José Crespo y Castillo - Huánuco, Peru. Geohelminths were detected and quantified and the modal profiles and physicochemical properties were characterized based on the Soil Taxonomy, and contrast with the quality standard for cadmium (Cd) and determination of the environmental quality index of the soil using the main component analysis. Modal profiles are Fluventic Eutrudepts, Lithic Udorthents, Typic Dystrudepts, Typic Dystrudepts - Lithic Udorthents, Typic Dystrudepts - Typic Endoaquents, Typic Endoaquents, Typic Eutrudepts - Typic Eutrudepts, Typic Udifluvents, and Typic Udorthents; the physicochemical parameters texture, pH, organic matter, nitrogen, available phosphorus, available potassium, available cadmium, effective cation exchange capacity, calcium, magnesium, aluminium, hydrogen, exchangeable bases and acids and percentage of aluminum saturation, determining that cadmium available is within the environmental quality standards of Peru; and the environmental quality index of the soil is 41.48%, having the qualification of a regular soil of environmental quality. And the contamination by Ascaris lumbricoides was in 25 of the pits (55.56%), present in the 8 types of cataloged soils, followed by the unicinarias represented by Necator americano and Ancylostoma duodenale in 14 pits (31.11%) of pH slightly to medium acid, and Taenias and Capilaria, both at 8.29%; As a public health risk, geohelminths remain in the soil for a long time, regardless of quality and in wide pH ranges, favored by levels of organic substrates derived from anthropogenesis(AU)

Análisis de la producción científica sobre bajo peso al nacer publicada en revistas médicas cubanas / Analysis of scientific production on low birth weight published in Cuban medical journals

Introducción: El peso al nacer es el determinante más importante de las posibilidades de un recién nacido de experimentar un crecimiento y desarrollo satisfactorios, por tanto, constituye un indicador importante de salud. Estudiar la producción científica en este campo complementa de manera eficaz las opiniones y los juicios emitidos por los expertos. Objetivo: Caracterizar la producción científica sobre bajo peso al nacer publicada en revistas médicas cubanas. Material y métodos: Investigación descriptiva, de corte transversal, en la que se empleó como fuente primaria de información las revistas médicas cubanas certificadas como científicas. Se analizaron indicadores de producción científica, colaboración, impacto y co-ocurrencia de términos. Resultados: La producción científica cubana estuvo constituida por 34 publicaciones con predominio de 27 artículos originales. Se evidenció baja productividad por autores, elevada colaboración intrainstitucional e interprovincial y baja colaboración nacional e internacional con un índice de colaboración de 5,15. La Revista Electrónica Dr. Zoilo E. Marinello Vidaurreta fue la más productiva con 14,7 por ciento de las publicaciones. El análisis de co-ocurrencia de términos arrojó 3 clústeres que configuraron los principales focos emergentes de investigación en Cuba, relacionados con el bajo peso al nacer, los factores de riesgo y la prematuridad. Conclusiones: La producción científica sobre bajo peso al nacer en revistas médicas cubanas se caracterizó por ser baja e inestable. No existe un liderazgo en los investigadores, revistas e instituciones cubanas en la investigación sobre el tema. Se registró un predominio de la colaboración a nivel local e investigaciones sobre los factores de riesgo asociados al bajo peso al nacer y su relación con la prematuridad(AU)

Introduction: Birth weight is the most important determinant of a newborn's chances of experiencing satisfactory growth and development; therefore, it is an important indicator of health. Studying scientific production in this field effectively complements the opinions and judgments issued by experts. Objective: To characterize the scientific production on low birth weight published in Cuban medical journals. Material and Methods: A descriptive, cross-sectional investigation was carried using the Cuban medical journals certified as scientific as the primary source of information. Indicators of scientific production, collaboration, impact and co-occurrence of terms were analyzed. Results: The Cuban scientific production consisted of 34 publications, with a predominance of 27 original articles. Authors with low productivity, high intra-institutional and interprovincial collaboration, and low national and international collaboration were evidenced, with a collaboration index of 5,15. The Dr. Zoilo E. Marinello Vidaurreta Electronic Journal was the most productive one, with 14.7 percent of the publications. The term co-occurrence analysis yielded 3 clusters that formed the main emerging research focuses in Cuba related to low birth weight, risk factors and prematurity. Conclusions: Scientific production on low birth weight in Cuban medical journals was characterized as low and unstable. There is no leadership of Cuban researchers(AU) journals and institutions in research on the subject. There was a predominance of collaboration at the local level and research on the risk factors associated with low birth weight and their relationship to prematurity(AU)

Fatores que influenciam o processo de rastreabilidade no centro de materiais e esterilização / Factors that influence the traceability process at the materials and sterilization center / Factores que influyen en el proceso de trazabilidad en el centro de materiales y esterilización

Objetivo: Analisar os fatores que influenciam o processo de rastreabilidade no centro de materiais e esterilização. Métodos: Estudo descritivo, de natureza quantitativa realizado em um hospital geral privado localizado em Belo Horizonte, Minas Gerais, Brasil. A amostra contemplou 209 registros de checklist e documentos de trabalho que se encontravam disponíveis em forma física e lançados no sistema de gestão da qualidade, onde as informações foram analisadas pela técnica de estatística descritiva e medidas de tendência central. Resultados: Entre julho de 2019 e junho de 2020 foram esterilizados 115.119 produtos para saúde que variou de 9.287 a 9.932/mês, com média de 9.593 (±221,6). A taxa de não conformidade, no período, foi de 0,08%. Em relação aos fatores que influenciaram a rastreabilidade, destaca-se a etiqueta trocada ou incorreta (32,6%), a embalagem violada (21,7%) e os produtos para saúde sem identificação (18,4%). Conclusão: Embora a taxa de não conformidade atribuída ao processo de rastreabilidade seja baixa, foi possível levantar os fatores que influenciam esta etapa e impactam no processamento de produtos para saúde. (AU)

Objective: To analyze the factors that influence the traceability process in the materials and sterilization center. Methods: A descriptive, quantitative study carried out in a private general hospital located in Belo Horizonte, Minas Gerais, Brazil. The sample included 209 checklist records and working documents that were available in physical form and released in the quality management system, where the information was analyzed using the technique of descriptive statistics and measures of central tendency. Results: Between July 2019 and June 2020, 115,119 health products were sterilized, ranging from 9,287 to 9,932 / month, with an average of 9,593 (± 221.6). The non-compliance rate in the period was 0.08%. Regarding the factors that influenced traceability, the changed or incorrect label (32.6%), violated packaging (21.7%) and unidentified health products (18.4%) stand out. Conclusion: Although the rate of non-compliance attributed to the traceability process is low, it was possible to raise the factors that influence this step and impact the processing of health products. (AU)

Objetivo: Analizar los factores que influyen en el proceso de trazabilidad en el centro de materiales y esterilización. Métodos: Estudio descriptivo cuantitativo realizado en un hospital general privado ubicado en Belo Horizonte, Minas Gerais, Brasil. La muestra incluyó 209 registros de checklist y documentos de trabajo que estuvieron disponibles en forma física y liberados en el sistema de gestión de calidad, donde se analizó la información mediante la técnica de estadística descriptiva y medidas de tendencia central. Resultados: Entre julio de 2019 y junio de 2020 se esterilizaron 115.119 productos sanitarios, que van desde 9.287 a 9.932 / mes, con un promedio de 9.593 (± 221,6). La tasa de incumplimiento en el período fue del 0,08%. En cuanto a los factores que influyeron en la trazabilidad, destacan la etiqueta modificada o incorrecta (32,6%), los envases violados (21,7%) y los productos sanitarios no identificados (18,4%). Conclusión: Si bien la tasa de incumplimiento atribuida al proceso de trazabilidad es baja, fue posible plantear los factores que influyen en este paso e impactan en el procesamiento de productos sanitarios. (AU)

Propuesta de un indicador para sobrepeso y obesidad: índicepeso-circunferencia de cintura (IPCC) / Proposal of an indicator for overweight and obesity: weight-circumference waist index (WCWI)

El objetivo es evaluar el IPCC, para proponerlo como indicador de sobrepeso y obesidad. Es un estudio descriptivo, prospectivo, transversal y correlacional, en una muestra de 896niños y adolescentes con edad de 6 y 19 años; 452 (50,4%)del sexo masculino y 444 (49,6%) del sexo femenino. Métodos: Se midieron las variables sexo, edad, peso, talla, IMC, PGC e IPCC; se determinaron promedios, desviación, correlaciones y curva ROC. Resultados: promedios de peso 43,1±14,8 kg; talla 146,2±15,8 cm; IMC 19,6±3,6 kg/m2; CC 66,7±9,3 cm; IPCC 0,64±0,2 y PGC 15,5±7,3. Correlaciones muy buenas entre Talla-Peso (0,87); Peso-IMC (0,84); Peso-IPCC (0,91);Talla-IPCC (0,80) e IMC-IPCC (0,75); porcentajes resultantes de clasificar a niños y adolescentes, según valores del IMC eI PCC, y los tres criterios asumidos como referencias, indican que: Sobrepeso 10,9% (IMC) y 11,6% (IPCC); Obesidad 5,3%(IMC) y 5,8% (IPCC). Para el criterio Media y Desviación, Sobrepeso 4,1% (IMC) y 8,1% (IPCC); Obesidad 0,3% (IMC)y 4,2% (IPCC). Para el criterio Fundacredesa, Sobrepeso 7,2%(IMC) y 8,0% (IPCC); Obesidad 3,3% (IMC) y 3,6% (IPCC).Promedios, por sexo, para las variables peso, talla, IMC, CC eI PCC, no significativos; si los promedios del PGC (p<0,000).Curva ROC se aleja de la diagonal, aunado al hecho que el área bajo la curva es 0,983, refleja la bondad del modelo, complementado con una alta sensibilidad y especificidad, garantizado así un al poder discriminante. Conclusión: Curva ROC del IPCC, con área bajo la curva es 0,983, alta sensibilidad y especificidad, con capacidad discriminante(AU)

The objective is to evaluate the WCWI, to propose it as an indicator of overweight and obesity. It is a descriptive, prospective, cross-cutting and correlational study, in a sample of 896 children and adolescents aged 6 and 19; 452 (50.4%)444 (49.6%) of the female sex. Methods: the variables sex, age, weight, size, BMI, BFP and WCWI were measured; averages, deviation, correlations and ROC curve were determined. Results: weight averages 43.1±14.8 kg; size 146.2±15.8 cm; BMI 19.6±3.6 kg/m2; WC 66.7±9.3 cm; WCWI 0.64±0.2 and BFP 15.5±7.3. Very good correlations between Size-Weight (0.87); Weight-BMI (0.84); WCWI-Weight (0.91);Size-WCWI (0.80) and BMI-WCWI (0.75); percentage Revista Digital de Postgrado, 2021, 10(3), e325, Septiembre-Diciembre, ISSN: 2244-761XPDF generado a partir de XML-JATS4 Rresulting from classifying children and adolescents, accordingto BMI and WCWI values, and the three criteria assumed as references, indicate that: Overweight 10.9% (BMI) and 11.6%(WCWI); Obesity 5.3% (BMI) and 5.8% (WCWI); for the Mean and Deviation criterion, Overweight 4.1% (BMI) and8.1% (WCWI); Obesity 0.3% (BMI) and 4.2% (WCWI).For the Fundacredesa criterion, Overweight 7.2% (BMI) and8.0% (WCWI); Obesity 3.3% (BMI) and 3.6% (WCWI).Averages by sex, for non-significant weight, size, BMI, WC and WCWI variables; BFP averages (p<0.000). ROC curvemoves away from the diagonal, coupled with the fact that thearea under the curve is 0.983, reflects the goodness of themodel, complemented by a high sensitivity and specificity, thusguaranteed a discriminating power. Conclusion: WCWI ROC curve, with are a under the curve is 0.983, high sensibility and specificity, with discriminating capacity(AU)

Incidencia del perímetro abdominal en la resistencia a esfuerzos intermitentes de universitarios físicamente activos / Incidence of abdominal perimeter in endurance to intermittent efforts by physically active university students

Introducción: El perímetro abdominal y la resistencia a esfuerzos intermitentes, reflejada en el VO2máx, son dos grandes indicadores; el primero del riesgo cardiovascular y el segundo de la capacidad aeróbica máxima. Este estudio permitirá determinar si las mediciones del perímetro abdominal tienen relación con la capacidad del sujeto de responder a esfuerzos intermitentes. Objetivo: Determinar la asociación entre el perímetro de cintura y la resistencia a esfuerzos intermitentes reflejada en el VO2máx. Métodos: Los participantes fueron 91 hombres y 22 mujeres estudiantes de la Licenciatura en Educación Física, Recreación y Deportes de la Universidad de Pamplona. Para la valoración de la resistencia intermitente se empleó el test de fitness intermitente 30-15 (30-15 ITF) con el cual se determinó el VO2máx. Se realizó la toma del perímetro de cintura teniendo en cuenta los criterios de la Federación Internacional de Diabetes. La tabulación y análisis de datos se llevó a cabo en el paquete estadístico PSPP, con la prueba de normalidad de Kolmogorov - Smirnov para hombres y Shapiro - Wilk para mujeres, y el coeficiente correlacional de Spearman (p < 0,05) (valor p de 0,05). Resultados: Se encontró una asociación negativa entre las variables perímetro abdominal e indicador de resistencia a esfuerzos intermitentes VO2máx, en hombres (r = -0,17) y en mujeres (r = 0,09), no obstante, para ambos sexos esta relación no fue estadísticamente significativa (p < 0,05). Conclusión: Se concluye que el perímetro abdominal no está relacionado de forma significativa con la resistencia a esfuerzos intermitentes en universitarios físicamente activos(AU)

Introduction: The abdominal perimeter and endurance to intermittent efforts reflected in VO2max are two major indicators; the first for cardiovascular risk and the second for maximum aerobic capacity. This study will make it possible to determine whether abdominal perimeter measurements are related to the subject's ability to respond to intermittent efforts. Objective: Determine the association between the abdominal perimeter and the endurance to intermittent efforts reflected in the VO2max. Methods: The participants were 91 men and 22 female students of the Bachelor's Degree in Physical Education, Recreation and Sports of the University of Pamplona. For the assessment of intermittent endurance, the intermittent fitness test 30-15 (30-15 ITF) was used with which the VO2max was determined. The abdominal perimeter was taken taking into account the criteria of the International Diabetes Federation. The tabulation and analysis of data was carried out in the PSPP statistical package, applying the Kolmogorov-Smirnov normality test for men and Shapiro-Wilk for women, and, Spearman's correlational coefficient (p < 0,05) (p-value of 0,05). Results: A negative association was found between the variables abdominal girth and the indicator of endurance to intermittent efforts VO2max, in men (r = -0,17) and in women (r = 0,09), however, for both sexes, this relationship was not statistically significant (p < 0,05). Conclusion: It is concluded that, the abdominal perimeter is not significantly related to resistance to intermittent efforts in physically active university students(AU)

Componentes principales en el agrupamiento de variables clínicas de la COVID-19 en Santiago de Cuba / Principal component analysis in COVID-19 clinical variable clustering in Santiago de Cuba

Introducción: Desde marzo de 2020 Cuba está siendo afectada por el SARS-CoV-2, coronavirus altamente infeccioso y causante de la COVID-19. La COVID-19 presenta un conjunto de síntomas asociados y la evolución de los pacientes puede estar influenciada por la presencia de ciertos antecedentes patológicos personales en el hospedero. Objetivo: Identificar mediante componentes principales el agrupamiento de variables clínicas en los pacientes con COVID-19 en la provincia de Santiago de Cuba. Método: Se realizó un estudio observacional, descriptivo y transversal. La población de estudio se conformó por los 49 casos confirmados con COVID-19 en la provincia de Santiago de Cuba desde el 20 de marzo hasta el 30 de abril del 2020. Se seleccionaron diez variables clínicas: nueve relacionadas con los síntomas y los antecedentes patológicos personales, y una con el estado fallecido. Se aplicó como técnica estadística el análisis de componentes principales. Resultados: Se obtuvo la representación de las variables en el plano de los dos primeros componentes principales. El primer componente estuvo asociado a los síntomas y el segundo componente a los antecedentes patológicos personales no asociados al aparato respiratorio. Esta representación reveló que en el primer y cuarto cuadrantes del plano se ubicaron las variables que llevaron a una evolución desfavorable de los casos, siendo notable para los que se ubican en el cuarto cuadrante. El segundo y tercer cuadrantes fueron indicadores de la evolución favorable, marcada en el segundo cuadrante. Conclusiones: El análisis de componentes principales agrupa las variables clínicas y corrobora que los antecedentes patológicos personales tienen el rol esencial en la evolución desfavorable de los pacientes con COVID-19(AU)

Introduction: Since March 2020, Cuba has been affected by SARS-CoV-2, a highly infectious coronavirus that causes COVID-19. In COVID-19 a set of associated symptoms is presented and its evolution can be influenced by the presence of certain personal pathological antecedents in the host. Objective: To identify through principal components the grouping of clinical variables in cases with COVID-19 in Santiago de Cuba province, Cuba. Methods: We conducted an observational, descriptive and transversal study. The study population consisted of the 49 confirmed cases with COVID-19 in the province of Santiago de Cuba. Ten clinical variables were selected: nine related to symptoms and personal pathological history, and one to the state "deceased". Principal component analysis was applied as a statistical technique. Results: Variables were represented at the level of the first two principal components. The first component was associated to symptoms and the second component to personal pathological antecedents not associated to the respiratory system. This representation revealed that variables leading to an unfavorable evolution of cases were located in the first and fourth quadrants of the plane, being remarkable for those located in the fourth quadrant. The second and third quadrants were indicators of the favorable evolution, being marked in the second quadrant. Conclusions: The principal component analysis groups the clinical variables and corroborates that personal pathological antecedents have an essential role in the unfavorable evolution of patients with COVID-19(AU)

Sífilis em gestantes residentes em São Luís, Maranhão: perfil e evolução de 2006 a 2018 / Syphilis in pregnant women living in São Luís, Maranhão: profile and evolution from 2006 to 2018 / Sífilis en gestantes residentes en São Luís, Maranhão: perfil y evolución de 2006 a 2018

Realizou-se um estudo descritivo com os casos notificados de Sífilis Gestacional (SG) em São Luís (Maranhão) no período de 2006 a 2018. Foram analisadas as tendências de indicadores epidemiológicos pela regressão Joinpoint e as características do agravo com base nos dados do Sistema de Informação de Agravos de Notificação (Sinan). Foram notificados 1.688 casos de SG no período estudado, com tendência significativa de aumento no número de casos novos, na prevalência e no coeficiente de detecção. O perfil das gestantes com SG mostrou que a infecção foi mais frequente em mulheres de 20 a 29 anos, com ensino médio e pardas. Além disso, houve predomínio da forma primária, frequentemente detectada no terceiro trimestre gestacional e tratada com penicilina. A persistência da infecção por sífilis na gestação demonstra uma falha na prevenção de infecções sexuais na população, especialmente na gestação, implicando riscos para e mãe e para o concepto.

A descriptive study was performed with the reported cases of Gestational Syphilis (GS) in São Luís (Maranhão) from 2006 to 2018. We analyzed the trends of epidemiological indicators by the Joinpoint regression and the characteristics of the disease based on the data from the Notifiable Disease Information System (Sinan). 1,688 cases of GS were reported in the period studied, with a significant tendency of increasing in the number of new cases, prevalence and detection coefficient. The profile of pregnant women with GS showed that the infection was more frequent in women aged 20 to 29 years, with high school and mixed race. Additionally, there was a predominance of the primary form, frequently detected in the third trimester of pregnancy and treated with penicillin. The persistence of syphilis infection during pregnancy demonstrates a failure to prevent sexual infections in the population, especially during pregnancy, implying risks for both the mother and the fetus.

Estudio descriptivo con los casos notificados de Sífilis Gestacional (SG) en São Luís (Maranhão) de 2006 a 2018. Se analizaron las tendencias de los indicadores epidemiológicos mediante regresión Joinpoint y las características de la enfermedad con base en datos del Sistema de Información de Quejas formales (Sinan). Se notificaron 1.688 casos de SG en el período estudiado, con una tendencia significativa al aumento en el número de nuevos casos, en la prevalencia y en el coeficiente de detección. El perfil de gestantes con SG mostró que la infección fue más frecuente en mujeres de 20 a 29 años, con estudios secundarios y mestizas. Además, predominó la forma primaria, frecuentemente detectada en el tercer trimestre del embarazo y tratada con penicilina. La persistencia de la infección por sífilis durante el embarazo demuestra la falta de prevención de las infecciones sexuales en la población, especialmente durante el embarazo, lo que implica riesgos tanto para la madre como para el feto.

Manual de laboratorio para el diagnóstico por PCR en tiempo real en laboratorios descentralizados y vigilancia genómica de SARS-CoV-2 / Laboratory manual for real-time PCR diagnosis in decentralized laboratories and genomic surveillance of SARS-CoV-2

En los antecedentes, brinda detalles técnicos de enfermedades previas al COVID-19 y sigue esta consigna internacional: "Sin embargo, a la luz de la posible introducción de un caso sospechoso relacionado con el 2019-nCoV en la Región de las Américas, la Organización Panamericana de la Salud / Organización Mundial de la Salud (OPS / OMS) recomienda a los Estados Miembros garantizar su identificación oportuna, el envío de las muestras a laboratorios Nacionales o de referencia y la implementación del protocolo de detección molecular para 2019-nCoV, según la capacidad del laboratorio." Aborda las tres mutaciones del virus conocidas hasta la fecha del documento y las tres variantes conocidas: Reino Unido e Irlanda del Norte, República de Sudáfrica y Brasil, siendo la de mayor transmisibilidad, según el documento, la del Reino Unido. El primero de los objetivos del documento es: "Brindar los lineamientos generales para la toma de muestra, conservación, transporte y diagnóstico del SARS-Cov-2 en los laboratorios descentralizados bajo la técnica de Reacción en Cadena de la Polimerasa (PCR) en tiempo Real, en atención a pacientes que cumplen con la definición de caso y se tipifica como "sospechoso inusitado"." Incluye como anexo 2 el documento: "Lineamientos para el abordaje de casos positivos para SARS-COV-2 de viajeros que ingresan al país por el aeropuerto internacional "La Aurora" (AILA)"

Desempenho de diferentes marcas de tiras reagentes relativo à densidade e à análise química da urina de cães e gatos / Performance of different brands of reagent strips for density and chemical analysis of dog and cat urine

Objetivou-se verificar a compatibilidade entre diferentes marcas de tiras reagentes para urinálise, tanto de uso veterinário, como de uso humano, e confrontar os parâmetros semiquantitativos desse instrumento com métodos quantitativos. Para isso, foram analisadas 77 amostras frescas de urina de cães e gatos e testados 04 modelos de tiras reagentes. Quanto à densidade urinária, houve correlação razoável entre os métodos quantitativo e semiquantitativo naquelas amostras com pH ácido, mas não naquelas com pH neutro ou alcalino. Quanto à concentração proteica, houve similaridade de 53,3% a 83,3% entre as marcas testadas e quando comparadas com a análise fotométrica houve uma correlação razoável (rs = 0,69752 a 0,75074). Em ponto de corte de 15mg/dL de proteína, a sensibilidade da tira reagente foi 82,5% e 100% para urina canina e felina, respectivamente. No tocante à hematúria, houve divergência razoável entre a sedimentoscopia e as diferentes marcas de tiras reativas. Quanto à piúria, há uma baixa sensibilidade das tiras em relação às amostras caninas com muitos resultados falso-negativos (33% a 75%), enquanto em amostras felinas a sensibilidade foi de 100%. Assim, independente da marca, as tiras reagentes devem servir apenas como teste rápido de triagem, sendo mais apropriado o uso de métodos quantitativos na avaliação clínica do paciente a partir da urinálise.

The aim was to verify the compatibility between different brands of urinary dipsticks, for both human and veterinary use, and to compare the semiquantitative parameters of this instrument with quantitative methods. For this, 77 fresh samples of urine from dogs and cats were analyzed e and 04 models of reagent strips were tested. Regarding urinary density, a reasonable correlation was observed between the quantitative and semiquantitative methods in those samples with acidic pH, which did not occur in those with neutral or alkaline pH. Regarding the protein concentration, there was similarity from 53.3% to 83.3% between the brands and in the comparative analysis between the control strip and the photometric analysis, there was a reasonable correlation (rs = 0.69752 to 0.75074). In cut-off point of 15mg/dL protein, the sensitivity of the reagent strip was 82.5% and 100% for canine and feline urine, respectively. Regarding hematuria, there was a reasonable divergence of results between sedimentation and tested dipsticks. As for pyuria, there is a low sensitivity of the strips in relation to canine samples with many false negative results (33% to 75%), while in feline samples the sensitivity was 100%. Thus, regardless of the brands, the reagent strips should serve only as a rapid screening test, while the use of quantitative methods in the clinical evaluation of the patient from urinalysis is more appropriate.