Evolution and importance of the Research Ethics Committee, CEP, in higher education institutions: a study in a western Amazonian institution between 2018 to 2022

The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

Meta-analysis of the efficacy of invisible orthodontic appliances for maxillary molar distalization in adult patients / 口腔疾病防治

Objective@#To evaluate the clinical efficacy of invisible orthodontic appliances without brackets for the distal movement of maxillary molars to improve the ability of orthodontists to predict treatment outcomes.@*Methods@#Web of Science, Cochrane Library, Embase, PubMed, Wanfang Database, CNKI Database, and VIP Database were searched for studies investigating the efficacy of invisible orthodontic appliances for distal movement of maxillary molars in adult patients and published from database inception to August 1, 2023. A total of three researchers screened the studies and evaluated their quality and conducted a meta-analysis of those that met quality standards.@*Results@#This study included 13 pre- and postcontrol trials with a total sample size of 281 patients. The meta-analysis revealed no significant differences in the sagittal or vertical parameters of the jawbone after treatment when compared with those before treatment (P>0.05). The displacement of the first molar was MD=-2.34, 95% CI (-2.83, -1.85); the displacement was MD=-0.95, 95% CI (-1.34, -0.56); and the inclination was MD=-2.51, 95% CI (-3.56, -1.46). There was a statistically significant difference in the change in sagittal, vertical, and axial tilt of the first molar before and after treatment. After treatment, the average adduction distance of the incisors was MD=-0.82, 95% CI (-1.54, -0.09), and the decrease in lip inclination was MD=-1.61, 95% CI (-2.86, -0.36); these values were significantly different from those before treatment (P<0.05).@*Conclusion@#Invisible orthodontic appliances can effectively move the upper molars in a distal direction and control the vertical position of the molars. When the molars move further away, there is some degree of compression and distal tilt movement, which is beneficial for patients with high angles. The sagittal movement of incisors is beneficial for improving the patient's profile.

Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products / 中国药房

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Interpretation and mirror of the National Health Education Standards in the United States / 中国学校卫生

Abstract@#In the context of frequent public health events, effective school health education is an important measure to improve students health literacy and public health system of China. The study examined the National Health Education Standards in the U.S., based on a literature review and comparative analysis, to provide guidance for China. Using the method of liberature riview paper interprets the curriculum of National Health Education Standards in the U.S. and provides a mirror for China. Health Education standards in the U.S. are characterized by their academic quality, standardized framework, assessment program, equity principles, and other components. A mirror for China includes promoting the construction of the standards based health education curriculum, developing the skills based health education curriculum system, and constructing a performancebased comprehensive evaluation system.

Performance of four simplified screening methods of elevated blood pressure among children and adolescents / 中国学校卫生

Objective@#To evaluate the performance of four simplified screening methods of elevated blood pressure commonly used among children and adolescents according to Chinese guidelines for prevention and treatment of hypertension (revised in 2018), so as to provide a reference for the early detection of the elevated blood pressure among children and adolescents.@*Methods@#Stratified cluster random sampling method was used to monitor the physical fitness of 5 211 children and adolescents in a city of Shanxi Province from October to November 2021. Chinese guidelines for prevention and treatment of hypertension was considered as gold standard, and sensitivity, specificity, area under the curve (AUC) and Kappa value were calculated to evaluate the screening effectiveness of formula method, height specific method, age group specific method, sex and age specific method for screening elevated blood pressure.@*Results@#The detection rates of elevated blood pressure among children and adolescents screened by gold standard, formula method, height specific method,age group specific method, sex and age specific method were 21.9%, 24.0%, 21.1%, 24.5% and 20.2%, respectively. There was no significant difference between prevalence of elevated blood pressure screened by formula method, sex and age specific method and gold standard( χ 2=1.21, 1.41, P >0.05), whereas height specific method and age group specific method had significant differences with gold standard ( χ 2=20.39, 67.09, P <0.05). AUC was the largest for height specific method [0.94(95% CI =0.93-0.95)], and the smallest for age group specific method [0.87(95% CI = 0.86 -0.88)]. The Kappa values of height specific method (0.89) and sex and age specific method (0.89) were both greater than 0.85 , which were more consistent with the screening effectiveness of gold standard. When comparing by sex, age and body mass index (BMI), the screening effectivenesses were consistent with the overall in boys, 6-11 years and normal body weight groups, while the screening effectivenesses were different in girls, 12-17 years, overweight and obese groups. The AUC (0.87), Kappa value (0.71) and sensitivity (82.33%) of age group specific method were the lowest and the screening effectiveness was the worst.@*Conclusion@#Height specific method is more effective and can be used for early identification and self detection of blood pressure abnormalities among children and adolescents.

Application of two different methods of visual acuity assessment for myopia screening among lower grade elementary school students / 中国学校卫生

Objective@#To explore two visual acuity standards for examining uncorrected visual acuity (UCVA) to define poor vision in lower grade elementary school students, and to compare the difference of screening myopia rates when combined with non cycloplegic auto refraction (NCAR), so as to provide a scientific basis for standardizing UCVA examination methods using CAR as the gold standard of authenticity and reliability.@*Methods@#From March 22nd to April 9th, 2023, a total of 549 first and second grade students aged 7-8 years from a primary school in Hefei City were selected for the study by convenient cluster sampling method. Two methods were employed for UCVA examination:the first method involved charts where the student could not make mistakes in identifying at least half of the characters per line (V1), and the second method used charts with character sizes ranging from 4.0 -4.5, 4.6-5.0 and 5.1-5.3, without allowing 1, 2 and 3 errors per line (V2). While NCAR was performed, then 187 students underwent CAR examination. Paired Wilcoxon rank-sum test and McNemar test were used to compare the differences between V1 and V2 methods in defining poor vision and screening myopia rates. Using CAR as the gold standard, the authenticity and reliability of defining screening myopia rates through the combination of V1 and V2 methods along with NCAR were evaluated.@*Results@#The UCVA examination results for V1 and V2 showed statistically significant differences in both the right eye [5.0(4.9,5.0), 4.9(4.8,5.0)] and the left eye [ 5.0 (4.9,5.0), 4.9(4.8,5.0)] ( Z=-13.95, -13.34, P <0.01). The detection rates of poor vision for the right eye were 43.53% for V1 and 63.21% for V2, and the left eye with 44.08% for V1 and 62.11% for V2, with statistically significant differences ( χ 2= 106.01 , 95.09, P <0.01). When screening myopia rates were assessed for UCNA methods combined with NCAR, the right eye rates were 21.49% for V1 and 24.59% for V2, and the left eye rates were 21.31% for V1 and 23.13% for V2, with statistically significant differences ( χ 2=15.06, 8.10, P <0.01). Using CAR as the gold standard, the detection rates in the right eye and left eye were 16.58 % and 17.11%, respectively. The Youden indices for defining screening myopia in the right eye were 0.80 for V1 and 0.79 for V2, and the left eye with 0.85 for V1 and 0.83 for V2. The agreement rates for the right eye were 91.98 % for V1 and 89.30% for V2, and the left eye with 94.12% for V1 and 91.98% for V2. The Kappa values for the right eye were 0.73 for V1 and 0.67 for V2, and the left eye with 0.81 for V1 and 0.75 for V2.@*Conclusions@#Authenticity and reliability of two UCVA examination methods combined with NCAR in defining screening myopia are higher in V1 than V2 methods. It is recommended to unify the visual acuity examination methods by requiring the correct identification of more than half of the total number of visual markers in a row.

Development and implications of physical fitness assessment for children and adolescents in Japan / 中国学校卫生

Abstract@#To help children and adolescents grow up healthily, using literature, comparative analysis and other research methods, the historical development of Japan s physical fitness assessment system for children and adolescents are analyzed for the content structure of the latest version of its physical fitness assessment system (Sports adaptability assessment Ⅱ). On the basis of this analysis, some practical suggestions are proposed for improving the National Physical Fitness Standards for Students in China, such as adding a physical fitness assessment system for preschoolers, grouping the test subjects by age and setting common test indicators for males and females. Thus, the improved National Student Physical Fitness Standard is more aligned with the physical and mental growth patterns of Chinese children and adolescents.

Opinion on the development and research status of intelligent ophthalmology in China / 国际眼科杂志(Guoji Yanke Zazhi)

This paper provides a comprehensive analysis of the current state of intelligent ophthalmology in China, including technological advancements, academic exchange platforms, policy support, future challenges, and potential solutions. Technologically, remarkable progress have been made in various areas of intelligent ophthalmology in China, including diabetic retinopathy, fundus image analysis, and crucial aspects such as quality assessment of medical artificial intelligence products, clinical research methods, technological evaluation, and industrial standards. Researchers are constantly improving the safety and standardization of intelligent ophthalmology technology by formulating clinical application guidelines and standards. Academic exchange platforms have been established to provide extensive collaboration opportunities for professionals across diverse fields, and various academic journals serve as publication platforms for intelligent ophthalmology research. Regarding public policy, the Chinese government has not only established a supportive policy environment for the advancement of intelligent ophthalmology through various documents and regulations, but provided a legal basis and management framework. However, there are still challenges to overcome, such as technological innovation, data privacy and security, outdated regulations, and talent shortages. To tackle these issues, there is a requirement for increased technological research and development, the establishment of regulatory frameworks, talent cultivation, and greater awareness and acceptance of new technologies among patients. By comprehensively addressing these challenges, intelligent ophthalmology in China is expected to continue leading the industry's global development, bringing more innovation and convenience to the field of ophthalmic healthcare.

The body as a mirror of inequality in México during the second half of the twentieth century / El cuerpo como espejo de la desigualdad en México durante la segunda mitad del siglo XX

Abstract This paper examines how variations in the height and health of Mexicans during the second half of the twentieth century reflect the evolution of economic inequality, as its effects have repercussions on the health and nutritional conditions of the population. The average height of Mexican adults had a modest increase with respect to the possibilities of human plasticity. These anthropometric variations were the result of the incorporation of advances in science and technology leading to improved standards of living among the population. Body changes were impacted by dietary habits, urbanization, and government policies supporting food production and distribution.

Resumen Este trabajo examina cómo las variaciones en la estatura y la salud de los mexicanos durante la segunda mitad del siglo XX son un reflejo de la evolución de la desigualdad económica pues sus efectos repercuten en las condiciones de salud y alimentación de la población. La estatura promedio de adultos mexicanos tuvo un aumento modesto con respecto a las posibilidades de la plasticidad humana. Estas variaciones antropométricas fueron resultado de la incorporación de avances en ciencia y tecnología conducentes a mejorar los niveles de vida de la población. Los cambios corporales fueron impactados por hábitos alimenticios, de urbanización y políticas gubernamentales de apoyo a la producción y distribución de alimentos.

Implementación de paquete de medidas de conductas perinatales en recién nacidos con gastrosquisis congénita

Introducción: la gastrosquisis congénita (GC) es una patología con creciente demanda asistencial. Atentos a esto, en el Centro Hospitalario Pereira Rossell (CHPR) se implementó un protocolo de cuidados llevado adelante por un equipo multidisciplinario. En este trabajo nos proponemos evaluar el impacto en la sobrevida y morbilidad a partir de su aplicación. Material y método: estudio comparativo tipo antes y después de pacientes portadores de GC (n = 47), 29 de una cohorte histórica (GH) y 18 de una cohorte posaplicación de protocolo (GP). Con edad gestacional ≥ 36 semanas y peso al nacer ≥ 2500 g, asistidos en el CHPR entre los años 2016 y 2021. Resultados: no se observaron diferencias perinatales entre ambos grupos, ni en la incidencia de GQ complicadas. En el GP se observó mayor incidencia de cierre abdominal precoz (p < 0,01), menor necesidad de realización de silo quirúrgico (p < 0,01), menor tiempo de administración de ventilación mecánica (p = 0,03), de uso total de opioides (p < 0,01), de administración de nutrición parenteral (p = 0,03), e inicio más temprano de la alimentación enteral (p = 0,03). Sin diferencias en la sobrevida al egreso hospitalario. Conclusiones: la aplicación de un protocolo estandarizado se asoció a una reducción significativa en el tiempo de cierre abdominal, de ventilación mecánica, nutrición parenteral y de opioides, con inicio más precoz de la nutrición enteral.

Summary: Introduction: congenital gastroschisis is an increasingly demanded pathology, therefore a care protocol was implemented at the Pereira Rossell Pediatric Hospital (CHPR), and it has been carried out by a multidisciplinary team. In this paper, we aim at assessing the morbidity and mortality impact of survival and morbidity of this application. Materials and Methods: comparative before and after study of a historical cohort (GH, n=29) versus a post-protocol application cohort (GP, n=18), in patients with a gestational age ≥36 weeks and birth weight ≥2500 grams assisted in CHPR between 2016-2021. Results: no perinatal differences were observed between both groups or in the incidence of complicated GQ. In the GP, a higher incidence of early abdominal closure was decreased (GH 3.4% vs GP 67%, p<0.01), less need to perform a surgical silo (GH 100% vs GP 33%, p<0.01 ), shorter mechanical ventilation administration time (GH 2 days vs GP 0.5 days, p=0.03), total use of opioids (GH 3.5 days vs GP 7 days, p<0.01) , of administration of parenteral nutrition (GH 24.5 days vs GP 20 days, p=0.03), and earlier start of enteral feeding (GH 11 days vs GP 7 days, p=0.03). No differences in survival after hospital discharge (93% vs 89%, p=0.63). Conclusions: the application of a standardized protocol was linked to a significant reduction in the time of abdominal closure, mechanical ventilation, parenteral nutrition, and opioids, with earlier initiation of enteral nutrition.

Introdução: a gastrosquise congênita (GC) é uma patologia com demanda crescente de atendimento e, porém, foi implementado um protocolo de atendimento por equipe multidisciplinar no Centro Hospitalar Pediátrico Pereira Rossell (CHPR). Neste trabalho propomos avaliar o impacto na mortalidade e morbidade depois de sua aplicação. Material e Métodos: estudo comparativo antes e depois de pacientes com CG (n=47), sendo 29 de uma coorte histórica (GH) e 18 de uma coorte pós-aplicação de protocolo (GP). Idade gestacional ≥ 36 semanas e peso ao nascer ≥ 2.500 gramas atendidos no CHPR entre os anos de 2016-2021. Resultados: não foram observadas diferenças perinatais entre os dois grupos ou na incidência de QG complicada. No GP observou-se maior incidência de fechamento abdominal precoce (p<0,01), menor necessidade de silos cirúrgicos (p<0,01), menor tempo de administração de ventilação mecânica (p=0,03) e uso total de opioides. (p<0,01), administração de nutrição parenteral (p=0,03) e início mais precoce da alimentação enteral (p=0,03). Não houve diferenças na sobrevivência até a alta hospitalar. Conclusões: a aplicação de protocolo padronizado foi associada à redução significativa do tempo de fechamento abdominal, ventilação mecânica, nutrição parenteral e opioides, com início mais precoce da nutrição enteral.

Repercussions of the Emergency neurological life support on scientific literature: a bibliometric study / Repercussões do Emergency neurological life support na literatura científica: um estudo bibliométrico

Abstract Background In 2012, the Neurocritical Care Society launched a compilation of protocols regarding the core issues that should be addressed within the first hours of neurological emergencies - the Emergency neurological life support (ENLS). Objective We aim to evaluate this repercussion through a bibliometric analysis. Methods We searched Scopus on October 2022 for articles mentioning ENLS. The following variables were obtained: number of citations; number of citations per year; number of publications per year; year of publication; research type; research subtype; country of corresponding author and its income category and world region; journal of publication and its 5-year impact factor (IF); and section where ENLS appeared. Results After applying eligibility criteria, we retrieved 421 articles, published from 2012 to 2022. The mean number of citations per article was 17.46 (95% Confidence Interval (CI) = 8.20-26.72), while the mean number of citations per year per article was 4.05 (95% CI = 2.50-5.61). The mean destiny journal 5-year IF was 5.141 (95% CI = 4.189-6.093). The majority of articles were secondary research (57.48%; n= 242/421) of which most were narrative reviews (71.90%; n= 174/242). High-Income countries were the most prominent (80.05%; n= 337/421 articles). There were no papers from low-income countries. There were no trials or systematic reviews from middle-income countries. Conclusion Although still low, the number of publications mentioning ENLS is increasing. Articles were mainly published in journals of intensive care medicine, neurology, neurosurgery, and emergency medicine. Most articles were published by authors from high-income countries. The majority of papers were secondary research, with narrative review as the most frequent subtype.

Resumo Antecedentes Em 2012, a Neurocritical Care Society lançou uma compilação de protocolos sobre as questões centrais que devem ser abordadas nas primeiras horas de emergências neurológicas - Emergency neurological life support (ENLS). Objetivo Avaliar a repercussão do ENLS por meio de uma análise bibliométrica. Métodos A base de dados Scopus foi utilizada em outubro de 2022 para a busca por artigos mencionando o ENLS. As seguintes variáveis foram obtidas: número de citações; número de citações por ano; número de publicações por ano; ano de publicação; tipo de pesquisa; país do autor correspondente e sua categoria de renda; revista de publicação e seu fator de impacto de 5 anos (IF); e seção onde o ENLS apareceu. Resultados Os 421 artigos incluídos foram publicados de 2012 a 2022. A média de citações por artigo foi de 17.46 (intervalo de confiança (IC) 95% = 8.20-26.72), enquanto a de citações por ano por artigo foi de 4.05 (IC95% = 2.50-5.61). O IF médio por revista foi de 5.14 (IC95% = 4.19-6.09). A maioria dos artigos era de pesquisa secundária (57.48%; n= 242/421), dos quais a maioria eram revisões narrativas (71.90%; n= 174/242). Os países de alta renda foram os mais prolíficos (80.05%; n= 337/421 artigos). Não houve publicações de países de baixa ou média renda. Conclusão Embora ainda baixo, o número de publicações mencionando o ENLS vem aumentando recentemente. A maioria dos artigos foram publicados em revistas de medicina intensiva, neurologia, neurocirurgia e medicina de emergência. Artigos de pesquisa secundária foram os mais comuns, com revisões narrativas sendo o subtipo mais frequente.

Sistema de procedimientos para la formación interdisciplinar de la habilidad diagnosticar en residentes de dermatología / A System of Procedures for the Interdisciplinary Training of the Dill To Diagnose in Dermatology Residents

Introducción: En las prácticas de laboratorio se adquiere la habilidad que permite corroborar el diagnóstico de las enfermedades de la piel y anejos después de un diagnóstico presuntivo, con la utilización del método clínico. Esto se respalda en las exigencias establecidas en los documentos normativos de ese proceso formativo. Objetivo: Proponer un sistema de procedimientos para la formación interdisciplinar de la habilidad "diagnosticar enfermedades dermatológicas en los residentes de dermatología, a partir de insuficiencias detectadas en el programa de la especialidad. Métodos: La investigación fue cualitativa, con un estudio descriptivo en el Hospital Provincial General Docente Dr. Antonio Luaces Iraola, de Ciego de Ávila, desde 2018 hasta 2022. Se trabajó con toda la población conformada por 16 residentes de primer año en dermatología. Se utilizaron métodos de nivel teórico, empírico y estadístico. Resultados: En el sistema de procedimientos propuesto, se concretan fortalezas y debilidades, objetivo general, orientaciones metodológicas, precisión de los objetivos específicos y sistema de acciones para cada procedimiento, y sistema de control y evaluación de la efectividad de las acciones realizadas. La demostración de la formación de la habilidad diagnosticar, a través de un caso clínico real, reveló como esencial la consecutividad lógica de las acciones del residente desde la atención médica del caso y la formulación del diagnóstico presuntivo hasta el establecimiento del diagnóstico corroborativo en los laboratorios de anatomía patológica, microbiología y parasitología médica. Conclusiones: Se aporta un sistema de procedimientos que posibilita la formación de la habilidad "diagnosticar enfermedades dermatológicas en los residentes, con carácter secuencial, interdisciplinar e investigativo(AU)

Introduction: Laboratory practices provide the ability that allows corroborating the diagnosis of skin and adnexal diseases after a presumptive diagnosis, with the use of the clinical method. This is supported by the requirements established in the standardization documents of this training process. Objective: To propose a system of procedures for the interdisciplinary training of the skill to diagnose dermatological diseases in Dermatology residents, based on insufficiencies detected in the specialty program. Methods: The research was qualitative and consisted in a descriptive study carried out in Hospital General Docente Dr. Antonio Luaces Iraola, of Ciego de Avila, from 2018 to 2022. The work was done with the entire population made up of 16 first-year residents in Dermatology. Theoretical, empirical and statistical methods were used. Results: In the proposed system of procedures, strengths and weaknesses are specified, together with general objective, methodological guidelines, precision of specific objectives and system of actions for each procedure, as well as system of control and evaluation of the effectiveness of the actions. Demonstrating the received formation for the diagnostic skill, through a real clinical case, revealed as essential the logical consecutivity of the resident's actions from the medical attention of the case and the formulation of the presumptive diagnosis to the establishment of the corroborative diagnosis in the laboratories of pathological anatomy, microbiology and medical parasitology. Conclusions: A system of procedures is provided that makes possible the formation of the skill to diagnose dermatological diseases in residents, with sequential, interdisciplinary and investigative character(AU)

Impact of accreditation on knowledge and awareness of laboratory technicians about the aspects of laboratory quality in a tertiary care public-sector teaching hospital

Background: Laboratory diagnosis in Indian health-care setup is usually the mainstay of screening and diagnosis of diseases. Accreditation is a process of approval by establishing adherence of pre-defined quality standards to the existing system which can bring about utmost quality in service delivery by increasing accuracy and reliability and minimizing errors. Need for accreditation is ever-increasing in public sector health-care centers. Aim and Objectives: To ascertain and to quantify the impact of accreditation via training and exposure in the cadre of laboratory technicians in tertiary care public sector hospital. Materials and Methods: It was an interventional study to check competency of laboratory technicians in various domains of NABL standards, before and after training and exposure to accreditation process. It was carried out amongst MLT students and employed laboratory technicians in the clinical biochemistry department of a public sector, tertiary care, teaching hospital and lasted for 2 months. Preformed questionnaire was used. Difference between pre- and post-test results was compared with appropriate statistical analysis. Results: Marked difference was seen in the performance of study subjects before (27.6 ± 9.9) and after (56.7 ± 6.2) exposure to training and accreditation process (Max. score of 80). Average gain was 37.5%. The difference was highly significant for each domain. Domains of pre-analytical, analytical, and post-analytical procedures saw the highest difference. There was a significant difference in competence gain between student lab. techs. and employed lab. techs. Conclusion: Benefits of accreditation are immense, yet it is a voluntary process in our country. Strict adherence to already laid out standards and protocols at national level can be achieved by continuous sensitization and capacity building. Public sector laboratories need to gear up and embrace this need. The same should also be incorporated effectively in the curriculum of laboratory technician students.

Responsabilidad profesional derivada del ejercicio de la odontología en Costa Rica: I Parte / Professional responsibility derived from the practice of dentistry in Costa Rica: Part I

El aumento a nivel mundial de las denuncias por responsabilidad profesional en Ciencias de la Salud hace imprescindible que quienes ejerzan esta profesión deban conocer las implicaciones de su labor, así como cumplir con los principios bioéticos y jurídicos para garantizar una sana relación odontólogo-paciente. Es importante comprender que el ejercicio de la odontología en Costa Rica está regulado por normas, códigos y leyes como cualquier otra actividad humana en un Estado de Derecho.

The number of complaints related to professional liability in health sciences has increased worldwide, it is essential for dental professionals to be aware of the implications of their labor, as well as to comply with bioethical and legal principles to ensure a healthy dentist-patient relationship. It is important to understand that the practice of dentistry in Costa Rica is regulated by norms, codes, and laws like any other human activity in a State governed by the rule of law.

Analysis of Formulation and Characteristics of Provincial Standards for Traditional Chinese Medicine Dispensing Granules / 中国实验方剂学杂志

In order to standardize the quality control of traditional Chinese medicine（TCM） dispensing granules， the Chinese Pharmacopoeia Commission has promulgated and implemented 200 national drug standards for TCM dispensing granules， but there are still varieties of TCM dispensing granules without unified standards. Many provinces have actively invested in the formulation of provincial standards for TCM dispensing granules to make up for the gaps in standards for varieties of traditional Chinese medicine dispensing granules other than the national standards. By the end of July 2022， 29 provincial-level administrative regions have successively promulgated and implemented a total of 5 602 provincial standards for TCM dispensing granules， involving more than 400 varieties. In order to better understand the formulation and characteristics of provincial standards， this study took 105 provincial standards that have been promulgated and implemented in Henan province as an example， and comprehensively analyzed the formulation and characteristics through quality control indicators such as dry extract rate of raw materials， contents of index components and their transfer rates， specifications and so on. The formulation and characteristics of the same TCM dispensing granules in the provincial standards of different provinces were further analyzed， in order to provide reference for the formulation of provincial standards of TCM dispensing granules and the implementation of national standards.

Development and application progress of standards for antibody against SARS-CoV-2 / 中国生物制品学杂志

@#Coronavirus Disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)seriously threatens human health and public health safety.Vaccination plays an important role in effectively controlling the epidemic situation.More than 150 SARS-CoV-2 vaccines have entered the clinical trial stage and 38 have been approved for emergency use or marketing.Neutralizing antibody level is the main index for evaluation of the immunogenicity of vaccines,but there has been no standardized detection method for SARS-CoV-2 neutralizing antibody till now,which makes it difficult to compare the neutralizing antibody levels among different laboratories and different products horizontally,and seriously restricts the development and evaluation of vaccines and antibody therapeutic drugs.With the rapid sale of the first generation of standards for SARS-CoV-2 antibody and the emergence of variants of concern(VOC)of SARS-CoV-2,WHO and China carried out the development of the second generation of standards simultaneously in 2022.This paper reviews the development and application progress of the standards for SARS-CoV-2 antibody in WHO and China.

Development and application progress of standards for antibody against SARS-CoV-2 / 中国生物制品学杂志

@#Coronavirus Disease 2019(COVID-19)caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)seriously threatens human health and public health safety.Vaccination plays an important role in effectively controlling the epidemic situation.More than 150 SARS-CoV-2 vaccines have entered the clinical trial stage and 38 have been approved for emergency use or marketing.Neutralizing antibody level is the main index for evaluation of the immunogenicity of vaccines,but there has been no standardized detection method for SARS-CoV-2 neutralizing antibody till now,which makes it difficult to compare the neutralizing antibody levels among different laboratories and different products horizontally,and seriously restricts the development and evaluation of vaccines and antibody therapeutic drugs.With the rapid sale of the first generation of standards for SARS-CoV-2 antibody and the emergence of variants of concern(VOC)of SARS-CoV-2,WHO and China carried out the development of the second generation of standards simultaneously in 2022.This paper reviews the development and application progress of the standards for SARS-CoV-2 antibody in WHO and China.

Current status of health standards and health management system in childcare institutions / 中国学校卫生

Abstract@#Children in childcare institutions are involved with a high degree of contact, poor personal hygiene habits, low resistance, high incidence of disease, infections diseases are easily spread without proper public health management. Compared with child care centers, the construction of national standards, industry standards and management systems for primary and secondary school health is relatively complete, while the applicability of the current hygiene standards and management systems for childcare centers is worth exploring. By reviewing the previous literature, the study sorted out the current status of hygiene standards and hygiene management system in childcare institutions, and assesse their applicability in childcare institutions, so as to provide references for the establishment of hygiene standards and hygiene management system in childcare institutions.

Application of International Standards for Neurological Classification of Spinal Cord Injury in China: a bibliometrics re-analysis / 中国康复理论与实践

ObjectiveTo analyze the application of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) in China. MethodsResearches using ISNCSCI in the spinal cord injury were retrieved from CNKI, from January 1st, 2020 to December 31st, 2022. The authors and the keywords of the included literatures were analyzed using VOSviewer and CiteSpace to generate a collaboration network graph of authors and a theme distribution map of keywords. The objects, purposes, causes of spinal cord injury, distribution of researchers' departments, ISNCSCI version used, corresponding publication time and other information of the included studies were manual searched and analyzed. ResultsA total of 285 literatures were finally included, involving 1 279 authors, out of whom 111 published 97.19% of the total number of articles. The main keywords included spinal cord injury, spinal fractures, neurological function, thoracolumbar fractures and spinal tuberculosis, which classified in seven clusters, and the topics of spinal cord injury, efficacy, spinal fractures, quality of life and prognosis were the hotspots in the field. With manual searching, the main topic was spinal cord injury; the main object was traumatic spinal cord injury; the main purpose was to evaluate the surgical efficacy; the research institutions were mostly the comprehensive hospitals or specialized hospitals focusing on orthopedics (spinal surgery); the clinical departments that used ISNCSCI the most were orthopedics (including spinal surgery) and rehabilitation medicine, and nursing teams were paying more attention to ISNCSCI; the most commonly used versions of ISNCSCI were 2011 (7th edition) and 2000 (6th edition), however, for a large number of articles, the versions were not clear or earlier than 2000. ConclusionThe application of ISNCSCI in China should be improved in the standardization.

Preparation of the first batch of national standard of recombinant trypsin / 中国生物制品学杂志

@#Objective To prepare the 1st batch of national standard of recombinant trypsin in order to standardize and improve the quality of recombinant trypsin.Methods Enzyme-substrate identification,HPLC identification,N-terminal sequencing and TOF-MS were used to confirm the property and structure of recombinant trypsin;the purity was determined by HPLC;according to the methods in Chinese Pharmacopoeia(Volume Ⅲ 3603,2020 edition),the specific activity of the candidate standard was determined,and the stability and uniformity were investigated.Results The structure of recombinant trypsin was confirmed,and the specific activity of the 1 st batch of national standard of recombinant trypsin was 5 169 U/mg,containing 80% β-trypsin and 9% α-trypsin.The RSD of purity of α,β-trypsin and retention time of 12 candidate standards were all less than 2.0%.The purity of α,β-trypsin showed no obvious decrease stored at 25 ℃ and relative humidity(RH) 80% for 10 d,while the purity of β-trypsin decreased slightly and the purity of α-trypsin increased slightly stored at 40℃ and RH 80% for 10 d.The purity of β-trypsin decreased slightly when exposed to light(4 000 lx) for 10 d.Conclusion The national standard of recombinant trypsin with accurate structure and high purity was prepared,which can be used for system suitability test of the purity determination.