Publicações científicas sobre direção veicular por pessoas idosas: revisão de escopo / Scientific publications on driving by older adults: scope review

Resumo Objetivo Mapear evidências científicas nacionais e internacionais sobre a condução veicular por pessoas idosas. Método Revisão de escopo baseada no manual proposto pelo Joanna Briggs Institute. Para as buscas foram acessadas as bases MEDLINE, Web of Science, Scopus, SciELO e a literatura cinzenta, por meio do Google Scholar. Resultados Dos 1.194 estudos encontrados, selecionaram-se 189 artigos submetidos aos critérios de elegibilidade. Os países precursores nas publicações foram Austrália e Estados Unidos, e o ápice das pesquisas ocorreu entre 2013 e 2014. Os participantes dos estudos eram pessoas idosas saudáveis, 63,49% (120); seguidos de 17,46% (33) com doença de Alzheimer; 11,11% (21) com Transtorno Neurocognitivo Leve; 6,88% (13) com doença de Parkinson; e 19,58% (37) com outras comorbidades. Diferentes tipos de intervenções foram identificadas nos estudos, destas, 94,02% (178) avaliaram a eficácia de instrumentos que mensuram a aptidão do motorista idoso. Conclusão Houve predominância de estudos na busca de instrumentos de avaliação que mensurassem a funcionalidade do condutor idoso. Esse fato ratifica a importância de avaliação padronizada, validada e economicamente viável que colabore na identificação do motorista em risco. Evidenciou-se a necessidade de intervenções para a prática da geriatria e gerontologia, por meio de ações para formação de equipe multidisciplinar especializada em condução veicular, de modo a adequar as diretrizes de licenciamento a fim de atender às especificidades dos condutores idosos, considerando os aspectos sociais, econômicos, políticos e educacionais, especialmente nos departamentos de trânsito brasileiro.

Abstract Objective To map national and international scientific evidence regarding driving by older adults. Method Scope review based on the manual proposed by the Joanna Briggs Institute. Searches were conducted in the MEDLINE, Web of Science, Scopus, SciELO databases, and grey literature through Google Scholar. Results Out of 1,194 studies identified, 189 papers meeting eligibility criteria were selected. Pioneering countries in publications were Australia and the United States, with the peak of research occurring between 2013 and 2014. Study participants included healthy older adults (63.49%, 120), followed by those with Alzheimer's disease (17.46%, 33), Mild Neurocognitive Disorder (11.11%, 21), Parkinson's disease (6.88%, 13), and other comorbidities (19.58%, 37). Various interventions were identified, with 94.02% (178) assessing the effectiveness of instruments measuring the fitness of older drivers. Conclusion There was a prevalence of studies aimed at identifying assessment tools to measure the functionality of older drivers. This underscores the importance of standardized, validated, and economically viable assessments that contribute to identifying at-risk drivers. The need for interventions in geriatrics and gerontology was evident, emphasizing the necessity for actions to establish a specialized multidisciplinary team in vehicular driving. This approach seeks to align licensing guidelines with the specific needs of older drivers, taking into account social, economic, political, and educational aspects, particularly within the Brazilian traffic departments.

¿Cuáles son las medidas de aislamiento implementadas a nivel internacional tras el término de la emergencia de salud pública de importancia internacional por COVID-19?: síntesis rápida de evidencia: experiencias internacionales / What are the isolation measures implemented at the international level, after the end of the public health emergency of international concern by COVID-19?: rapid evidence synthesis: international experiences

ANTECEDENTES Y OBJETIVO Tras 3 años de pandemia, la OMS ha declarado que el COVID-19 no constituye una Emergencia de Salud Pública de Importancia Internacional. En Chile, la Comisión Nacional de Respuesta Pandémica del Ministerio de Salud se ha propuesto reevaluar las medidas de aislamiento y las licencias laborales de casos positivos por COVID-19, para lo cual ha solicitado la presente Síntesis Rápida de Evidencia. METODOLOGÍA Para analizar las indicaciones internacionales de aislamiento de casos positivos de COVID-19 y la correspondiente licencia médica, se definieron las siguientes preguntas orientadoras: ¿Cuántos días de aislamiento se recomiendan para casos positivos de COVID-19?; ¿El aislamiento es obligatorio para los casos positivos de COVID-19?; ¿Cuáles son las indicaciones de cuidado de los casos positivos de COVID-19?; y ¿Cuáles son los criterios para entregar licencia médica a trabajadores que resulten positivos de COVID-19?. Selección de países de interés. Para definir los países de interés, se utilizó el Ranking de Resiliencia de COVID, el cual los jerarquiza en función de su desempeño y logros durante la pandemia. Este ranking se basa en 11 indicadores. Los países seleccionados fueron: Irlanda; Noruega; Arabia Saudita; Dinamarca; Países Bajos; Australia; Suiza; Colombia; Singapur; Bélgica; Israel; y Alemania. Se buscó información exclusivamente en las páginas web oficiales y en documentos elaborados por instituciones gubernamentales. RESULTADO - De los 12 países revisados, 10 no establecen el aislamiento como obligatorio para los casos positivos de COVID-19. - Colombia y Arabia Saudita mantienen indicaciones de aislamiento obligatorio a mayo del 2023, estableciendo periodos de 7 y de 7 a 21 días, respectivamente. - Ocho de los países actualizaron sus indicaciones de aislamiento durante el primer semestre del año 2023.

¿Cuál es el periodo de infección de la variante ómicron del SARS-CoV-2?: síntesis rápida de evidencia / What is the infection period of the omicron variant of SARS-Cov-2?: rapid evidence synthesis

ANTECEDENTES Y OBJETIVO Tras 3 años de pandemia, la OMS ha declarado que el COVID-19 no constituye una Emergencia de Salud Pública de Importancia Internacional. En Chile, la Comisión Nacional de Respuesta Pandémica del Ministerio de Salud se ha propuesto reevaluar las medidas de aislamiento y las licencias laborales de casos positivos por COVID-19, para lo cual ha solicitado la presente Síntesis Rápida de Evidencia. METODOLOGÍA Se realizó una estrategia de búsqueda amplia en EMBASE y MEDLINE, a través de OVID, y una búsqueda específica en GOOGLE, sin filtrar por estudios primarios o secundarios. Se identificaron 2.128 referencias, de las cuales se incluyeron 3 estudios tras eliminar los duplicados y aplicar los criterios de inclusión y exclusión. Se utiliza la metodología de la certeza de evidencia GRADE. RESULTADOS Se describen normativas de 12 países - La variante ómicron tiene un periodo medio de contagio de 3,6 días, IC 95%: 3,5 a 6,6 días (certeza de la evidencia alta). - El 81% de los contagios ocurren antes del 5to día desde el inicio de síntomas (certeza de la evidencia alta). - No se identificó evidencia respecto al impacto del aislamiento obligatorio en la morbi-mortalidad asociada al COVID-19, en los estudios incluidos.

Insuficientes políticas universitarias sobre integridad científica y su relación con la denegación de licenciamiento institucional

El objetivo del estudio fue analizar la relación existente entre las políticas institucionales sobre integridad científica y la obtención de licenciamiento en universidades peruanas. Se trata de un estudio descriptivo de observación documental y análisis de la normativa peruana sobre evaluación de la calidad universitaria, licenciamiento de universidades, normativa de integridad científica y resoluciones de denegación de licencias de funcionamiento de universidades. Se encontró que, de las 48 universidades y 2 escuelas de postgrado que no demostraron en su evaluación el cumplimiento de las Condiciones Básicas de Calidad, bajo el Modelo de Licenciamiento Institucional, 32 universidades y 1 escuela de postgrado (66%) han sido observadas por presentar deficiencias en aspectos relacionados con políticas de integridad científica requisitas. El estudio concluye en que la política universitaria de integridad científica es un criterio importante para recibir el Licenciamiento Institucional en el sistema universitario peruano.

The aim of this study was to analyze the relation between institutional policies on scientific integrity and licensing of Peruvian universities. It is a descriptive study analyzing Peruvian regulations on university quality assessment, university licensing (accreditation), scientific integrity regulations and the denial of university operating licenses. It was found that, of the 48 universities and 2 graduate schools that did not meet the Basic Quality Conditions under the Peruvian Institutional Licensing Model, 32 universities and 1 graduate school (66%) had deficiencies related to required scientific integrity policies. The study concludes that universities' scientific integrity policies are an important criterion for receiving Institutional Licensing in the Peruvian university system.

Analysis and optimization of the record management practice in occupational health examination institutions / 中国职业医学

The Prevention and Control of Occupational Diseases Law revised in 2017 abolished the qualification test and approval for occupational health examination institutions, and replaced it with record management. The record does not belong to any type of administrative permit and does not require the premise of “general prohibition”. Its core idea is that “the public law actively acts as an obligation”, which does not prohibit administrative counterpart from carrying out specific tasks, mainly information collection, supervision and management of follow-ups, and emphasizes on simplifying procedures, improving working efficiency and stimulating market vitality. It is a strategic measure of the government's reform on “release, control and service”. It has the functional significance of alleviating information asymmetry, cultivating market credit mechanism and reflecting the government's flexible supervision and management mechanisms. However, China has not yet unified legislation on record management, and individuals on the theoretical and practical circles have different understandings on the concept, operation principle, and management effectiveness of the record management. There are practical dilemmas in the record management of occupational health examination institutions, such as alienation of record management into licensing, insufficient regulation of record management procedures, and weak in-process and post-process supervision and management capabilities. It is suggested to clarify the legal nature of record management, unify and improve the record management procedures, and improve in-process and post-process supervision and management capabilities. By building a legal, scientific and systematic regulation for the record management of occupational health examination institutions, adhering to the unity of “discharge” and “control”, it could effectively safeguard the legitimate rights and interests of occupational health examination institutions, workers and employers.

Application and management of human genetic resources in China / 上海预防医学

Human genetic resources include specimen samples and related information. The application and regulation of human genetic resources in China started at the end of the 20th century and have progressed rapidly. However， many challenges remain. In this paper， we reviewed the current status of sample conservation and management and provided recommendations for further development of human genetic resources in China. The aim is to effectively protect and rationally utilize China's human genetic resources， safeguard national security and people's health， and promote the building of a community of common health for mankind.

Investigation on demands for license skill training among grassroots public health personnel in Hohhot City / 预防医学

Objective@#To investigate the needs for license skill training among grassroots public health personnel in Hohhot City, so as to provide the advice for improvements in training among grassroots public health personnel in Hohhot City. @*Methods@#A total of 1 802 staff were sampled from 108 grassroots healthcare institutions in four districts, four counties and one banner of Hohhot City using a multi-stage stratified random sampling method. Participants' demographics and five dimensions of training needs, including professional knowledge, professional skills, basic public health service guidelines, epidemiological survey and development of interventions, were collected through questionnaire surveys, and factors affecting the training demands were identified using a generalized linear mixed-effect model.@*Results@#The respondents included 789 men (43.78%) and 958 individuals at ages of 31 to 50 years (53.16%). There were 1 379 respondents (76.53%) that wished to receive training on professional knowledge, 1 312 respondents (72.81%) that wished to receive training on professional skills, 1 012 respondents (56.16%) that wished to receive training on basic public health service guidelines, 333 respondents (18.48%) that wished to receive training on epidemiological survey and 206 respondents (11.43%) that wished to receive training on development of interventions. Participants at ages of 41 to 50 years and 61 years and older, participants with a specialty in nursing, and participants that worked on construction of resident archives and health management of patients with tuberculosis had higher demands for training on professional knowledge; participants that worked on construction of resident archives, children healthcare management and health management of patients with chronic diseases had higher demands for training on professional skills; participants with a specialty in general practice, preventive medicine and public health, participants that worked on construction of resident archives, health management of pregnant and lying-in women, health management of elderly people and health management of patients with severe mental disorders, report and response of infectious diseases and emergency public health events had higher demands for training on basic public health service guidelines; participants that worked on vaccination, report and response of infectious diseases and emergency public health events and assisted management of health and family planning supervision had higher demands for training on epidemiological surveys; participants that worked on health management of patients with chronic diseases, assisted management of health and family planning supervision, and participants with experiences of clinical practices had higher demands for training on development of interventions (all P<0.05). @*Conclusions@#The grassroots public health personnel have a high demand for license skill training in Hohhot City, and age-, specialty- and job-specific training is required.

Sistema Obligatorio de Garantía de Calidad en Salud: aplicación al laboratorio clínico / Mandatory Quality Assurance System in Health: application to the clinical laboratory

En 1993, el Estado estableció el Sistema General de Seguridad Social en Salud, en el que se introdujeron los diferentes mecanismos legales para promover la calidad en las instituciones prestadoras de servicios de salud en el país. A partir de allí, se implantaron diferentes decretos. En la actualidad, el Sistema Obligatorio de Garantía de Calidad en Salud (SOGCS) se encuentra reglamentado en el Decreto 780 de 2016, Decreto Único Reglamentario del Sector Salud. El SOGCS está integrado por cuatro componentes principales: el Sistema Único de Habilitación (SUH), la Auditoría para el Mejoramiento de la Calidad, el Sistema Único de Acreditación (SUA) y el Sistema de Información para la Calidad en Salud, para dirigir y evaluar el desempeño de estas instituciones en términos de calidad y satisfacción social; además, se adoptó el Manual de Inscripción de Prestadores y Habilitación de Servicios de Salud, el cual contiene las condiciones mínimas que deben cumplir los servicios de salud ofertados y prestados en el país, para brindar seguridad a los usuarios en el proceso de la atención en salud. Dicho manual tiene por objeto definir las condiciones de verificación para la habilitación, como la capacidad técnico-administrativa, suficiencia patrimonial y financiera, y la capacidad tecnológica y científica. En este artículo se revisarán algunos conceptos generales del Sistema Obligatorio de Garantía de Calidad en Salud, así como los estándares y criterios de habilitación para laboratorios clínicos

In 1993, the State established the General System of Social Security in Health, in which different legal mechanisms were introduced to promote quality in the institutions providing health services in the country. From then on, different decrees were implemented. Currently, the Mandatory Health Quality Assurance System (SOGCS) is regulated by Decree 780 of 2016, the Sole Regulatory Decree of the Health Sector. SOGCS is made up of four main components: the Single Qualification System (SUH), the Audit for Quality Improvement, the Single Accreditation System (SUA) and the Health Quality Information System, to direct and evaluate the performance of these institutions in terms of quality and social satisfaction; in addition, the Health Services Provider Registration and Qualification Manual was adopted, which contains the minimum conditions that health services in the country must meet to provide security to users in the health care process. The purpose of this manual is to define the verification conditions for accreditation, such as technical-administrative capacity, patrimonial and financial sufficiency, and technological and scientific capacity. This article will review some general concepts of the Mandatory System of Quality Assurance in Health, as well as the standards and qualification criteria for clinical laboratories

Discussion on problems and countermeasures of military medical radiation license management / 中国辐射卫生

@#Practice in military medical radiation license management in the new era of military reform have surfaced problems in military radiation protection, involving radiation protection management regulation, occupational health monitoring for radiation workers, inspection of radiation equipment and site protection, implementation of the “Three Synchronizations System” for construction, renovation, and extension projects of radiation facilities, as well as quality control for radiation protection and diagnosis and treatment. Efforts should be focused on radiation protection training, self-management of medical radiation institutions, supervision and regulation from medical radiation license management institutions, and joint coordination of relevant departments. Under new regulations and standards, creatively conducting medical radiation license management and running the army in accordance with the law in the new era of military reform are of great significance for standardizing military radiation protection and ensuring the healthy development of military medical radiation services.

Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development

Drug metabolism and pharmacokinetics (DMPK) is an important branch of pharmaceutical sciences. The nature of ADME (absorption, distribution, metabolism, excretion) and PK (pharmacokinetics) inquiries during drug discovery and development has evolved in recent years from being largely descriptive to seeking a more quantitative and mechanistic understanding of the fate of drug candidates in biological systems. Tremendous progress has been made in the past decade, not only in the characterization of physiochemical properties of drugs that influence their ADME, target organ exposure, and toxicity, but also in the identification of design principles that can minimize drug-drug interaction (DDI) potentials and reduce the attritions. The importance of membrane transporters in drug disposition, efficacy, and safety, as well as the interplay with metabolic processes, has been increasingly recognized. Dramatic increases in investments on new modalities beyond traditional small and large molecule drugs, such as peptides, oligonucleotides, and antibody-drug conjugates, necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME properties. In this review, we highlight some of the most notable advances in the last decade, and provide future perspectives on potential major breakthroughs and innovations in the translation of DMPK science in various stages of drug discovery and development.

Considerations on Clinical Development and Regulatory of the Oversea License-in Anti-tumor Drugs / 中国肺癌杂志

With the boom of China's innovative pharmaceutical industry, licensing-in model has gradually become an important research and development model for innovative pharmaceutical companies. The in-licensed drugs at different stages need different research and development (R&D) strategy in China. The pharmaceutical companies take the responsibility to comprehensively collate the oversea clinical data and conduct a detailed analysis of clinical pharmacology, safety, efficacy and ethnic sensitivity. Clinical R&D strategy should be made based on the results of the above data and analysis. We encourage high-quality drugs which fill unmet clinical needs licensed in, and as early as possible, so as to conduct multi-regional clinical trials (MRCTs). The clinical R&D strategy in China is particularly important for the drug's approval. Guidelines published by the National Medical Products Administration (NMPA) and clinical associations should be followed. Communications about clinical R&D strategy with Center of Drug Evaluation (CDE) are encouraged.
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Impacto del síndrome de apneas obstructivas del sueño en accidentes de tránsito en Chile

Resumen Introducción: Existe abundante evidencia para considerar al síndrome de apnea obstructiva del sueño (SAOS) como un factor de riesgo significativo en la ocurrencia de accidentes de tránsito. En el año 2018, los accidentes de tránsito en Chile provocaron 1.507 muertes, 60 mil lesionados, y generaron un costo país de US $5.985 millones al año (2,1% PIB). Sin embargo, se desconoce la prevalencia de SAOS en conductores, ni su impacto en la accidentabilidad a nivel nacional. Objetivo: Estimar la prevalencia de SAOS en conductores nacionales, y su importancia relativa en el número de accidentes, lesionados, muertes y costos asociados. Material y Método: Revisión de la literatura, análisis descriptivo con bases de datos secundarias. Estimación de prevalencia de riesgo de SAOS en conductores nacionales, profesionales, y cálculo de costos asociados a accidentabilidad. Resultados: Se estima prevalencia de SAOS moderado a severo en un 28,6% para conductores nacionales y 30,2% para conductores profesionales. Utilizando un odds ratio de 2,52 (IC 1,84-3,35) como estimador de riesgo, se obtiene un riesgo atribuible porcentual poblacional de 30,28%, que se traduce en que SAOS sería responsable de 27.046 accidentes, 17.545 lesionados, 456 muertes, y un costo país de US $1.812,4 millones al año atribuibles a SAOS para las cifras de accidentabilidad 2018. Conclusión: El presente trabajo es la primera aproximación al tema a nivel chileno. Se requieren estudios de prevalencia de SAOS en conductores para realizar estimaciones más precisas. Impresiona necesario colocar este tema en la agenda pública, por la posible reducción de riesgos.

Abstract Introduction: There is abundant evidence to consider obstructive sleep apnea syndrome (OSAS) as a significant risk factor in the occurrence of traffic accidents. In 2018, traffic accidents in Chile caused 1,507 deaths, 60 thousand injured, and generated a country cost of US $ 5,985 million per year (2.1% GDP). However, the prevalence of OSAS in national drivers, nor its impact on accident rate level is unknown. Aim: To estimate the prevalence of OSAS in Chilean drivers, and their relative importance in the number of accidents, injuries, deaths and associated costs. Material and Method: Literature review, descriptive analysis with secondary databases. Estimation of risk prevalence of OSAS in Chilean drivers, professional drivers, and calculation of costs associated with accident rates. Results: The prevalence of moderate to severe OSAS is estimated at 28,6% for national drivers, 30,2% for professional drivers. Using an OR of 2.52 (CI 1.84-3.35) as a risk estimator), a population attributable risk percentage of 30,28% is obtained, which translates to 27,046 accidents, 17,545 injured, 456 deaths, and a country cost of US $ 1,812.4 million per year attributable to OSAS for accidents in 2018. Conclusion: This paper is the first approach to the subject at the Chilean level. OSAS prevalence studies in drivers are required to make more accurate estimates. It is necessary to place this topic on the public agenda, due to the possible risk reduction.

Discussion on emergency transfer of hospital service invention patent during COVID-19 pandemic period / 中华医学科研管理杂志

Objective:At present, there are several modes of patent transformation of hospital service invention in our country. However, most of them are one-to-one style which is time-consuming and difficult to achieve industrialization in a short time. This study focuses on whether it is appropriate for public hospitals to use the mode of general license (i.e. one patent licensed to several enterprises concurrently or successively) to turn the patents of invention into productivity more efficiently.Methods:Combined with the period of COVID-19 pandemic, Zhongshan Hospital Fudan University successfully applied the mode of general license to achieve the patent transfer experience, and discussed the important value of the mode of general license for translational medicine.Results:The latest achievements of medical research are turned into clinical medical technologies and products quickly and effectively, proposing an appropriate scheme for the rapid transformation of patents, which balanced the interest of different stakeholders to gain the win-win situation.Conclusions:The innovative general licensing model can enable the patents transformation quickly and efficiently as long as it′s used properly.

A Licenciatura em Psicologia na Década de 1960: Um estudo do Caso do Curso da UFMG / The Teaching License Degree in Psychology in the 1960s: A Case Study of the UFMG Course / La Licenciatura en Psicología en la Década de 1960: Un Estudio del Caso del Curso de la UFMG

No intuito de compreendermos o lugar da licenciatura na formação de psicólogos, logo após a Lei nº 4119/62, este artigo apresenta um estudo de caso sobre a inserção da licenciatura no curso de Psicologia da Universidade Federal de Minas Gerais (UFMG) durante a década de 1960 e suas contribuições para os ex-alunos, ingressantes nesse período. O estudo historiográfico é fruto de pesquisa de doutorado e utiliza como procedimento metodológico a análise de fontes primárias e entrevistas com ex-alunos. Os resultados demonstraram que a licenciatura em Psicologia foi inserida no curso da UFMG desde a primeira turma de entrada de alunos de 1963 e ofertada no formato de cumprimento obrigatório para todos os alunos daquele ano. Em 1965, a licenciatura tornou-se uma formação opcional e, a partir de então, cada vez menos alunos passaram a optar por ela. Os entrevistados confirmaram os dados obtidos na análise documental relativos ao funcionamento da modalidade e apontaram os aspectos metodológicos aprendidos durante a licenciatura como as principais contribuições para suas formações profissionais. Esperamos que a pesquisa contribua com as reflexões sobre a oferta da licenciatura na formação dos psicólogos brasileiros e com os estudos históricos sobre a Psicologia no Brasil. (AU)

In the intent to understand the place of the Teaching License Degree in the training of psychologists, right after the Law nº 4119/62, this article presents the case study on the insertion of the Teaching License Degree in Psychology course of the Federal University of Minas Gerais (UFMG) during the decade of 1960 and its contributions to the former students, who entered this period. The historiographic study is the result of doctoral research and uses as methodological procedure the analysis of primary sources and interviews with former students. The results showed that the Teaching License Degree in Psychology was inserted in the course of UFMG since the first class of students entrance in 1963 and offered in the form of compulsory compliance for all the students of that year. From 1965, as the Teaching License Degree became an optional training, fewer and fewer students opted for it. The interviews confirmed the data obtained in the documentary analysis related to the operation of the modality and pointed out the methodological aspects learned during the Teaching License Degree as main contributions to the professional formation of the same. We hope that the research contributes with the reflections on the offer of the Teaching License Degree in the training of Brazilian psychologists and with the historical studies on Psychology in Brazil. (AU)

En este artículo se presenta el estudio de caso sobre la inserción de la licenciatura en el curso de Psicología de la Universidad Federal de Minas Gerais (UFMG) durante la década de 1960, con el fin de comprender el lugar de la licenciatura en la formación de psicólogos, poco después de la Ley nº 4119/62, 1960 y sus contribuciones a los ex alumnos, ingresantes en ese período. El estudio historiográfico es fruto de investigación de doctorado y utiliza como procedimiento metodológico el análisis de fuentes primarias y entrevistas a los ex alumnos. Los resultados demostraron que la licenciatura en Psicología fue insertada en el curso de la UFMG desde la primera clase de ingreso de alumnos en 1963 y ofrecida en el formato de cumplimiento obligatorio para todos los alumnos de ese año. A partir de 1965, como la licenciatura pasó a ser una formación opcional, cada vez menos alumnos optaron por la misma. Los entrevistados confirmaron los datos obtenidos en el análisis documental relativos al funcionamiento de la modalidad y señalaron los aspectos metodológicos aprendidos durante la licenciatura como principales contribuciones para la formación profesional de los mismos. Esperamos que la investigación contribuya con las reflexiones sobre la oferta de la licenciatura en la formación de los psicólogos brasileños y con los estudios históricos sobre la Psicología en Brasil. (AU)

Humphrey custom program for driver's license verification to evaluate visual field of unilateral visual impaired applicants / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To evaluate visual field of the unilateral visually impaired applicants by a custom program test of Humphrey perimeter, which was indispensable for car driving.<p>METHODS: A retrospective study was performed. The process of a custom defined Humphrey ‘1 EYE Screening' program was set covers field region from temporal 90° to nasal 60°, and over 30° vertically away from the horizontal line. The candidates were qualified eligibility by range of visual field and reliability of the results. This study conducted statistics on the applicants who fulfilled the test from July 1st, 2016 to June 30th, 2017, and compared the impact factors of the pass rate.<p>RESULTS: After excluding repeated measurement reports, this study included 618 subjects, the most common causes of these eyes impaired were ocular trauma(49.7%)and unhealed amblyopia(29.3%). A total of 497 candidates(80.4%)passed the test. 85 of the 121 failure cases(70.2%)were due to a limitation of the nasal visual field(less than 60°), and 12 cases were failed by fixation loss because of nystagmus or poor cooperation. Compared with the test failure group, the subjects in the passing group are older, the average correct response points is more, and the average test time is shorter, all with statistically significant differences(<i>P</i><0.05). In the passing group, the proportion of subjects with equivalent spherical mirror <0.5D was 77.5%, which was significantly higher than 62.8% in the failure group(χ2=7.264, <i>P</i>=0.007).<p>CONCLUSION: The custom program ‘1 EYE Screening' of Humphrey perimetry can be used to qualify eligibility of driving for unilateral visual impaired applicants. In order to prevent peripheral interfering from eye frames, corneal contact lenses were recommended for applicants with refractive errors.

Introduction of basic medicine examination in Korean Medical License Examination to improve physician's science competency

Physicians play a central role in the fields of medical service, research, and industry, so it is imperative to produce well-qualified doctors. Medicine is composed of science and arts, both necessary for its practice, and thus, the education outcomes in basic medical education in a medical school include basic biomedical sciences, social sciences and clinical sciences. Adequate science competencies create a deeper and better understanding of scientific knowledge, concepts, and methods fundamental to clinical science, and contribute to the scientific, technological, and clinical developments. The science competencies are primarily obtained by studying basic medicine in basic medical education, which has been criticized for failing to do so sufficiently in Korea. The failure is attributed to insufficient education time, teachers, and budgets, but the most critical factor is the lack of awareness regarding the importance of the science competencies of the physicians. Such ignorance also affects the Korean Medical Licensing Examination (KMLE). The KMLE tests competency in clinical sciences, preventive medicine, and medical laws, but not in basic biomedical sciences, which might result in insufficient science competency of the physicians and a decrease in the overall quality of the medical health service. Tests must be urgently introduced in KMLE on the competencies of basic biomedical sciences to improve the science competency of the physicians. The representative organizations of the medical society should take vigorous actions for the introduction of the basic medicine examination in KMLE.

Humphrey custom program for driver's license verification to evaluate visual field of unilateral visual impaired applicants / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To evaluate visual field of the unilateral visually impaired applicants by a custom program test of Humphrey perimeter, which was indispensable for car driving.<p>METHODS: A retrospective study was performed. The process of a custom defined Humphrey ‘1 EYE Screening' program was set covers field region from temporal 90° to nasal 60°, and over 30° vertically away from the horizontal line. The candidates were qualified eligibility by range of visual field and reliability of the results. This study conducted statistics on the applicants who fulfilled the test from July 1st, 2016 to June 30th, 2017, and compared the impact factors of the pass rate.<p>RESULTS: After excluding repeated measurement reports, this study included 618 subjects, the most common causes of these eyes impaired were ocular trauma(49.7%)and unhealed amblyopia(29.3%). A total of 497 candidates(80.4%)passed the test. 85 of the 121 failure cases(70.2%)were due to a limitation of the nasal visual field(less than 60°), and 12 cases were failed by fixation loss because of nystagmus or poor cooperation. Compared with the test failure group, the subjects in the passing group are older, the average correct response points is more, and the average test time is shorter, all with statistically significant differences(<i>P</i><0.05). In the passing group, the proportion of subjects with equivalent spherical mirror <0.5D was 77.5%, which was significantly higher than 62.8% in the failure group(χ2=7.264, <i>P</i>=0.007).<p>CONCLUSION: The custom program ‘1 EYE Screening' of Humphrey perimetry can be used to qualify eligibility of driving for unilateral visual impaired applicants. In order to prevent peripheral interfering from eye frames, corneal contact lenses were recommended for applicants with refractive errors.

Renewal of driving license in India and glaucoma: A study of prevalent practice and its lacunae

Purpose: Glaucoma affects different aspects of vision including visual field. This prospective observational study aims to collect details of driving license (DL) renewal procedure (in an urban metro in India) among patients with diagnosed glaucoma and the method of reporting of vision-related requirements during renewal. Methods: One-hundred patients with diagnosed glaucoma above 40 years, having valid DL (with at least one renewal cycle), were included. Patients with other ocular comorbidities were excluded. Driving Habits Questionnaire and a questionnaire about license renewal were administered. Driving eligibility was compared to international guidelines. Results: Study population included patients with 69% early, 29% moderate, and 2% advanced glaucoma. Sixteen percent of patients had stopped driving. Legal license renewal procedure was bypassed by 45%. Form-1 was not submitted by 43% and 49% did not submit Form-1A at the time of renewal. Only 7.01% mentioned about glaucoma in the self-declaration form. None were asked about their visual field during renewal. Among 61 patients who submitted a medical certificate, the undersigning doctor was an ophthalmologist in only six patients. Thirty percent patients with valid Indian DL would not have satisfied International College of Ophthalmologists guidelines. Driving difficulties were experienced by 44%, more so in advanced glaucoma (F (1, 82) = 22.12, P < 0.001). Conclusion: Vision-related testing at the time of renewal of DL is inadequate in India. Chronic eye diseases such as glaucoma are commonly not self-declared or detected at pre-renewal testing. Clear-cut guidelines about visual requirements and implementation are required to prevent road traffic events because of vision-related errors.

Chemistry, manufacturing and controls regulatory considerations for marketing authorization application of therapeutic antibody in China / 药学学报

The marketing authorization application is a milestone of drug life cycle, which indicates a candidate has potential to become a commercial drug. As of now, there are only 12 domestic therapeutic antibodies approved in China. The chemistry, manufacturing and controls (CMC) development and evaluation of monoclonal antibody were more challenging for both industry and authority agency. As the result of domestic biopharmaceutical industry development and implement of priority review system, the marketing authorization application of domestic antibody biosimilar and imported antibodies had dramatic increased in recent years. Thus, the CMC evaluation of monoclonal antibody become the important task of biological product's marketing authorization registration management. In the article, the CMC regulatory considerations for marketing authorization application based on author's review experience was proposed, in order to accelerate development and registration of commercial antibody in China.

Reference and Innovation: Research on the Construction of Medical Device Registrar System / 中国医疗器械杂志

In order to strengthen the integration of reform system and build a comprehensive integration of openness and innovation, the medical device registrar system has become the institutional choice to promote the reform of the medical approval system and the innovation and development of the industry. The system allows scientific researchers, R&D institutions and enterprises to become applicants for medical device registration and to consign the production of samples and products, thus realizing the separation of market license and production license, and breaking the binding relationship between registration and production in current regulations. The medical device registrar system has laid a theoretical foundation for remolding the management system of medical devices, and has also made practical exploration for improving the reform of the medical devices supervision system, so it has important theoretical and practical significance.