What is an "ongoing" clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an "ongoing study" seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of "ongoing clinical trial" across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still "ongoing" during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of "ongoing clinical trials" lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial.

Estudio de patrones de lateralidad en futbolistas juveniles

El insuficiente estudio de los patrones de lateralidad en el deporte limita el diagnóstico del tipo de motricidad y obstaculiza notablemente los procesos de planificación del entrenamiento, desde las individualidades de los futbolistas, para buscar el rendimiento óptimo. El objetivo del estudio fue caracterizar los patrones de lateralidad predominantes en futbolistas masculinos del equipo Habana, categoría juvenil. Se desarrolló un estudio exploratorio y descriptivo que aplicó métodos de carácter teórico, empírico (entrevistas y encuestas), y estadístico-matemático (por medio de hojas de cálculo de Excel). Fueron aplicados seistest (Ojo director, Mano directora, Lateralidad de cadera, Lateralidad de hombro, Pierna dinámica y Pie director), con instrumentos internacionales contextualizados y avalados en investigaciones especializadas para su uso en Cuba. La heterogeneidad de la muestra mostró la tendencia genérica en el comportamiento preferencial de los futbolistas estudiados.

O estudo insuficiente dos padrões de lateralidade no esporte limita o diagnóstico do tipo de motricidade e dificulta significativamente os processos de planejamento do treinamento, a partir das individualidades dos jogadores de futebol, a fim de buscar um desempenho ideal. O objetivo do estudo foi caracterizar os padrões predominantes de lateralidade em jogadores de futebol masculino da equipe Habana, categoria juvenil. Foi realizado um estudo exploratório e descritivo com métodos teóricos, empíricos (entrevistas e pesquisas) e estatístico-matemáticos (por meio de planilhas do Excel). Foram aplicados seis testes (Olho Direcionado, Mão Direcionada, Lateralidade do Quadril, Lateralidade do Ombro, Perna Dinâmica e Pé Direcionado), com instrumentos internacionais contextualizados e aprovados em pesquisas especializadas para uso em Cuba. A heterogeneidade da amostra mostrou a tendência genérica no comportamento preferencial dos jogadores de futebol estudados.

The insufficient study of laterality patterns in sport limits the diagnosis of the type of motor skills and significantly hinders the training planning processes, from the individualities of the soccer players, to seek optimal performance. The objective of the study was to characterize the predominant laterality patterns in male soccer players of the Havana team, youth category. An exploratory and descriptive study was developed that applied theoretical, empirical (interviews and surveys), and statistical-mathematical methods (using Excel spreadsheets). Six tests were applied (Directing eye, Directing hand, Laterality of the hip, Laterality of the shoulder, Dynamic leg and Directing foot), with contextualized international instruments and endorsed by specialized research for their use in Cuba. The heterogeneity of the sample showed the generic trend in the preferential behavior of the soccer players studied.

Diet of Moenkhausia bonita (Benine, Castro & Sabino 2004) (Characiformes: Characidae) in streams in the basin of rio Formoso, Brazilian Midwest

To characterize the diet composition of Moenkhausia bonita and its temporal and ontogenetic variations in streams in the Formoso River basin (MS). The collections were carried out in seven sampling points in two periods throughout the year (dry and rainy). The food items were analyzed according to the volumetric and occurrence frequency methods and the diet was characterized through the Food Index (IAi%). To determine ontogeny, the specimens were divided into five size classes in the dry (D1 to D5) and rainy (R1 to R5) periods. To verify the difference between the species' diet between the size classes and the periods of the year, the Permutational Multivariate Analysis of Variance ­ PERMANOVA analysis was performed. Moenkhausia bonita was classified as an invertivore when it consumed basically both aquatic and terrestrial invertebrates (99.5% of the diet), with higher consumption of aquatic invertebrates. There was a significant difference in the diet of between the dry and rainy periods, and although the species basically consumed the same items in the two studied periods, the proportions were different and there was no difference in the diet between size classes. M. bonita diet is based on autochthonous resources regardless of the size class, but that there were different consumption patterns when comparing the different periods of the year. The present study provided the first information on the feeding of M. bonita in a lotic environment and diet spectrum in the developmental phases, (ontogeny) and periods of the year, enabling a better understanding of the species, the importance of invertebrates in its diet, and the need for future studies on the biology, autoecology, and behavior of this species.

Diet of Moenkhausia bonita (Benine, Castro & Sabino 2004) (Characiformes: Characidae) in streams in the basin of rio Formoso, Brazilian Midwest

To characterize the diet composition of Moenkhausia bonita and its temporal and ontogenetic variations in streams in the Formoso River basin (MS). The collections were carried out in seven sampling points in two periods throughout the year (dry and rainy). The food items were analyzed according to the volumetric and occurrence frequency methods and the diet was characterized through the Food Index (IAi%). To determine ontogeny, the specimens were divided into five size classes in the dry (D1 to D5) and rainy (R1 to R5) periods. To verify the difference between the species' diet between the size classes and the periods of the year, the Permutational Multivariate Analysis of Variance ­ PERMANOVA analysis was performed. Moenkhausia bonita was classified as an invertivore when it consumed basically both aquatic and terrestrial invertebrates (99.5% of the diet), with higher consumption of aquatic invertebrates. There was a significant difference in the diet of between the dry and rainy periods, and although the species basically consumed the same items in the two studied periods, the proportions were different and there was no difference in the diet between size classes. M. bonita diet is based on autochthonous resources regardless of the size class, but that there were different consumption patterns when comparing the different periods of the year. The present study provided the first information on the feeding of M. bonita in a lotic environment and diet spectrum in the developmental phases, (ontogeny) and periods of the year, enabling a better understanding of the species, the importance of invertebrates in its diet, and the need for future studies on the biology, autoecology, and behavior of this species.

: Caracterizar a composição alimentar de Moenkhausia bonita e as variações temporais e ontogenéticas na dieta desta espécie em riachos da bacia do rio Formoso (MS). As coletas foram realizadas em sete pontos amostrais em dois períodos do ano (seco e chuvoso). Os itens alimentares foram analisados de acordo com os métodos volumétrico e de frequência de ocorrência e a dieta foi caracterizada através do Índice Alimentar (IAi%). Para determinar a ontogenia, os espécimes foram divididos em cinco classes de tamanho nos períodos seco (D1 a D5) e chuvoso (R1 a R5). Para verificar a diferença entre a dieta da espécie entre as classes de tamanho e os períodos do ano foi realizado a Análise de Variância Multivariada Permutacional ­ PERMANOVA. M. bonita foi classificada como invertívora ao consumir basicamente invertebrados tanto aquáticos quanto terrestres (99,5% da dieta), com consumo maior de invertebrados aquáticos. Houve diferença significativa na dieta entre os períodos seco e chuvoso, apesar da espécie consumir basicamente os mesmos itens nos dois períodos estudados, as proporções foram distintas e não houve diferença na dieta entre as classes de tamanho. A dieta de M. bonita é baseada em recursos autóctones independente da classe de tamanho, mas que houve consumo diferente entre os períodos do ano. O presente estudo forneceu as primeiras informações sobre a alimentação de M. bonita em ambiente lótico e seu espectro alimentar nas fases de desenvolvimento(ontogenia)e períodos do ano, possibilitando melhor conhecimento da espécie, a importância dos invertebrados em sua dieta e a necessidade de estudos futuros sobre a biologia, autoecologia e comportamento desta espécie.

Analysis of current status and risk of development in occupational medical examination institutions in Guangdong Province / 中国职业医学

Objective: To analyze the status of occupational medical examination (OME) institutions in Guangdong Province and the critical control points affecting their future development. Methods: A total of 211 OME institutions registered in Guangdong Province were selected as the research subjects. Their current statue was investigated, and the risk assessment of their future development was carried out based on hazard analysis and critical control point theory. Results: The OME institutions were mainly concentrated in the Pearl River Delta, accounting for 72.0%. The public and private medical and health institutions accounted for 70.6% and 29.4% respectively. The filing rates of different OME categories from high to low in the order were physical factors, chemical factors, dust, other, radiation factors, biological factors (P<0.01), and the filing rates were 89.6%, 88.6%, 84.8%, 63.0%, 7.1% and 1.0%, respectively. The rates of excellence in the field assessment from high to low in the order were hearing atlas analysis personnel, lung function examination operators, chest film reading personnel, chief examination physician, technical director, quality director (P<0.01), and the rates of excellence were 49.4%, 26.2%, 20.6%, 10.8%, 8.2% and 4.6%, respectively. A total of 37 institutions did not submit OME information, of which 23 institutions did not carry out OME work after filing. The required diagnosis rate and confirmed diagnosis rate of suspected occupational diseases in 2020 were 34.3% and 55.3%, respectively. In 2021, the detection rate of suspected occupational diseases was only 1.1‰. Among the institutions with biological monitoring records, 64.1% did not participate in external quality assessment program in laboratory, and the unqualified rate of 38 participating institutions was 55.3%. The risk assessment results show that the future development of OME institutions needs to focus on private institutions, institutions that have not reported OME information, institutions that have missed diagnosis and missed reporting of suspected occupational diseases, institutions that have not participated in external quality assessment program in laboratory and core personnel such as quality managers, technical leaders, and main inspection physicians. Conclusion: OME institutions in Guangdong Province show the characteristics of centralized filing category, centralized filing region and centralized filing institution nature. Combined with the potential risks of OME institutional capacity building, it is necessary to implement classified management, strengthen information construction, supervision and management, implement post responsibilities, and promote the high-quality development of OME institutions.

Class-imbalance Prediction and High-dimensional Risk Factor Identification of Adverse Reactions of Traditional Chinese Medicine with Centralized Monitoring in Real-world Hospitals / 中国实验方剂学杂志

ObjectiveTo achieve high-dimensional prediction of class imbalanced of adverse drug reaction（ADR） of traditional Chinese medicine（TCM） and to classify and identify risk factors affecting the occurrence of ADR based on the post-marketing safety data of TCM monitored centrally in real world hospitals. MethodThe ensemble clustering resampling combined with regularized Group Lasso regression was used to perform high-dimensional balancing of ADR class-imbalanced data， and then to integrate the balanced datasets to achieve ADR prediction and the risk factor identification by category. ResultA practical example study of the proposed method on a monitoring data of TCM injection performed that the accuracy of the ADR prediction， the prediction sensitivity， the prediction specificity and the area under receiver operating characteristic curve（AUC） were all above 0.8 on the test set. Meanwhile， 40 risk factors affecting the occurrence of ADR were screened out from total 600 high-dimensional variables. And the effect of risk factors on the occurrence of ADR was identified by classification weighting. The important risk factors were classified as follows：past history， medication information， name of combined drugs， disease status， number of combined drugs and personal data. ConclusionIn the real world data of rare ADR with a large amount of clinical variables， this paper realized accurate ADR prediction on high-dimensional and class imbalanced condition， and classified and identified the key risk factors and their clinical significance of categories， so as to provide risk early warning for clinical rational drug use and combined drug use， as well as scientific basis for reevaluation of safety of post-marketing TCM.

Prevalence of tinnitus in noise-exposed workers and its influencing factors / 环境与职业医学

Background Tinnitus is a common symptom in workers exposed to noise, and no specific treatment is available yet. Paying attention to the influencing factors of tinnitus is very important to prevent tinnitus. Objective To investigate the situation of tinnitus among noise-exposed workers and its influencing factors. Methods Using a cross-sectional study design, 1011 noise-exposed male workers in Hangzhou were studied. Tinnitus status, age, education, personal protection, smoking history, drinking history, and family history of the participants were surveyed by questionnaires. Binaural pure tone hearing threshold test was performed on all study subjects. The environmental noise in the workplace was measured. The relationships of tinnitus with noise exposure intensity, noise exposure time, noise exposure category, cumulative noise exposure, and wearing hearing protectors among the noise-exposed workers were analyzed by logistic regression. Results The prevalence of tinnitus among the noise-exposed workers was 36.1%. The mean hearing thresholds at 500, 3000, 4000, and 6000 Hz in the right and left ears were higher in the tinnitus group than in the non-tinnitus group (P<0.05); the hearing threshold at 2000 Hz in the right ear was higher in the tinnitus group than in the non-tinnitus group (P<0.05). There was no statistically significant difference between the two groups in the prevalence of monaural speech-frequency hearing loss or monaural high-frequency hearing loss (P>0.05). The on-site noise intensity was divided into three groups: ＜85, 85-＜95, and ≥95 dB(A); the prevalence of tinnitus in the three groups was 19.6%, 40.5%, and 66.7% respectively. The years of noise exposure was divided into three groups: ＜1, 1-＜5, and ≥5 years; the prevalence of tinnitus in the three groups was 17.9%, 34.0%, and 45.4% respectively. The cumulative noise exposure was divided into six groups: ＜80, 80-＜85, 85-＜90, 90-＜95, 95-＜100, and ≥100 dB(A)·year; the prevalence of tinnitus in the six groups was 6.8%, 25.0%, 31.0%, 39.6%, 43.1%, and 46.7% respectively. The prevalence of tinnitus was higher in the non-stationary noise group (42.5%) than in the stationary noise group (26.8%) (χ2=26.18, P<0.01), and the prevalence in the group without or with hearing protection was 39.7% and 35.5% respectively. The results of logistic regression showed that workers exposed to higher intensity, longer noise exposure, higher cumulative noise exposure, and non-stationary noise (reference: stationary noise) resulted in a higher risk of tinnitus (Ptrend<0.01 or P<0.01); workers wearing of hearing protection device versus those not showed a lower risk of tinnitus (P<0.05). Conclusion Higher intensity, longer exposure to noise, and more cumulative noise exposure associate with a higher risk of tinnitus. Wearing hearing protective device can reduce the risk of tinnitus. Tinnitus in noise-exposed workers can precede the presentation of abnormal hearing loss.

Twofold technique for iridodialysis repair

Background: Disinsertion of iris leads to debilitating sequelae like diplopia and glare. Hence, iridodialysis repair is essential to optimize the visual quality. Iris base repair often leads to corectopia that necessitates an additional procedure to optimize the pupil shape and size. Twofold technique helps to achieve both the aspects. Purpose: To highlight the technique of twofold iridodialysis repair. Synopsis: The video highlights the method of twofold iridodialysis repair, wherein nonappositional repair is followed by single?pass four?throw (SFT) pupilloplasty thatallows adequate closure of varied degrees of iridodialysis along with centration of eccentric pupil. Highlights: The twofold technique is a combination of nonappositional iris repair and SFT procedure. It can be clinically applied in all cases of iridodialysis with varied degrees of severity

Clinical Profile, Adverse Drug Reaction, and Outcome of Category V Patients at a Drug-resistant Tuberculosis Center, Mumbai

Background: Drug regimens for the treatment of drug-resistant tuberculosis (DR-TB) are composed of salvage drugs to which a patient has never been exposed to previously. Methods: A retrospective observational study was conducted in a DR-TB Center attached to a medical college in a metropolitan city using the database of category V patients (n = 100) who were prediagnosed and referred. The clinical records of the patients were reviewed for demographic data, history, sputum examinations, co-morbidities, and adverse drug reactions (ADRs). The therapy outcomes were assessed as per Revised National Tuberculosis Control Programme (RNTCP) guidelines. Results: Their mean age was 29.1 years; there were 57 males. Mean body weight was 41.8 kg. Pediatric patients (age 12�) constituted 13%. All the patients had pulmonary TB. Of the 100 cases, 80 were Category IV failure; 5% were defaulters of Category IV; and 15% were treated with second-line drugs adequately in private. Durg-susceptibility test (DST) showed extensively drug-resistant TB (XDR-TB) in 63 and pre-XDR-TB in 37 patients. The outcomes of Category V treatment were cure (7%), died (33%), failed on therapy (4%), transferred out (16%), lost to follow-up (2%), and still on the therapy (35%). Various comorbidities were present in 25% patients. ADRs were seen in 44%, and peripheral neuropathy (18%) was the most commonly observed ADR. Conclusions: DR-TB patients were younger and males were more affected. Mortality of Category V regimen was high (33%). Most common comorbidities were anemia and hypothyroidism. Adverse reactions were common (44%); ADR peripheral neuropathy being the most common.

A study of prescribing patterns in high-risk pregnancy at a tertiary care hospital

Background: High-risk pregnancy is defined as pregnancy complicated by factors that can adversely affect maternal and perinatal outcome. About 10–30% of pregnancies are high risk which accounts for 70–80% perinatal mortality and morbidity. Drug utilization data help to monitor the drugs prescribed and to assess the outcome by evaluating appropriateness and rationality of prescription. Aims and Objectives: This study aims to evaluate the pattern of drug use in high-risk pregnancy and to assess the WHO core prescribing indicator and US FDA category. Materials and Methods: A total of 250 case record forms of pregnant women admitted to high-risk ward were analyzed. Patient’s demographic data and detailed information about prescription were recorded and analyzed as per the WHO core drug prescribing indicators and US-FDA category. Descriptive statistics were used. Results: A total of 1121 drugs were prescribed among which antimicrobials (33.7%) were used more frequently followed by antihypertensive (13.9%), intravenous (609, 54.2%) route was the major route of drug administration, followed by oral (527, 47%), intramuscular (33, 2.9%), and subcutaneous (16, 1.4%). Average number of drugs per encounter was 4.48, percentage of encounters with an antimicrobials prescribed is around 70.4%, percentage of drugs prescribed by generic name was 93.5%, percentage of drugs prescribed from essential drugs list was 73.3%, and percentage of encounters with an injection prescribed was 50.4%. Majority of drugs belong to the US-FDA pregnancy Category B (45.04%), followed by Category C (39.4%), A (10.8%), and D (4.6%). Conclusion: Majority of drugs were prescribed by generic name and belonged to Category B drugs which are considered safe. Standards of prescription were in accordance with the WHO prescribing indicators. Overall prescribing behavior is rational and encouraging.

Clinical factors associated with composition of lung microbiota and important taxa predicting clinical prognosis in patients with severe community-acquired pneumonia / 医学前沿

Few studies have described the key features and prognostic roles of lung microbiota in patients with severe community-acquired pneumonia (SCAP). We prospectively enrolled consecutive SCAP patients admitted to ICU. Bronchoscopy was performed at bedside within 48 h of ICU admission, and 16S rRNA gene sequencing was applied to the collected bronchoalveolar lavage fluid. The primary outcome was clinical improvements defined as a decrease of 2 categories and above on a 7-category ordinal scale within 14 days following bronchoscopy. Sixty-seven patients were included. Multivariable permutational multivariate analysis of variance found that positive bacteria lab test results had the strongest independent association with lung microbiota (R2 = 0.033; P = 0.018), followed by acute kidney injury (AKI; R2 = 0.032; P = 0.011) and plasma MIP-1β level (R2 = 0.027; P = 0.044). Random forest identified that the families Prevotellaceae, Moraxellaceae, and Staphylococcaceae were the biomarkers related to the positive bacteria lab test results. Multivariable Cox regression showed that the increase in α-diversity and the abundance of the families Prevotellaceae and Actinomycetaceae were associated with clinical improvements. The positive bacteria lab test results, AKI, and plasma MIP-1β level were associated with patients' lung microbiota composition on ICU admission. The families Prevotellaceae and Actinomycetaceae on admission predicted clinical improvements.

Category of Chinese medicine registration:historical evolution,current status,and problems / 中国中药杂志

The development of traditional Chinese medicine(TCM) has always been highly valued and supported since 1949. However, Chinese medicine industry still faces great challenges in view of the current status of the industry and registration and approval of new products in recent years. Related policies also directly influence the development of the industry. The latest version of the Provisions for Drug Registration and Requirement on Registration Classification and Application Information of Traditional Chinese Medicines have been put into practice since 2020. Registration classification is the core content of the Chinese medicine registration management system, as it is closely related to the research, development, and registration of Chinese medicine and the innovative development of the industry. This article aims to systematically review the historical evolution of the category of Chinese medicine registration and analyze the current status and problems, which is expected to provide a reference for the formulation of supporting documents according to related laws and regulations.

Programa de planificación semanal para el desarrollo de la fuerza en judocas de la categoría 9-10 años / Programa semanal de planeamento para o desenvolvimento da força nos judocas da categoria dos 9-10 anos de idade / Weekly planning program for the development of strength in female judo athletes of the 9-10 years old category

RESUMEN El presente trabajo consistió en la elaboración de un programa de planificación semanal para el desarrollo de la fuerza en judocas de la categoría 9-10 años. El mismo tuvo como propósito esencial, ofertar una vía para influir positivamente en el rendimiento de los judocas pertenecientes a este grupo etario, a la vez que se dispone de un nuevo recurso para elaborar la planificación de la fuerza para esta disciplina deportiva, con lo que se contribuye, además, con el proceso de superación de los profesores deportivos que laboran en el eslabón de base. Para ello, se tuvieron en cuenta los fundamentos morfo-biomecánicos de los ejercicios de fuerza, así como las características morfo-funcionales de los niños que pertenecen a la misma. Para la obtención de información, se utilizaron como métodos la revisión de documentos, la encuesta y la observación. Al no encontrarse referentes al respecto en la bibliografía especializada que fue consultada, así como la falta de evidencia de una planificación semanal del entrenamiento de la fuerza, sustentado en los parámetros anteriormente mencionados, lo que pudo constatarse a través del diagnóstico efectuado. Los autores lograron diseñar un programa de planificación semanal para el desarrollo de la fuerza en judocas de la categoría 9-10 años, acorde con las exigencias fisiológicas de este grupo etario. De este modo, se pudo influir de forma positiva en el desarrollo de esta capacidad motora, sin daños para el organismo de estos niños.

RESUMO O presente trabalho consistiu na elaboração de um programa de planeamento semanal para o desenvolvimento da força nos judocas da categoria dos 9-10 anos de idade. O seu objectivo essencial era oferecer uma forma de influenciar positivamente o desempenho dos judocas pertencentes a esta faixa etária, tendo ao mesmo tempo um novo recurso para desenvolver o planeamento de força para esta disciplina desportiva, o que também contribui para o processo de melhoria dos professores de desporto que trabalham no elo básico. Para tal, foram tidos em conta os fundamentos morfo-biomecânicos dos exercícios de força, bem como as características morfofuncionais das crianças que a ela pertencem. A fim de obter informações, foram utilizados como métodos a revisão, o levantamento e a observação de documentos. Uma vez que não foram encontradas referências na bibliografia especializada que foi consultada, bem como a falta de provas de um planeamento semanal do treino de força, baseado nos parâmetros acima mencionados, que pôde ser verificado através do diagnóstico efetuado, os autores puderam conceber um programa de planeamento semanal para o desenvolvimento da força nos jogadores de judô da categoria dos 9-10 anos, de acordo com as exigências fisiológicas desta faixa etária. Desta forma, foi possível influenciar positivamente o desenvolvimento desta capacidade motora, sem danificar o corpo destas crianças.

ABSTRACT The present work consisted in the elaboration of a weekly planning program for the development of strength in judo female athletes of the 9-10 years old category. Its essential purpose was to offer a way to positively influence the performance of judo female athletes belonging to this age group, at the same time that a new resource is available to elaborate the planning of strength for this sport discipline, which also contributes to the process of improvement of sports teachers who work in the basic link. For this purpose, the morpho-biomechanical fundamentals of strength exercises were taken into account, as well as the morpho-functional characteristics of the children who belong to it. To obtain information, document review, survey and observation were used as methods. Since no references were found in the specialized bibliography that was consulted, as well as the lack of evidence of a weekly planning of strength training, based on the aforementioned parameters, which could be verified through the diagnosis carried out, the authors were able to design a weekly planning program for the development of strength in judo female athletes of the 9-10 years old category, according to the physiological demands of this age group. In this way, it was possible to have a positive influence on the development of this motor capacity, without harming the organism of these children.

Contenidos de coordinación óculo-pédica en conducción del balón para fútbol femenino juvenil. Validación por especialistas / Conteúdos da coordenação óculo-pédica no manejo de bolas para o futebol feminino júnior. Validação por especialistas / Oculo-pedic coordination contents in ball conduction for juvenile female soccer. Validation by specialists

RESUMEN La coordinación óculo-pédica se refiere a movimientos realizados con la coordinación visual con el pie, elemento motriz de utilidad para diversos deportes y, en especial, para establecer estrategias de trabajo en futbolistas de diversas categorías de formación. Esta investigación tiene como objetivo validar teóricamente mediante especialistas una propuesta de ejercicios físicos que potencien la coordinación óculo-pédica, en la técnica de conducción del balón para futbolistas juveniles del género femenino. Esta investigación es de tipo descriptiva-correlacional, de orden cualitativa. Se seleccionan a 30 especialistas, divididos en tres niveles de competencias profesionales, a los cuales se les aplica un cuestionario para evaluar tres indicadores prepropuesta, que validan una idea de entrenamiento coordinativo (pertinencia, complejidad, prioridad), más un cuestionario que evaluará un indicador (efectividad) luego de diseñada la propuesta de intervención con 30 ejercicios físicos especializados. Como resultados, se plantea que no se evidencian diferencias significativas en tres indicadores (complejidad: p=0.850; prioridad: p=0.075; efectividad: p=0.419) de cuatro posibles (pertinencia: p=0.014) por nivel de especialistas, existiendo consenso en las calificaciones emitidas. Los indicadores prepropuesta presentaron una evaluación cualitativa entre regular a muy bien y el indicador evaluador de la propuesta obtiene una calificación cualitativa general De acuerdo. Se evidencia, en sentido general, el criterio consensado de varios especialistas con competencias diversas, calificando cuantitativa y cualitativamente, de forma positiva, la calidad de la prepropuesta y la propuesta.

RESUMO A coordenação óculo-pédica refere-se a movimentos feitos com a coordenação visual com o pé, um elemento motor útil para vários desportos e, especialmente, para estabelecer estratégias de trabalho em jogadores de futebol de várias categorias de treino. O objetivo desta investigação é validar teoricamente através de especialistas uma proposta de exercícios físicos que potenciem a coordenação óculo-pédica, na técnica de condução de bola para jovens jogadoras de futebol feminino. Esta é uma investigação descritivo-correlacional e qualitativa. São selecionados trinta especialistas, divididos em três níveis de competências profissionais, aos quais é aplicado um questionário para avaliar três indicadores de pré-proposta, que validam uma ideia de formação de coordenação (pertinência, complexidade, prioridade), mais um questionário que avaliará um indicador (eficácia) após a concepção da proposta de intervenção com 30 exercícios físicos especializados. Como resultados, afirma-se que não são evidenciadas diferenças significativas em três indicadores (complexidade: p=0,850; prioridade: p=0,075; eficácia: p=0,419) de quatro possíveis (pertinência: p=0,014) por nível de especialistas, consenso existente nas qualificações emitidas. Os indicadores de pré-proposta apresentaram uma avaliação qualitativa entre regular a muito bom e o indicador do avaliador da proposta obtém uma qualificação qualitativa geral Acordado. É evidente, num sentido geral, o critério consensual de vários especialistas com diversas competências, qualificando quantitativa e qualitativamente, de forma positiva, a qualidade da pré-proposta e da proposta.

ABSTRACT The oculo-pedic coordination refers to movements made with the visual coordination with the foot, a useful motor element for various sports and especially for establishing work strategies in soccer players of various teaching-educational categories. The objective of this research is to theoretically validate, through specialists, a physical exercises proposal that enhance the oculo-pedic coordination in the ball conduction technique for female youth soccer players. This is a descriptive-correlational research of qualitative order. Thirty specialists are selected, divided into three levels of professional competencies, to whom a questionnaire is applied to evaluate three pre-proposal indicators, which validate an idea of coordination training (relevance, complexity, priority), plus a questionnaire that will evaluate an indicator (effectiveness) after designing the intervention proposal with 30 specialized physical exercises. As results, there are no significant differences in three indicators (complexity: p=0.850; priority: p=0.075; effectiveness: p=0.419) out of four possible indicators (relevance: p=0.014) by level of specialists, and there is consensus in the ratings issued. The pre-proposal indicators presented a qualitative evaluation between fair to very good and the evaluator indicator of the proposal obtained an overall qualitative rating of Agreed. It is evident, in general, the consensus criterion of several specialists with diverse competences, qualifying quantitatively and qualitatively, in a positive way, the quality of the pre-proposal and the proposal.

Profesionalización docente del tutor en el primer nivel de atención / Teaching Professionalization of the Tutor in the First Level of Healthcare

Introducción: La docencia universitaria reviste gran complejidad. En la carrera de Medicina el proceso formativo es dirigido a la enseñanza de competencias profesionales y a la adquisición de valores necesarios para el perfil de salida del profesional de la salud. Se propuso como objetivo caracterizar la profesionalización docente del tutor en el proceso de formación del médico general durante el año 2018. Métodos: Se realizó estudio descriptivo transversal sobre los tutores de pregrado del Municipio de Sagua la Grande. Se encuestaron 13 especialistas en Medicina General Integral y 12 residentes de 2do año. Variables: categoría profesional y docente, grado académico, experiencia como tutor, años de graduado como especialista, tiempo desarrollado como tutor y participación en actividades metodológicas. Resultados: De los 25 consultorios acreditados para la docencia en pregrado, 13 fueron cubiertos por especialista de primer grado en Medicina General Integral y 12 por residentes de 2do año, solo 5 especialistas categorizados. El 61,54 por ciento mostró más de 5 años de experiencia en la asistencia y la docencia, pero con poca preparación metodológica. Conclusiones: En Sagua, la tutoría en pregrado recayó en residentes y especialistas de primer grado en Medicina General Integral, la mayoría sin categoría docente. La preparación profesional, profesoral e investigativa del claustro fue insuficiente. Se evidenció la responsabilidad de la dirección de las unidades docentes asistenciales en garantizar que los consultorios acreditados para la docencia sean cubiertos por residentes en formación o especialistas de Medicina General Integral con categoría docente, como garantía de la calidad del proceso formativo(AU)

Introduction: University teaching is characterized by its high complexity. In the medical major, the training process is aimed at teaching professional skills and acquiring the values necessary for the working profile of the health professional. Objective: To characterize the teaching professionalization of the tutor in the general practitioner´s training process during 2018. Methods: A descriptive and cross-sectional study was carried out about undergraduate tutors from Sagua la Grande Municipality. Thirteen specialists in Family Medicine and twelve second-year residents were surveyed. The variables studied were professional and teaching category, academic degree, tutor experience, years of graduate as a specialist, time spent as a tutor, and participation in methodological activities. Results: Of the 25 family medical offices accredited for undergraduate teaching, thirteen were attended by a first-degree specialist in Family Medicine and 12 were under second-year residents; of which there were only five categorized specialists. 61.54 percent showed more than five years of experience in care and teaching, but with little methodological preparation. Conclusions: In Sagua, undergraduate tutoring corresponded to first-degree residents and specialists in Family Medicine, the majority without teaching category. The professional, teaching and research training of the faculty was insufficient. The responsibility of the management of the teaching care units was evidenced in guaranteeing that the accredited teaching family medical offices are run by residents in training or specialists in Family Medicine with teaching category, as a guarantee of the quality of the training process(AU)

Analysis of innovative drug category 1.2 in traditional Chinese medicine and considerations on quality control of extracts / 中国中药杂志

In this article, the essence of innovative drug category 1.2 extracts and preparations in the new version of the New Drug Registration Category of traditional Chinese medicines(TCM) was analyzed by combing through the history of provisions on drug registration and comparing with other categories of drugs. After analyzing the characteristics of this type of preparations, the author concluded that the quality control objectives of category 1.2 extract should focus on ensuring the quality consistency of the active ingredients/components in batches, so as to guarantee the consistency of drug quality and efficacy. With reference to the relevant technical requirements for herbal medicinal products in European Medicines Agency(EMA) and botanicals in Food and Drug Administration(FDA),the key points in quality control of the extract should include the content and composition of the therapeutic constituents, the type and content of the concomitants, and the influence of exogenous contaminants on drug safety.

Exploration and practice of staff training of a general hospital / 中华医院管理杂志

Systematic and scientific training for all employees is an important means to improve the medical quality and service level of general hospitals. The authors′ hospital established a staff training university in 2012, built an integrated training management platform, and explored the combination of online and offline training for all its staff. Guided by the hospital′s development goals and service objectives, professional courses and comprehensive courses were set. Each specialty sets the course content and credit requirements according to the level of staffs, and dynamically adjusts the course setting according to the needs and training effect evaluation. This training mode ensured the effective implementation of in-hospital training, and the credit qualification rate of staffs had increased from 29.31% in 2012 to 85.37% in 2020; Improved the pertinence, timeliness and practicability of training; It enriched the training resources, broke the time and space constraints of training, and eliminated the contradiction between work and study.

Reflections on the evaluation and management of SCI papers based on the category normalized citation impact: Taking a university hospital as an example / 中华医学科研管理杂志

Objective:Analyze the basic information and characteristics of SCI papers published by an institution in 2015-2019 based on the Category Normalized Citation Impact (CNCI), to provide a reference basis for SCI paper management policy improvement.Methods:Retrieve SCI papers completed by the first or correspondent unit from 2015 to 2019 from the scientific research management system of the institution. Obtain index data including journal information, impact factors, and CNCI of this group of papers from Web of science and InCites databases, and use SPSS21.0 statistical software to perform descriptive and chi-square tests.Results:The university-affiliated hospital published 3201 SCI papers from 2015-2019, with a growing trend. These papers were most frequently published in the 1<IF<3 zone, accounted for 44.92%, followed by the 3<IF<5 zone, accounted for 32.27%. These papers are mainly in Q2 journals, accounted for 31.52%, while Q1 and Q3 journals each account for 25%. From the perspective of CNCI, the average CNCI of papers in 2015-2017 was less than 1, and the average CNCI of papers in 2018-2019 was greater than 1, with no statistical difference in CNCI values between years. The proportion of high CNCIs was higher for papers with high IF. The average CNCI per page for papers in Q1 and Q2 was greater than 1, and the average CNCI per page for papers in Q3 and Q4 was less than 1. The proportion of high CNCIs was higher for papers in Q1.Conclusions:The evaluation conclusions reached under different research management perspectives are in-consistent. A comprehensive evaluation of papers based on journal divisions and CNCI is more reasonable. In a new era where indicators such as number of papers and impact factor are not the only thing that matters, it is relevant to select the top journals in the discipline and to apply comprehensive evaluation indicators such as CNCI to the evaluation of papers.

Category and working mechanisms of SARS-CoV-2 vaccines and their effectiveness in clinical trials / 上海预防医学

Since the pandemic outbreak of the COVID-19， there had been about 121 million confirmed cases and more than 2.6 million deaths， which had significantly affected the economies and health resources in more than 233 countries and regions. Currently， no effective therapeutic option is available for the COVID-19， andimplementation of public health interventions suffers inconvenience. Consequently， the development of COVID-19 vaccines remains crucial. This review updates the current research progression， advantages and disadvantages of inactivated vaccine， live attenuated vaccine， recombinant subunit vaccine， recombinant virus-vectored vaccine， DNA vaccine， and RNA vaccine for the COVID-19. It warrants joint research and development of vaccines on multiple platforms， which would facilitate better control and prevention of the COVID-19 epidemic.

Formación docente, científica y académica en los profesores consultantes de la Facultad de Estomatología en Santiago de Cuba / Teaching, scientific and academic training of consultant professors from the Stomatology Faculty in Santiago de Cuba

Introducción: El profesor, docente o enseñante es quien se dedica profesionalmente a la enseñanza y, además, a la transmisión de valores de conducta, técnicas y conocimientos; facilita el aprendizaje para que el alumno lo alcance de la mejor manera posible. Objetivo: Describir las características fundamentales de las funciones y el trabajo de profesores consultantes. Métodos: Se realizó un estudio descriptivo en la Clínica Estomatológica Provincial Docente Mártires del Moncada de Santiago de Cuba, durante diciembre de 2018, cuyo universo estuvo formado por los 29 profesores consultantes, adjuntos a la Facultad de Estomatología hasta ese año. Como variables de interés se consideraron la edad, el sexo, la especialidad, la categoría docente y su año de otorgamiento, así como los grados académico y científico. Resultados: Los años con mayor asignación de profesores titulares y auxiliares fueron 1998 y 2009, respectivamente. En general, la mayoría de los docentes correspondieron al grupo etario de 65-70 años y al sexo femenino, en tanto la categoría de profesor auxiliar la ostentaban 82,8 % y la de titular 17,2 %. En cuanto al grado académico, el mayor número de profesores titulares y auxiliares eran especialistas de segundo grado, muy pocos de los docentes titulares habían cursado maestrías y ninguno de los profesores auxiliares había optado por el doctorado. Conclusiones: La condición especial de profesor consultante representa y continúa siendo un reconocimiento a la labor académica desplegada en la asesoría de las tareas docentes, asistenciales e investigativas durante la vida profesional.

Introduction: The professor, teaching staff or teacher is the one professionally devoted to teaching and, also, to the transmission of behavior values, techniques and knowledge; that facilitates learning so that the student reaches it in the best possible way. Objective: To describe the fundamental characteristics of consultant professors functions and work. Methods: A descriptive study was carried out in Mártires del Moncada Teaching Provincial Stomatologic Clinic in Santiago de Cuba, during December, 2018, which universe was formed by the 29 consultant professors, associated to the Stomatology Faculty until that year. The age, sex, specialty, teaching category and granting year were considered as variables of interest, as well as the academic and scientific degrees. Results: The years with more assignment of associate or instructor professors were 1998 and 2009, respectively. In general, most of the teaching staff corresponded to the 65-70 age group and the female sex, as long as instructor professor category constituted the 82.8 % and associate professor 17.2 %. As for the academic degree, the highest number of associate and instructor professors was second degree specialists, very few of the associate professors had studied masters degrees and none of the instructor professors had applied for the doctorate. Conclusions: The special condition of consultant professor represents and still is a recognition to the academic work showed in the consultancy of the teaching, assistance and investigative tasks during the professional life.