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.

Study 3: Anterior segment optical coherence tomography-guided surgical approach in slipped medial rectus muscle

Purpose: To discuss the novel swept?source anterior segment optical coherence tomography (SS?ASOCT)?guided surgical approach in slipped medial rectus muscles. Methods: Prospectively (between February 2020 and July 2022), six patients with a clinical suspicion of slipped medial rectus muscle were recruited. After complete ophthalmic and orthoptic evaluation, the missing medial rectus muscle is screened using Anterior Segment Optical Coherence Tomography (ASOCT). In presence of a traceable muscle, its morphology, depth, and distance from a fixed anatomical landmarks were noted; in its absence, the status of other recti was noted. Intraoperatively, the features were confirmed and the intended intervention was performed. Results: The mean age of six patients was 25.66 ± 9.72 years, two with surgical trauma and four with penetrating trauma (66.66%). In five patients, the ASOCT traced the slipped medial rectus muscle successfully (83.33%); intraoperatively, the same was confirmed (within 1–2 millimeters) with favorable outcomes. ASOCT made a significant contribution in all subjects by reducing the number of interventions and muscle surgeries. Conclusions: In eyes with slipped medial rectus muscle, especially those which are within a finite distance from the angle can be traced using ASOCT. This approach impacts the outcomes in many ways

Abordando el cuerpo de evidencia: conceptos fundamentales de los overviews / Approaching the body of evidence: Key concepts of Overviews

El aumento de la producción de investigación primaria y de las revisiones de la literatura durante las últimas décadas ha hecho necesario el desarrollo de un nuevo diseño metodológico para sintetizar la evidencia: los overviews. Un overview es un diseño de síntesis de evidencia que toma como unidad de análisis a las revisiones sistemáticas, con el objetivo de extraer y analizar los resultados para una pregunta de interés nueva o más amplia, ayudando así a mejorar los procesos de toma de decisiones informadas. El objetivo de este artículo es introducir al lector a este tipo de resúmenes de evidencia, destacando las diferencias con los otros tipos de síntesis de evidencia, los aspectos metodológicos particulares de los overviews, y los desafíos pendientes. Este artículo es el duodécimo de una serie metodológica colaborativa de revisiones narrativas sobre temáticas de bioestadística y epidemiología clínica.

The increasing production of primary research and literature reviews in the last decades has made it necessary to develop a new methodological design to synthesize the evidence: the overviews. An overview is a type of evidence synthesis that uses systematic reviews as the unit of analysis, with the aim of extracting and analyzing the results for a new or broader research question, helping the shared decision-making processes. The aim of this article is to introduce the reader to this type of evidence summaries, highlighting the differences between overviews and other types of synthesis, the unique methodological aspects of overviews, and future challenges. This is the twelfth article from a collaborative methodological series of narrative reviews about biostatistics and clinical epidemiology.

Análise SWOT no setor de vigilância epidemiológica do município de Teresópolis (RJ): relato de experiência realizada pelo PET-Saúde / SWOT analysis in the epidemiological surveillance sector in the municipality of Teresópolis (RJ): experience report carried out by PET-Saúde / Análisis SWOT en el sector de monitoreo epidemiológico en la ciudad de Teresópolis, Rio de Janeiro: informe de experiencia realizado por PET-Saúde

Frente ao trabalho administrativo do sistema de saúde pública pautado em métodos tradicionais, torna-se necessário a implementação de estratégias facilitadoras para o planejamento das ações em saúde. O diagnóstico situacional (DS) e a análise SWOT auxiliam no ordenamento do pensamento e na implementação de ações efetivas, assim minimizando os desafios que perpassam o campo de atuação. O objetivo deste estudo foi realizar um diagnóstico situacional do Serviço de Vigilância Epidemiológica do município de Teresópolis (RJ). Trata-se de um relato de experiência de estudantes e profissionais da saúde pertencentes ao Programa de Educação pelo Trabalho para Saúde (PET-Saúde) e inseridos no cenário da vigilância epidemiológica local. Para suporte teórico, realizou-se uma busca nas bases PubMed, Scholar Google e SciELO. Forças, fraquezas, oportunidades e ameaças foram observadas a partir do DS realizado, tanto de fatores referentes ao ambiente interno como de fatores externos, possibilitando recomendações para melhor atuação e avanço organizacional. A vivência no território viabilizou o planejamento de estratégias que, além de serem empregadas na divisão de vigilância epidemiológica, abrangessem os serviços de saúde externos, assim alcançando as fragilidades laborais e garantindo atitudes resolutas para o serviço de epidemiologia do munícipio. O PET-Saúde mostrou-se uma grande oportunidade para o pensar e agir em saúde. A partir da percepção dos estudantes e profissionais envolvidos, ações foram ponderadas tanto para os fatores intrínsecos, que podem ser executadas de maneira direta pela equipe, quanto para os fatores extrínsecos, que demandam medidas indiretas para serem resolvidas, sendo revertidas em ganho para a população.

Dealing with the administration work of the public health system based in traditional methods, the implementation of strategies to ease the plans of actions in health is needed. The situational diagnosis (SD) and the SWOT analysis support the alignment of ideas and the implementation of effective actions, thus minimizing the challenges that pervade this field of action. This study aims to carry out a situational diagnosis of the epidemiological surveillance service of the Teresopolis (RJ) municipality. This is an experience report of students and health professionals belonging to the Program of Education for the Health Work (PET-Saúde) and inserted in the scenario of local epidemiological surveillance. For theoretical support, a search was carried out in the bases PubMed, Scholar Google, and SciELO. Strengths, weaknesses, opportunities, and threats were observed from the SD carried out, both from factors related to the internal environment and from external factors, allowing recommendations for better performance and organizational advancement. Living in the territory made it possible to plan strategies that, in addition to being used in the epidemiological surveillance division, covered external health services, thus addressing labor weaknesses and guaranteeing resolute attitudes towards the municipality's epidemiology service. The PET-Saúde was a great opportunity for thinking and acting in health. From the perspectives of the involved students and professionals, actions were planned both aiming at the inner factors, which can be executed in a direct manner by the team, and at the external factors which demand indirect measurements to be resolved, which turn into gains for the population.

Frente al trabajo administrativo del sistema de salud pública pautado en métodos tradicionales, es necesario la implementación de estrategias y herramientas facilitadoras para la planificación de las acciones en salud. El diagnóstico situacional (DS) y el análisis SWOT auxilian en el ordenamiento del pensamiento y en la implementación de acciones resolutivas, minimizando así los desafíos que permean el campo de acción. El objetivo de este estudio es efectuar un diagnóstico situacional del servicio de Monitoreo Epidemiológico del municipio de Teresópolis, en Rio de Janeiro (Brasil). Este es un informe de experiencia de estudiantes y profesionales de la salud, pertenecientes al Programa de Educación por el Trabajo para la Salud (PET-Saúde), insertos en el escenario de monitoreo epidemiológico local. Para el marco teórico se realizó una búsqueda en las bases PubMed, Google Scholar y SciELO. A partir del DS realizado se observaron fortalezas, debilidades, oportunidades y amenazas, tanto de factores relacionados con el ambiente interno como de factores externos, lo que permitió hacer recomendaciones para un mejor desempeño y avance organizacional. Vivir en el territorio permitió planificar estrategias que, además de ser utilizadas en la división de monitoreo epidemiológico, cubrieron los servicios de salud externos, atendiendo así las debilidades laborales y garantizando actitudes resolutivas hacia el servicio de epidemiología del municipio. El PET-Saúde se mostró una gran oportunidad para pensar y actuar en salud. A partir de la percepción de los estudiantes y profesionales implicados en el diagnóstico situacional, se plantean acciones resolutivas, tanto para los factores intrínsecos que pueden ser ejecutados de forma directa por el equipo como para los factores extrínsecos que exigen medidas indirectas para ser resueltos, convirtiéndose en ganancias para la población.

Educational Interventions in Adults with Type 2 Diabetes Mellitus in Primary Health Care Settings. A Scoping Review / Intervenciones educativas en adultos con diabetes mellitus tipo 2 en entornos de atención primaria de salud: una revisión de alcance / Intervenções educacionais em adultos com diabetes mellitus tipo 2 em ambientes de atenção primária à saúde: uma revisão de escopo

Objective. To synthesize the evidence of studies with educational interventions for adults with type-2 diabetes mellitus (DM2) in primary health care settings. Methods. A scoping review was conducted following the recommendations by the Joanna Briggs Institute and by the PRISMA declaration. The protocol was registered in INPLASY20215009. The search was carried out in: MEDLINE (via PubMed), EMBASE, Web of Science, LILACS, and grey literature. Results. Seventeen studies were included; most were randomized clinical trials of which 65% were conducted in high-income countries,and all the studies represented 5 656 participants. The results showed four big categories derived from educational interventions: therapeutic adherence (significant results on the satisfaction with the treatment); self-care and self-management in diabetes (improvement in self-efficacy, empowerment, and disease awareness); glycemic control in diabetes (significant results in reducing glycosylated hemoglobin); nursing and its role in the educational interventions on patients with DM2 (guidance in restructuring behaviors). Conclusion. The findings of this review suggest that educational interventions on patients with DM2 within the setting of primary health care can impact positively on therapeutic adherence, self-control, and knowledge of the disease. Moreover, it was possible to identify the influence of multidisciplinary health teams, where the relevance of nursing professionals in the construction and implementation of educational interventions is evidenced in obtaining better health results.

Objetivo. Sintetizar la evidencia de estudios con intervenciones educativas para adultos con diabetes mellitus tipo 2 (DM2) en la atención primaria de salud. Métodos. Se realizó una revisión de alcance siguiendo las recomendaciones del Instituto Joanna Briggs y de la declaración PRISMA. El protocolo se registró en INPLASY20215009. La búsqueda se realizó en: MEDLINE (vía PubMed), EMBASE, Web of Science, LILACS y literatura gris. Resultados. Diecisiete estudios fueron incluidos, la mayoría fueron ensayos clínicos aleatorizados, de estos 65% fueron conducidos en países de ingresos altos, y todos los estudios en total representaron 5656 participantes. Los resultados mostraron cuatro grandes categorías derivadas de las intervenciones educativas: adherencia terapéutica (resultados significativos en la satisfacción con el tratamiento); autocuidado y automanejo en diabetes (mejora en la autoeficacia, empoderamiento y conciencia de la enfermedad); control glucémico en diabetes (resultados significativos en la reducción de la hemoglobina glicosilada); enfermería y su papel en las intervenciones educativas en pacientes con DM2 (orientación en la reestructuración de comportamientos). Conclusión. Los hallazgos de esta revisión sugieren que las intervenciones educativas en pacientes con DM2 en el ámbito de la atención primaria de salud pueden impactar positivamente en la adherencia terapéutica, el autocontrol y el conocimiento de la enfermedad. Además, fue posible identificar la influencia de los equipos multidisciplinarios de salud, donde se evidencia la relevancia de los profesionales de enfermería en la construcción e implementación de intervenciones educativas para la obtención de mejores resultados de salud.

Objetivo. Sintetizar as evidências de estudos sobre intervenções educacionais para adultos com diabetes mellitus tipo 2 (DM2) na atenção primária à saúde. Métodos.Foi realizada uma revisão de escopo seguindo as recomendações do Joanna Briggs Institute e a declaração PRISMA. O protocolo foi registrado no INPLASY20215009. A pesquisa foi realizada em: MEDLINE (via PubMed), EMBASE, Web of Science, LILACS e literatura cinzenta. Resultados. Dezessete estudos foram incluídos, a maioria eram ensaios clínicos randomizados, 65% deles foram conduzidos em países de alta renda e todos os estudos, no total, contaram com 5656 participantes. Os resultados mostraram quatro grandes categorias derivadas das intervenções educacionais: adesão (resultados significativos na satisfação com o tratamento); autocuidado e autogestão da diabetes (melhoria na autoeficácia, fortalecimento e conscientização sobre a doença); controle glicêmico na diabetes (resultados significativos na redução da hemoglobina glicada); enfermagem e seu papel nas intervenções educacionais em pacientes com DM2 (orientação na reestruturação de comportamentos). Conclusão. Os achados desta revisão sugerem que as intervenções educacionais em pacientes com DM2 no ambiente da atenção primária à saúde podem impactar positivamente na adesão, no autogerenciamento e no conhecimento da doença. Além disso, foi possível identificar a influência das equipes multidisciplinares de saúde, onde fica evidente a relevância dos profissionais de enfermagem na construção e implementação de intervenções educacionais para obter melhores resultados de saúde.

Behavior of total alkaline phosphatase after radium-233 therapy in metastatic castration-resistant prostate cancer: a single-center, real-world retrospective study / Estudo retrospectivo de vida-real, em centro único, para avaliação do comportamento da fosfatase alcalina total após terapia com rádio-223 no câncer de próstata resistente a castração

Abstract Objective: To describe the behavior of total alkaline phosphatase (tALP) in patients with metastatic castration-resistant prostate cancer receiving radium-223 therapy, in a real-world scenario, and to describe overall survival (OS) among such patients. Materials and Methods: This was a retrospective study involving 97 patients treated between February 2017 and September 2020. Patients were stratified by the baseline tALP (normal/elevated). A tALP response was defined as a ≥ 30% reduction from baseline at week 12. For patients with elevated baseline tALP, we also evaluated treatment response as a ≥ 10% reduction in tALP after the first cycle of treatment. We defined OS as the time from the first treatment cycle to the date of death. Results: There was a significant reduction in the median tALP after each cycle of treatment (p < 0.05 for all). Data for tALP at week 12 were available for 71 of the 97 patients. Of those 71 patients, 26 (36.6%) responded. Elevated baseline tALP was observed in 47 patients, of whom 19 (40.4%) showed a response. Longer OS was observed in the patients with normal baseline tALP, in those with elevated baseline tALP that showed a response to treatment (≥ 10% reduction), and in those who received 5-6 cycles of therapy. Conclusion: The tALP may be used to predict which patients will benefit from treatment with a greater number of cycles of radium-223 therapy and will have longer OS.

Resumo Objetivo: Descrever o comportamento da fosfatase alcalina total (tALP) em pacientes com carcinoma de próstata metastático resistente a castração, submetidos a terapia com rádio-223 em um cenário do mundo real, e a sobrevida global (SG) desses pacientes. Materiais e Métodos: Estudo retrospectivo envolvento 97 pacientes, no período de fevereiro/2017 a setembro/2020. Os pacientes foram estratificados de acordo com a tALP basal (normal/elevada). A resposta à tALP foi definida como uma redução em relação à linha de base de ≥ 30% na semana-12. Para pacientes com tALP basal elevada, também foi avaliada a resposta ao tratamento como uma redução de ≥ 10% de tALP após o primeiro ciclo. A SG foi definida como o tempo entre o primeiro ciclo e a data do óbito. Resultados: A redução da tALP média após cada ciclo foi significativa (p < 0,05). A tALP na semana 12 estava disponível para 71 dos 97 pacientes. Desses 71 pacientes, 26 (36,6%) responderam. Dezenove (40,4%) dos 47 pacientes com tALP elevada apresentaram resposta. Foi observada uma SG mais longa nos pacientes com tALP basal normal, nos pacientes com tALP basal elevada que apresentaram resposta ao tratamento (redução de ≥ 10%) e nos pacientes que receberam 5-6 ciclos. Conclusão: A tALP pode ser usada para prever parte dos pacientes que se beneficiarão do tratamento com um maior número de ciclos e uma SG mais longa.

Conduta dos cirurgiões-dentistas frente à violência contra a mulher: uma revisão integrativa / Attitudes of dental surgeons towards violence against women: an integrative review / Conductasde los cirujanos dentistas frente a la violencia contra la mujer: una revisión integradora

Introdução:A violência doméstica, um fenômenoconstante na vida de muitas mulheres, possui dimensões globais. Esse infortúnio que assombra o sistema de saúde se intensificou ainda mais com as medidas de restrição social e o confinamento das vítimas com seus agressores por um longo período, no cenário de pandemia da Covid-19. Objetivo:Essa pesquisa teve por objetivo identificar a conduta dos cirurgiões-dentistas frente à violência contra a mulher, por meio de uma revisão integrativa.Metodologia:A busca dos estudos foi realizada nas plataformas de bancos de dados da Biblioteca Virtual de Saúde e da National Library of Medicine. Foram selecionados os textos completos, disponíveis em português, referentes aos últimos cinco anos (2017-2022) e utilizando os descritores "Violência contra as mulheres", "Saúde bucal", "Autoimagem" e "Traumatismos da Face", combinados com o operador booleano "and". Resultados:Foram recuperados 51 estudos, dos quais utilizaram-se 13, pois esses satisfizeram os critérios de inclusão e exclusão, demonstrando que o tema de maior destaque foi a violência contra a mulher associada com a autoestima, autoimagem e predominantemente estudos transversais. Observou-se que o impacto emocional ultrapassa os danos físicos provenientes da violência contra a mulher. A face, principalmente a boca, é a área mais afetada pela violência doméstica. O uso do álcool e de drogas pelos agressores aumentam as chances de violência contra a mulher. Ainda, os dados encontrados não contemplaram completamente a indagação sobre o papel do cirurgião-dentista diante do acolhimento das vítimas da violência doméstica. Conclusões:Os cirurgiões-dentistas como profissionais de saúde, inseridos diariamente no manejo das lesões de cabeça e pescoço, fazem parte do acolhimento das vítimas de violência doméstica e devem estarcapacitadosno cuidado integral à saúdepara lidar com as demandas necessárias (AU).

Introduction:Domestic violence, a constant phenomenonin the lives of many women, has global dimensions. Social distancing measures and house confinement of victims with their aggressors for long periods in the scenario of the Covid-19 pandemic has further escalated this misfortune with which the health systemhas to deal. Objective:This study sought to identify the attitudes of dental surgeons towards violence against women through an integrative review.Methodology:A search of studies was conducted in the Virtual Health Library and National Library of Medicine databases. The descriptors "Violence against women", "Oral health", "Self-image" and "Facial trauma" were used, combined with the Boolean operator "AND". Full texts available in Portuguese published in the last five years (2017-2022) were selected.Results:Fifty-one studies were retrieved and 13 were selected after application of inclusion and exclusion criteria. They were predominantly cross-sectional studies and showed that the most prominent theme was violence against women associated with self-esteem andself-image. It was observed that the emotional impact goes beyond the physical damage resulting from violence against women. The face, especially the mouth, is the area most affected by domestic violence. The use of alcohol and drugs by aggressors increases the chances of violence against women. The data found did not fully cover the question about the role of dental surgeons in the support for victims of domestic violence. Conclusions:As health professionals involved with daily management of cases of head and neck injuries, dental surgeons have a role in the care and support for victims of domestic violence and must be trained in comprehensive health care to deal with the necessary demands (AU).

Introducción: La violencia doméstica, un fenómeno constante en la vida de muchas mujeres, tiene dimensiones globales. Esta desgracia que acecha al sistema de salud se ha recrudecido aún más con las medidas de restricción social y el confinamiento de las víctimas con sus agresores durante un largo periodo en el escenario de la pandemia del Covid-19. Objetivo: Esta investigación tuvo como objetivo identificar el comportamiento de los odontólogos frente a la violencia contra la mujer. Metodología: La búsqueda de estudios se realizó en las plataformas de bases de datos de la Biblioteca Virtual en Salud y la Biblioteca Nacional de Medicina. Fueron seleccionados textos completos, disponibles en portugués, referidos a los últimos cinco años (2017-2022) y utilizando los descriptores "Violencia contra la mujer", "Salud bucal", "Autoimagen" y "Trauma facial", combinado con el operador booleano "AND". Resultados: Fueron recuperados 51 estudios, de los cuales 13 fueron utilizados, ya que cumplieron con los criterios de inclusión y exclusión, demostrando que el tema más destacado fue la violencia contra la mujer asociada a la autoestima, la autoimagen y estudios predominantemente transversales. Se observó que el impacto emocional va más allá del daño físico derivado de la violencia contra las mujeres. La cara, especialmente la boca, es la zona más afectada por la violencia doméstica. El uso de alcohol y drogas por parte de los agresores aumenta las posibilidades de violencia contra las mujeres. Aun así, los datos encontrados no contemplaron en su totalidad la pregunta sobre el papel del odontólogo en la acogida de víctimas de violencia doméstica.Conclusiones: Los cirujanos dentistas como profesionales de la salud, insertos cotidianamente en el manejo de traumatismos de cabeza y cuello, forman parte del cuidado de víctimas de violencia doméstica y deben estar capacitados en atención integral de salud para hacer frente a las demandas necesarias (AU).

Percepções e Vivências de Psicólogos/as sobre a Punição Física em Crianças / Perceptions and Experiences of Psychologists about Physical Punishment in Children / Percepciones y Experiencias de los Psicólogos/as sobre el Castigo Físico en Niños/as

Este estudo qualitativo e transversal investigou as percepções e vivências dos/as psicólogos/as sobre o uso da punição física em crianças. Participaram do estudo 13 psicólogos/as brasileiros/as, que responderam a um questionário sociodemográfico on-line, um roteiro de entrevista e vinhetas de situação-problema. A análise de conteúdo revelou duas categorias: Ambivalência nas percepções sobre o uso da punição física: A palmada não é uma forma de agressão?; e Reprodução da punição física geração após geração: a forma de educar mudou?. Constataram-se percepções endossando o uso da punição física e experiências pessoais de punição física na infância, mas vários participantes buscam não repetir com os filhos e são desfavoráveis a todos os níveis dessa prática. Participantes favoráveis ao uso, principalmente da palmada, demonstraram desconhecimento da sua ineficácia enquanto método educativo e de seus efeitos prejudiciais. A transgeracionalidade e a naturalização da palmada foram motivos salientados para a persistência do uso da punição física. São necessárias capacitações a psicólogos/as e estudantes sobre os prejuízos e alternativas à punição física em crianças.

This qualitative and transversal work aimed to investigate the perceptions and experiences of psychologists about the use of physical punishment in children. Thirteen Brazilian psychologists participated in the study, who answered a socio-demographic questionnaire, an interview script and problem-situation vignettes online. Content analysis revealed two categories: Ambivalence in perceptions about the use of physical punishment: Isn't spanking a form of aggression? and Reproduction of physical punishment generation after generation: has the way of educating changed? Perceptions endorsing the use of physical punishment and personal experiences of physical punishment in childhood were found, but several participants try not to repeat it with their children and are unfavorable to all levels of this practice. Participants favorable to the use, mainly of spanking, demonstrated ignorance of its ineffectiveness as an educational method and its harmful effects. The transgenerationality and the naturalization of spanking were highlighted reasons for the persistence of the use of physical punishment. Training is needed for psychologists and students on the harm and alternatives to physical punishment in children.

Este estudio cualitativo y transversal tuvo como objetivo investigar las percepciones y experiencias de psicólogos sobre el uso del castigo físico en niños. Participaron del estudio trece psicólogos brasileños, que respondieron un cuestionario sociodemográfico, un guión de entrevista y viñetas de situaciones-problema en línea. El análisis de contenido reveló dos categorías: Ambivalencia en las percepciones sobre el uso del castigo físico: ¿Las nalgadas no son una forma de agresión? y Reproducción del castigo físico generación tras generación: ¿ha cambiado la forma de educar? Se encontraron percepciones que avalan el uso del castigo físico y experiencias personales del castigo físico en la infancia, pero varios participantes intentan no repetirlo con sus hijos y son desfavorables a todos los niveles de esta práctica. Los participantes favorables al uso, principalmente de las nalgadas, demostraron desconocer su ineficacia como método educativo y sus efectos nocivos. La transgeneracionalidad y la naturalización de las nalgadas fueron razones destacadas para la persistencia del uso del castigo físico. Se necesita capacitación para psicólogos y estudiantes sobre el daño y las alternativas al castigo físico en los niños.

Salud bucal de niños y niñas intervenidos por el programa odontológico Sembrando Sonrisas, Comuna de Ovalle, año 2019

Objetivo: Evaluar el estado actual de la salud bucal de niños(as) de 2 a 5 años intervenidos por el programa Sembrando Sonrisas, Comuna de Ovalle, año 2019. Materiales y Métodos: Estudio observacional, de corte transversal, realizado en niños(as) con examen clínico dental que asistían a establecimientos educacionales beneficiados por el programa Sembrando Sonrisas. La información fue solicitada a la Municipalidad de Ovalle mediante ley de transparencia, no teniendo control del levantamiento de los datos. Se abordó la prevalencia de niños(as) sin/con historias de caries según el índice dientes cariados-extraídos-obturados e intensidad del daño, relacionándolas con variables sociodemográficas. Resultados: De los n=4.201 niños(as) evaluados(as), el 62,8% no presentaba historia de caries, disminuyendo de 92,0% (2 años) a 48,9% (5 años) (P<0,001). No hubo diferencias según sexo (P≥0,159) pero fue significativamente menor en niños(as) de sectores urbanos (P≤0,048). Por tipo de establecimiento educacional, la prevalencia de niños(as) con historia de caries y la intensidad del daño fue siempre mayor en el sector rural, mientras que en el sector urbano los menores valores fueron registrados en colegios particulares subvencionados. Conclusiones: El estudio mostró mejoras importantes en la prevalencia de historia de caries, pero sigue evidenciando las desigualdades en acceso a la salud que están presentes en nuestra sociedad.

Objective: To evaluate the current oral health status of children aged 2 to 5 years in Ovalle, treated in the Sembrando Sonrisas program, year 2019. Materials and Methods: Observational, cross-sectional study, carried out in children with a clinical dental examination, who attended educational establishments benefiting from the Sembrando Sonrisas program. The information was requested from the Municipality of Ovalle through the transparency law, without control of the data collection. The prevalence of children with and without caries history according to the decayed, extracted, filled teeth index, and the intensity of the damage were addressed, relating them to sociodemographic variables. Results: A n=4,201 of children was evaluated, where 62.8% did not present a history of caries, decreasing from 92.0% (2 years) to 48.9% (5 years) (P<0.001). There were no differences between sexes (P≥0.159) but it was significantly lower in children from urban sectors (P≤0.048). By type of educational establishment, the prevalence of children with a history of caries and the intensity of the damage was always higher in the rural sector, while in the urban sector the lowest prevalence was registered in private subsidized schools. Conclusions: The study showed important improvements in the prevalence of this disease, but it also showed that inequalities in access to health are still present in our society.

Características de las tesis para titularse de médico: estudio transversal en Perú / Characteristics of theses for physician graduation: a cross-sectional study in Peru

Introducción La investigación en Perú presenta diversas barreras que impiden su desarrollo. Ello afecta también las tesis para graduarse de médico. Nuestro objetivo fue caracterizar las tesis para obtener el título de médico en Perú. Métodos Se realizó un estudio observacional y descriptivo de las tesis para obtener el título de médico del año 2019 en 22 universidades que son miembros titulares de la Asociación Peruana de Facultades de Medicina. La revisión se efectuó durante enero de 2022. Se evaluaron características de las universidades (región, régimen: pública/privada), y de las tesis, incluyendo el contar con la aprobación por un comité institucional de ética en investigación, si estuvieron alineadas con una prioridad de investigación nacional y si fueron publicadas en una revista científica. Los datos de cada tesis evaluada fueron extraídos en una ficha de recolección de datos para el posterior cálculo de frecuencias absolutas y relativas de las variables de estudio. Resultados Se evaluaron 1838 tesis. La mayoría de ellas fueron elaboradas por un único alumno (66,16%). El diseño de estudio más común fue el tipo transversal descriptivo (42,3%). El 53,86% de las tesis respondieron a una prioridad de investigación nacional, siendo la más estudiada "salud materna, perinatal y neonatal" (26,01%). Del total de tesis, el 56,75% no indicó si contó con la aprobación de un comité institucional de ética en investigación. Sólo 40 tesis (2,19%) se publicaron en una revista científica (14 en revistas indexadas). Conclusión Dos tercios de las tesis realizadas por estudiantes de medicina en Perú son estudios descriptivos. La mitad responde a prioridades nacionales de investigación. Cuatro de cada diez tesis informan sobre la aprobación por un comité institucional de ética en investigación. El número de las tesis publicadas es bajo. Los resultados muestran carencias de las políticas institucionales universitarias que estimulen al cumplimiento ético y desarrollo de la investigación.

Introduction Research in Peru presents several barriers that impede its development and that also affects the theses to graduate as physician. Our objective was to characterize the theses for obtaining a medical degree in Peru. Methods An observational and descriptive study evaluating the theses for obtaining a medical degree of 2019, evaluated in January 2022 from 22 universities that are full members of the Peruvian Association of Faculties of Medicine. Characteristics of the universities and theses were evaluated, including the evaluation of a institutional research ethics committee, the aligment with a national research priority, and publication status in a scientific journal. The absolute and relative frequencies of the study variables were described. Results A total of 1838 theses were evaluated. Most of the theses were written by a single student (66.16%). The most common study design was the descriptive cross-sectional type (42.33%). We found that 53.86% of the theses responded to a national research priority, the most common being "maternal, perinatal and neonatal health" (26.01%). Of the total, 56.75% did not indicate whether they had the approval of an institutional research ethics committee. Only 40 theses (2.19%) were published in a scientific journal (14 in indexed journals). Conclusion Two-thirds of the theses conducted by medical students in Peru are descriptive studies. Half respond to national research priorities. Four out of ten theses were approved by an institutional research ethics committee. The number of published theses is low. The results show shortcomings in university institutional policies that encourage ethical compliance and research development.

Most Cochrane systematic reviews and protocols did not adhere to the Cochrane's risk of bias 2.0 tool

SUMMARY OBJECTIVE: The aim of this study was to identify the frequency of Cochrane systematic reviews and Cochrane systematic reviews protocols using (or planning to use) the risk of bias 2.0 tool to assess the risk of bias of the included randomized clinical trials. STUDY DESIGN: This is a meta-research study. METHODS: We included Cochrane systematic reviews or Cochrane systematic reviews protocols that planned to include randomized clinical trials. We assessed the Cochrane Database of Systematic Reviews and screened for issues published after the launch of risk of bias 2.0 tool (2019-2022). Two independent investigators performed the study selection and data extraction. RESULTS: We analyzed 440 Cochrane systematic reviews and 536 Cochrane systematic reviews protocols. Overall, 4.8% of the Cochrane systematic reviews and 28.5% of the Cochrane systematic reviews protocols used or planned to use risk of bias 2.0 tool. Although low, adherence is increasing over time. In 2019, 0% of Cochrane systematic reviews used risk of bias 2.0 tool, compared to 24.1% in 2022. In Cochrane systematic reviews protocols, adherence increased from 6.9% in 2019 to 41.5% in 2022. A total of 274 (62.1%) Cochrane systematic reviews had their protocols published before 2018; only one used risk of bias 2.0 tool and reported the change of versions in the "Differences between protocol and revision" section. CONCLUSION: The Cochrane's risk of bias 2.0 tool has low adherence among Cochrane protocols and systematic reviews. Further efforts are necessary to facilitate the implementation of this new tool.

Crystalline lens decentration and tilt in eyes with different axial lengths and their associated factors

Purpose: To analyze crystalline lens decentration and tilt in eyes with different axial lengths (ALs) using a swept?source anterior segment optical coherence tomography (SS?AS?OCT). Methods: Patients with normal right eyes who visited our hospital between December 2020 and January 2021 were included in this cross?sectional study. Data on crystalline lens decentration and tilt, AL, aqueous depth (AD), central corneal thickness (CCT), lens thickness (LT), lens vault (LV), anterior chamber width (ACW), and angle ? were collected. Results: A total of 252 patients were included and divided into normal (n = 82), medium–long (n = 89), and long (n = 81) AL groups. The average age of these patients was 43.63 ± 17.02 years. The crystalline lens decentration (0.16 ± 0.08, 0.16 ± 0.09, and 0.20 ± 0.09 mm, P = 0.009) and tilt (4.58° ± 1.42°, 4.06° ± 1.32°, and 2.84° ± 1.19°, P < 0.001) were significantly different among the normal, medium, and long AL groups. Crystalline lens decentration was correlated with AL (r = 0.466, P = 0.004), AD (r = 0.358, P = 0.006), ACW (r = ?0.004, P = 0.020), LT (r = ?0.141, P = 0.013), and LV (r = ?0.371, P = 0.003). Crystalline lens tilt was correlated with age (r = 0.312, P < 0.001), AL (r = ?0.592, P < 0.001), AD (r = ?0.436, P < 0.001), ACW (r = ?0.018, P = 0.004), LT (r = 0.216, P = 0.001), and LV (r = 0.311, P = 0.003). Conclusion: Crystalline lens decentration was positively correlated with AL, and tilt was negatively correlated with AL

Guía práctica para el uso de clozapina en niños/as y adolescentes / Practical guidelines for the use of clozapine in children and adolescents

El uso de clozapina (CZP) en niños/as y adolescentes ha estado históricamente limitado, debido a los efectos adversos y riesgos médicos asociados al fármaco, a pesar de ser una herramienta farmacológica de gran efectividad en la psiquiatría general. A continuación, se presenta una guía clínica con los siguientes objetivos: 1) identificar los criterios de indicación de CZP en niños, niñas y adolescentes (NNA) según la evidencia disponible; 2) entregar algunas directrices a los clínicos y profesionales de salud respecto a la prescripción de CZP y precauciones a tener en consideración en esta población y; 3) entregar algunos datos comparativos del uso de CZP entre población infantojuvenil y población adulta. Todo lo anterior tiene como finalidad poder entregar la información necesaria para que los clínicos no limiten el uso de este fármaco y puedan prescribirlo de acuerdo con la evidencia científica disponible. Palabras clave: Clozapina, niños/as y adolescentes, esquizofrenia de inicio precoz, efectos adversos.

The use of clozapine (CZP) in children and adolescents has historically been limited due to the adverse effects and medical risks commonly associated with the drug, despite being a highly effective pharmacological tool in general psychiatry. Below we developed a clinical guideline with the following objectives: 1) identify the indication criteria for CZP in children and adolescents (NNA) according to the available evidence; 2) provide some guidelines to clinicians and health professionals regarding the prescription of CZP and precautions to be taken into account in this population and; 3) provide some comparative data on the use of CZP between the pediatric and adult population. The purpose of the guideline is to provide the necessary information so that clinicians do not limit the use of CLZ when needed and can prescribe it safely and according to the available scientific evidence. Key words: Clozapine, child, adolescent, early-onset, schizophrenia spectrum disorders, adverse events.

Formulation and evaluation of Buccal mucoadhesive tablets of diclofenac sodium using 23 factorial designs

Buccal tablets

Diclofenac sodium

Drug release

Mucoadhesion

Mucoadhesive tablets

Release kinetics

Estudios de corte transversal: un diseño de investigación a considerar en ciencias morfológicas / Cross section studies: a research design to consider in morphological sciences

Los estudios de corte transversal (ECT) inician en la década de los 40 en países Europeos. Los ECT corresponden a investigaciones de tipo observacional que permiten estudiar prevalencia de enfermedad, determinar asociación entre variables y el desarrollo de un efecto de interés, conocer propiedades de una prueba diagnóstica, y censar poblaciones; describiendo las características de una población en un momento y lugar determinado. Esto implica, que no se requieren periodos de seguimiento, que no son prospectivos ni retrospectivos; características que permiten que sean más baratos y fáciles de realizar en relación a los estudios longitudinales. Por otro lado, al ser de carácter descriptivo sirven como insumo y evidencia preliminar para estudios de mayor complejidad metodológica, como estudios de cohortes. Sin embargo, tienen limitantes y sesgos que deben ser considerados por los investigadores. El objetivo de este manuscrito fue generar un documento de estudio para revisar características esenciales, fortalezas y debilidades; discutir cuestiones metodológicas de los ECT en ciencias de la salud; y proporcionar algunos ejemplos obtenidos de la literatura, para mejor comprensión del diseño.

SUMMARY: Cross-sectional studies (CSS) began European countries in the 1940s in. The CSSs correspond to observational-type investigations that allow studying the prevalence of disease, determining the association between variables and the development of an effect of interest, discovering the properties of a diagnostic test, and censusing populations, describing the characteristics of a population at a given time and place. This implies that follow-up periods are not required, and that they are neither prospective nor retrospective. These characteristics allow them to be cheaper and easier to perform in relation to longitudinal studies. On the other hand, being descriptive in nature, they serve as input and preliminary evidence for studies of greater methodological complexity, such as cohort studies. However, they have limitations and biases that must be considered by researchers. The aim of this manuscript was to generate a study document to review essential characteristics, strengths and weaknesses; discuss methodological issues of ECT in health sciences; and provide some examples obtained from the literature, for a better understanding of the design.

Dilemas ético-legais da prática de enfermagem em emergências e desastres: protocolo de revisão de escopo / Ethical-legal dilemmas of nursing practice in emergencies and disasters: scoping review protocol

OBJETIVO: Mapear os dilemas éticos e legais relacionados à prática de Enfermagem em situações de emergências e desastres. MÉTODO: Protocolo conduzido a partir da metodologia Joanna Briggs Institute (JBI), com utilização da extensão do checklist PRISMA-ScR. A busca das fontes será realizada em bases de dados e portais de informação científica: LILACS, IBECS, BDENF, Elsevier, Embase e CINAHL, além de literatura cinzenta. A seleção ocorrerá por dois revisores, utilizando o software Rayyan. As discordâncias serão tratadas por um terceiro revisor. A extração e síntese dos dados serão norteadas por um formulário. Nesse sentido, serão operacionalizados os seguintes passos: identificação da questão de pesquisa; identificação dos estudos relevantes; seleção dos estudos; extração dos dados; separação, sumarização e relatório dos resultados; divulgação dos resultados. Os resultados finais serão apresentados em tabelas ou quadros com discussão narrativa. Registro da revisão no Open Science Framework: osf.io/zgpfw.

OBJECTIVE: To map the ethical and legal dilemmas related to nursing practice in emergencies and disasters situations. METHOD: Protocol conducted from JBI methodology, using the extension of the PRISMA-ScR checklist. The search for the sources will be carried out in databases and portals of scientific information: LILACS, IBECS, BDENF, Elsevier, Embase and CINAHL, in addition to gray literature. The selection will take place by two reviewers, using Rayyan software. Disagreements will be dealt with by a third reviewer. The data extraction and synthesis will be guided by a form. In this sense, the following steps will be operationalized: Identification of research question; identification of relevant studies; selection of studies; data extraction separation, summarization and results report; dissemination of results. The final results will be presented in tables and narrative discussion. Revision record in the Open Science Framework: osf.io/zgpfw.

LncRNA MCM3AP-AS1 serves as a competing endogenous RNA of miR-218 to upregulate GLUT1 in papillary thyroid carcinoma

ABSTRACT Objective: MCM3AP-AS1 has been characterized as an oncogenic long non-coding RNA (lncRNA) in several cancers including papillary thyroid cancer (PTC), but its role in PTC has not been fully elucidated. Considering the critical role of lncRNAs in cancer biology, further functional analysis of MCM3AP-AS1 in PTC may provide novel insights into PTC management. Subjects and methods: Paired tumor and non-tumor tissues were collected from 63 papillary thyroid carcinoma (PTC) patients. Expression levels of MCM3AP-AS1 , miR-218 and GLUT1 in tissue samples were analyzed by qRT-PCR. Cell transfection was performed to explore the interactions among MCM3AP-AS1 , miR-218 and GLUT1 . Cell proliferation assay was performed to evaluate the effects of MCM3AP-AS1 and miR-218 on cell proliferation. Results: MCM3AP-AS1 accumulated to high levels in PTC tissues and was affected by clinical stage. MCM3AP-AS1 showed a positive correlation with GLUT1 across PTC tissues. RNA interaction prediction showed that MCM3AP-AS1 could bind to miR-218 , which can directly target GLUT1 . MCM3AP-AS1 and miR-218 showed no regulatory role regulating the expression of each other, but overexpression of MCM3AP-AS1 upregulated GLUT1 and enhanced cell proliferation. In contrast, overexpression of miR-218 downregulated GLUT1 and attenuated cell proliferation. In addition, miR-218 suppressed the role of MCM3AP-AS1 in regulating the expression of GLUT1 and cell proliferation. Conclusions: MCM3AP-AS1 may serve as a competing endogenous RNA of miR-218 to upregulate GLUT1 in PTC, thereby promoting cell proliferation. The MCM3AP-AS1/miR-218/GLUT1 pathway characterized in the present study might serve as a potential target to treat PTC.

Uso y resultados del astegolimab en el manejo del asma severa: ¿qué se conoce?

El asma es una enfermedad inflamatoria crónica de las vías respiratorias que acarrea elevados costos en salud, afecta sustancialmente la calidad de vida y, dependiendo de ciertos factores de riesgo asociados, disminuye la capacidad funcional de quien lo padece. Para el 2019, el asma afectó a 262 millones de personas (4,3 % de la población mundial) y causó 461 000 muertes. Se estima que habrá 100 millones de personas adicionales con asma para el año 2025. El asma severa es un fenotipo resistente a corticoides que ocasiona mayor número de exacerbaciones, afecta sustancialmente la calidad de vida y capacidad funcional del afectado. Su manejo inicialmente se encamina a suprimir los síntomas, y este ha ido evolucionando hasta la comprensión, aún no completa, de los sistemas intrínsecos de su generación, con lo cual se han estudiado nuevas formas de incidir en su manejo, mediante la modulación de la respuesta inmune y la cascada inflamatoria, con la generación de medicamentos biológicos. A raíz del estudio e identificación de endotipos y fenotipos variados, se han diseñado este tipo de medicamentos, con distintos mecanismos de acción, que han demostrado una utilidad sólida en los últimos años. No obstante, existe evidencia de que se ha encontrado resistencia incluso a estos medicamentos, por lo que ha sido necesario seguir investigando nuevas dianas terapéuticas. El astegolimab es un novedoso anticuerpo monoclonal Ig G2 humano que bloquea la señalización de IL-33 al dirigirse a ST2, su receptor, por consiguiente, controla la respuesta inflamatoria en el asma severa. Actualmente, se encuentra en realización de ensayo clínico fase 2b, aunque experimentaciones previas han encontrado resultados positivos y significativos respecto a la inmunomodulación, función pulmonar, sintomatología y calidad de vida. En la actualidad, casi no existe literatura que haya analizado el potencial del astegolimab en el asma grave, y están disponibles prácticamente solo los ensayos que lo han evaluado y algunas revisiones que han compartido su farmacocinética y farmacodinamia. Sobre la base de lo anterior, el objetivo de esta revisión consiste en sintetizar evidencia relacionada con los resultados del uso del astegolimab en asma severa, discutiendo aspectos epidemiológicos y fisiopatológicos que resalten la necesidad del desarrollo de un fármaco seguro, eficaz y eficiente.

Asthma is a chronic inflammatory disease of the respiratory tract which causes high health costs, substantially affects the quality of life and, depending on certain associated risk factors, reduces the functional capacity of the sufferer. By 2019, asthma affected 262 million people (4.3 % of the world's population) and caused 461,000 deaths. It is estimated that there will be an additional 100 million people with asthma by 2025. Severe asthma is a phenotype resistant to corticosteroids which causes a greater number of exacerbations and substantially affects the quality of life and functional capacity of the affected person. Its management was initially aimed at suppressing the symptoms and then evolved to understand, although not completely, the intrinsic systems of its generation. Thus, new ways of influencing its management have been studied by modulating the immune response and the inflammatory cascade with the generation of biological drugs. As a result of the study and identification of various endotypes and phenotypes, drugs with different mechanisms of action have been designed and have demonstrated to be considerably useful in recent years. However, there is evidence that resistance even to these drugs has occurred, being necessary to continue researching new therapeutic targets. Astegolimab is a novel human IgG2 monoclonal antibody that blocks IL-33 signaling by targeting ST2, its receptor, thus controlling the inflammatory response in severe asthma. A phase 2b clinical trial is currently undergoing, although previous results have found positive and significant results regarding immunomodulation, pulmonary function, symptomatology and quality of life. At present, there is almost no literature that has analyzed the potential of astegolimab in severe asthma, and practically only trials that have evaluated it and some reviews that have shared its pharmacokinetics and pharmacodynamics are available. Based on the above, the aim of this review is to synthesize evidence related to the results of the use of astegolimab in severe asthma and discuss epidemiological and pathophysiological aspects that highlight the need for the development of a safe, effective and efficient drug.