Unveiling the dynamics of sexual crimes in Colombia based on complaints over a decade / Desvelando la dinámica de los delitos sexuales en Colombia a partir de las denuncias de más de una década / Revelando a dinâmica de crimes sexuais na Colômbia, com sede em reclamações ao longo de uma década

The aim of this article was to analyse the dynamics of sexual offense reports in Colombia over the period between 2010 and 2022. For this, a mixed methodology was applied in the following phases: first, the Colombian National Police registry ­which included 286 604 sexual crimes reported in the aforementioned period­ was analysed. Then, a causal loop diagram of System Dynamics was designed to highlight the role of reporting sexual crimes in the Colombian Penal System. The main findings of this article include that 85.73 % of the complaints are mostly associated with women and 68 % of the victims are minors or adolescents of both sexes. It must be noted that Colombian legislation divides these crimes into those that are aggravated by violence and those that are not. It was also found that when the victim was a woman, the crimes occurred in a higher proportion with the aggravating factor of violence. It can also be concluded that during the COVID-19 pandemic confinement, there was a decrease in the number of sexual offense reports due to its negative effect on the possibility of adult women reporting crimes. In addition, it was found that it is imperative to direct the criminal policies towards the general positive prevention of sexual crimes, without instrumentalising individuals, and aimed at completing a detailed follow-up of complaints.

El objetivo de este artículo fue analizar la dinámica de las denuncias por delitos sexuales en Colombia en el periodo comprendido entre 2010 y 2022. Para ello, se aplicó una metodología mixta en las siguientes fases: primero, se analizó el registro de la Policía Nacional de Colombia -que incluyó 286 604 delitos sexuales denunciados en el periodo mencionado-. Luego, se diseñó un diagrama de bucle causal de Dinámica de Sistemas para resaltar el papel de la denuncia de delitos sexuales en el Sistema Penal Colombiano. Entre los principales hallazgos de este artículo se destaca que el 85.73 % de las denuncias están asociadas mayoritariamente a mujeres y el 68 % de las víctimas son menores de edad o adolescentes de ambos sexos. Es de anotar que la legislación colombiana divide estos delitos en agravados por violencia y no agravados por violencia. También se encontró que cuando la víctima es mujer, los delitos se presentan en mayor proporción con el agravante de violencia. También se puede concluir que durante el encierro pandémico COVID-19, hubo una disminución en el número de denuncias de delitos sexuales debido a su efecto negativo en la posibilidad de que las mujeres adultas denuncien delitos. Además, se constató que es imperativo orientar las políticas criminales hacia la prevención general positiva de los delitos sexuales, sin instrumentalizar a los individuos, y dirigidas a completar un seguimiento detallado de las denuncias.

O objetivo deste artigo foi analisar a dinâmica das denúncias de crimes sexuais na Colômbia no período entre 2010 e 2022. Para isso, foi aplicada uma metodologia mista nas seguintes fases: primeiro, foi analisado o registro da Polícia Nacional da Colômbia, que incluía 286 604 crimes sexuais denunciados no período mencionado. Em seguida, foi elaborado um diagrama de loop causal do System Dynamics para destacar o papel da denúncia de crimes sexuais no sistema penal colombiano. As principais conclusões desse artigo incluem que 85.73 % das denúncias estão associadas principalmente a mulheres e 68 % das vítimas são menores ou adolescentes de ambos os sexos. Deve-se observar que a legislação colombiana divide esses crimes entre aqueles que são agravados pela violência e aqueles que não são. Também foi constatado que, quando a vítima era mulher, os crimes ocorreram em uma proporção maior com o agravante de violência. Também se pode concluir que, durante o confinamento da pandemia da COVID-19, houve uma diminuição no número de denúncias de crimes sexuais devido ao seu efeito negativo sobre a possibilidade de mulheres adultas denunciarem crimes. Além disso, constatou-se que é imprescindível direcionar as políticas criminais para a prevenção geral positiva dos crimes sexuais, sem instrumentalizar os indivíduos, e visando à conclusão de um acompanhamento detalhado das denúncias.

Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system / 中国药房

OBJECTIVE To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）. METHODS The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals. RESULTS There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc. CONCLUSIONS When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

Signal mining and analysis of adverse drug event signals of darolutamide / 中国药房

OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of darolutamide and provide a reference for its clinical safe use. METHODS ADEs related to darotamide were collected based on the US FDA adverse event reporting system （FAERS） database from the third quarter of 2019 to the third quarter of 2022. Data mining and analysis were conducted by the report odds ratio （ROR） and proportional reporting ratio （PRR） methods. RESULTS A total of 565 ADE reports related to darolutamide were extracted， 356 ADE reports about darolutamide as the primary suspected drug were included， 38 ADE signals with darolutamide as the primary suspected drug were excavated， involving 15 system organ class （SOC）， mainly concentrated in patients over 65 years old. The SOC of darotamide ADE signal mainly focused on various examinations， systemic diseases and various reactions at the administration site， benign/malignant tumors or those with unknown nature （including cystic and polypoid）， kidney and urinary system diseases. A total of 13 ADE signals not mentioned in the instructions included increased prostate-specific antigen， dysphagia， cognitive impairment， erectile dysfunction， rhabdomyolysis， gynecomastia and decreased platelet count， etc. CONCLUSIONS When using darolutamide， in addition to ADE in the drug instruction， we should pay close attention to potential ADE， such as increased prostate-specific antigen， rhabdomyolysis， gynecomastia and decreased platelet count， so as to avoid drug withdrawal or organ damage caused by ADE.

Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework / 中国实验方剂学杂志

ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine（CPM） based on Evidence and Value：Impact on DEcisionMaking（EVIDEM） framework， so as to promote the scientific， systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review， semi-structured interview and Delphi method， and the weights of each index were clarified by analytic hierarchy process（AHP）. ResultThe recovery rates of both rounds of expert consultation were 100%， and the authority coefficient of experts was 0.90 and 0.905， respectively. Kendall's coordination coefficients（W） of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283（P<0.001）， and in the second round were 0.411 and 0.351， respectively（P<0.001）. The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators， 13 second-level indicators and 28 third-level indicators. Among the first-level indicators， the weights of effectiveness， safety， economy， innovation， suitability and accessibility were 37.34%， 32.68%， 11.85%， 5.87%， 5.79% and 6.47%， respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM， and the domain and criteria are introduced and interpreted in detail， which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM， but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine （Part 7）： Introduction and Interpretation of the Guideline Reporting Checklist / 中医杂志

The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines （CPMs）， thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear， complete and transparent reporting of the whole process of developing CPMs guidelines， containing 4 domains， 17 topics and 43 items， and involving the basic information， recommendations and methods of guideline development. Especially， it details the items related to the rules and regulations of the use of CPMs in the recommendations， which is helpful for improving the completeness， scientificity and practicality of the reporting of CPMs guideline.

Profile and characteristics of violence against older adults during the COVID-19 pandemic / Perfil e características da violência contra a pessoa idosa durante a pandemia COVID-19 / Perfil y características de la violencia contra los adultos mayores durante la pandemia de COVID-19

Abstract Objective: to identify the sociodemographic profile and the characteristics of interpersonal violence against older adults during the first year of the COVID-19 pandemic in a capital city from the Brazilian Southeast region. Method: a descriptive and exploratory research study with a cross-sectional design based on the notifications of suspected or confirmed cases of violence against older adults between March 2020 and March 2021. A univariate statistical analysis and Fisher's exact test (p<0.05) were performed. Results: a total of 2,681 notifications were recorded during the period. The main victims were individuals aged between 60 and 64 years old, female, white-skinned and with low schooling levels. The instances of violence were more frequent in the victims' homes. Physical and psychological violence predominated, through physical force/beatings and threats, respectively. Most of the aggressors were male, younger than the victims and generally their children or intimate partners. The aggressions were perpetrated more than once and were driven by generational conflicts. There was low referral to entities for the protection of older adults. Conclusion: the sociodemographic profile found evidences vulnerable victims, subjected to many types of violence, and at a potential risk against their overall health.

Resumo Objetivo: identificar o perfil sociodemográfico e as características da violência interpessoal contra a pessoa idosa no primeiro ano da pandemia COVID-19 em uma capital da região sudeste do Brasil. Método: pesquisa descritiva, exploratória, com delineamento transversal a partir da análise das notificações de casos suspeitos ou confirmados de violência contra a pessoa idosa, ocorridas entre março de 2020 e março de 2021. Foi realizada a análise estatística univariada e teste exato de Fisher (p<0,05). Resultados: houve 2681 notificações no período. As principais vítimas foram pessoas com idade entre 60 e 64 anos, do sexo feminino, brancas e com baixa escolaridade. As ocorrências tiveram maior frequência nos domicílios. As violências físicas e psicológicas foram as mais comuns, com uso de força física/espancamento e ameaça, respectivamente. O agressor era, em sua maioria, do sexo masculino, mais jovem do que a vítima, geralmente filho ou parceiro íntimo. As agressões ocorreram mais de uma vez e foram motivadas por conflitos geracionais. Houve baixo encaminhamento para órgãos de proteção a pessoa idosa. Conclusão: o perfil sociodemográfico encontrado evidencia vítimas vulneráveis, sujeitas a muitas formas de violência e com potenciais riscos à integralidade de sua saúde.

Resumen Objetivo: identificar el perfil sociodemográfico y las características de la violencia interpersonal contra los adultos mayores en el primer año de la pandemia de COVID-19 en una ciudad capital de la región sureste de Brasil. Método: investigación descriptiva, exploratoria con diseño transversal a partir del análisis de las notificaciones de casos sospechosos o confirmados de violencia contra el adulto mayor, ocurridos entre marzo de 2020 y marzo de 2021. Se realizó un análisis estadístico univariado y la prueba exacta de Fisher (p< 0,05). Resultados: hubo 2681 notificaciones en el período. Las principales víctimas fueron personas entre 60 y 64 años, de sexo femenino, blancas y con baja escolaridad. La mayoría de los casos se registró en el hogar. La violencia física y psicológica fueron las más comunes, con uso de fuerza física/golpes y amenaza, respectivamente. El agresor era generalmente del sexo masculino, más joven que la víctima, hijo o pareja. Las agresiones se produjeron más de una vez y fueron motivadas por conflictos generacionales. Hubo baja derivación a organismos de protección de adultos mayores. Conclusión: el perfil sociodemográfico obtenido revela que son víctimas vulnerables, sujetas a múltiples formas de violencia y que la integridad de su salud está en riesgo potencial.

The use of citizen information in criminal investigation through a collaborative technological innovation process to counteract theft from the person in Bogotá / El uso de la información ciudadana en la investigación criminal mediante un proceso de innovación tecnológico colaborativo para contrarrestar el hurto a personas en Bogotá / O uso da informação dos cidadãos na investigação criminal através de um processo colaborativo de inovação tecnológica para combater o roubode pessoas em Bogotá

Theft from the person is one of the highest impact crimes in Bogotá, with a national share of approximately 38 %. This crime brought to the attention of the authorities is referred to by academics as recorded or reported crime and is used by the police for different purposes, particularly for criminal investigation, but with inefficient results in the identification of perpetrators. Therefore, the type of research is qualitative and has the objective of linking the citizen through a process of collaborative technological innovation, with the purpose of collecting, processing and analysing reported or non-reported information (hidden crime) in a timely, anonymous and efficient manner with disruptive technologies prioritized for the project.The methodology used begins with the discovery stage by identifying key actors and building user stories. Then, in the understanding stage, the value proposition is put forth by means of a hypothesis that is validated in a process of experimentation, and finally, in the build stage, a technology watch analysis is carried out and the proposal for the collaborative system between the citizen and the police with a technological approach is put forward. The results are based on the identification and prioritization of five technologies, two actors, three variables and application of six low and medium fidelity prototypes, as well as the acceptance of citizens in collecting and sharing timely information at 87 %; that information focuses on video, audio, photos and localization at 55 %.On the other hand, with the entry into operation of the collaborative system, the researchers indicate that it would optimise investigation by 50 % through the timely identification of the perpetrators. As for the conclusion, the information analyzed and obtained from the results allows to reach, in a first phase, validation of the established hypothesis, but at the same time recognising the importance of including methodologies such as System Dynamics that allow for the systemic analysis of the information established by other actors and its impact on the proposed collaborative system.The use of citizen information in criminal investigation through a collaborative technological innovation process to counteract theft from the person in Bogotá

El hurto a personas es uno de los delitos de mayor impacto en temas de seguridad para Bogotá con una participación a nivel nacional del 38 % aproximadamente. Este delito puesto en conocimiento de las autoridades es denominado por académicos como criminalidad registrada o denunciada y es utilizada por la institución policial para diferentes fines, en especial para la investigación criminal, pero con resultados poco eficientes en la identificación de victimarios. Por lo tanto, el tipo de investigación es cualitativa y tiene como objetivo vincular al ciudadano mediante un proceso de innovación tecnológico colaborativo, con el propósito de recolectar, tratar y analizar información denunciada y no denunciada (criminalidad oculta) de manera oportuna, anónima y eficiente con tecnologías disruptivas priorizadas para el proyecto. La metodología empleada inicia con la etapa de descubrir mediante la identificación de actores claves y la construcción de historias de usuario. Luego, en la etapa comprender se plantea la propuesta de valor mediante una hipótesis que se valida en un proceso de experimentación, y por último en la etapa construir, se realiza un análisis de vigilancia tecnológica y se plantea la propuesta del sistema colaborativo entre el ciudadano y la policía con enfoque tecnológico. Los resultados se basan en la identificación y priorización de cinco tecnologías, dos actores, tres variables y aplicación de seis prototipos de baja y mediana fidelidad, así como la aceptación de la ciudadanía en recolectar y compartir información oportuna en un87 %, esa información se centra en videos, audios, fotos y localización con un 55 %. Por otro lado, con la entrada en funcionamiento del sistema colaborativo, los investigadores indican que optimizaría la investigación en un 50 % mediante la identificación oportuna de los victimarios. En cuanto a la conclusión, la información analizada y obtenida de los resultados, permite llegar en una primera fase, a validar la hipótesis establecida, pero a la vez, la importancia de incluir metodologías como la Dinámica de Sistemas que permita el análisis sistémico de la información establecida por otros actores y su impacto en el sistema colaborativo propuesto.

O roubo de pessoas é um dos crimes de maior impacto nas questões de segurança de Bogotá, com uma participação nacional de aproximadamente 38 %. Este crime levado ao conhecimento das autoridades é denominado pelos acadêmicos como crime registrado ou denunciado e é utilizado pela instituição policial para diversos fins, principalmente para investigação criminal, mas com resultados ineficientes na identificação dos autores. Portanto, o tipo de pesquisa é qualitativo e visa vincular os cidadãos por meio de um processo colaborativo de inovação tecnológica, com o objetivo de coletar, tratar e analisar informações denunciadas e não denunciadas (crimes ocultos) de maneira oportuna, anônima e eficiente, priorizando tecnologias disruptivas. para o projeto. A metodologia utilizada começa com a fase de descoberta, identificando os principais atores e construindo histórias de usuários. Depois, na fase de compreensão, é proposta a proposta de valor através de uma hipótese que é validada num processo de experimentação e, finalmente, na fase de construção, é realizada uma análise de vigilância tecnológica e é proposta a proposta de um sistema colaborativo entre cidadãos. e a polícia com foco tecnológico. Os resultados baseiam-se na identificação e priorização de cinco tecnologias, dois atores, três variáveis e aplicação de seis protótipos de baixa e média fidelidade, bem como na aceitação dos cidadãos na recolha e partilha de informação atempada em 87 %, esta informação centra-se em vídeos, áudios, fotos e localização com 55 %. Por outro lado, com a entrada em funcionamento do sistema colaborativo, os investigadores indicam que otimizaria a investigação em 50 % através da identificação atempada dos autores. Quanto à conclusão, a informação analisada e obtida a partir dos resultados permite-nos chegar numa primeira fase à validação da hipótese estabelecida, mas ao mesmo tempo, a importância de incluir metodologias como a Dinâmica de Sistemas que permite a análise sistémica da informação estabelecida por outros atores e seu impacto no sistema colaborativo proposto.

Risk of bias in dentistry-related randomized controlled trials in spanish language journals

Objectives: To assess the risk of bias (RoB) of randomized controlled trials (RCTs) published in dental journals in the Spanish language. Methods: A systematic retrospective survey was conducted of all RCTs published from 1980 to 2019 in dentistry Spanish and Latin American journals. We extracted data and performed RoB assessments using the Cochrane Risk of Bias tool. Results: 292 RCTs published in 51 journals were included. The best-rated domains were incomplete outcome data, selective reporting, and other biases. The domains assessed with higher proportions of an unclear or high risk of bias were sequence generation, allocation concealment, and blinding of outcome assessment. There is a low proportion of RCTs published in Spanish language journals. However, the number has been increasing over the years, and the low risk of bias assessment rates across domains show an increasing trend. Conclusions: A low percentage of Spanish-language dental journals issue RCTs. Our assessment of these RCTs' RoB suggests higher difficulties in the design and conduction phase than in the posterior reporting stage.

As práticas profissionais realizadas em situações de maus-tratos infantis: uma revisão integrativa / Professional practices in situations of child abuse: an integrative review

Resumo A violência infantil é um problema que afeta crianças no mundo todo. O presente estudo objetiva identificar e analisar os principais resultados apresentados em artigos publicados no Brasil sobre as práticas profissionais desenvolvidas em situações de maus-tratos infantis. Para tanto, realizou-se uma revisão integrativa da literatura, com buscas nas bases de dados Google Acadêmico, no SciELO Brasil, nos Periódicos da Coordenação de Aperfeiçoamento de Pessoal de Nível Superior do Ministério da Educação (CAPES/MEC), no MEDLARS ONLINE (Medline), na Biblioteca Virtual em Saúde (BVS Saúde) e nos Periódicos Eletrônicos em Psicologia (Pepsic), abrangendo publicações de 2017 a 2022. Após a leitura dos títulos e resumos, 24 artigos foram selecionados para a análise. Os resultados apontam a dificuldade na proteção integral da criança devido à deficiência na formação do profissional, que influencia na identificação e notificação do abuso infantil. O presente estudo revela o lugar que os maus-tratos infantis ocupam na formação dos profissionais e subsidia pesquisas futuras sobre práticas profissionais para o enfrentamento da violência infantil.

Abstract Child abuse is a problem that affects children all over the world. The present study therefore aimed to identify and analyze the main findings relating to professional practices for dealing with situations of child maltreatment in articles published in Brazil. To this end, we conducted an integrative literature review of articles published between 2017 and 2022 based on searches of the following databases: Google Scholar, SciELO Brasil, the periodicals database of the Agency for the Improvement of Higher Education Personnel (CAPES), MEDLINE, the Virtual Health Library, and Electronic Journals in Psychology (PePSIC). A total of 24 publications were selected for the review after screening the titles and abstracts. The findings reveal several challenges to ensuring the protection of children caused by shortcomings in professional training, which have a negative influence on the identification and reporting of child maltreatment. The present study reveals the lack of priority given to the issue of child maltreatment in professional training and provides important inputs to inform future research on professional practices for dealing with child violence.

Knowledge, attitudes, and experiences of a group of turkish dentists regarding child abuse / Conocimientos, actitudes y experiencias de un grupo de dentistas turcos en relación con el abuso infantil

Child abuse is a universal problem with critical lifelong effects. This study aimed to evaluate knowledge, attitudes, experiences of dentists regarding child abuse and to increase relevant awareness of them. A self-administered questionnaire with 48 questions about dentists' personal and educational information and their level of knowledge, attitudes, experiences on child abuse was implemented. Out of targeted 305 participants, 183 (60.0%) returned completely filled out questionnaires. Majority of participants knew signs and symptoms of child abuse. Of the participants, more than half were well-informed on what to do, however, one quarter had no knowledge about where to report in case of child abuse. In identifying child abuse, 39.3% of the participants found themselves inadequate. The most commonly stated reason for low rate of reporting was hesitancy to identify the case as abuse, and all participants needed more training. Only 12 (6.6%) participants suspected a case of child abuse. Dentists who had children and were long-time experienced and generalist did not have sufficient knowledge about legal obligations, signs and symptoms of child abuse (p<0.05). Arrangements and training programs to increase knowledge, awareness, and responsibility levels of dentists about child abuse appear to be a critically important topic.

El abuso infantil es un problema universal con efectos críticos de por vida. Este estudio tuvo como objetivo evaluar el conocimiento, las actitudes y las experiencias de los dentistas con respecto el abuso infantil y aumentar la conciencia relevante sobre ellos. Se implementó un cuestionario autoadministrado con 48 preguntas sobre información personal y educativa de los odontólogos y su nivel de conocimientos, actitudes, experiencias sobre el abuso infantil. De los 305 participantes seleccionados, 183 (60.0%) devolvieron los cuestionarios completos. La mayoría de los participantes conocían los signos y síntomas del abuso infantil. De los participantes, más de la mitad estaban bien informados sobre qué hacer, sin embargo, una cuarta parte no sabía dónde denunciar en caso de abuso infantil. Al identificar el abuso infantil, el 39.3% de los participantes se encontraron inadecuados. La razón más común para la baja tasa de informes fue la vacilación para identificar el caso como abuso, y todos los participantes necesitaban más capacitación. Solo 12 (6.6%) participantes sospecharon un caso de abuso infantil. Los odontólogos que tenían hijos y eran de larga experiencia y generalistas no tenían suficiente conocimiento sobre las obligaciones legales, signos y síntomas de abuso infantil (p<0,05). Los arreglos y los programas de capacitación para aumentar los niveles de conocimiento, conciencia y responsabilidad de los dentistas sobre el abuso infantil parecen ser un tema de importancia crítica.

A study on the knowledge, attitude, and practice on adverse drug reactions and pharmacovigilance among nursing staff

Background: Lack of knowledge of pharmacovigilance and underreporting of adverse drug reaction (ADR) are worldwide problems of big concern. Gross underreporting of ADR in India led to increased hospital admissions, increase in length of hospital stay, and increase in healthcare cost burden. Aims and Objectives: This study was planned to assess knowledge, attitude, and practice on ADR and pharmacovigilance among nursing staff in Gandhi Medical College and Associated Hospitals, Bhopal Madhya Pradesh. Materials and Methods: A questionnaire-based, cross-sectional, and observational study was conducted among nursing staff in a tertiary care Centre. Data were collected in the form of a validated questionnaire comprised of 17 questions regarding knowledge, attitude, and practice of nursing staff toward ADR and Pharmacovigilance. Data were analysis by descriptive statistics and result was computed. Results: Around 33% of respondents were aware of Pharmacovigilance program of India and 99% of them had knowledge about main objective of pharmacovigilance. Out of total filled questionnaire received, only 12% nurses practiced reporting ADR. The major factor discouraging participants from reporting ADR was lack of time to report. The majority of nursing staff had a positive attitude toward awareness of pharmacovigilance and ADR reporting. Conclusion: Our study has shown that there is lack of correct knowledge regarding ADR reporting and pharmacovigilance among staff nurses. Although, the attitude toward ADR reporting was adequate, the actual practice of ADR reporting is unsatisfactory. Hence, it is essential to train staff nurses regarding pharmacovigilance and ADR reporting

Reporting of conflict of interests, source of funding, and ethics committee approval in randomized trials of three clinical specialties published in Spanish language

Background: Confidence in the results reported by randomized clinical trials (RCTs) depends mainly on the internal validity of the trial and its conduct, but also on other aspects related to health research such as the complete reporting of conflicts of interest (COI), funding sources and approval by ethics committees. Bias in the study results may arise from any one of these elements. Prior studies have explored the reporting of these items in the medical literature, but there are no reports on RCTs published in Spanish and Latin American journals. This study aimed to evaluate the reporting of COIs, funding sources, and approval by ethics committees of RCTs published in Spanish and Latin American journals in dentistry, geriatrics and neurology. Methods: We did a systematic retrospective survey of all RCTs published from 1990 to 2018 in dentistry, neurology, and geriatrics journals published in Spain and Latin America and included in the BADERI database (Iberoamerican journals and trials database by its initials in Spanish). We completed with hand searching. We included RCTs with a recoverable full text published between 1990 and 2018. We extracted data on sources of funding, COI statements, and ethics reviews. The extraction of these items in the RCTs included was done independently by two pairs of reviewers and in parallel for each article, with a third independent reviewer resolving discrepancies. We analysed compliance for each item. Results: We identified RCTs in 69 journals from Spain and Latin American countries. Dentistry accounted for 75% (n = 52) of the journals, neurology 20.6% (n = 14), and geriatrics 4.4% (n = 3). Of the total number of RCTs included in this study (n = 392), only 102 (26%) reported the presence or absence of a COI, 103 (26%) studies reported funding, and 43 (36%) included the ethics committee approval. Conclusions: RCTs published in the Spanish language in dentistry, neurology, and geriatrics had poor compliance with the reporting of a COI, source of funding, and ethics committee approval. Future research should evaluate the accuracy and completeness of COI statements and their relationship to the funding source and direction of the results.

Leishmaniasis cutánea en Colombia: una mirada epidemiológica / Cutaneous leishmaniasis in Colombia: an epidemiological overview

La leishmaniasis resulta una enfermedad infectocontagiosa causada por un protozoo del género Leishmania. Esta constituye un problema de salud importante para diversas regiones de América Latina. El aislamiento social impuesta a raíz de la pandemia de COVID-19 favoreció que disminuyera la incidencia de esta entidad, pero las actividades sociales de la normalidad se retomaron paulatinamente, imponiéndose que se retomen las medidas de seguimiento y control correspondientes.

Leishmaniasis is an infectious disease caused by a protozoan of the genus Leishmania. Leishma-niasis constitutes a significant health problem for various regions of Latin America. The social isolation imposed because of the COVID-19 pandemic favored a decrease in the incidence of this entity. However, regular social activities were gradually resumed, imposing the correspon-ding monitoring and control measures.

Signal mining of valproic acid-induced adverse drug events based on FAERS / 中国药房

OBJECTIVE To provide reference for clinically safe and rational drug use through mining and analyzing adverse drug event （AE） signals induced by valproic acid （VPA）. METHODS Reporting Odds Ratio （ROR） and Bayesian Confidence Propagation Neural Network （BCPNN） methods of Measures of Disproportionality were performed to mine and analyze the data of VPA-related AE reports in the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2013 to the fourth quarter of 2022. RESULTS A total of 1 253 （ROR） and 1 109 （BCPNN） valid signals of preferred terms （PT） were obtained after data processing by the two analysis methods， involving 27 system organs （SOC）， mainly focusing on nervous system disorders， psychiatric disorders， general disorders and administration site conditions. Signals that did not appear in the instruction were associated with 2 SOCs： ear and labyrinth disorders， infections and infestations. CONCLUSIONS As a first-line broad-spectrum anti-epileptic drug， attention should also be paid to eye toxicity and infection risk in the clinical application in addition to paying attention to common adverse events in the instruction.

Risk signal mining of ixazomib based on the database of FAERS / 中国药房

OBJECTIVE To explore the risk signal of ixazomib and provide a reference for clinically rational drug use. METHODS The Open Vigil 2.1 online tool was used to extract the data of adverse drug events （ADE） reported by the database of FDA adverse event reporting system （FAERS） from the launch of ixazomib in America （November 20th， 2015） to the latest update of the Open Vigil website （March 31st， 2023）. The data were mined by using the proportional reporting ratio （PRR） and Bayesian confidence propagation neural network （BCPNN） of the proportional imbalance method. The signals were coded by system organ class （SOC） and preferred term （PT） according to MedDRA v25.1. RESULTS A total of 13 841 ADE reports with ixazomib as the “primary subject” were extracted， involving slightly more male patients （49.53%）， and most of them were 65 years old and above （72.48%）； the reports came from 57 countries/regions， mainly America （52.90%）. A total of 186 positive signals were excavated， with 51 high-intensity， 99 medium-intensity， and 36 low-intensity signals， involving 19 SOCs. The top 50 PT in frequency and signal intensity of PRR included neuropathy peripheral （414 cases， high-intensity signal）， platelet count decreased （379 cases， high-intensity signal）， thrombocytopenia （360 cases， high-intensity signal）， cytopenia （75 cases， high-intensity signal） and neurological symptoms （41 cases， high-intensity signal）. SOC involved included nervous system disorders， investigations， and blood and lymphatic system disorders. ADE occurred most frequently in gastrointestinal diseases （2 588 cases）， including diarrhea （1 077 cases， high-intensity signal）， nausea （737 cases， medium-intensity signal）， vomiting （459 cases， medium-intensity signal）， constipation （275 cases， medium-intensity signal）， and so on. The positive signals of infections and infestations contained the largest number of PTs， and most of them were not recorded in the drug instruction， including 12 high-intensity signals （1 030 cases） and 30 medium-intensity signals （627 cases）， which were mainly distributed in lung infection， upper respiratory infection， gastrointestinal infection， sepsis， herpes zoster and so on. The signals of cardiac amyloidosis （7 cases， high-intensity signal） and acute coronary syndrome （14 cases， high-intensity signal） of cardiac disorders and renal dysfunction （91 cases， medium-intensity signal） of renal and urinary disorders were all strong and had not been recorded in the drug instruction. CONCLUSIONS In addition to routine attention to the common ADE of ixazomib in gastrointestinal diseases，nervous system disorders and blood and lymphatic system disorders， clinical attention should also be paid to various infections that may occur during the treatment of patients， and the occurrence of cardiovascular toxicity and renal dysfunction should be monitored.

Mining and analysis of adverse drug events signals of nilotinib based on FDA adverse event database / 中国药房

OBJECTIVE To provide a reference for safe drug use in clinic. METHODS ADE reports related to nilotinib from the first quarter of 2007 to the fourth quarter of 2022 were collected from the US FDA adverse event reporting system database. The reporting odds ratio （ROR） and proportional reporting ratio （PRR） of disproportionality measures were used to mine potential ADE signals，which were compared with drug instruction and related case report， and were screened and analyzed according to the designated medical events （DME） list formulated by the European Medicines Agency. RESULTS Totally 23 332 cases of ADE with nilotinib as the primary suspected drug were reported. A total of 359 positive signals were obtained，involving 24 system organ classes （SOC），mainly concentrated in various examinations，heart organ diseases，vascular and lymphatic diseases，all kinds of nervous system diseases，etc. Among them，ADEs such as vertebral artery stenosis，coronary artery stenosis，arterial disease，liver infection and the second primary malignant tumor were not mentioned in the instructions. Seven DMEs were detected，of which bone marrow failure，pulmonary hypertension and deafness were not mentioned in the drug instruction. CONCLUSIONS The common ADE signals of nilotinib excavated in this study are consistent with the instructions. In clinical use，special attention should be paid to DME not mentioned in the instructions such as bone marrow failure，pulmonary hypertension and deafness； cardiac function， blood glucose and blood lipid indexes should be monitored closely.

Safety of human papilloma virus vaccine based on Vaccine Adverse Event Reporting System from 2006 to 2021 / 中国生物制品学杂志

@#Objective To investigate the characteristics of distribution of adverse event(AE)associated with human papillomavirus(HPV)vaccine by analysis of data on AE collected from the Vaccine Adverse Event Reporting System(VAERS).Methods The data on AE reported in VAERS from January 1st,2006 to December 31st,2021 were analyzed and compared by using Pearson Chi-square test and Mann-Whitney U test.Results A total of 53 571 cases of AE were included in the study,in which the ratio of male to female was 0. 25∶1,and the median age of vaccinees was 15 years. A portion of 36. 1%of AE occurred after the first dose,while 90. 7% occurred within 3 d after vaccination. Both the gender ratios(χ~2=72. 570,P < 0. 001) and the median ages(Z = 4. 255,P < 0. 001)of vaccinees in non-serious and serious adverse event(SAE)showed significant difference. In terms of classification of SAE,hospitalization,prolonged hospitalization and disability were more common in females than in males,of which the percentages decreased with the increasing age. Among the AE,syncope was the most common clinical symptom. In the SAE,the highest proportion of deaths was caused by HPV2 vaccine,which was 19. 0%. The proportion of prolonged hospitalization caused by HPV4 vaccine was higher than that by HPV9vaccine. In general,HPV4 vaccine was more prone to cause SAE than HPV9 vaccine(χ~2=183. 267,P < 0. 001).Conclusion In all the AE,the largest proportion occurred in the age group of 9 ～ 17 years,followed by those in the groups of 18 ～ 26 and 27 ～ 45 years. Most of the AE occurred after the first dose. The clinical symptoms of AE caused by three vaccines were different. The analysis of distribution characteristics of AE may provide a reference for the study on clinical safety of HPV vaccine and optimization of vaccination.

Mining and analysis of ADE signals of romiplostim and eltrombopag based on FAERS database / 中国药房

OBJECTIVE To provide a reference for the safe use of thrombopoietin receptor agonists romiplostim and eltrombopag in clinic. METHODS FDA adverse event reporting system （FAERS） in the United States was adopted to collect adverse drug event （ADE） reports of romiplostim and eltrombopag from their launch in the United States to September 30， 2022； the ADE signals of the two drugs were analyzed using the reporting odds ratio （ROR） method and the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency. RESULTS A total of 14 021 and 4 431 ADE reports were collected about romiplostim and eltrombopag， respectively， with a gender composition of more females than males. After signal screening， 563 ADE signals were obtained about romiplostim， involving 25 system organ classes （SOC）； eltrombopag had 433 ADE signals， involving 26 SOC. The most frequently reported ADE for both drugs was platelet count decreased （2 060， 1 585 cases）， which was mentioned in their drug instructions. In terms of signal intensity， romiplostim exhibited the highest signal for abnormal thrombopoietin levels （ROR of 2 268.85）， while eltrombopag had the highest signal for positive dengue virus test （ROR of 954.50）， with neither of these signals mentioned in their respective drug instructions. CONCLUSIONS The ADE of romiplostim and eltrombopag mainly affects the blood and lymphatic system， and there are many new suspicious high-risk signals.

Research progress of just culture in medical institutions / 中华医院管理杂志

As a safety culture placed between a culture of punishment and that of exemption, just culture can effectively improve the reporting rate of medical adverse events, promote medical staff to learn from events, and continuously improve patient safety management. The authors searched for literature on the study of just culture in medical institutions both domestically and internationally, including such databases as CNKI, Wanfang Data, and PubMed from 2001 to January 2023. They reviewed the concept of just culture and its connotation in the field of patient safety management, as well as the current research status of just culture in medical institutions both domestically and internationally. On such basis, they proposed for the construction of just culture in medical institutions in China, for reference in the construction and evaluation of a just culture in such institutions.

Safety of interferon β-1a for treatment of COVID-19： a real-world study based on FAERS database / 上海预防医学

ObjectiveTo systematically evaluate the safety of interferon β-1a for treatment of corona virus disease 2019 （COVID-19）， and to provide references for interferon β-1a's clinical application. MethodsThis study was conducted with the database from US Food and Drug Administration adverse event reporting system （FAERS） from January 1， 2015 to March 31， 2021. Information component （IC） and reporting odds ratio （ROR） methods were applied for signal mining. ResultsA total of 463 700 records of COVID-19 were selected for analysis， and 45 positive drug adverse event signals were detected. Headache （IC025=1.09， ROR025=2.28）， pyrexia （IC025=0.51， ROR025=1.51） and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events with higher frequency. Autoimmune disorder （IC025=4.42， ROR025=24.03）， streptococcal infection （IC025=4.12， ROR025=19.82）， and multiple sclerosis relapse （IC025=3.67， ROR025=14.71） were positive adverse events. Acute lung injury， cardio-respiratory arrest and metabolic acidosis were associated with a higher proportion and frequency of death. ConclusionThere are certain safety issues with interferon β-1a in the treatment of COVID-19， and some adverse events with high frequency and high death rate deserve further attention by medical staffs.