Eventos adversos em crianças submetidas a cirurgias orofaciais / Adverse events in children submitted to orofacial surgery / Eventos adversos en niños sometidos a cirugía orofacial

Objetivo: Identificar os eventos adversos no pós-operatório imediato de queiloplastia e/ou palatoplastia em crianças e comparar os eventos identificados aos notificados ao Núcleo de Segurança do Paciente. Métodos: Estudo descritivo, retrospectivo e quantitativo, realizado em um hospital público e terciário brasileiro. Os dados foram coletados por meio da descrição nos registros de enfermagem e comparados aos notificados ao Núcleo de Segurança do Paciente, referente a junho e dezembro de 2019. Os resultados foram submetidos a análise estatística descritiva. Resultados: A amostra constou de 203 crianças, das quais 51% (n=103) apresentaram evento adverso. Foram identificados 176 eventos adversos, de 8 tipos, com prevalência da laringite pós-extubação (n=50; 28%), edema de língua (n=34; 19%) e lesão de comissura labial (n=25; 14%). Destes, apenas 5% (n=9) foram notificados ao Núcleo de Segurança do Paciente. Conclusão: Os eventos adversos prevalentes se relacionaram a cavidade oral e tecidos adjacentes, e a subnotificação foi expressiva. (AU)

Objective: To identify adverse events in the immediate postoperative period of cheiloplasty and/or palatoplasty in children and compare the identified events to those notified to the Patient Safety Center. Methods: Descriptive, retrospective and quantitative study, carried out in a Brazilian public and tertiary hospital. Data were collected through descriptions in nursing records and compared to those notified to the Patient Safety Center, referring to June and December 2019. The results were subjected to descriptive statistical analysis. Results: The sample consisted of 203 children, of which 51% (n=103) had an adverse event. A total of 176 adverse events of 8 types were identified, with prevalence of post-extubation laryngitis (n=50; 28%), tongue edema (n=34; 19%) and labral commissure lesion (n=25; 14%). Of these, only 5% (n=9) were notified to the Patient Safety Center. Conclusion: The prevalent adverse events were related to the oral cavity and adjacent tissues, and underreporting was significant. (AU)

Objetivo: Identificar eventos adversos en el postoperatorio inmediato de queiloplastia y/o palatoplastia en niños y comparar los eventos identificados con los notificados al Centro de Seguridad del Paciente. Métodos: Estudio descriptivo, retrospectivo y cuantitativo, realizado en un hospital público y terciario brasileño. Los datos se recolectaron mediante descripciones en registros de enfermería y se compararon con los notificados al Centro de Seguridad del Paciente, referidos a junio y diciembre de 2019. Los resultados fueron sometidos a análisis estadístico descriptivo. Resultados: La muestra estuvo conformada por 203 niños, de los cuales el 51% (n = 103) tuvo un evento adverso. Se identificaron un total de 176 eventos adversos de 8 tipos, con prevalencia de laringitis posextubación (n=50; 28%), edema de lengua (n=34; 19%) y lesión de la comisura del labrum (n=25; 14%). De estos, solo el 5% (n=9) fueron notificados al Centro de Seguridad del Paciente. Conclusion: Los eventos adversos prevalentes se relacionaron con la cavidad bucal y los tejidos adyacentes y el subregistro fue significativo. (AU)

Construcción de la alimentación en trayectorias vitales de personas mayores

Introducción: La alimentación se construye a partir de experiencias y significados adquiridos en el curso de la vida. Las personas mayores tienen un acervo importante que informa de valores y prácticas culturales aplicadas a la alimentación. El objetivo del estudio fue interpretar los significados que entregan personas mayores a la construcción de su alimentación en trayectorias del curso de vida. Métodos: La investigación utilizó un enfoque cualitativo de alcance exploratorio, utilizando el método de teoría fundamentada de Strauss y Corbin. Para la recolección de datos se aplicó una entrevista semiestructurada entre julio de 2021 y junio de 2022. El tipo de muestreo fue teórico y el análisis de los datos cualitativos respondió al proceso de codificación abierta, axial y selectiva. Resultados: Participaron 54 personas mayores (72% mujeres) con edad promedio de 68,6 años (6,9 años). Las personas mayores construyeron su alimentación con un alto significado a las comidas caseras, con influencia de género femenino durante la niñez y adolescencia. En la adultez, se reconstruye la alimentación al ingresar al mundo laboral. En la actualidad, cimentan la alimentación con un enfoque de cuidados para su salud. Reconocen transiciones y puntos de inflexión en la alimentación provocados por terremotos, pandemia por COVID-19, situación política en el país, embarazos o el diagnóstico de alguna enfermedad crónica. Discusión: Las personas mayores reconocen diversas vivencias en trayectorias vitales que han marcado sus patrones alimentarios. Estas experiencias de vida pueden ser la base de estrategias o acciones en la práctica clínica que aporten a su bienestar.

Introduction: Food is intricately woven into the fabric of our experiences and the meanings accumulated throughout life. Older people possess a rich cultural heritage that shapes the values and practices surrounding food.The aim of the study was to interpret the meanings attributed to older people to the construction of their feeding in life course trajectories. Methods: The research employed a qualitative exploratory approach, utilizing the Grounded Theory method developed by Strauss and Corbin. Data collection took place through semi-structured interviews conducted between July 2021 and June 2022. The sampling method employed was theoretical, and the analysis of qualitative data followed the open, axial, and selective coding process. Results: A total of 54 older individuals (72% women), with an average age of 68.6 years (6,9 years), participated in the study. These individuals constructed their relationship with food, assigning significant value to homemade meals, influenced by gender roles during childhood and adolescence. In adulthood, the relationship with food transformed with entry into the workforce. Currently, their feeding are guided by a health-centric approach. They recognize transitions and turning pointsin food provoked by earthquakes, pandemic by COVID-19, political situation in the country, pregnancies or the diagnosis of a chronic disease. Discussion: Older people recognize a multitude of life experiences that have left imprints on their eating patterns. These life experiences can be the basis for strategies or actions in clinical practice that contribute to their well-being.

Effect of a Nursing intervention on the uncertainty of family members in Intensive Care

Introduction: Family members of patients admitted to an Intensive Care Unit present high uncertainty level due to not knowing what is happening and to not having clear details about the related events; therefore, interventions are required to allow modulating those levels. Objective: To evaluate the effect of an educational Nursing intervention compared to conventional care on the uncertainty of family members of patients hospitalized in an ICU. Materials and methods: An experimental study with a sample comprised by 132 relatives of patients admitted to an ICU, randomly distributed in four Solomon groups (33 in each group). The Nursing intervention based on the concepts of the Uncertainty in Illness Theory was applied to both experimental groups and devised under the Whittemore and Grey parameters with three moments: assessment; education about the relative's hospitalization in the ICU; and accompaniment. This was done with pre-assessments for two groups and post-assessments for the four groups, using the PPUS-FM Uncertainty Scale. The data were analyzed by means of descriptive statistics and respective non-parametric analyses. The study took into account the ethical principles in research. Results: The family members in the experimental groups presented a lower final uncertainty level when compared to the control groups, with a difference of 73.04 points and a p-value of 0.001. Discussion: Standardized interventions and under a theoretical model allow reducing uncertainty in relatives of patients in ICUs. Conclusions: The Nursing intervention based on the Uncertainty theory allows reducing uncertainty in relatives of patients hospitalized in an Intensive Care Unit.

Myelotoxicity and kidney dysfunction related to the use of trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia: a case report of severe adverse events with a common drug

ABSTRACT Trimethoprim-sulfamethoxazole (TMP-SMX) is the primary therapeutic option for Pneumocystis jirovecii pneumonia (PCP). Gastrointestinal symptoms and cutaneous rash are common side effects, with hyperkalemia being uncommon in patients without kidney dysfunction, and myelotoxicity being even rarer. We present the case of a male patient with hypertension and a recent diagnosis of non-Hodgkin lymphoma, undergoing rituximab treatment for two months. He was admitted to the intensive care unit due to dyspnea, tachypnea, and pleuritic pain, requiring mechanical ventilation. Chest computed tomography showed bilateral and multilobed ground-glass opacities, compromising more than 80% of the lung parenchyma. Pulmonary tuberculosis and COVID-19 were ruled out. An angiotomography and Doppler ultrasound revealed an extensive pulmonary thrombus and deep venous thrombosis. Empiric treatment with TMP-SMX for PCP was initiated, but within four days, the patient experienced metabolic acidosis and severe hyperkalemia, necessitating hemodialysis. He also presented with progressive pancytopenia and critical levels of leukopenia and thrombocytopenia. The hypothesis of TMP-SMX-induced myelotoxicity was suspected. Considering the unavailability of an alternative treatment, it was opted to continue TMP-SMX and initiate a granulocyte-colony-stimulating factor. However, the patient maintained medullary deterioration, becoming refractory to the transfusion of blood derivates. On the 17th day of treatment, a clinical decision was made to suspend TMP-SMX, leading to improvements within 48 hours in marrow and kidney functions, metabolic acidosis, and hyperkalemia. Despite all efforts, the patient died after 35 days of hospitalization due to hospital-acquired infections. This case highlights the importance of clinicians recognizing potential myelotoxicity with TMP-SMX and promptly discontinuing the drug if necessary.

As redes vivas na produção do cuidado com o usuário na centralidade do tratamento para tuberculose multidroga resistente / Las redes vivas en la producción del cuidado con el usuario en la centralidad del tratamiento para la tuberculosis multidrogo resistente / Live networks in care production with the user at the center of the treatment for multidrugresistant tuberculosis

Vivenciamos a trajetória de uma usuária-guia no tratamento para tuberculose multidroga resistente (TB-MDR). As narrativas das redes vivas na produção de cuidado apontam para os seguintes itens: 1) cuidar no ato de viver: suplantar os estigmas e cultivar vínculos que ajudem a superar os discursos fomentados pelo medo, preconceitos, exclusão e invisibilidade dos sujeitos; 2) redes vivas de cuidado: os entremeios da norma; e 3) as interfaces de atenção usuário-trabalhador da saúde: como desmistificar o julgamento dos trabalhadores da saúde, que, subordinados a protocolos limitantes, muitas vezes estigmatizam o usuário como "abandonador de tratamento"?. A usuária-guia vislumbrou que cuidar é se desterritorializar, é colocar os desejos como potência para transformação, saindo do modus operandi rumo à criatividade, tendo o usuário no centro do processo. (AU)

Presenciamos la trayectoria de una usuaria-guía en el tratamiento para tuberculosis multidrogo resistente (TB-MDR). Las narrativas de las Redes Vivas en la producción de cuidado señalan: 1) cuidar en el acto de vivir: suplantar los estigmas y cultivar vínculos que ayuden a superar los discursos fomentados por el miedo, prejuicios, exclusión e invisibilidad de los sujetos. 2) Redes Vivas de cuidado: los entresijos de la norma y 3) las interfaces de atención usuario-trabajador de la salud: ¿cómo desmistificar el juicio de los trabajadores de la salud quienes, subordinados a protocolos limitantes, muchas veces estigmatizan al usuario como "abandonador de tratamiento"? La usuaria-guía vislumbró que cuidar es desterritorializarse, es colocar los deseos como potencia para trasformación, saliendo del modus operandi rumbo a la creatividad, colocando al usuario en el centro del proceso. (AU)

We followed the trajectory of a guiding user undergoing treatment for multidrug-resistant tuberculosis (MDR-TB). The narratives of Live Networks in care production showed: 1) Caring in the act of living: Overcoming stigmas and cultivating bonds that help overcome discourses fostered by fear, prejudice, exclusion and invisibility of subjects; 2) Live Networks of care: The in-betweens of the norm; and 3) Interfaces of user-health worker care: How can we demystify the judgment of health workers who, subordinated to limiting protocols, often stigmatize the user as someone who "abandons the treatment"? The guiding user perceived that caring means deterritorializing oneself, expressing one's desires as power for transformation, and leaving the modus operandi towards creativity, with the user at the center of the process. (AU)

Fatores associados ao comprometimento da segurança do paciente na unidade de terapia intensiva / Factors associated with the commitment of patient safety in the intensive care unit / Factores asociados al compromiso de la seguridad del paciente en la unidad de cuidados intensivos

Objetivo: conhecer os fatores associados ao comprometimento da segurança do paciente. Método: trata-se de um artigo de revisão integrativa da literatura a partir das bases de dados Scientific Electrônic Library Online, PubMed e Literatura Latino-americana e do Caribe em Ciências da Saúde, realizada entre abril e maio de 2022. Resultados: foi visto os principais fatores que corroboram para o comprometimento da segurança, sendo a utilização inadequada dos equipamentos, falta de rotina e ausência de protocolo no setor. Foi detectado a problemática da carga exacerbada de trabalho. Conflitos na equipe também foi tido como um preditor para existência de evento adverso. E por fim, o quesito da subnotificação dos erros. Conclusão: é visto a necessidade da gestão reverter esses problemas, para que a assim a porcentagem de erros seja diminuída.

Objective: to know the factors associated with compromised patient safety. Method: this is an integrative literature review article based on the Scientific Electronic Library Online, PubMed and Latin American and Caribbean Literature in Health Sciences databases, carried out between April and May 2022. Results: it was seen the main factors that corroborate for the compromise of safety, being the inadequate use of equipment, lack of routine and lack of protocol in the sector. The problem of exacerbated workload was detected. Conflicts in the team was also considered a predictor for the existence of an adverse event. And finally, the issue of underreporting of errors. Conclusion: the need for management to reverse these problems is seen, so that the percentage of errors is reduced.

Objetivos:conocer los factores asociados a la seguridad del paciente comprometida. Método: este es un artículo de revisión integradora de la literatura basado en las bases de datos Scientific Electronic Library Online, PubMed y Latin American and Caribbean Literature in Health Sciences, realizado entre abril y mayo de 2022. Resultados: se vieron los principales factores que corroboran para el compromiso de seguridad, siendo el uso inadecuado de equipos, falta de rutina y falta de protocolo en el sector. Se detectó el problema de la sobrecarga de trabajo. Los conflictos en el equipo también fueron considerados predictores de la existencia de un evento adverso. Y por último, el tema del subregistro de errores. Conclusión: se ve la necesidad de que la gestión revierta estos problemas, de modo que se reduzca el porcentaje de errores.

Headache as the most prevalent post-vaccination adverse event after Covid-19 vaccination / Dor de cabeça como evento adverso pós-vacinação mais prevalente após a vacinação contra Covid-19

BACKGROUND: In 2020, the first vaccines were approved, according to the WHO. However, speculations arose regarding their efficacy and post-vaccination adverse events (AEFV). OBJECTIVE: To evaluate the prevalence of headache as AEFI from the SARSCoV-2 vaccine in Piauí, Brazil. METHODS: This is a quantitative, observational, cross-sectional, and prevalence study. Data were provided by the Post-Vaccination Adverse Event Information System (SI-AEFV), from reported cases from January to September 2021. Data were analyzed, and the research was approved by the UFPI Research Ethics Committee. RESULTS: A total of 2,008 cases were analyzed. Headache was reported in 752 cases (27.99%) as an AEFV after vaccination against SARS-CoV-2. In most cases, patients were from Teresina (67.62%), of brown race/ethnicity (52.67%), female (79.00%), and the majority were not healthcare professionals (54.27%). The most common age of patients, with the original data, was 33 years. After data correction, the most common age was 28 years. The majority of these cases were not severe (96.44%), and the majority of cases were associated with the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine (43.18%).CONCLUSION: Thus, it is concluded from the partial analysis of the results that headache is the most common adverse event after vaccination against SARS-CoV-2. The profile of patients with the most notifications was brown women aged 30 to 40 years who received the first dose of the Covid-19-Covishield-Oxford/AstraZeneca vaccine. Regarding the severity of events, the vast majority were considered non-severe, and no deaths were mentioned, demonstrating the safety of immunobiologicals.

FUNDAMENTO: Em 2020, foram aprovadas as primeiras vacinas, segundo a OMS. No entanto, surgiram especulações quanto à sua eficácia e eventos adversos pós-vacinais (EAPV). OBJETIVO: Avaliar a prevalência de cefaleia como EAPV da vacina SARSCoV-2 no Piauí, Brasil. MÉTODOS: Trata-se de um estudo quantitativo, observacional, transversal e de prevalência. Os dados foram fornecidos pelo Sistema de Informação de Eventos Adversos Pós-Vacinação (SI-AEFV), dos casos notificados no período de janeiro a setembro de 2021. Os dados foram analisados ​​e a pesquisa foi aprovada pelo Comitê de Ética em Pesquisa da UFPI. RESULTADOS: Foram analisados ​​2.008 casos. Cefaleia foi relatada em 752 casos (27,99%) como EAPV após vacinação contra SARS-CoV-2. Na maioria dos casos, os pacientes eram procedentes de Teresina (67,62%), de raça/etnia parda (52,67%), do sexo feminino (79,00%) e a maioria não era profissional de saúde (54,27%). A idade mais comum dos pacientes, com os dados originais, era de 33 anos. Após correção dos dados, a idade mais comum foi 28 anos. A maioria desses casos não foi grave (96,44%), e a maioria dos casos esteve associada à primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca (43,18%).CONCLUSÃO: Assim, conclui-se a partir da análise parcial dos resultados de que cefaleia é o evento adverso mais comum após vacinação contra SARS-CoV-2. O perfil dos pacientes com mais notificações foi de mulheres pardas com idade entre 30 e 40 anos que receberam a primeira dose da vacina Covid-19-Covishield-Oxford/AstraZeneca. Quanto à gravidade dos eventos, a grande maioria foi considerada não grave e não foram mencionados óbitos, demonstrando a segurança dos imunobiológicos.

Importancia de la vigilancia poscomercialización en las vacunas contra SARS-CoV-2 / Importance of post-marketing surveillance of SARS-CoV-2 vaccines

Introducción: La vacunación ha sido una de las intervenciones sanitarias más costo-efectivas, por su impacto en el control de las enfermedades inmunoprevenibles. La pandemia ocasionada por SARS-CoV-2 condujo al desarrollo mundial de más de doscientas vacunas en diferentes fases de investigación con diversas plataformas. Objetivo: Caracterizar la evaluación del control de calidad de las vacunas contra SARS-CoV-2 y los eventos adversos de las aprobadas contra otros agentes patógenos en las diferentes etapas del ensayo preclínico y clínico. Métodos: Se realizó una búsqueda en Google Académico y PubMed/Medline de artículos publicados entre 1969 y marzo de 2021. Se seleccionaron los de mayor relevancia. Desarrollo: Las vacunas se desarrollaron en un corto tiempo ante la pandemia de COVID-19, sin comprometer el adecuado control de los ensayos clínicos. Aunque resultan seguras, no están exentas de eventos adversos; por ello se debe vigilar su seguridad durante el proceso de poscomercialización. Muchas de ellas han comprometido su seguridad. Conclusiones: Las vacunas deben poseer inmunogenicidad, eficacia y seguridad comprobadas. Los eventos adversos pueden surgir en cualquier etapa de la investigación; por tanto, resulta fundamental la vigilancia en la fase de poscomercialización(AU)

Introduction: Vaccination has been one of the most cost-effective health interventions, due to its impact on the control of immunopreventable diseases. The pandemic caused by SARS-CoV-2 led to the worldwide development of more than two hundred vaccines in different phases of research with diverse platforms. Objective: To characterize the quality control assessment of vaccines against SARS-CoV-2 and adverse events of those approved against other pathogens at different stages of preclinical and clinical trials. Methods: We searched Google Scholar and PubMed/Medline for articles published between 1969 and March 2021. The most relevant articles were selected. Development: Vaccines were developed in a short time in the face of the COVID-19 pandemic, without compromising the adequate control of clinical trials. Although they are safe, they are not free of adverse events; therefore, their safety should be monitored during the post-marketing process. Many of them have compromised their safety. Conclusions: Vaccines should possess proven immunogenicity, efficacy and safety. Adverse events can arise at any stage of research; therefore, post-marketing surveillance is essential(AU)

Relationship between depressive symptoms, negative life events, and resilience in primary and secondary school teachers / 中国学校卫生

Objective@#To explore the relationship between depressive symptoms, negative life events and resilience among primary and secondary school teachers, so as to provide a reference for mental health promotion in school teachers.@*Methods@#During November to December 2022, a questionnaire survey was conducted using convenient cluster sampling method to select 11 332 in service teachers from 38 schools in 8 provinces (cities) including Beijing, Guangdong, Anhui, Hubei, Sichuan, Xinjiang, Liaoning, and Heilongjiang. The Patient Health Questionnaire-9 items, a self developed 21-item Adverse Life Events questionnaire, and a 10-item Conner-Davidson Resilience Scale were used to assess depressive symptoms, experiences of negative life events, and resilience levels of the teachers, respectively. The relationship between depressive symptoms, negative life events and psychological resilience were analyzed by multiple linear regression and stratified regression.@*Results@#The detection rate of depressive symptoms among primary and secondary school teachers was 14.0%. Negative life events of primary and secondary school teachers were positively correlated with depressive symptoms ( r =0.35), while psychological resilience was negatively correlated with depressive symptoms ( r =-0.45) ( P <0.05). After adjusting for possible covariates including gender and marital status, negative life events were positively correlated with depressive symptoms ( β=0.22, P <0.01). Resilience played a moderating role in the association of negative life events with depressive symptoms among primary and secondary school teachers ( B=-0.15, P <0.01).@*Conclusions@#Negative life events experiences are associated with higher level of depressive symptoms among school teachers. However, resilience might mitigate the negative effects of negative life events on depressive symptoms, playing a protective role in teachers mental health.

Relationship between ruminative thinking, life events and learning value doubt among junior high school students / 中国学校卫生

Objective@#To explore the mediating effect of rumination between life events and learning value doubt among junior high school students, so as to provide reference for the psychological health education of junior high school students.@*Methods@#From March to July 2023, a total of 930 junior high school students from Guangdong, Jiangsu and Hebei were selected by a combination of convenient sampling methods. Participants completed the Scales of Value of Learning (SVL), Ruminative Response scale (RRS) and Adolescent Self rating Life Events Checklist (ASLEC). The t test and ANOVA were used for inter group comparisons and Pearson correlation analysis was used for correlation analysis and bootstrap method was used for mediating effect test.@*Results@#The life events of junior middle school students were positively correlated with learning value doubt ( r =0.18), rumination ( r = 0.65 ) and its three dimensions (brooding, reflective pondering, and symptom focused rumination) ( r =0.60, 0.59, 0.66). Learning value doubt was positively correlated with rumination ( r =0.15) and its three dimensions ( r =0.07, 0.13, 0.19) ( P <0.05).The symptom focused rumination (effect size=0.09, 95% CI =0.06-0.11) and brooding (effect size=-0.07, 95% CI =-0.09--0.04) dimensions partially mediated the relationship between life events and learning value doubt. In the two influential pathways, symptom focused rumination exerts a stronger impact, and the difference was statistically significant (effect size=0.15, 95% CI =0.11- 0.20 , excluding 0) ( P <0.05).@*Conclusions@#Life events experienced by junior high school students can positively predict learning value doubt through symptom focused rumination, and negatively predict learning value doubt through brooding. Active attention should be paid to the mental health status of junior high school students, intervene promptly when they experience life events, reduce symptom based rumination, and improve their learning enthusiasm.

Moral Schema Based on the Integration of the Mechanism of Moral Injury / 中国医学伦理学

Moral injury is a kind of trauma symptom caused by the impact of external immoral events on the internal moral value system of individuals or groups. Its origin lies in the deviation between individual’s internal moral schema and external moral situation. As a collection of moral consciousness units with value orientation in the regular activities of individuals in the moral environment, moral schema is composed of periphery and core. Moral schema realizes the domination of moral ego by supervising individual’s speech and behavior, exercising moderate control over individuals based on moral practice, and examining individual behavior with self-guilt as the tool of judgment. Moral schema is selective about what happened and acts as a filter for trauma events. Based on this, individuals can interpret or be subverted by moral events, thus playing a preventive role in moral injury.

Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia / 中国实验方剂学杂志

ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized， double-blind， double-simulated， positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions， laboratory indicators， vital signs， and electrocardiogram （ECG） results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial， and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules， donepezil， and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial， and the symptoms were mild and recovered. Laboratory tests （blood routine， urine routine， liver function， kidney function， and coagulation） and vital signs were compared before treatment （baseline） and after treatment of 12 and 24 weeks， respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial， there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort， with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules， and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.

Segunda victima: experiencia y medidas de apoyo percibidas por los profesionales sanitarios / Second victim experience and support from health prof fessionals

Resumen Introducción : Las segundas víctimas son aquellos profesionales que, ante un error, quedan traumatizados, cuestionándose sus habilidades profesionales y perso nales. El conocimiento de su experiencia permite a las instituciones entender las consecuencias del error en los profesionales para realizar acciones de atención a los profesionales involucrados mejorando la seguridad de atención. El objetivo de este estudio es caracterizar el fenómeno de segundas víctimas y conocer las medidas de apoyo percibidas. Métodos : Estudio cuantitativo observacional descrip tivo transversal. Participaron profesionales de la salud de cinco instituciones de alta complejidad a través de un muestreo por conveniencia. El instrumento de recogida de datos fue el Second Victim Experience and Support Tool (SVEST) validado en Argentina, compuesta por dimen siones de impacto (psicológico, físico y de habilidades profesionales) de apoyo recibido (colegas, supervisores, institucional y medidas no relacionadas al ámbito la boral) y dos dimensiones de resultado (abandono pro fesional y ausentismo). Resultados : Participaron 1134 profesionales. El 56% manifestó haber cometido un error y completó el SVEST. La media del SVEST fue de 2.5 predominando la dimen sión de impacto psicológico (x = 3.4). Como parte de las medidas de apoyo los profesionales percibieron mayor apoyo en familiares y amigos (x = 3.1). A mayor impacto menor percepción de las medidas de apoyo (Rho: -0.8, p = 0.047). Discusión : Más de la mitad de los profesionales re fieren ser segundas víctimas con un impacto psicológico importante, los cuales, a pesar de trabajar en institu ciones que cuentan con protocolos de seguridad del paciente, reciben el apoyo principalmente de entornos no relacionados al trabajo.

Abstract Introduction : The second victims are those profes sionals who, when faced with a mistake, are traumati zed, questioning their professional and personal skills. Knowledge of their experience allows institutions to understand the consequences of error in professionals to carry out care actions for the professionals involved, improving care security. The objective of this study is to characterize the phenomenon of second victims and to know the perceived support measures. Method : Cross-sectional descriptive observational quantitative study. Health professionals from five highly complex institutions participated through convenience sampling. The data collection instrument was the Second Victim Experience and Support Tool (SVEST) validated in Argentina, composed of impact dimensions (psychologi cal, physical and professional skills) of support received (colleagues, supervisors, institutional and measures not related to the workplace) and two outcome dimensions (professional abandonment and absenteeism). Results : 1134 professionals participated and 56% said they had made a mistake. The mean STEVS was 2.5, with the psychological impact dimension predominating (x = 3.4). As part of the support measures, professionals perceived greater support from family and friends (not re lated to work) (x = 3.1). The greater the impact, the lower the perception of support measures (Rho: -0.8, p = 0.047). Discussion : More than half of the professionals refer to being second victim with a significant psychological impact, who, despite working in institutions that have patient safety protocols, received support from non-work-related environments.

Caregiver Experience from the Perspective of Men and Women: An Integrative Review

Introduction: The need for care has increased exponentially in recent years, along with chronic noncommunicable diseases. Caregivers have been predominantly women, although in recent years there has been an increase in the number of men assuming this role. Each of them approaches caregiving differently, shaping their caregiving experience differently from one another. Objective: To identify, through scientific evidence, the meaning of being a caregiver for men and women who assume this role. Methodology: This is an integrative literature review of articles published from 2012 to 2023, following Whittemore and Knafl's proposal. Keywords in Spanish, English, and Portuguese were used. The databases searched were Scopus, CINAHL, Web of Science, Ovid, and PubMed. Twenty-four articles that met the inclusion criteria were analyzed. Results: The following themes emerged: "Losses and limitations due to the caregiver's role," "Feelings experienced by the caregiver," "Caregiving as an act of love," and "Transcendence of care: between spirituality and religiosity." Conclusions: It was found that men focus their care on the person's comfort, cleanliness, and medication, while women provide care focused on continuous emotional support, assuming this commitment at all times and places, building an experience of care aimed at "always being aware." In both genders, the onset of stress, loss of meaning in life, and negative feelings are highlighted.

Introducción: la necesidad de cuidado se ha incrementado de manera exponencial en los últimos años, asociada a enfermedades crónicas no transmisibles. Los cuidadores han sido principalmente mujeres, si bien en los últimos años se ha incrementado el número de hombres que asumen este papel. Cada uno de ellos aborda el cuidado de manera diferente, construyendo su experiencia del cuidado distinto uno del otro. Objetivo: identificar a través de la evidencia científica el significado de ser cuidador para hombres y mujeres que asumen el rol. Metodología: se realizó una revisión integrativa de la literatura, siguiendo la propuesta de Whittemore y Knafl, de artículos publicados en el periodo de 2012 a 2023. Se utilizaron las palabras claves en español, inglés y portugués. Las bases de datos consultadas fueron: Scopus, CINAHL, Web of Science, Ovid y PubMed. Se analizaron veinticuatro artículos que cumplieron con los criterios de inclusión. Resultados: emergieron los siguientes temas: "Pérdidas y limitaciones por el rol del cuidador", "Sentimientos experimentados por el cuidador", "Cuidar como un acto de amor" y "Trascendencia del cuidado: entre la espiritualidad y la religiosidad". Conclusiones: se evidenció que los hombres enfocan sus cuidados hacia el confort, aseo y medicación de la persona cuidada. Las mujeres prestan sus cuidados enfocados en el apoyo emocional incesante, asumiendo tal disposición en todo tiempo y lugar, construyendo una experiencia de cuidado dirigida a "estar siempre pendiente". En ambos géneros, se resalta la aparición de estrés, pérdida del sentido de la vida y sentimientos negativos.

Introdução: a necessidade de cuidado aumentou exponencialmente nos últimos anos, associada a doenças crônicas não transmissíveis. Os cuidadores têm sido predominantemente mulheres, embora nos últimos anos tenha havido um aumento no número de homens que assumem essa função. Cada um deles aborda o cuidado de forma diferente, construindo sua experiência de cuidado de forma diferente um do outro. Objetivo: identificar, por meio de evidências científicas, o significado de ser um cuidador para homens e mulheres que assumem essa função. Metodologia: foi realizada uma revisão integrativa da literatura, seguindo a proposta de Whittemore e Knafl, de artigos publicados no período de 2012 a 2023. Foram utilizadas palavras-chave em espanhol, inglês e português. As bases de dados consultadas foram: Scopus, CINAHL, Web of Science, Ovid e PubMed. Vinte e quatro artigos que atenderam aos critérios de inclusão foram analisados. Resultados: os seguintes temas emergiram: "Perdas e limitações devido ao papel do cuidador", "Sentimentos vivenciados pelo cuidador", "Cuidar como um ato de amor" e "Transcendência do cuidado: entre espiritualidade e religiosidade". Conclusões: Verificou-se que os homens concentram seus cuidados no conforto, na limpeza, e na medicação da pessoa cuidada. As mulheres prestam cuidados com foco no apoio emocional incessante, assumindo essa disposição em todos os momentos e lugares, construindo uma experiência de cuidado voltada para "estar sempre atento". Em ambos os gêneros, destaca-se a ocorrência de estresse, perda de sentido da vida, e sentimentos negativos.

Un diálogo teórico de la diplomacia cultural y la comunicación promovido por la escuela de verano alaic xviii en pandemia

Se plantea como antecedente y ámbito de referencia para este artículo de reflexión desarrollar un haz de observación predominantemente bibliográfico, acerca de la tangencia entre los campos de las relaciones internacionales y los estudios de comunicación. Para develar en esta intersección diálogos teóricos sobre la diplomacia cultural y aplicarlos como óptica en el desempeño de la Escuela de Verano ALAIC. Exponer e interpretar a esta última como una institución académica internacional de investigación. Este abordaje parte de un recorte bibliográfico teórico sobre los principales diálogos sobre el concepto de diplomacia cultural, para luego plantear como estudio de caso, el desarrollo y desempeño como curso documental de la escuela de Verano ALAIC, sus propósitos, objetivos y prácticas. Desde este prisma de observación se pretende buscar asociaciones entre los temas, y así verificar si es adecuado interpretar la iniciativa como un movimiento catalizador de espacios y encuentros de alteridad para la diplomacia cultural.

A predominantly bibliographic observation context, on the tangency between the fields of international relations and communication studies, is proposed as background and scope of reference for this article to be developed,. To reveal, in this intersection, theoretical dialogues on cultural diplomacy, and to apply them as an optic, in the performance of the ALAIC's Summer School. Thus, to expose and to interpret this association as an international academic research institution. This approach starts from a theoretical bibliographic clipping on the main dialogues on the concept of cultural diplomacy, ergo, to propose its development and performance of the ALAIC summer school of an academic course, its purposes, objectives, and practices, as a case study. From this perspective of observation, it is intended to look for associations between themes, and thereby, to verify if it is appropriate to interpret the initiative as a catalyst movement of spaces and encounters of otherness, for cultural diplomacy.

Los significados de la menopausia, una mirada desde la teoría de las transiciones

Introducción: La menopausia es una etapa, si bien normal, de profundos cambios en la vida de la mujer; la transición hacia la menopausia impone un reto al profesional de enfermería, encaminado a promover la salud, facilitar la transición y apoyar la búsqueda de solución a las necesidades que se presentan. Objetivo: El presente estudio está orientado a comprender los significados de la menopausia en mujeres de Armenia, Quindío, Colombia. Metodología: Se utilizó un enfoque cualitativo, fenomenológico e interpretativo desde la teoría de las transiciones de Meléis. Se efectuaron entrevistas a profundidad a seis mujeres de Armenia, previo consentimiento informado, con muestreo intencional, grabación y diario de campo; la información se analizó con apoyo de la base de datos ATLAS.ti, mediante codificación, categorización inductiva, triangulación y contestación con la literatura. Resultados: Se encontró una percepción negativa de la menopausia por sensación de fogajes, desasosiego, depresión y disfunción sexual; para los síntomas recurren a terapias complementarias y medicación, al respecto, algunas refieren una experiencia tranquilizadora y agradable. Urgen redes de acompañamiento en salud para promoción, prevención y apoyo familiar. Las participantes solicitan programas educativos específicos desde edades tempranas. Discusión: Los resultados coinciden con la literatura en cuanto a la experiencia de las participantes y la necesidad de apoyo y orientación. Desde la teoría de Meléis, la transición es de desarrollo, organizacional, con patrones múltiples, simultáneos y relacionados. La experiencia fue sentida y vivida negativamente, se necesitan espacios de análisis, reflexión y acompañamiento desde edades tempranas, para deconstruir el concepto de menopausia y climaterio como problema de salud, y abordarlo como evento vital y de renacimiento, como apertura a una nueva forma de vivir, con estilos de vida saludables. Conclusiones: Se concluye que la menopausia es percibida y experimentada como una etapa de ansiedad, desasosiego, tristeza y desesperanza, por el poco acompañamiento, deficiente educación y preparación de la mujer; las mujeres adultas "menopaúsicas" son poco reconocidas, rechazadas, y muchas veces solo toleradas por personas cercanas. Urgen redes de acompañamiento en salud.

Introduction: Menopause is a stage, although normal, of profound changes in a woman's life. The transition to menopause imposes a challenge on the nursing professional, aimed at promoting health, facilitating the transition and supporting the search for a solution to the needs that arise. Objective: The present study is aimed at understanding the meanings of menopause in women from Armenia, Quindio Department, Colombia. Metodology: A qualitative, phenomenological and interpretative approach was used, based on Meleis's theory of transitions. In-depth interviews were carried out on six women from Armenia, with prior informed consent, with intentional sampling, recording, and field diary; the information was analyzed with support of the ATLAS.ti database, through coding, inductive categorization, triangulation, and comparison with the literature. Results: A negative perception of menopause was found due to hot flashes, restlessness, depression and sexual dysfunction; for the symptoms they resort to complementary therapies and medication, as a result, some report a calming and pleasant experience; health accompaniment networks are urgently needed for promotion and prevention, and family support. They request specific educational programs from an early age. Discussion. The results coincide with the literature regarding the experience of the participants and the need for support and guidance. From Meleis's theory, the transition is developmental, organizational, with multiple, simultaneous and related patterns. The experience was felt and lived negatively, spaces for analysis, reflection and accompaniment are needed from an early age, to deconstruct the concept of menopause and climacteric as a health problem, and address it as a vital and rebirth event, as an opening to a new way of living, with healthy lifestyles. Conclusions: It is concluded that the menopause is perceived and experienced as a stage of anxiety, restlessness, sadness and hopelessness, due to the lack of accompaniment, poor education and preparation of women; "menopausal" adult women are little recognized, rejected and, many times, only tolerated by close people. Health support networks are urgently needed.

Sistemas de notificación de eventos adversos como estrategia para la cultura de calidad y seguridad del paciente / Adverse event reporting systems as a strategy for a culture of quality and patient safety

Introducción: el objetivo de los Sistemas de Notificación de Eventos Adversos, Eventos Centinela y Cuasifallas, es conocer la frecuencia con la que se presentan y generar las estrategias para su disminución y la no repetición de dichos eventos. Se debe informar al personal de salud involucrado en los procesos de atención, principalmente a quienes tienen contacto directo con los pacientes. Desarrollo: se realizó una revisión bibliográfica conceptual y de investigación sobre los sistemas de notificación de eventos adversos. La búsqueda y selección de artículos publicados de 2016 a 2021, fue en la base de datos PubMed y el índice de revistas de acceso abierto Medigraphic, mediante los siguientes criterios de búsqueda en español e inglés: sistemas de notificación, evento adverso, evento centinela, sistema VENCER, Instituto Mexicano del Seguro Social, Secretaría de Salud; así como el uso del operador booleano AND: Notificatión AND adverse event, notification system AND sentinel event, adverse event AND quality plan. Se obtuvo un aproximado de 194 resultados, de los cuales se seleccionaron los artículos que se apegaban al objetivo de esta revisión. Conclusiones: con la presente revisión bibliográfica se muestra que la notificación de los eventos adversos por parte del personal de la salud involucrados en los procesos de atención, adquiere especial relevancia cuando ésta es proporcional a la adquisición de luna cultura de calidad y seguridad en la atención de los pacientes... (AU)

Abstract Introduction: The objective of the Notification Systems for Adverse Events, Sentinel Events and Near Failures is to know the frequency with which they occur and to generate strategies for their reduction and non-repetition of said events. Health personnel involved in the care processes should be informed, mainly those who have direct contact with patients. Development: A conceptual and research literature review on adverse event reporting systems was carried out. The search and selection of articles published from 2016 to 2021 was in the PubMed database and the Medigraphic open access journal index, using the following search criteria in Spanish and English: notification systems, adverse event, sentinel event, VENCER system, Mexican Institute of Social Security, Ministry of Health, as well as the use of the boolean operator AND: Notification AND adverse event, notification system AND sentinel event, adverse event AND quality plan. An approximate of 194 results were obtained, from which the articles that met the objective of this review were selected. Conclusions: This bibliographic review shows that the notification of adverse events by health personnel involved in care processes acquires special relevance when it is proportional to the acquisition of a culture of quality and safety in care. from the patients.

Frecuencia de eventos cardiovasculares en pacientes con lupus eritematoso sistémico / Frequency of cardiovascular events in patients with systemic lupus erythematosus

Resumen Introducción: el progreso en los tratamientos para el lupus eritematoso sistémico (LES) resultó en una disminución de la mortalidad; sin embargo, la enfermedad cardiovascular y las complicaciones infecciosas aún son las principales causas de muerte. La evidencia apoya la participación del sistema inmunológico en la generación de la placa aterosclerótica, así como su conexión con las enfermedades autoinmunes. Objetivos: describir la frecuencia de eventos cardiovasculares (ECV) en el Registro de Lupus Eritematoso Sistémico de la Sociedad Argentina de Reumatología (RELESSAR) transversal, así como sus principales factores de riesgo asociados. Materiales y métodos: estudio descriptivo y transversal para el cual se tomaron los pacientes ingresados en el registro RELESSAR transversal. Se describieron las variables sociodemográficas y clínicas, las comorbilidades, score de actividad y daño. ECV se definió como la presencia de al menos una de las siguientes patologías: enfermedad arterial periférica, cardiopatía isquémica o accidente cerebrovascular. El evento clasificado para el análisis fue aquel posterior al diagnóstico del LES. Se conformaron dos grupos macheados por edad y sexo 1:2. Resultados: 1515 pacientes mayores de 18 años participaron del registro. Se describieron 80 pacientes con ECV (5,3%). En este análisis se incluyeron 240 pacientes conformando dos grupos. La edad media fue de 47,8 (14,4) y 47,6 (14,2) en el grupo con y sin ECV respectivamente. Los pacientes con ECV tuvieron mayor duración del LES en meses, mayor índice de Charlson, mayor SLICC (Systemic Lupus International Collaborating Clinics/American College of Rheumatology), mayor frecuencia de manifestaciones neurológicas, síndrome antifosfolípido, hospitalizaciones y uso de ciclofosfamida. Las únicas variables asociadas en el análisis multivariado fueron el índice de Charlson (p=0,004) y el SLICC (p<0,001). Conclusiones: los ECV influyen significativamente en nuestros pacientes, y se asocian a mayor posibilidad de daño irreversible y comorbilidades.

Abstract Introduction: progress in treatments for systemic lupus erythematosus (SLE) has resulted in a decrease in mortality; however, cardiovascular and infectious diseases remain the leading causes of death. Evidence supports the involvement of the immune system in the generation of atherosclerotic plaque, as well as its connection to autoimmune diseases. Objectives: to describe the frequency of cardiovascular disease (CVD) in the cross-sectional RELESSAR registry, as well as its associated variables. Materials and methods: a descriptive and cross-sectional study was performed using patients admitted to the cross-sectional RELESSAR registry. Sociodemographic variables, clinical variables, comorbidities, activity and damage scores were described. CVD was defined as at least one of the following: peripheral arterial disease, ischemic heart disease, or cerebrovascular accident. All patients with at least one CVD were included in our analysis (heart attack, central nervous system vascular disease, and peripheral arteries atherosclerotic disease). The event classified for the analysis was that after the diagnosis of SLE. SLE diagnosis was previous to CVD. Two groups matched by age and sex, 1:2 were formed. Results: a total of 1515 patients older than 18 years participated in the registry. Eighty patients with CVD (5.3%) were described in the registry. Two-hundred and forty patients were included, according to two groups. The mean age was 47.8 (SD 14.4) and 47.6 (SD 14.2) in patients with and without CVD, respectively. Patients with CVD had a longer duration of SLE in months, a higher Charlson index, a higher SLICC, increased frequency of neurological manifestations, antiphospholipid syndrome, hospitalizations, and use of cyclophosphamide. The associated variables in the multivariate were the Charlson Index (p=0.004) and the SLICC (p<0.001). Conclusions: CVDs have a significant influence on our patients, being associated with a greater possibility of damage and comorbidities.

Neurotoxidad inducida por ifosfamida / Ifosfamide-induced neurotoxicity

Introducción: La ifosfamida es un agente alquilante utilizado para el tratamiento de enfermedades oncohematológicas. Entre sus eventos adversos agudos se encuentra la neurotoxicidad. Esta puede presentarse desde el inicio de la infusión hasta tres días después. El tratamiento consiste en suspender la administración y asegurar una adecuada hidratación. Objetivo: Describir eventos neurológicos asociados al uso de ifosfamida en pacientes pediátricos con enfermedades oncohematológicas. Materiales y métodos: Estudio observacional, descriptivo, retrospectivo y transversal. Los datos se obtuvieron de historias clínicas de pacientes internados en el Hospital Garrahan que infundieron ifosfamida y desarrollaron síntomas neurológicos. Se analizaron edad, diagnóstico de base, dosis de ifosfamida, síntomas neurológicos y su relación con la infusión, tratamiento instaurado, exámenes complementarios y posibles factores de riesgo asociados. Resultados: Se registraron un total de catorce eventos neurológicos en doce pacientes, sin diferencia de sexo, con una mediana de edad de 9,5 años. La enfermedad de base más prevalente fue osteosarcoma. Las convulsiones fueron el síntoma más frecuente (50%), seguido de somnolencia y paresias. La combinación de ifosfamida y etopósido con/sin carboplatino se asoció en un 36% cada uno. El 64% desarrolló neurotoxicidad dentro de las primeras cuatro horas. Ningún paciente presentó alteraciones en los exámenes complementarios. Todos presentaron recuperación ad integrum. Conclusión: Este estudio brinda información acerca del tiempo de aparición de esta complicación, lo cual facilitará su detección precoz y tratamiento oportuno (AU)

Introduction: Ifosfamide is an alkylating agent used for the treatment of cancer. Among its acute adverse events is neurotoxicity. This can occur from the beginning of the infusion up to three days afterwards. Treatment consists of discontinuing administration and ensuring adequate hydration. Objective: To describe neurological events associated with the use of ifosfamide in children with cancer. Materials and methods: Observational, descriptive, retrospective, and cross-sectional study. Data were obtained from clinical records of patients admitted to the Garrahan Hospital who received ifosfamide infusion and developed neurological symptoms. Age, baseline diagnosis, ifosfamide dose, neurological symptoms and their relationship with the infusion, treatment, complementary tests, and possible associated risk factors were analyzed. Results: A total of fourteen neurological events were recorded in twelve patients, without difference in sex and with a median age of 9.5 years. The most prevalent underlying disease was osteosarcoma. Seizures were the most frequent symptom (50%), followed by drowsiness and paresis. The combination of ifosfamide and etoposide with/without carboplatin was associated in 36% each. Sixty-four percent developed neurotoxicity within the first four hours. None of the patients presented with abnormalities in the complementary examinations. All recovered ad integrum. Conclusion: This study provides information about the time of onset of this complication, which will facilitate its early detection and timely treatment (AU)

Adverse Events Following Immunization- The Known Unknowns and Black Box

Although vaccines are one of the most rigorously tested biological products, the safety concerns persist globally. The vaccine safety concerns linked to measles, pentavalent and human papillomavirus (HPV) vaccines have affected the vaccine coverage significantly in past. While surveillance of adverse events following immunization (AEFI) is part of the national immunization program mandate, it suffers from challenges and biases related to reporting, completeness, and quality. Some conditions of concern, termed as adverse events of special interest (AESI) following vaccination, mandated specialised studies to prove/disprove the association. The AEFIs/AESIs are usually caused by one of the four pathophysiologic mechanisms, but for several AEFIs/AESIs, the exact pathophysiology remains elusive. For the causality assessment of AEFIs, a systematic process with checklists and algorithm are followed to classify into one of the four causal association categories. While the causal association primarily banks on epidemiological observations for several AEFIs, the emerging evidences indicate roles of underlying genetic, gender, age and other pro-inflammatory risk factors for AEFIs and AESIs. The emerging evidences suggest role of antigenic mimicry, autoantibody(ies) and underlying genetic susceptibility for the AEFIs/AESIs. The uncertainty about the frequency, profile, interval, and severity of AEFIs/AESIs and variations across the population, ambiguity about the exact pathophysiology mechanism, absence of definite markers, suggest a possible black box effect of the vaccines. Unless these unanswered questions concerning the AEFIs/AESIs are addressed appropriately and communicated to the stakeholders (professionals, care providers, beneficiaries, general public and media), the anti-vaccine movement shall keep challenging the vaccine and vaccination program.