A review on cardiovascular risk in rheumatoid arthritis

A systemic inflammatory disease known as rheumatoid arthritis (RA) is distinguished by excessive cardiovascular disease (CVD) morbidity and death. Traditional CV risk factors may partially contribute to CV disease in RA. Shared inflammatory mediators, post-translational modifications of peptides/proteins and subsequent immune responses, changes in the composition and function of lipoproteins, increased oxidative stress, and endothelial dysfunction are some of the mechanisms that link RA and CVD. The detailed pathogenetic pathway by which this association between RA and CVD might be explained is still not entirely known. It is crucial for controlling cardiovascular risk in people with RA. Optimizing care of traditional risk factors in addition to those inherent to RA is necessary to lessen the burden caused by CVD. The potential effect of planned Cardiac risk management in these individuals is highlighted by findings for under diagnosis and inadequate treatment of conventional CVD risk factors in RA. Present cardiovascular standards suggest RA patients to be examined for and treated for CVD risk factors without appropriate treatment goals. Utilizing potent anti-rheumatic medications that can reduce disease activity and treating the conventional CV risk factors should both be part of the therapy of CV risk in RA. There is currently insufficient scientific data to develop therapy targets for RA-related CVD risk factors. Thus, more study is required on the traditional CVD risk factor screening and management in RA patients.

Vivencias y estrategias comunitarias de manejo del riesgo dentro de las prácticas chemsex: un estudio cualitativo / Community experiences and strategies of risk management within chemsex practices: a qualitative study

Resumen El auge en el estudio del uso sexualizado de drogas entre hombres gais, bisexuales u otros hombres que tienen sexo con hombres (HSH), conocido como chemsex, ha generado una multiplicidad de datos que contribuyen a su problematización en tanto cuestión de salud pública a través del vínculo con el VIH y las adicciones. El estudio de estas prácticas, desde un paradigma biomédico, se ha centrado en el riesgo y ha contribuido a su reducción como fenómeno único y cuantificable. Este estudio tiene como objetivo explorar la vivencia del riesgo en el transcurso de las prácticas, para conocer qué estrategias de manejo emplean frente a éste y de qué manera son generadas. Se realizaron entrevistas semiestructuradas a cinco practicantes de chemsex en el Área Metropolitana de Barcelona y, posteriormente se aplicó un análisis temático. Los hallazgos muestran cómo estos hombres detectan, asumen y enfrentan los riesgos presentes en estas prácticas, donde toman relevancia el tipo de relaciones que allí se dan y el círculo social del que disponen. Este estudio destaca también la creación de estrategias basadas en la experiencia y cómo la transmisión de estos saberes entre participantes facilita la toma de decisiones y el manejo del riesgo.

Abstract The rise in the study of sexualised drug use among gay, bisexual and other men who have sex with men (MSM), known as chemsex, has generated a multiplicity of data that contribute to its problematisation as a public health issue through the link with HIV and addictions. The study of these practices, from a biomedical paradigm, has focused on risk and has contributed to its reduction as a unique and quantifiable phenomenon. This study aims to explore the experience of risk in the course of the practices, to find out what management strategies they employ in the face of risk and how they are generated. Semi-structured interviews were conducted with five chemsex practitioners in the Metropolitan Area of Barcelona and, subsequently, a thematic analysis was applied. The findings show how these men detect, assume and confront the risks present in these practices, where the type of relationships that take place and the social circle available to them are relevant. This study also highlights the creation of strategies based on experience and how the transmission of this knowledge among participants facilitates decision-making and risk management.

Análise da efetividade do grupo de gestantes na modalidade online como ferramenta de aprendizagem gravídico puerperaleral / Analysis of the effectiveness of the online pregnancy group as a pregnancy and puerperal learning tool

Objetivo: Analisar a efetividade do grupo de gestantes na modalidade online como ferramenta de aprendizagem. Método: Estudo epidemiológico, transversal, observacional e descritivo. As participantes foram pacientes que participaram do grupo de gestantes, em um centro de parto normal, na modalidade presencial ou online. Os dados foram coletados através de um questionário estruturado, contendo 16 perguntas fechadas, acerca dos assuntos abordados no curso. Resultado: Verificamos a predominância de maiores acertos de questões no grupo presencial em comparação ao grupo online. Porém, observou-se que a média de acertos do grupo online gira em torno de 12,44 de um total de 16 questões, o que é muito efetivo. Conclusão: O grupo de gestante na modalidade online, se mostra como uma ferramenta efetiva no processo de ensino-aprendizagem, na medida que os ensinamentos e compartilhamentos de informações são absorvidos em sua maioria pelas gestantes.(AU)

Objective: to identify improvement through risk management applied to the acquisition and distribution processes of NPH human insulins. Method: The study was carried out in stages: in the 1st moment, meetings were held (Brainstorming) and in the 2nd moment, an electronic form was elaborated in the form of a questionnaire, showing the risk "events" with the weights inherent to the probability and impact they generated the risk inherent in the acquisition and distribution processes of NPH and Regular human insulins by the Ministry of Health. Results: Considering the processes, there was a higher incidence of medium risks. No very low risk was indicated, no extreme risk was identified and only 02 (two) high risks were presented. Conclusion: The risk management of the aforementioned study is an improvement tool for the processes of acquisition and distribution of NPH and Regular human insulins by the Ministry of Health.(AU)

Objetivo: identificar la mejora a través de la gestión de riesgos aplicada a los procesos de adquisición y distribución de insulinas humanas NPH. Método: El estudio se realizó por etapas: en el 1er momento se realizaron reuniones (Brainstorming) y en el 2do momento se elaboró un formulario electrónico en forma de cuestionario, mostrando los "eventos" de riesgo con los pesos inherentes a la probabilidad e impacto que generaron los riesgos inherentes a los procesos de adquisición y distribución de insulinas humanas NPH y Regular por parte del Ministerio de Salud. Resultados: Considerando los procesos, hubo una mayor incidencia de riesgos medios. No se indicó riesgo muy bajo, no se identificó riesgo extremo y solo se presentaron 02 (dos) riesgos altos. Conclusión: La gestión de riesgos del mencionado estudio es una herramienta de mejora para los procesos de adquisición y distribución de insulina humana NPH y Regular por parte del Ministerio de Salud.(AU)

Gerenciamento do protocolo de prevenção de lesão por pressão: construção de painel de bordo informatizado / Management of the pressure injury prevention protocol: construction of a computerized dashboard / Gestión del protocolo de prevención de lesiones por presión: construcción de panel informatizado

Objetivo: Relatar a construção e implantação de painel de bordo, desenvolvido por enfermeiros e profissionais da tecnologia da informação, para gerenciamento do Protocolo de Prevenção de Lesão por Pressão. Métodos: Trata-se de um relato de experiência sobre a construção e implantação de painel de bordo informatizado para gerenciamento de protocolo em um hospital privado universitário, localizado no interior do estado de São Paulo. Resultados: A construção do painel de bordo foi dividida nas seguintes etapas: revisão e atualização do protocolo, construção do modelo eletrônico e implementação. A divulgação foi realizada pela Comissão de Prevenção de Lesão por Pressão. Conclusão: O painel de bordo possibilitou a visualização rápida e em tempo real dos riscos dos pacientes, intervenções propostas e efetividade das medidas de prevenção, além de promover a integração e empoderamento dos profissionais na gestão do cuidado. (AU)

Objective: To report the construction and implementation of a dashboard, developed by nurses and information technology professionals, to manage the Pressure Injury Prevention Protocol. Methods: This is an experience report on the construction and implementation of a computerized dashboard for protocol management in a private university hospital, located in the interior of the state of São Paulo. Results: The construction of the dashboard was divided into the following steps: review and update of the protocol, construction of the electronic model and implementation. The Pressure Injury Prevention Commission disclosed the tool. Conclusion: The dashboard enabled the quick and real-time visualization of patient risks, proposed interventions and effectiveness of prevention measures, in addition to promoting the integration and empowerment of professionals in the management of care. (AU)

Objetivo: Informar la construcción e implementación de un panel, desarrollado por enfermeras y profesionales de tecnologías de la información, para gestionar el Protocolo de Prevención de Lesiones por Presión. Métodos: Se trata de un informe de experiencia sobre la construcción e implementación de un panel computarizado para la gestión del protocolo en un hospital universitario privado, en el interior del estado de São Paulo. Resultados: La construcción del panel se dividió en los siguientes pasos: revisión y actualización del protocolo, construcción del modelo electrónico e implementación. La divulgación fue realizada por la Comisión de Prevención de Lesiones por Presión. Conclusión: El panel permitió la visualización rápida y en tiempo real de los riesgos del paciente, las intervenciones propuestas y la efectividad de las medidas de prevención, además de promover la integración y el empoderamiento de los profesionales en la gestión del cuidado. (AU)

Implementation effect of PDCA in legal risk management of medical disputes / 现代医院

Objective To explore the implementation effect of PDCA model in medical dispute legal risk management.Methods Conduct research on medical disputes,early warning,and disposal methods before and after PDCA cycle improvement(January 2022 to December 2022)and after PDCA cycle improvement(January 2023 to August 2023).Results Before imple-menting the PDCA model(2022),there were 2 cases(20.00％)of medical disputes among patients in thoracic surgery,head and neck surgery,oncology,and gynecology,as well as 1 case(10.00％)in the radiology group and 1 case(10.00％)in the early diagnosis of urban cancer.After implementing the PDCA model(2023),4 cases occurred and the incidence of medical dis-putes in relevant departments decreased(P＜0.05);There were 28 complaints before the implementation of the PDCA model(2022),and 7 after the implementation of the PDCA model(2023).There was a statistically significant difference(P＜0.05)in the reported departments of thoracic surgery,head and neck surgery,oncology,laboratory,and hospital epidemic prevention and control issues before and after management.Conclusion The PDCA model can improve the ability of medical dispute risk warning and resolution,as well as the quality of risk management work,reduce the incidence rate,and is worth promoting and applying.

Discussion on hot topics and promotion paths for post-market surveillance and supervise of medical consumables based on non-active medical devices / 中国医学装备

Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.

Application of Good Engineering Practice in rabies vaccine engineering projects / 中国生物制品学杂志

@#Good Engineering Practice(GEP)is an engineering practice specifically designed for pharmaceutical engineering projects,aimed at ensuring product quality,patient safety,and Good Manufacturing Practice of Medical Products(GMP).Based on the existing management system,biopharmaceutical engineering,and international engineering project management models of Changchun Institute of Biological Products Co.,Ltd.(referred to as CCIBP),as well as combined with the characteristics of GEP technology,this paper summarizes the construction of GEP system of CCIBP and its application in rabies vaccine engineering projects starting with the key control points such as User Requirement Specification(URS),plan,design,change,quality,and handover,so as to provide technical support and theoretical references for vaccine engineering projects in risk management,organization and control,cost management,innovation and continuous improvement.

Occurrence and Risk Factors of Volume Depletion Requiring Treatment Following SGLT2 Inhibitor Therapy / 医薬品情報学

Objective: Sodium glucose cotransporter 2 inhibitors (SGLT2i) are widely used for diabetes, chronic heart failure, and chronic kidney disease. However, the incidence of volume depletion in patients when pharmacists implement risk-minimization strategies is unknown. Risk factors for volume depletion requiring further treatment have not been investigated in detail. Therefore, we retrospectively investigated the occurrence and risk factors of volume depletion in patients taking SGLT2i. Methods: This study included patients 18 years or older using SGLT2i between November 2014 and December 2021. Patients prescribed an SGLT2i at another hospital who were referred to our clinic where their initial SGLT2i prescription was a continuation prescription, patients who were referred to another medical institution during their 52-week follow-up, patients who discontinued their visits to our clinic or unknown reasons were excluded. The pharmacist provided patients with risk management plan literature at their first provision of an SGLT2 inhibitor. The endpoints were the rate of patients on SGLT2i who experienced volume depletion, rate of hospitalization to treat volume depletion, discontinuation rate, and risk factors. Results: SGLT2i caused volume depletion in 12 patients (0.5 %) and hospitalization in 1 patient (0.04 %), 83.3% of them occurred within 3 months after starting treatment. Risk factors for volume depletion were identified as age ≧ 75 years, renal dysfunction with eGFR less than 60 mL/min/1.73 m2, history of chronic heart failure, and chronic kidney disease. Conclusion: This study revealed risk factors associated with SGLT2i-induced volume depletion, but further investigation is required with an increased number of cases.

A Study on Continuous Risk Management Plan Utilization after Drug Approval: / 医薬品情報学

Objective: In Japan, pharmaceutical manufacturers have been required to develop a Risk Management Plan (RMP) since April 2013. Publication of the RMP is expected to enable the wide content-sharing of post-marketing risk management and its utilization among medical professionals to further enhance and strengthen post-marketing safety measures. In this study, we examined what points should be focused on for continuous utilization of RMPs after drug approvals by investigating the numbers of safety concerns addition of antineoplastic and immunomodulating agents, and where safety concerns added after approval are listed in package inserts. Furthermore, we investigated the reasons why these safety concerns were considered as such. Methods: Antineoplastics and immunomodulating agents, which account for more than half of all drugs containing new active ingredients approved in recent years, among drugs containing new active ingredients approved from fiscal year (FY) 2013 to FY 2019 were included in the study. The safety concerns (excluding important missing information) in RMPs as of April 1, 2021 for the subject drugs were compared with those at the time of approval. Safety concerns added after approval were investigated where they were listed in package inserts as of April 1, 2021. Furthermore, risks that were added as important potential risks were investigated as to why they were considered as such. Results: There were 117 risks added after approval. Those added to the important identified risks were listed in one of the sections of the package insert, whereas 11 risks were added to the important potential risks that could not be confirmed in the package inserts. Some important potential risks added after approval are suspected to have a causal relationship with the drug, but were not listed in the package inserts. Conclusion: It is important to utilize RMPs continuously to further understand risks of taking the drug.

Moderate and severe adverse events in pediatrics: characteristics of incidents reported during the COVID-19 pandemic / Eventos adversos moderados y graves en pediatría: características de los incidentes reportados durante la pandemia del COVID-19 / Eventos adversos moderados e graves em pediatria: características dos incidentes notificados durante a pandemia COVID-19

ABSTRACT Objective: To verify the characteristics of safety incident reports resulting in moderate and severe harm to pediatric patients in two hospitals during the COVID-19 pandemic. Method: Cross-sectional study conducted in two hospitals in southern Brazil. The sample consisted of 137 notifications from March 2020 to August 2021. The data were collected through the electronic records of the institutions' notification systems and analyzed using descriptive and inferential statistics. Results: The most prevalent incidents were related to clinical processes or procedures (41.6%), affecting slightly more females (49.6%) and infants (39.4%). The majority of incidents (48.2%) occurred in inpatient units. The event sector (p=0.001) and the shift (p=0.011) showed statistically significant associations in both hospitals. Conclusion: The characteristics of the notifications are similar between the institutions surveyed, with a low number of moderate and severe incidents.

RESUMEN Objetivo: Verificar las características de los informes de incidentes de seguridad que resultaron en daños moderados y graves a pacientes pediátricos en dos hospitales durante la pandemia de COVID-19. Método: Estudio transversal realizado en dos hospitales del sur de Brasil. La muestra consistió en 137 notificaciones entre marzo de 2020 y agosto de 2021. Los datos se recogieron a través de los registros electrónicos de los sistemas de notificación de las instituciones y se analizaron mediante estadística descriptiva e inferencial. Resultados: Los incidentes más prevalentes estuvieron relacionados con procesos o procedimientos clínicos (41,6%), afectando ligeramente más a mujeres (49,6%) y lactantes (39,4%). La mayoría de los incidentes (48,2%) se produjeron en unidades de hospitalización. El sector del suceso (p=0,001) y el turno (p=0,011) se asociaron de forma estadísticamente significativa en ambos hospitales. Conclusión: Las características de las notificaciones son similares entre las instituciones encuestadas, con un bajo número de incidentes moderados y graves.

RESUMO Objetivo: Verificar as características das notificações de incidentes de segurança resultantes em dano moderado e grave em pacientes pediátricos de dois hospitais durante a pandemia COVID-19. Método: Estudo transversal, realizado em dois hospitais no sul do Brasil. A amostra foi composta por 137 notificações correspondentes ao período de março de 2020 a agosto de 2021. Os dados foram coletados pelo registro eletrônico dos sistemas de notificação das instituições e analisados por estatística descritiva e inferencial. Resultados: Os incidentes mais prevalentes foram relacionados aos processos ou procedimentos clínicos (41,6%), acometeram discretamente mais o sexo feminino (49,6%) e lactentes (39,4%). A maioria dos incidentes (48,2%) ocorreram em unidades de internação. O setor do evento (p=0,001) e o turno (p=0,011) obtiveram associação estatística significativa nos dois hospitais. Conclusão: As características das notificações são semelhantes entre as instituições pesquisadas, sendo evidenciado baixo número de incidentes moderados e graves.

Panorama dos incidentes de segurança envolvendo pacientes pediátricos em um hospital universitário / Overview of safety incidents involving pediatric patients at a university hospital / Panorama de los incidentes de seguridad de los pacientes pediátricos en un hospital universitario

RESUMO: Objetivo: analisar o perfil e as características dos incidentes de segurança ocorridos entre 2015 e 2019 com pacientes pediátricos notificados no sistema informatizado de um hospital universitário. Método: estudo quantitativo, descritivo, transversal, com 2.558 notificações em instituição do sul do Brasil. Estatística descritiva e teste qui-quadrado foram utilizados para a análise dos dados. Resultados: ocorrência maior de incidentes de segurança relacionada a medicações/fluidos intravenosos (n=643; 25,1%), dieta/alimentação (n=448; 17,5%), processo/procedimento clínico (n=384; 15,0%), dispositivos/equipamentos médicos (n=304; 11,9%), acidentes do paciente (n=273; 10,7%). Unidades de internação e terapia intensiva estão mais relacionadas à ocorrência de incidentes; turno de trabalho não esteve relacionado ao tipo de incidente notificado. Conclusão: o panorama dos incidentes de segurança pode nortear estratégias para a qualificação do cuidado na instituição em estudo e colaborar com outros serviços de saúde na identificação de situações de risco para a criança hospitalizada.

ABSTRACT Objective: To analyze the profile and characteristics of safety incidents that occurred between 2015 and 2019 with pediatric patients reported in the computerized system of a university hospital. Method: quantitative, descriptive, cross-sectional study with 2,558 notifications at an institution in southern Brazil. Descriptive statistics and the chi-square test were used to analyze the data. Results: higher occurrence of safety incidents related to medications/intravenous fluids (n = 643; 25.1%), diet/food (n = 448; 17.5%), clinical process/procedure (n = 384; 15.0%), medical devices/equipment (n = 304; 11.9%), and patient accidents (n = 273; 10.7%). Inpatient and intensive care units are more related to the occurrence of incidents; work shifts were not related to the type of incident reported. Conclusion: The overview of safety incidents can guide strategies for improving care in the institution under study and collaborate with other health services in identifying risk situations for hospitalized children.

RESUMEN: Objetivo: analizar el perfil y las características de los incidentes de seguridad ocurridos entre 2015 y 2019 con pacientes pediátricos notificados en el sistema informatizado de un hospital universitario. Método: estudio cuantitativo, descriptivo, transversal, de 2.558 notificaciones en una institución del sur de Brasil. Para el análisis de los datos se utilizó estadística descriptiva y la prueba de chi-cuadrado. Resultados: mayor incidencia de incidentes de seguridad relacionados con medicamentos/líquidos intravenosos (n=643; 25,1%), dieta/alimentación (n=448; 17,5%), proceso clínico/procedimiento (n=384; 15,0%), dispositivos/equipos médicos (n=304; 11,9%), accidentes de pacientes (n=273; 10,7%). Las unidades de hospitalización y de cuidados intensivos están más relacionadas con la aparición de incidentes; el turno de trabajo no estaba relacionado con el tipo de incidente notificado. Conclusión: el panorama de los incidentes de seguridad puede orientar estrategias para mejorar la atención en la institución estudiada y colaborar con otros servicios de salud en la identificación de situaciones de riesgo para los niños hospitalizados.

A contribuição de terapeutas ocupacionais no domínio da gestão de risco e desastres: um protocolo de revisão de escopo / Contribution of occupational therapists to the field of risk and disaster management: a scoping review protocol

Resumo Introdução Desastres trazem consequências humanas, socioeconômicas e ambientais e agravam situações de vulnerabilidade. Tanto países centrais, altamente industrializados, como países com dificuldades econômicas estão sujeitos a esses eventos. No Brasil, a pandemia de COVID-19 e o rompimento de barragens evidenciam dificuldades em se antecipar e responder esses tipos de eventos. Ações da terapia ocupacional no campo das emergências e desastres são escassas na literatura, notadamente na esfera da prevenção. Objetivo Explorar as evidências da contribuição de terapeutas ocupacionais no domínio da gestão de risco e desastres a partir das características, prioridades e principais áreas de interesse da produção intelectual em terapia ocupacional. Método Uma pesquisa abrangente será conduzida nos periódicos Disasters, Hazards & Crisis in Public Policy, International Journal of Mass Emergencies and Disasters, and Risk, International Journal of Risk Reduction e Journal of Contingencies and Crisis Management, assim como nas bases de dados Occupational Therapy Literature Search Service (OTDBASE), PubMed e Web of Science. Critérios de inclusão Ações e experiências no âmbito da terapia ocupacional, notadamente aquelas de terapeutas ocupacionais na gestão de riscos e desastres, encontradas em estudos revisados por pares, que adotem métodos quantitativos, qualitativos e mistos, nos idiomas espanhol, inglês e português, sem restrição temporal. A abordagem preconizada pelo Joanna Briggs Institute (JBI) para seleção de estudos, avaliação crítica, extração e síntese de dados será utilizada.

Abstract Introduction Disasters bring human, socioeconomic, and environmental consequences and exacerbate situations of vulnerability. Both highly industrialized core countries and those facing economic difficulties are subject to these events. In Brazil, the COVID-19 pandemic and the collapse of dams highlight difficulties in anticipating and responding to these types of events. Actions of occupational therapy in the field of emergencies and disasters are scarce in the literature, notably in the sphere of prevention. Objective To explore the evidence of the contribution of occupational therapists in the field of risk management and disasters based on the characteristics, priorities, and main areas of interest of intellectual production in occupational therapy. Method A comprehensive search will be conducted in the journals Disasters, Hazards & Crisis in Public Policy, International Journal of Mass Emergencies and Disasters, and Risk, International Journal of Risk Reduction, and Journal of Contingencies and Crisis Management, as well as in the databases Occupational Therapy Literature Search Service (OTDBASE), PubMed, and Web of Science. Inclusion Criteria Actions and experiences in the field of occupational therapy, notably those of occupational therapists in risk and disaster management, found in peer-reviewed studies adopting quantitative, qualitative, and mixed methods, in Spanish, English, and Portuguese, without temporal restriction. The approach advocated by the Joanna Briggs Institute (JBI) for study selection, critical appraisal, and data collection and synthesis will be used.

Impact of a research-action on vaccination indicators in the state of Minas Gerais, Brazil / Impacto de uma pesquisa-ação nos indicadores vacinais em Minas Gerais

ABSTRACT OBJECTIVE Analyze the impact of the state research-action project on immunization indicators (vaccination coverage - VC, homogeneity of vaccination coverage - HVC, dropout rate - DR, and risk rating) before and after the intervention in municipalities and priority Regional Health Administrations/Regional Health Superintendencies (RHA/RHS). METHODS The state research-action project was a before-after community clinical trial conducted in 212 municipalities belonging to eight RHA/RHS in the state of Minas Gerais, Brazil. The study sample comprised RHA/RHS with a decreasing trend for routine vaccination coverage in children under one year from 2015 to 2020. This study used secondary VC and DR data from 10 immunobiologicals recommended for children younger than two years from January to December 2021 (pre-intervention period, prior to the state research-action project) and from January to December 2022 (post-intervention period). The categorical variables were presented in proportions, and initially, a comparison was made between those of DR, HVC, and the risk rating for the transmission of vaccine-preventable diseases, according to the two periods (2021 and 2022), using the McNemar test. RESULTS All immunization indicators increased after conducting the research-action project. In 2021, 80.66% of the state's municipalities had a risk rating for the transmission of vaccine-preventable diseases as "high and very high." In 2022, the value reduced to 68.40%. CONCLUSIONS Risk rating for the transmission of vaccine-preventable diseases is an important mechanism to assist managers in defining priorities. The state research-action project used a method that enabled the construction and execution of unique action plans for each municipality, directing the improvement of immunization indicators in the state.

RESUMO OBJETIVO Analisar o impacto do projeto estadual de pesquisa-ação nos indicadores de imunização (coberturas vacinais - CV, homogeneidade de cobertura vacinal - HCV, taxa de abandono - TA e classificação de risco) antes e após a intervenção em municípios e Gerências Regionais de Saúde/Superintendências Regionais de Saúde (GRS/SRS) prioritários. MÉTODOS O projeto estadual de pesquisa-ação foi um ensaio clínico comunitário, do tipo antes-depois, realizado em 212 municípios pertencentes a oito GRS/SRS do estado de Minas Gerais, Brasil. Compuseram a amostra do estudo as SRS/GRS com tendência decrescente para a cobertura vacinal de rotina em crianças menores de 1 ano, no período de 2015 a 2020. Neste estudo, foram utilizados dados secundários de CV e TA de 10 imunobiológicos recomendados para crianças menores de 2 anos, no período de janeiro a dezembro de 2021 (período pré-intervenção, anterior ao projeto estadual de pesquisa-ação) e de janeiro a dezembro de 2022 (período pós-intervenção). As variáveis categóricas foram apresentadas em proporções e, inicialmente, realizou-se a comparação entre as de TA, HCV e a classificação de risco para a transmissão de doenças imunopreveníveis, segundo os dois períodos (2021 e 2022), utilizando-se o teste McNemar. RESULTADOS Observou-se um aumento de todos os indicadores de imunização após a realização do projeto de pesquisa-ação. No ano de 2021, 80,66% dos municípios do estado tiveram a classificação de risco para transmissão de doenças imunopreveníveis como "alto e muito alto risco". Em 2022, o valor foi reduzido para 68,40%. CONCLUSÕES A classificação de risco para transmissão de doenças imunopreveníveis é um mecanismo importante para auxiliar os gestores na definição de prioridades. O projeto estadual de pesquisa-ação empregou um método que possibilitou a construção e a execução de planos de ação singulares a cada município, direcionando a melhoria dos indicadores de imunização no estado.

Avaliação da atuação da gestão em saúde no desastre-crime de derramamento de petróleo na costa do estado do Pernambuco / Assessment of health management performance in the oil spill disaster crime on the coast of the state of Pernambuco

RESUMO Este estudo objetivou analisar as ações desenvolvidas pela gestão de saúde no enfrentamento do desastre-crime de derramamento de petróleo na costa pernambucana em 2019. Trata-se de estudo de caso que investigou a atuação do setor saúde em quatro municípios de Pernambuco. A coleta de dados foi mediante entrevistas com 16 gestores de secretarias de saúde (municipal e estadual), utilizando roteiro semiestruturado com perguntas sobre atuação, impactos, ações desenvolvidas, dificuldades, desafios e lições aprendidas. A análise do Discurso do Sujeito Coletivo evidenciou quatro eixos temáticos: a) percepção dos gestores sobre os impactos do desastre-crime; b) ações desenvolvidas no processo de gestão de risco do desastre-crime pelo setor saúde; c) dificuldades enfrentadas no processo de mitigação do desastre; d) avaliação das ações da gestão durante o desastre-crime e preparação futura. Identificaram-se fragilidades da gestão em saúde nas ações de mitigação do desastre, resultado da falta de preparo dos serviços e dos profissionais de saúde. A falta de instrumentos e a desarticulação entre os entes federados intensificaram as dificuldades, gerando situações de calamidade no território. Isso aponta para a necessidade de construção de instrumentos e protocolos que guiem tais ações nessas situações, para que as atividades sejam desenvolvidas com mais eficiência e eficácia.

ABSTRACT This study aimed to analyze the actions taken by health management to deal with the criminal disaster of an oil spill off the coast of Pernambuco in 2019. It is a case study investigating the health sector's actions in four municipalities in Pernambuco. Data was collected through interviews with 16 health department managers (municipal and state), using a semi-structured script with questions about performance, impacts, actions taken, difficulties, challenges, and lessons learned. The Collective Subject Discourse analysis revealed four thematic axes: a) managers' perception of the impacts of the crime disaster; b) actions taken in the process of risk management of the disaster crime by the health sector; c) difficulties faced in the process of mitigating the disaster; d) evaluation of management actions during the disaster crime and future preparation. Weaknesses in health management were identified in disaster mitigation actions due to the need for more preparation of health services and professionals. The lack of instruments and coordination between the federated entities intensified the difficulties, generating calamity in the territory. This points to the need to build instruments and protocols to guide such actions in these situations so that activities can be carried out more efficiently and effectively.

Adaptação transcultural e validação do instrumento "Violence Risk Screening-10 (V-RISK-10)" para a versão brasileira: "Rastreio do Risco de Violência-10" / Cross-cultural adaptation and validation of the "Violence Risk Screening-10 (V-RISK-10)" instrument for the Brazilian version: "Rastreio do Risco de Violência-10"

Introdução: "Violence Risk Screening-10" (V-Risk-10) é um instrumento de gestão do risco de violência (GRV) em saúde mental para pacientes com transtornos mentais graves (TMG). Tem como objetivo identificar brevemente os pacientes mais suscetíveis à agitação psicomotora e a partir desta percepção, elaborar proposta de plano de cuidado. Foi desenvolvido na Noruega e para utilizá-lo no Brasil, é necessário que seja realizada a adaptação transcultural (ATC) e a validação do instrumento. Para isto, adequa-se o conteúdo à linguagem e ao contexto do grupo social que será beneficiado, seguido de análises estatísticas que comprovem a precisão do instrumento. Objetivo: descrever o processo da ATC e validação do V-Risk-10 para a cultura brasileira com a elaboração final do instrumento "Rastreio do Risco de Violência-10". Método: estudo de ATC composto pelas etapas de análise conceitual e semântica; avaliação por comitê de juízes e proposição final do instrumento. Para realizar o estudo de validação, é necessário avaliar a confiabilidade e precisão, utilizando a medida estatística Kappa de Cohen, que mensura a concordância entre dois avaliadores independentes. Resultados: o estudo gerou o instrumento de GRV "Rastreio do Risco de Violência­10", versão da V-Risk-10 adaptada ao português/Brasil, para ser utilizada em pacientes com transtorno mental grave. Conclusão: a ferramenta adaptada apresenta conteúdo concordante ao cenário brasileiro, constituindo um apoio para a GRV em pacientes com TMG, de fácil e rápida operacionalização. A mediana geral do instrumento apresentou coeficiente Kappa 0,83, que significa elevada confiabilidade do instrumento em geral.

Introduction: Violence Risk Screening-10 (V-Risk-10) is a violence risk management (VRM) tool in mental health for patients with severe mental disorders (SMD). Its aim is to briefly identify most susceptible patients to psychomotor agitation and, based on this perception, develop a proposed care plan. It was developed in Norway, and to use it in Brazil, cross-cultural adaptation (CCA) and validation of the instrument are necessary. This involves adapting the content to the language and context of the social group that will benefit, followed by statistical analyses to prove the instrument's accuracy. Objective: To describe the process of CCA and validation of V-Risk-10 for Brazilian culture, with the final development of "Rastreio do Risco de Violência-10" instrument. Method: CCA study consisting of conceptual and semantic analysis stages; evaluation by a panel of judges; and final proposition of the instrument. To conduct the validation study, it is necessary to assess reliability and accuracy using Cohen's Kappa statistical measure, which assesses agreement between two independent raters. Results: The study generated "Rastreio do Risco de Violência-10" instrument, a version of V-Risk-10 adapted to Portuguese/Brazilian for use in patients with severe mental disorder. Conclusion: The adapted tool presents content consistent with the Brazilian scenario, providing support for violence risk management in patients with SMD, with easy and quick operationalization. The overall median of the instrument showed a Kappa coefficient of 0.83, indicating high reliability of the instrument overall. Keywords: Cross-Cultural Adaptation. Validation. V-Risk-10. Portuguese. Brazil. Risk Management. Violence. Mental Health.

Instrumento brasileiro para investigação de eventos adversos na saúde: estudo de validação / Instrumento brasileño para investigación de eventos adversos en salud: estudio de validación / Brazilian instrument for investigating adverse events in health: validation study

Resumo Objetivo Construir o instrumento brasileiro para investigação de eventos adversos em saúde e avaliar as evidências da validade de conteúdo e o processo de resposta. Métodos Este estudo psicométrico foi realizado conforme o Standards for Education and Psychological Testing e conduzido nas seguintes etapas: busca por evidências da validade de conteúdo e do processo de resposta. Na evidência de conteúdo participaram 46 especialistas de todas as regiões do Brasil. No processo de resposta, participaram 76 profissionais de 31 instituições de saúde. Foi usado o programa Statistical Package for the Social Sciences para distribuição de variáveis quantitativas e síntese, via cálculo de estatísticas descritivas. Na etapa de evidência de conteúdo, foi usado o Content Validity Ratio (CVR) aceitável maior que o CVR crítico esperado para N juízes; neste estudo, foi usado o CVR crítico de 0,35. Já o grupo focal foi realizado para o processo de resposta. Resultados No total, 46 especialistas participaram na etapa de validação de conteúdo, predominantemente enfermeiros de formação (84,8%) formados há 11 anos (60,7%) ou mais. Os resultados obtidos na validação de conteúdo para cada nível foram: nivel I apresentou um CVR: 0,88, nível II 0,76 e nível III 0,97. Já na etapa de processo de resposta, foram realizados ajustes na nomenclatura e encadeamento das etapas. Conclusão Foi possível construir e validar o primeiro Instrumento Brasileiro para Investigação de Eventos Adversos na Saúde com as fontes necessárias para assegurar o conteúdo e processo de resposta, considerando as melhores evidências articuladas com as referências nacionais e internacionais, permitindo o aprimoramento dos sistemas de investigação para instituições de saúde privadas e públicas.

Resumen Objetivo Elaborar un instrumento brasileño para la investigación de eventos adversos en salud y evaluar las evidencias de la validez de contenido y el proceso de respuesta. Métodos Este estudio psicométrico fue realizado de acuerdo con el Standards for Education and Psychological Testing y cumplió las siguientes etapas: búsqueda de evidencias de la validez de contenido y del proceso de respuesta. En la evidencia de contenido participaron 46 especialistas de todas las regiones de Brasil. En el proceso de respuesta, fueron 76 profesionales de 31 instituciones de salud. Se utilizó el programa Statistical Package for the Social Sciences para la distribución de variables cuantitativas y síntesis, a través del cálculo de estadísticas descriptivas. En la etapa de evidencia de contenido, se utilizó el Content Validity Ratio (CVR) aceptable más alto que el CVR crítico esperado para N jueces. En este estudio, el CVR crítico usado fue 0,35. Para el proceso de respuesta, se realizó un grupo focal. Resultados En total, participaron 46 especialistas en la etapa de validación de contenido, predominantemente enfermeros de formación (84,8 %) graduados hace 11 años (60,7 %) o más. Los resultados obtenidos en la validación de contenido de cada nivel fueron: CVR 0,88 en el nivel I, 0,76 en el nivel II y 0,97 en el nivel III. En la etapa de proceso de respuesta, se realizaron ajustes en la nomenclatura y en la concatenación de las etapas. Conclusión Fue posible elaborar y validar el primer Instrumento Brasileño para la Investigación de Eventos Adversos en Salud, con las fuentes necesarias para garantizar el contenido y el proceso de respuesta, y las mejores evidencias conectadas con las referencias nacionales e internacionales, lo que permite la mejora de los sistemas de investigación para instituciones de salud públicas y privadas.

Abstract Objective To build the Brazilian instrument for investigating adverse health events and evaluate the evidence of content validity and the response process. Methods This psychometric study was conducted according to the Standards for Education and Psychological Testing in the following stages: search for evidence of content validity and response process. In the content evidence, 46 experts from all regions of Brazil participated. In the response process, 76 professionals from 31 health institutions participated. The Statistical Package for the Social Sciences program was used for the distribution of quantitative variables and synthesis, via the calculation of descriptive statistics. In the content evidence stage, the acceptable Content Validity Ratio (CVR) greater than the expected critical CVR for N judges was used; the critical CVR of 0.35 was used in this study. The focus group has been performed for the response process. Results In total, 46 experts participated in the content validation stage, predominantly training nurses (84.8%), and nurses who graduated 11 years ago (60.7%) or more. The results obtained for each level in content validation were as follows: levels I, II, and III respectively presented the following CVR values: 0.88, 0.76, and 0.97. In the response process stage, adjustments to the nomenclature and sequence of steps were performed. Conclusion Building and validating the first Brazilian Instrument for Investigating Adverse Events in Health was possible with the necessary sources to ensure the content and response process. The best evidence articulated with national and international references was considered, making it possible to improve investigation systems in private and public health institutions.

Safety of nursing professionals and patient facing COVID-19 pandemic in critical care unit / Segurança dos profissionais de enfermagem e do paciente frente à pandemia da COVID-19 em unidades críticas / Seguridad de los profesionales de enfermería y del paciente ante la pandemia de COVID-19 en unidades críticas

Abstract Objective: to evaluate nursing professionals and patient safety culture during the professional performance in the care of suspected or infected patients with COVID-19. Method: a cross-sectional study carried out with 90 professionals from critical care units of two teaching hospitals. An instrument for sociodemographic characterization and health conditions was used, in addition to the constructs "Nursing professional and patient safety" and the Hospital Survey on Patient Safety Culture. Univariate analyzes were performed between the diagnosis of COVID-19 and the characteristics of Nursing professionals, applying Kendell's correlation between the constructs. Results: the COVID-19 diagnosis presented a significant statistical difference between nursing professionals that worked for more than six years at the critical care unit (p=0.020) and the items of the construct "Nursing professional and patient safety" regarding the doubts about how to remove the personal protective equipment (p=0.013) and safety flow (p=0,021). The dimensions 2 (p=0.003), 3 (p=0.009), 4 (p=0.013), 6 (p<0.001), and 9 (p=0.024) of the Hospital Survey on Patient Safety Culture were associated with the accomplishment of training. Conclusion: a higher professional nursing experience time was associated with non-infection by COVID-19. The perception of the safety culture of the patient was related to the accomplishment of training.

Resumo Objetivo: avaliar a segurança dos profissionais de enfermagem e a cultura de segurança do paciente durante a atuação profissional no atendimento de pacientes suspeitos ou com COVID-19. Método: estudo transversal realizado com 90 profissionais de unidades críticas de dois hospitais-escola. Foi utilizado um instrumento para caracterização sociodemográfica e condições de saúde, além dos constructos "Segurança do profissional e do paciente" e Hospital Survey on Patient Safety Culture. Foram realizadas análises univariadas entre o diagnóstico de COVID-19 e as características dos profissionais, aplicando-se a correlação de Kendell entre os constructos. Resultados: o diagnóstico de COVID-19 apresentou diferença estatisticamente significativa entre os profissionais que trabalhavam há mais de seis anos na unidade (p=0,020) e os itens do constructo "Segurança do profissional e do paciente" referentes às dúvidas sobre como retirar o equipamento de proteção individual (p=0,013) e fluxo seguro (p=0,021). As dimensões 2 (p=0,003), 3 (p=0,009), 4 (p=0,013), 6 (p<0,001) e 9 (p=0,024) do Hospital Survey on Patient Safety Culture foram associadas à realização de treinamentos. Conclusão: maior tempo de experiência profissional do profissional de enfermagem esteve associado a não infecção por COVID-19. A percepção de cultura de segurança do paciente esteve relacionada à realização de treinamentos.

Resumen Objetivo: evaluar la seguridad de los profesionales de enfermería y la cultura de seguridad del paciente durante su actuación profesional en el cuidado de pacientes sospechosos o con COVID-19. Método: estudio transversal realizado con 90 profesionales de unidades críticas de dos hospitales universitarios. Se utilizó un instrumento de caracterización sociodemográfica y de condiciones de salud, además de los constructos "Seguridad del profesional y del paciente" y Hospital Survey on Patient Safety Culture. Se realizaron análisis univariados entre el diagnóstico de COVID-19 y las características de los profesionales y se aplicó la correlación de Kendell entre los constructos. Resultados: el diagnóstico de COVID-19 mostró diferencia estadísticamente significativa entre los profesionales que actuaron por más de seis años en la unidad (p=0,020) y los ítems del constructo "Seguridad del profesional y del paciente" referentes a dudas sobre cómo retirar el Equipo de Protección Personal (p=0,013) y flujo seguro (p=0,021). Las dimensiones 2 (p=0,003), 3 (p=0,009), 4 (p=0,013), 6 (p<0,001) y 9 (p=0,024) del Hospital Survey on Patient Safety Culture se asociaron a la realización de formación. Conclusión: mayor tiempo de experiencia profesional de enfermería se asoció con la no infección por COVID-19. La percepción de la cultura de seguridad del paciente se relacionó con la realización de entrenamiento.

Determinantes de la gestión del riesgo en salud en el Régimen Subsidiado en Colombia: estudio cualitativo

Introducción: El Régimen Subsidiado (RS) del sistema de salud colombiano tiene problemáticas estructurales que no han sido solucionadas y son pocos los estudios que profundizan en la explicación de estas. Objetivo: Explorar la experiencia en la dirección estratégica y gestión operativa y financiera de este régimen, sus aspectos operativos y de gestión del riesgo en esta población, así como las diferencias percibidas frente al Régimen Contributivo. Metodología: Estudio cualitativo. Se utilizó el análisis del discurso desde la perspectiva sociohermenéutica como técnica analítica. Se entrevistaron diez participantes, entre directivos de aseguradoras del RS y gestores del sistema de salud. Las entrevistas fueron grabadas y anonimizadas, previo consentimiento informado. Resultados: Emergen tres patrones discursivos que explican la gestión del riesgo en el RS y su diferenciación con el contributivo. Estos patrones se conectan por medio del rol de los determinantes sociales de la salud como ordenador principal de los procesos de salud-enfermedad y de atención en este régimen. A su vez, estas condiciones de vida son las que determinan de manera importante el perfil epidemiológico, acceso, costo de la atención y en general la forma cómo se consumen los servicios de salud por la población afiliada. Discusión: La literatura del aseguramiento en salud reporta que la gestión del riesgo es una función central y supone un ejercicio estratégico para el adecuado manejo de la siniestralidad para optimizar el uso de la Unidad de Pago por Capitación (UPC) asignada. Los hallazgos muestran que los determinantes sociales de la salud no están siendo tenidos en cuenta como ordenador para la atención, por lo tanto, la gestión del riesgo se centra en la atención de patologías en estados avanzados. Conclusiones: los actores perciben que en general, la situación de salud de los afiliados en este régimen es más grave, más complicada y con mayor carga, lo cual genera una tensión en materia de suficiencia de la unidad per cápita. Existe una ausencia discursiva sobre el rol del modelo de atención y su correlación con las necesidades de esta población.

Introduction: The subsidized regime (SR) of the Colombian health system has structural problems that have not yet been resolved and there is a lack of studies that allow the understanding of most of them. The aim of this study was to explore with stakeholders of the subsidized regime the experience about strategic, financial, and health risk management and the differences perceived with the contributory regime. Methods: A qualitative study was performed; the analytic technique used was the discourse analysis under socio-hermeneutic perspective. 10 participants were interviewed, among them directors of insurance companies of SR and health care system managers. The interviews were recorded, prior informed consent, and analyzed according to the discourse analysis. Finding: Three discursive patterns emerged that explain risk management in SR and its differentiation from contributory regime. These patterns are connected through the role of the social determinants of health as the main axis that explain the health-disease and care processes in this regimen. At the same time, these living conditions are what determine the epidemiological profile, access, cost of care and, in general, the way in which health services are consumed by the affiliated population. Discussion: The health insurance literature reports that risk management is a central function, and it is a strategic exercise for the proper management of claims to optimize the use of resources, however, the findings show that the social determinants of health are not being taken into account as a key element for healthcare organization, therefore, risk management focuses on care for pathologies in advanced stages. Conclusions: The actors perceive that the health situation in this regime is more severe, more complicated and with a greater burden disease, which generates a tension in terms of sufficiency of the Per Capita Unit. There is a discursive absence on the role of the care model and its correlation with the needs of this population.

Administração de anti-infecciosos em pacientes críticos: gestão proativa de riscos / Administration of anti-infectives in critically ill patients: proactive risk management / Administración de antiinfecciosos en pacientes críticos: gestión proactiva del riesgo

Objetivo: analisar a gestão de riscos proativa do processo de administração de anti-infecciosos em Unidade de Terapia Intensiva. Método: estudo qualitativo, em pesquisa-ação, com observação participante e grupo focal, realizado de 2019 a 2021. Foi mapeado o processo, analisados os riscos, planejadas ações de melhorias e redesenhado o processo. Resultados: a prescrição ocorria em sistema eletrônico e os registros da administração em impressos. O processo de administração de anti-infecciosos possuía 19 atividades, dois subprocessos, 16 modos de falhas e 23 causas potenciais. Os modos de falhas foram relacionados à assepsia e erro de dose no preparo de anti-infecciosos e as causas apontadas foram a falha humana na violação das técnicas e o lapso de memória. Cinco especialistas redesenharam o processo resultando em alterações de atividades e no sistema. Conclusão: a gestão de riscos proativa aplicada ao processo de administração de anti-infecciosos propiciou identificar riscos, suas causas e priorizar ações de melhorias, o que pode viabilizar tomadas de decisões apropriadas(AU)

Objective: to analyze the proactive risk management of the anti-infective administration process in an Intensive Care Unit. Method: qualitative study, in action research, with participant observation and focus group, from 2019 to 2021. The process was mapped, risks analyzed, improvement actions planned and the process redesigned. Results: the prescription occurred in an electronic system and the administration records in printed form. The anti-infective administration process had 19 activities, two sub-processes, 16 failure modes and 23 potential causes. The failure modes were related to asepsis and dose error in the preparation of anti-infectives and the identified causes were human error in violating techniques and memory lapse. Five specialists redesigned the process resulting in changes in activities and in the system. Conclusion: proactive risk management applied to the anti-infective administration process was effective in identifying risks, their causes and prioritizing improvement actions(AU)

Objetivo: analizar la gestión proactiva de riesgos del proceso de administración de antiinfecciosos en una Unidad de Cuidados Intensivos. Método: estudio cualitativo, en investigación-acción, con observación participante y grupo focal, que tuvo lugar del 2019 al 2021. Se mapeó el proceso, se analizaron los riesgos, se planificaron acciones de mejora y se rediseñó el proceso. Resultados: la prescripción ocurrió en sistema electrónico y los registros de administración en forma impresa. El proceso de administración de antiinfecciosos tuvo 19 actividades, dos subprocesos, 16 modos de falla y 23 causas potenciales. Los modos de falla estuvieron relacionados con la asepsia y error de dosis en la preparación de antiinfecciosos y las causas identificadas fueron error humano por violación de técnicas y lapsus de memoria. Cinco especialistas rediseñaron el proceso generando cambios en las actividades y en el sistema. Conclusión: la gestión proactiva de riesgos aplicada al proceso de administración de antiinfecciosos fue efectiva para identificar riesgos, sus causas y priorizar acciones de mejora, lo que puede factibilizar la toma de decisiones adecuadasa(AU)