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Abstract:Objective: To characterize adverse events in cells, tissue, and organs donation, and transplantation notified in the state of São Paulo, Brazil. Method: Descriptive study with quantitative approach. Data provided by Transplantation Central of São Paulo from the “Individual notification form of adverse reactions in Biovigilance”, of the FormSUS platform, between 2016 and 2019, and categorized according to the nomenclature recommended by the World Health Organization regarding nature and type of event, severity, and imputability. Analysis was performed using descriptive statistics. Results: Fifty-two notifications were characterized, 90.4% related to the recipient, 78.8% from allogeneic procedures, 48.2% related to organs, and 44.2% to hematopoietic stem cells. The causes of notifications were infections (55.7%), other ones (30.8%), and neoplasms (13.5%). Most of the events were moderate (44.3%), and 36.5% were confirmed. Conclusion: It was possible to identify the scenario of biovigilance in the state, visualizing that the main adverse events are related to the receptor from allogeneic procedures. In addition, the major cause of adverse events in the state of São Paulo are infections, especially those caused by Mycobacterium tuberculosis and Klebsiellapneumoniae. The characterization of these events can support the development of safety strategies to prevent recurrence, the realization of institutional training and public policies to encourage notification and expand the understanding of adverse events in this scenario, since it is only possible to ensure quality and safety in health care, especially in the context of donations and transplants, from the recognition of reality.
Abstract:Objective: To characterize adverse events in cells, tissue, and organs donation, and transplantation notified in the state of São Paulo, Brazil. Method: Descriptive study with quantitative approach. Data provided by Transplantation Central of São Paulo from the “Individual notification form of adverse reactions in Biovigilance”, of the FormSUS platform, between 2016 and 2019, and categorized according to the nomenclature recommended by the World Health Organization regarding nature and type of event, severity, and imputability. Analysis was performed using descriptive statistics. Results: Fifty-two notifications were characterized, 90.4% related to the recipient, 78.8% from allogeneic procedures, 48.2% related to organs, and 44.2% to hematopoietic stem cells. The causes of notifications were infections (55.7%), other ones (30.8%), and neoplasms (13.5%). Most of the events were moderate (44.3%), and 36.5% were confirmed. Conclusion: It was possible to identify the scenario of biovigilance in the state, visualizing that the main adverse events are related to the receptor from allogeneic procedures. In addition, the major cause of adverse events in the state of São Paulo are infections, especially those caused by Mycobacterium tuberculosis and Klebsiellapneumoniae. The characterization of these events can support the development of safety strategies to prevent recurrence, the realization of institutional training and public policies to encourage notification and expand the understanding of adverse events in this scenario, since it is only possible to ensure quality and safety in health care, especially in the context of donations and transplants, from the recognition of reality.
Resumen:Objetivo: Caracterizar los eventos adversos en la donación y trasplante de células, tejidos y órganos informados en el estado de São Paulo. Método: Estudio descriptivo con enfoque cuantitativo. Los datos fueron proporcionados por el Centro Estatal de Trasplantes del estado de São Paulo, a partir del “Formulario de notificación individual de reacciones adversas en Biovigilancia” de la plataforma FormSUS entre 2016 y 2019. Categorizados según la nomenclatura recomendada por la Organización Mundial de la Salud en cuanto a: naturaleza y tipo de evento, gravedad y imputabilidad. Análisis realizado mediante estadística descriptiva. Resultados: se caracterizaron 52 notificaciones, 90,4% relacionadas con el receptor, 78,8% de procedimientos alogénicos, 48,2% relacionadas con órganos y 44,2% con células madre hematopoyéticas. Las causas de notificación fueron infecciones (55,7%), otras causas (30,8%) y neoplasias (13,5%). La mayoría de los eventos informados tuvieron resultados moderados (44,3 %) y el 36,5 % de los informes se consideraron confirmados. Conclusión: Se logró identificar el escenario de biovigilancia en el estado, visualizando que los principales eventos adversos están relacionados al receptor de procedimientos alogénicos. Además, la mayor causa de eventos adversos en el estado de São Paulo son las infecciones, especialmente las causadas por M. tuberculosis y K. pneumoniae. La caracterización de estos eventos puede apoyar el desarrollo de estrategias de seguridad para prevenir la recurrencia, la realización de capacitaciones institucionales y políticas públicas para incentivar la notificación y ampliar la comprensión de los eventos adversos en este escenario. Ya que sólo es posible garantizar la calidad y la seguridad en la atención sanitaria, especialmente en el contexto de las donaciones y trasplantes, desde el reconocimiento de la realidad.
Objetivo: Caracterizar os eventos adversos em doação e transplantes de células, tecidos e órgãos notificados no estado de São Paulo. Método: Estudo descritivo de abordagem quantitativa. Os dados foram fornecidos pela Central Estadual de Transplantes do estado de São Paulo, por intermédio da “Ficha de notificação individual de reações adversas em Biovigilância”, da plataforma FormSUS, entre 2016 e 2019, e categorizados conforme nomenclatura preconizada pela Organização Mundial da Saúde quanto a: natureza e tipo do evento, gravidade e imputabilidade. Análise realizada por meio de estatística descritiva. Resultados: Foram caracterizadas 52 notificações, 90,4% relacionadas ao receptor, 78,8% a procedimentos alogênicos, 48,2% a órgãos e 44,2% a células-tronco hematopoéticas. As causas de notificação foram infecções (55,7%), outras (30,8%) e neoplasias (13,5%). A maior parte dos eventos notificados apresentou desfecho moderado (44,3%), e 36,5% das notificações foram imputadas como confirmadas. Conclusão: Foi possível identificar o cenário da biovigilância no estado, visualizando que os principais eventos adversos estão relacionados ao receptor mediante procedimentos alogênicos. Também, a maior causa de eventos adversos no estado de São Paulo são as infecções, especialmente causadas por Mycobacterium tuberculosis e Klebsiella pneumoniae. A caracterização desses eventos pode subsidiar o desenvolvimento de estratégias de segurança a fim de prevenir a recorrência, a realização de capacitações institucionais e políticas públicas em busca de incentivar a notificação e ampliar a compreensão dos eventos adversos nesse cenário, uma vez que só é possível assegurar qualidade e segurança na assistência à saúde, sobretudo no contexto das doações e dos transplantes, pelo reconhecimento da realidade.
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