Adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020.

OBJECTIVE: To describe adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020, resulting from immunization errors in children from zero to nine years old. METHODS: An ecological, descriptive study with a quantitative approach, based on event notifications available in the National Immunization Program Information System. RESULTS: Among the 39,903,277 doses of immunobiologicals in children aged zero to nine, administered in the state of MG, 3,259 events of types of immunization errors were recorded, around 0.008% of the total and, of these, 91.86% did not result in adverse events and 56.02% were children under one year of age. The most frequent diagnosis was application outside the recommended age (29.12%). Among the manifestations, 71.91% were local and systemic, with fever being the most common (40.85%). CONCLUSION: The study demonstrated that immunization errors were rare and that most of them were not associated with adverse events, which reinforces the safety of the immunization process. This undoubtedly raises reflection on the need and relevance of continuing education for health professionals.

Adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020 / Eventos supostamente atribuíveis à imunização ou vacinação em crianças de Minas Gerais: de 2015 a 2020

ABSTRACT Objective: To describe adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020, resulting from immunization errors in children from zero to nine years old. Methods: An ecological, descriptive study with a quantitative approach, based on event notifications available in the National Immunization Program Information System. Results: Among the 39,903,277 doses of immunobiologicals in children aged zero to nine, administered in the state of MG, 3,259 events of types of immunization errors were recorded, around 0.008% of the total and, of these, 91.86% did not result in adverse events and 56.02% were children under one year of age. The most frequent diagnosis was application outside the recommended age (29.12%). Among the manifestations, 71.91% were local and systemic, with fever being the most common (40.85%). Conclusion: The study demonstrated that immunization errors were rare and that most of them were not associated with adverse events, which reinforces the safety of the immunization process. This undoubtedly raises reflection on the need and relevance of continuing education for health professionals.

RESUMO Objetivo: Descrever os eventos supostamente atribuíveis à imunização ou vacinação em crianças de Minas Gerais, de 2015 a 2020, decorrentes dos erros de imunização em crianças de 0 a 9 anos. Métodos: Estudo ecológico, descritivo, de abordagem quantitativa, fundamentado nas notificações de eventos disponíveis no Sistema de Informações do Programa Nacional de Imunizações. Resultados: Dentre os 39.903.277 de doses de imunobiológicos administrados em crianças de 0 a 9 anos, no estado de Minas Gerais, registraram-se 3.259 eventos do tipo erros de imunizaçõo, cerca de 0,008% do total e, destes, 91,86% não acarretaram eventos adversos e 56,02% ocorreram em crianças menores de 1 ano. O diagnóstico mais frequente foi a aplicação fora da idade recomendada (29,12%). Dentre as manifestações, 71,91% foram locais e, em relação às sistêmicas, a mais comum foi a febre (40,85%). Conclusão: O estudo demonstrou que os erros de imunização foram raros e a maioria deles não se associou aos eventos adversos, o que reitera a segurança no processo de imunização. Isso suscita, indubitavelmente, a reflexão sobre a necessidade e a relevância de educação permanente dos profissionais da saúde.

Environmental factors associated with human papillomavirus vaccine coverage in adolescents: 2016-2020 analysis.

OBJECTIVE: to analyze the association between the factors of the social environment and the coverage rates of the human papillomavirus (HPV) vaccine in adolescents, in the State of Minas Gerais, Brazil. METHOD: this is an epidemiological, ecological study, with panel and trend analysis from 2016 to 2020. The population consisted of adolescents aged 9 to 13 years. The environmental variables were coverage rates, the municipal index of human development, income, education, and longevity; and the rate of violence. The Prais-Winsten autoregression and the panel regression model were used, in addition to the estimate of the mean annual percentage variation. RESULTS: the vaccination coverage rates are below the goals recommended by the Ministry of Health for all regions analyzed. Moreover, these rates are associated with factors related to the application of the first dose and to aspects inherent to the social environment, such as the rate of violence. CONCLUSION: our findings showed that, although tenuous, aspects of the environment, in addition to individual characteristics, provide relevant information to understand the occurrence of health outcomes, since this vaccination campaign presents a strong influence of the environment and age as factors associated with the low rates. HIGHLIGHTS: (1) The coverage of human papillomavirus vaccination is below the target in Minas Gerais.(2) The rates are associated with aspects inherent to the social environment, such as violence.(3) The environment provides relevant information for understanding health outcomes.

Eventos adversos após a vacina papilomavírus humano em adolescentes no estado de Minas Gerais / Eventos adversos después de la vacunación contra el virus del papiloma humano, en adolescentes en el estado de Minas Gerais / Adverse events following human papillomavirus vaccine in adolescents in the state of Minas Gerais

RESUMO Objetivo: investigar as notificações dos eventos adversos pós-vacinação papilomavírus humano no estado de Minas Gerais, de acordo com a localidade de notificação, a causalidade, a gravidade e a evolução dos casos. Métodos: estudo epidemiológico realizado com os dados de 2015-2019, notificados no Sistema de Informação de Vigilância de Eventos Adversos. Os dados foram analisados e apresentados em proporções, segundo as macrorregiões de saúde e os anos do estudo. Resultados: em 2015, foram notificados 26,41% eventos adversos, sendo o ano com maior notificação. Na análise das macrorregiões de saúde, Vale do Jequitinhonha apresentou a menor prevalência de registro (0,43%), e a Centro a maior prevalência de notificação (30,95%). Os eventos adversos locais mais prevalentes foram: dor (56,48%) e edema (38,89%). Já quanto aos eventos sistêmicos, a cefaleia (29,69%) e a gastroenterite (29,69%) tiveram os maiores registros de casos. Os eventos classificados como adversos não graves (59,82%) foram os mais prevalentes, e quanto à causa, 35,94% deles foram atribuídos aos erros de imunização. Conclusão: este estudo reforça que os eventos adversos pós-vacina de HPV foram, em sua maioria, eventos não graves, demonstrando, portanto, a segurança da vacina HPV para o público adolescente, contribuindo para o aumento das taxas de cobertura vacinal.

RESUMEN Objetivo: investigar las notificaciones de eventos adversos de papilomavirus humano en el Estado de Minas Gerais, según la localidad de notificación, la causalidad, la gravedad y la evolución de los casos. Métodos: estudio epidemiológico realizado con datos de 2015-2019, notificados en el Sistema de Información de Vigilancia de Eventos Adversos. Los datos fueron analizados y presentados en proporciones, según las macrorregiones sanitarias y los años del estudio. Resultados: en 2015 se notificaron un 26,41% de eventos adversos, siendo el año con mayor notificación. Al analizar las macrorregiones sanitarias, el Valle de Jequitinhonha tuvo la menor prevalencia de registro, con un 0,43%, y el Centro tuvo la mayor prevalencia de notificación (30,95%). Los efectos adversos locales más frecuentes fueron el dolor (56,48%) y el edema (38,89%). En cuanto a los eventos sistémicos, la cefalea (29,69%) y la gastroenteritis (29,69%) presentaron el mayor número de casos. Los eventos clasificados como adversos no graves (59,82%) fueron los más prevalentes y, en cuanto a la causa, el 35,94% de ellos se atribuyeron a los errores de inmunización. Conclusión: este estudio refuerza que los eventos adversos posteriores a la vacuna contra el VPH fueron en su mayoría eventos no graves, demostrando así la seguridad de la vacuna contra el VPH para el público adolescente y contribuyendo al aumento de las tasas de cobertura de vacunación.

ABSTRACT Objective: to investigate reports of adverse events following human papillomavirus vaccination in the state of Minas Gerais, according to the location of notification, causality, severity, and evolution of cases. Methods: epidemiological study carried out with data from 2015-2019, reported in the Adverse Event Surveillance Information System. Data were analyzed and presented in proportions, according to health macro-regions and years of study. Results: in 2015, 26.41% of adverse events were reported, being the year with the highest number of notifications. In the analysis of health macro-regions, Vale do Jequitinhonha had the lowest prevalence of registration (0.43%), and the Center had the highest prevalence of notification (30.95%). The most prevalent local adverse events were pain (56.48%) and edema (38.89%). As for systemic events, headache (29.69%) and gastroenteritis (29.69%) had the highest number of cases. Events classified as non-serious adverse events (59.82%) were the most prevalent, and regarding the cause, 35.94% of them were attributed to immunization errors. Conclusion: this study reinforces that adverse events following HPV vaccination were, for the most part, non-serious events, thus demonstrating the safety of the HPV vaccine for the adolescent public, contributing to the increase in vaccine coverage rates.

Impact of COVID-19 pandemic on vaccination against meningococcal C infection in Brazil.

Objective: Analyzing the impact of COVID-19 pandemic on meningococcal C conjugate vaccination in Brazil. Methods: Ecological study, based on interrupted time series, carried out with data collected through the Information System of the National Immunization Program (IS-NIP). Collected data refer to the number of meningococcal C conjugate vaccine doses administered from March 2019 to December 2020. Results: In total, 14,832,054 meningococcal C conjugate vaccine doses were administered throughout the investigated period; 66.30% of them, from March 2019 to February 2020 and 33.70%, from March to December 2020. Statistically significant steps were observed, i.e., the COVID-19 pandemic had negative impact on the number of MenC vaccine doses administered in the North and South regions (26,98% and 41.47%, respectively) and in the eleven Brazilian States. Conclusion: The current study has shown that the COVID-19 pandemic had negative impact on the number of MenC vaccine doses administered in the Northern and Southern Brazil, and in eleven Brazilian states. Among all challenges experienced during the COVID-19 pandemic, one finds reduced MenC vaccine coverage, which, consequently, may lead to increased meningococcal infection rates in Brazil.

Environmental factors associated with human papillomavirus vaccine coverage in adolescents: 2016-2020 analysis / Fatores ambientais associados à cobertura da vacina contra o papilomavírus humano em adolescentes: análise de 2016 a 2020 / Factores ambientales asociados con la cobertura de la vacuna contra el virus del papiloma humano en adolescentes: análisis de 2016 a 2020

Abstract Objective: to analyze the association between the factors of the social environment and the coverage rates of the human papillomavirus (HPV) vaccine in adolescents, in the State of Minas Gerais, Brazil. Method: this is an epidemiological, ecological study, with panel and trend analysis from 2016 to 2020. The population consisted of adolescents aged 9 to 13 years. The environmental variables were coverage rates, the municipal index of human development, income, education, and longevity; and the rate of violence. The Prais-Winsten autoregression and the panel regression model were used, in addition to the estimate of the mean annual percentage variation. Results: the vaccination coverage rates are below the goals recommended by the Ministry of Health for all regions analyzed. Moreover, these rates are associated with factors related to the application of the first dose and to aspects inherent to the social environment, such as the rate of violence. Conclusion: our findings showed that, although tenuous, aspects of the environment, in addition to individual characteristics, provide relevant information to understand the occurrence of health outcomes, since this vaccination campaign presents a strong influence of the environment and age as factors associated with the low rates.

Resumo Objetivo: analisar a associação entre os fatores do ambiente social e as taxas de cobertura da vacina contra o papilomavírus humano (HPV) nos adolescentes do estado de Minas Gerais. Método: estudo epidemiológico, ecológico, com análise em painel e de tendência, no período de 2016 a 2020. A população foi composta por adolescentes de 9 a 13 anos. As variáveis ambientais foram as taxas de cobertura; o índice de desenvolvimento humano municipal, de renda, de educação e de longevidade; e a taxa de violência. Utilizou-se o modelo autorregressivo de Prais-Winsten, o cálculo da variação percentual média anual e a regressão em painel. Resultados: as taxas de cobertura da vacina em todas as regiões analisadas estão abaixo das metas preconizadas pelo Ministério da Saúde. Ademais, tais taxas estão associadas aos fatores relacionados à aplicação da primeira dose e a aspectos inerentes ao ambiente social, como a taxa de violência. Conclusão: as evidências encontradas demonstraram que, embora tênues, aspectos do ambiente, além das características individuais, fornecem informações relevantes para compreensão da ocorrência dos desfechos de saúde, uma vez que para essa vacina temos a forte influência do ambiente e da idade como fatores associados à baixa taxa de vacinação.

Resumen Objetivo: analizar la asociación entre los factores del entorno social y las tasas de cobertura de la vacuna contra el virus del papiloma humano (VPH) en los adolescentes del estado de Minas Gerais. Método: estudio epidemiológico, ecológico, con análisis de panel y de tendencia, en el período de 2016 a 2020. La población estaba compuesta por adolescentes de 9 a 13 años. Las variables ambientales fueron las tasas de cobertura; el índice de desarrollo humano municipal, la renta, la educación y la longevidad, y la tasa de violencia. Se utilizó el modelo autorregresivo de Prais-Winsten, el cálculo de la variación porcentual media anual y la regresión en panel. Resultados: las tasas de cobertura de la vacuna en todas las regiones analizadas están por debajo de los objetivos recomendados por el Ministerio de Salud. Además, estas tasas están asociadas a los factores relacionados con la aplicación de la primera dosis y a aspectos inherentes al entorno social, como la tasa de violencia. Conclusión: las evidencias encontradas demostraron que, aunque tenues, aspectos del entorno, además de las características individuales, proporcionan informaciones relevantes para comprensión de la ocurrencia de los resultados de salud, una vez que para esa vacuna tenemos la fuerte influencia del entorno y de la edad como factores asociados a la baja tasa de vacunación.

Adverse events following immunization in pregnant women from Minas Gerais.

OBJECTIVE: To analyze the distribution of adverse events following immunization (AEFI) in pregnant women in the state of Minas Gerais, between 2015 and 2019. METHODS: This is an epidemiological, descriptive study conducted with AEFI data from 2015 to 2019, recorded in the Adverse Events Surveillance Information System, in the state of Minas Gerais (MG), Brazil. A total of 670 AEFI were analyzed in pregnant women. The estimates were presented in proportions, according to the year of occurrence, health macro-region of Minas Gerais and immunobiological administered. RESULTS: The year in which there were the most records was 2017 (36.8%). Among the 14 macro-regions, the ones with the lowest and highest number of records were the Vale do Jequitinhonha (0.5%) and Center (31.8%), respectively. The vaccines contraindicated during pregnancy represented 27.6% of the total notifications. The total of 69.5% of the cases were considered immunization errors. In 75.9% of the records, the variable of medical care was ignored, and in 73.7% of the cases no information on the evolution was presented. CONCLUSION: This study shows the need for continuing education for the multidisciplinary team, in order to reduce cases of AEFI and ensure the adequate completion of notifications by health professionals.

Test-retest reliability of Brazilian version of Memorial Symptom Assessment Scale for assessing symptoms in cancer patients.

OBJECTIVE: To assess the test-retest reliability of the Memorial Symptom Assessment Scale translated and culturally adapted into Brazilian Portuguese. METHODS: The scale was applied in an interview format for 190 patients with various cancers type hospitalized in clinical and surgical sectors of the Instituto Nacional de Câncer José de Alencar Gomes da Silva and reapplied in 58 patients. Data from the test-retest were double typed into a Microsoft Excel spreadsheet and analyzed by the weighted Kappa. RESULTS: The reliability of the scale was satisfactory in test-retest. The weighted Kappa values obtained for each scale item had to be adequate, the largest item was 0.96 and the lowest was 0.69. The Kappa subscale was also evaluated and values were 0.84 for high frequency physic symptoms, 0.81 for low frequency physical symptoms, 0.81 for psychological symptoms, and 0.78 for Global Distress Index. CONCLUSION: High level of reliability estimated suggests that the process of measurement of Memorial Symptom Assessment Scale aspects was adequate. OBJETIVO: Avaliar a confiabilidade teste-reteste da versão traduzida e adaptada culturalmente para o português do Brasil do Memorial Symptom Assessment Scale. MÉTODOS: A escala foi aplicada em forma de entrevista em 190 pacientes com diversos tipos de câncer internados nos setores clínicos e cirúrgicos do Instituto Nacional de Câncer José de Alencar Gomes da Silva e reaplicada em 58 pacientes. Os dados dos testes-retestes foram inseridos num banco de dados por dupla digitação independente em Excel e analisados pelo Kappa ponderado. RESULTADOS: A confiabilidade da escala mostrou-se satisfatória nos testes-retestes. Os valores do Kappa ponderado obtidos para cada item da escala apresentaram-se adequados, sendo o maior item de 0,96 e o menor de 0,69. Também se avaliou o Kappa das subescalas, sendo de 0,84 para sintomas físicos de alta frequência, de 0,81 para sintomas físicos de baixa frequência, de 0,81 também para sintomas psicológicos, e de 0,78 para Índice Geral de Sofrimento. CONCLUSÃO: Altos níveis de confiabilidade estimados permitem concluir que o processo de aferição dos itens do Memorial Symptom Assessment Scale foi adequado.

Test-retest reliability of Brazilian version of Memorial Symptom Assessment Scale for assessing symptoms in cancer patients / Confiabilidade teste-reteste da versão Brasileira do instrumento Memorial Symptom Assessment Scale para avaliação de sintomas em pacientes oncológicos

ABSTRACT Objective To assess the test-retest reliability of the Memorial Symptom Assessment Scale translated and culturally adapted into Brazilian Portuguese. Methods The scale was applied in an interview format for 190 patients with various cancers type hospitalized in clinical and surgical sectors of the Instituto Nacional de Câncer José de Alencar Gomes da Silva and reapplied in 58 patients. Data from the test-retest were double typed into a Microsoft Excel spreadsheet and analyzed by the weighted Kappa. Results The reliability of the scale was satisfactory in test-retest. The weighted Kappa values obtained for each scale item had to be adequate, the largest item was 0.96 and the lowest was 0.69. The Kappa subscale was also evaluated and values were 0.84 for high frequency physic symptoms, 0.81 for low frequency physical symptoms, 0.81 for psychological symptoms, and 0.78 for Global Distress Index. Conclusion High level of reliability estimated suggests that the process of measurement of Memorial Symptom Assessment Scale aspects was adequate.

RESUMO Objetivo Avaliar a confiabilidade teste-reteste da versão traduzida e adaptada culturalmente para o português do Brasil do Memorial Symptom Assessment Scale. Métodos A escala foi aplicada em forma de entrevista em 190 pacientes com diversos tipos de câncer internados nos setores clínicos e cirúrgicos do Instituto Nacional de Câncer José de Alencar Gomes da Silva e reaplicada em 58 pacientes. Os dados dos testes-retestes foram inseridos num banco de dados por dupla digitação independente em Excel e analisados pelo Kappa ponderado. Resultados A confiabilidade da escala mostrou-se satisfatória nos testes-retestes. Os valores do Kappa ponderado obtidos para cada item da escala apresentaram-se adequados, sendo o maior item de 0,96 e o menor de 0,69. Também se avaliou o Kappa das subescalas, sendo de 0,84 para sintomas físicos de alta frequência, de 0,81 para sintomas físicos de baixa frequência, de 0,81 também para sintomas psicológicos, e de 0,78 para Índice Geral de Sofrimento. Conclusão Altos níveis de confiabilidade estimados permitem concluir que o processo de aferição dos itens do Memorial Symptom Assessment Scale foi adequado.

Conceptual equivalence of items and semantic equivalence of the Brazilian version of the EORTC QLQ-ELD14 instrument to evaluate the quality of life of elderly people with cancer / Equivalência conceitual de itens e semântica da versão brasileira do instrumento EORTC QLQ-ELD14 para avaliação de qualidade de vida em idosos com câncer

Abstract Objective: to describe the process of semantic equivalence, the first stage in the validation of the EORTC QLQ-ELD14 instrument for Brazilian Portuguese. Method: Direct and independent translations of the instrument into Portuguese were carried out and validated by a meeting of experts to generate a synthesis version. The version chosen was submitted to reverse translations into English, and the form was pre-tested with patients. At the conclusion of the process, a summary version was presented. The pre-test and the final version of the instrument were applied to a total of 28 patients at a high complexity oncology treatment center. Result: after completion of the first round of pretesting, some adjustments for the next phase of the study were necessary by the expert committee. After these adjustments, in the second phase of pre-testing, the instrument was well-accepted by the population. Conclusion: the Portuguese summary version of the EORTC QLQ-ELD14 instrument for assessing the quality of life of elderly cancer patients is ready to be submitted to the next stages of the evaluation of its psychometric properties.

Resumo Objetivo: descrever o processo de equivalência semântica, primeira etapa da validação do instrumento EORTC QLQ-ELD14, para o português falado no Brasil. Método: Foram realizadas traduções diretas e independentes do instrumento para o português, validadas em reunião com especialistas para gerar uma versão síntese. A versão escolhida foi submetida a traduções reversas para o inglês e foi realizado pré-teste do formulário com pacientes. Ao final, uma versão síntese foi apresentada. O pré-teste aplicado em um total de 28 pacientes internados, em um centro de tratamento de alta complexidade em oncologia e a versão final do instrumento. Resultado: após a realização da primeira rodada de pré-testes, foram necessários alguns ajustes pelo comitê de especialistas para uma nova rodada de pré-testes, após esses ajustes, na segunda fase de pré-testes, o instrumento foi bem aceito pela população em estudo. Conclusão: a versão síntese, em português, do instrumento EORTC QLQ-ELD14 para avaliação da Qualidade de vida de pacientes idosos com câncer é adequado para ser submetida às próximas etapas de avaliação de suas propriedades psicométricas.