Case-control and case-cohort study designs: methodological considerations / Delineamentos caso-controle e caso-coorte: considerações metodológicas

The "case-control" study is not a homogeneous entity in epidemiology. This article presents a narrative review of characteristics that differentiate "traditional case-control", "population-based case-control", "nested case-control", and "case-cohort" studies. The use of a secondary basis for the choice of controls makes case-control studies particularly vulnerable to selection biases and limits the representativeness of the control group relative to the study population base. The choice of prevalent cases, although useful for maximizing statistical power, undermines the interpretation of associations since determinants of incidence are mixed with determinants of disease duration. "Nested case-control" and "case-cohort" studies partly overcome these limitations because they are based on a true cohort and often use incident cases. "Case-cohort" studies give emphasis to the contrast between case exposure experience and population-based exposure experience, providing additional benefits when there is temporal matching between cases and the reference group. This article provides insights into the methodological arsenal of case-control studies and highlights some of the methodologies discussed - particularly those in which controls are included - favors the use of secondary databases without the need for a key variable that correlates them.

O delineamento tipo "caso-controle" não é uma entidade homogênea em Epidemiologia. Este artigo apresenta uma revisão narrativa de características que diferenciam os estudos caso-controle, tradicional e de base populacional, caso-controle aninhado e caso-coorte. O uso de uma base secundária para a escolha dos controles deixa os estudos caso-controle particularmente vulneráveis ao viés de seleção e limita a representatividade do grupo controle em relação à base populacional do estudo. A opção por casos prevalentes, útil para maximizar o poder estatístico, prejudica a interpretação das associações já que determinantes da incidência são mesclados com os determinantes da duração da doença. Os "casos e controles aninhados" e "caso-coorte", superam em parte essas limitações, pois são baseados em uma coorte verdadeira e usam frequentemente casos incidentes. Os "caso-coorte" enfatizam o contraste entre a experiência de exposição dos casos e de exposição da base populacional, fornecendo benefícios adicionais quando existe pareamento temporal entre casos e controles. Este artigo oferece elementos para a discussão sobre o arsenal metodológico dos estudos "caso-controle" e destaca as metodologias discutidas ­ particularmente aqueles em que os controles são inclusivos - favorece o uso de bases de dados secundários sem que haja a necessidade de uma variável chave que as correlacione.

Factors associated with post-mortem notification of tuberculosis cases in Brazil, 2014. / Fatores associados à notificação pós-óbito de casos de tuberculose no Brasil, 2014.

According to the World Health Organization (WHO), 1.6 million deaths and 10.6 million cases of tuberculosis (TB) were reported worldwide in 2021. If treated opportunely with the recommended therapy, 85% of patients with TB are healed. The occurrence of death from TB without prior notification of the disease indicates failure in the timely access to this effective treatment. Therefore, this study aimed to identify TB cases with post-mortem notification in Brazil. This is a nested case-control study using a cohort of new TB cases reported to the Braziliam Information System for Notificable Diseases (SINAN). This study analyzed the following variables: selected characteristics of the individual (gender, age, race/color, education), the municipality (Municipality Human Development Index - M-HDI, poverty rate, size, region, and municipality), health services, and underlying or associated cause of death. Logistic regression was estimated using a hierarchical analysis model. People with TB aged 60 years or older (OR = 1.43), with low educational level (OR = 1.67), and with malnutrition (OR = 5.54), living in municipalities with low M-HDI and medium population size (OR = 1.26), located in the North Region of Brazil (OR = 2.42) had a higher chance of post-mortem notification. Protective factors were HIV-TB coinfection (OR = 0.75), malignant neoplasms (OR = 0.62), and living in cities with broad primary care coverage (OR = 0.79). Vulnerable populations should be prioritized in order to address the obstacles to the access to TB diagnosis and treatment in Brazil.

Segundo a Organização Mundial da Saúde (OMS), estima-se que 1,6 milhão de mortes e 10,6 milhões de casos de tuberculose (TB) ocorreram no mundo em 2021. Quando a doença é oportunamente tratada com o esquema terapêutico recomendado, 85% dos pacientes se curam. A ocorrência de óbito por TB sem notificação anterior denuncia falhas no acesso ao tratamento oportuno e efetivo. Sendo assim, este estudo objetivou caracterizar os casos de TB notificados pós-óbito no Brasil. Trata-se de estudo caso-controle aninhado na coorte de casos novos de TB notificados ao Sistema de Informação de Agravos de Notificação (SINAN). As variáveis analisadas foram: características selecionadas do indivíduo (sexo, idade, raça/cor, escolaridade), do município (Índice de Desenvolvimento Humano Municipal - IDH-M, taxa de pobreza, porte municipal, região e município), dos serviços de saúde e causa básica ou associada de morte. Foi estimada regressão logística respeitando um modelo de análise hierárquico. Pessoas com TB de 60 anos de idade ou mais (OR = 1,43), de baixa escolaridade (OR = 1,67), com desnutrição (OR = 5,54), residentes em municípios com baixo IDH-M, de porte populacional médio (OR = 1,26), na Região Norte (OR = 2,42) apresentaram maior chance de notificação pós-óbito. Fatores protetores foram coinfecção HIV-TB (OR = 0,75), neoplasias malignas (OR = 0,62) e residência em municípios com alta cobertura de atenção básica (OR = 0,79). A priorização das populações vulneráveis é necessária para enfrentar as dificuldades de acesso ao diagnóstico e tratamento da TB no Brasil.

La Organización Mundial de la Salud (OMS) estima que en 2021 se produjeron 1,6 millones de muertes por tuberculosis (TB) y 10,6 millones de casos de esta afección por todo el mundo. Si los pacientes siguen el tratamiento recomendado para la TB, un 85% logran la cura. Las muertes por TB sin notificación previa de caso indican fallas en el acceso a este tratamiento oportuno y efectivo. Por lo tanto, este estudio tuvo como objetivo caracterizar los casos de TB que tuvieron notificación posterior a la muerte en Brasil. Este es un estudio de caso-control anidado dentro de la cohorte de nuevos casos de TB informados al Sistema de Información de Enfermedades de Notificación Obligatoria (SINAN). Las siguientes variables fueron analizadas: características seleccionadas del individuo (sexo, edad, etnia/color, nivel de instrucción) y del municipio (Índice de Desarrollo Humano Municipal -IDH-M, tasa de pobreza, tamaño del municipio, región y municipio), servicios de salud y condiciones y causa de la muerte o su asociación. La regresión logística se estimó desde un modelo de análisis jerárquico. Las personas con TB de 60 años o más (OR = 1,43), con bajo nivel de instrucción (OR = 1,67), con desnutrición (OR = 5,54), residentes en municipios con bajo IDH-M, de tamaño poblacional medio (OR = 1,26) y en la Región Norte (OR = 2,42) tuvieron mayor probabilidad de notificación posterior a la muerte. Los factores protectores fueron la coinfección VIH-TB (OR = 0,75), neoplasias malignas (OR = 0,62) y vivir en ciudades con alta cobertura de atención primaria (OR = 0,79). Es necesario priorizar las poblaciones vulnerables para enfrentar las dificultades de acceso al diagnóstico y tratamiento de la TB en Brasil.

Factors associated with yellow fever vaccine failure: A systematic literature review.

INTRODUCTION: Considering that vaccination with yellow fever vaccine (YFV) is the most important method to prevent and control yellow fever (YF), this study synthesized evidence on factors associated with YFV failure. METHODS: A systematic review (SR) was performed in the PubMed, Cochrane CENTRAL, Embase, and LILACS databases up to November 2019. Observational and experimental analytical epidemiological studies that analyzed the failure of YFV were included. This review followed the guidelines of the Preferred Reporting Items for Systematic Reviews and meta-Analyses. RESULTS: A total of 1,466 articles were identified after searching the databases of which 46 were included in the qualitative analysis after applying the elegibility criteria. Our findings indicated that YFV confers protective immunity in different age groups; when produced by different producers; when administered simultaneously with a range of other vaccines; when used as fractional doses and when used with prophylactic and immunosuppressive therapies. It failed to produce a protective response in some pregnant women, children under two years of age, children with Kwashiorkor and when long periods of time have passed after vaccination. For individuals with human immunodeficiency virus (HIV), the results were divergent. CONCLUSIONS: The results of this SR revealed the factors associated with the failure of the YFV, and the results can support recommendations on vaccination policies, support the safety of health professionals who work directly with immunization in the implementation of the vaccination schedule, in addition to guiding future research and enhance the credibility of YFV in the prevention of a serious disease such as YF.

Fatores associados à notificação pós-óbito de casos de tuberculose no Brasil, 2014 / Factores asociados a la notificación posterior a la muerte por casos de tuberculosis en Brasil, 2014 / Factors associated with post-mortem notification of tuberculosis cases in Brazil, 2014

Resumo: Segundo a Organização Mundial da Saúde (OMS), estima-se que 1,6 milhão de mortes e 10,6 milhões de casos de tuberculose (TB) ocorreram no mundo em 2021. Quando a doença é oportunamente tratada com o esquema terapêutico recomendado, 85% dos pacientes se curam. A ocorrência de óbito por TB sem notificação anterior denuncia falhas no acesso ao tratamento oportuno e efetivo. Sendo assim, este estudo objetivou caracterizar os casos de TB notificados pós-óbito no Brasil. Trata-se de estudo caso-controle aninhado na coorte de casos novos de TB notificados ao Sistema de Informação de Agravos de Notificação (SINAN). As variáveis analisadas foram: características selecionadas do indivíduo (sexo, idade, raça/cor, escolaridade), do município (Índice de Desenvolvimento Humano Municipal - IDH-M, taxa de pobreza, porte municipal, região e município), dos serviços de saúde e causa básica ou associada de morte. Foi estimada regressão logística respeitando um modelo de análise hierárquico. Pessoas com TB de 60 anos de idade ou mais (OR = 1,43), de baixa escolaridade (OR = 1,67), com desnutrição (OR = 5,54), residentes em municípios com baixo IDH-M, de porte populacional médio (OR = 1,26), na Região Norte (OR = 2,42) apresentaram maior chance de notificação pós-óbito. Fatores protetores foram coinfecção HIV-TB (OR = 0,75), neoplasias malignas (OR = 0,62) e residência em municípios com alta cobertura de atenção básica (OR = 0,79). A priorização das populações vulneráveis é necessária para enfrentar as dificuldades de acesso ao diagnóstico e tratamento da TB no Brasil.

Resumen: La Organización Mundial de la Salud (OMS) estima que en 2021 se produjeron 1,6 millones de muertes por tuberculosis (TB) y 10,6 millones de casos de esta afección por todo el mundo. Si los pacientes siguen el tratamiento recomendado para la TB, un 85% logran la cura. Las muertes por TB sin notificación previa de caso indican fallas en el acceso a este tratamiento oportuno y efectivo. Por lo tanto, este estudio tuvo como objetivo caracterizar los casos de TB que tuvieron notificación posterior a la muerte en Brasil. Este es un estudio de caso-control anidado dentro de la cohorte de nuevos casos de TB informados al Sistema de Información de Enfermedades de Notificación Obligatoria (SINAN). Las siguientes variables fueron analizadas: características seleccionadas del individuo (sexo, edad, etnia/color, nivel de instrucción) y del municipio (Índice de Desarrollo Humano Municipal -IDH-M, tasa de pobreza, tamaño del municipio, región y municipio), servicios de salud y condiciones y causa de la muerte o su asociación. La regresión logística se estimó desde un modelo de análisis jerárquico. Las personas con TB de 60 años o más (OR = 1,43), con bajo nivel de instrucción (OR = 1,67), con desnutrición (OR = 5,54), residentes en municipios con bajo IDH-M, de tamaño poblacional medio (OR = 1,26) y en la Región Norte (OR = 2,42) tuvieron mayor probabilidad de notificación posterior a la muerte. Los factores protectores fueron la coinfección VIH-TB (OR = 0,75), neoplasias malignas (OR = 0,62) y vivir en ciudades con alta cobertura de atención primaria (OR = 0,79). Es necesario priorizar las poblaciones vulnerables para enfrentar las dificultades de acceso al diagnóstico y tratamiento de la TB en Brasil.

Abstract: According to the World Health Organization (WHO), 1.6 million deaths and 10.6 million cases of tuberculosis (TB) were reported worldwide in 2021. If treated opportunely with the recommended therapy, 85% of patients with TB are healed. The occurrence of death from TB without prior notification of the disease indicates failure in the timely access to this effective treatment. Therefore, this study aimed to identify TB cases with post-mortem notification in Brazil. This is a nested case-control study using a cohort of new TB cases reported to the Braziliam Information System for Notificable Diseases (SINAN). This study analyzed the following variables: selected characteristics of the individual (gender, age, race/color, education), the municipality (Municipality Human Development Index - M-HDI, poverty rate, size, region, and municipality), health services, and underlying or associated cause of death. Logistic regression was estimated using a hierarchical analysis model. People with TB aged 60 years or older (OR = 1.43), with low educational level (OR = 1.67), and with malnutrition (OR = 5.54), living in municipalities with low M-HDI and medium population size (OR = 1.26), located in the North Region of Brazil (OR = 2.42) had a higher chance of post-mortem notification. Protective factors were HIV-TB coinfection (OR = 0.75), malignant neoplasms (OR = 0.62), and living in cities with broad primary care coverage (OR = 0.79). Vulnerable populations should be prioritized in order to address the obstacles to the access to TB diagnosis and treatment in Brazil.

Epidemiological burden of Chikungunya fever in Brazil, 2016 and 2017.

OBJECTIVES: To describe Chikungunya fever (CHIKF) cases and estimate the burden of the disease in Brazil between 2016 and 2017. METHODS: The first stage of this study consisted of a descriptive epidemiological study with estimations of incidence, mortality and case-fatality rates for each Brazilian state. The second stage provided estimates of the disease burden using DALY, an indicator that aggregates measures of morbidity (years lived with disability - YLD) and mortality (years of life lost - YLL) into a single value. RESULTS: In Brazil, the incidence rate in 2016 was 114.70 per 100,000 inhabitants, while the mortality rate was 0.15 per 100,000, for a case-fatality rate of 0.13%. In 2017, these figures were 87.59 and 0.12 per 100,000 inhabitants and 0.14%, respectively. The estimated CHIKF burden for Brazil in 2016 was 77,422.61 DALY or 0.3757 per 1000 inhabitants. In 2016, the YLL share of DALY was 10.04%, with YLD accounting for the remaining 89.96%. In 2017, the estimated burden was 59,307.59 DALY or 0.2856 per 1000 inhabitants, with YLL accounting for 9.65% of the total and YLD for 90.35%. CONCLUSION: CHIKF causes a significant disease burden in Brazil. The chronic phase of CHIKF is responsible for the largest portion of DALY. Deaths from CHIKF are a significant component of the disease burden, with YLL accounting for approximately 10% of the total DALY value.

Factors associated with the evaluation of Primary Health Care from the user's perspective: results of the telephone survey Vigitel, 2015. / Fatores associados à avaliação da Atenção Primária à Saúde na perspectiva do usuário: resultados do inquérito telefônico Vigitel, 2015.

This paper aims to evaluate the performance of PHC from the perspective of users and its association with sociodemographic characteristics, self-reported health conditions, and behavioral risk factors for Chronic Noncommunicable Diseases. This is a population-based cross-sectional study with data from the 2015 VIGITEL Telephone Survey. The Primary Care Assessment Tool short version was adopted. The study population covers adults over 18 years of age who used PHC services in Belo Horizonte in the last 12 months (n = 872). The multiple logistic regression model was performed to estimate the odds ratio. We observed that adults without a health insurance plan are 3.21 (95% CI 2.08-4.96) more likely than those with a health insurance plan to evaluate PHC with a high score (≥ 6.6), and adults with low schooling (95% CI 1.48-5.32), people with diabetes (95% CI 1.05-3.24), obese (95% CI 1.20-3.24), and older adults (95% CI 1.00-1.41) were 2.81, 1.84, 1.97, and 1.19 more likely to report a high score for PHC quality than the others, respectively. The use of the PCATool short version in a telephone survey showed a new possibility for PHC performance assessment and can become useful in managing health services.

O objetivo deste artigo é avaliar o desempenho da APS sob a perspectiva dos usuários e sua associação com as características sociodemográficas, condições de saúde autorreferidas e fatores de risco comportamentais para Doenças Crônicas Não Transmissíveis. Estudo transversal de base populacional, com dados do Inquérito Telefônico Vigitel 2015. Utilizou-se o "Primary Care Assessment Tool" versão reduzida. A população do estudo são adultos maiores de 18 anos que utilizaram os serviços da APS em Belo Horizonte nos últimos 12 meses (n = 872). Realizado o modelo de regressão logística múltipla para estimar o odds ratio. Observa-se que adultos sem plano de saúde têm 3,21 (IC95% 2,08-4,96) mais chances do que com plano de saúde de avaliarem a APS com alto escore (≥ 6,6), bem como adultos com baixa escolaridade tem 2,81 (IC95% 1,48-5,32) mais chances, os diabéticos têm 1,84 (IC95% 1,05-3,24) mais chances, os obesos tem 1,97 (IC95% 1,20-3,24) mais chances e os idosos tem 1,19 (IC95% 1,00-1,41) chances de reportar alto escore para a qualidade da APS do que os demais. A utilização do PCATool na versão reduzida em inquérito telefônico, mostrou-se nova possibilidade de avaliação do desempenho da APS e pode se tornar útil na gestão dos serviços de saúde.

Fatores associados à avaliação da Atenção Primária à Saúde na perspectiva do usuário: resultados do inquérito telefônico Vigitel, 2015 / Factors associated with the evaluation of Primary Health Care from the user's perspective: results of the telephone survey Vigitel, 2015

Resumo O objetivo deste artigo é avaliar o desempenho da APS sob a perspectiva dos usuários e sua associação com as características sociodemográficas, condições de saúde autorreferidas e fatores de risco comportamentais para Doenças Crônicas Não Transmissíveis. Estudo transversal de base populacional, com dados do Inquérito Telefônico Vigitel 2015. Utilizou-se o "Primary Care Assessment Tool" versão reduzida. A população do estudo são adultos maiores de 18 anos que utilizaram os serviços da APS em Belo Horizonte nos últimos 12 meses (n = 872). Realizado o modelo de regressão logística múltipla para estimar o odds ratio. Observa-se que adultos sem plano de saúde têm 3,21 (IC95% 2,08-4,96) mais chances do que com plano de saúde de avaliarem a APS com alto escore (≥ 6,6), bem como adultos com baixa escolaridade tem 2,81 (IC95% 1,48-5,32) mais chances, os diabéticos têm 1,84 (IC95% 1,05-3,24) mais chances, os obesos tem 1,97 (IC95% 1,20-3,24) mais chances e os idosos tem 1,19 (IC95% 1,00-1,41) chances de reportar alto escore para a qualidade da APS do que os demais. A utilização do PCATool na versão reduzida em inquérito telefônico, mostrou-se nova possibilidade de avaliação do desempenho da APS e pode se tornar útil na gestão dos serviços de saúde.

Abstract This paper aims to evaluate the performance of PHC from the perspective of users and its association with sociodemographic characteristics, self-reported health conditions, and behavioral risk factors for Chronic Noncommunicable Diseases. This is a population-based cross-sectional study with data from the 2015 VIGITEL Telephone Survey. The Primary Care Assessment Tool short version was adopted. The study population covers adults over 18 years of age who used PHC services in Belo Horizonte in the last 12 months (n = 872). The multiple logistic regression model was performed to estimate the odds ratio. We observed that adults without a health insurance plan are 3.21 (95% CI 2.08-4.96) more likely than those with a health insurance plan to evaluate PHC with a high score (≥ 6.6), and adults with low schooling (95% CI 1.48-5.32), people with diabetes (95% CI 1.05-3.24), obese (95% CI 1.20-3.24), and older adults (95% CI 1.00-1.41) were 2.81, 1.84, 1.97, and 1.19 more likely to report a high score for PHC quality than the others, respectively. The use of the PCATool short version in a telephone survey showed a new possibility for PHC performance assessment and can become useful in managing health services.

Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system. / Reações adversas a medicamentos em pacientes com COVID-19 no Brasil: análise das notificações espontâneas do sistema de farmacovigilância brasileiro.

In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher's chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student's t-test and Mann-Whitney's test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.

Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.

En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.

Reações adversas a medicamentos em pacientes com COVID-19 no Brasil: análise das notificações espontâneas do sistema de farmacovigilância brasileiro / Reacciones adversas a medicamentos en pacientes con COVID-19 en Brasil: análisis de las notificaciones espontáneas del sistema de farmacovigilancia brasileño / Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system

Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.

En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.

In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher's chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student's t-test and Mann-Whitney's test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.

Tuberculosis cases with post-mortem notification in Brazil, 2014: a descriptive study based on surveillance data. / Casos de tuberculose com notificação após o óbito no Brasil, 2014: um estudo descritivo com base nos dados de vigilância.

OBJECTIVE: To characterize tuberculosis cases notified at post-mortem in Brazil in 2014. METHODS: This is a descriptive study of tuberculosis cases notified at post-mortem. Data resulted from linkage of the Notifiable Health Conditions Information System-TB (SINAN-TB) and the Mortality Information System (SIM), and were described according to underlying cause of death: tuberculosis, AIDS and other. RESULTS: In the 2,703 tuberculosis cases notified at post-mortem, a higher proportion was found of people of the male sex (73.5%), aged over 39 (80.8%), <8 years of schooling (66.5%), of Black and brown race/skin color (62.8%), with the pulmonary clinical form of tuberculosis (75.2%); there was also a higher proportion of cases notified by the public health service (57.6%) and in municipalities with HDI-M >0.7 (66.6%). CONCLUSION: The characteristics described of people with post-mortem notification and the magnitude of this outcome suggest weaknesses in tuberculosis care and surveillance services.

Visceral leishmaniasis lethality in Brazil: an exploratory analysis of associated demographic and socioeconomic factors.

INTRODUCTION: It is believed that delays in diagnosis and treatment of Visceral Leishmaniasis (VL) contribute significantly to the burden of VL lethality in Brazil. METHODS: This study included several parts: a descriptive cross-sectional study of the individual characteristics of deaths from disease; a descriptive ecological study of the spatial distribution of deaths from disease; and an ecological analytical study to evaluate the association between disease lethality rates and the demographic, socioeconomic, and health indicators. The study population comprised all cases diagnosed throughout the country per the National Disease Notification System (SINAN) and the total number of disease deaths recorded in the Mortality Information System (SIM) from 2007 to 2012. RESULTS: Of the 223 deaths from disease captured by pairing the databases, 59.1% were reported as "death from other causes". There were significant associations between VL lethality rate and municipalities with the highest proportion of vulnerable individuals (rate ratio (RR)=1.18, 95% confidence interval (CI): 1.01-1.27), with VL lower incidence rate (RR=0.62, 95% CI: 0.58-0.67) and a higher incidence rate of Acquired Immune Deficiency Syndrome (AIDS) (RR=1.20, 95% CI: 1.17-1.51). CONCLUSIONS: Linking the SINAN and SIM databases allowed the inclusion of 14% of otherwise underreported deaths from VL for the study period, showing that this method is useful for the surveillance of VL-related deaths. The size of the municipal population, proportion of the vulnerable population, incidence of disease, and the incidence of AIDS were associated with municipal lethality rates related to VL in Brazil.

Tuberculosis cases with post mortem notification in Brazil, 2014: a descriptive study based on surveillance data / Casos de tuberculosis notificados después de la muerte en Brasil, 2014: un estudio descriptivo basado en datos de vigilancia / Casos de tuberculose com notificação após o óbito no Brasil, 2014: um estudo descritivo com base nos dados de vigilância

Objective. To characterize cases with post-mortem notification of Tuberculosis in Brazil, in 2014. Methods. This is a descriptive study of tuberculosis cases with post-mortem notification. Data were resulted from the linkage of the Notifiable Diseases Information System-TB (Sinan-TB) and the Mortality Information System (SIM); and were described according to the underlying cause of death: TB, AIDS and others. Results. 2,703 tuberculosis cases had post-mortem notification in Brazil in 2014. There were a high proportion of male (73.5%), age over 39(80.8%), <8 years of education (66.5%), black & brown ethnicity (62.8%), pulmonary clinic form (75.2%), notified by public health service (57.6%) and from municipalities with MHDI >0.7 (66.6%). Conclusion. The described characteristics of people with post-mortem notification and the magnitude of this outcome suggest weaknesses in tuberculosis care and surveillance services.

Objetivo. Caracterizar os casos com notificação pós-óbito da tuberculose no Brasil em 2014. Métodos. Estudo descritivo dos casos de tuberculose com notificação pós-óbito. Os dados são resultantes da vinculação do Sistema de Informação de Agravos de Notificação (Sinan-TB) com o Sistema de Informações sobre Mortalidade (SIM), e foram descritos segundo causa básica de óbito: tuberculose, aids e outras. Resultados. Nos 2.703 casos de tuberculose com notificação pós-óbito, observou-se maior proporção de pessoas do sexo masculino (73,5%), com mais de 39 anos de idade (80,8%), com escolaridade <8 anos de estudo (66,5%), de raça/cor da pele negra e parda (62,8%), que adoeceram de tuberculose na forma clínica pulmonar (75,2%); também prevaleceram notificações pelo serviço público (57,6%) e em municípios com índice de desenvolvimento humano >0,7 (66,6%). Conclusão. As características descritas das pessoas notificadas pós-óbito e a magnitude desse desfecho sugerem fragilidades dos serviços de atenção e vigilância da tuberculose

An evaluation of Primary Health Care from the users' perspective: reflections on the usage of the Primary Care Assessment Tool-Brazil in telephone surveys. / Avaliação da Atenção Primária à Saúde na ótica dos usuários: reflexões sobre o uso do Primary Care Assessment Tool-Brasil versão reduzida nos inquéritos telefônicos.

OBJECTIVE: To evaluate the attributes of PHC from the perspective of users, interviewed in a telephone survey in Belo Horizonte. METHODS: Cross-sectional population-based study. Data from Vigitel 2015 that included an additional module on PHC assessment were used. A reduced version of PCATool-Brasil with adaptations was used. RESULTS: We interviewed 872 users and there was a predominance of women, older adults, adults with low levels of education, those without a partner, those who described themselves as brown, and those without health insurance. The overall score of the Vigitel assessment was 5.48 (95%CI 5.35 - 5.61) and the reduced PCATool was 5.01 (95%CI 4.86 - 5.15). In both instruments, the scores of the attributes first contact (utilization), longitudinality, and coordination (care) were higher than the general score with the highest value (5.48). The mean score of the first contact attribute (utilization) was the highest rated by users considering the Vigitel assessment instrument (7.09; 95%CI 6.93 - 7.26). In general, the evaluations of the instruments are coinciding, but the attributes first contact (utilization), completeness (available services) and coordination (information system) presented better mean scores in the Vigitel evaluation instrument when compared to the reduced PCATool. There was no difference in the evaluation according to Regional Health. CONCLUSION: The use of the reduced version of the PCATool in a telephone survey and with small adaptations to the local reality, showed a new possibility for the evaluation of PHC services, and may become useful in the management of health services.

Identification of micro-regions with under-reported tuberculosis cases in Brazil, 2012-2014. / Identificação de microrregiões com subnotificação de casos de tuberculose no Brasil, 2012 a 2014.

OBJECTIVE: to identify Brazilian micro-regions with under-reported tuberculosis cases, from 2012 to 2014. METHODS: this was an ecological study using data from the Notifiable Health Conditions Information System (SINAN). The indirect estimator of the proportion of notified cases (EIPCN) was calculated as the mean between the proportion of cases that adhered to treatment and the proportion of those who underwent sputum smear microscopy. Negative Binomial Regression was used to investigate evidence of under-reporting in the micro-regions selected through EIPCN. RESULTS: under-reporting was suspected in 89 (17.5%) micro-regions with EIPCN below 83%. The EIPCN rate ratio in the regression model was 0.996 (95%CI 0.988;1.003) considering all the data and equal to 0.987 (95%CI 0.974;0.999) excluding the 89 micro-regions with suspected under-reporting. CONCLUSION: evidence of tuberculosis case under-reporting was found in micro-regions where basic indicators of surveillance system quality had poor performance.

Estimated mortality rate and leading causes of death among individuals with chikungunya in 2016 and 2017 in Brazil.

INTRODUCTION: In 2014, the first cases of autochthonous chikungunya (CHIK) were recorded in Brazil. Lethality associated with this disease is underestimated. Thus, this study aimed to analyze the causes of death among individuals with CHIK in Brazil. METHODS: A descriptive observational study was conducted on individuals with CHIK who died within 6 months from symptom onset. Data pairing between the Information System for Notifiable Diseases and the Mortality Information System was performed. Deaths were classified according to case confirmation criterion, mention of CHIK in the death certificates (DCs), and disease phase. The lethality rate per 1,000 cases was corrected for underreporting and was estimated according to region, sex, age, years of education, race/color, and cause groups. RESULTS: We identified 3,135 deaths (mention of CHIK in the DCs, 764 [24.4%]). In 17.6% of these cases, CHIK was the underlying cause. Most deaths occurred in the acute (38.1%) and post-acute (29.6%) phases. The corrected LR (5.7; x1,000) was 6.8 times higher than that obtained from the Information System for Notifiable Diseases (0.8). The highest corrected LRs were estimated for among individuals living in the Northeast region (6.2), men (7.4), those with low years of education and those aged <1 year (8.6), 65-79 years (20.7), and ≥80 years (75.4). CONCLUSIONS: The LR of CHIK estimates based on information system linkage help to reveal the relevance of this disease as the direct cause or as a cause associated with serious or fatal events, provide timely interventions, and increase the knowledge about this disease.