Association between ultra-processed food consumption and the incidence of type 2 diabetes: the ELSA-Brasil cohort.

BACKGROUND: Ultra-processed food (UPF) consumption increases the risk of type 2 diabetes in various high-income countries, with some variation in the magnitude across studies. Our objective was to investigate the association of UPF consumption and specific subgroups with incident type 2 diabetes in Brazilian adults. METHODS: The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) is a multicenter cohort study of 15,105 adults (35-74 years) enrolled in public institutions in Brazil (2008-2010). We followed participants with two clinic visits (2012-2014; 2017-2019) and annual telephone surveillance. After excluding those with diabetes at baseline, who died or were lost in the follow-up, with missing data, with implausible energy food intake, or reporting bariatric surgery, there were 10,202 participants. We used the NOVA classification to assess UPF consumption based on a food frequency questionnaire. We defined type 2 diabetes by self-report, medication use, or comprehensive laboratory tests. We estimated relative risks (RR) and 95% confidence intervals (95% CI) using robust Poisson regression. RESULTS: Median UPF consumption was 372 g/day. Over 8.2 (0.7) years of follow-up, we detected 1799 (17.6%) incident cases. After adjustment for socio-demographics, family history of diabetes, and behavioral risk factors, comparing the fourth (≥ 566 g/day) with the first (< 236 g/day) quartile of UPF distribution, RR was 1.24 (1.10-1.39); every 150 g/day increments in UPF consumption resulted in a RR of 1.05 (1.03-1.07). Reclassifying natural beverages with added sweeteners as UPF increased risk (RR 1.40; 1.25-1.58). Among UPF subgroupings, consumption of processed meats and sweetened beverages increased diabetes risk, while yogurt and dairy sweets decreased the risk (p < 0.05). CONCLUSIONS: UPF consumption increased the incidence of type 2 diabetes in Brazilian adults, with heterogeneity across specific food items. These findings add to previous evidence for the role of UPFs in the development of diabetes and other chronic diseases, supporting recommendations to avoid their intake in diabetes prevention and management.

Impact of socioeconomic factors on lifestyle changes among employees of public higher education institutions in ELSA-Brasil during COVID-19 pandemic.

This study aimed to identify lifestyle changes and associated sociodemographic factors in women and men participating in the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) cohort during the COVID-19 pandemic. Longitudinal study with 3,776 (aged 58.8 years; SD ± 8.5) employees of public higher education institutions in the second follow-up and the wave-COVID of ELSA-Brasil. Data collected using structured questionnaires. An exploratory analysis was performed using binary and multinomial logistic regression on the dependent variables with two and three categories, respectively, by obtaining crude and adjusted odds ratio estimates in SPSS 20.0, considering a p-value < 0.05. There was a reduction in physical activity of 195.5 (SD ± 1,146.4) metabolic equivalents per week in women and 240.5 (SD ± 1,474.2) in men, and in smoking by 15.2%. There was an increase in alcohol consumption in men and women (434.2 ± 5,144.0; and 366.1 ± 4,879.0, respectively), in the food quality score (0.8 ± 3.7, women; 0.5 ± 3.7, men), sleeping time (0.4 ± 1.2, women; 0.5 ± 1.1, men), screen time (1.7 ± 2.4, women; 1.4 ± 2.3, men), and sitting time (1.7 ± 2.6, women; 1.5 ± 2.4, men) (hours/day). In total, 18.6% increased the purchase of ultra-processed foods and 36% increased the purchase of natural foods. Age and work activity contributed to increase the chance of purchasing ultra-processed foods, and age and adherence to social distancing influenced the shift to a more sedentary behavior, while income and active work favored the increase in alcoholic beverage consumption. These factors should be considered when developing public policies to avoid individual behaviors that are harmful to health during pandemics.

Inconsistent condom use with casual partners among men who have sex with men in Brazil: a cross-sectional study / Uso inconsistente do preservativo com parceiros casuais entre homens que fazem sexo com homens no Brasil: um estudo transversal

ABSTRACT Objective: This study aimed to evaluate factors associated with inconsistent condom use with casual partners in a population of men who have sex with men (MSM) in Brazil. Methods: In 2016, 4,176 MSM >18 years were enrolled in 12 capitals of Brazil using a Respondent Driven Sampling (RDS) method. For the construction of the outcome, we evaluated questions about condom use in all anal intercourse (receptive and insertive) in the previous six months and the last sexual intercourse. Estimates were calculated using a weighted complex sample design. We performed a logistic regression analysis to determine the associations between sociodemographic and behavioral factors and inconsistent condom use in sexual relationships with casual male partners. Results: More than half of our sample (50.8%) had not used condoms consistently with casual partners in the previous six months. Inconsistent condom use was significantly associated with: low education (weighted odds ratio — wOR: 1.55; 95% confidence interval — CI 0.99-2.40), lack of counseling on sexually transmitted infections STI (wOR: 1.51; 95%CI 1.05-2.17), non-use of condoms at sexual debut (wOR: 3.05; 95%CI 2.12-4.40) and moderate and high perceived risk for HIV (wOR: 1.51; 95%CI 1.07-2.14). Higher age was negatively associated with inconsistent condom use (wOR=0.97, 95%CI 0.89-0.99). Conclusion: Despite being an individual behavior, condom use is related to factors beyond the individual scope. HIV/Aids prevention policies should focus on younger MSM, providing qualified information about condom use, preferably before the beginning of their sexual life.

RESUMO Objetivo: Este estudo tem como objetivo avaliar os fatores associados ao uso inconsistente do preservativo com parceiros casuais em uma população de homens que fazem sexo com homens (HSH) no Brasil. Métodos: Trata-se de um estudo transversal, com método de amostragem Respondent Driven Sampling (RDS), desenvolvido em 12 capitais do Brasil, com 4.176 HSH. Para a construção do desfecho, foram avaliadas questões sobre o uso do preservativo em todas as relações anais (receptivas e insertivas) nos últimos seis meses e a última relação sexual. As estimativas foram calculadas usando um desenho amostral complexo ponderado. Realizamos uma análise de regressão logística para determinar as associações entre fatores sociodemográficos e comportamentais e o uso inconsistente do preservativo. Resultados: Mais da metade da nossa amostra (50,8%) não usou preservativo de forma consistente com parceiros casuais nos últimos seis meses. O uso inconsistente do preservativo foi significativamente associado a: falta de aconselhamento sobre infecções sexualmente transmissíveis (weighted odds ratio — wOR: 1,51; intervalo de confiança — IC95% 1,05-2,17), não uso de preservativo na primeira relação sexual (wOR: 3,05; IC95% 2,12-4,40) e autopercepção de risco para o HIV como moderado e alto (wOR: 1,51; IC95% 1,07-2,14). Maior idade foi negativamente associada ao uso inconsistente do preservativo (wOR=0,97, IC95% 0,89-0,99). Conclusão: Apesar de ser um comportamento individual, o uso do preservativo está relacionado a fatores além do âmbito privado. As políticas de prevenção ao HIV/AIDS devem focar nos HSH mais jovens, fornecendo informações qualificadas sobre o uso do preservativo, preferencialmente antes do início da vida sexual.

Impact of socioeconomic factors on lifestyle changes among employees of public higher education institutions in ELSA-Brasil during COVID-19 pandemic / Impacto de fatores socioeconômicos na mudança do estilo de vida de funcionários de instituições públicas de Ensino Superior no ELSA-Brasil durante a pandemia de COVID-19 / Impacto de los factores socioeconómicos en el cambio del estilo de vida de los funcionarios en instituciones públicas de educación superior en ELSA-Brasil durante la pandemia de la COVID-19

Abstract: This study aimed to identify lifestyle changes and associated sociodemographic factors in women and men participating in the Brazilian Longitudinal Study for Adult Health (ELSA-Brasil) cohort during the COVID-19 pandemic. Longitudinal study with 3,776 (aged 58.8 years; SD ± 8.5) employees of public higher education institutions in the second follow-up and the wave-COVID of ELSA-Brasil. Data collected using structured questionnaires. An exploratory analysis was performed using binary and multinomial logistic regression on the dependent variables with two and three categories, respectively, by obtaining crude and adjusted odds ratio estimates in SPSS 20.0, considering a p-value < 0.05. There was a reduction in physical activity of 195.5 (SD ± 1,146.4) metabolic equivalents per week in women and 240.5 (SD ± 1,474.2) in men, and in smoking by 15.2%. There was an increase in alcohol consumption in men and women (434.2 ± 5,144.0; and 366.1 ± 4,879.0, respectively), in the food quality score (0.8 ± 3.7, women; 0.5 ± 3.7, men), sleeping time (0.4 ± 1.2, women; 0.5 ± 1.1, men), screen time (1.7 ± 2.4, women; 1.4 ± 2.3, men), and sitting time (1.7 ± 2.6, women; 1.5 ± 2.4, men) (hours/day). In total, 18.6% increased the purchase of ultra-processed foods and 36% increased the purchase of natural foods. Age and work activity contributed to increase the chance of purchasing ultra-processed foods, and age and adherence to social distancing influenced the shift to a more sedentary behavior, while income and active work favored the increase in alcoholic beverage consumption. These factors should be considered when developing public policies to avoid individual behaviors that are harmful to health during pandemics.

Resumo: O objetivo do estudo é identificar mudanças no estilo de vida e fatores sociodemográficos associados em mulheres e homens participantes da coorte Estudo Longitudinal da Saúde do Adulto (ELSA-Brasil) durante a pandemia de COVID-19. Estudo longitudinal com 3.776 (58,8 anos; DP ± 8,5) funcionários de instituições públicas de Ensino Superior no segundo acompanhamento e na onda COVID do ELSA-Brasil. Os dados foram coletados por meio de questionários estruturados. Foi realizada análise exploratória por meio de regressão logística binária e multinomial nas variáveis dependentes com duas e três categorias, respectivamente, obtendo-se estimativas brutas e ajustadas de odds ratio no SPSS 20.0, considerando um valor de p < 0,05. Houve redução da atividade física de 195,5 (DP ± 1.146,4) equivalentes metabólicos por semana nas mulheres e de 240,5 (DP ± 1.474,2) nos homens, e do tabagismo de 15,2%. Houve aumento do consumo de álcool em homens e mulheres (434,2 ± 5.144,0 e 366,1 ± 4.879,0, respectivamente), do escore de qualidade alimentar (0,8 ± 3,7, mulheres; 0,5 ± 3,7, homens), do tempo de sono (0,4 ± 1,2, mulheres; 0,5 ± 1,1, homens), do tempo de tela (1,7 ± 2,4, mulheres; 1,4 ± 2,3, homens) e do tempo sentado (1,7 ± 2,6, mulheres; 1,5 ± 2,4, homens) (horas/dia). Além disso, 18,6% aumentaram a compra de alimentos ultraprocessados e 36% aumentaram a compra de alimentos naturais. A idade e a atividade laboral contribuíram para aumentar a chance de compra de alimentos ultraprocessados, e a idade e a adesão ao distanciamento social influenciaram a mudança para um comportamento mais sedentário, enquanto a renda e o trabalho ativo favoreceram o aumento do consumo de bebidas alcoólicas. Estes fatores devem ser considerados na elaboração de políticas públicas a fim de evitar comportamentos individuais deletérios à saúde em períodos de pandemia.

Resumen: El objetivo de este estudio es identificar los cambios en el estilo de vida y los factores sociodemográficos asociados en mujeres y hombres que participan en la cohorte Estudio Longitudinal de Salud del Adulto en Brasil (ELSA-Brasil) durante la pandemia de la COVID-19. Estudio longitudinal con 3.776 (58,8 años; DE ± 8,5) funcionarios en instituciones públicas de educación superior en el segundo seguimiento y en la ola COVID de ELSA-Brasil. Los datos se recopilaron de cuestionarios estructurados. El análisis exploratorio se realizó mediante regresión logística binaria y multinomial en variables dependientes con dos y tres categorías, respectivamente, en la cual se obtuvieron estimaciones brutas y ajustadas de odds ratios en SPSS 20.0, teniendo en cuenta un valor de p < 0,05. Hubo una reducción en la actividad física de 195,5 (DE ± 1.146,4) equivalentes metabólicos por semana en mujeres y de 240,5 (DE ± 1.474,2) en hombres, y del tabaquismo del 15,2%. Hubo un aumento en el consumo de alcohol en hombres y mujeres (434,2 ± 5.144,0 y 366,1 ± 4.879,0, respectivamente), en el puntaje de calidad de los alimentos (0,8 ± 3,7, mujeres; 0,5 ± 3,7, hombres), en el tiempo de sueño (0,4 ± 1,2, mujeres; 0,5 ± 1,1, hombres), en el tiempo frente a la pantalla (1,7 ± 2,4, mujeres; 1,4 ± 2,3, hombres) y en el tiempo sentado (1,7 ± 2,6, mujeres; 1,5 ± 2,4, hombres) (horas/día). Además, el 18,6% aumentó la compra de alimentos ultraprocesados y el 36% la compra de alimentos.

Marker events associated with adherence to HIV/AIDS treatment in a cohort study / Eventos marcadores associados à adesão ao tratamento para HIV/aids em um estudo de coorte

ABSTRACT OBJECTIVE To analyze how clinical and social events may impact adherence to antiretroviral treatment for HIV. METHODS This is a historical cohort study with 528 patients who underwent treatment for HIV in a specialized care service in Alvorada, RS. A total of 3429 queries executed between the years 2004 and 2017 were analyzed. For each visit, data on treatment characteristics and the patients' clinical picture were collected. Adherence, as measured by patients' self-report, was the endpoint of the study. The logistic regression model via generalized estimating equations was used for estimating the associations. RESULTS 67.8% of the patients analyzed have up to 8 years of education and 24.8% have a history of crack and/or cocaine use. Among men, being asymptomatic [odds ratio (OR) = 1.43; 95%CI 1.05-1.93], having more than 8 years of education (OR= 2.32; 95%CI 1.27-4.23), and never having used crack (RC = 2.35; 95%CI 1.20-4.57) were associated with adherence. For women, being older than 24 years (CR = 1.82; 95%CI 1.09-3.02), never having used cocaine (CR = 2.54; 95%CI 1.32-4.88) and being pregnant (RC = 3.28; 95%CI 1.83-5.89) increased the odds of adherence. CONCLUSIONS In addition to defined sociodemographic characteristics, one-off events that may occur in the trajectory of patients on long treatment, such as starting a new pregnancy and not having symptoms, can impact patients' chances of treatment adherence.

RESUMO OBJETIVO Analisar como eventos clínicos e sociais podem impactar na adesão ao tratamento antirretroviral para o HIV. MÉTODOS Trata-se de um estudo de coorte histórica com 528 pacientes que realizaram o tratamento para o HIV em um serviço de assistência especializada em Alvorada, RS. Foram analisadas 3429 consultas executadas entre os anos de 2004 e 2017. Para cada consulta, foram coletados dados de características do tratamento e do quadro clínico dos pacientes. A adesão, aferida pelo autorrelato dos pacientes, foi o desfecho do estudo. O modelo de regressão logística via equações de estimação generalizadas foi utilizado para estimação das associações. RESULTADOS 67,8% dos pacientes analisados possuem até 8 anos de estudos e 24,8% têm histórico de uso de crack e/ou cocaína. Entre os homens, estar assintomático [razão de chances (RC) = 1,43; IC95% 1,05-1,93], possuir mais de 8 anos de estudo (RC = 2,32; IC95% 1,27-4,23) e nunca ter usado crack (RC = 2,35; IC95% 1,20-4,57) estiveram associados à adesão. Para as mulheres, possuir mais de 24 anos (RC = 1,82; IC95% 1,09-3,02), nunca ter usado cocaína (RC = 2,54; IC95% 1,32-4,88) e estar em gestação (RC = 3,28; IC95% 1,83-5,89) aumentaram as chances de adesão. CONCLUSÕES Além de características sociodemográficas definidas, eventos pontuais que podem ocorrer na trajetória de pacientes em tratamentos longos, como início de uma nova gestação e não apresentar sintomas, podem impactar nas chances de adesão dos pacientes ao tratamento.

Breastfeeding Rates and Related Factors at 1 Year Postpartum in Women With Gestational Diabetes Initially Recruited for a Diabetes Prevention Program.

OBJECTIVES: Our aim in this study was to evaluate breastfeeding up to 1 year postpartum and factors related to weaning in women with recent gestational diabetes mellitus (GDM). METHODS: We assembled a cohort study of women with GDM enrolled in prenatal clinics of the Brazilian National Health System as possible candidates for the Lifestyle Intervention for Diabetes Prevention After Pregnancy (LINDA-Brasil) postpartum trial (N=2,220). Sociodemographics and clinical and nutritional information, including breastfeeding, were obtained by interview or chart review. Follow-up by telephone was done at specific intervals during the first year postpartum. RESULTS: The probability of breastfeeding at 1 year postpartum, estimated from Kaplan-Meier survival analysis, was 53.5%. Cox regression models showed increased risk of weaning for those introducing milk or formula before 6 months (hazard ratio [HR], 2.55; 95% confidence interval [CI], 2.10 to 3.09); reporting problems in breastfeeding (HR, 1.49; 95% CI, 1.22 to 1.82); being Caucasian (HR, 1.46; 95% CI, 1.21 to 1.76); smoking during pregnancy (HR, 1.68; 95% CI, 1.28 to 2.20); and living in 2 southern cities of Brazil (HR, 1.58; 95% CI, 1.16 to 2.16; and HR, 1.76; 95% CI, 1.20 to 2.58). CONCLUSIONS: About half of the women with GDM ceased breastfeeding before 1 year postpartum, a rate matching that of the general population in Brazil. The main risk factor was not exclusively breastfeeding up to 6 months. Given the possibility of curbing diabetes risk by maintaining longer breastfeeding, further promotion of exclusive breastfeeding up to 6 months for these high-risk women is much needed.

Population-based prevalence surveys during the Covid-19 pandemic: A systematic review.

Population-based prevalence surveys of Covid-19 contribute to establish the burden of infection, the role of asymptomatic and mild infections in transmission, and allow more precise decisions about reopen policies. We performed a systematic review to evaluate qualitative aspects of these studies, assessing their reliability and compiling practices that can influence the methodological quality. We searched MEDLINE, EMBASE, bioRxiv and medRxiv, and included cross-sectional studies using molecular and/or serological tests to estimate the prevalence of Covid-19 in the general population. Survey quality was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies. A correspondence analysis correlated methodological parameters of each study to identify patterns related to higher, intermediate and lower risks of bias. The available data described 37 surveys from 19 countries. The majority were from Europe and America, used antibody testing, and reached highly heterogeneous sample sizes and prevalence estimates. Minority communities were disproportionately affected by Covid-19. Important risk of bias was detected in four domains: sample size, data analysis with sufficient coverage, measurements in standard way and response rate. The correspondence analysis showed few consistent patterns for high risk of bias. Intermediate risk of bias was related to American and European studies, municipal and regional initiatives, blood samples and prevalence >1%. Low risk of bias was related to Asian studies, nationwide initiatives, reverse-transcriptase polymerase chain reaction tests and prevalence <1%. We identified methodological standards applied worldwide in Covid-19 prevalence surveys, which may assist researchers with the planning, execution and reporting of future population-based surveys.

Formulários de notificação de reações adversas a medicamento nos sistemas de farmacovigilância do Brasil e outros doze países latino-americanos: análise comparativa / Adverse drug reaction notification forms of the pharmacovigilance systems in Brazil and twelve other Latin-American countries: a comparative analysis

Resumo Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latino-americanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.

Abstract The scope of this study was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study comprised three stages. In the first stage, the forms were attributed a score relating to the presence of critical items to generate ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate assessment of causality. In the last stage, hierarchical clustering was used to identify similar forms. The Venezuelan form achieved the highest score (18 points). The median number of variables in the forms of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the variables of the form were classified as life-critical and the majority contribute as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two distinct groups, 1 and 3 respectively. The results of this study indicate the need to change the forms of the different countries studied or even delete some variables, making them more appropriate for the process of assessment of ADR causality.

Cancer Cell Fitness Is Dynamic.

Several phenotypes that impact the capacity of cancer cells to survive and proliferate are dynamic. Here we used the number of cells in colonies as an assessment of fitness and devised a novel method called Dynamic Fitness Analysis (DynaFit) to measure the dynamics in fitness over the course of colony formation. DynaFit is based on the variance in growth rate of a population of founder cells compared with the variance in growth rate of colonies with different sizes. DynaFit revealed that cell fitness in cancer cell lines, primary cancer cells, and fibroblasts under unhindered growth conditions is dynamic. Key cellular mechanisms such as ERK signaling and cell-cycle synchronization differed significantly among cells in colonies after 2 to 4 generations and became indistinguishable from randomly sampled cells regarding these features. In the presence of cytotoxic agents, colonies reduced their variance in growth rate when compared with their founder cell, indicating a dynamic nature in the capacity to survive and proliferate in the presence of a drug. This finding was supported by measurable differences in DNA damage and induction of senescence among cells of colonies. The presence of epigenetic modulators during the formation of colonies stabilized their fitness for at least four generations. Collectively, these results support the understanding that cancer cell fitness is dynamic and its modulation is a fundamental aspect to be considered in comprehending cancer cell biology and its response to therapeutic interventions. SIGNIFICANCE: Cancer cell fitness is dynamic over the course of the formation of colonies. This dynamic behavior is mediated by asymmetric mitosis, ERK activity, cell-cycle duration, and DNA repair capacity in the absence or presence of a drug.

Aryl-hydrocarbon receptor binding and the incidence of type 2 diabetes: the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

BACKGROUND: Persistent organic pollutants (POPs) may cause diabetes, in part through aryl hydrocarbon receptor (AhR) binding. Ensuing mitochondrial dysfunction is postulated to mediate this effect. We aim to investigate the association of POPs with incident diabetes indirectly by bio-assaying AhR ligand bioactivity and intracellular ATP level induced by participant serum samples. METHODS: In incident case-cohort analyses of one ELSA-Brasil center, 1605 eligible subjects without diabetes at baseline had incident diabetes ascertained by self-report, medication use, OGTT or HbA1c at follow-up 4 years later. We assayed AhR ligand bioactivity (AhRL) and intracellular ATP content, the latter reflecting the presence of mitochondria-inhibiting substances (MIS), following incubation of recombinant mouse Hepa1c1c7 cells with participant sera for 71 incident diabetes cases and 472 randomly selected controls. RESULTS: In multiply-adjusted proportional hazards regression analyses, those with above-median AhRL and below-median MIS-ATP had 69 and 226% greater risk of developing diabetes (HR = 1.69; 95%CI 1.01-2.83 and 3.26; 1.84-5.78), respectively. A strong interaction was seen between the two exposures (HRhigh AhRL/low MIS-ATP vs. low AhRL/high MIS-ATP = 8.15; 2.86-23.2). CONCLUSION: The markedly increased incidence of diabetes seen in those with both higher AhR ligand bioactivity and increased mitochondrial inhibition supports the hypothesis that widespread POPs exposure contributes to the diabetes epidemic.

[Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive study]. / Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo.

The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.

Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.

El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.

Distance Education to Improve the Quality of Asthma Treatment in Primary Health Care: Cluster Randomized Clinical Trial - RESPIRANET / Educação a distância para melhorar a qualidade do tratamento da asma na Atenção Primária à Saúde: ensaio clínico randomizado em cluster - RESPIRANET / Educación a distancia para mejorar la calidad del tratamiento del asma en la atención primaria de salud: ensayo clínico aleatorizado grupal - RESPIRANET

Objective: The mere dissemination of standard care recommendations has been insufficient to improve clinical results in patients with asthma. The objective of the present study was to evaluate the clinical effectiveness of a multifaceted asthma distance education for primary care providers. Methods: Cluster randomized controlled trial. Full primary care teams were included if they had access to telehealth support and free basic asthma treatment. Before randomization, selected teams indicated asthma patients between 5-45 years old for inclusion. The intervention group received three interactive online sessions, printed educational material, reminders, booklet for patients, and frequent stimulus to use consulting services. The control group received no intervention. Symptomfree days per two weeks was the primary result. Controlled asthma, unscheduled asthma doctor visits, and preventive inhaled corticosteroid use were the secondary results. Six months after intervention, the results were compared with baseline data using generalized estimating equations for repeated measures and clustering effect. Results: Were enrolled 71 primary care teams and 443 individuals. Most patients (60.3%) were female, and 44% were younger than 12 years old. The attendance of interactive sessions by the teams was 50%. The odds ratio (OR) for additional symptom-free day was 1.31 (95%CI 0.61-2.82; p=0.49). For the secondary results, the results were: controlled asthma OR 1.29 (95%CI 0.89-1.87; p=0.18); unscheduled asthma doctor visits OR 0.81 (95%CI 0.60-1.10; p=0.17); and preventive inhaled corticosteroid use OR 1.02 (95%CI 0.71-1.47; p=0.91). Conclusions: Multifaceted distance education in asthma care for primary care providers was not effective to improve patients' results. Telemedicine needs to deal with significant obstacles in professional education. ClinicalTrials.gov registry: NCT01595971.

Objetivo: A mera disseminação de recomendações de cuidados padronizados tem sido insuficiente para melhorar os desfechos clínicos em pacientes com asma. O objetivo do presente estudo foi avaliar a eficácia clínica de uma intervenção educativa multifacetada a distância sobre asma para profissionais da atenção primária à saúde. Métodos: Ensaio clínico randomizado por cluster. Equipes completas de atenção primária foram incluídas se tinham acesso a suporte de telessaúde e tratamento básico gratuito para asma. Antes da randomização, as equipes selecionadas indicaram pacientes asmáticos entre 5-45 anos para inclusão. O grupo de intervenção recebeu três sessões online interativas, material educativo impresso, lembretes, folheto para pacientes e estímulos frequentes para o uso de serviços de consultoria. O grupo controle não recebeu intervenção. O desfecho primário foi dias sem sintomas por duas semanas. Asma controlada, consultas médicas não programadas para asma e uso preventivo de corticosteroides inalatórios foram os desfechos secundários. Seis meses após a intervenção, os resultados foram comparados com a linha de base, usando equações de estimativas generalizadas para medidas repetidas e efeito de agrupamento. Resultados: Foram inscritas 71 equipes de atenção primária e 443 indivíduos. A maioria dos pacientes (60,3%) era do sexo feminino e 44% tinha menos de 12 anos de idade. A frequência das equipes nas sessões interativas foi de 50%. O odds ratio (OR) para dias sem sintomas adicionais foi de 1,31 (IC 95% 0,61-2,82; p=0,49). Para os desfechos secundários, os resultados foram: asma controlada 1,29 (IC 95% 0,89-1,87; p=0,18); visitas não programadas de asma ao médico OR 0,81 (IC 95% 0,60-1,10; p=0,17); e uso preventivo de corticosteroides inalatórios OR 1,02 (IC 95% 0,71-1,47; p=0,91). Conclusões: Ações multifacetadas de educação a distância em cuidados de asma para profissionais de saúde da atenção primária não foram eficazes para melhorar os resultados nos pacientes. A telemedicina precisa lidar com obstáculos significativos na educação profissional. Registro ClinicalTrials.gov: NCT01595971.

Objetivo: La mera difusión de las recomendaciones de atención estándar ha sido insuficiente para mejorar los resultados clínicos en pacientes con asma. El objetivo del presente estudio fue evaluar la efectividad clínica de una educación multifacética a distancia sobre el asma para los proveedores de atención primaria. Métodos: Ensayo controlado aleatorizado por grupos. Se incluyeron equipos completos de atención primaria si tenían acceso a apoyo de telesalud y tratamiento básico gratuito para el asma. Antes de la aleatorización, los equipos seleccionados indicaron pacientes con asma entre 5-45 años de edad para inclusión. El grupo de intervención recibió tres sesiones interactivas en línea, material educativo impreso, recordatorios, folleto para los pacientes y estímulos frecuentes para utilizar los servicios de consultoría. El grupo control no recibió ninguna intervención. El resultado primario fue días sin síntomas por dos semanas. Los resultados secundarios fueron asma controlada, visitas médicas no programadas para el asma y el uso preventivo de corticosteroides inhalados. Seis meses después de la intervención, los resultados se compararon con los datos de referencia utilizando ecuaciones de estimación generalizadas para medidas repetidas y efecto de agrupación. Resultados: Se inscribieron 71 equipos de atención primaria y 443 personas. La mayoría de los pacientes (60,3%) eran mujeres y el 44% eran menores de 12 años. La asistencia a sesiones interactivas por parte de los equipos fue del 50%. La razón de probabilidades (OR) para un día sin síntomas adicional fue de 1.31 (IC del 95%: 0.61 a 2.82; p=0.49). Para los resultados secundarios, los resultados fueron: asma controlada O 1.29 (IC del 95%: 0.89 a 1.87; p=0.18); visitas al médico para el asma no programadas O 0,81 (IC del 95%: 0,60 a 1,10; p=0,17); y el uso preventivo de corticosteroides inhalados OR 1.02 (IC del 95%: 0.71 a 1.47; p=0.91). Conclusiones: La educación a distancia multifacética en el cuidado del asma para los proveedores de atención primaria no fue efectiva para mejorar los resultados de los pacientes. La telemedicina debe enfrentar obstáculos significativos en la educación profesional. Registro de ClinicalTrials.gov: NCT01595971.

Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo / Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive study / Reacciones adversas a medicamentos en el sistema de farmacovigilancia de Brasil, de 2008 a 2013: estudio descriptivo

Resumo: Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.

Abstract: The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.

Resumen: El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.

Evolução e elementos-chave do sistema de farmacovigilância do Brasil: uma revisão de escopo a partir da criação da Agência Nacional de Vigilância Sanitária / Evolución y elementos-clave del sistema de farmacovigilancia de Brasil: una revisión de alcance a partir de la creación de la Agencia Nacional de Vigilancia Sanitaria / Evolution and key elements of the Brazilian pharmacovigilance system: a scoping review beginning with the creation of the Brazilian Health Regulatory Agency

Esta revisão de escopo objetiva descrever e caracterizar o sistema de farmacovigilância do Brasil (SINAF) e averiguar o atendimento aos requisitos mínimos propostos pela Organização Mundial da Saúde para um desempenho funcional de sistemas nacionais dessa natureza. A estratégia de pesquisa bibliográfica utilizou recomendações do STARLITE e termos de busca nas bases de dados MEDLINE/PubMed, Google, Imprensa Nacional da República do Brasil e website da Agência Nacional de Vigilância Sanitária (Anvisa), compreendendo o período entre 1999, ano de criação da Anvisa, e março de 2016. Foram incluídas 47 (4,4%) publicações, de um total de 1.068 identificadas, prevalecendo, nesta ordem: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos e 10 (21,3%) artigos científicos. Os estudos e documentos técnicos analisados compreenderam a criação, em âmbito federal, da primeira unidade técnica de farmacovigilância do sistema de notificação de eventos adversos, o Centro Nacional de Monitorização e a Câmara Técnica de Medicamentos. A taxa de notificação de eventos adversos a medicamentos no Brasil correspondeu, em 2013, a 36 notificações/1 milhão de habitantes, bastante inferior à meta proposta na literatura internacional, que sugere 300 notificações/1 milhão de habitantes. Este estudo identificou aspectos estruturais e funcionais que podem comprometer o desempenho do SINAF, como a falta de legislação que institua oficialmente o próprio sistema e suas finalidades.

Esta revisión de alcance tiene como objetivo describir y caracterizar el sistema de farmacovigilancia de Brasil (SINAF) y constatar su adscripción a los requisitos mínimos propuestos por la Organización Mundial de la Salud, respecto al desempeño funcional de los sistemas nacionales de esta naturaleza. La estrategia de investigación bibliográfica utilizó recomendaciones del STARLITE y términos de búsqueda en las bases de datos MEDLINE/PubMed, Google, Imprenta Nacional de la República de Brasil y de la página web de la Agencia Nacional de Vigilancia Sanitaria (Anvisa), comprendiendo el período entre 1999, año de creación de la Anvisa, y marzo de 2016. Se incluyeron 47 (4,4%) publicaciones, de un total de 1.068 identificadas, predominando por este orden: 14 normas jurídicas (29,8%), 13 (27,6%) documentos técnicos y 10 (21,3%) artículos científicos. Los estudios y documentos técnicos analizados incluyeron la creación, en el ámbito federal, de la primera unidad técnica de farmacovigilancia del sistema de notificación de eventos adversos, el Centro Nacional de Monitoreo y la Cámara Técnica de Medicamentos. La tasa de notificación de eventos adversos en medicamentos dentro de Brasil correspondió, en 2013, a 36 notificaciones/1 millón de habitantes, bastante inferior a la meta propuesta en la literatura internacional, que sugiere 300 notificaciones/1 millón de habitantes. Este estudio identificó aspectos estructurales y funcionales que pueden comprometer el desempeño del SINAF, como la falta de legislación que instituya oficialmente al propio sistema y sus finalidades.

This scoping review aims to describe and characterize the Brazilian pharmacovigilance system Brazil (SINAF) and verify to what extent it meets the minimum requirements proposed by the World Health Organization for the functional performance of this type of national system. The literature search strategy used STARLITE recommendations and search terms in MEDLINE/PubMed, Google, the Brazilian National Press, and the website of the Brazilian Health Regulatory Agency (Anvisa), from 1999, when Anvisa was created, to March 2016. The review included 47 publications (4.4%), out of a total of 1,068 identified, in the following order: 14 legal provisions (29.8%), 13 (27.6%) technical documents, and 10 (21.3%) scientific articles. The studies and technical documents covered the creation of the first pharmacovigilance technical unit at the federal level, the reporting system for adverse events, the National Monitoring Center, and the Technical Chambers on Medications. The reporting rate for adverse drug events in Brazil in 2013 was 36 reports per million inhabitants, considerably lower than the target proposed in the international literature, which suggests 300 reports per million inhabitants. This study identified structural and functional aspects that can compromise the performance of SINAF, such as lack of legislation officially establishing the system itself and its objectives.

Recomendação de códigos da CID-10 para vigilância de reações adversas e intoxicações a medicamentos / Recommendation of ICD-10 codes for surveillance of adverse drug reactions and drug intoxication

Resumo Propor uma lista-referência de códigos da Classificação Internacional de Doenças e Problemas Relacionados à Saúde (CID-10) para a vigilância de reações adversas e intoxicações a medicamentos, denominados de eventos adversos. A elaboração da lista-referência percorreu quatro fases: definição dos códigos, validação e duas de caracterização da lista. As associações entre variáveis foram avaliadas por qui-quadrado de Pearson e análise de correspondência múltipla. Foram identificados 691 códigos relacionados com reação adversa a medicamentos (52,1%) e intoxicação medicamentosa (47,9%). Um total de 687 (99,4%) e 511 (73,9%) códigos foram validados na 1ª e 2ª validação, respectivamente. Há diferenças estatisticamente significativas (p < 0,05) entre reações adversas e intoxicação medicamentosa nas variáveis utilizadas para a caracterização da lista-referência. A associação entre medicamento e admissão hospitalar e óbito foi estatisticamente significativa quando estratificada por tipo de evento adverso (p < 0,001). Na análise de correspondência múltipla identificou-se três agrupamentos de códigos em que há associações entre as categorias de resposta das variáveis estudadas. A lista-referência pode ser uma ferramenta útil nas ações de farmacovigilância no Brasil.

Abstract ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization. It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. Associations between variables were evaluated using Pearson's chi-squared test and multiple correspondence analysis. Six hundred and ninety-one (691) codes were identified related to adverse drug reactions (52.1%) and drug poisoning (47.9%). A total of 687 (99.4%) and 511 (73.9%) codes were validated in 1st and 2nd validation, respectively. There were statistically significant differences (p <0.05) between adverse reactions and drug poisoning in the variables used to characterize the reference list. The association between drug and hospital admission and death was statistically significant when stratified by type of adverse event (p <0.001). Three groupings of codes were identified in multiple correspondence analysis where there are associations between categories of response assessed. The reference list can be a useful tool in pharmacovigilance actions in Brazil.

Transcriptional characterization of immunological infiltrates and their relation with glioblastoma patients overall survival.

Introduction: Several cell populations from the peripheral immune system interact to create a complex immunologic status during glioblastoma growth and response to therapy. The aim of this study was to integrate the impact of different immune cell populations present in glioblastoma tumor microenvironment on overall survival. Methodology: Gene expression and clinical data were generated by The Cancer Genome Atlas and previously reported meta-signatures representing cells of the immune system were used. The relationship between meta-signatures was evaluated through Pearson's correlation analyses. Survival analyses were performed through Kaplan-Meier plots and Cox regression model. Results and discussion: Meta-signatures corresponding to infiltrating immune cells with immunosuppressive roles, such as macrophages, NK and NK T cells, MDSCs and Tregs, correlated with poorer patient prognosis. Meta-signatures related to CD8+ T cells predicted improved survival only in patients with low immunosuppressive meta-signatures. By clustering the meta-signatures we found that the cluster containing high meta-signatures of macrophages, MDSCs and Tregs demonstrated the worst prognosis. Conclusion: Integrating the information provided by transcriptional signatures of immunological aspects is fundamental in understanding the impact of the immune system on patient survival. We found a predictive impact on survival with positive role for CD8 and negative roles for macrophages, MDSC, Tregs, NK and NK-T in glioblastoma patients. Understanding these regulatory and stimulatory factors of patients' immune system is essential to delineate an effective strategy to increase the anti-tumor immune response and to generate potential clinical benefits.

Video-assisted thoracoscopic surgery yields better outcomes than thoracotomy for anatomical lung resection in Brazil: a propensity score-matching analysis using the Brazilian Society of Thoracic Surgery database.

OBJECTIVES: The use of video-assisted anatomical lung resection is increasingly widespread for lung cancer and non-neoplastic diseases, showing excellent results. Nonetheless, a comparative analysis of the benefits of this technique has yet to be conducted in Latin America, a region with a completely different case mix from the USA or Europe. The purpose of this study was to compare the outcomes of video-assisted thoracoscopic surgery (VATS) and open thoracotomy (OT) for anatomical lung resection in patients included on the Brazilian Society of Thoracic Surgery (BSTS) database. METHODS: Using propensity score matching, we conducted an analysis of 1355 patients who underwent anatomical lung resection (704 OT and 651 VATS) registered in the BSTS database between August 2015 and December 2016. Propensity score matching was performed using the following baseline characteristics: age at surgery, gender, comorbidities, pulmonary lung function, type of resection and cancer and non-cancer diagnosis. The propensity score-matched sample comprised a well-matched group of 890 patients. The main outcomes tested were mortality, complications and major cardiopulmonary complications based on the European Society of Thoracic Surgeons (ESTS) database definitions and terminology. RESULTS: Standardized differences of means and proportions suggested that an adequate balance had been achieved. Major cardiopulmonary complications were shown to be more frequent in patients who underwent OT (16.0% compared with 9.2% in VATS patients; odds ratio = 1.87, 95% confidence interval 1.25-2.80) and the overall complications rate was higher among patients who underwent OT (30.1% compared with 21.8% in VATS patients; odds ratio = 1.55, 95% confidence interval 1.17-2.05). No statistically significant difference in mortality rate was observed between OT (2.5%) and VATS (1.8%) (odds ratio = 1.38, 95% confidence interval 0.54-3.50). CONCLUSIONS: In Brazil, the rate of complications associated with minimally invasive surgery (VATS) for anatomical lung resection is significantly lower than that of conventional OT.

Análise da preferência digital de idade no sistema de farmacovigilância do Brasil, 2008-2013 / Analysis of the digital preference for age in the pharmacovigilance system in Brazil, 2008-2013

Resumo Analisar a preferência digital na variável "idade" da base de dados de casos de eventos adversos a medicamentos notificados entre 2008 e 2013 no sistema de farmacovigilância do Brasil. A base de dados foi analisada em três etapas: 1) exploração inicial; 2) padronização de variáveis; e 3) manejo dos registros repetidos. A preferência digital da variável "idade", segundo sexo e regiões agrupadas do país, foi determinada usando os métodos de Whipple e Myers e medida, também, pelo teste de aderência baseado na estatística χ2 ao nível de 5% de significância.Predominou a população feminina (60,3%), perfazendo uma razão feminino/masculino de 1,5:1 e com maioria feminina em oito das 12 faixas etárias estudadas.Ao longo do período analisado não foi observado qualquer preferência de dígito terminal na variável "idade". As idades registradas nas notificações parecem não demonstrar imprecisão e, por conseguinte, esta informação pode ser interpretada como de qualidade não duvidosa. Tais resultados apontam para um bom desempenho na coleta de dados e informações relacionados à variável "idade" do sistema de farmacovigilância do Brasil.

Abstract The scope of this article is to analyze the digital preference for the "age" variable in the database of cases of adverse drug events reported between 2008 and 2013 in the pharmacovigilance system in Brazil. The database was analyzed in three stages: 1) Initial exploration; 2) standardization of variables; and 3) duplicate records management. The digital preference for the "age" variable according to sex and grouped regions of the country, was determined using the Whipple and Myers methods and also measured by the adhesion test based on statistical χ2 at 5% significance level. The female population was predominant (60.3%), with a female/male ratio of 1.5:1 and a female majority in 8 of the 12 age groups. Throughout the period under analysis, no preference for a terminal digit was observed in the "age" variable. The ages that were registered in the database appear not to reveal any imprecision and, therefore, this information cannot be interpreted as unreliable. These results point to a good performance in collecting data and information related to the "age" variable of the Brazil's pharmacovigilance system.

Lung cancer: changes in histology, gender, and age over the last 30 years in Brazil.

OBJECTIVE: To describe the trends in tumor histology, gender and age among patients with non-small cell lung cancer (NSCLC) treated with lung resection. The histology of lung cancer has changed in developed countries, and there is still little information available on the topic for developing countries. METHODS: This was a retrospective study of 1,030 patients with NSCLC treated with lung resection between 1986 and 2015 at a university hospital in southern Brazil. Differences in histology, stage, and type of surgery were analyzed by gender and for three periods (1986-1995, 1996-2005, and 2006-2015). RESULTS: Most (64.5%) of the patients were males, and the main histological types were squamous cell carcinoma (in 40.6%) and adenocarcinoma (in 44.5%). The mean age at surgery during the first period was 56.4 years for women and 58.9 years for men, compared with 62.2 for women and 64.6 for men in the third period (p < 0.001). The proportion of females increased from 26.6% in the first period to 44.1% in the third. From the first to the third period, the proportion of patients with squamous cell carcinoma decreased from 49.6% to 34.8% overall (p < 0.001), decreasing to an even greater degree (from 38.9% to 23.2%) among men. Among the NSCLC patients in our sample, females with adenocarcinoma accounted for 11.9% in the first period and 24.0% in the third period (p < 0.001). CONCLUSIONS: As has been seen in developed countries, the rates of lung cancer in females in southern Brazil have been rising over the last three decades, although they have yet to surpass those observed for males in the region. The incidence of squamous cell carcinoma has decreased in males, approaching adenocarcinoma rates, whereas adenocarcinoma has significantly increased among women.

Lung cancer: changes in histology, gender, and age over the last 30 years in Brazil / Câncer de pulmão: mudanças na histologia, sexo e idade nos últimos 30 anos no Brasil

ABSTRACT Objective: To describe the trends in tumor histology, gender and age among patients with non-small cell lung cancer (NSCLC) treated with lung resection. The histology of lung cancer has changed in developed countries, and there is still little information available on the topic for developing countries. Methods: This was a retrospective study of 1,030 patients with NSCLC treated with lung resection between 1986 and 2015 at a university hospital in southern Brazil. Differences in histology, stage, and type of surgery were analyzed by gender and for three periods (1986-1995, 1996-2005, and 2006-2015). Results: Most (64.5%) of the patients were males, and the main histological types were squamous cell carcinoma (in 40.6%) and adenocarcinoma (in 44.5%). The mean age at surgery during the first period was 56.4 years for women and 58.9 years for men, compared with 62.2 for women and 64.6 for men in the third period (p < 0.001). The proportion of females increased from 26.6% in the first period to 44.1% in the third. From the first to the third period, the proportion of patients with squamous cell carcinoma decreased from 49.6% to 34.8% overall (p < 0.001), decreasing to an even greater degree (from 38.9% to 23.2%) among men. Among the NSCLC patients in our sample, females with adenocarcinoma accounted for 11.9% in the first period and 24.0% in the third period (p < 0.001). Conclusions: As has been seen in developed countries, the rates of lung cancer in females in southern Brazil have been rising over the last three decades, although they have yet to surpass those observed for males in the region. The incidence of squamous cell carcinoma has decreased in males, approaching adenocarcinoma rates, whereas adenocarcinoma has significantly increased among women.

RESUMO Objetivo: Descrever as tendências da histologia do tumor, do gênero e da idade em pacientes com câncer de pulmão de células não pequenas (CPCNP) tratados com ressecção pulmonar. A histologia do câncer de pulmão mudou em países desenvolvidos, e ainda há pouca informação disponível sobre o tema em países em desenvolvimento. Métodos: Estudo retrospectivo com 1.030 pacientes com CPCNP tratados através de ressecção pulmonar entre 1986 e 2015 em um hospital universitário no sul do Brasil. As diferenças em histologia, estádio e tipo de cirurgia foram analisadas por gênero e em três períodos (1986-1995, 1996-2005 e 2006-2015). Resultados: A maioria dos pacientes (64,5%) era do sexo masculino, e os principais tipos histológicos foram carcinoma de células escamosas (40,6%) e adenocarcinoma (44,5%). A média de idade à cirurgia durante o primeiro período foi de 56,4 anos para mulheres e de 58,9 anos para homens, enquanto essa foi de 62,2 para mulheres e 64,6 para homens no terceiro período (p < 0,001). A proporção de mulheres aumentou de 26,6% no primeiro período para 44,1% no terceiro. Do primeiro ao terceiro período, a proporção de pacientes com carcinoma de células escamosas diminuiu de 49,6% para 34,8% no total (p < 0,001), diminuindo para um grau ainda maior (de 38,9% para 23,2%) entre os homens. Entre os pacientes com CPCNP em nossa amostra, mulheres com adenocarcinoma representaram 11,9% no primeiro período e 24,0% no terceiro período (p < 0,001). Conclusões: Como se observa em países desenvolvidos, as taxas de câncer de pulmão em mulheres no sul do Brasil têm aumentado nas últimas três décadas, embora ainda não tenham superado as observadas em homens na região. Entre homens no sul do Brasil, a incidência de carcinoma de células escamosas diminuiu, aproximando-se a de adenocarcinoma. A incidência de adenocarcinoma entre mulheres no sul do Brasil aumentou significativamente.