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Objective: Assess and classify the risks of bias in the clinical trials (CTs) that make up the technical notes (TNs) referring to direct-acting oral anticoagulants (DOAC) requests. Methods: The TNs related to the DOAC requests of apixaban, dabigatran, edoxaban, and rivaroxaban were selected on the e-NatJus website and, after excluding duplicate references, an analysis of the CT used for their writing was carried out. The CT risk of bias (low, high, or uncertain bias) was assessed using the Cochrane Risk of Bias tool, and the results were added to Review Manager 5.4. Results: 181 TNs were selected, 236 articles were analyzed and after applying the inclusion criteria, 28 CTs were analyzed in full. None of the CTs were free of bias. Most CTs, 71% (20/28), had a low risk of bias regarding attrition bias and reporting bias. In contrast, 61% (17/28) of the studies did not control for selection, performance, and detection bias, as they present uncertainties and a high risk of bias. In addition, it was observed that 21% (6/28) of the CTs had a high risk of bias for conflict of interest. Conclusion: The biases present in the CT cited as a reference for the TN referring to the DOAC request are significant and compromise their quality (AU).
Objetivo: Avaliar e classificar os riscos de vieses dos ensaios clínicos (EC) que compõem as NTs referentes à solicitação dos DOAC. Métodos: As NTs relacionadas à solicitação dos DOAC apixabana, dabigatrana, edoxabana e rivaroxabana foram selecionadas no website e-NatJus e, após exclusão das referências duplicadas, foi realizada uma análise dos EC utilizados para a redação das mesmas. O risco de viés dos EC (baixo, alto ou viés incerto) foi avaliado utilizando a ferramenta Cochrane Risk of Bias e os resultados foram adicionados no Review Manager 5.4. Resultados: Foram selecionadas 181 NTs, analisados 236 artigos e após aplicação dos critérios de inclusão, resultou em 28 EC analisados na íntegra. Nenhum dos EC ficou isento de viés. A maioria dos EC, 71% (20/28), apresentou baixo risco de viés em relação ao viés de atrito e viés de relato. Por outro lado, 61% (17/28) dos estudos não controlaram o viés de seleção, performance e detecção, uma vez que apresentam incertezas e alto risco de viés. Além disso, foi observado que 21% (6/28) dos EC apresentaram alto risco de viés para conflito de interesses. Conclusão: Os vieses presentes nos EC citados como referência das NT referentes a solicitação dos DOAC são significativos e comprometem a sua qualidade (AU).
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Viés , Ensaio Clínico , Judicialização da Saúde , AnticoagulantesRESUMO
ABSTRACT Numerous tests employed to predict cardiac and functional status are expensive and not widely accessible for a considerable number of patients, particularly those diagnosed with Chagas disease (CD) residing in remote and endemic regions. To date, there is no knowledge of studies that have validated instruments that address functionality in an expanded way, including the biopsychosocial factors in patients with CD. This study aims to evaluate the psychometric properties of the World Health Organization Disability Assessment Schedule (WHODAS 2.0), in its 12-item shortened version (WHODAS-12) when applied to patients with CD. This is a cross-sectional study of a prospective cohort that follows individuals with CD (SaMi-Trop). Data collection took place between October 2019 and March 2020. In the interviews, sociodemographic information, life habits, clinical information, and indicators of disability measured by WHODAS-12 were collected. Descriptive analysis, internal consistency and construct validity of the instrument were performed. A total of 628 patients with CD were interviewed, most were women (69.5%), their mean age was of 57 years, and most declared an average self-perception of health (43.4%). The 12 items of WHODAS-12 were distributed into three factors, which together account for 61% of the variance. The Kaiser-Meyer-Olkin (KMO) index was 0.90, indicating adequacy of the sample for factor analysis. The internal consistency of the global scale showed alpha = 0.87. The percentage of incapacity was 16.05%, indicating mild incapacity for the evaluated patients. WHODAS-12 is a valid and reliable measure to assess the disability of the Brazilian population with CD.
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ABSTRACT Background: Chagas disease (ChD) is a neglected tropical disease that is caused by the protozoan parasite Trypanosoma cruzi and can negatively impact quality of life (QoL). This study aimed to assess and compare QoL between individuals with and without ChD. Methods: This cross-sectional study was performed within a concurrent cohort study (REDS). The participants were derived from two blood donation centers: São Paulo capital and Montes Claros, Minas Gerais, Brazil. Participants with ChD were identified in blood donations by serological diagnosis between 2008 and 2010, and those without ChD were donors with negative serology identified during the same period. QoL was assessed using the World Health Organization Quality of Life-BREF questionnaire. Logistic regression was used to compare sociodemographic and clinical characteristics between the groups, and mean, standard deviation, and beta regression were used to compare QoL. Results: In total, 611 individuals participated in the study (328 with ChD and 283 without ChD). Participants with ChD had lower QoL in the physical (p=0.02) and psychological (p<0.01) domains than did individuals without CD. Conclusions: Individuals with ChD had worse QoL perceptions. These results provide a comprehensive understanding of the impact of ChD on individuals' QoL, while also highlighting potential opportunities for improving the care and treatment of those affected.
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O presente estudo teve como objetivo fazer um levantamento do perfil epidemiológico das notificações por intoxicação e das doenças de transmissão hídrica e alimentar (DTHA) no Brasil, entre 2016 a 2021. Trata-se de um estudo documental com análises quantitativas e descritivas dos dados coletados no Sistema de Informação de Agravos de Notificação - SINAN e Ministério da Saúde. Os resultados mostraram uma diminuição no número de notificações ao longo dos anos, apesar do grande número encontrado em 2017 e 2018. O perfil dos intoxicados entre 2016-2021, foi de indivíduos do sexo masculino (58,3%), com faixa etária 20-59 anos (60,5%) e cor parda (46,6%). Já quanto aos principais agentes etiológicos relacionados aos surtos de DTHA no período analisado, destacou-se a bactéria Escherichia coli (7,9%). A investigação dos dados disponibilizados acerca das intoxicações e DTHA se faz necessária para verificação e monitorização sobre os casos que ocorrem anualmente no Brasil e no mundo.
The present study aimed to investigate the epidemiological profile of notifications for intoxication and water and foodborne diseases (WFD) in Brazil, between 2016 and 2021. This was a documentary, quantitative, descriptive study with data collected from the Notifiable Diseases Information System - SINAN and Ministry of Health. The results showed a decrease in the number of notifications over the years, despite the high number found in 2017 and 2018. The profile of people intoxicated between 2016 and 2021 was male (58.3%), aged 20-59 years (60.5%) and brown (46.6%). As for the main etiological agents related to WFD outbreaks in the analyzed period, the bacterium Escherichia coli (7.9%) stood out. The investigation of available data on intoxications and WFD is necessary for verification and monitoring of cases that occur annually in Brazil and in the world.
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ABSTRACT Objective To identify and analyze the quality of scientific evidence from clinical efficacy studies present in the package inserts of coagulation factors, used in the treatment of hemophilia A and B. Methods Documentary study developed in two stages. The first stage consisted of identifying the medicine packages inserts electronically registered in the Brazilian Health Regulatory Agency, and analyzing the availability of the bibliographic references cited therein. This analysis was conducted in the PubMed, SciELO, Google Scholar, and Web of Science databases. The second step was the analysis of the methodological quality of the efficacy studies. Two trained researchers used the Cochrane Collaboration Risk of Bias version 5.1.0 tools for methodological quality analysis, and Review Manager 5.4 software to generate the risk of bias graph. Results Of the 17 medicines listed, 7 had referenced package inserts. Of these, 10 studies were eligible for analysis of methodological quality. More than half of the analyzed studies did not control for selection, performance, and detection bias. A total of 100% controlled attrition and reporting biases, and 50% had a high risk of conflict of interest. Conclusion The biases present are significant and may have influenced the overestimation of the effects of the outcomes of each of the studies.
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Introdução: nos dias atuais, a obesidade tornou-se um problema de saúde pública em escala global. Entre os tratamentos disponíveis, destaca-se o uso da sibutramina. Entretanto, este fármaco apresentou diversos efeitos adversos (EA), sendo os de maior relevância os cardiovasculares. Objetivo: o objetivo deste estudo foi avaliar se a terapia com a sibutramina traz malefícios à saúde humana. Métodos: a revisão sistemática foi realizada seguindo o protocolo PRISMA para revisões sistemáticas e utilizando as bases de dados PubMed, LILACS e SciElo. Nestas, buscaram-se estudos publicados entre 2006 e 2016, utilizando-se dos descritores "sibutramine" e "adverse effects" junto com o operador booleano "AND". Resultados: dezoito artigos, das 479 publicações encontradas, atenderam aos critérios de inclusão, sendo, então, utilizados para compor a presente revisão. Os EA mais encontrados foram complicações cardiocirculatórias (66,6%), sendo as mais frequentes a taquicardia e a hipertensão arterial sistêmica (HAS). Adicionalmente a esses, a constipação intestinal e a boca seca/xerostomia (55,5%), cefaleia e insônia (38,8%) e alterações de humor (26,6%) também foram relatados. Além disso, o tratamento com sibutramina mostrou-se eficaz na perda de peso em 88,88% dos estudos analisados. Conclusão: apesar da terapêutica com sibutramina ter apresentado efetividade na redução de peso, não se pode concluir acerca da segurança desse fármaco.(AU)
Introcuction: in the modern times, obesity has become a global health problem. Sibutramine stands out among the available treatments. However, this drug is associated to several adverse events (AE), being the cardiovascular the most relevant ones. Objetive: the aim of this study was to evaluate whether therapy with sibutramine is harmful to human health. Methods: the systematic review was performed following the PRISMA protocol for systematic reviews and using the databases PubMed, LILACS and SciElo, aiming for studies published between 2006 and 2016. For the search of the papers, the descriptors "sibutramine" and "adverse effects" were used, together with the boolean operator "AND". Results: eighteen studies of 479 publications met the inclusion criteria, and were used in the present review. The main AE founded after the analysis of the articles were cardiocirculatory complications (66.6%), with more frequent tachycardia and systemic arterial hypertension. In addition, intestinal constipation and dry mouth/xerostomia (55.5%), headache and insomnia (38.8%) and mood alteration (26.6%) were also reported. Furthermore, treatment with sibutramine was effective in reducing weight in 88.88% of the studies analyzed. Conclusion: although sibutramine therapy has an effective effect on weight reduction, the safety of the drug is not proved.(AU)
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Depressores do Apetite , ObesidadeRESUMO
Objetivo: Analisar as diferenças de gênero na utilização dos serviços de saúde dos indivíduos com diabetes tipo 2. Métodos: Trata-se de um estudo transversal realizado com 100 mulheres e 100 homens em Unidades de Saúde da Família de Ribeirão Preto, São Paulo. As variáveis de interesse foram sociodemográficas, estilo de vida e clínicas. Resultados: Predominou-se a autopercepção da saúde como muito boa/boa nos homens (61%) e mulheres (51%). O consumo do álcool foi maior nos homens (28%) que nas mulheres (4%). O tabagismo foi três vezes mais frequente entre os homens (18%). A maioria dos homens (73%) e mulheres (67%) utilizavam as Unidades de Saúde da Família para o tratamento do diabetes. A média de doenças autorreferidas associadas ao diabetes foi de 2,5 nas mulheres e 1,6 nos homens. Conclusões: Verificaram-se diferenças na relação entre gênero e cuidados em diabetes (AU).
OBJECTIVE: To analyze the gender differences in the use of health services by type 2 diabetes individuals. METHODS: This is a cross-sectional study with 100 women and 100 men in Family Health Units of the city of Ribeirão Preto, state of São Paulo. The variables of interest were the sociodemographic, lifestyle and clinical ones. RESULTS: Health self-perception as very good/good predominated in men (61%) and women (51%). Alcohol consumption was higher in men (28%) than in women (4%). Smoking was three times more frequent among men (18%). Most men (73%) and women (67%) went to the Family Health Units to treat diabetes. The mean number of self-reported diabetesassociated diseases was 2.5 in women and 1.6 in men. CONCLUSIONS: There were differences in genderdiabetes care relationship (AU).
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Humanos , Masculino , Feminino , Adulto , Doença Crônica , Diabetes Mellitus Tipo 2 , Saúde de Gênero , Acessibilidade aos Serviços de SaúdeRESUMO
O consumo alimentar adequado é de grande importância para pacientes com Diabetes Mellitus tipo 2 (DM2) por controlaros níveis glicêmicos e evitar complicações. Diante disso, o objetivo desse trabalho foi avaliar as variáveis associadas ao consumo alimentar de pacientes com DM2 cadastrados em Unidades de Saúde da Família (USF), da cidade de Ribeirão Preto-SP. Este é um estudo descritivo do tipo inquérito, com amostra constituída por 100 indivíduos cadastrados em Unidades de Saúde da Família, da cidade de Ribeirão Preto-SP. Para avaliação do consumo alimentar utilizou-se o Questionário de Frequência de Consumo Alimentar. Aplicou-se o Odds Ratio para verificar associações entre as variáveis sociodemográficas, de acesso ao serviço de saúde e o consumo alimentar. Foram analisados os dados por meio detestes estatísticos, com erro tipo I igual a 5% (IC 95%). Dos 100 participantes, 64% eram do sexo feminino, a média de idade dos participantes foi de 66,7 anos, com predomínio de brancos (78%), casados (58%), com ensino fundamental incompleto (56%). Foi encontrada associação entre o consumo adequado de macronutrientes e escolaridade (OR: 0,29;IC: 0,11; 0,73), e ter convenio de saúde privado (OR:0,13; IC:0,03; 0,51). No que se refere à quantidade de carboidratos,proteínas e lipídeos, 64%, 60% e 81% dos entrevistados, respectivamente, consomem quantidades adequadas; com r lação às fibras 79% consomem mais que 20 gramas/dia. A média de Valor Calórico Total observada foi de 1500 kcale da Taxa Metabólica Basal foi de 1.619,5 kcal. Assim conclui-se que, grande parte dos pacientes consome a quantidade recomendada de macronutrientes, e o consumo adequado está associado ao maior nível de escolaridade e ter convênio de saúde privado
Proper food intake is very important for patients with diabetes mellitus type 2 (DM2) for controlling blood sugar levels andpreventing complications. Thus, the aim of this study was to evaluate the variables associated with the food consumptionof patients with DM2, registered in Unidades de Saúde da Família (USF) of Ribeirão Preto city (São Paulo state, Brazil).This is a survey-type descriptive study, with a sample of 100 individuals who are registered in Unidades de Saúde da Família, of Ribeirão Preto city. Food consumption was evaluated using the Food Frequency Questionnaire. The OddsRatio was applied to verify association between the sociodemographic variables of access to a health service, and foodconsumption. The data were analyzed by statistical tests, with a type-I error of 5 % (95 % confidence interval, CI). Womancomprised 64 % of the population studied. The subjects averaged 66.7 years of age, were predominantly white (78 %),married (58 %), with an incomplete basic education (56 %). We found a significant correlation between macronutrientconsumption and schooling level (OR: 0.29; CI: 0.11; 0.73), and having private health insurance (OR:0.13; IC:0.03; 0.51).Concerning the uptake of carbohydrates, proteins and lipids, 64 %, 60 % and 81 % of the population, respectively,consumed properly; furthermore, 79 % of the subjects consume more than 20 g of fiber daily. The average total caloricvalue was 1500 Kcal, and the basal metabolic rate was 1,619.5 Kcal. Thus, it follows that the majority of the patientsconsume the recommended amount of macronutrients, and their behavior is closely related to a higher level of educationand having private health insurance