Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults.

BACKGROUND: Butantan-Dengue Vaccine (Butantan-DV) is an investigational, single-dose, live, attenuated, tetravalent vaccine against dengue disease, but data on its overall efficacy are needed. METHODS: In an ongoing phase 3, double-blind trial in Brazil, we randomly assigned participants to receive Butantan-DV or placebo, with stratification according to age (2 to 6 years, 7 to 17 years, and 18 to 59 years); 5 years of follow-up is planned. The objectives of the trial were to evaluate overall vaccine efficacy against symptomatic, virologically confirmed dengue of any serotype occurring more than 28 days after vaccination (the primary efficacy end point), regardless of serostatus at baseline, and to describe safety up to day 21 (the primary safety end point). Here, vaccine efficacy was assessed on the basis of 2 years of follow-up for each participant, and safety as solicited vaccine-related adverse events reported up to day 21 after injection. Key secondary objectives were to assess vaccine efficacy among participants according to dengue serostatus at baseline and according to the dengue viral serotype; efficacy according to age was also assessed. RESULTS: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) - 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure. Vaccine efficacy was 80.1% (95% CI, 66.0 to 88.4) among participants 2 to 6 years of age, 77.8% (95% CI, 55.6 to 89.6) among those 7 to 17 years of age, and 90.0% (95% CI, 68.2 to 97.5) among those 18 to 59 years of age. Efficacy against DENV-1 was 89.5% (95% CI, 78.7 to 95.0) and against DENV-2 was 69.6% (95% CI, 50.8 to 81.5). DENV-3 and DENV-4 were not detected during the follow-up period. Solicited systemic vaccine- or placebo-related adverse events within 21 days after injection were more common with Butantan-DV than with placebo (58.3% of participants, vs. 45.6%). CONCLUSIONS: A single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up. (Funded by Instituto Butantan and others; DEN-03-IB ClinicalTrials.gov number, NCT02406729, and WHO ICTRP number, U1111-1168-8679.).

Characteristics of patients diagnosed with cervical cancer in Brazil: preliminary results of the prospective cohort EVITA study (EVA001/LACOG 0215).

OBJECTIVES: Cervical cancer is the fourth most common cancer in women worldwide. Epidemiological and quality of life (QoL) data in patients with cervical cancer from low- and middle-income countries are scarce. We aimed to describe sociodemographic and clinicopathological characteristics and quality of life of patients with cervical cancer at diagnosis in Brazil. METHODS: EVITA is a prospective cohort study of newly diagnosed patients with cervical cancer from May 2016 to December 2017, stages I-IVB, from 16 Brazilian sites representing the five Brazilian regions. At baseline, medical evaluation was performed and European Organization for Research and Treatment of Cancer (EORTC) QLQ-CX24/C30 questionnaires were administered. RESULTS: A total of 631 patients were included. Mean±SD age was 49.3±13.9 years; skin color was non-white in 65.3%, and 68.0% had ≤8 years of formal education. In total, 85.1% of patients had a Pap smear. The main reasons reported by patients for not having a Pap smear were: lack of interest (46.9%), shame or embarrassment (19.7%), lack of knowledge (19.7%), and difficulty with access (9.1%). Most patients were diagnosed with locally advanced or metastatic disease (FIGO clinical stage II-IV in 81.8%- stage II in 35.2%, stage III in 36.1%, and stage IV in 10.5%). Patients with clinical stage III-IV had worse physical functioning and role functioning. CONCLUSIONS: Cervical cancer in Brazil is usually diagnosed at an advanced stage. Most patients have low formal education and are unemployed. Lack of interest was identified as a main reason for not having a screening test, and limited access was reported as a reason by <10% of the patients. Awareness campaigns must be a governmental priority, specially focused on the needy population, along with wide access to treatment.

Phase 2 randomized study on chloroquine, hydroxychloroquine or ivermectin in hospitalized patients with severe manifestations of SARS-CoV-2 infection.

Objective: Given the urgent need for strategies to minimize the damage caused by this pandemic, this study performed a randomized, double-blind phase 2 study to assess the safety of the effectiveness of chloroquine (CQ), hydroxychloroquine (HCQ) or ivermectin in severe forms of COVID-19, in addition to identifying predictors of mortality in this group of patients.Methods: Phase 2, double-blind, randomized study to assess the safety and efficacy of enteral CQ, HCQ or ivermectin in patients hospitalized for SARS-CoV-2 infection, admitted to a Reference Hospital in Roraima (Brazil) in may 2020. Patients were randomized in a 1:1:1 ratio. The endpoints were need of supplemental O2, invasive ventilation, admission in ICU and death. The study was approved by an independent IRB.Results: 168 patients were randomized. The mean age was 53.4 years (±15.6), most participants were male (n = 95; 58.2%). Therapy with corticosteroid, anticoagulant or antibiotics was a decision of the attending physicians, and there was no difference between the groups. The mortality was similar in three groups (22.2%; 21.3% and 23.0%) suggesting ineffectiveness of the drugs. No difference in the incidence of serious adverse events were observed. To be older than 60 years of age, obesity, diabetes, extensive pulmonary involvement and low SaO2 at hospital admission due to independent risk factors for mortality.Conclusion: Although CQ, HCQ or ivermectin revealed a favorable safety profile, the tested drugs do not reduce the need for supplemental oxygen, ICU admission, invasive ventilation or death, in patients hospitalized with a severe form of COVID-19.

Sexually transmitted infections in women deprived of liberty in Roraima, Brazil.

OBJECTIVE: To evaluate the prevalence of HIV, syphilis and hepatitis B infection among women deprived of liberty in the state of Roraima, Brazil, and its correlation with perceptions, knowledge and behavioral factors. METHOD: This is a cross-sectional study, with simple systematic sampling, conducted at the Public Female Prison in Boa Vista, State of Roraima, in 2017. A total of 168 inmates (93.8% of the population) were evaluated by in-person interviews and rapid tests. RESULTS: The prevalence of sexually transmitted infections (STI) was 20.2%, being 4.7% HIV, 15.5% syphilis, and 0.0% hepatitis B. Multivariate analysis confirmed as risk factors for acquiring an STI: being over 30 years of age [adjusted odds ratio (OR): 2.57; 95%CI 1.03-6.40); low schooling (adjusted OR: 2.77; 95%CI 1.08-5.05); little knowledge about condom use (adjusted OR: 2.37; 95%CI 1.01-7.31); and believing that there is no risk of contracting syphilis (adjusted OR: 2.36; 95%CI 1.08-6.50). CONCLUSION: The population deprived of liberty is a group of highly vulnerable to STI. The high prevalence of these infections can be explained by knowledge deficits on the subject, distorted perceptions and conditions peculiar to imprisonment, which result in risky behavior. We emphasize the need to implement educational programs for preventing, diagnosing and treating STI for this population.

Sexually transmitted infections in women deprived of liberty in Roraima, Brazil / Infecções sexualmente transmissíveis em mulheres privadas de liberdade em Roraima

ABSTRACT OBJECTIVE To evaluate the prevalence of HIV, syphilis and hepatitis B infection among women deprived of liberty in the state of Roraima, Brazil, and its correlation with perceptions, knowledge and behavioral factors. METHOD This is a cross-sectional study, with simple systematic sampling, conducted at the Public Female Prison in Boa Vista, State of Roraima, in 2017. A total of 168 inmates (93.8% of the population) were evaluated by in-person interviews and rapid tests. RESULTS The prevalence of sexually transmitted infections (STI) was 20.2%, being 4.7% HIV, 15.5% syphilis, and 0.0% hepatitis B. Multivariate analysis confirmed as risk factors for acquiring an STI: being over 30 years of age [adjusted odds ratio (OR): 2.57; 95%CI 1.03-6.40); low schooling (adjusted OR: 2.77; 95%CI 1.08-5.05); little knowledge about condom use (adjusted OR: 2.37; 95%CI 1.01-7.31); and believing that there is no risk of contracting syphilis (adjusted OR: 2.36; 95%CI 1.08-6.50). CONCLUSION The population deprived of liberty is a group of highly vulnerable to STI. The high prevalence of these infections can be explained by knowledge deficits on the subject, distorted perceptions and conditions peculiar to imprisonment, which result in risky behavior. We emphasize the need to implement educational programs for preventing, diagnosing and treating STI for this population.

RESUMO OBJETIVO Avaliar a prevalência de infecção por vírus da imunodeficiência humana (HIV), sífilis e hepatite B entre mulheres privadas de liberdade do estado de Roraima e sua correlação com percepções, conhecimento e fatores comportamentais. MÉTODO Trata-se de estudo de corte transversal, com amostragem sistemática simples, realizado na Cadeia Pública Feminina de Boa Vista, estado de Roraima, no ano de 2017. Foram avaliadas 168 detentas (93,8% da população) por meio de entrevista face a face e testes rápidos. RESULTADOS A prevalência de alguma infecção sexualmente transmissível (IST) foi de 20,2%, sendo 4,7% de HIV, 15,5% de sífilis, e 0,0% de hepatite B. A análise multivariada confirmou como fatores de risco para adquirir uma IST: ter mais de 30 anos de idade [ odds ratio (OR) ajustada: 2,57; IC95% 1,03-6,40); baixa escolaridade (OR ajustada: 2,77; IC95% 1,08-5,05); pouco conhecimento sobre o uso da camisinha (OR ajustada: 2,37; IC95% 1,01-7,31); e achar que não há risco de contrair sífilis (OR ajustada: 2,36; IC95% 1,08-6,50). CONCLUSÃO A população privada de liberdade constitui um grupo de alta vulnerabilidade às IST. A elevada prevalência dessas infecções pode ser explicada por déficits de conhecimento sobre o assunto, percepções distorcidas e condições peculiares ao aprisionamento, que resultam em comportamento de risco. Ressalta-se a necessidade de implantar programas educativos de prevenção, diagnóstico e tratamento de IST para essa população.

What clinical, functional, and psychological factors before treatment are predictors of poor quality of life in cancer patients at the end of chemotherapy? / Que fatores clínicos, funcionais e psíquicos antes do tratamento são preditores de baixa qualidade de vida em pacientes oncológicos ao término da quimioterapia?

Summary Objective: To correlate physical activity level (PAL), functional capacity and psychological state with quality of life (QoL) in cancer patients undergoing chemotherapy (CT). Method: Observational cohort study. Patients (n=121) with any primary cancer site with indications of chemotherapy with palliative or curative intent were evaluated at three moments: 1) patient admission (week 0), before chemotherapy; 2) week 8; 3) end of CT. Data were collected regarding QoL, PAL, clinical data, functional capacity (short walking distance test, sitting-rising test, isometric manual gripping force), and anxiety and depression tests. Results: There was significant improvement at the end of CT for: level of physical activity; walk test (> 500 meters); sitting-rising test (> 20x). There was a significant reduction in the prevalence of moderate/severe depression. The prevalence of high QoL showed a significant increase in evaluation 3 (42.4% vs. 40.0% vs. 59.2%, p=0.02). Education up to high school level, low PAL, walking < 300 meters, sitting and rising < 20 times, having depression (moderate to severe) and QoL that was not high at the start of treatment (week 0) all proved to be risk factors for low quality of life at week 16. Conversely, early staging, curative intent chemotherapy and low-grade symptoms were shown to be protective factors. Conclusion: Performing less than 20 movements in the sitting-rising test and low PAL at the start of chemotherapy represent independent risk factors for low quality of life at the end of chemotherapy.

Resumo Objetivo: Correlacionar nível de atividade física (NAF), capacidade funcional, estado psicológico com qualidade de vida (QdV) de pacientes com câncer em tratamento quimioterápico (QT). Método: Estudo de coorte observacional. Pacientes (n=121) com qualquer sítio primário de câncer, com indicação de quimioterapia com intuito paliativo ou curativo foram avaliados em three momentos: 1) admissão do paciente (semana 0), antes da quimioterapia; 2) semana 8; 3) ao término da QT. Foram coletados dados sobre QdV, NAF, dados clínicos, testes de capacidade funcional (teste de curta distância de caminhada, teste de sentar/levantar, força de preensão manual isométrica) e testes de ansiedade e depressão. Resultados: Houve melhora significativa ao término da QT para: nível de atividade física; teste de caminhada (> 500 metros); teste de sentar e levantar (> 20x). Notou-se redução significativa da prevalência de depressão moderada/grave. A prevalência de QdV elevada apresentou aumento significativo na avaliação 3 (42,4% vs. 40,0% vs. 59,2%; p=0,02). Escolaridade até nível médio, baixo NAF, caminhar < 300 metros, sentar e levantar < 20 vezes, ter depressão do humor (moderado a grave) e QdV não elevada no início do tratamento (semana 0) foram fatores de risco para baixa qualidade de vida na semana 16. Inversamente, estadiamento precoce, intuito de quimioterapia curativo, baixa escala de sintomas foram fatores de proteção. Conclusão: Realizar menos de 20 movimentos no teste de sentar e levantar e possuir baixo NAF no início do tratamento quimioterápico representam fatores de riscos independentes para baixa qualidade de vida ao fim da quimioterapia.

Factors related to non-adherence to mammography in a city of the Brazilian Amazonian area: A population-based study.

OBJECTIVE: To assess the prevalence of mammography use and factors related to non-adherence in Boa Vista, capital of Roraima, Brazil. METHOD: A cross sectional study, quantitative analysis, based on household survey was performed between June and August 2013, using a face-to-face interview with a pre-tested form. Target population was women between 40 and 69 years. The sample size target was 240 participants, and the sampling method was random cluster sampling. The study was approved by the Institutional Review Board of Federal University of Roraima. RESULTS: 241 women were included without refusals. The prevalence of non-use of mammography in the past two years was 55.6% (95CI 49.1-61.9). In univariate analysis, the risk factors for non-adherence to mammography were having low educational level, family income below three minimum wages, receiving government assistance, not having consulted with a doctor and no health insurance. In multivariate analysis, only low educational level and receiving government assistance remained as risk factors. Medical consultation or health worker visiting were protective factors. CONCLUSION: Adherence to mammography is unsatisfactory in Boa Vista, Roraima, and has a predominantly opportunistic character. Low educational level is confirmed as an independent risk factor, but belonging to a family that receives government assistance can be interpreted as a social marker of families and/or areas lacking of government intervention to increase access to breast cancer control programs.

Factors related to non-adherence to mammography in a city of the Brazilian Amazonian area: A population-based study / Fatores relacionados à não utilização de mamografia em capital brasileira da região Norte: um estudo de base populacional

Summary Objective: To assess the prevalence of mammography use and factors related to non-adherence in Boa Vista, capital of Roraima, Brazil. Method: A cross sectional study, quantitative analysis, based on household survey was performed between June and August 2013, using a face-to-face interview with a pre-tested form. Target population was women between 40 and 69 years. The sample size target was 240 participants, and the sampling method was random cluster sampling. The study was approved by the Institutional Review Board of Federal University of Roraima. Results: 241 women were included without refusals. The prevalence of non-use of mammography in the past two years was 55.6% (95CI 49.1-61.9). In univariate analysis, the risk factors for non-adherence to mammography were having low educational level, family income below three minimum wages, receiving government assistance, not having consulted with a doctor and no health insurance. In multivariate analysis, only low educational level and receiving government assistance remained as risk factors. Medical consultation or health worker visiting were protective factors. Conclusion: Adherence to mammography is unsatisfactory in Boa Vista, Roraima, and has a predominantly opportunistic character. Low educational level is confirmed as an independent risk factor, but belonging to a family that receives government assistance can be interpreted as a social marker of families and/or areas lacking of government intervention to increase access to breast cancer control programs.

Resumo Objetivo: Avaliar a prevalência de utilização da mamografia e fatores relacionados à não adesão em Boa Vista, capital de Roraima, Brasil. Método: Trata-se de um estudo de corte transversal, de análise quantitativa, baseado em inquérito domiciliar, por entrevista face a face, utilizando formulário previamente testado. Foram incluídas mulheres entre 40 e 69 anos, entre junho e agosto de 2013. A meta amostral foram 240 participantes, e o método de amostragem foi aleatório por conglomerado. O estudo foi aprovado pelo Comitê de Ética em Pesquisa da Universidade Federal de Roraima. Resultados: 241 mulheres foram incluídas, sem recusas. A prevalência de não utilização de mamografia nos últimos dois anos foi 55,6% (IC95% 49.1-61.9). Em análise univariada, os fatores de risco para não adesão à mamografia foram baixa escolaridade, renda familiar inferior a três salários mínimos, receber auxílio governamental, não ter sido consultado por médico e não ter plano de saúde. Em análise multivariada, apenas baixa escolaridade e receber auxílio governamental se mantiveram como fatores de risco, enquanto consulta médica ou visita de agente de saúde, como fatores de proteção independentes. Conclusão: A adesão à mamografia é insatisfatória em Boa Vista e tem caráter predominantemente oportunista. Baixa escolaridade se confirma como fator de risco independente, mas pertencer a uma família que recebe auxílio governamental pode ser interpretado como marcador social das famílias e/ou áreas mais carentes de intervenção governamental para aumentar o acesso aos programas de controle do câncer de mama.

What clinical, functional, and psychological factors before treatment are predictors of poor quality of life in cancer patients at the end of chemotherapy?

OBJECTIVE: To correlate physical activity level (PAL), functional capacity and psychological state with quality of life (QoL) in cancer patients undergoing chemotherapy (CT). METHOD: Observational cohort study. Patients (n=121) with any primary cancer site with indications of chemotherapy with palliative or curative intent were evaluated at three moments: 1) patient admission (week 0), before chemotherapy; 2) week 8; 3) end of CT. Data were collected regarding QoL, PAL, clinical data, functional capacity (short walking distance test, sitting-rising test, isometric manual gripping force), and anxiety and depression tests. RESULTS: There was significant improvement at the end of CT for: level of physical activity; walk test (> 500 meters); sitting-rising test (> 20x). There was a significant reduction in the prevalence of moderate/severe depression. The prevalence of high QoL showed a significant increase in evaluation 3 (42.4% vs. 40.0% vs. 59.2%, p=0.02). Education up to high school level, low PAL, walking < 300 meters, sitting and rising < 20 times, having depression (moderate to severe) and QoL that was not high at the start of treatment (week 0) all proved to be risk factors for low quality of life at week 16. Conversely, early staging, curative intent chemotherapy and low-grade symptoms were shown to be protective factors. CONCLUSION: Performing less than 20 movements in the sitting-rising test and low PAL at the start of chemotherapy represent independent risk factors for low quality of life at the end of chemotherapy.

Rastreamento do Transtorno de Despersonalização/Desrealização em Estudantes de Medicina de uma Universidade Federal no Brasil / Screening for Depersonalization/Derealization Disorder among Medical Students at a Brazilian Public University

RESUMO Objetivo Avaliar a prevalência de Transtorno de Despersonalização/Desrealização (DP/DR) em estudantes de Medicina da Universidade Federal de Roraima e correlacionar com dados socioeconômicos e pessoais. Métodos Estudo de corte transversal, quantitativo e descritivo, desenhado para avaliar a prevalência de DP/DR em estudantes de Medicina da Universidade Federal de Roraima (UFRR) em 2014 utilizando-se a Cambridge Depersonalization Scale como instrumento de pesquisa. Resultados A prevalência geral de DP/DR em estudantes de Medicina da UFRR foi de 11,5%. A prevalência foi maior nas séries iniciais (do primeiro ao terceiro ano) (OR = 10,7) em relação às séries finais. Não houve correlação de prevalência de DP/DR com fatores individuais, como idade, sexo ou renda. Conclusão Observamos uma prevalência expressiva de transtorno de DP/DR em acadêmicos de Medicina, que pode afetar negativamente a vida pessoal e profissional, gerando sofrimento significativo. É possível que as séries iniciais apresentem um risco maior de desenvolvimento do transtorno, e os mecanismos de enfrentamento do estresse desenvolvidos pelos estudantes podem exercer papel fundamental na suscetibilidade a este e a outros transtornos psíquicos.

ABSTRACT Objective To assess the prevalence of depersonalization/derealization disorder (DP/DR) among medical students at the Federal University of Roraima and to correlate this with socio-economic and personal variables. Methods A cross-sectional study that is both quantitative and descriptive and designed to assess the prevalence of DP/DR disorder among UFRR medical students in 2014 using the Cambridge Depersonalization Scale as a research tool. Results The overall prevalence of DP/DR among UFRR medical students was 11.5%, with the prevalence higher among lower grades (1st to 3rd year) (OR = 10.7) compared to the final series. There was no correlation between the prevalence of DP/DR and individual factors such as age, gender or income. Conclusion We observed a high prevalence of DP/DR disorder among medical students, which may adversely affect their personal and professional life, causing significant distress. It is possible that students in lower years are at a greater risk of developing the disorder, and that mechanisms developed by students used to face stress may play a key role in their susceptibility to this and other psychological disorders.

Factors related to non-compliance to HPV vaccination in Roraima-Brazil: a region with a high incidence of cervical cancer.

BACKGROUND: To evaluate the HPV vaccination coverage in Boa Vista, Roraima (Brazil) and to identify personal and socioeconomic factors related to non-compliance to HPV vaccination. METHODS: A school-based, cross-sectional study was conducted by distributing a self-administered questionnaire to the parents or guardians of pre-adolescent girls. The questionnaire addressed compliance to, knowledge about and perception of HPV and the HPV vaccine. Between July and November 2015, 13 private and public schools were visited based on a random cluster sampling method. RESULTS: A total of 1337 questionnaires were distributed to all female students in the target age group, and 797 were completed and returned (the participation rate was 59.6 %). The vaccination coverage rate was 82.7 % and was higher among public school students than among private school students (84.1 % vs 56.3 %; p = 0.003). Most parents (60 %) incorrectly answered more than half of the questions related to HPV knowledge, and limited knowledge about HPV and the HPV vaccine correlated with lower compliance to vaccination (adjusted OR = 1.42; 95 % CI: 1.01 to 2.76). In the perception analysis, the belief that the HPV vaccine is important for the daughter was an important protective factor (adjusted OR = 0.62; 95 % CI: 0.23 to 0.93), and concern about adverse effects of the HPV vaccine was a risk factor for non-compliance (adjusted OR = 1.66; 95 % CI: 1.01 to 2.71). Family income, religion and education level of the parents or guardians did not correlate with compliance to vaccination. CONCLUSION: HPV vaccination coverage was high in Boa Vista, Brazil, but knowledge about the vaccine was deficient. This deficiency was associated with a distorted perception and was negatively associated with compliance to vaccination. Actions aimed at informing the public about the HPV vaccine, including its risks and benefits, are needed to attain higher vaccination coverage in Brazil.

Pleural tuberculosis in the state of Roraima, Brazil, between 2005 and 2013: quality of diagnosis.

OBJECTIVE: To evaluate the quality of diagnosis and the epidemiological profile of patients with pleural tuberculosis in the state of Roraima, Brazil, in order to provide technical support for the development and implementation of public policies to combat the disease. METHODS: This was a cross-sectional study designed to determine the prevalence of pleural forms of tuberculosis in Roraima between 2005 and 2013 and to evaluate the diagnostic criteria used, as well as their determinants. This study was based on secondary data from the Brazilian Case Registry Database, including all reported cases of pleural tuberculosis in the state during the study period. Diagnoses based on bacteriological or histopathological confirmation were defined as high-quality diagnoses. RESULTS: Among the 1,395 cases of tuberculosis reported during the study period, 116 (8.3%) were cases of pleural tuberculosis, accounting for 38.9% of all cases of extrapulmonary tuberculosis in the sample. The incidence rate of pleural tuberculosis did not follow the downward trend observed for the pulmonary form of the disease during the same period. The prevalence of cases with a high-quality diagnosis was 28.5% (95% CI: 20.4-37.6%). In a univariate analysis, none of the demographic or clinical characteristics collected from the database were found to have a significant impact on the outcome (as explanatory variables). CONCLUSIONS: The quality of the diagnoses in our study sample was considered unsatisfactory. Limited access to specific diagnostic methods might have contributed to these results.

Pleural tuberculosis in the state of Roraima, Brazil, between 2005 and 2013: quality of diagnosis / Tuberculose pleural no estado de Roraima no período de 2005-2013: qualidade diagnóstica

Objective: To evaluate the quality of diagnosis and the epidemiological profile of patients with pleural tuberculosis in the state of Roraima, Brazil, in order to provide technical support for the development and implementation of public policies to combat the disease. Methods: This was a cross-sectional study designed to determine the prevalence of pleural forms of tuberculosis in Roraima between 2005 and 2013 and to evaluate the diagnostic criteria used, as well as their determinants. This study was based on secondary data from the Brazilian Case Registry Database, including all reported cases of pleural tuberculosis in the state during the study period. Diagnoses based on bacteriological or histopathological confirmation were defined as high-quality diagnoses. Results: Among the 1,395 cases of tuberculosis reported during the study period, 116 (8.3%) were cases of pleural tuberculosis, accounting for 38.9% of all cases of extrapulmonary tuberculosis in the sample. The incidence rate of pleural tuberculosis did not follow the downward trend observed for the pulmonary form of the disease during the same period. The prevalence of cases with a high-quality diagnosis was 28.5% (95% CI: 20.4-37.6%). In a univariate analysis, none of the demographic or clinical characteristics collected from the database were found to have a significant impact on the outcome (as explanatory variables). Conclusions: The quality of the diagnoses in our study sample was considered unsatisfactory. Limited access to specific diagnostic methods might have contributed to these results.

Objetivo: Avaliar a qualidade dos diagnósticos e o perfil epidemiológico de portadores de tuberculose pleural no estado de Roraima, visando embasar tecnicamente o fomento e a aplicação de políticas públicas para o enfrentamento dessa doença. Métodos: Estudo transversal, desenhado para determinar a prevalência de formas pleurais da tuberculose em Roraima entre 2005 e 2013 e avaliar os critérios diagnósticos utilizados e seus determinantes. Este estudo foi baseado na revisão de dados secundários do Sistema de Informação de Agravos de Notificação, incluindo todos os casos notificados como tuberculose pleural no estado durante o período de estudo. Diagnósticos baseados em confirmação bacteriológica ou histopatológica foram definidos como de qualidade. Resultados: Dos 1.395 casos de tuberculose notificados no período do estudo, 116 (8,3%) foram da apresentação pleural, totalizando 38,9% das formas extrapulmonares na amostra. A taxa de incidência dessa apresentação clínica não acompanhou a tendência decrescente da forma pulmonar da doença no período. A prevalência de diagnósticos de qualidade encontrada foi de 28,5% (IC95%: 20,4-37,6%) e, na análise univariada, nenhuma variável explicativa dentre as características demográficas e clínicas coletadas do banco de dados tiveram um impacto significativo no desfecho (como variáveis explicativas). Conclusões: A qualidade dos diagnósticos na amostra estudada foi considerada insatisfatória. O acesso limitado a métodos diagnósticos específicos pode ter contribuído para esses resultados.

Comparison of three human papillomavirus DNA detection methods: Next generation sequencing, multiplex-PCR and nested-PCR followed by Sanger based sequencing.

To compare the diagnostic performance for HPV infection using three laboratorial techniques. Ninty-five cervicovaginal samples were randomly selected; each was tested for HPV DNA and genotypes using 3 methods in parallel: Multiplex-PCR, the Nested PCR followed by Sanger sequencing, and the Next_Gen Sequencing (NGS) with two assays (NGS-A1, NGS-A2). The study was approved by the Brazilian National IRB (CONEP protocol 16,800). The prevalence of HPV by the NGS assays was higher than that using the Multiplex-PCR (64.2% vs. 45.2%, respectively; P = 0.001) and the Nested-PCR (64.2% vs. 49.5%, respectively; P = 0.003). NGS also showed better performance in detecting high-risk HPV (HR-HPV) and HPV16. There was a weak interobservers agreement between the results of Multiplex-PCR and Nested-PCR in relation to NGS for the diagnosis of HPV infection, and a moderate correlation for HR-HPV detection. Both NGS assays showed a strong correlation for detection of HPVs (k = 0.86), HR-HPVs (k = 0.91), HPV16 (k = 0.92) and HPV18 (k = 0.91). NGS is more sensitive than the traditional Sanger sequencing and the Multiplex PCR to genotype HPVs, with promising ability to detect multiple infections, and may have the potential to establish an alternative method for the diagnosis and genotyping of HPV.

HPV Infection and Cervical Screening in Socially Isolated Indigenous Women Inhabitants of the Amazonian Rainforest.

OBJECTIVE: Indigenous women from the Amazon regions have some of the highest rates of cervical cancer in the world. This study evaluated cervical cytology and human papillomavirus (HPV) in native women that differ by lifestyle and interaction with western society. Yanomami women are isolated deep in the Amazon with a hunter/gatherer lifestyle. Macuxi and Wapishana women live in proximity to western society. METHODS: To select a representative group of women from each district, random cluster sampling was used, considering each registered village as a cluster. Cervical samples were collected for cytology and HPV detection and typing by PCR amplification and next generation sequencing. The study was approved by the National IRB and by tribal leaders. RESULTS: 664 native women were enrolled from 13 indigenous villages (76% participation rate). Yanomami women had higher rates of abnormal cytology (5.1% vs. 1.8%, p = 0.04) and prevalent HR-HPV (34.1% vs. 19.2%, p<0.001). Yanomami women >35 y of age were significantly more likely to have HR-HPV, whereas women ≤ 35 y did not significantly differ between groups. Prevalence of HPV was significantly different amongst geographically clustered Yanomami women (p<0.004). The most prevalent HPV types in the entire group were HPV31 (8.7%), HPV16 (5.9%) and HPV18 (4.4%). CONCLUSION: Isolated endogenous Yanomami women were more likely to be HPV+ and rates increased with age. Study of HPV in isolated hunter-gather peoples suggests that long-term persistence is a characteristic of prehistoric humans and patterns reflecting decreased prevalence with age in western society represents recent change. These studies have implications for cervical cancer prevention and viral-host relationships.

Cervical cancer screening coverage in a high-incidence region.

OBJECTIVE To analyze the coverage of a cervical cancer screening program in a city with a high incidence of the disease in addition to the factors associated with non-adherence to the current preventive program. METHODS A cross-sectional study based on household surveys was conducted. The sample was composed of women between 25 and 59 years of age of the city of Boa Vista, RR, Northern Brazil who were covered by the cervical cancer screening program. The cluster sampling method was used. The dependent variable was participation in a women's health program, defined as undergoing at least one Pap smear in the 36 months prior to the interview; the explanatory variables were extracted from individual data. A generalized linear model was used. RESULTS 603 women were analyzed, with an mean age of 38.2 years (SD = 10.2). Five hundred and seventeen women underwent the screening test, and the prevalence of adherence in the last three years was up to 85.7% (95%CI 82.5;88.5). A high per capita household income and recent medical consultation were associated with the lower rate of not being tested in multivariate analysis. Disease ignorance, causes, and prevention methods were correlated with chances of non-adherence to the screening system; 20.0% of the women were reported to have undergone opportunistic and non-routine screening. CONCLUSIONS The informed level of coverage is high, exceeding the level recommended for the control of cervical cancer. The preventive program appears to be opportunistic in nature, particularly for the most vulnerable women (with low income and little information on the disease). Studies on the diagnostic quality of cervicovaginal cytology and therapeutic schedules for positive cases are necessary for understanding the barriers to the control of cervical cancer.

Cervical cancer screening coverage in a high-incidence region / Cobertura do rastreamento do câncer de colo de útero em região de alta incidência

OBJECTIVE To analyze the coverage of a cervical cancer screening program in a city with a high incidence of the disease in addition to the factors associated with non-adherence to the current preventive program. METHODS A cross-sectional study based on household surveys was conducted. The sample was composed of women between 25 and 59 years of age of the city of Boa Vista, RR, Northern Brazil who were covered by the cervical cancer screening program. The cluster sampling method was used. The dependent variable was participation in a women’s health program, defined as undergoing at least one Pap smear in the 36 months prior to the interview; the explanatory variables were extracted from individual data. A generalized linear model was used. RESULTS 603 women were analyzed, with an mean age of 38.2 years (SD = 10.2). Five hundred and seventeen women underwent the screening test, and the prevalence of adherence in the last three years was up to 85.7% (95%CI 82.5;88.5). A high per capita household income and recent medical consultation were associated with the lower rate of not being tested in multivariate analysis. Disease ignorance, causes, and prevention methods were correlated with chances of non-adherence to the screening system; 20.0% of the women were reported to have undergone opportunistic and non-routine screening. CONCLUSIONS The informed level of coverage is high, exceeding the level recommended for the control of cervical cancer. The preventive program appears to be opportunistic in nature, particularly for the most vulnerable women (with low income and little information on the disease). Studies on the diagnostic quality of cervicovaginal cytology and therapeutic schedules for positive cases are necessary for understanding the barriers to the control of cervical cancer. .

OBJETIVO Analisar a cobertura do programa de rastreamento do câncer do colo uterino em município com alta incidência da doença e os fatores relacionados à não adesão ao programa preventivo vigente. MÉTODOS Foi realizado estudo transversal, com base em inquérito domiciliar. A amostra foi composta por mulheres entre 25 e 59 anos de idade do município de Boa vista, RR, Brasil, com cobertura pelo programa de rastreamento do câncer do colo uterino. Foi utilizado o método de amostragem por conglomerado. A variável dependente foi a adesão ao programa de saúde da mulher, definida como a realização de pelo menos um teste de Papanicolaou nos 36 meses anteriores à data da entrevista; as variáveis explicativas foram extraídas a partir de informações individuais. Foi utilizado modelo linear generalizado. RESULTADOS Foram analisadas 603 mulheres, com idade média de 38,2 anos (DP = 10,2). Quinhentas e dezessete mulheres realizaram o exame, sendo a prevalência de realização, nos últimos três anos, de 85,7% (IC95% 82,5;88,5). Renda familiar per capita elevada e consulta médica recente associaram-se à menor taxa de não realização do exame na análise multivariada. O desconhecimento da doença, das causas e dos meios de prevenção correlacionou-se com a chance de não adesão ao rastreamento. Vinte por cento das mulheres relataram realização do exame em caráter oportunístico, e não rotineiro. CONCLUSÕES A cobertura informada é elevada, acima do recomendado para controle do câncer do colo uterino. O programa preventivo apresenta caráter oportunístico, sobretudo para as mulheres mais vulneráveis (com baixa renda e pouca informação sobre a doença). Estudos sobre a qualidade diagnóstica da citologia cervicovaginal e dos itinerários terapêuticos dos casos positivos são necessários para compreensão das barreiras para o controle do câncer do colo uterino. .

Systematic review of the cost-effectiveness of the vaccination against HPV in Brazil.

In Brazil, almost 16,000 new cases of cervical cancer (CC), the type of neoplasia that claims the more lives of young women than any other, are expected in 2014. Although the vaccine against HPV has been developed, the application of this strategies to large populations is costly, and its use in Brazil is limited. Studies of the economic implications of new preventive technologies for CC may support rational and evidence-based decisions in public health. A systematic search of articles published between 2000 and 2014 was conducted using MEDLINE, EMBASE, the Cochrane Collaboration of Systematic Reviews, and LILACS. The aim of this search was the identification of original articles that evaluated the cost-effectiveness of vaccination against HPV in Brazil. A total of 6 articles are included in this review, evaluating the addition of a vaccine against HPV in comparison to population screening. Although the vaccine against HPV increases the cost of preventing cervical cancer, this new preventive technology presents favorable cost-effectiveness profiles in the case of Brazil. Failure to utilize the newly available preventative technologies against CC can lead to misguided and perverse consequences in a country in which programs based on the Papanicolaou test have been only partially successful.

[Validity of cervicovaginal cytology in a Brazilian State with high incidence rate of cervical cancer]. / Acurácia dos exames citológicos cervicovaginais em Estado de elevada incidência de câncer de colo de útero.

PURPOSE: To evaluate the validity of cervicovaginal cytology performed at LAPER, the main Laboratory of Pathology of the State of Roraima, Brazil, by interrater agreement (external monitoring) and agreement with histopathologic results. METHODS: One hundred women were included, a population-based convenience sample. Their cervical cytological exams were evaluated by the laboratory staff and reviewed by expert medical pathologists, external to the laboratory. Cohen's Kappa index, sensitivity and specificity were evaluated. The study was approved by LAPER coordination and Federal University of Roraima Research Ethics Commitee. RESULTS: Regarding the prevalence of human papillomavirus-related atypical, there was no concordance between the results issued by LAPER and by the external pathologists (k=0.21). A low sensitivity (28.5%) and specificity (89,2%) was detected for the diagnostic performance of LAPER, with a high proportion of false positive and false negative results. The cytological reports of the external pathologists showed higher sensitivity and specificity (71.4 and 98.9%, respectively), ruling out the possibility that errors related to collection methods and staining would explain the low performance of the laboratory. CONCLUSION: A low diagnostic accuracy of cervicovaginal cytology can be a barrier against the control of cervical cancer in Roraima. We emphasize the need for professional training and internal and external monitoring in Brazilian states with a high incidence of cervical cancer.

Acurácia dos exames citológicos cervicovaginais em Estado de elevada incidência de câncer de colo de útero / Validity of cervicovaginal cytology in a Brazilian State with high incidence rate of cervical cancer

OBJETIVO: Avaliar a acurácia da citologia cervicovaginal realizada no principal laboratório do Estado de Roraima, por concordância entre avaliadores (monitoramento externo) e com resultados histopatológicos. MÉTODOS: Lâminas de 100 mulheres, de uma amostra de conveniência de base populacional, foram avaliadas pelo LAPER, principal laboratório de referência do Sistema Único de Saúde do Estado de Roraima e reavaliadas por médicos patologistas experts externos ao laboratório. Foram avaliados índice Kappa, sensibilidade e especificidade. O estudo foi aprovado pela Coordenação do Laboratório Estadual e pelo Comitê de Ética em Pesquisa da Universidade Federal de Roraima. RESULTADOS: Quanto à prevalência de atipias celulares (relacionadas ao papilomavírus humano), não houve concordância entre resultados emitidos pelo LAPER e pelos patologistas externos (k=0,21). Constatou-se baixa sensibilidade (28,5%) e especificidade de 89,2% para o desempenho do LAPER, com elevada proporção de resultados falsos positivos e falsos negativos. Os laudos citológicos de patologistas externos apresentaram sensibilidade e especificidade maiores (71,4 e 98,9%, respectivamente), descartando que erros de coleta e coloração possam explicar o baixo desempenho do LAPER. CONCLUSÃO: O baixo desempenho diagnóstico da citologia cervicovaginal pode ser uma barreira para o controle do câncer de colo de útero em Roraima. Ressalta-se a necessidade de capacitação profissional e monitoramento interno e externo em Estados brasileiros com alta incidência de câncer de colo de útero. .

PURPOSE: To evaluate the validity of cervicovaginal cytology performed at LAPER, the main Laboratory of Pathology of the State of Roraima, Brazil, by interrater agreement (external monitoring) and agreement with histopathologic results. METHODS: One hundred women were included, a population-based convenience sample. Their cervical cytological exams were evaluated by the laboratory staff and reviewed by expert medical pathologists, external to the laboratory. Cohen's Kappa index, sensitivity and specificity were evaluated. The study was approved by LAPER coordination and Federal University of Roraima Research Ethics Commitee. RESULTS: Regarding the prevalence of human papillomavirus-related atypical, there was no concordance between the results issued by LAPER and by the external pathologists (k=0.21). A low sensitivity (28.5%) and specificity (89,2%) was detected for the diagnostic performance of LAPER, with a high proportion of false positive and false negative results. The cytological reports of the external pathologists showed higher sensitivity and specificity (71.4 and 98.9%, respectively), ruling out the possibility that errors related to collection methods and staining would explain the low performance of the laboratory. CONCLUSION: A low diagnostic accuracy of cervicovaginal cytology can be a barrier against the control of cervical cancer in Roraima. We emphasize the need for professional training and internal and external monitoring in Brazilian states with a high incidence of cervical cancer. .