A comprehensive assessment of quality management methods in the SMESH study.

BACKGROUND: This paper aims to instigate discussion and publication of methodologies applied to enhance quality management through comprehensive scientific reports. It provides a detailed description of the design, implementation, and results of the quality control program employed in the SMESH study. METHODS: Cross-sectional, multicenter, national study designed to assess the prevalence of human papillomavirus in sex workers and in men who have sex with men (MSM). Respondent-driven sampling recruitment was used. An online system was developed for the study and checkpoints were defined for data entry. The system checked the quality of biological samples and performed a retest with part of the sample. RESULTS: A total of 1.598 participants (442 sex workers and 1.156 MSM) were included. Fifty-four health professionals were trained for face-to-face data collection. The retest showed Kappa values ranging between 0.3030 and 0.7663. CONCLUSION: The retest data were mostly classified as indicating a strong association. The data generated by the checkpoints showed the successful implementation of the quality control program.

Open-source real-time quantitative RT-PCR-based on a RNA standard for the assessment of SARS-CoV-2 viral load.

BACKGROUND: Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) target genes by molecular methods has been chosen as the main approach to identify individuals with Coronavirus disease 2019 (COVID-19) infection. OBJECTIVES: In this study, we developed an open-source RNA standard-based real-time quantitative RT-PCR (RT-qPCR) assay for quantitative diagnostics of SARS-CoV-2 from nasopharynx, oropharynx, saliva and plasma samples. METHODS AND FINDINGS: We evaluated three SARS-CoV-2 target genes and selected the RNA-dependent RNA polymerase (RdRp) gene, given its better performance. To improve the efficiency of the assay, a primer gradient containing 25 primers forward and reverse concentration combinations was performed. The forward and reverse primer pairs with 400 nM and 500 nM concentrations, respectively, showed the highest sensitivity. The LOD95% was ~60 copies per reaction. From the four biological matrices tested, none of them interfered with the viral load measurement. Comparison with the AllplexTM 2019-nCoV assay (Seegene) demonstrated that our test presents 90% sensitivity and 100% specificity. MAIN CONCLUSIONS: We developed an efficient molecular method able to measure absolute SARS-CoV-2 viral load with high replicability, sensitivity and specificity in different clinical samples.

Open-source real-time quantitative RT-PCR-based on a RNA standard for the assessment of SARS-CoV-2 viral load

BACKGROUND Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) target genes by molecular methods has been chosen as the main approach to identify individuals with Coronavirus disease 2019 (COVID-19) infection. OBJECTIVES In this study, we developed an open-source RNA standard-based real-time quantitative RT-PCR (RT-qPCR) assay for quantitative diagnostics of SARS-CoV-2 from nasopharynx, oropharynx, saliva and plasma samples. METHODS AND FINDINGS We evaluated three SARS-CoV-2 target genes and selected the RNA-dependent RNA polymerase (RdRp) gene, given its better performance. To improve the efficiency of the assay, a primer gradient containing 25 primers forward and reverse concentration combinations was performed. The forward and reverse primer pairs with 400 nM and 500 nM concentrations, respectively, showed the highest sensitivity. The LOD95% was ~60 copies per reaction. From the four biological matrices tested, none of them interfered with the viral load measurement. Comparison with the AllplexTM 2019-nCoV assay (Seegene) demonstrated that our test presents 90% sensitivity and 100% specificity. MAIN CONCLUSIONS We developed an efficient molecular method able to measure absolute SARS-CoV-2 viral load with high replicability, sensitivity and specificity in different clinical samples.

Food consumption of users of the Brazilian Unified Health System by type of assistance and participation in the "Bolsa Família". / Consumo alimentar de usuários do Sistema Único de Saúde segundo o tipo de assistência e participação no Bolsa Família.

A cross-sectional study was conducted to evaluate and compare dietary intake, type of assistance (Basic Health Units - UBS and Family Health Strategies - ESF) and participation in the "Bolsa Família" Program (PBF) among users of the Brazilian Unified Health System, (SUS). The sample was composed of individuals of both sexes between 18 and 78 years of age in Porto Alegre, state of Rio Grande do Sul. Socioeconomic, clinical and food consumption data were collected via a questionnaire adapted from the SISVAN and VIGITEL national surveys. The analyses were conducted using R3.1 software. Of the 187 patients, 91 were affiliated to the ESF, 96 to UBS and 40 were registered with the PBF. A healthy eating pattern was identified in only 41% of SUS users. It was observed that 55% did not consume raw salad (37% p = 0.04) and vegetable consumption was lower among the PBF users (67.5% versus 75.9%; p = 0.02). There was no significant difference in food consumption considering the kind of assistance (ESF or UBS). A healthy consumption pattern was not associated with demographic and socioeconomic variables. The majority of beneficiaries of the PBF did not admit to healthy eating patterns. Therefore, effective health promotion and prevention is needed for this population, mainly among the beneficiaries of the PBF.

Foi realizado estudo transversal com objetivo de avaliar e comparar o consumo alimentar de usuários do Sistema Único de Saúde (SUS), segundo tipo de assistência (Unidades Básicas de Saúde-UBS e Estratégias de Saúde da Família-ESF) e participação no Programa Bolsa Família (PBF). A amostra foi composta por indivíduos de 18 a 78 anos, de ambos sexos, de Porto Alegre-RS. Foram coletados dados socioeconômicos, clínicos e de consumo alimentar através de questionário adaptado dos inquéritos nacionais SISVAN e VIGITEL. As análises foram realizadas no software R3.1. Dos 187 entrevistados, 91 pertenciam à ESF, 96 à UBS e 40 eram beneficiários do PBF. O padrão alimentar saudável foi identificado em apenas 41% dos usuários do SUS. Entre os beneficiários do PBF, consumo de hortaliças foi menor (67,5% vs 75,9;p = 0,02) e 55% não consumiam salada crua (37%;p = 0,04). Não houve diferença significativa no consumo considerando o tipo de assistência recebida (ESF ou UBS). O padrão de consumo saudável não foi associado às variáveis demográficas e socioeconômicas. A maioria dos beneficiados pelo PBF também não demonstrou padrão alimentar saudável. Portanto, maiores esforços para efetiva promoção e prevenção da saúde são necessários para essa população, principalmente entre os beneficiados pelo PBF.

Consumo alimentar de usuários do Sistema Único de Saúde segundo o tipo de assistência e participação no Bolsa Família / Food consumption of users of the Brazilian Unified Health System by type of assistance and participation in the "Bolsa Família"

Resumo Foi realizado estudo transversal com objetivo de avaliar e comparar o consumo alimentar de usuários do Sistema Único de Saúde (SUS), segundo tipo de assistência (Unidades Básicas de Saúde-UBS e Estratégias de Saúde da Família-ESF) e participação no Programa Bolsa Família (PBF). A amostra foi composta por indivíduos de 18 a 78 anos, de ambos sexos, de Porto Alegre-RS. Foram coletados dados socioeconômicos, clínicos e de consumo alimentar através de questionário adaptado dos inquéritos nacionais SISVAN e VIGITEL. As análises foram realizadas no software R3.1. Dos 187 entrevistados, 91 pertenciam à ESF, 96 à UBS e 40 eram beneficiários do PBF. O padrão alimentar saudável foi identificado em apenas 41% dos usuários do SUS. Entre os beneficiários do PBF, consumo de hortaliças foi menor (67,5% vs 75,9;p = 0,02) e 55% não consumiam salada crua (37%;p = 0,04). Não houve diferença significativa no consumo considerando o tipo de assistência recebida (ESF ou UBS). O padrão de consumo saudável não foi associado às variáveis demográficas e socioeconômicas. A maioria dos beneficiados pelo PBF também não demonstrou padrão alimentar saudável. Portanto, maiores esforços para efetiva promoção e prevenção da saúde são necessários para essa população, principalmente entre os beneficiados pelo PBF.

Abstract A cross-sectional study was conducted to evaluate and compare dietary intake, type of assistance (Basic Health Units - UBS and Family Health Strategies - ESF) and participation in the "Bolsa Família" Program (PBF) among users of the Brazilian Unified Health System, (SUS). The sample was composed of individuals of both sexes between 18 and 78 years of age in Porto Alegre, state of Rio Grande do Sul. Socioeconomic, clinical and food consumption data were collected via a questionnaire adapted from the SISVAN and VIGITEL national surveys. The analyses were conducted using R3.1 software. Of the 187 patients, 91 were affiliated to the ESF, 96 to UBS and 40 were registered with the PBF. A healthy eating pattern was identified in only 41% of SUS users. It was observed that 55% did not consume raw salad (37% p = 0.04) and vegetable consumption was lower among the PBF users (67.5% versus 75.9%; p = 0.02). There was no significant difference in food consumption considering the kind of assistance (ESF or UBS). A healthy consumption pattern was not associated with demographic and socioeconomic variables. The majority of beneficiaries of the PBF did not admit to healthy eating patterns. Therefore, effective health promotion and prevention is needed for this population, mainly among the beneficiaries of the PBF.

Assessment of potential risk factors for breast cancer in a population in Southern Brazil.

PURPOSE: The aim of this study is to assess potential risk factors for breast cancer in a population in Southern Brazil and build a multivariate logistic model using these factors for breast cancer risk prediction. METHODS: A total of 4242 women between 40 and 69 years of age without a history of breast cancer were selected at primary healthcare facilities in Porto Alegre and submitted to mammographic screening. They were evaluated for potential risk factors. RESULTS: In all, 73 participants among the 4242 women had a breast cancer diagnosis during the follow-up of the project (10 years). The multivariate analysis considering all the patients aged 40-69 years showed that older age (OR 1.08, 95% CI 1.04-1.12), higher height (OR 1.04, 95% CI 1.01-1.09), and history of previous breast biopsy (OR 2.66, 95% CI 1.38-5.13) were associated with the development of breast cancer. Conversely, the number of pregnancies (OR 0.87, 95% CI 0.78-0.98) and use of hormone replacement therapy (OR 0.39, 95% CI 0.20-0.75) were considered a protective factor. Additionally, we performed an analysis separating the participants into groups of 40-49 and 50-69 years old, since a risk factor could have a specific behavior in these age groups. No additional risk factors were identified within these age brackets, and some factors lost statistical significance. CONCLUSION: The risk prediction model indicates that the following variables should be assessed in this specific population: age, height, having had previous breast biopsies, number of pregnancies, and use of hormone replacement therapy. These findings may help to better understand the causal model of breast cancer in Southern Brazil.