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.

A sharing oocyte donation program: a 15-year cohort stud.

OBJECTIVE: To evaluate clinical and laboratory outcomes of oocyte donation cycles and compare the results from donors and recipients. METHODS: A retrospective cohort study was conducted at a reproductive medicine center. A 586 first fresh oocyte donation cycles, performed from 01/2002 to 12/2017 were included. The outcomes of 290 cycles from donors and 296 from recipients, resulting in 473 fresh embryo transfers, were analyzed. The oocyte division was equally made, whereas, at an odd amount, the donor always had a preference. The data were collected from an electronic database, and analyzed using Chi-square test, Fisher's exact test, Mann-Whitney U-test or Student t-test depending on the data distribution, and multivariate logistic regression, considering p<0.05. RESULTS: The main results comparing donor and recipient, were, respectively: fertilization rate (72.0±21.4 vs. 74.6±24.2, p<0.001), implantation rate (46.2% vs. 48.5%, p=0.67); clinical pregnancy rate (41.9% vs. 37.7%, p=0.39), live birth rates by transfer (33.3 vs. 37.7, p=0.54). CONCLUSIONS: Oocyte donation is often the way donors can access in vitro fertilization, and for recipients seems to be a good option for pregnancy. Demographic and clinical characteristics have a secondary role in oocyte donors under 35 years and patient without comorbidities under 50 years and were not associated with pregnancy outcomes, emphasizing the power of oocyte quality on the success of intracytoplasmic sperm injection treatment. An oocyte-sharing program that offers good and comparable results is fair and worth being encouraged.

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.

A Nationwide Evaluation of the Prevalence of Human Papillomavirus in Brazil (POP-Brazil Study): Protocol for Data Quality Assurance and Control.

BACKGROUND: The credibility of a study and its internal and external validity depend crucially on the quality of the data produced. An in-depth knowledge of quality control processes is essential as large and integrative epidemiological studies are increasingly prioritized. OBJECTIVE: This study aimed to describe the stages of quality control in the POP-Brazil study and to present an analysis of the quality indicators. METHODS: Quality assurance and control were initiated with the planning of this nationwide, multicentric study and continued through the development of the project. All quality control protocol strategies, such as training, protocol implementation, audits, and inspection, were discussed one by one. We highlight the importance of conducting a pilot study that provides the researcher the opportunity to refine or modify the research methodology and validating the results through double data entry, test-retest, and analysis of nonresponse rates. RESULTS: This cross-sectional, nationwide, multicentric study recruited 8628 sexually active young adults (16-25 years old) in 119 public health units between September 2016 and November 2017. The Human Research Ethics Committee of the Moinhos de Vento Hospital approved this project. CONCLUSIONS: Quality control processes are a continuum, not restricted to a single event, and are fundamental to the success of data integrity and the minimization of bias in epidemiological studies. The quality control steps described can be used as a guide to implement evidence-based, valid, reliable, and useful procedures in most observational studies to ensure data integrity. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/31365.

Perinatal outcomes of first pregnancy after chemotherapy for gestational trophoblastic neoplasia: a systematic review of observational studies and meta-analysis.

OBJECTIVE: To assess perinatal outcomes of first pregnancy after remission from gestational trophoblastic neoplasia and the impact of the time between the end of chemotherapy and the subsequent pregnancy. DATA SOURCES: The Medical Subject Headings related to perinatal outcomes, chemotherapy, and gestational trophoblastic neoplasia were used alone or in combination to retrieve relevant articles. We searched all references registered until April, 2019 in Embase, LILACS, MEDLINE, the Cochrane Central Register of Controlled Trials, and Web of Science. STUDY ELIGIBILITY CRITERIA: We included any observational or interventional studies that evaluated perinatal outcomes of first pregnancy after chemotherapy for gestational trophoblastic neoplasia. Animal studies, narrative reviews, expert opinions, and previous treatments with potential risks for future perinatal outcomes which may introduce confounding bias were excluded. STUDY APPRAISAL AND SYNTHESIS METHODS: Two reviewers independently screened all identified references for eligibility and data extraction. Methodological quality and bias of included studies were assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies from the National Institutes of Health. For the meta-analysis, the measures of association were calculated using bivariate random-effects models. Statistical heterogeneity was evaluated with I2 statistics and explored through sensitivity analysis. Publication bias was assessed by visual inspection of the funnel plot or Egger's test, according to the number of articles included. For all analyses, a P value of <.05 indicated statistical significance. This study was registered on PROSPERO (CRD42018116513). RESULTS: A total of 763 studies were identified after literature search and 23 original studies were included in the systematic review and in the meta-analysis. The combined data from the subgroup meta-analysis (outcome vs time after chemotherapy) showed an incidence of spontaneous abortion of 15.28% (95% confidence interval, 12.37-18.74; I2=73%), 3.30% of malformation (95% confidence interval, 2.27-4.79; I2=31%), 6.19% of prematurity (95% confidence interval, 5.03-7.59; I2=0), and 1.73% of stillbirth (95% confidence interval, 1.17-2.55; I2=0%). These results were not influenced by the time between the end of chemotherapy and the subsequent pregnancy in most of the studied outcomes, including malformation (P=.14, I2=31%), prematurity (P=.46, I2=0), and stillbirth (P=.66, I2=0). However, there was a higher occurrence of spontaneous abortion (P<.01, I2=73%) in pregnancies that occurred ≤6 months after chemotherapy. CONCLUSION: Chemotherapy for gestational trophoblastic neoplasia does not appear to increase the chance of unfavorable perinatal outcomes, except for the higher occurrence of spontaneous abortion in pregnancies occurring ≤6 months after chemotherapy.

Using Voice Change as an Indicator of Dysphagia: A Systematic Review.

Voice change post-swallow, observed during a clinical swallow examination, is often used as a clinical indicator of dysphagia risk. However, there has been limited research that evaluated the level of agreement between voice change and swallow dysfunction reported to date. This systematic review aims to investigate existing evidence relating to the relationship between vocal change post-swallow and swallow deficits identified on a Videofluoroscopic Swallow Study (VFSS). The studies were selected by two independent evaluators for inclusion, without restriction on language or date of publication and the methodological quality and the risk of bias were assessed using QUADAS-2. Following the PRISMA recommendation, 271 articles were analyzed, of which 17 were included in the study. Of these, the methodology described in five studies employed voice analyses using only acoustic methods, seven others conducted only auditory-perceptual analyses, and five other studies used both. Across the studies there was no homogeneity in the voice quality parameters assessed, analytic methods used, and results obtained. Forty seven per cent of the studies presented a high risk of bias in the analysis of vocal quality due to lack of clarity and blinding of VFSS. There was no homogeneity in the choice of consistencies evaluated during swallowing, as well as standardization of the outcome investigated in VFSS without a vocal parameter attributable to accurate detection in each outcome. It is not possible to obtain a consensus regarding the recommendation of the use of vocal evaluation as an accurate method for identifying swallowing alterations due to heterogeneity of the vocal evaluation methods, the outcomes evaluated in the VFSS examination, heterogeneity in food and liquid consistencies, and the methodological quality of the studies.

Diagnostic properties of sensitivity changes in patients with maxillofacial fractures: a systematic review

Aim: Verify the accuracy of objective assessments compared to subjective tests in detecting changes in somatosensory perception in individuals affected by maxillofacial trauma. Methods: The review (PROSPERO n ° CRD42019125546) used the databases: MEDLINE, Cochrane, EMBASE, LILACS and other bibliographic resources. Prospective and retrospective studies that used objective and subjective methods of assessing facial sensitivity in maxillofacial fractures were included. There was no restriction on language or publication date. Risk of bias was assessed using the QUADAS-2. Data extraction and analysis were performed using a form developed for the study. Results: 21 studies were included. The clinical objective examination mainly includes assessments of: tactile sensitivity (95.24%) and nociceptive sensitivity (57.14%). The subjective assessment was based on the patient's report, spontaneously (61.90%), guided by structured questionnaires (33.33%) and/or using scales (9.52%) to measure the degree of impairment. In risk of bias assessment, were observed no adequate interpretation and classification of changes in subjective sensitivity, subject to inappropriate analysis of the data. In addition, the studies bring several instruments without standardization for assessing sensory modalities. Conclusion: The objective assessment is a complement to the subjective assessment, using the touch assessment as the main parameter in the profile of the facial peripheral integrity, associated or not with nociceptive assessment. Lack of consensus on the indication of specific instruments for testing is a limiting factor. Thus, based on the studies, is proposed a minimum battery of sensitivity assessment to obtain an overview of the patient's peripheral nervous situation

Prevalence, Circumstances, and Risk Factors of Falls Among Community Dwelling Members of University of the Third Age.

Introduction: The transition from adolescence to adulthood involves a variety of physical, behavioral, and social transformations, often including tobacco use. Because understanding smoking at this stage is important for tobacco control, we aimed to analyze the prevalence of cigarette smoking in the Brazilian youth population. Methods: This study included participants aged 16-25 years from all Brazilian capitals. A standardized questionnaire was administered by trained healthcare professionals to collect information about sociodemographic status, sexual behavior, and tobacco use. The samples from each capital were weighted by age range and sex. Results: Of the 8,581 participants, 15.1% were current smokers, and 20.0% were former smokers; the average age at first tobacco use was 15.5 years. The prevalence of smoking in men was higher than that in women (20.1 vs. 10.3%, p < 0.01). Education level was associated with current smoking and former smoking. Participants with an elementary education level had a higher smoking prevalence (PR: 5.84, 95%, CI: 4.29-7.95) than those with a secondary education (PR: 2.19, 95% CI: 1.63-2.93) and those with higher education. Those without current partners (PR: 1.27, 95% CI: 1.03-1.56) also had a higher prevalence of smoking than those with partners, and participants who had a previous same-sex sexual experience smoked more (PR: 2.29, 95% CI: 1.78-2.96) than those who did not. In addition, regular use of alcohol was associated with higher prevalence of cigarette smoking (PR: 5.65, 95% CI: 4.03-7.90) than a lack of alcohol consumption. Skin color and socioeconomic class did not exhibit significant relationships with tobacco use patterns. Conclusions: Smoking was associated with education level regardless of social class, and some specific behaviors associated with a same-sex sexual experience were associated with a higher prevalence of smoking. These findings are important for formulating policies and directing actions to combat and prevent smoking among young populations.

Behavioral factors associated with multiple-type HPV genital infections: data from a cross-sectional study in young women in Brazil.

OBJECTIVES: To investigate the pattern of multiple human papillomavirus (HPV) infections and associated factors in young women who access the Brazilian public health care system to better understand the characteristics of multiple HPV infections, a critical issue in this era of multivalent vaccines. METHODS: This was a cross-sectional, multicenter study with sexually active unvaccinated women (16-25 years old) from 119 primary Brazilian healthcare centers between September 2016 and November 2017. Cervical samples were collected by trained health professionals, and HPV detection was performed in a central laboratory by Linear Array. RESULTS: Of the 5268 women, 33.00% (95% CI 31.07-34.92) had multiple infections. At least one type of high-risk HPV was present in 85.50% of all multiple infections. All HPV types were detected more frequently in association with other types than alone. Young individuals who were single or in a casual relationship and those who had more than one sexual partner in the past year were more likely to have multiple infections. CONCLUSIONS: In this work, a high rate of multiple HPV infections among unvaccinated young adults tended to increase due to certain risk factors. Such data can provide insight for decision makers in the development of public policies regarding HPV prevention.

Understanding the characteristics of multiple infections is critical in the era of HPV multivalent vaccines for the prevention of cervical carcinomas. Therefore, in this cross-sectional study, we aimed to investigate the pattern of multiple HPV infections and associated factors in 5,268 sexually active unvaccinated women (16­25 years old) who access the Brazilian public health care system. Cervical samples were collected by trained health professionals, and HPV detection was performed in a central laboratory by Linear Array. A total of 33.00% (95% CI 31.07­34.92) had multiple infections (60.43% of the HPV-positive sample). The number of HPV types in a multiple infection ranged from 2 to 14 different types. The viral types more frequently identified were HPV 16 and 52. All HPV types were detected more frequently in association with other types than alone. The incidence of multiple infections was 1.29 times higher in single than in married or cohabitating participants. Women who had two or more partners in the last year also had higher rates of multiple infections than those who had fewer than two sexual partners. In conclusion, a high prevalence of multiple infections prior to the national HPV immunization program was observed, especially with the increase in less safe behavior factors.

Prevalence of human T-lymphotropic virus type 1 and 2 (HTLV-1/-2) infection in pregnant women in Brazil: a systematic review and meta-analysis.

Human T-lymphotropic virus type 1 (HTLV-1) infection may cause serious disease, while pathogenicity of HTLV-2 is less certain. There are no screening or surveillance programs for HTLV-1/-2 infection in Brazil. By performing this systematic review, we aimed to estimate the prevalence of HTLV-1/-2 infections in pregnant women in Brazil. This review included cohort and cross-sectional studies that assessed the presence of either HTLV-1/-2 infection in pregnant women in Brazil. We searched BVS/LILACS, Cochrane Library/CENTRAL, EMBASE, PubMed/MEDLINE, Scopus, Web of Science and gray literature from inception to August 2020. We identified 246 records in total. Twenty-six of those were included in the qualitative synthesis, while 17 of them were included in the meta-analysis. The prevalence of HTLV-1 in Brazilian pregnant women, as diagnosed by a positive screening test and a subsequent positive confirmatory test, was 0.32% (95% CI 0.19-1.54), while of HTLV-2 was 0.04% (95% CI 0.02-0.08). Subgroup analysis by region showed the highest prevalence in the Northeast region (0.60%; 95% CI 0.37-0.97) for HTLV-1 and in the South region (0.16%; 95% CI 0.02-1.10) for HTLV-2. The prevalence of HTLV-1 is much higher than HTLV-2 infection in pregnant Brazilian women with important differences between regions. The prevalence of both HTLV-1/-2 are higher in the Northeast compared to Center-West region.

Emergence of the novel SARS-CoV-2 lineage VUI-NP13L and massive spread of P.2 in South Brazil.

In this study, we analyzed 340 whole genomes of SARS-CoV-2, which were sampled between April and November 2020 in 33 cities of Rio Grande do Sul, South Brazil. We demonstrated the circulation of two novel emergent lineages, VUI-NP13L and VUI-NP13L-like, and five major lineages that had already been assigned (B.1.1.33, B.1.1.28, P.2, B.1.91, B.1.195). P.2 and VUI-NP13L demonstrated a massive spread in October 2020. Constant and consistent genomic surveillance is crucial to identify newly emerging SARS-CoV-2 lineages in Brazil and to guide decision making in the Brazilian Public Healthcare System.

Prevalence of oral HPV infection in unvaccinated young adults in Brazil.

OBJECTIVES: This study aimed to report the national prevalence of oral HPV infection among unvaccinated women and men aged 16-25 years who utilized the public primary care services. METHODS: POP-Brazil is a cross-sectional, multicentric, nationwide survey conducted between September 2016 and November 2017. Recruitment was based in 119 public primary care practices in 26 state capitals and the Federal District of Brazil. Trained health professionals conducted face-to-face interviews. Oral samples were collected with mouthwash and gargle cycles. Genotyping was performed using the Roche PCR-based linear array genotyping test. Sampling weights by sex and age were applied. RESULTS: Valid oral HPV samples were collected from 5071 (96.88%) participants; 4005 women and 1066 men. Mean participant age was 21.63 years. Overall HPV prevalence was 1.69% (n = 73, 95% CI 1.05-2.32). Thirty individuals presented at least one high-risk HPV type [0.57% (95% CI, 0.29-0.85)]. There were no associations between age, sex, sociodemographic characteristics, drug use or sexual behavior and oral HPV prevalence. CONCLUSION: The prevalence of oral HPV infection in Brazilian teenagers and young adults is low, with no sociodemographic or behavioral correlates.

Sexual behavior and its association with persistent oral lesions: analysis of the POP-Brazil study.

OBJECTIVES: To investigate whether the presence of persistent self-reported oral lesions (PSOLs) is associated with sexual behaviors and with the presence of sexually transmitted infections (STIs) in individuals aged 16-25 years in the state capitals of Brazil. MATERIALS AND METHODS: Data from the POP-Brazil study were analyzed. An association analysis was performed by Poisson regression with the presence of PSOLs as the outcome. The exposure variables were the age at first sexual intercourse, the number of partners, oral sex practice, and aspects of condom use for model 1, and the presence of a self-reported STI or a positive rapid test for HIV/syphilis and the presence of genital human papillomavirus (HPV) for model 2. The results were adjusted for socioeconomic variables. RESULTS: The prevalence of PSOLs was 76% higher among individuals who had two or more sexual partners in the past year (p = 0.046) and 68% higher in those who reported not using condoms for contraception (p = 0.032). The group with HIV/syphilis or self-reported STI had a 140% higher PSOL prevalence (p = 0.003). CONCLUSIONS: The self-report of oral lesions in adolescents and young adults may suggest risky sexual behavior and the presence of STI. CLINICAL RELEVANCE: It is necessary to contextualize the reality of the young person to optimize oral health care.

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.

Sex differences in the prevalence and determinants of HPV-related external genital lesions in young adults: a national cross-sectional survey in Brazil.

BACKGROUND: External genital lesions (EGL) are the most common sexually transmitted infections (STIs). We aimed to evaluate the prevalence, determinants and sex differences in EGL among young adults from Brazil. METHODS: Overall, 7694 participants (aged 16 to 25 years) underwent an interview, genital examination and sampling for HPV genotyping. RESULTS: The prevalence of EGL was 4.08% (234) and is more frequent in men (5.72%) than women (2.31%) (p <  0.001). Genital lesions were significantly associated with male sex, infection by high-risk and multiple HPV types, having more than two sexual partners in the last year, smoking status and the presence of other STI. While alcohol use was associated with a higher prevalence of EGL in women, same-sex sexual relationship increase the prevalence in men. In the EGL group, 67.79% (p = 0.032) were positive for HPV infection and the types HPV6 and HPV11 were the most prevalent ones. CONCLUSION: The prevalence of EGL in young adults was consistently high, and most cases were associated with genital HPV infection and STIs. Although men have a higher prevalence, both sexes share most genital lesion determinants. The promotion of sexual education and vaccination especially focus in young men, who are usually outside the targets of primary health care programmes, can prevent EGL in Brazilian young adults.

Prevalence of HPV infection among sexually active adolescents and young adults in Brazil: The POP-Brazil Study.

For Brazil, there are no nationwide data on HPV prevalence against which the impact of the HPV immunization program can be measured in the future. Therefore, we aim to evaluate the prevalence of genital HPV infection among adolescents and young adults in Brazil. A cross-sectional, multicentric, nationwide survey was conducted between September 2016 and November 2017. Sexually active unvaccinated women and men aged 16 to 25 years old were recruited from 119 public primary care units, including all 26 state capitals and the Federal District. All participants answered a face-to-face interview and provided biological samples for genital HPV analysis. We used an automated DNA extraction method and HPV genotyping was performed using the Linear Array genotyping test (Roche). Of 7,694 participants, 53.6% (95% CI 51.4-55.8) were positive for any HPV type. The prevalence of high-risk HPV types was significantly higher in women (38.6% vs. 29.2%, P < 0·001). The HPV types included in the quadrivalent vaccine were detected in 1002 (14.8%) specimens, with a different pattern of HPV infection between sexes. Characteristics associated with overall HPV detection included female gender, self-declaration of race as brown/pardo, lower socioeconomic class, single or dating, current smoking and having 2 or more sex partners in the past year. We found a high prevalence of HPV, with significant differences between regions. Our data provide information that may be considered when developing HPV prevention policies and constitute a baseline against which the impact of the HPV immunization program in Brazil can be measured in future years.

Prognosis of PD-L1 in human breast cancer: protocol for a systematic review and meta-analysis.

BACKGROUND: Breast cancer is one of the most common malignancies in women worldwide, and one of the leading causes of cancer-related death. Programmed cell death 1 (PD-1) and its ligand (PD-L1) are key physiologic suppressors of the cytotoxic immune reaction. Some authors advocate that PD-L1 expression may help in breast cancer prognosis. METHODS: We will conduct a systematic review of observational or interventional studies evaluating the prognostic ability of PD-L1 expression levels in predicting positive clinical outcomes in Human Breast Cancer. A sensitive search strategy will be employed in MEDLINE, EMBASE, LILACS, The Grey Literature Report, OpenGrey, OAIster, and Cochrane CENTRAL. Two reviewers will independently screen all identified references for eligibility and extract data. The outcomes evaluated will be Overall Survival, Breast Cancer-specific Survival, Disease-free Survival, Recurrence-free Survival, Positive Lymph Node, and Distant Metastasis. The outcomes will be extracted directly from the studies, if available. Methodological quality and bias of included studies will be assessed using a standardized checklist and overall quality of evidence will be assessed through the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. If meta-analysis is possible, the measures of association will be calculated using bivariate random-effects models. Statistical heterogeneity will be evaluated with I2 statistics and explored through sensitivity analysis. DISCUSSION: Immunomodulation seems to be a promising strategy in solid tumors. Breast cancer is the most common malignancies in women worldwide, and one of the leading causes of cancer death. PD-1 and PD-L1 are key physiologic suppressors of the cytotoxic immune reaction. TRIAL REGISTRATION: Systematic review registration: CRD42019121118 (PROSPERO).

Prevalence of human papillomavirus (HPV) in Brazil: A systematic review and meta-analysis.

OBJECTIVES: This study aimed to estimate the prevalence of genital, anal and oral HPV infection in Brazil through systematic review and meta-analysis. METHODS: We searched EMBASE, LILACS, MEDLINE, Web of Science and SciELO from inception to December 2018. Original research articles that assessed the prevalence of genital (i.e., cervical, penile), anal and oral HPV infection in Brazil were selected in pairs by independent authors. No sex, age, HPV vaccination, language or date restrictions were applied. HPV prevalence was estimated and stratified according to risk factors population and by geographic area throughout the country. The study prevalence was pooled using a random effects model. Analysis was performed using R (version 3.5.2), packages meta version 4.9-4 and metaphor 2.0-0. This review is registered on PROSPERO under protocol number CRD42016032751. RESULTS: We identified 3,351 references. After the screening process, 139 of them were eligible for this systematic review (57,513 total participants). Prevalence of cervical HPV was 25.41% (95% CI 22.71-28.32). Additionally, prevalence was 36.21% (95% CI 23.40, 51.33) in the penile region, 25.68% (95%CI 14.64, 41.04) in the anal region, and 11.89% (95%CI 6.26, 21.43) in the oral region. Subgroup analysis showed prevalence in each anatomic site was higher in high-risk populations. CONCLUSION: The prevalence of HPV is high in the Brazilian population and varies by population risk and anatomic body site, with lower rates in the oral cavity compared to that in the cervical, penile and anal region. Studies on HPV have primarily been developed to evaluate infection and cancer in the cervical region. There is a profound lack of HPV data in many geographic regions of Brazil and for different anatomic sites.

STOP HPV study protocol: a nationwide case-control study of the association between oropharyngeal cancer and human papillomavirus (HPV) infection in Brazil.

INTRODUCTION: Human papillomavirus (HPV) is the most common sexually transmitted infection and is associated with several types of cancer. The number of cases of HPV-associated head and neck squamous cell carcinomas (HNSCCs), especially oropharyngeal carcinomas, has increased significantly in recent years despite decreased tobacco smoking rates. Currently, no data concerning the risk factors and prevalence of HPV in HNSCC patients in all regions of Brazil are available, making it difficult to promote advances in this field of public health. Therefore, our goal is to determine the impact of infection by HPV, including HPVs with different genotypes, on head and neck cancer and the risk factors associated with the development of head and neck cancer in all regions of Brazil. METHODS AND ANALYSIS: This is a case-control study that will include 622 patients and 622 controls from all regions of Brazil. A questionnaire will be applied to gather information on sociodemographic, behavioural and health factors. Oral, cervical or penile/scrotal, and anal specimens and serum samples will be collected from all participants. Formalin-fixed paraffin-embedded tissue from tumour biopsies will be analysed only in the case group. Molecular and serological analyses will be performed to evaluate the presence and role of HPV in the development of head and neck cancer. ETHICS AND DISSEMINATION: This project was approved by the research ethical committee of the proposing institution (Hospital Moinhos de Vento, number 2.852.060). Ethical approval from the collaborators is currently under evaluation and is not yet complete. The results of this study will be presented at meetings with the Brazilian Ministry of Health through technical reports and to the scientific community at national and international events, with subsequent publication of scientific articles.

Innovating the fight against syphilis: SIM Project / Inovando a luta contra a sífilis: Projeto SIM

Introduction: Syphilis is a major public health problem. Its incidence has increased in Brazil, particularly in the Southern Region. New tools are available, and immediate action is necessary. Objective: To describe the pilot study of an investigation aimed to assess the prevalence of syphilis, hepatitis B and C, and HIV and evaluate three strategies for adherence to syphilis treatment. Methods: A spontaneous sample of participants was evaluated with a structured questionnaire and underwent rapid tests for syphilis, HIV, and hepatitis B and C after signing an informed consent form (ICF). Rapid tests reagent for syphilis were confirmed by quantitative venereal disease research laboratory (VDRL) and Treponema pallidum hemagglutination assay (TPHA). Participants with confirmation of syphilis were randomized into three groups for follow-up: telephone calls, SIM app, and usual care at the health unit. Results: During a two-day pilot, 68 participants were included. Fourteen (20.6%) had tests reagent for syphilis, 1 (1.5%) for hepatitis B, 3 (4.4%) for hepatitis C, and 1 (1.5%) for HIV. Eight (57.1%) of the initial 14 individuals with rapid tests reagent for syphilis agreed to participate in the study. Out of the 8 rapid tests for syphilis, 2 (25%) were confirmed as active syphilis (>1/8). Conclusion: The prevalence of active syphilis estimated in this population was 3.5%. The demand for tests was high. The COVID-19 epidemic had a negative impact on the development of the study, which is ready for implementation. Discussions on the role of such a testing unit and the coverage of the research project in a context that requires increasing COVID-19-focused testing are fundamental for the future development of the project.

Introdução: A sífilis é um importante problema de saúde pública. A incidência tem aumentado no Brasil, principalmente na Região Sul. Novas ferramentas estão disponíveis e uma ação imediata é necessária. Objetivo: Descrever o estudo piloto de uma pesquisa que avalia a prevalência de sífilis, hepatites B e C e HIV e três estratégias de aderência ao seguimento do tratamento. Métodos: Uma amostra espontânea de participantes foi avaliada com um questionário estruturado e testes rápidos para sífilis, HIV e hepatites B e C foram realizados após assinatura do Termo de Consentimento Livre e Esclarecido (TCLE). Os testes rápidos reagentes para sífilis foram confirmados por VDRL (venereal disease research laboratory) quantitativo e hemaglutinação para sífilis (Treponema pallidum hemagglutination assay ­ TPHA). Os participantes com confirmação de sífilis foram randomizados em três grupos para acompanhamento: ligações telefônicas, aplicativo do SIM e cuidados habituais na unidade de saúde. Resultados: Durante um piloto de dois dias, 68 participantes foram incluídos. Quatorze (20,6%) tiveram testes reagentes para sífilis, 1 (1,5%) para hepatite B, 3 (4,4%) para hepatite C e 1 (1,5%) para HIV. Oito (57,1%) dos 14 casos iniciais com teste rápido reagente para sífilis aceitaram participar do estudo. Dos 8 testes rápidos para sífilis, 2 (25%) foram confirmados como sífilis ativa (>1/8). Conclusão: A prevalência de sífilis ativa estimada nesta população foi de 3,5%. A demanda por exames foi alta. A epidemia de COVID-19 impactou negativamente o desenvolvimento do estudo, que está pronto para implementação. A discussão sobre o papel desta espécie de unidade de teste e a abrangência do projeto de pesquisa em um contexto que pede a expansão de testes focados na COVID-19 são fundamentais para o desenvolvimento futuro do projeto.