Sample dimensioning in epidemiological surveys based on the change of the dental caries prevalence and their implications in the costs

Orientadores: Glaucia Maria Bovi Ambrosano, Antonio Carlos PereiraDissertação (mestrado profissional) - Universidade Estadual de Campinas, Faculdade de Odontologia de PiracicabaResumo: O objetivo do presente estudo foi analisar como a prevalência e a distribuição da cárie dentária em escolares influencia no tamanho da amostra necessária em levantamentos epidemiológicos e, conseqüentemente, nos custos para realização dos mesmos pelos serviços públicos. Foram utilizados dados secundários de levantamentos de dois municípios de médio porte do estado de São Paulo, relativos à idade de 12 anos, sendo 1449 escolares de Bauru examinados nos anos de 1976, 1984, 1990, 1994 e 2001 e 1763 examinados em Piracicaba nos anos de 2001 e 2005. As amostras foram dimensionadas levandose em consideração a média e desvio padrão obtidos nos estudos, fixando-se erro amostral (d) em 1, 2, 5 e 10% da média. Após o dimensionamento das amostras, foram estimados os custos para os levantamentos de cárie considerando os preços reais dos materiais e mão-de-obra, incluindo os seguintes itens: material permanente, material de consumo e recursos humanos. Em ambos os municípios, foi constatada a necessidade de aumento no tamanho das amostras em decorrência da diminuição da prevalência da cárie dentária e aumento na variabilidade entre os escolares. Considerando erro amostral de 10%, no município de Bauru, a variação no tamanho da amostra seria de 119 em 1976 para 1118 em 2001. No município de Piracicaba os valores variam de 954 para 1252, em 2001 e 2005, respectivamente. Em relação aos custos para realização dos levantamentos epidemiológicos no município de Bauru foram estimados R$385,00 para o ano de 1976 e R$ 3.617,30 para 2001. No município de Piracicaba, os valores são de R$3.086,70 em 2001 para R$ 4.050,80 em 2005. Os valores mencionados se referem ao custo operacional, pois em ambos os municípios também foi estimado um custo fixo de R$1.190,00 referente ao material permanente. Conclui-se que a diminuição da prevalência da carie dentária determinou a necessidade de um aumento no tamanho das amostras e como conseqüência elevação dos custos e do tempo necessário para realização dos levantamentosAbstract: The objective of the present study was to analyze how the prevalence and the distribution of dental caries in schoolchildren influence the size of the necessary sample in epidemiological surveys and, consequently, in the costs for the completion of similar ones for public services. Secondary data of two medium load municipal districts in São Paulo state were used. 12-year-old age children were examined. 1,449 schoolchildren from Bauru were examined during 1976, 1984, 1990, 1994, and 2001. 1,763 were examined in Piracicaba during 2001 and 2005. The samples were dimensioned according to the average and standard deviation obtained in the studies. The amostral error was set (d) to 1, 2, 5 and 10$ 182,00 in 1976 and US$1.706,00 in 2001. In Piracicaba, the values were US$ 1.456,00 in 2001 and US$1.910,00 in 2005. The stated values refer to the operational cost, because, in both municipal districts, an additional fixed cost of US$ 561,00 regarding the permanent material was estimated. It is ended that the decrease of the prevalence of the dental caries determined the need of an increase in the size of the samples and, as a result, the increase in costs and time for completion of the surveysMestradoSaude ColetivaMestre Profissional em Odontologi

Diagnostic Performance of the HCV Core Antigen Test To Identify Hepatitis C in HIV-Infected Patients: a Systematic Review and Meta-Analysis

The standard algorithm for diagnosing hepatitis C virus (HCV) infection has two steps, an HCV antibody test for screening and a nucleic acid amplification test (NAAT) for confirmation. However, the HCV core antigen (HCVcAg) detection assay is an alternative for one-step diagnosis. We aimed to evaluate the diagnostic performance of the Abbott ARCHITECT HCV Ag assay to detect active hepatitis C in serum/plasma in people living with HIV/AIDS (PLWHA), through a systematic review and meta-analysis. PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library were searched until 20 September 2022 (PROSPERO, CRD42022348351). We included studies evaluating Abbott ARCHITECT HCV Ag assay (index assay) versus NAATs (reference test) in PLWHA coinfected with HCV who did not receive antiviral treatment for HCV. Meta-analysis was performed with the MIDAS module using Stata and random-effects models. The QUADAS-2 tool evaluated the risk of bias. The bivariate analysis was conducted on 11 studies with 2,407 samples. Pooled sensitivity was 0.95 (95% CI = 0.92 to 0.97), specificity 0.97 (95% CI = 0.93 to 0.99), positive likelihood ratio 37.76 (95% CI = 12.84 to 111.02), and negative likelihood ratio 0.06 (95% CI = 0.04 to 0.09). The area under the curve was 0.97 (95% CI = 0.20 to 1.00). For low prevalence (≤5%), the posttest probability that an individual with a positive test was a true positive ranged from 4% to 67%, whereas, at high prevalence (≥10%), the posttest probability was between 81% and 87%, indicating that a confirmatory test should be necessary, particularly with prevalence values of ≤1%. Regardless of prevalence, the probability that an individual with a negative test was a false negative was close to zero, indicating that the individual was not infected with HCV. In conclusion, the accuracy of the Abbott ARCHITECT HCV Ag assay was very good for HCV screening in serum/plasma samples from PLWHA. The clinical utility to confirm HCV infection was acceptable in high-prevalence settings (≥10%) but poor in low-prevalence settings (≤1%). Furthermore, it was excellent in excluding active HCV infection.This study was supported by grants from the Instituto de Salud Carlos III (ISCII; grant number PI20CIII/00004 to S.R., and PI19CIII/00009 to I.M.) and Gilead Science (grant number GLD20_0144 to S.R.). This research was also supported by CIBER (Consorcio Centro de Investigación Biomédica en Red) (CB 2021), Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación, and Unión Europea – NextGenerationEU (CB21/13/00044). D.S.-C. is a Sara Borrell researcher from ISCIII (grant no. CD20CIII/00001). A.T.-N. is a PhD student in the Program in Biomedical Sciences and Public Health of the UNED International Doctoral School. No funding bodies had any role in study design, data collection, analysis, decision to publish, or manuscript preparation.S

Meta-analysis: diagnostic accuracy of hepatitis C core antigen detection during therapy with direct-acting antivirals

Background: Treatment of hepatitis C virus (HCV) infection with direct-acting antivirals (DAAs) is monitored by assessing plasma HCV-RNA load. However, detection of HCV core antigen (HCVcAg) may be an alternative. Aim: To evaluate the diagnostic performance of the HCVcAg assay to monitor the efficacy of DAAs in HCV-infected patients METHODS: We performed searches in multiple electronic databases until 6 July 2022, of studies evaluating the HCVcAg detection in plasma or serum compared with the HCV-RNA test (gold standard). We calculated pooled measurement at 2 and 4 weeks of treatment, and at end-of-treatment (EOT), as well as sustained virological response (SVR; 12 weeks after EOT). Results: We selected 16 studies from 2016 to 2022, with 3237 patients and 8958 samples. Overall, the diagnostic performance and clinical utility of the HCVcAg assay were poor at week 2 (sensitivity = 0.40, specificity = 0.96, positive likelihood ratio (PLR) = 9.16, negative likelihood ratio (NLR) = 0.63, and area under the summary receiver operating curve (SROC) = 0.57), fair at week 4 (sensitivity = 0.30, specificity = 0.90, PLR = 3.18, NLR = 0.77, and AUC = 0.79), acceptable at EOT (sensitivity = 0.40, specificity =0.98, PLR = 16.54, NLR = 0.62, and AUC = 0.97) and excellent for SVR (sensitivity = 0.94, specificity = 0.99, PLR = 107.54, NLR = 0.06, and AUC = 0.99). Conclusions: The HCVcAg assay may be helpful for monitoring the efficacy of HCV treatment with DAAs in HCV-infected patients at EOT and for documenting SVR, but not at weeks 2 and 4 of treatment due to poor diagnostic performance.This study was supported by grants from Instituto de Salud Carlos III (ISCII; grant numbers PI20CIII/00004 to SR, and PI19CIII/00009 and PI22CIII/00019 to IM). This research was also supported by CIBER -Consorcio Centro de Investigación Biomédica en Red- (CB 2021), Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación and Unión Europea – NextGenerationEU (CB21/13/00044). DS-C is a ‘Sara Borrell’ researcher from ISCIII (grant nº CD20CIII/00001). No funding bodies had any role in study design, data collection, analysis, decision to publish, or manuscript preparation.S

Aerosolized lancovutide in adolescents (≥12 years) and adults with cystic fibrosis - a randomized trial.

Abstract Background Lancovutide activates a chloride channel (TMEM-16A) other than the cystic fibrosis (CF) transmembrane conductance regulator protein and could benefit CF patients. Methods In this randomized, multi-center, double-blind, placebo-controlled, parallel-group trial 161 patients ≥12 years with a confirmed diagnosis of CF were randomized to either placebo (saline) or active drug in 3 different dosing schemes of 2.5mg inhaled lancovutide (once daily, every other day or twice a week) for eight weeks. The primary endpoint was the change in the forced expiratory volume in 1 second (FEV1) percent predicted. Secondary endpoints included further lung function parameters (FEV1 (absolute), functional vital capacity percent predicted, forced expiratory flow percent predicted, pulse oximetry), quality of life assessment, pulmonary exacerbations, hospitalization due to pulmonary exacerbations, time to first pulmonary exacerbation, duration of anti-inflammatory, mucolytic or antibiotic treatment, and safety. Results There was no significant difference in the change in FEV1 percent predicted, quality of life, other lung function parameters, pulmonary exacerbations or requirement of additional treatment between groups. Overall, the inhalation of lancovutide was safe although a higher rate of adverse events, especially related to the respiratory system, occurred as compared to placebo. Conclusions Lancovutide did not improve FEV1 percent predicted when compared to placebo (NCT00671736)

TWEAK promotes peritoneal inflammation

Peritoneal dialysis (PD) is complicated by peritonitis episodes that cause loss of mesothelium and eventually sclerosing peritonitis. An improved understanding of the molecular contributors to peritoneal injury and defense may increase the therapeutic armamentarium to optimize peritoneal defenses while minimizing peritoneal injury. There is no information on the expression and function of the cytokine TWEAK and its receptor Fn14 during peritoneal injury. Fn14 expression and soluble TWEAK levels were measured in human PD peritoneal effluent cells or fluids with or without peritonitis. Fn14 expression was also analyzed in peritoneal biopsies from PD patients. Actions of intraperitoneal TWEAK were studied in mice in vivo. sTWEAK levels were increased in peritoneal effluent in PD peritonitis. Effluent sTWEAK levels correlated with the number of peritoneal macrophages (r = 0.491, p = 0.002). Potential TWEAK targets that express the receptor Fn14 include mesothelial cells and macrophages, as demonstrated by flow cytometry of peritoneal effluents and by analysis of peritoneal biopsies. Peritoneal biopsy Fn14 correlated with mesothelial injury, fibrosis and inflammation, suggesting a potential deleterious effect of TWEAK/Fn14. In this regard, intraperitoneal TWEAK administration to mice promoted peritoneal inflammation characterized by increased peritoneal effluent MCP-1, Fn14 and Gr1+ macrophages, increased mesothelial Fn14, MCP-1 and CCL21 expression and submesothelial tissue macrophage recruitment. Taken together these data suggest that the TWEAK/Fn14 system may promote inflammation and tissue injury during peritonitis and PD.This work was supported by FIS PS09/00447, PI08/1564, PI10/00234, MS12/03262, FEDER funds ISCIII-RETIC REDinREN/RD06/0016, RD12/0021, Comunidad de Madrid (Fibroteam S2010/BMD-2321, S2010/BMD-2378). Programa Intensificación Actividad Investigadora (ISCIII/Agencia Laı´n-Entralgo/CM) to AO, Programa Estabilizacio´n Investigadores to LB-C, Miguel Servet to ABS, Sara Borrell to BS, MDSN. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Characteristics of a novel treatment system for linear accelerator–based stereotactic radiosurgery

The purpose of this study is to characterize the dosimetric properties and accuracy of a novel treatment platform (Edge radiosurgery system) for localizing and treating patients with frameless, image-guided stereotactic radiosurgery (SRS) and stereotactic body radiotherapy (SBRT). Initial measurements of various components of the system, such as a comprehensive assessment of the dosimetric properties of the flattening filter-free (FFF) beams for both high definition (HD120) MLC and conical cone-based treatment, positioning accuracy and beam attenuation of a six degree of freedom (6DoF) couch, treatment head leakage test, and integrated end-to-end accuracy tests, have been performed. The end-to-end test of the system was performed by CT imaging a phantom and registering hidden targets on the treatment couch to determine the localization accuracy of the optical surface monitoring system (OSMS), cone-beam CT (CBCT), and MV imaging systems, as well as the radiation isocenter targeting accuracy. The deviations between the percent depth-dose curves acquired on the new linac-based system (Edge), and the previously published machine with FFF beams (TrueBeam) beyond Dmax were within 1.0% for both energies. The maximum deviation of output factors between the Edge and TrueBeam was 1.6%. The optimized dosimetric leaf gap values, which were fitted using Eclipse dose calculations and measurements based on representative spine radiosurgery plans, were 0.700 mm and 1.000 mm, respectively. For the conical cones, 6X FFF has sharper penumbra ranging from 1.2–1.8 mm (80%-20%) and 1.9–3.8 mm (90%-10%) relative to 10X FFF, which has 1.2–2.2mm and 2.3–5.1mm, respectively. The relative attenuation measurements of the couch for PA, PA (rails-in), oblique, oblique (rails-out), oblique (rails-in) were: -2.0%, -2.5%, -15.6%, -2.5%, -5.0% for 6X FFF and -1.4%, -1.5%, -12.2%, -2.5%, -5.0% for 10X FFF, respectively, with a slight decrease in attenuation versus field size. The systematic deviation between the OSMS and CBCT was -0.4 ± 0.2 mm, 0.1± 0.3mm, and 0.0 ± 0.1 mm in the vertical, longitudinal, and lateral directions. The mean values and standard deviations of the average deviation and maximum deviation of the daily Winston-Lutz tests over three months are 0.20 ± 0.03 mm and 0.66 ± 0.18 mm, respectively. Initial testing of this novel system demonstrates the technology to be highly accurate and suitable for frameless, linac-based SRS and SBRT treatment

Creación de un instrumento de medida de la comunicación médico-paciente. Validación para residentes

Crear y validar en nuestro país un Cuestionario base que permita su uso para el análisis de la comunicación medico-paciente que pueda ser utilizado en diferentes circunstancias. Validación para su uso en residentes con pacientes estandarizados (PE)