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Background: The first months of the coronavirus disease 2019 (COVID-19) pandemic demanded rapid re-organization of available local resources. This study evaluated the performance of a private hospital in the Brazilian state of Ceará that was swiftly repurposed into a public tertiary COVID-19 centre during the first wave of the COVID-19 pandemic, and how it improved in the second wave. Methods: This retrospective cohort study included 2492 patients with COVID-19 at Hospital Estadual Leonardo da Vinci (HELV) during the first and second waves. Demographic, clinical and laboratory data were collected using a dedicated web platform (ResCOVID). A Poisson regression model was used to estimate factors associated with in-hospital mortality. Results: Differences in demographics and clinical features were found between the two waves. There was reduced in-hospital mortality during the second wave (36.2%) in comparison with the first wave (48.8%). Invasive mechanical ventilation showed the strongest association with increased risk of death in both waves {first wave: relative risk (RR) 4.28 [95% confidence interval (CI) 2.86-6.41], P<0.001; second wave: RR 12.94 (95% CI 3.4-49.12), P<0.001}. Conclusions: HELV was a pillar in the strategic public health plan to respond to COVID-19 in Ceará, helping to assist a group of moderate-to-severe cases and reduce the pressure on emergency and primary care facilities. Although mortality in intubated individuals remained high, there was an overall decrease in the in-hospital mortality rate in the second wave.
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Introdução: O aumento da judicialização da saúde tem destacado a importância dos centros de avaliação judicial em decisões baseadas em evidências. A atrofia muscular espinhal (AME) é uma doença neurodegenerativa caracterizada principalmente por hipotonia muscular progressiva e alta mortalidade nos primeiros dois anos de vida. Embora o medicamento Zolgensma® (onasemnogeno abeparvoveque) seja indicado para o tratamento da AME, seu custo elevado e a indisponibilidade pelo sistema público de saúde brasileiro tornam o tratamento inviável, resultando em processos judiciais. Objetivo: Descrever o perfil das informações contidas nas notas técnicas (NT) disponíveis no Sistema Nacional de Pareceres e Notas Técnicas (e-NatJus), utilizadas como apoio nas decisões judiciais relacionadas ao Zolgensma®. Material e Métodos: Foi realizado um estudo descritivo com dados de notas técnicas disponíveis no e-NatJus no período entre setembro de 2021 a setembro de 2023. Resultados: Foram identificadas 63 notas técnicas, sendo que uma foi excluída por se tratar de nota complementar. Das 62 NTs consideradas elegíveis para análise neste estudo, a idade média dos participantes foi de 2,03 (± 1,54) anos, sendo a maioria do sexo masculino. A maioria das solicitações foi para tratamento de AME tipo 1 (N= 52; 82%). Destas, somente 23 atendiam a faixa etária inferior a 2 anos. Quanto à recomendação final, 14 NTs foram favoráveis ao fornecimento do Zolgensma®. Conclusão: Os resultados revelaram o perfil das NTs baseadas em evidências científicas, que subsidiam decisões judiciais visando minimizar impactos no orçamento da saúde. Iniciativas como o Sistema e-NatJus são fundamentais para acesso a esses subsídios, embora a disseminação de informações e capacitações continuadas sejam necessárias. Pesquisas adicionais sobre o impacto dos Núcleos de Avaliação de Tecnologias em Saúde (NATS) e Núcleos de Apoio Técnico ao Judiciário (NATJUS) na judicialização da saúde são importantes.
Introduction: The increasing judicialization of health has highlighted the importance of judicial evaluation centers in evidence-based decisions. Spinal Muscular Atrophy (SMA) is a neurodegenerative disease characterized mainly by progressive muscle hypotonia and high mortality in the first two years of life. Although the medication Zolgensma® (onasemnogene abeparvovec) is indicated for the treatment of SMA, its high cost and unavailability through the Brazilian public health system make the treatment unfeasible, resulting in legal proceedings. Objective: To describe the profile of the information contained in the Technical Notes (TN) available in the e-NatJus System used as support in Zolgensma® judicial decisions. Material and Methods: A descriptive study was conducted with data from technical notes available in the National System of Opinions and Technical Notes (e-NatJus) from September 2021 to September 2023. Results: 63 Technical Notes were identified, with one excluded as a Complementary Note. Of the 62 TNs considered eligible for analysis in this study, the mean age of the participants was 2.03 (± 1.54) years, with the majority being male. Most requests were for the treatment of SMA type 1 (N= 52; 82%). Of these, only 23 met the age criteria of less than 2 years. Regarding the final recommendation, 14 TNs were favorable to the provision of Zolgensma®. Conclusion: The results revealed the profile of technical notes based on scientific evidence, which support judicial decisions aimed at minimizing impacts on healthcare budgets. Initiatives like the e-NatJus System are essential for accessing these subsidies, although the dissemination of information and continuous training are necessary. Further research on the impact of NATS and NATJUS on healthcare judicialization is important.
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Pharmaceutical Preparations , Health's Judicialization , Technology Assessment, Biomedical , Muscular Atrophy, Spinal , Costs and Cost Analysis , Evidence-Based PracticeABSTRACT
Immune thrombocytopenia (ITP) is an acquired bleeding disorder observed in the clinical practice. Little is known about its epidemiology in Brazil. The present study was conducted at a hematology referral center which covers a population of over 8 million in 184 municipalities in the state of Ceará. The purpose of this study was to draw a demographic profile of adult ITP patients with regard to sex, age, geographical origin and distribution across the state, and the proportion of secondary ITP. Following ethics committee approval, information was collected with an ad hoc instrument. The sample consisted of 187 adult ITP patients attending the Walter Cantídio University Hospital in 2015. The median follow-up time was 67 months (range: 1 month to 29 years). Female sex (n = 154; 82.35 %) was strongly prevalent in all age brackets, with an overall female/male ratio of 4.7:1. The median age was 41 ± 16.1 with an interquartile range of 29-55.5 years; there was no difference between the genders. Secondary ITP (18/187; 9.6 %) displayed a bimodal distribution and a linear increase between 38 and >68 years of age. The results of this survey on the epidemiology of ITP in Brazil suggest that ethnic and geographical factors may have a great impact on age and sex distribution and on the distribution of secondary ITP.
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BACKGROUND: Lupus nephritis (LN) is a major source of morbidity and mortality in patients with systemic lupus erythematosus (SLE), with 10-25% of patients progressing to end-stage renal disease (ESRD). OBJECTIVE: This study aims to elucidate the predictive capabilities of 24-h proteinuria (24PTU) and serum creatinine (sCr) after 12 months of treatment with respect to long-term renal outcomes in LN in a single-center cohort of LN patients. METHODS: A retrospective analysis was performed on 214 patients diagnosed with LN followed in our center. Values of 24PTU and sCr were assessed at baseline and after 3, 6 and 12 months, and after 5 years and/or the last evaluation. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 for 3 months or longer. End-stage renal disease (ESRD) was defined as the need for permanent dialysis. Receiver operating characteristics curves (ROC) were used to test the best cut-off value of 24PTU and sCr at 12 months who predict bad long-term renal outcomes. RESULTS: The mean follow-up period was 11.2 ± 7.2 years. The best cut-off values for 24PTU and sCr as predictor of CKD were, respectively, 0.9 g/24 h and 0.9 mg/dL. ROC curve for 24PTU had a slightly lower performance than ROC curve for sCr as predictor for CKD (PTU AUC = 0.68; sCr AUC = 0.70), but sensitivity and specificity were better for 24PTU (24PTU: sensitivity = 63.5%, specificity = 71.2%; sCr: sensitivity = 54.8%, specificity = 75.3%). When the outcome was ESRD the best cut-off points were 0.9 g/24hs and 1.3 mg/dL for 24PTU and sCr, respectively, and the curve performance was better for 24PTU (PTU AUC = 0.72; sCr AUC = 0.61). CONCLUSIONS: In this ethnically diverse population with LN followed for a long time (> 10 years), levels of 24PTU > 0.9/day at 12 months was a good predictor of bad long-term renal outcome. The serum creatinine > 0.9 mg/dL and > 1.3 mg/dL at 12 months were also good predictors of CKD and ESRD, respectively. Patients with 24PTU < 0.9 g/day and sCr < 1.3 mg/dL at 12 months are not likely to develop ESRD because of the high negative predictive values (NPV) (93.2% and 82%). 24PTU and sCr are relevant as components for a treat-to-target strategy for LN treatment, since their high NPV corroborates their importance as good predictors of long-term renal outcome.
Subject(s)
Lupus Nephritis , Case-Control Studies , Creatinine , Humans , Lupus Nephritis/complications , Proteinuria/etiology , Retrospective StudiesABSTRACT
OBJECTIVES: A retrospective study was conducted to identify the prevalence of COVID-19 through serology and RT-PCR in children, adolescents and adults. A database of the COVID-19 Tracking Program in school children was used. METHODS: The data comprised sociodemographic and clinical variables, results of serological tests (IgM and IgG), and real-time-polymerase chain reaction (RT-PCR) results of IgM-positive individuals. The statistical analysis was performed with a 5% significance level. RESULTS: Among 423 children, 107 (25.3%) exhibited seroprevalence with IgG, IgM or IgG/IgM; among 854 adolescents, 250 (29.2%) had positive serology; and among 282 adults, 59 (20.9%) were positive. The frequency of positivity on RT-PCR for SARS-CoV-2 was 3.5%, 3.6% and 6.0% in children, adolescents and adults, respectively. Children had a lower incidence of symptoms than adolescents (p = 0.001) and adults (p = 0.003); the most frequent were fever, ageusia, anosmia, headache, dry cough, sore throat, muscle pain, runny nose, dyspnoea, and diarrhoea. CONCLUSIONS: The prevalence rate for all groups was 26.7% in serology and 4.04% in RT-PCR. Children had lower rates of IgM and fewer symptoms compared with adolescents and adults. The data suggest the potential for transmissibility in all age groups.
Subject(s)
COVID-19 , Adolescent , Adult , Brazil/epidemiology , Child , Humans , Prevalence , Retrospective Studies , SARS-CoV-2 , Seroepidemiologic StudiesABSTRACT
Objective: The aim was to analyze the factors associated with neonatal near miss (NNM) in twin pregnancies in a public referral maternity unit in Brazil. Material and Methods: This retrospective, cross-sectional study included 697 twin newborns. Cases of fetal and neonatal deaths were excluded. Neonates were divided into those meeting NNM criteria (5 min Apgar score <7, birth weight <1,500 g, gestational age at delivery <32 weeks, use of mechanical ventilation or congenital malformation, transfer before 28 days of life) and those who did not. In the bivariate analysis, the chi-square and Fisher's exact tests were used. Variables with a p-value ≤0.20 were subjected to the multiple analyses, which followed the Poisson regression model. Results: The cohort consisted of 130 (18.7%) neonates meeting NNM criteria and 567 (81.3%) with no NNM criteria after multiple analyses, the following variables were associated with NNM: no previous pregnancy, prevalence ratio (PR): 1.38 [95% confidence interval (CI), 1.03-1.85]; >3 previous pregnancies, PR: 1.93 (95% CI, 1.38-2.69); premature rupture of membranes, PR: 1.50 (95% CI, 1.70-2.12); intrauterine growth restriction, PR: 2.28 (95% CI, 1.53-3.33); premature labor, PR: 1.63 (95% CI, 1.13-2.35); resuscitation in the delivery room, PR: 1.80 (95% CI, 1.24-2.62); and transfusion of blood products, PR: 4.44 (95% CI, 3.14-6.28). Conclusion: The study findings indicate that having had 0 or >3 previous pregnancies, premature rupture of the membranes, intrauterine growth restriction, resuscitation in the delivery room, premature labor, and transfusion of blood products were associated with NNM in twin pregnancies.
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BACKGROUND: To evaluate the association between delays in obstetric care and neonatal near-miss mortality events and death in a public maternity referral center. METHODS: This case-control study enrolled 142 neonates, meeting the near-miss criteria of 5-min Apgar < 7, weight < 1500 g, gestational age < 32 weeks, and use of mechanical ventilation or congenital malformation, as well as 284 controls (without the near-miss criteria), at a ratio of 1:2. After follow-up, the following outcomes were reclassified: survival of the neonatal period without the near-miss criteria (true "controls"), "near-miss," and "neonatal death." Maternal sociodemographic characteristics, prenatal care, and pregnancy resolution were evaluated. Pearson's chi-square and Fisher's exact tests were used. Simple logistic regression was performed to determine the association between the three delay factors with near-miss outcomes and/or neonatal death. The variables that had maintained values of p < 0.05 were subjected to multinomial logistic regression. RESULTS: Comparisons revealed the following associations: for controls and near-miss events, delayed access to health services due to a lack of specialized services (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.8-5.1) and inappropriate conduct with the patient (OR, 12.1; 95% CI, 1.3-108.7); for controls and death, absent or inadequate prenatal care (OR, 3.3; 95% CI, 1.6-7.1) and delayed access to health services due to a lack of specialized services (OR, 2.5; 95% CI, 1.1-5.6); and for near-miss events and death, absent or inadequate prenatal care (OR, 2.2; 95% CI, 1.0-5.0). Logistic regression for the combined outcome (near-miss plus neonatal deaths) revealed absent or inadequate prenatal care (OR, 1.9; 95% CI, 1.2-2.8), lack of specialized services (OR, 2.8; 95% CI, 1.7-4.5), and improper conduct with the patient (OR, 10.6; 95% CI, 1.2-91.8). CONCLUSIONS: The delays in obstetric care associated with the presence of near-miss and/or neonatal death included absent or inadequate prenatal care, delayed access to health services due to a lack of specialized services, and inappropriate conduct with the patient.