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O presente artigo tem o propósito de analisar como o Constitucionalismo Multinível, mais especificamente o Constitucionalismo Subnacional referente às Constituições Estaduais, pode ser utilizado como mais instrumento na proteção dos direitos humanos. Assim, no primeiro tópico, é realizada uma análise da organização do Estado conforme o decorrer das Constituições Nacionais brasileiras, demonstrando que sempre houve uma luta entre interesses centralizadores e descentralizadores do poder nacional. A despeito da gradativa descentralização formal do Estado Brasileiro através de uma federação quadripartida, a Constituição de 1988 manteve a tradição quase secular de concentração de competências no poder central. No segundo tópico, é realizado um estudo do Constitucionalismo Subnacional como uma modalidade do Constitucionalismo Multinível, apresentando-se uma nova perspectiva para a autonomia dos Estados-membros, através de uma ótica “bottom-up” (de baixo para cima), onde são verificadas as potencialidades do espaço de autonomia das Constituições Estaduais a partir da legiferação dos direitos fundamentais estaduais. Por fim, no terceiro tópico, é apresentado o resultado de uma pesquisa qualitativa realizada nas Constituições Estaduais brasileiras, demonstrando-se vários dispositivos referentes à proteção de direitos humanos e de grupos vulneráveis. Assim, conclui-se que as Constituições Estaduais são mais um dos instrumentos do Constitucionalismo Multinível na proteção dos direitos humanos.

Introdução Para várias agências de avaliação de tecnologia em saúde em nível mundial, o processo de tomada de decisão para a incorporação de tecnologias específicas para o tratamento de doenças ultrarraras tem sido um grande desafio. Essas dificuldades incluem estabelecer uma estrutura de análise específica que considere diferentes aspectos desse tipo de doença e a especificidade das demandas. Para superar esse cenário, faz-se necessário uma reavaliação das bases teóricas e metodológicas que orientam a tomada de decisão para a incorporação de tecnologias para as doenças ultrarraras. O objetivo deste estudo foi realizar uma descrição e análise dos métodos utilizados nos relatórios de recomendação avaliados pela Conitec dirigidos a este grupo de doenças, com o intuito de fornecer um panorama dos processos atuais, bem como a identificação de novas práticas, métodos ou critérios, necessidades ou deficiências, bem como a sugestão de novas soluções. Métodos Os dados foram extraídos dos relatórios de recomendação de tecnologias para tratamento de doenças ultrarraras avaliadas pela Conitec entre 2012 e 2022. Para a classificar a doença como ultrarrara foi utilizado o critério epidemiológico ou uma consulta à plataforma ORPHANET. A proporção de referência foi a de prevalência ≤ a 1/50.000 hab. As variáveis extraídas foram: tipo de síntese de evidência, tipo de estudos incluídos, instrumento e resultado da avaliação da qualidade metodológica dos estudos, forma de apresentação da síntese de evidências, se graduou a evidência e resultado. Resultados Dos 53 relatórios, a maioria (34%) apresentou evidências utilizando dados de ECR com baixo risco de viés em sua maioria, seguida de revisão sistemática e estudos observacionais (24% e 25%). Observa-se que os relatórios que utilizaram revisão sistemática, foram aqueles que tiveram a maior proporção recomendada (63%). A maior parte das sínteses dos dados foi feita de forma descritiva (73%, n=39) e a graduação de todas as evidências foi em sua maioria moderada e baixa, para os 51% que aplicaram o GRADE. Não foi observada relação entre a graduação da evidência e o resultado final da recomendação. Quando comparado os dados de evidência com o resultado da recomendação, foi observado que 83% dos relatórios que apresentaram meta-análise tiveram seus relatórios recomendados, em comparação com os que apresentaram de forma descritiva (55%, n=21). Quanto ao tipo de desfecho utilizado nas análises, os classificados como substitutos foram os de maior ocorrência (exemplo: concentração de glicosaminoglicanos na urina, normalização dos níveis de IGF, Níveis de aminoácidos plasmáticos, Controle na melhora do escore HINE 2, Volume Expiratório Forçado). Discussões e conclusões O resultado desta análise mostrou que algumas características das evidências clínicas parecem influenciar na tomada de decisão final. Fazendo uma comparação com os argumentos apresentados nos textos finais das recomendações, percebe- -se que as evidências influenciam quando há menção de novos dados, ou que a mesma apresenta potencial de mudança do curso natural da doença, diminuição de eventos graves ou aumento da sobrevida. Como limitação para as análises aqui apresentadas, citamos a heterogeneidade na estrutura dos relatórios mais antigos para os relatórios mais recentes, que acompanham os avanços metodológicos da ATS no Brasil, que se refletem nos relatórios apresentados na CONITEC.

Introdução O processo de tomada de decisão para a incorporação de tecnologias especificas para doenças ultrarraras tem sido um grande desafio para diferentes agências de avaliação de tecnologia em nível mundial. Esses desafios envolvem desde a definição de uma estrutura específica de análise até a limiares de custo efetividade diferenciados. Ademais, tem-se observado que os custos de terapias inovadoras comumente são elevados, potencialmente afetando a sustentabilidade econômica do SUS. O objetivo deste trabalho foi avaliar os custos dos medicamentos para ultrarraras em submissões para a Conitec. Métodos Os dados foram extraídos dos relatórios de recomendação de tecnologias para tratamento de doenças ultrarraras avaliadas pela Conitec entre 2012 e 2022. Para a classificar a doença como ultrarrara foi utilizado o critério epidemiológico ou uma consulta à plataforma ORPHANET. A proporção de referência foi a de prevalência ≤ a 1/50.000 hab. As variáveis extraídas foram: preços inicial e final; custo de paciente por ano; RCEI e recomendações inicial e final da Conitec. A partir dos custos, foram calculadas as diferenças de preço em relação àquele definido como máximo pela CMED. Resultados Dos 53 relatórios, 30 apresentaram avaliação econômica comparativa de medicamentos. Destes, apenas 13,3% (n=4) tiveram recomendação inicial favorável à incorporação. Além destes, outros oito temas receberam recomendação final favorável, totalizando 40% (n=12). Dois destes, alfacerliponase e nusinersena, se deram após audiência pública. Das outras 10, três foram condicionadas a negociação de preço e uma a Acordo de Compartilhamento de Risco, o onasemnogeno abeparvoveque. Os custos anuais por paciente dos medicamentos incorporados foram bastante variados, assim como o desconto sobre o preço unitário máximo. Com exceção do sirolimo, que tem um custo anual relativamente baixo (R$ 5.234,10), a alfacerliponase teve o menor custo anual (R$ 90.052,56). E onasemnogeno abeparvoveque, o maior (R$ 5.722.712,79). Em geral, os medicamentos incorporados tiveram desconto sobre o preço PMVG entre 25% e 64%, faixa que também pode ser observada entre as tecnologias não incorporadas. Assim também, não necessariamente descontos maiores sobre a RCEI inicial levaram a uma incorporação, como ocorreu com givosirana (31,5%), lanadelumabe (27,6%) e inotersena (17,5%). Discussões e conclusões Apesar de ser relevante na tomada de decisão envolvendo incorporação de tecnologias em saúde, o custo é apenas um dos parâmetros dentre vários outros considerados pela Conitec em suas recomendações. O limiar de custo-efetividade, recentemente definido como um referencial, não contempla doenças ultrarraras, evidenciando a necessidade de se flexibilizar os critérios para a incorporação de tecnologias muitas vezes órfãos e com o potencial de mudar a história natural da doença. Os resultados dessa análise indicam que não necessariamente os medicamentos com custo anual mais baixo ou maiores descontos sobre o preço CMED estiveram relacionados a incorporações. Por outro lado, em casos de maior cautela econômica, foram adotados condicionantes pela Conitec, como o acordo de compartilhamento de risco. Em suma, a presente análise sugere que os custos são um parâmetro importante nas recomendações da Conitec, mas não são considerados de maneira isolada no processo de tomada de decisão.

Introdução A assistência a pacientes com doenças ultrarraras (com prevalência de menos de 1 em cada 50 mil pessoas) no Sistema Único de Saúde (SUS) representa um desafio para a gestão da saúde pública, incluindo a incorporação de tecnologias específicas. O processo de tomada de decisão para a incorporação de novas tecnologias no SUS é coordenado pela Comissão Nacional de Incorporação de Tecnologia no SUS (CONITEC). Além dos requisitos legais e administrativos envolvidos neste processo, há a necessidade de se seguir os princípios organizacionais e constitucionais do SUS, em especial o princípio da participação social, que pode ser alcançada por pacientes e familiares participando de etapas de incorporação como consultas públicas ou de reuniões do processo em que relatam suas experiências. O arcabouço técnico e teórico usado na ATS para a avaliação de tecnologias para doenças ultrarraras tem sido discutido devido à baixa ocorrência das mesmas. Por conta disso, novas propostas vêm sendo discutidas, como a incorporação de parâmetros e características diferentes daquelas utilizadas em análises tradicionais de custo--efetividade, como desfechos de significância para o paciente, em vez de desfechos clínicos. Portanto o objetivo deste estudo foi analisar os dados sobre a Perspectiva individual apresentados nos relatórios de recomendação da CONITEC relacionados às avaliações de tecnologias dirigidas para doenças ultrarraras com o intuito de colaborar com a criação de processos mais equitativos. Métodos Foram analisados 53 relatórios de recomendação avaliadas pela CONITEC de 2012 a 2022. Foram extraídos os seguintes dados: Perspectiva individual (sexo, idade, categoria familia ou paciente, experiência prévia com a tecnologia, tópicos abordados, desfecho relatados como importantes). Resultados Foram identificados 7 registros em 2022. Seis eram participantes do sexo feminino; quatro eram familiares e três pacientes; todos com experiência no uso da tecnologia. Os temas mencionados pelos participantes foram agrupados em: desfechos importantes relatados, relacionados com a tecnologia, e de ordem física ou emocional. Dentre os desfechos importantes estão: a independência para a realização das atividades de vida diária (retirar o casaco sozinha, pentear os cabelos, pegar uma travessa de comida, abrir a porta do micro-ondas, ir à praça). Os desfechos relacionados à tecnologia foram: ser capaz de ingeri-lo sozinha, conseguir abrir o frasco, colocá-lo na seringa. Nos desfechos de ordem física ou emocional destacam-se: melhora na fala e nas funções motoras, sentimento de ser mais forte e segura, diminuição da apneia noturna. Os resultados mostraram uma discrepância entre os desfechos de importância clínica utilizados tradicionalmente pela ATS, com aqueles relatados pelos participantes. Apesar de alguns destes problemas importantes para o usuário serem considerados quando se trata de dados de qualidade de vida, eles nem sempre aparecem como requisitos de tomada de decisão. Discussão e conclusões A avaliação dos desfechos de importância para a pessoa, além dos que já foram utilizados, é necessária para adaptações ao processo de incorporação que visam uma participação social eficaz. As tomadas de decisão baseadas em evidências quantitativas e qualitativas fornecem informações sobre viabilidade, adequação, significado, valores e preferências e aceitabilidade, resultando em um processo de tomada de decisão mais equitativo.

Introdução: O transplante renal (TxR) é a terapia substitutiva renal (TRS) de escolha, visando melhoria de qualidade de vida e redução de morbimortalidade em pacientes com doença renal crônica. A infecção do sítio cirúrgico (ISC) é uma complicação possível após o procedimento de transplante renal, podendo levar a disfunção aguda ou perda do enxerto. Segundo a literatura, as taxas de infecção de sítio cirúrgico em transplantes renais são variáveis. Coortes brasileiras mostram taxas de ISC em TxR em torno de 5%. Objetivo: Avaliar as taxas de incidência de infecção de sítio cirúrgico em transplantes renais realizados no Hospital das Clínicas da Faculdade de Medicina de Botucatu ao longo de 8 anos, entre 2013 e 2020. Identificar tendências e mudanças de tendência na série histórica. Método: Uma coorte retrospectiva avaliou a incidência de infecção de sítio cirúrgico em transplantes renais realizados no Hospital das Clínicas de Botucatu entre janeiro de 2013 e janeiro de 2020, seguindo os critérios diagnósticos da ANVISA, através de revisão de prontuário eletrônico. Foi construída uma série temporal mês a mês a partir das taxas de incidência encontradas. As séries temporais foram analisadas utilizando o software R versão 4.3.2 (R Core Team, 2023) e as mudanças de tendência o software Joinpoint Regression Program, versão 5.1.0.0 (National Cancer Institute, 2024). Resultados: Oitocentas e vinte quatro (824) cirurgias foram avaliadas no período, com 46 infecções detectadas. Observou-se uma taxa média de incidência de infecções de sítio cirúrgico de 5,26% ao mês (0,00-10,00 Q). Uma análise de tendências foi realizada através do teste de Mann-Kendall, sendo possível notar tendência positiva moderada da taxa de incidência de infecções ao longo dos meses (tau = 0,174; p < 0,05). As análises de regressão de Joinpoint não detectaram mudanças de tendência no período estudado. Conclusão: As taxas de infecção de sítio cirúrgico em transplantes renais variaram positivamente no período estudado, denotando tendência de aumento ao longo dos meses. Assim, possíveis fatores de risco para ocorrência de infecção e os procedimentos realizados no serviço devem ser estudados e revistos.

Background. The discard of expanded criteria donor (ECD) kidneys is unacceptably high, considering the growing demand for transplantation. Using machine perfusion may reduce the discard rate, increase the number of transplants, and reduce mortality on the waiting list. Methods. We developed a 5-y Markov model to simulate incorporating the pulsatile perfusion machine into the current government-funded healthcare system. The model compared the universal use of static cold storage for all kidneys with the selective use of machine perfusion for ECD kidneys. Real-life data were used to compose the cohort characteristics in this model. This pharmacoeconomic analysis aimed to determine the cost-effectiveness and budgetary impact of using machine perfusion to preserve ECD kidneys. Results. Compared with the universal use of static cold storage, the use of machine perfusion for ECD kidneys was associated with an increase in the number of kidney transplants (n = 1123), a decrease in the number of patients on the waiting list (n = 815), and decrease in mortality (n = 120), with a cost difference of US dollar 4 486 009 in the period. The budget impact analysis revealed an additional cost of US dollar 4 453 749 >5 y. The budget impact analysis demonstrated a progressive reduction in costs, becoming cost-saving during the last year of the analysis. Conclusions. This stochastic model showed that incorporating machine perfusion for ECD kidneys is most often a dominant or cost-effective technology associated with an increase in the number of transplants and a reduction in the number of patients on the waiting list, reducing mortality on the waiting list.

IntroductionIntegrating technology and active learning methods into Laboratory activities would be a transformative educational experience to familiarize physical therapy (PT) students with STEM backgrounds and STEM-based new technologies. However, PT students struggle with technology and feel comfortable memorizing under expositive lectures. Thus, we described the difficulties, uncertainties, and advances observed by faculties on students and the perceptions about learning, satisfaction, and grades of students after implementing laboratory activities in a PT undergraduate course, which integrated surface-electromyography (sEMG) and kinematic technology combined with active learning methods.MethodsSix cohorts of PT students (n = 482) of a second-year PT course were included. The course had expositive lectures and seven laboratory activities. Students interpreted the evidence and addressed different motor control problems related to daily life movements. The difficulties, uncertainties, and advances observed by faculties on students, as well as the students’ perceptions about learning, satisfaction with the course activities, and grades of students, were described.ResultsThe number of students indicating that the methodology was “always” or “almost always,” promoting creative, analytical, or critical thinking was 70.5% [61.0–88.0%]. Satisfaction with the whole course was 97.0% [93.0–98.0%]. Laboratory grades were linearly associated to course grades with a regression coefficient of 0.53 and 0.43 R-squared (p

Abstract Background Thrombotic Microangiopathy (TMA) is a syndrome characterized by the presence of anemia, thrombocytopenia and organ damage and has multiple etiologies. The primary aim is to develop an algorithm to classify TMA (TMA-INSIGHT score). Methods This was a single-center retrospective cohort study including hospitalized patients with TMA at a single center. We included all consecutive patients diagnosed with TMA between 2012 and 2021. TMA was defined based on the presence of anemia (hemoglobin level

Resumo Introdução: Pesquisas científicas indicam que a espiritualidade desempenha um papel importante na vida da maioria dos pacientes. Além disso, atividades e crenças religiosas podem, de acordo com algumas pesquisa, estar relacionadas à melhor saúde e qualidade de vida1. Objetivo: Este estudo teve como objetivos avaliar o nível de espiritualidade de estudantes de Medicina e de médicos já formados, e analisar o ensino da interface “medicina e espiritualidade” na escola médica. Método: Realizamos um estudo transversal descritivo por meio da aplicação de questionários a estudantes de Medicina e médicos de uma escola médica pública brasileira. Resultado: Avaliaram-se 234 participantes. A maioria acredita em uma força superior. A espiritualidade foi maior entre médicos já formados e entre pessoas do sexo feminino. A maioria acredita que a formação universitária não prepara o médico para abordar o tema com os pacientes. Apesar dessa limitação, a maioria já abordou a espiritualidade com seus pacientes. Conclusão: Médicos e estudantes de Medicina consideram importante contemplar, de maneira ecumênica e respeitosa, aspectos espirituais dos pacientes. Apesar disso, consideram que não receberam preparo suficiente na escola médica para essa abordagem.

This study evaluated the current practices of selecting cold storage preservation solutions in Brazil and their impact on delayed graft function (DGF) incidence and 1-year outcomes in kidney transplant recipients. A retrospective cohort study was conducted, including 3,134 brain-dead deceased donor kidney transplants performed between 2014 and 2015 in 18 Brazilian centers. The most commonly used preservation solution was Euro-collins (EC, 55.4%), followed by Histidine-tryptophan-ketoglutarate (HTK, 30%) and Institut Georges Lopez (IGL-1, 14.6%). The incidence of DGF was 54.4%, with 11.7% of patients requiring dialysis for more than 14 days, indicating prolonged DGF. Upon adjusting for confounding variables, HTK demonstrated a significantly lower risk of DGF than EC (OR 0.7350.82500.926), as did IGL-1 (OR 0.6050.7120.837). Similar protective effects were observed for prolonged DGF when comparing HTK (OR 0.4780.5990.749) and IGL-1 (OR 0.4780.6810.749) against EC. No significant association was found between preservation solutions and 1-year death-censored graft survival. In conclusion, EC was the most frequently used cold storage perfusion solution, demonstrating a higher incidence and duration of DGF compared with HTK and IGL-1, but with no impact on 1-year graft survival.

Objective: to analyze the investigative trends of theses and dissertations on COVID-19 from graduate programs in Nursing in Brazil. Methods: a bibliometric study conducted using the Theses and Dissertations Catalog from the Coordination for the Improvement of Higher Education Personnel, with bibliometric data analysis through IRAMUTEQ. Results: 82 works were selected, with the majority being dissertations (87.8%). They were distributed into six classes: 1) Nursing professionals’ mental health. 2) Pregnant and postpartum women health. 3) Adaptation of care for people in vulnerable situations. 4) Human being and being a nurse: living and facing the virus. 5) Nursing work reorganization, and 6) COVID-19 repercussions for nursing. Conclusion: research is concentrated on nursing working conditions, mental health, and the care workflows reorganization. Contributions to practice: the study brings visibility to the knowledge production in Nursing within the context of the COVID-19 pandemic in Brazil and identifies gaps for future studies.

IntroductionThe combination of tacrolimus/mTORi compared to tacrolimus/mycophenolate (MMF) was shown to be safe in the TRANSFORM trial. For donors with a high KDPI (Kidney Donor Profile Index), however, there are no data to support the effectiveness of this regimen. The main objective of this study was to explore the influence of the KDPI on 12-month renal function (eGFR) in patients receiving mTORi or MMF.MethodsMulticenter cohort study of four Brazilian services that use the tacrolimus with mTORi as a protocol. Data from 2008 to 2018 of the tacrolimus/mycophenolate (MMF) and tacrolimus/mTORi (mTORi) regimens in renal transplant recipients over 18 years old were collected. For better homogeneity, the propensity score was used. Afterward, the method used for group selection (“match”) was the K-nearest neighbor (KNN) method. New analyses were performed on this new balanced sample, and two different subsamples were constituted based on the median KDPI.ResultsThe global analysis (n = 870) showed that the major determinant of worse kidney function was high KDPI. Afterward, the three strata were analyzed. In the first stratum (KDPI up to 50), 242 patients were evaluated, with 121 in each group. The eGFR was 64 ml/min/1.73 m2 in the mTORi group compared to 63 in the MMF group, p = 0.4, and when imputed eGFR was evaluated, 61 in the mTORi and 53 in the MMF, p = 0.065. In the second stratum (KDPI from 50 to 85), 282 patients were evaluated, with 141 in each group. eGFR was 46 ml/min/1.73 m2 in mTORi compared to 48 in MMF, p = 0.4, and when imputed eGFR was evaluated, 40 mTORi and 41 MMF, p = 0.8. In the last stratum (KDPI higher than 85) with n = 126 and 63 cases per group, eGFR was 36 ml/min/1.73 m2 in mTORi compared to 39 in MMF, p = 0.2, and when imputed eGFR was evaluated, 30 mTORi and 34 MMF, p = 0.2.DiscussionThe regimen using mTOR inhibitor is an effective and safe regimen when compared to the standard regimen. In addition, the scheme seems to offer additional protection against infections and may be an important ally in cases of high risk for these pathologies.

Objectives To verify the relationships between sleep duration (Total Sleep Time – TST) and postural control of female night workers before and after shift. As well as, to verify if there is an influence of the body mass index (BMI) on the postural control of these female workers before and after shift.

Abstract Predicting risk factors for death in leptospirosis is challenging, and identifying high-risk patients is crucial as it might expedite the start of life-saving supportive care. Admission data of 295 leptospirosis patients were enrolled, and a machine-learning approach was used to fit models in a derivation cohort. The comparison of accuracy metrics was performed with two previous models—SPIRO score and quick SOFA score. A Lasso regression analysis was the selected model, demonstrating the best accuracy to predict mortality in leptospirosis [area under the curve (AUC-ROC) = 0.776]. A score-based prediction was carried out with the coefficients of this model and named LeptoScore. Then, to simplify the predictive tool, a new score was built by attributing points to the predictors with importance values higher than 1. The simplified score, named QuickLepto, has five variables (age > 40 years; lethargy; pulmonary symptom; mean arterial pressure

Background: The influence of different crystalloid solutions infused during deceased-donor kidney transplant on the incidence of delayed graft function remains unclear. We investigated the influence of Plasma-Lyte.½ vs. 0.9% saline on the incidence of delayed graft function in deceased-donor kidney transplant recipients. Methods: We conducted a single-blind randomized controlled trial of 104 patients aged 18 to 65 years who underwent deceased-donor kidney transplant under general anesthesia. Patients were randomly assigned to receive either Plasma-Lyte.½ (n.ß=.ß52) or 0.9% saline (n.ß=.ß52), at the same infusion volume, for intraoperative fluid replacement. The primary outcome was the occurrence of delayed graft function. Secondary outcomes included metabolic and electrolytic changes at the end of surgery. Results: Two patients in the Plasma-Lyte.½ group and one in the 0.9% saline group died postoperatively and were not included for analysis. The incidence of delayed graft function in Plasma-Lyte.½ and 0.9% saline groups were 60.0% (95% Confidence Interval [95% CI 46.2...72.4]) and 74.5% (95% CI 61.1...84.4), respectively (p.ß=.ß0.140). Mean (standard deviation) values of immediate postoperative pH and serum chloride levels in Plasma-Lyte.½ and 0.9% saline groups were 7.306 (0.071) and 7.273 (0.061) (p.ß=.ß0.013), and 99.6 (4.2) mEq.L-1 and 103.3 (5.6) mEq.L-1, respectively (p.ß.ß0.05). Conclusion: In deceased-donor kidney transplant recipients, the incidence of delayed graft function is not influenced by Plasma-Lyte.½ or 0.9% saline used for intraoperative fluid replacement.

Abstract Background Restriction of sodium intake is routinely recommended for patients with chronic kidney disease (CKD). Whether or not sodium intake is associated with the progression of CKD and mortality remains uncertain. We evaluated the association between urinary sodium excretion (as a surrogate for sodium intake) with the occurrence of renal failure and mortality in patients with non-dialytic CKD. Methods We conducted a retrospective study of patients followed at a CKD clinic care hospital from October 2006 to March 2017. Adult patients with non-dialytic CKD were included. Using a time-to-event analysis, we examined the association of urinary sodium excretion as a categorical variable (categorized as quintiles: 1st quintile: 0.54–2.51 g; 2nd quintile: 2.52–3.11 g, 3rd quintile: 3.12–3.97 g, 4th quintile: 3.98–5.24 g and 5th quintile: 5.26–13.80 g) and the outcomes of interest. The primary outcome was defined as progression to end-stage renal disease requiring any type of renal replacement therapy. The secondary outcome was mortality. Results Two hundred five patients were included in the study (mean follow up of 2.6 years) with a mean eGFR of 26 (19–41) ml/min/1.73m2. 37 patients (18%) required renal replacement therapy and 52 (25,3%) died. There was association between urinary sodium excretion and need for renal replacement therapy (adjusted HR 0.245; 95%CI 0.660–0.912). There was no association between urinary sodium excretion and mortality in adjusted models. Conclusion Moderate sodium intake was associated with a lower risk of renal failure.

ABSTRACT Introduction For the reduction of PTH levels, two classes of drugs are available in the Brazilian market: non-selective and selective vitamin D receptor activators and calcimimetics. Among the mentioned drugs, the SUS provides oral calcitriol, paricalcitol and cinacalcet. Objectives: Develop cost-effectiveness (CE) and budgetary impact (BI) analysis of cinacalcet versus paricalcitol for patients on dialysis with SHPT, from the perspective of SUS. Methodology: A decision tree model was constructed for CE analysis, which considered the outcome of avoided parathyroidectomy and a time horizon of 1 year. As for the BI analysis, two scenarios were considered, one of which was measured demand and other epidemiological, based on data from the Brazilian Society of Nephrology (BSN). Results: The CE analysis showed that the use of cinacalcet results in one-off savings of R$1,394.64 per year and an incremental effectiveness of 0.08, in relation to avoided parathyroidectomy. The incremental CE ratio (ICER) was - R$ 17,653.67 per avoided parathyroidectomy for cinacalcet, as it was more effective and cheaper compared to paricalcitol. As for the BI analysis, it was estimated that the incremental BI with the expansion of the use of cinacalcet in the SUS will be between - R$ 1,640,864.62 and R$ 166,368.50 in the first year, considering the main and the epidemiological scenarios. At the end of 5 years after the expansion of use, an BI was estimated between - R$ 10,740,743.86 and - R$ 1,191,339.37; considering the same scenarios. Conclusion: Cinacalcet was dominant to avoid parathyroidectomies, being cost-effective.

Abstract Fabry disease (FD) is an X-linked inherited disorder caused by mutations in the GLA gene encoding enzyme alpha-galactosidase A (α-Gal A). The purpose of this study was to produce a consensus statement to standardize the recommendations concerning kidney involvement in FD and provide advice on the diagnosis, screening, and treatment of adult and pediatric patients. This consensus document was organized from an initiative led by the Committee for Rare Diseases (Comdora) of the Brazilian Society of Nephrology (SBN). The review considered randomized clinical trials, real-world data studies, and the expertise of its authors. The purpose of this consensus statement is to help manage patient and physician expectations concerning the outcomes of treatment. Our recommendations must be interpreted within the context of available evidence. The decisions pertaining to each individual case must be made with the involvement of patients and their families and take into account not only the potential cost of treatment, but also concurrent conditions and personal preferences. The Comdora intends to update these recommendations regularly so as to reflect recent literature evidence, real-world data, and appreciate the professional experience of those involved. This consensus document establishes clear criteria for the diagnosis of FD and for when to start or stop specific therapies or adjuvant measures, to thus advise the medical community and standardize clinical practice.

ABSTRACT Introduction: Fabry disease (FD) is an inborn error of metabolism characterized by α-galactosidase A deficiency. The primary objective was to evaluate the genetic and phenotypic profile of Fabry disease in hemodialysis. Methods: Observational cohort study to determine the incidence of genetic variations and phenotypic changes for FD in hemodialysis patients in the Paraiba Valley and Eastern São Paulo. Genetic testing for the GLA gene was performed for men and women over 12 years of age at the hemodialysis clinics between January 2016 and December 2019 as a screening protocol. Results: The cases came from screening exams of the index case among patients with chronic kidney disease, resulting in 17 families and totaling 82 patients under study. The classification of the most prevalent variant was that of uncertain significance (54%), followed by the pathogenic variant (46%). Five patients in two families were described with two types of variants not previously described in the literature, with pathogenic behavior. Comparing the types of variants, the presence of a pathogenic variant was associated with higher levels of lysoGB3, lower values for alpha-GAL activity and higher frequency of symptoms related to FD. Conclusion: We characterized an extensive population of patients with FD variants with rich genetic, clinical and biomarker details. We believe that this study can help to better characterize the Brazilian population with FD and the most frequent types of variants.

Abstract Background The range of motion (RoM) of dorsiflexion (DF) plays an important role in human mobility, such as absorption of body weight during gait deceleration, jump landings, balance, and eccentric movements. This limitation can generate potentially damaging movements. This way, evaluating techniques for DF RoM increase could help improve immediate performance in such functional activities. This being the case, the objective of this study will be to verify the sum effect of different joint mobilization techniques for DF gain in persons practicing physical activities and its relationship with functional performance and balance. Methodology This is a randomized, controlled, and blind clinical trial. Fifty-four (54) volunteers will be recruited, aged between 18 and 40 years, who have DF limitations. After checking eligibility criteria, the participants will be submitted to a physiotherapeutic evaluation. A researcher, blind to evaluation and treatment, will perform the randomization of patients in groups: (A) Joint Mobilization - Mulligan Concept and (B) Joint Mobilization - Maitland Method. All volunteers will be submitted by two blind evaluators for randomization and treatment groups. They will realize the initial evaluation (A0), immediately after techniques (A1) and after 3–4 days of the technique application (A2). A different researcher, blind for evaluation, will perform the treatment, according to the randomization group. Discussion It is already known that DF RoM limitation can lead to compensatory and potentially damaging lower limb movements and that joint mobilizations are effective to treatment. However, there is no consensus whether the application of these techniques would also improve aspects of dynamic postural balance and performance in individuals practicing physical activity, and whether the sum of two joint mobilization techniques could enhance this effect. Trial registration Brazilian Registry of Clinical Trials (ReBEC) RBR-93xv9t . Registered on 09 April 2020.

Abstract Acute kidney injury (AKI) is frequently associated with COVID-19 and it is considered an indicator of disease severity. This study aimed to develop a prognostic score for predicting in-hospital mortality in COVID-19 patients with AKI (AKI-COV score). This was a cross-sectional multicentre prospective cohort study in the Latin America AKI COVID-19 Registry. A total of 870 COVID-19 patients with AKI defined according to the KDIGO were included between 1 May 2020 and 31 December 2020. We evaluated four categories of predictor variables that were available at the time of the diagnosis of AKI: (1) demographic data; (2) comorbidities and conditions at admission; (3) laboratory exams within 24 h; and (4) characteristics and causes of AKI. We used a machine learning approach to fit models in the training set using tenfold cross-validation and validated the accuracy using the area under the receiver operating characteristic curve (AUC-ROC). The coefficients of the best model (Elastic Net) were used to build the predictive AKI-COV score. The AKI-COV score had an AUC-ROC of 0.823 (95% CI 0.761–0.885) in the validation cohort. The use of the AKI-COV score may assist healthcare workers in identifying hospitalized COVID-19 patients with AKI that may require more intensive monitoring and can be used for resource allocation.

Purpose – Based on the assumption of the service-dominant logic (S-D logic) that every exchange is service-for-service and on the relevance of the beneficiary’s role in the co-creation of value, this paper aims to investigate the effects of engagement in the context of social marketing, where the value proposition is an invitation to practice mindfulness. Design/methodology/approach – A field experiment was carried out with 72 volunteers, using a pre-test/post-test control group design. The treatment applied was a set of strategies to increase the engagement of the participants to attain a better result in five dependent variables associated mainly with the benefits of mindfulness practice. Measurements were made from a profile analysis, and submitted to Mann-Whitney and t-tests. Findings – A large effect of group and time factors were observed in the multivariate test, as well as differences in the co-creation of value between groups. Originality/value – This study can contribute to stimulate experimental transdisciplinary research in humans, using concepts from S-D logic and social marketing to promote positive behavioral change. This approach is probably more efficient at explaining and improving human behavior, given its complex nature.

Abstract Introduction: Hyperparathyroidism (SHPT) secondary to chronic kidney disease (CKD) is characterized by high levels of parathyroid hormone (PTH), hyperplasia of the parathyroid glands and cardiovascular disease. Selective and non-selective and selective vitamin D-receptor activators, calcimimetics, are available in the Brazilian market to reduce PTH levels. Objectives: To develop a cost-effectiveness (C/E) and budgetary impact (BI) analysis of intravenous paricalcitol vs. oral calcitriol for patients on dialysis with SHPT, from the perspective of the Brazilian Public Health Care System (SUS). Methodology: We built a decision-tree model to analyze C/E, which considered the outcome of avoided death and a time horizon of 1 year. As for the BI analysis, two scenarios were considered, one of demand and one of epidemiological approach, based on data from the Brazilian Society of Nephrology. Results: The analysis showed that the C/E ratio was R$ 1,213.68 per year, and an incremental effectiveness of 0.032, referring to avoided death. The incremental C/E ratio was R$37,927.50 per death averted by paricalcitol. It was estimated that the incremental BI with the expansion of paricalcitol use will be between R$1,600,202.28 and R$4,128,565.65 in the first year, considering the main and epidemiological scenarios. At the end of 5 years after the expansion of its use, an incremental BI was estimated between R$ 48,596,855.50 and R$ 62,90,555.73. Conclusion: Intravenous paricalcitol has superior efficacy and similar safety to oral calcitriol, reducing the overall mortality of dialysis patients, although it implies a higher cost.

Introduction: Obesity is one of the components of the cardiometabolic syndrome that contributes to COVID-19 progression and mortality. Immunosuppressed individuals are at greater risk of the COVID-19 burden. Therefore, we sought to investigate the impact of the combination of overweight/obesity and kidney transplant on oxygen (O2) requirements in the COVID-19 setting. Methods: Retrospective analysis of 284 kidney transplant recipients (KTRs) from March/2020 to August/2020 in a single center. We investigated the risk factors associated with O2 requirements in overweight/obese KTRs. Results: Overall, 65.1% had a BMI (body mass index) ≥ 25 kg/m2, 52.4% were male, the mean age was 53.3 ± 11 years old, 78.4% had hypertension, and 41.1% had diabetes mellitus. BMI was an independent risk factor for O2 requirements (OR = 1.07, p = 0.02) alongside age, lymphopenia, and hyponatremia. When overweight/obese KTRs were older, smokers, they presented higher levels of lactate dehydrogenase (LDH), and lower levels of estimated glomerular filtration rate (eGFR), lymphocytes, and sodium at admission, and they needed O2 more often. Conclusion: Being overweight/obese is associated with greater O2 requirements in KTRs, in particular in older people and smokers, with worse kidney allograft functions, more inflammation, and lower sodium levels. Therefore, the early identification of factors that predict a worse outcome in overweight/obese KTRs affected by COVID-19 contributes to risk stratification and therapeutic decisions.

Abstract Background The objective of this study was to develop a new predictive equation of resting energy expenditure (REE) for acute kidney injury patients (AKI) on dialysis. Materials and methods A cross-sectional descriptive study was carried out of 114 AKI patients, consecutively selected, on dialysis and mechanical ventilation, aged between 19 and 95 years. For construction of the predictive model, 80% of cases were randomly separated to training and 20% of unused cases to validation. Several machine learning models were tested in the training data: linear regression with stepwise, rpart, support vector machine with radial kernel, generalised boosting machine and random forest. The models were selected by ten-fold cross-validation and the performances evaluated by the root mean square error. Results There were 364 indirect calorimetry measurements in 114 patients, mean age of 60.65 ± 16.9 years and 68.4% were males. The average REE was 2081 ± 645 kcal. REE was positively correlated with C-reactive protein, minute volume (MV), expiratory positive airway pressure, serum urea, body mass index and inversely with age. The principal variables included in the selected model were age, body mass index, use of vasopressors, expiratory positive airway pressure, MV, C-reactive protein, temperature and serum urea. The final r-value in the validation set was 0.69. Conclusion We propose a new predictive equation for estimating the REE of AKI patients on dialysis that uses a non-linear approach with better performance than actual models.

Abstract Introduction: The control of metabolic acidosis in dialysis patients focuses on the supply of bicarbonate during the dialysis session, and it is not standard in all hemodialysis to assess serum bicarbonate concentrations. Bicarbonate expressed in blood gas analysis is the most sensitive standard of analysis and it is measured indirectly, using the Henderson-Hasselbalch equation. There are no studies in this population evaluating the concordance between the calculated bicarbonate with the direct method of biochemical analysis. The aim of this study was to analyze the concordance between the measured and calculated serum bicarbonate levels using blood gas analysis. Methods: We analyzed blood samples from chronic kidney patients undergoing hemodialysis, using the same sample of bicarbonate analysis by biochemistry and gasometry. The concordance was assessed using the Bland-Altman method. Results: 51 samples were analyzed. The analysis revealed a high correlation (r = 0.73) and a mean difference (bias) of 1.15 ± 3 mmol/L. The median time between collection and examination was 241 minutes. Discussion: We can conclude that the biochemical bicarbonate analysis compared to that calculated from blood gas analysis in chronic renal patients was consistent. For greater concordance between the data, it is important that the time between the collection of the samples and the referral to the laboratory for carrying out the dosages does not exceed four hours. The serum bicarbonate dosage can result in cost savings when compared to that of bicarbonate in blood gas analysis.

Introduction Low vitamin D levels are associated with mortality in hemodialysis (HD) patients; however, the serum vitamin D thresholds are unclear. This study aimed to identify the vitamin D level below which mortality increases in HD patients. Methods A cohort of HD patients enrolled from January 2014 to January 2017 was evaluated. The variables were analyzed according to the season, namely, summer, winter, and annual average, mortality was the primary outcome. The patients were assigned to vitamin D quintiles, and multivariate Cox regression analysis adjusted for age, ethnicity, gender, body mass index (BMI), inhibitors of the renin-angiotensin system, statin, calcitriol, and antiplatelet drugs use, hemodialysis vintage, hypertension, diabetes mellitus, atherosclerotic disease, and C-reactive protein was performed. Results There were studied 306 patients. Vitamin D levels of 18.0–23.6 ng/mL (hazard ratio [HR] = 4.30; 95% confidence interval [CI] 1.60–11.54, p = 0.004) and 17.7 ng/dL and ≤23.1 ng/dL (adjusted HR = 3.91, 95% CI: 1.47–10.42, p = 0.006). Conclusions Annual average vitamin D levels

Abstract Fabry disease (FD) is a genetic disease, with X-chromosome linked inheritance, due to variants in the GLA gene that encodes the α-galactosidase A (α-GAL) enzyme. The purpose of the present study was to create a consensus aiming to standardize the recommendations regarding the renal involvement of FD with guidelines on the diagnosis, screening, and treatment of pediatric patients. This consensus is an initiative of the Rare Diseases Committee (Comdora) of the Brazilian Society of Nephrology (SBN). Randomized controlled clinical studies and studies with real-life data added to the authors' experience were considered for this review. The result of this consensus was to help manage patient and physician expectations regarding treatment outcomes. Thus, this consensus document recommends the investigation of the pediatric family members of an index case, as well as cases with suggestive clinical signs. From the diagnosis, assess all possible FD impairments and grade through scales. From an extensive review of the literature including pediatric protocols and particularly evaluating pediatric cases from general studies, it can be concluded that the benefits of early treatment are great, especially in terms of neuropathic pain and renal impairment parameters and outweigh the possible adverse effects that were mainly manifested by infusion reactions.

ABSTRACT Objective: to describe the changes implemented in the work environment of nurses in university hospitals considering the COVID-19 pandemic. Methods: this qualitative and descriptive research was developed from an online survey with 75 nurses from three Brazilian university hospitals. Data processing occurred through textual analysis with the aid of software IRAMUTEQ. Results: five semantic classes were obtained: Organization of units for exclusive care of patients with COVID-19; Adaptations in the use of personal protective equipment; Physical structure adaptation; Care flow institution; Increased number of beds and training courses. Final considerations: the results show the effort of healthcare and nursing professionals/managers in the development of structural adaptations and reorganizations of care processes, in the hospital context, to respond with quality and efficiency to the demands arising from the COVID-19 pandemic.

A cana-de-açúcar é a principal cultura agrícola produzida no estado da Paraíba. Sendo o Brejo Paraibano uma região historicamente ligada ao cultivo e beneficiamento dessa lavoura. Nesse sentido, esse estudo objetivou avaliar os aspectos produtivos da cultura da cana-de-açúcar no período de 1995–2019 no município de Areia, região do Brejo Paraibano. Os dados foram obtidos do banco de informações da Pesquisa Agrícola Municipal do Instituto Brasileiro de Geografia e Estatística, do qual sete variáveis foram extraídas: área colhida, área plantada, área plantada - percentual do total geral, quantidade produzida, produtividade, valor da produção e valor da produção - percentual do total geral. Os dados foram tabulados e posteriormente submetidos a análise de componentes principais. A dinâmica produtiva da cana-de-açúcar apresentou elevada variabilidade no período em estudo, reflexo de fortes oscilações nas variáveis produtivas dessa cultura. Observou-se redução temporal da área plantada e colhida, contudo a quantidade produzida não apresentou quedas acentuadas, pelo contrário, em diversos anos foi superior ao início do período amostral. Aumento da produtividade dessa cultura também foi registrado, bem como maior participação no valor total da produção das lavouras temporárias plantadas no município. A análise de componentes principais registrou 75.8% de explicação da variância original dos dados em seus dois primeiros eixos e evidenciou que anos com menor área plantada e colhida apresentaram maior produtividade para essa cultura em Areia. Diante da importância do setor canavieiro para a economia do município em estudo, estratégias de melhoria produtiva dessa cultura devem ser incentivadas e implementadas localmente.