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O artigo pretende retomar a importância do exercício do controle social democrático de políticas públicas, problematizando o seu alcance em um Estado capitalista, autoritário e conservador, a fim de estimular processos participativos no âmbito das políticas sociais, que simultaneamente lutem pela ampliação de direitos sociais na perspectiva emancipatória e ampliem a consciência coletiva e a organização popular. Primeiramente, apresenta-se uma visão das políticas públicas no contexto atual, posteriormente os desafios para o exercício do controle social democrático, finalizando com a indicação de algumas possibilidades estratégicas para a sua efetivação

Este trabalho realiza uma reflexão sobre a ação profissional realizada no Sistema Único de Assistência Social (SUAS) a partir de três eixos: os espaços sócio-ocupacionais, os procedimentos usados e o desenvolvimento da autonomia dos usuários. Inicia com uma apresentação da pesquisa sobre seus participantes. Usa dados empíricos obtidos com a aplicação de questionários, realização de entrevistas e discussão realizada em um workshop com alguns assistentes sociais que participaram nos momentos anteriores da pesquisa. Evidencia um período de transição da política, o qual produz novas possibilidades para a ação profissional, porém sem romper com os limites concretos de sua inserção em um modelo neoliberal. Problematiza o CRAS como lócus contraditório que pode favorecer o desenvolvimento de uma autonomia conservadora ou a descoberta de uma consciência de classe direcionada para a busca de uma sociedade justa, democrática e igualitária

A Constituição Federal de 1988, ao propor a criação de espaços de participação popular, buscou garantir a construção de políticas sociais públicas que atendam aos interesses da população e ao exercício do controle social. Este artigo apresenta reflexões acerca do controle social, na Política de Assistência Social, afirmando que este deve ser compreendido como um eixo que deve mover desde a sua construção, passando pela execução, e se expressando de forma mais objetiva na fiscalização e avaliação, que permanentemente devem acompanhar todas as ações, garantindo a participação da sociedade civil e, em especial, dos usuários da política, evitando, assim, que o Sistema Único de Assistência Social – SUAS – se materialize em um novo sistema que conserva a velha marca da subalternidade dos usuários dos serviços sócio-assistenciais

Background Various definitions used to describe cisplatin nephrotoxicity potentially lead to differences in determination of risk factors. This study evaluated incidence of kidney injury according to commonly used and alternative definitions in two cohorts of children who received cisplatin. Methods This retrospective cohort study included children from Vancouver, Canada (one center), and Mexico City, Mexico (two centers), treated with cisplatin for a variety of solid tumors. Serum creatinine-based definitions (KDIGO and Pediatric RIFLE (pRIFLE)), electrolyte abnormalities consisted of hypokalemia, hypophosphatemia and hypomagnesemia (based on NCI-CTCAE v5), and an alternative definition (Alt-AKI) were used to describe nephrotoxicity. Incidence with different definitions, definitional overlap, and inter-definition reliability was analyzed. Results In total, 173 children (100 from Vancouver, 73 from Mexico) were included. In the combined cohort, Alt-AKI criteria detected more patients with cisplatin nephrotoxicity compared to pRIFLE and KDIGO criteria (82.7 vs. 63.6 vs. 44.5%, respectively). Nephrotoxicity and all electrolyte abnormalities were significantly more common in Vancouver cohort than in Mexico City cohort except when using KDIGO definition. The most common electrolyte abnormalities were hypomagnesemia (88.9%, Vancouver) and hypophosphatemia (24.2%, Mexico City). The KDIGO definition provided highest overlap of cases in Vancouver (100%), Mexico (98.6%), and the combined cohort (99.4%). Moderate overall agreement was found among Alt-AKI, KDIGO, and pRIFLE definitions ([kappa] = 0.18, 95% CI 0.1-0.27) in which KDIGO and pRIFLE showed moderate agreement ([kappa] = 0.48, 95% CI 0.36-0.60). Conclusions Compared to pRIFLE and KDIGO criteria, Alt-AKI criteria detected more patients with cisplatin nephrotoxicity. pRIFLE is more sensitive to detect not only actual kidney injury but also patients at risk of cisplatin nephrotoxicity, while KDIGO seems more useful to detect clinically significant kidney injury. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information., Author(s): Zulfan Zazuli [sup.1] [sup.2] , Catharina J. P. Op 't Hoog [sup.3] , Susanne J. H. Vijverberg [sup.1] , Rosalinde Masereeuw [sup.3] , Shahrad Rod Rassekh [sup.4] , Mara [...]

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A study published in the Clinical Kidney Journal examined different formulae for estimating glomerular filtration rate (GFR) in young adults. The study found that the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula performed worse than the Lund-Malmö Revised (LMR) and European Kidney Function Consortium (EKFC) equations. The EKFC formula was recommended as a more accurate option for estimating GFR in young adults. However, further research is needed to develop precise and reliable methods for estimating GFR, including the use of additional biomarkers and the consideration of factors such as body weight and age. [Extracted from the article]

BackgroundDevelopment of noninvasive molecular assays to improve disease diagnosis and patient monitoring is a critical need. In renal transplantation, acute rejection (AR) increases the risk for chronic graft injury and failure. Noninvasive diagnostic assays to improve current late and nonspecific diagnosis of rejection are needed. We sought to develop a test using a simple blood gene expression assay to detect patients at high risk for AR.Methods and findingsWe developed a novel correlation-based algorithm by step-wise analysis of gene expression data in 558 blood samples from 436 renal transplant patients collected across eight transplant centers in the US, Mexico, and Spain between 5 February 2005 and 15 December 2012 in the Assessment of Acute Rejection in Renal Transplantation (AART) study. Gene expression was assessed by quantitative real-time PCR (QPCR) in one center. A 17-gene set--the Kidney Solid Organ Response Test (kSORT)--was selected in 143 samples for AR classification using discriminant analysis (area under the receiver operating characteristic curve [AUC] = 0.94; 95% CI 0.91-0.98), validated in 124 independent samples (AUC = 0.95; 95% CI 0.88-1.0) and evaluated for AR prediction in 191 serial samples, where it predicted AR up to 3 mo prior to detection by the current gold standard (biopsy). A novel reference-based algorithm (using 13 12-gene models) was developed in 100 independent samples to provide a numerical AR risk score, to classify patients as high risk versus low risk for AR. kSORT was able to detect AR in blood independent of age, time post-transplantation, and sample source without additional data normalization; AUC = 0.93 (95% CI 0.86-0.99). Further validation of kSORT is planned in prospective clinical observational and interventional trials.ConclusionsThe kSORT blood QPCR assay is a noninvasive tool to detect high risk of AR of renal transplants. Please see later in the article for the Editors' Summary.

Immunosuppressive drugs for solid organ transplantation are critical dose drugs with a narrow therapeutic index. Many of the most commonly used innovator drugs are off patent and have been replicated by generic counterparts, often at substantial cost-savings to the patient. However, serious adverse events caused by the transition from innovator to generic medications, specifically in pediatric solid organ transplant recipients, have questioned these autosubstitutions. The purpose of this review is to summarize the criteria set forth by the regulatory bodies, and to examine how major immunosuppressive drugs conform to these recommendations. Regulatory bodies have established inconsistent criteria to demonstrate bioequivalence between innovator and generic medications, causing approved generic variations to have varying levels of equivalence with the innovator drugs. In order to minimize the risk for under-immunosuppression, the following recommendations have been concluded. Brand prescribing of cyclosporine and tacrolimus are recommended due to evidence of adverse events after conversion to generic formulations and differences in dissolution parameters. Mycophenolate mofetil (MMF) shows better bioequivalence between innovator and generic formulations, however caution should be advised when switching between formulations. The institution of 'innovator only' policies may be appropriate at this time in order to minimize the risk of under-immunosuppressing patients until the evidence of more stringent bioequivalence has been established., Author(s): Mara Medeiros [sup.1] [sup.2] , Julia Lumini [sup.3] , Noah Stern [sup.4] , Gilberto Castañeda-Hernández [sup.5] , Guido Filler [sup.4] [sup.6] [sup.7] [sup.8] Author Affiliations: (Aff1) 0000 0004 0633 [...]

We have reviewed current evidence on the therapeutic drug monitoring (TDM) of mycophenolic acid (MPA) in relationship to drug efficacy and safety. The relationship between actual MPA exposure and mycophenolate mofetil (MMF) dose has been shown to be weak in children and adolescents. The TDM of MPA exposure should ideally be performed using full pharmacokinetic profiles or limited sampling strategies. Recent evidence has provided some rationale for using the post-dose trough level as a single measure. In terms of short-term efficacy, there is strong evidence that a MPA area under the time-concentration curve of >30 mg x h/L reduces acute rejection episodes early after renal transplantation, and there is evolving evidence that aiming for the same exposure over the long term may be a viable strategy to reduce the formation of donor-specific antibodies. Strong evidence also supports the existence of important drug interactions and age/developmental dependent differences in drug metabolism that may necessitate the need for TDM of MMF therapy. Based on these findings and given the substantial inter- and intra-patient variability of MPA exposure, it would appear that MMF therapy should be subject to TDM to avoid over- and under-dosing. This may be a viable strategy to reduce treatment-emergent adverse events and to increase the effective pediatric transplant survival rates., Author(s): Guido Filler[sup.1] [sup.2] [sup.3] [sup.7] , Ana Catalina Alvarez-Elias[sup.1] [sup.4] [sup.5] , Christopher McIntyre[sup.3] , Mara Medeiros[sup.5] [sup.6] Author Affiliations: (1) Department of Pediatrics, Schulich School of Medicine & [...]