Validation of a histologic scoring index for C3 glomerulopathy

12 p.-4 fig.-4 tab.Rationale & objective: A previous study that evaluated associations of kidney biopsy findings with disease progression in patients with C3 glomerulopathy (C3G) proposed a prognostic histologic index (C3G-HI) that has not yet been validated. Our objective was to validate the performance of the C3G-HI in a new patient population.Study design: Multicenter, retrospective cohort study.Setting & participants: 111 patients fulfilling diagnostic criteria of C3G between January 1995 and December 2019, from 33 nephrology departments belonging to the Spanish Group for the Study of Glomerular Diseases (GLOSEN).Predictors: Demographic, clinical parameters, C3G-HI total activity score, and the C3G-HI total chronicity score.Outcome: Time to kidney failure.Analytical approach: Intraclass correlation coefficients and κ statistic were used to summarize inter-rater reproducibility for assessment of histopathology in kidney biopsies. The nonlinear relationships of risk of kidney failure with the total activity score and total chronicity score were modeled using Cox proportional hazards analysis that incorporated cubic splines.Results: The study group included 93 patients with C3 glomerulonephritis and 18 with dense-deposit disease. Participants had an overall meanage of 35±22 (SD) years. Forty-eight patients (43%) developed kidney failure after a mean follow-up of 65±27 months. The overall inter-rater reproducibility was very good for the total activity score (intraclass correlation coefficient [ICC]=0.63) and excellent for total chronicity score (ICC=0.89). Baseline estimated glomerular filtration rate (eGFR), 24-hour proteinuria, and treatment with immunosuppression were the main determinants of kidney failure in a model with only clinical variables. Only tubular atrophy and interstitial fibrosis were identified as predictors in a model with histological variables. When the total activity score and total chronicity score were added to the model, only the latter was identified as an independent predictor of kidney failure.Limitations: Only a subset of the kidney biopsies was centrally reviewed. Residual confounding.Conclusions: We validated the performance of C3G-HI as a predictor of kidney failure in patients with C3G. The total chronicity score was the principal histologic correlate of kidney failure.Work in this study was supported by the Instituto de Salud Carlos III /Fondo Europeo de Desarrollo Regional (ISCIII/FEDER) grant PI16/01685 and Red de Investigación Renal (RedInRen) (RD12/0021/0029) (to MP), the Autonomous Region of Madrid (S2017/BMD-3673) (to MP); EGdeJ is supported by the Spanish “Ministerio de Ciencia, Innovación y Universidades" (RYC-2013-13395 and RTI2018-095955-B-100).Peer reviewe

Longitudinal change in proteinuria and kidney outcomes in C3 glomerulopathy

11 p.-4 fig.-4 tab.Introduction: The association between a change in proteinuria over time and its impact in kidney prognosis has not been analyzed in C3 glomerulopathy. This study aims to investigate the association between the longitudinal change in proteinuria and the risk of kidney failure.Methods: Retrospective, multicenter observational cohort study in 35 nephrology departments belonging to the Spanish Group for the Study of Glomerular Diseases (GLOSEN). Patients diagnosed with C3 glomerulopathy between 1995 and 2020 were enrolled. A joint modeling of linear mixed-effects models was applied to assess the underlying trajectory of a repeatedly measured proteinuria, and a Cox model to evaluate the association of this trajectory with the risk of kidney failure.Results: The study group consisted of 85 patients, 70 C3 glomerulonephritis and 15 dense deposit disease, with a median age of 26 years (range 13-41). During a median follow-up of 42 months, 25 patients reached kidney failure. The longitudinal change in proteinuria showed a strong association with the risk of this outcome, with a doubling of proteinuria levels resulting in a 2.5-fold increase of the risk. A second model showed that a ≥ 50% proteinuria reduction over time was significantly associated with a lower risk of kidney failure (HR: 0.79; 95% CI : 0.56-0.97; p < 0.001). This association was also found when the ≥50% proteinuria reduction was observed within the first 6 and 12 months of follow-up.Conclusion: The longitudinal change in proteinuria is strongly associated with the risk of kidney failure. The change in proteinuria over time can provide clinicians a dynamic prediction of kidney outcomes.This study was supported by the Instituto de Salud Carlos III/Fondo Europeo de Desarrollo Regional (ISCIII/FEDER) grant PI16/01685 and PI19/1624, and Red de Investigación Renal (RedInRen) (RD12/0021/0029) (to M.P.), the Autonomous Region of Madrid (S2017/BMD-3673) (to M.P.); E.G.d.J. was supported by the Spanish ‘Ministerio de Ciencia, Innovación y Universidades’ (RYC-2013-13395 and RTI2018-095955-B-100); S.R.d.C. was supported by Ministerio de Economía y Competitividad/FEDER grant SAF2015-66287R and Autonomous Region of Madrid grant S2017/BMD3673.Peer reviewe

Implementação da reforma sanitária: a formação de uma política Health reform implementation and policy formation

Este artigo procura interpretar o processo de implementação da reforma do sistema de saúde ocorrida na década de 1990. A implantação de uma política é dotada de autonomia e envolve decisões, além de ser um processo de adaptação em função das mudanças do contexto, portanto, sua implementação exige decisão e iniciativa governamental, e instrumentos para efetivá-la, entre os quais a disponibilidade de recursos financeiros e o suporte político organizado, particularmente, por parte dos grupos sociais afetados positivamente. O processo de implementação da reforma da política de saúde não é simplesmente a tradução concreta de decisões, mas um processo ainda de formulação da política de saúde. Durante esse processo, tiveram grande importância não apenas os efeitos do contexto político-econômico de ajustes e a reconfiguração da agenda pública, mas principalmente os efeitos de feedback das políticas de saúde anteriores, que se traduziram na ausência de suporte político, no subfinanciamento e na incapacidade de publicização da rede de serviços, os quais funcionaram como constrangimentos à implementação completa da reforma nos termos de seus formuladores. Dentro desses limites, foram tomadas decisões cruciais que redefiniram a reforma, sendo as mais significativas o estabelecimento do marco regulatório da assistência privada, que explicita a segmentação e derruba formalmente as pretensões universalistas, e as relacionada ao financiamento, que ainda configurava objeto de disputa. O resultado foi a consolidação de um sistema de saúde dual - público e privado.<br>This paper analyses the process of implementation of the health system reform in the 1990s. The starting point is the proposition that policy implementation is endowed with autonomy and involves decisions, apart from being a process of adaptation to changes in context; implementation requires governmental decision and initiative and tools to make it effective, among them the availability of financial resources and organized political support, especially from those groups that benefit more directly. The process of implementation of the health system reform was not simply a concrete translation of decisions, but also a process of health policy design. In it, the effects not only of adjustments in the political and economic contexts and of the reconfiguration of the public agenda, but mainly the feedback effects of previous health policies could be felt. The latter translated themselves into the absence of political support, underfinancing and the incapacity to create a public network of services. They acted as constraints to the full implementation of the reform, as it was conceived by its formulators. Within these limits, crucial decisions were made, which redefined the reform, the most important being, on the one hand, the creation of a regulatory framework for private assistance that made the segmentation explicit, formally abandoning any universalistic intent, and, on the other hand, those related to financing, which still are an object of dispute. The result is the consolidation of a dualistic health system - public and private

Política, atores e interesses no processo de mudança institucional: a criação do Ministério da Saúde em 1953 Politics, actors, and interests in the process of institutional change: the creation of the Brazilian Ministry of Health in 1953

Este trabalho analisa a criação do Ministério da Saúde, em 1953, por meio da identificação dos principais agentes envolvidos, seus interesses e estratégias utilizadas para atingir seus objetivos e influenciar o processo de mudança institucional. Relacionando este processo às características particulares do contexto político da época, identificaremos, entre as arenas de decisão, aquela que ganhou relevância; apresentaremos as variáveis políticas que interferiram no surgimento dessa nova agência estatal autônoma para a saúde pública.<br>This analysis of the 1953 creation of the Ministry of Health identifies the main actors involved, their interests, and the strategies they employed to reach their goals and influence the process of institutional change. Placing the process within the context of the era's specific political characteristics, the article identifies the predominant decision-making arena as well as the political variables that influenced the emergence of this new, autonomous government agency for public health