Chronic Kidney Disease: The Complex History of the Organization of Long-Term Care and Bioethics. Why Now, More Than Ever, Action is Needed.

Chronic kidney disease (CKD) has been redefined in the new millennium as any alteration of kidney morphology, function, blood, or urine composition lasting for at least 3 months. This broad definition also encompasses diseases or conditions that are associated with normal kidney function, such as a kidney scarring from an acute pyelonephritis episode or a single kidney, as a result of kidney donation. CKD is a relevant public health problem. According to the 2015 Global Burden of Disease Study, it was the 12th leading cause of death, leading to 1.1 million deaths, worldwide, each year. The role of CKD as a cause of death is evident where renal replacement therapy (RRT) is not available, however, its role in increasing death risk is not easily calculated. RRT consumes about 3⁻5% of the global healthcare budget where dialysis is available without restrictions. While the prevalence of CKD is increasing overall as lifespans extend, being linked to diabetes, hypertension, obesity, and atherosclerosis, CKD is at least partly preventable and its effects may be at least partly counterbalanced by early and appropriate care. We will welcome papers on all aspects of CKD, including organization, cost, and models of care. Papers from developing countries will be particularly welcomed.

Secretários Municipais de Saúde: o SUS visto pela ponta da corda / Municipal Secretaries of health - SUS seen by the end of the rope

Após vinte e quatro anos, o Sistema Único de Saúde brasileiro consagra-se por uma consolidação na assistência, acesso e na qualidade de serviços para a sociedade, principalmente nas esferas estaduais e municipais. Os modelos organizativos ajudaram a construir uma base, que já se encontra desgastado e carente de uma reestruturação, principalmente no âmbito da organização do Sistema, através de uma revisão das atribuições de cada ente participativo e do repasse de recursos, equilibrados pela necessidade municipal, invertendo o processo verticalização do Sistema. Outro ponto abordado foi a necessidade de incorporar um perfil profissional dos gestores municipais de saúde, peça fundamental do SUS, que assume um cargo político com responsabilidade técnica e administrativa e que hoje segura a ponta da corda em um eterno cabo de guerra contra o Estado e a União. Foi realizada como metodologia uma análise descritiva qualitativa e quantitativa da literatura e do cenário das políticas públicas em saúde, abordando os antecedentes históricos do SUS, o modelo atual das Políticas públicas de Saúde e do Sistema, no âmbito federal, estadual e municipal respectivamente, o perfil dos municípios brasileiros, assim como dos gestores municipais que organizam e controlam o Sistema na ponta mais difícil, a que se defronta com a real necessidade e com o próprio usuário do Sistema, e por fim proposto um novo modelo reestruturante do SUS, com caráter mais municipalista, atingindo uma questão primordial: O equilíbrio organizativo, financeiro e gestor do Sistema Único de saúde...

After twenty and four years the Brazilian health consecrated by a consolidation assistance, access and quality of service to society, especially in state and municipal level. Organizational models helped to build a base, which is already worn out and in need of restructuring, particularly in the organization of the system, through a review of the responsibilities of each participating entity and the transfer of resources, balanced by the need municipal , reversing the process of up righting system . Another point raised was the need to incorporate a professional profile of local health managers , keystone SUS , assuming political office with administrative and technical responsibility and today holds the end of the rope in an eternal tug of war against the state and Union was conducted as a descriptive analysis methodology qualitative and quantitative literature and landscape of public health policies , addressing the historical background of the SUS , the current model of public Policy and Health System , at the federal , state and municipal respectively the profile of municipalities , as well as municipal managers who organize and control the system in tip harder , which faces the real need and the proper user of the system, and finally proposed a new model of restorative SUS with a more municipalist reaching a primary issue : balancing organizational, financial and Manager of the Unified health...

Secretários Municipais de Saúde: o SUS visto pela ponta da corda / Municipal Secretaries of health - SUS seen by the end of the rope

Após vinte e quatro anos, o Sistema Único de Saúde brasileiro consagra-se por uma consolidação na assistência, acesso e na qualidade de serviços para a sociedade, principalmente nas esferas estaduais e municipais. Os modelos organizativos ajudaram a construir uma base, que já se encontra desgastado e carente de uma reestruturação, principalmente no âmbito da organização do Sistema, através de uma revisão das atribuições de cada ente participativo e do repasse de recursos, equilibrados pela necessidade municipal, invertendo o processo verticalização do Sistema. Outro ponto abordado foi a necessidade de incorporar um perfil profissional dos gestores municipais de saúde, peça fundamental do SUS, que assume um cargo político com responsabilidade técnica e administrativa e que hoje segura a ponta da corda em um eterno cabo de guerra contra o Estado e a União. Foi realizada como metodologia uma análise descritiva qualitativa e quantitativa da literatura e do cenário das políticas públicas em saúde, abordando os antecedentes históricos do SUS, o modelo atual das Políticas públicas de Saúde e do Sistema, no âmbito federal, estadual e municipal respectivamente, o perfil dos municípios brasileiros, assim como dos gestores municipais que organizam e controlam o Sistema na ponta mais difícil, a que se defronta com a real necessidade e com o próprio usuário do Sistema, e por fim proposto um novo modelo reestruturante do SUS, com caráter mais municipalista, atingindo uma questão primordial: O equilíbrio organizativo, financeiro e gestor do Sistema Único de saúde.

After twenty and four years the Brazilian health consecrated by a consolidation assistance, access and quality of service to society, especially in state and municipal level. Organizational models helped to build a base, which is already worn out and in need of restructuring, particularly in the organization of the system, through a review of the responsibilities of each participating entity and the transfer of resources, balanced by the need municipal , reversing the process of up righting system . Another point raised was the need to incorporate a professional profile of local health managers , keystone SUS , assuming political office with administrative and technical responsibility and today holds the end of the rope in an eternal tug of war against the state and Union was conducted as a descriptive analysis methodology qualitative and quantitative literature and landscape of public health policies , addressing the historical background of the SUS , the current model of public Policy and Health System , at the federal , state and municipal respectively the profile of municipalities , as well as municipal managers who organize and control the system in tip harder , which faces the real need and the proper user of the system, and finally proposed a new model of restorative SUS with a more municipalist reaching a primary issue : balancing organizational, financial and Manager of the Unified health.

Uma estratégia de desenvolvimento para o sistema nacional de inovação de produtos médicos / A strategy for the development of the medical devices national innovation system

O presente trabalho apresenta a proposta de um Programa para o desenvolvimento do Sistema Nacional de Inovação de Produtos Médicos  –   SNIPM no âmbito do Sistema Único de Saúde  – SUS, de forma integrada e alinhada com as ações do Ministério da Saúde. Os conhecimentos e as ferramentas em engenharia clínica permitiram realizar uma análise diferenciada do contexto socioeconômico do setor, a sistematização e a percepção dos fatores e atores que induzem ou retardam o crescimento tecnológico do setor. Neste artigo, buscou-se contextualizar o setor de produtos médicos no Brasil à luz da atual conjuntura socioeconômica nacional e mundial, caracterizando-o como de grande indutor de atividades inovadoras. Posteriormente, são abordadas as definições e teorias sobre os Sistemas Nacionais de Inovação e as especificidades do SNIPM no Brasil, apresentando seus atores incluindo suas atribuições e competências. A metodologia utilizada para a coleta e análises de dados econômicos é apresentada, de modo a caracterizar a importância deste segmento para a economia nacional e suas potencialidades na indução do surgimento de tecnologias inovadoras no SNIPM. A análise dos dados setoriais coletados durante a pesquisa é apresentada, como o objetivo de quantificar e apresentar os números socioeconômicos do setor de produtos. Por fim, é apresentado o delineamento de um Programa destinado acatalisar o desenvolvimento do SNIPM considerando as demandas tecnológicas e prioridades do SUS e as dos mercados-alvo do setor produtivo. A proposta, que foi desenvolvida e implementada no Ministério da Saúde, pode se constituir como uma das ferramentas no âmbito do SUS destinadas a fortalecer e modernizar o setor de equipamentos e materiais de uso em saúde, visando à ampliação da capacidade inovadora das empresas e mudança do seu patamar competitivo.

This paper presents a proposal of a program for the development of the Brazilian National Innovation System for Medical Products  (SNIPM) under the National Health System  (SUS) integrated and aligned with the actions of the Brazilian Ministry of Health. Clinical engineering knowledge and tools allowed performing a differentiated socio-economic analysis of the sector, the systematization and the perception of actors and factors that induce or retard the growth of the technology sector. In this article, the medical devices sector in Brazil was first contextualized to in the light of current national and global socio-economic conjuncture, in order to characterize it as a major inducer of innovative activities. The definitions and theories about the National Innovation Systems are described, followed by a discussion of the specifics of SNIPM in Brazil, with its actors, including their duties and responsibilities. The methodology for the collection and analysis of economic data, were shown, in order to characterize the importance of this sector to the national economy and its potential to induce the rising of innovative technologies whithin the SNIPM. The analysis of industry data is presented, which attempts to present and comment on some industry data collected during a survey. In the Results section, it is presented the design of a program used to to catalyze the development of the SNIPM considering the technological demands and priorities of the SUS and the target markets of the productive sector. The proposed program, which was developed and implemented within the Brazilian Ministry of Health, can become one of the tools within the SUS to strengthen and modernize the sector of medical equipments and materials, aiming to increase the innovative capacity of firms and change its competitive standing.

Strategic planning as a tool for achieving alignment in academic health centers.

After the passage of the Patient Protection and Affordable Care Act in March 2010, there is an urgent need for medical schools, teaching hospitals, and practice plans to work together seamlessly across a common mission. Although there is agreement that there should be greater coordination of initiatives and resources, there is little guidance in the literature to address the method to achieve the necessary transformation. Traditional approaches to strategic planning often engage a few leaders and produce a set of immeasurable initiatives. A nontraditional approach, consisting of a Whole-Scale (Dannemiller Tyson Associates, Ann Arbor, MI) engagement, appreciative inquiry, and a balanced scorecard can, more rapidly transform an academic health center. Using this nontraditional approach to strategic planning, increased organizational awareness was achieved in a single academic health center. Strategic planning can be an effective tool to achieve alignment, enhance accountability, and a first step in meeting the demands of the new landscape of healthcare.

Pediatric hospital medicine: a strategic planning roundtable to chart the future.

Given the growing field of Pediatric Hospital Medicine (PHM) and the need to define strategic direction, the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association sponsored a roundtable to discuss the future of the field. Twenty-one leaders were invited plus a facilitator utilizing established health care strategic planning methods. A "vision statement" was developed. Specific initiatives in 4 domains (clinical practice, quality of care, research, and workforce) were identified that would advance PHM with a plan to complete each initiative. Review of the current issues demonstrated gaps between the current state of affairs and the full vision of the potential impact of PHM. Clinical initiatives were to develop an educational plan supporting the PHM Core Competencies and a clinical practice monitoring dashboard template. Quality initiatives included an environmental assessment of PHM participation on key committees, societies, and agencies to ensure appropriate PHM representation. Three QI collaboratives are underway. A Research Leadership Task Force was created and the Pediatric Research in Inpatient Settings (PRIS) network was refocused, defining a strategic framework for PRIS, and developing a funding strategy. Workforce initiatives were to develop a descriptive statement that can be used by any PHM physician, a communications tool describing "value added" of PHM; and a tool to assess career satisfaction among PHM physicians. We believe the Roundtable was successful in describing the current state of PHM and laying a course for the near future.

Japanese Alzheimer's Disease Neuroimaging Initiative: present status and future.

Japanese Alzheimer's Disease Neuroimaging Initiative (J-ADNI) was launched in 2008, aiming at conducting a longitudinal workup of a standardized neuroimaging, biomarker and clinico-psychological surveys. The research protocol was designed to maximize compatibility with that of US-ADNI, including structural magnetic resonance imaging analysis for the evaluation of brain atrophy, fluorodeoxyglucose and amyloid positron emission tomography, cerebrospinal fluid sampling, APOE genotyping, together with a set of clinical and psychometric tests that were prepared to achieve the highest compatibility to those used in the United States. Japanese ADNI has recruited approximately 357 participants (142 amnestic mild cognitive impairment, approximately 134 normal aged and 72 mild Alzheimer's disease (AD), as of April 15, 2010). World-wide ADNI activities will establish the rigorous quantitative descriptions of the natural course of AD in its very early stages. The data, as well as the methodologies and infrastructures, will facilitate the clinical trials of disease-modifying therapies for AD using surrogate biomarkers.

The Personalized Medicine Coalition: goals and strategies.

The concept of personalized medicine--that medical care can be tailored to the genomic and molecular profile of the individual--has repercussions that extend far beyond the technology that makes it possible. The adoption of personalized medicine will require changes in healthcare infrastructure, diagnostics and therapeutics business models, reimbursement policy from government and private payers, and a different approach to regulatory oversight. Personalized medicine will shift medical practices upstream from the reactive treatment of disease, to proactive healthcare management including screening, early treatment, and prevention, and will alter the roles of both physician and patient. It will create a greater reliance on electronic medical records and decision support systems in an industry that has a long history of resistance to information technology. Personalized medicine requires a systems approach to implementation. But in a healthcare economy that is highly decentralized and market driven, it is incumbent upon the stakeholders themselves to advocate for a consistent set of policies and legislation that pave the way for the adoption of personalized medicine. To address this need, the Personalized Medicine Coalition (PMC) was formed as a nonprofit umbrella organization of pharmaceutical, biotechnology, diagnostic, and information technology companies, healthcare providers and payers, patient advocacy groups, industry policy organizations, major academic institutions, and government agencies. The PMC provides a structure for achieving consensus positions among these stakeholders on crucial public policy issues, a role which will be vital to translating personalized medicine into widespread clinical practice. In this article, we outline the goals of the PMC, and the strategies it will take to foster communication, debate, and consensus on issues such as genetic discrimination, the reimbursement structures for pharmacogenomic drugs and diagnostics, regulation, physician training and medical school curricula, and public education.