Introdução: Amplo debate tem associado a incorporação de novas tecnologias para a saúde com os custos crescentes dos sistemas de saúde. Face à dúvidas \"se as novas tecnologias são parte do problema, parte da solução ou as duas coisas\" relativamente à saúde da população e do sistema de saúde, este estudo de caso analisa a incorporação de três inovações no Instituto do Coração, InCor-HC/FMUSP, visando elaborar quais fatores influenciaram a decisão de adoção e exemplificar as metodologias de avaliação de novo medicamento, de procedimento diagnóstico e intervenção cirúrgica. A avaliação das tecnologias para a saúde, ATS, pode auxiliar a constituir algumas propostas de respostas. Metodologia: estudo qualitativo empírico em caso retrospectivo de incorporação de três inovações para assistência de alta complexidade em cardiologia. As metodologias utilizadas consistiram em entrevistas aos tomadores de decisão, revisões sistemáticas da literatura relevante, descritiva ou meta-analítica, e análise de impacto econômico hospitalar. Resultados: O padrão do InCor para a incorporação das inovações funciona como um sistema social criativo, sob uma estratégia prática pluralista, ou seja, utilizam as pesquisas, aprovadas pela Comissão de Ética e Pesquisa do InCor e do HC, que se sucederam e que sucedem em incrementos, verificando e ajustando as informações segundo os resultados obtidos para desenhar novas pesquisas. Os atores construíram conhecimentos e negociaram protocolos de pesquisa, promoveram a capacitação de super-especialistas técnicos, transferindo práticas internacionais e gerando conhecimentos adaptados à realidade do Brasil. A avaliação do medicamento tacrolimus demonstra que se poderia resgatar uma média de 75% das rejeições refratárias às terapias convencionais, proporcionando um custo hospitalar de R$ R$ 102,99 por dia de sobrevida nos 8 adultos e R$ 137,53 nas 13 crianças observadas, comparativamente à R$ 229,00 e R$ 260,00, com ciclosporina, respectivamente. Assim, se evitaria 37% da mortalidade associada à episódios de rejeição nos pacientes com transplante cardíaco e, mesmo no único óbito, o custo hospitalar por dia de sobrevida foi de metade que o custo dos períodos observados nos 32 pacientes sob ciclosporina que foram a óbito. O diagnóstico por angiotomocoronariografia em pacientes com angina atípica e risco moderado permitiria orientar o manejo de até dois terços destes casos evitandose coronariografias invasivas. Isto permitiria aumentar a resolutividade do Departamento de Hemodinâmica de 25% para mais 20% dos casos assim estudados, com economias para o InCor, aumento do acesso e resolutividade, podendo evitar até 2.000 mortes, e com o acréscimo estimado de <10% do valor destas 14% mais angioplastias e 6% mais revascularizações cirúrgicas para o SUS. A ablação cirúrgica tem o potencial de curar >10% das fibrilações atriais refratárias a medicamentos em pacientes com indicação de cirurgia aberta para correção de problemas cardíacos estruturais, evitando morbidade e mortalidade em até 1.000 pacientes por ano, se houver suposição que esta seja utilizada apenas com as cirurgias valvares no âmbito do SUS. Conclusões e discussão: As novas tecnologias estudadas proporcionam benefícios à saúde, mas ainda possuem variados graus de incerteza sobre aspectos de segurança e sobre seu potencial de impacto econômico para os programas assistenciais para o InCor e para o SUS. O InCor e os demais hospitais universitários possuem alta capacidade técnica instalada, onde a estruturação de pesquisas facilita e permite a incorporação de inovações de alta complexidade, sem contudo haver planejamento econômico para os programas de assistência à saúde. O isolamento destes atores, em relação às instâncias gestoras do SUS, permite construções sob visões parciais e imediatistas, permite desenvolvimento de interesses externos e diversos, e, por outro lado, pressiona de maneira desordenada a organização e o sistema de saúde. A integração da capacidade profissional, instalada nos hospitais universitários, dentro do circuito de planejamento de médio e longo prazo para o SUS, avaliando as tecnologias inovadoras comparativamente às estabelecidas para a saúde, com base na epidemiologia local observada, pode permitir uma atualização planejada e contínua dos serviços de saúde, construída sobre bases sólidas de conhecimento científico adaptado à nossa realidade e com o responsável equilíbrio orçamentário. / Introduction: There is an ongoing international debate associating the increasing health care costs with adoption of new health technologies. To aid to ascertain whether new health technologies are part of the problem, part of the solution or both in relation to the health of the population and of the health care system, this case study analyses retrospectively three recent decisions to adopt innovations at the Heart Institute, InCor-HC/FMUSP. In order to provide examples of the application of methods for health technologies assessment, the InCor Board of Directors indicated one innovative drug, a new diagnostic procedure and a recent surgery. Methods: Qualitative, retrospective field evaluation of the three decisions for the highest complexity of care in cardiology. Decision-makers survey, systematic reviews (descriptive or meta-analytic) and hospital economic impact analysis were the methodologies applied to this case. Results: A pattern of new technologies incorporation through incremental research, a strategic and pluralist practice emerged within a creative social system. Approved by the InCor and HC Research Ethics Boards and based on previous research results, successive investigations verified and adjusted the informations and generated additional research. Thus, the decision-makers do build knowledge, negotiate research protocols, promote very technical specialists formation and transfer international practice, inter- and up-grading it to the Brazilian reality. Evaluation of these three innovative technologies results are: - The drug tacrolimus may rescue and resolve an average of 75% of the episodes of rejection refractory to conventional medications. The average hospital cost observed (since conversion from CSA, censored at March the 30th, 2006) was of US$45 or R$102.99 per day of survival in 8 adults and of US$61 or R$137.53 for the 13 children (<18 years of age), compared with R$ 229.00 and R$ 260.00, respectively, in those who remained under cyclosporine treatment. Thus, it could prevent 37% rejection related mortality and bring some economy (even in the single child death observed, the hospital cost per day until death was the half of the cost observed for the 32 cyclosporine treated). - The tomoangiocoronariography diagnosis for patients presenting atypical angina and moderate to low risk of stenosis may orient and modify up to 66% clinical decisions preventing requirement of an invasive procedure. This would increase 20% to the Haemodynamic Department 25% resolutivity, may prevent up to 2000 deaths with an estimated additional 10% of the costs of 14% more angioplasties and 6% increase in surgical coronary bypasses for the health care system. - Surgical ablation has the potential to cure more than 10% of medications refractory atrial fibrillation in patients undergoing open heart surgery for structural corrections. Supposing it is restricted only to the group of patients undergoing valve surgery in the health care system, it could prevent morbidity and mortality for up to 1000 patients. Conclusions and discussion: The new technologies evaluated bring benefits to the health of the patients. Safety concerns and economic impact for the InCor and for the health care system assistance programs require further investigation. InCor and the other university hospitals have enhanced technical capacity installed. The structured research facilitates and allows incorporation of highly complex innovations without planning future programs for care. The isolation of these decision makers from the health care system decision planners allows partial views and immediacies. Such a distance facilitates development of external and diverse interests. These facts, consequently, pressures on the organization and the health care system. The integration of the university hospitals installed professional capacities, within an average and long term health care system plans, making evaluations of the innovative health technologies in comparison with the established ones based on local epidemiology, may permit a planned and continuous actualization of the health services on solid scientific basis adapted to the Brazilian reality and with a responsible financial balance.

Le vieillissement démographique augmente rapidement la représentation des personnes âgées de plus de 50 ans parmi les utilisateurs d’aides à la mobilité motorisées (AMMs), telles que le fauteuil roulant motorisé et le quadriporteur. Le but général de la thèse est de rendre compte d’une démarche d’analyse des effets des AMMs au cours des premiers 18 mois d’utilisation chez les adultes d’âge moyen et les aînés. Notre question de recherche concerne la nature et l'importance des effets sur le fonctionnement, la pertinence sociale et le bien-être subjectif, ainsi que les liens entre les divers facteurs impliqués dans leur impact optimal. La thèse s’articule en trois volets, synthétique, méthodologique et analytique, dont les principaux résultats sont présentés dans quatre articles scientifiques. Le volet synthétique comprend une recension systématique qui révèle la représentation marginale des personnes âgées de plus de 50 ans dans les publications scientifiques sur les effets des AMMs et le faible niveau de preuve dans ce champ d’études. Les travaux liés à ce volet proposent également un cadre d’analyse reliant l’intention d’utiliser l’AMM, les habitudes de déplacements, les dimensions d’effets des AMMs sur le fonctionnement, la pertinence sociale et le bien-être subjectif, ainsi que quatre catégories de cofacteurs associés à l’utilisation (personne, aide technique, intervention, environnement). Le volet méthodologique assemble un dispositif de mesure comprenant 5 questionnaires et 18 indicateurs arrimés au cadre d’analyse et démontre l’applicabilité de l’ensemble des questionnaires pour une administration téléphonique. La validation transculturelle de deux questionnaires implique deux études réalisées auprès d’utilisateurs d’AMMs âgés de 50 à 84 ans (n=45). Ces travaux confirment la fidélité test-retest et l’équivalence des questionnaires traduits avec la version d’origine. Finalement, le volet analytique se concentre sur l’étude des habitudes de déplacements chez 3 cohortes (n=116) de personnes âgées de 50 à 89 ans, recrutées en fonction du stade d’utilisation de l’AMM. Les résultats suggèrent une amélioration de l’aire de mobilité après l’utilisation initiale ou long terme de l’AMM en comparaison avec une cohorte en attente de l’AMM, ainsi qu’une augmentation significative de la fréquence des déplacements autour du domicile et dans le voisinage. Trois facteurs associés à une aire de mobilité optimale, à savoir le genre, la nature des objectifs de participation de l’utilisateur et le type d’appareil utilisé, sont identifiés par des analyses de régression linéaires contrôlant pour l’âge. La thèse soutient l’importance de tenir compte de l’environnement et d’une combinaison de facteurs reliés à la personne et à l’aide technique pour saisir les effets des AMMs au cours des premiers mois d’utilisation. Ces résultats ouvrent la voie au suivi systématique des utilisateurs d’AMMs par les professionels de réadaptation, puisqu’ils confirment l’utilité du dispositif pour en mesurer les effets et ciblent les déterminants de la mobilité des utilisateurs d’AMMs âgés de plus de 50 ans. / Mobility-related subsidy programs are being challenged by the aging of the population as adults aged over 50 years become the most prevalent users of power mobility devices (PMDs), such as power wheelchairs and scooters. The thesis examines the impacts of PMDs for middle-aged and older adults during the first 18 months of use. Our research question concerns the nature and magnitude of outcomes pertaining to effectiveness, social significance and subjective well-being, as well as the factors associated with outcomes. The thesis comprises three sections: conceptual, methodological and analytical. The main results are presented in four manuscripts. The conceptual section includes a systematic review that reveals the limited coverage and low level of evidence of PMD outcomes for middle-aged and older adults. Moreover, this section supports a conceptual framework linking intention to use the PMD, mobility habits, three dimensions of outcomes (effectiveness, social significance, subjective well-being) and four categories of co-factors asociated with the use of assistive technology (person, assistive device, intervention, environment). The methodological section assembled 5 questionnaires and 18 indicators, matched to the conceptual framework, and verified their applicability for a telephone administration. Two questionnaires required transcultural validation studies with PMD users (n=45, age 50-84 years) that confirmed the test-retest reliability and the equivalence of the questionnaires with the original versions. Finally, the analytical section examined the impact of PMDs on 3 cohorts (n=116, age 50-89 years), recruited as a function of stage of usage, and explored key factors asociated with greater life-space mobility. Cohort comparisons showed significantly greater life-space mobility for initial and long term users than for the reference group waiting for the PMD. Moreover, frequency of outings was higher for PMD users in the neighbourhood and around home. Age-adjusted linear regression analyses found greater life-space mobility associated with gender, the nature of PMD activities and device type. The thesis supports considering the environment and a combination of personal and device factors to appreciate PMD outcomes during the first months of use. The results are useful for rehabilitation services as they confirm the utility of following up PMD outcomes and identify key determinants of mobility for middle-aged and older PMD users.

Made available in DSpace on 2014-09-09T12:22:48Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 69591.pdf: 3878499 bytes, checksum: 34f8bc6b6d59a7f8f16d3a39356fd14f (MD5) Previous issue date: 2014 / Fundação Oswaldo Cruz. Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira. Departamento de Ensino. Programa de Pós-Graduação em Saúde da Criança e da Mulher. Rio de Janeiro, RJ, Brasil. / No Brasil, predomina a assistência obstétrica centrada no médico especialista em obstetrícia e uma excessiva medicalização do trabalho de parto e do parto. .O modelo colaborativo (MC) na assistência obstétrica significa a integração da obstetriz ou enfermeira obstétrica e do médico obstetra na equipe de assistência ao trabalho de parto e parto. Objetivo: Estudar modelos assistenciais, que incorporam a atuação da enfermeira obstétrica para a assistência ao trabalho de parto e parto, e sua associação com intervenções no trabalho de parto e parto e resultados maternos e neonatais. Métodos: Desenho do estudo foi transversal. População do estudo foi mulheres atendidas em hospitais do Município de Belo Horizonte, vinculados ao SUS, que apresentam o modelo colaborativo (equipe composta por médico obstetra e enfermeira obstétrica), modelo tradicional (equipe composto somente por médico obstetra) e um Centro de Parto Normal perihospitalar. O primeiro artigo analisa, por meio de regressão logística multivariada, a associação entre o modelo assistencial e intervenções utilizadas na condução do trabalho de parto. O segundo artigo analisa a associação entre o modelo e o parto vaginal espontâneo conforme um modelo hierarquizado. O terceiro artigo descreve e compara as intervenções, tipo de parto e resultados neonatais entre dois hospitais, que representam o modelo colaborativo e o modelo tradicional, e o Centro de Parto Normal. Resultados: Houve menor utilização da ocitocina, da amniotomia e da episiotomia e maior utilização de métodos não farmacológicos para alívio da dor nos modelos com incorporação da enfermeira obstétrica, sendo as proporções menores no CPN. A associação entre o MC e a redução no uso da ocitocina, da ruptura artificial das membranas e da episiotomia, e do parto vaginal espontâneo se manteve após o ajuste para fatores de confundimento... / In Brazil predominates, even for women of normal risk, physician - centered care and an excessive medicalization of chil dbirth care.The collaborative model (CM) in the obstetric care means midwife or nurse - midwife and obstetrician working together in the team which takes care for women in labor and delivery. Objective: To study care models, with and without incorporating the midwife role for care during labour and delivery, and their association with interventions in childbirth and with maternal and neonatal results. Methods: The study was transversal. The study population were women attended in hospitals from Belo Horizonte, linked to the national public health system (SUS), that represent the collaborative model (team with obstetrician and midwife), traditional model (team composed only by obstetrician) and a alongside birth centre. The first article analyses, by m ultivariate logistic regression, the association between the care model and the interventions used in labour. The second article analyses the association between the model and the spontaneous vaginal delivery according to a hierarchical model. The third ar ticle describes and compares the interventions, birth type and neonatal results between hospitals, th ose represent the collaborative and traditional models, and the birth center care model . Results: There was less use of oxytocin, of amniotomy and episi otomy and more use of non - pharmacological methods to relieve the pain in models incorporating midwives, being the smaller proportions in the birth center. The association between the CM and the reduction of oxytocin use, amniotomy and episiotomy and the in crease of the spontaneous vaginal delivery were kept after the adjustment for confounding factors. The care model was not associated to neonatal complications and use of conduction analgesia. Conclusion: The result suggest that care models incorporating t he midwife can reduce interventions in the labour and delivery care with perinatal similar results, as well as increase the rate of spontaneous vaginal delivery, including women with obstetric - clinic complications, birth induction or pharmacological analge sia. The MC is feasible in the Brazilian context and can be a tool in efforts to change the health care model

Submitted by Guilherme Espirito Santo Silva (guilherme.ess@gmail.com) on 2018-05-25T20:32:38Z No. of bitstreams: 1 A busca pelo Cuidado Baseado em Valor em um hospital universitário.pdf: 3828086 bytes, checksum: c2ae46952beae6b1b42cb4d40ed22f0c (MD5) / Rejected by Simone de Andrade Lopes Pires (simone.lopes@fgv.br), reason: Boa Noite Guilherme, Recebemos a postagem do seu trabalho na biblioteca digital e para ser aprovado será necessário alguns ajustes: 1º RESUSMO E ABSTRACT vem depois do AGRADECIMENTOS. 2º Na pagina da ficha catalográfica falta a frase " Ficha catalográfica elaborada por...." Por favor, faça as alterações e post o trabalho novamente na biblioteca. Atenciosamente Simone de A Lopes Pires on 2018-05-25T22:30:26Z (GMT) / Submitted by Guilherme Espirito Santo Silva (guilherme.ess@gmail.com) on 2018-05-26T02:52:27Z No. of bitstreams: 1 A busca pelo Cuidado Baseado em Valor em um hospital universitário.pdf: 3828639 bytes, checksum: 4d18934e4b18b9ac063ff23e76b195c0 (MD5) / Rejected by Simone de Andrade Lopes Pires (simone.lopes@fgv.br), reason: Prezado Guilherme, Ainda há alterações necessárias para aprovação. O RESUMO e ABSTRACT vem antes, da lista de tabelas, ilustrações e sumário. Atenciosamente, Simone de Andrade Lopes Pires SRA on 2018-05-29T17:12:57Z (GMT) / Submitted by Guilherme Espirito Santo Silva (guilherme.ess@gmail.com) on 2018-05-29T17:38:21Z No. of bitstreams: 1 A BUSCA PELO CUIDADO BASEADO EM VALOR EM UM HOSPITAL UNIVERSITÁRIO.pdf: 2226528 bytes, checksum: b7bd4d32df6d9f2b0d14fe5beb0478bf (MD5) / Rejected by Simone de Andrade Lopes Pires (simone.lopes@fgv.br), reason: Boa Tarde Guilherme, Falta somente 1 alteração. CAPA: o nome vem acima do título. Aguardo nova postagem. Atenciosamente, Simone de A Lopes Pires on 2018-05-29T19:27:18Z (GMT) / Submitted by Guilherme Espirito Santo Silva (guilherme.ess@gmail.com) on 2018-05-29T20:31:13Z No. of bitstreams: 1 A BUSCA PELO CUIDADO BASEADO EM VALOR EM UM HOSPITAL UNIVERSITÁRIO.pdf: 2227413 bytes, checksum: 92d485106b343bc707a3e4d0372d833a (MD5) / Approved for entry into archive by Simone de Andrade Lopes Pires (simone.lopes@fgv.br) on 2018-05-29T21:25:57Z (GMT) No. of bitstreams: 1 A BUSCA PELO CUIDADO BASEADO EM VALOR EM UM HOSPITAL UNIVERSITÁRIO.pdf: 2227413 bytes, checksum: 92d485106b343bc707a3e4d0372d833a (MD5) / Approved for entry into archive by Suzane Guimarães (suzane.guimaraes@fgv.br) on 2018-05-30T13:46:27Z (GMT) No. of bitstreams: 1 A BUSCA PELO CUIDADO BASEADO EM VALOR EM UM HOSPITAL UNIVERSITÁRIO.pdf: 2227413 bytes, checksum: 92d485106b343bc707a3e4d0372d833a (MD5) / Made available in DSpace on 2018-05-30T13:46:27Z (GMT). No. of bitstreams: 1 A BUSCA PELO CUIDADO BASEADO EM VALOR EM UM HOSPITAL UNIVERSITÁRIO.pdf: 2227413 bytes, checksum: 92d485106b343bc707a3e4d0372d833a (MD5) Previous issue date: 2018-05 / A estratégia do Cuidado Baseado em Valor propõe que o objetivo final das organizações e sistemas de saúde deve ser entregar alto valor aos pacientes, sendo este definido pela relação entre os resultados que importam para os pacientes e seus custos. Neste sentido, pretende-se estimular que a competição no mercado da saúde seja baseada em valor, não apenas no volume de procedimentos. Porém, a execução desta estratégia traz grandes desafios por exigir uma mudança radical no modelo assistencial predominante. Os hospitais universitários são os principais centros formadores de profissionais da saúde, o que lhes confere papel central nesta agenda transformadora. O presente trabalho buscou identificar os fatores críticos no processo inicial de implantação do Cuidado Baseado em Valor em um hospital universitário. Trata-se de uma pesquisa qualitativa exploratória e descritiva, realizada com o método da pesquisaação. O estudo descreve o processo de implantação desde as discussões iniciais sobre o tema até o desenvolvimento de um projeto piloto. Neste, é detalhada a preparação e o início da execução de uma Unidade de Prática Integrada para doenças cardíacas valvares, criada com o objetivo de aprimorar os desfechos clínicos e reduzir desperdícios. Os principais fatores críticos identificados foram: o poder de mobilização do tema sobre as equipes assistenciais; o potencial ganho de qualidade e eficiência no processo assistencial; a importância da presença da liderança e da construção coletiva no processo de implantação; a dificuldade em mudar o comportamento dos profissionais; e a complexidade da tomada de decisão em hospitais universitários. Por fim, o trabalho conclui que a implantação de estratégia da Cuidado Baseado em Valor tem potencial mobilizador positivo, mas que, para além desafios técnicos, exige intenso gerenciamento da mudança organizacional. / The Value-Based Health Care strategy proposes that the goal of health care organizations should be to deliver high value to patients – which is defined by the relation between outcomes that matter to patients and their corresponding costs. Thus, it is intended to encourage that competition in the health market should be based on value, not only on the volume of procedures. However, the implementation of this strategy presents major challenges, since it requires a radical change in the predominant care model. The university hospitals are the main training centers for health professionals, which gives them a central role in this transformational agenda. The present study sought to identify the critical factors in the initial process of implanting Value Based Health Care in a university hospital. This is an exploratory and descriptive qualitative research, carried out using the action research method. The study describes the implementation process from the initial discussions on the theme to the development of a pilot project. It details the preparation and start-up of an Integrated Practice Unit for cardiac valve disease, created to improve clinical outcomes and reduce waste. The main critical factors identified were: the mobilization power of the theme on the health professionals; the potential gain of quality and efficiency in the care process; the key role of the presence of leadership and collective efforts in the implementation process; the difficulty in changing the behavior of professionals; and the complexity of decision making in university hospitals. Finally, the paper concludes that the implementation of Value-Based Health Care strategy has a positive potential mobilizer, but that besides technical challenges, it requires intense management of organizational change.

Introdução: Amplo debate tem associado a incorporação de novas tecnologias para a saúde com os custos crescentes dos sistemas de saúde. Face à dúvidas \"se as novas tecnologias são parte do problema, parte da solução ou as duas coisas\" relativamente à saúde da população e do sistema de saúde, este estudo de caso analisa a incorporação de três inovações no Instituto do Coração, InCor-HC/FMUSP, visando elaborar quais fatores influenciaram a decisão de adoção e exemplificar as metodologias de avaliação de novo medicamento, de procedimento diagnóstico e intervenção cirúrgica. A avaliação das tecnologias para a saúde, ATS, pode auxiliar a constituir algumas propostas de respostas. Metodologia: estudo qualitativo empírico em caso retrospectivo de incorporação de três inovações para assistência de alta complexidade em cardiologia. As metodologias utilizadas consistiram em entrevistas aos tomadores de decisão, revisões sistemáticas da literatura relevante, descritiva ou meta-analítica, e análise de impacto econômico hospitalar. Resultados: O padrão do InCor para a incorporação das inovações funciona como um sistema social criativo, sob uma estratégia prática pluralista, ou seja, utilizam as pesquisas, aprovadas pela Comissão de Ética e Pesquisa do InCor e do HC, que se sucederam e que sucedem em incrementos, verificando e ajustando as informações segundo os resultados obtidos para desenhar novas pesquisas. Os atores construíram conhecimentos e negociaram protocolos de pesquisa, promoveram a capacitação de super-especialistas técnicos, transferindo práticas internacionais e gerando conhecimentos adaptados à realidade do Brasil. A avaliação do medicamento tacrolimus demonstra que se poderia resgatar uma média de 75% das rejeições refratárias às terapias convencionais, proporcionando um custo hospitalar de R$ R$ 102,99 por dia de sobrevida nos 8 adultos e R$ 137,53 nas 13 crianças observadas, comparativamente à R$ 229,00 e R$ 260,00, com ciclosporina, respectivamente. Assim, se evitaria 37% da mortalidade associada à episódios de rejeição nos pacientes com transplante cardíaco e, mesmo no único óbito, o custo hospitalar por dia de sobrevida foi de metade que o custo dos períodos observados nos 32 pacientes sob ciclosporina que foram a óbito. O diagnóstico por angiotomocoronariografia em pacientes com angina atípica e risco moderado permitiria orientar o manejo de até dois terços destes casos evitandose coronariografias invasivas. Isto permitiria aumentar a resolutividade do Departamento de Hemodinâmica de 25% para mais 20% dos casos assim estudados, com economias para o InCor, aumento do acesso e resolutividade, podendo evitar até 2.000 mortes, e com o acréscimo estimado de <10% do valor destas 14% mais angioplastias e 6% mais revascularizações cirúrgicas para o SUS. A ablação cirúrgica tem o potencial de curar >10% das fibrilações atriais refratárias a medicamentos em pacientes com indicação de cirurgia aberta para correção de problemas cardíacos estruturais, evitando morbidade e mortalidade em até 1.000 pacientes por ano, se houver suposição que esta seja utilizada apenas com as cirurgias valvares no âmbito do SUS. Conclusões e discussão: As novas tecnologias estudadas proporcionam benefícios à saúde, mas ainda possuem variados graus de incerteza sobre aspectos de segurança e sobre seu potencial de impacto econômico para os programas assistenciais para o InCor e para o SUS. O InCor e os demais hospitais universitários possuem alta capacidade técnica instalada, onde a estruturação de pesquisas facilita e permite a incorporação de inovações de alta complexidade, sem contudo haver planejamento econômico para os programas de assistência à saúde. O isolamento destes atores, em relação às instâncias gestoras do SUS, permite construções sob visões parciais e imediatistas, permite desenvolvimento de interesses externos e diversos, e, por outro lado, pressiona de maneira desordenada a organização e o sistema de saúde. A integração da capacidade profissional, instalada nos hospitais universitários, dentro do circuito de planejamento de médio e longo prazo para o SUS, avaliando as tecnologias inovadoras comparativamente às estabelecidas para a saúde, com base na epidemiologia local observada, pode permitir uma atualização planejada e contínua dos serviços de saúde, construída sobre bases sólidas de conhecimento científico adaptado à nossa realidade e com o responsável equilíbrio orçamentário. / Introduction: There is an ongoing international debate associating the increasing health care costs with adoption of new health technologies. To aid to ascertain whether new health technologies are part of the problem, part of the solution or both in relation to the health of the population and of the health care system, this case study analyses retrospectively three recent decisions to adopt innovations at the Heart Institute, InCor-HC/FMUSP. In order to provide examples of the application of methods for health technologies assessment, the InCor Board of Directors indicated one innovative drug, a new diagnostic procedure and a recent surgery. Methods: Qualitative, retrospective field evaluation of the three decisions for the highest complexity of care in cardiology. Decision-makers survey, systematic reviews (descriptive or meta-analytic) and hospital economic impact analysis were the methodologies applied to this case. Results: A pattern of new technologies incorporation through incremental research, a strategic and pluralist practice emerged within a creative social system. Approved by the InCor and HC Research Ethics Boards and based on previous research results, successive investigations verified and adjusted the informations and generated additional research. Thus, the decision-makers do build knowledge, negotiate research protocols, promote very technical specialists formation and transfer international practice, inter- and up-grading it to the Brazilian reality. Evaluation of these three innovative technologies results are: - The drug tacrolimus may rescue and resolve an average of 75% of the episodes of rejection refractory to conventional medications. The average hospital cost observed (since conversion from CSA, censored at March the 30th, 2006) was of US$45 or R$102.99 per day of survival in 8 adults and of US$61 or R$137.53 for the 13 children (<18 years of age), compared with R$ 229.00 and R$ 260.00, respectively, in those who remained under cyclosporine treatment. Thus, it could prevent 37% rejection related mortality and bring some economy (even in the single child death observed, the hospital cost per day until death was the half of the cost observed for the 32 cyclosporine treated). - The tomoangiocoronariography diagnosis for patients presenting atypical angina and moderate to low risk of stenosis may orient and modify up to 66% clinical decisions preventing requirement of an invasive procedure. This would increase 20% to the Haemodynamic Department 25% resolutivity, may prevent up to 2000 deaths with an estimated additional 10% of the costs of 14% more angioplasties and 6% increase in surgical coronary bypasses for the health care system. - Surgical ablation has the potential to cure more than 10% of medications refractory atrial fibrillation in patients undergoing open heart surgery for structural corrections. Supposing it is restricted only to the group of patients undergoing valve surgery in the health care system, it could prevent morbidity and mortality for up to 1000 patients. Conclusions and discussion: The new technologies evaluated bring benefits to the health of the patients. Safety concerns and economic impact for the InCor and for the health care system assistance programs require further investigation. InCor and the other university hospitals have enhanced technical capacity installed. The structured research facilitates and allows incorporation of highly complex innovations without planning future programs for care. The isolation of these decision makers from the health care system decision planners allows partial views and immediacies. Such a distance facilitates development of external and diverse interests. These facts, consequently, pressures on the organization and the health care system. The integration of the university hospitals installed professional capacities, within an average and long term health care system plans, making evaluations of the innovative health technologies in comparison with the established ones based on local epidemiology, may permit a planned and continuous actualization of the health services on solid scientific basis adapted to the Brazilian reality and with a responsible financial balance.

Estudos baseados em parâmetros fisiológicos tem mostrado que a fisioterapia tem papel imperativo na assistência de pacientes pré e pós-operatórios. Os efeitos da assistência fisioterapêutica na unidade de terapia intensiva (UTI) sobre o tempo de ventilação mecânica invasiva (VMI), tempo de internação e mortalidade do paciente crítico não foram elucidados. Tampouco, estudos sobre o impacto do turno diário da assistência fisioterapêutica nestes desfechos tem sido realizados. A despeito disto, e, possivelmente, baseadas na experiência clínica, as UTIs brasileiras adotarão turnos de 18 horas de assistência fisioterapêutica na UTI para atender a uma regulamentação governamental. O objetivo deste estudo foi comparar o efeito da assistência fisioterapêutica na UTI em turno diário de 24 horas (Fisio-24) ao turno diário de 12 horas (Fisio-12), sobre o tempo de VMI, tempo de internação na UTI, frequência de complicações respiratórias relacionadas a VMI e custos indiretos de pacientes pós-operatórios. Este estudo observacional, prospectivo, de coorte incluiu 114 pacientes de UTIs com Fisio-12 e 152 pacientes de UTIs com Fisio-24 em condição pós-operatória, idade 18 anos, submetidos a VMI por 24 horas e admitidos na UTI para rotina pós-operatória. Foram coletados dados demográficos e cirúrgicos. Os desfechos primários deste estudo foram tempo de VMI, tempo de internação na UTI, complicações respiratórias relacionadas a VMI e custos indiretos. O desfecho secundário foi o dia-livre de ventilação (VFD). Os custos foram avaliados através do Omega French Score que compreende três categorias (Omega 1, 2 e 3). Um modelo de regressão linear múltipla (MRL) foi construído para verificar a associação entre o turno diário de assistência fisioterapêutica na UTI e o tempo de VMI. A despeito dos pacientes Fisio-24 serem mais velhos (p=0,002), possuírem maior número de comorbidades (p=0,001), maior frequência de risco cirúrgico moderado a alto (p=0,003), maior frequência de complicações intra operatórias (p=0,012) e insuficiência renal aguda dialítica (p<0,001), comparados aos pacientes Fisio-12, apresentaram melhores desfechos clínicos, tais quais, menor mediana de tempo de VMI (4 dias versus 6 dias; p=0,002), maior mediana de VFD (24 dias versus 21 dias; p=0,004) e menor mediana de tempo de internação na UTI (10 dias versus 15 dias; p=0,015). Não foi encontrada diferença na frequência de complicações respiratórias relacionadas à VMI entre os dois grupos (p=0,704), embora pacientes Fisio-24 tenham recebido mais sessões de fisioterapia respiratória durante a internação na UTI (25 versus 20 sessões; p=0,014). Pacientes Fisio-24 apresentaram menor pontuação do Omega 2 (p=0,007). O MRL manteve como variáveis explicativas o número de sessões de fisioterapia respiratória, APACHE II, realização de Neurocirurgia e o turno diário de assistência fisioterapêutica na UTI. Mantidas constantes as outras variáveis explicativas, a presença de Fisio-24 na UTI reduziu o tempo de VMI em 2,80 unidades. Concluí-se que pacientes pós-operatórios admitidos em UTIs com Fisio-24 apresentaram menores tempo de VMI e tempo de internação na UTI, maior VFD, contudo, não foi encontrada diferença na frequência de complicações respiratórias relacionadas à VMI entre Fisio-12 e Fisio-24. A redução da pontuação de Omega 2 nos pacientes Fisio-24 não foi suficiente para promover diferenças no custo indireto entre os grupos / According to studies based on physiologic parameters, physiotherapy plays an imperative role on pre and postoperative patients. The effects of physiotherapy assistance (PTA) in the intensive care unit (ICU) on length of invasive mechanical ventilation (IMV), length of ICU stay, frequency of ventilator-associated pneumonia and mortality remain unclear. Moreover, studies about impact of PTA shifts have not been conducted. Despite this fact, and possibly based on clinical experiences, Brazilian ICUs are going to adopt 18 hours of PTA shifts in order to attend a governmental regulation. The objective of this study was to compare the effects of 24-hour PTA (Physio-24) to 12-hour PTA (Physio-12) daily shifts in the ICU on length of IMV, length of ICU stay, frequency of respiratory complications related to IMV and indirect costs of postoperative patients. This observational, prospective and cohort study included 114 patients from ICUs with Physio-12 and 152 patients from ICU with Physio-24. Patients presented postoperative conditions, were aged 18 years, who underwent IMV 24 hours and were admitted on ICU for postoperative routine. We collected demographical and surgical data. Our primaries end-points were duration of IMV, length of ICU stay, frequency of respiratory complications related to IMV and indirect costs. The secondary end-point was ventilator-free days (VFD). Indirect costs were assessed by Omega French Score which comprises three categories (Omega 1, 2 and 3). In addition, a multiple linear regression model (MLR) was constructed to verify the association between daily shifts of PTA in ICU and length of IMV. Despite of the fact that Physio-24 patients were older (p=0.002), with more severe conditions such as higher number of co morbidities (p<0.001), higher presence of moderate to severe surgical risk (p=0.003), higher frequency of intraoperative complications (p=0.012) and dialytic acute renal failure in ICU (p<0.001), compared to Physio-12 patients, they presented better clinical outcomes such as fewer median days spent in IMV (4 versus 6 days; p=0.002), higher median of VFD (24 versus 21 days; p=0.004) and shorter median of ICU stay (10 versus 15 days; p=0.015). No differences were found concerning respiratory complications related to IMV between groups (p=0.704), although Physio-24 patients had received more sessions of chest physiotherapy during ICU stay (25 versus 20 sessions; p=0.014). Physio-24 patients presented lower scores of Omega 2 (p=0.007). The number of chest physiotherapy sessions, APACHE II, Neurosurgery, and daily shifts of PTA in ICU remained as independent variables to length of IMV in the MLR model. According to this model, Physio-24 may reduce 2.80 units from length of IMV if the other independent variables are constant. We concluded that postoperative patients admitted in ICUs with daily shifts of 24-hour PTA showed shorter length of IMV and length of ICU stay and increased VFD; however, no reduction in frequency of respiratory complications related to IMV was found between groups. Despite the fact that Physio-24 patients had lower score of Omega 2, it was not enough to provoke a difference on indirect costs between Physio-12 and Physio-24 patients

Background: Cognitive impairment is prevalent in survivors of acute coronary syndrome (ACS) and increases risk for poor outcomes. Lifestyle changes are recommended to patients after ACS to reduce their risk for recurrent events, but cognitively impaired patients may encounter difficulties initiating these changes. This dissertation had three aims: (1) to examine cognitive status as a predictor of lifestyle changes after ACS, (2) to examine whether caregiver support moderates the association of cognitive status and initiation of lifestyle changes, and (3) to assess the reliability of self-reported lifestyle changes in cognitively impaired patients through comparison of their reports of lifestyle change with those from their caregivers. Methods: For aims 1 and 2, Poisson regression with robust error variance was used to examine the association of cognitive status and caregiver support with patient-reported initiation of five lifestyle changes (improving diet, increasing exercise, quitting smoking, reducing stress, and attending cardiac rehabilitation) in 881 patients from TRACE-CORE, a prospective longitudinal observational study of outcomes in ACS. For aim 3, pilot data from 78 patient-caregiver dyads from TRACE-CARE, an ancillary substudy, were used to examine whether patient-caregiver congruence on reports of lifestyle changes varied according to patients’ cognitive function. Results: Patient-reported rates of lifestyle change did not vary according to cognitive status, except for participation in cardiac rehabilitation. Caregiver support improved patient-reported rates of lifestyle change among cognitively intact patients but not cognitively impaired patients. Patients’ cognitive function was positively associated with patient-caregiver congruence on reports of initiation of lifestyle changes and patients with decreased cognitive function tended to over-report initiation of lifestyle changes compared to reports by their caregivers. Conclusion: Although cognitive status was not associated with initiation of most lifestyle changes and the influence of caregiver support on initiation of lifestyle changes was only beneficial to cognitively intact patients in this cohort of ACS patients, these null findings may be explained by the questionable validity of self-report in cognitively impaired patients. This dissertation yields new knowledge about secondary prevention in ACS patients and provides insight into the challenges of conducting patient-reported outcomes research in cognitively compromised populations.

Osteoporosis is a significant public health problem in the U.S. It not only affects the physical well-being of the older women but also creates a substantial financial burden for the health care system. The mainstay of osteoporosis medications is bisphosphonate treatment of which alendronate and risedronate are the most commonly prescribed in clinical practice. However, there have been no head-to-head randomized controlled trials (RCTs) evaluating the effects of these two bisphosphonates on fracture outcomes. In the absence of RCTs, observational studies are necessary to provide alternative evidence on the comparative effectiveness between alendronate and risedronate on fracture outcomes. However, existing observational studies have provided inconclusive results partially due to residual confounding from unobserved variables such as patients’ health status or behavior. IV analysis may be one method to address unmeasured confounding bias in observational studies. While it has not been applied in bisphosphonate research, it has been used in research on a variety of other prescription medications. In this dissertation, we applied the IV approach with an IV, date of generic alendronate availability, to evaluate the comparative effectiveness between alendronate and risedronate using observational data. This dissertation improved current research in several ways. First, we extended the IV approach to research on bisphosphonates. Second, compared with the current observational studies on bisphosphonates, this dissertation may more accurately estimate the relative effects between alendronate and risedronate because IV analysis is not subject to unmeasured confounding bias. Third, the study results extended the current evidence of the comparative effectiveness between the two most commonly prescribed bisphosphonates. Finally, we proposed and provided empirical evidence of a new IV that might be used for future prescription drug research. The finding of this dissertation can be summarized from three aspects. First, we found that the evidence supported the validity of the date of generic availability as an IV in the study of bisphosphonates. Second, applying IV approach to study the comparative effectiveness of alendronate and risedronate, we found that alendronate and risedronate were comparable to reduce the risk of 12-month non-vertebral fractures in older women. Since generic alendronate is availability on the market while generic risedronate is not, promoting the use of alendronate may help reduce the healthcare cost and not sacrifice the clinical effectiveness. Finally, by comparing the proposed IV with a popular IV-physician preference, we found that both the calendar time IV based on the date of generic availability and the physician preference appeared to be valid. It might be practically easier to use the calendar time IV than the physician preference IV.

To enable improved interpretation of the total score and faster scoring of the Rivermead Mobility Index (RMI) by studying item ordering or hierarchy and formulating start-and-stop rules in patients after stroke. DESIGN: Cohort study. SETTING: Rehabilitation center in the Netherlands; stroke rehabilitation units and the community in the United Kingdom. PARTICIPANTS: Item hierarchy of the RMI was studied in an initial group of patients (n=620; mean age +/- SD, 69.2+/-12.5y; 297 [48%] men; 304 [49%] left hemisphere lesion, and 269 [43%] right hemisphere lesion), and the adequacy of the item hierarchy-based start-and-stop rules was checked in a second group of patients (n=237; mean age +/- SD, 60.0+/-11.3y; 139 [59%] men; 103 [44%] left hemisphere lesion, and 93 [39%] right hemisphere lesion) undergoing rehabilitation after stroke. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Mokken scale analysis was used to investigate the fit of the double monotonicity model, indicating hierarchical item ordering. The percentages of patients with a difference between the RMI total score and the scores based on the start-and-stop rules were calculated to check the adequacy of these rules. RESULTS: The RMI had good fit of the double monotonicity model (coefficient H(T)=.87). The interpretation of the total score improved. Item hierarchy-based start-and-stop rules were formulated. The percentages of patients with a difference between the RMI total score and the score based on the recommended start-and-stop rules were 3% and 5%, respectively. Ten of the original 15 items had to be scored after applying the start-and-stop rules. CONCLUSIONS: Item hierarchy was established, enabling improved interpretation and faster scoring of the RMI.

A osteomielite possui elevada prevalência e morbidade. O tratamento depende de apropriada terapia antimicrobiana por tempo prolongado e frequentemente requer cirurgia para remoção de tecidos necróticos. A aderência dos pacientes com osteomielite à prescrição do antibiótico, embora fundamental para o sucesso terapêutico, tem sido pouco estudada. O objetivo deste estudo foi mensurar a aderência à terapia antimicrobiana oral em pacientes adultos com osteomielite; identificar se alguns fatores relacionados na literatura estavam associados com a não aderência; estabelecer o valor preditivo dos fatores associados a não aderência ao tratamento em pacientes com osteomielite. Foi realizado um estudo transversal, fundamentado na avaliação por meio de métodos indiretos da aderência para 83 pacientes. Foram considerados pelo menos 30 dias de uso do antimicrobiano à entrevista e os pacientes foram classificados como aderentes de acordo com o questionário de Morisky, que é constituído por 4 questões com respostas dicotômicas para avaliar a aderência. Os pacientes com < 2 pontos foram considerados de baixa aderência e os que obtiverem > 3 pontos, de alta aderência. O presente estudo identificou uma prevalência de alta aderência de 83,1% (n=63). O ajuste dos modelos de regressão logística múltipla não resultou em variáveis conjuntas influenciando a aderência ao tratamento, porém pacientes do gênero masculino sugeriram apresentar maior frequência de baixa aderência ao tratamento em relação aos pacientes do gênero feminino (p = 0,053). Com relação à idade, a análise dos dados mostrou que os pacientes com idade entre 31 e 59 anos possuíam probabilidade de baixa aderência 68% menor que pacientes com idade entre 18 e 30 anos. A aderência observada foi semelhante à encontrada na literatura. Os fatores sociodemográficos podem interferir na aderência de pacientes em uso de antibióticos orais para tratamento de osteomielite / Osteomyelitis is a highly prevalent disease and a major cause of morbidity. Clinical treatment is based on appropriate antimicrobial therapy. Adherence of patients with osteomyelitis to the prescribed treatment, although critical for successful treatment, has been little studied. The aim of the study was: to measure the adherence to oral antimicrobial therapy in adult patients with osteomyelitis; to identify whether some of the factors listed in health literature were associated with non-adherence; to establish the predictive values associated with non-adherence to antimicrobial therapy in patients with osteomyelitis. We conducted a cross-sectional study, based on evaluation through indirect methods of adherence for 83 patients. We included patients receiving at least 30 days of antimicrobial use. Patients were interviewed and classified as adherent according to the Morisky questionnaire, that consists of 4 questions with dichotomous responses to assess adherence. Patients with 3 points, with high adherence. This study identified a prevalence of high adherence of 83.1% (n = 63). The multivariate logistic regression analysis did not result in multiple variables influencing adherence to treatment. Gender was the only variable with an suggested association with low adherence, male gender was more associated with low adherence than female (p = 0,053). Regarding age, data analysis showed that patients aged between 31 and 59 years had low adherence probability 68% lower than patients aged between 18 and 30 years. The high adherence observed in this study was similar than previous reported in the literature. Social and demographic factors may interfere in the adherence with patients using oral antibiotics for the treatment of osteomyelitis