A Avaliação Tecnológica em Saúde (ATS) é uma sistemática que avalia os impactos clínicos, sociais e econômicos das tecnologias em saúde e tem como finalidade auxiliar os gestores na tomada de decisão quanto ao desenvolvimento, incorporação e descontinuação destas tecnologias. Agências de ATS têm destacado a importância da existência de métodos que visem padronizar e implantar esta sistemática em diferentes contextos. Assim, o objetivo geral desta tese é propor procedimentos para apoiar a avaliação tecnológica de equipamentos médico-hospitalares, por meio de uma pesquisa construtiva (Constructive Research) aplicada à terapia de hemodiálise. Os procedimentos propostos compõem um modelo adaptado do EuroScan, modelo desenvolvido por agências Europeias e indicado como boa prática pelo Ministério da Saúde do Brasil. Também são procedimentos ajustados às necessidades de pesquisadores de centros regionais de avaliação de equipamentos médico-hospitalares. Inicialmente, foi desenvolvida uma coleta de dados sobre os problemas de desenvolvimento e incorporação das tecnologias da saúde por meio de duas fontes: uma revisão sistemática de literatura sobre oportunidades de melhorias do EuroScan no mundo e discussões com pesquisadores no país. A partir destas investigações foi proposto um modelo preliminar de ATS, aplicado para o domínio Operacional e de Inovação na hemodiálise. Finalmente a aplicação foi validada e examinada por especialistas para a geração de um modelo final. Os principais procedimentos resultantes foram: (i) validação da relevância das avaliações para novos desenvolvimentos e incorporações tecnológicas do ponto de vista de diferentes especialistas, integrando diferentes áreas do conhecimento na ATS; (ii) operação de Observatórios Tecnológicos, auxiliando na definição das tecnologias e domínios a serem avaliadas; (iii) definição de técnicas para análise dos domínios de ATS, como o uso de séries temporais e o Technology Roadmap (TRM) para previsões sobre o futuro das inovações e o uso das dimensões da usabilidade e de incidentes críticos de riscos para os aspectos operacionais; e (iv) integração das diretrizes de ATS no Brasil em um único modelo, amparando pesquisadores não relacionados a saúde na compreensão sobre ATS e no desenvolvimento ágil de novos estudos tanto para equipamentos emergentes como em uso. Já a avaliação dos domínios selecionados para a hemodiálise resultou: (i) na identificação de um crescimento médio anual de 7% dos indicadores da terapia; (ii) no diagnóstico de usabilidade de máquinas eficazes, porém com possibilidades de gerarem maior satisfação aos usuários quanto: ao espaço entre elas, a redução dos desperdícios de água e materiais, aos planos de manutenção para evitar temperaturas elevadas, a capacitação visando mais atenção e treinamento para tarefas de apoio e aos aspectos de display (realimentação de dados e visualização); e (iii) na consolidação entre profissionais sobre um futuro promissor, para os próximos 10 anos no Brasil, da assistência homecare com máquinas de hemodiálise portáteis, mais seguras e sustentáveis. / The Health Technology Assessment (HTA) is a systematic evaluation of clinical, social and economic impacts of health technologies aiming to assist managers in the decision making process related to the development, consolidation and discontinuation of these technologies. HTA agencies have been highlighting the importance of methods to standardize and apply this systematic evaluation in different contexts. Thus, the general objective of this thesis is to propose procedures to support the technology assessment of medical-hospital equipment through a constructive research applied to hemodialysis therapy. The proposed procedures compose a EuroScan adapted model, which was developed by European agencies and is recommended as a good practice by the Brazilian Ministry of Health, and also are procedures adjusted to the needs of researchers in regional centers of medical equipment assessment. Initially, a data collection on the problems of developing and incorporating health technologies was carried out using two sources: a systematic review of the literature on opportunities to improve the EuroScan around the world and discussions with Brazilian researchers. Based on these investigations, it was proposed a preliminary HTA model applied to the hemodialysis’ Operational and Innovation domain. The application of the model was reviewed and evaluated by experts to produce a final version. The main resulting procedures were: (i) to validate the importance of assessments for new technological developments and incorporations considering the point of view of different experts from diverse knowledge areas; (ii) to operate Technological Observatories, assisting to define the technologies and domains to be evaluated; (iii) to set techniques for the analysis of HTA domains such as the use of time series and the Technology Roadmap (TRM) to make predictions about the future of innovations and the use of usability dimensions and critical incidents of risks to the operational aspects; and (iv) to integrate HTA Brazilian guidelines in a single model, supporting researchers not related to health in the understanding of HTA and fast development of new studies for both emerging and in use equipment. The assessment of the domains selected for hemodialysis led to: (i) the identification of an annual growth in therapy indicators (7% in average); (ii) the usability diagnosis of efficient machines, however with the potential to generate greater user satisfaction considering: distance between machines, reduction in the waste of water and materials, maintenance plans to avoid high temperatures, training aiming more attention to supporting tasks as well as focus on display aspects (data feedback and visualization); and (iii) the consolidation among professionals of a future, for the next 10 years in Brazil, based on homecare with portable machines, safer and more sustainable.

A Avaliação de Tecnologias em Saúde (ATS) é investigada neste trabalho como uma forma de minimizar as consequências da excessiva judicialização do direito à saúde, ao vincular o conhecimento científico à tomada de decisão, já que pondera riscos, benefícios, custos e impactos referentes à ética e equidade, no estudo de uma determinada tecnologia. O direito ao acesso a medicamentos é apenas uma faceta do direito à saúde, considerando a abrangência de seu conceito. Todavia, a assistência farmacêutica é hoje uma das áreas mais problemáticas e assíduas no debate sobre o direito à saúde, motivo pelo qual o foco deste estudo são as avaliações das tecnologias medicamentosas. Um dos fatores mais relevantes no incremento dos custos em saúde é a utilização de tecnologias cada vez mais caras e de uso específico, cuja inovação, nessa área, tende a ser cumulativa, e não substitutiva. Daí a importância de políticas públicas eficazes em saúde, que consigam gerir as tecnologias de modo a cumprir os princípios de universalidade, equidade e integralidade do SUS. Este trabalho é orientado pela interdisciplinaridade inerente ao estudo dos direitos humanos, pautando-se em pesquisas teóricas e documentais que demonstram tanto a evolução do direito à saúde no ordenamento jurídico brasileiro, quanto a contextualização e a afirmação da ATS como pressuposto à incorporação de tecnologias no SUS e auxiliar na tomada de decisões, possuindo um papel fundamental como fator de justiça social e instrumento de garantia dos direitos humanos. / The Health Technology Assessment (HTA) is studied as a way of minimizing the consequences of the excessive judicialization of the right to health when taking decisions is linked to the scientific knowledge. It weighs risks, benefits, costs and impacts referred to ethics and equity in the study of a certain technology. The right of access to medicines is only a tiny part of the right to health considering the scope of its concept. However, the pharmacy assistance is currently one of the most problem and constant subject presents in debates about the right to health, reason why the focus of this study are the evaluations of medicines technologies. One of the most relevant fact in the increasing of costs in health is the using of technologies increasingly expensive and specific, which innovation tend to be cumulative and not substitutive. That is the importance of effective public policies in health, which are able to manage the technologies in a way of compliance with universality, equity and integrality principles of SUS. This work is oriented by the intrinsic interdisciplinarity of the human rights studies and guided by theoretical and documental researches that demonstrate the evolution of the right to health in Brazilian legal system and the contextualization and predication of HTA as an important point to be considered when incorporating technologies in SUS and taking decisions, having an important role as a factor of social justice and human rights guaranties.

Cette thèse évalue l'hémodynamique artérielle et les marqueurs métaboliques du risque cardio-vasculaire associé dans une population HIV et Pygmée du Cameroun / Doctorat en Sciences médicales (Médecine) / info:eu-repo/semantics/nonPublished

No description available.

Survival analysis is a statistical discipline that analyzes the time to occurrence of certain events. The aim of this thesis is to describe the possibilities of survival analysis in the environment of statistical software R. Theoretical knowledge is applied to real data, parametric and nonparametric estimates of survival functions are evaluated by different methods and compared with each other. In the section focusing on nonparametric models Kaplan-Meier and Nelson-Aalen functions are described. Among the parametric estimates there were included well-known probability distributions, survival functions and risk functions derived from these distributions are presented and there is discussed their usefulness in survival analysis. Another aim is to show the possibility of deriving transition probabilities from estimates and building a Markov chain model to capture the changes of studied cohort over time. The second part of the work contains a description of the applications of the theory of survival analysis. In this section there are shown possibilities of statistical modeling in the field of survival analysis using the software R. Outputs from R were used to create Markov model. There are presented possibilities of pharmacoeconomic models and description of the basic concepts of HTA. Cost-effectiveness calculations using ICER were conducted in accordance with the methodology of SUKL. It was shown that the statistical modelling of survival plays an important role in the evaluation of the cost-effectiveness of medicines.

The master thesis is focused on the reliability of the human factor in the operation of the production machine. In the first part the basic legislative requirements for safety and reliability of work are presented. In the second part, the reliability of the human factor is discussed along with a description of selected methods for assessing the reliability of the human factor. The research section then concludes with a proposed methodology for human factors assessment for the manufacturing process. In the practical part, the proposed methodology is applied to the selected process, which includes risk identification and outputs from the selected methods. The thesis then concludes by recommending preventive measures to eliminate the identified risks.

Background: Health technology assessment (HTA) is a form of policy analysis to inform recommendations for decision-makers. An equity-focused HTA recommendation consists of one that explicitly addresses the impact of health technologies on individuals disadvantaged in society because of their social conditions. However, there is a need for more evidence on the relationships between patient engagement and the development of equity-focused HTA recommendations. Objectives: The objectives of this dissertation were to examine the association between patient engagement and equity-focused HTA recommendations and identify implementation considerations for patient engagement in HTA. Methods: I used explanatory sequential mixed methods to analyze 60 HTA reports and 11 interviews with patients and analysts from Canadian organizations: the Canadian Agency for Drugs and Technologies in Health (CADTH) and Health Quality Ontario (HQO). Results: Quantitative analysis of the HTA reports showed that patient engagement significantly predicts equity-focused HTA recommendations (OR: 0.26; 95% CI: [0.16 – 0.41]). HTA reviews where HTA analysts directly interviewed patients (OR: 3.85; 95% CI: [2.40 – 6.20]) and where an advisory committee used consensus were more likely to contain equity-focused recommendations (OR: 2.27; 95% CI: [1.35 – 3.84]). Qualitative analysis of the interviews identified strategies for engaging diverse patients in HTA. Conclusion: The findings of this dissertation can inform the designing of patient engagement in HTA.

.

Les travaux de la thèse se focalisent sur la protection des réseaux de distribution HTA en présence des générateurs distribués (éoliennes, fermes solaires,...). Dans un premier temps, un état de l’art a été réalisé sur les comportements des générateurs en creux de tension, leurs impacts sur le système de protection et les pistes de solution proposées pour y remédier. L’étape suivante est la mise au point d’algorithmes directionnels de détection de défauts, sans mesure de tension. Ces algorithmes s’appuient sur la décomposition en composantes symétriques des courants mesurés. Ces relais doivent empêcher le déclenchement intempestif de protections de surintensité dû au courant de défaut provenant des générateurs distribués. Ils sont moins coûteux par rapport à ceux traditionnels car les capteurs de tension, qui sont indispensables pour ces derniers, peuvent être enlevés. Après détection d’un défaut sur critère de seuil simple (max de I ou max de I résiduel), la direction est évaluée à l’aide d’un algorithme en delta basé sur les rapports courants inverse-homopolaire ou inverse-direct, selon le type de défaut (monophasé ou biphasé). En se basant sur ces rapports, un classifieur SVM (Support Vector Machines), entrainé préalablement à partir des simulations, donne ensuite l’estimation de la direction du défaut (amont ou aval par rapport au relais). La bonne performance de ces algorithmes a été montrée dans la thèse pour différents paramètres du réseau et en présence de différents types de générateurs. Le développement de tels algorithmes favorise la mise en œuvre des protections en réseau, qui pourraient être installées dans les futurs Smart Grids. / This research focuses on the protection of MV distribution networks with Distributed Generators (DGs), such as wind farms or photovoltaic farms, etc. First, the state of art is carried out on fault behaviour of DGs, their impacts on protection system and the mitigation solutions. Next, algorithms are developed for directional relays without voltage sensors. Based on the symmetrical component method, these algorithms help the overcurrent protections to avoid the false tripping issue due to fault contribution of DGs. With the suppression of voltage sensors, such directional relays become cheaper in comparison with the traditional ones. Following the fault detection (the phase or residual current reaches the pick-up value) and depending on fault type (line-to-ground or line-to-line fault), the ratios between the variation (before and during fault) of negative-zero sequence or negative-positive sequence currents are calculated. From these ratios, a SVM (Support Vector Machines) classifier estimates the fault direction (upstream or downstream the detector). The classifier is trained beforehand from transient simulations. This survey shows good performances of the directional algorithms with different network parameters and different kinds of DGs. Such algorithms could be implemented in protections along the feeders in the future smart grids.

La mise à la terre du point neutre des réseaux de distribution par une bobine de compensation réduit le courant de défaut lors d'un défaut monophasé, ce qui est le type de défaut le plus souvent rencontré dans l'exploitation. Cette mesure améliore la qualité de service, mats rend la détection et la localisation de défauts plus difficiles. Cette thèse traite de la localisation de défauts à faible résistance, auto-extincteurs ou permanents dans les réseaux compensés arborescents. Les phénomènes transitoires lors d'un défaut sont étudiés et une nouvelle approche pour la localisation est développée. L'approche est basée sur l'exploitation des signaux au niveau du poste de transformation HT/MT à une fréquence de résonance caractéristique. Un algorithme de localisation de défaut a été conçu, réalisé et testé. Son fonctionnement est validé avec des simulations de réseau et avec des enregistrements de défauts réels. L'influence des différents paramètres sur la précision de l'algorithme est examinée et expliquée.