Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

A qualitative, non-experimental, explorative and descriptive research design based on the phenomenological philosophical tradition by Heidegger to broaden hermeneutics was conducted. The study was conducted at Umkhanyakude District to investigate the perspectives of eligible nursing students relating to the provision of spiritual care to patients. A purposive sample of 9 participants was recruited and consent form obtained. An unstructured interview guide, with a grand tour question, was used to conduct face to face individual interviews. The Thematic analysis and interpretative phenomenological method of analysis were employed until three themes, six categories and eleven subcategories emerged from the data. Data analysis revealed that nurses had difficulty to differentiate spiritual care from religious care. Commonly cited methods of providing spiritual care were prayer, reading sacred text and singing spiritual songs. Nurses still felt inadequately prepared educationally on how to provide spiritual care in nursing practice. Most of the participants provided spiritual care out of their own interest and not as part of their professional responsibility. Recommendations proposed that the matter be taken up by nurse managers to conduct related in-service education and mentoring programs and nurse educators to guide curriculum planning which evidently include spiritual care. / Health Studies / M.A. (Health Studies)

Made available in DSpace on 2015-07-22T20:50:25Z (GMT). No. of bitstreams: 0 Previous issue date: 2006-01-01 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) / Contexto: consideramos as revisões sistemáticas como melhor nível de evidência para a tomada de decisão nos cuidados com a saúde, cujo rigor metodológico oferece uma diversidade de implicações para a prática clínica e para a pesquisa científica. Objetivo: avaliar a proporção de revisões sistemáticas completas da Colaboração Cochrane que permitem a aplicação prática dos resultados e implicações para a pesquisa científica. Tipo de Estudo: estudo transversal de revisões sistemáticas da Cochrane Library issue 4, 2004. Método: Análise da amostra aleatória de revisões sistemáticas dos 50 grupos colaborativos especializados da Cochrane. A extração de dados foi baseada nas conclusões dos autores, interpretações de metanálises e no contexto de cada revisão sistemática. As implicações para a prática foram classificadas em três categorias: A) “evidências que apóiam a utilização da intervenção testada”; B) ”evidências que contra-indicam a utilização da intervenção”; C) “ausência de evidências para recomendar ou desestimular a intervenção”. As implicações para a pesquisa científica foram categorizadas em: 1) “recomendação para mais pesquisas” e 2) “sem necessidade para recomendar novos estudos”. Número de estudos incluídos e metanálises foram também quantificados. Resultados: 1016 revisões sistemáticas foram analisadas, o que correspondeu a 46,60% da totalidade disponível na Cochrane Library, issue 4, 2004. As proporções e intervalo de confiança (IC) de 95% das implicações para a prática clínica foram: A) 44,39 (95% IC, 42,16 – 46,62) %; B) 6,79 (95% IC, 5,66 – 7,92)%; C) 48,81 (95% IC, 46,57 – 51,07)%. O total de revisões sistemáticas que recomendam a realização de mais estudos foi de 95,96% (95% IC, 95,08 – 97,04). O número de estudos incluídos foi de 13.830 (mediana 8 e moda 2) e o total de metanálises incluídas nas revisões sistemáticas avaliadas, de 6.461 (mediana 2 e moda 0). Conclusão: A grande maioria das revisões sistemáticas não traz orientações específicas com relação ao benefício ou malefício de uma intervenção, comparativamente ao grupo controle para determinada situação clínica. Há uma proporção significativa de revisões sistemáticas que sugerem recomendações de novos estudos para responderem à questão clínica da revisão. Há poucos estudos primários que respondem ao critério de inclusão da revisão sistemática, sugerindo uma qualidade metodológica pobre. Há pouca quantidade de metanálise por revisão sistemática para os desfechos clínicos de interesse. / Context: we consider systematic reviews the best level of evidence for the decision making in the health care, which methodological severity offers a diversity of implications to clinical practice and to scientific research. Objective: to assess the proportion of the complete systematic reviews of Cochrane Colaboration that allow practice application of results and implication to scientific research. Design and Setting: Cross-sectional study of systematic reviews of Cochrane Library issue 4, 2004. Main Outcomes Measures: 1016 systematic reviews published throughout 50 Cochrane Collaborative Review Groups were analysed randomly. Data extraction was based on the authors’ conclusions, meta-analysis interpretations and on the context of each systematic review. The implications to practice had been classified in three categories: A) evidences that support the use of the tested intervention. B) evidences that contraindicate the intervention use. C) absence of evidences to recommend or discourage the intervention. The implications to scientific research had been categorized in: 1) recommendation to further research and 2) no necessity to recommend new studies. Number of included studies and meta-analysis were also quantified. Results: 1016 systematic reviews were analyzed, which corresponded to 46,60% of the available totality in the Cochrane Library, issue 4, 2004. The proportions and confidence interval (CI) of 95% of the implications to clinical practice were: A) 44,39 (95% IC, 42,16 – 46,62) %; B) 6,79 (95% IC, 5,66 – 7,92)%; C) 48,81 (95% IC, 46,57 – 51,07)%. The totality of systematic reviews that recommend the accomplishment of further studies was 13.830 (medium 8 and mode 2) and the totality of included meta-analysis of the evaluated systematic reviews, 6.641 (medium 2 and mode 0). Conclusion: the great majority of systematic reviews do not bring specific orientations with relations to the benefit or curse of an intervention, comparatively to control group for certain clinical situation. There are a significant proportion of systematic reviews that suggest recommendations of new studies to answer to the clinical question of the review. There are few primary studies that answer the inclusion criterion of the systematic review and suggest a poor methodological quality. There is a little amount of meta-analysis by systematic review for the clinical outcomes of interest. / TEDE / BV UNIFESP: Teses e dissertações

Introdução: Os estudos clínicos promovem inovação no âmbito da saúde e podem proporcionar novos tratamentos e benefícios à população. Os estudos de intervenção com medicamentos são fundamentais para demonstrar a eficácia, a toxicidade e a segurança de novas terapias. O uso de medicamentos experimentais na assistência médica é uma realidade observada tanto na continuidade do tratamento pelos participantes após o término da pesquisa, como na possibilidade do uso assistencial destes medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) regulamenta, com base na RDC n. 38/2013, três Programas assistenciais com medicamentos experimentais: Acesso Expandido, Uso Compassivo e Fornecimento de Medicamento Pós-Estudo. Mais recentemente, uma nova alternativa está em desenvolvimento no Hospital de Clínicas de Porto Alegre, definida como Uso Assistencial Extraordinário. Objetivos: Propor fluxos e materiais informativos para orientar a prática e a condução de Programas de Acesso Expandido, Uso Compassivo, Fornecimento de Medicamento Pós-Estudo e Uso Assistencial Extraordinário no Hospital de Clínicas de Porto Alegre, assim como em outras instituições de saúde. Métodos: Foram revisadas as publicações acerca do assunto, analisados alguns fluxogramas existentes na condução dos Programas acima citados, bem como realizado questionário aos profissionais que atuam nesta área no CPC-HCPA. Resultados: Foram elaborados fluxos e materiais informativos para a condução destes distintos Programas, considerando as diretrizes éticas, regulatórias e de boas práticas, que visam auxiliar a prática e a educação dos profissionais envolvidos. / Introduction: Clinical research can provide valuable evidence to support to health care system in informed decision making. At the same time, from the patient perspective, trials can the way to gain access to more appropriate treatments. The main goal of intervention studies is to determine safety and efficacy of new therapies. The Agência Nacional de Vigilância Sanitária (Anvisa) regulates, based on RDC n° 38/2013, three care programs with experimental drugs: Expanded Access, Compassionate Use and Post-trial Access. Also, in the Hospital de Clínicas de Porto Alegre, a new alternative program is being explored - defined as Extraordinary Care Use. Objectives: Propose guidelines to Expanded Access, Compassionate Use, Post-trial Access programs and Extraordinary Care Use in the format of flow sheets and informative leaflets at Hospital de Clínicas de Porto Alegre, and perhaps become a benchmarking project to other institutions. Methods: After review of literature and analysis of existing flow sheets on how to conduct the above mentioned programs, we administered a survey questionnaire on challenges encountered by investigators from clinical research center at our institution. Results: Flow sheets and informative materials were developed to support professionals their research groups in conducting clinical interventional initiatives, considering the ethical, regulatory and good practices guidelines.

The 50+ generation has become an age group that is aging according to the statistical data and the number of individuals in this age category is rising. The aging process is accompanied by numerous physical, mental and social changes. As a consequence of these processes new and modified needs occur in these individuals, to which the provided care has to be adapted. We have linked this issue with conceptual models in nursing. This is because a conceptual model will help us integrate patient information into coherent and comprehensible blocks. An important goal of conceptual models is to simplify the work of nurses, who can see a patient as a whole thanks to them. We chose two models in relation to this issue, namely Calista Roy's model and Betty Neuman's model. We chose two research goals on the basis of the topic of the thesis. The first one was to map the knowledge of selected conceptual models among nurses. And the second goal was to find out the specifics of the nursing care in the 50+ group with the application of selected conceptual models from the point of view of nurses. We applied both, qualitative and quantitative methods to the research. Within the quantitative research we used a non-standardized questionnaire. In the qualitative part we applied the focus group method. Three hypotheses and one research question were set in relation to the research. We are able to confirm two of the three hypotheses. The statistical results have shown that the knowledge of the open-systems model and the adaptation model corresponds with the education of the respondents. Respondents with tertiary education show better knowledge of these models. On the other hand, no relation in taking the specifics in the satisfaction of the needs into account in the provision of nursing care in the 50+ generation was confirmed. A procedure for collection of the nursing anamnesis in the 50+ generation was created on the basis of the research. On the basis of this procedure we can enable healthcare staff to classify the patient information into logical systems and therefore to obtain a quality and comprehensive view of a patient. After the completion of the qualitative research we evaluated the proposals of our respondents for the theoretical as well as the practical part of the anamnesis collection. These respondents showed knowledge of the models. They most often criticized bad intelligibility or even redundancy of a question. Among benefits they named simplicity, reasonability and quality evaluation of the nursing care.

This paper aims to examine possible ways for a clinical practice in/of territory -not only "psi", but disposal bodies - in the context of Sistema Único de Saúde (SUS), the brazilian unified health system. Cartography was used as a method of researchintervention. It is a procedural dimension of the study method of subjectivity and its production process, in which the researcher work is not oriented by predefined goals, these are outlined during the survey. I worked from 2007 to 2015 in different units of SUS - family health units, psychosocial care centers, general and maternity hospitals - which served as a field of research. During this period, scenes related to clinical practice in SUS were recorded in formation notebooks and later in fieldwork diaries. The scenes were revisited and transformed into experience-question narratives that, receiving the unexpected, exposed a problem and forced to think. With the experience-questions, we discuss the contributions of Platonic and Cartesian thought to a way of inhabiting our bodies and the world that is marked by the dichotomous relationship between man and reality. We point out the problems of the relationship between subjectivity production, capitalism and the construction of the individual, emphasizing the connection of these elements to condition setting for the emergence of psychology. We also explain different ground of power compositions: disciplinary power, biopolitics and biopotency. We approach health as production process, raising powers of life (Canguilhem) and plastic capacity of the bodies to affirm their will to power (Nietzsche). Understanding health in these terms, we discuss the ties and possibilities of the relationship between state, SUS and capitalism for creating health producing practices in the SUS context. Given the above, we bet on a clinical forged in the motion of disposal bodies in a process of opening ourselves to the intensive differences pulsating in us. It is the balance between forms and forces that imply creating new contours on the bodies, through them, inventing health-producing relationships by expanding life. We leverage this process through an interdisciplinary clinical practice in the / of territory. A clinic made in a living area, used, experienced, procedural, time-space of an expression. Territory also political, conflictual and negotiations. Clinical practice in territory and clinical practice of territory are inseparable. We mean that the form of update at clinical practice in the SUS is done through the ability to inhabit its paradoxes. Test its borders to the limit, and trough this (un)build territories and operate passages. / O presente trabalho tem como objetivo analisar caminhos possíveis para uma prática clínica no/de território não só psi , mas de corpos agenciadores no contexto do Sistema Único de Saúde (SUS). A cartografia foi utilizada como método de pesquisaintervenção. Trata-se de um método de estudo da dimensão processual da subjetividade e de seu processo de produção, cuja orientação do trabalho do pesquisador não se faz através de metas pré-definidas, estas são traçadas no percurso da pesquisa. Trabalhei de 2007 a 2015 em diferentes unidades do SUS Unidades de Saúde da Família, Centros de Atenção Psicossocial, Hospital Geral e Maternidades , que serviram de campo de pesquisa. Durante este período, cenas relacionadas à prática clínica no SUS foram registradas em cadernos de formação e, posteriormente, em diários de campo. As cenas foram revisitadas e transformadas em narrativas de experiências-questão que, ao acolherem o inesperado, expuseram um problema e forçaram a pensar. Com as experiências-questão, discutimos as influências do pensamento platônico e do cartesiano para uma forma de habitar nosso corpo e o mundo marcada pela relação dicotômica entre o homem e a realidade. Problematizamos a relação entre produção de subjetividade, capitalismo e a construção do indivíduo, ressaltando a conexão desses elementos no estabelecimento de condições para o surgimento da psicologia. Explanamos ainda diferentes composições do plano do poder: o poder disciplinar, a biopolítica e a biopotência. Abordamos a saúde como processo de produção, capacidade normativa da vida (Canguilhem) e capacidade plástica dos corpos afirmarem sua vontade de potência (Nietzsche). Concebendo a saúde nesses termos, discutimos amarras e potencialidades na relação entre Estado, SUS e capitalismo para criação de práticas produtoras de saúde no contexto do SUS. Diante do exposto, apostamos numa clínica forjada no movimento de corpos agenciadores, num processo de abertura às diferenças intensivas que pulsam em nós. Trata-se do manejo entre formas postas e forças que se insinuam criando novos contornos nos corpos, atravessando-os, inventando relações produtoras de saúde por expandirem a vida. Potencializamos esse processo por meio de uma prática clínica transdisciplinar no/de território. Uma clínica que se faz num território vivo, usado, experimentado, processual, tempo-espaço de uma expressão. Território também político, de conflitos e negociações. Clínica no território e clínica de território são indissociáveis. Queremos dizer com isso que a forma própria de a prática clínica no SUS se atualizar se faz por meio da possibilidade de habitarmos os paradoxos que a constituem. Testar até o limite suas fronteiras, e assim (des)construir territórios, operar passagens.

Submitted by Raquel Vergara Gondran (raquelvergara38@yahoo.com.br) on 2016-03-09T22:14:56Z No. of bitstreams: 1 dlenice.pdf: 1516345 bytes, checksum: 930c729b0216458e24773e1f6778bc27 (MD5) / Approved for entry into archive by Lilian M. Silva (lilianmadeirasilva@hotmail.com) on 2016-03-13T15:54:53Z (GMT) No. of bitstreams: 1 dlenice.pdf: 1516345 bytes, checksum: 930c729b0216458e24773e1f6778bc27 (MD5) / Made available in DSpace on 2016-03-13T15:54:53Z (GMT). No. of bitstreams: 1 dlenice.pdf: 1516345 bytes, checksum: 930c729b0216458e24773e1f6778bc27 (MD5) Previous issue date: 2013 / Este estudo teve por objetivo analisar o trabalho do enfermeiro sob a ótica da produção de cuidados em saúde e do exercício da clínica. Para sua realização, optou-se pela utilização do referencial filosófico de Deleuze e Guattari devido às suas convicções acerca de um modo de pensar interconectado. Para tanto, foi realizada uma pesquisa qualitativa e exploratória, na forma de Estudo de Caso, em uma unidade de internação cirúrgica de um hospital universitário, tendo como unidade de análise um grupo de seis enfermeiros dessa mesma unidade de internação. Utilizou-se a observação não participante, a pesquisa documental e a entrevista em profundidade como métodos de coleta de dados. Os dados foram analisados, de acordo com a análise textual discursiva. O projeto dessa pesquisa, elaborado consoante às diretrizes da Resolução196/96 do Conselho Nacional de Saúde, foi aprovado sob parecer n° 87/2012. Obteve-se como um dos principais resultados que o resgate da clínica como saber pode ser um mecanismo de fortalecimento da Enfermagem capaz de propiciar um cuidar que, concomitantemente, legitima a autonomia e a visibilidade das ações de enfermagem. Verificou-se que o modelo clínico/biomédico de assistência traz em suas raízes conhecimentos advindos da clínica como ciência arborífica que, quando incorporados ao trabalho do enfermeiro, possibilitam cuidados resolutivos e coerentes às necessidades de saúde da clientela assistida e ao contexto de trabalho. Os cuidados de enfermagem são instituídos pelo enfermeiro de maneiras distintas e dependentes de conhecimento clínico: seja a partir de conexões diretas com o paciente, assim como, com a criação de linhas de fuga com outros membros da equipe de saúde multiprofissional. Atua como base para a conexão de outros saberes e práticas que expandem o fazer do enfermeiro, por meio de interligações com o ambiente. Deste modo, existe a formação de rizomas, por meio de linhas de fuga que partem da própria estrutura arborífica. Os rizomas são fundamentados e transformados, com base nas necessidades que emergem da prática clínica do enfermeiro e demonstram a capacidade desse profissional de superar o modelo clínico/biomédico hegemônico de assistência, confirmando a tese de que: o trabalho da enfermagem é organizado segundo duas perspectivas interconectadas e interdependentes: a perspectiva do modelo clínico, que compõe a estrutura-mestre da sua prática e equipara-se à estrutura arborescente do referencial de Deleuze e Guattari, que é representada pelos saberes biológico, fisiológico, patológico e farmacológico; e a perspectiva caracterizada por uma estrutura rizomática, composta por elementos múltiplos e heterogêneos, que pode ser representada por aspectos que interferem no ambiente em que o paciente está inserido, seja no âmbito social, familiar, de trabalho, entre outros. Deste modo, o modelo clínico de assistência organiza-se como uma estrutura centrada que possibilita a resolutividade das necessidades biológicas e atua como base para a conexão de outros saberes e práticas que expandem o fazer do enfermeiro, por meio de interligações com o ambiente, resultando em uma prática clínica mais próxima do que se considera/denomina integralidade. / This study aimed at analyzing the nurse's work in the perspective of health care production and clinical practice. For carrying out this study, Deleuze and Guattari's philosophical reference was chosen for their convictions about an interconnected way of thinking. Therefore, a qualitative and exploratory case study was performed in a surgery unit of a university hospital, and a group of six nurses from this unit were taken as unit of analysis. Data were collected through non-participant observation, documentary research and depth interview. They were analyzed according to the discursive textual analysis. The project of this research was set up in accordance with Resolution n. 196/96 of the National Health Council and approved by the opinion n. 87/2012. One of the main results indicated that the revival of clinical practice as knowledge might be a strengthening mechanism in Nursing which would provide a sort of health care which concurrently legitimates autonomy and visibility of nursing actions. It was determined that the clinical/biomedical model of health care has in its roots knowledges based on clinical practice as an arborescent science. When such knowledges are incorporated in the nurse's work, they enable resolutive health care which is coherent to clientele's health needs and to the work context. Nursing cares are distinctively instituted by the nurse and depend on clinical knowledge from direct connections with patients as well as by creating lines of flight with other members of the multi professional health team. The clinical model of health care acts as a basis for the connection of other knowledges and practices which expand the nurse's practices through interconnections with the working environment. This way, the creation of rhizomes occurs through lines of flight which comes from the very arborescent structure. The rhizomes are founded and transformed according to the needs which arise from the nurse's clinical practice and show the professional's capacity to overcome the hegemonic clinical/biomedical model of health care. This confirms the thesis that the nursing work is organized according to two interconnected and interdependent perspectives. First, the perspective of clinical model, which forms the main structure of the nursing practice and is on the level with the arborescent structure of Deleuze and Guattari's referential, which on its turn is represented by biological, physiological, pathological and pharmacological knowledges. Second, the perspective characterized by a rhizomatic structure, formed by multiple and heterogeneous elements, which can be represented by the aspects that interfere in patient's environment - be it social, family, work or other. This way, the clinical model of health care is organized as a centralized structure that enables resolutivity of biological needs and acts as a basis for connecting other knowledges and practices that expand the nurse's practice through interconnections with the work environment. As a result, clinical practice gets closer to what is considered as or called integrality. / Este estudio tuvo como objetivo analizar el trabajo de enfermeros bajo la óptica de la producción de asistencias en la salud y del ejercicio de la clínica. Para su realización se optó por el uso del referencial filosófico de Deleuze y Guattari debido a sus convicciones acerca de un modo de pensar interconectado. Para eso fue realizada una investigación cualitativa y exploratoria con la forma de estudio de caso en una unidad de internación quirúrgica de un hospital universitario, teniendo como unidad de análisis un grupo de seis enfermeros de esa unidad de internación. Se usó observación no participativa, investigación documental y entrevista en profundidad como métodos de recopilación de datos. Los mismos fueron analizados de acuerdo con el análisis textual discursivo. El proyecto de esta investigación, elaborado de acuerdo con las directrices de la Resolución 196/96 del Consejo Nacional de Salud, fue aprobado por el Dictamen N° 87/2012. Uno de los principales resultados obtenidos fue que el rescate de la clínica como un saber puede ser un mecanismo de fortalecimiento de la enfermería, capaz de proporcionar una asistencia que, concomitantemente, legitima la autonomía y la visibilidad de las acciones de enfermería. Se verificó que el modelo clínico/biomédico de asistencia posee en sus raíces conocimientos provenientes de la clínica como ciencia arborífica que al ser incorporados al trabajo de los enfermeros hacen posibles asistencias resolutivas y coherentes con las necesidades de salud de la clientela asistida y con el contexto de trabajo. Las asistencias de enfermería son proporcionadas por los enfermeros de modos distintos y dependientes del conocimiento clínico: sea a partir de conexiones directas con los pacientes como con la creación de líneas de fuga con otros miembros del equipo de salud multiprofesional. Por lo tanto, existe la formación de rizomas por medio de líneas de fuga que parten de la propia estructura arborífica. Los rizomas son fundamentados y transformados con base en las necesidades que surgen de la práctica clínica de los enfermeros y demuestran la capacidad de esos profesionales para superar el modelo clínico/biomédico hegemónico de asistencia, confirmando la tesis de que el trabajo de la enfermería se organiza de acuerdo con dos perspectivas interconectadas e interdependientes: la perspectiva del modelo clínico, que compone la estructura maestra de su práctica y se equipara a la estructura arborescente del referencial de Deleuze y Guattari que es representada por los saberes biológico, fisiológico, patológico y farmacológico; y la perspectiva caracterizada por una estructura rizomática, compuesta por elementos múltiples y heterogéneos, que puede ser representada por aspectos que interfieren en el ambiente en que el paciente está inserido, sea en el ámbito social, familiar o de trabajo, entre otros. De ese modo, el modelo clínico de asistencia se organiza como una estructura centrada que hace posible la resolutividad de las necesidades biológicas y actúa como base para la conexión de otros saberes y prácticas que expanden el hacer de los enfermeros por medio de interligaciones con el ambiente, resultando en una práctica clínica más próxima de lo que se considera/denomina integralidad.

Le continuel développement des outils statistiques permet aujourd’hui la modélisation de nombreux phénomènes, toujours plus complexes. En combinant l’approche offerte par des modèles statistiques spécifiques, dit "multiniveaux", et leurs applications à différentes problématiques médicales, cette thèse s’inscrit à la croisée de divers domaines : celui des statistiques, de par la méthodologie sur laquelle reposent les résultats ; mais aussi, celui de l’économie de la santé et de la santé publique en général, au travers des applications présentées.La première partie de cette thèse s’intéresse aux aspects théoriques, et plus particulièrement à l’évolution des méthodologies, du modèle de régression linéaire simple aux modèles multiniveaux pour des liens non nécessairement linéaires. Le déroulé historique de la modélisation mais également les hypothèses, le principe, la stratégie d'analyse et enfin les limites y sont abordés.La seconde partie s’articule autour de deux applications multiniveaux distinctes. La première concerne les déterminants de l'observance et des interruptions de traitement, chez les personnes infectées par le virus du VIH/Sida suivant un traitement par antirétroviraux, dans le contexte du Cameroun. La seconde, quant à elle, s'intéresse au recours aux soins dentaires chez les personnes âgées de 60 ans et plus et vivant en domicile ordinaire. Ces deux applications sont comparables dans leurs méthodologies puisqu’il s’agit de déterminer les comportements étudiés par des variables individuelles habituellement retenues, mais aussi des variables de "contexte" (caractéristiques de l’offre de soins).La troisième partie est consacrée aux applications sur le panel de médecins généralistes et traite deux études autonomes. La première expose les réticences des médecins, et le rôle de leurs aprioris, face aux Recommandations de Bonnes Pratiques (RBP). Elle nous permet de déboucher sur quelques pistes pour améliorer l’usage des RBP en médecine de ville. La seconde analyse la similarité – ou parfois la dissimilarité – entre le cycle d’activité des médecins généralistes et la saisonnalité des épidémies, dans le but d’identifier les facteurs favorisant l’ajustement des médecins généralistes aux variations saisonnières des besoins des patients. Cette étude pourrait permettre, notamment, d’anticiper et de mieux gérer des situations de crise sanitaire, avec l’appui effectif de la médecine de ville. / The continual development of statistical tools allows the modelling of numerous phenomena, including the complex ones. Using a set of statistical techniques and applications, based on the so-called “multilevel” modelling, this thesis deals with different aspects related to the statistical methodology and applications as per health economics and public health.The first part reconsiders the evolution of methodology, starting from the simple linear regression techniques to the more complex multilevel modelling as applied to both the linear and non-linear relations. It addresses issues related to the historical development, the hypotheses, the strategy of analysis, and the scope of applications. The second part presents two distinct multilevel studies. The first concerns the determinants of observance and interruptions of treatment for persons infected by the HIV/AIDS and treated with antiretroviral in Cameroon. The second one focuses on the use of dental services for the elderly. The two studies are methodologically comparable in that, besides integrating the usually retained individual variables, the analyses examine health seeking behaviours, particularly, the utilisation of health care services, while accounting for contextual determinants such as the characteristics of health supply (clinic, department or region).The third part is dedicated to the applications on GPs' panel and contains two different studies. The first one explains the GPs’ behaviours and the role of their aprioris vis-à-vis Clinical Practice Guidelines (CPG), and suggests solutions to overcome their negative attitudes. The second study analyses the similarity – sometimes the differences – between the cycle of GPs’ activity and the seasonality of epidemics with the aim of better understanding determinants favouring the adjustment of the GP in the seasonal variations of the patients needs. This study helps anticipate and manage situations of sanitary crisis, with the effective support of general practitioners.

L’information est un des besoins les plus importants des patients atteints de cancer. Leurs attentes fortes, variables et hétérogènes, en matière d’informations sur les différents aspects de la prise en charge de la maladie, soulèvent la question de la qualité de ces informations mises à disposition des patients. L’élaboration d’outils d’information et d’aide à la décision de qualité, qu’ils soient destinés aux cliniciens, tels que les recommandations pour la pratique clinique (RPC), ou aux patients, tels que des documents écrits d’information, implique la prise en compte des trois composantes essentielles de la décision médicale : données actuelles de la science (evidence-based medicine), expertise professionnelle, et préférences et valeurs des patients. Pour pouvoir baser la décision médicale sur ces trois dimensions, l’enjeu est de partager avec les patients les données actuelles de la science, et d’intégrer les préférences des patients dans les RPC. Notre hypothèse est qu’il est possible d’intégrer les préférences des patients à deux niveaux de production des connaissances : l’élaboration de documents écrits d’information des patients dans le cadre du programme SOR SAVOIR Patient d’une part, et l’élaboration de RPC pour les cliniciens d’autre part. Les résultats de ces travaux fournissent une contribution méthodologique pour améliorer la qualité des documents écrits et impliquer les patients atteints de cancer dans le développement de ces informations / Information is one of the most important needs of cancer patients. Their strong, variable and heterogeneous expectations, in terms of information on different aspects of the management of the disease, raise the question of the quality of the information made available to patients. The development of good-quality information materials and decision aids, dedicated to clinicians, such as clinical practice guidelines (CPG), or dedicated to patients, such as patient information leaflets, requires taking into account the three essential components of medical decision: current scientific data (evidence-based medicine), professional expertise and patient values and preferences. To be able to base medical decisions on these three dimensions, the challenge is to share with the patients current scientific data, and incorporate patient preferences in the development process of CPG. Our hypothesis is that it is possible to integrate the preferences of patients at two levels of knowledge production: the development of written patient information in the French SOR SAVOIR Patient program on the one hand, and development of CPG for clinicians on the other hand. The results of this work provide a methodological contribution to improve the quality of written documents and involve cancer patients in the development of this information.

Cervical cancer, a completely curable disease with early detection and management, is an international concern. Early identification allows for treatment of the disease, which prevents or slows progression, ultimately reducing morbidity and mortality. Due to the regressive nature of most cervical lesions, the duration between cervical cytology has been lengthened to prevent over diagnosis and treatment. This was reflected in the 2012 United States Preventative Services Task Force (USPSTF) clinical practice guideline for cervical cancer screening. The purpose of this project was to determine the effectiveness of a quality improvement initiative to increase adherence to the 2012 USPSTF guideline at a volunteer medical clinic for the working uninsured. In this retrospective, time series observational evaluation, data were collected via chart review regarding adherence to the guideline. The intervention consisted of the placement of a visual algorithm educational tool for clinical decision-making for cervical cytology screening in each exam room. Data were collected during three time periods: (1) the 3 months prior to initial education of clinic staff regarding the guideline; (2) the 3months between initial education and introduction of the algorithm; and (3) the 3 months post introduction of the algorithm. A total of 335 charts were reviewed. There was a significant difference in the proportion of appropriate screening among the three groups (Χ2= 6.83 p=.03). There was also a significant difference in appropriate screening rates between the new and established patients’ group, controlling for group (p<.0001). The use of the interventional algorithm is recommended to improve adherence to evidence-based practice guideline related to cervical screening as it decreases harm(s) to the patient by reduction of fear, cost to the patient, and overtreatment of benign regressive lesions.