Background: There is a high incidence of Mycobacterium tuberculosis (M tb) infection and active Tuberculosis (TB) disease among adolescents in high TB burden countries, such as South Africa (SA), which indicates that clinical trials assessing vaccine-induced protection are critical in this age group. In educating adolescents regarding TB and clinical trials it is important to ensure that this population has received some relevant prior information if they are approached for clinical research, as well as for the benefits to their own health. Method: Applied theatre was used to educate and inform adolescents to improve their knowledge about TB and clinical research. The script used was based on a young mother's decision to enroll her baby as a participant in a TB vaccine trial and the questions asked by her family and the community. The story played itself out in public transport, a local clinic and the participants' household, using singing, dancing and rap in the local dialect. The message was visually delivered by actors from the Worcester Senior Secondary (WSS) School's drama class in an adolescent-friendly format to learners. A pre-performance multiple choice knowledge survey was completed by the study population before they watched the play and approximately seven days after the play the same knowledge survey was completed as a post-test. Results: Of the total study population 4.56% of the adolescents had had TB previously and 39.15 % had been involved in TB research. A high number of the adolescents (97. 7 0 %) had heard about TB and 78. 39 % indicated that they heard about TB at school. The majority of adolescents knew that TB is contagious: 82.92 % in pre-and 97.26 % in post-test. The results for mode of prevention (covering your mouth when coughing / sneezing) in the pre-test for all the schools were above 9 1.28 %. In all tested schools combined there was a slight knowledge increase from pre-to post-test that TB is curable. There was a significant knowledge improvement (P=0.009) for the question: "TB can easily be cured if you take your treatment?" Reassuringly, 9 4.84 % (pre-test) and 9 2.78 % (post-test) indicated that they would consult a medical doctor or go to the clinic if they thought they had TB. Clinical research knowledge did not improve. Conclusion: Using applied theatre to sensitize a rural adolescent population to TB-related clinical research was a novel approach to educate and convey sensitive information to potential study participants. Through theatre, SATVI raised awareness and established strong partnerships with the Department of Basic Education (DoE), school principals, teachers and adolescents as well as indirectly with their parents. It created a platform to engage with the adolescents as well as sensitizing them for a future clinical trial.

Includes bibliographical references. / Aims : 1. To determine the proportion of patients who present with TB treatment and or ART-associated drug-induced liver injury (DILI) amongst all patients presenting with significant liver injury to GF Jooste Hospital during the study period. 2. To describe base line clinical characteristics and management of TB treatment and or ART-associated DILI patients. 3. To describe the in-patient and 3-month mortality of TB treatment and or ART-associated DILI patients. Background and Rationale : GF Jooste Hospital is a public sector referral hospital and serves a densely populated area with a high burden of HIV and tuberculosis (TB). ART rollout in the Western Cape started in 2001/2002 at two pilot clinics and is now well established (1). Many patients are on concomitant TB treatment and ART. At ART clinics in the referral area 25 - 40% of patients are on TB treatment when they start ART (2, 3) . At GF Jooste hospital many HIV positive patients are seen who are on TB treatment and or ART, and present with symptomatic liver dysfunction. Patients are on multiple hepatotoxic drugs, may have multiple opportunistic infections, systemic sepsis and hepatic TB immune reconstitution disease also plays a role. Anecdotally, these patients are complex to manage, require frequent specialist input, spend a long time in hospital and have high mortality. Management guidelines are based on expert opinion and is not evidence based. In practice management relies heavily on the attending clinicians’ experience and clinical judgment and management often differ widely between clinicians. Mortality could be due to progression of TB and or HIV because of interruption of effective therapy, other opportunistic infections or hospital acquired infections. Few early liver biopsies are done and it is not known if early liver biopsies would aid by guiding management of these patients. Prospective studies are urgently needed to guide management in these patients. The burden of TB treatment and or ART-associated drug induced liver injury in this setting has not been described to our knowledge, neither has management, outcome or mortality. This study was performed to aid planning of prospective studies in this field.

No description available.

Thesis (M.S.)--Boston University / PLEASE NOTE: Boston University Libraries did not receive an Authorization To Manage form for this thesis or dissertation. It is therefore not openly accessible, though it may be available by request. If you are the author or principal advisor of this work and would like to request open access for it, please contact us at open-help@bu.edu. Thank you. / 2031-01-01

Made available in DSpace on 2014-06-11T19:23:07Z (GMT). No. of bitstreams: 0 Previous issue date: 2011-03-30Bitstream added on 2014-06-13T18:09:08Z : No. of bitstreams: 1 lago_ar_me_botfm.pdf: 686937 bytes, checksum: bf3207ac9af78684b885e65c7b4ac7c6 (MD5) / Fundação Pio Xii - Barretos / A gestão administrativa e de informação são ferramentas indispensáveis nas empresas e contribuem decisivamente para um melhor desempenho e otimização de recursos, podendo melhorar a estratégia e visão de futuro, possibilitando projetar cenários diferenciados e privilegiados para tomadas de decisão. Presente no país há duas décadas aproximadamente, a Pesquisa Clínica em oncologia pouco utiliza estas ferramentas. É indiscutível a importância e necessidade de definição da unidade de pesquisa clínica como ponto estratégico de uma entidade médico/hospitalar. Em 2006, após reestruturação de área física e profissional da unidade de Pesquisa Clínica do Hospital de Câncer de Barretos foi implementado um modelo de gestão profissionalizado, sendo designado a gerência geral e tomada de decisão para um profissional atuante em administração médico/hospitalar. Foi necessária a criação de um sistema informatizado capaz de monitorar, controlar e gerenciar todos os processos na condução de estudos clínicos oncológicos. Este software foi desenvolvido pelo departamento de tecnologia da informação da instituição e contou com a participação de um analista de sistemas, um programador e um analista de negócios, utilizando banco de dados e ferramentas de desenvolvimento Oracle®. O programa computacional demonstrou atender as necessidades mínimas do departamento, além de se revelar como perfeitamente aplicável em estrutura e recursos de uma instituição médico/hospitalar em oncologia / The management of business and information are indispensable tools in companies and contribute decisively for a better performance and optimization of resources, which can improve the performance and vision of future, allowing to project differential and privileged sceneries for decision-making. Oncology Clinical Research is present in our country for about two decades and makes very little use of those tools. The importance and necessity of definition of Clinical Research Unit as a strategic item of a medical/hospital entity is unquestionable. In 2006, after area and professional re-structuration of the Clinical Research Unit of Hospital de Cancer de Barretos, a professional pattern of administration, general management and decision-making was designated to a professional who was used to act on medical/hospital administration. It was necessary the creation of a computerized system, able to monitoring, controlling and managing all the process on the conduction of oncology clinical trials. This software was developed by the information technology department of the institution, with participation of a systems analyst, a programmer and a business analyst, using database and Oracle® development tools. It was observed that the computational program attended the minimal necessities of the department. Besides, it was considered perfectly applied on structure and resources of an oncology medical/hospital institution

Established in 1923, the Thorndike Memorial Laboratory at Boston City Hospital was the first clinical research laboratory in a municipal hospital in the United States of America. Minor and Castle, who were the second and third directors of the Laboratory, were pioneer haematologists and clinical investigators of the highest calibre who created an atmosphere at the Laboratory that would foster patient-centred research and attract the best physician-scientists to work and train there. The haematology research division of the Laboratory made important original contributions to the understanding of the pathophysiology of anaemia, the mechanisms of red cell and platelet destruction and the phagocytic role of the spleen, the nature of haemoglobin (normal and sickle cell), the nature of haemophilia and its therapy and the early classification of lymphoma. It contributed to the Thorndike Memorial Laboratory's worldwide reputation as a model research laboratory and established its reputation as the birthplace of modern haematology.

Le cancer du sein a touché près de 49000 femmes en France en 2012. Deux pour cents surviennent chez des femmes de moins de 35 ans. Comme beaucoup de femmes reportent leur maternité à plus tard, les médecins font de plus en plus face aux questions relatives à une grossesse post-traitement. L’histoire reproductive, les influences hormonales et le cancer du sein semblent liés. Pourtant aucune étude n’a rapporté d’impact péjoratif de la grossesse sur l’évolution du cancer ; par contre beaucoup d’études ont annoncé que la grossesse n’avait aucun impact, et pourrait même avoir un effet de protection à long terme. Toutefois l’interprétation des résultats est souvent limitée par un biais de confusion connu, le « healthy mother bias » : seules les femmes se sentant en bonne santé vont mener une grossesse. La grossesse est donc un événement dont la survenue est liée au statut pronostique de la patiente et qui pourrait interagir avec l’hormonosensibilité du cancer du sein. Pour tenter de prendre en compte ce biais de confusion dans l’estimation et l’interprétation de l’effet d’une grossesse qui est un événement survenant au cours du temps, nous avons exploré deux approches. La grossesse est assimilée à une exposition survenant au cours du temps. Dans un premier temps nous avons appliqué le modèle « illness-death » sur des données de cohorte : l’exposition est l’état intermédiaire dont la valeur dépend du temps ; l’estimation des facteurs influençant le passage vers l’exposition permet une évaluation qualitative de la confusion. L’effet de l’exposition est étudié à partir de la comparaison des transitions vers l’événement d’intérêt : celles ayant eu l’événement intermédiaire versus les autres. Cet effet est estimé en prenant en compte l’interaction entre les facteurs pronostiques caractérisant le niveau de gravité de la maladie et l’exposition. Dans la seconde approche, nous avons constitué, à partir de la cohorte, des paires composées d’un sujet exposé et d’un sujet non exposé. Dans la littérature, l’appariement est réalisé en créant les paires a posteriori comme si la grossesse était connue lors du diagnostic du cancer. Nous proposons, dans ce cas particulier où l’événement caractérisant les sujets d’une paire survient au cours du temps, une nouvelle méthode d’appariement. De plus, nous étudions des modèles d’analyse connus et dédiés aux données censurées corrélées : le modèle de Cox stratifié de Holt et Prentice, le plus utilisé, et le modèle de Cox de Lee Wei et Amato. Tout le travail est basé sur une large étude de simulation afin d’estimer et interpréter l’effet pronostique d’un événement survenant au cours du temps et en lien avec le statut pronostique. Les conclusions de ces simulations ont été appliquées à l’analyse d’une cohorte réelle de patientes jeunes traitées pour un cancer du sein, afin d’évaluer l’effet d’une éventuelle grossesse post-traitement sur l’évolution de la maladie. / Almost fifty thousand women were treated for breast cancer in France in 2012. Two percents occur in women under 35 years old. As more women are postponingchildbearing until later life, physicians are more often faced with questions regarding their subsequent pregnancy. Reproductive history, hormonal influences, and breastcarcinoma may be interrelated. However no study has reported a pejorative effect of the pregnancy on the breast cancer recurrences; many studies have found that pregnancy has no adverse effects on clinical outcome in women diagnosed previously with breast cancer, and may even have a long-term protective effect in some. This phenomenon may be due to the « healthy mother bias »: only women who feel well will pursue a subsequent pregnancy. So the pregnancy is an event which occurrence is linked to the prognostic status of the patient; and its appearance might interact with the hormonal sensitivity of the breast cancer. To try to take into account this confusion bias in the estimation and interpretation of the pregnancy effect, we explore two approaches. The pregnancy is considered as an exposure. In a first way, we apply the illness-death model to analyze cohort data: the exposition is the intermediate state which value depends on time; the estimation of the factors related to the transition to the exposure allows a qualitative evaluation of the confusion. The effect of the exposure is studied through the comparison between the transitions to the event of interest: those which underwent the intermediate state and the others. This effect is estimated by taking into account the interaction between the exposure and the prognostic factors characterizing the gravity of the disease as reflecting the health status. In the second approach, pairs composed of an exposed and a non-exposed subject are created from the cohort data. In the literature, the matching is realized by creating pairs a posteriori, as if the pregnancy was known at the cancer diagnosis date. We propose in this particular case where the event characterizing the member of the pair is an event occurring over time, a newmatching method. Moreover, we studied some known models of analysis dedicated to the censored correlated data: the stratified Cox model of Holt and Prentice, the more used, and the Cox model of Lee, Wei and Amato. All the work is based on a large simulation study in order to estimate and interpret the prognostic effect of an event occurring over time and related to the prognostic status. The simulations conclusions were applied to the analysis of real data of young women treated for a breast cancer, in order to evaluate the possible prognostic effect of a subsequent pregnancy.

Orientador: Sérgio Vicente Serrano / Banca: Maria Inês de Moura Campos Pardini / Banca: Umberto Tachinardi Andrade Silva / Resumo: A gestão administrativa e de informação são ferramentas indispensáveis nas empresas e contribuem decisivamente para um melhor desempenho e otimização de recursos, podendo melhorar a estratégia e visão de futuro, possibilitando projetar cenários diferenciados e privilegiados para tomadas de decisão. Presente no país há duas décadas aproximadamente, a Pesquisa Clínica em oncologia pouco utiliza estas ferramentas. É indiscutível a importância e necessidade de definição da unidade de pesquisa clínica como ponto estratégico de uma entidade médico/hospitalar. Em 2006, após reestruturação de área física e profissional da unidade de Pesquisa Clínica do Hospital de Câncer de Barretos foi implementado um modelo de gestão profissionalizado, sendo designado a gerência geral e tomada de decisão para um profissional atuante em administração médico/hospitalar. Foi necessária a criação de um sistema informatizado capaz de monitorar, controlar e gerenciar todos os processos na condução de estudos clínicos oncológicos. Este software foi desenvolvido pelo departamento de tecnologia da informação da instituição e contou com a participação de um analista de sistemas, um programador e um analista de negócios, utilizando banco de dados e ferramentas de desenvolvimento Oracle®. O programa computacional demonstrou atender as necessidades mínimas do departamento, além de se revelar como perfeitamente aplicável em estrutura e recursos de uma instituição médico/hospitalar em oncologia / Abstract: The management of business and information are indispensable tools in companies and contribute decisively for a better performance and optimization of resources, which can improve the performance and vision of future, allowing to project differential and privileged sceneries for decision-making. Oncology Clinical Research is present in our country for about two decades and makes very little use of those tools. The importance and necessity of definition of Clinical Research Unit as a strategic item of a medical/hospital entity is unquestionable. In 2006, after area and professional re-structuration of the Clinical Research Unit of Hospital de Cancer de Barretos, a professional pattern of administration, general management and decision-making was designated to a professional who was used to act on medical/hospital administration. It was necessary the creation of a computerized system, able to monitoring, controlling and managing all the process on the conduction of oncology clinical trials. This software was developed by the information technology department of the institution, with participation of a systems analyst, a programmer and a business analyst, using database and Oracle® development tools. It was observed that the computational program attended the minimal necessities of the department. Besides, it was considered perfectly applied on structure and resources of an oncology medical/hospital institution / Mestre

Made available in DSpace on 2014-06-11T19:27:57Z (GMT). No. of bitstreams: 0 Previous issue date: 2001Bitstream added on 2014-06-13T18:56:50Z : No. of bitstreams: 1 mantovanineto_f_me_botfm.pdf: 1481420 bytes, checksum: 1b888bb63cac554aeea6a214944c0cf2 (MD5) / Pesquisas envolvendo seres humanos têm sido realizadas há muito tempo. Com o passar dos anos, regulamentações foram sendo instituídas com o objetivo de proteger os direitos e integridade dos participantes e de assegurar que os dados e resultados dos estudos fossem dignos de credibilidade. Hoje, além de regulamentações locais, os estudos clínicos devem ser conduzidos de acordo com normas internacionais (Good Clinical Practice - GCP) de pesquisa clínica. Neste trabalho, tentamos avaliar, através de questionários, o crescimento da pesquisa clínica no Brasil, nos últimos cinco anos. Fizemos contato com 61 indústrias farmacêuticas situadas na cidade de São Paulo e 200 investigadores brasileiros, envolvidos em estudos clínicos. 44% das indústrias comprometeram-se a responder um questionário. Desses 44%, obtivemos retorno de 59% delas. A taxa de resposta por parte dos investigadores foi de 23%. Comparações de dados em dois períodos distintos (há cinco anos e atualmente) demonstraram aumento, estatisticamente significativo, de número de pessoas nos departamentos de pesquisa, número de protocolos, número de pacientes envolvidos em estudos clínicos, número de centros habilitados e estados onde as pesquisas são conduzidas. Houve ainda, diminuição de protocolos fase IV, aumento de protocolos fase II e III, e mais investimentos financeiros por parte das indústrias farmacêuticas. Através de respostas abertas e subjetivas, concluímos que, além do crescimento quantitativo, houve crescimento qualitativo da pesquisa clínica no Brasil. Hoje, o país é considerado emergente e com grande potencial para desenvolvimento de novos produtos... / Clinical research has been conducted for a long time. Along the years, resolutions have been implemented to assure that the rights and integrity of trial subjects are protected, and that the data and reported results are credible. Nowadays, besides local resolutions, clinical trials must be conducted according to international guidelines (Good Clinical Practices – GCP). In this study we tried to evaluate, through questionnaires, the growth of clinical research in Brazil in the last five years. Sixty-one pharmaceutical industries located in São Paulo city and 200 Brazilian investigators involved with clinical trials were contacted. Forty-four percent of the industries committed to answer a questionnaire. Results were obtained from 59% of them. The rate of response from the investigators was 23%. Comparing data from two different points in time (five years ago and nowadays) there was significant difference in the number of members working in clinical research departments, number of protocols, number of trial patients, number of qualified sites, and number of states where the trials have been conducted. It was also observed a decrease in phase IV trials, increase of phase II and III trials, and more financial investments from industries in this area. Opened and spontaneous responses allowed us to conclude that clinical research in Brazil has not only increased, but has also improved its quality. Today, Brazil is considered to be an emergent country and presents with high potential to develop new products. Although clinical research has grown, one of the biggest concerns to conduct clinical trials in the country is the lack of trained and qualified human resources to... (Complete abstract, click electronic access below)

Orientador: Marcelo Fabiano de Franco / Resumo: Pesquisas envolvendo seres humanos têm sido realizadas há muito tempo. Com o passar dos anos, regulamentações foram sendo instituídas com o objetivo de proteger os direitos e integridade dos participantes e de assegurar que os dados e resultados dos estudos fossem dignos de credibilidade. Hoje, além de regulamentações locais, os estudos clínicos devem ser conduzidos de acordo com normas internacionais (Good Clinical Practice - GCP) de pesquisa clínica. Neste trabalho, tentamos avaliar, através de questionários, o crescimento da pesquisa clínica no Brasil, nos últimos cinco anos. Fizemos contato com 61 indústrias farmacêuticas situadas na cidade de São Paulo e 200 investigadores brasileiros, envolvidos em estudos clínicos. 44% das indústrias comprometeram-se a responder um questionário. Desses 44%, obtivemos retorno de 59% delas. A taxa de resposta por parte dos investigadores foi de 23%. Comparações de dados em dois períodos distintos (há cinco anos e atualmente) demonstraram aumento, estatisticamente significativo, de número de pessoas nos departamentos de pesquisa, número de protocolos, número de pacientes envolvidos em estudos clínicos, número de centros habilitados e estados onde as pesquisas são conduzidas. Houve ainda, diminuição de protocolos fase IV, aumento de protocolos fase II e III, e mais investimentos financeiros por parte das indústrias farmacêuticas. Através de respostas abertas e subjetivas, concluímos que, além do crescimento quantitativo, houve crescimento qualitativo da pesquisa clínica no Brasil. Hoje, o país é considerado emergente e com grande potencial para desenvolvimento de novos produtos... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Clinical research has been conducted for a long time. Along the years, resolutions have been implemented to assure that the rights and integrity of trial subjects are protected, and that the data and reported results are credible. Nowadays, besides local resolutions, clinical trials must be conducted according to international guidelines (Good Clinical Practices - GCP). In this study we tried to evaluate, through questionnaires, the growth of clinical research in Brazil in the last five years. Sixty-one pharmaceutical industries located in São Paulo city and 200 Brazilian investigators involved with clinical trials were contacted. Forty-four percent of the industries committed to answer a questionnaire. Results were obtained from 59% of them. The rate of response from the investigators was 23%. Comparing data from two different points in time (five years ago and nowadays) there was significant difference in the number of members working in clinical research departments, number of protocols, number of trial patients, number of qualified sites, and number of states where the trials have been conducted. It was also observed a decrease in phase IV trials, increase of phase II and III trials, and more financial investments from industries in this area. Opened and spontaneous responses allowed us to conclude that clinical research in Brazil has not only increased, but has also improved its quality. Today, Brazil is considered to be an emergent country and presents with high potential to develop new products. Although clinical research has grown, one of the biggest concerns to conduct clinical trials in the country is the lack of trained and qualified human resources to... (Complete abstract, click electronic access below) / Mestre