Made available in DSpace on 2016-01-26T12:51:50Z (GMT). No. of bitstreams: 1 margareteartico_dissert.pdf: 621420 bytes, checksum: d6484338aa944f835c788d5909f93257 (MD5) Previous issue date: 2006-05-17 / The reuse of health care products [medical and supply hospital products] is a practice carried out by several countries. The hemodynamic catheters, which are used for diagnosis examination and cardiac procedures, such as coronary angioplasty, are the most reutilized ones. The technical difficulties to reprocess the products and the adverse events are important issues for those who decide for the reutilization of these products. Objectives: To describe the adverse events presented by the patients during and after the coronary angioplasty possibly related to the reuse of health care products [medical and supply hospital products], and to quantify and identify the reasons to discard the products in relation to both the first use and to the reuse. Casuistic and Method: Of 60 patients who were submitted to coronary angioplasty, 33 (55%) were men. The age ranged from 42 to 88 years-old, 63 ± 10 years [mean ± SD]. According to the anamnesis, 22 patients (36.7%) presented hypertension, and 10 (16.7%) had diabetes. Of this group, 15 patients (25%) were smokers, and 8 (13.3%) were alcoholics. Of the 60 patients, 29 (48.3%) presented unstable angina, 27 (45%) had AMI (acute myocadial infarction), and 4 (6.6%) other diagnoses. During the procedure and the permanence in the Intensive Care Unit (ICU) the occurrences of adverse events, such as fever, hypertension, hypotension, chills, sudoresis, bleeding, nausea, and vomit presented by the patients have been observed. Seven medical devices have been evaluated: introductor, guiding catheter, guidewire 0.35, guidewire 0.014, balloon catheter for angioplasty, a syringe with manometer to insufflate the balloon (indeflator), and a three-way (3) stopcock (manifold). Of these, 76 were first-use products and 410 reprocessed products. It was verified if the same products were discarded before or during the procedure, and which were the reasons that led these products to be discarded. The categorical variables have been analyzed with the chi-square test (χ2 test). The discrete quantitative variables have been analyzed with a nonparametric statistical test for ordinal data (Mann-Whitney test). A type I error of 5% was admitted. Results: The results have highlighted that 26 patients presented adverse events. Hypotension was the most clinically significant adverse event and occurred in 11 (18.3%) of the patients. There was not, however, a statistical significance between the hypotension adverse event and the reuse of the products. Four first-use products and 80 reused products have been discarded. Three first-use products and 55 reused products have been discarded because they were damaged. We want to emphasize that all the syringes used to insufflate the balloon, which have been discarded, have been so for this reason. Conclusions: The adverse events presented by the patients submitted to angioplasty are not related to the reuse of the health care products. The medical devices integrity and functionality have been the main reason of the discards. / O reuso dos produtos médico-hospitalares é uma prática realizada por vários países. Os cateteres de hemodinâmica que são empregados para os exames de diagnósticos e intervenções cardíacas como a angioplastia coronária, são os mais reutilizados. As dificuldades técnicas para o reprocessamento dos produtos e os eventos adversos são questões importantes para quem decide pela reutilização desses produtos. Objetivos: Descrever os eventos adversos apresentados pelos pacientes durante e após a angioplastia coronária, possivelmente relacionadas ao reuso dos produtos médico-hospitalares além de quantificar e identificar os motivos de descarte dos produtos em relação ao primeiro uso e ao reuso. Casuística e Método: Foram estudados 60 pacientes submetidos a angioplastia coronária. Deste grupo 33 (55%) eram homens. A idade variou de 42 a 88 anos, com média e desvio padrão de 63 ± 10 anos. De acordo a anamnese 22 (36,7%) apresentavam hipertensão arterial e 10 (16,7%) tinham diabetes. Deste grupo 15 (25%) eram fumantes e 8 (13,3%) eram etilistas. Dos 60 pacientes, 29 (48,3%) apresentavam angina instável, 27 (45%) IAM e 4 (6,6%) outros diagnósticos. Durante o procedimento e na permanência na Unidade Intensiva Coronariana (UCOR), foram observadas as ocorrências dos eventos adversos, febre, hipertensão, hipotensão, calafrios, sudorese, sangramento, náuseas e vômitos, apresentados pelos pacientes. Foram avaliados, sete produtos médico-hospitalares, introdutor, cateter guia, fio guia 0.35, fio guia 0.014, cateter balão para angioplastia, seringa com manômetro para insuflar balão (indeflator) e torneirinha de 3 vias descartável (manifold), sendo 76 de primeiro uso e 410 reprocessados. Verificou-se se os mesmos foram descartados antes ou durante o procedimento e quais os motivos que levaram a esses descartes. As variáveis categóricas foram analisadas com o auxilio do teste Qui Quadrado. As variáveis quantitativas discretas foram analisadas com o auxilio de teste não paramétrico (Mann-Whitney). Foi admitido erro alfa de 5%. Resultados: Os resultados evidenciaram que 26 (43,3%) dos pacientes apresentaram eventos adversos. A hipotensão foi o evento adverso mais relevante clinicamente e ocorreu em 11(18,3%) dos pacientes. Não houve, porém, significância estatística entre o evento adverso hipotensão e o reuso dos produtos médico-hospitalares. Foram descartados 4 produtos de primeiro uso e 80 dos reutilizados. Por não estarem íntegros, foram descartados 3 produtos de primeiro uso e 55 produtos dos reutilizados. Destaca-se que todas as seringas de insuflar balão, que foram descartadas, o foram por esse motivo. Conclusões: Os eventos adversos apresentados pelos pacientes submetidos à angioplastia não estão associados ao reuso dos produtos médico-hospitalares. A integridade e funcionalidade foram os motivos principais de descartes dos produtos médico-hospitalares.

Made available in DSpace on 2011-05-04T12:36:26Z (GMT). No. of bitstreams: 0 Previous issue date: 2010 / Hoje em dia, uma série de vacinas são capazes de proteger as pessoas, reduzindo drasticamente a incidência de doenças. Para gerenciar as ações de imunização em saúde pública, o Programa Nacional de Imunizações foi criado em 1973. Através dos seus mecanismos de trabalho, tais como, fornecimento de vacinas para toda a população, financiada pelo Governo Federal, sem custos diretos para os vacinados; armazenamento, transporte e suprimento de vacinas em redes de frio adequadas; sistemas de informações confiáveis, o Programa Nacional de Imunizações tem êxito em seus objetivos por controlar várias doenças evitáveis pela imunização. No entanto, sabemos que a ocorrência de eventos adversos pode surgir após a administração desses produtos imunizantes EAPV. Para monitorar e controlar EAPV, a Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação foi criado pelo Programa Nacional de Imunização, em 1992. Este serviço foi estruturado para reconhecer e identificar os casos de EAPV, subsidiar pesquisas, e assessorar os profissionais de saúde na vigilância de casos, entre outros objetivos que contribuem para o controle de vacinas, saúde e bem-estar da população. Para fazer o controle de eventos adversos, a Vigilância Epidemiológica de EAPV usa um formulário de notificação, manual de monitoramento com informações e instruções para notificar e investigar casos de EAPV e fornecer dados para o sistema de informação. Este último é fundamental para acompanhar os casos suspeitos e confirmados de EAPV, identificando os casos graves, os surtos e controlar os lotes de vacinas que podem causar eventos adversos à população vacinada. Desde 1998, o Programa Nacional de Imunizações tem administrado o Sistema de Informações de Eventos Adversos Pós-Vacinação, desenvolvido pela equipe técnica do Departamento de Informática do Ministério da Saúde DATASUS. Com base nas diretrizes e critérios para avaliação de sistemas de vigilância do Centers for Disease Control and Prevention (CDC) - Atlanta / EUA, várias falhas e erros foram apontadas no sistema, onde surgiu a proposta de um novo sistema de informação para melhorar a eficácia da Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação. O sistema foi revisto de acordo com a padronização da Terminologia de Reações Adversas (WHO-ART) e o Dicionário Médico de Atividades Reguladoras (MedDRA) da Rede Uppsala Monitoring Centre(UMC). O novo sistema de informações proposto nesta dissertação pode beneficiar de Vigilância Epidemiológica de Eventos Adversos Pós-Vacinação facilitando o fluxo de dados de EAPV, ampliando o acesso às informações aos diversos profissionais de saúdee fabricantes de vacinas, atualizando e facilitando a operação, enquanto mantém a segurança e privacidade da informação. Esta proposta inclui um novo formulário de notificação com base no atual formato em uso nas unidades de saúde no país, além das fichas de notificação dos sistemas de vigilância do Canadá e EUA. O Centro de Vigilância Epidemiológica da Secretária de Estado da Saúde de São Paulo, também contribuiu com o seu modelo de formulário. / Nowadays, a number of vaccines are able to protect people, reducing dramatically the incidence of diseases. To manage the immunizing actions in public health, the Brazilian National Immunization Program was created in 1973. Through its working mechanisms, such as, providing vaccines for the whole population, funded the Federal Government, without direct cost for vaccinees; storage, transportation and supply of vaccines in appropriate cold chain settings; reliable information systems, the National Immunization Program has succeed in its goal to control many diseases preventable by immunization. However, we know that the occurrence of adverse events may follow the administration of immunizing products – AEFI. To monitor and control AEFI, the Epidemiological Surveillance of Adverse Events Following Immunization was created by National Immunization Program in 1992. This service was structured to recognize and identify AEFI cases, subsidize research work, and support health professionals in surveillance, and other objectives that contribute to vaccines control, health and welfare of the population. To control adverse events, AEFI’s Epidemiological Surveillance use a notification form, monitoring manual with information and instructions to report and investigate AEFI’s cases and supply data to the information system. The latter is critical to follow up suspected and confirmed cases of AEFI, identifying severe cases, outbreaks and monitor vaccine lots that may cause adverse events to the vaccinated population. Since 1998, the National Immunization Program has managed the Adverse Events Following Immunization’s Informations System, developed by the technical staff in the Ministry of Health Department - DATASUS. Based on the guidelines and criteria for evaluation of the Surveillance Systems for the Centers for Disease Control and Prevention (CDC) – Atlanta / USA, several flaws and errors in systems were pointed out, and a proposal for a new information system was conceived to improve the effectiveness of the Epidemiological Surveillance of Adverse Events Following Immunization. The system was revised according to the standardization of Adverse Reactions Terminology (WHO-ART) and Medical Dictionary of Regulatory Activities (MedDRA) of the Network Uppsala Monitoring Center (UMC). The new informations system proposed in this dissertation may benefit the Epidemiological Surveillance of Adverse Events Following Immunization by expediting the flow of AEFI’s data, expanding the access to information to various health professionals, and to vaccine manufacturers, updating and facilitating operation, while mantaining security and privacy. This proposal include a new notification form based on the current format in use in the health units in the country besides the notification forms of Surveillance Systems in Canada and USA. The Epidemiological Surveillance Center of State Secretary for Health in São Paulo, also contributed to its model of form.

Submitted by Anderson Silva (avargas@icict.fiocruz.br) on 2012-09-27T17:08:04Z No. of bitstreams: 1 debora_h_g_paula_ipec_pesquisaclinicadi_0007_2010.pdf: 1005728 bytes, checksum: b98fa20a9a16f91bb1e9a163dcd87107 (MD5) / Made available in DSpace on 2012-09-27T17:08:04Z (GMT). No. of bitstreams: 1 debora_h_g_paula_ipec_pesquisaclinicadi_0007_2010.pdf: 1005728 bytes, checksum: b98fa20a9a16f91bb1e9a163dcd87107 (MD5) Previous issue date: 2010 / Instituto Nacional de Cardiologia. Rio de Janeiro, RJ, Brasil / Eventos Adversos (EAs) são complicações indesejadas que podem decorrer durante os cuidados prestados ao paciente, não atribuídas à evolução natural da doença de base, podendo resultar em seqüela, prolongando a permanência no hospital ou mesmo levar ao óbito. A utilização do acesso intravenoso no tratamento medicamentoso da endocardite infecciosa (EI) pode trazer EAs ao paciente, com riscos de desfechos desfavoráveis. O objetivo deste estudo é identificar os EAs infecciosos e não infecciosos relacionados à utilização do acesso intravenoso no tratamento da EI no Instituto Nacional de Cardiologia (INC) nos anos de 2009 e 2010. Trata-se de estudo observacional, analítico, e prospectivo, a partir do diagnóstico possível e definitivo para EI, pelos critérios de Duke modificados, através do preenchimento de instrumentos de coleta de dados adaptados de outros estudos primários [International Collaboration on Endocarditis (ICE) e de um estudo piloto de terapia intravenosa (INC)] dos acessos intravenosos [periférico, profundo, hemodiálise, e catéter central de inserção periférica (PICC)]. Foram incluídos 37 episódios de EI, que ocorreram em 35 pacientes. A idade média foi 44,32 ± 15,32 anos; sendo 22 (63%) pacientes do sexo masculino e 13 (37%) do sexo feminino. A amostra estudada totalizou 253 acessos intravenosos sendo 148 acessos periféricos, 85 acessos intravenosos (21 de hemodiálise) profundos de curta permanência não tunelizado (CVP), e 20 cateteres centrais de inserção periférica (PICC). “Hiperemia” e “infiltração” foram os eventos mais frequentes nos acessos periféricos; “febre” foi o evento mais frequente nos acessos profundos; “obstrução” e “exteriorização” mais frequente no PICC. A análise estatística relacionando os EAs com cada tipo de acesso intravenoso mostrou significância estatística para febre (p<0,005), bacteremia (p<0,05), saída acidental e exteriorização (p<0,001), e obstrução (p<0,001). Com relação ao tempo de permanência dos cateteres, o número de cateteres-dia foi 360 para periféricos, 1156 para CVP e 420 para PICC. A construção de curvas de Kaplan Meyer para CVP e PICC mostrou diferença estatística para obstrução (p<0,001) e manuseio (saída acidental, mais exteriorização mais obstrução, p<0,001), sendo estes eventos mais comuns na PICC. Houve mais bacteremias no CVP, mas sem diferença estatística (p=0,23). Observa-se que os eventos descritos decorrem do manuseio inadequado e de possíveis falhas nas técnicas assépticas. Deste modo, é necessário implementação mais rigorosa de medidas efetivas de controle de infecções relacionadas a acessos e ações educativas para evitar complicações mecânicas. / Adverse events (AEs) are undesirable complications that may occur during patient care that cannot be attributed to the natural history of the underlying disease. They may result in incapacity, lengthening of hospital stay or even death. The use of intravenous access in the medical treatment of infective Endocarditis (IE) may result in AE to the patient, with unfavorable outcomes. The goal of the present study was to identify the infectious and non-infectious AEs related to the use of intravenous access sites for IE treatment at national Institute of Cardiology (INC) in the years from 2009 to 2010. This is an observational, analytic and prospective study based on cases of IE diagnosed as possible or definite by the modified Duke criteria. A case report form was created for data collection on intravenous lines (peripheral, central vascular, haemodyalisis and peripherally inserted central catheter/ PICC), based on data collection forms from other primary studies[International Collaboration on Endocarditis (ICE), and a pilot study on intravenous therapy (INC)].Thirty-seven episodes of IE in 35 patients were studied. Patients’ mean age was 44.32 ± 15.2 years; 22 patients (63%) were male, and 13 (37%) female. A total of 253 vascular catheters were studied, 148 were peripheral catheters, 85 were short term, non tunneled central venous catheters (21 of which were for haemodyalisis) and 20 were PICC. “Erythema” and “infiltration” were the most frequently observed AEs in the peripheral catheters, while “fever” was the most frequent AEs for CVPs, and “obstruction”, and “externalization” were more frequent in PICCs. Statistical analysis relating AEs with venous catheters type showed significance for fever (p<0.005), bacteraemia (p<0.05), accidental extrusion and externalization (p<0.001), and obstruction (p<0.001). As to the time catheters remained, the number of catheter-days was 360 for peripheral catheters, 1,156 for CVP and 420 for PICC. Kaplan Meyer curves for CVP and PICC showed statistical difference for obstruction (p<0.001) and “manipulation” (accidental extrusion, externalization, and obstruction, p<0.001), and these events were more common in PICC. More bacteraemia occurred in CVP, but this was of no statistical significance (p=0.23). The described adverse events resulted from inadequate handling and breakdown in aseptic techniques. Therefore, it is important that stricter implementation of infection control measures to prevent catheter related infections and educational measures to minimize mechanical complications are implemented.

O avanço econômico, científico e tecnológico, vem levando a um aumento da expectativa de vida e consequente envelhecimento da população. Assim, o idoso requer atenção especial pela maior incidência de doenças crônicas e degenerativas e pelo aumento concomitante no uso de fármacos, podendo ocasionar complicações pela sua maior vulnerabilidade à eventos adversos (EAs), uso inapropriado e abusivo, exposição à interações medicamentosas sérias, e casos de iatrogenias. Acrescenta-se o fato particular de um aumento abusivo no uso de benzodiazepínicos (BDZs). O objetivo deste trabalho foi rever e sintetizar as evidências geradas por ensaios clínicos controlados e randomizados sobre a incidência de EAs relacionados ao uso de BDZs em idosos com ansiedade ou insônia em comparação àqueles que, sob as mesmas condições clínicas, não o utilizaram. Desenvolveu-se a recuperação de artigos em cinco bases de dados eletrônicas na área da saúde (PubMed, SCOPUS, Web of Science, Cochrane Central, e LILACS), para posterior análise combinada (metanálise) dos resultados evidenciados. / The economic, scientific and technological progresses have provided an increase in life expectancy and the consequent process of aging. Thus, the elderly requires special attention due to the higher incidence of chronic and degenerative diseases and the higher concomitant increase in the drugs use that may cause complications by increasing ulnerability for adverse events (AEs); nappropriate and abusive use; exposition to serious drug interactions, and iatrogenic cases. Add to these the particular abusive increase in benzodiazepine (BDZ) use. The objective of this study was to review and synthesize the evidence generated by randomized controlled trials on the incidence of AEs related to therapy with BDZs in elderly with anxiety or insomnia compared to those under the same clinical conditions, not medicated. The articles were recovered in five healthcare electronic databases (PubMed, SCOPUS, Web of Science, Cochrane Central, and LILACS), for subsequent combined analysis (meta-analysis) of the results.

Submitted by Cinthia Ferreira Costa (cinthiac.costa@gmail.com) on 2018-09-03T13:17:52Z No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5) / Approved for entry into archive by Simone de Andrade Lopes Pires (simone.lopes@fgv.br) on 2018-09-03T19:51:28Z (GMT) No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5) / Approved for entry into archive by Suzane Guimarães (suzane.guimaraes@fgv.br) on 2018-09-04T14:41:02Z (GMT) No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5) / Made available in DSpace on 2018-09-04T14:41:02Z (GMT). No. of bitstreams: 1 TA_Cinthia Costa_versão final.pdf: 765367 bytes, checksum: f616f7fa6b7603c5ba1ac56f1db7dfbf (MD5) Previous issue date: 2018-07-30 / A segurança do paciente é uma preocupação mundial e de alta prioridade na agenda da Organização Mundial da Saúde (OMS) e seus países membros. Nesse contexto, a gestão de incidentes nos serviços de saúde tem papel essencial para a redução de riscos e danos aos pacientes. Esta pesquisa teve como objetivo conhecer como é realizada a gestão de incidentes nos hospitais paulistanos e qual a visão dos gestores sobre a segurança do paciente como um fator estratégico e de competitividade. Foi realizada pesquisa qualitativa, por meio de entrevistas semiestruturadas com o auxílio de roteiro de entrevista em oito hospitais, sendo cinco privados e três filantrópicos no período de março e abril de 2018. A pesquisa demonstrou um maior número de organizações com sistema de notificação de incidentes informatizado, o crescimento dos serviços de atendimento ao cliente como referência para o contato do paciente ou familiar quando da ocorrência de um incidente e o papel da direção na informação ao paciente e familiar sobre os incidentes ocorridos. Considerando que o movimento pela segurança do paciente é relativamente recente no Brasil, o nível de maturidade da cultura de segurança dos hospitais entrevistados demonstrou ser positiva. O uso de indicadores aponta a valorização do tema dentre as preocupações da gestão e, em alguns casos, da alta direção. Pelas respostas dos entrevistados, é possível afirmar que a segurança do paciente faz parte da estratégia das organizações participantes deste estudo, demonstrando um cuidado corporativo de direcionar os esforços da qualidade e da segurança. / Patient safety is a global concern and hight priority on the schedule of the World Health Organization (WHO) and its member countries. In this context, incident management in health services plays a key role in reducing risks and damaging patients. This research had as objective to know how the management of incidents at the hospitals in São Paulo is and what the managers' view on patient safety as a strategic and competitive factor. A qualitative research of an exploratory nature was carried out, through semi-structured interviews in eight hospitals, five private and three philanthropic in the period of March and April of 2018. The research demonstrated the largest number of organizations with computerized incident reporting system, the growth of customer service as a reference for patient or family contact when an incident occurred, the role of management in patient information and familiarity with the incidents. Considering that the patient safety movement is relatively recent in Brazil, the level of safety culture maturity of the hospitals interviewed demonstrated to be positive. The use of indicators points out the appreciation of the theme among the concerns of management and, in some cases, top management. From the respondents' answers, it is possible to affirm that patient safety is part of the strategy of the organizations participating in this study demonstrating a care corporate effort to direct quality and safety efforts.

Submitted by Fabiana Gonçalves Pinto (benf@ndc.uff.br) on 2016-10-14T19:51:11Z No. of bitstreams: 1 Rai Moreira Rocha.pdf: 1807471 bytes, checksum: c2ea27558ae2146160a4ffdac0c85d1b (MD5) / Made available in DSpace on 2016-10-14T19:51:11Z (GMT). No. of bitstreams: 1 Rai Moreira Rocha.pdf: 1807471 bytes, checksum: c2ea27558ae2146160a4ffdac0c85d1b (MD5) Previous issue date: 2016 / Mestrado Acadêmico em Ciências do Cuidado em Saúde / Introdução: Trata-se de um estudo sobre as Competências Profissionais do Enfermeiro no Gerenciamento dos Eventos Adversos na UTI Neonatal tendo como problema de pesquisa: Quais competências o enfermeiro deve possuir para gerenciar os eventos adversos na Unidade de Terapia Intensiva Neonatal? A partir disso elencou-se como objetivos:: Mapear as competências do enfermeiro para o gerenciamento dos eventos adversos na UTI Neonatal, descrever as atividades desenvolvidas pelos enfermeiros na UTI Neonatal, identificar os eventos adversos ocorridos na UTI Neonatal, correlacionar as atividades desenvolvidas pelos enfermeiros na UTI Neonatal relacionadas aos eventos adversos com as competências profissionais. Como método, utilizou-se da pesquisa de abordagem qualitativa, de caráter descritivo-exploratório tendo como participantes os enfermeiros e residentes da UTI Neonatal do Hospital Universitário Antônio Pedro. A pesquisa se delineou através de entrevista semi-estruturada e observação não participante. A análise das entrevistas foi realizada pelo software Análise Lexical de Co-ocorrências em Enunciados Simples de um Texto (ALCESTE) e triangulados com os dados das observações não participantes a fim de articular a discussão. Resultados: A partir da análise e da disposição de 5 classes apresentadas pelo software, foram elaboradas 3 categorias temáticas: 1- Ações instrumentais do Enfermeiro na Unidade de Terapia Intensiva Neonatal; 2- O Gerenciamento das Tecnologias utilizadas no Cuidado ao Recém-nascido; 3- A Unidade de Terapia Intensiva Neonatal: a influência do ambiente no surgimento dos eventos adversos. A partir dos resultados das entrevistas e dos dados da observação não participante, foram mapeadas 9 competências profissionais para o gerenciamento dos eventos adversos na UTIN. Conclusão: O estudo demonstrou a relação multifatorial entre as competências profissionais e o gerenciamento dos eventos adversos na Unidade de terapia intensiva neonatal. Ao descrever a atuação do enfermeiro, foi possível identificar a diferença entre o que se faz e o como deve ser feito, o que possibilitou avaliar, através das competências, o ponto chave para melhorar o serviço em saúde. / Introduction: This is a study on the Nurse's Professional Skills in the Adverse Event Management in NICU having as research problem: What skills nurses must have to manage the adverse events in Intensive Care Unit Neonatal From that listed the themselves as goals :: Map the skills of nurses for management of adverse events in the NICU, describe the activities performed by nurses in the NICU, identify adverse events in the NICU, correlate the activities performed by nurses in the NICU related adverse events with professional skills. As a method, we used the qualitative research, descriptive and exploratory having as participants, nurses and residents of Neonatal ICU University Hospital Antonio Pedro. The research is outlined through semi-structured interviews and non-participant observation. The data analysis was performed by Lexical Analysis Software Co-occurrences in Utterances a Simple Text (Alceste) and triangulated with data from observations not participants to articulate the discussion. Results: From the analysis and the provision of 5 classes presented by the software, were developed three thematic categories: 1 instrumental Nurses Shares in the Neonatal Intensive Care Unit; 2. The Management Technologies used in the Care of the Newborn; 3- The Neonatal Intensive Care Unit: the influence of the environment in the emergence of events adversos. A from the results of interviews and data from non-participant observation, were mapped 9 professional skills for the management of adverse events in the NICU. Conclusion: The study showed the multifactorial relationship between professional skills and management of adverse events in the neonatal intensive care unit. In describing the work of nurses, it was possible to identify the difference between what is done and how it should be done, which made it possible to evaluate, through the skills, the key point to improve the health service.

L’analyse de la causalité, qui consiste à déterminer si la prise d’un médicament est la cause de la survenue d’un événement, est la problématique centrale de la pharmacovigilance et de la pharmaco-épidémiologie.La première partie de ce travail aborde l’étude de la causalité au plan individuel, au travers des méthodes d’imputabilité. Nous avons d’abord comparé une méthode d’imputabilité récemment développée, la méthode logistique, et la méthode d’imputabilité officiellement utilisée en France à un jugement consensuel d’experts pris comme référence. Les résultats montrent que la méthode française d’imputabilité tend à sous-coter la responsabilité du médicament (faible sensibilité) alors que la méthode logistique tend à la surestimer (faible spécificité). Par la suite, une nouvelle version de la méthode française d’imputabilité visant à améliorer sa sensibilité et son pouvoir discriminant a été proposée. Le travail de validation portant sur cette méthode réactualisée montre une amélioration de sa sensibilité et des résultats se rapprochant plus du jugement consensuel d’experts. Pour la méthode logistique, les critères d’imputabilité et leurs poids ont été réévalués sur un échantillon plus important d’observations que celui ayant servi à la pondération initiale. La validité de cette nouvelle version et celle de l’un des algorithmes les plus couramment utilisés en pharmacovigilance, la méthode Naranjo, ont été comparées à un jugement consensuel d’experts. Les résultats concernant la validité interne et les qualités prédictives de la méthode Naranjo ne sont pas satisfaisants alors que la méthode logistique présente une spécificité améliorée ainsi qu’une bonne sensibilité et valeurs prédictives. Cette dernière méthode présente donc des caractéristiques qui devraient améliorer l’évaluation de la responsabilité des médicaments dans la survenue des événements indésirables. La mise en place de méthode d’imputabilité spécifique à une classe thérapeutique et/ou à un type d’événement indésirable pourrait aussi améliorer l’évaluation des événements indésirables. Nous proposons une grille d’imputabilité adaptée aux accidents hémorragiques sous antithrombotique. Dans la deuxième partie de cette thèse, l’analyse épidémiologique de la causalité est abordée en proposant deux méthodes : l’analyse populationnelle des cas individuels, en particulier leur délai de survenue après exposition médicamenteuse, et l’approche cas-population. Bien que beaucoup moins robustes que les méthodes classiques, elles sont testées sur des problématiques réelles de pharmacovigilance et les résultats montrent qu’elles peuvent être utiles pour une première exploration d’une association causale potentielle. En conclusion, ce travail méthodologique pourrait aider à mieux évaluer la responsabilité des médicaments dans la survenue d’événements indésirables après leurs autorisations de mise sur le marché. / The analysis of causality, which consists of determining if drug intake is the cause of the event occurrence, is the central issue of pharmacovigilance and pharmacoepidemiology. The first part of this work deals with the study of causality assessment methods at the level of individual cases. We first compared the recently developed logistic causality assessment method and the method officially used in France, to consensusual expert judgement taking as a reference. The results showed that the French causality assessment method tended to underestimate the responsibility of the drug (low sensitivity) whereas the logistic method tended to overestimate it (low specificity). Subsequently a new version of the French causality assessment method aiming to improve its sensitivity and discriminating power was proposed. The validation phase of this updated method showed improved sensitivity and a performance closer to consensual expert judgement. For the logistic method, the criteria of causality assessment and their weights were re-evaluated on a larger sample of drug-event pairs that had been used in the initial weighting. The validity of this method and that of one of the most commonly used algorithms in pharmacovigilance, the Naranjo method, were compared to consensual expert judgement. Results concerning the internal validity and the predictive qualities of the Naranjo method were not satisfactory while the logistic method presented an improved specificity and good sensitivity and predictive values. The logistic method now presents characteristics that should improve the assessment of drug responsibility in the occurrence of adverse events. The implementation of causality assessment method specific to a therapeutic class and / or to a type of adverse event could also improve the assessment of adverse events. We proposed a scale adapted to hemorrhages with antithrombotics and derived from the French causality assessment method. In the second part of this thesis, the epidemiological analysis of causality was tackled by proposing two methods: the populational analysis of individual cases, in particular their time to onset after drug exposure, and the case-population approach. Although less robust than the conventional methods, these were tested on real problems of pharmacovigilance and the results indicate that they may be useful for an initial exploration of a potential causal association. In conclusion, this methodological work could help to better assess drug causality in the occurrence of adverse event in post maketing surveillance.

INTRODUÇÃO: A análise de eventos clínicos em um ensaio randomizado estabelece a eficácia e segurança de um novo tratamento. Os eventos clínicos são divididos em eventos adversos (EAs) e desfechos clínicos. A literatura é escassa em informações sobre o processo de coleta de eventos clínicos em estudos, bem como sobre a variabilidade entre os centros de pesquisa em reportar eventos clínicos. OBJETIVOS: Descrever todos os eventos clínicos (EAs e desfechos clínicos) reportados pelos centros participantes do estudo APPRAISE-2 (Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome) e caracterizar a sua seriedade. Avaliar a variabilidade entre os centros de pesquisa em reportar eventos clínicos, além de identificar características basais dos participantes associadas ao ato de reportar eventos. MÉTODOS: Os investigadores clínicos foram responsáveis por reportar todos os eventos apresentados pelos participantes em formulários específicos. Formulários para EAs e para cada um dos desfechos clínicos do estudo foram disponibilizados (infarto agudo do miocárdio ou angina instável, acidente vascular encefálico e sangramento). Suspeitas de desfechos clínicos foram enviadas ao comitê de classificação de eventos clínicos (CEC), que as validou de acordo com critérios pré-estabelecidos. Tanto os desfechos clínicos quanto os EAs foram classificados como \"sérios\" ou \"não-sérios\" pelos investigadores clínicos. Para avaliar a variabilidade em reportar eventos clínicos, somente centros com inclusão de >= 10 participantes foram considerados. Modelos estatísticos foram utilizados para avaliar a influência de região geográfica e de características dos participantes na variabilidade entre os centros em reportar eventos. Os dados coletados estão concentrados no Instituto de Pesquisa Clínica da Universidade de Duke, na Carolina do Norte, Estados Unidos. RESULTADOS: Um total de 13.909 eventos clínicos foram reportados por 858 centros de pesquisa em 39 países. A maioria desses eventos foram EAs (91,6%), sendo os demais desfechos clínicos. Dentre os desfechos clínicos reportados, 66,0% foram confirmados pelo CEC. A maior parte dos desfechos confirmados pelo CEC (94,0%) preencheu critérios de seriedade, enquanto que 63,2% dos desfechos negados pelo CEC foram considerados sérios. De todos os EAs, 17,9% foram sérios. O critério de seriedade mais comumente observado foi hospitalização (N=2594), seguido de morte (N=321). Um ajuste para região geográfica explicou 28,7% e 26,4% da variabilidade entre os centros em reportar desfechos clínicos e EA sérios, respectivamente; a adição de características dos participantes ao modelo explicou mais 25,4% da variabilidade entre os centros em reportar desfechos clínicos e 13,4% em reportar EAs sérios. Os ajustes promoveram pouco impacto em explicar a variabilidade em reportar EAs não-sérios. Diversas características clínicas foram associadas ao ato de reportar eventos clínicos. CONCLUSÃO: Em um ensaio clínico multicêntrico de fase III, a maioria dos eventos clínicos reportados foram EAs não-sérios. Região geográfica e características dos pacientes influenciaram a variabilidade entre os centros em reportar desfechos clínicos e EAs sérios, com pouco impacto em EAs não-sérios. Uma coleta integrada de desfechos clínicos e EAs é viável, informativa e ilustra as características que estes eventos compartilham / BACKGROUND: The collection of adverse events (AEs) and clinical endpoints determines the overall efficacy and safety of the study treatment in clinical trials. However, AEs and clinical endpoints are captured and processed separately with limited information on various aspects of this data collection, its integration, and its variation across sites. OBJECTIVES: To describe all site-reported clinical events in the APPRAISE-2 (Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome) trial and report their seriousness. To evaluate the variability in reporting clinical events across sites and identify characteristics associated with clinical event reporting. METHODS: All clinical events were collected in case report forms (CRF) by site-investigators, as AEs or suspected endpoints. Data on suspected endpoints were collected in specific CRFs (myocardial infarction or unstable angina, cerebrovascular event and bleeding) and sent to review by a clinical events committee (CEC) that adjudicated these events according to predefined criteria. Seriousness criteria was collected for all AEs and suspected endpoints. To explore site-level variability i n event reporting, sites with >=10 participants were i ncluded. Statistical models explored the influence of geographic region and patient characteristics in between-site variability in event reporting. All collected data is centered in the Duke Clinical Research Institute, North Carolina, Unites States. RESULTS: A total of 13.909 clinical events were reported by 858 sites in 39 countries. Most clinical events were AEs (91.6%), followed by suspected endpoints. Of suspected endpoints reviewed by CEC, 66.0% were confirmed. Most CEC-confirmed endpoints met serious criteria (94.0%) and, of CEC-negatively adjudicated endpoints, 63.4% were serious. Of all AEs, 17.9% were considered serious events. Hospitalization was the most common criterion for classification as serious event (N=2594), followed by death (N=321). In models accounting for geographic region, site variation in reporting endpoints and serious AEs was explained by 28.7% and 26.4%, respectively; adding patient characteristics further explained site variation by 25.4% for endpoint reporting and 13.4% for serious AE reporting. Non-serious AE reporting variation was not explained by patient characteristics or region. Several clinical characteristics were associated with clinical event reporting. CONCLUSION: In a multicenter phase III clinical trial, the majority of reported events were non-serious AEs. Geographic region and patient characteristics influenced between-site variability in reporting of clinical endpoints and serious AEs, with limited impact in non-serious AEs. An integrated collection of endpoints and AEs is feasible, possible in a multinational trial and illustrates the shared characteristics of events

Les antipsychotiques de seconde génération (ASG) peuvent induire des effets métaboliques tels qu’une prise de poids, des troubles cardio-métaboliques, des effets endocriniens et dans de très rares cas une mort soudaine d’origine cardiaque. Les effets indésirables métaboliques potentiels des ASG doivent être surveillés. L’Alliance canadienne pour la surveillance de l’efficacité et de l’innocuité des antipsychotiques (CAMESA) propose des lignes directrices à cet effet. Les objectifs de cette étude rétrospective sont d’évaluer, à long terme, les taux d’enfants et d’adolescents recevant pour la première fois un ASG bénéficiant d’un monitoring dans les cliniques de santé mentale et de documenter les facteurs qui peuvent les influencer. À cet effet, les dossiers médicaux de 180 enfants et adolescents (âge moyen 13,3 ± 3,1 ans, 54,4 % garçons), traités pour la première fois par ASG entre janvier 2016 et juin 2018, ont été examinés. Les périodes de monitoring ont été divisées en baseline, de 1 à 6 et de 9 à 24 mois. La population étudiée a été stratifiée en enfants (4- 12 ans) vs adolescents (13-18 ans). Les caractéristiques sociodémographiques, le diagnostic psychiatrique et les comorbidités, les types d’ASG et les comédications prescrites, les mesures anthropométriques (MA), la pression artérielle (PA), les bilans sanguins (BS), l’électrocardiogramme (ECG) et les années de pratique du psychiatre ont été collectés. Des tableaux croisés ont été utilisés pour présenter les taux de monitoring. Les catégories ont été comparées par analyse de co-variable. Les taux de patients monitorés ont été comparés à travers les catégories de monitoring, en ayant recours au test exact de Fisher. Nos résultats démontrent des taux de monitoring pour MA, BS et PA de : 55 %, 47,8 % et 46,7 % au baseline ; 50 %, 41,7 % et 45,2 % à 1-6 mois ; et 47,2 %, 41,5 % et 40,6 % à 9-24 mois, respectivement. Des taux de monitoring plus élevés étaient associés de manière significative au statut d’adolescent (MA, BS et PA au baseline ; MA et PA à 1-6 mois), à un diagnostic de trouble psychotique et / ou affectif (MA, BS et PA au baseline ; MA et PA à 1-6 mois; BS à 9-24 mois), avoir ≤ 1 comorbidités psychiatriques (BS à 1-6 mois), et à l’expérience du clinicien (BS et ECG à 1-6 mois). En conclusion, cinq ans après les recommandations de CAMESA, le monitoring métabolique est effectué chez moins de la moitié des patients et diminue tout au long de la durée du traitement. Dans notre échantillon, les catégories d’âge, de diagnostic, de comorbidités psychiatriques et d’expérience du clinicien ont influencé les taux de monitoring. Toutefois, des progrès importants doivent encore être réalisés pour parvenir à un taux de monitoring satisfaisant. / Second generation antipsychotics (SGA) can induce metabolic effects such as weight gain, cardiometabolic disorders, endocrine effects and in very rare cases sudden cardiac death. The potential metabolic side effects of second generation antipsychotics need to be monitored. The Canadian Alliance for Monitoring the Efficacy and Safety of Antipsychotics (CAMESA) offers guidelines for this purpose. The objectives of this retrospective study are to evaluate, the long-term rates of youths receiving monitoring in mental health clinics and document the factors that may influence them. To this end, the charts of 180 children and adolescents (average age 13.3 ± 3.1 years, 54.4 % males) receiving SGA treatment for the first time between January 2016 and June 2018 were reviewed. Monitoring was divided into baseline and 1 to 6 and 9 to 24-month periods. The population under study was stratified into children (4-12 years) vs adolescents (13-18 years). Sociodemographic characteristics, psychiatric diagnosis and comorbidities, prescribed SGAs and comedications, anthropometric measurements (AM), blood pressure (BP), blood tests (BT), electrocardiogram (ECG) and the psychiatrist’s years of practice were collected. Cross tables were used to present the monitoring rates. Categories were compared by covariate analysis. Rates of patients monitored across categories were compared using Fisher’s exact test. Our results show that monitoring rates for AM, BT, and BP were: 55 %, 47.8 %, and 46.7 % at baseline, 50 %, 41.7 %, and 45.2 % at 1 to 6 months, and 47.2 %, 41.5 %, and 40.6 % at 9 to 24 months, respectively. Higher monitoring rates were significantly associated with adolescent status vs child (baseline AM, BT, and BP; 1-6-month AM and BP), a diagnosis of psychotic and/or affective disorder (baseline AM, BT, and BP; 1-6-month AM and BP; 9-24-month BT), having ≤ 1 psychiatric comorbidities (1-6-month BT), and clinician’s experience (1-6-month BT and ECG). In conclusion, five years after publication of the CAMESA guidelines, metabolic monitoring is conducted for less than half of patients and decreases over time. In our sample, age, diagnostic category, psychiatric comorbidities, and clinician’s experience influenced the monitoring rates. Major progress still needs to be made before reaching a satisfactory level of monitoring.

Background: Venous thromboembolism (VTE), comprising the conditions of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common acute cardiovascular event associated with increased long-term morbidity, functional disability, all-cause mortality, and high rates of recurrence. Major advances in identification, prophylaxis, and treatment over the past 3-decades have likely changed its clinical epidemiology. However, there are little published data describing contemporary, population-based, trends in VTE prevention and management. Objectives: To examine recent trends in the epidemiology of clinically recognized VTE and assess the risk of recurrence after a first acute episode of VTE. Methods: We used population-based surveillance to monitor trends in acute VTE among residents of the Worcester, Massachusetts, metropolitan statistical area (WMSA) from 1985 through 2009, including in-hospital and ambulatory settings. Results: Among 5,025 WMSA residents diagnosed with acute PE and/or lower-extremity DVT between 1985 and 2009 (mean age = 65 years), 46% were men and 95% were white. Age- and sex-adjusted annual event rates (per 100, 000) of clinically recognized acute first-time and recurrent VTE was 142 overall, increasing from 112 in 1985/86 to 168 in 2009, due primarily to increases in PE occurrence. During this period, non-invasive diagnostic VTE testing increased, vi while treatment shifted from the in-hospital (chiefly with warfarin and unfractionated heparin) to out-patient setting (chiefly with low-molecular-weight heparins and newer anticoagulants). Among those with community-presenting first-time VTE, subsequent 3-year cumulative event rates of key outcomes decreased from 1999 to 2009, including all-cause mortality (41% to 26%), major bleeding episodes (12% to 6%), and recurrent VTE (17% to 9%). Active-cancer (with or without chemotherapy), a hypercoagulable state, varicose vein stripping, and Inferior vena cava filter placement were independent predictors of recurrence during short- (3-month) and long-term (3-year) follow-up after a first acute episode of VTE. We developed risk score calculators for VTE recurrence based on a 3-month prognostic model for all patients and separately for patients without active cancer. Conclusions: Despite advances in identification, prophylaxis, and treatment between 1985 and 2009, the disease burden from VTE in residents of central Massachusetts remains high, with increasing annual events. Declines in the frequency of major adverse outcomes between 1999 and 2009 were reassuring. Still, mortality, major bleeding, and recurrence rates remained high, suggesting opportunities for improved prevention and treatment. Clinicians may be able to use the identified predictors of recurrence and risk score calculators to estimate the risk of VTE recurrence and tailor outpatient treatments to individual patients.