En France, 73.3% des décès maternels liés à une hémorragie du post partum (HPP) ont été jugés comme « évitables » par le comité national d’experts en 2006. Le premier objectif de cette recherche a été l’observation des événements indésirables graves (EIG) en obstétrique et l’analyse des facteurs contributifs. Trois études ont été réalisées et ont montré une proportion de cas potentiellement évitables de 22% pour les embarrures, 72% pour les asphyxies néonatales et 73% pour les transferts maternels en service de réanimation. Le second objectif a été l’amélioration de la qualité de la prise en charge de l’HPP, première cause de mortalité maternelle. Deux études ont été réalisées. La première étude a montré que le protocole de prise en charge de l’HPP était appliqué partiellement après sa diffusion passive dans un réseau périnatal en Rhône Alpes. La seconde étude, PITHAGORE 6, un essai randomisé initié dans six réseaux de périnatalité en France pour mesurer l’impact d’un programme d’intervention multifacettes, a permis de réduire le taux d’HPP graves. De nouvelles méthodes doivent être développées en intégrant l’apport des sciences humaines pour optimiser la sécurité des soins en périnatalité. / In France, 73,3% of maternal deaths from post partum haemorrhage (PPH) were considered as «avoidable» by national experts committee in 2006. The first goal of this research was to observe adverse events (AEs) in obstetrics and to analyse latent and active conditions. The three observational studies highlighted that 22% of depressed skull fractures, 72% of birth asphyxia and 73% of maternal transfers to intensive care unit care might have been avoidedThe second aim was to improve PPH management, which is a leading cause of maternal mortality. Two studies were realized. The first has shown that regional guideline of PPH management was partly applied after passive dissemination in a regional perinatal network. The second study, PITHAGORE 6, a randomised trial conducted in six perinatal networks to assess impact of multi-faceted intervention program, reduced the rate of severe PPH. New methods have to be developed and might take into account human sciences to improve safety in perinatal care.

The aim of our work was to map the process of identification, evaluation, and implementation of activities directed at prevention or management of nursing safety risks in organizations providing urgent ward care in the Czech Republic from the point of view of top management of nursing. Our work traced a quantitative research. For collecting data we used a non-standard questionnaire made up only for the purposes of this work. The questionnaire was distributed by the top representative of nursing management (ward sister/deputy in charge of nursing care) of the above specified health centres. The research was carried out in the period February - April 2008 and for assessment of the results obtained we used 110 questionnaires. For the purposes of our work we determined six hypotheses. Hypothesis 1 saying that hospitals create conditions for the development of safe organizational culture proved true. For the future it is essential to discuss this topic more profoundly, as well as to get rid of the fear of punishment for acknowledging a mistake and accept the fact that we all make mistakes, therefore we must minimalize their frequency and consequences and above all learn from them. Hypothesis 2 stating that hospitals watch risk factors for occurence of emergencies proved true, too. As a negative finding we can consider proving hypothesis 3 saying that hospitals do not reveal particulat risks of nursing care until the elimination of their consequences. Uncovering insufficient use of proactive strategy led us to a more detailed description of a FMEA method. Hypothesis 4 saying that hospitals have created a procedure for occurence of emergency and hypothesis 5 - nursing personnel is obligated to observe and report at minimum three kinds of emergencies related to nursing care proved true, too. The last hypothesis 6 presenting the fact that hospitals do not make their patients/clients involved in prevention of mistakes of medical workers was also confirmed by the results, but it was pleasant to find out that 43,3% of respondents stated that this possibility is being used at their place. We suggest to include the prevention of mistakes in the nursing process whether by means of particular nursing diagnoses or global education of patients/clients. As a suggestion of a feasible content of education we translated and adapted a document SPEAK UP into Czech named 7P.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2017-01-26T16:56:53Z No. of bitstreams: 1 Georgia Kerley da Silva.pdf: 1240095 bytes, checksum: c26efb5916052a7fc67a0ae41a430ee4 (MD5) / Made available in DSpace on 2017-01-26T16:56:53Z (GMT). No. of bitstreams: 1 Georgia Kerley da Silva.pdf: 1240095 bytes, checksum: c26efb5916052a7fc67a0ae41a430ee4 (MD5) Previous issue date: 2016-12-12 / Healthcare in Brazil has undergone significant upgrade in the last decades, due to population growth and the increase in the awareness of getting high quality services. However, while there have been positive and considerable changes in the healthcare area, failures in patient safety have emerged as a priority in global health, as they can cause high morbidity and mortality, and can increase hospitalization days and costs. In 2013, the National Patient Safety Plan was published by the Ministry of Health with the purpose of improving the qualification of care in all health facilities in Brazil. The majority of patient safety incidents are preventable. Consequently, their detection and prevention by hospital organizations should be be sought to increase efficiency in health systems. The purpose of this study was to evaluate the adherence of a public hospital in São Paulo to the National Patient Safety Program and, therefore to propose improvements to reduce possible failures in healthcare. The approach adopted was a case study. We used semi-structured interviews with the managers of the participant hospital for data collection followed by analysis using an electronic platform (Survey Monkey®). All health managers invited (n=43) participated in the study. Of these 76.7% have been working in the participant hospital for more than 10 years and 70% had a specialization or postgraduate level. However, it was possible to observe that the fundamental concepts about patient safety and protocols of the National Patient Safety Program were not disseminated in the hospital under investigation. There was also lack of actions and training in the hospital evaluated. We also observed that adverse event is the most recognized patient safety incident (71.2%), while other types of incidents were identified by a small number of respondents. These data allow us to conclude that there is underreporting of patient safety incidents in the hospital under study, since the managers were not able to completly identifying them. Whenever a failure is reported, investigation and disclosure of corrective actions are not made in all cases. Finally, the adherence of the participating hospital to the PNSS is incipient and partly explained by the lack of continuous educational measures and the discussion of this issue among managers. As a contribution to the practice, main patient safety processes were mapped according to the National Patient Safety Plan for implementation in the unit evaluated as well as suggestions for staff training and for performance monitoring. / A saúde no Brasil tem passado por transformações nas últimas décadas, dado o crescimento da população e ao aumento da consciência em cobrar serviços que ofereçam qualidade. Entretanto, embora tenha havido mudanças positivas e consideráveis na área, as falhas na segurança do paciente têm emergido como uma prioridade na saúde global, uma vez que pode causar elevada morbidade e mortalidade, além de poder aumentar os dias de internação e os custos hospitalares. Em 2013, foi publicado o Programa Nacional de Segurança do Paciente pelo Ministério da Saúde com o propósito de aprimorar a qualificação da assistência e mitigar e previnir as falhas relacionadas à segurança do paciente em todos os estabelecimentos de saúde do Brasil. O objetivo deste estudo foi avaliar a aderência de um hospital público de São Paulo ao Programa Nacional de Segurança do Paciente e mediante ao diagnóstico encontrado, propor melhorias para reduzir possíveis falhas na assistência. A abordagem adotada foi um estudo de caso, como técnica de coleta de dados foram realizadas entrevistas semiestruturadas com os gestores da unidade hospitalar pesquisada e para analisar os dados, foi utilizada a plataforma eletrônica survey monkey. Dos 43 participantes, 100% responderam à pesquisa, 76,7% trabalhavam há mais de 10 anos no hospital e 70% possuíam nível de especialização ou pós-graduação, contudo, foi possível observar que mesmo com um bom nível de escolaridade e algumas ações isoladas relacionadas à segurança do paciente, os conceitos fundamentais sobre segurança do paciente e os protocolos do Programa Nacional de Segurança do Paciente não estavam disseminados no hospital pesquisado demonstrando uma carência de ações e de treinamento no hospital participante desta pesquisa. Constatou-se também que o evento adverso é o tipo de incidente mais reconhecido como incidente de segurança (71,2%), enquanto que outros tipos de incidentes foram identificados por uma parcela reduzida dos respondentes como incidentes de segurança. Esses dados, permitem concluir que há subnotificação de incidentes de segurança no hospital, uma vez que os gestores não foram capazes de identificá-los em sua totalidade, além de que, quando uma falha é notificada, a investigação e a divulgação de ações corretivas não são feitas em todos os casos. Enfim, a aderência do hospital participante ao PNSP é incipiente e, em parte explicada pela falta de medidas educativas continuadas e de discussão dessa temática entre gestores. Como contribuição para a prática foram mapeados os processos de segurança de acordo com o PNSP para sugestão de implantação na unidade, além de sugestões para treinamento dos colaboradores e para o monitoramento de desempenho.

Submitted by Nadir Basilio (nadirsb@uninove.br) on 2016-04-11T16:55:58Z No. of bitstreams: 1 Chang Chung Sing Waldman.pdf: 929870 bytes, checksum: 9c2405646665a0d26bcfa0c59f66fc38 (MD5) / Made available in DSpace on 2016-04-11T16:55:58Z (GMT). No. of bitstreams: 1 Chang Chung Sing Waldman.pdf: 929870 bytes, checksum: 9c2405646665a0d26bcfa0c59f66fc38 (MD5) Previous issue date: 2015-11-30 / Adverse events (AEs) occur in all ages. The elder requires more hospitalizations, with longer length of stay associated with other diseases and daily consumption of several drugs, becoming more vulnerable to AEs. As the main purpose of this study was to analyze the patient safety incidents hospitalized geriatric patients, the strategy adopted was the single case study. Data collection was performed by means of document analysis based on information recorded in medical registries of 221 geriatric patients, aged 60 or older, admitted into the internal medicine infirmary of Mandaqui Complex Hospital, which is located in the North of São Paulo city, during 2014. Results obtained by this research may contribute to support public policies in the health managements, including female (52,9%), predominance of aged 80 to 89 years (41,6%) (p=0,017), presence of 16,3% of seniors with 90 years and more; diseases of the digestive system and circulatory system as a cause of hospitalization showing length of stay and number of AEs above the median for the total of patients; increase in the number of AEs with increasing the length of stay (p<0,0001); incidence rate of 0,61 AEs by patient/day, increasing with age (p<0,0001); presence of comorbidities in 91,4% of the patients and their close relationship with time of hospitalization and frequency of AEs (p=0, 012). The patient safety incidents were classified according to International Classification for Patient Safety (ICPS). We found 4752 incidents, 47,0% of these were of no harm and 53,0% classified as AEs. According to the degree of harm, 45,4% were mild, 47,8% moderate and 0,5% severe harm. In this study, all identified incidents were avoidable and their recognition make possible to plan health specific strategies for elders in different levels of patient health assistance. / Eventos adversos (EAs) ocorrem com qualquer paciente e em qualquer idade, o idoso, necessitando de número maior de internações, com tempo de permanência mais prolongado, associado a outras doenças e consumo diário de vários medicamentos, torna-se mais vulnerável aos EAs. Sendo o objeto dessa pesquisa a análise dos incidentes relacionados à segurança do paciente geriátrico internado, a estratégia adotada foi o estudo de caso. A coleta dos dados foi realizada por meio da análise documental baseada em informações registradas em prontuários de 221 pacientes com idade de 60 anos ou mais, internados em enfermaria de clínica médica do Conjunto Hospitalar do Mandaqui, região norte do município de São Paulo, em 2014. Resultados obtidos por esta pesquisa podem subsidiar políticas públicas no setor saúde, entre eles: sexo feminino (52,9%); predomínio da faixa etária de 80 a 89 anos (41,6%) (p=0,017); presença de 16,3% de idosos com 90 anos e mais; doenças do aparelho digestivo e circulatório como causa de internação apresentam tempo de permanência e número de EAs superiores à mediana para o total de pacientes; aumento no número de EAs à medida que aumenta o tempo de internação (p<0,0001); taxa de incidência de 0,61 EAs por paciente/dia, aumentando com a idade (p<0,0001), razão de taxas (RT=2,3); comorbidades presente em 91,4% dos pacientes e com estreita relação com tempo de internação e frequência dos EAs (p=0,012). Quanto aos incidentes identificados segundo a Classificação Internacional de Segurança do Paciente (ICPS), encontramos 4752 incidentes sendo 47,0% sem dano e 53,0% com dano. Em relação ao grau de danos, identificamos 45,4% com dano leve, 47,8% dano moderado e 0,5 % dano grave. Neste estudo todos os incidentes detectados foram do tipo evitáveis, passíveis de redução e o seu conhecimento sinaliza a necessidade do planejamento de políticas de saúde específicas para a terceira idade nos diversos níveis da assistência à saúde.

The current thesis deals with the issue of adverse events. However, it does not concern the number of described and recorded adverse events in healthcare facilities or their spectrum. I am particularly interested in the attitude of the staff at the University Hospital Pilsen and how to respond to the requirements of the TOP management in the recording of adverse events. The theoretical part will concentrate on explaining the concept "adverse event", the description of influences which cause such events to arise and also to summarize the current situation concerning the approach to adverse events in the Czech Republic. The empirical part of the thesis describes the implementation of qualitative research, its results and recommendations for future practice. I am interested in researching the perspective of employees and their level of cooperation and openness in the approach to the reporting of adverse events in the provision of therapeutic, diagnostic and nursing care in inpatient health care facilities. The respondents in my research are employees of the University Hospital in Pilsen. I researched their views using a structured interview. I've contacted 14 employees who are employed in various functional and professional positions at the University Hospital in Pilsen. I believe that the role of...

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Background: The increasing consumption of dietary supplements (DS) has drawn the attention of regulatory agencies, researchers and healthcare professionals. The US Food and Drug Administration (FDA) does not require premarketing assessment of DS considering them safe unless proven otherwise. However, the reporting rate of DS adverse events (DS-AE) is low. Objective: To describe pharmacists’ attitudes and knowledge of DS and DS information resources, and to determine the importance of selected attributes in pharmacists’ decisions to report a DS-AE. Methods: A convenience sample of practicing pharmacists in Virginia was surveyed using a web-based self-administered questionnaire. A conjoint analysis exercise was developed using several scenarios based on a set of five attributes: patient’s age, initiation of DS, last modification in drug therapy, evidence supporting the AE, and outcome of the AE. Participants were asked to indicate their decision to report the AE in each scenario to prescriber, drug manufacturer, DS manufacturer and FDA on a 6-point ordered scale. Participants’ attitude, knowledge of DS, demographic information, and DS information resources were also requested. Linear regression models were used to determine the relative importance of the profile attributes on a pharmacist’s decision to report the AE. The effects of other characteristics on the importance of the attributes were assessed. Results: Participants’ overall attitudes were relatively positive for the clinical use of DS but negative for safe of DS. Formal training on DS was associated with better knowledge of DS regulation. The average knowledge score of DS identification was relatively good but was low for DS regulation. Lexi-Comp® was the most widely used and available information resource and the Natural Medicines Comprehensive Database was the most useful once. The most important attribute that a pharmacist considered in the decision to report a DS-AE to DS manufacturer, drug manufacturer and FDA was the outcome of the AE followed by the evidence supporting the AE. Ranking of these two factors was the reversed in reporting to prescriber. Conclusions: Outcome and evidence of the AE are the most important factors participants considered when reporting. Other characteristics do not have an impact on the relative importance of the attributes.

Introdução: A segurança é considerada um pilar da qualidade dos cuidados à saúde e seu sucesso depende do comprometimento individual e coletivo. Os ensinamentos teórico-práticos transferidos aos alunos acerca dessa temática garantem melhoria na assistência prestada. Objetivo: Avaliar o impacto de intervenção sobre segurança do paciente no conhecimento e atitude dos alunos de medicina. Metodologia: Trata-se de uma análise do tipo intervenção, não randomizado, com grupo único de comparação - antes e depois -, prospectivo e exploratório, com abordagem quantitativa, realizado com 98 estudantes do curso do 6º ano de Medicina da Faculdade de Medicina de Ribeirão Preto (FMRP-USP), São Paulo, Brasil. A coleta de dados ocorreu de janeiro a novembro de 2017, utilizando um questionário físico contemplando a caracterização dos alunos, bem como os aspectos conceituais e atitudinais sobre o erro humano e a segurança do paciente. Discussão: Como resultados, verificou-se o predomínio de estudantes do sexo masculino (62%) com a média de idade de 25,8 anos, enquanto, em relação aos aspectos conceituais evidenciou-se a melhoria do entendimento sobre a temática \"erro humano e segurança do paciente\", como se pode destacar nas assertivas \"Cometer erros na área da saúde é inevitável\", com média 4,0 na escala de Likert - mostrando que 70% dos alunos de medicina concordaram com a afirmação antes da intervenção educativa (pré-teste), sendo que, após a mesma (pós-teste), a média foi para 1,8 (68% discordaram). 42% dos estudantes (média de 3,6) ainda começaram concordando que \"para a análise do erro humano é importante saber as características individuais do profissional que cometeu o erro\", enquanto no pós-teste 59% deles (média de 2,3) discordaram. Conclusão: Conclui-se que os alunos, depois da intervenção educativa em sala de aula, conseguiram contemplar vários aspectos conceituais relacionados à segurança do paciente e às responsabilidades dos docentes e discentes frente à assistência. Porém, a intervenção educativa teve sua limitação quanto à evidência de mudanças nas atitudes dos alunos, uma vez que, a aprendizagem é considerada condição necessária, mas não suficiente, pois fatores contextuais e as características do próprio indivíduo podem influenciar a transferência efetiva do conhecimento, habilidades e atitudes para as atividades laborais. Nesse sentido, os próximos estudos podem levar em consideração a teoria dos fatores humanos, que não promete soluções instantâneas para a melhoria no cuidado prestado, mas pode fornecer uma riqueza de recursos para o progresso sustentável que minimizem erros e promovam uma cultura de segurança organizacional / Introduction: Safety is considered a pillar of the quality in health care and its success depends on both individual and collective commitment. The theoretical-practical teachings transferred to the students on this thematic assure improvements on the care provided. Aim: The aim is to evaluate the impact of interventions about patient\'s safety in the knowledge and actions of medical students. Methodology: It is an analysis from the interventional type, nonrandomized, with a single group of comparison - before and after-, prospective and exploratory, with quantitative approach, performed with 98 students of the 6º year of medical school from the Medical School of Ribeirão Preto (FMRP-USP), São Paulo, Brazil. The collection of data occurred from January to November 2017, using a questionnaire about the description of the students, as well as conceptual and attitudinal aspects about human error and patient\'s safety. Discussion: As results, there was a predominance of male students (62%) with average age of 25,8 years old, while, regarding to conceptual aspects, it was observed an improvement of the understanding about the thematic \"human error and patient\'s safety\", as it can be highlighted in the statement \"Making mistakes in health is inevitable\", with an average of 4,0 on Likert scale - showing that 70% of the medical students agreed with the statement before the educational intervention (pre-test), and after the intervention (after-test), the average dropped to 1,8 (68% disagreed). 42% of the students (average of 3,6 ) still began agreeing that \"for the analysis of the human error it is important to know individual characteristics of the professional who made the mistake\", while after-test 59% of them (average of 2,3) disagreed. Conclusions: It is concluded that after the educative intervention in classroom, they managed to contemplate several conceptual aspects related to patient\'s safety e to the responsibilities of the teachers and students involved on the assistance. However, the educative intervention had its limitation regarding the evidence of changes in the students\' attitudes, once that the learning process is considered a necessary condition, but it is not enough, due to contextual factors and individuals characteristics that may influence the effective transfer of knowledge, skills and attitudes to labor activities. So, the following essays may take into consideration the human factor theory, which doesn\'t promise instantaneous solutions to the improvement in the care provided, but may be able to provide a wealth of resources to sustainable progress that minimize errors and promote a culture of organizational safety

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To increase medicine safety, researchers use adverse event reports to assess causal relationships between drugs and suspected adverse reactions. VigiBase, the world's largest database of such reports, collects data from numerous sources, introducing the risk of several records referring to the same case. These duplicates negatively affect the quality of data and its analysis. Thus, efforts should be made to detect and clean them automatically.  Today, VigiBase holds more than 3.8 million COVID-19 vaccine adverse event reports, making deduplication a challenging problem for existing solutions employed in VigiBase. This thesis project explores methods for this task, explicitly focusing on records with a COVID-19 vaccine. We implement Jaccard similarity, TF-IDF, and BERT to leverage the abundance of information contained in the free-text narratives of the reports. Mean-pooling is applied to create sentence embeddings from word embeddings produced by a pre-trained SapBERT model fine-tuned to maximise the cosine similarity between narratives of duplicate reports. Narrative similarity is quantified by the cosine similarity between sentence embeddings.  We apply a Gradient Boosted Decision Tree (GBDT) model for classifying report pairs as duplicates or non-duplicates. For a more calibrated model, logistic regression fine-tunes the leaf values of the GBDT. In addition, the model successfully implements a ruleset to find reports whose narratives mention a unique identifier of its duplicate. The best performing model achieves 73.3% recall and zero false positives on a controlled testing dataset for an F1-score of 84.6%, vastly outperforming VigiBase’s previously implemented model's F1-score of 60.1%. Further, when manually annotated by three reviewers, it reached an average 87% precision when fully deduplicating 11756 reports amongst records relating to hearing disorders.