998 resultados para Safety equipment.


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AIMS: To evaluate the long-term clinical outcomes following percutaneous coronary intervention (PCI) with the Genous stent in an unselected population. METHODS: All patients admitted to a single center who underwent PCI using the GS exclusively, between May 2006 and May 2012, were enrolled, and a clinical follow-up of up to 60 months was carried out. The primary endpoint of major adverse cardiac event (MACE) rate was defined as the composite of cardiac death, acute myocardial infarction (AMI), and target lesion revascularization (TLR). RESULTS: Of the 450 patients included (75.1% male; 65.5 ± 11.7 years), 28.4% were diabetic and acute coronary syndrome was the reason for PCI in 76.4%. Angioplasty was performed in 524 lesions using 597 Genous stents, with angiographic success in 97.1%. At a median of 36 months of follow-up (range, 1-75 months), MACE, AMI, TLR, stent restenosis (SR), and stent thrombosis (ST) rates were 15.6%, 8.4%, 4.4%, 3.8%, and 2.2%, respectively. Between 12 and 24 months, the TLR, SR, and ST rates practically stabilized, up to 60 months. Bifurcation lesions were independently associated with MACE, TLR, and SR. CONCLUSION: This is the first study reporting clinical results with the Genous stent up to 60 months. The Genous stent was safe and effective in the long-term, in an unselected population.

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OBJECTIVE: Combined hyperlipidaemia is a common and highly atherogenic lipid phenotype with multiple lipoprotein abnormalities that are difficult to normalise with single-drug therapy. The ATOMIX multicentre, controlled clinical trial compared the efficacy and safety of atorvastatin and bezafibrate in patients with diet-resistant combined hyperlipidaemia. PATIENTS AND STUDY DESIGN: Following a 6-week placebo run-in period, 138 patients received atorvastatin 10mg or bezafibrate 400mg once daily in a randomised, double-blind, placebo-controlled trial. To meet predefined low-density lipoprotein-cholesterol (LDL-C) target levels, atorvastatin dosages were increased to 20mg or 40mg once daily after 8 and 16 weeks, respectively. RESULTS: After 52 weeks, atorvastatin achieved greater reductions in LDL-C than bezafibrate (percentage decrease 35 vs 5; p < 0.0001), while bezafibrate achieved greater reductions in triglyceride than atorvastatin (percentage decrease 33 vs 21; p < 0.05) and greater increases in high-density lipoprotein-cholesterol (HDL-C) [percentage increase 28 vs 17; p < 0.01 ]. Target LDL-C levels (according to global risk) were attained in 62% of atorvastatin recipients and 6% of bezafibrate recipients, and triglyceride levels <200 mg/dL were achieved in 52% and 60% of patients, respectively. In patients with normal baseline HDL-C, bezafibrate was superior to atorvastatin for raising HDL-C, while in those with baseline HDL-C <35 mg/dL, the two drugs raised HDL-C to a similar extent after adjustment for baseline values. Both drugs were well tolerated. CONCLUSION: The results show that atorvastatin has an overall better efficacy than bezafibrate in concomitantly reaching LDL-C and triglyceride target levels in combined hyperlipidaemia, thus supporting its use as monotherapy in patients with this lipid phenotype.

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Lamivudine has been demonstrated safe and efficacious in the short term in a large cohort of children with chronic hepatitis B (CHB), but optimal duration of treatment has not been elucidated and limited data on the safety of long-term lamivudine administration have been reported. In addition, the durability of favourable therapeutic outcomes after lamivudine therapy in children has not been well characterized. The aim of this study was to examine the safety of lamivudine and the durability of clinical responses in a group of children who received up to 3 years of treatment for CHB. One hundred and fifty-one children from centres in nine countries who had previously received lamivudine in a large prospective trial were enrolled. During the first year, children had been randomized to either lamivudine or placebo treatment. Subsequently, in a separate extension study, those who remained hepatitis B e antigen (HBeAg) positive were given lamivudine for up to 2 years and those who were HBeAg negative were observed for additional 2 years. Results of these studies have been previously reported. In this study, these children were followed for 2 additional years. Data gathered from medical record review included weight, height, signs and symptoms of hepatitis, alanine aminotransferase (ALT) levels, serologic markers, hepatitis B virus (HBV) DNA levels and serious adverse events (SAEs). Other pharmacological treatments for CHB were allowed according to the practices of individual investigators and were documented. Subjects were divided into two groups for analysis, those who had achieved virological response (VR), defined as HBeAg negative and undetectable HBV DNA by the bDNA assay by the end of the extension study at 3 years, and those who had not. In those who had achieved VR by the end of the extension study, long-term durability of HBeAg seroconversion was 82% and >90% in those who had received lamivudine for 52 weeks and at least 2 years respectively. This compares to 75% for those who had achieved seroconversion after placebo. In those who had not achieved VR by the end of the extension study, an additional 11% did so by the end of the study; they had all received lamivudine in the previous trial, and none had received further treatment during the study. Eight children lost hepatitis B surface antigen during the study and all had received lamivudine at some point during the previous trials. Evaluation of safety data revealed no SAEs related to lamivudine. There was no effect of treatment on weight or height z scores. Clinically benign ALT flares (>10 times normal) were seen in 2% of children. Favourable outcomes from lamivudine treatment of CHB in children are maintained for at least several years after completion of treatment. Up to 3 years of lamivudine treatment is safe in children.

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Dissertação para a obtenção de grau de doutor em Ciências da Engenharia e Tecnologia

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The frequency and description of side effects secondaiy to the subcutaneous application of SPf66 malaria vaccine and placebo are reported for each dose of application in the participants of the vaccine efficacy trial in Brazil. Side effects evaluated two hours after each application were detected in 8.0%, 30.2% and 8.8%, for the Is', and 3"' dose, respectively, in the SPf66group, and in 7.0%, 8.5% and 2.9% in the placebo group. Local reactions such as mild inflammation, nodule and pain or erythema frequently accompanied by pruritus were the most common reactions detected in both groups (3-8%, 29.1% and 8.5% in the SPf66 group and 4.0%, 7.6% and 2.5% in the placebo group). Among vaccinees, local side effects after the 2nd dose were more frequent in females. Systemic side effects were expressed mainly through general symptoms referred by the participants and were most frequent after the 1st dose in both groups (4.3% in the SPf66 group and 3-0% in the placebo group). Muscle aches and fever were refewred by few participants. No severe adverse reactions were detected for either dose of application or group.

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Dissertação para obtenção do Grau de Mestre em Engenharia Biomédica

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Magnetic resonance imaging (MRI) is a method of image diagnose proven to be of undeniable importance when it comes to neuro and cardio related diseases. In fact, these diseases (such as: ischemic heart disease, stroke and acute myocardial infection) have high incidence in Portugal. For these reasons, the allocation of this medical technology should not be considered with light thoughts. In fact, making decision of resource allocation in health care can be a very complex and contested matter. The impacts of new technology allocation, such MRI, can be assessed in a variety of ways. However, a fundamental component should always be present: the use of evidence-based decision-making methods. One of these methods is Technology Assessment (TA). This paper aims to characterize the equity on access of the Portuguese population in general, to a specific medical device such as MRI, under the TA point of view. It is hoped to promote a bridge of scientific knowledge between the gap on research and policy-making through TA that can emerge as a tool to aid decision-makers in the organization of health systems. There are gaps in providing healthcare, due to geographical imbalances, with some areas unable to provide certain specialized services, as hospitals in the countryside do not provide all medical specialties. Portugal has also a large independent private sector that provides diagnostic and therapeutic services to NHS users under contracts called conventions. These medical contracts cover ambulatory health facilities for laboratory tests and examinations such as diagnostic tests and Radiology. However, there is no convention from the NHS when concerning the MRI exam. Therefore, this reality can be considered a limitation in the access of the general population to this kind of clinical exam. TA can play an useful and important role in helping the decision-makers to explore potential gains that might be achieved by introducing a more rational decision making into health care management, namely into the Radiology area, regarding the allocation of MRI equipment.

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A Work Project, presented as part of the requirements for the Award of a Masters Degree in Management from the NOVA – School of Business and Economics

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A Work Project, presented as part of the requirements for the Award of a Masters Degree in Management from the NOVA – School of Business and Economics

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Vaccination of infants with conjugated Haemophilus influenzae type b (Hib) vaccines has been proven to reduce Hib meningitis by 95% and pneumoniae by 20%. The routine use of Hib vaccine is facilitated by the introduction of combination vaccines into the EPI (Expanded Plan of Immunization). The objective of this study was to compare the immunogenicity and reactogenicity of an extemporaneously mixed DTPw/Hib (diphtheria-tetanus-whole cell pertussis) combination, using the technology of two Brazilian manufacturers, against a licensed DTPw/Hib European combination in 108 infants vaccinated at 2, 4 and 6 months according to the local national schedule. The Brazilian combination was highly immunogenic with Hib seroprotection rates (anti-PRP > 0.15 mg /ml of 98% after 2 doses and 100% after 3). Also for tetanus and pertussis the new Brazilian combination was as immunogenic as the European counterpart, except the diphtheria seroprotection rates and titers were lower. There was also no clinically relevant difference in reactogenicity. If these feasibility results are confirmed, the Brazilian DTPw/Hib combination should help to boost the uptake of Hib vaccination in Brazil.

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Dissertação para obtenção do Grau de Mestre em Engenharia Mecânica

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RESUMO:RESUMO: Nos últimos anos a ultrassonografia emergiu como um instrumento importante no diagnóstico da patologia torácica. O progresso tecnológico possibilitou a conceção de novos equipamentos como a ecoendoscopia brônquica radial e linear. Verificou-se, igualmente, o aparecimento de indicações para a realização de ecografia transtorácica. Uma das principais doenças impulsionadoras da técnica ultrassonográfica no tórax foi o cancro do pulmão, primeira causa de morte oncológica a nível mundial. A aplicabilidade e conhecimento do papel dos ultrassons no âmbito do diagnóstico e estadiamento do cancro do pulmão não se encontram esgotados, persistindo focos de controvérsia e dúvida científica que se pretendem esclarecer. A presente tese foi organizada em cinco capítulos: o primeiro abordou de forma geral e introdutória o estado da arte referente à ultrassonografia torácica, cancro do pulmão e a sua conjugação; o segundo destacou os principais objetivos; o terceiro sumarizou a metodologia utilizada; o quarto englobou os cinco estudos publicados, descritos subsequentemente, e o quinto incluiu uma discussão concisa, as principais conclusões e perspetivas futuras. O primeiro estudo avaliou a rentabilidade diagnóstica, segurança e curva de aprendizagem num coorte de 179 doentes submetidos a ecoendoscopia brônquica linear. De acordo com as indicações para este procedimento os doentes foram subdivididos em três grupos: (1) diagnóstico, (2) diagnóstico e estadiamento e (3) estadiamento. Para o primeiro, segundo e terceiro grupos a sensibilidade da ecoendoscopia foi 86.1%, 86.7% e 95% respetivamente e a precisão técnica foi 87.5%, 93.1% e 97.7% respetivamente. O treino originou um aumento progressivo do número de locais puncionados por doente, com menor duração e sem complicações, comprovando a eficácia e segurança do método quando realizado na população Portuguesa por broncologistas com experiência. O segundo estudo foi conduzido para averiguar a eficácia e custo da ecoendoscopia brônquica linear realizada através da via aérea e/ou esófago no diagnóstico de lesões sugestivas de neoplasia do pulmão, após ineficácia das técnicas convencionais. Nos doentes incluídos prospetivamente alcançou-se um diagnóstico definitivo em 106 casos (87.6%). A sensibilidade global para o diagnóstico de cancro do pulmão foi 89.8%, a especificidade foi 100%, o valor preditivo positivo foi 100%, o valor preditivo negativo foi 20% e a precisão foi 90.1%. Esta estratégia ultrassonográfica abrangente evitou intervenções cirúrgicas diagnósticas em doentes anteriormente submetidos a broncoscopia flexível ou punção aspirativa transtorácica guiada por tomografia computorizada, proporcionando uma redução significativa dos custos. No terceiro estudo investigou-se a viabilidade e papel da conjugação da ecoendoscopia brônquica linear com técnicas moleculares na avaliação de antigénios tumorais e padrões de metastização ganglionar em doentes com cancro do pulmão de não-pequenas células (CPNPC). Os marcadores citoqueratina 19 (CK-19), antigénio carcinoembrionário (CEA), molécula de adesão celular epitelial (EPCAM), sialyl-Lewis X e CD44 foram determinados nos aspirados ganglionares de 33 doentes com neoplasia e 17 controlos 10 Ultrassonografia através de citometria de fluxo (CF) e reação em cadeia da polimerase em tempo real (RTPCR). Os doentes com CPNPC possuíam um compartimento celular epitelial significativamente aumentado e com marcação superior de CK-19 comparativamente ao grupo de controlo. O compartimento imune foi também analisado nestas amostras e revelou-se alterado no CPNPC com aumento da população de monócitos e diminuição das subpopulações linfocitárias. Os transcriptos de CK-19, CEA e EPCAM estavam elevados nos doentes com cancro do pulmão, identificando-se uma correlação positiva entre estes marcadores e o tamanho da lesão primária. Concluiu-se que a identificação de CK-19, CEA e EPCAM nas amostras obtidas por ecoendoscopia e avaliadas por CF e RTPCR foi viável, podendo auxiliar na deteção de metástases ganglionares no CPNPC. O quarto estudo envolveu a combinação da ecoendoscopia brônquica radial com uma criosonda para o diagnóstico de lesões pulmonares sólidas periféricas. Foi determinada a viabilidade, rentabilidade diagnóstica, tamanho das amostras e segurança do método. Lesões inferiores a 40mm foram localizadas por ultrassonografia sendo os doentes randomizados para a realização de biópsias transbrônquicas com pinça seguidas por criosonda ou vice-versa. Nos 39 casos incluídos a lesão foi visualizada pela minisonda em 31 doentes (79.5%), com 80.6% de prevalência de cancro do pulmão na amostra. A rentabilidade diagnóstica da pinça de biópsia foi 61.3% e da criosonda foi 74.2%. O tamanho do tecido adquirido pelas criobiópsias foi significativamente maior do que o alcançado por pinça (11.17mm2 vs. 4.69mm2, p<0.001). Ocorreu um único caso de hemorragia moderada, controlada através de medidas conservadoras. As biópsias transbrônquicas com criosonda sob orientação de ecoendoscopia radial foram seguras e eficazes na obtenção de amostras histológicas. O quinto estudo determinou o valor diagnóstico da ecografia transtorácica na identificação de malignidade em doentes com derrame pleural de natureza indeterminada. Foram examinados de forma prospetiva 154 doentes. Os resultados clínicos e radiológicos de cada caso foram ocultados ao executante do exame que gerou imagens estáticas e vídeos ultrassonográficos relevantes. Estes foram posteriormente visualizados, sendo as suas características classificadas por revisores independentes e comparadas com o diagnóstico definitivo. Em 66 casos o diagnóstico foi de derrame pleural maligno (68.2% com cancro do pulmão) e em 67 de derrame benigno. A ecografia torácica obteve 80.3% de sensibilidade, 83.6% de especificidade, 81.2% de valor preditivo negativo e 82.8% de valor preditivo positivo na deteção de malignidade. A nodularidade pleural ou diafragmática, espessamento pleural superior a 10mm e sinal de swirling foram significativamente diferentes (p<0.001) sendo sugestivos de derrame maligno. A existência de nodularidade pleural e ausência de broncograma aéreo ecográfico aumentaram a probabilidade de malignidade (OR 29.0 e OR 10.4, respetivamente). A ecografia transtorácica permitiu diferenciar derrame pleural maligno do benigno. A existência de nódulos pleurais constituiu o fator discriminador mais relevante. Em conclusão, os resultados desta tese possibilitam uma melhor compreensão do papel da ecoendoscopia brônquica (linear e radial) e ecografia transtorácica no diagnóstico e estadiamento do cancro do pulmão, com implicações e aplicabilidade na prática clínica.------------- ABSTRACT: In recent years ultrasonography has emerged as an important instrument in the diagnosis of thoracic diseases. Technological progress has enabled the design of new equipment such as radial and linear endobronchial ultrasound. In addition, indications for transthoracic echography were established. One of the main diseases responsible for the progression of chest sonography was lung cancer, the leading cause of cancer mortality worldwide. The applicability and knowledge of the role of ultrasonography in diagnosing and staging lung cancer is not depleted, persisting foci of controversy and scientific doubt that we intend to elucidate. The present thesis was organized into five chapters: the first included a general introduction regarding chest ultrasound, lung cancer and their combination; the second emphasized the main objectives; the third summarized the methodology used; the fourth encompassed the five published studies, subsequently described, and the fifth included a concise discussion, the main findings and future perspectives. The first study evaluated the diagnostic yield, safety and learning curve in a cohort of 179 patients submitted to linear endobronchial ultrasound. According to procedure indications, the patients were divided into three groups: (1) diagnosis, (2) diagnosis and staging, and (3) staging. For the first, second and third groups, endobronchial ultrasound sensitivity was 86.1%, 86.7% and 95% respectively and accuracy was 87.5%, 93.1% and 97.7% respectively. Practise led to an increase number of punctured sites per patient, in a shorter period of time and without complications, proving the safety and efficacy of the method when performed in the Portuguese population by expert echoscopists. The second study was conducted to determine the efficacy and cost of linear endobronchial ultrasound performed through the airway and/or oesophagus for diagnosis of lesions suggestive of lung cancer, after failure of conventional techniques. Of the patients prospectively enrolled a definitive diagnosis was reached in 106 cases (87.6%). The overall sensitivity for the diagnosis of lung cancer was 89.8%, specificity was 100%, positive predictive value was 100%, negative predictive value was 20% and accuracy was 90.1%. In conclusion, this global ultrasonographic strategy avoided diagnostic surgical procedures in patients that had undergone flexible bronchoscopy or computed tomography-guided transthoracic needle aspiration, providing a significant cost reduction. In the third study, the feasibility and role of linear endobronchial ultrasound combined with molecular techniques in the evaluation of tumour antigens and patterns of lymph node metastasis in patients with non-small cell lung cancer (NSCLC) was investigated. Cytokeratin 19 (CK-19), carcinoembryonic antigen (CEA), epithelial cell adhesion molecule (EPCAM), sialyl Lewis-X and CD44 were determined in lymph node aspirates of 33 lung cancer patients and 17 controls, using flow cytometry (FC) and reverse transcription polymerase chain reaction (RT-PCR). In patients with NSCLC the epithelial cell compartment was significantly increased nd showed brighter CK-19 staining, compared to the control group. In NSCLC patients the immune compartment revealed an increased monocyte population and decreased lymphocyte subsets. The transcripts of CK- 19, CEA and EPCAM were higher in lung cancer patients and a positive correlation between these markers and the size of the primary lesion was also found. We concluded that the identification of CK-19, CEA and EPCAM in endobronchial ultrasound samples, using RT-PCR and FC was feasible and might aid in the detection of NSCLC lymph node metastases. The fourth study involved the combination of the radial endobronchial ultrasound with the cryoprobe for diagnosing solid peripheral lung lesions. We determined the feasibility, diagnostic yield, sample size and safety of the method. Lesions less than 40mm were located by ultrasound and forceps or cryobiopsies were performed in a randomized order. Of the 39 cases included, the lesion could be visualized by the miniprobe in 31 patients (79.5%), and lung cancer prevalence was 80.6%. The diagnostic yield of the biopsy forceps was 61.3% and for the cryobiopsy was 74.2 %. Cryobiopsies were significantly larger than forceps biopsies (11.17mm2 vs. 4.69mm2, p<0.001). There was only one case of moderate bleeding that was controlled by conservative measures. Transbronchial cryobiopsies under radial endobronchial ultrasound guidance were safe and effective in obtaining histological samples. The fifth study determined the diagnostic value of transthoracic sonography in predicting malignancy in patients with an undiagnosed pleural effusion. One hundred and fifty four patients were prospectively scanned. Relevant ultrasound images and videos were generated by an operator blinded to clinical and radiological results. These were subsequently visualized, its characteristics classified by independent reviewers and compared to the final diagnosis. A malignant pleural effusion was diagnosed in 66 cases (68.2 % with lung cancer) and a benign effusion in 67 cases. Thoracic ultrasound had a sensitivity of 80.3 %, specificity of 83.6%, negative predictive value of 81.2 % and positive predictive value of 82.8% to detect malignancy. The presence of pleural or diaphragmatic nodularity, pleural thickening greater than 10mm and swirling signal were significantly different (p<0.001 ), being suggestive of malignant effusion. The existence of pleural nodularity and absence of lung air bronchogram were more likely to indicate malignancy (OR 29.0 and OR 10.4, respectively). Transthoracic ultrasonography permits the distinction between malignant and benign pleural effusions. Pleural nodules were the most relevant feature. In conclusion, the results of this thesis provide a better understanding of the role of endobronchial ultrasound (linear and radial) and transthoracic sonography in lung cancer diagnosis and staging, with direct implications and applicability in clinical practice.

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Tese de Doutoramento em Psicologia na área de especialização de Psicologia das Organizações apresentada ao ISPA - Instituto Universitário

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RESUMO - As quedas têm na sua grande maioria uma causa multifatorial. As investigações são substancialmente direcionadas na identificação dos fatores de risco intrínsecos ao doente. Os principais fatores do envolvimento físico e organizacional são frequentemente segregados, ignorando-se as contribuições que estes podem ter na ocorrência de quedas. O propósito desta investigação foi perceber a influência de alterações do envolvimento ambiental e organizacional na redução das quedas em doentes em meio hospitalar. De forma a alcançar este objetivo, analisou-se a informação de uma base de dados referente às quedas ocorridas num hospital da zona da Grande Lisboa, que mudou de instalações a meio do período em estudo. Entre 2012-2014 verificou-se um total 361 notificações de quedas. Nos 3 anos existiu uma redução de 55%. As quedas relacionadas com os fatores do Estado de Saúde do Doente reduziram em 46%, não apresentando significância estatística. Relativamente às quedas devido aos fatores de risco do envolvimento Ambiental e Organizacional, houve uma redução de 67%, considerada estatisticamente significativa. Ao analisar em detalhe os doentes com Nível de risco Elevado (escala de Morse), constata-se que a redução das quedas ao longo do período em estudo não é estatisticamente relevante. Conclui-se que as mudanças de instalações e a renovação de equipamentos poderão ter contribuído positivamente para uma redução das quedas durante o período em estudo. A nível organizacional, a aplicação das medidas preventivas, específicas para doentes com elevado risco de queda, aparentemente não foram suficientemente efetivas.

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ABSTRACT - Objectives: We attempted to show how the implementation of the key elements of the World Health Organization Patient Safety Curriculum Guide Multi-professional Edition in an undergraduate curriculum affected the knowledge, skills, and attitudes towards patient safety in a graduate entry Portuguese Medical School. Methods: After receiving formal recognition by the WHO as a Complementary Test Site and approval of the organizational ethics committee , the validated pre-course questionnaires measuring the knowledge, skills, and attitudes to patient safety were administered to the 2nd and3rd year students pursuing a four-year course (N = 46). The key modules of the curriculum were implemented over the academic year by employing a variety of learning strategies including expert lecturers, small group problem-based teaching sessions, and Simulation Laboratory sessions. The identical questionnaires were then administered and the impact was measured. The Curriculum Guide was evaluated as a health education tool in this context. Results: A significant number of the respondents, 47 % (n = 22), reported having received some form of prior patient safety training. The effect on Patient Safety Knowledge was assessed by using the percentage of correct pre- and post-course answers to construct 2 × 2 contingency tables and by applying Fishers’ test (two-tailed). No significant differences were detected (p < 0.05). To assess the effect of the intervention on Patient Safety skills and attitudes, the mean and standard deviation were calculated for the pre and post-course responses, and independent samples were subjected to Mann-Whitney’s test. The attitudinal survey indicated a very high baseline incidence of desirable attitudes and skills toward patient safety. Significant changes were detected (p < 0.05) regarding what should happen if an error is made (p = 0.016), the role of healthcare organizations in error reporting (p = 0.006), and the extent of medical error (p = 0.005). Conclusions: The implementation of selected modules of the WHO Patient Safety Curriculum was associated with a number of positive changes regarding patient safety skills and attitudes, with a baseline incidence of highly desirable patient safety attitudes, but no measureable change on the patient safety knowledge, at the University of Algarve Medical School. The significance of these results is discussed along with implications and suggestions for future research.