Safety and immunogenicity of hepatitis B vaccine ButaNG in adults

Recombinant yeast-derived hepatitis B vaccine manufactured by Instituto Butantan was administered in two groups of adult volunteers (I, II) following two different schedules of immunization. In the first trial (10 mg doses and 0, 1, 3 months vaccination schedule) 106 individuals completed the full immunization program. The results of seroconversion by age group varied from 70 to 100% and the GMT from 46.5 to 124.9 mIU mL-1. In the second trial with 68 individuals (for dosage comparison and 0, 1, 6 months vaccination schedule) indicated that the vaccine formulated in 20 mg was more effective than in 10 mg. The adverse reactions observed in the vaccinees were less frequent than the ones previously found since the introduction of similar vaccines.

The patient safety journey in Portugal : challenges and opportunities from a public health perspective

ABSTRACT - Despite improvements in healthcare interventions, the incidence of adverse events and other patient safety problems constitutes a major contributor to the global burden of diseases and a concern for Public Health. In the last years there have been some successful individual and institutional efforts to approach patient safety issues in Portugal, unless such effort has been fragmented or focused on specific small areas. Long-term and global improvement has remained elusive, and most of all the improvement of patient safety in Portugal, must evaluate not only the efficacy of a change but also what was effective for implementing the change. Clearly, patient safety issues result from various combinations of individual, team, organization, system and patient factors. A systemic and integrated approach to promote patient safety must acknowledge and strive to understand the complexity of work systems and processes in health care, including the interactions between people, technology, and the environment. Safety errors cannot be productively attributed to a single human error. Our objective with this paper is to provide a brief overview of the status quo in patient safety in Portugal, highlighting key aspects that should be taken into account in the design of a strategy for improving patient safety. With these key aspects in mind, policy makers and implementers can move forward and make better decisions about which changes should be made and about the way the needed changes to improve patient safety should be implemented. The contribution of colleagues that are international leaders on healthcare quality and patient safety may also contribute to more innovative research methods needed to create the knowledge that promotes less costly successful changes.---- ---------------------- RESUMO – As questões relacionadas com a Segurança do Doente, e em particular, com a ocorrência de eventos adversos tem constituído, de há uns tempos a esta parte, uma crescente preocupação para as organizações de saúde, para os decisores políticos, para os profissionais de saúde e para os doentes/utentes e suas famílias, sendo por isso considerado um problema de Saúde Pública a que urge dar resposta. Em Portugal, nos últimos anos, têm sido desenvolvidos esforços baseados, maioritariamente, em iniciativas isoladas, para abordar os aspectos da Segurança do Doente. O facto de essas iniciativas não serem integradas numa estratégia explícita e de dimensão regional ou nacional, faz com que os resultados sejam parcelares e tenham visibilidade reduzida. Paralelamente, a melhoria da qualidade dos cuidados de saúde (a longo prazo) resultante dessas iniciativas tem sido esparsa e nem sempre a avaliação tem sido feita tendo em conta critérios de efectividade e de eficiência. A Segurança do Doente resulta da interacção de diversos factores relacionados, por um lado, com o doente e, por outro, com a prestação de cuidados que envolvem elementos de natureza individual (falhas activas) e organizacional/estrutural (falhas latentes). Devido à multifactorialidade que está na base de «problemas/falhas» na Segurança do Doente, qualquer abordagem a considerar deve ser sistémica e integrada. Simultaneamente, tais abordagens devem contemplar a compreensão da complexidade dos sistemas e dos processos de prestação de cuidados de saúde e as suas interdependências (envolvendo aspectos individuais, tecnológicos e ambientais). O presente trabalho tem por objectivo reflectir sobre o «estado da arte» da Segurança do Doente em Portugal, destacando os elementos-chave que se consideram decisivos para uma estratégia de acção nesse domínio. Com esses elementos os responsáveis pela governação da saúde poderão valorizar os aspectos que consideram decisivos para uma política de Segurança do Doente mais eficaz. A contribuição de quatro colegas internacionalmente reconhecidos como líderes na área da Qualidade em Saúde e da Segurança do Doente, constitui, por certo, uma oportunidade ímpar para a identificação e discussão de alguns dos principais desafios, ameaças e oportunidades que s

Ventos de Mudança – A Energia Eólica em Port

No contexto das energias renováveis, a energia eólica em Portugal tem registado um forte incremento nos últimos anos, sendo hoje uma referência incontornável no panorama europeu e mundial. A dependência externa de fontes energéticas fósseis, o crescimento da procura interna e a actual política de protecção ambiental, tornaram cada vez mais atractiva a exploração de energias renováveis. Entre as várias modalidades disponíveis (solar, hídrica, eólica, geotérmica, das marés e das ondas), a energia eólica tornou-se uma das mais exploradas, quer pelos avanços tecnológicos entretanto obtidos na sua eficiência, quer pelos incentivos e maior rentabilidade a curto e médio prazo do investimento. O seu contributo para o desenvolvimento da economia nacional é já notório e os seus efeitos podem medir-se por vários indicadores, nomeadamente pela redução da utilização de petróleo na produção de electricidade, pelos ganhos na redução da emissão de gases poluentes para a atmosfera ou pela criação de emprego e desenvolvimento económico que lhe está directa e indirectamente associado. Este artigo pretende deste modo: (i) analisar a evolução de alguns indicadores da energia eólica em Portugal por comparação com os de outros países; (ii) destacar os principais desafios, nomeadamente as metas definidas pelo Protocolo de Quioto; (iii) e suscitar alguma reflexão sobre a importância deste tipo de en

Terapêutica Redutora Intensiva do Colesterol: a Certeza da Segurança

A terapêutica antidislipidémica redutora do colesterol é um paradigma da melhor aplicação da evidência científica na prática clínica. Face às opções disponíveis, é fundamental que as estatinas tenham um perfil claro de segurança e tolerabilidade e uma relação de benefícios e risco favorável. A terapêutica intensiva do colesterol não está associada a consequências deletérias, dependentes da maior eficácia, ou a efeitos laterais graves. As estatinas não são hepatotóxicas. A flutuação enzimática é um fenómeno corrente na dislipidemia. O risco de aumento das transamínases está directa e intimamente relacionada com a dose (e com o tipo de estatina usada). Alterações pouco importantes do perfil hepático basal não são uma contra-indicação ao seu uso (doentes com um risco cardiovascular justificável). A monitorização iterada do perfil hepático não está justificada. A causa da miotoxicidade com as estatinas não está devidamente esclarecida. O risco de miopatia ou rabdomiólise não tem relação com a redução percentual ou absoluta do LDL-C (nem com o valor de LDL-C alcançado). Os efeitos adversos das estatinas podem depender das características físico-químicas da molécula e das suas características farmacocinéticas. Numa estratégia de farmacovigilância, o doente tem também uma palavra. A partilha de propósitos obriga o doente a responsabilidades partilhadas com a sua Equipa de Saúde, motivadoras de tratamentos mais seguros e de melhor prevenção cardiovascular. Aperfeiçoar o ingresso em programas de Saúde de qualidade e aprimorar o tratamento e os objectivos alcançados são as razões que devem fundamentar a terapêutica e a redução efectiva intensiva das dislipidemias.

Octreótido - Uma Terapêutica Opcional para Quilotórax Pós-Cirúrgico em Crianças com Cardiopatia Congénita

INTRODUCTION: Chylothorax is a rare but serious postoperative condition in children with congenital heart disease. Conventional medical treatment consists of specific long-term dietary modification, and surgical reintervention, such as lymphatic duct ligation, may be indicated in refractory cases. In recent years, an additional conservative treatment, octreotide, a synthetic analog of somatostatin, has been used in management of congenital and postoperative chylothorax. METHODS: The objective of this work was to analyze the efficacy and safety of this treatment for chylothorax after congenital heart surgery. We reviewed the records of sixteen patients with chylothorax after surgery for congenital heart disease between January 1999 and December 2007, and collected the following data: demographic information; type of surgical procedure; onset, duration and management of chylothorax and treatment; and duration of hospital stay. To analyze efficacy we compared these parameters in children receiving conventional treatment only with those receiving octreotide. To analyze safety we compared the adverse effects of both treatments. Octreotide was administered at a dose of 4 to 10 microg/kg/hour, with monitoring of side effects. RESULTS: The incidence of chylothorax in our population was 1.6%. It occurred more often after Glenn and Fontan procedures (8 patients). Octreotide was begun three days after diagnosis of chylothorax and continued for a median of seventeen days (ranging from 4 to 26 days), until complete resolution. Side effects were frequent (in 3 of the 8 patients) but of no clinical relevance. All patients responded to the therapy and there was no indication for further surgical intervention. DISCUSSION AND CONCLUSIONS: Octreotide is safe and effective in the treatment of postoperative chylothorax in children with congenital heart disease. It is a useful adjunctive therapy to the conventional treatment of this complication.

Encerramento Percutâneo de Shunts Interauriculares: Experiência de uma Década de um Centro Terciário

INTRODUCTION: Atrial septal defects (ASD) are among the most common congenital anomalies and account for 10% of congenital heart disease in the pediatric age-group and 30% in adults. Closure is indicated when there is evidence of hemodynamic significance or after a paradoxical embolic event. Ten years ago, percutaneous closure became the treatment of choice in our center for all patients with a clear indication and favorable anatomy. In this paper we report the experience of this first decade. OBJECTIVE: To assess the short- and long-term results of our ten-year experience with percutaneous closure of atrial septal defects. METHODS: We studied retrospectively all patients with ASD treated with a percutaneous approach between November 1998 and December 2008. The pediatric age-group consisted of patients younger than 19 years old. Demographic data, clinical indications, minor and major complication rates, success rate and long-term outcome were assessed. RESULTS: In the first ten years of experience 510 patients, of whom 166 were in the pediatric group, were treated in our center by a team of adult and pediatric cardiologists. The overall success rate of the procedure was 98% (97.5% in ASD and 99.5% in patent foramen ovale (PFO). The minor complication rate was 3% (3.4% in ASD and 2% in PFO). The most frequent complication was supraventricular tachycardia. The major complication rate was 1.2% (0.6% in ASD and 2% in PFO). Two patients developed cardiac tamponade due to hemopericardium that was resolved by pericardiocentesis, without need for surgery. One patient had an arterial pseudoaneurysm corrected by vascular surgery. There was no device embolization and no need for urgent surgery in this population. During follow-up two patients had recurrence of ischemic stroke, one had a transient ischemic attack and another had a hemorrhagic stroke. Mortality was 0.6% (0.6% in ASD and 0.5% in PFO). There were no in-hospital deaths. During follow-up there were two deaths, both in the adult group. DISCUSSION AND CONCLUSION: In this population the success rate was high and most of the complications were minor. The results of this collaboration between adult and pediatric cardiologists in the first ten years of activity confirm the safety and efficacy of percutaneous closure of septal defects, when there is careful patient selection and a standardized technique.

Estudo Comparativo, Aleatorizado, em Dupla Ocultação, de Orlistat Versus Placebo, de Eficácia e Segurança, em Doentes Obesos com Hipercolesterolemia Ligeira a Moderada

INTRODUCTION: Obesity is a chronic disease and a serious health problem that leads to increased prevalence of diabetes, hypertension, dyslipidemia and gallbladder disease. OBJECTIVE: To evaluate the efficacy of orlistat for weight loss and improved lipid profile compared to placebo in obese patients with hypercholesterolemia, treated over a period of 6 months. METHODOLOGY: In a 6-month, multicenter (10 centers in Portugal), double-blind, parallel, placebo-controlled study, 166 patients, aged 18-65 years, body mass index (BMI) > or = 27 kg/m2, LDL cholesterol > 155 mg/dl, were randomized to a reduced calorie diet (600 kcal/day deficit) plus orlistat three times a day or placebo. Exclusion criteria included triglycerides > 400 mg/dl, severe cardiovascular disease, uncontrolled hypertension, type 1 or 2 diabetes under pharmacological treatment, and gastrointestinal or pancreatic disease. RESULTS: The mean difference in weight from baseline was 5.9% (5.6 kg) in the orlistat group vs. 2.3% (2.2 kg) in the placebo group. In the orlistat group 49% of patients achieved 5-10% weight loss and 8.8% achieved > 10%. The orlistat group showed a significant reduction in total and LDL cholesterol, with similar changes for HDL in both treatment groups. The frequency of gastrointestinal adverse events was slightly higher in the orlistat group than in the placebo group, leading to discontinuation in 7 patients. CONCLUSION: Treatment with orlistat plus a reduced calorie diet for 6 months achieved significant reductions in weight, BMI and lipid parameters.

Avaliação da Performance Cirúrgica: Como Fazer?

Assessment of surgical performance is a must for every surgical practice nowadays and can be done by using scientific methods imported mostly from the Quality control tools that have been in use for long in industry. Surgical performance comprises several dimensions including clinical activity (mortality and morbidity as end points), academic activities, research and, more and more, efficiency. Stable long time results (efficacy), reducing error (safety) and meeting patient expectations (patient satisfaction) are among other performance components. This paper focus on the precise definitions of mortality and morbidity related to surgical activities and on the tools to evaluate patient complexity and assess pre operative risk. Some graphic representations are suggested to compare performance profiles of surgeons and to define individual performance profiles. Strong emphasis is put on pre operative risk assessment and its crucial role to interpret divergent surgical results. Where risk assessment is not possible or is unavailable, observed / expected ratios (O/E) for a given endpoint , be it mortality, length of stay or morbidity, must be established and routinely used to refer results and to identify performance outliers. Morbidity is being pointed out as a most valuable performance indicator in surgery because it is sensitive and comprises efficiency, safety and quality, at large.

Environmental modeling with precision navigation using ROAZ autonomous surface vehicle

The use of robotic vehicles for environmental modeling is discussed. This paper presents diverse results in autonomous marine missions with the ROAZ autonomous surface vehicle. The vehicle can perform autonomous missions while gathering marine data with high inertial and positioning precision. The underwater world is an, economical and environmental, asset that need new tools to study and preserve it. ROAZ is used in marine environment missions since it can sense and monitor the surface and underwater scenarios. Is equipped with a diverse set of sensors, cameras and underwater sonars that generate 3D environmental models. It is used for study the marine life and possible underwater wrecks that can pollute or be a danger to marine navigation. The 3D model and integration of multibeam and sidescan sonars represent a challenge in nowadays. Adding that it is important that robots can explore an area and make decisions based on their surroundings and goals. Regard that, autonomous robotic systems can relieve human beings of repetitive and dangerous tasks.

Utilização de Stents Revestidos com Fármaco em Angioplastia Primária - Resultados Clínicos a Longo Prazo

INTRODUCTION: The use of drug-eluting stents in the context of mechanical reperfusion following ST-segment elevation myocardial infarction (MI) was initially viewed with concern. The main fear was that the drugs' action in unstable lesions could increase the risk of thrombotic stent occlusion. Furthermore, there was no evidence that the proven benefit of reduced instent restenosis could be extended to such patients, since they were excluded from the initial clinical trials. OBJECTIVES: To assess the safety and long-term clinical outcomes of the use of drug-eluting stents in primary angioplasty. METHODS: The first 100 consecutive and non-selected patients admitted for MI and treated by primary angioplasty with drug-eluting stent implantation in the target lesion were analyzed retrospectively. The efficacy and safety of the procedure, in-hospital clinical evolution and the occurrence of major adverse cardiac events in the first year were assessed. RESULTS: Patients' mean age was 58.2 +/- 11.5 years, and 78 were male. The success rate of primary angioplasty was 99%. Stents coated with sirolimus were used in 67 patients, paclitaxel in 19 and dexamethasone in 16. In-hospital mortality was 3%. The follow-up rate at 12 months was 98%. During this period, the rate of target vessel revascularization was 1% (with no patient requiring target lesion revascularization), MI 2%, and overall mortality 3.9%. Fourteen patients had clinical indication for repeat coronary angiography, which showed no significant in-stent restenosis. One event was considered to be due to acute stent thrombosis. The incidence of major adverse events was 5.9%. CONCLUSION: The use of drug-eluting stents in MI patients undergoing primary mechanical revascularization is safe and is associated with a reduced incidence of major adverse events, thrombosis and clinical restenosis at one year.

Toward a Run-Time Verification Framework for Real-Time Safety-Critical Systems

Presented at SEMINAR "ACTION TEMPS RÉEL:INFRASTRUCTURES ET SERVICES SYSTÉMES". 10, Apr, 2015. Brussels, Belgium.

A New Electronic Approach for the Surgical Safety Checklist

To improve surgical safety, and to reduce the mortality and surgical complications incidence, the World Health Organization (WHO) developed the Surgical Safety Checklist (SSC). The SSC is a support of information that aids health professionals to reduce the number of complications, induction of anaesthesia, period before skin incision and period before leaving the operating room (OR). The SSC was tested in several countries of the world and their results shown that after introduction of the SSC the incidence of patient complication lowered from 11.0% to 7.0% (P<0.001), the rate of death declined from 1.5% to 0.8% (P = 0.003) and the nurses recognized that patients identity was more often con rmed (81.6% to 94.2%, P<0.01) in many institutions. Recently the SSC was also implemented in Portuguese hospitals, which led us to its study in the real clinical environment. An observational study was performed: several health professionals were observed and interviewed, to understand the functioning of the SSC in an OR, during the clinical routine. The objective of this study was to understand the current use of the SSC, and how it may be improved in terms of usability, taking advantage of the technological advancements such as mobile applications. During two days were observed 14 surgeries, only 2 surgeries met the requirements for the three phases of the SSC, as de ned by the WHO. Of the remaining 12 observed surgeries, 9 surgeries completed the last phase at the correct time. It was also observed that only in 2 surgeries all the phases of the SSC were read aloud to the team and that, in 7 surgeries, several items were read aloud and answered but no one was checking the SSC, only after the end of the phase. The observational study results disclose that several health professionals do not meet with rules of the WHO manual. This study demonstrates that it is urgent to change the mindset of health professionals, and that di erent features in the SSC may be useful to make it more easy to use. With the results of the observational study, a SSC application proposal was developed with new functionalities to improve and aid the health professional in its use. In this application the user can chose between a SSC already created to a speci c surgery or to create a new SSC, adding and adapting some questions from the WHO standard. To create a new SSC, the application is connected to an online questionnaire builder (JotForm). The choice for this online questionnaire builder went through three essential characteristics: number of types of questions, mainly checkbox, radio button and text; the possibility of to create sections inside sections and the API. In addition, in this proposal the improvements are focused in forcing the user to focus in the work ow of the SSC and to save the input timestamps and any actions made by them. Therefore, the following features was implemented to achieve that goal: display one item of the SSC at a time; display the stage where the SSC is; do not allow going back to the previous step; do not allow going forward to the next item if the current is not lled; do not allow going forward to the next item if the time it took to ll the item was too short and log any action made by the user.

Esterilização Feminina: Estudo Comparativo entre Esterilização Histeroscópica e Laparoscópica

Overview and Aims: Female sterilization is increasingly requested as a contraceptive method. Hysteroscopic sterilization by transcervical placing of Essure® micro-inserts in the initial portion of the tubes is a recent alternative to laparoscopic sterilization. The objective of this study is to evaluate the safety and effectiveness of hysteroscopic versus laparoscopic sterilization. Study Design: Retrospective cohort study. Population: A total of 98 women undergoing sterilization in an outpatient clinic between July 2005 and July 2009. Methods: Patients’ age, associated diseases, anesthesic risk, procedure time, discomfort, adverse events and success rate were evaluated. Results: Mean age at surgery was 37.8 years (19-49), and there were no statistically significant differences between the groups regarding this parameter. Women in the hysteroscopic group had a significant number of associated diseases (98% versus 47%), obesity (31% versus 6%), and anesthesic risk (ASA III- 31% versus 0%). The mean duration of the procedure was the same for both techniques (laparoscopy 28 minutes and hysteroscopy 26 minutes). All laparoscopic sterilizations were successfully completed. In the hysteroscopic group 4% failed to complete the technique. There were no cases of severe pain. Women in the hysteroscopy group reported pain less frequently (40% versus 57%, χ2 p<0.05). Long term success rate was similar in both groups (96% for hysteroscopy and 98% for laparoscopy). Conclusions: In spite of a higher incidence of associated diseases, obesity and anesthetic risks in the hysteroscopy group, there were no significant differences in the duration of the procedure, adverse events and success rate. The hysteroscopic approach can therefore be considered an alternative to laparoscopy, eliminating the need for incisional surgery and for general anaesthesia. If women with high surgical risk and several associated diseases can safely undergo this procedure, it could well become the preferred method for women who want a permanent and irreversible contraceptive method.

Multilevel model of safety climate for furniture industries

BACKGROUND: Furniture companies can analyze their safety status using quantitative measures. However, the data needed are not always available and the number of accidents is under-reported. Safety climate scales may be an alternative. However, there are no validated Portuguese scales that account for the specific attributes of the furniture sector. OBJECTIVE: The current study aims to develop and validate an instrument that uses a multilevel structure to measure the safety climate of the Portuguese furniture industry. METHODS: The Safety Climate in Wood Industries (SCWI) model was developed and applied to the safety climate analysis using three different scales: organizational, group and individual. A multilevel exploratory factor analysis was performed to analyze the factorial structure. The studied companies’ safety conditions were also analyzed. RESULTS: Different factorial structures were found between and within levels. In general, the results show the presence of a group-level safety climate. The scores of safety climates are directly and positively related to companies’ safety conditions; the organizational scale is the one that best reflects the actual safety conditions. CONCLUSIONS: The SCWI instrument allows for the identification of different safety climates in groups that comprise the same furniture company and it seems to reflect those groups’ safety conditions. The study also demonstrates the need for a multilevel analysis of the studied instrument.