Seroepidemiology and occupational and environmental variables for leptospirosis, brucellosis and toxoplasmosis in slaughterhouse workers in the Paraná State, Brazil

Leptospirosis, brucellosis and toxoplasmosis are widely-distributed zoonosis, being the man an accidental participant of their epidemiological chains. The aim of this paper was to make a seroepidemiological report and identify occupational and environmental variables related to these illnesses in 150 workers in a slaughterhouse in the Northern region of Paraná. For the diagnosis of leptospirosis a microscopical seroagglutination test was applied; for brucellosis, the tamponated acidified antigen test and the 2-mercaptoetanol tests were used, and for toxoplasmosis the indirect immunofluorescence reaction test. For each employee an epidemiological survey was filled, which investigated occupational and environmental variables which could be associated with these infections. Positive results for leptospirosis were found in 4.00% of the samples, for brucellosis in 0.66% of samples and toxoplasmosis in 70.00%. From the three diseases researched, only the results for leptospirosis suggest occupational infection.

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.

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.

Frequency of hepatitis B immunity and occupational exposures to body fluids among brazilian medical students at a public university

In the present study the frequencies of immunity against hepatitis B (HB) and of potentially contaminating accidents among medical students of a Brazilian public university were evaluated. Of all the 400 students who should have been immunized, 303 (75.7%), 66.3% of whom were women, answered an anonymous, self-administered questionnaire. Serum anti-HBs were determined in 205 of them and titers > 10 UI/L were considered to be protective. A total of 86.8% of students had received three doses of HB vaccine. The frequency of immunity among women (96.4%) was higher (p = 0.04) than that among men (87.7%). Among those who did not have immunity, 12/13 (92.3%) had been vaccinated before entering medical school. Only 11% of the students with complete vaccination had previously verified serological response to the vaccine. A total of 23.6% reported having been somehow exposed to blood or secretions. Among final-year students, this frequency was 45.0%, being similar among men (47.8%) and women (43.2%). Of all these accidents, 57.7% were due to body fluids coming in contact with mucosa and 42.3% due to cut and puncture accidents. The results from this study show that: 1) the frequency of immunity against HB is high among the evaluated medical students, although verification of response to vaccination is not a concern for them; 2) anti-HBs titers should be verified after complete vaccination and on a regular basis, especially by men; and 3) the frequency of potentially contaminating accidents is high.

Safety and skin delayed-type hypersensitivity response in vervet monkeys immunized with Leishmania donovani sonicate antigen delivered with adjuvants

In this study, we report on the safety and skin delayed-type hypersensitivity (DTH), responses of the Leishmania donovani whole cell sonicate antigen delivered in conjunction with alum-BCG (AlBCG), Montanide ISA 720 (MISA) or Monophosphoryl lipid A (MPLA) in groups of vervet monkeys. Following three intradermal injections of the inoculums on days 0, 28 and 42, safety and DTH responses were assessed. Preliminary tumor necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) levels were also measured and these were compared with DTH. Only those animals immunized with alum-BCG reacted adversely to the inoculum by producing ulcerative erythematous skin indurations. Non-parametric analysis of variance followed by a post-test showed significantly higher DTH responses in the MISA+Ag group compared with other immunized groups (p < 0.001). The MPLA+Ag group indicated significantly lower DTH responses to the sonicate antigen compared with the AlBCG+Ag group. There was a significant correlation between the DTH and cytokine responses (p < 0.0001). Based on this study we conclude that Leishmania donovani sonicate antigen containing MISA 720 is safe and is associated with a strong DTH reaction following immunization.

In situ measured cross section geometry of old timber structures and its influence on structural safety

Old timber structures may show significant variation in the cross section geometry along the same element, as a result of both construction methods and deterioration. As consequence, the definition of the geometric parameters in situ may be both time consuming and costly. This work presents the results of inspections carried out in different timber structures. Based on the obtained results, different simplified geometric models are proposed in order to efficiently model the geometry variations found. Probabilistic modelling techniques are also used to define safety parameters of existing timber structures, when subjected to dead and live loads, namely self-weight and wind actions. The parameters of the models have been defined as probabilistic variables, and safety of a selected case study was assessed using the Monte Carlo simulation technique. Assuming a target reliability index, a model was defined for both the residual cross section and the time dependent deterioration evolution. As a consequence, it was possible to compute probabilities of failure and reliability indices, as well as, time evolution deterioration curves for this structure. The results obtained provide a proposal for definition of the cross section geometric parameters of existing timber structures with different levels of decay, using a simplified probabilistic geometry model and considering a remaining capacity factor for the decayed areas. This model can be used for assessing the safety of the structure at present and for predicting future performance.

Safety function analysis in an industrial production process

Dissertação para obtenção do Grau de Mestre em Engenharia e Gestão Industrial

Phototherapy in Childhood: a 17-Year Retrospective Study Regarding Effectiveness and Safety

Introduction: Skin diseases in paediatric age are often distressing conditions with significant impact in children’s psychosocial development. Additionally, systemic therapeutic options are often limited in childhood, due to its potential toxicity in this vulnerable group. Phototherapy is therefore an endorsed option for photo-responsive dermatological conditions. Objective and Methods:This observational retrospective study aims to access efficacy and safety of Phototherapy in our paediatric population. Relevant clinical data from 1996 to present concerning patients aged 18 years or less was collected. Results: 78 patients were included, of which64,1%was female. Mean age was 12,9 years (range 2-18). Distribution according to diagnosis was:47,4%psoriasis, 34,6% alopecia areata, 9,0% vitiligo, 9,0% other diagnosis. Mean number of cycles was 1,5 (range 1-7), with an average of 16,3 treatments per cycle and mean cumulative dose 134 J/cm2. 70,5% was treated with one single cycle. Topic and systemic PUVA were the first choice in 37,2% and 39,7%, respectively, while UVB TL01 and broadband UVB were used in 11,5% each. On the first cycle 67,5% improved, 14,3% showed no sustained clinical response and 19,5% were lost to follow-up. Psoriasis patients had the best response rates (81,8%), followed by alopecia areata (59,3%). Side effects occurred in 21%, being erythema the most common (12%). None led to therapeutic interruption. Discussion: Phototherapy is a safe and effective option in childhood, yet the withdraw rate might be an important limitation.

Safety and Effectiveness of the Genous™ Endothelial Progenitor Cell-Capture Stent in the First Year Following ST-Elevation Acute Myocardial Infarction: A Single Center Experience and Review of the Literature

PURPOSE: The Genous™ stent (GS) is designed to accelerate endothelization, which is potentially useful in the pro-thrombotic environment of ST-elevation acute myocardial infarction (STEMI). We aimed to evaluate the safety and effectiveness of the GS in the first year following primary percutaneous coronary intervention (PCI) and to compare our results with the few previously published studies. METHODS AND MATERIALS: All patients admitted to a single center due to STEMI that underwent primary PCI using exclusively GS, between May 2006 and January 2012, were enrolled. The primary study endpoints were major adverse cardiac events (MACEs), defined as the composite of cardiac death, acute myocardial infarction and target vessel revascularization, at one and 12months. RESULTS: In the cohort of 109 patients (73.4% male, 59 ±12years), 24.8% were diabetic. PCI was performed in 116 lesions with angiographic success in 99.1%, using 148 GS with median diameter of 3.00mm (2.50-4.00) and median length of 15mm (9-33). Cumulative MACEs were 2.8% at one month and 6.4% at 12months. Three stent thromboses (2.8%), all subacute, and one stent restenosis (0.9%) occurred. These accounted for the four target vessel revascularizations (3.7%). At 12months, 33.9% of patients were not on dual antiplatelet therapy. CONCLUSIONS: GS was safe and effective in the first year following primary PCI in STEMI, with an apparently safer profile comparing with the previously published data. SUMMARY: We report the safety and effectiveness of the Genous™ stent (GS) in the first year following primary percutaneous coronary intervention in ST-elevation acute myocardial infarction. A comprehensive review of the few studies that have been published on this subject was included and some suggest a less safe profile of the GS. Our results and the critical review included may add information and reinforce the safety and effectiveness of the GS in ST-elevation in acute myocardial infarction.

OCCUPATIONAL EXPOSURES TO BODY FLUIDS AND BEHAVIORS REGARDING THEIR PREVENTION AND POST-EXPOSURE AMONG MEDICAL AND NURSING STUDENTS AT A BRAZILIAN PUBLIC UNIVERSITY

A cross-sectional study was conducted to assess the frequencies and characteristics of occupational exposures among medical and nursing students at a Brazilian public university, in addition to their prevention and post-exposure behavior. During the second semester of 2010, a self-administered semi-structured questionnaire was completed by 253/320 (79.1%) medical students of the clinical course and 149/200 (74.5%) nursing students who were already performing practical activities. Among medical students, 53 (20.9%) suffered 73 injuries, which mainly occurred while performing extra-curricular activities (32.9%), with cutting and piercing objects (56.2%), in the emergency room (39.7%), and as a result of lack of technical preparation or distraction (54.8%). Among nursing students, 27 (18.1%) suffered 37 injuries, which mainly occurred with hollow needles (67.6%) in the operating room or wards (72.2%), and as a result of lack of technical preparation or distraction (62.1%). Among medical and nursing students, respectively, 96.4% and 48% were dissatisfied with the instructions on previously received exposure prevention; 48% and 18% did not always use personal protective equipment; 67.6% and 16.8% recapped used needles; 49.3% and 35.1% did not bother to find out the source patient's serological results post-exposure; and 1.4% and 18.9% officially reported injuries. In conclusion, this study found high frequencies of exposures among the assessed students, inadequate practices in prevention and post-exposure, and, consequently, the need for training in “standard precautions” to prevent such exposures.

Safety and Effectiveness of the Genous Endothelial Progenitor Cell-Capture Stent: Follow-Up to 5 Years

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.

Atorvastatin versus Bezafibrate in Mixed Hyperlipidaemia : Randomised Clinical Trial of Efficacy and Safety (the ATOMIX Study)

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.

Long-Term Lamivudine Treatment of Children with Chronic Hepatitis B: Durability of Therapeutic Responses and Safety

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.

Development and Characterization of bioactive, edible whey protein films and coatings to improve quality and safety of Food products

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