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Sample records for safety study comparing

  1. Safety and security in acute admission psychiatric wards in Ireland and London: a comparative study.

    Science.gov (United States)

    Cowman, Seamus; Bowers, Len

    2009-05-01

    The comparative element of this study is to describe safety and security measures in psychiatric acute admission wards in the Republic of Ireland and London; to describe differences and similarities in terms of safety and security patterns in the Republic of Ireland and London; and to make recommendations on safety and security to mental health services management and psychiatric nurses. Violence is a serious problem in psychiatric services and staff experience significant psychological reactions to being assaulted. Health and Safety Authorities in the UK and Ireland have expressed concern about violence and assault in healthcare, however, there remains a lack of clarity on matters of procedure and policy pertaining to safety and security in psychiatric hospitals. A descriptive survey research design was employed. Questionnaires were circulated to all acute wards in London and in Ireland and the resulting data compared. A total of 124 psychiatric wards from London and 43 wards from Ireland were included in this study and response rates of 70% (London) and 86% (Ireland) were obtained. Differences and similarities in safety and security practices were identified between London and Ireland, with Irish wards having generally higher and more intensive levels of security. There is a lack of coherent policy and procedure in safety and security measures across psychiatric acute admission wards in the Republic of Ireland and London. Given the trends in European Union (EU) regulation, there is a strong argument for the publication of acceptable minimum guidelines for safety and security in mental health services across the EU. There must be a concerted effort to ensure that all policy and procedure in safety and security is founded on evidence and best practice. Mental health managers must establish a review of work safety and security procedures and practices. Risk assessment and environmental audits of all mental health clinical environments should be mandatory.

  2. Comparative cardiovascular safety of dementia medications

    DEFF Research Database (Denmark)

    Fosbøl, Emil L; Peterson, Eric D; Holm, Ellen

    2012-01-01

    To compare the cardiovascular safety of currently marketed dementia medications in new users in the United States and Denmark.......To compare the cardiovascular safety of currently marketed dementia medications in new users in the United States and Denmark....

  3. Driving behaviours, traffic risk and road safety: comparative study between Malaysia and Singapore.

    Science.gov (United States)

    Khan, Saif ur Rehman; Khalifah, Zainab Binti; Munir, Yasin; Islam, Talat; Nazir, Tahira; Khan, Hashim

    2015-01-01

    The present study aims to investigate differences in road safety attitude, driver behaviour and traffic risk perception between Malaysia and Singapore. A questionnaire-based survey was conducted among a sample of Singaporean (n = 187) and Malaysian (n = 313) road users. The data was analysed using confirmatory factor analysis and structural equation modelling applied to measure comparative fit indices of Malaysian and Singaporean respondents. The results show that the perceived traffic risk of Malaysian respondents is higher than Singaporean counterparts. Moreover, the structural equation modelling has confirmed perceived traffic risk performing the role of full mediation between perceived driving skills and perceived road safety for both the countries, while perceived traffic skills was found to perform the role of partial mediation between aggression and anxiety, on one hand, and road safety, on the other hand, in Malaysia and Singapore. In addition, in both countries, a weak correlation between perceived driving skills, aggression and anxiety with perceived road safety was found, while a strong correlation exists with traffic risk perception. The findings of this study have been discussed in terms of theoretical, practical and conceptual implications for both scholars and policy-makers to better understand the young drivers' attitude and behaviour relationship towards road safety measures with a view to future research.

  4. Age and workers' perceptions of workplace safety: a comparative study.

    Science.gov (United States)

    Gyekye, Seth Ayim; Salminen, Simo

    2009-01-01

    The study examined the relationship between age and (i) safety perception; (ii) job satisfaction; (iii) compliance with safety management policies; and (iv) accident frequency. Participants were Ghanaian industrial workers (N=320) categorized into 4 age groups: 19-29 years; 30-39 years; 40-50 years; and 51 years and above. Workplace safety perception was assessed with Hayes, Perander, Smecko, and Trask's (1998) 50-item Work Safety Scale (WSS): a scale that effectively captures the dimensions identified by safety experts to influence perceptions of workplace safety. ANOVA was used to test for differences in the mean scores of the 4 groups. Post Hoc analysis revealed differences of statistical significance between the 2 younger cohorts and the 2 older cohorts. The results indicated a positive association between age and safety perception. Older workers had the best perceptions on safety, indicated the highest level of job satisfaction, were the most compliant with safety procedures, and recorded the lowest accident involvement rate. From a practical perspective, understanding age-related perceptions of workplace safety would benefit management's decisions regarding workers' adaptability, general work effectiveness, accident frequency, implementation of safety management policies, and handling of age-related accident characteristics.

  5. Comparing safety climate in naval aviation and hospitals: implications for improving patient safety.

    Science.gov (United States)

    Singer, Sara J; Rosen, Amy; Zhao, Shibei; Ciavarelli, Anthony P; Gaba, David M

    2010-01-01

    Evidence of variation in safety climate suggests the need for improvement among at least some hospitals. However, comparisons only among hospitals may underestimate the improvement required. Comparison of hospitals with analogous industries may provide a broader perspective on the safety status of our nation's hospitals. The purpose of this study was to compare safety climate among hospital workers with personnel from naval aviation, an organization that operates with high reliability despite intrinsically hazardous conditions. We surveyed a random sample of health care workers in 67 U.S. hospitals and, for generalizability, 30 veterans affairs hospitals using questions comparable with those posed at approximately the same time (2007) to a census of personnel from 35 squadrons of U.S. naval aviators. We received 13,841 (41%) completed surveys in U.S. hospitals, 5,511 (50%) in veterans affairs hospitals, and 14,854 (82%) among naval aviators. We examined differences in respondents' perceptions of safety climate at their institution overall and for 16 individual items. Safety climate was three times better on average among naval aviators than among hospital personnel. Naval aviators perceived a safer climate (up to seven times safer) than hospital personnel with respect to each of the 16 survey items. Compared with hospital managers, naval commanders perceived climate more like frontline personnel did. When contrasting naval aviators with hospital personnel working in comparably hazardous areas, safety climate discrepancies increased rather than decreased. One individual hospital performed as well as naval aviation on average, and at least one hospital outperformed the Navy benchmark for all but three individual survey items. Results suggest that hospitals have not sufficiently created a uniform priority of safety. However, if each hospital performed as well as the top-performing hospital in each area measured, hospitals could achieve safety climate levels comparable

  6. Safety culture: a comparative study of space, nuclear and oil-gas sectors

    International Nuclear Information System (INIS)

    Morais, David; Assis, Altair Souza de

    2008-01-01

    Full text:We access in this paper the safety culture methodology adopted by three different industrial sectors: Nuclear, space/aeronautics and oil-gas, in Brazil. In this work, It is evaluated the planning, training, personal monitoring and the interaction between the technical personal, such as engineers and physicists, with human ones, such social workers and physiologists, key factor to understand the efficacy of the local safety culture pattern. The research is made through the analysis of the relevant manuals and interviewing the safety, human areas personal, and regulatory managers, concerned with/related to safety/working with safety culture at the specific industrial sector. It is compared the efficacies and the official regulatory vision on the issue, for the different sectors, in order to detect confluences and divergences and, so, to propose a model that better treat the safety culture as a global industrial value. (author)

  7. A Comparative Study of Natural Antimicrobial Delivery Systems for Microbial Safety and Quality of Fresh-Cut Lettuce.

    Science.gov (United States)

    Hill, Laura E; Oliveira, Daniela A; Hills, Katherine; Giacobassi, Cassie; Johnson, Jecori; Summerlin, Harvey; Taylor, T Matthew; Gomes, Carmen L

    2017-05-01

    Nanoencapsulation can provide a means to effectively deliver antimicrobial compounds and enhance the safety of fresh produce. However, to date there are no studies which directly compares how different nanoencapsulation systems affect fresh produce safety and quality. This study compared the effects on quality and safety of fresh-cut lettuce treated with free and nanoencapsulated natural antimicrobial, cinnamon bark extract (CBE). A challenge study compared antimicrobial efficacy of 3 different nanoencapsulated CBE systems. The most effective antimicrobial treatment against Listeria monocytogenes was chitosan-co-poly-N-isopropylacrylamide (chitosan-PNIPAAM) encapsulated CBE, with a reduction on bacterial load up to 2 log 10 CFU/g (P lettuce was stored at 5 °C and 10 °C for 15 d. Subsequently, chitosan-PNIPAAM-CBE nanoparticles (20, 40, and 80 mg/mL) were compared to a control and free CBE (400, 800, and 1600 μg/mL) for its effects on fresh-cut lettuce quality over 15 d at 5 °C. By the 10th day, the most effective antimicrobial concentration was 80 mg/mL for chitosan-PNIPAAM-CBE, up to 2 log 10 CFU/g reduction (P lettuce shelf-life. Overall, nanoencapsulation provided a method to effectively deliver essential oil and enhanced produce safety, while creating little to no detrimental quality changes on the fresh-cut lettuce. © 2017 Institute of Food Technologists®.

  8. A comparative study on the effective safety of nuclear technology in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Soh, Young Jin [Daegu University, Daegu (Korea); Kim, Young Pyoung [Korea University, Seoul (Korea); Jung, Yoon Soo [Myoungji University, Seoul (Korea); Chung, Ik Jae; Choi, Byung Sun [Seoul National University, Seoul (Korea)

    2001-12-01

    The main purpose of this research is to analyze Korean perception of nuclear risk in comparison with other technological risks. In order to understand the characteristics of risk perception, the concept of 'effective safety' is clarified and defined. This research also covers such issues as relative riskiness of major risks, risk attitude, risk attribution, behavioral pattern for risky situation, and risk knowledge. A nation-wide survey was conducted for this study with a sample size of 1870. It was based on the purposive quota sampling to compare nuclear risk and other technological risks selected are 6 groups of risk; nuclear risk, environmental risk, traffic risk, chemical materials, industrial safety, and other recent risks. Accross these groups, a total of 25 risks are examined. 52 refs., 14 figs., 125 tabs. (Author)

  9. Safety Aspects of Radioactive Waste Management in Different Nuclear Fuel Cycle Policies, a Comparative Study

    International Nuclear Information System (INIS)

    Gad Allah, A.A.

    2009-01-01

    With the increasing demand of energy worldwide, and due to the depletion of conventional natural energy resources, energy policies in many countries have been devoted to nuclear energy option. On the other hand, adopting a safe and reliable nuclear fuel cycle concept guarantees future nuclear energy sustain ability is a vital request from environmental and economic point of views. The safety aspects of radioactive waste management in the nuclear fuel cycle is a topic of great importance relevant to public acceptance of nuclear energy and the development of nuclear technology. As a part of nuclear fuel cycle safety evaluation studies in the department of nuclear fuel cycle safety, National Center for Nuclear Safety and Radiation Control (NCNSRC), this study evaluates the radioactive waste management policies and radiological safety aspects of three different nuclear fuel cycle policies. The once-through fuel cycle (OT- fuel cycle) or the direct spent fuel disposal concept for both pressurized light water reactor ( PWR) and pressurized heavy water reactor (PHWR or CANDU) systems and the s elf-generated o r recycling fuel cycle concept in PWR have been considered in the assessment. The environmental radiological safety aspects of different nuclear fuel cycle options have been evaluated and discussed throughout the estimation of radioactive waste generated from spent fuel from these fuel cycle options. The decay heat stored in the spent fuel was estimated and a comparative safety study between the three fuel cycle policies has been implemented

  10. A comparative study of the safety and economics of fusion fuel cycles

    International Nuclear Information System (INIS)

    Brereton, S.J.; Kazimi, M.S.

    1988-01-01

    The safety and economic characteristics of the deuterium-tritium (DT), deuterium-deuterium (DD) and deuterium-helium-3 (DHe) fusion fuel cycles have been compared. Representative tokamak designs for each fuel cycle were established based on consistent design criteria, using modest extrapolations of present day technologies. The economic analysis of these designs took into account the possible variation in capital and operating costs, and plant availability. Safety analyses examined tritium inventories, routine tritium releases, inventories of activation products and the level of hazard associated with plant wastes. The annual dose incurred by plant workers was estimated for all fuel cycles. The impact of using a reduced activation steel as a blanket material on the economics and safety during normal conditions for the DD fuel cycle was examined. A loss of coolant accident (LOCA) was investigated to determine the relative safety and economic impact of this event for the various fuel cycles. Finally, a cost/benefit analysis was performed to determine if the increased costs associated with these designs are justified by the improved safety which they provide. (orig.)

  11. Instrumental variable methods in comparative safety and effectiveness research.

    Science.gov (United States)

    Brookhart, M Alan; Rassen, Jeremy A; Schneeweiss, Sebastian

    2010-06-01

    Instrumental variable (IV) methods have been proposed as a potential approach to the common problem of uncontrolled confounding in comparative studies of medical interventions, but IV methods are unfamiliar to many researchers. The goal of this article is to provide a non-technical, practical introduction to IV methods for comparative safety and effectiveness research. We outline the principles and basic assumptions necessary for valid IV estimation, discuss how to interpret the results of an IV study, provide a review of instruments that have been used in comparative effectiveness research, and suggest some minimal reporting standards for an IV analysis. Finally, we offer our perspective of the role of IV estimation vis-à-vis more traditional approaches based on statistical modeling of the exposure or outcome. We anticipate that IV methods will be often underpowered for drug safety studies of very rare outcomes, but may be potentially useful in studies of intended effects where uncontrolled confounding may be substantial.

  12. Instrumental variable methods in comparative safety and effectiveness research†

    Science.gov (United States)

    Brookhart, M. Alan; Rassen, Jeremy A.; Schneeweiss, Sebastian

    2010-01-01

    Summary Instrumental variable (IV) methods have been proposed as a potential approach to the common problem of uncontrolled confounding in comparative studies of medical interventions, but IV methods are unfamiliar to many researchers. The goal of this article is to provide a non-technical, practical introduction to IV methods for comparative safety and effectiveness research. We outline the principles and basic assumptions necessary for valid IV estimation, discuss how to interpret the results of an IV study, provide a review of instruments that have been used in comparative effectiveness research, and suggest some minimal reporting standards for an IV analysis. Finally, we offer our perspective of the role of IV estimation vis-à-vis more traditional approaches based on statistical modeling of the exposure or outcome. We anticipate that IV methods will be often underpowered for drug safety studies of very rare outcomes, but may be potentially useful in studies of intended effects where uncontrolled confounding may be substantial. PMID:20354968

  13. Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

    Science.gov (United States)

    Gu, Yong Hong; Ng, Chui Shan; Cai, Xiao; Xu, Jun; Zhang, Xin Shi; Ke, Dong Ge; Yu, Qian Hui; Chan, Chi Kuen

    2018-01-01

    Background The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a “bottom-up” approach to cultural change, to build up a comprehensive and integrated incident management system, and to improve team building and staffing for patient safety. PMID:29750061

  14. Diclofenac topical solution compared with oral diclofenac: a pooled safety analysis

    Directory of Open Access Journals (Sweden)

    Roth SH

    2011-06-01

    Full Text Available Sanford H Roth1, Philip Fuller21Arizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USA; 2Medical Affairs, Covidien, Hazelwood, MO, USABackground: Topical nonsteroidal anti-inflammatory drug (NSAID formulations, which produce less systemic exposure compared with oral formulations, are an option for the management of osteoarthritis (OA. However, the overall safety and efficacy of these agents compared with oral or systemic therapy remains controversial.Methods: Two 12-week, double-blind, double-dummy, randomized, controlled, multicenter studies compared the safety and efficacy profiles of diclofenac topical solution (TDiclo with oral diclofenac (ODiclo. Each study independently showed that TDiclo had similar efficacy to ODiclo. To compare the safety profiles of TDiclo and ODiclo, a pooled safety analysis was performed for 927 total patients who had radiologically confirmed symptomatic OA of the knee. This pooled analysis included patients treated with TDiclo, containing 45.5% dimethyl sulfoxide (DMSO, and those treated with ODiclo. Safety assessments included monitoring of adverse events (AEs, recording of vital signs, dermatologic evaluation of the study knee, and clinical laboratory evaluation.Results: AEs occurred in 312 (67.1% patients using TDiclo versus 298 (64.5% of those taking ODiclo. The most common AE with TDiclo was dry skin at the application site (24.1% vs 1.9% with ODiclo; P < 0.0001. Fewer gastrointestinal (25.4% vs 39.0%; P < 0.0001 and cardiovascular (1.5% vs 3.5%; P = 0.055 AEs occurred with TDiclo compared with ODiclo. ODiclo was associated with significantly greater increases in liver enzymes and creatinine, and greater decreases in creatinine clearance and hemoglobin (P < 0.001 for all.Conclusions: These findings suggest that TDiclo represents a useful alternative to oral NSAID therapy in the management of OA, with a more favorable safety profile.Keywords: diclofenac, gastropathy

  15. Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

    Science.gov (United States)

    Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

    2018-01-01

    Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

  16. Safety culture assessment in petrochemical industry: a comparative study of two algerian plants.

    Science.gov (United States)

    Boughaba, Assia; Hassane, Chabane; Roukia, Ouddai

    2014-06-01

    To elucidate the relationship between safety culture maturity and safety performance of a particular company. To identify the factors that contribute to a safety culture, a survey questionnaire was created based mainly on the studies of Fernández-Muñiz et al. The survey was randomly distributed to 1000 employees of two oil companies and realized a rate of valid answer of 51%. Minitab 16 software was used and diverse tests, including the descriptive statistical analysis, factor analysis, reliability analysis, mean analysis, and correlation, were used for the analysis of data. Ten factors were extracted using the analysis of factor to represent safety culture and safety performance. The results of this study showed that the managers' commitment, training, incentives, communication, and employee involvement are the priority domains on which it is necessary to stress the effort of improvement, where they had all the descriptive average values lower than 3.0 at the level of Company B. Furthermore, the results also showed that the safety culture influences the safety performance of the company. Therefore, Company A with a good safety culture (the descriptive average values more than 4.0), is more successful than Company B in terms of accident rates. The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

  17. Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

    Directory of Open Access Journals (Sweden)

    Xu XP

    2018-05-01

    Full Text Available Xiao Ping Xu,* Dong Ning Deng,* Yong Hong Gu, Chui Shan Ng, Xiao Cai, Jun Xu, Xin Shi Zhang, Dong Ge Ke, Qian Hui Yu, Chi Kuen Chan Clinical Service Department, The University of Hong Kong - Shenzhen Hospital, Shenzhen, Guangdong, People’s Republic of China *These authors contributed equally to this work Background: The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing attention is being paid to patient safety in Mainland China, yet few studies focus on patient safety in organizations with mixed cultures. This paper evaluates the current patient safety culture in an experimental Chinese hospital with a Hong Kong hospital management culture, and it aims to explore the application of Hong Kong’s patient safety strategies in the context of Mainland China. Methods: A quantitative survey of 307 hospital staff members was conducted using the Hospital Survey on Patient Safety Culture questionnaire. The findings were compared with a similar study on general Chinese hospitals and were appraised with reference to the Manchester Patient Safety Framework. Results: Lower scores were observed among participants with the following characteristics: males, doctors, those with more work experience, those with higher education, and those from the general practice and otolaryngology departments. However, the case study hospital achieved better scores in management expectations, actions and support for patient safety, incident reporting and communication, and teamwork within units. Its weaknesses were related to non-punitive responses to errors, teamwork across units, and staffing. Conclusions: The case study hospital contributes to a changing patient safety culture in Mainland China, yet its patient safety culture remains mostly bureaucratic. Further efforts could be made to deepen the staff’s patient safety culture mind-set, to realize a

  18. Hydrogen Safety Issues Compared to Safety Issues with Methane and Propane

    International Nuclear Information System (INIS)

    Green, Michael A.

    2005-01-01

    The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs

  19. Hydrogen Safety Issues Compared to Safety Issues with Methane andPropane

    Energy Technology Data Exchange (ETDEWEB)

    Green, Michael A.

    2005-08-20

    The hydrogen economy is not possible if the safety standards currently applied to liquid hydrogen and hydrogen gas by many laboratories are applied to devices that use either liquid or gaseous hydrogen. Methane and propane are commonly used by ordinary people without the special training. This report asks, 'How is hydrogen different from flammable gasses that are commonly being used all over the world?' This report compares the properties of hydrogen, methane and propane and how these properties may relate to safety when they are used in both the liquid and gaseous state. Through such an analysis, sensible safety standards for the large-scale (or even small-scale) use of liquid and gaseous hydrogen systems can be developed. This paper is meant to promote discussion of issues related to hydrogen safety so that engineers designing equipment can factor sensible safety standards into their designs.

  20. Efficacy and safety of injection with poly-L-lactic acid compared with hyaluronic acid for correction of nasolabial fold: a randomized, evaluator-blinded, comparative study.

    Science.gov (United States)

    Hyun, M Y; Lee, Y; No, Y A; Yoo, K H; Kim, M N; Hong, C K; Chang, S E; Won, C H; Kim, B J

    2015-03-01

    Hyaluronic acid (HA) fillers and poly-L-lactic acid (PLA) fillers are frequently used to correct facial wrinkles. To compare the efficacy and safety of a novel injectable poly-L-lactic acid (PLA) filler and a well-studied biphasic HA filler for the treatment of moderate to severe nasolabial folds. In this multicentre, randomized, evaluator-blinded, comparative study, subjects were randomized for injections with PLA or HA into both nasolabial folds. Efficacy was determined by calculating the change in Wrinkle Severity Rating Scale (WSRS) relative to baseline. Local safety was assessed by reported adverse events. At week 24, mean improvement in WSRS from baseline was 2.09 ± 0.68 for the PLA side and 1.54 ± 0.65 for the HA side. Both injections were well tolerated, and the adverse reactions were mild and transient in most cases. PLA provides noninferior efficacy compared with HA 6 months after being used to treat moderate to severe nasolabial folds. © 2014 British Association of Dermatologists.

  1. Comparing NICU teamwork and safety climate across two commonly used survey instruments.

    Science.gov (United States)

    Profit, Jochen; Lee, Henry C; Sharek, Paul J; Kan, Peggy; Nisbet, Courtney C; Thomas, Eric J; Etchegaray, Jason M; Sexton, Bryan

    2016-12-01

    Measurement and our understanding of safety culture are still evolving. The objectives of this study were to assess variation in safety and teamwork climate and in the neonatal intensive care unit (NICU) setting, and compare measurement of safety culture scales using two different instruments (Safety Attitudes Questionnaire (SAQ) and Hospital Survey on Patient Safety Culture (HSOPSC)). Cross-sectional survey study of a voluntary sample of 2073 (response rate 62.9%) health professionals in 44 NICUs. To compare survey instruments, we used Spearman's rank correlation coefficients. We also compared similar scales and items across the instruments using t tests and changes in quartile-level performance. We found significant variation across NICUs in safety and teamwork climate scales of SAQ and HSOPSC (pteamwork scales (teamwork climate and teamwork within units) of the two instruments correlated strongly (safety r=0.72, pteamwork r=0.67, p<0.001). However, the means and per cent agreements for all scale scores and even seemingly similar item scores were significantly different. In addition, comparisons of scale score quartiles between the two instruments revealed that half of the NICUs fell into different quartiles when translating between the instruments. Large variation and opportunities for improvement in patient safety culture exist across NICUs. Important systematic differences exist between SAQ and HSOPSC such that these instruments should not be used interchangeably. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  3. Comparing non-safety with safety device sharps injury incidence data from two different occupational surveillance systems.

    Science.gov (United States)

    Mitchell, A H; Parker, G B; Kanamori, H; Rutala, W A; Weber, D J

    2017-06-01

    The United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard as amended by the Needlestick Safety and Prevention Act requiring the use of safety-engineered medical devices to prevent needlesticks and sharps injuries has been in place since 2001. Injury changes over time include differences between those from non-safety compared with safety-engineered medical devices. This research compares two US occupational incident surveillance systems to determine whether these data can be generalized to other facilities and other countries either with legislation in place or considering developing national policies for the prevention of sharps injuries among healthcare personnel. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  4. An open-label, two-period comparative study on pharmacokinetics and safety of a combined ethinylestradiol/gestodene transdermal contraceptive patch

    Directory of Open Access Journals (Sweden)

    Zhang C

    2017-03-01

    Full Text Available Chao Zhang,1 Haiyan Li,2 Xin Xiong,1 Suodi Zhai,1 Yudong Wei,2 Shuang Zhang,2 Yuanyuan Zhang,1 Lin Xu,2 Li Liu1 1Department of Pharmacy, 2Institute of Clinical Trial, Peking University Third Hospital, Beijing, People’s Republic of China Abstract: We investigated the pharmacokinetics and safety profiles of a newly developed combined ethinylestradiol (EE/gestodene (GSD transdermal contraceptive patch after a single-dose administration and compared with the market available tablet formulation in healthy adult subjects. An open-label, two-period comparative study was conducted in 12 healthy women volunteers. A single dose of the study combined EE/GE transdermal contraceptive patch and oral tablet (Milunet® were administered. Blood samples at different time points after dose were collected, and concentrations were analyzed. A reliable, highly sensitive and accurate high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC/MS/MS assay method was developed in this study to determine the plasma concentrations of EE and GSD. Compared to the tablet, the study patch had a significantly decreased maximum plasma concentration (Cmax, extended time to reach the Cmax and half-life, as well as increased clearance and apparent volume of distribution. The half-lives of EE and GSD of the patch were 3.3 and 2.2 times, respectively, than the half-life of the tablet. The areas under the plasma concentration–time curve (AUCs of EE and GSD of the patch were 8.0 and 16.2 times, respectively, than the AUC of the tablet. No severe adverse event was observed during the whole study, and the general safety was acceptable. In conclusion, compared to the oral tablet Milunet, the study contraceptive patch was well tolerated and showed potent drug exposure, significant extended half-life and stable drug concentrations. Keywords: pharmacokinetics, safety, ethinylestradiol/gestodene, transdermal contraceptive patch

  5. Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

    Science.gov (United States)

    Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter

    2015-01-01

    Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures

  6. A Comparative Study of Efficacy and Safety of Eberconazole versus Terbinafine in Patients of Tinea Versicolor.

    Science.gov (United States)

    Sharma, Jyoti; Kaushal, Jyoti; Aggarwal, Kamal

    2018-01-01

    Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

  7. A comparative study of efficacy and safety of eberconazole versus terbinafine in patients of tinea versicolor

    Directory of Open Access Journals (Sweden)

    Jyoti Sharma

    2018-01-01

    Full Text Available Background: Tinea versicolor (TV is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure. Aim: This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV. Materials and Methods: An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done. Results: There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%, respectively. However, early response (at the end of week 1 was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile. Conclusion: Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.

  8. Comparative analysis of safety related site characteristics

    International Nuclear Information System (INIS)

    Andersson, Johan

    2010-12-01

    This document presents a comparative analysis of site characteristics related to long-term safety for the two candidate sites for a final repository for spent nuclear fuel in Forsmark (municipality of Oesthammar) and in Laxemar (municipality of Oskarshamn) from the point of view of site selection. The analyses are based on the updated site descriptions of Forsmark /SKB 2008a/ and Laxemar /SKB 2009a/, together with associated updated repository layouts and designs /SKB 2008b and SKB 2009b/. The basis for the comparison is thus two equally and thoroughly assessed sites. However, the analyses presented here are focussed on differences between the sites rather than evaluating them in absolute terms. The document serves as a basis for the site selection, from the perspective of long-term safety, in SKB's application for a final repository. A full evaluation of safety is made for a repository at the selected site in the safety assessment SR-Site /SKB 2011/, referred to as SR-Site main report in the following

  9. Comparative analysis of safety related site characteristics

    Energy Technology Data Exchange (ETDEWEB)

    Andersson, Johan (ed.)

    2010-12-15

    This document presents a comparative analysis of site characteristics related to long-term safety for the two candidate sites for a final repository for spent nuclear fuel in Forsmark (municipality of Oesthammar) and in Laxemar (municipality of Oskarshamn) from the point of view of site selection. The analyses are based on the updated site descriptions of Forsmark /SKB 2008a/ and Laxemar /SKB 2009a/, together with associated updated repository layouts and designs /SKB 2008b and SKB 2009b/. The basis for the comparison is thus two equally and thoroughly assessed sites. However, the analyses presented here are focussed on differences between the sites rather than evaluating them in absolute terms. The document serves as a basis for the site selection, from the perspective of long-term safety, in SKB's application for a final repository. A full evaluation of safety is made for a repository at the selected site in the safety assessment SR-Site /SKB 2011/, referred to as SR-Site main report in the following

  10. Comparative Study on Research Reactor Operation Requirements of IAEA and Korea

    International Nuclear Information System (INIS)

    Yune, Young Gill; Chang, Woo Joon; Lee, Jinho

    2014-01-01

    The IAEA safety requirements represent a consensus view of the IAEA's member states and encompass the recommendations of international experts for the safety of the research reactor. The IAEA safety standards are acknowledged as a global standard by most countries in the world. Therefore, it is desirable to harmonize domestic safety requirements with those of the IAEA. Also, since the IAEA safety requirements include international endeavors to strengthen nuclear safety and to apply the latest nuclear safety technologies to nuclear facilities, a comparative analysis of the safety requirements of the IAEA and Korea for the research reactor will be beneficial to obtaining the insights to improve regulations of the research reactor in Korea. For the reason, a comparative study has been conducted for the research reactor operation safety requirements of the IAEA and Korea in this paper. This paper briefly introduced operation safety requirements in the NS-R-4, analysis methods of this study, and the analysis results. A comparative study has been performed on research reactor operation safety requirements of the IAEA and Korea. This study has identified some gaps in operation safety requirements for the NPP of Korea, comparing with those for the research reactor of the IAEA in the following areas: periodic safety assessment, utilization and modification of the reactor, extended shutdown, inspection/testing/maintenance, operating organization, emergency planning, and commissioning

  11. Learning Patient Safety in Academic Settings: A Comparative Study of Finnish and British Nursing Students' Perceptions.

    Science.gov (United States)

    Tella, Susanna; Smith, Nancy-Jane; Partanen, Pirjo; Turunen, Hannele

    2015-06-01

    Globalization of health care demands nursing education programs that equip students with evidence-based patient safety competences in the global context. Nursing students' entrance into clinical placements requires professional readiness. Thus, evidence-based learning activities about patient safety must be provided in academic settings prior to students' clinical placements. To explore and compare Finnish and British nursing students' perceptions of learning about patient safety in academic settings to inform nursing educators about designing future education curriculum. A purpose-designed instrument, Patient Safety in Nursing Education Questionnaire (PaSNEQ) was used to examine the perceptions of Finnish (n = 195) and British (n = 158) nursing students prior to their final year of registration. Data were collected in two Finnish and two English nursing schools in 2012. Logistic regressions were used to analyze the differences. British students reported more inclusion (p motivation" related to patient safety in their programs. Both student groups considered patient safety education to be more valuable for their own learning than what their programs had provided. Training patient safety skills in the academic settings were the strongest predictors for differences (odds ratio [OR] = 34.69, 95% confidence interval [CI] 7.39-162.83), along with work experience in the healthcare sector (OR = 3.02, 95% CI 1.39-6.58). To prepare nursing students for practical work, training related to clear communication, reporting errors, systems-based approaches, interprofessional teamwork, and use of simulation in academic settings requires comprehensive attention, especially in Finland. Overall, designing patient safety-affirming nursing curricula in collaboration with students may enhance their positive experiences on teaching and learning about patient safety. An international collaboration between educators could help to develop and harmonize patient safety education and to better

  12. Aviation and healthcare: a comparative review with implications for patient safety.

    Science.gov (United States)

    Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

    2016-01-01

    Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

  13. A methodological study to compare survey-based and observation-based evaluations of organisational and safety cultures and then compare both approaches with markers of the quality of care.

    Science.gov (United States)

    Freeth, D; Sandall, J; Allan, T; Warburton, F; Berridge, E J; Mackintosh, N; Rogers, M; Abbott, S

    2012-05-01

    Patient safety concerns have focused attention on organisational and safety cultures, in turn directing attention to the measurement of organisational and safety climates. First, to compare levels of agreement between survey- and observation-based measures of organisational and safety climates/cultures and to compare both measures with criterion-based audits of the quality of care, using evidence-based markers drawn from national care standards relating to six common clinical conditions. (This required development of an observation-based instrument.) Second, to examine whether observation-based evaluations could replace or augment survey measurements to mitigate concerns about declining response rates and increasing social desirability bias. Third, to examine mediating factors in safety and organisational climate scores. The study had three strands: (A) a postal questionnaire survey to elicit staff perceptions of organisational and safety climates, using six prevalidated scales; (B) semistructured non-participant observation of clinical teams; and (C) a retrospective criterion-based audit carried out by non-clinical auditors to minimise hindsight bias. Standardised summary scores were created for each strand, and pairs of measurements were compared (strand A with strand B, strand A with strand C, and strand B with strand C) using Bland-Altman plots to evaluate agreement. Correlations were also examined. Multilevel modelling of Strand A scores explored mediating factors. Eight emergency departments and eight maternity units in England, UK. None. Examination of feasibility, correlation and agreement. Strand A: the overall response rate was 27.6%, whereas site-specific rates ranged from 9% to 47%. We identified more mediating factors than previous studies; variable response rates had little effect on the results. Organisational and safety climate scores were strongly correlated (r = 0.845) and exhibited good agreement [standard deviation (SD) differences 0.449; 14 (88

  14. The usability of ventilators: a comparative evaluation of use safety and user experience.

    Science.gov (United States)

    Morita, Plinio P; Weinstein, Peter B; Flewwelling, Christopher J; Bañez, Carleene A; Chiu, Tabitha A; Iannuzzi, Mario; Patel, Aastha H; Shier, Ashleigh P; Cafazzo, Joseph A

    2016-08-20

    The design complexity of critical care ventilators (CCVs) can lead to use errors and patient harm. In this study, we present the results of a comparison of four CCVs from market leaders, using a rigorous methodology for the evaluation of use safety and user experience of medical devices. We carried out a comparative usability study of four CCVs: Hamilton G5, Puritan Bennett 980, Maquet SERVO-U, and Dräger Evita V500. Forty-eight critical care respiratory therapists participated in this fully counterbalanced, repeated measures study. Participants completed seven clinical scenarios composed of 16 tasks on each ventilator. Use safety was measured by percentage of tasks with use errors or close calls (UE/CCs). User experience was measured by system usability and workload metrics, using the Post-Study System Usability Questionnaire (PSSUQ) and the National Aeronautics and Space Administration Task Load Index (NASA-TLX). Nine of 18 post hoc contrasts between pairs of ventilators were significant after Bonferroni correction, with effect sizes between 0.4 and 1.09 (Cohen's d). There were significantly fewer UE/CCs with SERVO-U when compared to G5 (p = 0.044) and V500 (p = 0.020). Participants reported higher system usability for G5 when compared to PB980 (p = 0.035) and higher system usability for SERVO-U when compared to G5 (p ventilators from market leaders compare and highlights the importance of medical technology design. Within the boundaries of this study, we can infer that SERVO-U demonstrated the highest levels of use safety and user experience, followed by G5. Based on qualitative data, differences in outcomes could be explained by interaction design, quality of hardware components used in manufacturing, and influence of consumer product technology on users' expectations.

  15. National Food Safety Systems in the European Union: A Comparative Survey

    Directory of Open Access Journals (Sweden)

    Andreas Hadjigeorgiou

    2013-04-01

    Full Text Available This paper is a comparative survey of the National Food Safety Systems (NFSS of the European Union (EU Member-States (MS and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA, risk management (RM, and risk communication (RC. We found that in 12 Member States, all three areas of activity (RA, RM, and RC are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

  16. A comparative study of formal methods for safety critical software in nuclear power plant

    International Nuclear Information System (INIS)

    Sohn, Se Do; Seong Poong Hyun

    2000-01-01

    The requirement of ultra high reliability of the safety critical software can not be demonstrated by testing alone. The specification based on formal method is recommended for safety system software. But there exist various kinds of formal methods, and this variety of formal method is recognized as an obstacle to the wide use of formal method. In this paper six different formal method have been applied to the same part of the functional requirements that is calculation algorithm intensive. The specification results were compared against the criteria that is derived from the characteristics that good software requirements specifications should have and regulatory body recommends to have. The application experience shows that the critical characteristics should be defined first, then appropriate method has to e selected. In our case, the Software Cost Reduction method was recommended for internal condition or calculation algorithm checking, and state chart method is recommended for the external behavioral description. (author)

  17. A comparative analysis of occupational health and safety risk prevention practices in Sweden and Spain.

    Science.gov (United States)

    Morillas, Rosa María; Rubio-Romero, Juan Carlos; Fuertes, Alba

    2013-12-01

    Scandinavian countries such as Sweden implemented the occupational health and safety (OHS) measures in the European Directive 89/391/EEC earlier than other European counties, including Spain. In fact, statistics on workplace accident rates reveal that between 2004 and 2009, there were considerably fewer accidents in Sweden than in Spain. The objective of the research described in this paper was to reduce workplace accidents and to improve OHS management in Spain by exploring the OHS practices in Sweden. For this purpose, an exploratory comparative study was conducted, which focused on the effectiveness of the EU directive in both countries. The study included a cross-sectional analysis of workplace accident rates and other contextual indicators in both national contexts. A case study of 14 Swedish and Spanish companies identified 14 differences in the preventive practices implemented. These differences were then assessed with a Delphi study to evaluate their contribution to the reduction of workplace accidents and their potential for improving health and safety management in Spain. The results showed that there was agreement concerning 12 of the 14 practices. Finally, we discuss opportunities of improvement in Spanish companies so that they can make their risk management practices more effective. The findings of this comparative study on the implementation of the European Directive 89/391/EEC in both Sweden and Spain have revealed health and safety managerial practices which, if properly implemented, could contribute to improved work conditions and accident statistics of Spanish companies. In particular, the results suggest that Spanish employers, safety managers, external prevention services, safety deputies and Labour Inspectorates should consider implementing streamlined internal preventive management, promoting the integration of prevention responsibilities to the chain of command, and preventing health and safety management from becoming a mere exchange of

  18. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

    Science.gov (United States)

    Hilton, Said; Sattler, Gerhard; Berg, Anna-Karin; Samuelson, Ulf; Wong, Cindy

    2018-02-01

    Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

  19. Comparative studies of CERCER and CERMET fuels for EFIT from the viewpoint of core performance and safety

    International Nuclear Information System (INIS)

    Chen, X.N.; Rineiski, A.; Maschek, W.; Liu, P.; Boccaccini, C.M.; Sobolev, V.; Delage, F.; Rimpault, G.

    2011-01-01

    The European Facility for Industrial Transmutation (EFIT) has been developed within the 6. EU Framework by the EUROTRANS Program, aiming at a generic conceptual design of an accelerator driven transmuter. This paper deals with assessments of EFIT cores with CERCER and CERMET fuels from the viewpoint of core performance and safety. The conclusive remarks can be drawn as follows. Because of its much better thermal conductivity, the CERMET core can be designed by using thicker pins, so that it has the same or even better transmutation performance compared to the CERCER core. Both CERCER and CERMET fuels fulfill safety requirements. Moreover the CERMET fuel has higher fuel safety margins than the CERCER one. Preliminary analyses show that the CERMET total core power can be further increased by 50% at least without exceeding fuel and clad temperature limits. (authors)

  20. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  1. Safety Culture Assessment in Petrochemical Industry: A Comparative Study of Two Algerian Plants

    Directory of Open Access Journals (Sweden)

    Assia Boughaba

    2014-06-01

    Conclusion: The comparison between the two petrochemical plants of the group Sonatrach confirms these results in which Company A, the managers of which are English and Norwegian, distinguishes itself by the maturity of their safety culture has significantly higher evaluations than the company B, who is constituted of Algerian staff, in terms of safety management practices and safety performance.

  2. Airline Safety: A Comparative Analysis.

    Science.gov (United States)

    1987-01-01

    shrinking FAA inspector force handling a rapidly growing number of air carriers. These studies have always shown an improvement in airline safety in the...EhCLhEmohhhhhhhEoo EhhshhEEmhhhhE EhhEohhEshhhhE EhhhEEEohEohEE EohEEEmhshEmhE IEEE...mmmo 1-2. jI. Mi6 NEW - secuRily CLASSIFICATION OF THIS PAGE (When De

  3. Comparative study of Malaysian and Philippine regulatory infrastructures on radiation and nuclear safety with international standards

    International Nuclear Information System (INIS)

    Cayabo, Lynette B.

    2013-06-01

    This study presents the results of the critical reviews, analysis, and comparison of the regulatory infrastructures for radiation and nuclear safety of Malaysis and the Philippines usi ng the IAEA safety requirements, GSR Part 1, G overnment, Legal and Regulatory Framework for Safety'' as the main basis and in part, the GSR Part 3, R adiation Protection and Safety of Radiation Sources: International Basic Safety Standards . The scope of the comparison includes the elements of the relevant legislations, the regulatory system and processes including the core functions of the regulatory body (authorization, review and assessment, inspection and enforcement, development of regulations and guides); and the staffing and training of regulatory body. The respective availabe data of the Malaysian and Philippine regulatory infrastructures and current practices were gathered and analyzed. Recommendations to fill the gaps and strengthen the existing regulatory infrastructure of each country was given using as bases relevant IAEA safety guides. Based on the analysis made, the main findings are: the legislations of both countries do not contain al the elements of teh national policy and strategy for safety as well as those of teh framework for safety in GR Part I. Among the provision that need to be included in the legislations are: emergency planning and response; decommissioning of facilities safe management of radioactive wastes and spent fuel; competence for safety; and technical sevices. Provisions on coordination of different authorities with safety responsibilities within the regulatory framework for safety as well as liaison with advisory bodies and support organizations need to be enhanced. The Philippines needs to establish an independent regulatory body, ie. separate from organizations charged with promotion of nuclear technologies and responsible for facilitiesand activities. Graded approach on the system of notification and authorization by registration and

  4. A comparative study of vocational education and occupational safety and health training in China and the UK.

    Science.gov (United States)

    Nie, Baisheng; Huang, Xin; Xue, Fei; Chen, Jiang; Liu, Xiaobing; Meng, Yangyang; Huang, Jinxin

    2018-06-01

    In order to enhance Chinese workers' occupational safety awareness, it is essential to learn from developed countries' experiences. This article investigates thoroughly occupational safety and health (OSH) in China and the UK; moreover, the article performs a comparison of Chinese and British OSH training-related laws, regulations and education system. The following conclusions are drawn: China's work safety continues to improve, but there is still a large gap compared with the UK. In China a relatively complete vocational education and training (VET) system has been established. However, there exist some defects in OSH. In the UK, the employer will not only pay attention to employees' physiological health, but also to their mental health. The UK's VET is characterized by classification and grading management, which helps integrate OSH into the whole education system. China can learn from the UK in the development of policies, VET and OSH training.

  5. A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol

    Directory of Open Access Journals (Sweden)

    Weggelaar Anne-Marie

    2011-10-01

    Full Text Available Abstract Background although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. Methods/design in-depth multi-level (macro, meso and micro-system analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims. Discussion the protocol is based on the premise that

  6. Safety study application guide

    International Nuclear Information System (INIS)

    1993-07-01

    Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Included are analyses of existing facilities done under the aegis of the Safety Analysis Report Upgrade Program, and analyses of new and modified facilities. A graded approach is used wherein the level of analysis and documentation for each facility is commensurate with the magnitude of the hazard(s), the complexity of the facility and the stage of the facility life cycle. Safety analysis reports (SARs) for hazard Category 1 and 2 facilities are usually detailed and extensive because these categories are associated with public health and safety risk. SARs for Category 3 are normally much less extensive because the risk to public health and safety is slight. At Energy Systems, safety studies are the name given to SARs for Category 3 (formerly open-quotes lowclose quotes) facilities. Safety studies are the appropriate instrument when on-site risks are limited to irreversible consequences to a few people, and off-site consequences are limited to reversible consequences to a few people. This application guide provides detailed instructions for performing safety studies that meet the requirements of DOE Orders 5480.22, open-quotes Technical Safety Requirements,close quotes and 5480.23, open-quotes Nuclear Safety Analysis Reports.close quotes A seven-chapter format has been adopted for safety studies. This format allows for discussion of all the items required by DOE Order 5480.23 and for the discussions to be readily traceable to the listing in the order. The chapter titles are: (1) Introduction and Summary, (2) Site, (3) Facility Description, (4) Safety Basis, (5) Hazardous Material Management, (6) Management, Organization, and Institutional Safety Provisions, and (7) Accident Analysis

  7. Fluid dispersal from safety cannulas: an in vitro comparative test.

    Science.gov (United States)

    Rosenthal, Victor D; Hughes, Gavin

    2015-03-01

    We report a comparative laboratory study between 2 peripheral intravenous catheters equipped with a passive fully automatic safety mechanism to assess generation of blood droplets during withdrawal. One presented no fluid droplets, whereas the other presented droplets in 48% and 60% for the best and worst case, with analysis of variance showing positive effects on the number of droplets generated (P blood splatter. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  8. Comparative Study on Research Reactor Design Requirements between IAEA and Korea

    International Nuclear Information System (INIS)

    Chang, Won Joon; Yune, Young Gill; Song, Myung Ho; Cho, Seung Ho

    2013-01-01

    This study has identified the gaps in the safety requirements for design of research reactors of Korea comparing with those of the IAEA. The review results showed that the gaps have arisen mainly from the following aspects: - The differences in the characteristics of design and operation between power reactor and research reactor - Enhancement of the level of safety of nuclear reactor facility - Consideration of advanced safety technologies. The review results will be utilized to reflect the IAEA safety requirements for design of research reactors into those of Korea, which will contribute to enhancing the level of safety and improving the technical standards of research reactors of Korea. The IAEA safety standards encompass international consensus to strengthen the nuclear safety and to reflect the latest advancement of nuclear safety technologies. Also, they provide reliable means to ensure the effective fulfillment of obligations under the various international safety conventions. Many countries have adopted the IAEA safety standards as their national standards in nuclear regulations. Since Korea has exported research reactor technologies abroad these days and will continue to export them in the future, it is desirable to harmonize domestic safety requirements for research reactor with those of the IAEA. The KINS (Korea Institute of Nuclear Safety) has performed a review of the IAEA safety requirements for design of research reactors comparing with those of Korea. The purpose of this comparative study is to harmonize the safety requirements for the design of research reactors of Korea with those of the IAEA as a member state of the IAEA, and to encompass global efforts to enhance the nuclear safety and to reflect the latest advancement of nuclear safety technologies into the safety requirements for the design of research reactors of Korea. Design requirements for structures, systems, and components of research reactors important to safety, which are required to

  9. Protection of Health and Safety at Workplace: A comparative legal study of the European Union and China

    NARCIS (Netherlands)

    Liu, K.

    2017-01-01

    The objective of this research is to obtain a better view of and insight into the approaches adopted by the jurisdictions being researched by means of a comparative and critical analysis of the similarities and differences of the approaches concerned aiming at the protection of health and safety of

  10. Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.

    Science.gov (United States)

    Rudroju, Neelima; Bansal, Dipika; Talakokkula, Shiva Teja; Gudala, Kapil; Hota, Debasish; Bhansali, Anil; Ghai, Babita

    2013-01-01

    Anticonvulsants and antidepressants are mostly used in management of painful diabetic neuropathy (PDN). However there are few direct comparisons between drugs of these classes, making evidence-based decision-making in the treatment of painful diabetic neuropathy difficult. This study aimed to perform a network meta-analysis and benefit-risk analysis to evaluate the comparative efficacy and safety of these drugs in PDN treatment. Comparative effectiveness study. Medical Education and Research facility in India. A comprehensive data search was done in PubMed, Cochrane, and Embase up to August 2012. We then systematically reviewed the studies which compared any of 6 drugs for the management of PDN: amitriptyline, duloxetine, gabapentin, pregabalin, valproate, and venlafaxine or any of their combinations. We performed a random-effects network meta-analysis to rank treatments in terms of efficacy and safety. We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively. We also performed benefit-risk analysis, taking efficacy outcome as benefit and safety outcome as risk. Analysis was intention-to-treat. We included 21 published trials in the analysis. Duloxetine, gabapentin, pregabalin, and venlafaxine were shown to be significantly efficacious compared to placebo with odds ratios (OR) of 2.12, 3.98, 2.78, and 4.43, respectively. Amitriptyline (OR: 7.03, 95% confidence interval [CI]: 1.87, 29.05) and duloxetine (OR: 3.26, 95% CI: 1.04, 9.97) caused more withdrawals than gabapentin. The ranking order of efficacy was gabapentin, venlafaxine, pregabalin, duloxetine/gabapentin, duloxetine, amitriptyline, and placebo and the ranking order of safety was placebo, gabapentin, pregabalin, venlafaxine, duloxetine/gabapentin combination, duloxetine, and amitriptyline. Benefit-risk balance favored the order: gabapentin, venlafaxine, pregabalin, duloxetine

  11. SUNflower +6 : a comparative study of the development of road safety in the SUNflower +6 countries : final report.

    NARCIS (Netherlands)

    Wegman, F.C.M. Eksler, V. Hayes, S. Lynam, D. Morsink, P. & Oppe, S. (eds.)

    2006-01-01

    This project has developed the SUNflower approach, originally used to assess Sweden, Great Britain and the Netherlands, for comparing safety programmes and records between countries. The approach has been applied to nine countries, adding three Central European countries (the Czech Republic, Hungary

  12. A Comparative Study on Effective Factors in Patient Safety Culture from the Nursing Staff Points of View

    Directory of Open Access Journals (Sweden)

    Khalil Alimohammadzadeh

    2017-04-01

    Full Text Available Introduction: Patient safety and its requirements fulfillment are today one of the useful valuation indicators in healthcare organizations. Thus, patient safety culture and its promotion are referred to as one of the most important issues raised in the country. The present study aims to examine the effective factors (personal and organizational in patient safety culture from the point of view of nursing staff in Bahman and Parsian private hospitals. Method: The study has an analytical cross-sectional design and is an applied research. HSOPSC (with Cronbach’s alpha coefficient was 0.82 and researcher-devised questionnaires (with Cronbach’s Alpha equal to 0.912 were the only data collection tools. Statistical population includes nursing staff of Bahman and Parsian private hospitals in north-west Tehran. A sample consisting of 150 nurse shift supervisors and head nurses was selected from the population. Necessary data for completing questionnaires were collected by interview. Data were analyzed using SPSS16 software. Given the levels of measurement for the variables, valid measures of central tendency (mean, standard deviation, correlation tests, Chi-square, t- test, and ANOVA were used. Results: The findings showed us that such factors as organizational commitment, error reporting system, management support, reward system, and employee empowerment equipment distribution have important roles in patient safety. Their P-values are reported <0.001 for all of them. Patient safety was not significantly associated with age (P=0.964, educational level (P=0.154, and work experience (P=0.888 There is no low awareness about safety culture in any hospital and their mean awareness about patient safety culture was equal to 3.13 ±0.478 and 3.68 ±0.587 in Parsian and Bahman hospitals, respectively (P<0.001. Conclusion: Error reporting system and organizational commitment respectively have the most and the least effect on promoting patient safety culture

  13. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

    Science.gov (United States)

    Wolf, Luise; Eertmans, Frank; Wolf, Doerte; Rossel, Bart; Adriaens, Els

    2016-01-01

    Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action. German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.

  14. Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

    Science.gov (United States)

    Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

    2016-01-01

    Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems.

  15. A comparative study between transport and criticality safety indexes for fissile uranium nuclearly pure

    Energy Technology Data Exchange (ETDEWEB)

    Moraes da Silva, T. de; Sordi, G.M.A.A. [Instituto de Pesquisas Energeticas e Nucleares, IPEN/CNEN (Brazil)]. e-mail: tmsilva@ipen.br

    2006-07-01

    The international and national standards determine that during the transport of radioactive materials the package to be sent should be identified by labels of risks specifying content, activity and the transport index. The result of the monitoring of the package to 1 meter identifies the transport index, TI, which represents the dose rate to 1 meter of this. The transport index is, by definition, a number that represents a gamma radiation that crosses the superficial layer the radioactive material of the package to 1 meter of distance. For the fissile radioactive material that is the one in which a neutron causes the division of the atom, the international standards specify criticality safety index CSI, which is related with the safe mass of the fissile element. In this work it was determined the respective safe mass for each considered enrichment for the compounds of uranium oxides UO{sub 2}, U{sub 3}O{sub 8} and U{sub 3}Si{sub 2}. In the study of CSI it was observed that the value 50 of the expression 50/N being N the number of packages be transported in subcriticality conditions it represents a fifth part of the safe mass of the element uranium or 9% of the smallest mass critical for a transport not under exclusive use. As conclusion of the accomplished study was observed that the transport index starting from 7% of enrichment doesn't present contribution and that criticality safety index is always greater than the transport index. Therefore what the standards demand to specify, the largest value between both indexes, was clearly identified in this study as being the criticality safety index. (Author)

  16. Endometrial ablation by rollerball electrocoagulation compared to uterine balloon thermal ablation. Technical and safety aspects.

    NARCIS (Netherlands)

    Zon-Rabelink, I.A.A. van; Vleugels, M.P.; Merkus, J.M.W.M.; Graaf, R.M. de

    2003-01-01

    OBJECTIVE: To compare two methods of endometrial ablation, hysteroscopic rollerball electrocoagulation (RBE) and non-hysteroscopic uterine balloon thermal (UBT) ablation (Thermachoice), regarding intra- and post-operative technical complications and safety aspects. STUDY DESIGN: A randomised

  17. Cookstove options for safety and health: Comparative analysis of technological and usability attributes

    International Nuclear Information System (INIS)

    Kimemia, David; Van Niekerk, Ashley

    2017-01-01

    Energy use in low-income households in South Africa is considerably more hazardous than in middle to high-income households. Poverty is a key underlying factor. However, poor quality domestic energy technologies, including stoves, heaters and light sources contribute to this vulnerability. The problem is compounded by behavioural and environmental factors. Since cooking is a key energy-using chore, access to efficient, safe and versatile stoves portend safety improvements. This paper reports on a comparative analysis of eleven technological and usability attributes (CO emissions, firepower, efficiency, fuel toxicity, fuel cost, stove price, controllability, durability, availability, temperature of touchable-parts, and mechanical stability) of commercially available stoves that utilise four energy sources (kerosene, methanol, ethanol gel, and LPG). The ensuing discussion serves as a guide to enable the selection of the best-fit stove-fuel combination for low-income households. The findings indicate that LPG stoves have comparatively better overall rankings for cleanliness, firepower, safety, and durability. This analysis highlights that no combustion technology is risk-proof and there remains a burden on users to exercise diligence. We recommend that South Africa adopts an affirmative policy and strategic actions that discourage the use of kerosene as a household combustion fuel, and promotes the adoption of LPG as a safer and practical alternative. - Highlights: • Inefficient fuel combustion stoves raise risk profile in energy-poor households. • This study uses quantitative methods to compare the attributes of four stove types. • LPG stoves have comparatively better ranking for emissions, safety, and durability. • Transformative policies and strategies are required to promote safe, clean stoves.

  18. Efficacy and Safety of a Mineral Oil-Based Head Lice Shampoo: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

    Directory of Open Access Journals (Sweden)

    Luise Wolf

    Full Text Available Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo.This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23 was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere, registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution. In total, 107 patients (>1 year with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54. All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10.Cure rates at day 10 (corrected for re-infestation for the test product (96.1% and control (94% significantly exceeded the pre-defined target (70% (p < 0.001, 2-sided, 1-sample, chi-square test with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%. Both products were safe and well tolerated, offering good esthetical effects.This study showed that substance-based medical devices (including the tested mineral oil shampoo can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because

  19. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  20. Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

    Science.gov (United States)

    Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

    2017-10-01

    Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65

  1. Review of light--water reactor safety studies. Volume 3 of health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California

    International Nuclear Information System (INIS)

    Nero, A.V.; Farnaam, M.R.K.

    1977-01-01

    This report summarizes and compares important studies of light-water nuclear reactor safety, emphasizing the Nuclear Regulatory Commission's Reactor Safety Study, work on risk assessment funded by the Electric Power Research Institute, and the Report of the American Physical Society study group on light-water reactor safety. These reports treat risk assessment for nuclear power plants and provide an introduction to the basic issues in reactor safety and the needs of the reactor safety research program. Earlier studies are treated more briefly. The report includes comments on the Reactor Safety Study. The manner in which these studies may be used and alterations which would increase their utility are discussed

  2. A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

    Science.gov (United States)

    Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

    2016-01-01

    Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

  3. A longitudinal, multi-level comparative study of quality and safety in European hospitals

    DEFF Research Database (Denmark)

    Robert, Glenn B; Anderson, Janet E; Burnett, Susan J

    2011-01-01

    makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis......, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy...... by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how...

  4. Study on safety subsidiary objective of nuclear power plant in USA

    International Nuclear Information System (INIS)

    Chen Yan; Zhang Chunming; Fu Zhiwei; Song Wei; Li Chaojun; Wang Zhe; Zuo Jiaxu

    2013-01-01

    This paper reviewed the development of the quantitative safety objective and subsidiary objective in USA. The expressions of CDF and LERF were obtained according to NUREG-1150. The relationship between the subsidiary objective and the quantitative safety objective was derived. The method was compared with that used in NUREG-1860. The requirements of safety objective for the future nuclear power plant and the development of probabilistic safety analysis (PSA) technology in USA were studied and can be used as reference in China. (authors)

  5. Comparative approach between nuclear safety and security

    International Nuclear Information System (INIS)

    2009-04-01

    Adopting the definition of nuclear safety and nuclear security as they are specified by IAEA glossaries, this report first outlines that these both notions refer to similar risks but with causes of different nature. They discuss the notions of transparency and confidentiality and outline that security and safety both aims at the protection of population and of the environment. They discuss their organisational principles, notice that both have their own legal and regulatory framework, that authorities have expertise on both, that the responsibility is distributed among operators and the State, and that safety and security cultures are complementary. They analyse the design, exploitation and management principles of security and safety approaches: graded approach, defence-in-depth, synergy between security and safety, same daily monitoring requirement, same necessity to address the return on experience, same need to update a referential, a more constrained exchange of good practices in safety, a necessity to deal with their respective requirements, elaboration of emergency plans, performance of exercises

  6. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

    Science.gov (United States)

    Schweizer, Anja; Dejager, Sylvie; Foley, James E; Kothny, Wolfgang

    2011-01-01

    Aim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs), of vildagliptin based on a large pooled database of Phase II and III clinical trials. Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks’ duration. AE profiles of vildagliptin (50 mg bid; N = 6116) were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210). Absolute incidence rates were calculated for all AEs, serious AEs (SAEs), discontinuations due to AEs, and deaths. Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively) and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively), whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators). The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas. Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies. PMID:21415917

  7. Assessing the general safety and tolerability of vildagliptin: value of pooled analyses from a large safety database versus evaluation of individual studies

    Directory of Open Access Journals (Sweden)

    Schweizer A

    2011-02-01

    Full Text Available Anja Schweizer1, Sylvie Dejager2, James E Foley3, Wolfgang Kothny31Novartis Pharma AG, Basel, Switzerland; 2Novartis Pharma SAS, Rueil-Malmaison, France; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAAim: Analyzing safety aspects of a drug from individual studies can lead to difficult-to-interpret results. The aim of this paper is therefore to assess the general safety and tolerability, including incidences of the most common adverse events (AEs, of vildagliptin based on a large pooled database of Phase II and III clinical trials.Methods: Safety data were pooled from 38 studies of ≥12 to ≥104 weeks' duration. AE profiles of vildagliptin (50 mg bid; N = 6116 were evaluated relative to a pool of comparators (placebo and active comparators; N = 6210. Absolute incidence rates were calculated for all AEs, serious AEs (SAEs, discontinuations due to AEs, and deaths.Results: Overall AEs, SAEs, discontinuations due to AEs, and deaths were all reported with a similar frequency in patients receiving vildagliptin (69.1%, 8.9%, 5.7%, and 0.4%, respectively and patients receiving comparators (69.0%, 9.0%, 6.4%, and 0.4%, respectively, whereas drug-related AEs were seen with a lower frequency in vildagliptin-treated patients (15.7% vs 21.7% with comparators. The incidences of the most commonly reported specific AEs were also similar between vildagliptin and comparators, except for increased incidences of hypoglycemia, tremor, and hyperhidrosis in the comparator group related to the use of sulfonylureas.Conclusions: The present pooled analysis shows that vildagliptin was overall well tolerated in clinical trials of up to >2 years in duration. The data further emphasize the value of a pooled analysis from a large safety database versus assessing safety and tolerability from individual studies.Keywords: type 2 diabetes, dipeptidyl peptidase-4, edema, safety, vildagliptin

  8. Improving safety culture through the health and safety organization: a case study.

    Science.gov (United States)

    Nielsen, Kent J

    2014-02-01

    International research indicates that internal health and safety organizations (HSO) and health and safety committees (HSC) do not have the intended impact on companies' safety performance. The aim of this case study at an industrial plant was to test whether the HSO can improve company safety culture by creating more and better safety-related interactions both within the HSO and between HSO members and the shop-floor. A quasi-experimental single case study design based on action research with both quantitative and qualitative measures was used. Based on baseline mapping of safety culture and the efficiency of the HSO three developmental processes were started aimed at the HSC, the whole HSO, and the safety representatives, respectively. Results at follow-up indicated a marked improvement in HSO performance, interaction patterns concerning safety, safety culture indicators, and a changed trend in injury rates. These improvements are interpreted as cultural change because an organizational double-loop learning process leading to modification of the basic assumptions could be identified. The study provides evidence that the HSO can improve company safety culture by focusing on safety-related interactions. © 2013. Published by Elsevier Ltd and National Safety Council.

  9. [Comparative Study of the Efficacy and Safety of Caffeine and Aminophylline for the Treatment of Apnea in Preterm Infants].

    Science.gov (United States)

    Nagasato, Akane; Nakamura, Masatoshi; Kamimura, Hidetoshi

    2018-01-01

     Methylxanthine is widely administered for the treatment of apnea of prematurity in many countries, and previous reports have clearly established that caffeine is effective for the treatment of apnea of prematurity. In Japan, caffeine has been available since December 2014. Thus, we compared the efficacy and safety of caffeine with that of aminophylline in our hospital. There was no significant difference between the caffeine group and aminophylline group regarding the characteristics of the study patients. The mean efficacy rate from day 1 to day 10 was 89.5% in the caffeine group, and 81.9% in the aminophylline group, although the rate of improvement in apnea episodes each day from day 1 to day 10 was not significantly different between the two groups. On the other hand, the adverse event rates in the caffeine group and the aminophylline group were 70.6% and 75.0%, respectively. No significant difference was observed in the adverse event rates between the two groups. Moreover, suspected abdominal distension due to the drug administration was more frequently observed with the aminophylline group. Our findings indicate that caffeine is as effective as aminophylline, while it is superior to aminophylline regarding its overall safety.

  10. Study on the KALIMER safety approach

    International Nuclear Information System (INIS)

    Kim, Eui Kwang; Han, Do Hee; Kim, Young Cheol.

    1997-01-01

    This study describes KALIMER's safety approach, how to establish the safety criteria and temperature limit, how to define safety evaluation events, and some safety research and development needs items. It is recommended that the KALIMER's approach to safety use seven levels of safety design and a defense-in-depth design approach with particular emphasis on inherent passive features. In order to establish as set DBEs for KALIMER safety evaluation, the procedure is explained how to define safety evaluation events. Final selection is to be determined later with the final establishment of design concepts. On the basis of preliminary studies and evaluation of the plant safety related areas, the KALIMER and PRISM have following three main difference that may require special research and development for KALIMER. (author). 7 refs., 6 tabs., 6 figs

  11. Double blind clinical trail comparing the safety and efficacy of ...

    African Journals Online (AJOL)

    Double blind clinical trail comparing the safety and efficacy of nimesulide (100g) and diclofenac in osteoarthrosis of the hip and knee joints. ... A significant proportion of the patients in the diclofenac group (50% vs 17.6%) had break through pain that warranted the use of at least two tablets of 500mg of paracetamol per week ...

  12. Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study

    Directory of Open Access Journals (Sweden)

    Dahl R

    2013-10-01

    Full Text Available Ronald Dahl,1 Dalal Jadayel,2 Vijay KT Alagappan,3 Hungta Chen,3 Donald Banerji31Department of Dermatology, Allergy Centre, Odense University Hospital, Odense, Denmark; 2Novartis Horsham Research Centre, Horsham, UK; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USAIntroduction: The BEACON study evaluated the efficacy and safety of QVA149, a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA indacaterol and long-acting muscarinic antagonist (LAMA glycopyrronium (NVA237, in development for the treatment of patients with chronic obstructive pulmonary disease (COPD, compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY.Methods: In this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010 were randomized (1:1 to once-daily QVA149 (110 µg indacaterol/50 µg glycopyrronium or concurrent administration of indacaterol (150 µg and glycopyrronium (50 µg via the Breezhaler® device (Novartis AG, Basel, Switzerland for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1 after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0–4 hours at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period.Results: Of 193 patients randomized, 187 (96.9% completed the study. Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.46 L ± 0.02 and 1.46 L ± 0.18, respectively. The FEV1 AUC0–4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group

  13. Comparative study of legal limits of safety requirements for nuclear installations

    International Nuclear Information System (INIS)

    Schattke, Herbert.

    1983-01-01

    This paper makes a detailed analysis of safety philosophies and principles of radiological protection at international and national levels according to a standardised plan for purposes of comparison. It describes the relevant regulations of the IAEA, OECD/NEA and Euratom and those of the US, UK, France, Italy, the Netherlands, Switzerland and the Federal Republic of Germany. The author points out that the ICRP recommendations are the guidelines in the radiation protection field. (NEA) [fr

  14. Comparative study of dihydroartemisinin and artesunate safety in healthy Thai volunteers.

    Science.gov (United States)

    Kongpatanakul, S; Chatsiricharoenkul, S; Khuhapinant, A; Atipas, S; Kaewkungwal, J

    2009-09-01

    As part of new drug development initiatives in Thailand, a new tablet formulation of dihydroartemisinin (DHA, an antimalarial drug) has been developed. Our previous bioequivalence study indicated that the new and reference DHA formulations were well tolerated; however, a significant decrease in hemoglobin was detected after a single 200-mg oral dose. To explore further, a clinical study with an emphasis on hematological parameters was conducted. A single-center, randomized, single-blind, cross-over clinical study was conducted in 18 healthy volunteers with a dosage of 300 mg daily for 2 days. Artesunate was used as a comparator. Adverse events were monitored and laboratory parameters on study Days 0, 2, 5, and 7 post drug administrations were analyzed. Eighteen volunteers completed both rounds of the study. Both drugs were well tolerated. All adverse events were mild. Significant decrease in hemoglobin compared to baseline was detected for both drugs 7 days after administration (DHA: 0.48 g/dl, p = 0.007; artesunate 0.38 g/dl, p = 0.001). Transient bone marrow suppression was evidenced by reduction of reticulocytes with a lowest number on study Day 5 (artesunate 75% reduction in reticulocyte count; DHA 47%, p < 0.001 for both drugs compared to baseline). The present study confirmed our previous finding on significant decrease in hemoglobin. Artesunate appeared to have more negative effects on the numbers of reticulocytes and white blood cells than DHA. Systemic laboratory and toxicity profiles presented in this study may be used as a framework for future clinical studies of artemisinin and its derivatives.

  15. Safety of 100??g venom immunotherapy rush protocols in children compared to adults

    OpenAIRE

    Stoevesandt, Johanna; Hosp, Christine; Kerstan, Andreas; Trautmann, Axel

    2017-01-01

    Background There is a paucity of studies examining the safety of venom immunotherapy (VIT) in children. We aimed to assess the incidence of anaphylactic side effects during rush VIT in a cohort of pediatric patients and adult controls. Methods 72 consecutive cycles of VIT-buildup in 71 children/adolescents aged 7?17?years were retrospectively evaluated and compared to an adult control group (n?=?981) with regard to baseline parameters (sex, causative venom, severity of index sting reaction, r...

  16. Safety of 100 µg venom immunotherapy rush protocols in children compared to adults

    OpenAIRE

    Stoevesandt, Johanna; Hosp, Christine; Kerstan, Andreas; Trautmann, Axel

    2018-01-01

    Background: There is a paucity of studies examining the safety of venom immunotherapy (VIT) in children. We aimed to assess the incidence of anaphylactic side effects during rush VIT in a cohort of pediatric patients and adult controls. Methods: 72 consecutive cycles of VIT-buildup in 71 children/adolescents aged 7–17 years were retrospectively evaluated and compared to an adult control group (n = 981) with regard to baseline parameters (sex, causative venom, severity of index sting ...

  17. A study on optimization of the nuclear safety system

    International Nuclear Information System (INIS)

    Lee, Sang Hoon; Koh, Byung Joon; Kim, Jin Soo; Kim, Byoung Do; Cho, Seong Won; Kwon, Seog Kwon; Choi, Kwang Sik

    1986-12-01

    The number of nuclear facilities (nuclear power plants, research reactors, nuclear fuel facilities) under construction or in operation in Korea continues to increase and this has brought about increased importance and concerns toward nuclear safety in Korea. Also, domestic nuclear related organizations are increasingly carrying out the design/construction of nuclear power plants and the development /supply of nuclear fuels. In order to flexibly respond to these changes and to suggest direction to take, it is necessary to re-examine the current nuclear safety regulation system. This study is carried out in two stages and this report describes the results of the analysis and the assessment of the nuclear licencing system of such foreign countries as sweden and German, as the first of the two. In this regard, this study includes the analysis on the backgrounds on the choice of nuclear licensing system, the analysis on the licensing procedures, the analysis on the safety inspection system and the enforcement laws, the analysis on the structure and function of the regulatory, business and research organizations as well as the analysis on the relationship between the safety research and the regulatory duties. In this study, the German safety inspection system and the enforcement procedures and the Swedish nuclear licensing system are analyzed in detail. By comparing and assessing the finding with the current Korea Nuclear Licensing System, this study points out some reform measures of the Korean system that needs to improved. With the changing situations in mind, this study aims to develop the nuclear safety regulation system optimized for Korean situation by re-examining the current regulation system. (Author)

  18. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study.

    Science.gov (United States)

    Jun, Min; Lix, Lisa M; Durand, Madeleine; Dahl, Matt; Paterson, J Michael; Dormuth, Colin R; Ernst, Pierre; Yao, Shenzhen; Renoux, Christel; Tamim, Hala; Wu, Cynthia; Mahmud, Salaheddin M; Hemmelgarn, Brenda R

    2017-10-17

    Objective  To determine the safety of direct oral anticoagulant (DOAC) use compared with warfarin use for the treatment of venous thromboembolism. Design  Retrospective matched cohort study conducted between 1 January 2009 and 31 March 2016. Setting  Community based, using healthcare data from six jurisdictions in Canada and the United States. Participants  59 525 adults (12 489 DOAC users; 47 036 warfarin users) with a new diagnosis of venous thromboembolism and a prescription for a DOAC or warfarin within 30 days of diagnosis. Main outcome measures  Outcomes included hospital admission or emergency department visit for major bleeding and all cause mortality within 90 days after starting treatment. Propensity score matching and shared frailty models were used to estimate adjusted hazard ratios of the outcomes comparing DOACs with warfarin. Analyses were conducted independently at each site, with meta-analytical methods used to estimate pooled hazard ratios across sites. Results  Of the 59 525 participants, 1967 (3.3%) had a major bleed and 1029 (1.7%) died over a mean follow-up of 85.2 days. The risk of major bleeding was similar for DOAC compared with warfarin use (pooled hazard ratio 0.92, 95% confidence interval 0.82 to 1.03), with the overall direction of the association favouring DOAC use. No difference was found in the risk of death (pooled hazard ratio 0.99, 0.84 to 1.16) for DOACs compared with warfarin use. There was no evidence of heterogeneity across centres, between patients with and without chronic kidney disease, across age groups, or between male and female patients. Conclusions  In this analysis of adults with incident venous thromboembolism, treatment with DOACs, compared with warfarin, was not associated with an increased risk of major bleeding or all cause mortality in the first 90 days of treatment. Trial registration  Clinical trials NCT02833987. Published by the BMJ Publishing Group Limited. For permission to use (where not

  19. Comparing performance level estimation of safety functions in three distributed structures

    International Nuclear Information System (INIS)

    Hietikko, Marita; Malm, Timo; Saha, Heikki

    2015-01-01

    The capability of a machine control system to perform a safety function is expressed using performance levels (PL). This paper presents the results of a study where PL estimation was carried out for a safety function implemented using three different distributed control system structures. Challenges relating to the process of estimating PLs for safety related distributed machine control functions are highlighted. One of these examines the use of different cabling schemes in the implementation of a safety function and its effect on the PL evaluation. The safety function used as a generic example in PL calculations relates to a mobile work machine. It is a safety stop function where different technologies (electrical, hydraulic and pneumatic) can be utilized. It was detected that by replacing analogue cables with digital communication the system structure becomes simpler with less number of failing components, which can better the PL of the safety function. - Highlights: • Integration in distributed systems enables systems with less components. • It offers high reliability and diagnostic properties. • Analogue signals create uncertainty in signal reliability and difficult diagnostics

  20. Calculational study for criticality safety data of fissionable actinides

    International Nuclear Information System (INIS)

    Nojiri, Ichiro; Fukasaku, Yasuhiro.

    1997-01-01

    This study has been carried out to obtain basic criticality safety characteristics of minor actinides nuclides. Criticality safety data of minor actinides nuclides have been surveyed through public literatures. Critical mass of seven nuclides, Np-237, Am-241, Am-242m, Am-243, Cm-243, Cm-244 and Cm-245, have been calculated by using two code systems of criticality safety analysis, SCALE-4 and MCNP4A, under some material and reflector conditions. Some applicable cross-section libraries have been used for each code systems. Calculated data have been compared with each other and with published data. The results of this comparison shows that there is no discrepancy within the computational codes and the calculated data is strongly depend on the cross-section library. (author)

  1. Nordic studies in reactor safety

    International Nuclear Information System (INIS)

    Pershagen, N.

    1993-01-01

    The Nordic Nuclear Safety Research Programme SIK programme in reactor safety is part of a major joint Nordic research effort in nuclear safety. The report summarizes the achievements of the SIK programme, which was carried out during 1990-1993 in collaboration between Nordic nuclear utilities, safety authorities, and research institutes. Three main projects were successfully completed dealing with: 1) development and application of a living PSA concept for monitoring the risk of core damage, and of safety indicators for early warning of possible safety problems; 2) review and intercomparison of severe accident codes, case studies of potential core melt accidents in nordic reactors, development of chemical models for the MAAP code, and outline of a system for computerized accident management support; 3) compilation of information about design and safety features of neighbouring reactors in Germany, Lithuania and Russia, and for naval reactors and nuclear submarines. The report reviews the state-of-the-art in each subject matter as an introduction to the individual project summaries. The main findings of each project are highlighted. The report also contains an overview of reactor safety research in the Nordic countries and a summary of fundamental reactor safety principles. (au) (69 refs.)

  2. A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

    Directory of Open Access Journals (Sweden)

    Hosseini K

    2016-11-01

    Full Text Available Kamran Hosseini,1 Thomas Walters,2 Robert DaVanzo,3 Richard L Lindstrom4 1InSite Vision Inc., Alameda, CA, 2Texan Eye, Austin, TX, 3Cornerstone Health Care, High Point, NC, 4Minnesota Eye Consultants, Bloomington, MN, USA Purpose: The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075% compared with DuraSite® vehicle (vehicle alone for the treatment of postoperative inflammation and ocular pain after cataract surgery.Methods: A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC and anterior chamber flare (ACF. The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS assessment and the proportion of subjects with an ACF grade of 0 at Day 15.Results: At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001. At each of the postsurgical time points (Days 1, 8, 15, and 29, proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively had no pain (a VAS score of 0 compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively, and at each time point, these differences in proportions were statistically significant (P<0.001. More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4% compared to those in the vehicle group (54/85; 63

  3. Comparative efficacy and safety of mavacoxib and carprofen in the treatment of canine osteoarthritis.

    Science.gov (United States)

    Payne-Johnson, M; Becskei, C; Chaudhry, Y; Stegemann, M R

    2015-03-14

    A multi-site, masked, randomised parallel group study employing a double dummy treatment design was performed in canine veterinary patients to determine the comparative efficacy and safety of mavacoxib and carprofen in the treatment of pain and inflammation associated with osteoarthritis for a period of 134 days. Treatments were administered according to their respective summaries of product characteristics. Of 139 dogs screened, 124 were suitable for study participation: 62 of which were dosed with mavacoxib and 62 with carprofen. Both treatments resulted in a very similar pattern of considerable improvement as indicated in all parameters assessed by both owner and veterinarian. The primary efficacy endpoint 'overall improvement' was a composite score of owner assessments after approximately six weeks of treatment. Both drugs were remarkably effective, with 57/61 (93.4 per cent) of mavacoxib-treated dogs and 49/55 (89.1 per cent) of carprofen-treated dogs demonstrating overall improvement and with mavacoxib's efficacy being non-inferior to carprofen. The treatments had a similar safety profile as evidenced by documented adverse events and summaries of clinical pathology parameters. The positive clinical response to treatment along with the safety and dosing regimen of mavacoxib makes it an attractive therapy for canine osteoarthritis. British Veterinary Association.

  4. Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.

    Science.gov (United States)

    Gold, Rachel; Hollombe, Celine; Bunce, Arwen; Nelson, Christine; Davis, James V; Cowburn, Stuart; Perrin, Nancy; DeVoe, Jennifer; Mossman, Ned; Boles, Bruce; Horberg, Michael; Dearing, James W; Jaworski, Victoria; Cohen, Deborah; Smith, David

    2015-10-16

    Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting. This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices. Having a better understanding of how different

  5. The comparative study of clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury

    Directory of Open Access Journals (Sweden)

    Dejun Luo

    2017-05-01

    Full Text Available In the present study we compared the clinical efficacy and safety of baclofen vs tolperisone in spasticity caused by spinal cord injury. A total of 150 patients were enrolled in the present study and were divided into two groups with 75 patients in each group, receiving baclofen or tolperisone, respectively. We used Modified Ashworth Scale, Medical research council scale, Barthel Index, and Coefficient of efficacy to measure clinical efficacy. After 6-week treatment, both groups demonstrated significant improvement in muscle tone, muscle strength and functional outcome (Group I, 1.55 ± 0.053, 2.79 ± 0.032, 59.31 ± 1.32; Group II, 1.57 ± 0.053, 3.04 ± 0.032, 73 ± 1.32 respectively. There was no significant difference regarding improvement in muscle tone and muscle strength between the two groups (Group I, 1.055 ± 0.053 vs Group II, 1.57 ± 0.053; Group I, 2.79 ± 0.032 vs Group II, 3.04 ± 0.032, p > 0.05. However, the improvement in functional outcomes was greater in group II as compared to that in group I (Group I, 59.31 ± 1.32 vs Group II, 73 ± 1.32, p < 0.05. In addition, overall efficacy coefficient was greater for group II as compared to group I (Group I, 3.6 vs Group II, 2.3, p < 0.05. Group I had more side effects compared to Group II. Compared to baclofen, tolperisone offers greater improvement in activities of daily living compared to baclofen.

  6. Study on real working performance and overload safety factor of high arch dam

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Considering the fact that high arch dams have problems such as complicated stress,high cost,and hazards after being damaged,this paper intends to study the effects of load,material strength,and safety analysis method on dam safety and working performance of arch dams.In this article,the effects of temperature,self weight exaction way and water loading on structure response are first discussed,and a more reasonable way of considering is then put forward.By taking into consideration the mechanical property of materials and comparing the effects of different yield criteria on overloading safety of high arch dams,this paper concludes that brittle characteristics of concrete should be fully considered when conducting safety assessment for high arch dams to avoid overestimating the bearing capacity of the dams.By comparing several typical projects,this paper works out a safety assessment system of multiple safety and relevant engineering analogical analysis methods,which is closer to the actual situation,and thus is able to assess the response of high arch dam structure in a more comprehensive way,elicit the safety coefficients in different situations,and provide a new way of considering the safety assessment of high arch dams.

  7. Measuring Safety Culture on Ships Using Safety Climate: A Study among Indian Officers

    Directory of Open Access Journals (Sweden)

    Yogendra Bhattacharya

    2015-12-01

    Full Text Available Workplace safety continues to be an area of concern in the maritime industry due to the international nature of the operations. The effectiveness of extensive legislation to manage shipboard safety remains in doubt. The focus must therefore shift towards the human element - seafarers and their perceptions of safety. The study aims to understand the alignment that exists between safety culture and safety climate on board ships as perceived by seafarers. The underlying factors of safety climate were identified using factor analysis which isolated seven factors - Support on Safety, Organizational Support, Resource Availability, Work Environment, Job Demands, ‘Just’ Culture, and Safety Compliance. The perception of safety level of seafarers was found to be low indicating the existence of misalignments between safety culture values and the actual safety climate. The study also reveals that the safety perceptions of officers employed directly by ship owners and those by managers do not differ significantly, nor do they differ between senior and junior officers. A shift in perspective towards how seafarers themselves feel towards safety might provide more effective solutions – instead of relying on regulations - and indeed aid in reducing incidents on board. This paper details practical suggestions on how to identify the factors that contribute towards a better safety climate on board ships.

  8. A comparative study of radiation safety practices at selected hospitals in the UK and USA

    International Nuclear Information System (INIS)

    White, D.R.; Showalter, C.K.; Hamilton, D.R.

    1984-01-01

    The radiation safety practices in a group of 25 UK and USA hospitals have recently been assessed. This took the form of detailed inspections of some 62 medical radiation departments, including Diagnostic X-ray, Radiotherapy, Nuclear Medicine and Pathology/Research (Radionuclide) Departments. Empirical expressions called ''Radiation Safety Indices'' were devised to evaluate the incidence of personal doses and radiological incidents occurring from 1977-82 and to characterise the safety facilities, procedures, supervision and educational techniques in each department. An outline is given of national legislative material and voluntary codes of conduct, together with the results of the departmental inspections. The computed indices are presented graphically and an analysis given of apparent national trends. (author)

  9. How Does Patient Safety Culture in the Surgical Departments Compare to the Rest of the County Hospitals in Xiaogan City of China?

    Science.gov (United States)

    Wang, Manli; Tao, Hongbing

    2017-09-26

    Objectives : Patient safety culture affects patient safety and the performance of hospitals. The Hospital Survey on Patient Safety Culture (HSOPSC) is generally used to assess the safety culture in hospitals and unit levels. However, only a few studies in China have measured surgical settings compared with other units in county hospitals using the HSOPSC. This study aims to assess the strengths and weaknesses of surgical departments compared with all other departments in county hospitals in China with HSOPSC. Design : This research is a cross-sectional study. Methods : In 2015, a Chinese translation of HSOPSC was administered to 1379 staff from sampled departments from 19 county hospitals in Xiaogan City (Hubei Province, China) using a simple random and cluster sampling method. Outcome Measures : The HSOPSC was completed by 1379 participants. The percent positive ratings (PPRs) of 12 dimensions (i.e., teamwork within units, organizational learning and continuous improvement, staffing, non-punitive response to errors, supervisor/ manager expectations and actions promoting patient safety, feedback and communication about errors, communication openness, hospital handoffs and transitions, teamwork across hospital units, hospital management support for patient safety, overall perception of safety, as well as frequency of events reported) and the positive proportion of outcome variables (patient safety grade and number of events reported) between surgical departments and other departments were compared with t -tests and X² tests, respectively. A multiple regression analysis was conducted, with the outcome dimensions serving as dependent variables and basic characteristics and other dimensions serving as independent variables. Similarly, ordinal logistic regression was used to explore the influencing factors of two categorical outcomes. Results : A total of 56.49% of respondents were from surgical departments. The PPRs for "teamwork within units" and "organizational

  10. Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis

    NARCIS (Netherlands)

    Reitamo, Sakari; van Leent, Edwin J. M.; Ho, Vincent; Harper, John; Ruzicka, Thomas; Kalimo, Kirsti; Cambazard, Frédéric; Rustin, Malcolm; Taïeb, Alain; Gratton, David; Sauder, Daniel; Sharpe, Graham; Smith, Catherine; Jünger, Michael; de Prost, Yves

    2002-01-01

    Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment in the treatment of patients with atopic dermatitis (AD). This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 1% hydrocortisone acetate ointment in children 2 to 15 years of age with

  11. Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

    International Nuclear Information System (INIS)

    Oh, Kyemin; Kang, Myoung-suk; Heo, Gyunyoung; Kim, Hyoung-chan

    2014-01-01

    Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

  12. Safety studies on Korean fusion DEMO plant using integrated safety assessment methodology

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Kyemin; Kang, Myoung-suk [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Heo, Gyunyoung, E-mail: gheo@khu.ac.kr [Kyung Hee University, Youngin-si, Gyeonggi-do 446-701 (Korea, Republic of); Kim, Hyoung-chan [National Fusion Research Institute, Daejeon-si 305-333 (Korea, Republic of)

    2014-10-15

    Highlights: •The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant. •The concepts of integrated safety assessment methodology (ISAM) that can be applied in addressing regulatory requirements and recognizing safety issues for K-DEMO were emphasized. •Phenomena identification and ranking table (PIRT) was proposed. It can recognize vulnerabilities of systems and identify the gaps in technical areas requiring additional researches. •This work is expected to contribute on the conceptual design of safety features for K-DEMO to design engineers and the guidance for regulatory requirements to licensers. -- Abstract: The purpose of this paper is to suggest methodology that can investigate safety issues and provides a case study for Korean fusion DEMO plant (K-DEMO) as a part of R and D program through the National Fusion Research Institute of Korea. Even though nuclear regulation and licensing framework is well setup due to the operating and design experience of Pressurized Water Reactors (PWRs) since 1970s, the regulatory authority of South Korea has concerns on the challenge of facing new nuclear facilities including K-DEMO due to the differences in systems, materials, and inherent safety feature from conventional PWRs. Even though the follow-up of the ITER license process facilitates to deal with significant safety issues of fusion facilities, a licensee as well as a licenser should identify the gaps between ITER and DEMO in terms of safety issues. First we reviewed the methods of conducting safety analysis for unprecedented nuclear facilities such as Generation IV reactors, particularly very high temperature reactor (VHTR), which is called as integrated safety assessment methodology (ISAM). Second, the analysis for the conceptual design of K-DEMO on the basis of ISAM was conducted. The ISAM consists of five analytical tools to develop the safety requirements from licensee

  13. Comparative approach between nuclear safety and security; Approche comparative entre surete et securite nucleaires

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-04-15

    Adopting the definition of nuclear safety and nuclear security as they are specified by IAEA glossaries, this report first outlines that these both notions refer to similar risks but with causes of different nature. They discuss the notions of transparency and confidentiality and outline that security and safety both aims at the protection of population and of the environment. They discuss their organisational principles, notice that both have their own legal and regulatory framework, that authorities have expertise on both, that the responsibility is distributed among operators and the State, and that safety and security cultures are complementary. They analyse the design, exploitation and management principles of security and safety approaches: graded approach, defence-in-depth, synergy between security and safety, same daily monitoring requirement, same necessity to address the return on experience, same need to update a referential, a more constrained exchange of good practices in safety, a necessity to deal with their respective requirements, elaboration of emergency plans, performance of exercises

  14. Endoscopic treatments for Barrett's esophagus: a systematic review of safety and effectiveness compared to esophagectomy

    Directory of Open Access Journals (Sweden)

    Lau Darren

    2010-09-01

    Full Text Available Abstract Background Recently, several new endoscopic treatments have been used to treat patients with Barrett's esophagus with high grade dysplasia. This systematic review aimed to determine the safety and effectiveness of these treatments compared with esophagectomy. Methods A comprehensive literature search was undertaken to identify studies of endoscopic treatments for Barrett's esophagus or early stage esophageal cancer. Information from the selected studies was extracted by two independent reviewers. Study quality was assessed and information was tabulated to identify trends or patterns. Results were pooled across studies for each outcome. Safety (occurrence of adverse events and effectiveness (complete eradication of dysplasia were compared across different treatments. Results The 101 studies that met the selection criteria included 8 endoscopic techniques and esophagectomy; only 12 were comparative studies. The quality of evidence was generally low. Methods and outcomes were inconsistently reported. Protocols, outcomes measured, follow-up times and numbers of treatment sessions varied, making it difficult to calculate pooled estimates. The surgical mortality rate was 1.2%, compared to 0.04% in 2831 patients treated endoscopically (1 death. Adverse events were more severe and frequent with esophagectomy, and included anastomotic leaks (9.4%, wound infections (4.1% and pulmonary complications (4.1%. Four patients (0.1% treated endoscopically experienced bleeding requiring transfusions. The stricture rate with esophagectomy (5.3% was lower than with porfimer sodium photodynamic therapy (18.5%, but higher than aminolevulinic acid (ALA 60 mg/kg PDT (1.4%. Dysphagia and odynophagia varied in frequency across modalities, with the highest rates reported for multipolar electrocoagulation (MPEC. Photosensitivity, an adverse event that occurs only with photodynamic therapy, was experienced by 26.4% of patients who received porfimer sodium. Some

  15. A comparative analysis between France and Japan on local governments' involvement in nuclear safety governance

    International Nuclear Information System (INIS)

    Sugawara, Shin-etsu; Shiroyama, Hideaki

    2011-01-01

    This paper shows a comparative analysis between France and Japan on the way of the local governments' involvement in nuclear safety governance through some interviews. In France, a law came into force that requires related local governments to establish 'Commision Locale d'Information' (CLI), which means the local governments officially involve in nuclear regulatory activity. Meanwhile, in Japan, related local governments substantially involve in the operation of nuclear facilities through the 'safety agreements' in spite of the lack of legal authority. As a result of comparative analysis, we can point out some institutional input from French cases as follows: to clarify the local governments' roles in the nuclear regulation system, to establish the official channels of communication among nuclear utilities, national regulatory authorities and local governments, and to stipulate explicitly the transparency as a purpose of safety regulation. (author)

  16. Efficacy and safety of sorafenib versus apatinib in the treatment of intermediate and advanced hepatocellular carcinoma: a comparative retrospective study

    Directory of Open Access Journals (Sweden)

    Wang Y

    2018-06-01

    Full Text Available Yizhuo Wang,1,2 Qing Gou,1 Rongde Xu,1 Xiaoming Chen,1 Zejian Zhou1 1Department of Interventional Oncology, Guangdong Academy of Medical Sciences, Guangdong General Hospital, Guangzhou, Guangdong, People’s Republic of China; 2Medical College Shantou University, Shantou, Guangdong, People’s Republic of China Objective: To compare the efficacy and safety profiles of sorafenib and apatinib in patients with intermediate- and advanced-stage hepatocellular carcinoma (HCC. Methods: This was a single-center, retrospective study where we collected the clinical data of 72 patients, diagnosed with intermediate or advanced HCC from January 2014 to December 2016. Depending on the treatment received, 38 patients were categorized into group S (sorafenib group and 34 into group A (apatinib group. The patients in group A received the initial recommended dose of 750 mg once daily (QD, which was reduced to 250 mg QD in the case of any class 3 or 4 adverse event (AE. Sorafenib was administered orally 400 mg twice daily (BID, and dose was modified to 400 mg or 200 mg QD in the case of grade 3 or 4 AEs. The median overall survival (OS, progression-free survival (PFS, and AEs reported in the two groups were analyzed and compared. Results: Among the 38 patients treated with sorafenib, one patient had complete response (CR, 5 patients had partial response (PR, and 10 patients had stable disease (SD, and among the 34 patients treated with apatinib, 6 patients had PR and 7 patients had SD with no cases of CR. PFS in group S was significantly longer compared with that in group A (7.39 vs 4.79 months, respectively, P=0.031. Similar observations were made for median OS (10.4 months in group S vs 7.18 months in group A, P=0.011. However, there was no significant difference in the objective response rates (ORRs among the study population (15.7 vs 17.6%, P=0.829. Common AEs in group S included hand and foot syndrome (HFS and diarrhea, whereas common AEs in group A

  17. Safety Study of Doxicycline in Broiler Chickens

    Directory of Open Access Journals (Sweden)

    Romeo Teodor Cristina

    2010-05-01

    Full Text Available Doxicycline is a structural isomer who meets the European reference standard (Ph.Eur. III 1997:0272 and respect EU Regulations for M.R.L. The good solubility permits high tissular absorption and distribution after administration in drinking water. The aim was to ascertain the clinical effects and tolerance consecutive to risen doses administration, as a part of safety study for this antibiotic in poultry in the respect of current drug testing methodology. The safety study revealed: good local and general tolerance to therapeutic doses (10 mg x kgb.w.-1 and to x2 dose, diarrhoea in lots which received x3 and x5 the therapeutic dose. Comparatively with the Control lot, haemoleucogram doesn’t suffer evident changes the registered values being between the references limits (exception of leucocitary formula. Also it was found an increased creatinin concentration consecutively to x3 and x5 greater doses administration and marked increasing of ASAT level and limited for ALAT’s, comparatively to control lot in the case of E4 lot, but light to reference values. Macro and microscopy revealed for the liver samples: hepatomegaly, diffuse hepatic degenerescence, nuclear heterochromatinization, vacuolar degenerescence; renal changes in nefrons and renal corpuscles, light splenomegaly, caecal sacs distension and brown-yellowish gaseous content to lots E3 and E4.

  18. A Study on University Student's Perception of Food Safety

    International Nuclear Information System (INIS)

    Koh, K.H.

    2007-01-01

    The present study compared the perception of food safety between students majoring in Food Science and Nutrition and other students who are ordinary food consumers. The importance of factors related to food safety was high in order of pesticide residue (45%), food additives (24%), food pathogens (15%), GM foods (7%), antibiotics (4%) and irradiated foods (4%), and no significant difference was observed according to major(p less than 0.10). Particularly with regard to irradiated food, students majoring in Food Science and Nutrition replied 'no hamful' (21%), 'harmful' (58%) or 'not sure' (21%), showing that more than half of them thought that irradiated food is harmful

  19. Research study about the establishment of safety culture. Effects of organizational factors in construction industry's safety indices

    International Nuclear Information System (INIS)

    Kojima, Mitsuhiro; Hirose, Humiko; Takano, Kenichi; Hasegawa, Naoko

    1999-01-01

    To find the relationships between safety related activities (such as safety patrol' or '4s/5s activities') and accidents rate in the workplace, questionnaires were sent to 965 construction companies and 120 answers were returned. In this questionnaire, safety activities, safety regulations and safety policies of the companies were asked and organizational climates, company policies, philosophies and the number of accidents in workplace were also asked. There seems some relationships between accidents rate and safety activities, safety regulations and safety policies in the companies, but the deviations between estimate values and observed values are so great that it seems impossible to estimate the accidents rate in the working place from the safety activities, safety regulations and safety policies of the companies. On the other hand, some characteristics of safety activities and organizational climates in the construction industry were identified using multi variants analysis. More detailed researches using sophisticated questionnaire will be conducted in the construction industry and petrochemical industry and relationships between the accidents rate and the safety activities will be compared between different industries. (author)

  20. Railway safety climate: a study on organizational development.

    Science.gov (United States)

    Cheng, Yung-Hsiang

    2017-09-07

    The safety climate of an organization is considered a leading indicator of potential risk for railway organizations. This study adopts the perceptual measurement-individual attribute approach to investigate the safety climate of a railway organization. The railway safety climate attributes are evaluated from the perspective of railway system staff. We identify four safety climate dimensions from exploratory factor analysis, namely safety communication, safety training, safety management and subjectively evaluated safety performance. Analytical results indicate that the safety climate differs at vertical and horizontal organizational levels. This study contributes to the literature by providing empirical evidence of the multilevel safety climate in a railway organization, presents possible causes of the differences under various cultural contexts and differentiates between safety climate scales for diverse workgroups within the railway organization. This information can be used to improve the safety sustainability of railway organizations and to conduct safety supervisions for the government.

  1. Description of the food safety system in hotels and how it compares with HACCP standards.

    Science.gov (United States)

    Fletcher, Stephanie M; Maharaj, Satnarine R; James, Kenneth

    2009-01-01

    Tourism is an important earner of foreign exchange in Jamaica; hence, the protection of the visitors' health is very important. A study of travelers to Jamaica in 1996 to 1997 found that travelers' diarrhea (TD) affected almost 25% of visitors. The Ministry of Health (Jamaica) initiated a program for the prevention and control of TD aimed at reducing attack rates from 25.0% to 12.0% over a 5-year period through environmental health and food safety standards of hotels. This article examines the food safety systems in Jamaican hotels located in a popular resort area to find out how comparable they are with the Hazard Analysis Critical Control Point (HACCP) strategy. A cross-sectional study was done of hotels in St. Mary and St. Ann. Quantitative data were obtained from food and beverage/sanitation staff and qualitative data through in-depth interviews with hotel managers. Observation of the food safety operations was also done. The majority (75%) of larger hotels used a combination of HACCP and Ministry of Health food safety strategies (p = 0.02) and offered all-inclusive services (r =-0.705, p = 0.001). Larger hotels were more likely to have a better quality team approach, HACCP plan, and monitoring of critical control points (CCPs) and more likely to receive higher scores (p hotel staff were knowledgeable of HACCP. Significantly smaller hotels (87.5%) received less than 70% in overall score (r = 0.75, p = 0.01). Identification of CCPs and monitoring of CCPs explained 96.6% of the change in the overall HACCP scores (p = 0.001). Hotel managers felt that some hotels' systems were comparable with HACCP and that larger properties were ready for mandatory implementation. Conclusions. While some components of the HACCP system were observed in larger hotels, there were serious shortcomings in its comparison. Mandatory implementation of HACCP would require that sector-specific policies be developed for smaller hotels and implemented on a phased basis.

  2. A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f® in women undergoing ovarian stimulation for IVF

    DEFF Research Database (Denmark)

    Rettenbacher, M; Andersen, A N; Garcia-Velasco, J A

    2015-01-01

    injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre......Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm...

  3. The impact of health and safety committees. A study based on survey, interview, and Occupational Safety and Health Administration data.

    Science.gov (United States)

    Boden, L I; Hall, J A; Levenstein, C; Punnett, L

    1984-11-01

    In a study conducted to determine if the existence of a joint labor-management health and safety committee (HSC) was correlated with either the number of Occupational Safety and Health Administration (OSHA) complaints or hazardousness, as measured by OSHA serious citations, virtually no effect could be detected in a sample of 127 Massachusetts manufacturing firms. At a sample of 13 firms, interviews of HSC members were conducted. Committee attributes and perceptions about committee effectiveness were compared with the number of OSHA complaints and serious citations. There were fewer complaints and fewer serious citations at firms with HSCs that were perceived as effective. Results of the study suggest that the objective attributes of the committee may be less important to its success than the commitment of management and labor to solving workplace safety problems.

  4. Focus on safety : a comparative analysis of pipeline safety performance 2000-2002

    International Nuclear Information System (INIS)

    2004-01-01

    Canada's National Energy Board (NEB) is responsible for the promotion of safety, environmental protection and economic efficiency in the Canadian public interest in regulating the design, construction, operation and abandonment of interprovincial and international pipelines within Canada. This second annual report provides a review of the safety performance of oil and gas pipeline companies that are regulated by the NEB. The data used to prepare this report originates from two sources: incident reports submitted under the Onshore Pipeline Regulations, 1999, and from information voluntarily provided by pipeline companies under the Safety Performance Indicators (SPI) initiative. Data comparisons with external reference organizations were included. Six key indicators have been identified to provide comprehensive measures of safety performance for pipeline companies: fatalities, ruptures, injury frequencies, liquid releases, gas releases, and unauthorized activities on the right of way. The safety performance of the federally regulated pipeline industry within Canada was satisfactory during this reporting period (2000-2002). The contractor injury frequency rates reported in 2002 were lower than those reported in 2001, and exhibited more consistency with the levels reported in 2000. The NEB is of the opinion that the elevated number of liquid hydrocarbon spills reported in 2000 were a result of elevated construction levels. No fatalities were reported. There was an increase to three from two in the number of ruptures, due in large part to metal loss (corrosion) and cracking, and external interference (third party damage). The number of spills increased to 76 in 2002 from 55 in 2001, which appears to be more in line with industry averages. The volume of hydrocarbon liquid released in 2002 represented one third the volume released in 2001. refs., 5 tabs., 14 figs

  5. Risk indices in comparative risk assessment studies

    International Nuclear Information System (INIS)

    Hubert, P.

    1984-01-01

    More than a decade ago the development of comparative risk assessment studies aroused overwhelming interest. There was no doubt that data on the health and safety aspects of energy systems would greatly benefit, or even end, the debate on nuclear energy. Although such attempts are still strongly supported, the rose-coloured expectations of the early days have faded. The high uncertainties, and the contradictory aspect, of the first results might explain this evolution. The loose connection between the range of computed risk indices and the questions on which the debate was focused is another reason for this decline in interest. Important research work is being carried out aiming at reducing the different kinds of uncertainties. Rather than the uncertainties, the paper considers the meaning of available risk indices and proposes more significant indices with respect to the goals of risk assessment. First, the indices which are of frequent use in comparative studies are listed. The stress is put on a French comparative study from which most examples are drawn. Secondly, the increase in magnitude of the indices and the decrease in the attributability of the risk to a given system is shown to be a consequence of the trend towards more comprehensive analyses. Thirdly, the ambiguity of such indices as the collective occupational risk is underlined, and a possible solution is suggested. Whenever risk assessments are related to pragmatic decision making problems it is possible to find satisfactory risk indices. The development of cost-effectiveness analyses and the proposals for quantitative safety goals clearly demonstrate this point. In the field of comparison of social impacts some proposals are made, but there remain some gaps still to be filled. (author)

  6. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  7. Randomised, double-blind, comparative study to evaluate the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia.

    Science.gov (United States)

    Amarapurkar, Deepak N; Rane, Priya

    2004-12-01

    Prokinetic agents like itopride hydrochloride and mosapride citrate are commonly used in the management of functional dyspepsia. However, in a recently conducted international, multicentric study, efficacy of 3 different regimens of mosapride was shown to be comparable to placebo. The objective of this phase 4 randomised, double blind, prospective study was to compare the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia among patients attending the gastroenterology outpatient department of a tertiary care hospital. Ganaton 50 mg or mosapride citrate 5 mg three times daily before meals for a period of 2 weeks was administered orally. Thirty functional dyspepsia patients in each group (total = 60) were randomised to receive itopride hydrochloride or mosapride citrate treatment for 2 weeks. In itopride versus mosapride groups, global efficacy as judged by patients was excellent in 17 versus 9 (p itopride versus mosapride group global efficacy as judged by physician was excellent in 24 (80%) versus 15 (50%) and poor in 0 (0%) versus 3 (10%) patients respectively. The global efficacy was rated as excellent to good in significantly (p itopride (93.3%) group as compared to mosapride (63.33 %) group. None of the patients reported any adverse events with itopride treatment. In the mosapride group 5 patients (16.7%) reported adverse events. Two patients (6.7%) were withdrawn from mosapride treatment due to adverse events. The physician rated global tolerability ofitopride versus mosapride treatment as excellent in 23 (76.7%) versus 8 (26.7%) (p itopride hydrochloride) is superior in efficacy and safety over mosapride citrate in the management of functional dyspepsia.

  8. A comparative study of bike lane injuries.

    Science.gov (United States)

    Wee, Jung Hee; Park, Jeong Ho; Park, Kyu Nam; Choi, Seung Pill

    2012-02-01

    Because of the increased number of bicycle riders and governmental promotions, a recent increase in the construction of bicycle lanes has occurred. We aimed to characterize injuries specific to bicycle lane accidents by comparing them with injuries that occurred on regular roadways. On the basis of our findings, we provide suggestions on proper preventive strategies. We performed a retrospective study on 408 cases obtained between January 1, 2009, and December 31, 2010. Of these cases, 387 met the criterion that the location of the injury could be confirmed by telephone or via review of the patient's chart. Data regarding age, gender, Injury Severity Score, time of the accident, location of the accident, and other characteristics were collected. Data were analyzed using SPSS 12.0K. Of the 387 cases, 204 (52.7%) patients were injured in bicycle lanes and 183 (47.3%) were injured on regular roadways. Comparing cases of bicycle lane injuries and non-bicycle lane injuries, there were no differences in age, day of the week, season, or the time at which the accident occurred. Bicycle helmets were used more frequently in bicycle lane injuries (33.2% vs. 13.7%; p cases, falls (42.6%) and collisions with other vehicles (39.3%) were the most common causes of injury. Although the severity of injuries was slightly lower in bicycle lane cases, it was not significantly lower than non-bicycle lane cases. Although people are increasingly using bicycle lanes for safety, this study shows that they are not definitively safer. Therefore, improvements in the policies related to implementing bicycle lane safety are needed, for example, by enforcing the use of protective gear or preventing the use of bicycle lanes by pedestrians. More safety education programs are also needed. III.

  9. Studies on environment safety and application of advanced reactor for inland nuclear power plants

    International Nuclear Information System (INIS)

    Wei, L.; Jie, L.

    2014-01-01

    To study environment safety assessment of inland nuclear power plants (NPPs), the impact of environment safety under the normal operation was researched and the environment risk of serious accidents was analyzed. Moreover, the requirements and relevant provisions of site selection between international nuclear power plant and China's are comparatively studied. The conclusion was that the environment safety assessment of inland and coastal nuclear power plant have no essential difference; the advanced reactor can meet with high criteria of environment safety of inland nuclear power plants. In this way, China is safe and feasible to develop inland nuclear power plant. China's inland nuclear power plants will be as big market for advanced reactor. (author)

  10. A comparative approach to nuclear safety and nuclear security

    International Nuclear Information System (INIS)

    2009-01-01

    The operators in charge of nuclear facilities or activities have to deal with nuclear and radiological risks, which implies implementing two complementary approaches - safety and security - each of which entails specific methods. Targeting the same ultimate purpose, these two approaches must interact to mutually reinforce each other, without compromising one another. In this report, IRSN presents its reflections on the subject, drawing on its expertise in assessing risks on behalf of the French safety and security authorities, together with the lessons learned from sharing experience at international level. Contents: 1 - Purpose and context: Definitions, Similar risks but different causes, Transparency and confidentiality, Synergy in dealing with sabotage, A common purpose: protecting Man and the environment; 2 - Organizational principles: A legislative and regulatory framework relative to safety as well as security, The competent nuclear safety and security authorities, A difference in the distribution of responsibilities between the operators and the State (Prime responsibility of operators, A different involvement of the State), Safety culture and security culture; 3 - Principles for the application of safety and security approaches: Similar design principles (The graded approach, Defence-in-depth, Synergy between safety and security), Similar operating principles (The same requirement regarding constant monitoring, The same need to take account of feedback, The same need to update the baseline, Sharing good practices is more restricted in the area of security, The need to deal with the respective requirements of safety and security), Similar emergency management (Developing emergency and contingency plans, Carrying out exercises), Activities subject to quality requirements; 4 - Conclusion

  11. Efficacy and safety of statins and exercise combination therapy compared to statin monotherapy in patients with dyslipidaemia: A systematic review and meta-analysis.

    Science.gov (United States)

    Gui, Ya-Jun; Liao, Cai-Xiu; Liu, Qiong; Guo, Yuan; Yang, Tao; Chen, Jing-Yuan; Wang, Ya-Ting; Hu, Jia-Hui; Xu, Dan-Yan

    2017-06-01

    Background Statin treatment in association with physical exercise can substantially reduce mortality in dyslipidaemic individuals. However, the available data to compare the efficacy and safety of statins and exercise combination therapy with statin monotherapy are limited. Design Systematic review and meta-analysis. Methods We systematically searched PubMed, Embase and the Cochrane Library from database inception until December 2016. We included randomised and non-randomised studies that compared the efficacy and safety of statins and exercise combination therapy with statin monotherapy in patients with dyslipidaemia. Standardised mean differences were calculated and pooled by means of fixed effects models. The risk of bias and heterogeneity among trials was also assessed. Seven articles were assessed in terms of the efficacy of therapy and 13 from the viewpoint of therapeutic safety. Results In terms of efficacy, statins and exercise combination decreased the incidence of diabetes mellitus, improved insulin sensitivity and inflammation, but caused no change in lipid profile compared to statins alone. In terms of safety, statins and exercise combination increased peak oxygen uptake (standardised mean difference 1.01, 95% confidence interval 0.46 to 1.57) compared to statins alone. In contrast to statin-induced myopathy, chronic exercise training prior to statin treatment could counteract statin-induced adverse effects in skeletal muscle. Conclusion Statins and exercise combination therapy is more effective than statin monotherapy in terms of insulin sensitivity, inflammation and exercise capacity. The small number of studies warrants the need for more randomised controlled trials evaluating the efficacy and safety of combination therapy.

  12. Defining safety culture and the nexus between safety goals and safety culture. 1. An Investigation Study on Practical Points of Safety Management

    International Nuclear Information System (INIS)

    Hasegawa, Naoko; Takano, Kenichi; Hirose, Ayako

    2001-01-01

    In a report after the Chernobyl accident, the International Atomic Energy Agency indicated the definition and the importance of safety culture and the ideal organizational state where safety culture pervades. However, the report did not mention practical approaches to enhance safety culture. In Japan, although there had been investigations that clarified the consciousness of employees and the organizational climate in the nuclear power and railway industries, organizational factors that clarified the level of organization safety and practical methods that spread safety culture in an organization had not been studied. The Central Research Institute of the Electric Power Industry conducted surveys of organizational culture for the construction, chemical, and manufacturing industries. The aim of our study was to clarify the organizational factors that influence safety in an organization expressed in employee safety consciousness, commitment to safety activities, rate of accidents, etc. If these areas were clarified, the level of organization safety might be evaluated, and practical ways could be suggested to enhance the safety culture. Consequently, a series of investigations was conducted to clarify relationships among organizational climate, employee consciousness, safety management and activities, and rate of accidents. The questionnaire surveys were conducted in 1998-1999. The subjects were (a) managers of the safety management sections in the head offices of the construction, chemical, and manufacturing industries; (b) responsible persons in factories of the chemical and manufacturing industries; and (c) general workers in factories of the chemical and manufacturing industries. The number of collected data was (a) managers in the head office: 48 from the construction industry and 58 from the chemical and manufacturing industries, (b) responsible persons in factories: 567, and (c) general workers: from 29 factories. Items in the questionnaires were selected from

  13. To dimension safety valves. Probabilist study

    International Nuclear Information System (INIS)

    Noel, Robert; Couvreur, Denis

    1982-01-01

    The gauge of safety valves of a steam pressure apparatus is usually determined according to an operating situation envelope which it is admitted covers all that can happen in reality. For the safety of the dryer-superheaters of turbines in nuclear power stations, Electricite de France and Alsthom-Atlantique made a reliability study; its method is exposed and the results are discussed. Such a study is heavy going and complex, but in return it permits a better quantitative understanding of the various dimension and operating parameters of an installation which condition its safety. It is therefore a source of progress [fr

  14. Model quality and safety studies

    DEFF Research Database (Denmark)

    Petersen, K.E.

    1997-01-01

    The paper describes the EC initiative on model quality assessment and emphasizes some of the problems encountered in the selection of data from field tests used in the evaluation process. Further, it discusses the impact of model uncertainties in safety studies of industrial plants. The model...... that most of these have never been through a procedure of evaluation, but nonetheless are used to assist in making decisions that may directly affect the safety of the public and the environment. As a major funder of European research on major industrial hazards, DGXII is conscious of the importance......-tain model is appropriate for use in solving a given problem. Further, the findings from the REDIPHEM project related to dense gas dispersion will be highlighted. Finally, the paper will discuss the need for model quality assessment in safety studies....

  15. A longitudinal, multi-level comparative study of quality and safety in European hospitals: The QUASER study protocol

    NARCIS (Netherlands)

    G. Robert (Glenn); J.E. Anderson (Janet); S. Burnett (Susan); K. Aase (Karina); B. Andersson-Gare (Boel); R.A. Bal (Roland); J.E. Calltorp (Johan); F. Nunes (Francisco); A.M. Weggelaar (Anne Marie); C. Vincent (Charles); N.J. Fulop (Naomi)

    2011-01-01

    textabstractBackground: although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in

  16. 77 FR 27776 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2012-05-11

    ... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Services Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study... standard grants review and funding cycles pertaining to research issues in occupational safety and health...

  17. 76 FR 18220 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2011-04-01

    ... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In... Services Office, CDC, pursuant to Public Law 92-463. Purpose: The Safety and Occupational Health Study... standard grants review and funding cycles pertaining to research issues in occupational safety and health...

  18. Fusion reactor safety studies, FY 1977

    International Nuclear Information System (INIS)

    Darby, J.B. Jr.

    1978-04-01

    This report reviews the technical progress in the fusion reactor safety studies performed during FY 1977 in the Fusion Power Program at the Argonne National Laboratory. The subjects reported on include safety considerations of the vacuum vessel and first-wall design for the ANL/EPR, the thermal responses of a tokamak reactor first wall, the vacuum wall electrical resistive requirements in relationship to magnet safety, and a major effort is reported on considerations and experiments on air detritiation

  19. 75 FR 26266 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2010-05-11

    ... Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH) In...) Public Law 92-463. Purpose: The Safety and Occupational Health Study Section will review, discuss, and... cycles pertaining to research issues in occupational safety and health, and allied areas. It is the...

  20. A Study on Drug Safety Monitoring Program in India

    Science.gov (United States)

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  1. Comparative evaluation of safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus: Indian multicentric randomized trial - START Study

    Directory of Open Access Journals (Sweden)

    T V Devarajan

    2017-01-01

    Full Text Available Background and Objective: Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM. Methods: In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202 or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103 for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c. Secondary endpoints were change in fasting plasma glucose (FPG, postprandial plasma glucose (PPG, body mass index (BMI and to assess overall safety profile. Results: At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42% as compared to sitagliptin group (0.30% (P = 0.001. Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.008. There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m2 vs. 0.08 ± 0.31 kg/m2 in glimepiride and sitagliptin groups, respectively, (P = 0.644 between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. Conclusion: In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.

  2. A Quantitative Feasibility Study on Potential Safety Improvement Effects of Advanced Safety Features in APR-1400 when Applied to OPR-1000

    Energy Technology Data Exchange (ETDEWEB)

    Ualikhan Zhiyenbayev [KAIST, Daejeon (Korea, Republic of); Chung, Dae Wook [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-10-15

    This study aims to test the feasibility of the applications using Probabilistic Safety Assessment (PSA). Particularly, three of those advanced safety features are selected as follows: 1. Providing an additional Emergency Diesel Generator (EDG); 2. Increasing the capacity of Class 1E batteries; 3. Placing a Refueling Water Storage Tank (RWST) inside containment, i.e., change from RWST to IRWST. The Advanced Power Reactor 1400 (APR-1400) adopts several advanced safety features compared to its predecessor, the Optimized Power Reactor 1000 (OPR-1000), which includes an additional Emergency Diesel Generator, increase in battery capacity, in-containment refueling water storage tank (IRWST), and so on. Considering the remarkable advantages of these safety features in safety improvement and the design similarities between APR-1400 and OPR-1000, it is feasible to apply key advanced safety features of APR-1400 to OPR-1000 to enhance the safety. The selected safety features are incorporated into OPR-1000 PSA model using the Advanced Information Management System (AIMS) for PSA and CDFs are re-evaluated for each application and combination of three applications. Based on current results, it is concluded that three of key advanced safety features of APR-1400 can be effectively applied to OPR-1000, resulting in considerable safety improvement. In aggregate, three advanced safety features, which are an additional EDG, increased battery capacity and IRWST, can reduce the CDF of OPR-1000 by more than 15% when applied altogether.

  3. A Quantitative Feasibility Study on Potential Safety Improvement Effects of Advanced Safety Features in APR-1400 when Applied to OPR-1000

    International Nuclear Information System (INIS)

    Ualikhan Zhiyenbayev; Chung, Dae Wook

    2015-01-01

    This study aims to test the feasibility of the applications using Probabilistic Safety Assessment (PSA). Particularly, three of those advanced safety features are selected as follows: 1. Providing an additional Emergency Diesel Generator (EDG); 2. Increasing the capacity of Class 1E batteries; 3. Placing a Refueling Water Storage Tank (RWST) inside containment, i.e., change from RWST to IRWST. The Advanced Power Reactor 1400 (APR-1400) adopts several advanced safety features compared to its predecessor, the Optimized Power Reactor 1000 (OPR-1000), which includes an additional Emergency Diesel Generator, increase in battery capacity, in-containment refueling water storage tank (IRWST), and so on. Considering the remarkable advantages of these safety features in safety improvement and the design similarities between APR-1400 and OPR-1000, it is feasible to apply key advanced safety features of APR-1400 to OPR-1000 to enhance the safety. The selected safety features are incorporated into OPR-1000 PSA model using the Advanced Information Management System (AIMS) for PSA and CDFs are re-evaluated for each application and combination of three applications. Based on current results, it is concluded that three of key advanced safety features of APR-1400 can be effectively applied to OPR-1000, resulting in considerable safety improvement. In aggregate, three advanced safety features, which are an additional EDG, increased battery capacity and IRWST, can reduce the CDF of OPR-1000 by more than 15% when applied altogether

  4. Comparing REACH Chemical Safety Assessment information with practice-a case-study of polymethylmethacrylate (PMMA) in floor coating in The Netherlands.

    Science.gov (United States)

    Spee, Ton; Huizer, Daan

    2017-10-01

    On June 1st, 2007 the European regulation on Registration, Evaluation and Restriction of Chemical substances (REACH) came into force. Aim of the regulation is safe use of chemicals for humans and for the environment. The core element of REACH is chemical safety assessment of chemicals and communication of health and safety hazards and risk management measures throughout the supply chain. Extended Safety Data Sheets (Ext-SDS) are the primary carriers of health and safety information. The aim of our project was to find out whether the actual exposure to methyl methacrylate (MMA) during the application of polymethylmethacrylate (PMMA) in floor coatings as assessed in the chemical safety assessment, reflect the exposure situations as observed in the Dutch building practice. Use of PMMA flooring and typical exposure situations during application were discussed with twelve representatives of floor laying companies. Representative situations for exposure measurements were designated on the basis of this inventory. Exposure to MMA was measured in the breathing zone of the workers at four construction sites, 14 full shift samples and 14 task based samples were taken by personal air sampling. The task-based samples were compared with estimates from the Targeted Risk Assessment Tool (v3.1) of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC-TRA) as supplied in the safety assessment from the manufacturer. For task-based measurements, in 12 out of 14 (86%) air samples measured exposure was higher than estimated exposure. Recalculation with a lower ventilation rate (50% instead of 80%) together with a higher temperature during mixing (40°C instead of 20°C) in comparison with the CSR, reduced the number of underestimated exposures to 10 (71%) samples. Estimation with the EMKG-EXPO-Tool resulted in unsafe exposure situations for all scenarios, which is in accordance with the measurement outcomes. In indoor situations, 5 out of 8 full shift exposures (62

  5. Pilot Study on Harmonisation of Reactor Safety in WENRA Countries

    International Nuclear Information System (INIS)

    2003-03-01

    Most of the objectives, set for the Pilot Study, were met. It can be concluded that the methodology was adequate for its purpose. National requirements on selected safety issues have been systematically compared and the major gaps and differences have been identified. Convenient overviews have been provided of differences and similarities between the countries. Furthermore, the conclusions are based on a safety justification and are detailed enough to provide input to a further more detailed analysis on the national level. It was not possible, however, to provide fully verified conclusions about the implementation of the reference levels in the different countries. This has to do with the following constraints on the study: In line with the Terms of Reference, the comparison of formal requirements did not address the more detailed use of criteria and methods to verify compliance. The same requirement could be enforced differently in different regulatory systems, and hence lead to different implementation. The Pilot Study also assessed the implementation, but it was not possible to do this in sufficient detail to identify such differences. The implementation was assessed on the basis of current knowledge of the respective regulatory body, but it was not possible to provide the panels with evidence of the implementation. For these reasons, conclusions about implemented safety provisions in the different countries should be drawn with precaution. The introduction of the panel assessments greatly improved the quality and consistency of the comparison assessments. Uncertainties in the assessments are mainly connected with lack of time to make a detailed analysis in some cases. The reliability of the assessments seems to be sufficient for the objectives of the Pilot Study. The introduction of the IAEA safety standards in the study proved to be helpful and provided confidence in the scope and strictness of the reference levels. This Pilot Study has contributed to

  6. Center for Maritime Safety and Health Studies

    Data.gov (United States)

    Federal Laboratory Consortium — Established in November 2015, the Center for Maritime Safety and Health Studies (CMSHS) promotes safety and health for all maritime workers, including those employed...

  7. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.

    Science.gov (United States)

    El-Mashad, Abd El-Rahman; El-Mahdy, Heba; El Amrousy, Doaa; Elgendy, Marwa

    2017-02-01

    In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P  0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study.

  8. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    Directory of Open Access Journals (Sweden)

    Duszynski Katherine M

    2011-01-01

    Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

  9. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

    Science.gov (United States)

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-04

    The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

  10. Study on Fusion Safety Infrastructure using ISAM

    International Nuclear Information System (INIS)

    Oh, Kyemin; Kang, Myungsuk; Heo, Gyunyoung; Kim, Hyoungchan

    2013-01-01

    The regulation of nuclear facilities have checked and managed safety throughout the entire process from design, construction, operation and decommissioning. Also, the same meaning as the regulatory requirements and design requirements, it will be important indicators for detailed design of K-DEMO. K-DEMO has many uncertainties because it is in conceptual design phase. Also, there is no reference material because demonstration scale fusion power plants were not operated yet in overseas. So, hazard that threaten the integrity of K-DEMO have to be defined preferentially to define regulatory or design requirements. This study proposed method that educe regulatory or design requirements and introduce web-based cloud infrastructure to perform renewal and sharing of information related with safety that is required in the study rapidly as a part of the R and D program funded by National Fusion Research Institute of Korea (NFRI). We have been performing QSR and PIRT in accordance with development of fusion DEMO plant, and preparing OPT, PSA and DPA for regulation requirements. This study introduces our recent research activities about ISAM for fusion and CCI built for expert and extant safety related information. Unlike fission, nuclear fusion's safety goal is non-evacuation of the public during an accident. To satisfy this goal not only various safety issues should be analyzed, but safety objectives, regulatory requirements, and design variables should also be established in detailed design phase. The web-based cloud infrastructure proposed in this paper will be able to offer input data of future studies and, it is expected to contribute on general and technical safety principles for national fusion power plant technology plan

  11. The first symposium of Research Center for Radiation Safety, NIRS. Perspective of future studies of radiation safety

    International Nuclear Information System (INIS)

    Shimo, Michikuni

    2002-03-01

    This paper summarizes presentations given in the title symposium, held at the Conference Room of National Institute of Radiological Sciences (NIRS) on November 29 and 30, 2001. Contained are Introductory remarks: Basic presentations concerning exposure dose in man; Environmental levels of radiation and radioactivity, environmental radon level and exposure dose, and radiation levels in the specific environment (like in the aircraft): Special lecture (biological effects given by space environment) concerning various needs for studies of radiation safety; Requirement for open investigations, from the view of utilization, research and development of atomic energy, from the clinical aspect, and from the epidemiological aspect: Special lecture (safety in utilization of atomic energy and radiation-Activities of Nuclear Safety Commission of Japan) concerning present state and perspective of studies of radiation safety; Safety of radiation and studies of biological effects of radiation-perspective, and radiation protection and radiation safety studies: Studies in the Research Center for Radiation Safety; Summary of studies in the center, studies of the biological effects of neutron beam, carcinogenesis by radiation and living environmental factors-complicated effects, and studies of hereditary effects: Panel discussion (future direction of studies of radiation safety for the purpose of the center's direction): and concluding remarks. (N.I.)

  12. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

    Science.gov (United States)

    Park, Won; Hrycaj, Pawel; Jeka, Slawomir; Kovalenko, Volodymyr; Lysenko, Grygorii; Miranda, Pedro; Mikazane, Helena; Gutierrez-Ureña, Sergio; Lim, MieJin; Lee, Yeon-Ah; Lee, Sang Joon; Kim, HoUng; Yoo, Dae Hyun; Braun, Jürgen

    2013-10-01

    To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

  13. Comparative assessment of safety indicators for vehicle trajectories on the highway

    NARCIS (Netherlands)

    Mullakkal Babu, F.A.; Wang, M.; Farah, H.; van Arem, B.; Happee, R.

    2017-01-01

    Safety measurement and analysis have been a challenging and well-researched topic in transportation. Conventionally, surrogate safety measures have been used as safety indicators in simulation models for safety assessment, in control formulations for driver assistance systems, and in data analysis

  14. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

    Science.gov (United States)

    Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

    2017-10-01

    ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Lessons learned from measuring safety culture: an Australian case study.

    Science.gov (United States)

    Allen, Suellen; Chiarella, Mary; Homer, Caroline S E

    2010-10-01

    adverse events in maternity care are relatively common but often avoidable. International patient safety strategies advocate measuring safety culture as a strategy to improve patient safety. Evidence suggests it is necessary to fully understand the safety culture of an organisation to make improvements to patient safety. this paper reports a case study examining the safety culture in one maternity service in Australia and considers the benefits of using surveys and interviews to understand safety culture as an approach to identify possible strategies to improve patient safety in this setting. the study took place in one maternity service in two public hospitals in NSW, Australia. Concurrently, both hospitals were undergoing an organisational restructure which was part of a major health reform agenda. The priorities of the reform included improving the quality of care and patient safety; and, creating a more efficient health system by reducing administration inefficiencies and duplication. a descriptive case study using three approaches: the safety culture was identified to warrant improvement across all six safety culture domains. There was reduced infrastructure and capacity to support incident management activities required to improve safety, which was influenced by instability from the organisational restructure. There was a perceived lack of leadership at all levels to drive safety and quality and improving the safety culture was neither a key priority nor was it valued by the organisation. the safety culture was complex as was undertaking this study. We were unable to achieve a desired 60% response rate highlighting the limitations of using safety culture surveys in isolation as a strategy to improve safety culture. Qualitative interviews provided greater insight into the factors influencing the safety culture. The findings of this study provide evidence of the benefits of including qualitative methods with quantitative surveys when examining safety culture

  16. Ageing study of the engineered safety features actuation system of the Loviisa NPP

    International Nuclear Information System (INIS)

    Simola, K.; Maskuniitty, M.

    1995-06-01

    An ageing study of the engineered safety features actuation system of the Loviisa nuclear power plant has been performed. The operating experience, including failure and maintenance histories of analog measuring devices, logics for safety signal formation and individual control electronics of pumps and valves, has been collected and analysed. The safety importance of system components has been studied with a fault tree analysis of a selected safety function. Based on the results of the analysis of operating experiences and the fault tree analysis, some components were selected for deeper analyses. According to the operating experience, the amount of failures in the Loviisa plant safety system has been low and no increasing trend in the failure history can yet be observed. Only a few failures had prohibited the propagation of the safety signal, mostly the failures have caused a false alarm. The failures reported have concerned mainly limit signal units, transmitters, and priority units. According to the fault tree analysis of one safety function, the most important components of this subsystem are individual control units and pulse/DC converters. Failure modes and effect analyses were performed for priority and individual control unit, limit signal unit and comparator and pulse/DC converter in order to identify the critical failure modes of these devices. (orig.) (15 refs., 26 figs., 9 tabs.)

  17. Independent safety organization

    International Nuclear Information System (INIS)

    Kato, W.Y.; Weinstock, E.V.; Carew, J.F.; Cerbone, R.J.; Guppy, J.G.; Hall, R.E.; Taylor, J.H.

    1985-01-01

    Brookhaven National Laboratory has conducted a study on the need and feasibility of an independent organization to investigate significant safety events for the Office for Analysis and Evaluation of Operational Data, USNRC. The study consists of three parts: the need for an independent organization to investigate significant safety events, alternative organizations to conduct investigations, and legislative requirements. The determination of need was investigated by reviewing current NRC investigation practices, comparing aviation and nuclear industry practices, and interviewing a spectrum of representatives from the nuclear industry, the regulatory agency, and the public sector. The advantages and disadvantages of alternative independent organizations were studied, namely, an Office of Nuclear Safety headed by a director reporting to the Executive Director for Operations (EDO) of NRC; an Office of Nuclear Safety headed by a director reporting to the NRC Commissioners; a multi-member NTSB-type Nuclear Safety Board independent of the NRC. The costs associated with operating a Nuclear Safety Board were also included in the study. The legislative requirements, both new authority and changes to the existing NRC legislative authority, were studied. 134 references

  18. A Study of Time Response for Safety-Related Operator Actions in Non-LOCA Safety Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Min Seok; Lee, Sang Seob; Park, Min Soo; Lee, Gyu Cheon; Kim, Shin Whan [KEPCO E and C Company, Daejeon (Korea, Republic of)

    2014-10-15

    The classification of initiating events for safety analysis report (SAR) chapter 15 is categorized into moderate frequency events (MF), infrequent events (IF), and limiting faults (LF) depending on the frequency of its occurrence. For the non-LOCA safety analysis with the purpose to get construction or operation license, however, it is assumed that the operator response action to mitigate the events starts at 30 minutes after the initiation of the transient regardless of the event categorization. Such an assumption of corresponding operator response time may have over conservatism with the MF and IF events and results in a decrease in the safety margin compared to its acceptance criteria. In this paper, the plant conditions (PC) are categorized with the definitions in SAR 15 and ANS 51.1. Then, the consequence of response for safety-related operator action time is determined based on the PC in ANSI 58.8. The operator response time for safety analysis regarding PC are reviewed and suggested. The clarifying alarm response procedure would be required for the guideline to reduce the operator response time when the alarms indicate the occurrence of the transient.

  19. Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

    International Nuclear Information System (INIS)

    Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.; Buczek, Jeffrey A.; Lietzow, J.; McCoy, F.; Beranek, F.; Gupta, M.

    2013-01-01

    A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25 recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved

  20. Angra-1 probabilistic safety study-phase B

    International Nuclear Information System (INIS)

    Fernandes Filho, T.L.; Gibelli, S.M.O.

    1988-05-01

    This study represents the Phase B of the Angra-1 Probabilistic Safety Study and is the the final report prepared for the IAEA under Research Contract No. 3423/R2/RB. The three main items covered in this report are the establishment of interim safety goals, analysis of Angra-1 operational experience and development of emergency procedures to address severe accidents. For establishment of interim safety goals a methodology for calculating consequences and risks associated to the Angra-1 operation was developed based on the available data and codes. The proposed safety goals refer to the individual risk of early fatality for people living in the vicinity of the plant, colective risk of cancer fatalities for people living near the plant, the propobability of core melt occurrence and the probability of dominant accident sequences. (author) [pt

  1. Behavioral integrity for safety, priority of safety, psychological safety, and patient safety : a team-level study

    NARCIS (Netherlands)

    Leroy, H.; Dierynck, B.; Anseel, F.; Simons, T.; Halbesleben, J.R.; McCaughey, D.; Savage, G.T.; Sels, L.

    2012-01-01

    This article clarifies how leader behavioral integrity for safety helps solve follower's double bind between adhering to safety protocols and speaking up about mistakes against protocols. Path modeling of survey data in 54 nursing teams showed that head nurse behavioral integrity for safety

  2. Laparoscopic versus open splenectomy for portal hypertension: a systematic review of comparative studies.

    Science.gov (United States)

    Cai, Yunqiang; Liu, Zhihong; Liu, Xubao

    2014-08-01

    Laparoscopic splenectomy has become the gold-standard procedure for normal to moderately enlarged spleens. However, the safety of laparoscopic splenectomy for patients with portal hypertension remains controversial. We carried out this systematic review to identify the feasibility and safety of laparoscopic splenectomy in treating portal hypertension. A systematic search for comparative studies that compared laparoscopic splenectomy with open splenectomy for portal hypertension was carried out. Studies were independently reviewed for quality, inclusion and exclusion criteria, demographic characteristics, and perioperative outcomes. Although laparoscopic splenectomy is associated with longer operating time, it offers advantages over the open procedure in terms of less blood loss, lower operative complications, earlier resumption of oral intake, and shorter posthospital stay. Therefore, laparoscopic splenectomy is a safe and feasible intervention for portal hypertension. © The Author(s) 2014.

  3. A study on safety climate at nuclear power plants

    International Nuclear Information System (INIS)

    Fukui, Hirokazu; Yoshida, Michio; Yoshiyama, Naohiro

    2001-01-01

    In the current study, we define safety climate as an organizational environment that induces members of the organization to give consideration to safety or take safety actions. It is of utmost importance that people holding managerial positions in an organization have a good understanding of the characteristics of the safety climate of the organization and implement safety promotion activities effectively. In the current research, we studied the rating scales and the characteristics of a safety climate. A survey was conducted, targeting technical engineers who belong to the three power stations of Kansai Electric Power Co., Inc. The questionnaire mainly consisted of questions concerning safety measures taken by individuals and questions concerning safety measures taken by the organization, to which the individuals belong. As a result of a factor analysis of the responses, we extracted five factors, namely, 'confidence in knowledge and skill', attitude of supervisors,' 'safety education in workplace', 'clarity of tasks' and 'safety confirmation/report'. In studying the rating scales of the safety climate, we selected five items from each of the above five factors, and used the total scores of the ratings of the five items as scores of each factor. Then, we examined the correlation between scores of personal factors and scores of organizational environment factors. We treated the scores of safety confirmation/report' and 'confidence in knowledge and skill', which are personal factors, as criterion variables, and the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks', which are organizational environment factors, as predictor variables. As a result, we found that levels of 'safety confirmation/report' and 'confidence in knowledge and skill' can be deduced from the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks.' Hence, we have decided to use these three organizational environment

  4. Categorization of safety related motor operated valve safety significance for Ulchin Unit 3

    International Nuclear Information System (INIS)

    Kang, D. I.; Kim, K. Y.

    2002-03-01

    We performed a categorization of safety related Motor Operated Valve (MOV) safety significance for Ulchin Unit 3. The safety evaluation of MOV of domestic nuclear power plants affects the generic data used for the quantification of MOV common cause failure ( CCF) events in Ulchin Units 3 PSA. Therefore, in this study, we re-estimated the MGL(Multiple Greek Letter) parameter used for the evaluation of MOV CCF probabilities in Ulchin Units 3 Probabilistic Safety Assessment (PSA) and performed a classification of the MOV safety significance. The re-estimation results of the MGL parameter show that its value is decreased by 30% compared with the current value in Ulchin Unit 3 PSA. The categorization results of MOV safety significance using the changed value of MGL parameter shows that the number of HSSCs(High Safety Significant Components) is decreased by 54.5% compared with those using the current value of it in Ulchin Units 3 PSA

  5. Criticality safety basics, a study guide

    Energy Technology Data Exchange (ETDEWEB)

    V. L. Putman

    1999-09-01

    This document is a self-study and classroom guide, for criticality safety of activities with fissile materials outside nuclear reactors. This guide provides a basic overview of criticality safety and criticality accident prevention methods divided into three parts: theory, application, and history. Except for topic emphasis, theory and history information is general, while application information is specific to the Idaho National Engineering and Environmental Laboratory (INEEL). Information presented here should be useful to personnel who must know criticality safety basics to perform their assignments safely or to design critically safe equipment or operations. However, the guide's primary target audience is fissile material handler candidates.

  6. Criticality safety basics, a study guide

    International Nuclear Information System (INIS)

    Putman, V.L.

    1999-01-01

    This document is a self-study and classroom guide, for criticality safety of activities with fissile materials outside nuclear reactors. This guide provides a basic overview of criticality safety and criticality accident prevention methods divided into three parts: theory, application, and history. Except for topic emphasis, theory and history information is general, while application information is specific to the Idaho National Engineering and Environmental Laboratory (INEEL). Information presented here should be useful to personnel who must know criticality safety basics to perform their assignments safely or to design critically safe equipment or operations. However, the guide's primary target audience is fissile material handler candidates

  7. Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

    Science.gov (United States)

    Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique

    2005-07-01

    This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (pOGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

  8. Application of patient safety indicators internationally: a pilot study among seven countries.

    Science.gov (United States)

    Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

    2009-08-01

    To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

  9. Safety certification of airborne software: An empirical study

    International Nuclear Information System (INIS)

    Dodd, Ian; Habli, Ibrahim

    2012-01-01

    Many safety-critical aircraft functions are software-enabled. Airborne software must be audited and approved by the aerospace certification authorities prior to deployment. The auditing process is time-consuming, and its outcome is unpredictable, due to the criticality and complex nature of airborne software. To ensure that the engineering of airborne software is systematically regulated and is auditable, certification authorities mandate compliance with safety standards that detail industrial best practice. This paper reviews existing practices in software safety certification. It also explores how software safety audits are performed in the civil aerospace domain. The paper then proposes a statistical method for supporting software safety audits by collecting and analysing data about the software throughout its lifecycle. This method is then empirically evaluated through an industrial case study based on data collected from 9 aerospace projects covering 58 software releases. The results of this case study show that our proposed method can help the certification authorities and the software and safety engineers to gain confidence in the certification readiness of airborne software and predict the likely outcome of the audits. The results also highlight some confidentiality issues concerning the management and retention of sensitive data generated from safety-critical projects.

  10. Comparative instrumental evaluation of efficacy and safety between a binary and a ternary system in chemexfoliation.

    Science.gov (United States)

    Cameli, Norma; Mariano, Maria; Ardigò, Marco; Corato, Cristina; De Paoli, Gianfranco; Berardesca, Enzo

    2017-09-20

    To instrumentally evaluate the efficacy and the safety of a new ternary system chemo exfoliating formulation (water-dimethyl isosorbide-acid) vs traditional binary systems (water and acid) where the acid is maintained in both the systems at the same concentration. Different peelings (binary system pyruvic acid and trichloroacetic acid-TCA, and ternary system pyruvic acid and TCA) were tested on the volar forearm of 20 volunteers of both sexes between 28 and 50 years old. The outcomes were evaluated at the baseline, 10 minutes, 24 hours, and 1 week after the peeling by means of noninvasive skin diagnosis techniques. In vivo reflectance confocal microscopy was used for stratum corneum evaluation, transepidermal waterloss, and Corneometry for skin barrier and hydration, Laser Doppler velocimetry in association with colorimetry for irritation and erythema analysis. The instrumental data obtained showed that the efficacy and safety of the new ternary system peel compounds were significantly higher compared with the binary system formulations tested. The new formulation peels improved chemexfoliation and reduced complications such as irritation, redness, and postinflammatory pigmentation compared to the traditional aqueous solutions. The study showed that ternary system chemexfoliation, using a controlled delivery technology, was able to provide the same clinical effects in term of stratum corneum reduction with a significantly reduced barrier alteration, water loss, and irritation/erythema compared to traditional binary system peels. © 2017 Wiley Periodicals, Inc.

  11. Understanding lean & safety projects: analysis of case studies

    Directory of Open Access Journals (Sweden)

    Maria Crema

    2017-12-01

    Full Text Available Facing the current socio-economic contingency while guaranteeing a high level of care quality is particularly challenging in the field of healthcare. Through an integrated adoption of emerging managerial solutions, projects that allow organizations to achieve both efficiency and patient safety improvements could be implemented, thereby transposing policy directives towards a safer and more sustainable healthcare system. Therefore, the purpose of this paper is to investigate the features of Lean & Safety (L&S projects. Three Health Lean Management (HLM projects that had unexpected patient safety results were selected from the same region. Differences and similarities among the cases have been highlighted and interesting points of evidence have been noted. Despite the fact that the projects were pursuing similar objectives and benefiting from comparable support, the obtained changes had direct impact on patient safety enhancement in the cases that involved the front-office processes, and an indirect impact on patient safely for the L&S project that focused on back-office activities. The implementation processes and the Information and Communication Technologies (ICT adoption of the cases are also different.

  12. Quality management of pharmacology and safety pharmacology studies

    DEFF Research Database (Denmark)

    Spindler, Per; Seiler, Jürg P

    2002-01-01

    to safety pharmacology studies, and, when indicated, to secondary pharmacodynamic studies, does not influence the scientific standards of studies. However, applying formal GLP standards will ensure the quality, reliability and integrity of studies, which reflect sound study management. It is important...... to encourage a positive attitude among researchers and academics towards these lines, whenever possible. GLP principles applied to the management of non-clinical safety studies are appropriate quality standards when studies are used in the context of protecting public health, and these quality standards...... of pharmacology studies (ICH S7A): primary pharmacodynamic, secondary pharmacodynamic and safety pharmacology studies, and guidance on the quality standards (expectations for GLP conformity) for these study types have been provided. Primary pharmacodynamic studies are the only study types that are fully exempt...

  13. ROAD ACCIDENT AND SAFETY STUDY IN SYLHET REGION OF BANGLADESH

    Directory of Open Access Journals (Sweden)

    B. K. BANIK

    2011-08-01

    Full Text Available Roads, highways and streets are fundamental infrastructure facilities to provide the transportation for passenger travel and goods movement from one place to another in Sylhet, north–eastern division of Bangladesh with rapid growth of road vehicle, being comparatively developed economic tourist prone area faces severe road traffic accident. Such severe road accidents cause harsh safety hazards on the roads of Sylhet area. This research work presents an overview of the road traffic accident and degraded road safety situation in Sylhet zone which in particular, discusses the key road accident problem characteristics identifying the hazardous roads and spots, most responsible vehicles and related components, conditions of drivers and pedestrians, most victims of accident, effects of accident on society, safety priorities and options available in Sylhet. In this regard, a comprehensive questionnaire survey was conducted on the concerned groups of transportation and detailed accident data was collected from a popular local newspaper. Analysis of the study reveals that Dhaka- Sylhet highway is the most hazardous in road basis and Sylhet Sador thana is the most vulnerable in thana basis in Sylhet region.

  14. A study on safety climate at nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Fukui, Hirokazu [Institute of Nuclear Safety System Inc., Mihama, Fukui (Japan); Yoshida, Michio; Yoshiyama, Naohiro [Japan Institute for Group Dynamics, Fukuoka (Japan)

    2001-09-01

    In the current study, we define safety climate as an organizational environment that induces members of the organization to give consideration to safety or take safety actions. It is of utmost importance that people holding managerial positions in an organization have a good understanding of the characteristics of the safety climate of the organization and implement safety promotion activities effectively. In the current research, we studied the rating scales and the characteristics of a safety climate. A survey was conducted, targeting technical engineers who belong to the three power stations of Kansai Electric Power Co., Inc. The questionnaire mainly consisted of questions concerning safety measures taken by individuals and questions concerning safety measures taken by the organization, to which the individuals belong. As a result of a factor analysis of the responses, we extracted five factors, namely, 'confidence in knowledge and skill', attitude of supervisors,' 'safety education in workplace', 'clarity of tasks' and 'safety confirmation/report'. In studying the rating scales of the safety climate, we selected five items from each of the above five factors, and used the total scores of the ratings of the five items as scores of each factor. Then, we examined the correlation between scores of personal factors and scores of organizational environment factors. We treated the scores of safety confirmation/report' and 'confidence in knowledge and skill', which are personal factors, as criterion variables, and the scores of 'attitude of supervisors', 'safety education in workplace' and 'clarity of tasks', which are organizational environment factors, as predictor variables. As a result, we found that levels of 'safety confirmation/report' and 'confidence in knowledge and skill' can be deduced from the scores of 'attitude of supervisors', 'safety

  15. Comparative health and safety assessment of alternative future electrical-generation systems

    International Nuclear Information System (INIS)

    Habegger, L.J.; Gasper, J.R.; Brown, C.D.

    1980-01-01

    The report is an analysis of health and safety risks of seven alternative electrical generation systems, all of which have potential for commercial availability in the post-2000 timeframe. The systems are compared on the basis of expected public and occupational deaths and lost workdays per year associated with 1000 MWe average unit generation. Risks and their uncertainties are estimated for all phases of the energy production cycle, including fuel and raw material extraction and processing, direct and indirect component manufacture, on-site construction, and system operation and maintenance. Also discussed is the potential significance of related major health and safety issues that remain largely unquantifiable. The technologies include: the SPS; a low-Btu coal gasification system with an open-cycle gas turbine combined with a steam topping cycle (CG/CC); a light water fission reactor system without fuel reprocessing (LWR); a liquid metal fast breeder fission reactor system (LMFBR); a central station terrestrial photovoltaic system (CTPV); and a first generation fusion system with magnetic confinement. For comparison with the baseload technologies, risk from a decentralized roof-top photovoltaic system with 6 kWe peak capacity and battery storage (DTPV) was also evaluated

  16. Reactor parameters for European economic, safety and environmental studies

    International Nuclear Information System (INIS)

    Hancox, R.; Cooke, P.I.H.; Spears, W.R.

    1990-01-01

    Parameter sets for five 1200 MW e tokamak reactors were developed for the European Study Group on the Environmental, Safety-related and Economic Potential of Fusion Power, showing today's perception of the range of reactors likely to be available as a result of the Commission's fusion programme. On the basis of the cost of generating electricity, relative to a fission reactor, a reference set was chosen and endorsed by the Group for further studies including that on the environmental impact of fusion power. Key physics and technology parameters for the reference reactor are compared with values used in the ITER design, and with those from American studies. (author)

  17. On groundwater flow modelling in safety analyses of spent fuel disposal. A comparative study with emphasis on boundary conditions

    Energy Technology Data Exchange (ETDEWEB)

    Jussila, P

    1999-11-01

    Modelling groundwater flow is an essential part of the safety assessment of spent fuel disposal because moving groundwater makes a physical connection between a geological repository and the biosphere. Some of the common approaches to model groundwater flow in bedrock are equivalent porous continuum (EC), stochastic continuum and various fracture network concepts. The actual flow system is complex and measuring data are limited. Multiple distinct approaches and models, alternative scenarios as well as calibration and sensitivity analyses are used to give confidence on the results of the calculations. The correctness and orders of magnitude of results of such complex research can be assessed by comparing them to the results of simplified and robust approaches. The first part of this study is a survey of the objects, contents and methods of the groundwater flow modelling performed in the safety assessment of the spent fuel disposal in Finland and Sweden. The most apparent difference of the Swedish studies compared to the Finnish ones is the approach of using more different models, which is enabled by the more resources available in Sweden. The results of more comprehensive approaches provided by international co-operation are very useful to give perspective to the results obtained in Finland. In the second part of this study, the influence of boundary conditions on the flow fields of a simple 2D model is examined. The assumptions and simplifications in this approach include e.g. the following: (1) the EC model is used, in which the 2-dimensional domain is considered a continuum of equivalent properties without fractures present, (2) the calculations are done for stationary fields, without sources or sinks present in the domain and with a constant density of the groundwater, (3) the repository is represented by an isotropic plate, the hydraulic conductivity of which is given fictitious values, (4) the hydraulic conductivity of rock is supposed to have an exponential

  18. Study on 'Safety qualification of process computers used in safety systems of nuclear power plants'

    International Nuclear Information System (INIS)

    Bertsche, K.; Hoermann, E.

    1991-01-01

    The study aims at developing safety standards for hardware and software of computer systems which are increasingly used also for important safety systems in nuclear power plants. The survey of the present state-of-the-art of safety requirements and specifications for safety-relevant systems and, additionally, for process computer systems has been compiled from national and foreign rules. In the Federal Republic of Germany the KTA safety guides and the BMI/BMU safety criteria have to be observed. For the design of future computer-aided systems in nuclear power plants it will be necessary to apply the guidelines in [DIN-880] and [DKE-714] together with [DIN-192]. With the aid of a risk graph the various functions of a system, or of a subsystem, can be evaluated with regard to their significance for safety engineering. (orig./HP) [de

  19. Comparative safety assessment of plant-derived foods

    NARCIS (Netherlands)

    Kok, E.J.; Keijer, J.; Kleter, G.A.; Kuiper, H.A.

    2008-01-01

    The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting

  20. Prospective open randomized study comparing efficacies and safeties of a 3-day course of azithromycin and a 10-day course of erythromycin in children with community-acquired acute lower respiratory tract infections

    NARCIS (Netherlands)

    Roord, JJ; Goossens, MMHT; Kimpen, JLL; Wolf, B.H.

    1996-01-01

    The efficacies and safeties of a 3-day, 3-dose course of azithromycin (10 mg/kg of body weight per day) and a 10-day, 30-dose course of erythromycin (40 mg/kg/day) for the treatment of acute lower respiratory tract infections in children were compared in an open randomized multicenter study.

  1. Comparing the cardiovascular therapeutic indices of glycopyrronium and tiotropium in an integrated rat pharmacokinetic, pharmacodynamic and safety model

    International Nuclear Information System (INIS)

    Trifilieff, Alexandre; Ethell, Brian T.; Sykes, David A.; Watson, Kenny J.; Collingwood, Steve; Charlton, Steven J.; Kent, Toby C.

    2015-01-01

    Long acting inhaled muscarinic receptor antagonists, such as tiotropium, are widely used as bronchodilator therapy for chronic obstructive pulmonary disease (COPD). Although this class of compounds is generally considered to be safe and well tolerated in COPD patients the cardiovascular safety of tiotropium has recently been questioned. We describe a rat in vivo model that allows the concurrent assessment of muscarinic antagonist potency, bronchodilator efficacy and a potential for side effects, and we use this model to compare tiotropium with NVA237 (glycopyrronium bromide), a recently approved inhaled muscarinic antagonist for COPD. Anaesthetized Brown Norway rats were dosed intratracheally at 1 or 6 h prior to receiving increasing doses of intravenous methacholine. Changes in airway resistance and cardiovascular function were recorded and therapeutic indices were calculated against the ED 50 values for the inhibition of methacholine-induced bronchoconstriction. At both time points studied, greater therapeutic indices for hypotension and bradycardia were observed with glycopyrronium (19.5 and 28.5 fold at 1 h; > 200 fold at 6 h) than with tiotropium (1.5 and 4.2 fold at 1 h; 4.6 and 5.5 fold at 6 h). Pharmacokinetic, protein plasma binding and rat muscarinic receptor binding properties for both compounds were determined and used to generate an integrated model of systemic M 2 muscarinic receptor occupancy, which predicted significantly higher M 2 receptor blockade at ED 50 doses with tiotropium than with glycopyrronium. In our preclinical model there was an improved safety profile for glycopyrronium when compared with tiotropium. - Highlights: • We use an in vivo rat model to study CV safety of inhaled muscarinic antagonists. • We integrate protein and receptor binding and PK of tiotropium and glycopyrrolate. • At ED 50 doses for bronchoprotection we model systemic M 2 receptor occupancy. • Glycopyrrolate demonstrates lower M 2 occupancy at

  2. Comparing the cardiovascular therapeutic indices of glycopyrronium and tiotropium in an integrated rat pharmacokinetic, pharmacodynamic and safety model

    Energy Technology Data Exchange (ETDEWEB)

    Trifilieff, Alexandre; Ethell, Brian T. [Respiratory Disease Area, Novartis Institutes for Biomedical Research, Wimblehurst Road, Horsham, West Sussex RH12 5AB (United Kingdom); Sykes, David A. [Respiratory Disease Area, Novartis Institutes for Biomedical Research, Wimblehurst Road, Horsham, West Sussex RH12 5AB (United Kingdom); School of Life Sciences, Queen' s Medical Centre, University of Nottingham, Nottingham, NG7 2UH (United Kingdom); Watson, Kenny J.; Collingwood, Steve [Respiratory Disease Area, Novartis Institutes for Biomedical Research, Wimblehurst Road, Horsham, West Sussex RH12 5AB (United Kingdom); Charlton, Steven J. [Respiratory Disease Area, Novartis Institutes for Biomedical Research, Wimblehurst Road, Horsham, West Sussex RH12 5AB (United Kingdom); School of Life Sciences, Queen' s Medical Centre, University of Nottingham, Nottingham, NG7 2UH (United Kingdom); Kent, Toby C., E-mail: tobykent@me.com [Respiratory Disease Area, Novartis Institutes for Biomedical Research, Wimblehurst Road, Horsham, West Sussex RH12 5AB (United Kingdom)

    2015-08-15

    Long acting inhaled muscarinic receptor antagonists, such as tiotropium, are widely used as bronchodilator therapy for chronic obstructive pulmonary disease (COPD). Although this class of compounds is generally considered to be safe and well tolerated in COPD patients the cardiovascular safety of tiotropium has recently been questioned. We describe a rat in vivo model that allows the concurrent assessment of muscarinic antagonist potency, bronchodilator efficacy and a potential for side effects, and we use this model to compare tiotropium with NVA237 (glycopyrronium bromide), a recently approved inhaled muscarinic antagonist for COPD. Anaesthetized Brown Norway rats were dosed intratracheally at 1 or 6 h prior to receiving increasing doses of intravenous methacholine. Changes in airway resistance and cardiovascular function were recorded and therapeutic indices were calculated against the ED{sub 50} values for the inhibition of methacholine-induced bronchoconstriction. At both time points studied, greater therapeutic indices for hypotension and bradycardia were observed with glycopyrronium (19.5 and 28.5 fold at 1 h; > 200 fold at 6 h) than with tiotropium (1.5 and 4.2 fold at 1 h; 4.6 and 5.5 fold at 6 h). Pharmacokinetic, protein plasma binding and rat muscarinic receptor binding properties for both compounds were determined and used to generate an integrated model of systemic M{sub 2} muscarinic receptor occupancy, which predicted significantly higher M{sub 2} receptor blockade at ED{sub 50} doses with tiotropium than with glycopyrronium. In our preclinical model there was an improved safety profile for glycopyrronium when compared with tiotropium. - Highlights: • We use an in vivo rat model to study CV safety of inhaled muscarinic antagonists. • We integrate protein and receptor binding and PK of tiotropium and glycopyrrolate. • At ED{sub 50} doses for bronchoprotection we model systemic M{sub 2} receptor occupancy. • Glycopyrrolate demonstrates lower M

  3. COMPARATIVE STUDY OF OLANZAPINE AND QUETIAPINE IN PSYCHOTIC DISORDERS

    Directory of Open Access Journals (Sweden)

    Bithorai Basumatary

    2018-01-01

    Full Text Available BACKGROUND Psychotic disorders are a group of chronic debilitating psychiatric illness characterised by loss in touch with reality and disorders of thought, behaviour, appearance and speech. The second generation atypical antipsychotic olanzapine has been reported to be the commonly prescribed antipsychotic. However, olanzapine can cause adverse effects like weight gain, hyperglycaemia, diabetes, dyslipidaemia and metabolic syndrome. Quetiapine, another second generation antipsychotic has good efficacy and has become well established in the treatment of schizophrenia and manic episodes. There are reports on adverse effects of hyperglycaemia and diabetes with quetiapine, but these are comparatively lesser than olanzapine. The aim of the study is to compare the efficacy of olanzapine and quetiapine in patients with psychotic disorders. MATERIALS AND METHODS It was an unicentric, open label, prospective and comparative clinical study. Subjects (n=80 who were diagnosed with psychotic disorder were randomly assigned to receive olanzapine (group 1 or quetiapine (group 2. The efficacy of the two drugs was assessed on the basis Brief Psychiatric Rating Scale (BPRS scores at baseline, 1 week and 6 weeks. UKU scale (Udvalg Kliniske Undersogelser and laboratory investigations were used to assess the safety profile. RESULTS The two study groups had comparable sociodemographic profile. Both the groups showed significant reduction in psychotic symptoms as compared from baseline to 1 week and 6 weeks (p<0.001. The intergroup comparison of the efficacy of the two groups did not show any statistically significant results. There was statistically insignificant differences in the occurrence of adverse effects in both the groups. Sedation (50% in both the groups was the most common adverse effect in both the groups. The use of concomitant medications was comparable in both the groups. Benzodiazepines (56.3% in the olanzapine group and 51.9% in the quetiapine group

  4. Language barriers and patient safety risks in hospital care. A mixed methods study.

    Science.gov (United States)

    van Rosse, Floor; de Bruijne, Martine; Suurmond, Jeanine; Essink-Bot, Marie-Louise; Wagner, Cordula

    2016-02-01

    A language barrier has been shown to be a threat for quality of hospital care. International studies highlighted a lack of adequate noticing, reporting, and bridging of a language barrier. However, studies on the link between language proficiency and patient safety are scarce, especially in Europe. The present study investigates patient safety risks due to language barriers during hospitalization, and the way language barriers are detected, reported, and bridged in Dutch hospital care. We combined quantitative and qualitative methods in a sample of 576 ethnic minority patients who were hospitalized on 30 wards within four urban hospitals. The nursing and medical records of 17 hospital admissions of patients with language barriers were qualitatively analyzed, and complemented by 12 in-depth interviews with care providers and patients and/or their relatives to identify patient safety risks during hospitalization. The medical records of all 576 patients were screened for language barrier reports. The results were compared to patients' self-reported Dutch language proficiency. The policies of wards regarding bridging language barriers were compared with the reported use of interpreters in the medical records. Situations in hospital care where a language barrier threatened patient safety included daily nursing tasks (i.e. medication administration, pain management, fluid balance management) and patient-physician interaction concerning diagnosis, risk communication and acute situations. In 30% of the patients that reported a low Dutch proficiency, no language barrier was documented in the patient record. Relatives of patients often functioned as interpreter for them and professional interpreters were hardly used. The present study showed a wide variety of risky situations in hospital care for patients with language barriers. These risks can be reduced by adequately bridging the language barrier, which, in the first place, demands adequate detecting and reporting of a

  5. Environmental Regulation and Food Safety: Studies of Protection ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Environmental Regulation and Food Safety: Studies of Protection and Protectionism. Book cover Environmental Regulation and Food Safety: Studies of Protection and Protectionism. Directeur(s) : Veena Jha. Maison(s) d'édition : Edward Elgar, IDRC. 1 janvier 2006. ISBN : 184542512X. 250 pages. e-ISBN : 155250185X.

  6. The comparative analysis of safety and economic competitiveness of the advanced high-power reactor projects of NPP

    International Nuclear Information System (INIS)

    Batyrbekov, G.A.; Makhanov, U.M.; Philimonova, R.A.; Kichutkina, E.G.

    2002-01-01

    The comparative analysis results of the safety and economic competitiveness of the seven advanced large sized reactors projects (900 MW and more) are submitted in that report: EPR, Frameatome France, Siemens Germany; EP-1000 Westinghouse, USA and Genesi Italy; Candu 9, Atomic Energy of Canada Ltd; System 80 +, ABB, USA; KNGR, group NSSS Engineering and Development, Korea Power Engineering Company, Inc; APWR, Electric Power company, Japan Atomic Power Company, Mitsubishi Heavy Industries, Westinghouse Electric; and WWER-1000 (V-392), Atomenergoproject/Gidropress Russian Federation. According to the economic competitiveness of listed compared power reactors the 14 criteria of safety have been accepted. These criteria: 1. Features of the barrier system of 'defence-in-depth'. 2. The self-security of a reactor under increase of power and reactivity of a reactor, decrease of the expense and phase transformations of the reactor core coolant (presence of negative feedbacks). 3. Presence of the reactor shutdown systems responding principles of a variety, independence and reservation. Presence of the passive means of initiation and operation of the emergency protection. 4. The emergency cooling of the core of reactor. A presence of the passive means of cooling. Presence of the water reservation for the water supply of the different safety systems. 5. The emergency electrical supply, its reliability and degree of reservation. 6. The prevention measures of the heavy accident with the melt core. The decrease of the heavy accident probability. 7. The account of the heavy accident under development of the levels of protection. 8. The protection levels of NPP, the technological criteria of efficiency of the each safety barriers and the limiting radiation criteria for the each level of protection , in particular for the design-basis and beyond-design-basis accidents. 9. The measures for reduction of the heavy accident consequences. The management by the beyond

  7. Nitrogen-system safety study: Portsmouth Gaseous Diffusion Plant

    International Nuclear Information System (INIS)

    1982-07-01

    The Department of Energy has primary responsibility for the safety of operations at DOE-owned nuclear facilities. The guidelines for the analysis of credible accidents are outlined in DOE Order 5481.1. DOE has requested that existing plant facilities and operations be reviewed for potential safety problems not covered by standard industrial safety procedures. This review is being conducted by investigating individual facilities and documenting the results in Safety Study Reports which will be compiled to form the Existing Plant Final Safety Analysis Report which is scheduled for completion in September, 1984. This Safety Study documents the review of the Plant Nitrogen System facilities and operations and consists of Section 4.0, Facility and Process Description, and Section 5.0, Accident Analysis, of the Final Safety Analysis Report format. The existing nitrogen system consists of a Superior Air Products Company Type D Nitrogen Plant, nitrogen storage facilities, vaporization facilities and a distribution system. The system is designed to generate and distribute nitrogen gas used in the cascade for seal feed, buffer systems, and for servicing equipment when exceptionally low dew points are required. Gaseous nitrogen is also distributed to various process auxiliary buildings. The average usage is approximately 130,000 standard cubic feet per day

  8. Safety and economic study of special trains

    International Nuclear Information System (INIS)

    Loscutoff, W.V.; Hall, R.J.

    1976-01-01

    A comparative evaluation is being conducted of the safety and economics of special (35 mph and less) and regular trains for shipment of spent fuels. The approach, pertinent considerations, and results to date are discussed. The preliminary conclusion is that special train requirements have potential for only a small reduction in the accident likelihood, while increasing the cost

  9. On Safety Management. A Frame of Reference for Studies of Safety Management with Examples From Non-Nuclear Contexts of Relevance for Nuclear Safety

    International Nuclear Information System (INIS)

    Svensson, Ola; Salo, Ilkka; Allwin, Pernilla

    2004-11-01

    A good knowledge about safety management from risk technologies outside the area of nuclear power may contribute to both broaden the perspectives on safety management in general, and point at new opportunities for improving safety measures within the nuclear industry. First, a theoretical framework for the study of safety management in general is presented, followed by three case studies on safety management from different non-nuclear areas with potential relevance for nuclear safety. The chapters are written as separate reports and can be read independently of each other. The nuclear industry has a long experience about the management of risky activities, involving all the stages from planing to implementation, both on a more generalized level and in the specific branches of activities (management, administration, operation, maintenance, etc.). Here, safety management is a key concept related to these areas of activities. Outside the field of nuclear power there exist a number of different non-nuclear risk technologies, each one with their own specific needs and experiences about safety management. The differences between the areas consist partly of the different experiences caused by the different technologies. Besides using own experiences in safety practices within the own areas of activities, it may be profitable to take advantage in knowledge and experiences from one area and put it in practice in another area. In order to facilitate knowledge transfer from one technological area to another it may be possible to adapt a common theoretical model, for descriptions and explanations, to the different technologies. Such a model should admit that common denominators for safety management across the areas might be identified and described with common concepts. Systems theory gives the opportunity to not only create models that are descriptive for events within the limits of a given technology, but also to generate knowledge that can be transferred to other

  10. A Review and Comparative Analysis of Security Risks and Safety Measures of Mobile Health Apps

    Directory of Open Access Journals (Sweden)

    Karen Scott

    2015-11-01

    Full Text Available In line with a patient-centred model of healthcare, Mobile Health applications (mhealth apps provide convenient and equitable access to health and well-being resources and programs that can enable consumers to monitor their health related problems, understand specific medical conditions and attain personal fitness goals. This increase in access and control comes with an increase in risk and responsibility to identify and manage the associated risks, such as the privacy and security of consumers’ personal and health information. Based on a review of the literature, this paper identifies a set of risk and safety features for evaluating mHealth apps and uses those features to conduct a comparative analysis of the 20 most popular mHealth apps. The comparative analysis reveals that current mHealth apps do pose a risk to consumers. To address the safety and privacy concerns, recommendations to consumers and app developers are offered together with consideration of mHealth app future trends.

  11. Studying the Safety Impact of Autonomous Vehicles Using Simulation-Based Surrogate Safety Measures

    Directory of Open Access Journals (Sweden)

    Mark Mario Morando

    2018-01-01

    Full Text Available Autonomous vehicle (AV technology has advanced rapidly in recent years with some automated features already available in vehicles on the market. AVs are expected to reduce traffic crashes as the majority of crashes are related to driver errors, fatigue, alcohol, or drugs. However, very little research has been conducted to estimate the safety impact of AVs. This paper aims to investigate the safety impacts of AVs using a simulation-based surrogate safety measure approach. To this end, safety impacts are explored through the number of conflicts extracted from the VISSIM traffic microsimulator using the Surrogate Safety Assessment Model (SSAM. Behaviours of human-driven vehicles (HVs and AVs (level 4 automation are modelled within the VISSIM’s car-following model. The safety investigation is conducted for two case studies, that is, a signalised intersection and a roundabout, under various AV penetration rates. Results suggest that AVs improve safety significantly with high penetration rates, even when they travel with shorter headways to improve road capacity and reduce delay. For the signalised intersection, AVs reduce the number of conflicts by 20% to 65% with the AV penetration rates of between 50% and 100% (statistically significant at p<0.05. For the roundabout, the number of conflicts is reduced by 29% to 64% with the 100% AV penetration rate (statistically significant at p<0.05.

  12. Outcome and safety analysis of 3D printed patient specific pedicle screw jigs for complex spinal deformities: A comparative study.

    Science.gov (United States)

    Garg, Bhavuk; Gupta, Manish; Singh, Menaka; Kalyanasundaram, Dinesh

    2018-05-03

    ), Government of India under DBT Innovative young Biotechnologist Award. No study-specific conflicts of interest-associated biases is declared by the authors. No superior or inferior screw violation was observed in any of our patients in either group. We found significant (p=0.03) difference between 2 groups regarding perfect screw placement in favour of 3D printing. There were 13 grade 2 medial perforations in free hand group and 3 in 3D printing group. There was no grade 3 medial perforation in either group. There were 6 grade 2 lateral perforations in free hand group and 7 in 3D printing group were observed. There were 3 grade 3 lateral perforation in free hand group and 2 in 3D printing group were observed. Analysis showed a statistically significant (p-value: 0.005) medial violation in free hand group. Surgical time was significantly (p-value: 0.03) less in 3D printing group as compared to free hand group. Mean Blood loss was higher in free hand group, however it was not statistically significant (p-value: 0.3) in 3D printing group. Fluoroscopic shots required were less in number in 3D printing group in comparison to free hand group. There was no neurological deficit in any of the patient in any group. In our study, focusing on spinal deformities statistically significant higher rate of accurate screw positioning and higher number of inserted screws with 3D printing was possible due to enhanced safety particularly at apical levels. As such, spinal deformities are difficult to treat worldwide. In India, these deformities are often neglected and present at a very late and much more deformed state when their treatment becomes even more challenging. Developing these patient specific drill templates will enable an average spine surgeon to treat these patients with much ease and safety. Copyright © 2018. Published by Elsevier Inc.

  13. Contribution of operating feedback to probabilistic safety studies

    International Nuclear Information System (INIS)

    Guio, J.M. de; Lannoy, A.

    1992-03-01

    This paper presents the method used for PWR unit operation feedback analysis and its contribution to probabilistic safety studies. The targets were as follows: - use of failure data banks to assess reliability parameters, - use of event data banks to identify and quantify main system initiating events, - determination of a standard operating profile. These studies, performed in the context of nuclear power plant safety programs, prove useful not only to safety engineers but also to equipment experts, designers, operators and maintenance specialists. They constitute basic data for studies in all these areas or the departure point for new investigations. (authors). 3 figs., 3 tabs., 3 refs

  14. Safety culture in a pharmacy setting using a pharmacy survey on patient safety culture: a cross-sectional study in China.

    Science.gov (United States)

    Jia, P L; Zhang, L H; Zhang, M M; Zhang, L L; Zhang, C; Qin, S F; Li, X L; Liu, K X

    2014-06-30

    To explore the attitudes and perceptions of patient safety culture for pharmacy workers in China by using a Pharmacy Survey on Patient Safety Culture (PSOPSC), and to assess the psychometric properties of the translated Chinese language version of the PSOPSC. Cross-sectional study. Data were obtained from 20 hospital pharmacies in the southwest part of China. We performed χ(2) test to explore the differences on pharmacy staff in different hospital and qualification levels and countries towards patient safety culture. We also computed descriptive statistics, internal consistency coefficients and intersubscale correlation analysis, and then conducted an exploratory factor analysis. A test-retest was performed to assess reproducibility of the items. A total of 630 questionnaires were distributed of which 527 were responded to validly (response rate 84%). The positive response rate for each item ranged from 37% to 90%. The positive response rate on three dimensions ('Teamwork', 'Staff Training and Skills' and 'Staffing, Work Pressure and Pace') was higher than that of Agency for Healthcare Research and Quality (AHRQ) data (pculture at different hospital and qualification levels. The internal consistency of the total survey was comparatively satisfied (Cronbach's α=0.89). The results demonstrated that among the pharmacy staffs surveyed in China, there was a positive attitude towards patient safety culture in their organisations. Identifying perspectives of patient safety culture from pharmacists in different hospital and qualification levels are important, since this can help support decisions about action to improve safety culture in pharmacy settings. The Chinese translation of the PSOPSC questionnaire (V.2012) applied in our study is acceptable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  15. Criticality safety studies at VTT Energy

    International Nuclear Information System (INIS)

    Roine, T.; Anttila, M.

    1995-01-01

    At VTT Energy a compact reactor physics calculation system is applied in many kind of problems. Generation of group constants for static and dynamic core calculations, flux and dose rate calculations as well as criticality safety studies are performed basically with the same codes. In the presentation a short overview of the wide variety of criticality safety problems analyzed at VTT Energy is given. The calculation system with some illustrative examples is also described. (12 refs., 1 tab.)

  16. The efficacy and safety of diphenylcyclopropenone solutions in propylene glycol and isopropanol. A comparative study of two formulas used for the treatment of 100 patients with alopecia areata

    Directory of Open Access Journals (Sweden)

    Katarzyna Borowska

    2017-10-01

    Full Text Available Alopecia areata (AA is a T cell-mediated autoimmune disease involving hair follicles characterized by hair loss. 2,3-diphenylcyclopropenone (DCP is a topically administered drug intended for treating AA. The study investigates an efficacy and safety of DCP for the purpose of the treatment of AA. It presents a comparative study of two formulas: DCP in propylene glycol and DCP in isopropanol. While the treatment efficacy in both groups was very simmilar, the tolerance of the DCP in isopropanol was better than DCP in propylene glycol. Authors indicate the potential clinical applications of latter formula.

  17. The German nuclear power plant safety study

    International Nuclear Information System (INIS)

    1979-01-01

    With this study a new approach has been chosen, taking nuclear power plants as an example to assess and to describe the risks arising from the use of modern technology, including those hazards emanating from the rather hypothetical possibility of occurrence of very serious accidents. Following the definition of basic concepts and methods to be applied in risk assessment studied, as well as a brief account of the design and operating mode of nuclear power plants with PWRs', accidents and failures to be considered in a safety study are described. Using the course-of-event and fault tree analysis, the probability of fission product release as a consequence of failures in safety systems or of core meltdown is evaluated. Subsequently, the theoretical model for assessment of reactor accident consequences is presented, discussing such aspects as the dispersion of radioactivity in the atmosphere, the radiation dose model, safety and countermeasures, the model for the evaluation of health hazards as well as methods and calculations for estimating the reliability of risk assessments together with the remaining uncertainties. In an appendix to this study, the analyses presented in the study are discussed in the light of the TMI-2 event. This safety study showing the possibilities of detecting, keeping in check and minimizing harmful effects, can be regarded as a contribution to a better understanding of our modern, highly industrialised society, and eventually to an improvement of the quality of life. (GL) 891 GL/GL 892 MB [de

  18. On Safety Management. A Frame of Reference for Studies of Safety Management with Examples From Non-Nuclear Contexts of Relevance for Nuclear Safety

    Energy Technology Data Exchange (ETDEWEB)

    Svensson, Ola; Salo, Ilkka; Allwin, Pernilla (Risk Analysis, Social and Decision Research Unit, Dept. of Psychology, Stockholm Univ., Stockholm (Sweden))

    2004-11-15

    A good knowledge about safety management from risk technologies outside the area of nuclear power may contribute to both broaden the perspectives on safety management in general, and point at new opportunities for improving safety measures within the nuclear industry. First, a theoretical framework for the study of safety management in general is presented, followed by three case studies on safety management from different non-nuclear areas with potential relevance for nuclear safety. The chapters are written as separate reports and can be read independently of each other. The nuclear industry has a long experience about the management of risky activities, involving all the stages from planing to implementation, both on a more generalized level and in the specific branches of activities (management, administration, operation, maintenance, etc.). Here, safety management is a key concept related to these areas of activities. Outside the field of nuclear power there exist a number of different non-nuclear risk technologies, each one with their own specific needs and experiences about safety management. The differences between the areas consist partly of the different experiences caused by the different technologies. Besides using own experiences in safety practices within the own areas of activities, it may be profitable to take advantage in knowledge and experiences from one area and put it in practice in another area. In order to facilitate knowledge transfer from one technological area to another it may be possible to adapt a common theoretical model, for descriptions and explanations, to the different technologies. Such a model should admit that common denominators for safety management across the areas might be identified and described with common concepts. Systems theory gives the opportunity to not only create models that are descriptive for events within the limits of a given technology, but also to generate knowledge that can be transferred to other

  19. Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Patamaporn Rachawat

    2017-01-01

    Full Text Available Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK extract for treating primary osteoarthritis (OA of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

  20. Safety, Efficacy and Recurrence rate following tenosynovectomy and ...

    African Journals Online (AJOL)

    Objective: This study was conducted to compare the safety, efficacy and recurrence rate of primary tenosynovectomy versus intralesional steroid injection in the treatment of sclerosing tenosynovitis of deQuervain. Method: A prospective, comparative study of the safety, efficacy and recurrence rate following intralesional ...

  1. Preliminary study on improving safety culture in Malaysian nuclear industries

    International Nuclear Information System (INIS)

    Ibrahim, Sabariah Kader; Lee, Y. E.

    2012-01-01

    This paper presents preliminary study on safety culture and its implementation in Malaysian nuclear industries by realizing the importance of safety culture; identification of important safety culture attributes; safety culture assessment and the practices to incorporate the identified safety culture attributes in organization. The first section of this paper explains the terms and definitions related to safety culture. Second, for the realization of importance of safety culture in organization, the international operational experiences emphasizing the importance of safety culture are described. Third, important safety culture attributes which are frequently cited in literature are provided. Fourth, methods to assess safety culture in operating organization are described. Finally, the practices to enhance the safety culture in an organization are discussed

  2. Preliminary study on improving safety culture in Malaysian nuclear industries

    Energy Technology Data Exchange (ETDEWEB)

    Ibrahim, Sabariah Kader [KAIST, Daejeon (Korea, Republic of); Lee, Y. E. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2012-10-15

    This paper presents preliminary study on safety culture and its implementation in Malaysian nuclear industries by realizing the importance of safety culture; identification of important safety culture attributes; safety culture assessment and the practices to incorporate the identified safety culture attributes in organization. The first section of this paper explains the terms and definitions related to safety culture. Second, for the realization of importance of safety culture in organization, the international operational experiences emphasizing the importance of safety culture are described. Third, important safety culture attributes which are frequently cited in literature are provided. Fourth, methods to assess safety culture in operating organization are described. Finally, the practices to enhance the safety culture in an organization are discussed.

  3. Safety barriers and safety functions a comparison of different applications

    International Nuclear Information System (INIS)

    Harms-Ringdahl, L.

    1998-01-01

    A study is being made with the focus on different theories and applications concerning 'safety barriers' and 'safety functions'. One aim is to compare the characteristics of different kinds of safely functions, which can be purpose, efficiency, reliability, weak points etc. A further aim is to summarize how the combination of different barriers are described and evaluated. Of special interest are applications from nuclear and chemical process safety. The study is based on a literature review, interviews and discussions. Some preliminary conclusions are made. For example, it appears to exist a need for better tools to support the design and evaluation of procedures. There are a great number of theoretical models describing safety functions. However, it still appears to be an interest in further development of models, which might give the basis for improved practical tools. (author)

  4. Review of studies on criticality safety evaluation and criticality experiment methods

    International Nuclear Information System (INIS)

    Naito, Yoshitaka; Yamamoto, Toshihiro; Misawa, Tsuyoshi; Yamane, Yuichi

    2013-01-01

    Since the early 1960s, many studies on criticality safety evaluation have been conducted in Japan. Computer code systems were developed initially by employing finite difference methods, and more recently by using Monte Carlo methods. Criticality experiments have also been carried out in many laboratories in Japan as well as overseas. By effectively using these study results, the Japanese Criticality Safety Handbook was published in 1988, almost the intermediate point of the last 50 years. An increased interest has been shown in criticality safety studies, and a Working Party on Nuclear Criticality Safety (WPNCS) was set up by the Nuclear Science Committee of Organisation Economic Co-operation and Development in 1997. WPNCS has several task forces in charge of each of the International Criticality Safety Benchmark Evaluation Program (ICSBEP), Subcritical Measurement, Experimental Needs, Burn-up Credit Studies and Minimum Critical Values. Criticality safety studies in Japan have been carried out in cooperation with WPNCS. This paper describes criticality safety study activities in Japan along with the contents of the Japanese Criticality Safety Handbook and the tasks of WPNCS. (author)

  5. Comparative Analysis of Performance Measures for Network Screening: A Case Study of Brazilian Urban Areas

    Directory of Open Access Journals (Sweden)

    Vanessa Jamille Mesquita Xavier

    2017-01-01

    Full Text Available The overall effectiveness of the roadway safety management process relies on a robust method for identifying and ranking sites with major potential for safety improvements. In Brazil, guidelines for hotspot identification are usually based only on crash frequency and Crash Rate as safety performance measures. This study presents a comparative analysis of safety performance measures, considering its limitations of applicability in a sample of signalized intersections from Fortaleza city, Brazil. The performance of each measure to rank the sample intersection was obtained through the rank difference between each safety performance measure and the Excess Expected Average Crash Frequency with EB Adjustment (EEB. In addition, it has taken a temporal analysis based on the consistency of safety performance measures during subsequent time periods. The results have suggested a reasonable matching between the most comprehensive safety performance measure (EEB and very simple safety performance measures such as crash frequency and Crash Rate. It is recommended to investigate the consistency of the results for longer observation period as well as for a different jurisdiction in Brazil.

  6. On safety management and nuclear safety - A frame of reference for studies of safety management with examples from non-nuclear contects of relevance for nuclear safety

    International Nuclear Information System (INIS)

    Svenson, O.; Allwin, P.; Salo, I.

    2004-03-01

    The report includes three case studies of safety management. The studies are presented as chapters, but are written in a format that makes them easy to read separately. Two of the studies cover regulators (the Swedish Civil Aviation Safety Authority, Luftfartsinspektionen) and the Norwegian Petroleum Directorate) and one a regulated activity/industry (a car manufacturer, Volvo Car). The introduction outlines a living system framework and relates this to concepts used in organizational management. The report concludes with some findings with potential relevance for safety management in the nuclear power domain. In the next phase of the work, the regulated counterparts of the regulators here will be investigated in addition to a fourth case study of a regulated activity/industry. (au)

  7. A study of passive safety conditions for fast reactor core

    International Nuclear Information System (INIS)

    Shimizu, Akinao

    1991-01-01

    A study has been made for passive safety conditions of fast reactor cores. Objective of the study is to develop a concept of a core with passive safety as well as a simple safety philosophy. A simple safety philosophy, which is wore easy to explain to the public, is needed to enhance the public acceptance for nuclear reactors. The present paper describes a conceptual plan of the study including the definition of the problem a method of approach and identification of tasks to be solved

  8. Study of industry safety management

    International Nuclear Information System (INIS)

    Park, Pil Su

    1987-06-01

    This book deals with general remarks, industrial accidents, statistics of industrial accidents, unsafe actions, making machinery and facilities safe, safe activities, having working environment safe, survey of industrial accidents and analysis of causes, system of safety management and operations, safety management planning, safety education, human engineering such as human-machines system, system safety, and costs of disaster losses. It lastly adds individual protective equipment and working clothes including protect equipment for eyes, face, hands, arms and feet.

  9. Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS).

    Science.gov (United States)

    Ware, Mark A; Wang, Tongtong; Shapiro, Stan; Collet, Jean-Paul

    2015-12-01

    Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed. The study was registered with www.controlled-trials.com (ISRCTN19449752). This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher

  10. A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomnia.

    Science.gov (United States)

    Huang, Yu-Shu; Hsu, Shih-Chieh; Liu, Shen-Ing; Chen, Chih-Ken

    2011-01-01

    Benzodiazepines cause a high proportion of adverse effects while non-benzodiazepine compounds have demonstrated high efficacy and less adverse effects in patients with insomnia. The objective of this study was to compare the effectiveness and safety of non-BZ zaleplon and zolpidem in primary insomnia. This was a randomized, double-blind, active-controlled, double-dummy, comparative study. A total of 48 patients were enrolled, of which 45 patients completed the study. Patients who entered the study were required to take the study drug orally once daily at bedtime for two weeks. Each patient kept a sleep diary and answered a questionnaire. We used these documents to measure and evaluate changes from baseline to Week 2 in sleep latency, duration and quality of sleep, the number of awakenings and incidence of rebound insomnia. The data revealed a significant decrease in sleep latency from baseline to Week 2 for patients receiving zaleplon 10 mg and zolpidem 10 mg. Patients receiving zaleplon exhibited a marginally greater, but not statistically significant, reduction in sleep latency than those who received zolpidem. There was no significant difference in the frequency of adverse effects between the zaleplon and zolpidem groups; however, during this clinical trial there was one lethal event caused by a traffic accident in the zaleplon group. There was no significant difference between zaleplon and zolpidem in the efficacy of reducing sleep latency or adverse effects. A large pharmacovigilance study is needed before concluding that either zolpidem or zaleplon is free from next-day residual effects.

  11. Safety Culture Enhancement Project. Final Report. A Field Study on Approaches to Enhancement of Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Lowe, Andrew; Hayward, Brent (Dedale Asia Pacific, Albert Park VIC 3206 (Australia))

    2006-08-15

    This report documents a study with the objective of enhancing safety culture in the Swedish nuclear power industry. A primary objective of this study was to ensure that the latest thinking on human factors principles was being recognised and applied by nuclear power operators as a means of ensuring optimal safety performance. The initial phase of the project was conducted as a pilot study, involving the senior management group at one Swedish nuclear power-producing site. The pilot study enabled the project methodology to be validated after which it was repeated at other Swedish nuclear power industry sites, providing a broad-ranging analysis of opportunities across the industry to enhance safety culture. The introduction to this report contains an overview of safety culture, explains the background to the project and sets out the project rationale and objectives. The methodology used for understanding and analysing the important safety culture issues at each nuclear power site is then described. This section begins with a summary of the processes used in the information gathering and data analysis stage. The six components of the Management Workshops conducted at each site are then described. These workshops used a series of presentations, interactive events and group exercises to: (a) provide feedback to site managers on the safety culture and safety leadership issues identified at their site, and (b) stimulate further safety thinking and provide 'take-away' information and leadership strategies that could be applied to promote safety culture improvements. Section 3, project Findings, contains the main observations and output from the project. These include: - a brief overview of aspects of the local industry operating context that impinge on safety culture; - a summary of strengths or positive attributes observed within the safety culture of the Swedish nuclear industry; - a set of identified opportunities for further improvement; - the aggregated

  12. Comparing the Affordable Care Act's Financial Impact on Safety-Net Hospitals in States That Expanded Medicaid and Those That Did Not.

    Science.gov (United States)

    Dobson, Allen; DaVanzo, Joan E; Haught, Randy; Phap-Hoa, Luu

    2017-11-01

    Safety-net hospitals play a vital role in delivering health care to Medicaid enrollees, the uninsured, and other vulnerable patients. By reducing the number of uninsured Americans, the Affordable Care Act (ACA) was also expected to lower these hospitals’ significant uncompensated care costs and shore up their financial stability. To examine how the ACA’s Medicaid expansion affected the financial status of safety-net hospitals in states that expanded Medicaid and in states that did not. Using Medicare hospital cost reports for federal fiscal years 2012 and 2015, the authors compared changes in Medicaid inpatient days as a percentage of total inpatient days, Medicaid revenues as a percentage of total net patient revenues, uncompensated care costs as a percentage of total operating costs, and hospital operating margins. Medicaid expansion had a significant, favorable financial impact on safety-net hospitals. From 2012 to 2015, safety-net hospitals in expansion states, compared to those in nonexpansion states, experienced larger increases in Medicaid inpatient days and Medicaid revenues as well as reduced uncompensated care costs. These changes improved operating margins for safety-net hospitals in expansion states. Margins for safety-net hospitals in nonexpansion states, meanwhile, declined.

  13. Study on the Safety Classification Criteria of Mechanical Systems and Components for Open Pool-Type Research Reactors

    International Nuclear Information System (INIS)

    Belal, Al Momani; Jo, Jong Chull

    2013-01-01

    This paper describes a new compromised safety classification approach based on the comparative study of the different practices in safety classification of mechanical systems and components of open pool-type RRs, which have been adopted by several developed countries in the nuclear power area. It is hoped that the proposed safety classification criteria will be used to develop a harmonized consensus international standard. Different safety classification criteria for systems, structures, and components (SSCs) of nuclear reactors are used among the countries that export or import nuclear reactor technology, which may make the nuclear technology trade and exchange difficult. Thus, such various different approaches of safety classification need to be compromised to establish a global standard. This article proposes practicable optimized criteria for safety classification of SSCs for open pool-type research reactors (RRs)

  14. Study on the Safety Classification Criteria of Mechanical Systems and Components for Open Pool-Type Research Reactors

    Energy Technology Data Exchange (ETDEWEB)

    Belal, Al Momani [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Jo, Jong Chull [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    This paper describes a new compromised safety classification approach based on the comparative study of the different practices in safety classification of mechanical systems and components of open pool-type RRs, which have been adopted by several developed countries in the nuclear power area. It is hoped that the proposed safety classification criteria will be used to develop a harmonized consensus international standard. Different safety classification criteria for systems, structures, and components (SSCs) of nuclear reactors are used among the countries that export or import nuclear reactor technology, which may make the nuclear technology trade and exchange difficult. Thus, such various different approaches of safety classification need to be compromised to establish a global standard. This article proposes practicable optimized criteria for safety classification of SSCs for open pool-type research reactors (RRs)

  15. Bioequivalence study of two losartan tablet formulations with special emphasis on cardiac safety.

    Science.gov (United States)

    Khandave, Suhas S; Sawant, Satish V; Sahane, Rakhi V; Murthi, Vivekanand; Dhanure, Shivanand S; Surve, Pradeep G

    2012-05-01

    To study the bioequivalence of Losartan Potassium Tablets 50 mg manufactured by Micro Labs Ltd. India to Cozaar® Tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in normal healthy adult subjects under fasting condition along with the comparative safety evaluation of both treatments. The in vitro dissolution studies were carried out on 12 units each of test and reference products using the paddle method and dissolution media like water, 0.1 N hydrochloric acid with pH 1.2, pH 4.5 acetate buffer and pH 6.8 phosphate buffer. An open label, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study with a washout period of 7 days was conducted in 60 healthy Indian male subjects. Serial blood samples were collected after drug administration in each study period. Plasma concentrations of losartan and losartan acid were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of losartan and losartan acid were determined using a non compartmental model. Occurrence of adverse events, change in systolic blood pressure, diastolic blood pressure, heart rate and QT interval from the baseline to 3.50 h post dose were studied and compared between the two treatments as safety parameters. The in vitro study proved the essential similarity of both the formulations as evident from the similarity factor of > 50% in all the dissolution media. The ratios for geometric least square means and 90% confidence intervals were within the acceptance criteria of 80% to 125% for log transformed C(max), AUC(0-t) and AUC(0-∞) for losartan. No statistically significant difference between the two treatments was observed for either of the safety parameters. The test product Losartan Potassium tablets 50 mg manufactured by Micro Labs Limited, India was bioequivalent to Cozaar® tablets 50 mg, manufactured by Merck Sharp and Dohme Ltd., UK in terms of rate and extent of absorption. Both treatments were well tolerated and had similar non

  16. Efficacy and safety of the partial PPARγ agonist balaglitazone compared with pioglitazone and placebo: A phase III, randomised, parallel-group study in patients with type 2 diabetes on stable insulin therapy

    DEFF Research Database (Denmark)

    Henriksen, Kim; Byrjalsen, Inger; Qvist, Per

    2011-01-01

    Treatment of patients with full PPARγ agonists is associated with weight gain, heart failure, peripheral oedema and bone loss. However, the safety of partial PPARγ agonists has not been established in a clinical trial. The BALLET trial aimed to establish the glucose-lowering effects and safety...... in all treatment arms. DXA analyses showed balaglitazone 10mg led to less fat and fluid accumulation and no change in bone mineral density, when compared to pioglitazone. In the balaglitazone 10mg treated group clinically relevant reductions in HbA(1c) and glucose levels were observed, although...... it appeared to be a little less potent that pioglitazone 45mg. On the other hand significantly less fluid and fat accumulation were observed, highlighting this treatment regimen for further studies....

  17. Patient safety event reporting in critical care: a study of three intensive care units.

    Science.gov (United States)

    Harris, Carolyn B; Krauss, Melissa J; Coopersmith, Craig M; Avidan, Michael; Nast, Patricia A; Kollef, Marin H; Dunagan, W Claiborne; Fraser, Victoria J

    2007-04-01

    To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Prospective, single-center, interventional study. A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Adult patients admitted to these three study ICUs. Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79-2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These differences may reveal

  18. Probabilistic studies for a safety assurance program

    International Nuclear Information System (INIS)

    Iyer, S.S.; Davis, J.F.

    1985-01-01

    The adequate supply of energy is always a matter of concern for any country. Nuclear power has played, and will continue to play an important role in supplying this energy. However, safety in nuclear power production is a fundamental prerequisite in fulfilling this role. This paper outlines a program to ensure safe operation of a nuclear power plant utilizing the Probabilistic Safety Studies

  19. Activities on safety culture study. Study status in public and private sectors

    International Nuclear Information System (INIS)

    Makino, Maomi; Takano, Kenichi

    2004-01-01

    Around after entering in the 21st century, organizational accidents had occurred in Japan at various industries including nuclear industry, which were caused directly by unsafe action, human error and illegal conduct of personnel but there were problems in safety culture of organization such as slow retreat of safety system stimulated by management, schedule control and procedure management becoming a dead letter, lack of safety education, and workplace climate of schedule priority. This article referred to organizational factors common to many severe accidents and introduced safety culture study in public and private sectors to overcome those factors. Safety Culture Evaluation Support Tool (SCEST) was developed for self-evaluation of safety culture of organization as well as Organizational Reliability model (OR model) for analysis of initiation and propagation process of risk event. Safety diagnosis system and feedback type risk assessment system for promoting safe organizational climate and culture were also developed. (T. Tanaka)

  20. Changes in patient safety culture after restructuring of intensive care units: Two cross-sectional studies.

    Science.gov (United States)

    Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

    2016-02-01

    Compare changes in registered nurses' perception of the patient safety culture in restructured and not restructured intensive care units during a four-year period. Two cross-sectional surveys were performed, in 2008/2009 (time 1) and 2012/2013 (time 2). During a period of 0-3 years after time 1, three of six hospitals merged their general and medical intensive care units (restructured). The other hospitals maintained their structure of the intensive care units (not restructured). Intensive care units in hospitals at one Norwegian hospital trust. The safety culture was measured with Hospital Survey on Patient Safety Culture. At times 1 and 2, 217/302 (72%) and 145/289 (50%) registered nurses participated. Restructuring was negatively associated with change in the safety culture, in particular, the dimensions of the safety culture within the unit level. The dimensions most vulnerable for restructuring were manager expectations and actions promoting safety, teamwork within hospital units and staffing. In this study, the restructuring of intensive care units was associated with a negative impact on the safety culture. When restructuring, the management should be particularly aware of changes in the safety culture dimensions manager expectations and actions promoting safety, teamwork within hospital units and staffing. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    OpenAIRE

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-01

    Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

  2. How Agencies Inspect. A Comparative Study of Inspection Policies in Eight Swedish Government Agencies

    International Nuclear Information System (INIS)

    Lindblom, Lars; Clausen, Jonas; Edvardsson, Karin; Hayenhielm, Madeleine; Hermansson, Helene; Nihlen, Jessica; Palm, Elin; Ruden, Christina; Wikman, Per; Hansson, Sven Ove

    2003-04-01

    Eight Swedish authorities with inspection tasks in the areas of health, safety, and environmental protection have been compared, namely the authorities responsible for nuclear safety, radiation protection, railway, marine and aviation safety, environmental protection, chemicals control, and health and safety on workplaces. Significant differences in inspection policies and practices between the authorities were found, such as: diverging definitions of supervision and inspection that complicate comparisons, different priority-setting principles for inspections, variations in inspection frequencies (between 13 and 0.03 inspections per company and year), different practices with respect to notifying companies before inspection visits, and in particular, large differences in the extent to which non-compliance with regulations is reported to legal authorities. It was concluded that these agencies have much to gain from increasing their cooperation in methods development, evaluation studies, and education of inspectors

  3. Safety Culture Enhancement Project. Final Report. A Field Study on Approaches to Enhancement of Safety Culture

    International Nuclear Information System (INIS)

    Lowe, Andrew; Hayward, Brent

    2006-08-01

    This report documents a study with the objective of enhancing safety culture in the Swedish nuclear power industry. A primary objective of this study was to ensure that the latest thinking on human factors principles was being recognised and applied by nuclear power operators as a means of ensuring optimal safety performance. The initial phase of the project was conducted as a pilot study, involving the senior management group at one Swedish nuclear power-producing site. The pilot study enabled the project methodology to be validated after which it was repeated at other Swedish nuclear power industry sites, providing a broad-ranging analysis of opportunities across the industry to enhance safety culture. The introduction to this report contains an overview of safety culture, explains the background to the project and sets out the project rationale and objectives. The methodology used for understanding and analysing the important safety culture issues at each nuclear power site is then described. This section begins with a summary of the processes used in the information gathering and data analysis stage. The six components of the Management Workshops conducted at each site are then described. These workshops used a series of presentations, interactive events and group exercises to: (a) provide feedback to site managers on the safety culture and safety leadership issues identified at their site, and (b) stimulate further safety thinking and provide 'take-away' information and leadership strategies that could be applied to promote safety culture improvements. Section 3, project Findings, contains the main observations and output from the project. These include: - a brief overview of aspects of the local industry operating context that impinge on safety culture; - a summary of strengths or positive attributes observed within the safety culture of the Swedish nuclear industry; - a set of identified opportunities for further improvement; - the aggregated results of the

  4. Nanotechnology Safety Self-Study

    Energy Technology Data Exchange (ETDEWEB)

    Grogin, Phillip W. [Los Alamos National Laboratory

    2016-03-29

    Nanoparticles are near-atomic scale structures between 1 and 100 nanometers (one billionth of a meter). Engineered nanoparticles are intentionally created and are used in research and development at Sandia National Laboratories (SNL) and Los Alamos National Laboratory (LANL). This course, Nanotechnology Safety Self-Study, presents an overview of the hazards, controls, and uncertainties associated with the use of unbound engineered nanoscale particles (UNP) in a laboratory environment.

  5. Raised crosswalks on entrance to the roundabout-a case study on effectiveness of treatment on pedestrian safety and convenience.

    Science.gov (United States)

    Candappa, Nimmi; Stephan, Karen; Fotheringham, Nicola; Lenné, Michael G; Corben, Bruce

    2014-01-01

    A common concern in the use of a roundabout is providing adequately for the pedestrian. This unique roundabout layout, which introduces raised crosswalks directly at the roundabout entrance, as opposed to at a car length back, aims at improving safety and convenience for pedestrians at roundabouts. A preliminary evaluation of the layout was undertaken to establish its effectiveness in meeting study objectives. A quasi-experimental before-and-after study design was used to compare speeds on approach and immediately prior to the crossing to ascertain potential impact speed and implications for pedestrian safety. Compliance to crossing and crossing time were also compared in relation to safety and convenience outcomes. A questionnaire assessed pedestrian perception of the safety and convenience at the roundabout before and after treatment. Results from this case study indicate that mean approach speeds (free speeds 30 m from crossing) reduced from 32.7 to 30.7 km/h and immediately prior to crossing, mean speeds reduced from 19.1 to 16.3 km/h. There was also a marked reduction in proportions of vehicles traveling at speeds that could elevate risk to pedestrians. Total crossing time after treatment reduced by around 4 s, and crossing compliance increased from approximately half to approximately 90 percent. Survey of pedestrians indicated positive response to the perceived safety and convenience posttreatment. Preliminary results of the case study suggest positive safety and convenience outcomes. Implications for pedestrian safety include less exposure to traffic and lower risk of serious injury, particularly for elderly pedestrians; convenience outcomes include shorter waiting times to cross and greater compliance to the crossing. A larger study is required to substantiate the findings.

  6. 78 FR 64504 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2013-10-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH or..., Number 177, Pages 56235-56236. Contact Person for More Information: Price Connor, Ph.D., NIOSH Health...

  7. Canadian Consumer Food Safety Practices and Knowledge: Foodbook Study.

    Science.gov (United States)

    Murray, Regan; Glass-Kaastra, Shiona; Gardhouse, Christine; Marshall, Barbara; Ciampa, Nadia; Franklin, Kristyn; Hurst, Matt; Thomas, M Kate; Nesbitt, Andrea

    2017-10-01

    Understanding consumers' food safety practices and knowledge supports food safety education for the prevention of foodborne illness. The objective of this study was to describe Canadian consumer food safety practices and knowledge. This study identifies demographic groups for targeted food safety education messaging and establishes a baseline measurement to assess the effectiveness of food safety interventions over time. Questions regarding consumer food safety practices and knowledge were included in a population-based telephone survey, Foodbook, conducted from November 2014 to March 2015. The results were analyzed nationally by age group and by gender. The results showed that approximately 90% of Canadians reported taking the recommended cleaning and separating precautions when handling raw meat to prevent foodborne illness. Only 29% of respondents reported using a food thermometer when cooking any meat, and even fewer (12%) reported using a food thermometer for small cuts of meat such as chicken pieces. The majority (>80%) of Canadians were aware of the foodborne illness risks related to chicken and hamburger, but fewer (poultry.

  8. Flammable Gas Safety Self-Study 52827

    Energy Technology Data Exchange (ETDEWEB)

    Glass, George [Los Alamos National Laboratory

    2016-03-17

    This course, Flammable Gas Safety Self-Study (COURSE 52827), presents an overview of the hazards and controls associated with commonly used, compressed flammable gases at Los Alamos National Laboratory (LANL).

  9. A Phase 1, open-label, multicentre study to compare the capsule and tablet formulations of AZD5363 and explore the effect of food on the pharmacokinetic exposure, safety and tolerability of AZD5363 in patients with advanced solid malignancies: OAK.

    Science.gov (United States)

    Dean, Emma; Banerji, Udai; Schellens, Jan H M; Krebs, Matthew G; Jimenez, Begona; van Brummelen, Emilie; Bailey, Chris; Casson, Ed; Cripps, Diana; Cullberg, Marie; Evans, Stephen; Foxley, Andrew; Lindemann, Justin; Rugman, Paul; Taylor, Nigel; Turner, Guy; Yates, James; Lawrence, Peter

    2018-05-01

    AZD5363 is a potent pan-AKT inhibitor originally formulated as a capsule; a tablet was developed for patient convenience and manufacturing ease. This study assessed the PK comparability of both formulations (Part A) and the effect of food (Part B) on the PK/safety of the tablet. Adults with advanced solid tumours received AZD5363 480 mg bid in a partially fasted state by tablet (Week 1) and capsule (Week 2) in a '4-days-on/3-days-off' schedule (Part A). PK parameters were evaluated using pre-defined 90% CIs for AUCτ and C max ratios of 0.75-1.33 to assess comparability. In Part B, AZD5363 tablet was given to a new cohort of patients under the same conditions as Part A, except on the morning of PK assessment days, when it was administered after an overnight fast (Week 1) and standard meal (Week 2). In evaluable patients (N = 11), the geometric least-squares mean ratios (tablet:capsule) for AUCτ and C max were 0.90 (0.77-1.06) and 1.02 (0.86-1.20), respectively, demonstrating comparable PK in the partially fasted state. Tablet and capsule safety data were also comparable. Tablet PK profiles indicated later t max and lower C max after food versus overnight fast. Fed and fasted AUCτ and C max ratios were 0.89 (0.76-1.05) and 0.67 (0.55-0.82), respectively (N = 9). The safety/tolerability profile of the tablet was comparable between fed and fasted states. PK and safety/tolerability of AZD5363 tablet and capsule were comparable. Food did not affect the bioavailability of AZD5363, but reduced the absorption rate without discernibly affecting safety/tolerability.

  10. Modeling the Relationship between Safety Climate and Safety Performance in a Developing Construction Industry: A Cross-Cultural Validation Study.

    Science.gov (United States)

    Zahoor, Hafiz; Chan, Albert P C; Utama, Wahyudi P; Gao, Ran; Zafar, Irfan

    2017-03-28

    This study attempts to validate a safety performance (SP) measurement model in the cross-cultural setting of a developing country. In addition, it highlights the variations in investigating the relationship between safety climate (SC) factors and SP indicators. The data were collected from forty under-construction multi-storey building projects in Pakistan. Based on the results of exploratory factor analysis, a SP measurement model was hypothesized. It was tested and validated by conducting confirmatory factor analysis on calibration and validation sub-samples respectively. The study confirmed the significant positive impact of SC on safety compliance and safety participation , and negative impact on number of self-reported accidents/injuries . However, number of near-misses could not be retained in the final SP model because it attained a lower standardized path coefficient value. Moreover, instead of safety participation , safety compliance established a stronger impact on SP. The study uncovered safety enforcement and promotion as a novel SC factor, whereas safety rules and work practices was identified as the most neglected factor. The study contributed to the body of knowledge by unveiling the deviations in existing dimensions of SC and SP. The refined model is expected to concisely measure the SP in the Pakistani construction industry, however, caution must be exercised while generalizing the study results to other developing countries.

  11. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection.

    Science.gov (United States)

    Seto, Wai-Kay; Asahina, Yasuhiro; Brown, Todd T; Peng, Cheng-Yuan; Stanciu, Carol; Abdurakhmanov, Dzhamal; Tabak, Fehmi; Nguyen, Tuan T; Chuang, Wan-Long; Inokuma, Tetsuro; Ikeda, Fusao; Santantonio, Teresa Antonia; Habersetzer, François; Ramji, Alnoor; Lau, Audrey H; Suri, Vithika; Flaherty, John F; Wang, Hongyuan; Gaggar, Anuj; Subramanian, G Mani; Mukewar, Shrikant; Brunetto, Maurizia R; Fung, Scott; Chan, Henry Lik-Yuen

    2018-06-19

    Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). Tenofovir alafenamide (TAF), a new prodrug of tenofovir, has shown non-inferior efficacy to TDF in patients with chronic hepatitis B virus (HBV) infection, with improved bone effects at 48 weeks. We performed a randomized trial to evaluate the bone safety of TAF compared with TDF over 2 years, assessing baseline risk factors for bone loss, were evaluated after 2 years of treatment. In a double-blind study, hepatitis B e antigen (HBeAg)-positive patients (n=873) and HBeAg-negative patients (n=425) were randomly assigned (2:1) to groups given TAF (25 mg, n=866) or TDF (300 mg, n=432) once daily. We assessed bone safety, including hip and spine BMD, using dual-energy X-ray absorptiometry and measured changes in serum markers of bone turnover over 96 weeks. At baseline, treatment groups were well matched. At week 96, patients receiving TAF had significantly smaller decreases in hip BMD (mean reduction of 0.33%) than patients receiving TDF (mean reduction of 2.51%) (PTAF vs reduction of 2.57% in patients receiving TDF) (PTAF and TDF groups increased at week 96 compared to week 48 (PTAF group had minimal changes in markers of bone turnover by 12 weeks of treatment, but the TDF group had significant changes, compared to baseline. Risk factors for bone loss had fewer effects in patients receiving TAF than TDF at week 96. In double-blind randomized trials, we found that after 2 years of treatment, patients receiving TAF had continued improvements in bone safety compared with patients receiving TDF. Clinicaltrial.gov no: NCT01940471 and NCT01940341. Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

  12. Is culture associated with patient safety in the emergency department? A study of staff perspectives.

    NARCIS (Netherlands)

    Verbeek-van Noord, I.; Wagner, C.; Dyck, C. van; Twisk, J.W.R.; Bruijne, M.C. de

    2014-01-01

    Objective: To describe the patient safety culture of Dutch emergency departments (EDs), to examine associations between safety culture dimensions and patient safety grades as reported by ED staff and to compare these associations between nurses and physicians. DESIGN: Cross-sectional survey

  13. Case study: the Argentina Road Safety Project: lessons learned for the decade of action for road safety, 2011-2020.

    Science.gov (United States)

    Raffo, Veronica; Bliss, Tony; Shotten, Marc; Sleet, David; Blanchard, Claire

    2013-12-01

    This case study of the Argentina Road Safety Project demonstrates how the application of World Bank road safety project guidelines focused on institution building can accelerate knowledge transfer, scale up investment and improve the focus on results. The case study highlights road safety as a development priority and outlines World Bank initiatives addressing the implementation of the World Report on Road Traffic Injury's recommendations and the subsequent launch of the Decade of Action for Road Safety, from 2011-2020. The case study emphasizes the vital role played by the lead agency in ensuring sustainable road safety improvements and promoting the shift to a 'Safe System' approach, which necessitated the strengthening of all elements of the road safety management system. It summarizes road safety performance and institutional initiatives in Argentina leading up to the preparation and implementation of the project. We describe the project's development objectives, financing arrangements, specific components and investment staging. Finally, we discuss its innovative features and lessons learned, and present a set of supplementary guidelines, both to assist multilateral development banks and their clients with future road safety initiatives, and to encourage better linkages between the health and transportation sectors supporting them.

  14. Safety analysis and related studies

    International Nuclear Information System (INIS)

    Lelievre, J.

    1979-12-01

    Several examples of reactor safety studies are given. For light water reactors, the consequences of loss of coolant, the disposition of the fuel elements and the behaviour under irradiation of the steels used for containment are described. For fast reactors, the disposition of fuel elements in the case of cooling accidents and sodium fies are described. Examples given of studies not specific to a particular reactor type include studies of non-destructive testing and those of reliability

  15. Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study

    Directory of Open Access Journals (Sweden)

    Masayoshi Zaitsu

    2011-01-01

    Full Text Available Objectives. Overactive bladder (OAB is a chronic disease, but comparative trials of anticholinergics, which are commonly used for treatment of OAB, have generally been performed for up to 12 weeks only. There is no comparative study of a long-term intervention. Methods. We conducted a 52-week prospective randomized comparative study to evaluate the efficacy and tolerability of two anticholinergics. Results. Forty-one Japanese patients with untreated OAB were randomly assigned to imidafenacin and solifenacin groups. There was no difference in OABSS and KHQ scores between the two groups, but the severity and incidence of adverse events caused by the anticholinergics showed increased differences between the groups with time. The severity of dry mouth and the incidence of constipation were significantly lower in the imidafenacin group (=0.0092 and =0.0013, resp.. Conclusions. This study is the first long-term trial to show differences in the properties of anticholinergics that were not detected in short-term studies. Since OAB is a chronic disease, we conclude that imidafenacin is preferable to solifenacin from a perspective of safety.

  16. The advanced neutron source facility: Safety philosophy and studies

    International Nuclear Information System (INIS)

    Greene, S.R.; Harrington, R.M.

    1988-01-01

    The Advanced Neutron Source (ANS) is currently the only new civilian nuclear reactor facility proposed for construction in the United States. Even though the thermal power of this research-oriented reactor is a relatively low 300 MW, the design will undoubtedly receive intense scrutiny before construction is allowed to proceed. Safety studies are already under way to ensure that the maximum degree of safety in incorporated into the design and that the design is acceptable to the Department of Energy (DOE) and can meet the Nuclear Regulatory Commission regulations. This document discusses these safety studies

  17. Patient safety: Safety culture and patient safety ethics

    DEFF Research Database (Denmark)

    Madsen, Marlene Dyrløv

    2006-01-01

    ,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...

  18. Adaptation of the ToxRTool to Assess the Reliability of Toxicology Studies Conducted with Genetically Modified Crops and Implications for Future Safety Testing.

    Science.gov (United States)

    Koch, Michael S; DeSesso, John M; Williams, Amy Lavin; Michalek, Suzanne; Hammond, Bruce

    2016-01-01

    To determine the reliability of food safety studies carried out in rodents with genetically modified (GM) crops, a Food Safety Study Reliability Tool (FSSRTool) was adapted from the European Centre for the Validation of Alternative Methods' (ECVAM) ToxRTool. Reliability was defined as the inherent quality of the study with regard to use of standardized testing methodology, full documentation of experimental procedures and results, and the plausibility of the findings. Codex guidelines for GM crop safety evaluations indicate toxicology studies are not needed when comparability of the GM crop to its conventional counterpart has been demonstrated. This guidance notwithstanding, animal feeding studies have routinely been conducted with GM crops, but their conclusions on safety are not always consistent. To accurately evaluate potential risks from GM crops, risk assessors need clearly interpretable results from reliable studies. The development of the FSSRTool, which provides the user with a means of assessing the reliability of a toxicology study to inform risk assessment, is discussed. Its application to the body of literature on GM crop food safety studies demonstrates that reliable studies report no toxicologically relevant differences between rodents fed GM crops or their non-GM comparators.

  19. Alternative perspectives of safety in home delivered health care: a sequential exploratory mixed method study.

    Science.gov (United States)

    Jones, Sarahjane

    2016-10-01

    The aim of this study was to discover and describe how patients, carers and case management nurses define safety and compare it to the traditional risk reduction and harm avoidance definition of safety. Care services are increasingly being delivered in the home for patients with complex long-term conditions. However, the concept of safety remains largely unexplored. A sequential, exploratory mixed method design. A qualitative case study of the UK National Health Service case management programme in the English UK National Health Service was deployed during 2012. Thirteen interviews were conducted with patients (n = 9) and carers (n = 6) and three focus groups with nurses (n = 17) from three community care providers. The qualitative element explored the definition of safety. Data were subjected to framework analysis and themes were identified by participant group. Sequentially, a cross-sectional survey was conducted during 2013 in a fourth community care provider (patient n = 35, carer n = 19, nurse n = 26) as a form of triangulation. Patients and carers describe safety differently to case management nurses, choosing to focus on meeting needs. They use more positive language and recognize the role they have in safety in home-delivered health care. In comparison, case management nurses described safety similarly to the definitions found in the literature. However, when offered the patient and carer definition of safety, they preferentially selected this definition to their own or the literature definition. Patients and carers offer an alternative perspective on patient safety in home-delivered health care that identifies their role in ensuring safety and is more closely aligned with the empowerment philosophy of case management. © 2016 John Wiley & Sons Ltd.

  20. Discussion on the safety classification of nuclear safety mechanical equipment

    International Nuclear Information System (INIS)

    Shen Wei

    2010-01-01

    The purpose and definition of the equipment safety classification in nuclear plant are introduced. The differences of several safety classification criterions are compared, and the object of safety classification is determined. According to the regulation, the definition and category of the safety functions are represented. The safety classification method, safety classification process, safety class interface, and the requirement for the safety class mechanical equipment are explored. At last, the relation of the safety classification between the mechanical and electrical equipment is presented, and the relation of the safety classification between mechanical equipment and system is also presented. (author)

  1. Preliminary Study on the Revision of Nuclear Safety Policy Statement

    International Nuclear Information System (INIS)

    Lee, Y. E.; Lee, S. H.; Chang, H. S.; Choi, K. S.; Jung, S. J.

    2011-01-01

    Nuclear safety policy in Korea is currently declared in the Nuclear Safety Charter as the highest tier document and safety principles and directions are announced in the Nuclear Safety Policy Statement. As the circumstances affecting on the nuclear safety policy change, it needs to revise the Statement. This study aims to develop the revised Nuclear Safety Policy Statement to declare that securing safety is a prerequisite to the utilization of nuclear energy, and that all workers in nuclear industry and regulatory body must adhere to the principle of priority to safety. As a result, two different types of revision are being prepared as of August. One is based on the spirit of Nuclear Safety Charter as well as the direction of future-oriented safety policies including the changes in the environment after declaration of the Statement. The other is to declare the fundamental safety objective and safety principles as the top philosophy of national nuclear safety policy by adopting the '10 Safety Principles in IAEA Safety Fundamental' instead of the current Charter. Both versions of revision are subject to further in-depth discussion. However once the revision is finalized and declared, it would be useful to accomplish effectively the organizational responsibilities and to enhance the public confidence in nuclear safety by performing the regulatory activities in a planned and systematic manner and promulgating the government's dedication to priority to safety

  2. Variability of patient safety culture in Belgian acute hospitals.

    Science.gov (United States)

    Vlayen, Annemie; Schrooten, Ward; Wami, Welcome; Aerts, Marc; Barrado, Leandro Garcia; Claes, Neree; Hellings, Johan

    2015-06-01

    The aim of this study was to measure differences in safety culture perceptions within Belgian acute hospitals and to examine variability based on language, work area, staff position, and work experience. The Hospital Survey on Patient Safety Culture was distributed to hospitals participating in the national quality and safety program (2007-2009). Hospitals were invited to participate in a comparative study. Data of 47,136 respondents from 89 acute hospitals were used for quantitative analysis. Percentages of positive response were calculated on 12 dimensions. Generalized estimating equations models were fitted to explore differences in safety culture. Handoffs and transitions, staffing, and management support for patient safety were considered as major problem areas. Dutch-speaking hospitals had higher odds of positive perceptions for most dimensions in comparison with French-speaking hospitals. Safety culture scores were more positive for respondents working in pediatrics, psychiatry, and rehabilitation compared with the emergency department, operating theater, and multiple hospital units. We found an important gap in safety culture perceptions between leaders and assistants within disciplines. Administration and middle management had lower perceptions toward patient safety. Respondents working less than 1 year in the current hospital had more positive safety culture perceptions in comparison with all other respondents. Large comparative databases provide the opportunity to identify distinct high and low scoring groups. In our study, language, work area, and profession were identified as important safety culture predictors. Years of experience in the hospital had only a small effect on safety culture perceptions.

  3. Progress in the development of methodology for fusion safety systems studies

    International Nuclear Information System (INIS)

    Ho, S.K.; Cambi, G.; Ciattaglia, S.; Fujii-e, Y.; Seki, Y.

    1994-01-01

    The development of fusion safety systems-study methodology, including the aspects of schematic classification of overall fusion safety system, qualitative assessment of fusion system for identification of critical accident scenarios, quantitative analysis of accident consequences and risk for safety design evaluation, and system-level analysis of accident consequences and risk for design optimization, by a consortium of international efforts is presented. The potential application of this methodology into reactor design studies will facilitate the systematic assessment of safety performance of reactor designs and enhance the impacts of safety considerations on the selection of design configurations

  4. Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

    Energy Technology Data Exchange (ETDEWEB)

    Deray, Gilbert [Pitie Salpetriere Hospital, Department of Nephrology, Paris cedex 13 (France); Rouviere, Olivier [Hopital E. Herriot, Universite de Lyon, Hospices Civils de Lyon, Department of Urinary and Vascular Imaging, Lyon (France); Universite Lyon 1, faculte de medecine Lyon Est, Lyon (France); Bacigalupo, Lorenzo [E.O. Ospedali Galliera, Radiology Department, Genova (Italy); Maes, Bart [Heilig Hartziekenhuis Roeselare, Department of Nephrology, Roeselare (Belgium); Hannedouche, Thierry [University Hospitals, Department of Nephrology, Strasbourg (France); Vrtovsnik, Francois [Bichat Hospital, Department of Nephrology, Paris (France); Rigothier, Claire [Pellegrin Hospital, Department of Nephrology Transplantation Dialysis, Bordeaux (France); Billiouw, Jean-Marie [Onze Lieve Vrouw Ziekenhuis, Department of Nephrology, Aalst (Belgium); Campioni, Paolo [Azienda Ospedaliero-Universitaria Sant' Anna, Ferrara (Italy); Ferreiros, Joaquin [Hospital Clinico de San Carlos, Servicio de Radiodiagnostico, Madrid (Spain); Devos, Daniel [Gent University Hospital, Department of Radiology, Gent (Belgium); Alison, Daniel [Trousseau Hospital, Department of Radiology, Tours (France); Glowacki, Francois [University Hospitals, Department of Nephrology, Lille (France); Boffa, Jean-Jacques [Tenon Hospital, Department of Nephrology and Dialysis, Paris (France); Marti-Bonmati, Luis [University of Valencia, Department of Radiology, Valencia (Spain)

    2013-05-15

    To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 {+-} 24 h after the MRI procedure, by at least 25 % or 44.2 {mu}mol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 {+-} 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up. Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [{Delta} = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted. Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD. (orig.)

  5. Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study)

    International Nuclear Information System (INIS)

    Deray, Gilbert; Rouviere, Olivier; Bacigalupo, Lorenzo; Maes, Bart; Hannedouche, Thierry; Vrtovsnik, Francois; Rigothier, Claire; Billiouw, Jean-Marie; Campioni, Paolo; Ferreiros, Joaquin; Devos, Daniel; Alison, Daniel; Glowacki, Francois; Boffa, Jean-Jacques; Marti-Bonmati, Luis

    2013-01-01

    To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients. Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h after MRI and the percentage of patients with a decrease in eGFR of at least 25 % from baseline. Patients were screened for signs of nephrogenic systemic fibrosis (NSF) at 3-month follow-up. Among the 114 evaluable patients, one (1.4 %) in the Gd-DOTA-MRI group and none in the control group met the criteria of the primary endpoint [Δ = -1.4 %, 95%CI = (-7.9 %; 6.7 %)]. Non-inferiority was therefore demonstrated (P = 0.001). No clinically significant differences were observed between groups for the secondary endpoints. No serious safety events (including NSF) were noted. Meglumine gadoterate did not affect renal function and was a safe contrast agent in patients with CKD. (orig.)

  6. Project safety studies - nuclear waste management (PSE)

    International Nuclear Information System (INIS)

    1981-10-01

    The project 'Safety Studies-Nuclear Waste Management' (PSE) is a research project performed by order of the Federal Minister for Research and Technology, the general purpose of which is to deepen and ensure the understanding of the safety aspects of the nuclear waste management and to prepare a risk analysis which will have to be established in the future. Owing to this the project is part of a series of projects which serve the further development of the concept of nuclear waste management and its safety, and which are set up in such a way as to accompany the realization of that concept. This report contains the results of the first stage of the project from 1978 to mid-1981. (orig./RW) [de

  7. Are measurements of patient safety culture and adverse events valid and reliable? Results from a cross sectional study.

    Science.gov (United States)

    Farup, Per G

    2015-05-02

    The association between measurements of the patient safety culture and the "true" patient safety has been insufficiently documented, and the validity of the tools used for the measurements has been questioned. This study explored associations between the patient safety culture and adverse events, and evaluated the validity of the tools. In 2008/2009, a survey on patient safety culture was performed with Hospital Survey on Patient Safety Culture (HSOPSC) in two medical departments in two geographically separated hospitals of Innlandet Hospital Trust. Later, a retrospective analysis of adverse events during the same period was performed with the Global Trigger Tool (GTT). The safety culture and adverse events were compared between the departments. 185 employees participated in the study, and 272 patient records were analysed. The HSOPSC scores were lower and adverse events less prevalent in department 1 than in department 2. In departments 1 and 2 the mean HSOPSC scores (SD) were at the unit level 3.62 (0.42) and 3.90 (0.37) (p culture and adverse events. Until the criterion validity of the tools for measuring patient safety culture and tracking of adverse events have been further evaluated, measurement of patient safety culture could not be used as a proxy for the "true" safety.

  8. Safety performance comparation of MOX, nitride and metallic fuel based 25-100 MWe Pb-Bi cooled long life fast reactors without on-site refuelling

    International Nuclear Information System (INIS)

    Su'ud, Zaki

    2008-01-01

    In this paper the safety performance of 25-100 MWe Pb-Bi cooled long life fast reactors based on three types of fuels: MOX, nitride and metal is compared and discussed. In the fourth generation NPP paradigm, especially for Pb-Bi cooled fast reactors, inherent safety capability is necessary against some standard accidents such as unprotected loss of flow (ULOF), unprotected rod run-out transient over power (UTOP), unprotected loss of heat sink (ULOHS). Selection of fuel type will have important impact on the overall system safety performance. The results of safety analysis of long life Pb-Bi cooled fast reactors without on-site fuelling using nitride, MOX and metal fuel have been performed. The reactors show the inherent safety pattern with enough safety margins during ULOF and UTOP accidents. For MOX fuelled reactors, ULOF accident is more severe than UTOP accident while for nitride fuelled cores UTOP accident may push power much higher than that comparable MOX fuelled cores. (author)

  9. Study on some safety-related aspects of tyre use

    NARCIS (Netherlands)

    Jansen, S.T.H.; Schmeitz, A.J.C.; Maas, S.; Rodarius, C.; Akkermans, L.

    2014-01-01

    The tyre is a key component that affects road safety. The European commission has posted a tender aimed to study what measures on a European level can be taken in relation to the use of tyres to improve road safety. The results of this study, supported by a cost benefit analyses and carried out by

  10. A study of software safety analysis system for safety-critical software

    International Nuclear Information System (INIS)

    Chang, H. S.; Shin, H. K.; Chang, Y. W.; Jung, J. C.; Kim, J. H.; Han, H. H.; Son, H. S.

    2004-01-01

    The core factors and requirements for the safety-critical software traced and the methodology adopted in each stage of software life cycle are presented. In concept phase, Failure Modes and Effects Analysis (FMEA) for the system has been performed. The feasibility evaluation of selected safety parameter was performed and Preliminary Hazards Analysis list was prepared using HAZOP(Hazard and Operability) technique. And the check list for management control has been produced via walk-through technique. Based on the evaluation of the check list, activities to be performed in requirement phase have been determined. In the design phase, hazard analysis has been performed to check the safety capability of the system with regard to safety software algorithm using Fault Tree Analysis (FTA). In the test phase, the test items based on FMEA have been checked for fitness guided by an accident scenario. The pressurizer low pressure trip algorithm has been selected to apply FTA method to software safety analysis as a sample. By applying CASE tool, the requirements traceability of safety critical system has been enhanced during all of software life cycle phases

  11. COLD-SAT feasibility study safety analysis

    Science.gov (United States)

    Mchenry, Steven T.; Yost, James M.

    1991-01-01

    The Cryogenic On-orbit Liquid Depot-Storage, Acquisition, and Transfer (COLD-SAT) satellite presents some unique safety issues. The feasibility study conducted at NASA-Lewis desired a systems safety program that would be involved from the initial design in order to eliminate and/or control the inherent hazards. Because of this, a hazards analysis method was needed that: (1) identified issues that needed to be addressed for a feasibility assessment; and (2) identified all potential hazards that would need to be controlled and/or eliminated during the detailed design phases. The developed analysis method is presented as well as the results generated for the COLD-SAT system.

  12. Social media for arthritis-related comparative effectiveness and safety research and the impact of direct-to-consumer advertising.

    Science.gov (United States)

    Curtis, Jeffrey R; Chen, Lang; Higginbotham, Phillip; Nowell, W Benjamin; Gal-Levy, Ronit; Willig, James; Safford, Monika; Coe, Joseph; O'Hara, Kaitlin; Sa'adon, Roee

    2017-03-07

    Social media may complement traditional data sources to answer comparative effectiveness/safety questions after medication licensure. The Treato platform was used to analyze all publicly available social media data including Facebook, blogs, and discussion boards for posts mentioning inflammatory arthritis (e.g. rheumatoid, psoriatic). Safety events were self-reported by patients and mapped to medical ontologies, resolving synonyms. Disease and symptom-related treatment indications were manually redacted. The units of analysis were unique terms in posts. Pre-specified conditions (e.g. herpes zoster (HZ)) were selected based upon safety signals from clinical trials and reported as pairwise odds ratios (ORs); drugs were compared with Fisher's exact test. Empirically identified events were analyzed using disproportionality analysis and reported as relative reporting ratios (RRRs). The accuracy of a natural language processing (NLP) classifier to identify cases of shingles associated with arthritis medications was assessed. As of October 2015, there were 785,656 arthritis-related posts. Posts were predominantly US posts (75%) from patient authors (87%) under 40 years of age (61%). For HZ posts (n = 1815), ORs were significantly increased with tofacitinib versus other rheumatoid arthritis therapies. ORs for mentions of perforated bowel (n = 13) were higher with tocilizumab versus other therapies. RRRs associated with tofacitinib were highest in conditions related to baldness and hair regrowth, infections and cancer. The NLP classifier had a positive predictive value of 91% to identify HZ. There was a threefold increase in posts following television direct-to-consumer advertisement (p = 0.04); posts expressing medication safety concerns were significantly more frequent than favorable posts. Social media is a challenging yet promising data source that may complement traditional approaches for comparative effectiveness research for new medications.

  13. Measurement equivalence of patient safety climate in Chinese hospitals: can we compare across physicians and nurses?

    Science.gov (United States)

    Zhu, Junya

    2018-06-11

    Self-report instruments have been widely used to better understand variations in patient safety climate between physicians and nurses. Research is needed to determine whether differences in patient safety climate reflect true differences in the underlying concepts. This is known as measurement equivalence, which is a prerequisite for meaningful group comparisons. This study aims to examine the degree of measurement equivalence of the responses to a patient safety climate survey of Chinese hospitals and to demonstrate how the measurement equivalence method can be applied to self-report climate surveys for patient safety research. Using data from the Chinese Hospital Survey of Patient Safety Climate from six Chinese hospitals in 2011, we constructed two groups: physicians and nurses (346 per group). We used multiple-group confirmatory factor analyses to examine progressively more stringent restrictions for measurement equivalence. We identified weak factorial equivalence across the two groups. Strong factorial equivalence was found for Organizational Learning, Unit Management Support for Safety, Adequacy of Safety Arrangements, Institutional Commitment to Safety, Error Reporting and Teamwork. Strong factorial equivalence, however, was not found for Safety System, Communication and Peer Support and Staffing. Nevertheless, further analyses suggested that nonequivalence did not meaningfully affect the conclusions regarding physician-nurse differences in patient safety climate. Our results provide evidence of at least partial equivalence of the survey responses between nurses and physicians, supporting mean comparisons of its constructs between the two groups. The measurement equivalence approach is essential to ensure that conclusions about group differences are valid.

  14. An open, comparative clinical study on the efficacy and safety of 10% trichloroacetic acid, 25% trichloroacetic acid and cryotherapy for verruca plana.

    Science.gov (United States)

    Cengiz, Fatma Pelin; Emiroglu, Nazan

    2015-01-01

    Although there are several methods to treat Verruca plana, warts do not respond well to the common therapeutic options. In this study, we compared the safety and efficacy of 10% trichloroacetic acid, 25% trichloroacetic acid, and cryotherapy for the treatment of warts caused by Verruca plana. Ten percent and 25% trichloroacetic acid were applied to warts weekly until all lesions cleared. Cryotherapy was performed by liquid nitrogen spray for 5-10 seconds for each lesion per week until the lesions cleared. The number of Verruca plana lesions and adverse effects were evaluated five times during the treatment (the initial visit, week 2, week 4, week 6, and week 8). The number of lesions decreased through week 8 for all three treatments, and the reductions in the mean numbers of lesions were statistically similar (p > 0.05). Those in the cryotherapy group exhibited more erythema, pain, erosions, bullae, and hyperpigmentation (p cryotherapy group (p cryotherapy are effective methods to treat Verruca plana. 10% trichloroacetic acid offers a safer and easier treatment than either 25% trichloroacetic acid or cryotherapy.

  15. Prospective study comparing laparoscopic and open radical cystectomy: Surgical and oncological results.

    Science.gov (United States)

    Esquinas, C; Alonso, J M; Mateo, E; Dotor, A; Martín, A M; Dorado, J F; Arance, I; Angulo, J C

    2018-03-01

    Laparoscopic radical cystectomy with lymphadenectomy and urinary diversion is an increasingly widespread operation. Studies are needed to support the oncological effectiveness and safety of this minimally invasive approach. A nonrandomised, comparative prospective study between open radical cystectomy (ORC) and laparoscopic radical cystectomy (LRC) was conducted in a university hospital. The main objective was to compare cancer-specific survival. The secondary objective was to compare the surgical results and complications according to the Clavien-Dindo scale. We treated 156 patients with high-grade invasive bladder cancer with either ORC (n=70) or LRC (n=86). The mean follow-up was 33.5±23.8 (range 12-96) months. The mean age was 66.9+9.4 years, and the male to female ratio was 19:1. Both groups were equivalent in age, stage, positive lymph nodes, in situ carcinoma, preoperative obstructive uropathy, adjuvant chemotherapy and type of urinary diversion. There were no differences between the groups in terms of cancer-specific survival (log-rank; P=.71). The histopathology stage was the only independent variable that predicted the prognosis. The hospital stay (P=.01) and operative transfusion rates (P=.002) were less for LRC. The duration of the surgery was greater for LRC (P<.001). There were no differences in the total complications rate (p=.62) or major complications (P=.69). The risk of evisceration (P=.02), surgical wound infection (P=.005) and pneumonia (P=.017) was greater for ORC. The risk of rectal lesion (P=.017) and urethrorectal fistulae (P=.065) was greater for LRC. LRC is an equivalent treatment to ORC in terms of oncological efficacy and is advantageous in terms of transfusion rates and hospital stays but not in terms of operating room time and overall safety. Studies are needed to better define the specific safety profile for each approach. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  16. Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.

    Science.gov (United States)

    Mintzes, Barbara; Lexchin, Joel; Sutherland, Jason M; Beaulieu, Marie-Dominique; Wilkes, Michael S; Durrieu, Geneviève; Reynolds, Ellen

    2013-10-01

    The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards. This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was "minimally adequate safety information" (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications). Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. "Minimally adequate safety information" did not differ: 1.7 % of promotions; range 0.9-3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver: 61 % vs. 34 %, OR = 4.0; 95 % CI 2.8-5.6, or Sacramento (39 %), OR = 2.4; 95 % CI 1.7-3.6. Serious adverse events were rarely mentioned (5-6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) "black box" warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time. "Minimally adequate safety information" did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about

  17. Behavior-based safety on construction sites: a case study.

    Science.gov (United States)

    Choudhry, Rafiq M

    2014-09-01

    This work presents the results of a case study and describes an important area within the field of construction safety management, namely behavior-based safety (BBS). This paper adopts and develops a management approach for safety improvements in construction site environments. A rigorous behavioral safety system and its intervention program was implemented and deployed on target construction sites. After taking a few weeks of safety behavior measurements, the project management team implemented the designed intervention and measurements were taken. Goal-setting sessions were arranged on-site with workers' participation to set realistic and attainable targets of performance. Safety performance measurements continued and the levels of performance and the targets were presented on feedback charts. Supervisors were asked to give workers recognition and praise when they acted safely or improved critical behaviors. Observers were requested to have discussions with workers, visit the site, distribute training materials to workers, and provide feedback to crews and display charts. They were required to talk to operatives in the presence of line managers. It was necessary to develop awareness and understanding of what was being measured. In the process, operatives learned how to act safely when conducting site tasks using the designed checklists. Current weekly scores were discussed in the weekly safety meetings and other operational site meetings with emphasis on how to achieve set targets. The reliability of the safety performance measures taken by the company's observers was monitored. A clear increase in safety performance level was achieved across all categories: personal protective equipment; housekeeping; access to heights; plant and equipment, and scaffolding. The research reveals that scores of safety performance at one project improved from 86% (at the end of 3rd week) to 92.9% during the 9th week. The results of intervention demonstrated large decreases in

  18. A comparative study on the immunogenicity, safety and tolerance of purified duck embryo vaccine (PDEV) manufactured in India (Vaxirab) and Switzerland (Lyssavac-N): a randomized simulated post-exposure study in healthy volunteers.

    Science.gov (United States)

    Mahendra, Bangalore Jayakrishnappa; Madhusudana, Shampur Narayan; Ashwathnarayana, Doddabele Hanumanthaiah; Sampath, Gadey; datta, Soma Subhra; Sudarshan, Mysore Kalappa; Venkatesh, Gonibeedu Manjunatah; Muhamuda, Kader; Bilagumba, Gangaboraiah; Shamanna, Manjula

    2007-12-05

    Purified duck embryo vaccine (PDEV, Vaxirab) for rabies prophylaxis is now indigenously manufactured in India under technology transfer from Berna Biotech who made the original PDEV (Lyssavac). In the present study we have compared the two vaccines in terms of safety, immunogenicity and tolerance. The study was conducted in 220 adult healthy volunteers. It was observed that both vaccines produced neutralizing antibody titers (as determined by rapid fluorescent focus inhibition test, RFFIT) more than 0.5 IU/mL (minimum level for seroconversion) on all days tested but the titers on days 90 and 180 were significantly higher with Lyssavac. The adverse reactions produced were slightly more with Lysssavac but both vaccines were well tolerated. In conclusion, the indigenously produced PDEV (Vaxirab) was found to be equally safe and immunogenic as the original PDEV (Lyssavac) manufactured at Switzerland.

  19. A prospective, comparative, evaluator-blind clinical study investigating efficacy and safety of two injection techniques with Radiesse ® for the correction of skin changes in aging hands

    Directory of Open Access Journals (Sweden)

    Elena I Gubanova

    2015-01-01

    Full Text Available Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse ® . Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse ® (0.8 mL/0.2 mL 2% lidocaine was injected subdermally on Day (D01, using a needle multipoint technique in one hand (N and a fan-like cannula technique in the other (C. Assessments were made pre-injection, on D14, Month (M02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS and Global Aesthetic Improvement Scale (GAIS. Participants completed questionnaires on satisfaction, pain and adverse events (AEs. Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene′s tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse ® . Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction and 3 (optimal cosmetic result at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30. Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse ® .

  20. Comparative analysis of different configurations of PLC-based safety systems from reliability point of view

    Science.gov (United States)

    Tapia, Moiez A.

    1993-01-01

    The study of a comparative analysis of distinct multiplex and fault-tolerant configurations for a PLC-based safety system from a reliability point of view is presented. It considers simplex, duplex and fault-tolerant triple redundancy configurations. The standby unit in case of a duplex configuration has a failure rate which is k times the failure rate of the standby unit, the value of k varying from 0 to 1. For distinct values of MTTR and MTTF of the main unit, MTBF and availability for these configurations are calculated. The effect of duplexing only the PLC module or only the sensors and the actuators module, on the MTBF of the configuration, is also presented. The results are summarized and merits and demerits of various configurations under distinct environments are discussed.

  1. Preliminary study for unified management of CANDU safety codes and construction of database system

    International Nuclear Information System (INIS)

    Min, Byung Joo; Kim, Hyoung Tae

    2003-03-01

    It is needed to develop the Graphical User Interface(GUI) for the unified management of CANDU safety codes and to construct database system for the validation of safety codes, for which the preliminary study is done in the first stage of the present work. The input and output structures and data flow of CATHENA and PRESCON2 are investigated and the interaction of the variables between CATHENA and PRESCON2 are identified. Furthermore, PC versions of CATHENA and PRESCON2 codes are developed for the interaction of these codes and GUI(Graphic User Interface). The PC versions are assessed by comparing the calculation results with those by HP workstation or from FSAR(Final Safety Analysis Report). Preliminary study on the GUI for the safety codes in the unified management system are done. The sample of GUI programming is demonstrated preliminarily. Visual C++ is selected as the programming language for the development of GUI system. The data for Wolsong plants, reactor core, and thermal-hydraulic experiments executed in the inside and outside of the country, are collected and classified following the structure of the database system, of which two types are considered for the final web-based database system. The preliminary GUI programming for database system is demonstrated, which is updated in the future work

  2. The Effect of Safety Costs on Productivity and Quality: A Case Study of Five Steel Companies in Ahvaz

    Directory of Open Access Journals (Sweden)

    Gholamabbas Shirali

    2016-10-01

    Full Text Available Background The implementation of a safety program is one of the most effective factors in increasing productivity. A look to safety from the perspective of efficiency can indicate necessary investment in safety for all, especially the managers of companies. Objectives The aim of this study was to evaluate the effect of safety costs on some indicators of productivity and quality in industrial companies. Methods This study was a retrospective analysis and was implemented in five steel companies in Ahvaz. The data relating to the safety costs such as staffing costs and total safety costs, and productivity and quality indicators were collected in five years. This information and data were collected according to statistics from documents and archives of safety, accounting, and production sectors of companies. Costs as well as numbers and figures of variables were expressed in the form of per capita and percentage to make the data comparable. Linear and generalized regression models and Wald Chi-Square test were used by the SPSS 22 software to determine the relationships between them. Results Safety costs such as capita labor safety costs and capita total safety costs or percentage safety labor costs to labor costs, showed a significant positive effect on labor productivity, labor competitiveness, total factor productivity, quality index and production rates (in some cases, P = 0.001. Conclusions The total safety cost and safety labor compensation generally, regardless of the nature and quality of the safety management system, can impact productivity, quality and quantity of production in addition to other factors of production. Surely if safety programs are targeted and codified, the effect of the investment will be doubled.

  3. Main lessons for FBR safety study from the CABRI experiments

    International Nuclear Information System (INIS)

    Sato, Ikken

    2006-01-01

    CABRI project has been carried out FBR safety study with international cooperation of five nations since 1978. The project consists of four periods such as CABRI-1, CABRI-2, CABRI-FAST and CABRI-RAFT. The objects and the main information for hypothetical core decay accident and safety study of fuel are described. The behavior of core decay accident was studied in the first period (CABRI-1), the safety study of fuel was investigated after the second period (CABRI-2). Change of phenomena at the initial process of core decay accident, comparison between analysis and data of fuel diffusion behavior of neutron horoscope by CABRI-2 experiment, representative in-core experiment under slow TOP conditions, the damaged and undamaged pin under slow TOP conditions, the exterior of CABRI and TREAT and the upper part of CABRI and TREAT reactor are shown. CABRI experiments changed to LWR safety study and a part of TREAT is stated. (S.Y.)

  4. Health and safety. Preliminary comparative assessment of the satellite power system (SPS) and other energy alternatives

    International Nuclear Information System (INIS)

    Habegger, L.J.; Gasper, J.R.; Brown, C.D.

    1980-04-01

    Existing data on the health and safety risks of a satellite power system and four electrical generation systems are analyzed: a combined-cycle coal power system with a low-Btu gasifier and open-cycle gas turbine, a fission power system with fuel reprocessing, a central-station, terrestrial, solar-photovoltaic power system, and a first-generation design for a fusion power system. The systems are compared on the basis of expected deaths and person-days lost per year associated with 1000 MW of average electricity generation and the number of health and safety risks that are identified as potentially significant but unquantifiable. The appendices provide more detailed information on risks, uncertainties, additional research needed, and references for the identified impacts of each system

  5. Aerosol measles vaccination in macaques: Preclinical studies of immune responses and safety

    NARCIS (Netherlands)

    R.L. de Swart (Rik); T. Kuiken (Thijs); J. Fernandez-de Castro (Jorge); M.J. Papania (Mark); J.V. Bennett (John); J.L. Valdespino (José); P.D. Minor; C.L. Witham (Clyde); S. Yüksel (Selma); H.W. Vos (Helma); G. van Amerongen (Geert); A.D.M.E. Osterhaus (Albert)

    2006-01-01

    textabstractThe comparative efficacy and safety of measles vaccination via the aerosol route versus subcutaneous injection has not been fully resolved. We vaccinated cynomolgus monkeys (Macaca fascicularis) with the live-attenuated Edmonston-Zagreb measles virus (MV) vaccine and compared different

  6. Colorectal Cancer Safety Net: Is It Catching Patients Appropriately?

    Science.gov (United States)

    Althans, Alison R; Brady, Justin T; Times, Melissa L; Keller, Deborah S; Harvey, Alexis R; Kelly, Molly E; Patel, Nilam D; Steele, Scott R

    2018-01-01

    Disparities in access to colorectal cancer care are multifactorial and are affected by socioeconomic elements. Uninsured and Medicaid patients present with advanced stage disease and have worse outcomes compared with similar privately insured patients. Safety net hospitals are a major care provider to this vulnerable population. Few studies have evaluated outcomes for safety net hospitals compared with private institutions in colorectal cancer. The purpose of this study was to compare demographics, screening rates, presentation stage, and survival rates between a safety net hospital and a tertiary care center. Comparative review of patients at 2 institutions in the same metropolitan area were conducted. The study included colorectal cancer care delivered either at 1 safety net hospital or 1 private tertiary care center in the same city from 2010 to 2016. A total of 350 patients with colorectal cancer from each hospital were evaluated. Overall survival across hospital systems was measured. The safety net hospital had significantly more uninsured and Medicaid patients (46% vs 13%; p presentation, a similar percentage of patients at each hospital presented with stage IV disease (26% vs 20%; p = 0.06). For those undergoing resection, final pathologic stage distribution was similar across groups (p = 0.10). After a comparable median follow-up period (26.6 mo for safety net hospital vs 29.2 mo for tertiary care center), log-rank test for overall survival favored the safety net hospital (p = 0.05); disease-free survival was similar between hospitals (p = 0.40). This was a retrospective review, reporting from medical charts. Our results support the value of safety net hospitals for providing quality colorectal cancer care, with survival and recurrence outcomes equivalent or improved compared with a local tertiary care center. Because safety net hospitals can provide equivalent outcomes despite socioeconomic inequalities and financial constraints, emphasis should be focused

  7. A comparative safety review between GLP-1 receptor agonists and SGLT2 inhibitors for diabetes treatment.

    Science.gov (United States)

    Consoli, Agostino; Formoso, Gloria; Baldassarre, Maria Pompea Antonia; Febo, Fabrizio

    2018-03-01

    Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it is more and more important to gather and discuss information about their safety profile. Area Covered: adverse events and the safety concerns most often emerged in trials with GLP-1RA namely, exenatide long acting release (LAR), dulaglutide, liraglutide, semaglutide, lixisenatide or SGLT2i, namely empagliflozin, dapagliflozin, canagliflozin and SGLT2i with an attempt at comparing the safety profiles of molecules of these two classes. Expert opinion: GLP-1RA and SGLT2i, although each associated with different specific side effects, share a 'similar' safety profile and are both drugs relatively easy to handle. The potentially complementary mechanisms of action, the cardio and nephroprotective effects demonstrated by molecules of both classes, make these drugs potentially useful even in add on to each other.

  8. Neighborhood safety and adipose tissue distribution in African Americans: the Jackson Heart Study.

    Directory of Open Access Journals (Sweden)

    Do Quyen Pham

    Full Text Available Patterns of fat distribution are heavily influenced by psychological stress, sex, and among women, by menopause status. Emerging evidence suggests the lack of perceived neighborhood safety due to crime may contribute to psychological stress and obesity among exposed residents. Our objective is to determine if perceived neighborhood safety is associated with abdominal adiposity among African-American men and women, and among pre- and postmenopausal women in the Jackson Heart Study.We examined associations between perceived neighborhood safety, fat distribution, and other individual-level covariates among Jackson Heart Study participants (N = 2,881. Abdominal adiposity was measured via computed tomography scans measuring the volumes of visceral, subcutaneous and total adipose tissue. We also measured body mass index (BMI, and waist circumference. Multivariable regression models estimated associations between perceived neighborhood safety, adiposity, and covariates by sex and menopause status.Adjusting for all covariates, women who strongly disagreed their neighborhood was safe from crime had a higher BMI compared to women who felt safe [Std B 0.083 95% CI (0.010, 0.156]. Premenopausal women who felt most unsafe had higher BMI, waist circumference, and volumes of visceral and total adipose tissue than those who felt safe [Std B 0.160 (0.021, 0.299, Std B 0.142 (0.003, 0.280, Std B 0.150 (0.014, 0.285, Std B 0.154 (0.019, 0.290, respectively]. We did not identify associations between neighborhood safety and adiposity among men and postmenopausal women.Our data suggest that abdominal adipose tissue distribution patterns are associated with perceived neighborhood safety in some groups, and that patterns may differ by sex and menopause status, with most associations observed among pre-menopausal women. Further research is needed to elucidate whether there are causal mechanisms underlying sex and menopause-status differences that may mediate

  9. Status of conceptual safety design study of Japanese sodium-cooled fast reactor

    International Nuclear Information System (INIS)

    Kubo, Shigenobu; Kurisaka, Kenichi; Niwa, Hajime; Shimakawa, Yoshio

    2005-01-01

    In this paper, the current conceptual safety design and related evaluation of Japanese Sodium-cooled Fast Reactor which is studied in the framework of the Feasibility Study (FS) on commercialized Fast Reactor Cycle Systems in Japan are described. The purpose of the safety design is to establish a feasible safety concept of FBR which aims at a sustainable energy source of the next generations. The safety targets and the safety design principle are set aiming at realizing worldwide acceptability of the safety level. The basic safety design concept, which can meet the safety targets, was formulated taking along with the defense-in-depth philosophy as the basic safety design principle. In order to cope with wide range of energy and resource demands, there are some various designs both of oxide and metal fuel for JSFR. Some analytical results of typical design basis events, design extension conditions and core damage frequency estimation show the feasibility of the safety design concept for them. (author)

  10. Safety evaluation of zotepine for the treatment of schizophrenia.

    Science.gov (United States)

    Riedel, Michael; Musil, Richard; Seemüller, Florian; Spellmann, Ilja; Möller, Hans-Jürgen; Schennach-Wolff, Rebecca

    2010-07-01

    Atypical antipsychotics have become the first-line treatment for patients suffering from schizophrenia in the industrialized world. Given the frequent necessity of a life-long enduring antipsychotic treatment, the compounds' safety profile is of great importance for patients and caregivers. Zotepine is an antipsychotic with atypical properties and previous data have suggested a very favorable side effect profile. The aim of this review is to provide a broad knowledge base on the safety profile of zotepine deriving from currently available research results published in English medical databases. The focus of this research reports starts in the 1990s with zotepine's approval in Europe. This paper incorporates data on placebo-controlled studies of zotepine as well as studies with comparator compounds also beyond the diagnostic boarder of schizophrenia regarding zotepine's safety. The take home message of this safety evaluation of zotepine is that compared to typical compounds zotepine induces less extrapyramidal side effects; however, in terms of comparing zotepine's safety with other atypical antipsychotics more studies are needed to draw final conclusions.

  11. Safety and efficacy of direct oral anticoagulants compared to warfarin for extended treatment of venous thromboembolism -a systematic review and meta-analysis

    DEFF Research Database (Denmark)

    Sindet-Pedersen, Caroline; Pallisgaard, Jannik Langtved; Olesen, Jonas Bjerring

    2015-01-01

    OBJECTIVE: To examine and compare the safety and efficacy of extended treatment with dabigatran, apixaban, rivaroxaban and warfarin in patients with unprovoked venous thromboembolism. METHODS: PubMed and Embase were searched for randomized clinical trials reporting on the use of direct oral...... anticoagulants (DOACs) and warfarin for the extended treatment of VTE. Meta-analysis was performed on studies reporting similar study design and comparator. RESULTS: A total of 729 articles were identified and 5 studies covering 6 randomized clinical trials met the eligibility criteria and were included...... in the study. 5 studies were included in the meta-analysis. Results from the meta-analysis showed that the extended use of DOACs and warfarin significantly decreased the risk of recurrent VTE with 83 % when compared placebo. Warfarin (RR: 0.03, CI: 0.00-0.49) and dabigatran (RR: 0.08, CI: 0.03-0.27) showed...

  12. Studies on Labour Safety in Construction Sites

    Directory of Open Access Journals (Sweden)

    S. Kanchana

    2015-01-01

    Full Text Available Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites.

  13. Studies on Labour Safety in Construction Sites

    Science.gov (United States)

    Kanchana, S.; Sivaprakash, P.; Joseph, Sebastian

    2015-01-01

    Construction industry has accomplished extensive growth worldwide particularly in past few decades. For a construction project to be successful, safety of the structures as well as that of the personnel is of utmost importance. The safety issues are to be considered right from the design stage till the completion and handing over of the structure. Construction industry employs skilled and unskilled labourers subject to construction site accidents and health risks. A proper coordination between contractors, clients, and workforce is needed for safe work conditions which are very much lacking in Indian construction companies. Though labour safety laws are available, the numerous accidents taking place at construction sites are continuing. Management commitment towards health and safety of the workers is also lagging. A detailed literature study was carried out to understand the causes of accidents, preventive measures, and development of safe work environment. This paper presents the results of a questionnaire survey, which was distributed among various categories of construction workers in Kerala region. The paper examines and discusses in detail the total working hours, work shifts, nativity of the workers, number of accidents, and type of injuries taking place in small and large construction sites. PMID:26839916

  14. Design for safety: theoretical framework of the safety aspect of BIM system to determine the safety index

    Directory of Open Access Journals (Sweden)

    Ai Lin Evelyn Teo

    2016-12-01

    Full Text Available Despite the safety improvement drive that has been implemented in the construction industry in Singapore for many years, the industry continues to report the highest number of workplace fatalities, compared to other industries. The purpose of this paper is to discuss the theoretical framework of the safety aspect of a proposed BIM System to determine a Safety Index. An online questionnaire survey was conducted to ascertain the current workplace safety and health situation in the construction industry and explore how BIM can be used to improve safety performance in the industry. A safety hazard library was developed based on the main contributors to fatal accidents in the construction industry, determined from the formal records and existing literature, and a series of discussions with representatives from the Workplace Safety and Health Institute (WSH Institute in Singapore. The results from the survey suggested that the majority of the firms have implemented the necessary policies, programmes and procedures on Workplace Safety and Health (WSH practices. However, BIM is still not widely applied or explored beyond the mandatory requirement that building plans should be submitted to the authorities for approval in BIM format. This paper presents a discussion of the safety aspect of the Intelligent Productivity and Safety System (IPASS developed in the study. IPASS is an intelligent system incorporating the buildable design concept, theory on the detection, prevention and control of hazards, and the Construction Safety Audit Scoring System (ConSASS. The system is based on the premise that safety should be considered at the design stage, and BIM can be an effective tool to facilitate the efforts to enhance safety performance. IPASS allows users to analyse and monitor key aspects of the safety performance of the project before the project starts and as the project progresses.

  15. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients

    Directory of Open Access Journals (Sweden)

    Yu Sue

    2008-09-01

    Full Text Available Abstract Background Lumiracoxib is a selective cyclooxygenase-2 inhibitor effective in the treatment of osteoarthritis (OA with a superior gastrointestinal (GI safety profile as compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs, ibuprofen and naproxen. This safety study compared the GI tolerability, the blood pressure (BP profile and the incidence of oedema with lumiracoxib and rofecoxib in the treatment of OA. Rofecoxib was withdrawn worldwide due to an associated increased risk of CV events and lumiracoxib has been withdrawn from Australia, Canada, Europe and a few other countries following reports of suspected adverse liver reactions. Methods This randomised, double-blind study enrolled 309 patients (aged greater than or equal to 50 years with primary OA across 51 centres in Europe. Patients were randomly allocated to receive either lumiracoxib 400 mg od (four times the recommended dose in OA (n = 154 or rofecoxib 25 mg od (n = 155. The study was conducted for 6 weeks and assessments were performed at Weeks 3 and 6. The primary safety measures were the incidence of predefined GI adverse events (AEs and peripheral oedema. The secondary safety measures included effect of treatment on the mean sitting systolic and diastolic blood pressure (msSBP and msDBP. Tolerability of lumiracoxib 400 mg was assessed by the incidence of AEs. Results Lumiracoxib and rofecoxib displayed similar GI safety profiles with no statistically significant difference in predefined GI AEs between the two groups (43.5% vs. 37.4%, respectively. The incidence and severity of individual predefined GI AEs was comparable between the two groups. The incidence of peripheral oedema was low and identical in both the groups (n = 9, 5.8%. Only one patient in the lumiracoxib group and three patients in the rofecoxib group had a moderate or severe event. At Week 6 there was a significantly lower msSBP and msDBP in the lumiracoxib group compared to the rofecoxib

  16. Comparative Study of some Parameters reported in the Safety Analysis Report of TRIGA MARK II Research reactor with Calculations

    International Nuclear Information System (INIS)

    Chakrobortty, T.K.; Huda, M.Q.; Bhuiyan, S.I.; Mondal, M.A.W.

    1997-06-01

    An attempt has been made to investigate some of the parametric results reported in the safety Analysis Report (SAR) with the theoretical analysis carried out by different computer codes and data bases. Different neutronics, thermal hydraulics and safety parameters such as core criticality and burnup lifetime, power peaking factor, prompt negative temperature coefficient, neutron flux, pulse characteristics, steady state and transient behaviors of the TRIGA reactor were analyzed. The investigated results were found to be in fairly good agreement with the values reported in the SAR. 12 refs., 14 figs., 1 table (Author)

  17. Comparative risk analysis

    International Nuclear Information System (INIS)

    Niehaus, F.

    1988-01-01

    In this paper, the risks of various energy systems are discussed considering severe accidents analysis, particularly the probabilistic safety analysis, and probabilistic safety criteria, and the applications of these criteria and analysis. The comparative risk analysis has demonstrated that the largest source of risk in every society is from daily small accidents. Nevertheless, we have to be more concerned about severe accidents. The comparative risk analysis of five different energy systems (coal, oil, gas, LWR and STEC (Solar)) for the public has shown that the main sources of risks are coal and oil. The latest comparative risk study of various energy has been conducted in the USA and has revealed that the number of victims from coal is 42 as many than victims from nuclear. A study for severe accidents from hydro-dams in United States has estimated the probability of dam failures at 1 in 10,000 years and the number of victims between 11,000 and 260,000. The average occupational risk from coal is one fatal accident in 1,000 workers/year. The probabilistic safety analysis is a method that can be used to assess nuclear energy risks, and to analyze the severe accidents, and to model all possible accident sequences and consequences. The 'Fault tree' analysis is used to know the probability of failure of the different systems at each point of accident sequences and to calculate the probability of risks. After calculating the probability of failure, the criteria for judging the numerical results have to be developed, that is the quantitative and qualitative goals. To achieve these goals, several systems have been devised by various countries members of AIEA. The probabilistic safety ana-lysis method has been developed by establishing a computer program permit-ting to know different categories of safety related information. 19 tabs. (author)

  18. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Jeong-Whun Kim

    Full Text Available There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA with those of power-assisted adenoidectomy.Prospective multi-institutional study.Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C or without cauterization (PAA-C due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated.A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1 CA (n = 116; (2 PAA+C (n = 153; and (3 PAA-C (n = 119. Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001 and degree of intraoperative bleeding was significantly less (P < 0.001 compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016.This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding.

  19. Fusion-reactor blanket-material safety-compatibility studies

    International Nuclear Information System (INIS)

    Jeppson, D.W.; Muhlestein, L.D.; Keough, R.F.; Cohen, S.

    1982-11-01

    Blanket material selection for fusion reactors is strongly influenced by the desire to minimize safety and environmental concerns. Blanket material safety compatibility studies are being conducted to identify and characterize blanket-coolant-material interactions under postulated reactor accident conditions. Recently completed scoping compatibility tests indicate that : (1) ternary oxides (LiAlO 2 , Li 2 ZrO 3 , Li 2 SiO 3 , Li 4 SiO 4 and LiTiO 3 ) at postulated blanket operating temperatures are compatible with water coolant, while liquid lithium and Li 7 Pb 2 alloy reactions with water generate heat, aerosol and hydrogen; (2) lithium oxide and Li 17 Pb 83 alloy react mildly with water requiring special precautions to control hydrogen release; (3) liquid lithium reacts substantially, while Li 17 Pb 83 alloy reacts mildly with concrete to produce hydrogen; and (4) liquid lithium-air reactions present some major safety concerns

  20. Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion

    DEFF Research Database (Denmark)

    Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir

    2015-01-01

    OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...

  1. Ferrocyanide Safety Program: Safety criteria for ferrocyanide watch list tanks

    International Nuclear Information System (INIS)

    Postma, A.K.; Meacham, J.E.; Barney, G.S.

    1994-01-01

    This report provides a technical basis for closing the ferrocyanide Unreviewed Safety Question (USQ) at the Hanford Site. Three work efforts were performed in developing this technical basis. The efforts described herein are: 1. The formulation of criteria for ranking the relative safety of waste in each ferrocyanide tank. 2. The current classification of tanks into safety categories by comparing available information on tank contents with the safety criteria; 3. The identification of additional information required to resolve the ferrocyanide safety issue

  2. A comparative study of five centrally acting drugs on the pharmacological treatment of obesity.

    Science.gov (United States)

    Suplicy, H; Boguszewski, C L; dos Santos, C M C; do Desterro de Figueiredo, M; Cunha, D R; Radominski, R

    2014-08-01

    No long-term studies have compared centrally acting drugs for treating obesity. To compare the efficacy and safety of diethylpropion (DEP), fenproporex (FEN), mazindol (MZD), fluoxetine (FXT) and sibutramine (SIB) in promoting weight loss. A prospective, randomized, placebo (PCB)-controlled study conducted at a single academic institution. A total of 174 obese premenopausal women. Participants randomly received DEP 75 mg (n=28), FEN 25 mg (n=29), MZD 2 mg (n=29), SIB 15 mg (n=30), FXT 20 mg (n=29) or PCB (n=29) daily over 52 weeks. Diet and physical activity were encouraged. The primary endpoints were changes in body weight and the proportion of women who achieved at least 5% weight loss by week 52 in the intent-to-treat population. Other measurements included anthropometry, safety, metabolic and cardiovascular parameters. Weight loss was greater than PCB (-3.1±4.3 kg) with DEP (-10.0±6.4 kg; Pobese premenopausal women, with a satisfactory benefit-risk profile.

  3. Preliminary Study on the Development of Quantitative Safety Culture Index

    International Nuclear Information System (INIS)

    Lee, Young Eal; Kim, Hun Sil; Ahn, Nam Sung

    2005-01-01

    Safety culture is that assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance. Because it needs to be recognized as the most significant consciousness to achieve the nuclear safety performance, Korean government and nuclear power generation company have tried to develop the practical method to improve the safety culture from the long term point view. In this study, based on the site interviews to define the potential issues on organizational behavior for the safe operation and the survey on the level of safety culture of occupied workers are conducted. Survey results are quantified as a few indicators of nuclear safety by the statistical method and it can be simulated by the dynamic modeling as time goes on. Currently index and dynamic modeling are still being developed, however, results can be used to suggest the long term strategy which safety is clearly integrated into all activities in the nuclear organization

  4. Study Of Safety Management By Using Gis In Coimbatore

    Directory of Open Access Journals (Sweden)

    S. Kanchana

    2015-08-01

    Full Text Available The safety management is very important in the process of construction .The traditional methods of construction safety control cannot meet the construction of big project. To ensure the safety of construction and reduce accidents in the process of construction the current situation and problems we face in construction safety management should be studied first. And then the project risk warning mechanism based on the GIS is constructed according to the problems we faced to achieve visual monitoring and warning of construction safety risk management and to provide decision support for construction. This project aims to develop a web-based spatial decision support system model for proactive health and safety management in linear construction projects. 5 Currently health and safety management is usually performed reactively instead of proactive management since hazard identification and risk assessment is mostly performed on paper based documents that are not effectively used at site. An information system relates to a chain of operations lead to planning the observation and collection of data to storage and analysis of data to the use of derived information in decision-making processes. To create a web-based free and open sourced GIS that can work with different data formats by exchanging and presenting data as a real-time map on web.

  5. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study.

    Science.gov (United States)

    Chhatbar, Pratik Y; Chen, Rong; Deardorff, Rachael; Dellenbach, Blair; Kautz, Steven A; George, Mark S; Feng, Wuwei

    A prior meta-analysis revealed that higher doses of transcranial direct current stimulation (tDCS) have a better post-stroke upper-extremity motor recovery. While this finding suggests that currents greater than the typically used 2 mA may be more efficacious, the safety and tolerability of higher currents have not been assessed in stroke patients. We aim to assess the safety and tolerability of single session of up to 4 mA in stroke patients. We adapted a traditional 3 + 3 study design with a current escalation schedule of 1»2»2.5»3»3.5»4 mA for this tDCS safety study. We administered one 30-min session of bihemispheric montage tDCS and simultaneous customary occupational therapy to patients with first-ever ischemic stroke. We assessed safety with pre-defined stopping rules and investigated tolerability through a questionnaire. Additionally, we monitored body resistance and skin temperature in real-time at the electrode contact site. Eighteen patients completed the study. The current was escalated to 4 mA without meeting the pre-defined stopping rules or causing any major safety concern. 50% of patients experienced transient skin redness without injury. No rise in temperature (range 26°C-35 °C) was noted and skin barrier function remained intact (i.e. body resistance >1 kΩ). Our phase I safety study supports that single session of bihemispheric tDCS with current up to 4 mA is safe and tolerable in stroke patients. A phase II study to further test the safety and preliminary efficacy with multi-session tDCS at 4 mA (as compared with lower current and sham stimulation) is a logical next step. ClinicalTrials.gov Identifier: NCT02763826. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Injection-associated pain in femoral arteriography: A European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide

    International Nuclear Information System (INIS)

    Justesen, Per; Downes, Mark; Grynne, Birthe Hougens; Lang, Hanne; Rasch, Wenche; Seim, Eva

    1997-01-01

    Purpose. To evaluate injection-associated pain, safety, and efficacy with the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) compared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography. Methods. A multicenter, double-blind, randomized, parallel-group clinical investigation was carried out in 54 hospitals in Europe. Of the patients evaluated, 1225 received iodixanol and 1227 iopromide in conventional and/or digital subtraction angiography. Results. The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p<0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19.8% in the iopromide group (p<0.001). In the iodixanol group, 1.8% of the patients experienced contrast-related adverse events vs 2.4% in the iopromide group (p=NS). Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide group (p=NS). Conclusions. Iodixanol 270 mg I/ml causes significantly less injection-associated pain during femoral arteriography and is as safe and efficatious as iopromide 300 mg I/ml

  7. Safety and Tolerability of Theta Burst Stimulation versus Single and Paired Pulse Transcranial Magnetic Stimulation: A Comparative Study of 165 Pediatric Subjects

    Directory of Open Access Journals (Sweden)

    Yaejee H Hong

    2015-02-01

    Full Text Available Background: Although single- and paired-pulse (sp/pp transcranial magnetic stimulation (TMS studies are considered minimal risk in adults and children, the safety profile for theta-burst TMS (TBS is unknown.Objective: In this comparative analysis, we explored the rate, severity, and specific symptoms of TMS-related adverse effects (AEs between sp/ppTMS and TBS in subjects between ages 6 and 18 years.Method: Data from 165 participants from 2009-2014 were analyzed. Assessment of AEs was performed based on baseline and post-TMS administration of a symptom-based questionnaire that rated AEs on a 5-level ordinal scale (minimal, mild, moderate, marked, severe. AE rates and severity were compared using Chi Square or Fisher’s Exact Test depending on data characteristics.Result: Overall, no seizures or severe-rated AEs were reported by 165 pediatric participants. The rate of AE in all TBS sessions was 10.5% (n=76, 95% CI: 4.7 - 19.7%, whereas the rate of AE in all sp/ppTMS sessions was 12.4% (n=89, 95% CI: 6.3 - 21.0%. There was no statistical difference in AE rates between TBS and sp/ppTMS (p=0.71. In all sp/ppTMS and TBS sessions, 20 subjects reported a total of 35 AEs, among these 31 (~88.6% were rated as minimal or mild. There was no difference in the severity of AE between TBS and sp/ppTMS (p=1.0. Only one of 76 TBS participants reported an AE rated as more than minimal/mild.Conclusion: Our comparative analysis showed that TBS appears to be as safe as sp/ppTMS in terms of AE rate and severity. This report supports further investigation of TBS in children.

  8. Clinical implementetion of vildagliptin: data from recent studies comparing incretin-based medications

    Directory of Open Access Journals (Sweden)

    Elena Valer'evna Biryukova

    2014-03-01

    Full Text Available The introduction of DPP-4 inhibitors substantially increased therapeutic options for type 2 diabetes mellitus (T2DM. The unique mechanism of action allows using these agents both as monotherapy and in combination with conventional anti-diabetes drugs. Evidence base for efficacy and safety of DPP-4 inhibitors deepens every year, but to date only a few studies addressed direct comparison between individual agents within this pharmacological class. Current article presents data from the studies comparing vildagliptin with other DPP-4 inhibitors, as well as GLP-1 agonists.

  9. Safety of pressurized water reactors: problems and corresponding studies

    International Nuclear Information System (INIS)

    Cogne, F.

    1976-01-01

    The author recalls the safety problems subject to researches in the CEA, either because of their importance or because studies made abroad were not sufficiently developed or were classified or in order to acquire an independent judgement when safety is concerned. Those problems and studies are submitted referring to the 3 existing shields between man and dangerous materials: fuel element can, thermal shield, (pressure vessel and pipes), biological shield of which the behaviour is studied in connection with outside aggressions such as earthquakes, plane crashes, chemical explosions.. [fr

  10. 75 FR 5333 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2010-02-02

    ...) Place: Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia 22314, Telephone (703) 684-5900... matters related to the conduct of Study Section business and for the study section to consider safety and...

  11. Abstract of results of safety study. Nuclear fuel cycle field in fiscal 2003

    International Nuclear Information System (INIS)

    2004-11-01

    This report descried the results of studies of nuclear fuel cycle field (nuclear fuel facilities, seismic design, all subjects of environmental radiation and waste disposal, and subjects on nuclear fuel cycle in probabilistic safety assessment) in fiscal 2003 on the basis of the principle project of safety study (from fiscal 2001 to 2005). It consists of four chapters; the first chapter is outline of the principle of project, the second is objects and subjects of safety study in the nuclear fuel cycle field, the third list of questionnaire of results of safety study and the forth investigation of results of safety study in fiscal 2003. There are 49 lists, which include 22 reports on the nuclear fuel facility, one on the seismic design, 4 on the probabilistic safety assessment, 7 on the environmental radiation and 15 on the waste disposal. (S.Y.)

  12. Esomeprazole use is independently associated with significant reduction of BMD: 1-year prospective comparative safety study of four proton pump inhibitors.

    Science.gov (United States)

    Bahtiri, Elton; Islami, Hilmi; Hoxha, Rexhep; Qorraj-Bytyqi, Hasime; Rexhepi, Sylejman; Hoti, Kreshnik; Thaçi, Kujtim; Thaçi, Shpetim; Karakulak, Çağla

    2016-09-01

    Because of the efficacy of proton pump inhibitors (PPIs), their the use is increasing dramatically. The risk of adverse effects of short-term PPI therapy is low, but there are important safety concerns for potential adverse effects of prolonged PPI therapy. Findings from studies assessing the association between PPI use and bone mineral density (BMD) and/or fracture risk are contradictory. The aim of this study was to prospectively assess potential association of PPI treatment with the 12-month change in BMD of the lumbar spine, femur neck, and total hip. The study was performed in 200 PPI users and 50 PPI nonusers. Lumbar spine (L1-L4), femur neck, and total hip BMD were measured by dual-energy X-ray absorptiometry at the baseline and at 12 months. A total of 209 subjects completed the entire 12 months of the study and were included in the final analysis. A Wilcoxon signed-rank test showed that at 12 months PPI use was associated with statistically significant reductions in femur neck and total hip T scores (Z = -2.764, p = 0.005 and Z = -3.281, p = 0.001, respectively). A multiple linear regression analysis showed that only esomeprazole added significantly to the prediction of total lumbar spine and femur neck T scores (p = 0.048 and p = 0.037, respectively). Compared with the baseline, 12 months of PPI treatment resulted in lower femur neck and total hip BMD T scores. Among the four PPIs studied, esomeprazole was independently associated with significant reduction of BMD, whereas omeprazole had no effects on BMD. Considering the widespread use of PPIs, BMD screening should be considered in the case of prolonged PPI use.

  13. A feasibility study for Arizona's roadway safety management process using the Highway Safety Manual and SafetyAnalyst : final report.

    Science.gov (United States)

    2016-07-01

    To enable implementation of the American Association of State Highway Transportation (AASHTO) Highway Safety Manual using : SaftetyAnalyst (an AASHTOWare software product), the Arizona Department of Transportation (ADOT) studied the data assessment :...

  14. Safety study of PCC 2140 and ALILOG 21 used as part of safety measurement systems

    International Nuclear Information System (INIS)

    Meriaux, Pierre; Adnot, Serge; Rayrolles, Catherine.

    1978-03-01

    The PCC 2140 and ALILOG 21 equipment may be used at C.E.A. or E.D.F., as part of safety measurement systems. In a study of a similar, but earlier equipment, it was noticed that certain types of failures caused the system to switch to the least sensitive measurement range, which was detrimental to safety. This report analyses failure modes leading to unsafe failures and evaluates the risks ran into taking in account tests during use [fr

  15. Monitoring antimalarial safety and tolerability in clinical trials: A case study from Uganda

    Directory of Open Access Journals (Sweden)

    Mpimbaza Arthur

    2008-06-01

    Full Text Available Abstract Background New antimalarial regimens, including artemisinin-based combination therapies (ACTs, have been adopted widely as first-line treatment for uncomplicated malaria. Although these drugs appear to be safe and well-tolerated, experience with their use in Africa is limited and continued assessment of safety is a priority. However, no standardized guidelines for evaluating drug safety and tolerability in malaria studies exist. A system for monitoring adverse events in antimalarial trials conducted in Uganda was developed. Here the reporting system is described, and difficulties faced in analysing and interpreting the safety results are illustrated, using data from the trials. Case description Between 2002 and 2007, eleven randomized, controlled clinical trials were conducted to compare the efficacy, safety, and tolerability of different antimalarial regimens for treatment of uncomplicated malaria in Uganda. The approach to adverse event monitoring was similar in all studies. A total of 5,614 treatments were evaluated in 4,876 patients. Differences in baseline characteristics and patterns of adverse event reporting were noted between the sites, which limited the ability to pool and analyse data. Clinical failure following antimalarial treatment confounded associations between treatment and adverse events that were also common symptoms of malaria, particularly in areas of lower transmission intensity. Discussion and evaluation Despite prospectively evaluating for adverse events, limitations in the monitoring system were identified. New standardized guidelines for monitoring safety and tolerability in antimalarial trials are needed, which should address how to detect events of greatest importance, including serious events, those with a causal relationship to the treatment, those which impact on adherence, and events not previously reported. Conclusion Although the World Health Organization has supported the development of

  16. Empirical Analysis of Construction Safety Climate - A Study

    OpenAIRE

    S.V.S.RAJA PRASAD; K.P.REGHUNATH

    2010-01-01

    Safety in the construction industry has always been a major issue. Though much improvement in construction safety has been achieved, the industry still continues to lag behind most other industries with regard to safety. The safety climate of any organization consists of employee’s attitudes towards and perceptions of, health and safety behavior. Construction workers attitudes towards safety are influenced by their perceptions of risk, management, safety rulesand procedures. A measure of safe...

  17. Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: a pilot study.

    Science.gov (United States)

    Jerajani, Hr; Janaki, C; Kumar, Sharath; Phiske, Meghana

    2013-01-01

    Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses. To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses. 83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial 'Treatment Phase' involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a 'Follow-up Phase' at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse. Of the 83 patients, 62 completed the study, sertaconazole (n = 20), terbinafine (n = 22) and luliconazole (n = 20). The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85%) showed resolution of pruritus as compared to terbinafine (54.6%); and luliconazole (70%), (P terbinafine). There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation) in sertaconazole group (97.1%) as compared to terbinafine (91.2%) and luliconazole (92.9%). All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis. Sertaconazole was better than terbinafine and luliconazole in relieving signs and symptoms during study and follow up period. At the end of

  18. Comparative assessment of the efficacy and safety of sertaconazole (2% cream versus terbinafine cream (1% versus luliconazole (1% cream in patients with dermatophytoses: A pilot study

    Directory of Open Access Journals (Sweden)

    H R Jerajani

    2013-01-01

    Full Text Available Background : Sertaconazole is a new, broad spectrum, fungicidal and fungistatic imidazole with added antipruritic and anti-inflammatory activity that would provide greater symptomatic relief and hence would be beneficial in improving the quality of life for the patient with dermatophytoses. Aims and Objectives : To compare efficacy and safety of sertaconazole, terbinafine and luliconazole in patients with dermatophytoses. Materials and Methods : 83 patients with tinea corporis and tinea cruris infections were enrolled in this multicentre, randomized, open label parallel study. The initial ′Treatment Phase′ involved three groups receiving either sertaconazole 2% cream applied topically twice daily for four weeks, terbinafine 1% cream once daily for two weeks, luliconazole 1% cream once daily for two weeks. At the end of treatment phase, there was a ′Follow-up Phase′ at end of 2 weeks, where the patients were assessed clinically and mycologically for relapse. Results : Of the 83 patients, 62 completed the study, sertaconazole (n = 20, terbinafine (n = 22 and luliconazole (n = 20. The primary efficacy variables including change in pruritus, erythema, vesicle, desquamation and mycological cure were significantly improved in all the three groups, as compared to baseline, in the Treatment and Follow-up phase. Greater proportion of patients in sertaconazole group (85% showed resolution of pruritus as compared to terbinafine (54.6%; and luliconazole (70%, (P < 0.05 sertaconazole vs terbinafine. There was a greater reduction in mean total composite score (pruritus, erythema, vesicle and desquamation in sertaconazole group (97.1% as compared to terbinafine (91.2% and luliconazole (92.9%. All groups showed equal negative mycological assessment without any relapses. All three study drugs were well tolerated. Only one patient in sertaconazole group withdrew from the study due to suspected allergic contact dermatitis. Conclusion : Sertaconazole was

  19. Safety management and control policy. A study of the safety regulation of offshore oil activity by the Norwegian Petroleum Directorate. Sikkerhetsstyring og reguleringsteknikk. Oljedirektoratets regulering av sikkerheten ved produksjon av petroleum

    Energy Technology Data Exchange (ETDEWEB)

    Graver, H P

    1983-01-01

    The Norwegian Petroleum Directorate (NPD) is the main administrative body with responsibility to regulate and control the safety aspects of drilling for and production of petroleum on the Norwegian Continental Shelf. Its responsibility does not, however, include the aspects of maritime safety, which are regulated by the Norwegian Maritime Directorate. This study is limited to the regulation of safety on fixed installations for production of petroleum. The object has been to describe the methods applied by the NPD to achieve better safety, and to give answers to why these specific methods of approach have developed as they have. A conclusion that may be drawn from this study is that there exists a relationship of close cooperation between the NPD and the oil industry represented by the operating companies. Only this can explain the differences we find in the NPD approach as compared to the approach of other parts of public administration. Such a relationship probably leads to better safety within the scope of technical rationality than would have a more hostile relationship between the Directorate and the industry. This has its price, however. Aspects of the safety question not included within the limits of a purely technical approach are not as easily taken into account. Partly due to this fact, other parties with interests in safety are not represented.

  20. Contractors’ Attitude towards Enhancing Safety Performance: Case Study on Construction Firms in Penang

    Directory of Open Access Journals (Sweden)

    Ulang N. Md

    2014-01-01

    Full Text Available A qualitative study was conducted to investigate the contractors’ attitude towards enhancing the safety performance in construction site. Despite the fact that there are many safety initiatives established by the government, the rates of accidents are still in a critically high condition. Thus the purpose of this research is to study the contractors’ attitude towards enhancing the implementation of safety management system in construction site in order to increase the safety awareness of construction practitioners in construction site and improve the safety condition of construction sites. This study is conducted through oral interviews with the construction practitioners, and visual inspection of construction sites. The attitudes of contractors are evaluated from 3 aspects: Contractors’ efforts in implement and enforce the safety rules, Contractors efforts in overcoming the rate of accidents, and Reasons given by the contractors for not implement safety law.

  1. Studying the Safety Impact of Autonomous Vehicles Using Simulation-Based Surrogate Safety Measures

    OpenAIRE

    Morando, Mark Mario; Tian, Qingyun; Truong, Long T.; Vu, Hai L.

    2018-01-01

    Autonomous vehicle (AV) technology has advanced rapidly in recent years with some automated features already available in vehicles on the market. AVs are expected to reduce traffic crashes as the majority of crashes are related to driver errors, fatigue, alcohol, or drugs. However, very little research has been conducted to estimate the safety impact of AVs. This paper aims to investigate the safety impacts of AVs using a simulation-based surrogate safety measure approach. To this end, safety...

  2. 77 FR 75633 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2012-12-21

    ... (Closed). 8:00 a.m.-5:00 p.m., February 22, 2013 (Closed). Place: Embassy Suites, 1900 Diagonal Road... conduct of Study Section business and for the study section to consider safety and occupational health...

  3. Efficacy and Safety of Citalopram Compared to Atypical Antipsychotics on Agitation in Nursing Home Residents With Alzheimer Dementia.

    Science.gov (United States)

    Viscogliosi, Giovanni; Chiriac, Iulia Maria; Ettorre, Evaristo

    2017-09-01

    To assess efficacy and safety of citalopram compared to quetiapine and olanzapine for the treatment of agitation in patients with Alzheimer disease (AD). Longitudinal, 6-month study. Nursing home (NH). 75 NH residents with AD and agitation, randomized to citalopram (n = 25), quetiapine (n = 25), or olanzapine (n = 25). Changes in Neuropsychiatric Inventory (NPI) agitation subscale score and the modified Alzheimer Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) were used to assess treatment efficacy. Participants were surveilled for adverse health outcomes. Citalopram treatment (30±5.8 mg/d) resulted in similar 6-month efficacy compared to both quetiapine (94.0±40.4 mg/d) and olanzapine (5.2±1.6 mg/d), lower occurrence of falls than olanzapine [odds ratio (OR) = 0.81, 95% confidence interval (CI) = 0.68-0.97, P = .012], lower incidence of orthostatic hypotension than both quetiapine (OR = 0.80, 95% CI = 0.66-0.95, P = .032) and olanzapine (OR = 0.75, 95% CI = 0.69-0.91, P = .02), and less all-cause hospitalizations than both quetiapine (OR = 0.92, 95% CI = 0.88-0.95, P = .016) and olanzapine (OR = 0.78, 95% CI = 0.64-0.92, P = .004), after multiple adjustment for potentially confounding variables. No differences were observed for cognitive and functional decline, QTc prolongation, and infections. Citalopram resulted in similar efficacy and less adverse outcomes when compared to 2 atypical antipsychotics for treatment of agitation in NH residents with AD. Replication of these findings and assessment of long-term efficacy and safety of citalopram for treatment of neuropsychiatric symptoms in dementia are needed. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  4. Safety and efficacy of cervical laminoplasty using a piezosurgery device compared with a high-speed drill.

    Science.gov (United States)

    Li, Kunpeng; Zhang, Wen; Li, Bin; Xu, Hui; Li, Zhong; Luo, Dawei; Zhang, Jingtao; Ma, Jinzhu

    2016-09-01

    Piezosurgery is a relatively new osteotomy technique using microvibrations of scalpels at ultrasonic frequencies to perform safe and effective osteotomies without damage to adjacent soft tissue, which is widely used in spinal, oral, and maxillofacial surgery. We hypothesized that such a device could also be useful in cervical laminoplasty. The purpose of this study was to compare the safety and efficacy of a piezosurgery device with those of a highspeed drill in cervical laminoplasty. A prospectively randomized clinical study was designed. Forty-two consecutive patients were enrolled in the study. All patients underwent modified expansive open-door laminoplasty and were randomly divided into 2 groups according to the instrument for transection of the lamina, using high-speed drill (drill group) or piezosurgery device (piezosurgery group). The operation time, intraoperative blood loss, and postoperative drainage were recorded. Japanese Orthopedic Association (JOA) score and visual analogue scale (VAS) as clinical assessments were quantified. No significant difference was observed in the operation time between the 2 groups. In the piezosurgery group, there were less loss of the intraoperative blood and postoperative drainage compared with the drill group. However, clinical results (VAS and JOA scores) showed no significant difference between both groups during the all follow-up periods. The piezosurgery is a useful instrument and at least as safe and efficacious as the conventional high-speed drill in cervical laminoplasty.

  5. Why is patient safety so hard? A selective review of ethnographic studies.

    Science.gov (United States)

    Dixon-Woods, Mary

    2010-01-01

    Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics.

  6. Advances made in French safety studies on pressurized water reactors

    International Nuclear Information System (INIS)

    Pelce, J.

    1979-01-01

    The programme of French safety studies on reactors is supposed to be known in its main outlines. A few recent results, obtained in different fields are presented. They concern the safety margins evaluation, the contamination transfer and the effect of external aggressions

  7. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.

    Science.gov (United States)

    Park, Won; Yoo, Dae Hyun; Miranda, Pedro; Brzosko, Marek; Wiland, Piotr; Gutierrez-Ureña, Sergio; Mikazane, Helena; Lee, Yeon-Ah; Smiyan, Svitlana; Lim, Mie-Jin; Kadinov, Vladimir; Abud-Mendoza, Carlos; Kim, HoUng; Lee, Sang Joon; Bae, YunJu; Kim, SuYeon; Braun, Jürgen

    2017-02-01

    To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS). This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102. Efficacy end points included the proportion of patients achieving Assessment of SpondyloArthritis international Society (ASAS)20. Antidrug antibodies (ADAs) were measured using an electrochemiluminescent method. Data were analysed for patients treated with CT-P13 in the main PLANETAS study and the extension (maintenance group) and those who were switched to CT-P13 during the extension study (switch group). Overall, 174 (82.9%) of 210 patients who completed the first 54 weeks of PLANETAS and agreed to participate in the extension were enrolled. Among these, 88 were maintained on CT-P13 and 86 were switched to CT-P13 from RP. In these maintenance and switch groups, respectively, ASAS20 response rates at week 102 were 80.7% and 76.9%. ASAS40 and ASAS partial remission were also similar between groups. ADA positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively. This is the first study to show that switching from RP to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS. In the maintenance group, CT-P13 was effective and well tolerated over 2 years of treatment. NCT01571206; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

    Science.gov (United States)

    Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

    2016-01-01

    In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product. © 2015, The American College of Clinical Pharmacology.

  9. Benchmarking Global Food Safety Performances: The Era of Risk Intelligence.

    Science.gov (United States)

    Valleé, Jean-Charles Le; Charlebois, Sylvain

    2015-10-01

    Food safety data segmentation and limitations hamper the world's ability to select, build up, monitor, and evaluate food safety performance. Currently, there is no metric that captures the entire food safety system, and performance data are not collected strategically on a global scale. Therefore, food safety benchmarking is essential not only to help monitor ongoing performance but also to inform continued food safety system design, adoption, and implementation toward more efficient and effective food safety preparedness, responsiveness, and accountability. This comparative study identifies and evaluates common elements among global food safety systems. It provides an overall world ranking of food safety performance for 17 Organisation for Economic Co-Operation and Development (OECD) countries, illustrated by 10 indicators organized across three food safety risk governance domains: risk assessment (chemical risks, microbial risks, and national reporting on food consumption), risk management (national food safety capacities, food recalls, food traceability, and radionuclides standards), and risk communication (allergenic risks, labeling, and public trust). Results show all countries have very high food safety standards, but Canada and Ireland, followed by France, earned excellent grades relative to their peers. However, any subsequent global ranking study should consider the development of survey instruments to gather adequate and comparable national evidence on food safety.

  10. Safety design study of fast breeder reactors in Japan

    International Nuclear Information System (INIS)

    Miura, M.; Inagaki, T.

    1992-01-01

    This paper reports on two fast breeder reactor (FBR) concepts, the tank type and the loop type, that have been studied as possible reactor designs to be used for a demonstration FBR (DFBR). The basic principle fo the DFBR design is to ensure plant safety through a defense-in-depth methodology. Improvements in the seismic and thermal stress designs have been attempted for both reactor concepts. The system design study strives to maximize the reliability of the safety-related systems and to rationalize commercialization of the plant

  11. Patient safety challenges in a case study hospital--of relevance for transfusion processes?

    Science.gov (United States)

    Aase, Karina; Høyland, Sindre; Olsen, Espen; Wiig, Siri; Nilsen, Stein Tore

    2008-10-01

    The paper reports results from a research project with the objective of studying patient safety, and relates the finding to safety issues within transfusion medicine. The background is an increased focus on undesired events related to diagnosis, medication, and patient treatment in general in the healthcare sector. The study is designed as a case study within a regional Norwegian hospital conducting specialised health care services. The study includes multiple methods such as interviews, document analysis, analysis of error reports, and a questionnaire survey. Results show that the challenges for improved patient safety, based on employees' perceptions, are hospital management support, reporting of accidents/incidents, and collaboration across hospital units. Several of these generic safety challenges are also found to be of relevance for a hospital's transfusion service. Positive patient safety factors are identified as teamwork within hospital units, a non-punitive response to errors, and unit manager's actions promoting safety.

  12. COMPARATIVE EFFICACY AND SAFETY OF HYPOLIPIDEMIC THERAPY WITH GENERIC AND ORIGINAL MEDICINAL PRODUCTS OF SIMVASTATIN

    Directory of Open Access Journals (Sweden)

    E. I. Tarlovskaya

    2011-01-01

    Full Text Available Aim. To compare efficacy , safety and pharmacoeconomical characteristics of generic and original medicinal products of simvastatin in achievement of cholesterol and low density lipoprotein target levels. Material and methods. 38 patients with arterial hypertension accompanied by type 2 diabetes with dyslipidemia were included into the study. They had no clinically obvious ischemic heart disease and did not receive hypolipidemic pharmacotherapy for a month before the study start. The patients were randomized into group A or group B. Patients of group A (n=18 received original simvastatin, patients of group B (n=20 received generic simvastatin. Initial simvastatin dose was 20 mg daily. Lipid plasma profile, liver enzymes, creatine phosphokinase were evaluated every 4 weeks. Cost-effectiveness ratio was calculated. Results. 11 patients (61% in group A and only 5 patients (25% in group B (χ2=5.05; р<0.05 achieved cholesterol target level with simvastatin in dose of 20 mg daily in 3 months of the treatment. Creatine phosphokinase blood level did not increase significantly. Achievement of cholesterol target level cost 814 and 952 RUB per patient in groups A and B, respectively , in 1 month of simvastatin treatment. These costs were 643 and 417 RUB per patient in groups A and B, respectively , in 3 months of treatment. Conclusion. The original simvastatin in comparison with generic one has advantages in hypolipidemic effect. Safety profile is similar for both medications. Original simvastatin therapy has lower cost than this for generic simvastatin therapy in achievement of cholesterol target level in 1 month of treatment. In 3 months the cost of treatment per patient is 227 RUB higher for original medication in comparison with this for generic medication.

  13. The reactor safety study of experimental multi-purpose VHTR design

    International Nuclear Information System (INIS)

    Yasuno, T.; Mitake, S.; Ezaki, M.; Suzuki, K.

    1981-01-01

    Over the past years, the design works of the Experimental Very High Temperature Reactor (VHTR) plant have been conducted at Japan Atomic Energy Research Institute. The conceptual design has been completed and the more detailed design works and the safety analysis of the experimental VHTR plant are continued. The purposes of design studies are to show the feasibility of the experimental VHTR program, to specify the characteristics and functions of the plant components, to point out the R and D items necessary for the experimental VHTR plant construction, and to analyze the feature of the plant safety. In this paper the summary of system design and safety features of the experimental reactor are indicated. Main issues are the safety philosophy for the design basis accident, the accidents assumed and the engineered safety systems adopted in the design works

  14. A comparative review of patient safety initiatives for national health information technology

    DEFF Research Database (Denmark)

    Magrabi, Farah; Aarts, Jos; Nøhr, Christian

    2013-01-01

    OBJECTIVE: To collect and critically review patient safety initiatives for health information technology (HIT). METHOD: Publicly promulgated set of advisories, recommendations, guidelines, or standards potentially addressing safe system design, build, implementation or use were identified...... by searching the websites of regional and national agencies and programmes in a non-exhaustive set of exemplar countries including England, Denmark, the Netherlands, the USA, Canada and Australia. Initiatives were categorised by type and software systems covered. RESULTS: We found 27 patient safety initiatives...... were aimed at certification in the USA, Canada and Australia. Safety is addressed alongside interoperability in the Australian certification programme but it is not explicitly addressed in the US and Canadian programmes, though conformance with specific functionality, interoperability, security...

  15. Comparative efficacy and safety of selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors in older adults: a network meta-analysis.

    Science.gov (United States)

    Thorlund, Kristian; Druyts, Eric; Wu, Ping; Balijepalli, Chakrapani; Keohane, Denis; Mills, Edward

    2015-05-01

    To establish the comparative efficacy and safety of selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors in older adults using the network meta-analysis approach. Systematic review and network meta-analysis. Individuals aged 60 and older. Data on partial response (defined as at least 50% reduction in depression score from baseline) and safety (dizziness, vertigo, syncope, falls, loss of consciousness) were extracted. A Bayesian network meta-analysis was performed on the efficacy and safety outcomes, and relative risks (RRs) with 95% credible intervals (CrIs) were produced. Fifteen randomized controlled trials were eligible for inclusion in the analysis. Citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, fluoxetine, and sertraline were represented. Reporting on partial response and dizziness was sufficient to conduct a network meta-analysis. Reporting on other outcomes was sparse. For partial response, sertraline (RR=1.28), paroxetine (RR=1.48), and duloxetine (RR=1.62) were significantly better than placebo. The remaining interventions yielded RRs lower than 1.20. For dizziness, duloxetine (RR=3.18) and venlafaxine (RR=2.94) were statistically significantly worse than placebo. Compared with placebo, sertraline had the lowest RR for dizziness (1.14) and fluoxetine the second lowest (1.31). Citalopram, escitalopram, and paroxetine all had RRs between 1.4 and 1.7. There was clear evidence of the effectiveness of sertraline, paroxetine, and duloxetine. There also appears to be a hierarchy of safety associated with the different antidepressants, although there appears to be a dearth of reporting of safety outcomes. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  16. Preferences for food safety and animal welare - a choice experiment study comparing organic and conventional consumers

    DEFF Research Database (Denmark)

    Christensen, Tove; Mørkbak, Morten; Denver, Sigrid

    Food quality attributes such as food safety and animal welfare are increasingly influencing consumers' choices of food products. These attributes are not readily traded in the markets. Hence, stated preference methods have proven to be valuable tools for eliciting preferences for such non......-traded attributes. A discrete choice experiment is employed, and the results indicate that consumers in general are willing to pay a premium for campylobacter-free chicken and for improved animal welfare; and they are willing to pay an additional premium for a product containing both attributes. Further, we find...

  17. A study of RFID application impacts on medical safety.

    Science.gov (United States)

    Chang, She-I; Ou, Chin-Shyh; Ku, Cheng-Yuan; Yang, Morris

    2008-01-01

    With the international reform in medical management systems gaining ground worldwide, hospital management has gradually begun to shift its focus from providing expensive medical treatment to improving medical service quality and patient safety. In this study, we discuss the application of Radio Frequency Identification (RFID) and data integrating technology with the medical service, and examine whether or not this technology can enhance medical safety. We also discuss the possible benefits following the application of the RFID system. The findings show that the application of RFID to hospitals can actually generate benefits, which can be further divided into operational structure benefits, users' structure benefits, and organisational and environmental benefits. However, not all these benefits can achieve medical safety. Among them, only the operator and environmental benefits can play such roles. Nevertheless, the application of RFID can bring hospitals towards the integration of technology benefits and improved medical safety.

  18. Bus safety study : a report to Congress.

    Science.gov (United States)

    2013-11-01

    Section 20021(b) of the Moving Ahead for Progress for the 21st Century (MAP-21) legislation requires the Secretary of Transportation : to submit a report of the results of a Bus Safety Study to the Committee on Banking, Housing, and Urban Affai...

  19. Per-Oral Endoscopic Myotomy Versus Laparoscopic Heller Myotomy for Achalasia: A Meta-Analysis of Nonrandomized Comparative Studies.

    Science.gov (United States)

    Zhang, Yuan; Wang, Hongjuan; Chen, Xingdong; Liu, Lan; Wang, Hongbo; Liu, Bin; Guo, Jianqiang; Jia, Hongying

    2016-02-01

    We aimed to assess the short-term outcomes of per-oral endoscopic myotomy (POEM) compared with laparoscopic Heller myotomy (LHM) for achalasia through a meta-analysis of nonrandomized comparative studies.We searched PubMed, Embase, Medline, Cochrane Library, and Google Scholar for studies that compared POEM and LHM for achalasia and were published between January 1, 2008 and December 31, 2014. The Methodological Index for Nonrandomized Studies (MINORS) was used to evaluate the quality of the studies. Random- and fixed-effects meta-analytical models were used, and between-study heterogeneity was assessed.Four nonrandomized comparative studies that included 317 patients (125 in the POEM group and 192 in the LHM group) met our research criteria and were assessed. There were no differences between the POEM and LHM groups in terms of sex, preoperative Eckhart score, length of myotomy, operation time, length of hospital stay, and complications. The patients in the POEM group were older than those in the LHM group (MD =2.81, 95% CI 0.27-5.35; P = 0.03) with high between-study homogeneity (χ = 1.96, df = 2, I = 0%; P = 0.38). The patients in the POEM group had a lower Eckardt score after surgery compared with those in the LHM group (MD = -0.30, 95% CI -0.42 to -0.18; P < 0.001) with high between-study homogeneity (χ = 0.00, df = 1, I = 0%; P = 1.00).The efficacy and safety of POEM appear to be comparable to those of LHM. Multicenter and randomized trials with larger sample size are needed to further compare the efficacy and safety of POEM and LHM for the treatment of achalasia.

  20. Safety in the ARIES Tokamak Design Study

    International Nuclear Information System (INIS)

    Herring, J.S.; Wong, C.P.-C.; Cheng, E.T.; Grotz, S.

    1989-01-01

    Safety is one of the primary goals of the ARIES Tokamak Design Study. Public safety goals are the achievement passive safety which is demonstrable in tests that could precede operation and the assurance that releases from accidents be passively limited such that no evacuation plan in necessary. Strategies for safety of the plant investment are factory fabrication, short construction times and a design such that no off-normal operational transient results in damage which could not be repaired in routine maintenance. ARIES-I, the first of three 'visions' of potential tokamak reactors, will use He at 5 MPa as a blanket coolant and SiC/composite ceramic for the first wall and blanket materials. Both the coolant and the structural material were chosen for their low activation, both in the short term after accidents and for long term waste management. The breeder, Li 4 SiO 4 , was also chosen for low activation. Contemporary plasma physics and aggressive technology are used in ARIES-I, which results in very high toroidal fields (24 T maximum at the coil). The stored TF energy will be about 130 GJ. A central concern is the safe discharge of this stored energy under electrical fault conditions and prevention of a failure in the magnet set from propagating into systems containing radioactive inventories. The TF coil system consists of 16 coils, each containing two separate windings powered by two independent power supplies. Arcs and shorts between the two power supply systems and across individual windings have been modeled. In addition, delay or failure in circuit breaker opening has been modeled. The safety impacts of LOCA, LOFA and disruptive events have also been evaluated. 8 refs., 4 figs., 7 tabs

  1. Comparative health and safety assessment of the satellite power system and other electrical generation alternatives

    International Nuclear Information System (INIS)

    1980-12-01

    The work reported here is an analysis of existing data on the health and safety risks of a satellite power system and six electrical generation systems: a combined-cycle coal power system with a low-Btu gasifier and open-cycle gas turbine; a light water fission power system without fuel reprocessing; a liquid-metal, fast-breeder fission reactor; a centralized and decentralized, terrestrial, solar-photovoltaic power system; and a first-generation design for a fusion power system. The systems are compared on the basis of expected deaths and person-days lost per year associated with 1000 MW of average electricity generation. Risks are estimated and uncertainties indicated for all phases of the energy production cycle, including fuel and raw material extraction and processing, direct and indirect component manufacture, on-site construction, and system operation and maintenance. Also discussed is the potential significance of related major health and safety issues that remain largely unquantifiable. The appendices provide more detailed information on risks, uncertainties, additional research needed, and references for the identified impacts of each system

  2. 77 FR 43090 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Science.gov (United States)

    2012-07-23

    ... Committee Act (Pub. L. 92-463) of October 6, 1972, that the Safety and Occupational Health Study Section... Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and...

  3. 75 FR 42455 - Safety and Occupational Health Study Section: Notice of Charter Renewal

    Science.gov (United States)

    2010-07-21

    ... Committee Act (Pub. L. 92-463) of October 6, 1972, that the Safety and Occupational Health Study Section... Secretary, Safety and Occupational Health Study Section, Department of Health and Human Services, 1600... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Safety and...

  4. EPR safety. Consideration of the internal and external hazards in the safety studies

    International Nuclear Information System (INIS)

    Gueguin, H.

    2008-04-01

    The author presents the main points of the Preliminary Safety Report of EDF on the EPR reactor safety. It concerns the considerations of the internal (fire, flood, explosions, pipes failures) and external (earthquakes, airplane falls, explosions, exceptional natural disasters, extreme meteorological conditions) damages. It presents how the safety report takes into account the aggression. (A.L.B.)

  5. [Efficacy and safety of tulobuterol patch versus oral salbutamol sulfate in children with mild or moderate acute attack of bronchial asthma: a comparative study].

    Science.gov (United States)

    Lin, Qian; Liu, Quan-Hua; Bao, Yi-Xiao

    2013-06-01

    To compare tulobuterol patch and oral salbutamol sulfate in terms of efficacy and safety in children with mild or moderate acute attack of bronchial asthma. A total of 92 children with mild and moderate acute asthmatic attack were randomly divided into salbutamol group (n=46) and tulobuterol group (n=46). Both groups received routine treatment with antihistamine, selective leukotriene receptor antagonist and glucocorticoid. In addition, the salbutamol group was given slow-release capsules of salbutamol sulfate, and the tulobuterol group was treated with tulobuterol patch. The two groups were compared with respect to symptom scores of cough, wheeze, respiratory rate, wheezing sound, three depression sign and peak expiratory flow, as well as adverse events. As the treatment proceeded, symptom scores decreased in both groups; on the third day of treatment, all symptom scores except cough score showed a significant decrease in both groups (Pattack.

  6. Fire safety study of Dodewaard and Borssele nuclear power plants

    International Nuclear Information System (INIS)

    1988-03-01

    From the nuclear and conventional fire safety audits of both Dutch nuclear power plants performed under supervision of the Nuclear Safety Inspectorate and the Inspectorate for the Fire Services it turns out that the fire safety is sufficient however amenable for improvement. Besides a detailed description of the method of examination, the study 'Fire Safety' contains the results of the audit and 14 respectively 15 recommendations for improvement of the fire safety in Dodewaard and Borssele. The suggested recommendations which are applicable to both power plants are the following: fire fighting training for operators and guards, a complete emergency ventilation system of the control room, increase in the number of detectors and alarms, an increase in the quantity of water available for high-pressure fire fighting, improvement of fire barriers between several redundancies of nuclear safety systems, an investigation and possible improvement of the heat and radiation protection offered by presently used fire fighting suits. For Dodewaard a closed emergency staircase in the reactor building (secondary containment) is deemed necessary for personnel emergency escape routes and continued fire fighting if required

  7. 78 FR 24751 - Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety...

    Science.gov (United States)

    2013-04-26

    ... 14, 2013 (Closed) Place: Embassy Suites, 1900 Diagonal Road, Alexandria, Virginia 22314, Telephone... business and for the study section to consider safety and occupational health-related grant applications...

  8. Patient safety in the operating room: an intervention study on latent risk factors

    Directory of Open Access Journals (Sweden)

    van Beuzekom Martie

    2012-06-01

    Full Text Available Abstract Background Patient safety is one of the greatest challenges in healthcare. In the operating room errors are frequent and often consequential. This article describes an approach to a successful implementation of a patient safety program in the operating room, focussing on latent risk factors that influence patient safety. We performed an intervention to improve these latent risk factors (LRFs and increase awareness of patient safety issues amongst OR staff. Methods Latent risk factors were studied using a validated questionnaire applied to the OR staff before and after an intervention. A pre-test/post-test control group design with repeated measures was used to evaluate the effects of the interventions. The staff from one operating room of an university hospital acted as the intervention group. Controls consisted of the staff of the operating room in another university hospital. The outcomes were the changes in LRF scores, perceived incident rate, and changes in incident reports between pre- and post-intervention. Results Based on pre-test scores and participants’ key concerns about organizational factors affecting patient safety in their department the intervention focused on the following LRFs: Material Resources, Training and Staffing Recourses. After the intervention, the intervention operating room - compared to the control operating room - reported significantly fewer problems on Material Resources and Staffing Resources and a significantly lower score on perceived incident rate. The contribution of technical factors to incident causation decreased significantly in the intervention group after the intervention. Conclusion The change of state of latent risk factors can be measured using a patient safety questionnaire aimed at these factors. The change of the relevant risk factors (Material and Staffing resources concurred with a decrease in perceived and reported incident rates in the relevant categories. We conclude that

  9. Assessment of Safety Standards for Automotive Electronic Control Systems

    Science.gov (United States)

    2016-06-01

    This report summarizes the results of a study that assessed and compared six industry and government safety standards relevant to the safety and reliability of automotive electronic control systems. These standards include ISO 26262 (Road Vehicles - ...

  10. Echocardiography-based hemodynamic management of left ventricular diastolic dysfunction: a feasibility and safety study.

    Science.gov (United States)

    Shillcutt, Sasha K; Montzingo, Candice R; Agrawal, Ankit; Khaleel, Maseeha S; Therrien, Stacey L; Thomas, Walker R; Porter, Thomas R; Brakke, Tara R

    2014-11-01

    Patients with left ventricular diastolic dysfunction (LVDD) are at increased risk of postoperative adverse events. The primary aim of this study was to evaluate the safety and feasibility of using echocardiography-guided hemodynamic management (EGHEM) during surgery in subjects with LVDD compared to conventional management. The feasibility of using echocardiography to direct a treatment algorithm and clinical outcomes were compared for safety between groups. Subjects were screened for LVDD by preoperative transthoracic echocardiography (TTE) and randomized to the conventional or EGHEM group. Subjects in EGHEM received hemodynamic management based on left ventricular filling patterns on transesophageal echocardiography (TEE). Primary outcomes measured were the feasibility to obtain TEE images and follow a TEE-based treatment algorithm. Safety outcomes also compared the following clinical differences between groups: length of hospitalization, incidence of atrial fibrillation, congestive heart failure (CHF), myocardial infarction, cerebrovascular accident, transient ischemic attack and renal failure measured 30 days postoperatively. Population consisted of 28 surgical subjects (14 in conventional group and 14 in EGHEM group). Mean subject age was 73.4 ± 6.7 years (36% male) in conventional group and 65.9 ± 14.4 years (36% male) in EGHEM group. Procedures included orthopedic (conventional = 29%, EGHEM 36%), general (conventional = 50%, EGHEM = 36%), vascular (conventional = 7%, EGHEM = 21%), and thoracic (conventional = 14%, EGHEM = 7%). There was no statistically significant difference in adverse clinical events between the 2 groups. The EGHEM group had less CHF, atrial fibrillation, and shorter length of stay. Echocardiography-guided hemodynamic management of patients with LVDD during surgery is feasible and may be a safe alternative to conventional management. © 2014, Wiley Periodicals, Inc.

  11. Simulation study of coal mine safety investment based on system dynamics

    Institute of Scientific and Technical Information of China (English)

    Tong Lei; Dou Yuanyuan

    2014-01-01

    To generate dynamic planning for coal mine safety investment, this study applies system dynamics to decision-making, classifying safety investments by accident type. It validates the relationship between safety investments and accident cost, by structurally analyzing the causality between safety investments and their influence factors. Our simulation model, based on Vensim software, conducts simulation anal-ysis on a series of actual data from a coalmine in Shanxi Province. Our results indicate a lag phase in safety investments, and that increasing pre-phase safety investment reduces accident costs. We found that a 24%increase in initial safety investment could help reach the target accident costs level 14 months earlier. Our simulation test included nine kinds of variation trends of accident costs brought by different investment ratios on accident prevention. We found an optimized ratio of accident prevention invest-ments allowing a mine to reach accident cost goals 4 months earlier, without changing its total investment.

  12. Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis.

    Directory of Open Access Journals (Sweden)

    Julian F Guest

    Full Text Available This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age with ABSSSI.Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1 clinical treatment success and (2 microbiological success at TOC visit. Safety-related endpoints were (1 number of discontinuations due to AEs/SAEs, (2 patients experiencing AEs, (3 patients experiencing SAEs and (4 all-cause mortality.Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline.Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings

  13. Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis

    Science.gov (United States)

    Esteban, Jaime; Manganelli, Anton G.; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

    2017-01-01

    Objective This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Methods Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Results Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Conclusion Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different

  14. Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis.

    Science.gov (United States)

    Guest, Julian F; Esteban, Jaime; Manganelli, Anton G; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

    2017-01-01

    This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings

  15. Comparative Investigation on 0.4 inch SBLOCA Scenario with Single and Dual Train Passive Safety Injection Systems using SMART-ITL

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hyun-Sik; Bae, Hwang; Ryu, Sung-Uk; Jeon, Byong-Guk; Yang, Jin-Hwa; Yun, Eun-Koo; Choi, Nam-Hyun; Min, Kyoung-Ho; Shin, Yong-Cheol; Bang, Yoon-Gon; Kim, Myoung-Jun; Seo, Chan-Jong; Yi, Sung-Jae [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    The Standard Design Approval (SDA) for SMART was certificated in 2012 at the Korea Atomic Energy Research Institute (KAERI). In December 2015, Saudi Arabia and Korea started conducting a three-year project of Pre-Project Engineering (PPE) to prepare a Preliminary Safety Analysis Report (PSAR) and to review the feasibility of constructing SMART reactors in Saudi Arabia. In addition, an Integral Test Loop for the SMART design (SMART-ITL, or FESTA) has been constructed and it finished its commissioning tests in 2012. Consequently, a set of Design Base Accident (DBA) scenarios have been simulated using SMART-ITL. In this paper, a comparative investigation was performed on 0.4 inch SBLOCA scenario with single and dual train passive safety injection systems using SMART-ITL. In this paper, the effect of the train number of PSIS on a SBLOCA scenario is investigated for a break size of 0.4 inch. The single and dual train tests show a similar trend in general but the injected water migrates slightly differently in the RV and is discharged through the break nozzle. The parameters of the RV pressure, RV water level, accumulated break mass, and injection flowrates from the CMT and SIT were compared. Compared with the single train test, the increased injection rates from the two trains of the PSIS during the dual train test raised the RV water level, ensuring the safety of the reactor core.

  16. Project Alternative Systems Study - PASS. Analysis of performance and long-term safety of repository concepts

    International Nuclear Information System (INIS)

    Birgersson, L.; Skagius, K.; Wiborgh, M.; Widen, H.

    1992-09-01

    This study is part of the Project on Alternative Systems Study, PASS, with the overall aim to perform a technical/economical ranking of alternative repository concepts and canisters for the final storage of spent nuclear fuel. The comparison should in the first stage separately assess technology in construction and operation, long-term performance and safety, and costs. Three of the repository concepts are assumed to be located at a depth of approximately 500 m in the host rock, KBS-3, Very Long Holes (VLH) and Medium Long Holes (MLH). In the KBS-3 concept the canisters are deposited in vertical deposition holes in a system of parallel storage tunnels. In the VLH concept larger canisters are deposited in long horizontal tunnels. The MLH concept, is an evolution of the two other concepts, with KBS-3 type canisters deposited in horizontal tunnels. Smaller canisters are to be deposited in deep bore holes at a depth between 2000 to 4000 m in the Very Deep Holes (VDH) concept. In all concepts the canisters will be surrounded by a bentonite buffer. The aim of the present study is to analyze and compare the performance and long-term safety of the repository concepts. Only a qualitative comparison of the concepts is made as no calculations of radionuclide releases or dose to man have been performed. The ranking of the repository concepts was carried out by comparing the VDH, VLH and MLH concept with the KBS-3 concept. The performance and long-term safety of the repositories located at 500 m level will be based on a multiple barrier system and the predictions for the concepts will involve similar uncertainties. (54 refs.)

  17. A phase 1, open-label, randomized study to compare the immunogenicity and safety of different administration routes and doses of virosomal influenza vaccine in elderly.

    Science.gov (United States)

    Levin, Yotam; Kochba, Efrat; Shukarev, Georgi; Rusch, Sarah; Herrera-Taracena, Guillermo; van Damme, Pierre

    2016-10-17

    Influenza remains a significant problem in elderly despite widespread vaccination coverage. This randomized, phase-I study in elderly compared different strategies of improving vaccine immunogenicity. A total of 370 healthy participants (⩾65years) were randomized equally 1:1:1:1:1:1 to six influenza vaccine treatments (approximately 60-63 participants per treatment arm) at day 1 that consisted of three investigational virosomal vaccine formulations at doses of 7.5, 15, and 45μg HA antigen/strain administered intradermally (ID) by MicronJet600™ microneedle device (NanoPass Technologies) or intramuscularly (IM), and three comparator registered seasonal vaccines; Inflexal V™ (Janssen) and MF59 adjuvanted Fluad™ (Novartis) administered IM and Intanza™ (Sanofi Pasteur) administered ID via Soluvia™ prefilled microinjection system (BD). Serological evaluations were performed at days 22 and 90 and safety followed-up for 6months. Intradermal delivery of virosomal vaccine using MicronJet600™ resulted in significantly higher immunogenicity than the equivalent dose of virosomal Inflexal V™ administered intramuscularly across most of the parameters and strains, as well as in some of the readouts and strains as compared with the 45μg dose of virosomal vaccine formulation. Of 370 participants, 300 (81.1%) reported ⩾1 adverse event (AE); more participants reported solicited local AEs (72.2%) than solicited systemic AEs (12.2%). Intradermal delivery significantly improved influenza vaccine immunogenicity compared with intramuscular delivery. Triple dose (45μg) virosomal vaccine did not demonstrate any benefit on vaccine's immunogenicity over 15μg commercial presentation. All treatments were generally safe and well-tolerated. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. Study on operational safety issues in the Japanese disposal concept

    International Nuclear Information System (INIS)

    Suzuki, Satoru; Kitagawa, Yoshito; Hyodo, Hideaki; Kubota, Shigeru; Iijima, Masayoshi; Tamura, Akio; Ishiguro, Katsuhiko; Fujihara, Hiroshi

    2014-01-01

    In Japan, vitrified high-level radioactive waste (HLW) and certain types of low-level radioactive waste that results from the reprocessing of spent fuel and classified as TRU waste will be disposed of in deep geological formations. NUMO aims to ensure the safety of local residents and workers during the operational phase and after repository closure and will therefore establish a safety case for the geological disposal programme at the end of each stage of the stepwise siting process. Although the Japanese programme is still in the stage before initiation of the siting process, updating the generic (non-site-specific) safety case is required for building confidence among stakeholders. This study focuses on operational safety issues for the Japanese HLW disposal concept. (authors)

  19. Preliminary study on functional performance of compound type multistage safety injection tank

    International Nuclear Information System (INIS)

    Bae, Youngmin; Kim, Young In; Kim, Keung Koo

    2015-01-01

    Highlights: • Functional performance of compound type multistage safety injection tanks is studied. • Effects of key design parameters are scrutinized. • Distinctive flow features in compound type safety injection tanks are explored. - Abstract: A parametric study is carried out to evaluate the functional performance of a compound type multistage safety injection tank that would be considered one of the components for the passive safety injection systems in nuclear power plants. The effects of key design parameters such as the initial volume fraction and charging pressure of gas, tank elevation, vertical location of a sparger, resistance coefficient, and operating condition on the injection flow rate are scrutinized along with a discussion of the relevant flow features. The obtained results indicate that the compound type multistage safety injection tank can effectively control the injection flow rate in a passive manner, by switching the driving force for the safety injection from gas pressure to gravity during the refill and reflood phases, respectively

  20. Tritium safety study using Caisson Assembly (CATS) at TPL/JAEA

    International Nuclear Information System (INIS)

    Hayashi, T.; Kobayashi, K.; Iwai, Y.; Isobe, K.; Nakamura, H.; Kawamura, Y.; Shu, W.; Suzuki, T.; Yamada, M.; Yamanishi, T.

    2008-01-01

    Tritium confinement is required as the most important safety Junction for a fusion reactor. In order to demonstrate the confinement performance experimentally, an unique equipment, called CATS: Caisson Assembly for Tritium Safety study, was installed in Tritium Process Laboratory of Japan Atomic Energy Agency and operated for about 10 years. Tritium confinement and migration data in CATS have been accumulated and dynamic simulation code was accumulated using these data. Contamination and decontamination behavior on various materials and new safety equipment functions have been investigated under collaborations with a lot of laboratories and universities. (authors)

  1. Randomized controlled trials and real-world observational studies in evaluating cardiovascular safety of inhaled bronchodilator therapy in COPD

    Directory of Open Access Journals (Sweden)

    Kardos P

    2016-11-01

    limitations of data derived from each study type. We also describe an ongoing prospective, observational, comparative post-authorization safety study of a LAMA/LABA combination therapy (umeclidinium/vilanterol and LAMA monotherapy (umeclidinium versus tiotropium, with a focus on the relative merits of the study design. Keywords: real-world observational study, cardiovascular, cerebrovascular, safety, umeclidinium, vilanterol

  2. The selection of field component reliability data for use in nuclear safety studies

    International Nuclear Information System (INIS)

    Coxson, B.A.; Tabaie, Mansour

    1990-01-01

    The paper reviews the user requirements for field component failure data in nuclear safety studies, and the capability of various data sources to satisfy these requirements. Aspects such as estimating the population of items exposed to failure, incompleteness, and under-reporting problems are discussed. The paper takes as an example the selection of component reliability data for use in the Pre-Operational Safety Report (POSR) for Sizewell 'B' Power Station, where field data has in many cases been derived from equipment other than that to be procured and operated on site. The paper concludes that the main quality sought in the available data sources for such studies is the ability to examine failure narratives in component reliability data systems for equipment performing comparable duties to the intended plant application. The main benefit brought about in the last decade is the interactive access to data systems which are adequately structured with regard to the equipment covered, and also provide a text-searching capability of quality-controlled event narratives. (author)

  3. Effect of static electronic advertising signs on road safety: an experimental case study.

    Science.gov (United States)

    Izadpanah, Pedram; Omrani, Reza; Koo, Sheldon; Hadayeghi, Ali

    2014-01-01

    As technology continues to advance, the outdoor advertising industry is taking advantage of electronic signs, some of which are static electronic signs (SES), with the ability to automatically change the message shown on the sign at regular intervals. Studies indicate that SES has a negative impact on the drivers' visual attention and on vehicle control. However, the actual effects of the SES on the number of collisions have been difficult to prove conclusively. The objective of this article is to generate a clear understanding of the safety impacts of SES on the number collisions by conducting a before-and-after analysis with comparison groups. The analysis was based on a total of 10 SES along the Highway 27 and the Gardiner Expressway of the city of Toronto. The results of the before-and-after study revealed that there was not enough evidence to suggest that these signs have any impact on road safety along the adjacent roadway sections at a 95% confidence interval. The same results were obtained by comparing collisions that occurred during daylight and artificial light.

  4. Global bike share: What the data tells us about road safety.

    Science.gov (United States)

    Fishman, Elliot; Schepers, Paul

    2016-02-01

    Bike share has emerged as a rapidly growing mode of transport in over 800 cities globally, up from just a handful in the 1990s. Some analysts had forecast a rise in the number of bicycle crashes after the introduction of bike share, but empirical research on bike share safety is rare. The goal of this study is to examine the impact of bike share programs on cycling safety. The paper has two substudies. Study 1 was a secondary analysis of longitudinal hospital injury data from the Graves et al. (2014) study. It compared cycling safety in cities that introduced bike share programs with cities that did not. Study 2 combined ridership data with crash data of selected North American and European cities to compare bike share users to other cyclists. Study 1 indicated that the introduction of a bike share system was associated with a reduction in cycling injury risk. Study 2 found that bike share users were less likely than other cyclists to sustain fatal or severe injuries. On a per kilometer basis, bike share is associated with decreased risk of both fatal and non-fatal bicycle crashes when compared to private bike riding. The results of this study suggest that concerns of decreased levels of cycling safety are unjustified and should not prevent decision makers from introducing public bike share schemes, especially if combined with other safety measures like traffic calming. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

  5. Safety benefits from CANDU reactor replacement - a case study

    International Nuclear Information System (INIS)

    Mottram, R.; Millard, J.W.F.; Purdy, P.

    2011-01-01

    Both total core replacement and core retubing have been used in the CANDU industry. For future plant refurbishments, based on experience both in new construction and in recent refurbishments, the concept of total core replacement has been revisited. This builds on practices for replacement of other large plant equipment like boilers. The Bruce CANDU reactors, with their local shield tanks built around the Calandria and containment closely located around that Calandria Shield Tank Assembly (CSTA), are believed to be good candidates for core replacement. A structured process was used to design a replacement CSTA suitable for Bruce A use. The work started with a study of opportunities for safety enhancements in the core. This progressed into design studies and related design assist safety analysis on the reactor. A key element of the work involved consideration of how verified features from later CANDU designs, and from our new reactor design work, could be tailored to fit this replacement core. The replacement reactor core brings in structural improvements in both calandria and end shield, and safety improvements like the natural circulation enhancing moderator cooling layout and further optimized reactivity layouts to improve shutdown system performance. Bruce Power are currently studying the business implications of this and retube techniques as part of preparation for future refurbishments. The work explained in this paper is in the context of the safety related changes and the work to choose and quantify them. (author)

  6. Safety benefits from CANDU reactor replacement. A case study

    International Nuclear Information System (INIS)

    Mottram, R.; Millard, J.W.F.; Purdy, P.

    2011-01-01

    Both total core replacement and core retubing have been used in the CANDU industry. For future plant refurbishments, based on experience both in new construction and in recent refurbishments, the concept of total core replacement has been revisited. This builds on practices for replacement of other large plant equipment like boilers. The Bruce CANDU reactors, with their local shield tanks built around the Calandria and containment closely located around that Calandria Shield Tank Assembly (CSTA), are believed to be good candidates for core replacement. A structured process was used to design a replacement CSTA suitable for Bruce A use. The work started with a study of opportunities for safety enhancements in the core. This progressed into design studies and related design assist safety analysis on the reactor. A key element of the work involved consideration of how verified features from later CANDU designs, and from our new reactor design work, could be tailored to fit this replacement core. The replacement reactor core brings in structural improvements in both calandria and end shield, and safety improvements like the natural circulation enhancing moderator cooling layout and further optimized reactivity layouts to improve shutdown system performance. Bruce Power are currently studying the business implications of this and retube techniques as part of preparation for future refurbishments. The work explained in this paper is in the context of the safety related changes and the work to choose and quantify them. (author)

  7. Ferrocyanide safety project ferrocyanide aging studies. Final report

    International Nuclear Information System (INIS)

    Lilga, M.A.; Hallen, R.T.; Alderson, E.V.

    1996-06-01

    This final report gives the results of the work conducted by Pacific Northwest National Laboratory (PNNL) from FY 1992 to FY 1996 on the Ferrocyanide Aging Studies, part of the Ferrocyanide Safety Project. The Ferrocyanide Safety Project was initiated as a result of concern raised about the safe storage of ferrocyanide waste intermixed with oxidants, such as nitrate and nitrite salts, in Hanford Site single-shell tanks (SSTs). In the laboratory, such mixtures can be made to undergo uncontrolled or explosive reactions by heating dry reagents to over 200 degrees C. In 1987, an Environmental Impact Statement (EIS), published by the U.S. Department of Energy (DOE), Final Environmental Impact Statement, Disposal of Hanford Defense High-Level Transuranic and Tank Waste, Hanford Site, Richland, Washington, included an environmental impact analysis of potential explosions involving ferrocyanide-nitrate mixtures. The EIS postulated that an explosion could occur during mechanical retrieval of saltcake or sludge from a ferrocyanide waste tank, and concluded that this worst-case accident could create enough energy to release radioactive material to the atmosphere through ventilation openings, exposing persons offsite to a short-term radiation dose of approximately 200 mrem. Later, in a separate study (1990), the General Accounting Office postulated a worst-case accident of one to two orders of magnitude greater than that postulated in the DOE EIS. The uncertainties regarding the safety envelope of the Hanford Site ferrocyanide waste tanks led to the declaration of the Ferrocyanide Unreviewed Safety Question (USQ) in October 1990

  8. Safety goals for commercial nuclear power plants

    International Nuclear Information System (INIS)

    Roe, J.W.

    1988-01-01

    In its official policy statement on safety goals for the operation of nuclear power plants, the Nuclear Regulatory Commission (NRC) set two qualitative goals, supported by two quantitative objectives. These goals are that (1) individual members of the public should be provided a level of protection from the consequences of nuclear power plant operation such that individuals bear no significant additional risk to life and health; and (2) societal risks to life and health from nuclear power plant operation should be comparable to or less than the risks of generating electricity by viable competing technologies and should not be a significant addition to other societal risks. As an alternative, this study proposes four quantitative safety goals for nuclear power plants. It begins with an analysis of the NRC's safety-goal development process, a key portion of which was devoted to delineating criteria for evaluating goal-development methods. Based on this analysis, recommendations for revision of the NRC's basic benchmarks for goal development are proposed. Using the revised criteria, NRC safety goals are evaluated, and the alternative safety goals are proposed. To further support these recommendations, both the NRC's goals and the proposed goals are compared with the results of three major probabilistic risk assessment studies. Finally, the potential impact of these recommendations on nuclear safety is described

  9. The Safety of Melatonin in Humans

    DEFF Research Database (Denmark)

    Andersen, Lars Peter Holst; Gögenür, Ismayil; Rosenberg, Jacob

    2016-01-01

    Exogenous melatonin has been investigated as treatment for a number of medical and surgical diseases, demonstrating encouraging results. The aim of this review was to present and evaluate the literature concerning the possible adverse effects and safety of exogenous melatonin in humans. Furthermore...... been reported. No studies have indicated that exogenous melatonin should induce any serious adverse effects. Similarly, randomized clinical studies indicate that long-term melatonin treatment causes only mild adverse effects comparable to placebo. Long-term safety of melatonin in children...

  10. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  11. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  12. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  13. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

    Science.gov (United States)

    Tanglertsampan, Chuchai

    2012-10-01

    Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

  14. Safety of 100 µg venom immunotherapy rush protocols in children compared to adults.

    Science.gov (United States)

    Stoevesandt, Johanna; Hosp, Christine; Kerstan, Andreas; Trautmann, Axel

    2017-01-01

    There is a paucity of studies examining the safety of venom immunotherapy (VIT) in children. We aimed to assess the incidence of anaphylactic side effects during rush VIT in a cohort of pediatric patients and adult controls. 72 consecutive cycles of VIT-buildup in 71 children/adolescents aged 7-17 years were retrospectively evaluated and compared to an adult control group (n = 981) with regard to baseline parameters (sex, causative venom, severity of index sting reaction, results of allergy testing, comorbidities) and the incidence of anaphylactic adverse reactions. Compared to adults, severe index sting-induced anaphylaxis was significantly less common in children ( P  = .001). Children were more likely to suffer from bee venom allergy ( P  bee venom-specific IgE ( P  = .013), but lower serum tryptase concentrations ( P  = .014). The overall rate of VIT-induced anaphylactic reactions was higher in children than in adults (6.9% vs 2.5%, P  = .046 by univariate analysis). In the final binary logistic regression model, however, only bee VIT ( P  = .039; odds ratio 2.25; confidence interval 1.04-4.87) and 5-day compared to 3-day buildup protocols ( P  = .011; odds ratio 2.64; confidence interval 1.25-5.57) were associated with an increased risk of treatment-induced anaphylaxis. All pediatric patients finally reached and tolerated the target maintenance dose of 100 µg. The higher anaphylactic reaction rate observed in pediatric patients may be attributed to a greater prevalence of bee venom allergy. VIT-induced anaphylaxis in children is usually mild and does not affect further updosing and maintenance of VIT.

  15. Technology-facilitated depression care management among predominantly Latino diabetes patients within a public safety net care system: comparative effectiveness trial design.

    Science.gov (United States)

    Wu, Shinyi; Ell, Kathleen; Gross-Schulman, Sandra G; Sklaroff, Laura Myerchin; Katon, Wayne J; Nezu, Art M; Lee, Pey-Jiuan; Vidyanti, Irene; Chou, Chih-Ping; Guterman, Jeffrey J

    2014-03-01

    Health disparities in minority populations are well recognized. Hispanics and Latinos constitute the largest ethnic minority group in the United States; a significant proportion receives their care via a safety net. The prevalence of diabetes mellitus and comorbid depression is high among this group, but the uptake of evidence-based collaborative depression care management has been suboptimal. The study design and baseline characteristics of the enrolled sample in the Diabetes-Depression Care-management Adoption Trial (DCAT) establishes a quasi-experimental comparative effectiveness research clinical trial aimed at accelerating the adoption of collaborative depression care in safety net clinics. The study was conducted in collaboration with the Los Angeles County Department of Health Services at eight county-operated clinics. DCAT has enrolled 1406 low-income, predominantly Hispanic/Latino patients with diabetes to test a translational model of depression care management. This three-group study compares usual care with a collaborative care team support model and a technology-facilitated depression care model that provides automated telephonic depression screening and monitoring tailored to patient conditions and preferences. Call results are integrated into a diabetes disease management registry that delivers provider notifications, generates tasks, and issues critical alerts. All subjects receive comprehensive assessments at baseline, 6, 12, and 18 months by independent English-Spanish bilingual interviewers. Study outcomes include depression outcomes, treatment adherence, satisfaction, acceptance of assessment and monitoring technology, social and economic stress reduction, diabetes self-care management, health care utilization, and care management model cost and cost-effectiveness comparisons. DCAT's goal is to optimize depression screening, treatment, follow-up, outcomes, and cost savings to reduce health disparities. Copyright © 2013 Elsevier Inc. All rights

  16. Occupational safety of different industrial sectors in Khartoum State, Sudan. Part 1: Safety performance evaluation.

    Science.gov (United States)

    Zaki, Gehan R; El-Marakby, Fadia A; H Deign El-Nor, Yasser; Nofal, Faten H; Zakaria, Adel M

    2012-12-01

    Safety performance evaluation enables decision makers improve safety acts. In Sudan, accident records, statistics, and safety performance were not evaluated before maintenance of accident records became mandatory in 2005. This study aimed at evaluating and comparing safety performance by accident records among different cities and industrial sectors in Khartoum state, Sudan, during the period from 2005 to 2007. This was a retrospective study, the sample in which represented all industrial enterprises in Khartoum state employing 50 workers or more. All industrial accident records of the Ministry of Manpower and Health and those of different enterprises during the period from 2005 to 2007 were reviewed. The safety performance indicators used within this study were the frequency-severity index (FSI) and fatal and disabling accident frequency rates (DAFR). In Khartoum city, the FSI [0.10 (0.17)] was lower than that in Bahari [0.11 (0.21)] and Omdurman [0.84 (0.34)]. It was the maximum in the chemical sector [0.33 (0.64)] and minimum in the metallurgic sector [0.09 (0.19)]. The highest DAFR was observed in Omdurman [5.6 (3.5)] and in the chemical sector [2.5 (4.0)]. The fatal accident frequency rate in the mechanical and electrical engineering industry was the highest [0.0 (0.69)]. Male workers who were older, divorced, and had lower levels of education had the lowest safety performance indicators. The safety performance of the industrial enterprises in Khartoum city was the best. The safety performance in the chemical sector was the worst with regard to FSI and DAFR. The age, sex, and educational level of injured workers greatly affect safety performance.

  17. Perceptions of patient safety culture among healthcare employees in tertiary hospitals of Heilongjiang province in northern China: a cross-sectional study.

    Science.gov (United States)

    Li, Ying; Zhao, Yanming; Hao, Yanhua; Jiao, Mingli; Ma, Hongkun; Teng, Baijun; Yang, Kai; Sun, Tongbo; Wu, Qunhong; Qiao, Hong

    2018-04-19

    Assessing the patient safety culture is necessary for improving patient safety. Research on patient safety culture has attracted considerable attention. Currently, there is little research on patient safety culture in China generally, and in Heilongjiang in northern China specifically. The aim of the study is to explore the perception of healthcare employees about patient safety culture and to determine whether perception differs per sex, age, profession, years of experience, education level and marital status. Cross-sectional study. Thirteen tertiary hospitals in Heilongjiang, northern China. About 1024 healthcare employees. The perception of healthcare employees was measured using the safety attitude questionnaire, which include six dimensions. Higher scores represented more positive attitudes. An analysis of variance was used to compare socio-demographic differences per position, marital status and education; t-tests were used for sex, age and experience. A total of 1024 (85.33%) valid questionnaires were returned. The mean score of the six dimensions was 73.74/100; work conditions (80.19) had the highest score of all the dimensions, and safety climate (70.48) had the lowest. Across distinct dimensions, there were significant differences in perceptions of patient safety culture per sex, age, years of experience, position, marital status and education level (P culture among healthcare employees and identifying dimensions that require improvement. Interventions aimed at specific socio-demographic groups are necessary to improve patient safety culture.

  18. Blame the Patient, Blame the Doctor or Blame the System? A Meta-Synthesis of Qualitative Studies of Patient Safety in Primary Care

    Science.gov (United States)

    Daker-White, Gavin; Hays, Rebecca; McSharry, Jennifer; Giles, Sally; Cheraghi-Sohi, Sudeh; Rhodes, Penny; Sanders, Caroline

    2015-01-01

    Objective Studies of patient safety in health care have traditionally focused on hospital medicine. However, recent years have seen more research located in primary care settings which have different features compared to secondary care. This study set out to synthesize published qualitative research concerning patient safety in primary care in order to build a conceptual model. Method Meta-ethnography, an interpretive synthesis method whereby third order interpretations are produced that best describe the groups of findings contained in the reports of primary studies. Results Forty-eight studies were included as 5 discrete subsets where the findings were translated into one another: patients’ perspectives of safety, staff perspectives of safety, medication safety, systems or organisational issues and the primary/secondary care interface. The studies were focused predominantly on issues seen to either improve or compromise patient safety. These issues related to the characteristics or behaviour of patients, staff or clinical systems and interactions between staff, patients and staff, or people and systems. Electronic health records, protocols and guidelines could be seen to both degrade and improve patient safety in different circumstances. A conceptual reading of the studies pointed to patient safety as a subjective feeling or judgement grounded in moral views and with potentially hidden psychological consequences affecting care processes and relationships. The main threats to safety appeared to derive from ‘grand’ systems issues, for example involving service accessibility, resources or working hours which may not be amenable to effective intervention by individual practices or health workers, especially in the context of a public health system. Conclusion Overall, the findings underline the human elements in patient safety primary health care. The key to patient safety lies in effective face-to-face communication between patients and health care staff or

  19. A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats

    DEFF Research Database (Denmark)

    Schrøder, Malene; Poulsen, Morten; Wilcks, Andrea

    2007-01-01

    An animal model for safety assessment of genetically modified foods was tested as part of the SAFOTEST project. In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15......, macroscopic and histopathological examinations were performed with only minor changes to report. The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design...... used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s)....

  20. Safety training parks – A case study on the effectiveness of the trainings

    DEFF Research Database (Denmark)

    Räsänen, Tuula; Sormunen, E.; Reiman, Arto

    The Safety Training Park (STP) concept is a unique Finnish safety training innovation. The STP provides different actors of the construction industry and other branches a practical occupational safety and health (OSH) training area. To the authors’ knowledge, no such parks exist in Europe besides...... Finland. Objec-tive was to study the effectiveness of the STP trainings at a large case company which participated in this study and which has actively trained its personnel in the park. The study was conducted from February 2015 to Feb-ruary 2017. Several key success factors were identified...... in the interviews of this case study. In addition, the company OSH statistics (2010 – 2016) showed a positive development at safety level. However, The Nordic Safety Climate Questionnaire did not show any significant change of results in a one year period. According to the results of the group interviews...

  1. AN EXPERIMENTAL STUDY OF THE EFFICACY AND SAFETY OF VARIOUS ENDOSCOPIC HEMOSTASIS TECHNIQUES

    Directory of Open Access Journals (Sweden)

    A. I. Cherepanin

    2014-01-01

    Full Text Available ABSTRACT. The treatment of bleeding peptic ulcers remains one of the pressing challenges in urgent surgery. Currently available endoscopic hemostasis modalities only partially meet the requirements of safety, efficiency and reliability, and therefore total and postoperative mortality rates are still high, both in our country, and around the world. The aim of the study was to identify the benefits and shortcomings of endoscopic radiofrequency energy exposure compared to standard hemostatic techniques used in the world practice to treat bleeding peptic ulcers. 

  2. Defining safety culture and the nexus between safety goals and safety culture. 4. Enhancing Safety Culture Through the Establishment of Safety Goals

    International Nuclear Information System (INIS)

    Tateiwa, Kenji; Miyata, Koichi; Yahagi, Kimitoshi

    2001-01-01

    efficient management. To seek compatibility between safety culture and efficient management, and to build an agreeable common perception among the utility, regulatory body, and the public on rationalizing the safety level to the extent acceptable, two issues must be considered: (a) establishing safety goals and (b) quantifying the safety culture. As for the first issue, currently no generic safety goal for the nuclear industry is available in Japan. This causes difficulty in deciding whether or not a specific action that takes place in a plant leading to a certain amount of risk increment is acceptable. Therefore, it is important for us to have a safety goal established. By establishing the safety goal, we could utilize it for the following usage: 1. to enable prompt response in case a safety level has entered an unacceptable level; 2. to sustain and enhance the safety culture centered by risk information (sustaining safety culture and achieving rational management simultaneously); 3. to use public relations for plant activities, where condemnation for overlooking safety culture might arrive for a minor risk increasing activity. As for the second issue, we must devise a method to quantify the level of safety culture. This could be done based on the safety culture indicators listed in the appendix of IAEA INSAG-4 (Ref. 1). By quantifying the level of safety culture, a comprehensive safety level of a plant can be evaluated by integrating with the safety level based on PSA. For example, when considering on-line maintenance for specific equipment, it is important not only to assess the safety level in terms of PSA but also to assess the level of safety culture in order to have a comprehensive view of the safety level and to compare it with the safety goal. By both establishing safety goals and quantifying the level of safety culture in a nuclear power plant, the ability to assess the comprehensive safety level of a plant and acknowledge the quantitative margin from the safety

  3. Studying Patient Safety Culture from the Viewpoint of Nurse in educational hospitals Ilam City

    Directory of Open Access Journals (Sweden)

    Milad Borji

    2016-12-01

    Full Text Available Introduction: Patient safety culture is the first necessary step to reduce medical errors and improve patient's condition. In this context, this article aims at studying the condition of patient safety culture in hospitals in Elam in 2016. Materials and Methods: In this cross-sectional study, 150 nurses in Ilam were randomly selected. The Culture Hospital Survey on Patient Safety (HSOPSC was used and its reliability and validity had been confirmed by the previous studies. The data were analyzed by SPSS17. Results: The results showed that the nurses' safety was at positive(62.37± 8.70 and there could be found no significant difference in patient safety among the studied hospitals in this article (P<.05. Extra-organizational teamwork and non-punitive response, among the aspects of patient safety, had the lowest means and organizational learning and general understanding had the highest. Conclusion: Considering the importance of patient safety, the interventions need to be performed in order to improve the patient safety condition among nurses, especially in two aspects of extra-organizational teamwork and non-punitive response that had the lowest means.

  4. Overview of the reactor safety study consequence model

    International Nuclear Information System (INIS)

    Wall, I.B.; Yaniv, S.S.; Blond, R.M.; McGrath, P.E.; Church, H.W.; Wayland, J.R.

    1977-01-01

    The Reactor Safety Study (WASH-1400) is a comprehensive assessment of the potential risk to the public from accidents in light water power reactors. The engineering analysis of the plants is described in detail in the Reactor Safety Study: it provides an estimate of the probability versus magnitude of the release of radioactive material. The consequence model, which is the subject of this paper, describes the progression of the postulated accident after the release of the radioactive material from the containment. A brief discussion of the manner in which the consequence calculations are performed is presented. The emphasis in the description is on the models and data that differ significantly from those previously used for these types of assessments. The results of the risk calculations for 100 light water power reactors are summarized

  5. Identifying organizational cultures that promote patient safety.

    Science.gov (United States)

    Singer, Sara J; Falwell, Alyson; Gaba, David M; Meterko, Mark; Rosen, Amy; Hartmann, Christine W; Baker, Laurence

    2009-01-01

    Safety climate refers to shared perceptions of what an organization is like with regard to safety, whereas safety culture refers to employees' fundamental ideology and orientation and explains why safety is pursued in the manner exhibited within a particular organization. Although research has sought to identify opportunities for improving safety outcomes by studying patterns of variation in safety climate, few empirical studies have examined the impact of organizational characteristics such as culture on hospital safety climate. This study explored how aspects of general organizational culture relate to hospital patient safety climate. In a stratified sample of 92 U.S. hospitals, we sampled 100% of senior managers and physicians and 10% of other hospital workers. The Patient Safety Climate in Healthcare Organizations and the Zammuto and Krakower organizational culture surveys measured safety climate and group, entrepreneurial, hierarchical, and production orientation of hospitals' culture, respectively. We administered safety climate surveys to 18,361 personnel and organizational culture surveys to a 5,894 random subsample between March 2004 and May 2005. Secondary data came from the 2004 American Hospital Association Annual Hospital Survey and Dun & Bradstreet. Hierarchical linear regressions assessed relationships between organizational culture and safety climate measures. Aspects of general organizational culture were strongly related to safety climate. A higher level of group culture correlated with a higher level of safety climate, but more hierarchical culture was associated with lower safety climate. Aspects of organizational culture accounted for more than threefold improvement in measures of model fit compared with models with controls alone. A mix of culture types, emphasizing group culture, seemed optimal for safety climate. Safety climate and organizational culture are positively related. Results support strategies that promote group orientation and

  6. Identification and comparative analysis of factors influencing road safety in US regions and in Polish voivodeships

    Directory of Open Access Journals (Sweden)

    Joanna WACHNICKA

    2013-01-01

    Full Text Available Analyses of road safety at national level have been run for many years and large number of publications concerning them appeared so far. How interdisciplinary the issue is, has been shown by literature studies done by the author of the paper. It appears that economists, mathematicians, doctors as well as engineers have studied the issue. It is not an easy one, as results of many analyses lead to conflicting conclusions and often fail to provide straightforward answers to questions asked. The administrative actions taken to improve road safety, uniform for the whole country, frequently fail to give expected results, including Poland’s case. Therefore there is a need to analyse what makes some provinces, and not the others, report improvement in road safety. This paper presents part of the work on author’s doctoral thesis, which analyses how regional characteristics may impact road safety in respective regions. However, during collection of data for the purpose of the doctoral thesis it turned out that many variables mentioned in literature as significant had not been collected on regional level in Europe, including Poland. There are, though, available data on respective American states, so the search for the best describing independent variables started from the analyses of US data. The analyses showed the impact of factors such as annual income per capita, transport activity, density of population, seatbelt rates, road and vehicle density, rate of doctors.

  7. CRASH - Community Road Accident System Homepage : feasibility study on a European Road Safety Information System, financially supported by the European Commission.

    NARCIS (Netherlands)

    Brouwer, M. Poppe, F. Blokpoel, A. & Kars, V.

    2000-01-01

    This report is the result of a feasibility study, financially supported by the European Commission. The study investigated the possibilities for the development and maintenance of a European Road Safety Information System with relevant and internationally comparable information. Recommendations on

  8. Patient safety culture assessment in oman.

    Science.gov (United States)

    Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S S; Al-Adawi, Samir

    2014-07-01

    To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included 'organizational learning and continuous improvement' while conversely, 'non-punitive response to errors' was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman.

  9. Patient Safety Culture Assessment in Oman

    Science.gov (United States)

    Al-Mandhari, Ahmed; Al-Zakwani, Ibrahim; Al-Kindi, Moosa; Tawilah, Jihane; Dorvlo, Atsu S.S.; Al-Adawi, Samir

    2014-01-01

    Objective To illustrate the patient safety culture in Oman as gleaned via 12 indices of patient safety culture derived from the Hospital Survey on Patient Safety Culture (HSPSC) and to compare the average positive response rates in patient safety culture between Oman and the USA, Taiwan, and Lebanon. Methods This was a cross-sectional research study employed to gauge the performance of HSPSC safety indices among health workers representing five secondary and tertiary care hospitals in the northern region of Oman. The participants (n=398) represented different professional designations of hospital staff. Analyses were performed using univariate statistics. Results The overall average positive response rate for the 12 patient safety culture dimensions of the HSPSC survey in Oman was 58%. The indices from HSPSC that were endorsed the highest included ‘organizational learning and continuous improvement’ while conversely, ‘non-punitive response to errors’ was ranked the least. There were no significant differences in average positive response rates between Oman and the United States (58% vs. 61%; p=0.666), Taiwan (58% vs. 64%; p=0.386), and Lebanon (58% vs. 61%; p=0.666). Conclusion This study provides the first empirical study on patient safety culture in Oman which is similar to those rates reported elsewhere. It highlights the specific strengths and weaknesses which may stem from the specific milieu prevailing in Oman. PMID:25170407

  10. Spent Nuclear Fuel Project path forward: nuclear safety equivalency to comparable NRC-licensed facilities

    International Nuclear Information System (INIS)

    Garvin, L.J.

    1995-11-01

    This document includes the Technical requirements which meet the nuclear safety objectives of the NRC regulations for fuel treatment and storage facilities. These include requirements regarding radiation exposure limits, safety analysis, design and construction. This document also includes administrative requirements which meet the objectives of the major elements of the NRC licensing process. These include formally documented design and safety analysis, independent technical review, and oppportunity for public involvement

  11. Nuclear safety

    International Nuclear Information System (INIS)

    Tarride, Bruno

    2015-10-01

    The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

  12. Environmental Regulation and Food Safety: Studies of Protection ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    2006-01-01

    Jan 1, 2006 ... Book cover Environmental Regulation and Food Safety: Studies of ... are sometimes perceived in developing countries as nontariff barriers to trade. ... In some cases, products that had initially been refused access to a ...

  13. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    Science.gov (United States)

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model. Copyright 2010 Elsevier Inc. All rights reserved.

  14. Alberta Environment's weir safety program : options for rehabilitation to improve public safety : a case study of the Calgary weir

    Energy Technology Data Exchange (ETDEWEB)

    Blakely, D [Alberta Environment, Edmonton, AB (Canada)

    2009-07-01

    Alberta Environment Water Management Operations (WMO) owns and operates 46 dams and 800 kilometres of canals in Alberta. The WMO consists of 120 staff and several contract operators to take care of this infrastructure. Most of the infrastructure supplies water for irrigation use, which adds 5 billion dollars to the provincial economy annually. Other water uses include stock watering, domestic use, municipal use, recreational use and habitat. Alberta Environment's weir safety program was also discussed along with options for rehabilitation to improve public safety. A case study of Calgary's Weir Dam on the Bow River was highlighted. A brief history of the dam was offered and safety programs around provincially-owned weirs were discussed. Photographs were included to illustrate some of the additional safety measures at the Calgary weir, such as suspended safety buoys upstream of the boom directing paddlers to the portage trail, and signage on the river that can be activated when the boom is out. Typical river users on the Calgary Bow River and safety history at the Calgary Weir were discussed along with other topics such as the Calgary Bow River weir project criteria; project design progress; pre-feasibility options; scale modelling; final design analysis; construction funding; and proposed changes to the safety program for the new weir configuration. figs.

  15. Risk and safety in the nuclear industry and conventional norms of society

    International Nuclear Information System (INIS)

    Tadmor, J.

    In the present study the societal acceptance of various risks is analyzed and rules of risk acceptance as a function of different parameters are spelled out. The monetary value of a human life is estimated, based on investments in safety of different human activities. The acceptable risks and safety investments in different human activities are then compared with risks and safety investments of the nuclear industry. Safety investments required to reduce the radioactivity releases and risks from nuclear power stations to ALAP levels are taken as a study case. It is found that risks in the nuclear industry are several orders of magnitude lower and safety investments per human life saved are several orders of magnitude higher, as compared with risks and safety investments in other human activities. It is also shown that the incremental safety investments needed to further reduce the radiation doses in the environment during normal and continuous operation of nuclear plants are extravagantly high as compared to safety investments in other human activities and in other facets of human life. Considering that there is a limit to the economic means available, societal expenditures for reducing risks should by spread, as much as possible, over all human activities to get the maximum return from investments. (B.G.)

  16. Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

    Science.gov (United States)

    Howell, Ann-Marie; Burns, Elaine M; Bouras, George; Donaldson, Liam J; Athanasiou, Thanos; Darzi, Ara

    2015-01-01

    The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were

  17. Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

    Science.gov (United States)

    Rawal, Narinder; Krøner, Karsten; Simin-Geertsen, Marija; Hejl, Charlotte; Likar, Rudolf

    2010-01-01

    Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard

  18. Safety-related topics from the Nuclear Power Options Viability Study

    International Nuclear Information System (INIS)

    Trauger, D.B.; White, J.D.

    1986-01-01

    The Nuclear Power Options Viability Study (NPOVS) evaluated innovative reactor concepts, and this article reviews NPOVS findings, with emphasis on safety and licensing. The reactors studied were of light-water, liquid-metal, and helium-cooled concepts, and most were of modular design. Prelicensed standard plants offer an important step toward regulatory stability and early licensing approvals with public participation before major expenditures. Advanced reactors with passive safety features offer the possibility of performance-based regulation. The concepts studied appear to be potentially viable, but more complete designs will be required before economic evaluations can be definitive

  19. Studying the Relationship between Individual and Organizational Factors and Nurses' Perception of Patient Safety Culture

    Directory of Open Access Journals (Sweden)

    Farahnaz Abdolahzadeh

    2012-11-01

    Full Text Available Introduction: Safety culture is considered as an important factor in improving patient safety. Therefore, identifying individual and organizational factors affecting safety culture is crucial. This study was carried out to determine individual and organizational factors associated with nurses' perception of patient safety culture. Methods: The present descriptive study included 940 nurses working in four training hospitals affiliated with Urmia University of Medical Sciences (Iran. Data was collected through the self-report questionnaire of patient safety culture. Descriptive (number, percent, mean, and standard deviation and inferential (t-test and analysis of variance statistics were used to analyze the data in SPSS. Results: Nurses' perception of patient safety culture was significantly correlated with marital status, workplace, and overtime hours. Conclusion: The results of this study revealed that some individual and organizational factors can impact on nurses' perception of patient safety culture. Nursing authorities should thus pay more attention to factors which promote patient safety culture and ultimately the safety of provided services.

  20. A Methodology for Safety Culture Impact Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

    2014-05-15

    The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively.

  1. A Methodology for Safety Culture Impact Assessment

    International Nuclear Information System (INIS)

    Han, Kiyoon; Jae, Moosung

    2014-01-01

    The purpose of this study is to develop methodology for assessing safety culture impact on nuclear power plants. A new methodology for assessing safety culture impact index has been developed and applied for the reference nuclear power plants. The developed SCII model might contribute to comparing the level of safety culture among nuclear power plants as well as to improving the safety of nuclear power plants. Safety culture is defined to be fundamental attitudes and behaviors of the plant staff which demonstrate that nuclear safety is the most important consideration in all activities conducted in nuclear power operation. Through several accidents of nuclear power plant including the Fukusima Daiichi in 2011 and Chernovyl accidents in 1986, the safety of nuclear power plant is emerging into a matter of interest. From the accident review report, it can be easily found out that safety culture is important and one of dominant contributors to accidents. However, the impact methodology for assessing safety culture has not been established analytically yet. It is difficult to develop the methodology for assessing safety culture impact quantitatively

  2. Example of a SWOV (Institute for Road Safety Research) safety study : "Avenida Marginal", Lisbon 1989.

    NARCIS (Netherlands)

    Janssen, S.T.M.C.

    1991-01-01

    This paper describes the accident study on the Marginal Road between Alges and Cascais in Portugal. The aim of this study was to produce a philosophy for a strategy to select the best safety measures out of several which had already been proposed. The general point of departure in this philosophy is

  3. The effects of outsourcing on occupational health and safety: a comparative study of factory-based workers and outworkers in the Australian clothing industry.

    Science.gov (United States)

    Mayhew, C; Quinlan, M

    1999-01-01

    Outsourcing has become increasingly widespread throughout industrialized societies over the past 20 years. Accompanying this has been a renewed growth in home-based work, sometimes using new technologies (telework) but also entailing a re-emergence of old forms, such as clothing outwork, used extensively 100 years ago. A growing body of research indicates that changes to work organization associated with outsourcing adversely affect occupational health and safety (OHS), both for outsourced workers and for those working alongside them. This study assessed the OHS implications of the shift to home-based workers in the Australian clothing industry by systematically comparing the OHS experiences of 100 factory-based workers and 100 outworkers. The level of self-reported injury was over three times higher among outworkers than factory-based workers undertaking similar tasks. The most significant factor explaining this difference was the payment system. All outworkers were paid solely by the piece, whereas factory workers were paid either under a time plus production bonus system or solely on a time basis. While the incidence of injury was far higher among outworkers, factory-based workers paid under an incentive system reported more injuries than those paid solely on a time basis. Increasing injury was correlated with piecework payment systems.

  4. Assessment of Safety Condition in One of the Teaching Hospitals in Kermanshah (2015: A Case Study

    Directory of Open Access Journals (Sweden)

    Masod Ghanbari Kakavand

    2016-09-01

    Full Text Available Background & Aims of the Study: Many working conditions-related stress factors that can produce injuries and illnesses are important in hospital environments. So, the health and safety of nurses and patients from workplace-induced injuries and illnesses is important. In this study, we have assessed the safety condition of one of the teaching hospitals in Kermanshah (2015. Materials and Methods: This descriptive and cross-sectional study was conducted in one of the teaching hospital of Kermanshah University of medical sciences. For this aim a checklist was prepared based on the Occupational Safety and Health Administration's standards and Part 3 of the manual of National Building Regulations. These checklists comprised (The final checklist had 239 questions of 9 dimensions various sections of safety including; fire safety, building safety, electrical safety, emergency exit routes safety, heating and cooling equipment safety, operating room and laundry room and salty home safety. Eventually, using SPSS 16 and descriptive statistics, data were analyzed. Results: According to the results of this study, 66.6% of the units had poor safety and 33.4% of them were moderately safe. As well as, only ICU and CCU unit, heating and cooling equipment and operational room showed moderate compliance with safety requirements and other sections were poorly complied. Conclusion: The results of this study showed that safety conditions of hospital were not at favorable level. These poor safety statues can jeopardize patients and hospital personnel. Thus some interventions such as improvement of working conditions, compliance with safety acts and implementation of health, safety and environmental management system would be necessary.

  5. Observational Study on Safety of Prehospital BLS CPAP in Dyspnea.

    Science.gov (United States)

    Sahu, Novneet; Matthews, Patrick; Groner, Kathryn; Papas, Mia A; Megargel, Ross

    2017-12-01

    Introduction Continuous positive airway pressure (CPAP) improves outcomes in patients with respiratory distress. Additional benefits are seen with CPAP application in the prehospital setting. Theoretical safety concerns regarding Basic Life Support (BLS) providers using CPAP exist. In Delaware's (USA) two-tiered Emergency Medical Service (EMS) system, BLS often arrives before Advanced Life Support (ALS). Hypothesis This study fills a gap in literature by evaluating the safety of CPAP applied by BLS prior to ALS arrival. This was a retrospective, observational study using Quality Assurance (QA) data collected from October 2009 through December 2012 throughout a state BLS CPAP pilot program; CPAP training was provided to BLS providers prior to participation. Collected data include pulse-oximetry (spO2), respiratory rate (RR), heart rate (HR), skin color, and Glasgow Coma Score (GCS) before and after CPAP application. Pre-CPAP and post-CPAP values were compared using McNemar's and t-tests. Advanced practitioners evaluated whether CPAP was correctly applied and monitored and whether the patient condition was "improved," "unchanged," or "worsened." Seventy-four patients received CPAP by BLS; CPAP was correctly indicated and applied for all 74 patients. Respiratory status and CPAP were appropriately monitored and documented in the majority of cases (98.6%). A total of 89.2% of patients improved and 4.1% worsened; CPAP significantly reduced the proportion of patients with SpO224, and cyanosis (PCPAP (mean difference [MD]=0.17; 95% CI, -0.49 to 0.83; P=.59). The HR decreased from 115.7 (SD=53) to 105.1 (SD=37) after CPAP (MD=-10.9; 95% CI, -3.2 to -18.6; PCPAP (MD=17.8; 95% CI, 14.2-21.5; PCPAP was indicated, to apply it correctly, and to appropriately monitor the status of these patients. The majority of patients who received CPAP by BLS providers had improvement in their clinical status and vital signs. The findings suggest that CPAP can be safely used by BLS providers

  6. Patient safety risk factors in minimally invasive surgery : A validation study

    NARCIS (Netherlands)

    Rodrigues, S.P.; Ter Kuile, M.; Dankelman, J.; Jansen, F.W.

    2012-01-01

    This study was conducted to adapt and validate a patient safety (PS) framework for minimally invasive surgery (MIS) as a first step in understanding the clinical relevance of various PS risk factors in MIS. Eight patient safety risk factor domains were identified using frameworks from a systems

  7. Yellin's review of the Nuclear Regulatory Commission's Reactor Safety Study: comment

    International Nuclear Information System (INIS)

    Wilson, R.

    1976-01-01

    Joel Yellin (Bell J. Economics, Vol. 7, No. 1 (Spr. 1976)) reviewed the Reactor Safety Study (WASH-1400, or Rasmussen Report) published by the Nuclear Regulatory Commission and makes several criticisms. Wilson finds that some of these criticisms are much overstated, while others, although valid, are mainly criticisms of presentation. To be useful for public policy, reactor risks--and indeed all nuclear risks--must be compared with other risks society faces. Wilson feels that the Rasmussen Report is weak in these comparisons, primarily because there exist few estimates of risk in other places, but that the comparisons he does make indeed confirm that the risk is smaller than Yellin suggests. 20 references

  8. Measuring and benchmarking safety culture: application of the safety attitudes questionnaire to an acute medical admissions unit.

    Science.gov (United States)

    Relihan, E; Glynn, S; Daly, D; Silke, B; Ryder, S

    2009-12-01

    To assess the safety culture in an acute medical admissions unit (AMAU) of a teaching hospital in order to benchmark results against international data and guide a unit-based, integrated, risk management strategy. The safety attitudes questionnaire (SAQ), a validated instrument for the measurement of safety culture was applied to an AMAU. All AMAU healthcare staff (n = 92) were surveyed: doctors, nurses, healthcare assistants (HCAs) and allied healthcare professionals (AHPs). Safety attitude scores for the overall unit and individual caregiver types were assessed across six domains of safety culture. When compared against an international benchmark, the AMAU scored significantly higher for four of the six safety domains: p < 0.01 for 'teamwork climate', 'safety climate' and 'stress recognition' and p < 0.05 for 'job satisfaction'. The difference between nurse manager scores and the overall mean for the study group was statistically significant for the domains of 'teamwork climate' (p < 0.05) and 'safety climate' (p < 0.01). HCAs scored significantly lower relative to staff overall with regard to 'working conditions' (p < 0.05) and 'perceptions of management' (p < 0.01). The SAQ was successfully applied to an AMAU setting giving a valuable insight into staff issues of concern across the safety spectrum: employee and environmental safety, clinical risk management and medication safety.

  9. Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

    Science.gov (United States)

    Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

    2018-03-27

    Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships

  10. An integrative review of patient safety in studies on the care and safety of patients with communication disabilities in hospital.

    Science.gov (United States)

    Hemsley, Bronwyn; Georgiou, Andrew; Hill, Sophie; Rollo, Megan; Steel, Joanne; Balandin, Susan

    2016-04-01

    To review the research literature on the experiences of patients with communication disabilities in hospital according to the Generic Model of patient safety. In 2014 and 2015, we searched four scientific databases for studies with an aim or result relevant to safety of hospital patients with communication disabilities. The review included 27 studies. A range of adverse event types were outlined in qualitative research. Little detail was provided about contributing or protective factors for safety incidents in hospital for these patients or the impact of the incidents on the patient or organisations involved. Further research addressing the safety of patients with communication disabilities is needed. Sufficient detail is required to identify the nature, timing, and detection of incidents; factors that contribute to or prevent adverse events; and detail the impact of the adverse events. In order to provide safe and effective care to people with communication disabilities in hospital, a priority for health and disability services must be the design and evaluation of ecologically appropriate and evidence-based interventions to improve patient care, communication, and reduce the risk of costly and harmful patient safety incidents. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  11. Involving fathers in teaching youth about farm tractor seatbelt safety--a randomized control study.

    Science.gov (United States)

    Jinnah, Hamida Amirali; Stoneman, Zolinda; Rains, Glen

    2014-03-01

    Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities. Farm machinery, especially tractors, is the most common cause of casualties to youth. A Roll-Over Protection Structure (ROPS) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns. Despite this knowledge, the use of seatbelts by farmers on ROPS tractors remains low. This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth. This research study used a longitudinal, repeated-measures, randomized-control design in which youth 10-19 years of age were randomly assigned to either of two intervention groups (parent-led group and staff-led group) or the control group. Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups. They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors. Consequently, youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test. This randomized control trial supports the effectiveness of a home-based, father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors (related to tractor seatbelts) on the farm. This intervention appealed to fathers' strong motivation to practice tractor safety for the sake of their youth. Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  12. Interpreting the quality of health care database studies on the comparative effectiveness of oral anticoagulants in routine care

    Directory of Open Access Journals (Sweden)

    Schneeweiss S

    2013-09-01

    Full Text Available Sebastian Schneeweiss, Krista F Huybrechts, Joshua J Gagne Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA Background: Dabigatran, an oral direct thrombin inhibitor, has now been available for 2 years in the US for the prevention of stroke in patients with nonvalvular atrial fibrillation, and direct Xa inhibitors are also starting to enter the market. Studies examining the effects of new oral anticoagulants in health care databases are beginning to emerge. The purpose of this study was to describe the validity of early published observational studies on the comparative safety and effectiveness of new oral anticoagulants in patients with atrial fibrillation. Methods: We identified published nonrandomized post-marketing studies (articles or conference abstracts or posters and critically appraised their internal validity, with a particular focus on their ability to control confounding and other biases. Results: Two full-length journal articles, three conference posters, two conference presentation abstracts, and a US Food and Drug Administration analysis form the basis of the early comparative effectiveness and safety experience with new oral anticoagulants. Some published studies exhibit substantial biases and have insufficient precision for several important endpoints. Several studies suffer from biases arising from comparing ongoing users of the older drug, warfarin, who seem to tolerate it, to initiators of the new treatment who may have switched from warfarin or have had no prior experience with anticoagulants. Analyses tended to not adjust or not adjust adequately for confounding, and unsound propensity score application was also observed. Several studies introduced selection bias by excluding patients who died during follow-up and by restricting the study population to those with continuous database enrollment following cohort entry. We

  13. Assessment of safety regulation using an artificial society

    International Nuclear Information System (INIS)

    Furuta, Kazuo; Nagase, Masaya

    2005-01-01

    This study proposes using an artificial society to assess impacts of safety regulation on the society. The artificial society used in this study is a multi-agent system, which consists of many agents representing companies. The agents cannot survive unless they get profits by producing some products. Safety regulation functions as the business environment, which the agents will evolve to fit to. We modeled this process of survival and adaptation by the genetic algorithm. Using the proposed model, case simulations were performed to compare various regulation styles, and some interesting insights were obtained how regulation style influences behavior of the agents and then productivity and safety level of the industry. In conclusion, an effective method for assessment of safety regulation has been developed, and then several insights were shown in this study

  14. Study of system safety evaluation on LTO of national project. NISA safety research project on system safety of nuclear power plants

    International Nuclear Information System (INIS)

    Takizawa, Masayuki; Sekimura, Naoto; Miyano, Hiroshi; Aoyama, Katsunobu

    2012-01-01

    Japanese safety regulatory body, that is, Nuclear and Industrial Safety Agency (NISA) started a 5-year national safety research project as 'the first stage' from 2006 FY to 2010 FY whose objective is 'Improve the technical information basis in order to utilize knowledge as well as information related to ageing management and maintenance of NPPs. Fukushima disaster happened in March 2011, and the priority of research needs for ageing management dramatically changed in Japan. The second-stage national project started in October 2011 with the concept of 'system safety' of NNPs where not only ageing management on degradation phenomena of important components but also safety management on total plant systems are paid attention to. The second-stage project is so called 'Japanese Ageing Management Program for System Safety (JAMPSS)'. (author)

  15. A Survey of Occupational Safety & Health Libraries in the United States.

    Science.gov (United States)

    Jensen, Karen S.

    There is very little published information available about occupational safety and health libraries. This study identified, described, and compared the occupational safety and health libraries in the United States. The questionnaire first filtered out those libraries that did not fit the definition of an occupational safety and health library;…

  16. Disentangling quality and safety indicator data: a longitudinal, comparative study of hand hygiene compliance and accreditation outcomes in 96 Australian hospitals

    Science.gov (United States)

    Mumford, Virginia; Greenfield, David; Hogden, Anne; Debono, Deborah; Gospodarevskaya, Elena; Forde, Kevin; Westbrook, Johanna; Braithwaite, Jeffrey

    2014-01-01

    Objectives The study aims are twofold. First, to investigate the suitability of hand hygiene as an indicator of accreditation outcomes and, second, to test the hypothesis that hospitals with better accreditation outcomes achieve higher hand hygiene compliance rates. Design A retrospective, longitudinal, multisite comparative survey. Setting Acute public hospitals in New South Wales, Australia. Participants 96 acute hospitals with accreditation survey results from two surveys during 2009–2012 and submitted data for more than four hand hygiene audits between 2010 and 2013. Outcomes Our primary outcome comprised observational hand hygiene compliance data from eight audits during 2010–2013. The explanatory variables in our multilevel regression model included: accreditation outcomes and scores for the infection control standard; timing of the surveys; and hospital size and activity. Results Average hand hygiene compliance rates increased from 67.7% to 80.3% during the study period (2010–2013), with 46.7% of hospitals achieving target compliance rates of 70% in audit 1, versus 92.3% in audit 8. Average hand hygiene rates at small hospitals were 7.8 percentage points (pp) higher than those at the largest hospitals (phand hygiene rates, accreditation outcomes and infection control scores is less clear. Conclusions Our results indicate that accreditation outcomes and hand hygiene audit data are measuring different parts of the quality and safety spectrum. Understanding what is being measured when selecting indicators to assess the impact of accreditation is critical as focusing on accreditation results would discount successful hand hygiene implementation by smaller hospitals. Conversely, relying on hand hygiene results would discount the infection control related research and leadership investment by larger hospitals. Our hypothesis appears to be confounded by an accreditation programme that makes it more difficult for smaller hospitals to achieve high infection

  17. Pressure Safety: Advanced Self-Study 30120

    Energy Technology Data Exchange (ETDEWEB)

    Glass, George [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-02-29

    Pressure Safety Advance Self-Study (Course 30120) consists of an introduction, five modules, and a quiz. To receive credit in UTrain for completing this course, you must score 80% or better on the 15-question quiz (check UTrain). Directions for initiating the quiz are appended to the end of this training manual. This course contains several links to LANL websites. UTrain might not support active links, so please copy links into the address line in your browser.

  18. System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

    Science.gov (United States)

    Hughes, B P; Anund, A; Falkmer, T

    2015-01-01

    Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Safety measures to prevent workplace violence in emergency primary care centres--a cross-sectional study.

    Science.gov (United States)

    Morken, Tone; Johansen, Ingrid H

    2013-10-03

    Employees in emergency primary care centres (EPCC) have raised personal safety as an issue. Despite a high risk of experiencing workplace violence at EPCCs in Norway, knowledge regarding applied preventive measures is limited. The description of existing safety measures is an important prerequisite to evaluate and make guidelines for the improvement of preventive practices on a national level. The objective of this study was to investigate to which extent general practitioners work alone in EPCCs in Norway, and to estimate the prevalence of other preventive measures against workplace violence. A survey was sent to the managers of all 210 registered EPCCs in Norway. The questionnaire included 22 items on safety measures, including available staff, architecture and outfitting of the reception and consulting rooms, and the availability of electronic safety systems and training or monitoring systems. The data were analysed using descriptive statistics. Differences between EPCCs staffed by one general practitioner alone and EPCCs with more health personnel on duty were explored. Sixty-one (30%) of the 203 participating EPCCs had more than one person on duty round-the-clock. These EPCCs reported the application of a significantly higher number of safety measures compared to the EPCCs with only one general practitioner on duty during some or part of the 24 hours. Examples of safety measures being more common in highly staffed EPCCs were automatic door locks (p < 0.001), arrangement of furniture in the consulting room ensuring that the patient is not seated between the clinician and the exit (p = 0.014), the possibility of bringing an extra person on emergency call-outs or home visits when needed for security reasons (p = 0.014), and having organised training regarding violence (p < 0.001). This study shows considerable differences between Norwegian EPCCs regarding applied preventive measures, and a higher prevalence of such measures in EPCCs staffed with

  20. Impact of a health safety warning and prior authorisation on the use of piroxicam: a time-series study.

    Science.gov (United States)

    Carracedo-Martínez, Eduardo; Pia-Morandeira, Agustin; Figueiras, Adolfo

    2012-03-01

    The aim of this study was to assess the quantitative changes in systemic use of piroxicam after the issue of a health safety warning about its risks and the subsequent implementation of prior authorisation. We determined the number of monthly daily defined doses/1000 inhabitants/day (DHDs) of piroxicam in the period 2005-2008 in a health area in Spain. The data were analysed graphically, and the impact of the safety warning and introduction of prior authorisation were estimated by using segmented regression analysis. The graph showed that the number of DHDs of piroxicam was stable both before and after the health safety warning but registered a very marked decrease after implementation of prior authorisation, after which DHDs of piroxicam remained stable at a 98% inferior level compared with previous to prior authorisation. Segmented regression analysis showed no statistically significant immediate jump in piroxicam utilisation after the safety warning nor a change in the slope afterwards, but it did show a significant immediate jump after prior authorisation. Population exposure to systemic piroxicam remained unaffected by a previous health safety warning but declined sharply after the introduction of prior authorisation. Copyright © 2012 John Wiley & Sons, Ltd.

  1. Key aspects in managing safety when working with multiple contractors: A case study

    NARCIS (Netherlands)

    Drupsteen, L.; Rasmussen, H.B.; Ustailieva, E.; Kampen, J. van

    2015-01-01

    Working with multiple contractors in a shared workplace can introduce and increase safety risks due to complexity. The aim of this study was to explore how safety issues are recognized in a specific case and to identify whether clients and contractors perceive problems similarly. The safety issues

  2. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

    Science.gov (United States)

    Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

    2016-01-20

    CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events

  3. System and safety studies of accelerator driven systems for transmutation. Annual report 2007

    International Nuclear Information System (INIS)

    Arzhanov, Vasily; Fokau, Andrei; Persson, Calle; Runevall, Odd; Sandberg, Nils; Tesinsky, Milan; Wallenius, Janne; Youpeng Zhang

    2008-05-01

    Within the project 'System and safety studies of accelerator driven systems for transmutation', research on design and safety of sub-critical reactors for recycling of minor actinides is performed. During 2007, the reactor physics division at KTH has calculated safety parameters for EFIT-400 with cermet fuel, permitting to start the transient safety analysis. The accuracy of different reactivity meters applied to the YALINA facility was assessed and neutron detection studies were performed. A model to address deviations from point kinetic behaviour was developed. Studies of basic radiation damage physics included calculations of vacancy formation and activation enthalpies in bcc niobium. In order to predict the oxygen potential of inert matrix fuels, a thermo-chemical model for mixed actinide oxides was implemented in a phase equilibrium code

  4. Preparing suitable climate scenario data to assess impacts on local food safety

    NARCIS (Netherlands)

    Liu, C.; Hofstra, N.; Leemans, R.

    2015-01-01

    Quantification of climate change impacts on food safety requires food safety assessment with different past and future climate scenario data to compare current and future conditions. This study presents a tool to prepare climate and climate change data for local food safety scenario analysis and

  5. Safety assessment for the passive system of the nuclear power plants (NPPs) using safety margin estimation

    International Nuclear Information System (INIS)

    Woo, Tae-Ho; Lee, Un-Chul

    2010-01-01

    The probabilistic safety assessment (PSA) for gas-cooled nuclear power plants has been investigated where the operational data are deficient, because there is not any commercial gas-cooled nuclear power plant. Therefore, it is necessary to use the statistical data for the basic event constructions. Several estimations for the safety margin are introduced for the quantification of the failure frequency in the basic event, which is made by the concept of the impact and affordability. Trend of probability of failure (TPF) and fuzzy converter (FC) are introduced using the safety margin, which shows the simplified and easy configurations for the event characteristics. The mass flow rate in the natural circulation is studied for the modeling. The potential energy in the gravity, the temperature and pressure in the heat conduction, and the heat transfer rate in the internal stored energy are also investigated. The values in the probability set are compared with those of the fuzzy set modeling. Non-linearity of the safety margin is expressed by the fuzziness of the membership function. This artificial intelligence analysis of the fuzzy set could enhance the reliability of the system comparing to the probabilistic analysis.

  6. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

    Science.gov (United States)

    Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

    2015-01-01

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

  7. Comparative study WWER-440/230 reactors and the Juragua-based WWER-440/318 project

    International Nuclear Information System (INIS)

    1994-01-01

    The work consists in a comparative analysis between WWER-440/230 and WWER-440/318 type reactors on the basis of the major findings and recommendations given in the extra budgetary Programme of the International Atomic Energy Agency on the safety of these reactors and summarized in the document 'The safety of WWER-440 model 230 nuclear power plant'. The fundamental emphasis was done in the design concept of these reactors

  8. Neonatal Safety of Elective Family-Centered Caesarean Sections: A Cohort Study

    Directory of Open Access Journals (Sweden)

    Ilona C. Narayen

    2018-02-01

    Full Text Available BackgroundAlthough little data are available concerning safety for newborns, family-centered caesarean sections (FCS are increasingly implemented. With FCS mothers can see the delivery of their baby, followed by direct skin-to-skin contact. We evaluated the safety for newborns born with FCS in the Leiden University Medical Center (LUMC, where FCS was implemented in June 2014 for singleton pregnancies with a gestational age (GA ≥38 weeks and without increased risks for respiratory morbidity.MethodsThe incidence of respiratory pathology, unplanned admission, and hypothermia in infants born after FCS in LUMC were retrospectively reviewed and compared with a historical cohort of standard elective cesarean sections (CS.ResultsFrom June 2014 to November 2015, 92 FCS were performed and compared to 71 standard CS in 2013. Incidence of respiratory morbidity, hypothermia, temperatures at arrival at the department, GA, and birth weight were comparable (ns. Unplanned admission occurred more often after FCS when compared to standard CS (21 vs 7%; p = 0.03, probably due to peripheral oxygen saturation (SpO2 monitoring. There was no increase in respiratory pathology (8 vs 6%, ns. One-third of the babies were separated from their mother during or after FCS.ConclusionUnplanned neonatal admissions after elective CS increased after implementing FCS, without an increase in respiratory morbidity or hypothermia. SpO2 monitoring might have a contribution. Separation from the mother occurred often.

  9. Study on safety educations against individual causal factors of unsafe acts and specification of target trainees

    International Nuclear Information System (INIS)

    Hirose, Ayako; Takeda, Daisuke

    2016-01-01

    Many accidents and incidents are caused by unsafe acts. It is important to reduce these unsafe acts for preventing the accidents. The countermeasures for each causal factor behind unsafe acts are needed, however, comparing with improvement of facilities, workers-oriented measures such as safety educations are not sufficient. Then the purposes of this study are as follows: 1) to investigate the individual factors which have great impact of unsafe acts and the existing safety educations which aim to mitigate the impact of these factors, 2) to specify the target trainees to perform these safety educations. To identify common factors that affect unsafe act significantly, a web survey was conducted to 500 workers who have regularly carried out accident prediction training (i.e. Kiken-Yochi training). They were asked the situation which they were apt to act unsafely by free description. As the result, the following three main factors were extracted: impatience, overconfidence, and bothersome. Also, it was found that there were few existing safety educations which aim to mitigate the impact of these factors except for overconfidence. To specify the target trainees to perform safety educations which aim to mitigate the impact of these three factors, another web survey was conducted to 200 personnel in charge of safety at the workplace. They were asked the features of workers who tended to act unsafely by age group. The relationship between the factor that need to mitigate and the trainee who need to receive the education were clarified from the survey. (author)

  10. [Analysis of the safety culture in a Cardiology Unit managed by processes].

    Science.gov (United States)

    Raso-Raso, Rafael; Uris-Selles, Joaquín; Nolasco-Bonmatí, Andreu; Grau-Jornet, Guillermo; Revert-Gandia, Rosa; Jiménez-Carreño, Rebeca; Sánchez-Soriano, Ruth M; Chamorro-Fernández, Carlos I; Marco-Francés, Elvira; Albero-Martínez, José V

    2017-04-04

    Safety culture is one of the requirements for preventing the occurrence of adverse effects. However, this has not been studied in the field of cardiology. The aim of this study is to evaluate the safety culture in a cardiology unit that has implemented and certified an integrated quality and risk management system for patient safety. A cross-sectional observational study was conducted in 2 consecutive years, with all staff completing the Spanish version of the questionnaire, "Hospital Survey on Patient Safety Culture" of the "Agency for Healthcare Research and Quality", with 42 items grouped into 12 dimensions. The percentage of positive responses in each dimension in 2014 and 2015 were compared, as well as national data and United States data, following the established rules. The overall assessment out of a possible 5, was 4.5 in 2014 and 4.7 in 2015. Seven dimensions were identified as strengths. The worst rated were: staffing, management support and teamwork between units. The comparison showed superiority in all dimensions compared to national data, and in 8 of them compared to American data. The safety culture in a Cardiology Unit with an integrated quality and risk management patient safety system is high, and higher than nationally in all its dimensions and in most of them compared to the United States. Copyright © 2017 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

  11. Consumer food handling in the home: a review of food safety studies.

    Science.gov (United States)

    Redmond, Elizabeth C; Griffith, Christopher J

    2003-01-01

    Epidemiological data from Europe, North America, Australia, and New Zealand indicate that a substantial proportion of foodborne disease is attributable to improper food preparation practices in consumers' homes. International concern about consumer food safety has prompted considerable research to evaluate domestic food-handling practices. The majority of consumer food safety studies in the last decade have been conducted in the United Kingdom and Northern Ireland (48%) and in the United States (42%). Surveys (questionnaires and interviews), the most frequent means of data collection, were used in 75% of the reviewed studies. Focus groups and observational studies have also been used. One consumer food safety study examined the relationship between pathogenic microbial contamination from raw chicken and observed food-handling behaviors, and the results of this study indicated extensive Campylobacter cross-contamination during food preparation sessions. Limited information about consumers' attitudes and intentions with regard to safe food-handling behaviors has been obtained, although a substantial amount of information about consumer knowledge and self-reported practices is available. Observation studies suggest that substantial numbers of consumers frequently implement unsafe food-handling practices. Knowledge, attitudes, intentions, and self-reported practices did not correspond to observed behaviors, suggesting that observational studies provide a more realistic indication of the food hygiene actions actually used in domestic food preparation. An improvement in consumer food-handling behavior is likely to reduce the risk and incidence of foodborne disease. The need for the development and implementation of food safety education strategies to improve specific food safety behaviors is reviewed in this paper.

  12. Human-animal interactions and safety during dairy cattle handling--Comparing moving cows to milking and hoof trimming.

    Science.gov (United States)

    Lindahl, C; Pinzke, S; Herlin, A; Keeling, L J

    2016-03-01

    Cattle handling is a dangerous activity on dairy farms, and cows are a major cause of injuries to livestock handlers. Even if dairy cows are generally tranquil and docile, when situations occur that they perceive or remember as aversive, they may become agitated and hazardous to handle. This study aimed to compare human-animal interactions, cow behavior, and handler safety when moving cows to daily milking and moving cows to more rarely occurring and possibly aversive hoof trimming. These processes were observed on 12 Swedish commercial dairy farms. The study included behavioral observations of handler and cows and cow heart rate recordings, as well as recording frequencies of situations and incidents related to an increased injury risk to the handler. At milking, cows were quite easily moved using few interactions. As expected, the cows showed no behavioral signs of stress, fear, or resistance and their heart rate only rose slightly from the baseline (i.e., the average heart rate during an undisturbed period before handling). Moving cows to hoof trimming involved more forceful and gentle interactions compared with moving cows to milking. Furthermore, the cows showed much higher frequencies of behaviors indicative of aversion and fear (e.g., freezing, balking, and resistance), as well as a higher increase in heart rate. The risk of injury to which handlers were exposed also increased when moving cows to hoof trimming rather than to routine milking. Some interactions (such as forceful tactile interactions with an object and pulling a neck strap or halter) appeared to be related to potentially dangerous incidents where the handler was being kicked, head-butted, or run over by a cow. In conclusion, moving cows to hoof trimming resulted in higher frequencies of behaviors indicating fear, more forceful interactions, and increased injury risks to the handler than moving cows to milking. Improving potentially stressful handling procedures (e.g., by better animal handling

  13. The safety designs for the TITAN reversed-field pinch reactor study

    International Nuclear Information System (INIS)

    Wong, C.P.C.; Cheng, E.T.; Creedon, R.L.; Hoot, C.G.; Schultz, K.R.; Grotz, S.P.; Blanchard, J.; Sharafat, S.; Najmabadi, F.

    1989-01-01

    TITAN is a study to investigate the potential of the reversed-field pinch concept as a compact, high-power density energy system. Two reactor concepts were developed, a self-cooled lithium design with vanadium structure and an aqueous solution loop-in-pool design, both operating at 18 MW/m 2 . The key safety features of the TITAN-I lithium-vanadium blanket design are in material selection, fusion power core configuration selection, lithium piping connections, and passive lithium drain tank system. Based on these safety features and results from accident evaluation, TITAN-I can at least be rated at a level 3 of safety assurance. For the TITAN-II aqueous loop-in-pool design, the key passive feature is the complete submersion of the fusion power core and the corresponding primary coolant loop system into a pool of low temperature water. Based on this key safety design feature, the TITAN-II design can be rated at a level 2 of safety assurance. (orig.)

  14. A study on quantitative V and V of safety-critical software

    International Nuclear Information System (INIS)

    Eom, H. S.; Kang, H. G.; Chang, S. C.; Ha, J. J.; Son, H. S.

    2004-03-01

    Recently practical needs have required quantitative features for the software reliability for Probabilistic Safety Assessment which is one of the important methods being used in assessing the overall safety of nuclear power plant. But the conventional assessment methods of software reliability could not provide enough information for PSA of NPP, therefore current assessments of a digital system which includes safety-critical software usually exclude the software part or use arbitrary values. This paper describes a Bayesian Belief Networks based method that models the rule-based qualitative software assessment method for a practical use and can produce quantitative results for PSA. The framework was constructed by utilizing BBN that can combine the qualitative and quantitative evidence relevant to the reliability of safety-critical software and can infer a conclusion in a formal and a quantitative way. The case study was performed by applying the method for assessing the quality of software requirement specification of safety-critical software that will be embedded in reactor protection system

  15. The safety designs for the TITAN reversed-field pinch reactor study

    International Nuclear Information System (INIS)

    Wong, C.P.C.; Cheng, E.T.; Creedon, R.L.; Hoot, C.G.; Schultz, K.R.; Grotz, S.P.; Blanchard, J.P.; Sharafat, S.; Najmabadi, F.

    1988-01-01

    TITAN is a study to investigate the potential of the reversed-field pinch concept as a compact, high-power density energy system. Two reactor concepts were developed, a self-cooled lithium design with vanadium structure and an aqueous solution loop-in-pool design, both operating at 18 MW/m 2 . The key safety features of the TITAN-I lithium-vanadium blanket design are in material selection, fusion power core configuration selection, lithium piping connections and passive lithium drain tank system. Based on these safety features and results from accident evaluation, TITAN-I can at least be rated as level 3 of safety assurance. For the TITAN-II aqueous loop-in-pool design, the key passive feature is the complete submersion of the fusion power core and the corresponding primary coolant loop system into a pool of low temperature water. Based on this key safety design feature, the TITAN-II design can be rated as level 2 of safety assurance. 7 refs., 2 figs

  16. A study for safety and health management problem of semiconductor industry in Taiwan.

    Science.gov (United States)

    Chao, Chin-Jung; Wang, Hui-Ming; Feng, Wen-Yang; Tseng, Feng-Yi

    2008-12-01

    The main purpose of this study is to discuss and explore the safety and health management in semiconductor industry. The researcher practically investigates and interviews the input, process and output of the safety and health management of semiconductor industry by using the questionnaires and the interview method which is developed according to the framework of the OHSAS 18001. The result shows that there are six important factors for the safety and health management in Taiwan semiconductor industry. 1. The company should make employee clearly understand the safety and health laws and standards. 2. The company should make the safety and health management policy known to the public. 3. The company should put emphasis on the pursuance of the safety and health management laws. 4. The company should prevent the accidents. 5. The safety and health message should be communicated sufficiently. 6. The company should consider safety and health norm completely.

  17. System and safety studies of accelerator driven systems for transmutation. Annual report 2007

    Energy Technology Data Exchange (ETDEWEB)

    Arzhanov, Vasily; Fokau, Andrei; Persson, Calle; Runevall, Odd; Sandberg, Nils; Tesinsky, Milan; Wallenius, Janne; Youpeng Zhang (Div. of Reactor Physics, Royal Institute of Technology, Stockholm (Sweden))

    2008-05-15

    Within the project 'System and safety studies of accelerator driven systems for transmutation', research on design and safety of sub-critical reactors for recycling of minor actinides is performed. During 2007, the reactor physics division at KTH has calculated safety parameters for EFIT-400 with cermet fuel, permitting to start the transient safety analysis. The accuracy of different reactivity meters applied to the YALINA facility was assessed and neutron detection studies were performed. A model to address deviations from point kinetic behaviour was developed. Studies of basic radiation damage physics included calculations of vacancy formation and activation enthalpies in bcc niobium. In order to predict the oxygen potential of inert matrix fuels, a thermo-chemical model for mixed actinide oxides was implemented in a phase equilibrium code

  18. The impact of masculinity on safety oversights, safety priority and safety violations in two male-dominated occupations

    DEFF Research Database (Denmark)

    Nielsen, Kent; Hansen, Claus D.; Bloksgaard, Lotte

    2015-01-01

    Background Although men have a higher risk of occupational injuries than women the role of masculinity for organizational safety outcomes has only rarely been the object of research. Aim The current study investigated the association between masculinity and safety oversights, safety priority......-related context factors (safety leadership, commitment of the safety representative, and safety involvement) and three safety-related outcome factors (safety violations, safety oversights and safety priority) were administered twice 12 months apart to Danish ambulance workers (n = 1157) and slaughterhouse workers...

  19. Survey of the state of the German safety study

    International Nuclear Information System (INIS)

    Heuser, F.W.; Kotthoff, K.

    1977-01-01

    In spring 1976 the Federal Ministry of Research and Technology has ordered a safety study to assess the risk for a nuclear power plant with a PWR. Giving first a survey on the main subtasks of the study the present state of work and some first results are discussed. Assuming a failure of safety systems a core melt event and a subsequent failure of the containment could occur. Corresponding accident sequences are discussed in some detail. Related hereto the results of some calculations for fission product release with respect to different containment failure modes are given. According to the results obtained so far the consequences of a core melt event can essentially be restricted by the retention function of the containment. (orig.) [de

  20. Nuclear Criticality Technology and Safety Project parameter study database

    International Nuclear Information System (INIS)

    Toffer, H.; Erickson, D.G.; Samuel, T.J.; Pearson, J.S.

    1993-03-01

    A computerized, knowledge-screened, comprehensive database of the nuclear criticality safety documentation has been assembled as part of the Nuclear Criticality Technology and Safety (NCTS) Project. The database is focused on nuclear criticality parameter studies. The database has been computerized using dBASE III Plus and can be used on a personal computer or a workstation. More than 1300 documents have been reviewed by nuclear criticality specialists over the last 5 years to produce over 800 database entries. Nuclear criticality specialists will be able to access the database and retrieve information about topical parameter studies, authors, and chronology. The database places the accumulated knowledge in the nuclear criticality area over the last 50 years at the fingertips of a criticality analyst

  1. Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

    Science.gov (United States)

    Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

    2008-10-01

    In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

  2. Safety in home care: A research protocol for studying medication management

    Directory of Open Access Journals (Sweden)

    Easty Anthony

    2010-06-01

    Full Text Available Abstract Background Patient safety is an ongoing global priority, with medication safety considered a prevalent, high-risk area of concern. Yet, we have little understanding of the supports and barriers to safe medication management in the Canadian home care environment. There is a clear need to engage the providers and recipients of care in studying and improving medication safety with collaborative approaches to exploring the nature and safety of medication management in home care. Methods A socio-ecological perspective on health and health systems drives our iterative qualitative study on medication safety with elderly home care clients, family members and other informal caregivers, and home care providers. As we purposively sample across four Canadian provinces: Alberta (AB, Ontario (ON, Quebec (QC and Nova Scotia (NS, we will collect textual and visual data through home-based interviews, participant-led photo walkabouts of the home, and photo elicitation sessions at clients' kitchen tables. Using successive rounds of interpretive description and human factors engineering analyses, we will generate robust descriptions of managing medication at home within each provincial sample and across the four-province group. We will validate our initial interpretations through photo elicitation focus groups with home care providers in each province to develop a refined description of the phenomenon that can inform future decision-making, quality improvement efforts, and research. Discussion The application of interpretive and human factors lenses to the visual and textual data is expected to yield findings that advance our understanding of the issues, challenges, and risk-mitigating strategies related to medication safety in home care. The images are powerful knowledge translation tools for sharing what we learn with participants, decision makers, other healthcare audiences, and the public. In addition, participants engage in knowledge exchange

  3. Cleaning and outgassing studies of machinable tungsten for beamline safety shutters

    International Nuclear Information System (INIS)

    Liu, C.; Ryding, D.; Nielsen, R.W.; Kruy, T.L.; Kuzay, T.M.

    1996-01-01

    Machinable tungsten blocks are used as safety shutters in the front ends and the beamlines at the Advanced Photon Source (APS). The machinable tungsten used is characterized as a UHV-compatible metal by the vendor and was developed through a joint research effort with the APS. However, because of the inherent porosity in the sintered tungsten metal, it may present a vacuum problem and has to be subjected to strict vacuum testing before it is put on the beamlines. We have chosen specially heat-treated machinable tungsten with a density of 18 g/cm 3 for safety shutters. In-house-developed, environmentally friendly vacuum cleaning procedures were used. In this paper, we present results of thermal outgassing tests for machinable tungsten safety shutter sets. Each set consists of five blocks and has a total area of 4500 cm 2 . A cleaning procedure using alkaline detergent ultrasonic washes, deionized water rinses, and a 500 degree C vacuum furnace baking was used before outgassing measurements. Outgassing rates 10 hours after initial pump down at room temperature reached ∼1.60x10 -10 Torr·l·s -1 ·cm -2 for machinable tungsten and ∼1.56x10 -10 Torr·l·s -1 ·cm -2 for the stainless steel vacuum chamber. The outgassing rate of machinable tungsten 24 hours after an in situ 48 h bake at 160 degree C is also comparable to that of the stainless steel vacuum chamber. The importance of a 500 degree C vacuum furnace baking has been confirmed by outgassing studies for machinable tungsten sets that were not subject to vacuum furnace baking. copyright 1996 American Institute of Physics

  4. Safety studies concerning nuclear power reactors

    International Nuclear Information System (INIS)

    Bailly, Jean; Pelce, Jacques

    1980-01-01

    The safety of nuclear installations poses different technical problems, whether concerning pressurized water reactors or fast reactors. But investigating methods are closely related and concern, on the one hand, the behavior of shields placed between fuel and outside and, on the other, analysis of accidents. The article is therefore in two parts based on the same plan. Concerning light water reactors, the programme of studies undertaken in France accounts for the research carried out in countries where collaboration agreements exist. Concerning fast reactors, France has the initiative of their studies owing to her technical advance, which explains the great importance of the programmes under way [fr

  5. Valuation of road safety effects in cost-benefit analysis.

    Science.gov (United States)

    Wijnen, Wim; Wesemann, Paul; de Blaeij, Arianne

    2009-11-01

    Cost-benefit analysis is a common method for evaluating the social economic impact of transport projects, and in many of these projects the saving of human lives is an issue. This implies, within the framework of cost-benefit analysis, that a monetary value should be attached to saving human lives. This paper discusses the 'Value of a Statistical Life' (VoSL), a concept that is often used for monetising safety effects, in the context of road safety. Firstly, the concept of 'willingness to pay' for road safety and its relation to the VoSL are explained. The VoSL approach will be compared to other approaches to monetise safety effects, in particular the human capital approach and 'quality adjusted life years'. Secondly, methods to estimate the VoSL and their applicability to road safety will be discussed. Thirdly, the paper reviews the VoSL estimates that have been found in scientific research and compares them with the values that are used in policy evaluations. Finally, a VoSL study in the Netherlands will be presented as a case study, and its applicability in policy evaluation will be illustrated.

  6. Reliability analysis of Angra I safety systems

    International Nuclear Information System (INIS)

    Oliveira, L.F.S. de; Soto, J.B.; Maciel, C.C.; Gibelli, S.M.O.; Fleming, P.V.; Arrieta, L.A.

    1980-07-01

    An extensive reliability analysis of some safety systems of Angra I, are presented. The fault tree technique, which has been successfully used in most reliability studies of nuclear safety systems performed to date is employed. Results of a quantitative determination of the unvailability of the accumulator and the containment spray injection systems are presented. These results are also compared to those reported in WASH-1400. (E.G.) [pt

  7. Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

    Science.gov (United States)

    Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

    2009-07-01

    An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

  8. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    NARCIS (Netherlands)

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical

  9. Safety distance assessment of industrial toxic releases based on frequency and consequence: A case study in Shanghai, China

    International Nuclear Information System (INIS)

    Yu, Q.; Zhang, Y.; Wang, X.; Ma, W.C.; Chen, L.M.

    2009-01-01

    A case study on the safety distance assessment of a chemical industry park in Shanghai, China, is presented in this paper. Toxic releases were taken into consideration. A safety criterion based on frequency and consequence of major hazard accidents was set up for consequence analysis. The exposure limits for the accidents with the frequency of more than 10 -4 , 10 -5 -10 -4 and 10 -6 -10 -5 per year were mortalities of 1% (or SLOT), 50% (SLOD) and 75% (twice of SLOD) respectively. Accidents with the frequency of less than 10 -6 per year were considered incredible and ignored in the consequence analysis. Taking the safety distance of all the hazard installations in a chemical plant into consideration, the results based on the new criterion were almost smaller than those based on LC50 or SLOD. The combination of the consequence and risk based results indicated that the hazard installations in two of the chemical plants may be dangerous to the protection targets and measurements had to be taken to reduce the risk. The case study showed that taking account of the frequency of occurrence in the consequence analysis would give more feasible safety distances for major hazard accidents and the results were more comparable to those calculated by risk assessment.

  10. Criticality safety (prospect of study in NUCEF)

    International Nuclear Information System (INIS)

    Itagaki, Masafumi

    1996-01-01

    Experimental studies of criticality safety are under way using STACY and TRACY in NUCEF. Collection of fundamental data on criticality in a solution system is undergoing with STACY to confirm that the likelihood of criticality safety in the system constructed on the assumption of apparatuses in a reprocessing plant is enough large. Whereas some experiments simulating criticality accidents in a reprocessing plant using TRACY were designed to investigate the behaviors of fuel solution and radioactive matters in order to clarify whether it is possible to safely shut them in the facility even if a critical accident occurs. Both STACY and TRACY reached the criticality in 1995. Up to now a series of criticality experiments have been done using STACY with a core tank φ60 cm and the first periodical examination is now under way. On the other hand, we have a plan using TRACY to investigate the behaviors of nuclear heat solution at a criticality accident, and the releasing, transfer and deposition of radioactive materials. After reaching the criticality for the first, the performance verification test has been conducted. The full-scale study using TRACY is planned to begin in the second half of 1996. (M.N.)

  11. 'BeSAFE', effect-evaluation of internet-based, tailored safety information combined with personal counselling on parents' child safety behaviours: study design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Beeck Eduard F

    2010-08-01

    Full Text Available Abstract Background Injuries in or around the home are the most important cause of death among children aged 0-4 years old. It is also a major source of morbidity and loss of quality of life. In order to reduce the number of injuries, the Consumer Safety Institute introduced the use of Safety Information Leaflets in the Netherlands to provide safety education to parents of children aged 0-4 years. Despite current safety education, necessary safety behaviours are still not taken by a large number of parents, causing unnecessary risk of injury among young children. In an earlier study an E-health module with internet-based, tailored safety information was developed and applied. It concerns an advice for parents on safety behaviours in their homes regarding their child. The aim of this study is to evaluate the effect of this safety information combined with personal counselling on parents' child safety behaviours. Methods/Design Parents who are eligible for the regular well-child visit with their child at child age 5-8 months are invited to participate in this study. Participating parents are randomized into one of two groups: 1 internet-based, tailored safety information combined with personal counselling (intervention group, or 2 personal counselling using the Safety Information Leaflets of the Consumer Safety Institute in the Netherlands for children aged 12 to 24 months (control group. All parents receive safety information on safety topics regarding the prevention of falling, poisoning, drowning and burning. Parents of the intervention group will access the internet-based, tailored safety information module when their child is approximately 10 months old. After completion of the assessment questions, the program compiles a tailored safety advice. The parents are asked to devise and inscribe a personal implementation intention. During the next well-child visit, the Child Health Clinic professional will discuss this tailored safety information

  12. Efficiency evaluation of a safety department in a construction company-A case study: A DEA approach

    Directory of Open Access Journals (Sweden)

    Solomon Odeyale

    2015-01-01

    Full Text Available Data Envelopment Analysis (DEA is a decision making tool based on linear programming for measuring the relative efficiency of a set of comparable units. DEA helps us identify the sources and level of inefficiency for each of the inputs and outputs. This approach has been used to evaluate the efficiency of the safety department in five construction companies. A three-input, safety workforce, safety training, and safety budget, and two-output, Perfect days and Uptime, constant returns-to-scale (CRS model was developed. The model indicated the necessary improvements required in the inefficient unit’s inputs and outputs to make it efficient, by identifying what factor is responsible for the low efficiency of performance, and also what factor should be improved in order to improve the efficiency of the safety department. The result shows that the safety department of firm A, B and D are efficient, but Firm C and Firm E can improve their efficiency by reducing inputs up to 3.34% and 6.05%, respectively. The inputs identified for reduction were; number of safety staffs and safety budget for Firm C and E respectively.

  13. Multi-sectoral action for child safety-a European study exploring implicated sectors.

    Science.gov (United States)

    Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

    2017-06-01

    Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  14. A Study on Enhancement of Understanding of Radiation and Safety Management

    Energy Technology Data Exchange (ETDEWEB)

    Yoo, Dong Han; Park, Ji Young; Lee, Jae Uk; Bae, Jun Woo; Kim, Hee Reyoung [Ulsan National Institute of Science and Technology, Ulsan (Korea, Republic of)

    2014-10-15

    Concerns for radiation exposure have been increased from small and big radiation works or experiments with radiation generator (RG) or radiation isotopes (RI) at institutions using radiation in Korea. Actually, due to radiation exposure occurred on the process of handling RI, etc., The exposure should be maintained as low as reasonably possible. To do this, above all, suitable training and establishment of safety culture have to be preceded. In this respect, an education institution is a place where people learn first about handling radiations in various specialties with purposes including academic research, and the first learned habits and practices acts as the basis for safety management of radiation when they continue to do radiation work after going into the society. Hereford, it is needed to establish the right safety culture on radiation for its safe managing. In the present study, the direction for the right understandings and safety improvement are suggested through the radiation survey on education institutions and preparation of safety guidances for users. The basic guidance at the radiation experiment was prepared for the right understanding of the radiation to prevent radiation accidents from careless handling by workers based on the surveyed results for education institutions. It is expected to be used as fundamentals for improvement for radiation safety management of workers and researchers and, further, safety policy for national nuclear energy and radiations.

  15. A Study on Enhancement of Understanding of Radiation and Safety Management

    International Nuclear Information System (INIS)

    Yoo, Dong Han; Park, Ji Young; Lee, Jae Uk; Bae, Jun Woo; Kim, Hee Reyoung

    2014-01-01

    Concerns for radiation exposure have been increased from small and big radiation works or experiments with radiation generator (RG) or radiation isotopes (RI) at institutions using radiation in Korea. Actually, due to radiation exposure occurred on the process of handling RI, etc., The exposure should be maintained as low as reasonably possible. To do this, above all, suitable training and establishment of safety culture have to be preceded. In this respect, an education institution is a place where people learn first about handling radiations in various specialties with purposes including academic research, and the first learned habits and practices acts as the basis for safety management of radiation when they continue to do radiation work after going into the society. Hereford, it is needed to establish the right safety culture on radiation for its safe managing. In the present study, the direction for the right understandings and safety improvement are suggested through the radiation survey on education institutions and preparation of safety guidances for users. The basic guidance at the radiation experiment was prepared for the right understanding of the radiation to prevent radiation accidents from careless handling by workers based on the surveyed results for education institutions. It is expected to be used as fundamentals for improvement for radiation safety management of workers and researchers and, further, safety policy for national nuclear energy and radiations

  16. Predicting safety culture: the roles of employer, operations manager and safety professional.

    Science.gov (United States)

    Wu, Tsung-Chih; Lin, Chia-Hung; Shiau, Sen-Yu

    2010-10-01

    This study explores predictive factors in safety culture. In 2008, a sample 939 employees was drawn from 22 departments of a telecoms firm in five regions in central Taiwan. The sample completed a questionnaire containing four scales: the employer safety leadership scale, the operations manager safety leadership scale, the safety professional safety leadership scale, and the safety culture scale. The sample was then randomly split into two subsamples. One subsample was used for measures development, one for the empirical study. A stepwise regression analysis found four factors with a significant impact on safety culture (R²=0.337): safety informing by operations managers; safety caring by employers; and safety coordination and safety regulation by safety professionals. Safety informing by operations managers (ß=0.213) was by far the most significant predictive factor. The findings of this study provide a framework for promoting a positive safety culture at the group level. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

  17. Employee motivation and work performance: A comparative study of mining companies in Ghana

    Energy Technology Data Exchange (ETDEWEB)

    Kuranchie-Mensah, E.; Amponsah-Tawiah, K.

    2016-07-01

    The paper empirically compares employee motivation and its impact on performance in Ghanaian Mining Companies, where in measuring performance, the job satisfaction model is used. The study employed exploratory research design in gathering data from four large-scale Gold mining companies in Ghana with regards to their policies and structures in the effectiveness of motivational tools and strategies used by these companies. The study observed that, due to the risk factors associated with the mining industry, management has to ensure that employees are well motivated to curb the rate at which employees embark on industrial unrest which affect performance, and employees are to comply with health and safety rules because the industry contribute hugely to the Gross Domestic Product (GDP) of the country. Limitation to the present study include the researcher’s inability to contact other mining companies. However, the study suggests possibilities for future research including contacting other mining companies, expanding the sample size, managers ensuring that the safety and health needs of staff are addressed particularly those exposed to toxic and harmful chemicals. A lot of studies have been done on mining companies in the past. This paper fills a gap perceived that employees in this sector are highly motivated in spite of the challenges being faced by them, and knowing more about what keeps employees moving is still of national interest. (Author)

  18. Employee motivation and work performance: A comparative study of mining companies in Ghana

    International Nuclear Information System (INIS)

    Kuranchie-Mensah, E.; Amponsah-Tawiah, K.

    2016-01-01

    The paper empirically compares employee motivation and its impact on performance in Ghanaian Mining Companies, where in measuring performance, the job satisfaction model is used. The study employed exploratory research design in gathering data from four large-scale Gold mining companies in Ghana with regards to their policies and structures in the effectiveness of motivational tools and strategies used by these companies. The study observed that, due to the risk factors associated with the mining industry, management has to ensure that employees are well motivated to curb the rate at which employees embark on industrial unrest which affect performance, and employees are to comply with health and safety rules because the industry contribute hugely to the Gross Domestic Product (GDP) of the country. Limitation to the present study include the researcher’s inability to contact other mining companies. However, the study suggests possibilities for future research including contacting other mining companies, expanding the sample size, managers ensuring that the safety and health needs of staff are addressed particularly those exposed to toxic and harmful chemicals. A lot of studies have been done on mining companies in the past. This paper fills a gap perceived that employees in this sector are highly motivated in spite of the challenges being faced by them, and knowing more about what keeps employees moving is still of national interest. (Author)

  19. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study

    Directory of Open Access Journals (Sweden)

    Kuptniratsaikul V

    2014-03-01

    Full Text Available Vilai Kuptniratsaikul,1 Piyapat Dajpratham,1 Wirat Taechaarpornkul,2 Montana Buntragulpoontawee,3 Pranee Lukkanapichonchut,4 Chirawan Chootip,5 Jittima Saengsuwan,6 Kesthamrong Tantayakom,7 Supphalak Laongpech8 1Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; 2Sirindhorn National Medical Rehabilitation Center, Ministry of Public Health, Nonthaburi, Thailand; 3Department of Rehabilitation Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 4Department of Rehabilitation Medicine, Ratchaburi Hospital, Ministry of Public Health, Ratchaburi, Thailand; 5Department of Rehabilitation Medicine, Songkhla Hospital, Ministry of Public Health, Songkhla, Thailand; 6Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 7Department of Rehabilitation Medicine, Rajvithi Hospital, Ministry of Public Health, Bangkok, Thailand; 8Department of Rehabilitation Medicine, Vachira Phuket Hospital, Ministry of Public Health, Phuket, Thailand Objective: To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement. Methods: 367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs were also recorded. Results: 185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval of WOMAC total

  20. Maintaining and Researching Port Safety: A Case Study of the Port of Kaohsiung

    OpenAIRE

    Tseng, Po-Hsing.; Pilcher, Nick.

    2017-01-01

    Maintaining port safety in full conformity with IMO standards is a requisite for every port and country. To do this, understanding the challenges and human factors involved is key. To date, much research has shed valuable light on these factors and considered how to address them. One aspect that is often noted is that both maintaining port safety and researching port safety presents numerous challenges. This paper considers both these aspects in the context of a case study of port safety in K...

  1. International standardization of safety requirements for fast reactors

    International Nuclear Information System (INIS)

    2011-06-01

    Japan Atomic Energy Agency (JAEA) is conducting the FaCT (Fast Reactor Cycle Technology Development) project in cooperation with Japan Atomic Power Company (JAPC) and Mitsubishi FBR systems inc. (MFBR), where an advanced loop-type fast reactor named JSFR (Japan Sodium-cooled Fast Reactor) is being developed. It is important to develop software technologies (a safety guideline, safety design criteria, safety design standards etc.) of FBRs as well as hardware ones (a reactor plant itself) in order to address prospective worldwide utilization of FBR technology. Therefore, it is expected to establish a rational safety guideline applicable to the JSFR and harmonized with national nuclear-safety regulations as well, including Japan, the United States and the European Union. This report presents domestic and international status of safety guideline development for sodium-cooled fast reactors (SFRs), results of comparative study for safety requirements provided in existing documents and a proposal for safety requirements of future SFRs with a roadmap for their refinement and worldwide utilization. (author)

  2. Changing patient safety culture in China: a case study of an experimental Chinese hospital from a comparative perspective

    OpenAIRE

    Xu XP; Deng DN; Gu YH; Ng CS; Cai X; Xu J; Zhang XS; Ke DG; Yu QH; Chan CK

    2018-01-01

    Xiao Ping Xu,* Dong Ning Deng,* Yong Hong Gu, Chui Shan Ng, Xiao Cai, Jun Xu, Xin Shi Zhang, Dong Ge Ke, Qian Hui Yu, Chi Kuen Chan Clinical Service Department, The University of Hong Kong - Shenzhen Hospital, Shenzhen, Guangdong, People’s Republic of China *These authors contributed equally to this work Background: The World Health Organization highlights that patient safety interventions are not lacking but that the local context affects their successful implementation. Increasing att...

  3. WHY IS THE STUDY OF THE COMPLEX SAFETY OF CELECOXIB FOR ARTHRITIS, WHICH IS CALLED PRECISION, LAST BUT NOT LEAST?

    Directory of Open Access Journals (Sweden)

    Yu. V. Muravyev

    2017-01-01

    Full Text Available The paper discusses the results of the long-term PRECISION study specially designed for the prospective comparative evaluation primarily of the cardiovascular safety of celecoxib, ibuprofen, and naproxen, which are long used for the treatment of pain in patients with arthritis. 

  4. Efficacy and safety of escitalopram versus desvenlafaxine in the treatment of major depression: A preliminary 1-year prospective randomized open label comparative trial

    Directory of Open Access Journals (Sweden)

    Brij Mohan Gupta

    2016-01-01

    Full Text Available Aim and Objective: To compare efficacy and safety of escitalopram with desvenlafaxine in the treatment of major depression.Materials and Methods: A total of 60 patients of depression were randomized into two groups after meeting inclusion criterion. In the first 3 weeks, escitalopram 10 mg/day was given and then 20 mg/day for the next 3 weeks in group 1 (n = 30. Desvenlafaxine in the first 3 weeks was given 50 mg/day and 100 mg/day for the next 3 weeks in group 2 (n = 30. The parameters evaluated during the study were efficacy assessments byHamilton Scale of Rating Depression (HAM-D, Hamilton Rating Scale of Anxiety (HAM-A, and Clinical Global Impression (CGI. Safety assessments were done by UKU-scale. Results: Escitalopram and desvenlafaxine significantly (P < 0.001, reduced HAM-D, HAM-A, and CGI scores from their respective base lines. However, on comparison failed show any statistical difference at 3 and 6 weeks of treatment. Escitalopram and desvenlafaxine were both found to be safe and well-tolerated and there was not much difference between the two groups as evident from UKU Scale and their effect on various biochemical parameters. Conclusion: The present study demonstrated similar efficacy and safety in reducing depression and anxiety with both escitalopram and desvenlafaxine, but clinical superiority of one drug over the other cannot be concluded due to limitations of the small sample size.

  5. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

    Science.gov (United States)

    Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

    2014-02-01

    Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

  6. Risk and safety in the nuclear industry and conventional norms of society

    International Nuclear Information System (INIS)

    Tadmor, J.

    1977-01-01

    The societal acceptance of various risks is analyzed and rules of risk acceptance as a function of different parameters (e. g., expected benefit, intensity of effect) are spelled out. The monetary value of a human life is estimated, based on investments in safety of different human activities. The acceptable risks and safety investments in different human activities are then compared with risks and safety investments of the nuclear industry. Safety investments required to reduce radioactivity releases and risks from nuclear power stations to ALAP (as low as practiable) levels are taken as a study case. It is found that risks in the nuclear industry are several orders of magnitude lower and safety investments per human life saved are several orders of magnitude higher, as compared with risks and safety investments in other human activities

  7. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.

    Science.gov (United States)

    Singh, Dig Vijay; Mete, Uttam Kumar; Mandal, Arup Kumar; Singh, Shrawan Kumar

    2014-01-01

    Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction are common disorders of advancing age. To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH. In this prospective randomized study, 133 men complaining of LUTS due to BPH were included. Forty-five patients received tamsulosin 0.4 mg/day alone (Group A), 44 patients received tadalafil 10 mg/day (Group B), and combination therapy (tamsulosin and tadalafil both) was instituted in 44 patients (Group C). After a 2-week medication free run-in period, they were evaluated for International Prostatic Symptom Score (IPSS), International Index of Erectile Function score (IIEF5), quality of life (IPSS QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR) volume, and safety parameters before and at 3 months of treatment. There were primary (IPSS, IPSS QoL index, Qmax, and PVR) and secondary (erectile function [EF] domain scores from IIEF5) efficacy end points. Safety assessment included laboratory tests and patient's reporting of adverse event. A significant improvement in IPSS score was observed in all the 3 groups A, B, and C (-50.90%, P tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS. Their EF also improves with these medications. The improvement is better with combination therapy compared with single agent alone. © 2013 International Society for Sexual Medicine.

  8. Plant air systems safety study: Portsmouth Gaseous Diffusion Plant

    International Nuclear Information System (INIS)

    1982-05-01

    The Portsmouth Gaseous Diffusion Plant Air System facilities and operations are reviewed for potential safety problems not covered by standard industrial safety procedures. Information is presented under the following section headings: facility and process description (general); air plant equipment; air distribution system; safety systems; accident analysis; plant air system safety overview; and conclusion

  9. Safety in cardiac surgery

    NARCIS (Netherlands)

    Siregar, S.

    2013-01-01

    The monitoring of safety in cardiac surgery is a complex process, which involves many clinical, practical, methodological and statistical issues. The objective of this thesis was to measure and to compare safety in cardiac surgery in The Netherlands using the Netherlands Association for

  10. Patient safety in surgical environments: Cross-countries comparison of psychometric properties and results of the Norwegian version of the Hospital Survey on Patient Safety

    Directory of Open Access Journals (Sweden)

    Nortvedt Monica W

    2010-09-01

    Full Text Available Abstract Background How hospital health care personnel perceive safety climate has been assessed in several countries by using the Hospital Survey on Patient Safety (HSOPS. Few studies have examined safety climate factors in surgical departments per se. This study examined the psychometric properties of a Norwegian translation of the HSOPS and also compared safety climate factors from a surgical setting to hospitals in the United States, the Netherlands and Norway. Methods This survey included 575 surgical personnel in Haukeland University Hospital in Bergen, an 1100-bed tertiary hospital in western Norway: surgeons, operating theatre nurses, anaesthesiologists, nurse anaesthetists and ancillary personnel. Of these, 358 returned the HSOPS, resulting in a 62% response rate. We used factor analysis to examine the applicability of the HSOPS factor structure in operating theatre settings. We also performed psychometric analysis for internal consistency and construct validity. In addition, we compared the percent of average positive responds of the patient safety climate factors with results of the US HSOPS 2010 comparative data base report. Results The professions differed in their perception of patient safety climate, with anaesthesia personnel having the highest mean scores. Factor analysis using the original 12-factor model of the HSOPS resulted in low reliability scores (r = 0.6 for two factors: "adequate staffing" and "organizational learning and continuous improvement". For the remaining factors, reliability was ≥ 0.7. Reliability scores improved to r = 0.8 by combining the factors "organizational learning and continuous improvement" and "feedback and communication about error" into one six-item factor, supporting an 11-factor model. The inter-item correlations were found satisfactory. Conclusions The psychometric properties of the questionnaire need further investigations to be regarded as reliable in surgical environments. The operating

  11. NPP Krsko periodic safety review. Safety assessment and analyses

    International Nuclear Information System (INIS)

    Basic, I.; Spiler, J.; Thaulez, F.

    2002-01-01

    Definition of a PSR (Periodic Safety Review) project is a comprehensive safety review of a plant after ten years of operation. The objective is a verification by means of a comprehensive review using current methods that the plant remains safe when judged against current safety objectives and practices and that adequate arrangements are in place to maintain plant safety. The overall goals of the NEK PSR Program are defined in compliance with the basic role of a PSR and the current practice typical for most of the countries in EU. This practice is described in the related guides and good practice documents issued by international organizations. The overall goals of the NEK PSR are formulated as follows: to demonstrate that the plant is as safe as originally intended; to evaluate the actual plant status with respect to aging and wear-out identifying any structures, systems or components that could limit the life of the plant in the foreseeable future, and to identify appropriate corrective actions, where needed; to compare current level of safety in the light of modern standards and knowledge, and to identify where improvements would be beneficial for minimizing deviations at justifiable costs. The Krsko PSR will address the following safety factors: Operational Experience, Safety Assessment, EQ and Aging Management, Safety Culture, Emergency Planning, Environmental Impact and Radioactive Waste.(author)

  12. [Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients].

    Science.gov (United States)

    Portillo Canizalez, Ligia Marcela; Blanco Rodriguez, Gerardo; Teyssier Morales, Gustavo; Penchyna Grub, Jaime; Trauernicht Mendieta, Sean; Zurita-Cruz, Jessie Nallely

    Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2g/kg/day) + bisacodyl in pediatric patients. A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ 2 for qualitative variables. There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4g/kg/day). Copyright © 2017 Hospital Infantil de México Federico Gómez. Publicado por Masson Doyma México S.A. All rights reserved.

  13. Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

    Science.gov (United States)

    Sinclair, Robert R; Martin, James E; Sears, Lindsay E

    2010-09-01

    Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

  14. Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer

    DEFF Research Database (Denmark)

    Smith, Ian; Yardley, Denise; Burris, Howard

    2017-01-01

    receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709.......9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR...

  15. Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

    International Nuclear Information System (INIS)

    Yunus, N A; Abdullah, M H R O; Said, M A; Ch'ng, P E

    2014-01-01

    All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia

  16. Assessment of radiation safety awareness among nuclear medicine nurses: a pilot study

    Science.gov (United States)

    Yunus, N. A.; Abdullah, M. H. R. O.; Said, M. A.; Ch'ng, P. E.

    2014-11-01

    All nuclear medicine nurses need to have some knowledge and awareness on radiation safety. At present, there is no study to address this issue in Malaysia. The aims of this study were (1) to determine the level of knowledge and awareness on radiation safety among nuclear medicine nurses at Putrajaya Hospital in Malaysia and (2) to assess the effectiveness of a training program provided by the hospital to increase the knowledge and awareness of the nuclear medicine nurses. A total of 27 respondents attending a training program on radiation safety were asked to complete a questionnaire. The questionnaire consists 16 items and were categorized into two main areas, namely general radiation knowledge and radiation safety. Survey data were collected before and after the training and were analyzed using descriptive statistics and paired sample t-test. Respondents were scored out of a total of 16 marks with 8 marks for each area. The findings showed that the range of total scores obtained by the nuclear medicine nurses before and after the training were 6-14 (with a mean score of 11.19) and 13-16 marks (with a mean score of 14.85), respectively. Findings also revealed that the mean score for the area of general radiation knowledge (7.59) was higher than that of the radiation safety (7.26). Currently, the knowledge and awareness on radiation safety among the nuclear medicine nurses are at the moderate level. It is recommended that a national study be conducted to assess and increase the level of knowledge and awareness among all nuclear medicine nurses in Malaysia.

  17. Road safety effects of porous asphalt: a systematic review of evaluation studies

    DEFF Research Database (Denmark)

    Elvik, R.; Greibe, Poul

    2005-01-01

    of eighteen estimates of the effect of porous asphalt on accident rates. No clear effect on road safety of porous asphalt was found. All summary estimates of effect indicated very small changes in accident rates and very few were statistically significant at conventional levels. Studies that have evaluated...... of these changes in risk factors on accident occurrence cannot be predicted. On the whole, the research that has been reported so far regarding road safety effects of porous asphalt is inconclusive. The studies are not of high quality and the findings are inconsistent.......This paper presents a systematic review of studies that have evaluated the effects on road safety of porous asphalt. Porous asphalt is widely used on motorways in Europe, mainly in order to reduce traffic noise and increase road capacity. A meta-analysis was made of six studies, containing a total...

  18. Safety Management. An Introduction to a Frame of Reference Exemplified with Case Studies from Non-Nuclear Contexts

    Energy Technology Data Exchange (ETDEWEB)

    Svensson, Ola (Risk Analysis, Social and Decision Research Unit, Dept. of Psychology, Stockholm Univ., Stockholm (Sweden)); Salo, Ilkka (Dept. of Psychology, Lund Univ., Lund (Sweden))

    2004-11-15

    A systems perspective on safety management is introduced followed by two briefly presented case studies of safety management in non-nuclear contexts. The first study concerns a car manufacturer and the second study a road traffic tunnel system. The risks of a car accident in the first case study are evident. The great exposure generates many incidents and accidents. In the second study, the rather low traffic intensity through the tunnel produces few incidents and accidents and only a few fatal accidents over the years. Yet, the risk of the individual traveler is much greater in the tunnel than on the average road. The case studies are presented in a systems perspective with emphasis on information feedback about the risks of the systems. The first case study illustrates high quality safety management, while the second case study shows many weaknesses of the safety management in the tunnel system. Some differences in safety management between the case studies are noted. The last part of the study presents an organizational perspective on safety management and offers alternative theoretical perspectives on the concept of safety management. The report shows that further studies are needed both (1) to develop a frame of reference for describing safety management across industries and activities and (2) to collect data illustrating of good and poor safety management. Then, the results can be used to strengthen and/or improving safety management in the nuclear power industry and its regulators

  19. Safety Management. An Introduction to a Frame of Reference Exemplified with Case Studies from Non-Nuclear Contexts

    International Nuclear Information System (INIS)

    Svensson, Ola; Salo, Ilkka

    2004-11-01

    A systems perspective on safety management is introduced followed by two briefly presented case studies of safety management in non-nuclear contexts. The first study concerns a car manufacturer and the second study a road traffic tunnel system. The risks of a car accident in the first case study are evident. The great exposure generates many incidents and accidents. In the second study, the rather low traffic intensity through the tunnel produces few incidents and accidents and only a few fatal accidents over the years. Yet, the risk of the individual traveler is much greater in the tunnel than on the average road. The case studies are presented in a systems perspective with emphasis on information feedback about the risks of the systems. The first case study illustrates high quality safety management, while the second case study shows many weaknesses of the safety management in the tunnel system. Some differences in safety management between the case studies are noted. The last part of the study presents an organizational perspective on safety management and offers alternative theoretical perspectives on the concept of safety management. The report shows that further studies are needed both (1) to develop a frame of reference for describing safety management across industries and activities and (2) to collect data illustrating of good and poor safety management. Then, the results can be used to strengthen and/or improving safety management in the nuclear power industry and its regulators

  20. A Study on the Main Steam Safety Valve Opening Mechanism by Flashing on NPPs

    International Nuclear Information System (INIS)

    Kim, Bae Joo

    2009-01-01

    A safety injection event happened by opening of the Main Steam Safety Valve at Kori unit 1 on April 16, 2005. The safety valves were opened at the lower system pressure than the valve opening set point due to rapid system pressure drop by opening of the Power Operated Relief Valve installed at the upstream of the Main Steam System. But the opening mechanism of safety valve at the lower set point pressure was not explained exactly. So, it needs to be understood about the safety valve opening mechanism to prevent a recurrence of this kind of event at a similar system of Nuclear Power Plant. This study is aimed to suggest the hydrodynamic mechanism for the safety valve opening at the lower set point pressure and the possibility of the recurrence at similar system conditions through document reviewing for the related previous studies and Kori unit 1 event

  1. An experimental study on passive safety systems for the SMART design with the SMART-ITL facility

    International Nuclear Information System (INIS)

    Park, Hyun-Sik; Bae, Hwang; Ryu, Sung-Uk; Jeon, Byong-Guk; Yang, Jin-Hwa; Yi, Sung-Jae

    2016-01-01

    Passive Safety Systems (PSSs) are added to the SMART design to increase the safety margin during accidents especially under a prolonged station blackout. A set of validation tests were performed for the PSSs of the SMART design with an integral effect test loop of SMART-ITL. Both single and dual trains of the Passive Safety Injection System (PSIS) were simulated to validate the SMART design together with two stages of Automatic Depressurization System (ADS) and four trains of Passive Residual Heat Removal System (PRHRS), and their results were compared. In this paper, the effect of the train number of PSIS on a Small-Break Loss of Coolant Accident (SBLOCA) scenario is investigated for a break size of 0.4 inch. The single and dual train tests show a similar trend in general but the injected water migrates slightly differently in the RV and is discharged through the break nozzle. The parameters of the Reactor Vessel (RV) pressure, RV water level, accumulated break mass, and injection flowrates from the Core Makeup Tank (CMT) and Safety Injection Tank (SIT) were compared. The acquired data will be used to validate the safety analysis code and its related models to evaluate the performance of SMART PSS, and to provide the base data during the application phase of construction licensing of the SMART design. (author)

  2. Ventilatory function assessment in safety pharmacology: Optimization of rodent studies using normocapnic or hypercapnic conditions

    International Nuclear Information System (INIS)

    Goineau, Sonia; Rompion, Sonia; Guillaume, Philippe; Picard, Sandra

    2010-01-01

    Although the whole body plethysmography for unrestrained animals is the most widely used method to assess the respiratory risk of new drugs in safety pharmacology, non-appropriate experimental conditions may mask deleterious side effects of some substances. If stimulant or bronchodilatory effects can be easily evidenced in rodents under standard experimental conditions, i.e. normal air breathing and diurnal phase, drug-induced respiratory depression remains more difficult to detect. This study was aimed at comparing the responsiveness of Wistar rats, Duncan Hartley guinea-pigs or BALB/c mice to the respiratory properties of theophylline (50 or 100 mg/kg p.o.) or morphine (30 mg/kg i.p.) under varying conditions (100% air versus 5% CO 2 -enriched air, light versus dark day phase), in order to select the most appropriate experimental conditions to each species for safety airway investigations. Our results showed that under normocapnia the ventilatory depressant effects of morphine can be easily evidenced in mice, slightly observed in guinea-pigs and not detected in rats in any day phase. Slight hypercapnic conditions enhanced the responsiveness of rats to morphine but not that of guinea-pigs and importantly they did not blunt the airway responsiveness of rats to the stimulation and bronchodilation evoked by theophylline, the most widely used reference agent in safety pharmacology studies. In conclusion, hypercapnic conditions associated with the non-invasive whole body plethysmography should be considered for optimizing the assessment of both the ventilatory depressant potential of morphine-like substances or the respiratory stimulant effects of new drugs in the rat, the most extensively used species in rodent safety and toxicological investigations.

  3. Collaboration and patient safety at an emergency department - a qualitative case study.

    Science.gov (United States)

    Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

    2018-03-19

    Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

  4. Efficacy and safety of olmesartan medoxomil and hydrochlorothiazide compared with benazepril and amlodipine besylate.

    Science.gov (United States)

    Kereiakes, Dean J; Neutel, Joel M; Punzi, Henry A; Xu, Jianbo; Lipka, Leslie J; Dubiel, Robert

    2007-01-01

    Most patients with stage 2 hypertension require two or more antihypertensive agents in order to achieve the BP goals recommended in current treatment guidelines. Accordingly, combinations of two drugs with different mechanisms of antihypertensive action are widely used. The aim of this randomized, double-blind, multicenter 12-week study was to compare the efficacy, safety, and tolerability of a combination of olmesartan medoxomil/hydrochlorothiazide (HCTZ) with that of benazepril plus amlodipine besylate in patients with stage 2 hypertension. Patients were eligible for randomization following a 3- to 4-week placebo run-in period if they had either (i) mean seated DBP>or=90 mm Hg butor=160 mm Hg but or=100 mm Hg butor=95 mm Hg and145 mm Hg andbenazepril (10 mg/day for 2 weeks; then 20 mg/day for 2 weeks; then benazepril 20 mg/day plus amlodipine besylate 5 mg/day for 4 weeks; then benazepril 20 mg/day plus amlodipine besylate 10 mg/day for 4 weeks). The primary endpoint was change from baseline in mean SBP at the end of week 12 (end of study). Secondary endpoints included DBP after completion of monotherapy and combination therapy at the end of weeks 4 and 12, SBP at the end of week 4, and percentage of patients attaining BP goals ofbenazepril plus amlodipine besylate (least square [LS] mean change: -32.5 vs -26.5 mm Hg, p=0.024; LS mean treatment difference -6.0 mm Hg; 95% CI -11.1, -0.8 mm Hg). The LS mean change for reduction in DBP approached statistical significance with olmesartan medoxomil/HCTZ compared with the benazepril-based regimen (p=0.056) at week 12 (end of study). BP reductions showed statistically significant differences between treatment groups favoring olmesartan medoxomil/HCTZ in both SBP and DBP at week 8. The percentage of patients achieving goal rates at the end of the study for olmesartan medoxomil/HCTZ and benazepril plus amlodipine besylate, respectively, were 66.3% versus 44.7% (p=0.006) forbenazepril plus amlodipine besylate 20/5 and 20

  5. Nurses' experiences and perspectives on medication safety practices: an explorative qualitative study.

    Science.gov (United States)

    Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester

    2014-04-01

    To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.

  6. The association between patient safety culture and burnout and sense of coherence: A cross-sectional study in restructured and not restructured intensive care units.

    Science.gov (United States)

    Vifladt, Anne; Simonsen, Bjoerg O; Lydersen, Stian; Farup, Per G

    2016-10-01

    To study the associations between registered nurses' (RNs) perception of the patient safety culture (safety culture) and burnout and sense of coherence, and to compare the burnout and sense of coherence in restructured and not restructured intensive care units (ICUs). Cross-sectional study. RNs employed at seven ICUs in six hospitals at a Norwegian Hospital Trust. One to four years before the study, three hospitals merged their general and medical ICUs into one general mixed ICU. The safety culture, burnout and sense of coherence were measured with the questionnaires Hospital Survey on Patient Safety Culture, Bergen Burnout Indicator and Sense of Coherence. Participant characteristics and working in restructured and not restructured ICUs were registered. In total, 143/289(49.5%) RNs participated. A positive safety culture was statistically significantly associated with a low score for burnout and a strong sense of coherence. No statistically significant differences were found in burnout and sense of coherence between RNs in the restructured and not restructured ICUs. In this study, a positive safety culture was associated with absence of burnout and high ability to cope with stressful situations. Burnout and sense of coherence were independent of the restructuring process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. Analysing supercritical water reactor's (SCWR's) special safety systems using probabilistic tools

    International Nuclear Information System (INIS)

    Ituen, I.; Novog, D.R.

    2011-01-01

    The next generation of reactors, termed Generation IV, has very attractive features -- its superior safety characteristics, high thermal efficiency, and fuel cycle sustainability. A key element of the Generation IV designs is the improvement in safety, which in turn requires improvements in safety system performance and reliability, as well as a reduction in initiating event frequencies. This study compares the response of the systems important to safety in the CANDU-Supercritical Water Reactor to those of the generic CANDU under a main steamline break accident and loss of forced circulation events -- to quantify the improvements in safety for the pre-conceptual CANDU SCWR design. Probabilistic safety analysis is the tool used in this study to test the behavior of the pre- conceptual design during these events. (author)

  8. Work Practice, Safety and Heedfulness. Studies of Organizational Reliability in Hospitals and Nuclear Power Plants

    International Nuclear Information System (INIS)

    Gauthereau, Vincent

    2003-01-01

    The study of safety in complex systems has focused on different issues over the past decades. This focus was often linked to the conclusions of previous accidents'/incidents' analyses. When accidents were attributed to technical causes, safety research focused on technical developments. When they were later attributed to 'human errors', safety research focused on this 'component'. And when, since the mid-eighties accidents have been attributed to 'organizational factors', safety research has focused on these very same 'organizational factors'. The present thesis argues for a 'practice view' over safety to be taken. This view is mainly drawn from the field of research on High Reliability Organizations (HRO). HRO theorists' point of view on safety is that we can operate complex systems safely despite the fact that we have made them so complex that they are prone to 'normal accidents'. Humans involved in the operation of our systems actually create safety. Safety is formed through the adaptation of work practice to local conditions, and this adaptation is part of safe operation. Safety is not only a substantial quality of our socio-technical systems: the discursive dimension of safety actually seems to be a central component of safety creation. However, the adaptive ability of HRO can sometimes become their downfall. Adaptation, which is the backbone of safety, can sometimes be a drawback as well. Consequently, the practice view of safety, proposed in the present work, argues that we need to further comprehend how work practice evolves over time, and more specifically what are the inherent characteristics of work practice that create this evolution. Empirical studies from health-care and nuclear power generation highlight different details about organizational reliability. For instance, one study of planning at a nuclear power plant draws our attention to the different roles of planning in the organization. Another study, within heath-care, underlines the evolution of

  9. Patients for patient safety in China: a cross sectional study.

    Science.gov (United States)

    Zhang, Qiongwen; Li, Yulin; Li, Jing; Mao, Xuanyue; Zhang, Lijuan; Ying, Qinghua; Wei, Xin; Shang, Lili; Zhang, Mingming

    2012-02-01

    To investigate the baseline status of patients' awareness, knowledge, and attitudes to patient safety in China, and to determine the factors that influence patients' involvement in patient safety. We conducted a cross sectional survey using questionnaires adapted from recent studies on patient safety from outside China. The items included medical errors, infection, medication safety, and other aspects of patient safety. The questionnaire included 17 items and 5 domains. The survey was conducted between Jan. 2009 and Dec. 2010 involving 1000 patients from ten grade-A hospitals in seven provinces or cities in China. Most patients from the surgery departments completed the questionnaires voluntarily and anonymously. Five reviewers independently input the data into Microsoft Excel 2003, and the data were double-checked. Data were analyzed using SPSS 15.0 software for differences in the perceptions and attitudes of patients toward patient safety among different genders, ages, and regions. We distributed 1000 questionnaires and collected 959 completed questionnaires (response rate: 96%). Among the respondents, 58% of patients did not know what medical error is. Sixty-five percent of patients wanted disclosure of all medical errors. After errors occurred, 58% of patients wanted explanations of all possible harms that had resulted. Among 187 patients who had experienced medical errors, 83% of patients had sought appropriate legal action. About 52% of patients understood hospital infection, but 28% patients did not know that infections could occur in hospital. Seventy-eight percent of patients thought that medical staff should wash their hands before examining patients. More than half of the patients (68%) were willing to remind the staff of hygiene if they saw unsanitary conditions in a health clinic. Only 14% of patients knew the side effects of medications that they took. The majority of patients surveyed expressed willingness to contribute to patient safety, but their

  10. Cost benefit study of a safety campaign's impact on road safety.

    Science.gov (United States)

    Stojanová, Hana; Blašková, Veronika

    2018-04-28

    The aim of this paper is to identify a break in the development trend of the time series of the number of fatal, light and heavy injuries in traffic accidents and compare the progress caused by the media campaign named "Think or you'll pay! "in the Czech Republic over the period 2000-2015. The campaign focuses on the age group of drivers under the age of 25 and the most common cause of their traffic accidents as the drivers in this age category are the most vulnerable group in road traffic. The campaign uses a method in which it tries to influence behaviour by negative action, or by causing negative emotions. The authors concentrate on the effects of mass media campaigns in the long-term development of accidents in the Czech Republic and a financial evaluation of the road safety campaign "Think or you'll pay! "by comparing the campaign costs, the cost of road fatalities, and the cost savings from the perspective of government expenditures. The secondary source data for the chart analysis and interpolation according to the criteria of analytical and mechanical balancing time series, the Chow test and Quandt Likelihood Ratio test, choosing the appropriate model trend of accidents and consequences of traffic accidents were obtained from the Czech Ministry of Transport, the database of The Losses due to Traffic Accident Rates (CZRSO) and the Czech Association of Victims of Traffic Accidents (CSODN, 2015) from period of 1990 till 2016. The impact of the media campaign "Think or you'll pay!", measured by enumerating the costs was compared with the number of fatalities in the years immediately after the campaign and the impact of the media campaign was evaluated and recognised. The conclusion and the highlights summarize the findings of research and the limits of media campaign evaluation approach. Copyright © 2018 Elsevier Ltd. All rights reserved.

  11. Hospital safety climate and safety behavior: A social exchange perspective.

    Science.gov (United States)

    Ancarani, Alessandro; Di Mauro, Carmela; Giammanco, Maria D

    Safety climate is considered beneficial to the improvement of hospital safety outcomes. Nevertheless, the relations between two of its key constituents, namely those stemming from leader-subordinate relations and coworker support for safety, are still to be fully ascertained. This article uses the theoretical lens of Social Exchange Theory to study the joint impact of leader-member exchange in the safety sphere and coworker support for safety on safety-related behavior at the hospital ward level. Social exchange constructs are further related to the existence of a shame-/blame-free environment, seen as a potential antecedent of safety behavior. A cross-sectional study including 166 inpatients in hospital wards belonging to 10 public hospitals in Italy was undertaken to test the hypotheses developed. Hypothesized relations have been analyzed through a fully mediated multilevel structural equation model. This methodology allows studying behavior at the individual level, while keeping into account the heterogeneity among hospital specialties. Results suggest that the linkage between leader support for safety and individual safety behavior is mediated by coworker support on safety issues and by the creation of a shame-free environment. These findings call for the creation of a safety climate in which managerial efforts should be directed not only to the provision of new safety resources and the enforcement of safety rules but also to the encouragement of teamwork and freedom to report errors as ways to foster the capacity of the staff to communicate, share, and learn from each other.

  12. Follow-up Study of ITER Safety Analysis : Large In-vessel First Wall Pipe Break with Wet Confinement Bypass

    Energy Technology Data Exchange (ETDEWEB)

    Moon, Sung Bo; Bang, In Cheol [Ulsan National Institute of Science and Technology, Ulsan (Korea, Republic of)

    2014-10-15

    Previous researches have been analyzed risk assessments of fusion reactors that are dangerous in the severe accidents where the radioactive material released from confinement building to the environment. To simulate the severe accidents in ITER, a number of thermal hydraulics simulation codes were used. Before construction of the fusion reactor, to obtain ITER license about safety issue, MELCOR is chosen as one of the several codes to be used to perform ITER safety analyses. Qualification of the simulation code is to simulate the cooling system in ITER, the transport of radionuclides during design basis accidents (DBAs) including beyond design basis accidents (BDBAs). MELCOR is fully integrated code that models the accidents in Light Water Reactor (LWR). To analyze the accidents in ITER, MELCOR 1.8.2 version is modified. In the nuclear fusion system, the amount of released radioactive material is criteria for safety permission. Tritium (or tritiated water: HTO) and radioactive dust aerosol are the source of radioactive leakage. In the Generic Site Safety Report (GSSR) for the ITER plant, Table I lists the release guidelines for tritium and activation products for normal operation, incidents and accidents. Several accident analyses have been studied to know how much radioactive material could be released from the severe accidents. In the present work, The MELCOR input deck of large First Wall (FW) coolant leak (pipe break) is used to study and radioactive material leakage thorough bypass accident are studied to follow up the ITER safety analysis. In this research, follow-up study of the in-vessel inboard/inboard-outboard FW pipe break was analyzed to investigate the amount of leakage of radioactive aerosol. All of the accident cases released the lower amount of radioactive aerosol compared to the IAEA guide lines. In addition, the OBB pipe break made lower HTO aerosol leakage because of condensation of HTO and adsorption between coolant and aerosol.

  13. Safety assessment of novel foods and strategies to determine their safety in use

    International Nuclear Information System (INIS)

    Edwards, Gareth

    2005-01-01

    Safety assessment of novel foods requires a different approach to that traditionally used for the assessment of food chemicals. A case-by-case approach is needed which must be adapted to take account of the characteristics of the individual novel food. A thorough appraisal is required of the origin, production, compositional analysis, nutritional characteristics, any previous human exposure and the anticipated use of the food. The information should be compared with a traditional counterpart of the food if this is available. In some cases, a conclusion about the safety of the food may be reached on the basis of this information alone, whereas in other cases, it will help to identify any nutritional or toxicological testing that may be required to further investigate the safety of the food. The importance of nutritional evaluation cannot be over-emphasised. This is essential for the conduct of toxicological studies in order to avoid dietary imbalances, etc., that might lead to interpretation difficulties, but also in the context of its use as food and to assess the potential impact of the novel food on the human diet. The traditional approach used for chemicals, whereby an acceptable daily intake (ADI) is established with a large safety margin relative to the expected exposure, cannot be applied to foods. The assessment of safety in use should be based upon a thorough knowledge of the composition of the food, evidence from nutritional, toxicological and human studies, expected use of the food and its expected consumption. Safety equates to a reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption

  14. A Computer Program for Assessing Nuclear Safety Culture Impact

    Energy Technology Data Exchange (ETDEWEB)

    Han, Kiyoon; Jae, Moosung [Hanyang Univ., Seoul (Korea, Republic of)

    2014-10-15

    Through several accidents of NPP including the Fukushima Daiichi in 2011 and Chernobyl accidents in 1986, a lack of safety culture was pointed out as one of the root cause of these accidents. Due to its latent influences on safety performance, safety culture has become an important issue in safety researches. Most of the researches describe how to evaluate the state of the safety culture of the organization. However, they did not include a possibility that the accident occurs due to the lack of safety culture. Because of that, a methodology for evaluating the impact of the safety culture on NPP's safety is required. In this study, the methodology for assessing safety culture impact is suggested and a computer program is developed for its application. SCII model which is the new methodology for assessing safety culture impact quantitatively by using PSA model. The computer program is developed for its application. This program visualizes the SCIs and the SCIIs. It might contribute to comparing the level of the safety culture among NPPs as well as improving the management safety of NPP.

  15. A study of the international trend and comprehensive enhancement program on the Nuclear Power Plant safety

    International Nuclear Information System (INIS)

    Jang, Soon Hong; Cho, Nam Jin; Paek, Won Phil

    1990-12-01

    The objectives of this study are as follows : overview of the international trend related to the safety of Nuclear Power Plant(NPPs), study of the present status of NPP safety in Korea in aspects of design, construction and operation, suggestion of the comprehensive program to improve NPP safety in Korea. The results of this study can contribute to improve the safety of existing and future NPPs, and to establish the severe accident policy in Korea

  16. A study of the international trend and comprehensive enhancement program on the Nuclear Power Plant safety

    Energy Technology Data Exchange (ETDEWEB)

    Jang, Soon Hong; Cho, Nam Jin; Paek, Won Phil [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    1990-12-15

    The objectives of this study are as follows : overview of the international trend related to the safety of Nuclear Power Plant(NPPs), study of the present status of NPP safety in Korea in aspects of design, construction and operation, suggestion of the comprehensive program to improve NPP safety in Korea. The results of this study can contribute to improve the safety of existing and future NPPs, and to establish the severe accident policy in Korea.

  17. A relational leadership perspective on unit-level safety climate.

    Science.gov (United States)

    Thompson, Debra N; Hoffman, Leslie A; Sereika, Susan M; Lorenz, Holly L; Wolf, Gail A; Burns, Helen K; Minnier, Tamra E; Ramanujam, Rangaraj

    2011-11-01

    This study compared nursing staff perceptions of safety climate in clinical units characterized by high and low ratings of leader-member exchange (LMX) and explored characteristics that might account for differences. Frontline nursing leaders' actions are critical to ensure patient safety. Specific leadership behaviors to achieve this goal are underexamined. The LMX perspective has shown promise in nonhealthcare settings as a means to explain safety climate perceptions. Cross-sectional survey of staff (n = 711) and unit directors from 34 inpatient units in an academic medical center was conducted. Significant differences were found between high and low LMX scoring units on supervisor safety expectations, organizational learning-continuous improvement, total communication, feedback and communication about errors, and nonpunitive response to errors. The LMX perspective can be used to identify differences in perceptions of safety climate among nursing staff. Future studies are needed to identify strategies to improve staff safety attitudes and behaviors. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins

  18. Safety evaluations required in the safety regulations for Monju and the validity confirmation of safety evaluation methods

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    The purposes of this study are to perform the safety evaluations of the fast breeder reactor 'Monju' and to confirm the validity of the safety evaluation methods. In JFY 2012, the following results were obtained. As for the development of safety evaluation methods needed in the safety examination achieved for the reactor establishment permission, development of the analysis codes, such as a core damage analysis code, were carried out according to the plan. As for the development of the safety evaluation method needed for the risk informed safety regulation, the quantification technique of the event tree using the Continuous Markov chain Monte Carlo method (CMMC method) were studied. (author)

  19. Identifying research priorities for patient safety in mental health: an international expert Delphi study

    Science.gov (United States)

    Murray, Kevin; Thibaut, Bethan; Ramtale, Sonny Christian; Adam, Sheila; Darzi, Ara; Archer, Stephanie

    2018-01-01

    Objective Physical healthcare has dominated the patient safety field; research in mental healthcare is not as extensive but findings from physical healthcare cannot be applied to mental healthcare because it delivers specialised care that faces unique challenges. Therefore, a clearer focus and recognition of patient safety in mental health as a distinct research area is still needed. The study aim is to identify future research priorities in the field of patient safety in mental health. Design Semistructured interviews were conducted with the experts to ascertain their views on research priorities in patient safety in mental health. A three-round online Delphi study was used to ascertain consensus on 117 research priority statements. Setting and participants Academic and service user experts from the USA, UK, Switzerland, Netherlands, Ireland, Denmark, Finland, Germany, Sweden, Australia, New Zealand and Singapore were included. Main outcome measures Agreement in research priorities on a five-point scale. Results Seventy-nine statements achieved consensus (>70%). Three out of the top six research priorities were patient driven; experts agreed that understanding the patient perspective on safety planning, on self-harm and on medication was important. Conclusions This is the first international Delphi study to identify research priorities in safety in the mental field as determined by expert academic and service user perspectives. A reasonable consensus was obtained from international perspectives on future research priorities in patient safety in mental health; however, the patient perspective on their mental healthcare is a priority. The research agenda for patient safety in mental health identified here should be informed by patient safety science more broadly and used to further establish this area as a priority in its own right. The safety of mental health patients must have parity with that of physical health patients to achieve this. PMID:29502096

  20. Reactor safety

    International Nuclear Information System (INIS)

    Butz, H.P.; Heuser, F.W.; May, H.

    1985-01-01

    The paper comprises an introduction into nuclear physics bases, the safety concept generally speaking, safety devices of pwr type reactors, accident analysis, external influences, probabilistic safety assessment and risk studies. It further describes operational experience, licensing procedures under the Atomic Energy Law, research in reactor safety and the nuclear fuel cycle. (DG) [de

  1. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 2-Domino Hazard Index and case study.

    Science.gov (United States)

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-12-15

    The design of layout plans requires adequate assessment tools for the quantification of safety performance. The general focus of the present work is to introduce an inherent safety perspective at different points of the layout design process. In particular, index approaches for safety assessment and decision-making in the early stages of layout design are developed and discussed in this two-part contribution. Part 1 (accompanying paper) of the current work presents an integrated index approach for safety assessment of early plant layout. In the present paper (Part 2), an index for evaluation of the hazard related to the potential of domino effects is developed. The index considers the actual consequences of possible escalation scenarios and scores or ranks the subsequent accident propagation potential. The effects of inherent and passive protection measures are also assessed. The result is a rapid quantification of domino hazard potential that can provide substantial support for choices in the early stages of layout design. Additionally, a case study concerning selection among various layout options is presented and analyzed. The case study demonstrates the use and applicability of the indices developed in both parts of the current work and highlights the value of introducing inherent safety features early in layout design.

  2. Light-water reactors. Safety problems and related studies in France

    International Nuclear Information System (INIS)

    Lelievre, J.

    1975-01-01

    The program of theoretical and experimental studies developed by the CEA on the safety of PWR reactors is presented: studies relative to the consequences of a LOCA following a rupture of the primary system, studies relative to fuel element behavior, studies on steels, reliability studies and studies of non-destructive testing methods [fr

  3. Fusion safety studies in Russia from 1996 to 2000

    Energy Technology Data Exchange (ETDEWEB)

    Kolbasov, B.N. E-mail: kolbasov@nfi.kiae.ru; Biryukov, A.Yu.; Davydov, D.A.; Guseva, M.I.; Khripunov, B.I.; Korshunov, S.N.; Martynenko, Yu.V.; Romanov, P.V.; Vasiliev, V.I

    2001-04-01

    The paper is a review of results of some fusion safety studies performed in Russia during 1996-2000 (after the 6th IAEA Technical Committee Meeting on 'Developments in Fusion Safety'). In particular, changes of hydrogen isotope inventory in co-deposited layers on tungsten and graphite under simulation of normal tokamak operation and plasma disruptions are reported. Size distribution of graphite and W-Be-dust under the experiments at issue revealed two maximums. Erosion products were collected within tokamak T-10. Their microstructure and chemical composition were studied and are reported in the paper. Chemical interaction of beryllium powder with steam (in temperature range of 400-600 deg. C) and air (at 500-1000 deg. C) was investigated. Mathematical models describing it were developed. Chemical interaction of Be-powder with carbon was studied too. A dependence of beryllium carbide layer thickness growth versus time at 950 deg. C was found on the basis of the experiments.

  4. How does the efficacy and safety of Oralair® compare to other products on the market?

    Directory of Open Access Journals (Sweden)

    Larenas-Linnemann D

    2016-05-01

    Full Text Available Désirée Larenas-Linnemann Pediatric Allergy and Asthma Clinic, Department of Investigation, Hospital Médica Sur, México City, México Abstract: Due to differences between allergen immunotherapy (AIT trials in patient populations, trial design (including primary efficacy variables, the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair® and Grazax®/Grastek®, should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair® is effective in a pre (2-months-coseasonal schedule to reduce symptoms and medication use, and improve a patients’ quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair® is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax®/Grastek® showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available, and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. Keywords: sublingual allergen immunotherapy, grass pollen, allergic rhinitis

  5. Impact of individual resilience and safety climate on safety performance and psychological stress of construction workers: A case study of the Ontario construction industry.

    Science.gov (United States)

    Chen, Yuting; McCabe, Brenda; Hyatt, Douglas

    2017-06-01

    The construction industry has hit a plateau in terms of safety performance. Safety climate is regarded as a leading indicator of safety performance; however, relatively little safety climate research has been done in the Canadian construction industry. Safety climate may be geographically sensitive, thus it is necessary to examine how the construct of safety climate is defined and used to improve safety performance in different regions. On the other hand, more and more attention has been paid to job related stress in the construction industry. Previous research proposed that individual resilience may be associated with a better safety performance and may help employees manage stress. Unfortunately, few empirical research studies have examined this hypothesis. This paper aims to examine the role of safety climate and individual resilience in safety performance and job stress in the Canadian construction industry. The research was based on 837 surveys collected in Ontario between June 2015 and June 2016. Structural equation modeling (SEM) techniques were used to explore the impact of individual resilience and safety climate on physical safety outcomes and on psychological stress among construction workers. The results show that safety climate not only affected construction workers' safety performance but also indirectly affected their psychological stress. In addition, it was found that individual resilience had a direct negative impact on psychological stress but had no impact on physical safety outcomes. These findings highlight the roles of both organizational and individual factors in individual safety performance and in psychological well-being. Construction organizations need to not only monitor employees' safety performance, but also to assess their employees' psychological well-being. Promoting a positive safety climate together with developing training programs focusing on improving employees' psychological health - especially post-trauma psychological

  6. Field study on the safety and efficacy of intradermal versus intramuscular vaccination against Mycoplasma hyopneumoniae.

    Science.gov (United States)

    Beffort, Lisa; Weiß, Christine; Fiebig, Kerstin; Jolie, Rika; Ritzmann, Mathias; Eddicks, Matthias

    2017-09-30

    The present study compares the safety and efficacy of a needle-free, intradermal Mycoplasma hyopneumoniae vaccine to an intramuscular one. 420 piglets (21+3 days of age) were randomly assigned to two vaccination groups (intradermal vaccination V1 (n=138), intramuscular vaccination V2 (n=144)) and one unvaccinated control group (CG, n=138). As safety parameters clinical observations, local injection site reactions (ISR) and rectal temperatures were assessed. Average daily weight gain (ADWG) and pneumonic lung lesions (LL) were measured as efficacy parameters. ISRs were minor in V1. After both vaccinations, no adverse impact on appetite was observed and mean rectal temperatures remained within physiological range. ADWG during the fattening period was significantly higher in vaccinated groups (V1: 913.4 g, V2: 924.5 g) compared with CG (875.6 g). No differences in ADWG were observed between V1 and V2. Vaccinated pigs had a significantly reduced mean extent of LL compared with CG. V1 was superior in reducing the extent and prevalence of LL compared with V2. These results reveal that a needle-free intradermal vaccination is safe and efficacious in reducing both the prevalence and extent of lung lesions, as well as in improving performance parameters, in a farrow-to-finish farm with a late onset of M hyopneumonia e infection. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Immunogenicity and safety of the new reduced-dose tetanus-diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Kim, Sang Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Lee, Kyung-Yil; Kim, Hwang Min; Choi, Young Youn; Ma, Sang Hyuk; Kim, Chun Soo; Kim, Dong Ho; Ahn, Dong Ho; Kang, Jin Han

    2017-04-01

    A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine. Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored. A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups. The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus. Copyright © 2015. Published by Elsevier B.V.

  8. A Comparative Study Between Modified Starch and Xanthan Gum Thickeners in Post-Stroke Oropharyngeal Dysphagia.

    Science.gov (United States)

    Vilardell, N; Rofes, L; Arreola, V; Speyer, R; Clavé, P

    2016-04-01

    Thickeners are used in post-stroke oropharyngeal dysphagia (OD) as a compensatory therapeutic strategy against aspirations. To compare the therapeutic effects of modified starch (MS) and xanthan gum (XG) thickeners on swallow safety and efficacy in chronic post-stroke OD patients using clinical and videofluoroscopic (VFS) assessment. Patients were studied by clinical assessment (volume-viscosity swallow test, V-VST) and VFS using 3 volumes (5, 10, 20 mL) and 3 viscosities (liquid, nectar and spoon thick), comparing MS and XG. We studied 122 patients (46MS, 76XG). (A) V-VST showed that both thickeners similarly improved safety of swallow. Prevalence of safe swallowing significantly increased with enhanced viscosity (P < 0.001 vs liquid), MS: 47.83 % at liquid, 84.93 % at nectar and 92.96 % at spoon thick; XG: 55.31 % at liquid, 77.78 % at nectar and 97.84 % at spoon thick. Patients on MS reported higher prevalence of pharyngeal residue at spoon-thick viscosities. (B) VFS: increasing bolus viscosity with either thickener increased prevalence of safe swallows (P < 0.001 vs liquid), MS: 30.25 % liquid, 61.07 % nectar and 92.64 % spoon thick; XG: 29.12 % liquid, 71.30 % nectar and 89.91 % spoon thick. Penetration-aspiration scale score was significantly reduced with increased viscosity with both thickeners. MS increased oral and pharyngeal residues at nectar and spoon-thick viscosities but XG did not. Timing of airway protection mechanisms and bolus velocity were not affected by either thickener. Increasing bolus viscosity with MS and XG thickeners strongly and similarly improved safety of swallow in chronic post-stroke OD by a compensatory mechanism; in contrast only MS thickeners increased oropharyngeal residue.

  9. Drug safety evaluation of defibrotide.

    Science.gov (United States)

    Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

    2013-01-01

    Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

  10. Patient Safety Outcomes in Small Urban and Small Rural Hospitals

    Science.gov (United States)

    Vartak, Smruti; Ward, Marcia M.; Vaughn, Thomas E.

    2010-01-01

    Purpose: To assess patient safety outcomes in small urban and small rural hospitals and to examine the relationship of hospital and patient factors to patient safety outcomes. Methods: The Nationwide Inpatient Sample and American Hospital Association annual survey data were used for analyses. To increase comparability, the study sample was…

  11. Annual report on occupational safety 1985

    International Nuclear Information System (INIS)

    1986-09-01

    This report presents information on occupational safety relating to the Company's employees for the year 1985, and compares data with figures for the previous year. The following headings are listed: principle activities of BNFL, general policy and organisation, radiological safety, including whole body, skin and extremity, and internal organ doses, non-radiological safety, incidents reportable to the health and safety executive. (U.K.)

  12. Safety probabilistic study of Almirante Alvaro Alberto nuclear power plant-Unit I

    International Nuclear Information System (INIS)

    Lederman, L.; Arrieta, L.A.I.; Fernandes Filho, T.L.; Gibelli, S.M.O.; Berthoud, J.S.; Ambros, P.C.; Soares, H.V.; Camargo, C.T.M.

    1985-04-01

    The phase A of probabilistic safety study of Angra I nuclear power plant is presented, to be used by CNEN and FURNAS Centrais Eletricas S.A. as standard model in operational and safety analysis. The methodology applied is a modernization of WASH 1400/2.11/ study. Angra I safety systems are described. The selection and qualification of initiating sequence accident events which can damage the reactor core are done. The accident scenes are developed using the method of event trees. The reactor in subcritical condition (pressure, fuel temperature within limits and controlled level of reactor vessel) is studied during 24 hours. The uncertainness in failure probabilities of systems and in the determination of sequence frequencies for core danification are evaluated. Total frequency of sequences which cause the fusion of reactor core are presented. (M.C.K.) [pt

  13. Comparative Study between Standard and Totally Tubeless Percutaneous Nephrolithotomy.

    Science.gov (United States)

    Yun, Sung Il; Lee, Yoon Hyung; Kim, Jae Soo; Cho, Sung Ryong; Kim, Bum Soo; Kwon, Joon Beom

    2012-11-01

    Several recent studies have reported the benefits of tubeless percutaneous nephrolithotomy (PNL). Postoperatively, tubeless PNL patients have an indwelling ureteral stent placed, which is often associated with stent-related morbidity. We have performed totally tubeless (tubeless and stentless) PNL in which no nephrostomy tube or ureteral stent is placed postoperatively. We evaluated the safety, effectiveness, and feasibility of totally tubeless PNL. From March 2008 to February 2012, 57 selected patients underwent standard or totally tubeless PNL. Neither a nephrostomy tube nor a ureteral stent was placed in the totally tubeless PNL group. We compared patient and stone characteristics, operation time, length of hospitalization, analgesia requirements, stone-free rate, blood loss, change in creatinine, and perioperative complications between the standard and totally tubeless PNL groups. There were no significant differences in preoperative patient characteristics, postoperative complications, or the stone-free rate between the two groups, but the totally tubeless PNL group showed a shorter hospitalization and a lesser analgesic requirement compared with the standard PNL group. Blood loss and change in creatinine were not significantly different between the two groups. Totally tubeless PNL appears to be a safe and effective alternative for the management of renal stone patients and is associated with a decrease in length of hospital stay.

  14. Confirmatory Factor Analysis of Patient Safety Culture in an Iranian Hospital: A Case Study of Fatemeh Zahra Hospital in Najafabad, Iran

    Directory of Open Access Journals (Sweden)

    Mohammadkarim Bahadori

    2016-04-01

    Full Text Available Introduction: Transformation of patient safety culture towards developing an open culture can be the greatest challenge for achieving a safe healthcare system. This study aimed to carry out a structural analysis of the Persian translation version of a questionnaire assessing patient safety culture. Materials and Methods: The study was conducted to evaluate the Persian translation of patient safety culture questionnaire, developed by the National Patient Safety Agency. The questionnaire includes seven sections and 43 items investigating 12 dimensions of patient safety culture. The reliability of this questionnaire was confirmed with Cronbach's alpha (α>0.8. The questionnaire was distributed among employees of the Fatemeh Zahra Hospital in Najafabad, Iran, 2015. The collected data were analyzed using SPSS 18 and Amos 18. Results: Sufficiency of the sample size, as determined by Kaiser-Meyer-Olkin measure, was 0.809, which was significantly associated with zero; therefore, performing factor analysis was acceptable and justifiable. The value of Bartlett's test was 696, P-value was less than 0.001, and degree of freedom was equal to 91. In the final model, the relative Chi-square was equal to 1.75 and P-value was less than 0.001. Also, parsimony normed fit index, parsimony-adjusted comparative fit index, and root mean square error of approximation were equal to 0.571, 0.621, and 0.065, respectively. Conclusion: Based on the results of fitting indices for the model and the questionnaire used in the present study for assessing patient safety culture, it can be stated that the Persian translation of this instrument is valid and hospitals can use it to monitor patient safety culture improvement.

  15. Comparative safety of gadodiamide, dimeglumine gadopentetate and meglumine gadoterate in MRI of the central nervous system

    International Nuclear Information System (INIS)

    Chanalet, S.; Bruneton, J.N.; Masson, B.; Boyer, L.; Laffont, J.

    1995-01-01

    The development of new non-ionic magnetic resonance (MR) contrast media as gadodiamide injection increased the choice of paramagnetic contrast agents available in MR of the central nervous system (CNS). The purpose of our paper was to compare at the dose of 0.1 mmol/kg b.w. the safety of gadodiamide (Gd-DTPA-BMA) to gadopentetate dimeglumine (Gd-DTPA) and to gadoterate meglumine (Gd-DOTA) in two multi centric double-blind studies. A total of 551 patients were enrolled with 143 patients in the Gd-DTPA group, 132 patients in the Gd-DOTA group and 276 patients in the Gd-DTPA-BMA group. Safety was assessed by recording the adverse events up to 24 hours after the injection. One or more adverse events were recorded in 14% of the Gd-DTPA patients, in 15.1% of the Gd-DOTA patients and in 11.6% of the Gd-DTPA-BMA patients. These reactions were related to the contrast media in 9.1%, 13.6% and 8.7% of the cases respectively. Their intensity was defined as mild in 8.4% of the patients in the Gd-DTPA group, in 13.6% of the patients in the Gd-DOTA group and in 8.3% of the patients in the Gd-DTPA-BMA group. No severe reaction or death were recorded. An injection-site reaction (heat, coldness, pain) has been observed in 43% of the cases although an adverse event other than local reactions (headache, dizziness, nausea) has been noticed in 57% of the cases. No significant statistical difference was observed between the groups. Gadodiamide is a safe and effective contrast agent in MRI of the CNS in comparison with Gd-DTPA and Gd-DOTA currently in routine use

  16. Theoretical Study on the Flow of Refilling Stage in a Safety Injection Tank

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jun Sang [Halla Univ. Daejeon (Korea, Republic of)

    2017-10-15

    In this study, a theoretical analysis was performed to the flow of refilling stage in a safety injection tank, which is the core cooling system of nuclear power plant in an emergency. A theoretical model was proposed with a nonlinear governing equation defining on the flow of the refilling process of the coolant. Utilizing the Taylor-series expansion, the 1st - order approximation flow equation was obtained, along with its analytic solution of closed type, which could predict accurately the variations of free surface height and flow rate of the coolant. The availability of theoretical result was confirmed by comparing with previous experimental results.

  17. Food safety issues in China: a case study of the dairy sector.

    Science.gov (United States)

    Dong, Xiaoxia; Li, Zhemin

    2016-01-15

    Over the past 10 years, food safety incidents have occurred frequently in China. Food safety issues in the dairy sector have increasingly gained the attention of the Chinese government and the public. The objective of this research is to explore consumption changes of dairy products of different income groups after these dairy safety incidents. The research indicates that consumers' response to dairy safety risk is very intense. Dairy consumption has experienced a declining trend in recent years, and the impact of dairy safety incidents has lasted for at least 5 years. Until 2012, dairy consumption had not yet fully recovered from this influence. Using the random effects model, this study examined the relationship between food safety incident and consumption. Overall, the results show that consumers in the low-income group are more sensitive to safety risk than those in the high-income group. It can be seen from this paper that the decrease of urban residents' dairy consumption was mainly driven by changes in fresh milk consumption, while the decline of milk powder consumption, which was affected by the melamine incident, was relatively moderate, and milk powder consumption for the high-income group even increased. © 2015 Society of Chemical Industry.

  18. Comparative safety testing of genetically modified foods in a 90-day rat feeding study design allowing the distinction between primary and secondary effects of the new genetic event.

    Science.gov (United States)

    Knudsen, Ib; Poulsen, Morten

    2007-10-01

    This article discusses the wider experiences regarding the usefulness of the 90-day rat feeding study for the testing of whole foods from genetically modified (GM) plant based on data from a recent EU-project [Poulsen, M., Schrøder, M., Wilcks, A., Kroghsbo, S., Lindecrona, R.H., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Shu, Q., Emami, K., Taylor, M., Gatehouse, A., Engel, K.-H., Knudsen, I., 2007a. Safety testing of GM-rice expressing PHA-E lectin using a new animal test design. Food Chem. Toxicol. 45, 364-377; Poulsen, M., Kroghsbo, S., Schrøder, M., Wilcks, A., Jacobsen, H., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Shu, Q., Emami, K., Sudhakar, D., Gatehouse, A., Engel, K.-H., Knudsen, I., 2007b. A 90-day safety in Wistar rats fed genetically modified rice expressing snowdrop lectin Galanthus nivalis (GNA). Food Chem. Toxicol. 45, 350-363; Schrøder, M., Poulsen, M., Wilcks, A., Kroghsbo, S., Miller, A., Frenzel, T., Danier, J., Rychlik, M., Emami, K., Gatehouse, A., Shu, Q., Engel, K.-H., Knudsen, I., 2007. A 90-day safety study of genetically modified rice expressing Cry1Ab protein (Bacillus thuringiensis toxin) in Wistar rats. Food Chem. Toxicol. 45, 339-349]. The overall objective of the project has been to develop and validate the scientific methodology necessary for assessing the safety of foods from genetically modified plants in accordance with the present EU regulation. The safety assessment in the project is combining the results of the 90-day rat feeding study on the GM food with and without spiking with the pure novel gene product, with the knowledge about the identity of the genetic change, the compositional data of the GM food, the results from in-vitro/ex-vivo studies as well as the results from the preceding 28-day toxicity study with the novel gene product, before the hazard characterisation is concluded. The results demonstrated the ability of the 90-day rat feeding study to detect the biological/toxicological effects of the

  19. A comparative study of non-lipid nanoemulsion of propofol with solutol and propofol emulsion with lecithin.

    Science.gov (United States)

    Rodrigues, Thiago Alves; Alexandrino, Ricardo Andrade; Kanczuk, Marcelo Epstein; Gozzani, Judymara Lauzi; Mathias, Ligia Andrade da Silva Telles

    2012-01-01

    Some formulations have been proposed to reduce the adverse reactions due to the lipid emulsion containing soybean oil used as propofol carrier. This study for endoscopy sedation was aimed at evaluating and comparing the safety, effectiveness and adverse effects of the use of propofol nanoemulsion compared to propofol currently commercialized. In this prospective study, 150 patients were submitted to upper digestive endoscopy. These patients were allocated into two groups: the control group (CONT Group; n=75) and the nanoemulsion group (NE Group; n=75). HR, SBP, DBP, SpO(2) and BIS (which is considered to be appropriate between 65 and 75 during procedure) were monitored. Gender, age, weight, height, BMI, ASA physical status, times and doses were analyzed, as well as adverse effects (phlogistic signs and pain on injection, apnea, nausea/vomiting) and alterations in monitoring variables. A p-value 0.05). The times, induction doses and the SBP and DBP values at the end of examination and at the moment of discharge from the PACU were lower in the NE Group (p<0.05). Lipid propofol and propofol nanoemulsion were equivalent concerning effectiveness, safety and adverse effects in the doses used. There was a lower incidence of pain on injection in the nanoemulsion formulation. Copyright © 2012 Elsevier Editora Ltda. All rights reserved.

  20. The impact of different strategies to handle missing data on both precision and bias in a drug safety study: a multidatabase multinational population-based cohort study

    Science.gov (United States)

    Martín-Merino, Elisa; Calderón-Larrañaga, Amaia; Hawley, Samuel; Poblador-Plou, Beatriz; Llorente-García, Ana; Petersen, Irene; Prieto-Alhambra, Daniel

    2018-01-01

    Background Missing data are often an issue in electronic medical records (EMRs) research. However, there are many ways that people deal with missing data in drug safety studies. Aim To compare the risk estimates resulting from different strategies for the handling of missing data in the study of venous thromboembolism (VTE) risk associated with antiosteoporotic medications (AOM). Methods New users of AOM (alendronic acid, other bisphosphonates, strontium ranelate, selective estrogen receptor modulators, teriparatide, or denosumab) aged ≥50 years during 1998–2014 were identified in two Spanish (the Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria [BIFAP] and EpiChron cohort) and one UK (Clinical Practice Research Datalink [CPRD]) EMR. Hazard ratios (HRs) according to AOM (with alendronic acid as reference) were calculated adjusting for VTE risk factors, body mass index (that was missing in 61% of patients included in the three databases), and smoking (that was missing in 23% of patients) in the year of AOM therapy initiation. HRs and standard errors obtained using cross-sectional multiple imputation (MI) (reference method) were compared to complete case (CC) analysis – using only patients with complete data – and longitudinal MI – adding to the cross-sectional MI model the body mass index/smoking values as recorded in the year before and after therapy initiation. Results Overall, 422/95,057 (0.4%), 19/12,688 (0.1%), and 2,051/161,202 (1.3%) VTE cases/participants were seen in BIFAP, EpiChron, and CPRD, respectively. HRs moved from 100.00% underestimation to 40.31% overestimation in CC compared with cross-sectional MI, while longitudinal MI methods provided similar risk estimates compared with cross-sectional MI. Precision for HR improved in cross-sectional MI versus CC by up to 160.28%, while longitudinal MI improved precision (compared with cross-sectional) only minimally (up to 0.80%). Conclusion CC may substantially

  1. Study on occupational safety and health strategy for Taiwan.

    Science.gov (United States)

    Chuang, Kuen-Yuan; Su, Teh-Sheng; Kuo, Chao-Yin; Lin, Chien-Liang; Lin, Han-Yu; Yu, Yi-Chun

    2009-12-01

    The aim of this study was to establish a set of occupational safety and health (OSH) issues and development policies suitable for adoption in Taiwan. A survey was conducted on a sample of 102 experts and 235 industrial work safety personnel in Taiwan for statistical analysis of the general consensus, with the results showing such consensus in 104 individual policy indicators. Our results reveal that the most appropriate targets were considered to be annual 10% reductions in the 'occupational accident disability rate', 'occupational accident injury rate' and 'occupational diseases before 2010'. Responding to the specific question of the appropriate method of achieving a reduction in the number of accidents in Taiwan, the primary consideration for 13.4% of the experts and 10.6% of the industry personnel was 'promoting OSH awareness and enhancing the overall safety culture'. As regards the current OSH policy focus, 11.2% of the experts considered 'improving OSH legislation, standards and systems' to be the most important, whilst 8.9% of the industry personnel felt that 'recognizing work stress, overwork and emerging OSH issues' were the most important.

  2. A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle.

    Science.gov (United States)

    Zhou, Cui; Wang, Jian Wu; Huang, Kun Lun; He, XiaoYun; Chen, Xiu Ping; Sun, Hong; Yu, Tian; Che, Hui Lian

    2011-10-01

    Transgenic cloned animals expressing beneficial human nutritional traits offer a new strategy for large-scale production of some kinds of functional substances. In some cases, the required safety testing for genetically modified (GM) foods do not seem appropriate for human food safety, though regulations do not seem to provide alternatives. A 90-day rat feeding study is the core study for the safety assessment of GM foods. The test material in this 90-day study was prepared nonfat milk powder containing recombinant human lactoferrin (rhLF), which was expressed in transgenic cloned cattle. Groups of 10 male and female Sprague-Dawley rats were given a nutritionally balanced purified diet containing 7.5, 15, or 30% transgenic or conventional milk powder for 90 days. A commercial AIN93G diet was used as an additional control group. Clinical, biological, and pathological parameters were compared between groups. The only significant effect of treatment was higher mean ferritin and Fe(+) concentrations for both male and female rats fed the transgenic milk powder diets, as compared to rats fed nontransgenic milk diets or the commercial diet. The results of the present study are consistent with previous research, which indicates that milk powder containing rhLF derived from healthy transgenic cloned cattle is as safe as conventional milk powder.

  3. A Study on the Holding Capacity Safety Factors for Torpedo Anchors

    Directory of Open Access Journals (Sweden)

    Luís V. S. Sagrilo

    2012-01-01

    Full Text Available The use of powerful numerical tools based on the finite-element method has been improving the prediction of the holding capacity of fixed anchors employed by the offshore oil industry. One of the main achievements of these tools is the reduction of the uncertainty related to the holding capacity calculation of these anchors. Therefore, it is also possible to reduce the values of the associated design safety factors, which have been calibrated relying on models with higher uncertainty, without impairing the original level of structural safety. This paper presents a study on the calibration of reliability-based safety factors for the design of torpedo anchors considering the statistical model uncertainty evaluated using results from experimental tests and their correspondent finite-element-based numerical predictions. Both working stress design (WSD and load and resistance factors design (LRFD design methodologies are investigated. Considering the WSD design methodology, the single safety is considerably lower than the value typically employed in the design of torpedo anchors. Moreover, a LRFD design code format for torpedo anchors is more appropriate since it leads to designs having less-scattered safety levels around the target value.

  4. Nuclear reactor safety in the USA

    International Nuclear Information System (INIS)

    Vigil, J.C.

    1983-01-01

    Nuclear reactor safety in the USA has emphasized a defense-in-depth approach to protecting the public from reactor accidents. This approach was severely tested by the Three Mile Island accident and was found to be effective in safeguarding the public health and safety. However, the economic impact of the TMI accident was very large. Consequently, more attention is now being given to plant protection as well as public-health protection in reactor-safety studies. Sophisticated computer simulations at Los Alamos are making major contributions in this area. In terms of public risk, nuclear power plants compare favorably with other large-scale alternatives to electricity generation. Unfortunately, there is a large gulf between the real risks of nuclear power and the present public perception of these risks

  5. EFFECT OF A ROAD SAFETY EDUCATION INTERVENTION ON ROAD SAFETY KNOWLEDGE OF UNIVERSITY DRIVERS IN IBADAN, NIGERIA.

    Science.gov (United States)

    Olumide, A O; Owoaje, E T

    2016-06-01

    It is essential for drivers employed in the formal sector to have good knowledge of road safety in order to safeguard their lives and those of the staff they are employed to drive. The study was conducted to determine the effect of a road safety education intervention on road safety knowledge of drivers employed in the University of Ibadan, Nigeria. A quasi-experimental study of 98 intervention and 78 control drivers selected using a cluster sampling technique was conducted. The intervention comprised a two-day training on road safety and first aid. The drivers' knowledge of road safety was measured at baseline, immediately and 4-months post-intervention. Aggregate scores of road safety knowledge were computed giving minimum and maximum obtainable scores of 0 and 16 respectively. Change in mean scores over the three measurement periods was assessed using Repeated Measures Analysis of Variance (ANOVA). Independent t-test was used to compare the scores between intervention and control drivers at each of the assessment periods. Twenty-nine drivers did not complete the study (attrition rate = 16.5%). At baseline, mean road safety knowledge scores for the intervention and control drivers were 12.7±2.2 and 12.9± 2.3 (p = 0.510) respectively. Immediately and four months post intervention, the scores of the intervention drivers were 13.8±1.9 and 12.8±1.6; while scores for the controls were 13.3±2.0 and 13.2±1.8. Repeated measures ANOVA revealed that the increase in knowledge over the three assessment periods was not statistically significant. The intervention resulted in an initial increase in road safety knowledge of the intervention drivers. However, this was not sustained to the forth month post-intervention. This finding suggests periodic refresher trainings to sustain the knowledge acquired.

  6. Comparative study on two different seal surface structure for reactor pressure vessel sealing behavior

    International Nuclear Information System (INIS)

    Chen Jun; Xiong Guangming; Deng Xiaoyun

    2014-01-01

    The seal surface structure is very important to reactor pressure vessel (RPV) sealing behavior. In this paper, two 3-D RPV sealing analysis finite models have been established with different seal surface structures, in order to study the influence of two structures. The separation of RPV upper and lower flanges, bolt loads and etc. are obtained, which are used to evaluate the sealing behavior of the RPV. Meanwhile, the comparative analysis of safety margin of two seal surface structural had been done, which provides the theoretical basis for RPV seal structure design optimization. (authors)

  7. The interplay between teamwork, clinicians' emotional exhaustion, and clinician-rated patient safety: a longitudinal study.

    Science.gov (United States)

    Welp, Annalena; Meier, Laurenz L; Manser, Tanja

    2016-04-19

    Effectively managing patient safety and clinicians' emotional exhaustion are important goals of healthcare organizations. Previous cross-sectional studies showed that teamwork is associated with both. However, causal relationships between all three constructs have not yet been investigated. Moreover, the role of different dimensions of teamwork in relation to emotional exhaustion and patient safety is unclear. The current study focused on the long-term development of teamwork, emotional exhaustion, and patient safety in interprofessional intensive care teams by exploring causal relationships between these constructs. A secondary objective was to disentangle the effects of interpersonal and cognitive-behavioral teamwork. We employed a longitudinal study design. Participants were 2100 nurses and physicians working in 55 intensive care units. They answered an online questionnaire on interpersonal and cognitive-behavioral aspects of teamwork, emotional exhaustion, and patient safety at three time points with a 3-month lag. Data were analyzed with cross-lagged structural equation modeling. We controlled for professional role. Analyses showed that emotional exhaustion had a lagged effect on interpersonal teamwork. Furthermore, interpersonal and cognitive-behavioral teamwork mutually influenced each other. Finally, cognitive-behavioral teamwork predicted clinician-rated patient safety. The current study shows that the interrelations between teamwork, clinician burnout, and clinician-rated patient safety unfold over time. Interpersonal and cognitive-behavioral teamwork play specific roles in a process leading from clinician emotional exhaustion to decreased clinician-rated patient safety. Emotionally exhausted clinicians are less able to engage in positive interpersonal teamwork, which might set in motion a vicious cycle: negative interpersonal team interactions negatively affect cognitive-behavioral teamwork and vice versa. Ultimately, ineffective cognitive

  8. Patient Safety Culture and the Ability to Improve: A Proof of Concept Study on Hand Hygiene.

    Science.gov (United States)

    Caris, Martine G; Kamphuis, Pim G A; Dekker, Mireille; de Bruijne, Martine C; van Agtmael, Michiel A; Vandenbroucke-Grauls, Christina M J E

    2017-11-01

    OBJECTIVE To investigate whether the safety culture of a hospital unit is associated with the ability to improve. DESIGN Qualitative investigation of safety culture on hospital units following a before-and-after trial on hand hygiene. SETTING VU University Medical Center, a tertiary-care hospital in the Netherlands. METHODS With support from hospital management, we implemented a hospital-wide program to improve compliance. Over 2 years, compliance was measured through direct observation, twice before, and 4 times after interventions. We analyzed changes in compliance from baseline, and selected units to evaluate safety culture using a positive deviance approach: the hospital unit with the highest hand hygiene compliance and 2 units that showed significant improvement (21% and 16%, respectively) were selected as high performing. Another 2 units showed no improvement and were selected as low performing. A blinded, independent observer conducted interviews with unit management, physicians, and nurses, based on the Hospital Survey on Patient Safety Culture. Safety culture was categorized as pathological (lowest level), reactive, bureaucratic, proactive, or generative (highest level). RESULTS Overall, 3 units showed a proactive or generative safety culture and 2 units had bureaucratic or pathological safety cultures. When comparing compliance and interview results, high-performing units showed high levels of safety culture, while low-performing units showed low levels of safety culture. CONCLUSIONS Safety culture is associated with the ability to improve hand hygiene. Interventions may not be effective when applied in units with low levels of safety culture. Although additional research is needed to corroborate our findings, the safety culture on a unit can benefit from enhancement strategies such as team-building exercises. Strengthening the safety culture before implementing interventions could aid improvement and prevent nonproductive interventions. Infect Control

  9. Comparative efficacy and safety of treatment options for MDR and XDR Acinetobacter baumannii infections: a systematic review and network meta-analysis.

    Science.gov (United States)

    Kengkla, Kirati; Kongpakwattana, Khachen; Saokaew, Surasak; Apisarnthanarak, Anucha; Chaiyakunapruk, Nathorn

    2018-01-01

    To comprehensively compare and rank the efficacy and safety of available treatment options for patients with MDR and XDR Acinetobacter baumannii (AB) infection. We searched PubMed, Embase and the Cochrane register of trials systematically for studies that examined treatment options for patients with MDR- and XDR-AB infections until April 2016. Network meta-analysis (NMA) was performed to estimate the risk ratio (RR) and 95% CI from both direct and indirect evidence. Primary outcomes were clinical cure and microbiological cure. Secondary outcomes were all-cause mortality and nephrotoxic and non-nephrotoxic adverse events. A total of 29 studies with 2529 patients (median age 60 years; 65% male; median APACHE II score 19.0) were included. Although there were no statistically significant differences between treatment options, triple therapy with colistin, sulbactam and tigecycline had the highest clinical cure rate. Colistin in combination with sulbactam was associated with a significantly higher microbiological cure rate compared with colistin in combination with tigecycline (RR 1.23; 95% CI 1.03-1.47) and colistin monotherapy (RR 1.21; 95% CI 1.06-1.38). No significant differences in all-cause mortality were noted between treatment options. Tigecycline-based therapy also appeared less effective for achieving a microbiological cure and is not appropriate for treating bloodstream MDR- and XDR-AB infections. Combination therapy of colistin with sulbactam demonstrates superiority in terms of microbiological cure with a safety profile similar to that of colistin monotherapy. Thus, our findings support the use of this combination as a treatment for MDR- and XDR-AB infections. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Employee motivation and work performance: A comparative study of mining companies in Ghana

    Directory of Open Access Journals (Sweden)

    Elizabeth Boye Kuranchie-Mensah

    2016-04-01

    Full Text Available Purpose: The paper empirically compares employee motivation and its impact on performance in Ghanaian Mining Companies, where in measuring performance, the job satisfaction model is used. Design/methodology/approach: The study employed exploratory research design in gathering data from four large-scale Gold mining companies in Ghana with regards to their policies and structures in the effectiveness of motivational tools and strategies used by these companies. Findings: The study observed that, due to the risk factors associated with the mining industry, management has to ensure that employees are well motivated to curb the rate at which employees embark on industrial unrest which affect performance, and employees are to comply with health and safety rules because the industry contribute hugely to the Gross Domestic Product (GDP of the country. Research Limitations/Implications: Limitation to the present study include the researcher’s inability to contact other mining companies. However, the study suggests possibilities for future research including contacting other mining companies, expanding the sample size, managers ensuring that the safety and health needs of staff are addressed particularly those exposed to toxic and harmful chemicals. Originality/Value: A lot of studies have been done on mining companies in the past. This paper fills a gap perceived that employees in this sector are highly motivated in spite of the challenges being faced by them, and knowing more about what keeps employees moving is still of national interest.

  11. Safety studies: Review of loss of plasma control transients in ITER with AINA 3.0 code

    International Nuclear Information System (INIS)

    Rivas, J.C.; Dies, J.

    2013-01-01

    Highlights: ► We have examined the methodology employed in the analysis of the “Loss of plasma transients in ITER” safety reference events. ► We have developed a new methodology based on the study of the plasma operating window. ► We have concluded that the combined effect of different perturbations should be studied also to determine the most severe transients. -- Abstract: The loss of plasma control events in ITER are safety cases investigated to give an upper bound of the worse effects foreseeable from a total failure of the plasma control function. In the past, conservative analyses based on simple 0D models for plasma balance equations and 1D models for wall heat transfer showed that a hypothetical scenario of first wall coolant tubes melting and subsequent entering of water in the vacuum vessel could not be totally excluded. AINA (Analyses of IN vessel Accidents) code is a safety code developed at Fusion Energy Engineering Laboratory (FEEL) in Barcelona. It uses a 0D–1D architecture, similar to that used for previous analyses of ITER loss of plasma control events. The results of this study show the simultaneous effect of two perturbations (overfuelling and overheating) over a plasma transient, and compare it with the isolated effects of each perturbation. It is shown that the combined effect can be more severe, and a method is outlined to locate the most dangerous transients over a nT diagram

  12. Countries compared on public performance

    NARCIS (Netherlands)

    Jedid-Jah Jonker

    2012-01-01

    How well is the public sector performing? Are citizens being well served? This report compares the performance of nine public services in 28 developed countries over the period 1995-2009. Four sectors - education, health care, social safety and housing - are studied in some detail, while the

  13. Efficacy and safety of fidaxomicin compared with oral vancomycin for the treatment of adults with Clostridium difficile-associated diarrhea: data from the OPT-80-003 and OPT-80-004 studies.

    Science.gov (United States)

    Chen, Luke F; Anderson, Deverick J

    2012-06-01

    Clostridium difficile is emerging as one of the most important and devastating pathogens affecting hospitalized populations around the world. The incidence of C. difficile infection is increasing and disease severity is worsening. Thus, an effective alternative to metronidazole and oral vancomycin is urgently needed. Two Phase III trials, OPT-80-003 and OPT-80-004, showed that oral fidaxomicin for 10 days was noninferior compared with treatment with oral vancomycin among adult patients with toxin-positive C. difficile-associated diarrhea (CDAD). Furthermore, fidaxomicin was associated with a lower rate of recurrence of CDAD within 4 weeks of completion of therapy. The safety and tolerability of fidaxomicin was consistent with earlier studies and established that fidaxomicin is an efficacious and well-tolerated treatment option for CDAD. Despite these potential advantages, the cost-effectiveness of this expensive agent remains poorly understood.

  14. Alberta Environment's weir safety program : options for rehabilitation to improve public safety : a case study of the Calgary weir

    Energy Technology Data Exchange (ETDEWEB)

    Blakely, D. [Alberta Environment, Edmonton, AB (Canada)

    2009-07-01

    Alberta Environment Water Management Operations (WMO) owns and operates 46 dams and 800 kilometres of canals in Alberta. The WMO consists of 120 staff and several contract operators to take care of this infrastructure. Most of the infrastructure supplies water for irrigation use, which adds 5 billion dollars to the provincial economy annually. Other water uses include stock watering, domestic use, municipal use, recreational use and habitat. Alberta Environment's weir safety program was also discussed along with options for rehabilitation to improve public safety. A case study of Calgary's Weir Dam on the Bow River was highlighted. A brief history of the dam was offered and safety programs around provincially-owned weirs were discussed. Photographs were included to illustrate some of the additional safety measures at the Calgary weir, such as suspended safety buoys upstream of the boom directing paddlers to the portage trail, and signage on the river that can be activated when the boom is out. Typical river users on the Calgary Bow River and safety history at the Calgary Weir were discussed along with other topics such as the Calgary Bow River weir project criteria; project design progress; pre-feasibility options; scale modelling; final design analysis; construction funding; and proposed changes to the safety program for the new weir configuration. figs.

  15. Hospital safety culture in Taiwan: a nationwide survey using Chinese version Safety Attitude Questionnaire.

    Science.gov (United States)

    Lee, Wui-Chiang; Wung, Hwei-Ying; Liao, Hsun-Hsiang; Lo, Chien-Ming; Chang, Fei-Ling; Wang, Pa-Chun; Fan, Angela; Chen, Hsin-Hsin; Yang, Han-Chuan; Hou, Sheng-Mou

    2010-08-10

    Safety activities have been initiated at many hospitals in Taiwan, but little is known about the safety culture at these hospitals. The aims of this study were to verify a safety culture survey instrument in Chinese and to assess hospital safety culture in Taiwan. The Taiwan Patient Safety Culture Survey was conducted in 2008, using the adapted Safety Attitude Questionnaire in Chinese (SAQ-C). Hospitals and their healthcare workers participated in the survey on a voluntary basis. The psychometric properties of the five SAQ-C dimensions were examined, including teamwork climate, safety climate, job satisfaction, perception of management, and working conditions. Additional safety measures were asked to assess healthcare workers' attitudes toward their collaboration with nurses, physicians, and pharmacists, respectively, and perceptions of hospitals' encouragement of safety reporting, safety training, and delivery delays due to communication breakdowns in clinical areas. The associations between the respondents' attitudes to each SAQ-C dimension and safety measures were analyzed by generalized estimating equations, adjusting for the clustering effects at hospital levels. A total of 45,242 valid questionnaires were returned from 200 hospitals with a mean response rate of 69.4%. The Cronbach's alpha was 0.792 for teamwork climate, 0.816 for safety climate, 0.912 for job satisfaction, 0.874 for perception of management, and 0.785 for working conditions. Confirmatory factor analyses demonstrated a good model fit for each dimension and the entire construct. The percentage of hospital healthcare workers holding positive attitude was 48.9% for teamwork climate, 45.2% for perception of management, 42.1% for job satisfaction, 37.2% for safety climate, and 31.8% for working conditions. There were wide variations in the range of SAQ-C scores in each dimension among hospitals. Compared to those without positive attitudes, healthcare workers with positive attitudes to each SAQ

  16. The association between EMS workplace safety culture and safety outcomes.

    Science.gov (United States)

    Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

    2012-01-01

    Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

  17. Validation study of safety assessment model for radioactive waste disposal

    Energy Technology Data Exchange (ETDEWEB)

    Munakata, Masahiro; Takeda, Seiji; Kimura, Hideo [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    2001-12-01

    The JAERI-AECL collaboration research program has been conducted to validate a groundwater flow and radionuclide transport models for safety assessment. JAERI have developed a geostatistical model for radionuclide transport through a heterogeneous geological media and verify using experimental results of field tracer tests. The simulated tracer plumes explain favorably the experimental tracer plumes. A regional groundwater flow and transport model using site-scale parameter obtained from tracer tests have been verified by comparing simulation results with observation ones of natural environmental tracer. (author)

  18. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study.

    Science.gov (United States)

    El-Kholey, K E

    2014-05-01

    For more than a decade, peri-implant tissues have been treated with soft tissue lasers to create a bloodless flap for implant placement and to uncover implants with minimal bleeding, trauma, and anaesthesia. This study was designed to assess if dental implant uncovering is possible with a diode laser without anaesthesia, and to compare its performance with traditional cold scalpel surgery. Thirty patients with a total of 45 completely osseointegrated implants participated in this study. Patients were divided into two groups. For the study group, second-stage implant surgery was done with a 970nm diode laser. For the control group, the implants were exposed with a surgical blade. Certain parameters were used for evaluation of the two techniques. The use of the diode laser obviated the need for local anaesthesia; there was a significant difference between the two groups regarding the need for anaesthesia (Pdiode laser can be used effectively for second-stage implant surgery, providing both the dentist and the patient with additional advantages over the conventional methods used for implant exposure. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  19. Safety of type and screen method compared to conventional antiglobulin crossmatch procedures for compatibility testing in Indian setting

    Directory of Open Access Journals (Sweden)

    Chaudhary Rajendra

    2011-01-01

    Full Text Available Background: Over the past 30 years, pretransfusion tests have undergone considerable modification. In 1984, AABB recommended that the full cross match could be replaced by an abbreviated cross match in patients with negative antibody screen. However, before implementation of such a policy, issue regarding safety of T & S needs to be evaluated. Objectives: The aim of pretransfusion testing (PTT is to ensure that enough red blood cells (RBCs in the selected red cell components will survive when transfused. Results and Conclusion: We have, therefore in this study; evaluated safety of T & S procedure for PTT in comparison with conventional test tube cross match. The T & S procedure gave a safety of 91.6%. Also, the usefulness of the T & S was shown through the detection of unexpected antibodies in 0.75% (15 out of 2026 of cases.

  20. Measuring microbial food safety output and comparing self-checking systems of food business operators in Belgium

    NARCIS (Netherlands)

    Jacxsens, L.; Kirezieva, K.; Luning, P.A.; Ingelrham, J.; Diricks, H.; Uyttendaele, M.

    2015-01-01

    The Belgian food safety authority has provided incentives for food business operators to set-up a certified self-checking system (SCS), based upon good practices and HACCP principles. A selection of food processing companies in Belgium was invited to take part in a self-assessment study to evaluate