14 CFR 31.25 - Factor of safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... envelope stress. (c) A factor of safety of at least five must be used in the design of all fibrous or non... any single failure will not jeopardize safety of flight. (d) In applying factors of safety, the effect...

A hierarchical factor analysis of a safety culture survey.

PubMed

Frazier, Christopher B; Ludwig, Timothy D; Whitaker, Brian; Roberts, D Steve

2013-06-01

Recent reviews of safety culture measures have revealed a host of potential factors that could make up a safety culture (Flin, Mearns, O'Connor, & Bryden, 2000; Guldenmund, 2000). However, there is still little consensus regarding what the core factors of safety culture are. The purpose of the current research was to determine the core factors, as well as the structure of those factors that make up a safety culture, and establish which factors add meaningful value by factor analyzing a widely used safety culture survey. A 92-item survey was constructed by subject matter experts and was administered to 25,574 workers across five multi-national organizations in five different industries. Exploratory and hierarchical confirmatory factor analyses were conducted revealing four second-order factors of a Safety Culture consisting of Management Concern, Personal Responsibility for Safety, Peer Support for Safety, and Safety Management Systems. Additionally, a total of 12 first-order factors were found: three on Management Concern, three on Personal Responsibility, two on Peer Support, and four on Safety Management Systems. The resulting safety culture model addresses gaps in the literature by indentifying the core constructs which make up a safety culture. This clarification of the major factors emerging in the measurement of safety cultures should impact the industry through a more accurate description, measurement, and tracking of safety cultures to reduce loss due to injury. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Structural Deterministic Safety Factors Selection Criteria and Verification

NASA Technical Reports Server (NTRS)

Verderaime, V.

1992-01-01

Though current deterministic safety factors are arbitrarily and unaccountably specified, its ratio is rooted in resistive and applied stress probability distributions. This study approached the deterministic method from a probabilistic concept leading to a more systematic and coherent philosophy and criterion for designing more uniform and reliable high-performance structures. The deterministic method was noted to consist of three safety factors: a standard deviation multiplier of the applied stress distribution; a K-factor for the A- or B-basis material ultimate stress; and the conventional safety factor to ensure that the applied stress does not operate in the inelastic zone of metallic materials. The conventional safety factor is specifically defined as the ratio of ultimate-to-yield stresses. A deterministic safety index of the combined safety factors was derived from which the corresponding reliability proved the deterministic method is not reliability sensitive. The bases for selecting safety factors are presented and verification requirements are discussed. The suggested deterministic approach is applicable to all NASA, DOD, and commercial high-performance structures under static stresses.

Driver behaviour profiles for road safety analysis.

PubMed

Ellison, Adrian B; Greaves, Stephen P; Bliemer, Michiel C J

2015-03-01

Driver behaviour is a contributing factor in over 90 percent of road crashes. As a consequence, there is significant benefit in identifying drivers who engage in unsafe driving practices. Driver behaviour profiles (DBPs) are introduced here as an approach for evaluating driver behaviour as a function of the risk of a casualty crash. They employ data collected using global positioning system (GPS) devices, supplemented with spatiotemporal information. These profiles are comprised of common risk scores that can be used to compare drivers between each other and across time and space. The paper details the development of these DBPs and demonstrates their use as an input into modelling the factors that influence driver behaviour. The results show that even having controlled for the influence of the road environment, these factors remain the strongest predictors of driver behaviour suggesting different spatiotemporal environments elicit a variety of psychological responses in drivers. The approach and outcomes will be of interest to insurance companies in enhancing the risk-profiling of drivers with on-road driving and government through assessing the impacts of behaviour-change interventions. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Safety profile of zolpidem: two studies of 3805 patients by Swiss practitioners].

PubMed

Ganzoni, E; Gugger, M

1999-06-24

Evaluation and treatment of insomnia are frequent procedures in the physician's everyday practice, since many patients seek medical treatment for this condition. Knowledge of pharmacological therapeutical alternatives is therefore decisive, in order to identify the most efficaceous and safe therapy for the patient among the available hypnotics. The short-acting hypnotic zolpidem has been investigated in Switzerland in two multicenter safety studies in ambulatory practice. In the first study 8.9% (n = 125 of 1,972 treated patients), and in the second 7.2% of the patients (n = 175 of 1,833 treated patients) reported an adverse event. The most frequent events were related to the central nervous system (CNS) (somnolence, headache, confusion, vertigo); gastrointestinal and cutaneous symptoms were the most frequent non CNS-dependent effects. New, unknown or serious adverse events were not found and no specific risk factor or population at risk was identified. The safety profile of zolpidem is consistent with its known pharmacological properties, the results of previous clinical trials and the international experience obtained in large patients groups.

Critical safety assurance factors for manned spacecraft - A fire safety perspective

NASA Technical Reports Server (NTRS)

Rodney, George A.

1990-01-01

Safety assurance factors for manned spacecraft are discussed with a focus on the Space Station Freedom. A hazard scenario is provided to demonstrate a process commonly used by safety engineers and other analysts to identify onboard safety risks. Fire strategies are described, including a review of fire extinguishing agents being considered for the Space Station. Lessons learned about fire safety technology in other areas are also noted. NASA and industry research on fire safety applications is discussed. NASA's approach to ensuring safety for manned spacecraft is addressed in the context of its multidiscipline program.

14 CFR 27.303 - Factor of safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Factor of safety. 27.303 Section 27.303 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT AIRWORTHINESS STANDARDS: NORMAL CATEGORY ROTORCRAFT Strength Requirements General § 27.303 Factor of safety. Unless...

Experimental validation of a Lyapunov-based controller for the plasma safety factor and plasma pressure in the TCV tokamak

NASA Astrophysics Data System (ADS)

Mavkov, B.; Witrant, E.; Prieur, C.; Maljaars, E.; Felici, F.; Sauter, O.; the TCV-Team

2018-05-01

In this paper, model-based closed-loop algorithms are derived for distributed control of the inverse of the safety factor profile and the plasma pressure parameter β of the TCV tokamak. The simultaneous control of the two plasma quantities is performed by combining two different control methods. The control design of the plasma safety factor is based on an infinite-dimensional setting using Lyapunov analysis for partial differential equations, while the control of the plasma pressure parameter is designed using control techniques for single-input and single-output systems. The performance and robustness of the proposed controller is analyzed in simulations using the fast plasma transport simulator RAPTOR. The control is then implemented and tested in experiments in TCV L-mode discharges using the RAPTOR model predicted estimates for the q-profile. The distributed control in TCV is performed using one co-current and one counter-current electron cyclotron heating actuation.

Evolution of the central safety factor during stabilized sawtooth instabilities at KSTAR

NASA Astrophysics Data System (ADS)

Messmer, M. C. C.; Ko, J.; Chung, J.; Woo, M. H.; Lee, K.-D.; Jaspers, R. J. E.

2018-01-01

A motional Stark effect (MSE) diagnostic has recently been installed in the KSTAR tokamak. A difficulty faced at KSTAR and common to other MSE diagnostics is calibration of the system for absolute measurements. In this report we present our novel calibration routine and discuss first results, evaluating the evolution of the the central safety factor during sawtooth instabilities. The calibration scheme ensures that the bandpass filters typically used in MSE systems are aligned correctly and identifies and removes systematic offsets present in the measurement. This is verified by comparing the reconstructed safety factor profile against various discharges where the locations of rational q surfaces have been obtained from MHD markers. The calibration is applied to analyse the evolution of q 0 in a shot where the sawteeth are stabilized by neutral beam injection. Within the analysed sawtooth periods q 0 drops below unity during the quiescent phase and relaxes close to or slightly above unity at the sawtooth crash. This finding is in line with the classical Kadomtsev model of full magnetic reconnection and earlier findings at JET.

Factors influencing patient safety in Sweden: perceptions of patient safety officers in the county councils

PubMed Central

2013-01-01

Background National, regional and local activities to improve patient safety in Sweden have increased over the last decade. There are high ambitions for improved patient safety in Sweden. This study surveyed health care professionals who held key positions in their county council’s patient safety work to investigate their perceptions of the conditions for this work, factors they believe have been most important in reaching the current level of patient safety and factors they believe would be most important for achieving improved patient safety in the future. Methods The study population consisted of 218 health care professionals holding strategic positions in patient safety work in Swedish county councils. Using a questionnaire, the following topics were analysed in this study: profession/occupation; number of years involved in a designated task on patient safety issues; knowledge/overview of the county council’s patient safety work; ability to influence this work; conditions for this work; and the importance of various factors for current and future levels of patient safety. Results The response rate to the questionnaire was 79%. The conditions that had the highest number of responses in complete agreement were “patients’ involvement is important for patient safety” and “patient safety work has good support from the county council’s management”. Factors that were considered most important for achieving the current level of patient safety were root cause and risk analyses, incident reporting and the Swedish Patient Safety Law. An organizational culture that encourages reporting and avoids blame was considered most important for improved patient safety in the future, closely followed by improved communication between health care practitioners and patients. Conclusion Health care professionals with important positions in the Swedish county councils’ patient safety work believe that conditions for this work are somewhat constrained. They attribute

The role of psychological factors in workplace safety.

PubMed

Kotzé, Martina; Steyn, Leon

2013-01-01

Workplace safety researchers and practitioners generally agree that it is necessary to understand the psychological factors that influence people's workplace safety behaviour. Yet, the search for reliable individual differences regarding psychological factors associated with workplace safety has lead to sparse results and inconclusive findings. The aim of this study was to investigate whether there are differences between the psychological factors, cognitive ability, personality and work-wellness of employees involved in workplace incidents and accidents and/or driver vehicle accidents and those who are not. The study population (N = 279) consisted of employees employed at an electricity supply organisation in South Africa. Mann-Whitney U-test and one-way ANOVA were conducted to determine the differences in the respective psychological factors between the groups. These results showed that cognitive ability did not seem to play a role in workplace incident/accident involvement, including driver vehicle accidents, while the wellness factors burnout and sense of coherence, as well as certain personality traits, namely conscientiousness, pragmatic and gregariousness play a statistically significant role in individuals' involvement in workplace incidents/accidents/driver vehicle accidents. Safety practitioners, managers and human resource specialists should take cognisance of the role of specifically work-wellness in workplace safety behaviour, as management can influence these negative states that are often caused by continuously stressful situations, and subsequently enhance work place safety.

Human factors in safety and business management.

PubMed

Vogt, Joachim; Leonhardt, Jorg; Koper, Birgit; Pennig, Stefan

2010-02-01

Human factors in safety is concerned with all those factors that influence people and their behaviour in safety-critical situations. In aviation these are, for example, environmental factors in the cockpit, organisational factors such as shift work, human characteristics such as ability and motivation of staff. Careful consideration of human factors is necessary to improve health and safety at work by optimising the interaction of humans with their technical and social (team, supervisor) work environment. This provides considerable benefits for business by increasing efficiency and by preventing incidents/accidents. The aim of this paper is to suggest management tools for this purpose. Management tools such as balanced scorecards (BSC) are widespread instruments and also well known in aviation organisations. Only a few aviation organisations utilise management tools for human factors although they are the most important conditions in the safety management systems of aviation organisations. One reason for this is that human factors are difficult to measure and therefore also difficult to manage. Studies in other domains, such as workplace health promotion, indicate that BSC-based tools are useful for human factor management. Their mission is to develop a set of indicators that are sensitive to organisational performance and help identify driving forces as well as bottlenecks. Another tool presented in this paper is the Human Resources Performance Model (HPM). HPM facilitates the integrative assessment of human factors programmes on the basis of a systematic performance analysis of the whole system. Cause-effect relationships between system elements are defined in process models in a first step and validated empirically in a second step. Thus, a specific representation of the performance processes is developed, which ranges from individual behaviour to system performance. HPM is more analytic than BSC-based tools because HPM also asks why a certain factor is

Organizational factors affecting safety implementation in food companies in Thailand.

PubMed

Chinda, Thanwadee

2014-01-01

Thai food industry employs a massive number of skilled and unskilled workers. This may result in an industry with high incidences and accident rates. To improve safety and reduce the accident figures, this paper investigates factors influencing safety implementation in small, medium, and large food companies in Thailand. Five factors, i.e., management commitment, stakeholders' role, safety information and communication, supportive environment, and risk, are found important in helping to improve safety implementation. The statistical analyses also reveal that small, medium, and large food companies hold similar opinions on the risk factor, but bear different perceptions on the other 4 factors. It is also found that to improve safety implementation, the perceptions of safety goals, communication, feedback, safety resources, and supervision should be aligned in small, medium, and large companies.

Investigation of structural factors of safety for the space shuttle

NASA Technical Reports Server (NTRS)

1972-01-01

A study was made of the factors governing the structural design of the fully reusable space shuttle booster to establish a rational approach to select optimum structural factors of safety. The study included trade studies of structural factors of safety versus booster service life, weight, cost, and reliability. Similar trade studies can be made on other vehicles using the procedures developed. The major structural components of a selected baseline booster were studied in depth, each being examined to determine the fatigue life, safe-life, and fail-safe capabilities of the baseline design. Each component was further examined to determine its reliability and safety requirements, and the change of structural weight with factors of safety. The apparent factors of safety resulting from fatigue, safe-life, proof test, and fail-safe requirements were identified. The feasibility of reduced factors of safety for design loads such as engine thrust, which are well defined, was examined.

Atorvastatin calcium encapsulated eudragit nanoparticles with enhanced oral bioavailability, safety and efficacy profile.

PubMed

Kumar, Nagendra; Chaurasia, Sundeep; Patel, Ravi R; Khan, Gayasuddin; Kumar, Vikas; Mishra, Brahmeshwar

2017-03-01

Atorvastatin calcium (ATR), a second generation statin drug, was encapsulated in eudragit RSPO-based polymeric nanoparticles. The effect of independent variables (polymer content, stabilizer concentration, volume of chloroform and homogenization speed) on response variables (mean diameter particle size and entrapment efficiency) were investigated by employing central composite experimental design. All the independent variables were found to be significant for determining the response variables. Solid-state characterization study indicated the absence of physicochemical interaction between drug and polymer in formulation. Morphological study exhibited homogenous spherical shape of formulated nanoparticles. In vitro release study in phosphate buffer (pH 7.4) demonstrated sustained release profile over 24 h. Pharmacokinetic study in Charles Foster rats showed significant enhancement in oral bioavailability as compared to pure drug suspension. Efficacy study (lipid profile and blood glucose level) significantly justified the effectiveness of formulation having 50% less dose of ATR as compared to pure drug suspension. The effectiveness of formulation was further justified with an improved plasma safety profile of treated rats. Hence, ATR encapsulated eudragit RSPO nanoparticles can serve as potential drug delivery approach to enhance drug bioavailability, efficacy and safety profiles to alter existing marketed drug products.

Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland-A cross-sectional survey study.

PubMed

Mascherek, Anna C; Schwappach, David L B

2017-01-01

Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of "climate strength" has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely.

Patient safety climate profiles across time: Strength and level of safety climate associated with a quality improvement program in Switzerland—A cross-sectional survey study

PubMed Central

Mascherek, Anna C.

2017-01-01

Safety Climate has been acknowledged as an unspecific factor influencing patient safety. However, studies rarely provide in-depth analysis of climate data. As a helpful approach, the concept of “climate strength” has been proposed. In the present study we tested the hypotheses that even if safety climate remains stable on mean-level across time, differences might be evident in strength or shape. The data of two hospitals participating in a large national quality improvement program were analysed for differences in climate profiles at two measurement occasions. We analysed differences on mean-level, differences in percent problematic response, agreement within groups, and frequency histograms in two large hospitals in Switzerland at two measurement occasions (2013 and 2015) applying the Safety Climate Survey. In total, survey responses of 1193 individuals were included in the analyses. Overall, small but significant differences on mean-level of safety climate emerged for some subgroups. Also, although agreement was strong at both time-points within groups, tendencies of divergence or consensus were present in both hospitals. Depending on subgroup and analyses chosen, differences were more or less pronounced. The present study illustrated that taking several measures into account and describing safety climate from different perspectives is necessary in order to fully understand differences and trends within groups and to develop interventions addressing the needs of different groups more precisely. PMID:28753633

Space station crew safety alternatives study. Volume 3: Safety impact of human factors

NASA Technical Reports Server (NTRS)

Rockoff, L. A.; Raasch, R. F.; Peercy, R. L., Jr.

1985-01-01

The first 15 years of accumulated space station concepts for Initial Operational Capability (IOC) during the early 1990's was considered. Twenty-five threats to the space station are identified and selected threats addressed as impacting safety criteria, escape and rescue, and human factors safety concerns. Of the 25 threats identified, eight are discussed including strategy options for threat control: fire, biological or toxic contamination, injury/illness, explosion, loss of pressurization, radiation, meteoroid penetration and debris. Of particular interest here is volume three (of five volumes) pertaining to the safety impact of human factors.

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes.

PubMed

Kullenberg, Torbjörn; Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-08-01

Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. ClincialTrials.gov, clinicaltrials.gov, NCT00069329. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes

PubMed Central

Löfqvist, Malin; Leinonen, Mika; Goldbach-Mansky, Raphaela; Olivecrona, Hans

2016-01-01

Objective. Anakinra is approved for the treatment of RA and cryopyrin-associated periodic syndromes (CAPS). While the anakinra safety profile is well established in RA, the long-term safety profile in severe CAPS is less well documented and will therefore be discussed in this report. Methods. A prospective, open-label, single centre, clinical cohort study was conducted at the National Institutes of Health in the USA, from 2003 to 2010, investigating the efficacy and safety of anakinra treatment for up to 5 years in 43 patients with CAPS. Safety was evaluated using adverse event (AE) reports, laboratory assessments, vital signs and diary reports. Results. In total, 1233 AEs were reported during the study, with a yearly rate of 7.7 AEs per patient. The event rate decreased over time, and dose escalation during the study did not affect AE frequency. Anakinra had similar safety profiles in adults and children. The most frequently reported AEs were typical CAPS disease symptoms such as headache and arthralgia. Injection site reactions occurred mainly during the first month of anakinra treatment. In total, 14 patients experienced 24 serious AEs (SAEs), all of which resolved during the study period. The most common types of SAEs were infections such as pneumonia and gastroenteritis. There were no permanent discontinuations of treatment due to AEs. Conclusion. In this study anakinra treatment of patients with severe CAPS for up to 5 years was safe and well tolerated both in paediatric and adult patients, with most AEs emerging during the first months after treatment initiation. Trial registration: ClincialTrials.gov, clinicaltrials.gov, NCT00069329 PMID:27143789

Analysis of factors influencing safety management for metro construction in China.

PubMed

Yu, Q Z; Ding, L Y; Zhou, C; Luo, H B

2014-07-01

With the rapid development of urbanization in China, the number and size of metro construction projects are increasing quickly. At the same time, and increasing number of accidents in metro construction make it a disturbing focus of social attention. In order to improve safety management in metro construction, an investigation of the participants' perspectives on safety factors in China metro construction has been conducted to identify the key safety factors, and their ranking consistency among the main participants, including clients, consultants, designers, contractors and supervisors. The result of factor analysis indicates that there are five key factors which influence the safety of metro construction including safety attitude, construction site safety, government supervision, market restrictions and task unpredictability. In addition, ANOVA and Spearman rank correlation coefficients were performed to test the consistency of the means rating and the ranking of safety factors. The results indicated that the main participants have significant disagreement about the importance of safety factors on more than half of the items. Suggestions and recommendations on practical countermeasures to improve metro construction safety management in China are proposed. Copyright © 2013 Elsevier Ltd. All rights reserved.

Critical factors and paths influencing construction workers' safety risk tolerances.

PubMed

Wang, Jiayuan; Zou, Patrick X W; Li, Penny P

2016-08-01

While workers' safety risk tolerances have been regarded as a main reason for their unsafe behaviors, little is known about why different people have different risk tolerances even when confronting the same situation. The aim of this research is to identify the critical factors and paths that influence workers' safety risk tolerance and to explore how they contribute to accident causal model from a system thinking perceptive. A number of methods were carried out to analyze the data collected through interviews and questionnaire surveys. In the first and second steps of the research, factor identification, factor ranking and factor analysis were carried out, and the results show that workers' safety risk tolerance can be influenced by four groups of factors, namely: (1) personal subjective perception; (2) work knowledge and experiences; (3) work characteristics; and (4) safety management. In the third step of the research, hypothetical influencing path model was developed and tested by using structural equation modeling (SEM). It is found that the effects of external factors (safety management and work characteristics) on risk tolerance are larger than that of internal factors (personal subjective perception and work knowledge & experiences). Specifically, safety management contributes the most to workers' safety risk tolerance through its direct effect and indirect effect; while personal subjective perception comes the second and can act as an intermedia for work characteristics. This research provides an in-depth insight of workers' unsafe behaviors by depicting the contributing factors as shown in the accident causal model developed in this research. Copyright © 2015 Elsevier Ltd. All rights reserved.

The safety and efficacy of the administration of recombinant activated factor VII in major surgery and trauma patients.

PubMed

Wilson, Stephen J; Bellamy, Mark C; Giannoudis, Peter V

2005-05-01

Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular injury makes it an attractive potential treatment for massive, uncontrolled bleeding associated with surgery and trauma. This article describes the evidence relating to surgery and trauma. The lack of large, controlled trials of rFVIIa means that a definitive recommendation regarding its use cannot be made at present. However, in the context of clearly defined protocols and balanced treatment strategies, rFVIIa may have a role in traumatic bleeding. Large scale, randomised controlled trials in trauma are required, as is further work on the safety profile of rFVIIa with an independent international safety monitoring committee.

Neural network evaluation of tokamak current profiles for real time control

NASA Astrophysics Data System (ADS)

Wróblewski, Dariusz

1997-02-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental datais demonstrated.

Factors influencing nurses' perceptions of occupational safety.

PubMed

Samur, Menevse; Intepeler, Seyda Seren

2017-01-02

To determine nurses' perceptions of occupational safety and their work environment and examine the sociodemographic traits and job characteristics that influence their occupational safety, we studied a sample of 278 nurses. According to the nurses, the quality of their work environment is average, and occupational safety is insufficient. In the subdimensions of the work environment scale, it was determined that the nurses think "labor force and other resources" are insufficient. In the occupational safety subdimensions "occupational illnesses and complaints" and "administrative support and approaches," they considered occupational safety to be insufficient. "Doctor-nurse-colleague relationships," "exposure to violence," and "work unit" (eg, internal medicine, surgical, intensive care) are the main factors that affect occupational safety. This study determined that hospital administrations should develop and immediately implement plans to ameliorate communication and clinical precautions and to reduce exposure to violence.

Human Factors Research in Anesthesia Patient Safety

PubMed Central

Weinger, Matthew B.; Slagle, Jason

2002-01-01

Patient safety has become a major public concern. Human factors research in other high-risk fields has demonstrated how rigorous study of factors that affect job performance can lead to improved outcome and reduced errors after evidence-based redesign of tasks or systems. These techniques have increasingly been applied to the anesthesia work environment. This paper describes data obtained recently using task analysis and workload assessment during actual patient care and the use of cognitive task analysis to study clinical decision making. A novel concept of “non-routine events” is introduced and pilot data are presented. The results support the assertion that human factors research can make important contributions to patient safety. Information technologies play a key role in these efforts.

Human factors research in anesthesia patient safety.

PubMed Central

Weinger, M. B.; Slagle, J.

2001-01-01

Patient safety has become a major public concern. Human factors research in other high-risk fields has demonstrated how rigorous study of factors that affect job performance can lead to improved outcome and reduced errors after evidence-based redesign of tasks or systems. These techniques have increasingly been applied to the anesthesia work environment. This paper describes data obtained recently using task analysis and workload assessment during actual patient care and the use of cognitive task analysis to study clinical decision making. A novel concept of "non-routine events" is introduced and pilot data are presented. The results support the assertion that human factors research can make important contributions to patient safety. Information technologies play a key role in these efforts. PMID:11825287

Neural network evaluation of tokamak current profiles for real time control (abstract)

NASA Astrophysics Data System (ADS)

Wróblewski, Dariusz

1997-01-01

Active feedback control of the current profile, requiring real-time determination of the current profile parameters, is envisioned for tokamaks operating in enhanced confinement regimes. The distribution of toroidal current in a tokamak is now routinely evaluated based on external (magnetic probes, flux loops) and internal (motional Stark effect) measurements of the poloidal magnetic field. However, the analysis involves reconstruction of magnetohydrodynamic equilibrium and is too intensive computationally to be performed in real time. In the present study, a neural network is used to provide a mapping from the magnetic measurements (internal and external) to selected parameters of the safety factor profile. The single-pass, feedforward calculation of output of a trained neural network is very fast, making this approach particularly suitable for real-time applications. The network was trained on a large set of simulated equilibrium data for the DIII-D tokamak. The database encompasses a large variety of current profiles including the hollow current profiles important for reversed central shear operation. The parameters of safety factor profile (a quantity related to the current profile through the magnetic field tilt angle) estimated by the neural network include central safety factor, q0, minimum value of q, qmin, and the location of qmin. Very good performance of the trained neural network both for simulated test data and for experimental data is demonstrated.

76 FR 35130 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors AGENCY: Pipeline and Hazardous Materials Safety Administration... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...

Safety Profile of Cough and Cold Medication Use in Pediatrics.

PubMed

Green, Jody L; Wang, George Sam; Reynolds, Kate M; Banner, William; Bond, G Randall; Kauffman, Ralph E; Palmer, Robert B; Paul, Ian M; Dart, Richard C

2017-06-01

The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program. Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described. Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children <2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553-0.593) or 1 case per 1.75 million units. The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts. Copyright © 2017 by the American Academy of Pediatrics.

Space station crew safety: Human factors interaction model

NASA Technical Reports Server (NTRS)

Cohen, M. M.; Junge, M. K.

1985-01-01

A model of the various human factors issues and interactions that might affect crew safety is developed. The first step addressed systematically the central question: How is this space station different from all other spacecraft? A wide range of possible issue was identified and researched. Five major topics of human factors issues that interacted with crew safety resulted: Protocols, Critical Habitability, Work Related Issues, Crew Incapacitation and Personal Choice. Second, an interaction model was developed that would show some degree of cause and effect between objective environmental or operational conditions and the creation of potential safety hazards. The intermediary steps between these two extremes of causality were the effects on human performance and the results of degraded performance. The model contains three milestones: stressor, human performance (degraded) and safety hazard threshold. Between these milestones are two countermeasure intervention points. The first opportunity for intervention is the countermeasure against stress. If this countermeasure fails, performance degrades. The second opportunity for intervention is the countermeasure against error. If this second countermeasure fails, the threshold of a potential safety hazard may be crossed.

Safety profile of methotrexate in inflammatory bowel disease.

PubMed

Gabbani, Tommaso; Deiana, Simona; Lunardi, Sarah; Manetti, Natalia; Annese, Vito

2016-10-01

Methotrexate, which was initially developed in 1948 for the treatment of leukemia, is known to be an immunomodulatory and anti-inflammatory drug. It has been widely used for over 60 years as both a low and high-dose therapy in chronic inflammatory diseases. The aim of this review was to analyze and summarize the available data specifically on the safety of this drug in the management of inflammatory bowel diseases. A structured search of articles was conducted using the PubMed database up to April 2016. All articles in English with isolated or combined keywords were included according to their relevance to the aims of this study. Numerous of studies have established the efficacy of parenteral methotrexate in the management of steroid-dependent and steroid-resistant Crohn's disease, either for inducing or maintaining remission. However, its efficacy in ulcerative colitis has not been properly investigated. Additionally, methotrexate has been shown to reduce the effect of immunization with anti-TNF agents when combined. The drug has potential advantages over thiopurines such as its weekly administration, a possible shorter time of action, low cost, decreased risk for malignancy and overall a comparable safety profile.

Improving Safety through Human Factors Engineering.

PubMed

Siewert, Bettina; Hochman, Mary G

2015-10-01

Human factors engineering (HFE) focuses on the design and analysis of interactive systems that involve people, technical equipment, and work environment. HFE is informed by knowledge of human characteristics. It complements existing patient safety efforts by specifically taking into consideration that, as humans, frontline staff will inevitably make mistakes. Therefore, the systems with which they interact should be designed for the anticipation and mitigation of human errors. The goal of HFE is to optimize the interaction of humans with their work environment and technical equipment to maximize safety and efficiency. Special safeguards include usability testing, standardization of processes, and use of checklists and forcing functions. However, the effectiveness of the safety program and resiliency of the organization depend on timely reporting of all safety events independent of patient harm, including perceived potential risks, bad outcomes that occur even when proper protocols have been followed, and episodes of "improvisation" when formal guidelines are found not to exist. Therefore, an institution must adopt a robust culture of safety, where the focus is shifted from blaming individuals for errors to preventing future errors, and where barriers to speaking up-including barriers introduced by steep authority gradients-are minimized. This requires creation of formal guidelines to address safety concerns, establishment of unified teams with open communication and shared responsibility for patient safety, and education of managers and senior physicians to perceive the reporting of safety concerns as a benefit rather than a threat. © RSNA, 2015.

Human factors and ergonomics as a patient safety practice

PubMed Central

Carayon, Pascale; Xie, Anping; Kianfar, Sarah

2014-01-01

Background Human factors and ergonomics (HFE) approaches to patient safety have addressed five different domains: usability of technology; human error and its role in patient safety; the role of healthcare worker performance in patient safety; system resilience; and HFE systems approaches to patient safety. Methods A review of various HFE approaches to patient safety and studies on HFE interventions was conducted. Results This paper describes specific examples of HFE-based interventions for patient safety. Studies show that HFE can be used in a variety of domains. Conclusions HFE is a core element of patient safety improvement. Therefore, every effort should be made to support HFE applications in patient safety. PMID:23813211

Multidimensional Characterization of Sexual Minority Adolescents’ Sexual Safety Strategies

PubMed Central

Masters, N. Tatiana; Beadnell, Blair; Morrison, Diane M.; Hoppe, Marilyn J.; Wells, Elizabeth A.

2013-01-01

Young adults have high rates of sexually transmitted infections (STIs). Sexual minority youths’ risk for STIs, including HIV, is as high as or higher than sexual majority peers’. Sexual safety, while often treated as a single behavior such as condom use, can be best conceptualized as the result of multiple factors. We used latent class analysis to identify profiles based on ever-used sexual safety strategies and lifetime number of partners among 425 self-identified LGBTQ youth aged 14-19. Data collection took place anonymously online. We identified four specific subgroup profiles for males and three for females, with each subgroup representing a different level and type of sexual safety. Profiles differed from each other in terms of age and outness for males, and in outness, personal homonegativity, and amount of education received about sexual/romantic relationships for females. Youths’ sexual safety profiles have practice implications for sexuality educators, health care professionals, and parents. PMID:24011111

Modeling for influenza vaccines and adjuvants profile for safety prediction system using gene expression profiling and statistical tools

PubMed Central

Sasaki, Eita; Momose, Haruka; Hiradate, Yuki; Furuhata, Keiko; Takai, Mamiko; Asanuma, Hideki; Ishii, Ken J.

2018-01-01

Historically, vaccine safety assessments have been conducted by animal testing (e.g., quality control tests and adjuvant development). However, classical evaluation methods do not provide sufficient information to make treatment decisions. We previously identified biomarker genes as novel safety markers. Here, we developed a practical safety assessment system used to evaluate the intramuscular, intraperitoneal, and nasal inoculation routes to provide robust and comprehensive safety data. Influenza vaccines were used as model vaccines. A toxicity reference vaccine (RE) and poly I:C-adjuvanted hemagglutinin split vaccine were used as toxicity controls, while a non-adjuvanted hemagglutinin split vaccine and AddaVax (squalene-based oil-in-water nano-emulsion with a formulation similar to MF59)-adjuvanted hemagglutinin split vaccine were used as safety controls. Body weight changes, number of white blood cells, and lung biomarker gene expression profiles were determined in mice. In addition, vaccines were inoculated into mice by three different administration routes. Logistic regression analyses were carried out to determine the expression changes of each biomarker. The results showed that the regression equations clearly classified each vaccine according to its toxic potential and inoculation amount by biomarker expression levels. Interestingly, lung biomarker expression was nearly equivalent for the various inoculation routes. The results of the present safety evaluation were confirmed by the approximation rate for the toxicity control. This method may contribute to toxicity evaluation such as quality control tests and adjuvant development. PMID:29408882

Establishment of a New Quality Control and Vaccine Safety Test for Influenza Vaccines and Adjuvants Using Gene Expression Profiling

PubMed Central

Momose, Haruka; Mizukami, Takuo; Kuramitsu, Madoka; Takizawa, Kazuya; Masumi, Atsuko; Araki, Kumiko; Furuhata, Keiko; Yamaguchi, Kazunari; Hamaguchi, Isao

2015-01-01

We have previously identified 17 biomarker genes which were upregulated by whole virion influenza vaccines, and reported that gene expression profiles of these biomarker genes had a good correlation with conventional animal safety tests checking body weight and leukocyte counts. In this study, we have shown that conventional animal tests showed varied and no dose-dependent results in serially diluted bulk materials of influenza HA vaccines. In contrast, dose dependency was clearly shown in the expression profiles of biomarker genes, demonstrating higher sensitivity of gene expression analysis than the current animal safety tests of influenza vaccines. The introduction of branched DNA based-concurrent expression analysis could simplify the complexity of multiple gene expression approach, and could shorten the test period from 7 days to 3 days. Furthermore, upregulation of 10 genes, Zbp1, Mx2, Irf7, Lgals9, Ifi47, Tapbp, Timp1, Trafd1, Psmb9, and Tap2, was seen upon virosomal-adjuvanted vaccine treatment, indicating that these biomarkers could be useful for the safety control of virosomal-adjuvanted vaccines. In summary, profiling biomarker gene expression could be a useful, rapid, and highly sensitive method of animal safety testing compared with conventional methods, and could be used to evaluate the safety of various types of influenza vaccines, including adjuvanted vaccine. PMID:25909814

Calibration of highway safety manual work zone crash modification factors.

DOT National Transportation Integrated Search

2014-06-01

The Highway Safety Manual is the national safety manual that provides quantitative methods for analyzing highway safety. The : HSM presents crash modification factors related to work zone characteristics such as work zone duration and length. These c...

2009 Human Factors and Roadway Safety Workshop : Teen Driver Safety [SD .WMV (720x480/29fps/177.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Teen Driver Safety : Keynote Speaker Dan McGehee, director, Human Factors & Vehicle Safety Res...

Confounding factors and genetic polymorphism in the evaluation of individual steroid profiling

PubMed Central

Kuuranne, Tiia; Saugy, Martial; Baume, Norbert

2014-01-01

In the fight against doping, steroid profiling is a powerful tool to detect drug misuse with endogenous anabolic androgenic steroids. To establish sensitive and reliable models, the factors influencing profiling should be recognised. We performed an extensive literature review of the multiple factors that could influence the quantitative levels and ratios of endogenous steroids in urine matrix. For a comprehensive and scientific evaluation of the urinary steroid profile, it is necessary to define the target analytes as well as testosterone metabolism. The two main confounding factors, that is, endogenous and exogenous factors, are detailed to show the complex process of quantifying the steroid profile within WADA-accredited laboratories. Technical aspects are also discussed as they could have a significant impact on the steroid profile, and thus the steroid module of the athlete biological passport (ABP). The different factors impacting the major components of the steroid profile must be understood to ensure scientifically sound interpretation through the Bayesian model of the ABP. Not only should the statistical data be considered but also the experts in the field must be consulted for successful implementation of the steroidal module. PMID:24764553

Human factors systems approach to healthcare quality and patient safety

PubMed Central

Carayon, Pascale; Wetterneck, Tosha B.; Rivera-Rodriguez, A. Joy; Hundt, Ann Schoofs; Hoonakker, Peter; Holden, Richard; Gurses, Ayse P.

2013-01-01

Human factors systems approaches are critical for improving healthcare quality and patient safety. The SEIPS (Systems Engineering Initiative for Patient Safety) model of work system and patient safety is a human factors systems approach that has been successfully applied in healthcare research and practice. Several research and practical applications of the SEIPS model are described. Important implications of the SEIPS model for healthcare system and process redesign are highlighted. Principles for redesigning healthcare systems using the SEIPS model are described. Balancing the work system and encouraging the active and adaptive role of workers are key principles for improving healthcare quality and patient safety. PMID:23845724

White Paper on Factors of Safety

NASA Technical Reports Server (NTRS)

Raju, Ivatury; Stadler, John; Kramer-White, Jule; Piascik, Robert

2012-01-01

Following the Columbia Accident Investigation Board (CAIB) Report, the "Diaz Team" identified CAIB Report elements with Agency-wide applicability. The "Diaz Report", A Renewed Commitment To Excellence, generated an action to "Review current policies and waivers on safety factors". This document addresses this action.

[A new method for safety monitoring of natural dietary supplements--quality profile].

PubMed

Wang, Juan; Wang, Li-Ping; Yang, Da-Jin; Chen, Bo

2008-07-01

A new method for safety monitoring of natural dietary supplements--quality profile was proposed. It would convert passive monitoring of synthetic drug to active, and guarantee the security of natural dietary supplements. Preliminary research on quality profile was completed by high performance liquid chromatography (HPLC) and mass spectrometry (MS). HPLC was employed to analyze chemical constituent profiles of natural dietary supplements. The separation was completed on C18 column with acetonitrile and water (0.05% H3PO4) as mobile phase, the detection wavelength was 223 nm. Based on HPLC, stability of quality profile had been studied, and abnormal compounds in quality profile had been analyzed after addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide. And by MS, detector worked with ESI +, capillary voltage: 3.5 kV, cone voltage: 30 V, extractor voltage: 4 V, RF lens voltage: 0.5 V, source temperature: 105 degrees C, desolvation temperature: 300 degrees C, desolvation gas flow rate: 260 L/h, cone gas flow rate: 50 L/h, full scan mass spectra: m/z 100-600. Abnormal compound in quality profile had been analyzed after addition of N-mono-desmethyl sibutramine. Quality profile based on HPLC had good stability (Similarity > 0.877). Addition of phenolphthalein, sibutramine, rosiglitazone, glibenclamide and gliclazide in natural dietary supplements could be reflected by HPLC, and addition of N-mono-desmethyl sibutramine in natural dietary supplements could be reflected by MS. Quality profile might monitor adulteration of natural dietary supplements, and prevent addition of synthetic drug after "approval".

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-08-01

We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC). A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through February 9, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC. Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta-analysis (NMA) was conducted for an induction phase (6-8 weeks) and maintenance phase (52-54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System (ADDIS) software. The PROSPERO registration number was CRD42016032607. Seven RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head-to-head comparisons between the analyzed biologics. © 2016 Pharmacotherapy Publications, Inc.

Safety and Antioxidant Efficacy Profiles of Rutin-Loaded Ethosomes for Topical Application.

PubMed

Cândido, Thalita Marcílio; De Oliveira, Camila Areias; Ariede, Maíra Bueno; Velasco, Maria Valéria Robles; Rosado, Catarina; Baby, André Rolim

2018-05-01

Topical application of dermocosmetics containing antioxidant and/or the intake of antioxidants through diet or supplementation are remarkable tools in an attempt to slow down some of the harmful effects of free radicals. Rutin is a strong antioxidant compound used in food and pharmaceutical industries. It was established that rutin presents a low skin permeation rate, a property that could be considered an inconvenience to the satisfactory action for a dermocosmetic formulation to perform its antioxidant activity onto the skin. Therefore, it is indispensable to improve its delivery, aiming at increasing its antioxidant capacity in deeper layers of the epidermis, being a possibility to associate the rutin to liposomal vesicles, such as ethosomes. Thus, in this work, the pre-clinical safety of rutin-loaded ethosomes was investigated employing an in vitro method, and the clinical safety and efficacy were also assessed. Rutin-loaded ethosomes were efficaciously obtained in a nanoscale dimension with a relevant bioactive compound loading (80.2%) and provided antioxidant in vitro activity in comparison with the blank sample. Pre-clinical and clinical safety assays assured the innocuous profile of the rutin-loaded ethosomes. The ethosomes containing the bioactive compound accomplished a more functional delivery system profile, since in the tape stripping assay, the deeper layers presented higher rutin amounts than the active delivered in its free state. However, the ex vivo antioxidant efficacy test detected no positive antioxidant activity from the rutin-loaded ethosomes, even though the in vitro assay demonstrated an affirmative antioxidant action.

14 CFR 31.25 - Factor of safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... STANDARDS: MANNED FREE BALLOONS Strength Requirements § 31.25 Factor of safety. (a) Except as specified in... of temperature, and other operating characteristics, or both, that may affect strength of the balloon...

Patient safety - the role of human factors and systems engineering.

PubMed

Carayon, Pascale; Wood, Kenneth E

2010-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety.

Patient Safety: The Role of Human Factors and Systems Engineering

PubMed Central

Carayon, Pascale; Wood, Kenneth E.

2011-01-01

Patient safety is a global challenge that requires knowledge and skills in multiple areas, including human factors and systems engineering. In this chapter, numerous conceptual approaches and methods for analyzing, preventing and mitigating medical errors are described. Given the complexity of healthcare work systems and processes, we emphasize the need for increasing partnerships between the health sciences and human factors and systems engineering to improve patient safety. Those partnerships will be able to develop and implement the system redesigns that are necessary to improve healthcare work systems and processes for patient safety. PMID:20543237

First-Principles-Driven Model-Based Optimal Control of the Current Profile in NSTX-U

NASA Astrophysics Data System (ADS)

Ilhan, Zeki; Barton, Justin; Wehner, William; Schuster, Eugenio; Gates, David; Gerhardt, Stefan; Kolemen, Egemen; Menard, Jonathan

2014-10-01

Regulation in time of the toroidal current profile is one of the main challenges toward the realization of the next-step operational goals for NSTX-U. A nonlinear, control-oriented, physics-based model describing the temporal evolution of the current profile is obtained by combining the magnetic diffusion equation with empirical correlations obtained at NSTX-U for the electron density, electron temperature, and non-inductive current drives. In this work, the proposed model is embedded into the control design process to synthesize a time-variant, linear-quadratic-integral, optimal controller capable of regulating the safety factor profile around a desired target profile while rejecting disturbances. Neutral beam injectors and the total plasma current are used as actuators to shape the current profile. The effectiveness of the proposed controller in regulating the safety factor profile in NSTX-U is demonstrated via closed-loop predictive simulations carried out in PTRANSP. Supported by PPPL.

Systematic review: cardiovascular safety profile of 5-HT(4) agonists developed for gastrointestinal disorders.

PubMed

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; De Maeyer, J H; Stanghellini, V

2012-04-01

The nonselective 5-HT(4) receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT(4) agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006-2008 and DDW 2008-2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT(4) agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT(4) agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT(1) receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT(4) agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT(4) agonists with no hERG or 5-HT(1) affinity (renzapride, clebopride, mosapride). 5-HT(4) agonists for GI disorders differ in chemical structure and selectivity for 5-HT(4) receptors. Selectivity for 5-HT(4) over non-5-HT(4) receptors may influence the agent's safety and overall risk-benefit profile. Based on available evidence, highly selective 5-HT(4) agonists may offer improved safety to treat patients with impaired GI motility. © 2012 Blackwell Publishing Ltd.

Systematic review: cardiovascular safety profile of 5-HT4 agonists developed for gastrointestinal disorders

PubMed Central

Tack, J; Camilleri, M; Chang, L; Chey, W D; Galligan, J J; Lacy, B E; Müller-Lissner, S; Quigley, E M M; Schuurkes, J; Maeyer, J H; Stanghellini, V

2012-01-01

Summary Background The nonselective 5-HT4 receptor agonists, cisapride and tegaserod have been associated with cardiovascular adverse events (AEs). Aim To perform a systematic review of the safety profile, particularly cardiovascular, of 5-HT4 agonists developed for gastrointestinal disorders, and a nonsystematic summary of their pharmacology and clinical efficacy. Methods Articles reporting data on cisapride, clebopride, prucalopride, mosapride, renzapride, tegaserod, TD-5108 (velusetrag) and ATI-7505 (naronapride) were identified through a systematic search of the Cochrane Library, Medline, Embase and Toxfile. Abstracts from UEGW 2006–2008 and DDW 2008–2010 were searched for these drug names, and pharmaceutical companies approached to provide unpublished data. Results Retrieved articles on pharmacokinetics, human pharmacodynamics and clinical data with these 5-HT4 agonists, are reviewed and summarised nonsystematically. Articles relating to cardiac safety and tolerability of these agents, including any relevant case reports, are reported systematically. Two nonselective 5-HT4 agonists had reports of cardiovascular AEs: cisapride (QT prolongation) and tegaserod (ischaemia). Interactions with, respectively, the hERG cardiac potassium channel and 5-HT1 receptor subtypes have been suggested to account for these effects. No cardiovascular safety concerns were reported for the newer, selective 5-HT4 agonists prucalopride, velusetrag, naronapride, or for nonselective 5-HT4 agonists with no hERG or 5-HT1 affinity (renzapride, clebopride, mosapride). Conclusions 5-HT4 agonists for GI disorders differ in chemical structure and selectivity for 5-HT4 receptors. Selectivity for 5-HT4 over non-5-HT4 receptors may influence the agent's safety and overall risk–benefit profile. Based on available evidence, highly selective 5-HT4 agonists may offer improved safety to treat patients with impaired GI motility. PMID:22356640

Human factors and safety in emergency medicine

NASA Technical Reports Server (NTRS)

Schaefer, H. G.; Helmreich, R. L.; Scheidegger, D.

1994-01-01

A model based on an input process and outcome conceptualisation is suggested to address safety-relevant factors in emergency medicine. As shown in other dynamic and demanding environments, human factors play a decisive role in attaining high quality service. Attitudes held by health-care providers, organisational shells and work-cultural parameters determine communication, conflict resolution and workload distribution within and between teams. These factors should be taken into account to improve outcomes such as operational integrity, job satisfaction and morale.

Evaluation of bioavailability, efficacy, and safety profile of doxorubicin-loaded solid lipid nanoparticles

NASA Astrophysics Data System (ADS)

Patro, Nagaraju M.; Devi, Kshama; Pai, Roopa S.; Suresh, Sarasija

2013-12-01

We investigated the bioavailability, efficacy, and toxicity of doxorubicin-loaded solid lipid nanoparticles (DOX-SLNs) prepared by a simple modified double-emulsification method. A 3-factor, 3-level Box-Behnken statistical design was adopted in the optimization of DOX-SLN formulation considering dependent factors particle size and entrapment efficiency. Optimized SLN formulation composed of lipid (2 %) consisting of soya lecithin and Precirol ATO 5 (1:3) with Pluronic F68 (0.3 %) resulted in 217.36 ± 3.31 nm particle size and 59.45 ± 1.75 % entrapment efficiency. DOX-SLN exhibited significant enhancement ( p < 0.05) in bioavailability as compared with free DOX in Sprague-Dawley (SD) rats. DOX-SLN exhibited higher peak plasma concentration (6.761 ± 0.08 vs. 2.412 ± 0.04 μg/ml), increased AUC (61.368 ± 3.54 vs. 5.812 ± 0.49 μg/ml h), decreased clearance (36 ± 0.01 vs. 619 ± 0.005 mL/h kg), and volume of distribution (733 ± 0.092 vs. 2,064 ± 0.061 mL/kg) when compared to free DOX. The collective results of cardiac and kidney enzyme assay, antioxidant enzyme levels, hematological parameters, effect on body weight and tumor volume, tumor necrosis factor-α level, histopathological examination, and survival analysis confirmed the improved efficacy and safety profile of DOX-SLN in 7,12-dimethyl benzanthracene-induced breast cancer in SD rats.

Central Safety Factor and Normalized Beta Control Under Near-Zero Input Torque Constraints in DIII-D

NASA Astrophysics Data System (ADS)

Pajares, Andres; Wehner, William; Schuster, Eugenio; Burrell, Keith; Ferron, John; Walker, Michael; Humphreys, David; Lehigh University Team; Atomics Team, General

2017-10-01

DIII-D experiments have assessed the capability of combined central safety factor (q0) and normalized beta (βN) control under near-zero net torque to facilitate access to QH-mode with reverse Ip and normal Bt. Regulation of q0 and βN can prevent magneto-hydrodynamic instabilities that deteriorate plasma performance in discharges with a monotonically increasing safety-factor profile. Zero-input-torque scenarios are of special interest because future burning plasma tokamaks such as ITER will most likely operate with very low input torque, which makes these scenarios more susceptible to locked modes. To support studies of such scenarios, a controller for simultaneous regulation of q0 and βN has been developed using near-zero net input torque actuators including balanced neutral beam injection (NBI) and electron-cyclotron heating & current drive (ECH/ECCD). Experimental results show that in spite of the presence of locked modes the use of feedback control resulted in good tracking of the commanded q0 and βN when both ECCD/ECH and NBI were available. Supported by the US DOE under DE-SC0010661 and DE-FC02-04ER54698.

New geometric design consistency model based on operating speed profiles for road safety evaluation.

PubMed

Camacho-Torregrosa, Francisco J; Pérez-Zuriaga, Ana M; Campoy-Ungría, J Manuel; García-García, Alfredo

2013-12-01

To assist in the on-going effort to reduce road fatalities as much as possible, this paper presents a new methodology to evaluate road safety in both the design and redesign stages of two-lane rural highways. This methodology is based on the analysis of road geometric design consistency, a value which will be a surrogate measure of the safety level of the two-lane rural road segment. The consistency model presented in this paper is based on the consideration of continuous operating speed profiles. The models used for their construction were obtained by using an innovative GPS-data collection method that is based on continuous operating speed profiles recorded from individual drivers. This new methodology allowed the researchers to observe the actual behavior of drivers and to develop more accurate operating speed models than was previously possible with spot-speed data collection, thereby enabling a more accurate approximation to the real phenomenon and thus a better consistency measurement. Operating speed profiles were built for 33 Spanish two-lane rural road segments, and several consistency measurements based on the global and local operating speed were checked. The final consistency model takes into account not only the global dispersion of the operating speed, but also some indexes that consider both local speed decelerations and speeds over posted speeds as well. For the development of the consistency model, the crash frequency for each study site was considered, which allowed estimating the number of crashes on a road segment by means of the calculation of its geometric design consistency. Consequently, the presented consistency evaluation method is a promising innovative tool that can be used as a surrogate measure to estimate the safety of a road segment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads

PubMed Central

Thompson, Kirrilly; Matthews, Chelsea

2015-01-01

Simple Summary Riding horses on roads can be dangerous, but little is known about accidents and near misses. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey, mostly attributed to speed. Whilst our findings confirmed factors identified overseas, we also identified issues around road rules, hand signals and road rage. This paper suggests strategies for improving the safety of horses, riders and other road users. Abstract Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles; (2) harmonising laws regarding passing horses; (3) mandating personal protective equipment; (4) improving road signage; (5) comprehensive data collection; (6) developing mutual understanding amongst road-users; (7) safer road design and alternative riding spaces; and (8) increasing investment

Safety and Efficacy Profile of Commercial Veterinary Vaccines against Rift Valley Fever: A Review Study

PubMed Central

2016-01-01

Rift Valley Fever (RVF) is an infectious illness with serious clinical manifestations and health consequences in humans as well as a wide range of domestic ruminants. This review provides significant information about the prevention options of RVF along with the safety-efficacy profile of commercial vaccines and some of RVF vaccination strategies. Information presented in this paper was obtained through a systematic investigation of published data about RVF vaccines. Like other viral diseases, the prevention of RVF relies heavily on immunization of susceptible herds with safe and cost-effective vaccine that is able to confer long-term protective immunity. Several strains of RVF vaccines have been developed and are available in commercial production including Formalin-Inactivated vaccine, live attenuated Smithburn vaccine, and the most recent Clone13. Although Formalin-Inactivated vaccine and live attenuated Smithburn vaccine are immunogenic and widely used in prevention programs, they proved to be accompanied by significant concerns. Despite Clone13 vaccine being suggested as safe in pregnant ewes and as highly immunogenic along with its potential for differentiating infected from vaccinated animals (DIVA), a recent study raised concerns about the safety of the vaccine during the first trimester of gestation. Accordingly, RVF vaccines that are currently available in the market to a significant extent do not fulfill the requirements of safety, potency, and DIVA. These adverse effects stressed the need for developing new vaccines with an excellent safety profile to bridge the gap in safety and immunity. Bringing RVF vaccine candidates to local markets besides the absence of validated serological test for DIVA remain the major challenges of RVF control. PMID:27689098

Inroads into Equestrian Safety: Rider-Reported Factors Contributing to Horse-Related Accidents and Near Misses on Australian Roads.

PubMed

Thompson, Kirrilly; Matthews, Chelsea

2015-07-22

Horse riding and horse-related interactions are inherently dangerous. When they occur on public roads, the risk profile of equestrian activities is complicated by interactions with other road users. Research has identified speed, proximity, visibility, conspicuity and mutual misunderstanding as factors contributing to accidents and near misses. However, little is known about their significance or incidence in Australia. To explore road safety issues amongst Australian equestrians, we conducted an online survey. More than half of all riders (52%) reported having experienced at least one accident or near miss in the 12 months prior to the survey. Whilst our findings confirm the factors identified overseas, we also identified issues around rider misunderstanding of road rules and driver misunderstanding of rider hand signals. Of particular concern, we also found reports of potentially dangerous rider-directed road rage. We identify several areas for potential safety intervention including (1) identifying equestrians as vulnerable road users and horses as sentient decision-making vehicles (2) harmonising laws regarding passing horses, (3) mandating personal protective equipment, (4) improving road signage, (5) comprehensive data collection, (6) developing mutual understanding amongst road-users, (7) safer road design and alternative riding spaces; and (8) increasing investment in horse-related safety initiatives.

Evaluating the impact of grade crossing safety factors through signal detection theory

DOT National Transportation Integrated Search

2012-10-22

The purpose of this effort was to apply signal detection theory to descriptively model the impact : of five grade crossing safety factors to understand their effect on driver decision making. The : safety factors consisted of: improving commercial mo...

Safety profile and long-term engraftment of human CD31+ blood progenitors in bone tissue engineering.

PubMed

Zigdon-Giladi, Hadar; Elimelech, Rina; Michaeli-Geller, Gal; Rudich, Utai; Machtei, Eli E

2017-07-01

Endothelial progenitor cells (EPCs) participate in angiogenesis and induce favorable micro-environments for tissue regeneration. The efficacy of EPCs in regenerative medicine is extensively studied; however, their safety profile remains unknown. Therefore, our aims were to evaluate the safety profile of human peripheral blood-derived EPCs (hEPCs) and to assess the long-term efficacy of hEPCs in bone tissue engineering. hEPCs were isolated from peripheral blood, cultured and characterized. β tricalcium phosphate scaffold (βTCP, control) or 10 6 hEPCs loaded onto βTCP were transplanted in a nude rat calvaria model. New bone formation and blood vessel density were analyzed using histomorphometry and micro-computed tomography (CT). Safety of hEPCs using karyotype analysis, tumorigenecity and biodistribution to target organs was evaluated. On the cellular level, hEPCs retained their karyotype during cell expansion (seven passages). Five months following local hEPC transplantation, on the tissue and organ level, no inflammatory reaction or dysplastic change was evident at the transplanted site or in distant organs. Direct engraftment was evident as CD31 human antigens were detected lining vessel walls in the transplanted site. In distant organs human antigens were absent, negating biodistribution. Bone area fraction and bone height were doubled by hEPC transplantation without affecting mineral density and bone architecture. Additionally, local transplantation of hEPCs increased blood vessel density by nine-fold. Local transplantation of hEPCs showed a positive safety profile. Furthermore, enhanced angiogenesis and osteogenesis without mineral density change was found. These results bring us one step closer to first-in-human trials using hEPCs for bone regeneration. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Human factors and systems engineering approach to patient safety for radiotherapy.

PubMed

Rivera, A Joy; Karsh, Ben-Tzion

2008-01-01

The traditional approach to solving patient safety problems in healthcare is to blame the last person to touch the patient. But since the publication of To Err is Human, the call has been instead to use human factors and systems engineering methods and principles to solve patient safety problems. However, an understanding of the human factors and systems engineering is lacking, and confusion remains about what it means to apply their principles. This paper provides a primer on them and their applications to patient safety.

Effects and safety of granulocyte colony-stimulating factor in healthy volunteers

PubMed Central

Anderlini, Paolo

2015-01-01

Purpose of Review Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is now widely used in normal donors for collection of peripheral blood progenitor cells (PBPCs) for allogeneic transplantation and granulocytes for transfusion. Currently available data on biologic and molecular effects, and safety of rhG-CSF in normal healthy volunteers are reviewed. Recent Findings In addition to its known activating role on neutrophil kinetics and functional status, rhG-CSF administration can affect monocytes, lymphocytes and the hemostatic system. G-CSF receptors were identified in a variety of non-myeloid tissues, although their role and functional activity have not always been well defined. Moreover, rhG-CSF is capable of modulating complex cytokine networks and can impact the inflammatory response. In addition to its known mobilizing role for PBPCs, rhG-CSF can mobilize dendritic and endothelial progenitor cells as well. On a clinical level, serious rhG-CSF-related adverse events are well described (e.g. splenic rupture) but remain rare. Summary rhG-CSF effects in healthy volunteers, while normally transient and self-limiting, are now believed to be more complex and heterogeneous that previously thought. While rhG-CSF administration to healthy volunteers continues to have a favorable risk-benefit profile, these new findings have implications for safeguarding the safety of normal individuals. PMID:19057203

School and Community Factors Involved in Chilean Students' Perception of School Safety

ERIC Educational Resources Information Center

López, Verónica; Torres-Vallejos, Javier; Villalobos-Parada, Boris; Gilreath, Tamika D.; Ascorra, Paula; Bilbao, Marian; Morales, Macarena; Carrasco, Claudia

2017-01-01

Identifying and understanding predictors of school safety perceptions is important due to its consequences for students. However, it is not clear what school-related factors most contribute to explaining students' perception of school safety, and how they relate to community-related factors such as neighborhood safety. The purpose of this study…

Modeling the factors affecting unsafe behavior in the construction industry from safety supervisors' perspective.

PubMed

Khosravi, Yahya; Asilian-Mahabadi, Hassan; Hajizadeh, Ebrahim; Hassanzadeh-Rangi, Narmin; Bastani, Hamid; Khavanin, Ali; Mortazavi, Seyed Bagher

2014-01-01

There can be little doubt that the construction is the most hazardous industry in the worldwide. This study was designed to modeling the factors affecting unsafe behavior from the perspective of safety supervisors. The qualitative research was conducted to extract a conceptual model. A structural model was then developed based on a questionnaire survey (n=266) by two stage Structural Equation Model (SEM) approach. An excellent confirmed 12-factors structure explained about 62% of variances unsafe behavior in the construction industry. A good fit structural model indicated that safety climate factors were positively correlated with safety individual factors (P<0.001) and workplace safety condition (P<0.001). The workplace safety condition was found to play a strong mediating role in linking the safety climate and construction workers' engagement in safe or unsafe behavior. In order to improve construction safety performance, more focus on the workplace condition is required.

Survey of factors associated with nurses' perception of patient safety.

PubMed

Park, Sun A; Lee, Sui Jin; Choi, Go Un

2011-01-01

To describe the nurses' perception of hospital organization related to cultural issues on the safety of the patient and reporting medical errors. In addition, to identify factors associated with the safety of the patient and the nurse. A survey conducted during December 2008-Jannuary 2009, with 126 nurses using the Korean version of the AHRQ patient safety survey, a self-report 5-point Likert scale. Stata 10.0 was used for descriptive analysis, ANOVA (Analysis of variance) and logistic regression. National Cancer Center in Korea. The means for a working environment related to patient safety was 3.4 (±0.62). The associated factors of duration were at a present hospital, a special area, and direct contact with patients. Among organizational culture factors related to patient safety, the means were 3.81(±0.54) for the boss/manager's perception of patient safety and 3.37(±0.49) for the cooperation/collaboration between units. The frequent number of errors reported by nurses were 1~2(22.2%) times over the past 12 months. For incidence reporting, the items that the 'nurses perceived for communication among clinicians as fair' had a means of 3.23(±0.40) and the 'overall evaluation of patient safety was a good' 3.34(±0.73). The nurses' perception of cooperation and collaboration between units were associated with the direct contact between the patient and the nurse. The frequency of incidence reporting was associated with the duration of working hours at the present hospital and also their work experience. The nurses' perception of hospital environment, organizational culture, and incidence reporting was above average and mostly associated with organizational culture.

21 CFR 170.22 - Safety factors to be considered.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to... be applied in determining whether the proposed use of a food additive will be safe: Except where... experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted...

21 CFR 170.22 - Safety factors to be considered.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to be considered. In accordance with... proposed use of a food additive will be safe: Except where evidence is submitted which justifies use of a... used; that is, a food additive for use by man will not be granted a tolerance that will exceed 1/100th...

21 CFR 170.22 - Safety factors to be considered.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to... be applied in determining whether the proposed use of a food additive will be safe: Except where... experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted...

21 CFR 170.22 - Safety factors to be considered.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVES Food Additive Safety § 170.22 Safety factors to... be applied in determining whether the proposed use of a food additive will be safe: Except where... experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted...

The Ultimate Factor of Safety for Aircraft and Spacecraft Its History, Applications and Misconceptions

NASA Technical Reports Server (NTRS)

Zipay, John J.; Modlin, C. Thomas, Jr.; Larsen, Curtis E.

2016-01-01

The ultimate factor of safety (FOSULT) concept used in aircraft and spacecraft has evolved over many decades. Currently an FOSULT 1.5 is the FAR-mandated value for aircraft while an FOSULT of 1.4 has been used in various spacecraft. This paper was motivated by the desire to concisely explain the origins, proper interpretation and application of the ultimate factor of safety concept, since the authors have seen throughout their careers many misconceptions and incorrect applications of this concept. The history of the ultimate factor of safety concept is briefly summarized, the proper application of the factor of safety in aircraft design, structural analysis and operations is covered in detail, examples of limit load exceedance in aircraft and spacecraft are discussed, the evolution of the 1.4 FOSULT for spacecraft is described and some misconceptions regarding the ultimate factor of safety concept are addressed. It is hoped that this paper can be a summary resource for engineers to understand the origin, purpose and proper application of the ultimate factor of safety.

A cross-cultural study of organizational factors on safety: Japanese vs. Taiwanese oil refinery plants.

PubMed

Hsu, Shang Hwa; Lee, Chun-Chia; Wu, Muh-Cherng; Takano, Kenichi

2008-01-01

This study attempts to identify idiosyncrasies of organizational factors on safety and their influence mechanisms in Taiwan and Japan. Data were collected from employees of Taiwanese and Japanese oil refinery plants. Results show that organizational factors on safety differ in the two countries. Organizational characteristics in Taiwanese plants are highlighted as: higher level of management commitment to safety, harmonious interpersonal relationship, more emphasis on safety activities, higher devotion to supervision, and higher safety self-efficacy, as well as high quality of safety performance. Organizational characteristics in Japanese plants are highlighted as: higher level of employee empowerment and attitude towards continuous improvement, more emphasis on systematic safety management approach, efficient reporting system and teamwork, and high quality of safety performance. The casual relationships between organizational factors and workers' safety performance were investigated using structural equation modeling (SEM). Results indicate that the influence mechanisms of organizational factors in Taiwan and Japan are different. These findings provide insights into areas of safety improvement in emerging countries and developed countries respectively.

75 FR 56972 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts... Factors AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION: Notice of...: Background There are roughly 170,000 miles of hazardous liquid pipelines, 295,000 miles of gas transmission...

Steady state scenario development with elevated minimum safety factor on DIII-D

DOE PAGES

Holcomb, Christopher T.; Ferron, John R.; Luce, Timothy C.; ...

2014-08-15

On DIII-D, a high β scenario with minimum safety factor (q min) near 1.4 has been optimized with new tools and shown to be a favourable candidate for long pulse or steady state operation in future devices. Furthermore, the new capability to redirect up to 5 MW of neutral beam injection (NBI) from on- to off-axis improves the ability to sustain elevated q min with a less peaked pressure profile. The observed changes increase the ideal magnetohydrodynamics (MHD) n = 1 mode β N limit thus providing a path forward for increasing the noninductive current drive fraction by operating atmore » high β N. Quasi-stationary discharges free of tearing modes have been sustained at βN = 3.5 and β T = 3.6% for two current profile diffusion timescales (about 3 s) limited by neutral beam duration. The discharge performance has normalized fusion performance expected to give fusion gain Q ≈ 5 in a device the size of ITER. Analysis of the poloidal flux evolution and current drive balance show that the loop voltage profile is almost relaxed even with 25% of the current driven inductively, and q min remains elevated near 1.4. Our observations increase confidence that the current profile will not evolve to one unstable to a tearing mode. In preliminary tests a divertor heat flux reduction technique based on producing a radiating mantle with neon injection appears compatible with this operating scenario. 0D model extrapolations suggest it may be possible to push this scenario up to 100% noninductive current drive by raising β N. Similar discharges with q min = 1.5–2 were susceptible to tearing modes and off-axis fishbones, and with q min > 2 lower normalized global energy confinement time is observed.« less

Factors associated with the enactment of safety belt and motorcycle helmet laws.

PubMed

Law, Teik Hua; Noland, Robert B; Evans, Andrew W

2013-07-01

It has been shown that road safety laws, such as motorcycle helmet and safety belt laws, have a significant effect in reducing road fatalities. Although an expanding body of literature has documented the effects of these laws on road safety, it remains unclear which factors influence the likelihood that these laws are enacted. This study attempts to identify the factors that influence the decision to enact safety belt and motorcycle helmet laws. Using panel data from 31 countries between 1963 and 2002, our results reveal that increased democracy, education level, per capita income, political stability, and more equitable income distribution within a country are associated with the enactment of road safety laws. © 2012 Society for Risk Analysis.

Ontogeny of intestinal safety factors: lactase capacities and lactose loads.

PubMed

O'Connor, T P; Diamond, J

1999-03-01

We measured intestinal safety factors (ratio of a physiological capacity to the load on it) for lactose digestion in developing rat pups. Specifically, we assessed the quantitative relationships between lactose load and the series capacities of lactase and the Na+-glucose cotransporter (SGLT-1). Both capacities increased significantly with age in suckling pups as a result of increasing intestinal mass and maintenance of mass-specific activities. The youngest pups examined (5 days) had surprisingly high safety factors of 8-13 for both lactase and SGLT-1, possibly because milk contains lactase substrates other than lactose; it also, however, suggests that their intestinal capacities were being prepared to meet future demands rather than just current ones. By day 10 (and also at day 15), increased lactose loads resulted in lower safety factors of 4-6, values more typical of adult intestines. The safety factor of SGLT-1 in day 30 (weanling) and day 100 (adult) rats was only approximately 1.0. This was initially unexpected, because most adult intestines maintain a modest reserve capacity beyond nutrient load values, but postweaning rats appear to use hindgut fermentation, assessed by gut morphology and hydrogen production assays, as a built-in reserve capacity. The series capacities of lactase and SGLT-1 varied in concert with each other over ontogeny and as lactose load was manipulated by experimental variation in litter size.

Central safety factor and βN control on NSTX-U via beam power and plasma boundary shape modification, using TRANSP for closed loop simulations

NASA Astrophysics Data System (ADS)

Boyer, M. D.; Andre, R.; Gates, D. A.; Gerhardt, S.; Goumiri, I. R.; Menard, J.

2015-05-01

The high-performance operational goals of NSTX-U will require development of advanced feedback control algorithms, including control of βN and the safety factor profile. In this work, a novel approach to simultaneously controlling βN and the value of the safety factor on the magnetic axis, q0, through manipulation of the plasma boundary shape and total beam power, is proposed. Simulations of the proposed scheme show promising results and motivate future experimental implementation and eventual integration into a more complex current profile control scheme planned to include actuation of individual beam powers, density, and loop voltage. As part of this work, a flexible framework for closed loop simulations within the high-fidelity code TRANSP was developed. The framework, used here to identify control-design-oriented models and to tune and test the proposed controller, exploits many of the predictive capabilities of TRANSP and provides a means for performing control calculations based on user-supplied data (controller matrices, target waveforms, etc). The flexible framework should enable high-fidelity testing of a variety of control algorithms, thereby reducing the amount of expensive experimental time needed to implement new control algorithms on NSTX-U and other devices.

A review on adverse event profiles of epidermal growth factor receptor-tyrosine kinase inhibitors in nonsmall cell lung cancer patients.

PubMed

Biswas, B; Ghadyalpatil, N; Krishna, M V; Deshmukh, J

2017-12-01

The epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of EGFR-mutant nonsmall cell lung cancer (NSCLC). These EGFR TKIs demonstrate a different adverse event (AE) profile as compared to conventional chemotherapy agents. They are more commonly associated with cutaneous AEs and diarrhea while hematological AEs occurred commonly with chemotherapy agents. These AEs are the extension of pharmacological effect and occur as a result of blockade of EGFR-regulated pathways in the skin and gastrointestinal tract. This review article sheds light on the safety profile of first-, second-, and third-generation EGFR TKIs based on data obtained from several clinical trials conducted in NSCLC patients and highlights trials comparing these agents with the conventional chemotherapy agents. The strategies to manage EGFR TKI-related AEs are also reviewed.

Consensus achievement of leadership, organisational and individual factors that influence safety climate: Implications for nursing management.

PubMed

Fischer, Shelly A; Jones, Jacqueline; Verran, Joyce A

2018-01-01

To validate a framework of factors that influence the relationship of transformational leadership and safety climate, and to enable testing of safety chain factors by generating hypotheses regarding their mediating and moderating effects. Understanding the patient safety chain and mechanisms by which leaders affect a strong climate of safety is essential to transformational leadership practice, education, and research. A systematic review of leadership and safety literature was used to develop an organising framework of factors proposed to influence the climate of safety. A panel of 25 international experts in leadership and safety engaged a three-round modified Delphi study with Likert-scored surveys. Eighty per cent of participating experts from six countries were retained to the final survey round. Consensus (>66% agreement) was achieved on 40 factors believed to influence safety climate in the acute care setting. Consensus regarding specific factors that play important roles in an organisation's climate of safety can be reached. Generally, the demonstration of leadership commitment to safety is key to cultivating a culture of patient safety. Transformational nurse leaders should consider and employ all three categories of factors in daily leadership activities and decision-making to drive a strong climate of patient safety. © 2017 John Wiley & Sons Ltd.

Safety climate in university and college laboratories: impact of organizational and individual factors.

PubMed

Wu, Tsung-Chih; Liu, Chi-Wei; Lu, Mu-Chen

2007-01-01

Universities and colleges serve to be institutions of education excellence; however, problems in the areas of occupational safety may undermine such goals. Occupational safety must be the concern of every employee in the organization, regardless of job position. Safety climate surveys have been suggested as important tools for measuring the effectiveness and improvement direction of safety programs. Thus, this study aims to investigate the influence of organizational and individual factors on safety climate in university and college laboratories. Employees at 100 universities and colleges in Taiwan were mailed a self-administered questionnaire survey; the response rate was 78%. Multivariate analysis of variance revealed that organizational category of ownership, the presence of a safety manager and safety committee, gender, age, title, accident experience, and safety training significantly affected the climate. Among them, accident experience and safety training affected the climate with practical significance. The authors recommend that managers should address important factors affecting safety issues and then create a positive climate by enforcing continuous improvements.

Safety and bleeding profile of continuous levonorgestrel 90 mcg/ethinyl estradiol 20 mcg based on 2 years of clinical trial data in Canada.

PubMed

Reid, Robert L; Fortier, Michel P; Smith, Lynne; Mirkin, Sebastian; Grubb, Gary S; Constantine, Ginger D

2010-12-01

The study was conducted to evaluate bleeding profile and safety of continuous oral contraceptive (OC) containing levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg. Healthy women who participated at seven Canadian sites in 1-year open-label study of LNG 90 mcg/EE 20 mcg daily were eligible for this second-year extension study. Primary end points included bleeding profile and adverse events. Seventy-nine women enrolled without interrupting pill taking; 62 (78.5%) completed. Adverse events were comparable to cyclic OC regimens, except unscheduled vaginal bleeding. Amenorrhea and absence of bleeding increased to about 80% and 90%, respectively, by Pill Pack 18. Mean (median) number of bleeding days for the last two 90-day intervals was 1.1 (0) and 0.7 (0) days, respectively. Continuous LNG 90 mcg/EE 20 mcg had a safety profile similar to low-dose cyclic OCs. Short-term safety profile remained excellent, with increasing rates of amenorrhea and decreasing incidence of unscheduled bleeding and/or spotting. Copyright © 2010 Elsevier Inc. All rights reserved.

Safety of Abiraterone Acetate in Castration-resistant Prostate Cancer Patients With Concomitant Cardiovascular Risk Factors.

PubMed

Procopio, Giuseppe; Grassi, Paolo; Testa, Isabella; Verzoni, Elena; Torri, Valter; Salvioni, Roberto; Valdagni, Riccardo; de Braud, Filippo

2015-10-01

The aim of this study was to evaluate the safety profile of abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) men with cardiovascular comorbidity, as little conclusive safety data are available in this patient subset. A retrospective analysis of mCRPC patients with controlled cardiovascular comorbidities, receiving AA 1000 mg administered orally once daily and prednisone 5 mg twice daily, between April 2011 and July 2012, was performed. All clinical and instrumental variables and toxicity data were analyzed by descriptive statistics: mean, standard deviation, minimum and maximum values for continuous variables, and absolute and relative frequencies for categorical variables. A total of 51 mCRPC patients were evaluated. Metastatic sites included the bone (74%), lungs, and liver (26%). All patients were previously treated with at least 2 lines of hormone and 1 docetaxel-based chemotherapy. Preexisting cardiac risk factors included hypertension (41%), cardiac ischemia (12%), arrhythmias (6%), dislipidemia (18%), and hyperglycemia (30%). No grade 3-4 adverse events were observed. Grade 1-2 adverse events included fluid retention (18%), asthenia (15%), and hypertension (16%). Median progression-free survival was 5.1 months (95% confidence interval, 0.5-12). Prostate specific antigen assessment revealed a good overall disease control rate (64%). AA appears to be safe and well tolerated even in patients with cardiovascular comorbidities or with increased risk factors for cardiovascular diseases.

Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis.

PubMed

Moćko, Paweł; Kawalec, Paweł; Pilc, Andrzej

2016-12-01

Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS ® software. The PROSPERO registration number was CRD42016032606. Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase. No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics. Copyright © 2016 Institute of Pharmacology, Polish Academy of Sciences. Published by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Community Violence, Protective Factors, and Adolescent Mental Health: A Profile Analysis

ERIC Educational Resources Information Center

Copeland-Linder, Nikeea; Lambert, Sharon F.; Ialongo, Nicholas S.

2010-01-01

This study examined interrelationships among community violence exposure, protective factors, and mental health in a sample of urban, predominantly African American adolescents (N = 504). Latent Profile Analysis was conducted to identify profiles of adolescents based on a combination of community violence exposure, self-worth, parental monitoring,…

75 FR 5536 - Pipeline Safety: Control Room Management/Human Factors, Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts...: Control Room Management/Human Factors, Correction AGENCY: Pipeline and Hazardous Materials Safety... following correcting amendments: PART 192--TRANSPORTATION OF NATURAL AND OTHER GAS BY PIPELINE: MINIMUM...

Evolved atmospheric entry corridor with safety factor

NASA Astrophysics Data System (ADS)

Liang, Zixuan; Ren, Zhang; Li, Qingdong

2018-02-01

Atmospheric entry corridors are established in previous research based on the equilibrium glide condition which assumes the flight-path angle to be zero. To get a better understanding of the highly constrained entry flight, an evolved entry corridor that considers the exact flight-path angle is developed in this study. Firstly, the conventional corridor in the altitude vs. velocity plane is extended into a three-dimensional one in the space of altitude, velocity, and flight-path angle. The three-dimensional corridor is generated by a series of constraint boxes. Then, based on a simple mapping method, an evolved two-dimensional entry corridor with safety factor is obtained. The safety factor is defined to describe the flexibility of the flight-path angle for a state within the corridor. Finally, the evolved entry corridor is simulated for the Space Shuttle and the Common Aero Vehicle (CAV) to demonstrate the effectiveness of the corridor generation approach. Compared with the conventional corridor, the evolved corridor is much wider and provides additional information. Therefore, the evolved corridor would benefit more to the entry trajectory design and analysis.

An examination of the impact of five grade crossing safety factors on driver decision making

DOT National Transportation Integrated Search

2014-04-01

The authors applied signal detection theory to model the impact : of five grade-crossing safety factors to understand their impact : on driver decision making. The safety factors were improving : commercial motor vehicle (CMV) driver safety through f...

21 CFR 601.32 - General factors relevant to safety and effectiveness.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) BIOLOGICS LICENSING Diagnostic Radiopharmaceuticals § 601.32 General factors relevant to safety and effectiveness. FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following: (a) The proposed use of the diagnostic...

Risk Factor Profile in Parkinson's Disease Subtype with REM Sleep Behavior Disorder.

PubMed

Jacobs, Marie L; Dauvilliers, Yves; St Louis, Erik K; McCarter, Stuart J; Romenets, Silvia Rios; Pelletier, Amélie; Cherif, Mahmoud; Gagnon, Jean-François; Postuma, Ronald B

2016-01-01

Numerous large-scale studies have found diverse risk factors for Parkinson's disease (PD), including caffeine non-use, non-smoking, head injury, pesticide exposure, and family history. These studies assessed risk factors for PD overall; however, PD is a heterogeneous condition. One of the strongest identifiers of prognosis and disease subtype is the co-occurrence of rapid eye movement sleep behavior disorder (RBD).In previous studies, idiopathic RBD was associated with a different risk factor profile from PD and dementia with Lewy bodies, suggesting that the PD-RBD subtype may also have a different risk factor profile. To define risk factors for PD in patients with or without associated RBD. In a questionnaire, we assessed risk factors for PD, including demographic, medical, environmental, and lifestyle variables of 189 PD patients with or without associated polysomnography-confirmed RBD. The risk profile of patients with vs. without RBD was assessed with logistic regression, adjusting for age, sex, and disease duration. PD-RBD patients were more likely to have been a welder (OR = 3.11 (1.05-9.223), and to have been regular smokers (OR = 1.96 (1.04-3.68)). There were no differences in use of caffeine or alcohol, other occupations, pesticide exposure, rural living, or well water use. Patients with RBD had a higher prevalence of the combined family history of both dementia and parkinsonism (13.3% vs. 5.5% , OR = 3.28 (1.07-10.0). The RBD-specific subtype of PD may also have a different risk factor profile.

Modelling of Field-Reversed Configuration Experiment with Large Safety Factor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Steinhauer, L; Guo, H; Hoffman, A

2005-11-28

The Translation-Confinement-Sustainment facility has been operated in the 'translation-formation' mode in which a plasma is ejected at high-speed from a {theta}-pinch-like source into a confinement chamber where it settles into a field-reversed-configuration state. Measurements of the poloidal and toroidal field have been the basis of modeling to infer the safety factor. It is found that the edge safety factor exceeds two, and that there is strong forward magnetic shear. The high-q arises because the large elongation compensates for the modest ratio of toroidal-to-poloidal field in the plasma. This is the first known instance of a very high-{beta} plasma with amore » safety factor greater than unity. Two-fluid modeling of the measurements also indicate several other significant features: a broad 'transition layer' at the plasma boundary with probable line-tying effects, complex high-speed flows, and the appearance of a two-fluid minimum-energy state in the plasma core. All these features may contribute to both the stability and good confinement of the plasma.« less

Use of a safety climate questionnaire in UK health care: factor structure, reliability and usability.

PubMed

Hutchinson, A; Cooper, K L; Dean, J E; McIntosh, A; Patterson, M; Stride, C B; Laurence, B E; Smith, C M

2006-10-01

To explore the factor structure, reliability, and potential usefulness of a patient safety climate questionnaire in UK health care. Four acute hospital trusts and nine primary care trusts in England. The questionnaire used was the 27 item Teamwork and Safety Climate Survey. Thirty three healthcare staff commented on the wording and relevance. The questionnaire was then sent to 3650 staff within the 13 NHS trusts, seeking to achieve at least 600 responses as the basis for the factor analysis. 1307 questionnaires were returned (36% response). Factor analyses and reliability analyses were carried out on 897 responses from staff involved in direct patient care, to explore how consistently the questions measured the underlying constructs of safety climate and teamwork. Some questionnaire items related to multiple factors or did not relate strongly to any factor. Five items were discarded. Two teamwork factors were derived from the remaining 11 teamwork items and three safety climate factors were derived from the remaining 11 safety items. Internal consistency reliabilities were satisfactory to good (Cronbach's alpha > or =0.69 for all five factors). This is one of the few studies to undertake a detailed evaluation of a patient safety climate questionnaire in UK health care and possibly the first to do so in primary as well as secondary care. The results indicate that a 22 item version of this safety climate questionnaire is useable as a research instrument in both settings, but also demonstrates a more general need for thorough validation of safety climate questionnaires before widespread usage.

Alaska Humans Factors Safety Study: The Southern Coastal Area

NASA Technical Reports Server (NTRS)

Chappell, Sheryl L.; Reynard, William (Technical Monitor)

1995-01-01

At the request of the Alaska Air Carriers Association, researchers from the NASA Aviation Safety Reporting System, at NASA Ames Research Center, conducted a study on aspects of safety in Alaskan Part 135 air taxi operations. An interview form on human factors safety issues was created by a representative team from the FAA-Alaska, NTSB-Alaska, NASA-ASRS, and representatives of the Alaska Air Carriers Association which was subsequently used in the interviews of pilots and managers. Because of the climate and operational differences, the study was broken into two geographical areas, the southern coastal areas and the northern portion of the state. This presentation addresses the southern coastal areas, specifically: Anchorage, Dillingham, King Salmon, Kodiak, Cold Bay, Juneau, and Ketchikan. The interview questions dealt with many of the potential pressures on pilots and managers associated with the daily air taxi operations in Alaska. The impact of the environmental factors such as the lack of available communication, navigation and weather information systems was evaluated. The results of this study will be used by government and industry working in Alaska. These findings will contribute important information on specific Alaska safety issues for eventual incorporation into training materials and policies that will help to assure the safe conduct of air taxi flights in Alaska.

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines.

PubMed

Pane, Josep; Coloma, Preciosa M; Verhamme, Katia M C; Sturkenboom, Miriam C J M; Rebollo, Irene

2017-01-01

Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle. A literature review served to examine the current tools for the safety evaluation of NAIMDs and those for medicines. We searched MEDLINE using these two categories. We supplemented this search with Google searches using the same key terms used in the MEDLINE search. Using a comparative approach, we summarized the new product design, development cycle (preclinical and clinical phases), and post-market phases for NAIMDs and drugs. We also evaluated and compared the respective processes to integrate and assess safety data during the life cycle of the products, including signal detection, signal management, and subsequent potential regulatory actions. The search identified a gap in NAIMD safety signal generation: no global program exists that collects and analyzes adverse events and product quality issues. Data sources in real-world settings, such as electronic health records, need to be effectively identified and explored as additional sources of safety information, particularly in some areas such as the EU and USA where there are plans to implement the unique device identifier (UDI). The UDI and other initiatives will enable more robust follow-up and assessment of long-term patient outcomes. The safety evaluation system for NAIMDs differs in many ways from those for drugs, but both systems face analogous challenges with respect to monitoring real-world usage. Certain features

Safety and the Human Factor.

ERIC Educational Resources Information Center

Smith, Ann

1982-01-01

Discusses four elements of safety programs: (1) safety training; (2) safety inspections; (3) accident investigations; and (4) protective safety equipment. Also discusses safety considerations in water/wastewater treatment facilities focusing on falls, drowning hazards, trickling filters, confined space entry, collection/distribution system safety,…

Influence of organizational factors on safety

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haber, S.B.; Metlay, D.S.; Crouch, D.A.

There is a need for a better understanding of exactly how organizational management factors at a nuclear power plant (NPP) affect plant safety performance, either directly or indirectly, and how these factors might be observed, measured, and evaluated. The purpose of this research project is to respond to that need by developing a general methodology for characterizing these organizational and management factors, systematically collecting information on their status and integrating that information into various types of evaluative activities. Research to date has included the development of the Nuclear Organization and Management Analysis Concept (NOMAC) of a NPP, the identification ofmore » key organizational and management factors, and the identification of the methods for systematically measuring and analyzing the influence of these factors on performance. Most recently, two field studies, one at a fossil fuel plant and the other at a NPP, were conducted using the developed methodology. Results are presented from both studies highlighting the acceptability, practicality, and usefulness of the methods used to assess the influence of various organizational and management factors including culture, communication, decision-making, standardization, and oversight. 6 refs., 3 figs., 1 tab.« less

Anxiety and Mood Clinical Profile following Sport-related Concussion: From Risk Factors to Treatment.

PubMed

Sandel, Natalie; Reynolds, Erin; Cohen, Paul E; Gillie, Brandon L; Kontos, Anthony P

2017-08-01

Conceptual models for assessing and treating sport-related concussion (SRC) have evolved from a homogenous approach to include different clinical profiles that reflect the heterogeneous nature of this injury and its effects. There are six identified clinical profiles, or subtypes from SRC, and one such clinical profile is the anxiety/mood profile. Athletes with this profile experience predominant emotional disturbance and anxiety following SRC. The purpose of this targeted review was to present an overview of the empirical evidence to support factors contributing to the anxiety/mood profile, along with methods of evaluation and treatment of this clinical profile following SRC. We discuss the potential underlying mechanisms and risk factors for this clinical profile, describe comprehensive assessments to evaluate concussed athletes with an anxiety/mood clinical profile, and explore behavioral and other interventions for treating these athletes. Although there is limited, but growing empirical evidence for the anxiety/mood clinical profile following SRC, understanding this clinical profile is germane for clinicians who are treating athletes with emotional sequelae after SRC.

Human Factors in Patient Safety as an Innovation

PubMed Central

Carayon, Pascale

2010-01-01

The use of Human Factors and Ergonomics (HFE) tools, methods, concepts and theories has been advocated by many experts and organizations to improve patient safety. To facilitate and support the spread of HFE knowledge and skills in health care and patient safety, we propose to conceptualize HFE as innovations whose diffusion, dissemination, implementation and sustainability need to be understood and specified. Using Greenhalgh et al. (2004) model of innovation, we identified various factors that can either hinder or facilitate the spread of HFE innovations in healthcare organizations. Barriers include lack of systems thinking, complexity of HFE innovations and lack of understanding about the benefits of HFE innovations. Positive impact of HFE interventions on task performance and the presence of local champions can facilitate the adoption, implementation and sustainability of HFE innovations. This analysis concludes with a series of recommendations for HFE professionals, researchers and educators. PMID:20106468

Central safety factor and β N control on NSTX-U via beam power and plasma boundary shape modification, using TRANSP for closed loop simulations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boyer, M. D.; Andre, R.; Gates, D. A.

The high-performance operational goals of NSTX-U will require development of advanced feedback control algorithms, including control of ßN and the safety factor profile. In this work, a novel approach to simultaneously controlling ßN and the value of the safety factor on the magnetic axis, q0, through manipulation of the plasma boundary shape and total beam power, is proposed. Simulations of the proposed scheme show promising results and motivate future experimental implementation and eventual integration into a more complex current profile control scheme planned to include actuation of individual beam powers, density, and loop voltage. As part of this work, amore » flexible framework for closed loop simulations within the high-fidelity code TRANSP was developed. The framework, used here to identify control-design-oriented models and to tune and test the proposed controller, exploits many of the predictive capabilities of TRANSP and provides a means for performing control calculations based on user-supplied data (controller matrices, target waveforms, etc.). The flexible framework should enable high-fidelity testing of a variety of control algorithms, thereby reducing the amount of expensive experimental time needed to implement new control algorithms on NSTX-U and other devices.« less

Factors related to increasing safety belt use in states with safety belt use laws : second annual report to Congress

DOT National Transportation Integrated Search

1989-01-01

This report is the second in a series of four annual reports to the Congress on provisions of state safety belt use laws and other programmatic factors related to increasing safety belt use levels. The first Congressional Report reviewed what was kno...

Teaching patient safety and human factors in undergraduate nursing curricula in England: a pilot survey.

PubMed

Robson, Wayne; Clark, Debbie; Pinnock, David; White, Nick; Baxendale, Bryn

Patient safety is a key priority for all healthcare systems, and there is growing recognition for the need to educate tomorrow's nurses about the role of human factors in reducing avoidable harm to patients. A pilot survey was sent to 20 schools of nursing in England to explore the teaching of patient safety and human factors. All 13 schools that responded (65% response rate) stated that patient safety was covered in their curricula and was allocated more than 4 hours; all the classes included human factors. Only two respondents indicated their teaching to be multi-professional. Awareness of the World Health Organization's multiprofessional patient safety curriculum guide was poor. Faculties also seemed unaware that the Institute for Healthcare Improvement provides free online patient safety modules for students and that there is a global network of student patient safety chapters.

Factors discriminating among profiles of resilience and psychopathology in children exposed to intimate partner violence (IPV).

PubMed

Graham-Bermann, Sandra A; Gruber, Gabrielle; Howell, Kathryn H; Girz, Laura

2009-09-01

To evaluate the social and emotional adjustment of 219 children in families with varying levels of intimate partner violence (IPV) using a model of risk and protection. To explore factors that differentiate children with poor adjustment from those with resilience. Mothers who experienced IPV in the past year and their children ages 6-12 were interviewed. Standardized measures assessed family violence, parenting, family functioning, maternal mental health, and children's adjustment and beliefs. Using cluster analysis, all cases with valid data on the Child Behavior Checklist, Child Depression Inventory, General Self-Worth and Social Self-Competence measures were described by four profiles of children's adjustment: Severe Adjustment Problems (24%); children who were Struggling (45%); those with Depression Only (11%); and Resilient (20%) with high competence and low adjustment problems. Multinomial logistic regression analyses showed children in the Severe Problems cluster witnessed more family violence and had mothers higher in depression and trauma symptoms than other children. Resilient and Struggling children had mothers with better parenting, more family strengths and no past violent partner. Parents of children with Severe Problems were lacking these attributes. The Depressed profile children witnessed less violence but had greater fears and worries about mother's safety. Factors related to the child, to the mother and to the family distinguish different profiles of adjustment for children exposed to IPV who are living in the community. Resilient children have less violence exposure, fewer fears and worries, and mothers with better mental health and parenting skills, suggesting avenues for intervention with this population. Findings suggest that child adjustment is largely influenced by parent functioning. Thus, services should be targeted at both the child and the parent. Clinical interventions shaped to the unique needs of the child might also be tested with

Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

PubMed

Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

2017-05-01

Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

Evaluation of the in-service safety performance of safety-shape and vertical concrete barriers.

DOT National Transportation Integrated Search

2011-12-16

Roadside concrete barriers have been widely used to protect errant motorists from hitting : roadside hazards or obstacles. Two concrete barrier profiles, vertical and safety-shape, have been used : for this purpose. The safety-shape profile has been ...

21 CFR 170.22 - Safety factors to be considered.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Safety factors to be considered. 170.22 Section 170.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... experimental animals. ...

Patient Safety Culture Survey in Pediatric Complex Care Settings: A Factor Analysis.

PubMed

Hessels, Amanda J; Murray, Meghan; Cohen, Bevin; Larson, Elaine L

2017-04-19

Children with complex medical needs are increasing in number and demanding the services of pediatric long-term care facilities (pLTC), which require a focus on patient safety culture (PSC). However, no tool to measure PSC has been tested in this unique hybrid acute care-residential setting. The objective of this study was to evaluate the psychometric properties of the Nursing Home Survey on Patient Safety Culture tool slightly modified for use in the pLTC setting. Factor analyses were performed on data collected from 239 staff at 3 pLTC in 2012. Items were screened by principal axis factoring, and the original structure was tested using confirmatory factor analysis. Exploratory factor analysis was conducted to identify the best model fit for the pLTC data, and factor reliability was assessed by Cronbach alpha. The extracted, rotated factor solution suggested items in 4 (staffing, nonpunitive response to mistakes, communication openness, and organizational learning) of the original 12 dimensions may not be a good fit for this population. Nevertheless, in the pLTC setting, both the original and the modified factor solutions demonstrated similar reliabilities to the published consistencies of the survey when tested in adult nursing homes and the items factored nearly identically as theorized. This study demonstrates that the Nursing Home Survey on Patient Safety Culture with minimal modification may be an appropriate instrument to measure PSC in pLTC settings. Additional psychometric testing is recommended to further validate the use of this instrument in this setting, including examining the relationship to safety outcomes. Increased use will yield data for benchmarking purposes across these specialized settings to inform frontline workers and organizational leaders of areas of strength and opportunity for improvement.

Factor analysis of safety for visitors to a mega-event.

PubMed

Kwon, Young Guk; Park, Hyun Jee

2002-01-01

This paper investigated the safety factors considered by visitors to the Kwangju Biennale 2000 and analyzed the correlation between the safety factors and the demographic characteristics of the visitors. Global tourism increased throughout the 1990s, with the biggest surge occurring in the Asia-Pacific region. Long-distance travel is also increasing, and at a rate faster than the global average. The opportunities for event tourism appear to be strong almost everywhere, even though recessions may have an impact on these destinations. Along with this upward trend, competition for more desirable tourists is also surging (Getz, 1997). Therefore event tourism is appearing as a powerful method in the fierce competition around the tourism industry.

Factors associated with the patient safety climate at a teaching hospital1

PubMed Central

Luiz, Raíssa Bianca; Simões, Ana Lúcia de Assis; Barichello, Elizabeth; Barbosa, Maria Helena

2015-01-01

Objectives: to investigate the association between the scores of the patient safety climate and socio-demographic and professional variables. Methods: an observational, sectional and quantitative study, conducted at a large public teaching hospital. The Safety Attitudes Questionnaire was used, translated and validated for Brazil. Data analysis used the software Statistical Package for Social Sciences. In the bivariate analysis, we used Student's t-test, analysis of variance and Spearman's correlation of (α=0.05). To identify predictors for the safety climate scores, multiple linear regression was used, having the safety climate domain as the main outcome (α=0.01). Results: most participants were women, nursing staff, who worked in direct care to adult patients in critical areas, without a graduate degree and without any other employment. The average and median total score of the instrument corresponded to 61.8 (SD=13.7) and 63.3, respectively. The variable professional performance was found as a factor associated with the safety environment for the domain perception of service management and hospital management (p=0.01). Conclusion: the identification of factors associated with the safety environment permits the construction of strategies for safe practices in the hospitals. PMID:26487138

Attention-deficit hyperactivity disorder medication use: factors involved in prescribing, safety aspects and outcomes.

PubMed

Martinez-Raga, Jose; Ferreros, Amparo; Knecht, Carlos; de Alvaro, Raquel; Carabal, Eloisa

2017-03-01

While treatment of patients with attention-deficit hyperactivity disorder (ADHD) is based on a multimodal approach that combines medication with specific psychological interventions, pharmacotherapy alone is generally considered an essential and cost-effective element. This paper aims to comprehensively and critically review factors involved in prescribing and medication use in individuals diagnosed with ADHD, focusing on the difficulties facing patients with ADHD seeking treatment, as well as the safety and tolerability aspects of ADHD pharmacotherapies, with particular attention on the cardiovascular adverse events and the potential risk of misuse or diversion of ADHD medications. A comprehensive and systematic literature search of PubMed/MEDLINE database was conducted to identify studies published in peer-reviewed journals until 1 August 2016. Children, adolescents and adults often encounter significant difficulties in the process of accessing specialist assessment and treatment for ADHD as a consequence of disparities in service organization and available treatment provision. Despite the well-established efficacy and overall safety profile, ADHD medications are not exempt from adverse events. The cardiovascular safety of pharmacotherapies used for treating individuals with ADHD has raised particular concerns; however there is little evidence of serious cardiovascular adverse events, including no serious corrected QT (QTc) abnormalities associated with stimulants, atomoxetine or α2-adrenergic receptor agonists. Although the abuse of prescription stimulant drugs, particularly, short-acting stimulants is a prevalent and growing problem, nonmedical use of prescription stimulants within the clinical context is very limited. In addition, nonstimulant ADHD medications lack any reinforcing effects and consequently any abuse potential.

Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches.

PubMed

Madureira, Ana Raquel; Nunes, Sara; Campos, Débora A; Fernandes, João C; Marques, Cláudia; Zuzarte, Monica; Gullón, Beatriz; Rodríguez-Alcalá, Luís M; Calhau, Conceição; Sarmento, Bruno; Gomes, Ana Maria; Pintado, Maria Manuela; Reis, Flávio

2016-01-01

Rosmarinic acid (RA) possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe) delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL) were evaluated for cell (lymphocytes) viability, necrosis and apoptosis, and antioxidant/prooxidant effects upon DNA. Wistar rats were orally treated for 14 days with vehicle (control) and with Witepsol or Carnauba nanoparticles loaded with RA at 1 and 10 mg/kg body weight/d. Blood, urine, feces, and several tissues were collected for analysis. Free and loaded RA, at 0.15 mg/mL, presented a safe profile, while genotoxic potential was found for the higher dose (1.5 mg/mL), mainly by necrosis. Our data suggest that both types of nanoparticles are safe when loaded with moderate concentrations of RA, without in vitro genotoxicity and cytotoxicity and with an in vivo safety profile in rats orally treated, thus opening new avenues for use in nutraceutical applications.

Safety profile of solid lipid nanoparticles loaded with rosmarinic acid for oral use: in vitro and animal approaches

PubMed Central

Madureira, Ana Raquel; Nunes, Sara; Campos, Débora A; Fernandes, João C; Marques, Cláudia; Zuzarte, Monica; Gullón, Beatriz; Rodríguez-Alcalá, Luís M; Calhau, Conceição; Sarmento, Bruno; Gomes, Ana Maria; Pintado, Maria Manuela; Reis, Flávio

2016-01-01

Rosmarinic acid (RA) possesses several protective bioactivities that have attracted increasing interest by nutraceutical/pharmaceutical industries. Considering the reduced bioavailability after oral use, effective (and safe) delivery systems are crucial to protect RA from gastrointestinal degradation. This study aims to characterize the safety profile of solid lipid nanoparticles produced with Witepsol and Carnauba waxes and loaded with RA, using in vitro and in vivo approaches, focused on genotoxicity and cytotoxicity assays, redox status markers, hematological and biochemical profile, liver and kidney function, gut bacterial microbiota, and fecal fatty acids composition. Free RA and sage extract, empty nanoparticles, or nanoparticles loaded with RA or sage extract (0.15 and 1.5 mg/mL) were evaluated for cell (lymphocytes) viability, necrosis and apoptosis, and antioxidant/prooxidant effects upon DNA. Wistar rats were orally treated for 14 days with vehicle (control) and with Witepsol or Carnauba nanoparticles loaded with RA at 1 and 10 mg/kg body weight/d. Blood, urine, feces, and several tissues were collected for analysis. Free and loaded RA, at 0.15 mg/mL, presented a safe profile, while genotoxic potential was found for the higher dose (1.5 mg/mL), mainly by necrosis. Our data suggest that both types of nanoparticles are safe when loaded with moderate concentrations of RA, without in vitro genotoxicity and cytotoxicity and with an in vivo safety profile in rats orally treated, thus opening new avenues for use in nutraceutical applications. PMID:27536103

Safety assessment of genetically modified rice expressing human serum albumin from urine metabonomics and fecal bacterial profile.

PubMed

Qi, Xiaozhe; Chen, Siyuan; Sheng, Yao; Guo, Mingzhang; Liu, Yifei; He, Xiaoyun; Huang, Kunlun; Xu, Wentao

2015-02-01

The genetically modified (GM) rice expressing human serum albumin (HSA) is used for non-food purposes; however, its food safety assessment should be conducted due to the probability of accidental mixture with conventional food. In this research, Sprague Dawley rats were fed diets containing 50% (wt/wt) GM rice expressing HSA or non-GM rice for 90 days. Urine metabolites were detected by (1)H NMR to examine the changes of the metabolites in the dynamic process of metabolism. Fecal bacterial profiles were detected by denaturing gradient gel electrophoresis to reflect intestinal health. Additionally, short chain fatty acids and fecal enzymes were investigated. The results showed that compared with rats fed the non-GM rice, some significant differences were observed in rats fed with the GM rice; however, these changes were not significantly different from the control diet group. Additionally, the gut microbiota was associated with blood indexes and urine metabolites. In conclusion, the GM rice diet is as safe as the traditional daily diet. Furthermore, urine metabonomics and fecal bacterial profiles provide a non-invasive food safety assessment rat model for genetically modified crops that are used for non-food/feed purposes. Fecal bacterial profiles have the potential for predicting the change of blood indexes in future. Copyright © 2014 Elsevier Ltd. All rights reserved.

Factors related to increasing safety belt use in states with safety belt use laws : second annual report to Congress, 1988.

DOT National Transportation Integrated Search

1989-01-01

This report. is the second in a series of four annual reports to the : Congress on provisions of state safety belt use laws and other : programmatic factors related to increasing safety belt use levels. : The first Congressional Report reviewed what ...

2009 Human Factors and Roadway Safety Workshop : Overviews of Safety Initiatives in Iowa [SD .WMV (720x480/29fps/80.2 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: Overview of Safety Initiatives in Iowa : Tom Welch, Iowa DOT Highway Division Safety Engineer,...

2009 Human Factors and Roadway Safety Workshop : National Perspectives on Safety [SD .WMV (720x480/29fps/227.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: National Perspectives on Safety : Essie Wagner, program analyst, National Highway Traffic Safe...

Appreciating Complexity in Adolescent Self-Harm Risk Factors: Psychological Profiling in a Longitudinal Community Sample.

PubMed

Stanford, Sarah; Jones, Michael P; Hudson, Jennifer L

2018-05-01

Past research identifies a number of risk factors for adolescent self-harm, but often fails to account for overlap between these factors. This study investigated the underlying, broader concepts by identifying different psychological profiles among adolescents. We then compared new self-harm rates over a six-month period across different psychological profiles. Australian high school students (n = 326, 68.1% female) completed a questionnaire including a broad range of psychological and socioenvironmental risk and protective factors. Non-hierarchical cluster analysis produced six groups with different psychological profiles at baseline and rate of new self-harm at follow-up. The lowest rate was 1.4% in a group that appeared psychologically healthy; the highest rate was 37.5% in a group that displayed numerous psychological difficulties. Four groups with average self-harm had varied psychological profiles including low impulsivity, anxiety, impulsivity, and poor use of positive coping strategies. Identifying multiple profiles with distinct psychological characteristics can improve detection, guide prevention, and tailor treatment.

Development of Integrated Magnetic and Kinetic Control-oriented Transport Model for q-profile Response Prediction in EAST Discharges

NASA Astrophysics Data System (ADS)

Wang, Hexiang; Schuster, Eugenio; Rafiq, Tariq; Kritz, Arnold; Ding, Siye

2016-10-01

Extensive research has been conducted to find high-performance operating scenarios characterized by high fusion gain, good confinement, plasma stability and possible steady-state operation. A key plasma property that is related to both the stability and performance of these advanced plasma scenarios is the safety factor profile. A key component of the EAST research program is the exploration of non-inductively driven steady-state plasmas with the recently upgraded heating and current drive capabilities that include lower hybrid current drive and neutral beam injection. Anticipating the need for tight regulation of the safety factor profile in these plasma scenarios, a first-principles-driven (FPD)control-oriented model is proposed to describe the safety factor profile evolution in EAST in response to the different actuators. The TRANSP simulation code is employed to tailor the FPD model to the EAST tokamak geometry and to convert it into a form suitable for control design. The FPD control-oriented model's prediction capabilities are demonstrated by comparing predictions with experimental data from EAST. Supported by the US DOE under DE-SC0010537,DE-FG02-92ER54141 and DE-SC0013977.

Highly selective peroxisome proliferator-activated receptor δ (PPARδ) modulator demonstrates improved safety profile compared to GW501516.

PubMed

Lagu, Bharat; Kluge, Arthur F; Goddeeris, Matthew M; Tozzo, Effie; Fredenburg, Ross A; Chellur, Shekar; Senaiar, Ramesh S; Jaleel, Mahaboobi; Babu, D Ravi Krishna; Tiwari, Nirbhay K; Takahashi, Taisuke; Patane, Michael A

2017-11-04

Compound 1 regulates significantly fewer genes than the PPARδ modulator, GW501516. Both compounds are efficacious in a thermal injury model of muscle regeneration. The restricted gene profile of 1 relative to GW501516 suggests that 1 may be pharmacoequivalent to GW501516 with fewer PPAR-related safety concerns. Copyright © 2017 Elsevier Ltd. All rights reserved.

Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update.

PubMed

Naeem, Farooq; Gire, Nadeem; Xiang, Shuo; Yang, Megan; Syed, Yumeen; Shokraneh, Farhad; Adams, Clive; Farooq, Saeed

2016-06-22

Recent years have seen a rapidly increasing trend towards the delivery of health technology through mobile devices. Smartphones and tablet devices are thus becoming increasingly popular for accessing information and a wide range of services, including health care services. Modern mobile apps can be used for a variety of reasons, ranging from education for the patients and assistance to clinicians to delivery of interventions. Mobile phone apps have also been established to benefit patients in a scope of interventions across numerous medical specialties and treatment modalities. Medical apps have their advantages and disadvantages. It is important that clinicians have access to knowledge to make decisions regarding the use of medical apps on the basis of risk-benefit ratio. Mobile apps that deliver psycho social interventions offer unique challenges and opportunities. A number of reviews have highlighted the potential use of such apps. There is a need to describe, report and study their side effects too. The adverse effects associated with these apps can broadly be divided into: (1) those resulting from the security and safety concerns; (2) those arising from the use of a particular psycho social intervention; and (3) those due to the interaction with digital technology. There is a need to refine and reconsider the safety and adverse effects in this area. The safety profile of a mobile PSI app should describe its safety profile in: (1) privacy and security; (2) adverse effects of psychotherapy; and (3) adverse effects unique to the use of apps and the internet. This is, however, a very new area and further research and reporting is required to inform clinical decision making.

Confirmatory Factor Analysis of the Elementary School Success Profile for Teachers

ERIC Educational Resources Information Center

Webber, Kristina C.; Rizo, Cynthia F.; Bowen, Natasha K.

2012-01-01

Objectives: This study examines the factor structure and scale quality of data collected with the online Elementary School Success Profile (ESSP) for Teachers from a sample of teachers of 1,145 third through fifth graders. Methods: Confirmatory factor analysis (CFA) using Mplus and weighted least squares means and variances adjusted (WLSMV)…

Factors impacting perceived safety among staff working on mental health wards

PubMed Central

Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

2017-01-01

Background Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. Aims This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. Method A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Results Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. Conclusions The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license. PMID:28904814

Factors impacting perceived safety among staff working on mental health wards.

PubMed

Haines, Alina; Brown, Andrew; McCabe, Rhiannah; Rogerson, Michelle; Whittington, Richard

2017-09-01

Safety at work is a core issue for mental health staff working on in-patient units. At present, there is a limited theoretical base regarding which factors may affect staff perceptions of safety. This study attempted to identify which factors affect perceived staff safety working on in-patient mental health wards. A cross-sectional design was employed across 101 forensic and non-forensic mental health wards, over seven National Health Service trusts nationally. Measures included an online staff survey, Ward Features Checklist and recorded incident data. Data were analysed using categorical principal components analysis and ordinal regression. Perceptions of staff safety were increased by ward brightness, higher number of patient beds, lower staff to patient ratios, less dayroom space and more urban views. The findings from this study do not represent common-sense assumptions. Results are discussed in the context of the literature and may have implications for current initiatives aimed at managing in-patient violence and aggression. None. © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) license.

Factors Implicated in Safety-related Firefighter Fatalities.

PubMed

Kahn, Steven A; Palmieri, Tina L; Sen, Soman; Woods, Jason; Gunter, Oliver L

Firefighting is wrought with risk, as 80-100 firefighters (FFs) die on the job each year in the United States. Many of the fatalities have been analyzed by the National Institute for Occupational Safety and Health (NIOSH) to determine contributing factors. The purpose of this study is to determine variables that put FFs at risk for potentially preventable workplace mortality such as use of personal protective equipment (PPE), seat belts, and appropriate training/fitness/clearance for duty. The NIOSH FF Fatality Database reports from 2009 to 2014 were analyzed. Data including age, gender, years on the job, weather, other calls on the same shift, and department type were compared between FFs who employed PPE, seat belts, or wellness/fitness and those who did not. A second group of FFs was determined by NIOSH to have inexperience, lack of training, or inappropriate clearance for duty implicated in their fatalities. Comparisons for the second group were between those whose department used training and safety-related standard operating protocols and those who did not. In 84/176 deaths, PPE/seat belts/fitness was implicated in the fatality. Lack of PPE was more likely on clear days (P = .03) but less likely on cloudy and windy days (P < .001). These FFs dying with lack of PPE had more time on the job in a single department, 18 vs 13 years (P = .03), and more time in a volunteer department, 17 vs 8 years (P < .01). Being deployed on another call during the same shift was associated with lack of PPE-34 vs 16% of those who had not been on another call (P = .005). Lack of training, experience, or medical clearance was implicated in fatalities for 100/176 FFs. FFs who worked in departments that lacked standard operating protocols for respirator fit testing, PPE, fitness testing, rapid intervention, medical clearance, safety/distress alarms, vehicle maintenance, or incident command were statistically more likely to have lack of experience/training/clearance implicated in the

Community violence, protective factors, and adolescent mental health: a profile analysis.

PubMed

Copeland-Linder, Nikeea; Lambert, Sharon F; Ialongo, Nicholas S

2010-01-01

This study examined interrelationships among community violence exposure, protective factors, and mental health in a sample of urban, predominantly African American adolescents (N = 504). Latent Profile Analysis was conducted to identify profiles of adolescents based on a combination of community violence exposure, self-worth, parental monitoring, and parental involvement and to examine whether these profiles differentially predict adolescents' depressive symptoms and aggressive behavior. Three classes were identified-a vulnerable class, a moderate risk/medium protection class, and a moderate risk/high protection class. The classes differentially predicted depressive symptoms but not aggressive behavior for boys and girls. The class with the highest community violence exposure also had the lowest self-worth.

Identifying at-risk profiles and protective factors for problem gambling: A longitudinal study across adolescence and early adulthood.

PubMed

Allami, Youssef; Vitaro, Frank; Brendgen, Mara; Carbonneau, René; Tremblay, Richard E

2018-05-01

Past studies have identified various risk and protective factors for problem gambling (PG). However, no study has examined the interplay between these factors using a combination of person-centered and variable-centered approaches embedded within a longitudinal design. The present study aimed to (a) identify distinct profiles in early adolescence based on a set of risk factors commonly associated with PG (impulsivity, depression, anxiety, drug-alcohol use, aggressiveness, and antisociality), (b) explore the difference in reported gambling problems between these profiles during midadolescence and early adulthood, and (c) identify family- and peer-related variables that could operate as protective or compensatory factors in this context. Two samples were used: (a) a population sample (N = 1,033) living in low socioeconomic-status neighborhoods and (b) a population sample (N = 3,017) representative of students attending Quebec schools. Latent profile analyses were conducted to identify at-risk profiles based on individual risk factors measured at age 12 years. Negative binomial regression models were estimated to compare profiles in terms of their reported gambling problems at ages 16 and 23. Finally, family- and peer-related variables measured at age 14 were included to test their protective or compensatory role with respect to the link between at-risk profiles and gambling problems. Four profiles were identified: well-adjusted, internalizing, externalizing, and comorbid. Compared to the well-adjusted profile, the externalizing and comorbid profiles reported more gambling problems at ages 16 and 23, but the internalizing profile did not differ significantly. Various protective and compensatory factors emerged for each profile at both time points. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The effects of the non-contingent presentation of safety signals on the elimination of safety behaviors: An experimental comparison between individuals with low and high obsessive-compulsive profiles.

PubMed

Angelakis, Ioannis; Austin, Jennifer L

2018-06-01

Safety behaviors, defined as engagement in avoidance within safe environments, are a key symptom of obsessive-compulsive and related disorders. They may interfere with daily functioning and as such their emission should be reduced. The purpose of the current study is to investigate the effects of the non-contingent presentation of safety signals (cues produced by safety behaviors) on reducing safety behaviors in participants self-reporting low and high OCD profiles. In total, 32 participants were asked to play a game to gain points and avoid their loss. After having developed avoidance behavior, evidenced by maintaining all of their earned points, they were exposed to safe environments where no point loss was programmed. In Test 1, safety cues (blue bar) were produced contingent on performing safety behaviors. In Test 2, safety cues were presented continuously without any response requirement. Findings demonstrated that high OCD group displayed higher rates of safety behaviors than low OCD group. However, exposure to the non-contingent presentation of safety signals eliminated their emission in both groups. Future studies need to evaluate the effects of different non-contingent schedules on the suppression of safety behaviors. These findings contribute to the literature by demonstrating that non-contingent introduction of safety signals eliminated safety behaviors completely, even in high OCD participants, who performed safety behavior at higher rates. Such a treatment protocol may ameliorate exposure therapy in which response prevention constitutes a key element and is generally associated with increased drop-out rates. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Epidermal growth factor, innovation and safety].

PubMed

Esquirol Caussa, Jordi; Herrero Vila, Elisabeth

2015-10-05

Bioidentical recombinant human epidermal growth factor (rhEGF) is available in concentrations and purity suitable for therapeutic use in long time stable formulations. Beneficial effects in several skin pathologies and lesions have been reported (traumatic and surgical wound healing, laser induced wounds, abnormal scars, keloids, radiation or chemotherapy induced dermatitis, post inflammatory hyperpigmentation or for skin aging damage repairing) and also may be considered for the treatment of several oropharingeal and high gastroesophageal tract mucosa diseases (mouth sores, pharyngeal fistulas, ulcers), and several corneal or conjunctive mucosa lesions. rhEGF has not shown any important side or collateral effects in humans or in laboratory experimentation animals, showing optimal tolerability and safety with continuous use for months. Compounding gives advantages of versatility, individualization, personalization, molecular stability, safety and effectiveness in ideal conditions, showing good tissue penetration, both on intact skin and skin lesions that expose the lower planes to the surface. rhEGF compounds can be considered for prevention or as a treatment of diverse skin and mucosa diseases and conditions through compounding preparations. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia.

PubMed

Nasrallah, Henry A; Newcomer, John W; Risinger, Robert; Du, Yangchun; Zummo, Jacqueline; Bose, Anjana; Stankovic, Srdjan; Silverman, Bernard L; Ehrich, Elliot W

2016-11-01

Aripiprazole lauroxil, a long-acting injectable antipsychotic, demonstrated safety and efficacy in treating symptoms of schizophrenia in a double-blind, placebo-controlled trial. Because the metabolic profile of antipsychotics is an important safety feature, the effects of aripiprazole lauroxil on body weight, endocrine and metabolic profiles, and safety were examined in a secondary analysis. Patients with schizophrenia (DSM-IV-TR criteria) were randomly assigned to aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, or placebo intramuscularly once monthly between December 2011 and March 2014. Changes in body weight, body mass index, fasting blood glucose and serum lipids, glycosylated hemoglobin (HbA1c), and prolactin over 12 weeks were assessed. The incidence of treatment-emergent adverse events (AEs) was evaluated. Among 622 randomized patients, no clinically relevant changes from baseline to week 12 were observed for any serum lipid, lipoprotein, plasma glucose, or HbA1c value with placebo or either dose of aripiprazole lauroxil. Both doses of aripiprazole lauroxil were associated with reductions in mean prolactin levels, whereas placebo treatment was not. The mean (standard deviation) change from baseline for body weight was 0.74 (3.9) kg, 0.86 (3.7) kg, and 0.01 (3.6) kg for aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. AEs related to metabolic parameters were reported in 2.4%, 1.4%, and 2.4% of patients in the aripiprazole lauroxil 441 mg, aripiprazole lauroxil 882 mg, and placebo groups, respectively. Aripiprazole lauroxil was well tolerated, with a low-risk metabolic profile relative to published data for other antipsychotics. Changes similar to those observed with placebo were observed in the aripiprazole lauroxil groups for metabolic parameters, with modest weight gain in the active treatment groups over the 12-week course. ClinicalTrials.gov identifier: NCT01469039. © Copyright 2016 Physicians

Mechanics-Based Definition of Safety Factors Against Flow Failure in Unsaturated Shallow Slopes

NASA Astrophysics Data System (ADS)

Buscarnera, G.; Lizarraga-Barrera, J.

2014-12-01

Physical models for landslide forecasting rely on the combination of hydrologic models for water infiltration and stability criteria based on infinite slope mechanics. Such concepts can be used to derive safety factors for shallow landsliding, in which the mobilization of the soil cover is associated with the attainment of critical values of pore water pressures expressed as a function of the frictional strength. While such models capture the role of important geomorphic features and geotechnical properties, their performance depends on the validity of the postulate of frictional failure. As a result, the safety factors do not to consider a broader range of solid-fluid interactions promoting different slope failure mechanisms, such as flow slides. This work combines principles of soil stability, unsaturated soil mechanics and plasticity theory to derive an alternative set of safety factors. While frictional slips are included in the study as a particular case, the proposed analytical methodology can also be applied to cases in which an increase in degree of saturation promotes liquefaction instabilities, i.e. possible transitions from solid- to fluid-like response. The study shows that the incorporation of principles of unsaturated soil mechanics into slope stability analyses generates suction-dependent coefficients that alter the value of the safety factors. As a result, while the proposed approach can still be combined with standard hydrologic models simulating the evolution of pore pressures in the near-surface, it can also provide a spatially distributed assessment of evolving safety conditions in landscapes susceptible to landslides of the flow type.

Determination of Slope Safety Factor with Analytical Solution and Searching Critical Slip Surface with Genetic-Traversal Random Method

PubMed Central

2014-01-01

In the current practice, to determine the safety factor of a slope with two-dimensional circular potential failure surface, one of the searching methods for the critical slip surface is Genetic Algorithm (GA), while the method to calculate the slope safety factor is Fellenius' slices method. However GA needs to be validated with more numeric tests, while Fellenius' slices method is just an approximate method like finite element method. This paper proposed a new method to determine the minimum slope safety factor which is the determination of slope safety factor with analytical solution and searching critical slip surface with Genetic-Traversal Random Method. The analytical solution is more accurate than Fellenius' slices method. The Genetic-Traversal Random Method uses random pick to utilize mutation. A computer automatic search program is developed for the Genetic-Traversal Random Method. After comparison with other methods like slope/w software, results indicate that the Genetic-Traversal Random Search Method can give very low safety factor which is about half of the other methods. However the obtained minimum safety factor with Genetic-Traversal Random Search Method is very close to the lower bound solutions of slope safety factor given by the Ansys software. PMID:24782679

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice.

PubMed

Oldenburg, J; Goudemand, J; Valentino, L; Richards, M; Luu, H; Kriukov, A; Gajek, H; Spotts, G; Ewenstein, B

2010-11-01

  Postauthorization safety surveillance of factor VIII (FVIII) concentrates is essential for assessing rare adverse event incidence. We determined safety and efficacy of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method, (rAHF-PFM)] during routine clinical practice. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Among 408 evaluable subjects, 386 (95%) received excellent/good efficacy ratings for all on-demand assessments; the corresponding number for subjects with previous FVIII inhibitors was 36/41 (88%). Among 276 evaluable subjects receiving prophylaxis continuously in the study, 255 (92%) had excellent/good ratings for all prophylactic assessments; the corresponding number for subjects with previous FVIII inhibitors was 41/46 (89%). Efficacy of surgical prophylaxis was excellent/good in 16/16 evaluable procedures. Among previously treated patients (PTPs) with >50 exposure days (EDs) and FVIII≤2%, three (0.75%) developed low-titre inhibitors. Two of these subjects had a positive inhibitor history; thus, the incidence of de novo inhibitor formation in PTPs with FVIII≤2% and no inhibitor history was 1/348 (0.29%; 95% CI, 0.01-1.59%). A PTP with moderate haemophilia developed a low-titre inhibitor. High-titre inhibitors were reported in a PTP with mild disease (following surgery), a previously untreated patient (PUP) with moderate disease (following surgery) and a PUP with severe disease. The favourable benefit/risk profile of rAHF-PFM previously documented in prospective clinical trials has been extended to include a broader range of haemophilia patients, many of whom would have been ineligible for registration studies. © 2010 Blackwell Publishing Ltd.

Motor carrier safety performance profile.

DOT National Transportation Integrated Search

2004-02-01

This report provides a summary of the safety performance of carriers across all the individual segments in the industry. It includes summaries for both for-hire and private carriers in each segment and is drawn from measures that are collected as par...

[Human factors and crisis resource management: improving patient safety].

PubMed

Rall, M; Oberfrank, S

2013-10-01

A continuing high number of patients suffer harm from medical treatment. In 60-70% of the cases the sources of harm can be attributed to the field of human factors (HFs) and teamwork; nevertheless, those topics are still neither part of medical education nor of basic and advanced training even though it has been known for many years and it has meanwhile also been demonstrated for surgical specialties that training in human factors and teamwork considerably reduces surgical mortality.Besides the medical field, the concept of crisis resource management (CRM) has already proven its worth in many other industries by improving teamwork and reducing errors in the domain of human factors. One of the best ways to learn about CRM and HFs is realistic simulation team training with well-trained instructors in CRM and HF. The educational concept of the HOTT (hand over team training) courses for trauma room training offered by the DGU integrates these elements based on the current state of science. It is time to establish such training for all medical teams in emergency medicine and operative care. Accompanying safety measures, such as the development of a positive culture of safety in every department and the use of effective critical incident reporting systems (CIRs) should be pursued.

The incidence and factors associated with child safety seat misuse

DOT National Transportation Integrated Search

1984-12-01

This report presents the findings for a study on the misuse of child safety seats. Data were collected in 10 cities across the country at Hardee's Restaurants. Data collection involved observation of seat use and determination of factors associated w...

Genetic variation in aryl N-acetyltransferase results in significant differences in the pharmacokinetic and safety profiles of amifampridine (3,4-diaminopyridine) phosphate.

PubMed

Haroldsen, Peter E; Garovoy, Marvin R; Musson, Donald G; Zhou, Huiyu; Tsuruda, Laurie; Hanson, Boyd; O'Neill, Charles A

2015-02-01

The clinical use of amifampridine phosphate for neuromuscular junction disorders is increasing. The metabolism of amifampridine occurs via polymorphic aryl N-acetyltransferase (NAT), yet its pharmacokinetic (PK) and safety profiles, as influenced by this enzyme system, have not been investigated. The objective of this study was to assess the effect of NAT phenotype and genotype on the PK and safety profiles of amifampridine in healthy volunteers (N = 26). A caffeine challenge test and NAT2 genotyping were used to delineate subjects into slow and fast acetylators for PK and tolerability assessment of single, escalating doses of amifampridine (up to 30 mg) and in multiple daily doses (20 mg QID) of amifampridine. The results showed that fast acetylator phenotypes displayed significantly lower C max, AUC, and shorter t 1/2 for amifampridine than slow acetylators. Plasma concentrations of the N-acetyl metabolite were approximately twofold higher in fast acetylators. Gender differences were not observed. Single doses of amifampridine demonstrated dose linear PKs. Amifampridine achieved steady state plasma levels within 1 day of dosing four times daily. No accumulation or time-dependent changes in amifampridine PK parameters occurred. Overall, slow acetylators reported 73 drug-related treatment-emergent adverse events versus 6 in fast acetylators. Variations in polymorphic NAT corresponding with fast and slow acetylator phenotypes significantly affects the PK and safety profiles of amifampridine.

21 CFR 70.40 - Safety factors to be considered.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... of a color additive will be safe: Except where evidence is submitted which justifies use of a...

21 CFR 70.40 - Safety factors to be considered.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... of a color additive will be safe: Except where evidence is submitted which justifies use of a...

21 CFR 70.40 - Safety factors to be considered.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... of a color additive will be safe: Except where evidence is submitted which justifies use of a...

21 CFR 70.40 - Safety factors to be considered.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... of a color additive will be safe: Except where evidence is submitted which justifies use of a...

21 CFR 70.40 - Safety factors to be considered.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Safety factors to be considered. 70.40 Section 70.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... of a color additive will be safe: Except where evidence is submitted which justifies use of a...

Integration Profile and Safety of an Adenovirus Hybrid-Vector Utilizing Hyperactive Sleeping Beauty Transposase for Somatic Integration

PubMed Central

Zhang, Wenli; Muck-Hausl, Martin; Wang, Jichang; Sun, Chuanbo; Gebbing, Maren; Miskey, Csaba; Ivics, Zoltan; Izsvak, Zsuzsanna; Ehrhardt, Anja

2013-01-01

We recently developed adenovirus/transposase hybrid-vectors utilizing the previously described hyperactive Sleeping Beauty (SB) transposase HSB5 for somatic integration and we could show stabilized transgene expression in mice and a canine model for hemophilia B. However, the safety profile of these hybrid-vectors with respect to vector dose and genotoxicity remains to be investigated. Herein, we evaluated this hybrid-vector system in C57Bl/6 mice with escalating vector dose settings. We found that in all mice which received the hyperactive SB transposase, transgene expression levels were stabilized in a dose-dependent manner and that the highest vector dose was accompanied by fatalities in mice. To analyze potential genotoxic side-effects due to somatic integration into host chromosomes, we performed a genome-wide integration site analysis using linker-mediated PCR (LM-PCR) and linear amplification-mediated PCR (LAM-PCR). Analysis of genomic DNA samples obtained from HSB5 treated female and male mice revealed a total of 1327 unique transposition events. Overall the chromosomal distribution pattern was close-to-random and we observed a random integration profile with respect to integration into gene and non-gene areas. Notably, when using the LM-PCR protocol, 27 extra-chromosomal integration events were identified, most likely caused by transposon excision and subsequent transposition into the delivered adenoviral vector genome. In total, this study provides a careful evaluation of the safety profile of adenovirus/Sleeping Beauty transposase hybrid-vectors. The obtained information will be useful when designing future preclinical studies utilizing hybrid-vectors in small and large animal models. PMID:24124483

Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer.

PubMed

Lousberg, Laurence; Jerusalem, Guy

2016-01-01

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus-exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile.

Safety, Efficacy, and Patient Acceptability of Everolimus in the Treatment of Breast Cancer

PubMed Central

Lousberg, Laurence; Jerusalem, Guy

2016-01-01

Everolimus combined with exemestane is an important treatment option for patients suffering from estrogen receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer (ABC) who have been previously treated with a nonsteroidal aromatase inhibitor (NSAI). After presentation of phase III registration trial BOLERO-2, several phase IIIb trials have been started to evaluate this regimen in a more real-world setting. Here, we review the efficacy and safety data published or presented at selected international meetings. These studies confirmed the outcome observed in the BOLERO-2 trial. Patient acceptance rate is also discussed by focusing on the permanent everolimus discontinuation rate in these trials. Factors influencing the safety profile are also reported, including the impact of age. The optimal sequence of combined therapy approaches associating targeted and endocrine therapy (ET) has yet to be determined as new treatment options such as cyclin-dependent kinase inhibitors become available. However, everolimus–exemestane remains an important treatment option with a major impact on progression-free survival (PFS) and an acceptable safety profile. PMID:28096680

Safety profile and protocol prevention of adverse reactions to uroangiographic contrast media in diagnostic imaging.

PubMed

Rossi, C; Reginelli, A; D'Amora, M; Di Grezia, G; Mandato, Y; D'Andrea, A; Brunese, L; Grassi, R; Rotondi, A

2014-01-01

The purpose of the study is to examine the incidence of adverse reactions caused by non-ionic contrast media in selected patients after desensitization treatment and to evaluate the safety profile of organ iodine contrast media (i.c.m.) in a multistep prevention protocol. In a population of 2000 patients that had received a CT scan, 100 patients with moderate/high risk for adverse reactions against iodinated contrast agents followed a premedication protocol and all adverse reactions are reported and classified as mild, moderate or severe. 1.7 percent of the pre-treated patients reported a mild, immediate type reaction to iodine contrast; of these five patients with allergy 0.71 percent had received iomeprol, 0.35 percent received ioversol and 0.71 percent received iopromide. The incidence of adverse reactions was reported to be higher (4 out of 5 patients) among those that referred a history of hypersensitivity against iodinated i.c.m. Although intravenous contrast materials have greatly improved, especially in terms of their safety profile, they should not be administered if there isn't a clear or justified indication. In conclusion, even if we know that the majority of these reactions are idiosyncratic and unpredictable we propose, with the aim of improving our knowledge on this subject, a multicenter study, based on skin allergy tests (prick test, patch test, intradermal reaction) in selected patients that have had previous experiences of hypersensitivity against parenteral organ iodine contrast media.

The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY).

PubMed

Rinderknecht, Stephen; Bryant, Kristina; Nolan, Terry; Pavia-Ruz, Noris; Doniz, Carlos Aranza; Weber, Miguel Angel Rodriguez; Cohen, Christopher; Aris, Emmanuel; Mesaros, Narcisa; Miller, Jacqueline M

2012-03-01

The safety profile of HibMenCY was compared with licensed Hib conjugate vaccines in a pooled analysis that included more than 8,500 subjects who were administered a four-dose series of HibMenCY or commercially available Hib vaccines at 2, 4, 6 and 12-15 mo of age in two primary vaccination and two fourth dose phase 3 studies. In all studies, HibMenCY or Hib vaccine was co-administered with age-appropriate, routinely recommended vaccines. In one primary and one fourth dose study (n = 4180), local and general symptoms were solicited using diary cards for 4 d after each dose. Serious adverse events (SAEs) and the occurrence of adverse events (AEs) indicating new onset of chronic disease (NOCD), rash, and conditions prompting Emergency Room (ER) visits were reported from dose 1 until 6 mo after dose 4. The incidences of solicited local and general symptoms were similar following HibMenCY and commercially available Hib vaccines. For some solicited symptoms (pain at the injection site and irritability), rates were lower in the HibMenCY group compared with the Hib control group (p value < 0.05). There were no statistically significant differences between groups in the incidences of SAEs, NOCDs, rash, or AEs leading to ER visits, with the exceptions of anemia and viral gastroenteritis, which occurred significantly less frequently in those receiving HibMenCY than those receiving commercially available Hib vaccines. In this pooled safety analysis, the safety profile of HibMenCY was similar to the safety profile of licensed monovalent Hib vaccines, despite the addition of meningococcal antigens. These studies are registered at www.clinicaltrials.gov NCT00345579 (primary vaccination study), NCT00345683 (fourth dose vaccination study) and NCT00289783 (primary and fourth dose vaccination studies).

Comparison on the Effects and Safety of Tualang Honey and Tribestan in Sperm Parameters, Erectile Function, and Hormonal Profiles among Oligospermic Males

PubMed Central

Ismail, Shaiful Bahari; Bakar, Mohd. Bustamanizan; Nik Hussain, Nik Hazlina; Sulaiman, Siti Amrah; Jaafar, Hasnan; Draman, Samsul; Ramli, Roszaman; Wan Yusoff, Wan Zahanim

2014-01-01

Introduction. This study aims to evaluate the effectiveness of Tualang honey on sperm parameters, erectile function, and hormonal and safety profiles. Methodology. A randomized control trial was done using Tualang honey (20 grams) and Tribestan (750 mg) over a period of 12 weeks. Sperm parameters including sperm concentration, motility, and morphology were analyzed and erectile function was assessed using IIEF-5 questionnaire. Hormonal profiles of testosterone, FSH, and LH were studied. The volunteers were randomized into two groups and the outcomes were analyzed using SPSS version 18. Results. A total of 66 participants were involved. A significant increment of mean sperm concentration (P < 0.001), motility (P = 0.015) and morphology (P = 0.008) was seen in Tualang honey group. In Tribestan group, a significant increment of mean sperm concentration (P = 0.007), and morphology (P = 0.009) was seen. No significant differences of sperm concentration, motility, and morphology were seen between Tualang honey and Tribestan group and similar results were also seen in erectile function and hormonal profile. All safety profiles were normal and no adverse event was reported. Conclusion. Tualang honey effect among oligospermic males was comparable with Tribestan in improving sperm concentration, motility, and morphology. The usage of Tualang honey was also safe with no reported adverse event. PMID:25505918

Efficacy, safety and pharmacokinetics of a new high-purity factor X concentrate in women and girls with hereditary factor X deficiency.

PubMed

Kulkarni, R; James, A H; Norton, M; Shapiro, A

2018-05-01

Essentials Plasma-derived factor X concentrate (pdFX) is used to treat hereditary factor X deficiency. pdFX pharmacokinetics, safety and efficacy were assessed in factor X-deficient women/girls. Treatment success rate was 98%; only 6 adverse events in 2 subjects were possibly pdFX related. On-demand pdFX 25 IU kg -1 was effective and safe in women/girls with factor X deficiency. Background A high-purity, plasma-derived factor X concentrate (pdFX) has been approved for the treatment of hereditary FX deficiency, an autosomal recessive disorder. Objective To perform post hoc assessments of pdFX pharmacokinetics, safety and efficacy in women and girls with hereditary FX deficiency. Patients/Methods Subjects aged ≥ 12 years with moderate/severe FX deficiency (plasma FX activity of < 5 IU dL -1 ) received on-demand or preventive pdFX (25 IU kg -1 ) for ≤ 2 years. Results Of 16 enrolled subjects, 10 women and girls (aged 14-58 years [median, 25.5 years]) received 267 pdFX infusions. Mean monthly infusions per subject were higher among women and girls (2.48) than among men and boys (1.62). In women and girls, 132 assessable bleeding episodes (61 heavy menstrual bleeds, 47 joint bleeds, 15 muscle bleeds, and nine other bleeds) were treated with pdFX, with a 98% treatment success rate versus 100% in men and boys. Mean pdFX incremental recovery was similar in the two groups (2.05 IU dL -1 versus 1.91 IU dL -1 per IU kg -1 ), as was the mean half-life (29.3 h versus 29.5 h). Of 142 adverse events in women and girls, headache was the most common (12 events in six subjects). Six events (two infusion-site erythema, two fatigue, one back pain, one infusion-site pain) in two subjects were considered to be possibly pdFX-related. Following the trial, pdFX was used to successfully maintain hemostasis in two subjects undergoing obstetric delivery. Conclusions pdFX was well tolerated and effective in women and girls with FX deficiency. Although women and girls had different bleeding

Exploring the possibility of a common structural model measuring associations between safety climate factors and safety behaviour in health care and the petroleum sectors.

PubMed

Olsen, Espen

2010-09-01

The aim of the present study was to explore the possibility of identifying general safety climate concepts in health care and petroleum sectors, as well as develop and test the possibility of a common cross-industrial structural model. Self-completion questionnaire surveys were administered in two organisations and sectors: (1) a large regional hospital in Norway that offers a wide range of hospital services, and (2) a large petroleum company that produces oil and gas worldwide. In total, 1919 and 1806 questionnaires were returned from the hospital and petroleum organisation, with response rates of 55 percent and 52 percent, respectively. Using a split sample procedure principal factor analysis and confirmatory factor analysis revealed six identical cross-industrial measurement concepts in independent samples-five measures of safety climate and one of safety behaviour. The factors' psychometric properties were explored with satisfactory internal consistency and concept validity. Thus, a common cross-industrial structural model was developed and tested using structural equation modelling (SEM). SEM revealed that a cross-industrial structural model could be identified among health care workers and offshore workers in the North Sea. The most significant contributing variables in the model testing stemmed from organisational management support for safety and supervisor/manager expectations and actions promoting safety. These variables indirectly enhanced safety behaviour (stop working in dangerous situations) through transitions and teamwork across units, and teamwork within units as well as learning, feedback, and improvement. Two new safety climate instruments were validated as part of the study: (1) Short Safety Climate Survey (SSCS) and (2) Hospital Survey on Patient Safety Culture-short (HSOPSC-short). Based on development of measurements and structural model assessment, this study supports the possibility of a common safety climate structural model across health

Evolutionary profiles from the QR factorization of multiple sequence alignments

PubMed Central

Sethi, Anurag; O'Donoghue, Patrick; Luthey-Schulten, Zaida

2005-01-01

We present an algorithm to generate complete evolutionary profiles that represent the topology of the molecular phylogenetic tree of the homologous group. The method, based on the multidimensional QR factorization of numerically encoded multiple sequence alignments, removes redundancy from the alignments and orders the protein sequences by increasing linear dependence, resulting in the identification of a minimal basis set of sequences that spans the evolutionary space of the homologous group of proteins. We observe a general trend that these smaller, more evolutionarily balanced profiles have comparable and, in many cases, better performance in database searches than conventional profiles containing hundreds of sequences, constructed in an iterative and computationally intensive procedure. For more diverse families or superfamilies, with sequence identity <30%, structural alignments, based purely on the geometry of the protein structures, provide better alignments than pure sequence-based methods. Merging the structure and sequence information allows the construction of accurate profiles for distantly related groups. These structure-based profiles outperformed other sequence-based methods for finding distant homologs and were used to identify a putative class II cysteinyl-tRNA synthetase (CysRS) in several archaea that eluded previous annotation studies. Phylogenetic analysis showed the putative class II CysRSs to be a monophyletic group and homology modeling revealed a constellation of active site residues similar to that in the known class I CysRS. PMID:15741270

Safety Profile of the Newest Antiepileptic Drugs: A Curated Literature Review.

PubMed

Palleria, Caterina; Cozza, Giuseppe; Khengar, Rajeshree; Libri, Vincenzo; De Sarro, Giovambattista

2017-01-01

Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice. However, the main cause of treatment failure is still poor patient compliance due to the occurrence of adverse drug reactions (ADRs) that lead to treatment withdrawal in about 25% of cases before achieving maximal efficacy, and is associated with increasing health care costs. In this Review, we conducted an online database search using Medline, PubMed, Embase, and the Cochrane Online Library to review the available studies highlighting the clinical relevance of side effects, pharmacological interactions, safety and tolerability of the newest AEDs: Brivaracetam (BRV), Cannabidiol (CBD), Eslicarbazepine acetate (ESL), Lacosamide (LCM), and Perampanel (PER). The principal benefit of the newest AEDs, in addition to reduced frequency and seizure severity, is the low number and severity of ADRs reported compared to more historic drugs. Early detection of ADRs could lead to an improvement in patients' quality of life, therefore it is important to monitor ADRs and to adequately perform post marketing surveillance in the clinical practice setting. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Work-related injury factors and safety climate perception in truck drivers.

PubMed

Anderson, Naomi J; Smith, Caroline K; Byrd, Jesse L

2017-08-01

The trucking industry has a high burden of work-related injuries. This study examined factors, such as safety climate perceptions, that may impact injury risk. A random sample of 9800 commercial driver's license holders (CDL) were sent surveys, only 4360 were eligible truck drivers. Descriptive statistics and logistic regression models were developed to describe the population and identify variables associated with work-related injury. 2189 drivers completed the pertinent interview questions. Driving less-than-truckload, daytime sleepiness, pressure to work faster, and having a poor composite score for safety perceptions were all associated with increased likelihood of work-related injury. Positive safety perception score was protective for odds of work-related injury, and increased claim filing when injured. Positive psychological safety climate is associated with decreased likelihood of work-related injury and increased likelihood that a driver injured on the job files a workers' compensation claim. © 2017 Wiley Periodicals, Inc.

Factors predicting change in hospital safety climate and capability in a multi-site patient safety collaborative: a longitudinal survey study.

PubMed

Benn, Jonathan; Burnett, Susan; Parand, Anam; Pinto, Anna; Vincent, Charles

2012-07-01

The study had two specific objectives: (1) To analyse change in a survey measure of organisational patient safety climate and capability (SCC) resulting from participation in the UK Safer Patients Initiative and (2) To investigate the role of a range of programme and contextual factors in predicting change in SCC scores. Single group longitudinal design with repeated measurement at 12-month follow-up. Multiple service areas within NHS hospital sites across England, Wales, Scotland and Northern Ireland. Stratified sample of 284 respondents representing programme teams at 19 hospital sites. A complex intervention comprising a multi-component quality improvement collaborative focused upon patient safety and designed to impact upon hospital leadership, communication, organisation and safety climate. A survey including a 31-item SCC scale was administered at two time-points. Modest but significant positive movement in SCC score was observed between the study time-points. Individual programme responsibility, availability of early adopters, multi-professional collaboration and extent of process measurement were significant predictors of change in SCC. Hospital type and size, along with a range of programme preconditions, were not found to be significant. A range of social, cultural and organisational factors may be sensitive to this type of intervention but the measurable effect is small. Supporting critical local programme implementation factors may be an effective strategy in achieving development in organisational patient SCC, regardless of contextual factors and organisational preconditions.

Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

PubMed

Würtzen, G

1993-01-01

The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

Quantifying Vermont transportation safety factors.

DOT National Transportation Integrated Search

2010-01-01

VTrans and its partners have selected traffic safety : priority areas in their Strategic Highway Safety Plan. : In this project, researchers focus on three of these : prioritized critical emphasis areas: 1) Keeping vehicles : on the roadway, 2) Young...

The influence of organizational factors on patient safety: Examining successful handoffs in health care.

PubMed

Richter, Jason P; McAlearney, Ann Scheck; Pennell, Michael L

2016-01-01

Although patient handoffs have been extensively studied, they continue to be problematic. Studies have shown poor handoffs are associated with increased costs, morbidity, and mortality. No prior research compared perceptions of management and clinical staff regarding handoffs. Our aims were (a) to determine whether perceptions of organizational factors that can influence patient safety are positively associated with perceptions of successful patient handoffs, (b) to identify organizational factors that have the greatest influence on perceptions of successful handoffs, and (c) to determine whether associations between perceptions of these factors and successful handoffs differ for management and clinical staff. A total of 515,637 respondents from 1,052 hospitals completed the Hospital Survey on Patient Safety Culture that assessed perceptions about organizational factors that influence patient safety. Using weighted least squares multiple regression, we tested seven organizational factors as predictors of successful handoffs. We fit three separate models using data collected from (a) all staff, (b) management only, and (c) clinical staff only. We found that perceived teamwork across units was the most significant predictor of perceived successful handoffs. Perceptions of staffing and management support for safety were also significantly associated with perceived successful handoffs for both management and clinical staff. For management respondents, perceptions of organizational learning or continuous improvement had a significant positive association with perceived successful handoffs, whereas the association was negative for clinical staff. Perceived communication openness had a significant association only among clinical staff. Hospitals should prioritize teamwork across units and strive to improve communication across the organization in efforts to improve handoffs. In addition, hospitals should ensure sufficient staffing and management support for patient safety

Profile and Risk Factor Analysis of Unintentional Injuries in Children.

PubMed

Bhamkar, Rahul; Seth, Bageshree; Setia, Maninder Singh

2016-10-01

To study the profile and various risk factors associated with unintentional injuries in children. The study is a cross sectional analysis of data collected from 351 children presenting with unintentional injury to a tertiary care hospital in Navi Mumbai, India. Data were collected about variables based on Haddon Phase Factor Matrix - host, environment and agent factors. Proportions for categorical variables across various groups were compared using Chi square test or Fisher's exact test. Logistic regression model was used to evaluate the factors. Falls (36 %) were the most common injuries followed by bites (23 %). Majority of children were school going children (38 %) followed by preschool children (29 %). Forty-seven percent were from lower socioeconomic class. Commonest place of injury was home (48 %) and the commonest time was evening (49 %). Though there was male predominance in injuries, the difference across gender did not vary significantly (p = 0.15). Poisonings were significantly more common in infants and toddlers and in rural population (p < 0.001); kerosene being the commonest agent. Rural population is at more risk of bites compared to urban (p < 0.001); dog bites being the commonest followed by scorpion bites. Foreign bodies were significantly more common in upper and middle socioeconomic class and bites, in lower socioeconomic class (p < 0.005). Injuries from rural area and lower socioeconomic class were more serious, requiring hospitalization; they were also more likely to present late to the hospital (p < 0.05). Profile of injuries varies widely as per the variations in agent, host and environmental factors. Socio-environmental, economic conditions and infancy-toddler age groups are predisposing risk factors for bites and poisoning. Although rural areas and lower socioeconomic class population are more vulnerable to serious types of injuries, they still lack essential basic medical care.

Nonclinical Safety Assessment of Anti-Factor D: Key Strategies and Challenges for the Nonclinical Development of Intravitreal Biologics.

PubMed

Bantseev, Vladimir; Erickson, Rebecca; Leipold, Douglas; Amaya, Caroline; Miller, Paul E; Booler, Helen; Thackaberry, Evan A

The nonclinical toxicology program described here was designed to characterize the safety profile of anti-factor D (AFD; FCFD4514S, lampalizumab) to support intravitreal (ITV) administration in patients with geographic atrophy (GA). The toxicity of AFD was assessed in a single-dose and 6-month repeat-dose study in monkeys at doses up to 10 mg/eye. Toxicity was assessed by clinical ophthalmic examinations, intraocular pressure measurements, ocular photography, electroretinography, fluorescein angiography, optical coherence tomography, and anatomic pathology. Systemic exposure to AFD generally increased with the increase in dose level. The increases in mean maximal concentration and area under the curve values were roughly dose proportional. No accumulation of AFD was observed following 10 doses, and drug exposures were not affected by anti-drug antibodies. AFD was locally and systemically well tolerated in monkeys following ITV doses of up to 10 mg/eye. Ocular effects associated with AFD were limited to transient, reversible, dose-related, aqueous cell responses and injection-related, mild, vitreal cell responses. In the 6-month repeat-dose study, 2 monkeys had a nonspecific immune response to AFD that resulted in severe ocular inflammation, attributed to administration of a heterologous (humanized) protein. The comprehensive toxicology program in monkeys described here was designed to evaluate the safety profile of AFD and to support multiple ITV injections in the clinic. Administration of a heterologous (humanized) protein presents a challenge, and immunogenicity in nonclinical species is not predictive of immunogenicity in humans. Taken together, the results of the nonclinical program described here support the use of AFD in patients with GA.

Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.

PubMed

Monaco, Luca; Biagi, Chiara; Conti, Valentino; Melis, Mauro; Donati, Monia; Venegoni, Mauro; Vaccheri, Alberto; Motola, Domenico

2017-07-01

Direct oral anticoagulants (DOACs) have shown noninferiority to warfarin for stroke prevention in nonvalvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to be addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase. Study based on reports of suspected ADRs held in VigiBase as at December 2014, in which a DOAC or warfarin were administered in patients with nonvalvular AF and listed as suspected/interacting drugs. Medical Dictionary for Regulatory Activities was used to classify ADRs. Reporting odds ratio (ROR) with 95% confidence interval were calculated. Results with P ≤ 0.05 were statistically significant. We retrieved 32 972 reports. We identified 204 ADRs with a ROR >1 (P ≤ 0.05) and we focused on 105 reactions. Positive ROR emerged for DOACs and gastrointestinal haemorrhage compared with warfarin [(1.6 (1.47-1.75)], but no disproportionality with cerebral haemorrhage was found [0.31 (0.28-0.34)]. We identified other potential signals that have not been associated with DOACs previously. As well as premarketing authorization clinical trial studies, we found a reduced risk of intracranial haemorrhage, but an increased risk of gastrointestinal haemorrhage in patients treated with DOACs compared to warfarin. We provide new data and we highlight several differences between the three novel oral anticoagulants, in the rate and type of ADRs occurred. © 2017 The British Pharmacological Society.

Safety of anti-tumor necrosis factor therapy during pregnancy in patients with inflammatory bowel disease.

PubMed

Androulakis, Ioannis; Zavos, Christos; Christopoulos, Panagiotis; Mastorakos, George; Gazouli, Maria

2015-12-21

Treatment of inflammatory bowel disease has significantly improved since the introduction of biological agents, such as infliximab, adalimumab, certolizumab pegol, and golimumab. The Food and Drug Administration has classified these factors in category B, which means that they do not demonstrate a fetal risk. However, during pregnancy fetuses are exposed to high anti-tumor necrosis factor (TNF) levels that are measurable in their plasma after birth. Since antibodies can transfer through the placenta at the end of the second and during the third trimesters, it is important to know the safety profile of these drugs, particularly for the fetus, and whether maintaining relapse of the disease compensates for the potential risks of fetal exposure. The limited data available for the anti-TNF drugs to date have not demonstrated any significant adverse outcomes in the pregnant women who continued their therapy from conception to the first trimester of gestation. However, data suggest that anti-TNFs should be discontinued during the third trimester, as they may affect the immunological system of the newborn baby. Each decision should be individualized, based on the distinct characteristics of the patient and her disease. Considering all the above, there is a need for more clinical studies regarding the effect of anti-TNF therapeutic agents on pregnancy outcomes.

The personality context of relational aggression: A Five-Factor Model profile analysis.

PubMed

Reardon, Kathleen W; Tackett, Jennifer L; Lynam, Don

2018-05-01

Relational aggression (RAgg) is a form of behavior intended to damage the victim's social status or interpersonal relationships through the use of purposeful interpersonal manipulation or social exclusion (Archer & Coyne, 2005). RAgg is impairing, stable, and largely defined by dysfunctional patterns of interpersonal interactions-all of which invokes comparisons to personality and, more specifically, personality pathology. Leveraging research using the Five Factor Model (FFM) in personality disorder (PD) work, the present study aims to understand the personality context of RAgg by applying this FFM profile approach in 2 ways: (a) by compiling a personality profile of RAgg based on a thorough review of the relevant literature and (b) by compiling a personality profile of RAgg based on expert ratings (N = 19). We then compared these profiles to each other and to existing personality profiles of Cluster B PDs to examine how RAgg fits into the personality space represented by Cluster B PDs. These analyses indicate that both FFM profiles of RAgg show substantial overlap with the FFM profile of narcissistic PD. The present study has important implications for bridging disjointed domains of research on personality pathology and RAgg and underscores the relevance of RAgg for early emergence of PD characteristics. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Safety Profile of Stromal Hydration of Clear Corneal Incisions with Cefuroxime in the Mouse Model.

PubMed

Moosajee, Mariya; Tracey-White, Dhani; Harbottle, Richard P; Ferguson, Veronica

2016-09-01

The use of sutureless clear corneal incisions (CCIs) for phacoemulsification is an established surgical technique, but the dynamic morphology of the wound and poor construction can lead to an increased risk of postoperative endophthalmitis. Stromal hydration with balanced salt solution (BSS) can improve the self-sealing status. Intracameral cefuroxime has reduced endophthalmitis rates. This study investigates the safety profile of stromal hydration with cefuroxime, as sequestering antibiotic at the wound may potentially provide added protection against infection. MF-1 mice underwent bilateral CCI, followed by stromal hydration with 5 μL of 10 mg/mL cefuroxime, cefuroxime-texas red conjugate (for detection using confocal microscopy), or BSS. Corneas were harvested from 1 h to 12 weeks postoperatively; gross morphology, histology, and apoptotic cell death levels were investigated to determine the safety profile. Bactericidal activity of cefuroxime was assayed using homogenized whole cornea following stromal hydration at 1 h, 24 h, and day 7 against gram-negative Escherichia coli. Cefuroxime stromal hydration did not alter corneal morphology, with no evidence of corneal scarring or vascularization. Corneal histology and levels of apoptosis were minimal and comparable to the BSS groups up to 12 weeks. Confocal microscopy detected cefuroxime-texas red up to 1 week surrounding the corneal wound. Whole corneal tissue homogenates displayed bactericidal activity up to 24 h postoperatively. Stromal hydration of CCI with cefuroxime is safe in mouse corneas. A reservoir of antibiotic at the wound can potentially act as a barrier of defense against infection following cataract and associated ocular surgery.

Impact of Lead Time and Safety Factor in Mixed Inventory Models with Backorder Discounts

NASA Astrophysics Data System (ADS)

Lo, Ming-Cheng; Chao-Hsien Pan, Jason; Lin, Kai-Cing; Hsu, Jia-Wei

This study investigates the impact of safety factor on the continuous review inventory model involving controllable lead time with mixture of backorder discount and partial lost sales. The objective is to minimize the expected total annual cost with respect to order quantity, backorder price discount, safety factor and lead time. A model with normal demand is also discussed. Numerical examples are presented to illustrate the procedures of the algorithms and the effects of parameters on the result of the proposed models are analyzed.

Genomic and Metabolomic Profile Associated to Clustering of Cardio-Metabolic Risk Factors

PubMed Central

Marrachelli, Vannina G.; Rentero, Pilar; Mansego, María L.; Morales, Jose Manuel; Galan, Inma; Pardo-Tendero, Mercedes; Martinez, Fernando; Martin-Escudero, Juan Carlos; Briongos, Laisa; Chaves, Felipe Javier; Redon, Josep; Monleon, Daniel

2016-01-01

Background To identify metabolomic and genomic markers associated with the presence of clustering of cardiometabolic risk factors (CMRFs) from a general population. Methods and Findings One thousand five hundred and two subjects, Caucasian, > 18 years, representative of the general population, were included. Blood pressure measurement, anthropometric parameters and metabolic markers were measured. Subjects were grouped according the number of CMRFs (Group 1: <2; Group 2: 2; Group 3: 3 or more CMRFs). Using SNPlex, 1251 SNPs potentially associated to clustering of three or more CMRFs were analyzed. Serum metabolomic profile was assessed by 1H NMR spectra using a Brucker Advance DRX 600 spectrometer. From the total population, 1217 (mean age 54±19, 50.6% men) with high genotyping call rate were analysed. A differential metabolomic profile, which included products from mitochondrial metabolism, extra mitochondrial metabolism, branched amino acids and fatty acid signals were observed among the three groups. The comparison of metabolomic patterns between subjects of Groups 1 to 3 for each of the genotypes associated to those subjects with three or more CMRFs revealed two SNPs, the rs174577_AA of FADS2 gene and the rs3803_TT of GATA2 transcription factor gene, with minimal or no statistically significant differences. Subjects with and without three or more CMRFs who shared the same genotype and metabolomic profile differed in the pattern of CMRFS cluster. Subjects of Group 3 and the AA genotype of the rs174577 had a lower prevalence of hypertension compared to the CC and CT genotype. In contrast, subjects of Group 3 and the TT genotype of the rs3803 polymorphism had a lower prevalence of T2DM, although they were predominantly males and had higher values of plasma creatinine. Conclusions The results of the present study add information to the metabolomics profile and to the potential impact of genetic factors on the variants of clustering of cardiometabolic risk factors

Genomic and Metabolomic Profile Associated to Clustering of Cardio-Metabolic Risk Factors.

PubMed

Marrachelli, Vannina G; Rentero, Pilar; Mansego, María L; Morales, Jose Manuel; Galan, Inma; Pardo-Tendero, Mercedes; Martinez, Fernando; Martin-Escudero, Juan Carlos; Briongos, Laisa; Chaves, Felipe Javier; Redon, Josep; Monleon, Daniel

2016-01-01

To identify metabolomic and genomic markers associated with the presence of clustering of cardiometabolic risk factors (CMRFs) from a general population. One thousand five hundred and two subjects, Caucasian, > 18 years, representative of the general population, were included. Blood pressure measurement, anthropometric parameters and metabolic markers were measured. Subjects were grouped according the number of CMRFs (Group 1: <2; Group 2: 2; Group 3: 3 or more CMRFs). Using SNPlex, 1251 SNPs potentially associated to clustering of three or more CMRFs were analyzed. Serum metabolomic profile was assessed by 1H NMR spectra using a Brucker Advance DRX 600 spectrometer. From the total population, 1217 (mean age 54±19, 50.6% men) with high genotyping call rate were analysed. A differential metabolomic profile, which included products from mitochondrial metabolism, extra mitochondrial metabolism, branched amino acids and fatty acid signals were observed among the three groups. The comparison of metabolomic patterns between subjects of Groups 1 to 3 for each of the genotypes associated to those subjects with three or more CMRFs revealed two SNPs, the rs174577_AA of FADS2 gene and the rs3803_TT of GATA2 transcription factor gene, with minimal or no statistically significant differences. Subjects with and without three or more CMRFs who shared the same genotype and metabolomic profile differed in the pattern of CMRFS cluster. Subjects of Group 3 and the AA genotype of the rs174577 had a lower prevalence of hypertension compared to the CC and CT genotype. In contrast, subjects of Group 3 and the TT genotype of the rs3803 polymorphism had a lower prevalence of T2DM, although they were predominantly males and had higher values of plasma creatinine. The results of the present study add information to the metabolomics profile and to the potential impact of genetic factors on the variants of clustering of cardiometabolic risk factors.

Exploratory factor analysis of the Oral Health Impact Profile.

PubMed

John, M T; Reissmann, D R; Feuerstahler, L; Waller, N; Baba, K; Larsson, P; Celebić, A; Szabo, G; Rener-Sitar, K

2014-09-01

Although oral health-related quality of life (OHRQoL) as measured by the Oral Health Impact Profile (OHIP) is thought to be multidimensional, the nature of these dimensions is not known. The aim of this report was to explore the dimensionality of the OHIP using the Dimensions of OHRQoL (DOQ) Project, an international study of general population subjects and prosthodontic patients. Using the project's Learning Sample (n = 5173), we conducted an exploratory factor analysis on the 46 OHIP items not specifically referring to dentures for 5146 subjects with sufficiently complete data. The first eigenvalue (27·0) of the polychoric correlation matrix was more than ten times larger than the second eigenvalue (2·6), suggesting the presence of a dominant, higher-order general factor. Follow-up analyses with Horn's parallel analysis revealed a viable second-order, four-factor solution. An oblique rotation of this solution revealed four highly correlated factors that we named Oral Function, Oro-facial Pain, Oro-facial Appearance and Psychosocial Impact. These four dimensions and the strong general factor are two viable hypotheses for the factor structure of the OHIP. © 2014 John Wiley & Sons Ltd.

75 FR 69912 - Pipeline Safety: Control Room Management/Human Factors

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-16

... 192 and 195 [Docket ID PHMSA-2007-27954] RIN 2137-AE64 Pipeline Safety: Control Room Management/Human... rulemaking; Extension of comment period. SUMMARY: On September 17, 2010, PHMSA published a Control Room... Control Room Management/Human Factors rule at 49 CFR 192.631 and 195.446. The NPRM proposes to expedite...

An Investigation of the Profiles of Satisfying and Dissatisfying Factors in E-Learning

ERIC Educational Resources Information Center

Chyung, Seung Youn; Vachon, Mark

2005-01-01

Various factors influence e-learners' feelings of satisfaction and dissatisfaction with their e-learning experience, but from an extensive search with six major academic research databases we did not find any research that demonstrated comprehensive profiles of satisfying and dissatisfying factors in e-learning. We conducted a qualitative study to…

Cultural factors influencing safety need to be addressed in design and operation of technology.

PubMed

Meshkati, N

1996-10-01

Cultural factors which influence aviation safety in aircraft design, air traffic control, and human factors training are examined. Analysis of the Avianca Flight 052 crash in New York in January, 1990, demonstrates the catastrosphic effects cultural factors can play. Cultural factors include attitude toward work and technology, organizational hierarchy, religion, and population stereotyping.

The challenge of compiling data profiles to stimulate local preventive health action: a European case study from child safety.

PubMed

Alexander, Denise; Rigby, Michael; Gissler, Mika; Köhler, Lennart; MacKay, Morag

2015-05-01

Positive recent experience of presenting comparative child safety data at national level has instigated policy action in Europe. It was hoped a Child Safety Index could quantify how safe a community, region or locality is for its children in comparison with similar areas within Europe, as a focus for local targeted action. Validated indicators proposed by previous European projects identified from areas of child injury prevention, such as road safety, burns or poisoning, were selected to give a balanced profile, and populated from available published data. An index using a sub-score for each specific injury topic was proposed. The indicators' presentation, sensitivity and appropriateness were considered, as well as data availability. Satisfactory indicators were not identified for all areas and very few local area data were available. This forced the researchers to conclude that at present, constructing a reliable Child Safety Index for use at the local level is not feasible. There is a worrying lack of data available at the sub-national level to support injury prevention, evaluate interventions, and enable informed local decision making.

Confirmatory factor analysis of the Oral Health Impact Profile.

PubMed

John, M T; Feuerstahler, L; Waller, N; Baba, K; Larsson, P; Celebić, A; Kende, D; Rener-Sitar, K; Reissmann, D R

2014-09-01

Previous exploratory analyses suggest that the Oral Health Impact Profile (OHIP) consists of four correlated dimensions and that individual differences in OHIP total scores reflect an underlying higher-order factor. The aim of this report is to corroborate these findings in the Dimensions of Oral Health-Related Quality of Life (DOQ) Project, an international study of general population subjects and prosthodontic patients. Using the project's Validation Sample (n = 5022), we conducted confirmatory factor analyses in a sample of 4993 subjects with sufficiently complete data. In particular, we compared the psychometric performance of three models: a unidimensional model, a four-factor model and a bifactor model that included one general factor and four group factors. Using model-fit criteria and factor interpretability as guides, the four-factor model was deemed best in terms of strong item loadings, model fit (RMSEA = 0·05, CFI = 0·99) and interpretability. These results corroborate our previous findings that four highly correlated factors - which we have named Oral Function, Oro-facial Pain, Oro-facial Appearance and Psychosocial Impact - can be reliably extracted from the OHIP item pool. However, the good fit of the unidimensional model and the high interfactor correlations in the four-factor solution suggest that OHRQoL can also be sufficiently described with one score. © 2014 John Wiley & Sons Ltd.

Hazard Management Dealt by Safety Professionals in Colleges: The Impact of Individual Factors.

PubMed

Wu, Tsung-Chih; Chen, Chi-Hsiang; Yi, Nai-Wen; Lu, Pei-Chen; Yu, Shan-Chi; Wang, Chien-Peng

2016-12-03

Identifying, evaluating, and controlling workplace hazards are important functions of safety professionals (SPs). The purpose of this study was to investigate the content and frequency of hazard management dealt by safety professionals in colleges. The authors also explored the effects of organizational factors/individual factors on SPs' perception of frequency of hazard management. The researchers conducted survey research to achieve the objective of this study. The researchers mailed questionnaires to 200 SPs in colleges after simple random sampling, then received a total of 144 valid responses (response rate = 72%). Exploratory factor analysis indicated that the hazard management scale (HMS) extracted five factors, including physical hazards, biological hazards, social and psychological hazards, ergonomic hazards, and chemical hazards. Moreover, the top 10 hazards that the survey results identified that safety professionals were most likely to deal with (in order of most to least frequent) were: organic solvents, illumination, other chemicals, machinery and equipment, fire and explosion, electricity, noise, specific chemicals, human error, and lifting/carrying. Finally, the results of one-way multivariate analysis of variance (MANOVA) indicated there were four individual factors that impacted the perceived frequency of hazard management which were of statistical and practical significance: job tenure in the college of employment, type of certification, gender, and overall job tenure. SPs within colleges and industries can now discuss plans revolving around these five areas instead of having to deal with all of the separate hazards.

Hazard Management Dealt by Safety Professionals in Colleges: The Impact of Individual Factors

PubMed Central

Wu, Tsung-Chih; Chen, Chi-Hsiang; Yi, Nai-Wen; Lu, Pei-Chen; Yu, Shan-Chi; Wang, Chien-Peng

2016-01-01

Identifying, evaluating, and controlling workplace hazards are important functions of safety professionals (SPs). The purpose of this study was to investigate the content and frequency of hazard management dealt by safety professionals in colleges. The authors also explored the effects of organizational factors/individual factors on SPs’ perception of frequency of hazard management. The researchers conducted survey research to achieve the objective of this study. The researchers mailed questionnaires to 200 SPs in colleges after simple random sampling, then received a total of 144 valid responses (response rate = 72%). Exploratory factor analysis indicated that the hazard management scale (HMS) extracted five factors, including physical hazards, biological hazards, social and psychological hazards, ergonomic hazards, and chemical hazards. Moreover, the top 10 hazards that the survey results identified that safety professionals were most likely to deal with (in order of most to least frequent) were: organic solvents, illumination, other chemicals, machinery and equipment, fire and explosion, electricity, noise, specific chemicals, human error, and lifting/carrying. Finally, the results of one-way multivariate analysis of variance (MANOVA) indicated there were four individual factors that impacted the perceived frequency of hazard management which were of statistical and practical significance: job tenure in the college of employment, type of certification, gender, and overall job tenure. SPs within colleges and industries can now discuss plans revolving around these five areas instead of having to deal with all of the separate hazards. PMID:27918474

[Safety profile of heterologous serum produced by the Butantan Institute, in São Paulo-SP, Brazil, from 2012 to 2015].

PubMed

Gattás, Vera Lúcia; Braga, Patrícia Emília; Koike, Marcelo Eiji; Lucchesi, Maria Beatriz; Precioso, Alexander Roberto

2017-01-01

to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil. a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015. 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.2 AEs per individual was observed; among the total of 173 AEs, 63.0% were expected considering that they were described in the package insert; most of them were classified as skin and subcutaneous tissue disorders (30.6%); there were six deaths temporally related to the use of serum, but this association was discarded. in the studied period, the serum produced by the BI had no changes in their safety profiles, considering that the AEs were expected, according to the information previously described in the package insert.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

PubMed

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

Finite mixture modeling approach for developing crash modification factors in highway safety analysis.

PubMed

Park, Byung-Jung; Lord, Dominique; Wu, Lingtao

2016-10-28

This study aimed to investigate the relative performance of two models (negative binomial (NB) model and two-component finite mixture of negative binomial models (FMNB-2)) in terms of developing crash modification factors (CMFs). Crash data on rural multilane divided highways in California and Texas were modeled with the two models, and crash modification functions (CMFunctions) were derived. The resultant CMFunction estimated from the FMNB-2 model showed several good properties over that from the NB model. First, the safety effect of a covariate was better reflected by the CMFunction developed using the FMNB-2 model, since the model takes into account the differential responsiveness of crash frequency to the covariate. Second, the CMFunction derived from the FMNB-2 model is able to capture nonlinear relationships between covariate and safety. Finally, following the same concept as those for NB models, the combined CMFs of multiple treatments were estimated using the FMNB-2 model. The results indicated that they are not the simple multiplicative of single ones (i.e., their safety effects are not independent under FMNB-2 models). Adjustment Factors (AFs) were then developed. It is revealed that current Highway Safety Manual's method could over- or under-estimate the combined CMFs under particular combination of covariates. Safety analysts are encouraged to consider using the FMNB-2 models for developing CMFs and AFs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety profile of bilastine: 2nd generation H1-antihistamines.

PubMed

Scaglione, F

2012-12-01

Bilastine is a new H1 antagonist with no sedative side effects, no cardiotoxic effects, and no hepatic metabolism. In addition, bilastine has proved to be effective for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Pharmacological studies have shown that bilastine is highly selective for the H1 receptor in both in vivo and in vitro studies, and with no apparent affinity for other receptors. The absorption of bilastine is fast, linear and dose-proportional; it appears to be safe and well tolerated at all doses levels in healthy population. Multiple administration of bilastine has confirmed the linearity of the kinetic parameters. The distribution in the brain is undetectable. The safety profile in terms of adverse effects is very similar to placebo in all Phase I, II and III clinical trials. Bilastine (20 mg), unlike cetirizine, does not increase alcohol effects on the CNS. Bilastine 20 mg does not increase the CNS depressant effect of lorazepam. Bilastine 20 mg is similar to placebo in the driving test. Therefore, it meets the current criteria for medication used in the treatment of allergic rhinitis and urticaria.

Development of an evidence-based framework of factors contributing to patient safety incidents in hospital settings: a systematic review

PubMed Central

McEachan, Rosemary R C; Giles, Sally J; Sirriyeh, Reema; Watt, Ian S; Wright, John

2012-01-01

Objective The aim of this systematic review was to develop a ‘contributory factors framework’ from a synthesis of empirical work which summarises factors contributing to patient safety incidents in hospital settings. Design A mixed-methods systematic review of the literature was conducted. Data sources Electronic databases (Medline, PsycInfo, ISI Web of knowledge, CINAHL and EMBASE), article reference lists, patient safety websites, registered study databases and author contacts. Eligibility criteria Studies were included that reported data from primary research in secondary care aiming to identify the contributory factors to error or threats to patient safety. Results 1502 potential articles were identified. 95 papers (representing 83 studies) which met the inclusion criteria were included, and 1676 contributory factors extracted. Initial coding of contributory factors by two independent reviewers resulted in 20 domains (eg, team factors, supervision and leadership). Each contributory factor was then coded by two reviewers to one of these 20 domains. The majority of studies identified active failures (errors and violations) as factors contributing to patient safety incidents. Individual factors, communication, and equipment and supplies were the other most frequently reported factors within the existing evidence base. Conclusions This review has culminated in an empirically based framework of the factors contributing to patient safety incidents. This framework has the potential to be applied across hospital settings to improve the identification and prevention of factors that cause harm to patients. PMID:22421911

JASPAR 2016: a major expansion and update of the open-access database of transcription factor binding profiles

PubMed Central

Mathelier, Anthony; Fornes, Oriol; Arenillas, David J.; Chen, Chih-yu; Denay, Grégoire; Lee, Jessica; Shi, Wenqiang; Shyr, Casper; Tan, Ge; Worsley-Hunt, Rebecca; Zhang, Allen W.; Parcy, François; Lenhard, Boris; Sandelin, Albin; Wasserman, Wyeth W.

2016-01-01

JASPAR (http://jaspar.genereg.net) is an open-access database storing curated, non-redundant transcription factor (TF) binding profiles representing transcription factor binding preferences as position frequency matrices for multiple species in six taxonomic groups. For this 2016 release, we expanded the JASPAR CORE collection with 494 new TF binding profiles (315 in vertebrates, 11 in nematodes, 3 in insects, 1 in fungi and 164 in plants) and updated 59 profiles (58 in vertebrates and 1 in fungi). The introduced profiles represent an 83% expansion and 10% update when compared to the previous release. We updated the structural annotation of the TF DNA binding domains (DBDs) following a published hierarchical structural classification. In addition, we introduced 130 transcription factor flexible models trained on ChIP-seq data for vertebrates, which capture dinucleotide dependencies within TF binding sites. This new JASPAR release is accompanied by a new web tool to infer JASPAR TF binding profiles recognized by a given TF protein sequence. Moreover, we provide the users with a Ruby module complementing the JASPAR API to ease programmatic access and use of the JASPAR collection of profiles. Finally, we provide the JASPAR2016 R/Bioconductor data package with the data of this release. PMID:26531826

Five factor model personality traits relate to adult attention-deficit/hyperactivity disorder but not to their distinct neurocognitive profiles.

PubMed

Van Dijk, Fiona E; Mostert, Jeannette; Glennon, Jeffrey; Onnink, Marten; Dammers, Janneke; Vasquez, Alejandro Arias; Kan, Cornelis; Verkes, Robbert Jan; Hoogman, Martine; Franke, Barbara; Buitelaar, Jan K

2017-12-01

Deficits in multiple neuropsychological domains and specific personality profiles have been observed in attention-deficit/hyperactivity disorder (ADHD). In this study we investigated whether personality traits are related to neurocognitive profiles in adults with ADHD. Neuropsychological performance and Five Factor Model (FFM) personality traits were measured in adults with ADHD (n = 133) and healthy controls (n = 132). Three neuropsychological profiles, derived from previous community detection analyses, were investigated for personality trait differences. Irrespective of cognitive profile, participants with ADHD showed significantly higher Neuroticism and lower Extraversion, Agreeableness, and Conscientiousness than healthy controls. Only the FFM personality factor Openness differed significantly between the three profiles. Higher Openness was more common in those with aberrant attention and inhibition than those with increased delay discounting and atypical working memory / verbal fluency. The results suggest that the personality trait Openness, but not any other FFM factor, is linked to neurocognitive profiles in ADHD. ADHD symptoms rather than profiles of cognitive impairment have associations with personality traits. Copyright © 2017 Elsevier B.V. All rights reserved.

[Factors predicting sensory profile of 4 to 18 month old infants].

PubMed

Pedrosa, Carina; Caçola, Priscila; Carvalhal, Maria Isabel Martins Mourão

2015-01-01

To identify environment factors predicting sensory profile of infants between 4 and 18 months old. This cross-sectional study evaluated 97 infants (40 females e 57 males), with a mean age of 1.05±0.32 years with the Test of Sensory Functions in Infants (TSFI) and also asked 97 parents and 11 kindergarten teachers of seven daycare centers to answer the Affordances in the Home Environment for Motor Development- Infant Scale (AHEMD-IS). The AHEMD-IS is a questionnaire that characterizes the opportunities in the home environment for infants between 3 and 18 months of age. We tested the association between affordances and the sensory profile of infants. Significant variables were entered into a regression model to determine predictors of sensory profile. The majority of infants (66%) had a normal sensory profile and 34% were at risk or deficit. Affordances in the home were classified as adequate and they were good in the studied daycare centers. The results of the regression revealed that only daily hours in daycare center and daycare outside space influenced the sensory profile of infants, in particular the Ocular-Motor Control component. The sensory profile of infants was between normal and at risk. While the family home offered adequate affordances for motor development, the daycare centers of the infants involved demonstrated a good quantity and quality of affordances. Overall, we conclude that daily hours in the daycare center and daycare outside space were predictors of the sensory profile, particular on Ocular-Motor Control component. Copyright © 2015 Associação de Pediatria de São Paulo. Publicado por Elsevier Editora Ltda. All rights reserved.

Seepage-Based Factor of Safety Analysis Using 3D Groundwater Simulation Results

DTIC Science & Technology

2014-08-01

Edris, and D . Richards. 2006. A first-principle, physics- based watershed model: WASH123D. In Watershed models, ed. V. P. Singh and D . K . Frevert...should be cited as follows: Cheng, H.-P., K . D . Winters, S. M. England, and R. E. Pickett. 2014. Factor of safety analysis using 3D groundwater...Journal of Dam Safety 11(3): 33–42. Pickett, R. E., K . D . Winters, H.-P. Cheng, and S. M. England. 2013. Herbert Hoover Dike (HHD) flow model. Project

Examining the macroergonomics and safety factors among teleworkers: development of a conceptual model.

PubMed

Robertson, Michelle M; Schleifer, Lawrence M; Huang, Yueng-hsiang

2012-01-01

With the rising number of teleworkers who are working in non-traditional work locations, health and safety issues are even more critical. While telework offers attractive alternatives to traditional work locations, it is not without challenges for employers and workers. A macroergonomics approach or work system design for telework programs is proposed to address these new challenges. This approach explains the impact of organizational, psychosocial and workplace risk factors on teleworker's health and safety. A process for managing the health and safety of teleworkers is presented along with preventive strategies to provide an injury-free working environment.

Universal analytical scattering form factor for shell-, core-shell, or homogeneous particles with continuously variable density profile shape.

PubMed

Foster, Tobias

2011-09-01

A novel analytical and continuous density distribution function with a widely variable shape is reported and used to derive an analytical scattering form factor that allows us to universally describe the scattering from particles with the radial density profile of homogeneous spheres, shells, or core-shell particles. Composed by the sum of two Fermi-Dirac distribution functions, the shape of the density profile can be altered continuously from step-like via Gaussian-like or parabolic to asymptotically hyperbolic by varying a single "shape parameter", d. Using this density profile, the scattering form factor can be calculated numerically. An analytical form factor can be derived using an approximate expression for the original Fermi-Dirac distribution function. This approximation is accurate for sufficiently small rescaled shape parameters, d/R (R being the particle radius), up to values of d/R ≈ 0.1, and thus captures step-like, Gaussian-like, and parabolic as well as asymptotically hyperbolic profile shapes. It is expected that this form factor is particularly useful in a model-dependent analysis of small-angle scattering data since the applied continuous and analytical function for the particle density profile can be compared directly with the density profile extracted from the data by model-free approaches like the generalized inverse Fourier transform method. © 2011 American Chemical Society

The Impact of System Factors on Quality and Safety in Arterial Surgery: A Systematic Review.

PubMed

Lear, R; Godfrey, A D; Riga, C; Norton, C; Vincent, C; Bicknell, C D

2017-07-01

A systems approach to patient safety proposes that a wide range of factors contribute to surgical outcome, yet the impact of team, work environment, and organisational factors, is not fully understood in arterial surgery. The aim of this systematic review is to summarize and discuss what is already known about the impact of system factors on quality and safety in arterial surgery. A systematic review of original research papers in English using MEDLINE, Embase, PsycINFO, and Cochrane databases, was performed according to PRISMA guidelines. Independent reviewers selected papers according to strict inclusion and exclusion criteria, and using predefined data fields, extracted relevant data on team, work environment, and organisational factors, and measures of quality and/or safety, in arterial procedures. Twelve papers met the selection criteria. Study endpoints were not consistent between papers, and most failed to report their clinical significance. A variety of tools were used to measure team skills in five papers; only one paper measured the relationship between team factors and patient outcomes. Two papers reported that equipment failures were common and had a significant impact on operating room efficiency. The influence of hospital characteristics on failure-to-rescue rates was tested in one large study, although their conclusions were limited to the American Medicare population. Five papers implemented changes in the patient pathway, but most studies failed to account for potential confounding variables. A small number of heterogenous studies have evaluated the relationship between system factors and quality or safety in arterial surgery. There is some evidence of an association between system factors and patient outcomes, but there is more work to be done to fully understand this relationship. Future research would benefit from consistency in definitions, the use of validated assessment tools, measurement of clinically relevant endpoints, and adherence to

Specific Safety Profile of Bevacizumab in Asian Patients With Advanced NSCLC

PubMed Central

Chen, Zhenguang; Zhong, Beilong; Lun, Xueping; Lai, Yingrong; Bella, Amos Ela; Yang, Weilin; Wu, Jiabin

2015-01-01

Abstract Randomized studies have obtained varying findings regarding the benefits and toxicities of bevacizumab in the treatment of nonsmall cell lung cancer (NSCLC). It is unclear whether the discrepancies among trials are due to ethnic/racial differences. We therefore performed a meta-analysis of all published, randomized, controlled clinical trials involving bevacizumab in patients with NSCLC to assess its effectiveness and safety in Asian and non-Asian populations. Results from the phase II JO19907 trial, the phase III AVAiL and ECOG 4599 trials, and the phase IV SAiL trials were used to calculate the benefits and toxicities of bevacizumab in Asian and non-Asian patients. Combined statistical estimates, including hazard ratios and odds ratios, were calculated using fixed-effects and random-effects models. A total of 4308 patients were evaluated. Combining bevacizumab with different chemotherapy regimens resulted in similar objective response rates, overall survival, and progression-free survival in Asian and non-Asian populations. Disease control rates, however, were only reported in Asian populations. The rates of severe bleeding (relative risk [RR], 2.17; P = 0.02) and thromboembolism (RR, 3.65; P < 0.0001) were significantly higher, while the rate of severe proteinuria was significantly lower (RR, 0.43; P < 0.0001), in non-Asian than in Asian populations. The rates of severe hypertension (P = 0.71) and hemoptysis (P = 0.66) were similar in Asian and non-Asian populations. Bevacizumab combined with chemotherapy for first-line NSCLC treatment showed similar benefits in Asian and non-Asian populations, but had specific safety profiles in each. PMID:26091469

2009 Human Factors and Roadway Safety Workshop : Opening Session [SD .WMV (720x480/29fps/546.0 MB)

DOT National Transportation Integrated Search

2009-11-05

Iowa Department of Transportation Research and Technology Bureau video presentation from the 2009 human factors and roadway safety workshop session titled: 2009 Human Factors and Roadway Safety Workshop Opening Session : Sandra Larson, director, Iowa...

States Respond to School Safety Concerns with 2013 Legislation. School Safety: 2013 Legislative Session

ERIC Educational Resources Information Center

Wixom, Micah Ann

2014-01-01

School safety policies are constantly evolving, often in response to fatal events. After several high-profile and tragic shootings over the past 15 years, school safety has become a major focus for parents, school officials, policymakers and the public nationwide. ECS [Education Commission of the States] conducted a scan of school safety-related…

Clinical strategies to aim an adequate safety profile for patients and effective training for surgical residents: The laparoscopic cholecystectomy model.

PubMed

Bresadola, Vittorio; Pravisani, Riccardo; Pighin, Marina; Seriau, Luca; Cherchi, Vittorio; Giuseppe, Sergio; Risaliti, Andrea

2016-11-01

Training programs for resident surgeons represent a challenge for the mentoring activity. The aim of the present study is to investigate the impact of our training program for laparoscopic cholecystectomy on patient's safety and on the modulation of the residents' exposure to clinical scenario with different grades of complexity. This is a retrospective study based on a clinical series of laparoscopic cholecystectomy performed in a teaching hospital. Study population was grouped according to the expertise of the attending primary operator among resident surgeons. Four groups were identified: consultant (C), senior resident (SR); intermediate level resident (IR); junior resident (JR). The intraoperative and postoperative outcomes were confronted to evaluate the patient's safety profile. 447 patients were submitted to LC: 96 cases were operated by a C, 200 by SR, 112 by IR and 39 by JR. The mean operative time was the longest for the JR group. A statistically higher rate of conversion to open approach was registered in C and IR groups in comparison to JR and SR groups. However, in C and IR groups, patients had worse ASA score, higher BMI and more frequent past history of previous abdominal surgery, cholecystitis or pancreatitis. Overall, it was not registered any statistically significant difference among the groups in terms of length of hospital stay and prevalence of major postoperative complications. Applying an educational model based on both graduated levels of responsibility and modulated grade of clinical complexity can guarantee an high safety profile.

Safety and Feasibility of Lin- Cells Administration to ALS Patients: A Novel View on Humoral Factors and miRNA Profiles.

PubMed

Sobuś, Anna; Baumert, Bartłomiej; Litwińska, Zofia; Gołąb-Janowska, Monika; Stępniewski, Jacek; Kotowski, Maciej; Pius-Sadowska, Ewa; Kawa, Miłosz P; Gródecka-Szwajkiewicz, Dorota; Peregud-Pogorzelski, Jarosław; Dulak, Józef; Nowacki, Przemysław; Machaliński, Bogusław

2018-04-27

Therapeutic options for amyotrophic lateral sclerosis (ALS) are still limited. Great hopes, however, are placed in growth factors that show neuroprotective abilities (e.g., nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEGF)) and in the immune modulating features, in particular, the anti-inflammatory effects. In our study we aimed to investigate whether a bone marrow-derived lineage-negative (Lin-) cells population, after autologous application into cerebrospinal fluid (CSF), is able to produce noticeable concentrations of trophic factors and inflammatory-related proteins and thus influence the clinical course of ALS. To our knowledge, the evaluation of Lin- cells transplantation for ALS treatment has not been previously reported. Early hematopoietic Lin- cells were isolated from twelve ALS patients’ bone marrow, and later, the suspension of cells was administered into the subarachnoid space by lumbar puncture. Concentrations of selected proteins in the CSF and plasma were quantified by multiplex fluorescent bead-based immunoassays at different timepoints post-transplantation. We also chose microRNAs (miRNAs) related to muscle biology (miRNA-1, miRNA-133a, and miRNA-206) and angiogenesis and inflammation (miRNA-155 and miRNA-378) and tested, for the first time, their expression profiles in the CSF and plasma of ALS patients after Lin- cells transplantation. The injection of bone marrow cells resulted in decreased concentration of selected inflammatory proteins (C3) after Lin- cells injection, particularly in patients who had a better clinical outcome. Moreover, several analyzed miRNAs have changed expression levels in the CSF and plasma of ALS patients subsequent to Lin- cells administration. Interestingly, the expression of miR-206 increased in ALS patients, while miR-378 decreased both in the CSF and plasma one month after the cells’ injection. We propose that autologous lineage

Factors influencing workers to follow food safety management systems in meat plants in Ontario, Canada.

PubMed

Ball, Brita; Wilcock, Anne; Aung, May

2009-06-01

Small and medium sized food businesses have been slow to adopt food safety management systems (FSMSs) such as good manufacturing practices and Hazard Analysis Critical Control Point (HACCP). This study identifies factors influencing workers in their implementation of food safety practices in small and medium meat processing establishments in Ontario, Canada. A qualitative approach was used to explore in-plant factors that influence the implementation of FSMSs. Thirteen in-depth interviews in five meat plants and two focus group interviews were conducted. These generated 219 pages of verbatim transcripts which were analysed using NVivo 7 software. Main themes identified in the data related to production systems, organisational characteristics and employee characteristics. A socio-psychological model based on the theory of planned behaviour is proposed to describe how these themes and underlying sub-themes relate to FSMS implementation. Addressing the various factors that influence production workers is expected to enhance FSMS implementation and increase food safety.

JASPAR 2016: a major expansion and update of the open-access database of transcription factor binding profiles.

PubMed

Mathelier, Anthony; Fornes, Oriol; Arenillas, David J; Chen, Chih-Yu; Denay, Grégoire; Lee, Jessica; Shi, Wenqiang; Shyr, Casper; Tan, Ge; Worsley-Hunt, Rebecca; Zhang, Allen W; Parcy, François; Lenhard, Boris; Sandelin, Albin; Wasserman, Wyeth W

2016-01-04

JASPAR (http://jaspar.genereg.net) is an open-access database storing curated, non-redundant transcription factor (TF) binding profiles representing transcription factor binding preferences as position frequency matrices for multiple species in six taxonomic groups. For this 2016 release, we expanded the JASPAR CORE collection with 494 new TF binding profiles (315 in vertebrates, 11 in nematodes, 3 in insects, 1 in fungi and 164 in plants) and updated 59 profiles (58 in vertebrates and 1 in fungi). The introduced profiles represent an 83% expansion and 10% update when compared to the previous release. We updated the structural annotation of the TF DNA binding domains (DBDs) following a published hierarchical structural classification. In addition, we introduced 130 transcription factor flexible models trained on ChIP-seq data for vertebrates, which capture dinucleotide dependencies within TF binding sites. This new JASPAR release is accompanied by a new web tool to infer JASPAR TF binding profiles recognized by a given TF protein sequence. Moreover, we provide the users with a Ruby module complementing the JASPAR API to ease programmatic access and use of the JASPAR collection of profiles. Finally, we provide the JASPAR2016 R/Bioconductor data package with the data of this release. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

National plan to enhance aviation safety through human factors improvements

NASA Technical Reports Server (NTRS)

Foushee, Clay

1990-01-01

The purpose of this section of the plan is to establish a development and implementation strategy plan for improving safety and efficiency in the Air Traffic Control (ATC) system. These improvements will be achieved through the proper applications of human factors considerations to the present and future systems. The program will have four basic goals: (1) prepare for the future system through proper hiring and training; (2) develop a controller work station team concept (managing human errors); (3) understand and address the human factors implications of negative system results; and (4) define the proper division of responsibilities and interactions between the human and the machine in ATC systems. This plan addresses six program elements which together address the overall purpose. The six program elements are: (1) determine principles of human-centered automation that will enhance aviation safety and the efficiency of the air traffic controller; (2) provide new and/or enhanced methods and techniques to measure, assess, and improve human performance in the ATC environment; (3) determine system needs and methods for information transfer between and within controller teams and between controller teams and the cockpit; (4) determine how new controller work station technology can optimally be applied and integrated to enhance safety and efficiency; (5) assess training needs and develop improved techniques and strategies for selection, training, and evaluation of controllers; and (6) develop standards, methods, and procedures for the certification and validation of human engineering in the design, testing, and implementation of any hardware or software system element which affects information flow to or from the human.

[The safety profile of escitalopram in pregnancy and breastfeeding].

PubMed

Bellantuono, Cesario; Orsolini, Laura; Bozzi, Francesca

2013-01-01

Escitalopram (ESC) is considered one of the most effective selective serotonin reuptake inhibitors (SSRI) for the treatment of major depression disorder. However, little is known on its potential risk of inducing major malformations (MM) and/or perinatal complications (PC). Aim of the present study is to provide a review of the available literature on the safety profile of ESC during pregnancy and breastfeeding and to compare data with the maternal and neonatal outcomes of 8 cases of the DEGRA Center. MEDLINE and PubMed databases were searched for English language articles by using the following keywords: "escitalopram", "selective serotonin reuptake inhibitors", "major malformations", "perinatal complications", "pregnancy", "breastfeeding". We also reported 8 cases of women treated with ESC during their pregnancy and breastfeeding at the Clinic of Affective Disorders in Pregnancy and Postpartum of the United Hospital of Ancona (DEGRA Center). Although some cases of MM have been reported in the literature after maternal exposure to ESC during early pregnancy, the rate of MM is substantially in the range of those reported in unexposed women. ESC exposure seems to be significantly associated with some PC such as lower rates of live births and higher rates of newborns with low birth weight. On the contrary, no short-term adverse effects in newborns were reported in the 5 studies evaluating the safety of ESC during breastfeeding. Data coming from DEGRA Center are consistent with the literature: all pregnancy were full term, all newborns were healthy and obtained normal APGAR score; no MM or miscarriage were reported. Only one case of mild withdrawal syndrome was reported in a newborn who was also exposed to benzodiazepines and paroxetine late in pregnancy. Two infants exposed to ESC also during the lactation did not reported any adverse effects at short-term. Data coming from published studies and from our cases seem to support the notion that ESC might be considered

Safety of recombinant human factor XIII in a cynomolgus monkey model of extracorporeal blood circulation.

PubMed

Ponce, R; Armstrong, K; Andrews, K; Hensler, J; Waggie, K; Heffernan, J; Reynolds, T; Rogge, M

2005-01-01

Factor XIII (FXIII) is a thrombin-activated plasma coagulation factor critical for blood clot stabilization and longevity. Administration of exogenous FXIII to replenish depleted stores after major surgery, including cardiopulmonary bypass, may reduce bleeding complications and transfusion requirements. Thus, a model of extracorporeal circulation (ECC) was developed in adult male cynomolgus monkeys (Macaca fascicularis) to evaluate the nonclinical safety of recombinant human FXIII (rFXIII). The hematological and coagulation profile in study animals during and after 2 h of ECC was similar to that reported for humans during and after cardiopulmonary bypass, including observations of anemia, thrombocytopenia, and activation of coagulation and platelets. Intravenous slow bolus injection of 300 U/kg (2.1 mg/kg) or 1000 U/kg (7 mg/kg) rFXIII after 2 h of ECC was well tolerated in study animals, and was associated with a dose-dependent increase in FXIII activity. No clinically significant effects in respiration, ECG, heart rate, blood pressure, body temperature, clinical chemistry, hematology (including platelet counts), or indicators of thrombosis (thrombin:anti-thrombin complex and D-Dimer) or platelet activation (platelet factor 4 and beta-thromboglobulin) were related to rFXIII administration. Specific examination of brain, heart, lung, liver, and kidney from rFXIII-treated animals provided no evidence of histopathological alterations suggestive of subclinical hemorrhage or thrombosis. Taken as a whole, the results demonstrate the ECC model suitably replicated the clinical presentation reported for humans during and after cardiopulmonary bypass surgery, and do not suggest significant concerns regarding use of rFXIII in replacement therapy after extracorporeal circulation.

Factors Of Environmental Safety And Environmentally Efficient Technologies Transportation Facilities Gas Transportation Industry

NASA Astrophysics Data System (ADS)

Vasiliev, Bogdan U.

2017-01-01

The stable development of the European countries depends on a reliable and efficient operation of the gas transportation system (GTS). With high reliability of GTS it is necessary to ensure its industrial and environmental safety. In this article the major factors influencing on an industrial and ecological safety of GTS are analyzed, sources of GTS safety decreasing is revealed, measures for providing safety are proposed. The article shows that use of gas-turbine engines of gas-compressor units (GCU) results in the following phenomena: emissions of harmful substances in the atmosphere; pollution by toxic waste; harmful noise and vibration; thermal impact on environment; decrease in energy efficiency. It is shown that for the radical problem resolution of an industrial and ecological safety of gas-transmission system it is reasonable to use gas-compressor units driven by electric motors. Their advantages are shown. Perspective technologies of these units and experience of their use in Europe and the USA are given in this article.

Meta-analysis of pemetrexed plus carboplatin doublet safety profile in first-line non-squamous non-small cell lung cancer studies.

PubMed

Okamoto, Isamu; Schuette, Wolfgang H W; Stinchcombe, Thomas E; Rodrigues-Pereira, José; San Antonio, Belén; Chen, Jian; Liu, Jingyi; John, William J; Zinner, Ralph G

2017-05-01

This meta-analysis compared safety profiles (selected drug-related treatment-emergent adverse events [TEAEs]) of first-line pemetrexed plus carboplatin (PCb) area under the concentration-time curve 5 mg/min•mL (PCb5) or 6 mg/min•mL (PCb6), two widely used regimens in clinical practice for advanced non-squamous non-small cell lung cancer. All patients received pemetrexed 500 mg/m 2 every 21 days with either of two carboplatin doses for up to 4-6 cycles. Safety profiles of PCb doses were compared using three statistical analysis methods: frequency table analysis (FTA), generalized linear mixed effect model (GLMM), and the propensity score method. Efficacy outcomes of PCb5 and PCb6 regimens were summarized. A total of 486 patients mainly from the US, Europe, and East Asia were included in the analysis; 22% (n = 105) received PCb5 in one trial and 78% (n = 381) received PCb6 in four trials. The FTA comparison demonstrated that PCb5 vs PCb6 was associated with a statistically significantly lower incidence of TEAEs, including all-grade thrombocytopenia, anemia, fatigue, and vomiting, and grade 3/4 thrombocytopenia. In the GLMM analysis, PCb5 patients were numerically less likely to experience all-grade and grade 3/4 neutropenia, anemia, and thrombocytopenia. The propensity score regression analysis showed PCb5 group patients were significantly less likely than PCb6 group patients to experience all-grade hematologic TEAEs and grade 3/4 thrombocytopenia and anemia. After applying propensity score 1:1 matching, FTA analysis showed that the PCb5 group had significantly less all-grade and grade 3/4 hematologic toxicities. Overall efficacy outcomes, including overall survival, progression-free survival, and response rate, were similar between the two carboplatin doses. Acknowledging the limitations of this meta-analysis of five trials, heterogeneous in patient's characteristics and trial designs, the results show that the PCb5 regimen was generally associated

Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes

PubMed Central

Hammer, Leslie B.; Truxillo, Donald M.; Bodner, Todd; Rineer, Jennifer; Pytlovany, Amy C.; Richman, Amy

2015-01-01

The goal of this study was to test the effectiveness of a workplace intervention targeting work-life stress and safety-related psychosocial risk factors on health and safety outcomes. Data were collected over time using a randomized control trial design with 264 construction workers employed in an urban municipal department. The intervention involved family- and safety-supportive supervisor behavior training (computer-based), followed by two weeks of behavior tracking and a four-hour, facilitated team effectiveness session including supervisors and employees. A significant positive intervention effect was found for an objective measure of blood pressure at the 12-month follow-up. However, no significant intervention results were found for self-reported general health, safety participation, or safety compliance. These findings suggest that an intervention focused on supervisor support training and a team effectiveness process for planning and problem solving should be further refined and utilized in order to improve employee health with additional research on the beneficial effects on worker safety. PMID:26557703

Advances in Predictive Toxicology for Discovery Safety through High Content Screening.

PubMed

Persson, Mikael; Hornberg, Jorrit J

2016-12-19

High content screening enables parallel acquisition of multiple molecular and cellular readouts. In particular the predictive toxicology field has progressed from the advances in high content screening, as more refined end points that report on cellular health can be studied in combination, at the single cell level, and in relatively high throughput. Here, we discuss how high content screening has become an essential tool for Discovery Safety, the discipline that integrates safety and toxicology in the drug discovery process to identify and mitigate safety concerns with the aim to design drug candidates with a superior safety profile. In addition to customized mechanistic assays to evaluate target safety, routine screening assays can be applied to identify risk factors for frequently occurring organ toxicities. We discuss the current state of high content screening assays for hepatotoxicity, cardiotoxicity, neurotoxicity, nephrotoxicity, and genotoxicity, including recent developments and current advances.

JASPAR 2010: the greatly expanded open-access database of transcription factor binding profiles

PubMed Central

Portales-Casamar, Elodie; Thongjuea, Supat; Kwon, Andrew T.; Arenillas, David; Zhao, Xiaobei; Valen, Eivind; Yusuf, Dimas; Lenhard, Boris; Wasserman, Wyeth W.; Sandelin, Albin

2010-01-01

JASPAR (http://jaspar.genereg.net) is the leading open-access database of matrix profiles describing the DNA-binding patterns of transcription factors (TFs) and other proteins interacting with DNA in a sequence-specific manner. Its fourth major release is the largest expansion of the core database to date: the database now holds 457 non-redundant, curated profiles. The new entries include the first batch of profiles derived from ChIP-seq and ChIP-chip whole-genome binding experiments, and 177 yeast TF binding profiles. The introduction of a yeast division brings the convenience of JASPAR to an active research community. As binding models are refined by newer data, the JASPAR database now uses versioning of matrices: in this release, 12% of the older models were updated to improved versions. Classification of TF families has been improved by adopting a new DNA-binding domain nomenclature. A curated catalog of mammalian TFs is provided, extending the use of the JASPAR profiles to additional TFs belonging to the same structural family. The changes in the database set the system ready for more rapid acquisition of new high-throughput data sources. Additionally, three new special collections provide matrix profile data produced by recent alternative high-throughput approaches. PMID:19906716

49 CFR 385.7 - Factors to be considered in determining a safety rating.

Code of Federal Regulations, 2010 CFR

2010-10-01

... information from safety reviews, compliance reviews and any other data. The factors may include all or some of... if their degree of formalization, automation, etc., is found to be substantially below the norm for...

Off-axis current drive and real-time control of current profile in JT-60U

NASA Astrophysics Data System (ADS)

Suzuki, T.; Ide, S.; Oikawa, T.; Fujita, T.; Ishikawa, M.; Seki, M.; Matsunaga, G.; Hatae, T.; Naito, O.; Hamamatsu, K.; Sueoka, M.; Hosoyama, H.; Nakazato, M.; JT-60 Team

2008-04-01

Aiming at optimization of current profile in high-β plasmas for higher confinement and stability, a real-time control system of the minimum of the safety factor (qmin) using the off-axis current drive has been developed. The off-axis current drive can raise the safety factor in the centre and help to avoid instability that limits the performance of the plasma. The system controls the injection power of lower-hybrid waves, and hence its off-axis driven current in order to control qmin. The real-time control of qmin is demonstrated in a high-β plasma, where qmin follows the temporally changing reference qmin,ref from 1.3 to 1.7. Applying the control to another high-β discharge (βN = 1.7, βp = 1.5) with m/n = 2/1 neo-classical tearing mode (NTM), qmin was raised above 2 and the NTM was suppressed. The stored energy increased by 16% with the NTM suppressed, since the resonant rational surface was eliminated. For the future use for current profile control, current density profile for off-axis neutral beam current drive (NBCD) is for the first time measured, using the motional Stark effect diagnostic. Spatially localized NBCD profile was clearly observed at the normalized minor radius ρ of about 0.6-0.8. The location was also confirmed by multi-chordal neutron emission profile measurement. The total amount of the measured beam driven current was consistent with the theoretical calculation using the ACCOME code. The CD location in the calculation was inward shifted than the measurement.

Towards an Enhancement of Organizational Information Security through Threat Factor Profiling (TFP) Model

NASA Astrophysics Data System (ADS)

Sidi, Fatimah; Daud, Maslina; Ahmad, Sabariah; Zainuddin, Naqliyah; Anneisa Abdullah, Syafiqa; Jabar, Marzanah A.; Suriani Affendey, Lilly; Ishak, Iskandar; Sharef, Nurfadhlina Mohd; Zolkepli, Maslina; Nur Majdina Nordin, Fatin; Amat Sejani, Hashimah; Ramadzan Hairani, Saiful

2017-09-01

Information security has been identified by organizations as part of internal operations that need to be well implemented and protected. This is because each day the organizations face a high probability of increase of threats to their networks and services that will lead to information security issues. Thus, effective information security management is required in order to protect their information assets. Threat profiling is a method that can be used by an organization to address the security challenges. Threat profiling allows analysts to understand and organize intelligent information related to threat groups. This paper presents a comparative analysis that was conducted to study the existing threat profiling models. It was found that existing threat models were constructed based on specific objectives, thus each model is limited to only certain components or factors such as assets, threat sources, countermeasures, threat agents, threat outcomes and threat actors. It is suggested that threat profiling can be improved by the combination of components found in each existing threat profiling model/framework. The proposed model can be used by an organization in executing a proactive approach to incident management.

Proceedings of the human factors workshop : improving railroad safety through understanding close calls.

DOT National Transportation Integrated Search

2004-05-01

On April 23 and 24, 2003, the Federal Railroad Administrations Office of Research and Development held a Human Factors Workshop: Improving Railroad Safety Through Understanding Close Calls in Baltimore, Maryland. The purpose of the workshop ...

Defining the patient safety attitudes and influencing factors of health professionals working at maternity hospitals.

PubMed

Tunçer Ünver, Gamze; Harmanci Seren, Arzu Kader

2018-02-27

To determine patient safety attitudes of midwives, nurses and physicians and to examine the difference or correlation in patient safety attitudes of midwives, nurses and physicians working in maternity hospitals. It has been suggested that it is necessary to define the factors affecting patient safety attitudes of health professionals working in maternity hospitals. A descriptive and correlational design was employed.The sample comprised 58 midwives, 134 nurses and 63 physicians (255) in two maternity hospitals in Istanbul, Turkey. The data were collected using an 'information form' and a 'Patient Safety Attitude Questionnaire'. The safety attitudes of participants were generally found to be negative. However, midwives had more positive patient safety attitudes and the age, unit, adequacy of patient safety training and the importance of patient safety were the most effective variables. As health professionals working in maternity hospitals generally have negative patient safety attitudes and because patient safety training provided better attitudes among the participants, these training programmes should be developed and implemented considering the differences among age groups and units. Health professionals have different views on the patient safety culture; therefore, training needs to involve everyone to create a shared vision for patient safety. © 2018 John Wiley & Sons Ltd.

Psychosocial influences on safety climate: evidence from community pharmacies.

PubMed

Phipps, Denham L; Ashcroft, Darren M

2011-12-01

To examine the relationship between psychosocial job characteristics and safety climate. Cross-sectional survey. Community pharmacies in Great Britain. Participants A random sample of community pharmacists registered in Great Britain (n = 860). Survey instruments Effort-reward imbalance (ERI) indicator and Job Content Questionnaire (JCQ). Main outcome measures Pharmacy Safety Climate Questionnaire (PSCQ). The profile of scores from the ERI indicated a relatively high risk of adverse psychological effects. The profile of scores from the JCQ indicated both high demand on pharmacists and a high level of psychological and social resources to meet these demands. Path analysis confirmed a model in which the ERI and JCQ measures, as well as the type of pharmacy and pharmacist role, predicted responses to the PSCQ (χ(2)(36) = 111.38, p < 0.001; Tucker-Lewis index = 0.96; comparative fit index = 0.98; root mean square error of approximation=0.05). Two general factors (effort vs reward and control vs demand) accounted for the effect of job characteristics on safety climate ratings; each had differential effects on the PSCQ scales. The safety climate in community pharmacies is influenced by perceptions of job characteristics, such as the level of job demands and the resources available to meet these demands. Hence, any efforts to improve safety should take into consideration the effect of the psychosocial work environment on safety climate. In addition, there is a need to address the presence of work-related stressors, which have the potential to cause direct or indirect harm to staff and service users. The findings of the current study provide a basis for future research to improve the safety climate and well-being, both in the pharmacy profession and in other healthcare settings.

Brief Talk about Lithium-ion Batteries’ Safety and Influencing Factors

NASA Astrophysics Data System (ADS)

Jin, Cheng

2017-12-01

A brief introduction of the development background, the concept, characteristic and advantages of lithium-ion battery was given. The typical fire accidents about lithium-ion battery in production process, the vehicle with new energy, portable electronic products were summarized. Some important factors for lithium-ion batteries’ safety were emphatically analyzed. Several constructive suggestions on improvement direction were given, meanwhile, we have a nice exception on the future of lithium-ion battery industry.

Safety profile of hymenoptera venom immunotherapy (VIT) in monosensitized patients: lack of new sensitization to nontreated insect venom.

PubMed

Spoerl, D; Bircher, A J; Scherer, K

2011-01-01

Venom immunotherapy (VIT) has proven to be efficacious in reducing the severity of anaphylactic reactions following field stings in patients with Hymenoptera venom allergy. Due to sequence homologies in the allergens used in Hymenoptera vaccines, there is concern that immunotherapy could lead to sensitization to allergens to which patients were not previously sensitized. The relevance of such an undesired phenomenon is unclear. To investigate the incidence of sensitization to Hymenoptera venoms other than those to which the patients were already sensitized and to assess the overall safety profile of VIT in order to compare the risk-benefit ratio in a subpopulation of monosensitized individuals. We performed a retrospective analysis of specific immunoglobulin E (sIgE) levels in patients with no prior detectable sIgE to Hymenoptera venom other than the one for which they received VIT. We assessed the safety profile of VIT using serological and clinical parameters. Of the 56 monosensitized patients who had VIT, 3 (5%) developed sIgE to the other insect with no history of field sting to explain it. This rate was similar to the rate of new sensitization due to field stings during VIT. VIT was well-tolerated and levels of serological markers improved. No patient had a systemic anaphylactic reaction after having been stung by an insect other than the one he/she was desensitized for during follow-up. VIT seems to be safe with respect to clinically significant new sensitizations.

Overview of critical risk factors in Power-Two-Wheeler safety.

PubMed

Vlahogianni, Eleni I; Yannis, George; Golias, John C

2012-11-01

Power-Two-Wheelers (PTWs) constitute a vulnerable class of road users with increased frequency and severity of accidents. The present paper focuses of the PTW accident risk factors and reviews existing literature with regard to the PTW drivers' interactions with the automobile drivers, as well as interactions with infrastructure elements and weather conditions. Several critical risk factors are revealed with different levels of influence to PTW accident likelihood and severity. A broad classification based on the magnitude and the need for further research for each risk factor is proposed. The paper concludes by discussing the importance of dealing with accident configurations, the data quality and availability, methods implemented to model risk and exposure and risk identification which are critical for a thorough understanding of the determinants of PTW safety. Copyright © 2012 Elsevier Ltd. All rights reserved.

Emissions from laboratory combustion of wildland fuels: Emission factors and source profiles

Treesearch

L.-W. Anthony Chen; Hans Moosmuller; W. Patrick Arnott; Judith C. Chow; John G. Watson; Ronald A. Susott; Ronald E. Babbitt; Cyle E. Wold; Emily N. Lincoln; Wei Min Hao

2007-01-01

Combustion of wildland fuels represents a major source of particulate matter (PM) and light-absorbing elemental carbon (EC) on a national and global scale, but the emission factors and source profiles have not been well characterized with respect to different fuels and combustion phases. These uncertainties limit the accuracy of current emission inventories, smoke...

Efficacy and Safety Profile of Diclofenac/Cyclodextrin and Progesterone/Cyclodextrin Formulations: A Review of the Literature Data.

PubMed

Scavone, Cristina; Bonagura, Angela Colomba; Fiorentino, Sonia; Cimmaruta, Daniela; Cenami, Rosina; Torella, Marco; Fossati, Tiziano; Rossi, Francesco

2016-06-01

According to health technology assessment, patients deserve the best medicine. The development of drugs associated with solubility enhancers, such as cyclodextrins, represents a measure taken in order to improve the management of patients. Different drugs, such as estradiol, testosterone, dexamethasone, opioids, non-steroidal anti-inflammatories (NSAIDs; i.e. diclofenac), and progesterone are associated with cyclodextrins. Products containing the association of diclofenac/cyclodextrins are available for subcutaneous, intramuscular, and intravenous administration in doses that range from 25 to 75 mg. Medicinal products containing the association of progesterone/cyclodextrins are indicated for intramuscular and subcutaneous injection at a dose equal to 25 mg. The effects of cyclodextrins have been discussed in the solubility profile and permeability through biological membranes of drug molecules. A literature search was performed in order to give an overview of the pharmacokinetic characteristics, and efficacy and safety profiles of diclofenac/hydroxypropyl-β-cyclodextrin (HPβCD) and progesterone/HPβCD associations. The results of more than 20 clinical studies were reviewed. It was suggested that the new diclofenac/HPβCD formulation gives a rapid and effective response to acute pain and, furthermore, has pharmacokinetic and efficacy/safety profiles comparable to other medicinal products not containing cyclodextrins. One of the principal aspects of these new diclofenac formulations is that in lowering the dose (lower than 50 mg) the drugs could be more tolerable, especially in patients with comorbid conditions. Moreover, results of studies investigating the characteristics of progesterone and cyclodextrins showed that the new formulation (progesterone/HPβCD 25 mg solution) has the same bioavailability as other products containing progesterone. It is more rapidly absorbed and allows the achievement of peak plasma concentrations in a shorter time. Finally, the

Safety climate and attitude as evaluation measures of organizational safety.

PubMed

Isla Díaz, R; Díaz Cabrera, D

1997-09-01

The main aim of this research is to develop a set of evaluation measures for safety attitudes and safety climate. Specifically it is intended: (a) to test the instruments; (b) to identify the essential dimensions of the safety climate in the airport ground handling companies; (c) to assess the quality of the differences in the safety climate for each company and its relation to the accident rate; (d) to analyse the relationship between attitudes and safety climate; and (e) to evaluate the influences of situational and personal factors on both safety climate and attitude. The study sample consisted of 166 subjects from three airport companies. Specifically, this research was centered on ground handling departments. The factor analysis of the safety climate instrument resulted in six factors which explained 69.8% of the total variance. We found significant differences in safety attitudes and climate in relation to type of enterprise.

Predicting safety culture: the roles of employer, operations manager and safety professional.

PubMed

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.

Analysis of contributing factors associated to related patients safety incidents in Intensive Care Medicine.

PubMed

Martín Delgado, M C; Merino de Cos, P; Sirgo Rodríguez, G; Álvarez Rodríguez, J; Gutiérrez Cía, I; Obón Azuara, B; Alonso Ovies, Á

2015-01-01

To explore contributing factors (CF) associated to related critical patients safety incidents. SYREC study pos hoc analysis. A total of 79 Intensive Care Departments were involved. The study sample consisted of 1.017 patients; 591 were affected by one or more incidents. The CF were categorized according to a proposed model by the National Patient Safety Agency from United Kingdom that was modified. Type, class and severity of the incidents was analyzed. A total 2,965 CF were reported (1,729 were associated to near miss and 1,236 to adverse events). The CF group more frequently reported were related patients factors. Individual factors were reported more frequently in near miss and task related CF in adverse events. CF were reported in all classes of incidents. The majority of CF were reported in the incidents classified such as less serious, even thought CF patients factors were associated to serious incidents. Individual factors were considered like avoidable and patients factors as unavoidable. The CF group more frequently reported were patient factors and was associated to more severe and unavoidable incidents. By contrast, individual factors were associated to less severe and avoidable incidents. In general, CF most frequently reported were associated to near miss. Copyright © 2014 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

[Role of some psycho-physiological factors on driving safety].

PubMed

Bergomi, M; Vivoli, G; Rovesti, S; Bussetti, P; Ferrari, A; Vivoli, R

2010-01-01

Within a research project on the role played by human factors on road accidents, the aim of the present study is to evaluate, in young adults, the relationships between driver behaviour and personality factors as well as to assess the neuroendocrine correlates of psychological and behavioural factors investigated. Another aim is to estimate in what measure the performance levels are affected by demographic, psychological and chronobiological variables. It has been found a positive relation between highway code violations, extroversion trait of personality and Sensation Seeking scores, so confirming that this component of personality can affect risky behaviour. Furthermore the subjects more oriented to morningness chronotype were found to be prone to adopt safe driving behaviour. Regarding the relations of the neuroendocrine parameters and driving behaviour a positive correlation was observed between dopamine levels and frequency of driving violations while a negative relationship was found between adrenaline levels and frequency of driving errors. In conclusion the identification of psycho-physiological variables related to driving risky behaviour might be a useful instrument to design traffic safety programs tailored to high risk subjects.

Missing focus on Human Factors – organizational and cognitive ergonomics – in the safety management for the petroleum industry

PubMed Central

Johnsen, Stig O; Kilskar, Stine Skaufel; Fossum, Knut Robert

2017-01-01

More attention has recently been given to Human Factors in petroleum accident investigations. The Human Factors areas examined in this article are organizational, cognitive and physical ergonomics. A key question to be explored is as follows: To what degree are the petroleum industry and safety authorities in Norway focusing on these Human Factors areas from the design phase? To investigate this, we conducted an innovative exploratory study of the development of four control centres in Norwegian oil and gas industry in collaboration between users, management and Human Factors experts. We also performed a literature survey and discussion with the professional Human Factors network in Norway. We investigated the Human Factors focus, reasons for not considering Human Factors and consequences of missing Human Factors in safety management. The results revealed an immature focus and organization of Human Factors. Expertise on organizational ergonomics and cognitive ergonomics are missing from companies and safety authorities and are poorly prioritized during the development. The easy observable part of Human Factors (i.e. physical ergonomics) is often in focus. Poor focus on Human Factors in the design process creates demanding conditions for human operators and impact safety and resilience. There is lack of non-technical skills such as communication and decision-making. New technical equipment such as Closed Circuit Television is implemented without appropriate use of Human Factors standards. Human Factors expertise should be involved as early as possible in the responsible organizations. Verification and validation of Human Factors should be improved and performed from the start, by certified Human Factors experts in collaboration with the workforce. The authorities should check-back that the regulatory framework of Human Factors is communicated, understood and followed. PMID:29278242

Factors influencing African-American mothers' concerns about immunization safety: a summary of focus group findings.

PubMed Central

Shui, Irene; Kennedy, Allison; Wooten, Karen; Schwartz, Benjamin; Gust, Deborah

2005-01-01

OBJECTIVE: To examine the vaccine safety concerns of African-American mothers who, despite concerns, have their children immunized. METHODS: Six focus groups of Atlanta-area African-American mothers who were very concerned about vaccine safety but whose children were fully vaccinated were conducted. RESULTS: Major factors influencing participants' concerns about immunizations included: lack of information and mistrust of the medical community and government. Factors that convinced parents to have their child immunized despite their concerns included social norms and/or laws supporting immunization and fear of the consequences of not immunizing. Suggestions given to reduce concerns included improving available information that addressed their concerns and provider-patient communication. CONCLUSIONS: Addressing mothers' concerns about immunization is important both from an ethical perspective, in assuring that they are fully informed of the risks and benefits of immunizations, as well as from a practical one, in reducing the possibility that they will decide not to immunize their child. Changes in the childhood immunization process should be made to reduce parental concern about vaccine safety. Some changes that may be considered include improved provider communication about immunizations and additional tailored information about the necessity and safety of vaccines. PMID:15926642

Modeling pedestrian crossing speed profiles considering speed change behavior for the safety assessment of signalized intersections.

PubMed

Iryo-Asano, Miho; Alhajyaseen, Wael K M

2017-11-01

Pedestrian safety is one of the most challenging issues in road networks. Understanding how pedestrians maneuver across an intersection is the key to applying countermeasures against traffic crashes. It is known that the behaviors of pedestrians at signalized crosswalks are significantly different from those in ordinary walking spaces, and they are highly influenced by signal indication, potential conflicts with vehicles, and intersection geometries. One of the most important characteristics of pedestrian behavior at crosswalks is the possible sudden speed change while crossing. Such sudden behavioral change may not be expected by conflicting vehicles, which may lead to hazardous situations. This study aims to quantitatively model the sudden speed changes of pedestrians as they cross signalized crosswalks under uncongested conditions. Pedestrian speed profiles are collected from empirical data and speed change events are extracted assuming that the speed profiles are stepwise functions. The occurrence of speed change events is described by a discrete choice model as a function of the necessary walking speed to complete crossing before the red interval ends, current speed, and the presence of turning vehicles in the conflict area. The amount of speed change before and after the event is modeled using regression analysis. A Monte Carlo simulation is applied for the entire speed profile of the pedestrians. The results show that the model can represent the pedestrian travel time distribution more accurately than the constant speed model. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cardiovascular benefits and safety profile of acarbose therapy in prediabetes and established type 2 diabetes

PubMed Central

Hanefeld, Markolf

2007-01-01

Dysglycaemic disease is one of the most important health issues facing the world in the 21st century. Patients with type 2 diabetes and individuals with prediabetes are at risk of developing macrovascular and microvascular complications. Long-term management strategies are therefore required that are effective at controlling dysglycaemia, well tolerated and, ideally, offer additional cardiovascular disease (CVD) risk-reduction benefits. The efficacy, safety and tolerability of the α-glucosidase inhibitor acarbose have been well-established in a wide range of patient populations in both clinical and community trials. In addition, acarbose has been shown to reduce cardiovascular complications in type 2 diabetes and prevent hypertension and CVD in individuals with impaired glucose tolerance (IGT). Acarbose has a very good safety profile and, owing to its straightforward, non-systemic mode of action, avoids most adverse events. The most common side-effects of acarbose are mild-to-moderate gastrointestinal complaints that subside as treatment continues. They can be minimised through the use of an appropriate stepwise dosing regimen and careful choice of diet. Acarbose is therefore a valuable option for the management of type 2 diabetes and, as the only oral antidiabetes agent approved for the treatment of prediabetes, can help to improve clinical management across the dysglycaemic disease continuum. PMID:17697384

JASPAR 2014: an extensively expanded and updated open-access database of transcription factor binding profiles.

PubMed

Mathelier, Anthony; Zhao, Xiaobei; Zhang, Allen W; Parcy, François; Worsley-Hunt, Rebecca; Arenillas, David J; Buchman, Sorana; Chen, Chih-yu; Chou, Alice; Ienasescu, Hans; Lim, Jonathan; Shyr, Casper; Tan, Ge; Zhou, Michelle; Lenhard, Boris; Sandelin, Albin; Wasserman, Wyeth W

2014-01-01

JASPAR (http://jaspar.genereg.net) is the largest open-access database of matrix-based nucleotide profiles describing the binding preference of transcription factors from multiple species. The fifth major release greatly expands the heart of JASPAR-the JASPAR CORE subcollection, which contains curated, non-redundant profiles-with 135 new curated profiles (74 in vertebrates, 8 in Drosophila melanogaster, 10 in Caenorhabditis elegans and 43 in Arabidopsis thaliana; a 30% increase in total) and 43 older updated profiles (36 in vertebrates, 3 in D. melanogaster and 4 in A. thaliana; a 9% update in total). The new and updated profiles are mainly derived from published chromatin immunoprecipitation-seq experimental datasets. In addition, the web interface has been enhanced with advanced capabilities in browsing, searching and subsetting. Finally, the new JASPAR release is accompanied by a new BioPython package, a new R tool package and a new R/Bioconductor data package to facilitate access for both manual and automated methods.

A qualitative investigation of Hispanic construction worker perspectives on factors impacting worksite safety and risk

PubMed Central

2011-01-01

Background Hispanic workers have higher rates of injury and death on construction worksites than workers of other ethnicities. Language barriers and cultural differences have been hypothesized as reasons behind the disparate rates. Methods We conducted two series of focus groups with union and non-union Hispanic construction workers to ask them about their perceptions of the causes for the unequal rates. Spanish transcripts were translated and coded in QSR NVivo software for common themes. Results Workers reported a difficult work environment characterized by supervisor pressure, competition for jobs and intimidation with regard to raising safety concerns. Language barriers or cultural factors were not strongly represented as causative factors behind the rates. Conclusion The results of this study have informed the development of an intervention trial that seeks to prevent falls and silica dust exposure by training contractors employing Hispanic construction workers in the elements of safety leadership, including building respect for their Hispanic workers and facilitating their participation in a safety program. PMID:21962128

Migration Factors in West African Immigrant Parents' Perceptions of Their Children's Neighborhood Safety.

PubMed

Rasmussen, Andrew; Cissé, Aïcha; Han, Ying; Roubeni, Sonia

2018-02-12

Immigrants make up large proportions of many low-income neighborhoods, but have been largely ignored in the neighborhood safety literature. We examined perceived safety's association with migration using a six-item, child-specific measure of parents' perceptions of school-aged (5-12 years of age) children's safety in a sample of 93 West African immigrant parents in New York City. Aims of the study were (a) to identify pre-migration correlates (e.g., trauma in home countries), (b) to identify migration-related correlates (e.g., immigration status, time spent separated from children during migration), and (c) to identify pre-migration and migration correlates that accounted for variance after controlling for non-migration-related correlates (e.g., neighborhood crime, parents' psychological distress). In a linear regression model, children's safety was associated with borough of residence, greater English ability, less emotional distress, less parenting difficulty, and a history of child separation. Parents' and children's gender, parents' immigration status, and the number of contacts in the U.S. pre-migration and pre-migration trauma were not associated with children's safety. That child separation was positively associated with safety perceptions suggests that the processes that facilitate parent-child separation might be reconceptualized as strengths for transnational families. Integrating migration-related factors into the discussion of neighborhood safety for immigrant populations allows for more nuanced views of immigrant families' well-being in host countries. © Society for Community Research and Action 2018.

Behavioral risk factors associated with listeriosis in the home: a review of consumer food safety studies.

PubMed

Evans, Ellen W; Redmond, Elizabeth C

2014-03-01

Listeria monocytogenes causes human listeriosis, which is associated with the highest hospitalization and mortality rates of all foodborne illnesses. In recent years, the incidence of listeriosis has doubled in Europe, almost exclusively among older adults (≥ 60 years of age). Food safety factors associated with increased risk of listeriosis include lack of adherence to "use by" dates and ineffective refrigerated storage of foods. Consequently, older adult consumers' implementation of safe food practices should be evaluated. This article is a review of consumer food safety cognitive and behavioral data relating to risk factors associated with listeriosis in the home as reported in 165 consumer food safety studies. Overall, only 41% of studies included assessment of consumer cognitive or behavioral data associated with listeriosis; of these studies 59% included data on safe refrigeration, 54% included data on storage time for opened ready-to-eat foods, and 49% included data on adherence to use-by dates. In most (83%) of the studies, survey-based data collection methods (questionnaires/interviews) were used; thus, the majority of findings were based on self-report (74%) and knowledge (44%). Observation (31%) and focus groups (12%) were less commonly used, resulting in a lack of actual behaviors and attitudinal data relating to listeriosis risk factors. Only 7% of studies included food safety data for older adults. Although older adults may fail to implement recommended practices, this review reveals a need for in-depth research to determine food safety attitudes and actual behaviors of older adults in conjunction with knowledge and selfreport of practices linked to increased risks of listeriosis. Such data combined with review findings would inform targeted food safety education to reduce risks associated with listeriosis in the home.

Confirmatory factor analysis of the Child Oral Health Impact Profile (Korean version).

PubMed

Cho, Young Il; Lee, Soonmook; Patton, Lauren L; Kim, Hae-Young

2016-04-01

Empirical support for the factor structure of the Child Oral Health Impact Profile (COHIP) has not been fully established. The purposes of this study were to evaluate the factor structure of the Korean version of the COHIP (COHIP-K) empirically using confirmatory factor analysis (CFA) based on the theoretical framework and then to assess whether any of the factors in the structure could be grouped into a simpler single second-order factor. Data were collected through self-reported COHIP-K responses from a representative community sample of 2,236 Korean children, 8-15 yr of age. Because a large inter-factor correlation of 0.92 was estimated in the original five-factor structure, the two strongly correlated factors were combined into one factor, resulting in a four-factor structure. The revised four-factor model showed a reasonable fit with appropriate inter-factor correlations. Additionally, the second-order model with four sub-factors was reasonable with sufficient fit and showed equal fit to the revised four-factor model. A cross-validation procedure confirmed the appropriateness of the findings. Our analysis empirically supported a four-factor structure of COHIP-K, a summarized second-order model, and the use of an integrated summary COHIP score. © 2016 Eur J Oral Sci.

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks.

PubMed

Ilfeld, Brian M; Viscusi, Eugene R; Hadzic, Admir; Minkowitz, Harold S; Morren, Michael D; Lookabaugh, Janice; Joshi, Girish P

2015-01-01

Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks. Data from 6 controlled (phases I-III) studies were compiled involving single-injection ankle, femoral nerve, and intercostal nerve blocks (2 each). Adverse events (AEs) were monitored for 1 to 30 days after study drug administration. Of 575 subjects, 335 received liposome bupivacaine (2-310 mg), 33 received bupivacaine HCl (75-125 mg), and 207 received normal saline (placebo). Overall, 76% of subjects receiving liposome bupivacaine experienced 1 or more AEs compared with 61% receiving bupivacaine HCl and 76% receiving placebo. The most frequently reported AEs among subjects receiving liposome bupivacaine were nausea, pyrexia, pruritus, constipation, and vomiting. The most common treatment-related AE was hypesthesia among subjects treated with liposome bupivacaine or bupivacaine HCl. Incidence of nervous system AEs for liposome bupivacaine, bupivacaine HCl, and placebo was 21%, 27%, and 21%, respectively. Similarly, incidence of cardiac AEs was 9%, 0%, and 12%, respectively. At least 1 serious AE occurred in 8% of subjects receiving liposome bupivacaine compared with 10% of those receiving placebo (none assessed by investigators as related to study medication). Liposome bupivacaine has a similar safety and side effect profile to bupivacaine HCl and normal saline, suggesting that most of the more common AEs are related to either opioid rescue or the surgical procedure itself.

On the Relation between the Linear Factor Model and the Latent Profile Model

ERIC Educational Resources Information Center

Halpin, Peter F.; Dolan, Conor V.; Grasman, Raoul P. P. P.; De Boeck, Paul

2011-01-01

The relationship between linear factor models and latent profile models is addressed within the context of maximum likelihood estimation based on the joint distribution of the manifest variables. Although the two models are well known to imply equivalent covariance decompositions, in general they do not yield equivalent estimates of the…

Insulin-like growth factor and fibroblast growth factor expression profiles in growth-restricted fetal sheep pancreas.

PubMed

Chen, Xiaochuan; Rozance, Paul J; Hay, William W; Limesand, Sean W

2012-05-01

Placental insufficiency results in intrauterine growth restriction (IUGR), impaired fetal insulin secretion and less fetal pancreatic β-cell mass, partly due to lower β-cell proliferation rates. Insulin-like growth factors (IGFs) and fibroblast growth factors (FGFs) regulate fetal β-cell proliferation and pancreas development, along with transcription factors, such as pancreatic and duodenal homeobox 1 (PDX-1). We determined expression levels for these growth factors, their receptors and IGF binding proteins in ovine fetal pancreas and isolated islets. In the IUGR pancreas, relative mRNA expression levels of IGF-I, PDX-1, FGF7 and FGFR2IIIb were 64% (P < 0.01), 76% (P < 0.05), 76% (P < 0.05) and 52% (P < 0.01) lower, respectively, compared with control fetuses. Conversely, insulin-like growth factor binding protein 2 (IGFBP-2) mRNA and protein concentrations were 2.25- and 1.2-fold greater (P < 0.05) in the IUGR pancreas compared with controls. In isolated islets from IUGR fetuses, IGF-II and IGFBP-2 mRNA concentrations were 1.5- and 3.7-fold greater (P < 0.05), and insulin mRNA was 56% less (P < 0.05) than control islets. The growth factor expression profiles for IGF and FGF signaling pathways indicate that declines in β-cell mass are due to decreased growth factor signals for both pancreatic progenitor epithelial cell and mature β-cell replication.

The Effect of Contextual Factors on Physiological and Activity Profiles in International Women's Rugby Sevens.

PubMed

Goodale, Tyler L; Gabbett, Tim J; Tsai, Ming-Chang; Stellingwerff, Trent; Sheppard, Jeremy

2017-03-01

To evaluate the effects of contextual game factors on activity and physiological profiles of international-level women's rugby sevens players. Twenty international-level female rugby sevens players from the same national team participated in this study. Global positioning system and heart-rate data were collected at 5 World Rugby Women's Sevens Series events (2013-14 season). Total, moderate-speed (0.2-3.5 m/s), and high-speed running (3.5-5.0 m/s) distances were significantly greater in the first half (20.1% ± 4.1%, 17.6% ± 6.9%, 24.5% ± 7.8%), during losses (11.4% ± 6.1%, 6.1% ± 6.4%, 26.9% ± 9.8%), during losses of large magnitudes (≥2 tries) (12.9% ± 8.8%, 6.8% ± 10.0%, 31.2% ± 14.9%), and against top-4 opponents (12.6% ± 8.7%, 11.3% ± 8.5%, 15.5% ± 13.9%). In addition, total distance increased (5.0% ± 5.5%) significantly from day 1 to day 2 of tournaments, and very-high-speed (5.0-6.5 m/s) running distance increased significantly (26.0% ± 14.2%) during losses. Time spent between 90% and 100% of maximum heart rate (16.4% ± 14.5%) and player load (19.0% ± 5.1%) were significantly greater in the second half. No significant differences in physiological or activity profiles were observed between forwards and backs. Game half, game outcome, tournament day, opponent rank, and margin of outcome all affected activity profiles, whereas game half affected physiological profiles. No differences in activity or physiological profiles were found between playing positions. Practitioners are advised to develop high-speed running ability in women's rugby sevens players to prepare them to tolerate the varying factors that affect activity profiles.

Opportunities for improved diabetes care among patients of safety net practices: a safety net providers' strategic alliance study.

PubMed

Reichsman, Ann; Werner, James; Cella, Peggi; Bobiak, Sarah; Stange, Kurt C

2009-01-01

To identify barriers and opportunities for quality diabetes care in safety net practices. In 3 federally qualified health centers and 1 free clinic, 19 primary care clinicians profiled patient and visit characteristics and quality of care measures for 181 consecutive visits by adult type 2 diabetic patients. Open-ended questions assessed patient and clinician perception of barriers to diabetes care and patient report of enabling factors. A multidisciplinary team identified themes from open-ended responses. Logistic regression analyses assessed the association of the identified barriers/enablers with 2 measures of quality care: glycosylated hemoglobin and prophylactic aspirin use. Ranked barriers noted by patients included adherence (40%), financial/insurance (23%), and psychosocial (13%) factors. Clinicians ranked systemic factors, including financial/ insurance (32%) and cultural/psychosocial (29%) factors, as important to adherence (29%) in determining quality diabetes care. Patients reported dietary and medical adherence (37%) and family/health care worker support (17%) as helpful factors. Among 175 patients with available data, glycosylated hemoglobin levels were associated with patient report of financial/insurance factors both as a barrier when visits and medications were unaffordable and as an opportunity when free or low-cost medications and services were provided. Patients' adherence with aspirin prophylaxis was strongly associated with African American race, prior prescription of aspirin and distribution of aspirin at the practice site (p<.001). Patients were less likely than clinicians to identify systemic and contextual factors contributing to poor diabetes care. From the front line's perspective, enabling patient self-management and systemic support is a target for improving diabetes care in safety net practices.

Investigation of Profiles of Risk Factors for Adolescent Psychopathology: A Person-Centered Approach

ERIC Educational Resources Information Center

Parra, Gilbert R.; DuBois, David L.; Sher, Kenneth J.

2006-01-01

Latent variable mixture modeling was used to identify subgroups of adolescents with distinct profiles of risk factors from individual, family, peer, and broader contextual domains. Data were drawn from the National Longitudinal Study of Adolescent Health. Four-class models provided the most theoretically meaningful solutions for both 7th (n = 907;…

Topical retinoids in acne vulgaris: update on efficacy and safety.

PubMed

Thielitz, Anja; Gollnick, Harald

2008-01-01

Topical retinoids represent a mainstay of acne treatment because they expel mature comedones, reduce microcomedone formation, and exert anti-inflammatory effects. The first-generation retinoid tretinoin (all-trans retinoic acid) and the synthetic third-generation polyaromatics adapalene and tazarotene are approved for acne treatment by the US FDA, whereas topical tretinoin, isotretinoin (13-cis retinoic acid), and adapalene are accredited in Canada and Europe. Topical retinoids have a favorable safety profile distinct from the toxicity of their systemic counterparts. Local adverse effects, including erythema, dryness, itching, and stinging, occur frequently during the early treatment phase. Their impact varies with the vehicle formation, skin type, frequency and mode of application, use of moisturizers, and environmental factors such as sun exposure or temperature. The broad anti-acne activity and safety profile of topical retinoids justifies their use as first-line treatment in most types of non-inflammatory and inflammatory acne. They are also suitable as long-term medications, with no risk of inducing bacterial resistance, for maintenance of remission after cessation of initial combination therapy.

Food safety knowledge and practices of abattoir and butchery shops and the microbial profile of meat in Mekelle City, Ethiopia

PubMed Central

Haileselassie, Mekonnen; Taddele, Habtamu; Adhana, Kelali; Kalayou, Shewit

2013-01-01

Objective To assess the food safety knowledge and practices in meat handling, and to determine microbial load and pathogenic organisms in meat at Mekelle city. Methods A descriptive survey design was used to answer questions concerning the current status of food hygiene and sanitation practiced in the abattoir and butcher shops. Workers from the abattoir and butcher shops were interviewed through a structured questionnaire to assess their food safety knowledge. Bacterial load was assessed by serial dilution method and the major bacterial pathogens were isolated by using standard procedures. Results 15.4% of the abattoir workers had no health certificate and there was no hot water, sterilizer and cooling facility in the abattoir. 11.3% of the butchers didn't use protective clothes. There was a food safety knowledge gap within the abattoir and butcher shop workers. The mean values of bacterial load of abattoir meat, butcher shops and street meat sale was found to be 1.1×105, 5.6×105 and 4.3×106 cfu/g, respectively. The major bacterial pathogens isolated were Escherichia coli, Staphylococcus aureus and Bacillus cereus. Conclusions The study revealed that there is a reasonable gap on food safety knowledge by abattoir and butcher shop workers. The microbial profile was also higher compared to standards set by World Health Organization. Due attention should be given by the government to improve the food safety knowledge and the quality standard of meat sold in the city. PMID:23646306

Organizational Factors Affect Safety-Net Hospitals' Breast Cancer Treatment Rates.

PubMed

Bickell, Nina A; Moss, Alexandra DeNardis; Castaldi, Maria; Shah, Ajay; Sickles, Alan; Pappas, Peter; Lewis, Theophilus; Kemeny, Margaret; Arora, Shalini; Schleicher, Lori; Fei, Kezhen; Franco, Rebeca; McAlearney, Ann Scheck

2017-12-01

To identify key organizational approaches associated with underuse of breast cancer care. Nine New York City area safety-net hospitals. Mixed qualitative-quantitative, cross-sectional cohort. We used qualitative comparative analysis (QCA) of key stakeholder interviews, defined organizational "conditions," calibrated conditions, and identified solution pathways. We defined underuse as no radiation after lumpectomy in women <75 years or mastectomy in women with ≥4 positive nodes, or no systemic therapy in women with tumors ≥1 cm. We used hierarchical models to assess organizational and patient factors' impact on underuse. Underuse varied by hospital (8-29 percent). QCA found lower underuse sites designated individuals to track and follow-up no-shows; shared clinical information during handoffs; had fully integrated electronic medical records enabling transfer of responsibility across specialties; had strong system support; allocated resources to cancer clinics; had a patient-centered culture paying close organizational attention to clinic patients. High underuse sites lacked these characteristics. Multivariate modeling found that hospitals with strong approaches to follow-up had low underuse rates (RR = 0.28; 0.08-0.95); individual patient characteristics were not significant. At safety-net hospitals, underuse of needed cancer therapies is associated with organizational approaches to track and follow-up treatment. Findings provide varying approaches to safety nets to improve cancer care delivery. © Health Research and Educational Trust.

Correction factor for ablation algorithms used in corneal refractive surgery with gaussian-profile beams

NASA Astrophysics Data System (ADS)

Jimenez, Jose Ramón; González Anera, Rosario; Jiménez del Barco, Luis; Hita, Enrique; Pérez-Ocón, Francisco

2005-01-01

We provide a correction factor to be added in ablation algorithms when a Gaussian beam is used in photorefractive laser surgery. This factor, which quantifies the effect of pulse overlapping, depends on beam radius and spot size. We also deduce the expected post-surgical corneal radius and asphericity when considering this factor. Data on 141 eyes operated on LASIK (laser in situ keratomileusis) with a Gaussian profile show that the discrepancy between experimental and expected data on corneal power is significantly lower when using the correction factor. For an effective improvement of post-surgical visual quality, this factor should be applied in ablation algorithms that do not consider the effects of pulse overlapping with a Gaussian beam.

Cardiovascular risk-benefit profile of sibutramine.

PubMed

Scheen, A J

2010-01-01

Sibutramine is a combined norepinephrine and serotonin reuptake inhibitor used as an antiobesity agent to reduce appetite and promote weight loss in combination with diet and exercise. At a daily dose of 10-20 mg, it was initially considered to have a good safety profile, as it does not induce primary pulmonary hypertension or adverse effects on cardiac valves, in contrast to previous reports relating to some other antiobesity agents. However, it exerts disparate effects on cardiovascular risk factors. On the one hand, sibutramine may have antiatherogenic activities, as it improves insulin resistance, glucose metabolism, dyslipidemia, and inflammatory markers, with most of these effects resulting from weight loss rather than from an intrinsic effect of the drug. On the other hand, because of its specific mode of action, sibutramine exerts a peripheral sympathomimetic effect, which induces a moderate increase in heart rate and attenuates the reduction in BP attributable to weight loss or even slightly increases BP. It may also prolong the QT interval, an effect that could induce arrhythmias. Because of these complex effects, it is difficult to conclude what the final impact of sibutramine on cardiovascular outcomes might be. Sibutramine has been shown to exert favorable effects on some surrogate cardiovascular endpoints such as reduction of left ventricular hypertrophy and improvement of endothelial dysfunction. A good cardiovascular safety profile was demonstrated in numerous 1- to 2-year controlled trials, in both diabetic and nondiabetic well selected patients, as well as in several observational studies. However, since 2002, several cardiovascular adverse events (hypertension, tachycardia, arrhythmias, and myocardial infarction) have been reported in sibutramine-treated patients. This led to a contraindication of the use of this antiobesity agent in patients with established coronary heart disease, previous stroke, heart failure, or cardiac arrhythmias. SCOUT

Cognitive factors affecting children's nonsymbolic and symbolic magnitude judgment abilities: A latent profile analysis.

PubMed

Chew, Cindy S; Forte, Jason D; Reeve, Robert A

2016-12-01

Early math abilities are claimed to be linked to magnitude representation ability. Some claim that nonsymbolic magnitude abilities scaffold the acquisition of symbolic (Arabic number) magnitude abilities and influence math ability. Others claim that symbolic magnitude abilities, and ipso facto math abilities, are independent of nonsymbolic abilities and instead depend on the ability to process number symbols (e.g., 2, 7). Currently, the issue of whether symbolic abilities are or are not related to nonsymbolic abilities, and the cognitive factors associated with nonsymbolic-symbolic relationships, remains unresolved. We suggest that different nonsymbolic-symbolic relationships reside within the general magnitude ability distribution and that different cognitive abilities are likely associated with these different relationships. We further suggest that the different nonsymbolic-symbolic relationships and cognitive abilities in combination differentially predict math abilities. To test these claims, we used latent profile analysis to identify nonsymbolic-symbolic judgment patterns of 124, 5- to 7-year-olds. We also assessed four cognitive factors (visuospatial working memory [VSWM], naming numbers, nonverbal IQ, and basic reaction time [RT]) and two math abilities (number transcoding and single-digit addition abilities). Four nonsymbolic-symbolic ability profiles were identified. Naming numbers, VSWM, and basic RT abilities were differentially associated with the different ability profiles and in combination differentially predicted math abilities. Findings show that different patterns of nonsymbolic-symbolic magnitude abilities can be identified and suggest that an adequate account of math development should specify the inter-relationship between cognitive factors and nonsymbolic-symbolic ability patterns. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk factors for fishermen's health and safety in Greece.

PubMed

Frantzeskou, Elpida; Kastania, Anastasia N; Riza, Elena; Jensen, Olaf C; Linos, Athena

2012-01-01

This is, to the best of our knowledge, the first occupational health study in Greek fishing. The aim of the study is to determine the risks for health and safety in Greek fisheries workers by exploring their health status and the health risk factors present in their occupational environment, thus providing a current baseline for further research in the future and for documentation of the needs for prevention. A questionnaire pilot study was carried out in a random sample of 100 Greek fishermen. Twenty-eight per cent (28%) had experienced at least one injury, of which half caused more than one day absence, while 14% had a near drowning experience. The health risks factors studied include excessive weight, cardiovascular incidents and dermatological, musculoskeletal, respiratory, hearing, stress, and anxiety problems. The occupational health risk factors include alcohol, fatty food consumption, smoking, and lack of physical exercise. The health effects observed are causally related to diet, smoking, and exercise, which in turn relate to the specific working conditions and culture in small-scale fishing that need to be taken into consideration in prevention programmes. The results are comparable with international fisheries experience, mainly from Poland, Denmark, and Turkey.

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism

PubMed Central

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

2016-01-01

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors’ expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers’ caring and communication (CCC) and coworkers’ role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry. PMID:27834823

Multilevel Safety Climate and Safety Performance in the Construction Industry: Development and Validation of a Top-Down Mechanism.

PubMed

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

2016-11-08

The character of construction projects exposes front-line workers to dangers and accidents. Safety climate has been confirmed to be a predictor of safety performance in the construction industry. This study aims to explore the underlying mechanisms of the relationship between multilevel safety climate and safety performance. An integrated model was developed to study how particular safety climate factors of one level affect those of other levels, and then affect safety performance from the top down. A questionnaire survey was administered on six construction sites in Vietnam. A total of 1030 valid questionnaires were collected from this survey. Approximately half of the data were used to conduct exploratory factor analysis (EFA) and the remaining data were submitted to structural equation modeling (SEM). Top management commitment (TMC) and supervisors' expectation (SE) were identified as factors to represent organizational safety climate (OSC) and supervisor safety climate (SSC), respectively, and coworkers' caring and communication (CCC) and coworkers' role models (CRM) were identified as factors to denote coworker safety climate (CSC). SEM results show that OSC factor is positively related to SSC factor and CSC factors significantly. SSC factor could partially mediate the relationship between OSC factor and CSC factors, as well as the relationship between OSC factor and safety performance. CSC factors partially mediate the relationship between OSC factor and safety performance, and the relationship between SSC factor and safety performance. The findings imply that a positive safety culture should be established both at the organizational level and the group level. Efforts from all top management, supervisors, and coworkers should be provided to improve safety performance in the construction industry.

Different Recovery Profiles of Coagulation Factors, Thrombin Generation, and Coagulation Function After Hemorrhagic Shock in Pigs

DTIC Science & Technology

2012-06-06

Different recovery profiles of coagulation factors, thrombin generation, and coagulation function after hemorrhagic shock in pigs Wenjun Z. Martini ...Defense. Address for reprints: Wenjun Z. Martini , PhD, The US Army Institute of Surgical Research, 3698 Chambers Pass, Ft. Sam Houston, San Antonio, TX...control number 1. REPORT DATE 01 SEP 2015 2. REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE Different recovery profiles of

Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

PubMed

Schwatka, Natalie V; Rosecrance, John C

2016-06-16

There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

Safety edge crash modification factors : tech brief.

DOT National Transportation Integrated Search

2016-08-01

The Safety Edge is a relatively low-cost : countermeasure that can be applied : in both asphalt and concrete paving : operations. The Safety Edge has been : promoted as a low-cost countermeasure : to reduce the frequency and severity : of rural roadw...

Safety of topical minoxidil solution: a one-year, prospective, observational study.

PubMed

Shapiro, Jerry

2003-01-01

Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.

The development of local calibration factors for implementing the highway safety manual in Maryland.

DOT National Transportation Integrated Search

2014-03-01

The goal of the study was to determine local calibration factors (LCFs) to adjust predicted motor : vehicle traffic crashes for the Maryland-specific application of the Highway Safety Manual : (HSM). Since HSM predictive models were developed using d...

Performance of food safety management systems in poultry meat preparation processing plants in relation to Campylobacter spp. contamination.

PubMed

Sampers, Imca; Jacxsens, Liesbeth; Luning, Pieternel A; Marcelis, Willem J; Dumoulin, Ann; Uyttendaele, Mieke

2010-08-01

A diagnostic instrument comprising a combined assessment of core control and assurance activities and a microbial assessment instrument were used to measure the performance of current food safety management systems (FSMSs) of two poultry meat preparation companies. The high risk status of the company's contextual factors, i.e., starting from raw materials (poultry carcasses) with possible high numbers and prevalence of pathogens such as Campylobacter spp., requires advanced core control and assurance activities in the FSMS to guarantee food safety. The level of the core FSMS activities differed between the companies, and this difference was reflected in overall microbial quality (mesophilic aerobic count), presence of hygiene indicators (Enterobacteriaceae, Staphylococcus aureus, and Escherichia coli), and contamination with pathogens such as Salmonella, Listeria monocytogenes, and Campylobacter spp. The food safety output expressed as a microbial safety profile was related to the variability in the prevalence and contamination levels of Campylobacter spp. in poultry meat preparations found in a Belgian nationwide study. Although a poultry meat processing company could have an advanced FSMS in place and a good microbial profile (i.e., lower prevalence of pathogens, lower microbial numbers, and less variability in microbial contamination), these positive factors might not guarantee pathogen-free products. Contamination could be attributed to the inability to apply effective interventions to reduce or eliminate pathogens in the production chain of (raw) poultry meat preparations.

Consideration of the FQPA Safety Factor and Other Uncertainty Factors in Cumulative Risk Assessment of Chemicals Sharing a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This guidance document provides OPP's current thinking on application of the provision in FFDCA about an additional safety factor for the protection of infants and children in the context of cumulative risk assessments.

Comparison of risk factor profiles in incidental Lewy body disease and Parkinson disease.

PubMed

Frigerio, Roberta; Fujishiro, Hiroshige; Maraganore, Demetrius M; Klos, Kevin J; DelleDonne, Anthony; Heckman, Michael G; Crook, Julia E; Josephs, Keith A; Parisi, Joseph E; Boeve, Bradley F; Dickson, Dennis W; Ahlskog, J Eric

2009-09-01

To explore whether associations of potential risk factors for incidental Lewy body disease (iLBD) are similar to those for Parkinson disease (PD). Brain autopsy study (1988-2004) of subjects without evidence of neurodegenerative disease or tremor who were evaluated by at least 1 physician within 1 year of death. Researchers analyzed incidental Lewy pathology blinded to clinical abstraction. Olmsted County, Minnesota. Subjects Residents of Olmsted County and the immediate vicinity aged older than 60 years. Whether risk factors previously associated with PD in Olmsted County are also associated with iLBD. Of 235 subjects, 34 had iLBD (14.5%). The overall risk factor profiles for iLBD and PD were fairly similar between the 2 sets of odds ratio (OR) estimates, with 11 of 16 ORs in the same direction. Prior Olmsted County studies documented 7 risk factors with statistically significant associations with PD; for physician occupation and caffeine intake, the ORs for iLBD were in the same direction and statistically significant, whereas for education, head injury, and number of children, they were in the same direction but not significant; they were in the opposite direction but not statistically significant for depression and anxiety. Incidental Lewy body disease was not associated with various end-of-life conditions or causes of death, though these patients were slightly older and more likely cachectic. Based on this exploratory study, iLBD and PD appear to have similar risk factor profiles. Thus, at least some cases of iLBD could represent preclinical PD, arrested PD, or a partial syndrome due to a lesser burden of causative factors. Incidental Lewy body disease is not explained by nonspecific end-of-life brain insults.

Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

PubMed

Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

2017-12-01

Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

Real-Life Efficacy, Immunogenicity and Safety of Biosimilar Infliximab.

PubMed

Vegh, Zsuzsanna; Kurti, Zsuzsanna; Lakatos, Peter L

2017-01-01

Recently, the use of biosimilar infliximab (IFX) in the treatment of inflammatory bowel diseases has become widespread in some European and non-European countries. Data on the efficacy, safety and immunogenicity from real-life cohorts are accumulating. The first reports showed similar outcomes in the induction and maintenance of remission, mucosal healing, safety and immunogenicity profile to the originator IFX. In the present review, we aimed to summarize the existing knowledge on the efficacy, safety and immunogenicity profile of biosimilar IFX reported from real-life cohorts. © 2017 S. Karger AG, Basel.

AGE-Related Differences of Novel Atherosclerotic Risk Factors and Angiographic Profile Among Gujarati Acute Coronary Syndrome Patients

PubMed Central

Joshi, Hasit; Sahoo, Sibasis; Virpariya, Kapil; Parmar, Meena; Shah, Komal

2015-01-01

Context Although numerous risk factors have been established to predict the development of acute coronary syndrome (ACS), the risk factor profile may be different between the younger and older individuals. Aim To analyse the frequency and pattern of atherogenic risk factors and angiographic profiles in age-stratified Gujarati patients with ACS. Materials and Methods ACS patients undergoing coronary angiography at U.N. Mehta Institute of Cardiology and Research, Gujarat, India between January 2008 and December 2012 were classified in to two age groups with 40y as cut-off. Patients were assessed for conventional risk factors (diabetes mellitus, dyslipidaemia, hypertension, smoking, obesity), novel risk factors (high sensitivity C-reactive protein, lipoprotein (a), homocysteine), and angiographic profiles.The statistical difference between two age groups was determined by Student’s t-test for continuous variables and Chi-square or Fisher’s exact test for categorical variables. Results A total of 200 patients, 100 patients ≤40 y of age and 100 patients >40 y of age, were evaluated. Older patients had higher frequency of hypertension (32 vs. 16%, p=0.008), while family history of coronary artery disease was more common among younger patients (19 vs. 9%, p=0.041). The incidence of diabetes, dyslipidaemia, smoking and tobacco chewing did not vary significantly between the two groups. Total cholesterol and low-density lipoprotein cholesterol levels were significantly higher in the younger group (p<0.05). Lipoprotein (a), homocysteine and high-sensitivity C reactive protein levels were comparable between two age groups. Multi-vessel coronary artery disease was more common among older group. The most commonly affected coronary artery was the left anterior descending artery among younger patients (44%) and the left circumflex artery among older patients (38.1%). Conclusion Young patients with ACS had different atherosclerotic risk profile and less extensive coronary

Profile of drowning victims in a coastal community.

PubMed

Nichter, M A; Everett, P B

1989-02-01

Accidental drowning accounts for 15% of all accidental deaths in Pinellas County, Florida, and this study was conducted to better understand the epidemiologic profile of the victim. The medical examiner's records of 230 drownings in Pinellas County from January 1, 1983, through December 31, 1987, were reviewed for demographic and epidemiologic data. Bodies of salt water were the most common drowning site (47%), followed by swimming pools (22%), lakes (11%), baths (7%), and canals (6%). The drowning incidence for males was more than three times that for females. Drowning was endemic among boys less than five years of age (30/100,000/year). Fifty-nine percent of young adult victims had detectable postmortem blood alcohol levels. Drowning rates were highest among children less than five years and adults more than 80 years. Epidemiologic profiles of populations at risk and contributing factors are described and public safety measures are suggested.

Factors Influencing Young Children's Risk of Unintentional Injury: Parenting Style and Strategies for Teaching about Home Safety

ERIC Educational Resources Information Center

Morrongiello, Barbara A.; Corbett, Michael; Lasenby, Jennifer; Johnston, Natalie; McCourt, Meghan

2006-01-01

This study examined mothers' teaching about home-safety issues to 24-30 month and 36-42 month old children, explored the relationship of teaching strategies to parenting styles, and assessed how these factors are related to children's risk of unintentional injury. A structured interview assessed home-safety issues relevant to falls, burns, cuts,…

JASPAR 2014: an extensively expanded and updated open-access database of transcription factor binding profiles

PubMed Central

Mathelier, Anthony; Zhao, Xiaobei; Zhang, Allen W.; Parcy, François; Worsley-Hunt, Rebecca; Arenillas, David J.; Buchman, Sorana; Chen, Chih-yu; Chou, Alice; Ienasescu, Hans; Lim, Jonathan; Shyr, Casper; Tan, Ge; Zhou, Michelle; Lenhard, Boris; Sandelin, Albin; Wasserman, Wyeth W.

2014-01-01

JASPAR (http://jaspar.genereg.net) is the largest open-access database of matrix-based nucleotide profiles describing the binding preference of transcription factors from multiple species. The fifth major release greatly expands the heart of JASPAR—the JASPAR CORE subcollection, which contains curated, non-redundant profiles—with 135 new curated profiles (74 in vertebrates, 8 in Drosophila melanogaster, 10 in Caenorhabditis elegans and 43 in Arabidopsis thaliana; a 30% increase in total) and 43 older updated profiles (36 in vertebrates, 3 in D. melanogaster and 4 in A. thaliana; a 9% update in total). The new and updated profiles are mainly derived from published chromatin immunoprecipitation-seq experimental datasets. In addition, the web interface has been enhanced with advanced capabilities in browsing, searching and subsetting. Finally, the new JASPAR release is accompanied by a new BioPython package, a new R tool package and a new R/Bioconductor data package to facilitate access for both manual and automated methods. PMID:24194598

Safety profile of topical VEGF neutralization at the cornea.

PubMed

Bock, Felix; Onderka, Jasmine; Rummelt, Carmen; Dietrich, Tina; Bachmann, Björn; Kruse, Friedrich E; Schlötzer-Schrehardt, Ursula; Cursiefen, Claus

2009-05-01

Bevacizumab eyedrops inhibit corneal neovascularization. The purpose of this study was to analyze the safety profile of VEGF-A neutralization at the ocular surface. Bevacizumab eyedrops (5 mg/mL) and an antimurine VEGF-A antibody (250 microg/mL) were applied to normal murine corneas five times a day for 7 and 14 days. Subsequently, corneas were analyzed for morphologic changes by light and electron microscopy. In a mouse model of corneal epithelial abrasion, the effects of topically applied anti-VEGF antibodies on epithelial wound healing were analyzed: the treatment group received bevacizumab (5 mg/mL) or the antimurine VEGF-A antibody (250 microg/mL) as eyedrops, and the control group received an equal volume of saline solution. After 12, 18, and 24 hours, corneas were photographed in vivo with and without fluorescein staining for morphometry. Afterwards the mice were killed, and eyes were removed for histology, immunohistochemistry with Ki67/DAPI, and electron microscopy. The effect of midterm anti-VEGF therapy on corneal nerve density was assessed by staining corneas treated with an FITC-conjugated anti-neurofilament antibody and morphometric analysis. Murine corneas treated with two different types of anti-VEGF antibody eyedrops did not show obvious corneal morphologic changes at the light and electron microscopic levels. Furthermore, anti-VEGF antibody eyedrops had no significant impact on the wound healing process after corneal epithelial injury or on normal murine corneal nerve fiber density. Topical neutralization of VEGF-A at the corneal surface does not have significant side effects on normal corneal epithelial wound healing, normal corneal integrity, or normal nerve fiber density. Therefore, anti-VEGF eyedrops seem to be a relatively safe option to treat corneal neovascularization.

Donor profiles: demographic factors and their influence on the donor career.

PubMed

Veldhuizen, I J T; Doggen, C J M; Atsma, F; De Kort, W L A M

2009-08-01

Studying the contribution of demographic factors to the donor career provides important knowledge to be used for donor management. The aim of this study is to gain insight into donor characteristics, more specifically into the demographic profile of active vs. resigned donors, and multi-gallon vs. occasional donors. The study population consisted of all registered Dutch whole-blood donors between 1 January 2004 and 1 January 2005 (N = 370 470). The effect of several blood donor characteristics and demographic variables on (i) resigning donating and (ii) being a multi-gallon donor were assessed. Blood donor characteristics were extracted from the blood bank information system and included age, sex, blood group, number of donations and invitations. Demographic characteristics were constituted by population data on urbanization level, socio-economic status (income, housing value), and ethnicity. Men clearly resigned less often than women (odds ratio (OR) 0.73, 95% confidence interval (CI) 0.72-0.75). Being older than 24 years, having a high income, a high-priced house, living in less urbanized areas or areas with relatively few ethnically diverse people also reduced the stopping risk. With respect to multi-gallon donorship, men were five times more often multi-gallon donor than women (OR 5.27, 95% CI 5.15-5.39) irrespective of the number of donation invitations. Furthermore, multi-gallon donors appeared to live in urbanized areas and have a higher income than occasional donors. Our results show that different donor profiles can be distinguished. Differences between active and resigned donors include age, the number of donations, sex, socio-economic-status, ethnicity, and urbanization level. The factors highly associated with being a multi-gallon donor are sex, age, socio-economic status, and to a lesser extent urbanization level. Donor profiles do provide the blood bank with knowledge on their donor population, which may be used as valuable information for donor

Multidimensional Profiling of Task Stress States for Human Factors: A Brief Review.

PubMed

Matthews, Gerald

2016-09-01

This article advocates multidimensional assessment of task stress in human factors and reviews the use of the Dundee Stress State Questionnaire (DSSQ) for evaluation of systems and operators. Contemporary stress research has progressed from an exclusive focus on environmental stressors to transactional perspectives on the stress process. Performance impacts of stress reflect the operator's dynamic attempts to understand and cope with task demands. Multidimensional stress assessments are necessary to gauge the different forms of system-operator interaction. This review discusses the theoretical and practical use of the DSSQ in evaluating multidimensional patterns of stress response. It presents psychometric evidence for the multidimensional perspective and illustrative profiles of subjective state response to task stressors and environments. Evidence is also presented on stress state correlations with related variables, including personality, stress process measures, psychophysiological response, and objective task performance. Evidence supports the validity of the DSSQ as a task stress measure. Studies of various simulated environments show that different tasks elicit different profiles of stress state response. Operator characteristics such as resilience predict individual differences in state response to stressors. Structural equation modeling may be used to understand performance impacts of stress states. Multidimensional assessment affords insight into the stress process in a variety of human factors contexts. Integrating subjective and psychophysiological assessment is a priority for future research. Stress state measurement contributes to evaluating system design, countermeasures to stress and fatigue, and performance vulnerabilities. It may also support personnel selection and diagnostic monitoring of operators. © 2016, Human Factors and Ergonomics Society.

Safety and Pharmacokinetic Profiles of Repeated-Dose Micafungin in Children and Adolescents Treated for Invasive Candidiasis

PubMed Central

Benjamin, Daniel K.; Deville, Jaime G.; Azie, Nkechi; Kovanda, Laura; Roy, Mike; Wu, Chunzhang; Arrieta, Antonio

2013-01-01

Background Micafungin is an echinocandin with proven efficacy against a broad range of fungal infections, including those caused by Candida species. Objective To evaluate the safety and pharmacokinetics of once-daily 3 mg/kg and 4.5 mg/kg micafungin in children with proven, probable, or suspected invasive candidiasis. Methods Micafungin safety and pharmacokinetics were assessed in two Phase I, open-label, repeat-dose trials. In Study 2101, children aged 2–16 years were grouped by weight to receive 3 mg/kg (≥25 kg) or 4.5 mg/kg (<25 kg) intravenous micafungin for 10–14 days. In Study 2102, children aged 4 months to <2 years received 4.5 mg/kg micafungin. Study protocols were otherwise identical. Results Safety was analyzed in seventy-eight and nine children in Studies 2101 and 2102, respectively. Although adverse events were experienced by most children (2101: n = 62; 2102: n = 9), micafungin-related adverse events were less common (2101: n = 28; 2102: n = 1), and the number of patients discontinuing due to adverse events was low (2101: n = 4; 2102: n = 1). The most common micafungin-related adverse events were infusion-associated symptoms, pyrexia, and hypomagnesemia (Study 2101), and liver function abnormalities (Study 2102). The micafungin pharmacokinetic profile was similar to that seen in other studies conducted in children, but different than that observed in adults. Conclusions In this small cohort of children, once-daily doses of 3 mg/kg and 4.5 mg/kg micafungin were well tolerated. Pharmacokinetic data will be combined in a population pharmacokinetic analysis to support U.S. dosing recommendations in children. PMID:23958810

A Graphical Modelling Approach to the Dissection of Highly Correlated Transcription Factor Binding Site Profiles

PubMed Central

Stojnic, Robert; Fu, Audrey Qiuyan; Adryan, Boris

2012-01-01

Inferring the combinatorial regulatory code of transcription factors (TFs) from genome-wide TF binding profiles is challenging. A major reason is that TF binding profiles significantly overlap and are therefore highly correlated. Clustered occurrence of multiple TFs at genomic sites may arise from chromatin accessibility and local cooperation between TFs, or binding sites may simply appear clustered if the profiles are generated from diverse cell populations. Overlaps in TF binding profiles may also result from measurements taken at closely related time intervals. It is thus of great interest to distinguish TFs that directly regulate gene expression from those that are indirectly associated with gene expression. Graphical models, in particular Bayesian networks, provide a powerful mathematical framework to infer different types of dependencies. However, existing methods do not perform well when the features (here: TF binding profiles) are highly correlated, when their association with the biological outcome is weak, and when the sample size is small. Here, we develop a novel computational method, the Neighbourhood Consistent PC (NCPC) algorithms, which deal with these scenarios much more effectively than existing methods do. We further present a novel graphical representation, the Direct Dependence Graph (DDGraph), to better display the complex interactions among variables. NCPC and DDGraph can also be applied to other problems involving highly correlated biological features. Both methods are implemented in the R package ddgraph, available as part of Bioconductor (http://bioconductor.org/packages/2.11/bioc/html/ddgraph.html). Applied to real data, our method identified TFs that specify different classes of cis-regulatory modules (CRMs) in Drosophila mesoderm differentiation. Our analysis also found depletion of the early transcription factor Twist binding at the CRMs regulating expression in visceral and somatic muscle cells at later stages, which suggests a CRM

The prevalence of fatigue and associated health and safety risk factors among taxi drivers in Singapore

PubMed Central

Lim, See Ming; Chia, Sin Eng

2015-01-01

INTRODUCTION Driver fatigue is one of the biggest health and safety concerns within the road transport sector. This study aimed to determine the prevalence of fatigue among taxi drivers in Singapore, to better understand the general working and health conditions of this group of people, and to determine the risk factors associated with fatigued driving. METHODS A total of 340 taxi drivers were randomly selected for participation in a self-administered questionnaire survey, which included height and weight measurements. The response rate was 68.2%. The survey consisted of four main categories: personal particulars; social habits; work patterns; and sleep profile. The Epworth Sleepiness Scale was used to estimate the level of daytime sleepiness and fatigue. Multiple logistic regression analysis was used to estimate the adjusted odd ratios and 95% confidence intervals associated with risk factors related to fatigue among taxi drivers. RESULTS A high proportion of taxi drivers were obese and had self-reported hypertension, diabetes mellitus and high cholesterol. Driver fatigue was associated with very poor/poor self-rating of quality of sleep, having an additional part-time job, drinking three or more caffeinated drinks daily, and driving more than 10 hours a day. CONCLUSION We hope that the findings of the present study will improve awareness of the work and health conditions of taxi drivers, and contribute toward efforts to achieve a healthier workforce. A lower prevalence of fatigued driving may lead to lower risks of road traffic accidents, decreased economic loss, increased productivity, and safer roads for all. PMID:25532512

The prevalence of fatigue and associated health and safety risk factors among taxi drivers in Singapore.

PubMed

Lim, See Ming; Chia, Sin Eng

2015-02-01

Driver fatigue is one of the biggest health and safety concerns within the road transport sector. This study aimed to find out the prevalence of fatigue among taxi drivers in Singapore, to better understand the general working and health conditions of this group of people and to determine the risk factors associated with fatigued driving. A total of 340 taxi drivers were randomly selected for participation in this self-administered questionnaire survey, with height and weight measurements. The response rate was 68.2%. The survey consisted of four main categories: personal particulars; social habits; work patterns and sleep profile; and Epworth Sleepiness Scale, which was used to estimate the level of daytime sleepiness and fatigue. Multiple logistic regression analysis was used to estimate the adjusted odd ratios and 95% confidence intervals associated with the risk factors related to fatigue among the taxi drivers. A high proportion of the taxi drivers were obese and had self-reported hypertension, diabetes mellitus and high cholesterol. Driver fatigue was associated with very poor/poor self-rating of the quality of sleep, having an additional part-time job, drinking three or more caffeinated drinks daily, and driving more than 10 hours a day. We hope that the findings of the present study will improve the awareness regarding the work and health conditions of taxi drivers, and contribute toward the effort to achieve a healthier workforce. A lower prevalence of fatigued driving will lead to lower risks of road traffic accidents, decreased economic loss, increased productivity, and safer roads for all.

Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects

PubMed Central

Frost, Charles; Nepal, Sunil; Wang, Jessie; Schuster, Alan; Byon, Wonkyung; Boyd, Rebecca A; Yu, Zhigang; Shenker, Andrew; Barrett, Yu Chen; Mosqueda-Garcia, Rogelio; LaCreta, Frank

2013-01-01

Aim Apixaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation and thromboprophylaxis in patients who have undergone elective hip or knee replacement surgery and under development for treatment of venous thromboembolism. This study examined the safety, pharmacokinetics and pharmacodynamics of multiple dose apixaban. Method This double-blind, randomized, placebo-controlled, parallel group, multiple dose escalation study was conducted in six sequential dose panels – apixaban 2.5, 5, 10 and 25 mg twice daily and 10 and 25 mg once daily– with eight healthy subjects per panel. Within each panel, subjects were randomized (3:1) to oral apixaban or placebo for 7 days. Subjects underwent safety assessments and were monitored for adverse events (AEs). Blood samples were taken to measure apixaban plasma concentration, international normalized ratio (INR), activated partial thromboplastin time (aPTT) and modified prothrombin time (mPT). Results Forty-eight subjects were randomized and treated (apixaban, n = 36; placebo, n = 12); one subject receiving 2.5 mg twice daily discontinued due to AEs (headache and nausea). No dose limiting AEs were observed. Apixaban maximum plasma concentration was achieved ∼3 h post-dose. Exposure increased approximately in proportion to dose. Apixaban steady-state concentrations were reached by day 3, with an accumulation index of 1.3–1.9. Peak : trough ratios were lower for twice daily vs. once daily regimens. Clotting times showed dose-related increases tracking the plasma concentration–time profile. Conclusion Multiple oral doses of apixaban were safe and well tolerated over a 10-fold dose range, with pharmacokinetics with low variability and concentration-related increases in clotting time measures. PMID:23451769

Analysis of human factors effects on the safety of transporting radioactive waste materials: Technical report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abkowitz, M.D.; Abkowitz, S.B.; Lepofsky, M.

1989-04-01

This report examines the extent of human factors effects on the safety of transporting radioactive waste materials. It is seen principally as a scoping effort, to establish whether there is a need for DOE to undertake a more formal approach to studying human factors in radioactive waste transport, and if so, logical directions for that program to follow. Human factors effects are evaluated on driving and loading/transfer operations only. Particular emphasis is placed on the driving function, examining the relationship between human error and safety as it relates to the impairment of driver performance. Although multi-modal in focus, the widespreadmore » availability of data and previous literature on truck operations resulted in a primary study focus on the trucking mode from the standpoint of policy development. In addition to the analysis of human factors accident statistics, the report provides relevant background material on several policies that have been instituted or are under consideration, directed at improving human reliability in the transport sector. On the basis of reported findings, preliminary policy areas are identified. 71 refs., 26 figs., 5 tabs.« less

Investigation and identification of factors affecting migrating peasant workers' usage of safety footwear in the Chinese construction industry.

PubMed

Suo, Qinghui; Zhang, Daming

2017-09-01

A sample of 300 migrating peasant workers from 15 Chinese building construction sites completed a demographic questionnaire to investigate the usage of safety footwear. The survey form was constructed based on the theory of planned behaviour, and a total of 12 questions focusing on the workers' past experience, attitudes, subjective norms and perceived behavioural control were included in the survey. It was found that 92% of the participants did not wear safety footwear while working on construction sites, although more than 91% of them believed that safety footwear would protect the foot from injury; none of the participants had been provided free safety footwear by their employer. Regression analysis shows that employers' attitude is the most important factor affecting their usage of safety footwear, 'providing free safety footwear' and 'comfortability of the safety footwear' ranking second and third respectively.

The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

PubMed

Sze, N N; Wong, S C; Lee, C Y

2014-12-01

In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Developing patient safety in dentistry.

PubMed

Pemberton, M N

2014-10-01

Patient safety has always been important and is a source of public concern. Recent high profile scandals and subsequent reports, such as the Francis report into the failings at Mid Staffordshire, have raised those concerns even higher. Mortality and significant morbidity associated with the practice of medicine has led to many strategies to help improve patient safety, however, with its lack of associated mortality and lower associated morbidity, dentistry has been slower at systematically considering how patient safety can be improved. Recently, several organisations, researchers and clinicians have discussed the need for a patient safety culture in dentistry. Strategies are available to help improve patient safety in healthcare and deserve further consideration in dentistry.

Cardiovascular risk factor profiles in mild to moderate hypertensives seen at Kenyatta National Hospital.

PubMed

Yonga, G O; Ogola, E N; Juma, F D

1993-11-01

Sixty newly diagnosed adult patients with mild to moderate essential hypertension were assessed to determine their cardiovascular risk factor profiles. Detailed history and physical examinations were done. Resting 12-lead ECG was done and serum levels of uric acid, fasting cholesterol, and fasting glucose were determined. Twenty nine patients had hypertension and two or more cardiovascular risk factors. The most prevalent cardiovascular risk factors other than hypertension were electro-cardiovascular left ventricular hypertrophy (31.7%), obesity (28.3%) and hypercholesterolaemia (28.3%). About a half of these patients (48.3%) can be classified as high risk hypertensives. This calls for aggressive management of cardiovascular risk factors as a whole and not just hypertension alone if we are to reduce incidence of hypertensive complications.

21 CFR 601.35 - Evaluation of safety.

Code of Federal Regulations, 2010 CFR

2010-04-01

... established, low-risk profile). Upon reviewing the relevant product characteristics and safety information..., carrier, or ligand; (3) The risks of an incorrect diagnostic determination; (4) The adverse reaction profile of the drug; (5) Results of human experience with the radiopharmaceutical for other uses; and (6...

Correlation of causal factors that influence construction safety performance: A model.

PubMed

Rodrigues, F; Coutinho, A; Cardoso, C

2015-01-01

The construction sector has presented positive development regarding the decrease in occupational accident rates in recent years. Regardless, the construction sector stands out systematically from other industries due to its high number of fatalities. The aim of this paper is to deeply understand the causality of construction accidents from the early design phase through a model. This study reviewed several research papers presenting various analytical models that correlate the contributing factors to occupational accidents in this sector. This study also analysed different construction projects and conducted a survey of design and site supervision teams. This paper proposes a model developed from the analysis of existing ones, which correlates the causal factors through all the construction phases. It was concluded that effective risk prevention can only be achieved by a global correlation of causal factors including not only production ones but also client requirements, financial climate, design team competence, project and risk management, financial capacity, health and safety policy and early planning. Accordingly, a model is proposed.

Applications of aerospace technology in industry, a technology transfer profile: Fire safety

NASA Technical Reports Server (NTRS)

Kottenstette, J. P.; Freeman, J. E.; Heins, C. R.; Hildred, W. M.; Johnson, F. D.; Staskin, E. R.

1971-01-01

The fire safety field is considered as being composed of three parts: an industry, a technology base, and a user base. An overview of the field is presented, including a perspective on the magnitude of the national fire safety problem. Selected NASA contributions to the technology of fire safety are considered. Communication mechanisms, particularly conferences and publications, used by NASA to alert the community to new developments in the fire safety field, are reviewed. Several examples of nonaerospace applications of NASA-generated fire safety technology are also presented. Issues associated with attempts to transfer this technology from the space program to other sectors of the American economy are outlined.

Coagulation Profile as a Risk Factor for 30-Day Morbidity and Mortality Following Posterior Lumbar Fusion.

PubMed

Bronheim, Rachel S; Oermann, Eric K; Cho, Samuel K; Caridi, John M

2017-06-15

A retrospective cohort study. The aim of this study was to identify associations between abnormal coagulation profile and postoperative morbidity and mortality in patients undergoing posterior lumbar fusion (PLF). The literature suggests that abnormal coagulation profile is associated with postoperative complications, notably the need for blood transfusion. However, there is little research that directly addresses the influence of coagulation profile on postoperative complications following PLF. The American College of Surgeons National Surgical Quality Improvement Program database (ACS-NSQIP) was utilized to identify patients undergoing PLF between 2006 and 2013. Nine thousand two hundred ninety-five patients met inclusion criteria. Multivariate analysis was utilized to identify associations between abnormal coagulation profile and postoperative complications. Low platelet count was an independent risk factor for organ space surgical site infections (SSIs) [odds ratio (OR) = 6.0, P < 0.001], ventilation >48 hours (OR = 4.5, P = 0.002), Acute renal failure (OR = 5.8, P = 0.007), transfusion (OR = 1.6, P < 0.001), sepsis (OR = 2.2, P = 0.037), reoperation (OR = 2.5, P = 0.001), and death (OR = 3.7, P = 0.049). High partial thromboplastin time (PTT) was an independent risk factor for ventilation >48 hours (OR = 5.6, P = 0.002), cerebrovascular accident (CVA)/stroke with neurological deficit (OR = 5.1, P = 0.011), cardiac arrest (OR = 5.4, P = 0.030), transfusion (OR = 1.5, P = 0.020), and death (OR = 4.5, P = 0.050). High International Normalized Ration (INR) was an independent risk factor for pneumonia (OR = 8.7, P = 0.001), pulmonary embolism (OR = 5.6, P = 0.021), deep venous thrombosis/Thrombophlebitis (OR = 4.8, P = 0.011), septic shock (OR = 8.4, P = 0.048), and death (OR = 9.8, P = 0.034). Bleeding disorder was an

Latent profiles of family background, personality and mental health factors and their association with behavioural addictions and substance use disorders in young Swiss men.

PubMed

Marmet, Simon; Studer, Joseph; Rougemont-Bücking, Ansgar; Gmel, Gerhard

2018-05-04

Recent theories suggest that behavioural addictions and substance use disorders may be the result of the same underlying vulnerability. The present study investigates profiles of family background, personality and mental health factors and their associations with seven behavioural addictions (to the internet, gaming, smartphones, internet sex, gambling, exercise and work) and three substance use disorder scales (for alcohol, cannabis and tobacco). The sample consisted of 5287 young Swiss men (mean age = 25.42) from the Cohort Study on Substance Use Risk Factors (C-SURF). A latent profile analysis was performed on family background, personality and mental health factors. The derived profiles were compared with regards to means and prevalence rates of the behavioural addiction and substance use disorder scales. Seven latent profiles were identified, ranging from profiles with a positive family background, favourable personality patterns and low values on mental health scales to profiles with a negative family background, unfavourable personality pattern and high values on mental health scales. Addiction scale means, corresponding prevalence rates and the number of concurrent addictions were highest in profiles with high values on mental health scales and a personality pattern dominated by neuroticism. Overall, behavioural addictions and substance use disorders showed similar patterns across latent profiles. Patterns of family background, personality and mental health factors were associated with different levels of vulnerability to addictions. Behavioural addictions and substance use disorders may thus be the result of the same underlying vulnerabilities. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Profiles of Bullying Victimization, Discrimination, Social Support, and School Safety: Links with Latino/a Youth Acculturation, Gender, Depressive Symptoms, and Cigarette Use

PubMed Central

Lorenzo-Blanco, Elma I.; Unger, Jennifer B.; Oshri, Assaf; Baezconde-Garbanati, Lourdes; Soto, Daniel

2016-01-01

Latino/a youth are at risk for symptoms of depression and cigarette smoking but this risk varies by acculturation and gender. To understand why some youth are at greater risk than others, we identified profiles of diverse community experiences (perceived discrimination, bullying victimization, social support, perceived school safety) and examined associations between profiles of community experience and depressive symptoms, cigarette smoking, acculturation, and gender. Data came from Project Red (Reteniendo y Entendiendo Diversidad para Salud), a school-based longitudinal study of acculturation among 1919 Latino/a adolescents (52% female; 84% 14 years old; 87% U.S. born). Latent profile analysis (LPA) revealed four distinct profiles of community experience which varied by gender and acculturation. Boys were overrepresented in profile groups with high perceived discrimination, some bullying, and lack of positive experiences, while girls were overrepresented in groups with high bullying victimization in the absence and presence of other community experiences. Youth low on both U.S. and Latino/a cultural orientation described high perceived discrimination and lacked positive experiences, and were predominantly male. Profiles characterized by high perceived discrimination and/or high bullying victimization in the absence of positive experiences had higher levels of depressive symptoms and higher risk of smoking, relative to the other groups. Findings suggest that acculturation comes with diverse community experiences that vary by gender and relate to smoking and depression risk. Results from this research can inform the development of tailored intervention and prevention strategies to reduce depression and/or smoking for Latino/a youth at risk for depression and/or smoking. PMID:26752445

Profiles of bullying victimization, discrimination, social support, and school safety: Links with Latino/a youth acculturation, gender, depressive symptoms, and cigarette use.

PubMed

Lorenzo-Blanco, Elma I; Unger, Jennifer B; Oshri, Assaf; Baezconde-Garbanati, Lourdes; Soto, Daniel

2016-01-01

Latino/a youth are at risk for symptoms of depression and cigarette smoking but this risk varies by acculturation and gender. To understand why some youth are at greater risk than others, we identified profiles of diverse community experiences (perceived discrimination, bullying victimization, social support, perceived school safety) and examined associations between profiles of community experience and depressive symptoms, cigarette smoking, acculturation, and gender. Data came from Project Red (Reteniendo y Entendiendo Diversidad para Salud), a school-based longitudinal study of acculturation among 1,919 Latino/a adolescents (52% female; 84% 14 years old; 87% U.S. born). Latent profile analysis (LPA) revealed 4 distinct profiles of community experience that varied by gender and acculturation. Boys were overrepresented in profile groups with high perceived discrimination, some bullying, and lack of positive experiences, while girls were overrepresented in groups with high bullying victimization in the absence and presence of other community experiences. Youth low on both U.S. and Latino/a cultural orientation described high perceived discrimination and lacked positive experiences, and were predominantly male. Profiles characterized by high perceived discrimination and /or high bullying victimization in the absence of positive experiences had higher levels of depressive symptoms and higher risk of smoking, relative to the other groups. Findings suggest that acculturation comes with diverse community experiences that vary by gender and relate to smoking and depression risk. Results from this research can inform the development of tailored intervention and prevention strategies to reduce depression and/or smoking for Latino/a youth. (c) 2016 APA, all rights reserved).

Safety assessment of adjuvanted vaccines: Methodological considerations

PubMed Central

Da Silva, Fernanda Tavares; Di Pasquale, Alberta; Yarzabal, Juan P; Garçon, Nathalie

2015-01-01

Adjuvants mainly interact with the innate immune response and are used to enhance the quantity and quality of the downstream adaptive immune response to vaccine antigens. Establishing the safety of a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in the laboratory, and that continues throughout the vaccine life-cycle. The strategy for the evaluation of safety pre-licensure is guided by the disease profile, vaccine indication, and target population, and it is also influenced by available regulatory guidelines. In order to allow meaningful interpretation of clinical data, clinical program methodology should be optimized and standardized, making best use of all available data sources. Post-licensure safety activities are directed by field experience accumulated pre- and post-licensure clinical trial data and spontaneous adverse event reports. Continued evolution of safety evaluation processes that keep pace with advances in vaccine technology and updated communication of the benefit-risk profile is necessary to maintain public confidence in vaccines. PMID:26029975

Normal Hemostatic Profiles and Coagulation Factors in Healthy Free-Living Florida Manatees ( Trichechus manatus latirostris).

PubMed

Barratclough, Ashley; Floyd, Ruth Francis; Conner, Bobbi; Reep, Roger; Ball, Ray; Stacy, Nicole

2016-10-01

Hemostatic disorders presumptively play an important role in the pathophysiology of several important disease conditions in the Florida manatee ( Trichechus manatus latirostris). Prior to pursuing such clinical implications, it is essential to establish normal hemostatic profiles in clinically healthy animals. During annual health assessments of free-living manatees organized by the US Geological Survey, blood samples were collected from 12 healthy animals from the Atlantic coast and 28 from the Gulf of Mexico coast of Florida, with body lengths of 210-324 cm. The following analyses were performed on citrated plasma: prothrombin (PT), partial thromboplastin time (PTT), and concentrations of fibrinogen, D-dimers, and coagulation factors VII, VIII, IX, X, XI, and XII. Compared to other mammalian species, manatees had short PT (9.2±1.5 s) and PTT (10.7±0.5 s), fibrinogen was 369±78.7 mg/dL, antithrombin III was 132±11%, and D-dimer was 142±122 ng/mL. Baseline concentrations for the listed coagulation factors were established. When comparing coagulation factors between locations, Atlantic coast manatees had significantly higher factors VIII, IX, and X than did Gulf Coast manatees. This finding may reflect differences in water salinity, diet, or genetics. There were no differences in coagulation factors when among sexes and sizes. These baselines for hemostatic profiles and coagulation factors in healthy free-living manatees lay the foundation for diagnosis and future research of hemostatic disorders and contribute to understanding their role in the pathophysiology of manatees affected by various diseases.

Human factors experts beginning to focus on organizational factors in safety.

PubMed

Westrum, R

1996-10-01

The role of organizational culture in aviation safety is explored. Information flow is used to demonstrate three ranges of climate within an organization. Organizations may be pathological in which information is hidden, bureaucratic in which information is ignored, or generative in which information is actively sought. The effects of organizational change on personnel are explored with emphasis on mergers between air carriers. The relationship between safety measures and economic pressures is discussed.

Safety profile comparison between extemporaneous and a licensed preparation of caffeine citrate in preterm infants with apnea of prematurity.

PubMed

Vatlach, Scarlet; Arand, Joerg; Engel, Corinna; Poets, Christian F

2014-01-01

Given the lack of a licensed product (LP), extemporaneous caffeine citrate (ECC) has been used by many hospital pharmacies. Since July 2011, an LP has been available in Germany. We prospectively compared the safety profile of ECC and LP in preterm infants with apnea of prematurity. Between April 2010 and April 2013, selected side effects occurring with ECC or LP were documented in 6 German NICUs for infants ≤34 weeks' gestation using a longitudinal study design. The software developed for daily prescriptions in NICU residents requires entries if any of the following symptoms occurred during the last 24 h: tachycardia (resting heart rate >200/min), clinical or encephalographic seizures, gastric residuals, vomiting, or necrotizing enterocolitis (NEC). ECC and LP were administered at identical doses (20 mg/kg/day loading, 5-10 mg/kg/day maintenance) and in similar formulations either orally or intravenously. 562 infants with 14,590 treatment days on ECC and 538 infants with 12,813 treatment days on LP were evaluated. The mean gestational age was similar (29.20 weeks for ECC vs. 29.14 weeks for LP). No relevant differences were seen concerning tachycardia, gastric residuals, or vomiting, but ECC was associated with a higher risk of NEC (risk ratio: 2.68, 95% CI: 1.01-7.23, p = 0.047) and, albeit not significantly so, seizures (risk ratio: 1.91, 95% CI: 0.53-6.96, p = 0.35). This survey demonstrates a similar safety profile for both forms of caffeine citrate. The lower NEC and seizure rate seen with the LP is intriguing, but requires confirmation in a controlled study design. © 2013 S. Karger AG, Basel.

Transcriptome Profiling of Pediatric Core Binding Factor AML

PubMed Central

Hsu, Chih-Hao; Nguyen, Cu; Yan, Chunhua; Ries, Rhonda E.; Chen, Qing-Rong; Hu, Ying; Ostronoff, Fabiana; Stirewalt, Derek L.; Komatsoulis, George; Levy, Shawn

2015-01-01

The t(8;21) and Inv(16) translocations disrupt the normal function of core binding factors alpha (CBFA) and beta (CBFB), respectively. These translocations represent two of the most common genomic abnormalities in acute myeloid leukemia (AML) patients, occurring in approximately 25% pediatric and 15% of adult with this malignancy. Both translocations are associated with favorable clinical outcomes after intensive chemotherapy, and given the perceived mechanistic similarities, patients with these translocations are frequently referred to as having CBF-AML. It remains uncertain as to whether, collectively, these translocations are mechanistically the same or impact different pathways in subtle ways that have both biological and clinical significance. Therefore, we used transcriptome sequencing (RNA-seq) to investigate the similarities and differences in genes and pathways between these subtypes of pediatric AMLs. Diagnostic RNA from patients with t(8;21) (N = 17), Inv(16) (N = 14), and normal karyotype (NK, N = 33) were subjected to RNA-seq. Analyses compared the transcriptomes across these three cytogenetic subtypes, using the NK cohort as the control. A total of 1291 genes in t(8;21) and 474 genes in Inv(16) were differentially expressed relative to the NK controls, with 198 genes differentially expressed in both subtypes. The majority of these genes (175/198; binomial test p-value < 10−30) are consistent in expression changes among the two subtypes suggesting the expression profiles are more similar between the CBF cohorts than in the NK cohort. Our analysis also revealed alternative splicing events (ASEs) differentially expressed across subtypes, with 337 t(8;21)-specific and 407 Inv(16)-specific ASEs detected, the majority of which were acetylated proteins (p = 1.5x10-51 and p = 1.8x10-54 for the two subsets). In addition to known fusions, we identified and verified 16 de novo fusions in 43 patients, including three fusions involving NUP98 in six patients

Relationship between organizational justice and organizational safety climate: do fairness perceptions influence employee safety behaviour?

PubMed

Gyekye, Seth Ayim; Haybatollahi, Mohammad

2014-01-01

This study investigated the relationships between organizational justice, organizational safety climate, job satisfaction, safety compliance and accident frequency. Ghanaian industrial workers participated in the study (N = 320). Safety climate and justice perceptions were assessed with Hayes, Parender, Smecko, et al.'s (1998) and Blader and Tyler's (2003) scales respectively. A median split was performed to dichotomize participants into 2 categories: workers with positive and workers with negative justice perceptions. Confirmatory factors analysis confirmed the 5-factor structure of the safety scale. Regression analyses and t tests indicated that workers with positive fairness perceptions had constructive perspectives regarding workplace safety, expressed greater job satisfaction, were more compliant with safety policies and registered lower accident rates. These findings provide evidence that the perceived level of fairness in an organization is closely associated with workplace safety perception and other organizational factors which are important for safety. The implications for safety research are discussed.

Risk for household safety hazards: Socioeconomic and sociodemographic factors.

PubMed

Mayes, Sunnye; Roberts, Michael C; Stough, Cathleen Odar

2014-12-01

Many unintentional injuries to young children occur in the home. The current study examines the relation between family socioeconomic and sociodemographic factors and risk factors for home injury. Presence of household hazards was examined in 80 families with toddler-aged children. Parental ability to identify household hazards in pictures was also assessed. ANOVAs and Pearson product-moment correlations examined the relationship between presence of household hazards, knowledge to identify hazards, and factors of yearly family income, parental age, parental education, parental marital status, child ethnicity, and the number of children living in the home. A greater number of hazards were found in the homes of both the lowest and highest income families, but poorer knowledge to identify household hazards was found only among parents of the lowest income families and younger parents. Across family socioeconomic status, parent knowledge of hazards was related to observed household hazards. The relationship between family income and risk for injury is complex, and children of both lower and higher SES families may be at risk for injury. While historically particular focus has been placed on risk for injury among children in low income families, injury prevention efforts should target reducing presence of household hazards in both high and low SES families. Copyright © 2014 National Safety Council and Elsevier Ltd. Published by Elsevier Ltd. All rights reserved.

Safety Profile of Oral Iron Chelator Deferiprone in Chinese Children with Transfusion-Dependent Thalassaemia.

PubMed

Botzenhardt, Sebastian; Sing, Chor W; Wong, Ian C K; Chan, Godfrey Chi-Fung; Wong, Lisa Y L; Felisi, Mariagrazia; Rascher, Wolfgang; Ceci, Adriana; Neubert, Antje

2016-01-01

There is a lack of knowledge regarding the incidence of serious adverse drug reactions (ADR) to the oral iron chelator deferiprone in Chinese children with transfusion-dependent thalassaemia. In this retrospective population-based cohort study, paediatric thalassaemia patients in Hong Kong were screened for serious and medically important adverse events related to deferiprone therapy using diagnosis codes, laboratory data and hospital admissions. Potential ADRs were assessed by reviewing concomitant medications, diagnoses and laboratory data and evaluated using standardised causality assessment. Eighty-seven patients contributing 169.8 person-years were included. Thirty ADRs were identified in 21 patients. Most ADRs (56.0%) occurred in the first three months of therapy. Neutropenia occurred in 11 patients (12.6%; incidence rate 6.5 per 100 patient-years) and severe neutropenia (agranulocytosis) was observed in 5 patients (5.7%, incidence rate 2.9 per 100 patient-years). Other identified ADRs involve severe arthropathy, elevated liver enzymes and mild thrombocytopenia. In conclusion, the safety profile of DFP therapy in Chinese children suffering from transfusion-dependent thalassaemia is in line with previous studies of non-Chinese children. However, unlike previous studies, we observed a relatively high incidence of agranulocytosis and neutropenia in patients with simultaneous combined therapy. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy. Further prospective clinical and pharmacogenetic studies are required to better evaluate this important safety signal. • Half of the identified ADRs related to deferiprone therapy occurred during the first three months of treatment. • A relatively high incidence of agranulocytosis and neutropenia. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy.

Identification of diverse nerve growth factor-regulated genes by serial analysis of gene expression (SAGE) profiling

PubMed Central

Angelastro, James M.; Klimaschewski, Lars; Tang, Song; Vitolo, Ottavio V.; Weissman, Tamily A.; Donlin, Laura T.; Shelanski, Michael L.; Greene, Lloyd A.

2000-01-01

Neurotrophic factors such as nerve growth factor (NGF) promote a wide variety of responses in neurons, including differentiation, survival, plasticity, and repair. Such actions often require changes in gene expression. To identify the regulated genes and thereby to more fully understand the NGF mechanism, we carried out serial analysis of gene expression (SAGE) profiling of transcripts derived from rat PC12 cells before and after NGF-promoted neuronal differentiation. Multiple criteria supported the reliability of the profile. Approximately 157,000 SAGE tags were analyzed, representing at least 21,000 unique transcripts. Of these, nearly 800 were regulated by 6-fold or more in response to NGF. Approximately 150 of the regulated transcripts have been matched to named genes, the majority of which were not previously known to be NGF-responsive. Functional categorization of the regulated genes provides insight into the complex, integrated mechanism by which NGF promotes its multiple actions. It is anticipated that as genomic sequence information accrues the data derived here will continue to provide information about neurotrophic factor mechanisms. PMID:10984536

Factor XI as a target for antithrombotic therapy

PubMed Central

Bane, Charles E.; Gailani, David

2014-01-01

Anticoagulants currently used in clinical practice to treat thromboembolic disorders are effective but increase the risk of severe bleeding because they target proteins that are essential for normal coagulation (hemostasis). Drugs with better safety profiles are required for prevention and treatment of thromboembolic disease. Coagulation factor XIa has emerged as a novel target for safer anticoagulant therapy because of its role in thrombosis and its relatively small contribution to hemostasis. PMID:24886766

Assessment of factors regulating the thermal lens profile and lateral brightness in high power diode lasers

NASA Astrophysics Data System (ADS)

Rieprich, J.; Winterfeldt, M.; Tomm, J.; Kernke, R.; Crump, P.

2017-02-01

The lateral beam parameter product, BPPlat, and resulting lateral brightness of GaAs-based high-power broad-area diode lasers is strongly influenced by the thermal lens profile. We present latest progress in efforts using FEM simulation to interpret how variation in chip construction influences the thermal lens profile, itself determined experimentally using thermography (thermal camera). Important factors are shown to include the vertical (epitaxial) structure, the properties of the submount and the transition between chip and submount, whose behavior is shown to be consistent with the presence of a significant thermal barrier.

Measuring safety climate in elderly homes.

PubMed

Yeung, Koon-Chuen; Chan, Charles C

2012-02-01

Provision of a valid and reliable safety climate dimension brings enormous benefits to the elderly home sector. The aim of the present study was to make use of the safety climate instrument developed by OSHC to measure the safety perceptions of employees in elderly homes such that the factor structure of the safety climate dimensions of elderly homes could be explored. In 2010, surveys by mustering on site method were administered in 27 elderly homes that had participated in the "Hong Kong Safe and Healthy Residential Care Home Accreditation Scheme" organized by the Occupational Safety and Health Council. Six hundred and fifty-one surveys were returned with a response rate of 54.3%. To examine the factor structure of safety climate dimensions in our study, an exploratory factor analysis (EFA) using principal components analysis method was conducted to identify the underlying factors. The results of the modified seven-factor's safety climate structure extracted from 35 items better reflected the safety climate dimensions of elderly homes. The Cronbach alpha range for this study (0.655 to 0.851) indicated good internal consistency among the seven-factor structure. Responses from managerial level, supervisory and professional level, and front-line staff were analyzed to come up with the suggestion on effective ways of improving the safety culture of elderly homes. The overall results showed that managers generally gave positive responses in the factors evaluated, such as "management commitment and concern to safety," "perception of work risks and some contributory influences," "safety communication and awareness," and "safe working attitude and participation." Supervisors / professionals, and frontline level staff on the other hand, have less positive responses. The result of the lowest score in the factors - "perception of safety rules and procedures" underlined the importance of the relevance and practicability of safety rules and procedures. The modified OSHC

Profiling healthy eaters. Determining factors that predict healthy eating practices among Dutch adults.

PubMed

Swan, Emily; Bouwman, Laura; Hiddink, Gerrit Jan; Aarts, Noelle; Koelen, Maria

2015-06-01

Research has identified multiple factors that predict unhealthy eating practices. However what remains poorly understood are factors that promote healthy eating practices. This study aimed to determine a set of factors that represent a profile of healthy eaters. This research applied Antonovsky's salutogenic framework for health development to examine a set of factors that predict healthy eating in a cross-sectional study of Dutch adults. Data were analyzed from participants (n = 703) who completed the study's survey in January 2013. Logistic regression analysis was performed to test the association of survey factors on the outcome variable high dietary score. In the multivariate logistic regression model, five factors contributed significantly (p < .05) to the predictive ability of the overall model: being female; living with a partner; a strong sense of coherence (construct from the salutogenic framework), flexible restraint of eating, and self-efficacy for healthy eating. Findings complement what is already known of the factors that relate to poor eating practices. This can provide nutrition promotion with a more comprehensive picture of the factors that both support and hinder healthy eating practices. Future research should explore these factors to better understand their origins and mechanisms in relation to healthy eating practices. Copyright © 2015 Elsevier Ltd. All rights reserved.

Tokamak Operation with Safety Factor q 95 < 2 via Control of MHD Stability

DOE PAGES

Piovesan, Paolo; Hanson, Jeremy M.; Martin, Piero; ...

2014-07-24

Magnetic feedback control of the resistive-wall mode has enabled DIII-D to access stable operation at safety factor q95 = 1:9 in divertor plasmas for 150 instability growth times. Magnetohydrodynamic stability sets a hard, disruptive limit on the minimum edge safety factor achievable in a tokamak, or on the maximum plasma current at given toroidal magnetic eld. In tokamaks with a divertor, the limit occurs at q95 = 2, as con rmed in DIII-D. Since the energy con cement time scales linearly with current, this also bounds the performance of a fusion reactor. DIII-D has overcome this limit, opening a wholemore » new high-current regime not accessible before. This result brings signi cant possible bene ts in terms of fusion performance, but it also extends resistive wall mode physics and its control to conditions never explored before. In present experiments, q95 < 2 operation is eventually halted by voltage limits reached in the feedback power supplies, not by intrinsic physics issues. Improvements to power supplies and to control algorithms have the potential to further extend this regime.« less

The geriatric polytrauma: Risk profile and prognostic factors.

PubMed

Rupprecht, Holger; Heppner, Hans Jürgen; Wohlfart, Kristina; Türkoglu, Alp

2017-03-01

In the German population, the percentage of elderly patients is increasing, and consequently there are more elderly patients among trauma cases, and particularly cases of polytrauma. The aim of this study was to present clinical results and a risk profile for geriatric polytrauma patients. Review of 140 geriatric (over 65 years of age) polytrauma patients who received prehospital treatment was performed. Severity of trauma was retrospectively assessed with Hannover Polytrauma Score (HPTS). Age, hemoglobin (Hb) level, systolic blood pressure (BP), Glasgow Coma Scale (GCS) score, timing of and necessity for intubation were analyzed in relation to mortality and in comparison with younger patients. Geriatric polytrauma patients (n=140) had overall mortality rate of 65%, whereas younger patients (n=1468) had mortality rate of 15.9%. Despite equivalent severity of injury (HPTS less age points) in geriatric and non-geriatric groups, mortality rate was 4 times higher in geriatric group. Major blood loss with Hb <8 g/dL was revealed to be 3 times more fatal than moderate or minor blood loss (Hb ≥8 g/dL). GCS score <12 corresponded to double mortality rate (39% vs 83%). Age by itself is significant risk factor and predictor of increased mortality in polytrauma patients. Additional risk factors include very low GCS score and systolic BP <80 mm Hg, for instance, as potential clinical indicators of massive bleeding and traumatic brain injury. Such parameters demand early and rapid treatment at prehospital stage and on admission.

Managing risk in healthcare: understanding your safety culture using the Manchester Patient Safety Framework (MaPSaF).

PubMed

Parker, Dianne

2009-03-01

To provide sufficient information about the Manchester Patient Safety Framework (MaPSaF) to allow healthcare professionals to assess its potential usefulness. The assessment of safety culture is an important aspect of risk management, and one in which there is increasing interest among healthcare organizations. Manchester Patient Safety Framework offers a theory-based framework for assessing safety culture, designed specifically for use in the NHS. The framework covers multiple dimensions of safety culture, and five levels of safety culture development. This allows the generation of a profile of an organization's safety culture in terms of areas of relative strength and challenge, which can be used to identify focus issues for change and improvement. Manchester Patient Safety Framework provides a useful method for engaging healthcare professionals in assessing and improving the safety culture in their organization, as part of a programme of risk management.

Efficacy and safety of a clinically relevant foamy vector design in human hematopoietic repopulating cells.

PubMed

Everson, Elizabeth M; Hocum, Jonah D; Trobridge, Grant D

2018-06-23

Previous studies have shown that foamy viral (FV) vectors are a promising alternative to gammaretroviral and lentiviral vectors and insulators can improve FV vector safety. However, in a previous analysis of insulator effects on FV vector safety, strong viral promoters were used to elicit genotoxic events. Here we developed and analyzed the efficacy and safety of a high-titer, clinically relevant FV vector driven by the housekeeping promoter elongation factor-1α and insulated with an enhancer blocking A1 insulator (FV-EGW-A1). Human CD34 + cord blood cells were exposed to an enhanced green fluorescent protein expressing vector, FV-EGW-A1, at a multiplicity of infection of 10 and then maintained in vitro or transplanted into immunodeficient mice. Flow cytometry was used to measure engraftment and marking in vivo. FV vector integration sites were analyzed to assess safety. FV-EGW-A1 resulted in high-marking, multi-lineage engraftment of human repopulating cells with no evidence of silencing. Engraftment was highly polyclonal with no clonal dominance and a promising safety profile based on integration site analysis. An FV vector with an elongation factor-1α promoter and an A1 insulator is a promising vector design for use in the clinic. This article is protected by copyright. All rights reserved.

Safety and tolerability profile of daclizumab in patients with relapsing-remitting multiple sclerosis: An integrated analysis of clinical studies.

PubMed

Giovannoni, Gavin; Kappos, Ludwig; Gold, Ralf; Khatri, Bhupendra O; Selmaj, Krzysztof; Umans, Kimberly; Greenberg, Steven J; Sweetser, Marianne; Elkins, Jacob; McCroskery, Peter

2016-09-01

Daclizumab has been evaluated in multicentre, randomised, double-blind studies for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS). Safety and tolerability are key considerations in MS treatment selection, as they influence adherence to medication. Evaluate the safety of daclizumab in patients with RRMS from an integrated analysis of six clinical studies. Patients treated with at least one dose of subcutaneous daclizumab 150mg or 300mg monthly in three completed and three ongoing clinical studies were included in this integrated analysis. Cumulative incidence of treatment-emergent adverse events (AEs) was the primary endpoint. This analysis included 2236 patients with 5214 patient-years of exposure to daclizumab. The cumulative incidence of any AE was 84% and of any serious AE excluding MS relapse was 16%. The incidences of AEs when evaluated by 6-month intervals remained stable over the 6.5 years of maximum follow-up. Most AEs were mild or moderate in severity. An important safety concern associated with daclizumab therapy involved hepatic AEs (16%) and serum transaminase elevations at least three times the upper limit of normal (10%), most of which were asymptomatic, self-limiting, and non-recurring. Cumulative incidences of cutaneous, infectious, and gastrointestinal AEs were 33%, 59%, and 25%, respectively; most events either resolved spontaneously or were treated successfully with standard medical interventions and did not result in discontinuation of treatment. This integrated analysis demonstrates that treatment of RRMS with daclizumab for periods of up to 6.5 years is associated with an acceptable safety profile with no evidence of cumulative toxicity over time. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Does the concept of safety culture help or hinder systems thinking in safety?

PubMed

Reiman, Teemu; Rollenhagen, Carl

2014-07-01

The concept of safety culture has become established in safety management applications in all major safety-critical domains. The idea that safety culture somehow represents a "systemic view" on safety is seldom explicitly spoken out, but nevertheless seem to linger behind many safety culture discourses. However, in this paper we argue that the "new" contribution to safety management from safety culture never really became integrated with classical engineering principles and concepts. This integration would have been necessary for the development of a more genuine systems-oriented view on safety; e.g. a conception of safety in which human, technological, organisational and cultural factors are understood as mutually interacting elements. Without of this integration, researchers and the users of the various tools and methods associated with safety culture have sometimes fostered a belief that "safety culture" in fact represents such a systemic view about safety. This belief is, however, not backed up by theoretical or empirical evidence. It is true that safety culture, at least in some sense, represents a holistic term-a totality of factors that include human, organisational and technological aspects. However, the departure for such safety culture models is still human and organisational factors rather than technology (or safety) itself. The aim of this paper is to critically review the various uses of the concept of safety culture as representing a systemic view on safety. The article will take a look at the concepts of culture and safety culture based on previous studies, and outlines in more detail the theoretical challenges in safety culture as a systems concept. The paper also presents recommendations on how to make safety culture more systemic. Copyright © 2013 Elsevier Ltd. All rights reserved.

Selective estrogen receptor modulators in clinical practice: a safety overview.

PubMed

Ellis, Amanda J; Hendrick, Vicky M; Williams, Robert; Komm, Barry S

2015-06-01

Selective estrogen receptor (ER) modulators (SERMs) are a class of nonsteroidal compounds that interact with ERs, each with a distinct tissue-specific profile. Depending upon the degree of ER agonism/antagonism at the target tissue, SERMs show efficacy for various indications including osteoporosis, dyspareunia, and breast cancer, and are associated with safety risks. This review describes the safety profile of SERMs (tamoxifen, raloxifene, toremifene, bazedoxifene, lasofoxifene, and ospemifene) and fulvestrant (a pure ER antagonist) from Phase III trials, long-term extension studies, and active comparator studies. Tamoxifen, a first-generation SERM, is indicated for breast cancer prevention and treatment but is associated with serious safety concerns including endometrial cancer, venous thromboembolic events (VTE), and stroke. Toremifene, raloxifene, bazedoxifene, lasofoxifene, and ospemifene present generally improved, though distinctly different, safety profiles compared with tamoxifen, especially with endometrial cancer and stroke. However, the risk of VTE remains a concern for most SERMs. Each SERM presents a unique risk/benefit profile based on varying indications and tissue-specific ER agonist and antagonist effects, making careful patient selection and ongoing patient monitoring crucial aspects of treatment. Future research may focus on identifying new SERMs for endocrine-resistant and endocrine-responsive cancers and post-menopausal symptoms.

Study on the creation and destruction of transport barriers via the effective safety factors for energetic particles

NASA Astrophysics Data System (ADS)

Ogawa, Shun; Leoncini, Xavier; Dif-Pradalier, Guilhem; Garbet, Xavier

2016-12-01

Charged particles with low kinetic energy move along the magnetic field lines, but so do not the energetic particles. We investigate the topological structure changes in the phase space of energetic particles with respect to the magnetic one. For this study, cylindrical magnetic fields with non-monotonic safety factors that induce the magnetic internal transport barrier are considered. We show that the topological structure of the magnetic field line and of the particle trajectories can be quite different. We explain this difference using the concept of an effective particle q-profile. Using this notion, we can investigate the location and existence of resonances for particle orbits that are different from the magnetic ones. These are examined both numerically by integrating an equation of motion and theoretically by the use of Alfvén's guiding center theory and by the use of an effective reduced Hamiltonian for the integrable unperturbed system. It is clarified that, for the energetic particles, the grad B drift effect shifts the resonances and the drift induced by curvature of the magnetic field line leads to the vanishing of the resonances. As a result, we give two different mechanisms that lead to the creation of transport barriers for energetic particles in the region where the magnetic field line is chaotic.

Safety-factor profile tailoring by improved electron cyclotron system for sawtooth control and reverse shear scenarios in ITER

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zucca, C.; Sauter, O.; Fable, E.

2008-11-01

The effect of the predicted local electron cyclotron current driven by the optimized electron cyclotron system on ITER is discussed. A design variant was recently proposed to enlarge the physics program covered by the upper and equatorial launchers. By extending the functionality range of the upper launcher, significant control capabilities of the sawtooth period can be obtained. The upper launcher improvement still allows enough margin to exceed the requirements for neoclassical tearing mode stabilization, for which it was originally designed. The analysis of the sawtooth control is carried on with the ASTRA transport code, coupled with the threshold model bymore » Por-celli, to study the control capabilities of the improved upper launcher on the sawtooth instability. The simulations take into account the significant stabilizing effect of the fusion alpha particles. The sawtooth period can be increased by a factor of 1.5 with co-ECCD outside the q = 1 surface, and decreased by at least 30% with co-ECCD inside q = 1. The present ITER base-line design has the electron cyclotron launchers providing only co-ECCD. The variant for the equatorial launcher proposes the possibility to drive counter-ECCD with 1 of the 3 rows of mirrors: the counter-ECCD can then be balanced with co-ECCD and provide pure ECH with no net driven current. The difference between full co-ECCD off-axis using all 20MW from the equatorial launcher and 20MW co-ECCD driven by 2/3 from the equatorial launcher and 1/3 from the upper launcher is shown to be negligible. Cnt-ECCD also offers greater control of the plasma current density, therefore this analysis addresses the performance of the equatorial launcher to control the central q profile. The equatorial launcher is shown to control very efficiently the value of q{sub 0.2}-q{sub min} in advanced scenarios, if one row provides counter-ECCD.« less

Nonlinear scaling of the Unit Hydrograph Peaking Factor for dam safety

NASA Astrophysics Data System (ADS)

Pradhan, N. R.; Loney, D.

2017-12-01

Existing U.S. Army Corps of Engineers (USACE) policy suggests unit hydrograph peaking factor (UHPF), the ratio of an observed and modeled event unit hydrograph peak, range between 1.25 and 1.50 to ensure dam safety. It is pertinent to investigate the impact of extreme flood events on the validity of this range through physically based rainfall-runoff models not available during the planning and design of most USACE dams. The UHPF range was analyzed by deploying the Gridded Surface Subsurface Hydrologic Analysis (GSSHA) model in the Goose Creek, VA, watershed to develop a UHPF relationship with excess rainfall across various return-period events. An effective rainfall factor (ERF) is introduced to validate existing UHPF guidance as well as provide a nonlinear UHPF scaling relation when effective rainfall does not match that of the UH design event.

Motor carrier industry profile study : financial and operating performance profiles by industry segment, 2001-2002.

DOT National Transportation Integrated Search

2004-09-01

This report profiles the motor carrier industry and its significant operating segments. It is one of a series of reports analyzing various aspects of the motor carrier industry. Other reports in the series focus on the safety performance of the indus...

A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional

PubMed Central

Karsh, B‐T; Holden, R J; Alper, S J; Or, C K L

2006-01-01

The goal of improving patient safety has led to a number of paradigms for directing improvement efforts. The main paradigms to date have focused on reducing injuries, reducing errors, or improving evidence based practice. In this paper a human factors engineering paradigm is proposed that focuses on designing systems to improve the performance of healthcare professionals and to reduce hazards. Both goals are necessary, but neither is sufficient to improve safety. We suggest that the road to patient and employee safety runs through the healthcare professional who delivers care. To that end, several arguments are provided to show that designing healthcare delivery systems to support healthcare professional performance and hazard reduction should yield significant patient safety benefits. The concepts of human performance and hazard reduction are explained. PMID:17142611

Safety climate and mindful safety practices in the oil and gas industry.

PubMed

Dahl, Øyvind; Kongsvik, Trond

2018-02-01

The existence of a positive association between safety climate and the safety behavior of sharp-end workers in high-risk organizations is supported by a considerable body of research. Previous research has primarily analyzed two components of safety behavior, namely safety compliance and safety participation. The present study extends previous research by looking into the relationship between safety climate and another component of safety behavior, namely mindful safety practices. Mindful safety practices are defined as the ability to be aware of critical factors in the environment and to act appropriately when dangers arise. Regression analysis was used to examine whether mindful safety practices are, like compliance and participation, promoted by a positive safety climate, in a questionnaire-based study of 5712 sharp-end workers in the oil and gas industry. The analysis revealed that a positive safety climate promotes mindful safety practices. The regression model accounted for roughly 31% of the variance in mindful safety practices. The most important safety climate factor was safety leadership. The findings clearly demonstrate that mindful safety practices are highly context-dependent, hence, manageable and susceptible to change. In order to improve safety climate in a direction which is favorable for mindful safety practices, the results demonstrate that it is important to give the fundamental features of safety climate high priority and in particular that of safety leadership. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

Factors influencing soft tissue profile changes following orthodontic treatment in patients with Class II Division 1 malocclusion.

PubMed

Maetevorakul, Suhatcha; Viteporn, Smorntree

2016-01-01

Several studies have shown soft tissue profile changes after orthodontic treatment in Class II Division 1 patients. However, a few studies have described factors influencing the soft tissue changes. The purpose of this study was to investigate the factors influencing the soft tissue profile changes following orthodontic treatment in Class II Division 1 patients. The subjects comprised 104 Thai patients age 8-16 years who presented Class II Division 1 malocclusions and were treated with different orthodontic modalities comprising cervical headgear, Class II traction and extraction of the four first premolars. The profile changes were evaluated from the lateral cephalograms before and after treatment by means of the X-Y coordinate system. Significant soft tissue profile changes were evaluated by paired t test at a 0.05 significance level. The correlations among significant soft tissue changes and independent variables comprising treatment modality, age, sex, pretreatment skeletal, dental and soft tissue morphology were evaluated by stepwise multiple regression analysis at a 0.05 significance level. The multiple regression analysis indicated that different treatment modalities, age, sex, pretreatment skeletal, dental and soft tissue morphology were related to the profile changes. The predictive power of these variables on the soft tissue profile changes ranged from 9.9 to 40.3%. Prediction of the soft tissue profile changes following treatment of Class II Division 1 malocclusion from initial patient morphology, age, sex and types of treatment was complicated and required several variables to explain their variations. Upper lip change in horizontal direction could be found only at the stomion superius and was less predictable than those of the lower lip. Variations in upper lip retraction at the stomion superius were explained by types of treatment (R(2) = 0.099), whereas protrusion of the lower lip at the labrale inferius was correlated with initial inclination of

Factors influencing safety among a group of commercial fishermen along the Texas Gulf Coast.

PubMed

Levin, Jeffrey L; Gilmore, Karen; Shepherd, Sara; Wickman, Amanda; Carruth, Ann; Nalbone, J Torey; Gallardo, Gilbert; Nonnenmann, Matthew W

2010-10-01

The commercial fishing trades are among the most dangerous jobs in the world. Little published information exists regarding some populations of commercial fishermen such as along the United States Gulf Coast. Studying these unique and often vulnerable groups is important to characterize potential influences on or barriers to safety in anticipation of designing interventions that can change safety behaviors. Working closely with the United States Coast Guard (USCG), a cross-sectional convenience sample of Gulf Coast shrimp fishermen in and near the Port of Galveston, Texas, was surveyed. The survey included demographic factors and broadly covered areas such as type of work and fishing activities, general or global perceptions and beliefs related to safety and accidents, self-report of ability to use safety equipment or apply procedures aboard vessel, and training considerations. Surveys were obtained following informed consent (n = 133). Of the participants, 96.7% were male with 60.9% ≥40 years old. A majority were of Asian descent (57.1% of all fishermen, 82.1% of shrimp fishermen). Over half claimed to speak little or no English and nearly 60% considered the job to be very safe to neutral. A third to half of respondents expressed doubt about their knowledge of using essential safety equipment in the event of emergency. A large portion of the participants preferred hands-on safety training (40.6%). Important findings about this group of commercial fishermen will help with future development of effective prevention practices through the delivery of culturally appropriate safety awareness training. One element that must be addressed in training programs is to increase the awareness among fishermen about the severe occupational risks inherent in this type of work. Community trust and collaborative partnerships are essential to the success of such initiatives.

Factor Analysis of Traffic Safety in Urban Roads Based on FTA-LEC

NASA Astrophysics Data System (ADS)

Shuicheng, TIAN; Xingbo, YANG; Xiaoqing, SHEN; Detao, ZHANG

2018-05-01

In order to reduce the number and the loss of urban road traffic accidents in our country, improve the safety of road traffic, a statistical analysis of the research report on major road traffic accidents in 2016 was conducted. The risk factors affecting urban road traffic in China were analyzed by using FTA to find the basic hidden events. Secondly, the risk value of the identified hidden danger events were calculated and classified into four levels I, II, III and IV through the LEC evaluation method. Finally, the graded results of risk factors are verified through a case of specific accidents in Beijing. The results show that: the case verified the scientificalness and effectiveness of hazard classification and provided guidance for urban road traffic management.

Longitudinal profiles of back pain across adulthood and their relationship with childhood factors: evidence from the 1946 British birth cohort

PubMed Central

Muthuri, Stella G.; Kuh, Diana; Cooper, Rachel

2018-01-01

Abstract This study aimed to (1) characterise long-term profiles of back pain across adulthood and (2) examine whether childhood risk factors were associated with these profiles, using data from 3271 participants in the Medical Research Council National Survey of Health and Development. A longitudinal latent class analysis was conducted on binary outcomes of back pain at ages 31, 36, 43, 53, 60 to 64, and 68 years. Multinomial logistic regression models were used to examine associations between selected childhood risk factors and class membership; adjusted for sex, adult body size, health status and behaviours, socioeconomic position, and family history of back pain. Four profiles of back pain were identified: no or occasional pain (57.7%), early-adulthood only (16.1%), mid-adulthood onset (16.9%), and persistent (9.4%). The “no or occasional” profile was treated as the referent category in subsequent analyses. After adjustment, taller height at age 7 years was associated with a higher likelihood of early-adulthood only (relative risk ratio per 1 SD increase in height = 1.31 [95% confidence interval: 1.05-1.65]) and persistent pain (relative risk ratio = 1.33 [95% confidence interval: 1.01-1.74]) in women (P for sex interaction = 0.01). Factors associated with an increased risk of persistent pain in both sexes were abdominal pain, poorest care in childhood, and poorer maternal health. Abdominal pain and poorest housing quality were also associated with an increased likelihood of mid-adulthood onset pain. These findings suggest that there are different long-term profiles of back pain, each of which is associated with different early life risk factors. This highlights the potential importance of early life interventions for the prevention and management of back pain. PMID:29408834

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme.

PubMed

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-09-01

Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%). Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

16 CFR Figure 8 to Subpart A of... - Standard Radiant Heat Energy Flux Profile

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Standard Radiant Heat Energy Flux Profile 8... PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION The Standard Pt. 1209, Subpt. A, Fig. 8 Figure 8 to Subpart A of Part 1209—Standard Radiant Heat Energy Flux Profile EC03OC91...

Human resource factors associated with workplace safety and health education of small manufacturing businesses in Korea.

PubMed

Park, Kyoung-Ok

2018-01-25

Human resources (HR) are essential indicators of safety and health (SH) status, and HR can be key sources of workplace safety management such as safety and health education at work (SHEW). This study analyzed significant HR factors associated with SHEW of small manufacturing businesses in Korea. The secondary data of the 2012 Korea Occupational Safety and Health Trend Survey were used to achieve this research purpose. A total of 2,089 supervisors or managers employed in the small manufacturing businesses completed the interview survey. Survey businesses were selected by multiple stratified sampling method based on industry code, business size, and region in Korea. The survey included workplace characteristics of HR and SHEW. SHEW was significantly related to business size, occupational injury incidence in the previous year, foreign and elderly worker employment, presence of site supervisors, and presence of SH committees (p <.05). SHEW for office workers, non-office workers, and newcomers was associated with business size, presence of site supervisors, and presence of SH committees in logistic regression analysis (p <.001). Businesses with 30-49 workers conducted SHEW 3.64 times more than did businesses with 5 to fewer than 10 workers. The companies that had occupational injuries in the previous year conducted SHEW 1.68 times more than the others. The businesses that had site supervisors and committees conducted SHEW 2.30 and 2.18 times more, respectively, than others. Site supervisors and SH committees were significant HR factors that improved SHEW in small manufacturing businesses.

Dimensions of Safety Climate among Iranian Nurses.

PubMed

Konjin, Z Naghavi; Shokoohi, Y; Zarei, F; Rahimzadeh, M; Sarsangi, V

2015-10-01

Workplace safety has been a concern of workers and managers for decades. Measuring safety climate is crucial in improving safety performance. It is also a method of benchmarking safety perception. To develop and validate a psychometrics scale for measuring nurses' safety climate. Literature review, subject matter experts and nurse's judgment were used in items developing. Content validity and reliability for new tool were tested by content validity index (CVI) and test-retest analysis, respectively. Exploratory factor analysis (EFA) with varimax rotation was used to improve the interpretation of latent factors. A 40-item scale in 6 factors was developed, which could explain 55% of the observed variance. The 6 factors included employees' involvement in safety and management support, compliance with safety rules, safety training and accessibility to personal protective equipment, hindrance to safe work, safety communication and job pressure, and individual risk perception. The proposed scale can be used in identifying the needed areas to implement interventions in safety climate of nurses.

Factors shaping effective utilization of health information technology in urban safety-net clinics.

PubMed

George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

2013-09-01

Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

School climate factors contributing to student and faculty perceptions of safety in select Arizona schools.

PubMed

Bosworth, Kris; Ford, Lysbeth; Hernandaz, Diley

2011-04-01

To ensure that schools are safe places where students can learn, researchers and educators must understand student and faculty safety concerns. This study examines student and teacher perceptions of school safety. Twenty-two focus groups with students and faculty were conducted in 11 secondary schools. Schools were selected from a stratified sample to vary in location, proximity to Indian reservations, size, and type. The data analysis was based on grounded theory. In 9 of 11 schools, neither faculty nor students voiced overwhelming concerns about safety. When asked what makes school safe, students tended to report physical security features. School climate and staff actions also increased feelings of safety. Faculty reported that relationships and climate are key factors in making schools safe. High student performance on standardized tests does not buffer students from unsafe behavior, nor does living in a dangerous neighborhood necessarily lead to more drug use or violence within school walls. School climate seemed to explain the difference between schools in which students and faculty reported higher versus lower levels of violence and alcohol and other drug use. The findings raise provocative questions about school safety and provide insight into elements that lead to perceptions of safety. Some schools have transcended issues of location and neighborhood to provide an environment perceived as safe. Further study of those schools could provide insights for policy makers, program planners, and educational leaders. © 2011, American School Health Association.

Cardiovascular Safety of Biologics and JAK Inhibitors in Patients with Rheumatoid Arthritis.

PubMed

Kang, Eun Ha; Liao, Katherine P; Kim, Seoyoung C

2018-05-30

Increased cardiovascular (CV) risk and associated mortality in rheumatoid arthritis (RA) are not fully explained by traditional CV risk factors. This review discusses the epidemiology and mechanisms of increased CV risk in RA and treatment effects on CV risk focusing on biologic disease-modifying anti-rheumatic drugs (DMARDs) and JAK inhibitors. Intermediary metabolic changes by inflammatory cytokines are observed in body composition, lipid profile, and insulin sensitivity of RA patients, leading to accelerated atherosclerosis and increased CV risk. Successful treatment with DMARDs has shown beneficial effects on these metabolic changes and ultimately CV outcomes, in proportion to the treatment efficacy in general but also with drug-specific mechanisms. Recent data provide further information on comparative CV safety between biologic DMARDs or JAK inhibitors as well as their safety signals for non-atherosclerotic CV events. CV benefits or safety signals associated with DMARD treatments can differ despite similar drug efficacy against RA, suggesting that both anti-inflammatory and drug-specific mechanisms are involved in altering CV risk.

Risk Factors Profile of Shoulder Dystocia in Oman: A Case Control Study

PubMed Central

Al-Khaduri, Maha M.; Abudraz, Rania Mohammed; Al-Farsi, Yahya M.

2014-01-01

Objective This study aimed to assess the risk factor profile of shoulder dystocia and associated neonatal complications in Oman, a developing Arab country. Methods A retrospective case-control study was conducted among 111 cases with dystocia and 111 controls, identified during 1994-2006 period in a tertiary care hospital in Oman. Controls were randomly selected among women who did not have dystocia, and were matched to cases on the day of delivery. Data related to potential risk factors, delivery, and obstetric complications were collected. Results Dystocia was significantly associated with older maternal age, higher parity, larger BMI, diabetes, and previous record of dystocia. In addition, dystocia was associated more with vacuum and forceps deliveries. Routine traction (51%) was the most used manoeuvre. Among dystocia cases, 13% were associated with fetal complications of which Erb’s Palsy was the most prevalent (79%). Conclusion Our finding of significant associations with risk factors lays out the ground to develop a predictability index for shoulder dystocia, which would help in making it preventable. Further p rospective studies are required to confirm the obtained results. PMID:25337307

Patient safety culture and associated factors: A quantitative and qualitative study of healthcare workers' view in Jimma zone Hospitals, Southwest Ethiopia.

PubMed

Wami, Sintayehu Daba; Demssie, Amsalu Feleke; Wassie, Molla Mesele; Ahmed, Ansha Nega

2016-09-20

Patient safety culture is an important aspect for quality healthcare delivery and is an issue of high concern globally. In Ethiopia health system little is known and information is limited in scope about patient safety culture. Therefore, the aim of this study was to assess the level of patient safety culture and associated factors in Jimma zone Hospitals, southwest Ethiopia. Facility based cross sectional quantitative study triangulated with qualitative approaches was employed from March to April 30/2015. Stratified sampling technique was used to select 637 study participants among 4 hospitals. The standardized tool which measures 12 patient safety culture composites was used for data collection. Bivariate and multivariate linear regression analyses were performed using SPSS version 20. Significance level was obtained at 95 % CI and p-value < 0.05. Semi structured guide in depth interview was used to collect the qualitative data. Content analysis of the interview was performed. The overall level of patient safety culture was 46.7 % (95 % CI: 43.0, 51.2). Hours worked per week (β =-0.06, 95 % CI:-0.12,-0.001), reporting adverse event (β = 3.34, 95 % CI: 2.12, 4.57), good communication (β = 2.78, 95 % CI: 2.29, 3.28), teamwork within hospital (β = 1.91, 95 % CI: 1.37, 2.46), level of staffing (β = 1.32, 95 % CI: 0.89, 1.75), exchange of feedback about error (β = 1.37, 95 % CI: 0.91, 1.83) and participation in patient safety program (β = 1.3, 95 % CI: 0.57, 2.03) were factors significantly associated with the patient safety culture. The in depth interview indicated incident reporting, resources, healthcare worker attitude and patient involvement as important factors that influence patient safety culture. The overall level of patient safety culture was low. Working hours, level of staffing, teamwork, communications openness, reporting an event and exchange of feedback about error were associated with patient safety

Safety and Efficacy of Microinvasive Glaucoma Surgery

PubMed Central

Chen, David Z.

2017-01-01

Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations. PMID:28512578

Protection and Safety.

ERIC Educational Resources Information Center

American School Board Journal, 1964

1964-01-01

Several aspects of school safety and protection are presented for school administrators and architects. Among those topics discussed are--(1) life safety, (2) vandalism controlled through proper design, (3) personal protective devices, and (4) fire alarm systems. Another critical factor in providing a complete school safety program is proper…

Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

PubMed

Kvalheim, Sverre A; Dahl, Øyvind

2016-12-01

Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

An update on the safety of nutraceuticals and effects on lipid parameters.

PubMed

Cicero, Arrigo F G; Colletti, Alessandro

2018-03-01

Cardiovascular diseases (CVDs) are the leading cause of mortality and disability in developed countries, whereas a large portion of patients in primary prevention have uncontrolled level of CVD risk factors. Dietary supplementation with bioactive natural compounds with demonstrated lipid-lowering effects is currently supported by the international guidelines for CVD prevention and some international expert panels. Areas covered: This review provides insights on issues concerning the tolerability and safety of the most commonly used nutraceuticals with demonstrated lipid-lowering effect in humans. They will be then divided into three main categories according to their mechanism of action (cholesterol synthesis inhibitors, intestinal cholesterol absorption inhibitors, and LDL-C excretion stimulants) and their pharmacological profile will be discussed. Expert opinion: A growing body of preclinical, epidemiological and clinical evidence has defined the tolerability and safety profile of the most commonly used lipid-lowering nutraceuticals. In the most part of cases, the side effects are mild and reversible. However, detailed knowledge of specific health risks and pharmacological interactions for each individual compound is needed for the management of frail patients, such as children, elderly, patients with liver or renal failure, and patients consuming numerous drugs.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study.

PubMed

Adleman, Jenna; Gillan, Caitlin; Caissie, Amanda; Davis, Carol-Anne; Liszewski, Brian; McNiven, Andrea; Giuliani, Meredith

2017-06-01

To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through web conference discussion and reranked in Round 2. An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs. Copyright © 2017 Elsevier Inc. All rights reserved.

Development of a Quality and Safety Competency Curriculum for Radiation Oncology Residency: An International Delphi Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Adleman, Jenna; Gillan, Caitlin; Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario

Purpose: To develop an entry-to-practice quality and safety competency profile for radiation oncology residency. Methods and Materials: A comprehensive list of potential quality and safety competency items was generated from public and professional resources and interprofessional focus groups. Redundant or out-of-scope items were eliminated through investigator consensus. Remaining items were subjected to an international 2-round modified Delphi process involving experts in radiation oncology, radiation therapy, and medical physics. During Round 1, each item was scored independently on a 9-point Likert scale indicating appropriateness for inclusion in the competency profile. Items indistinctly ranked for inclusion or exclusion were re-evaluated through webmore » conference discussion and reranked in Round 2. Results: An initial 1211 items were compiled from 32 international sources and distilled to 105 unique potential quality and safety competency items. Fifteen of the 50 invited experts participated in round 1: 10 radiation oncologists, 4 radiation therapists, and 1 medical physicist from 13 centers in 5 countries. Round 1 rankings resulted in 80 items included, 1 item excluded, and 24 items indeterminate. Two areas emerged more prominently within the latter group: change management and human factors. Web conference with 5 participants resulted in 9 of these 24 items edited for content or clarity. In Round 2, 12 participants rescored all indeterminate items resulting in 10 items ranked for inclusion. The final 90 enabling competency items were organized into thematic groups consisting of 18 key competencies under headings adapted from Deming's System of Profound Knowledge. Conclusions: This quality and safety competency profile may inform minimum training standards for radiation oncology residency programs.« less

Profiling ethanol-targeted transcription factors in human carcinoma cell-derived embryoid bodies.

PubMed

Mandal, Chanchal; Halder, Debasish; Chai, Jin Choul; Lee, Young Seek; Jung, Kyoung Hwa; Chai, Young Gyu

2016-01-15

Fetal alcohol spectrum disorder is a collective term that represents fetal abnormalities associated with maternal alcohol consumption. Prenatal alcohol exposure and related anomalies are well characterized, but the molecular mechanism behind this phenomenon is not yet understood. Few insights have been gained from genetic and epigenetic studies of fetal alcohol spectrum disorder. Our aim was to profile the important molecular regulators of ethanol-related alterations of the genome. For this purpose, we have analyzed the gene expression pattern of human carcinoma cell-derived embryoid bodies in the absence or presence of ethanol. A cDNA microarray analysis was used to profile mRNA expression in embryoid bodies at day 7 with or without ethanol treatment. A total of 493 differentially expressed genes were identified in response to 50 mM ethanol exposure. Of these, 111 genes were up-regulated, and 382 were down-regulated. Gene ontology term enrichment analysis revealed that these genes are involved in important biological processes: neurological system processes, cognition, behavior, sensory perception of smell, taste and chemical stimuli and synaptic transmission. Similarly, the enrichment of disease-related genes included relevant categories such as neurological diseases, developmental disorders, skeletal and muscular disorders, and connective tissue disorders. Furthermore, we have identified a group of 26 genes that encode transcription factors. We validated the relative gene expression of several transcription factors using quantitative real time PCR. We hope that our study substantially contributes to the understanding of the molecular mechanisms underlying the pathology of alcohol-mediated anomalies and facilitates further research. Copyright © 2015 Elsevier B.V. All rights reserved.

Improving safety in small enterprises through an integrated safety management intervention.

PubMed

Kines, Pete; Andersen, Dorte; Andersen, Lars Peter; Nielsen, Kent; Pedersen, Louise

2013-02-01

This study tests the applicability of a participatory behavior-based injury prevention approach integrated with safety culture initiatives. Sixteen small metal industry enterprises (10-19 employees) are randomly assigned to receive the intervention or not. Safety coaching of owners/managers result in the identification of 48 safety tasks, 85% of which are solved at follow-up. Owner/manager led constructive dialogue meetings with workers result in the prioritization of 29 tasks, 79% of which are accomplished at follow-up. Intervention enterprises have significant increases on six of eight safety-perception-survey factors, while comparisons increase on only one factor. Both intervention and comparison enterprises demonstrate significant increases in their safety observation scores. Interview data validate and supplement these results, providing some evidence for behavior change and the initiation of safety culture change. Given that over 95% of enterprises in most countries have less than 20 employees, there is great potential for adapting this integrated approach to other industries. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

PubMed

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.

Advances in Measuring Culturally Competent Care: A Confirmatory Factor Analysis of CAHPS-CC in a Safety-net Population

PubMed Central

Stern, RJ; Fernandez, A; Jacobs, EA; Neilands, TB; Weech-Maldonado, R; Quan, J; Carle, A; Seligman, HK

2012-01-01

Background Providing culturally competent care shows promise as a mechanism to reduce healthcare inequalities. Until the recent development of the CAHPS Cultural Competency Item Set (CAHPS-CC), no measures capturing patient-level experiences with culturally competent care have been suitable for broad-scale administration. Methods We performed confirmatory factor analysis and internal consistency reliability analysis of CAHPS-CC among patients with type 2 diabetes (n=600) receiving primary care in safety-net clinics. CAHPS-CC domains were also correlated with global physician ratings. Results A 7-factor model demonstrated satisfactory fit (χ2(231)=484.34, p<.0001) with significant factor loadings at p<.05. Three domains showed excellent reliability – Doctor Communication- Positive Behaviors (α=.82), Trust (α=.77), and Doctor Communication- Health Promotion (α=.72). Four domains showed inadequate reliability either among Spanish speakers or overall (overall reliabilities listed): Doctor Communication- Negative Behaviors (α=.54), Equitable Treatment (α=.69), Doctor Communication- Alternative Medicine (α=.52), and Shared Decision-Making (α=.51). CAHPS-CC domains were positively and significantly correlated with global physician rating. Conclusions Select CAHPS-CC domains are suitable for broad-scale administration among safety-net patients. Those domains may be used to target quality-improvement efforts focused on providing culturally competent care in safety-net settings. PMID:22895231

Evolutionary profiles derived from the QR factorization of multiple structural alignments gives an economy of information.

PubMed

O'Donoghue, Patrick; Luthey-Schulten, Zaida

2005-02-25

We present a new algorithm, based on the multidimensional QR factorization, to remove redundancy from a multiple structural alignment by choosing representative protein structures that best preserve the phylogenetic tree topology of the homologous group. The classical QR factorization with pivoting, developed as a fast numerical solution to eigenvalue and linear least-squares problems of the form Ax=b, was designed to re-order the columns of A by increasing linear dependence. Removing the most linear dependent columns from A leads to the formation of a minimal basis set which well spans the phase space of the problem at hand. By recasting the problem of redundancy in multiple structural alignments into this framework, in which the matrix A now describes the multiple alignment, we adapted the QR factorization to produce a minimal basis set of protein structures which best spans the evolutionary (phase) space. The non-redundant and representative profiles obtained from this procedure, termed evolutionary profiles, are shown in initial results to outperform well-tested profiles in homology detection searches over a large sequence database. A measure of structural similarity between homologous proteins, Q(H), is presented. By properly accounting for the effect and presence of gaps, a phylogenetic tree computed using this metric is shown to be congruent with the maximum-likelihood sequence-based phylogeny. The results indicate that evolutionary information is indeed recoverable from the comparative analysis of protein structure alone. Applications of the QR ordering and this structural similarity metric to analyze the evolution of structure among key, universally distributed proteins involved in translation, and to the selection of representatives from an ensemble of NMR structures are also discussed.

Neighborhood disadvantage, neighborhood safety and cardiometabolic risk factors in African Americans: biosocial associations in the Jackson Heart study.

PubMed

Clark, Cheryl R; Ommerborn, Mark J; Hickson, DeMarc A; Grooms, Kya N; Sims, Mario; Taylor, Herman A; Albert, Michelle A

2013-01-01

We examined associations between neighborhood socioeconomic disadvantage, perceived neighborhood safety and cardiometabolic risk factors, adjusting for health behaviors and socioeconomic status (SES) among African Americans. Study participants were non-diabetic African Americans (n = 3,909) in the baseline examination (2000-2004) of the Jackson Heart Study. We measured eight risk factors: the metabolic syndrome, its five components, insulin resistance and cardiovascular inflammation. We assessed neighborhood socioeconomic disadvantage with US Census 2000 data. We assessed perceived neighborhood safety, health behaviors and SES via survey. We used generalized estimating equations to estimate associations with a random intercept model for neighborhood effects. After adjustment for health behaviors and SES, neighborhood socioeconomic disadvantage was associated with the metabolic syndrome in women (PR 1.13, 95% CI 1.01, 1.27). Lack of perceived safety was associated with elevated glucose (OR 1.36, 95% CI 1.03, 1.80) and waist circumference (PR 1.06, 95% CI 1.02, 1.11) among women, and with elevated glucose (PR 1.30, 95% CI 1.02, 1.66) and insulin resistance (PR 1.25, 95% CI 1.08, 1.46) among men. Neighborhood socioeconomic disadvantage and perceived safety should be considered as targets for intervention to reduce cardiometabolic risks among African Americans.

Neighborhood Disadvantage, Neighborhood Safety and Cardiometabolic Risk Factors in African Americans: Biosocial Associations in the Jackson Heart Study

PubMed Central

Clark, Cheryl R.; Ommerborn, Mark J.; Hickson, DeMarc A.; Grooms, Kya N.; Sims, Mario; Taylor, Herman A.; Albert, Michelle A.

2013-01-01

Objective We examined associations between neighborhood socioeconomic disadvantage, perceived neighborhood safety and cardiometabolic risk factors, adjusting for health behaviors and socioeconomic status (SES) among African Americans. Methods Study participants were non-diabetic African Americans (n = 3,909) in the baseline examination (2000–2004) of the Jackson Heart Study. We measured eight risk factors: the metabolic syndrome, its five components, insulin resistance and cardiovascular inflammation. We assessed neighborhood socioeconomic disadvantage with US Census 2000 data. We assessed perceived neighborhood safety, health behaviors and SES via survey. We used generalized estimating equations to estimate associations with a random intercept model for neighborhood effects. Results After adjustment for health behaviors and SES, neighborhood socioeconomic disadvantage was associated with the metabolic syndrome in women (PR 1.13, 95% CI 1.01, 1.27). Lack of perceived safety was associated with elevated glucose (OR 1.36, 95% CI 1.03, 1.80) and waist circumference (PR 1.06, 95% CI 1.02, 1.11) among women, and with elevated glucose (PR 1.30, 95% CI 1.02, 1.66) and insulin resistance (PR 1.25, 95% CI 1.08, 1.46) among men. Conclusions Neighborhood socioeconomic disadvantage and perceived safety should be considered as targets for intervention to reduce cardiometabolic risks among African Americans. PMID:23691005

Visualizing variations in organizational safety culture across an inter-hospital multifaceted workforce.

PubMed

Kobuse, Hiroe; Morishima, Toshitaka; Tanaka, Masayuki; Murakami, Genki; Hirose, Masahiro; Imanaka, Yuichi

2014-06-01

To develop a reliable and valid questionnaire that can distinguish features of organizational culture for patient safety across subgroups such as hospitals, professions, management/non-management positions and units/wards. We developed a Hospital Organizational Culture Questionnaire based on a conceptual framework incorporating items from a review of existing literature. The questionnaire was administered to hospital staff including doctors, nurses, allied health personnel, and administrative staff at six public hospitals in Japan. Reliability and validity were assessed through exploratory factor analysis, multitrait scaling analysis, Cronbach's alpha coefficient and multiple regression analysis using staff-perceived achievement of safety as the response variable. Discriminative power across subgroups was assessed with radar chart profiling. Of the 3304 hospital staff surveyed, 2924 (88.5%) responded. After exploratory factor analysis and multitrait analysis, the finalized questionnaire was composed of 24 items in the following eight dimensions: improvement orientation, passion for mission, professional growth, resource allocation prioritization, inter-sectional collaboration, responsibility and authority, teamwork, and information sharing. Construct validity and internal consistency of dimensions were confirmed with multitrait analysis and Cronbach's alpha coefficients, respectively. Multiple regression analysis showed that improvement orientation, passion for mission, resource allocation prioritization and information sharing were significantly associated with higher achievement in safety practices. Our questionnaire tool was able to distinguish features of safety culture among different subgroups. Our questionnaire demonstrated excellent validity and reliability, and revealed distinct cultural patterns among different subgroups. Quantitative assessment of organizational safety culture with this tool may further the understanding of associated characteristics of

Bombyx mori Transcription Factors: Genome-Wide Identification, Expression Profiles and Response to Pathogens by Microarray Analysis

PubMed Central

Huang, Lulin; Cheng, Tingcai; Xu, Pingzhen; Fang, Ting; Xia, Qingyou

2012-01-01

Transcription factors are present in all living organisms, and play vital roles in a wide range of biological processes. Studies of transcription factors will help reveal the complex regulation mechanism of organisms. So far, hundreds of domains have been identified that show transcription factor activity. Here, 281 reported transcription factor domains were used as seeds to search the transcription factors in genomes of Bombyx mori L. (Lepidoptera: Bombycidae) and four other model insects. Overall, 666 transcription factors including 36 basal factors and 630 other factors were identified in B. mori genome, which accounted for 4.56% of its genome. The silkworm transcription factors' expression profiles were investigated in relation to multiple tissues, developmental stages, sexual dimorphism, and responses to oral infection by pathogens and direct bacterial injection. These all provided rich clues for revealing the transcriptional regulation mechanism of silkworm organ differentiation, growth and development, sexual dimorphism, and response to pathogen infection. PMID:22943524

Biologic Therapy in Inflammatory and Immunomediated Arthritis: Safety Profile.

PubMed

Luchetti, Michele Maria; Balloni, Andrea; Gabrielli, Armando

2016-01-01

The increasing insights into the pathogenetic mechanisms of inflammatory autoimmune arthritis and the development of innovative systems of industrial production have led to discover molecules that are able to target/block other molecules that play a critical role in the immune system functioning, and that have been introduced in clinical practice alone and/or in addiction with other "old" disease-modifying anti-rheumatic drugs. For this reason, such drugs are currently known as "biological drugs" and include molecules that induce the immunosuppression acting on several immune pathways. However, though the biological drugs have been employed from more than a decade, there still exist some drawbacks of their use, in particular about the high costs of this therapy and their overall safety, including the route of administration for the intravenous use. In this review we provide an update on the correct use and current therapeutic indications of such drugs, including some of the new biologic therapies that will be soon available for the clinical use, focusing on these biological drugs: • Tumor necrosis factor-alpha (TNF-alpha) inhibitors (adalimumab, certolizumab-pegol, etanercept, golimumab and infliximab); • The T cell co-stimulation inhibitor, abatacept; • The anti-CD20 receptor monoclonal B cell agent, rituximab; • The interlukin-6 (IL-6) receptor-blocking monoclonal antibody, tocilizumab; • The interlukin-1 (IL-1) inhibitor, anakinra; • The interlukin-IL17 (IL-17) pathway inhibitors (ustekinumab, secukinumab, brodalumab).

Improved guidelines for estimating the Highway safety manual calibration factors.

DOT National Transportation Integrated Search

2016-01-01

Crash prediction models can be used to predict the number of crashes and evaluate roadway safety. Part C of the first edition of the Highway Safety Manual (HSM) provides safety performance functions (SPFs). The HSM addendum that includes freeway and ...

Profile of atrial fibrillation inpatients: Cardiovascular risk factors and cardiac rehabilitation programme delivery and referral patterns.

PubMed

Gallagher, Robyn; Zhang, Ling; Roach, Kellie; Sadler, Leonie; Belshaw, Julie; Kirkness, Ann; Proctor, Ross; Neubeck, Lis

2015-12-01

Atrial fibrillation (AF) is increasingly common; however, the cardiovascular risk factor profile and the patterns of delivery and referral to cardiac rehabilitation (CR) in this population are poorly described. We conducted an audit of medical records (n = 145) of patients admitted with AF in one local health district in Sydney, Australia. Patients were aged a mean 72 years, and 51% were male. Lack of risk factor documentation was common. Despite this, 65% had two or more modifiable cardiovascular risk factors, including hypertension (63%) and hypercholesterolaemia (52%). Referral to Phase II CR occurred for 25% and was decreased with permanent AF diagnosis and increased with more risk factors. AF patients admitted to hospital have multiple cardiovascular risk factors but limited risk factor screening and/or referral to outpatient CR programmes. © 2014 Wiley Publishing Asia Pty Ltd.

Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme

PubMed Central

Holz, Frank G; Bandello, Francesco; Gillies, Mark; Mitchell, Paul; Osborne, Aaron; Sheidow, Tom; Souied, Eric; Figueroa, Marta S

2013-01-01

Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need. PMID:23850682

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

Curcuma longa L. as a therapeutic agent in intestinal motility disorders. 2: Safety profile in mouse.

PubMed

Micucci, Matteo; Aldini, Rita; Cevenini, Monica; Colliva, Carolina; Spinozzi, Silvia; Roda, Giulia; Montagnani, Marco; Camborata, Cecilia; Camarda, Luca; Chiarini, Alberto; Mazzella, Giuseppe; Budriesi, Roberta

2013-01-01

Curcuma extract exerts a myorelaxant effect on the mouse intestine. In view of a possible use of curcuma extract in motor functional disorders of the gastrointestinal tract, a safety profile study has been carried out in the mouse. Thirty mice were used to study the in vitro effect of curcuma on gallbladder, bladder, aorta and trachea smooth muscular layers and hearth inotropic and chronotropic activity. The myorelaxant effect on the intestine was also thoroughly investigated. Moreover, curcuma extract (200 mg/Kg/day) was orally administered to twenty mice over 28 days and serum liver and lipids parameters were evaluated. Serum, bile and liver bile acids qualitative and quantitative composition was were also studied. In the intestine, curcuma extract appeared as a not competitive inhibitor through cholinergic, histaminergic and serotoninergic receptors and showed spasmolytic effect on K(+) induced contraction at the level of L type calcium channels. No side effect was observed on bladder, aorta, trachea and heart when we used a dose that is effective on the intestine. An increase in gallbladder tone and contraction was observed. Serum liver and lipids parameters were normal, while a slight increase in serum and liver bile acids concentration and a decrease in bile were observed. Although these data are consistent with the safety of curcuma extract as far as its effect on the smooth muscular layers of different organs and on the heart, the mild cholestatic effect observed in absence of alteration of liver function tests must be further evaluated and the effective dose with minimal side effects considered.

Curcuma longa L. as a Therapeutic Agent in Intestinal Motility Disorders. 2: Safety Profile in Mouse

PubMed Central

Micucci, Matteo; Aldini, Rita; Cevenini, Monica; Colliva, Carolina; Spinozzi, Silvia; Roda, Giulia; Montagnani, Marco; Camborata, Cecilia; Camarda, Luca; Chiarini, Alberto; Mazzella, Giuseppe; Budriesi, Roberta

2013-01-01

Background Curcuma extract exerts a myorelaxant effect on the mouse intestine. In view of a possible use of curcuma extract in motor functional disorders of the gastrointestinal tract, a safety profile study has been carried out in the mouse. Methods Thirty mice were used to study the in vitro effect of curcuma on gallbladder, bladder, aorta and trachea smooth muscular layers and hearth inotropic and chronotropic activity. The myorelaxant effect on the intestine was also thoroughly investigated. Moreover, curcuma extract (200 mg/Kg/day) was orally administered to twenty mice over 28 days and serum liver and lipids parameters were evaluated. Serum, bile and liver bile acids qualitative and quantitative composition was were also studied. Results In the intestine, curcuma extract appeared as a not competitive inhibitor through cholinergic, histaminergic and serotoninergic receptors and showed spasmolytic effect on K+ induced contraction at the level of L type calcium channels. No side effect was observed on bladder, aorta, trachea and heart when we used a dose that is effective on the intestine. An increase in gallbladder tone and contraction was observed. Serum liver and lipids parameters were normal, while a slight increase in serum and liver bile acids concentration and a decrease in bile were observed. Conclusions Although these data are consistent with the safety of curcuma extract as far as its effect on the smooth muscular layers of different organs and on the heart, the mild cholestatic effect observed in absence of alteration of liver function tests must be further evaluated and the effective dose with minimal side effects considered. PMID:24260512

Coagulation Profile as a Risk Factor for 30-day Morbidity Following Cervical Laminectomy and Fusion.

PubMed

Bronheim, Rachel S; Oermann, Eric K; Cho, Samuel K; Caridi, John M

2018-02-15

Retrospective analysis of prospectively collected data. The aim of this study was to determine the ability of abnormal coagulation profile to predict adverse events following posterior cervical laminectomy and fusion (PCLF). PCLF is an increasingly common procedure used to treat a variety of traumatic and degenerative spinal conditions. Abnormal coagulation profile is associated with postoperative adverse events, including blood transfusion. There is a paucity of literature that specifically addresses the relationship between coagulation profile and complications following PCLF. ACS-NSQIP was utilized to identify patients undergoing PCLF between 2006 and 2013. A total of 3546 patients met inclusion criteria. Multivariate analysis was utilized to identify associations between abnormal coagulation profile and postoperative complications. Membership in the low-platelet cohort was an independent risk factor for myocardial infarction (Odds Ratio (OR) = 5.4 [1.0, 29.1], P = 0.049) and bleeding transfusion (OR = 2.0 [1.2, 3.4], P = 0.011). Membership in the high international normalized ratio group was an independent risk factor for pneumonia (OR = 6.3 [2.5, 16.1], P < 0.001), ventilation >48 hours (OR = 6.5 [2.3, 18.4], P < 0.001), organ space surgical site infection (OR = 11.1 [2.1, 57.3], P = 0.004), urinary tract infection (OR = 3.0 [1.2, 8.0], P = 0.024), bleeding transfusion (OR = 6.0 [3.4, 10.7], P < 0.001), sepsis (OR = 5.1 [1.6, 16.4], P = 0.006), and septic shock (OR = 6.8 [1.7, 27.4], P = 0.007). Membership in the bleeding disorders cohort was an independent predictor of unplanned intubation (OR = 3.2 [1.1, 9.5], P = 0.041), pneumonia (OR = 2.9 [1.2, 7.2], P = 0.023), ventilation >48 hours (OR = 4.8 [1.9, 12.4], P = 0.001), cerebrovascular accident/stroke with neurological deficit (OR = 24.8 [2.9, 210.6], P = 0.003), bleeding transfusion (OR = 2.1 [1

Development of a safety decision-making scenario to measure worker safety in agriculture.

PubMed

Mosher, G A; Keren, N; Freeman, S A; Hurburgh, C R

2014-04-01

Human factors play an important role in the management of occupational safety, especially in high-hazard workplaces such as commercial grain-handling facilities. Employee decision-making patterns represent an essential component of the safety system within a work environment. This research describes the process used to create a safety decision-making scenario to measure the process that grain-handling employees used to make choices in a safety-related work task. A sample of 160 employees completed safety decision-making simulations based on a hypothetical but realistic scenario in a grain-handling environment. Their choices and the information they used to make their choices were recorded. Although the employees emphasized safety information in their decision-making process, not all of their choices were safe choices. Factors influencing their choices are discussed, and implications for industry, management, and workers are shared.

Resistance profiles and risk factors of resistant microorganisms in bacteraemia of abdominal origin.

PubMed

Martín Jaramago, J; Armero Ibáñez, R; Camarena Miñana, J J; Morales Suárez-Varela, M

2017-11-01

The presence of resistant microorganisms is a major cause of failure in initial empirical antimicrobial therapy. The objectives of this study are to determine the resistance profile of microorganisms that cause bacteraemia of abdominal origin and to identify whether the previous use of antibiotics and the place of acquisition of bacteraemia are risk factors associated with the presence of resistant organisms. A clinical, observational, epidemiological, retrospective cohort study was conducted with all the adult patients admitted to a university hospital from 2011-2013. Antimicrobial resistance profiles were described and a 95% confidence interval chi-square test was used to determine whether the variables studied were risk factors in the isolation of resistant microorganisms. Of the 1245 patients with bacteraemia, 212 (17%) presented bacteraemia of abdominal origin. The resistance profile highlights the incidence of methicillin resistant Staphylococcus aureus (50%), coagulase-negative staphylococci resistant to linezolid (20.58%), enterococci resistant to vancomycin (3.12%), Escherichia coli resistant to third-generation cephalosporins (9.9%) and fluoroquinolones (35.64%), Klebsiella pneumoniae resistant to third-generation cephalosporins (8.33%), Pseudomonas aeruginosa resistant to fluoroquinolones and carbapenem (25% and 25% respectively) and Acinetobacter baumanii resistant to fluoroquinolones and carbapenem (100% and 100% respectively), Candida albicans resistant to fluconazole (11.11%), single Candida krusei isolate resistant to fluconazole and Candida parapsilosis resistant to echinocandins (12.5%). In our study, previous use of antibiotics had a statistically significant association with the isolation of resistant microorganisms (P=.013) but not the place of acquisition of bacteraemia (P=.239). Establishing the incidence of resistant organisms can improve empirical antimicrobial therapy in patients with bacteraemia of abdominal origin. Previous use of

The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities.

PubMed

Paxton, Elizabeth W; Inacio, Maria Cs; Kiley, Mary-Lou

2012-01-01

Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectiveness, and research. Eight KP implant registries leverage the integrated health care system's administrative databases and electronic health records system. Registry data collected undergo quality control and validation as well as statistical analysis. Patient safety has been enhanced through identification of affected patients during major recalls, identification of risk factors associated with outcomes of interest, development of risk calculators, and surveillance programs for infections and adverse events. Effective quality improvement activities included medical center- and surgeon-specific profiles for use in benchmarking reports, and changes in practice related to registry information output. Among the cost-effectiveness strategies employed were collaborations with sourcing and contracting groups, and assistance in adherence to formulary device guidelines. Research studies using registry data included postoperative complications, resource utilization, infection risk factors, thromboembolic prophylaxis, effects of surgical delay on concurrent injuries, and sports injury patterns. The unique KP implant registries provide important information and affect several areas of our organization, including patient safety, quality improvement, cost-effectiveness, and research.

Positive organizational behavior and safety in the offshore oil industry: Exploring the determinants of positive safety climate.

PubMed

Hystad, Sigurd W; Bartone, Paul T; Eid, Jarle

2014-01-01

Much research has now documented the substantial influence of safety climate on a range of important outcomes in safety critical organizations, but there has been scant attention to the question of what factors might be responsible for positive or negative safety climate. The present paper draws from positive organizational behavior theory to test workplace and individual factors that may affect safety climate. Specifically, we explore the potential influence of authentic leadership style and psychological capital on safety climate and risk outcomes. Across two samples of offshore oil-workers and seafarers working on oil platform supply ships, structural equation modeling yielded results that support a model in which authentic leadership exerts a direct effect on safety climate, as well as an indirect effect via psychological capital. This study shows the importance of leadership qualities as well as psychological factors in shaping a positive work safety climate and lowering the risk of accidents.

Advances in measuring culturally competent care: a confirmatory factor analysis of CAHPS-CC in a safety-net population.

PubMed

Stern, Rachel J; Fernandez, Alicia; Jacobs, Elizabeth A; Neilands, Torsten B; Weech-Maldonado, Robert; Quan, Judy; Carle, Adam; Seligman, Hilary K

2012-09-01

Providing culturally competent care shows promise as a mechanism to reduce health care inequalities. Until the recent development of the Consumer Assessment of Healthcare Providers and Systems Cultural Competency Item Set (CAHPS-CC), no measures capturing patient-level experiences with culturally competent care have been suitable for broad-scale administration. We performed confirmatory factor analysis and internal consistency reliability analysis of CAHPS-CC among patients with type 2 diabetes (n=600) receiving primary care in safety-net clinics. CAHPS-CC domains were also correlated with global physician ratings. A 7-factor model demonstrated satisfactory fit (χ²₂₃₁=484.34, P<0.0001) with significant factor loadings at P<0.05. Three domains showed excellent reliability-Doctor Communication-Positive Behaviors (α=0.82), Trust (α=0.77), and Doctor Communication-Health Promotion (α=0.72). Four domains showed inadequate reliability either among Spanish speakers or overall (overall reliabilities listed): Doctor Communication-Negative Behaviors (α=0.54), Equitable Treatment (α=0.69), Doctor Communication-Alternative Medicine (α=0.52), and Shared Decision-Making (α=0.51). CAHPS-CC domains were positively and significantly correlated with global physician rating. Select CAHPS-CC domains are suitable for broad-scale administration among safety-net patients. Those domains may be used to target quality-improvement efforts focused on providing culturally competent care in safety-net settings.

Implementation of safety management systems in Hong Kong construction industry - A safety practitioner's perspective.

PubMed

Yiu, Nicole S N; Sze, N N; Chan, Daniel W M

2018-02-01

In the 1980s, the safety management system (SMS) was introduced in the construction industry to mitigate against workplaces hazards, reduce the risk of injuries, and minimize property damage. Also, the Factories and Industrial Undertakings (Safety Management) Regulation was introduced on 24 November 1999 in Hong Kong to empower the mandatory implementation of a SMS in certain industries including building construction. Therefore, it is essential to evaluate the effectiveness of the SMS in improving construction safety and identify the factors that influence its implementation in Hong Kong. A review of the current state-of-the-practice helped to establish the critical success factors (CSFs), benefits, and difficulties of implementing the SMS in the construction industry, while structured interviews were used to establish the key factors of the SMS implementation. Results of the state-of-the-practice review and structured interviews indicated that visible senior commitment, in terms of manpower and cost allocation, and competency of safety manager as key drivers for the SMS implementation. More so, reduced accident rates and accident costs, improved organization framework, and increased safety audit ratings were identified as core benefits of implementing the SMS. Meanwhile, factors such as insufficient resources, tight working schedule, and high labor turnover rate were the key challenges to the effective SMS implementation in Hong Kong. The findings of the study were consistent and indicative of the future development of safety management practice and the sustainable safety improvement of Hong Kong construction industry in the long run. Copyright © 2018 National Safety Council and Elsevier Ltd. All rights reserved.

Why Some Walk and Others Don't: Exploring Interactions of Perceived Safety and Social Neighborhood Factors with Psychosocial Cognitions

ERIC Educational Resources Information Center

Beenackers, Marielle A.; Kamphuis, Carlijn B. M.; Mackenbach, Johan P.; Burdorf, Alex; van Lenthe, Frank J.

2013-01-01

Although physical activity is often believed to be influenced by both environmental and individual factors, little is known about their interaction. This study explores interactions of perceived safety and social neighborhood factors with psychosocial cognitions for leisure-time walking. Cross-sectional data were obtained from residents (age 25-75…

Phosphate binders for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis: a comparison of safety profiles.

PubMed

Locatelli, Francesco; Del Vecchio, Lucia; Violo, Leano; Pontoriero, Giuseppe

2014-05-01

Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help control phosphorus levels. Although effective at lowering serum phosphorus, they all have safety issues that need to be considered when selecting which one to use. This paper reviews the use of phosphate binders in patients with CKD on dialysis, with a focus on safety and tolerability. In addition to the more established agents, a new resin-based phosphate binder, colestilan, is discussed. Optimal phosphate control is still an unmet need in CKD. Nonetheless, we now have an extending range of phosphate binders available. Aluminium has potentially serious toxic risks. Calcium-based binders are still very useful but can lead to hypercalcemia and/or positive calcium balance and cardiovascular calcification. No long-term data are available for the new calcium acetate/magnesium combination product. Lanthanum is an effective phosphate binder, but there is insufficient evidence about possible long-term effects of tissue deposition. The resin-based binders, colestilan and sevelamer, appear to have profiles that would lead to less vascular calcification, and the main adverse events seen with these agents are gastrointestinal effects.

An examination of social interaction profiles based on the factors measured by the screen for social interaction.

PubMed

Mahoney, Emery B; Breitborde, Nicholas J K; Leone, Sarah L; Ghuman, Jaswinder Kaur

2014-10-01

Deficits in the capacity to engage in social interactions are a core deficit associated with Autistic Disorder (AD) and Pervasive Developmental Disorder-Not Otherwise Specified (PDD-NOS). These deficits emerge at a young age, making screening for social interaction deficits and interventions targeted at improving capacity in this area important for early identification and intervention. Screening and early intervention efforts are particularly important given the poor short and long term outcomes for children with Autism Spectrum Disorders (ASDs) who experience social interaction deficits. The Screen for Social Interaction (SSI) is a well-validated screening measure that examines a child's capacity for social interaction using a developmental approach. The present study identified four underlying factors measured by the SSI, namely, Connection with Caregiver, Interaction/Imagination, Social Approach/Interest, and Agreeable Nature. The resulting factors were utilized to compare social interaction profiles across groups of children with AD, PDD-NOS, children with non-ASD developmental and/or psychiatric conditions and typically developing children. The results indicate that children with AD and those with PDD-NOS had similar social interaction profiles, but were able to be distinguished from typically developing children on every factor and were able to be distinguished from children with non-ASD psychiatric conditions on every factor except the Connection with Caregiver factor. In addition, children with non-ASD developmental and/or psychiatric conditions could be distinguished from typically developing children on the Connection with Caregiver factor and the Social Approach/Interest factor. These findings have implications for screening and intervention for children with ASDs and non-ASD psychiatric conditions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Risk factor profile for sudden cardiac death during mountain hiking.

PubMed

Burtscher, M; Pachinger, O; Schocke, M F H; Ulmer, H

2007-07-01

Mountain hiking is associated with a death rate of about 4 deaths per 100,000 hikers annually. About 50 % of all fatalities during mountain hiking are sudden cardiac deaths (SCDs). But there are only few data available regarding risk factors and triggers associated with SCD during mountain hiking. Thus, a case-control analysis between persons who died suddenly during mountain hiking and randomly selected controls was carried out. Risk factor profiles of 179 males over the age of 34 who suffered SCD during mountain hiking were compared to those of 537 matched controls. Hikers who died suddenly during mountain hiking were much more likely to have had a prior MI (17% vs. 0.9%; p < 0.001), known coronary artery disease (CAD) without prior MI (17 % vs. 4%; p < 0.001), diabetes (6% vs. 1 %; p < 0.001), hypercholesterolemia (54 % vs. 20%; p < 0.001), and were less engaged in regular mountain sports activities (31% vs. 58%; p < 0.001) compared to hikers from the control group. Based on the reported relationship between traditional risk factors and coronary plaque morphology, acute plaque rupture with thrombus formation and subsequent lethal arrhythmias may be assumed to be a dominant mechanism precipitating SCD during hiking. In contrast, in skiers especially non-occlusive plaques may precipitate ischemia leading to an imbalance between oxygen demand and supply and subsequent lethal arrhythmias. As preventive measures recommended to hikers at risk, adaptation to regular mountain sports activities by an adequate training program and pharmacological interventions, e.g. lipid lowering drugs, aspirin, and beta-blockers, should be considered.

Discovering Innovation at the Intersection of Undergraduate Medical Education, Human Factors, and Collaboration: The Development of a Nasogastric Tube Safety Pack.

PubMed

Taylor, Natalie; Bamford, Thomas; Haindl, Cornelia; Cracknell, Alison

2016-04-01

Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. Since 2011, Leeds Medical School in the United Kingdom has used case study examples of nasogastric (NG) tube patient safety incidents within the undergraduate patient safety curriculum. In 2012, a medical undergraduate student approached a clinician with an innovative idea after undertaking an NG tubes root cause analysis case study. Simultaneously, a separate local project demonstrated low compliance (11.6%) with the United Kingdom's National Patient Safety Agency NG tubes guideline for use of the correct method to check tube position. These separate endeavors led to interdisciplinary collaboration between a medical student, health care professionals, researchers, and industry to develop the Initial Placement Nasogastric Tube Safety Pack. Human factors engineering was used to inform pack design to allow guideline recommendations to be accessible and easy to follow. A timeline of product development, mapped against key human factors and medical device design principles used throughout the process, is presented. The safety pack has since been launched in five UK National Health Service (NHS) hospitals, and the pack has been introduced into health care professional staff training for NG tubes. A mixed-methods evaluation is currently under way in five NHS organizations.

BloodChIP: a database of comparative genome-wide transcription factor binding profiles in human blood cells.

PubMed

Chacon, Diego; Beck, Dominik; Perera, Dilmi; Wong, Jason W H; Pimanda, John E

2014-01-01

The BloodChIP database (http://www.med.unsw.edu.au/CRCWeb.nsf/page/BloodChIP) supports exploration and visualization of combinatorial transcription factor (TF) binding at a particular locus in human CD34-positive and other normal and leukaemic cells or retrieval of target gene sets for user-defined combinations of TFs across one or more cell types. Increasing numbers of genome-wide TF binding profiles are being added to public repositories, and this trend is likely to continue. For the power of these data sets to be fully harnessed by experimental scientists, there is a need for these data to be placed in context and easily accessible for downstream applications. To this end, we have built a user-friendly database that has at its core the genome-wide binding profiles of seven key haematopoietic TFs in human stem/progenitor cells. These binding profiles are compared with binding profiles in normal differentiated and leukaemic cells. We have integrated these TF binding profiles with chromatin marks and expression data in normal and leukaemic cell fractions. All queries can be exported into external sites to construct TF-gene and protein-protein networks and to evaluate the association of genes with cellular processes and tissue expression.

[Drug safety warnings in psychiatry: adverse drug reactions' signaling from 2002 to 2014].

PubMed

Prisco, Vincenzo; Iannaccone, Teresa; Tusciano, Adriano; Boccardi, Mariangela; Perris, Francesco; Capuano, Annalisa; Catapano, Francesco; Fabrazzo, Michele

2016-01-01

Monitoring drug-related side effects in psychiatric patients is highly recommended. In fact, frequent exposure to long-term polipharmacotherapy, poor compliance to pharmachological treatment and comorbidity with organic illnesses requiring the prescription of other drugs are causes of pharmacokinetic/pharmacodynamic interactions. These vulnerability factors result in a certain increase in adverse drug reactions (ADRs). This study performes an analysis of Italian Medicine Agency data, in the section "signal analysis", to attempt an assessment of the safety warnings among the different psychotropic drug classes, belonging to the ATC class: N03 (antiepileptics), N05 (antipsychotics), N06 (psycho-analectic drugs). Then we analysed, in a descriptive way, the different association between the drug and the related ADR, evaluating the different safety profiles, in relation to experimental studies, supporting the importance of the signal. In the last years, among the new 25 ADRs, 10 were related to antidepressant drugs (8 SSRI, 1 mirtazapine, 1 agomelatine). In relation to antipsychotic drugs, 6 new correlations were found between drug and ADR onset, mainly among atypical antispychotics. Other correlations (6 above all) were found among antiepileptic drugs. Among benzodiazepines, a signal linked to rabdomylysis onset was found. It is also recommended an evaluation of safety profile in relation to zolpidem prescription. The results of our systematic review are a motivational input, considering the continuous increase of safety warnings, to attentively monitor drug's prescription. Spontaneous ADRs' signaling is a classical system to provide the required attention in relation to a potential risk. The clinician in charge must report this because he is the key figure in the drugs' safety process. In psychiatry, in which a long-term pharmachological therapy is frequent, clinicians are requested to find and signal ADRs to the competent authority.

Selective ribosome profiling as a tool to study the interaction of chaperones and targeting factors with nascent polypeptide chains and ribosomes

PubMed Central

Becker, Annemarie H.; Oh, Eugene; Weissman, Jonathan S.; Kramer, Günter; Bukau, Bernd

2014-01-01

A plethora of factors is involved in the maturation of newly synthesized proteins, including chaperones, membrane targeting factors, and enzymes. Many factors act cotranslationally through association with ribosome-nascent chain complexes (RNCs), but their target specificities and modes of action remain poorly understood. We developed selective ribosome profiling (SeRP) to identify substrate pools and points of RNC engagement of these factors. SeRP is based on sequencing mRNA fragments covered by translating ribosomes (general ribosome profiling, RP), combined with a procedure to selectively isolate RNCs whose nascent polypeptides are associated with the factor of interest. Factor–RNC interactions are stabilized by crosslinking, the resulting factor–RNC adducts are then nuclease-treated to generate monosomes, and affinity-purified. The ribosome-extracted mRNA footprints are converted to DNA libraries for deep sequencing. The protocol is specified for general RP and SeRP in bacteria. It was first applied to the chaperone trigger factor and is readily adaptable to other cotranslationally acting factors, including eukaryotic factors. Factor–RNC purification and sequencing library preparation takes 7–8 days, sequencing and data analysis can be completed in 5–6 days. PMID:24136347

Nursing Student Experiences Regarding Safe Use of Electronic Health Records: A Pilot Study of the Safety and Assurance Factors for EHR Resilience Guides.

PubMed

Whitt, Karen J; Eden, Lacey; Merrill, Katreena Collette; Hughes, Mckenna

2017-01-01

Previous research has linked improper electronic health record configuration and use with adverse patient events. In response to this problem, the US Office of the National Coordinator for Health Information Technology developed the Safety and Assurance Factors for EHR Resilience guides to evaluate electronic health records for optimal use and safety features. During the course of their education, nursing students are exposed to a variety of clinical practice settings and electronic health records. This descriptive study evaluated 108 undergraduate and 51 graduate nursing students' ratings of electronic health record features and safe practices, as well as what they learned from utilizing the computerized provider order entry and clinician communication Safety and Assurance Factors for EHR Resilience guide checklists. More than 80% of the undergraduate and 70% of the graduate students reported that they experienced user problems with electronic health records in the past. More than 50% of the students felt that electronic health records contribute to adverse patient outcomes. Students reported that many of the features assessed were not fully implemented in their electronic health record. These findings highlight areas where electronic health records can be improved to optimize patient safety. The majority of students reported that utilizing the Safety and Assurance Factors for EHR Resilience guides increased their understanding of electronic health record features.

Ignoring Adjuvant Toxicity Falsifies the Safety Profile of Commercial Pesticides

PubMed Central

Mesnage, Robin; Antoniou, Michael N.

2018-01-01

Commercial formulations of pesticides are invariably not single ingredients. Instead they are cocktails of chemicals, composed of a designated pesticidal “active principle” and “other ingredients,” with the latter collectively also known as “adjuvants.” These include surfactants, antifoaming agents, dyes, etc. Some adjuvants are added to influence the absorption and stability of the active principle and thus promote its pesticidal action. Currently, the health risk assessment of pesticides in the European Union and in the United States focuses almost exclusively on the stated active principle. Nonetheless, adjuvants can also be toxic in their own right with numerous negative health effects having been reported in humans and on the environment. Despite the known toxicity of adjuvants, they are regulated differently from active principles, with their toxic effects being generally ignored. Adjuvants are not subject to an acceptable daily intake, and they are not included in the health risk assessment of dietary exposures to pesticide residues. Here, we illustrate this gap in risk assessment by reference to glyphosate, the most used pesticide active ingredient. We also investigate the case of neonicotinoid insecticides, which are strongly suspected to be involved in bee and bumblebee colony collapse disorder. Authors of studies sometimes use the name of the active principle (for example glyphosate) when they are testing a commercial formulation containing multiple (active principle plus adjuvant) ingredients. This results in confusion in the scientific literature and within regulatory circles and leads to a misrepresentation of the safety profile of commercial pesticides. Urgent action is needed to lift the veil on the presence of adjuvants in food and human bodily fluids, as well as in the environment (such as in air, water, and soil) and to characterize their toxicological properties. This must be accompanied by regulatory precautionary measures to

A Bayesian procedure for evaluating the frequency of calibration factor updates in highway safety manual (HSM) applications.

PubMed

Saha, Dibakar; Alluri, Priyanka; Gan, Albert

2017-01-01

The Highway Safety Manual (HSM) presents statistical models to quantitatively estimate an agency's safety performance. The models were developed using data from only a few U.S. states. To account for the effects of the local attributes and temporal factors on crash occurrence, agencies are required to calibrate the HSM-default models for crash predictions. The manual suggests updating calibration factors every two to three years, or preferably on an annual basis. Given that the calibration process involves substantial time, effort, and resources, a comprehensive analysis of the required calibration factor update frequency is valuable to the agencies. Accordingly, the objective of this study is to evaluate the HSM's recommendation and determine the required frequency of calibration factor updates. A robust Bayesian estimation procedure is used to assess the variation between calibration factors computed annually, biennially, and triennially using data collected from over 2400 miles of segments and over 700 intersections on urban and suburban facilities in Florida. Bayesian model yields a posterior distribution of the model parameters that give credible information to infer whether the difference between calibration factors computed at specified intervals is credibly different from the null value which represents unaltered calibration factors between the comparison years or in other words, zero difference. The concept of the null value is extended to include the range of values that are practically equivalent to zero. Bayesian inference shows that calibration factors based on total crash frequency are required to be updated every two years in cases where the variations between calibration factors are not greater than 0.01. When the variations are between 0.01 and 0.05, calibration factors based on total crash frequency could be updated every three years. Copyright © 2016 Elsevier Ltd. All rights reserved.

Cross-modal work helps OMC improve the safety of commercial transportation

DOT National Transportation Integrated Search

1997-01-01

This article describes the Commercial Vehicle Information System (CVIS), designed to deploy a national safety program for the U.S. commercial trucking fleet. CVIS is built around a safety analysis algorithm called SafeStat which constructs a profile ...

Positive organizational behavior and safety in the offshore oil industry: Exploring the determinants of positive safety climate

PubMed Central

Hystad, Sigurd W.; Bartone, Paul T.; Eid, Jarle

2013-01-01

Much research has now documented the substantial influence of safety climate on a range of important outcomes in safety critical organizations, but there has been scant attention to the question of what factors might be responsible for positive or negative safety climate. The present paper draws from positive organizational behavior theory to test workplace and individual factors that may affect safety climate. Specifically, we explore the potential influence of authentic leadership style and psychological capital on safety climate and risk outcomes. Across two samples of offshore oil-workers and seafarers working on oil platform supply ships, structural equation modeling yielded results that support a model in which authentic leadership exerts a direct effect on safety climate, as well as an indirect effect via psychological capital. This study shows the importance of leadership qualities as well as psychological factors in shaping a positive work safety climate and lowering the risk of accidents. PMID:24454524

Factors Influencing Attitude, Safety Behavior, and Knowledge regarding Household Waste Management in Guinea: A Cross-Sectional Study

PubMed Central

Mamady, Keita

2016-01-01

Waste indiscriminate disposal is recognized as an important cause of environmental pollution and is associated with health problems. Safe management and disposal of household waste are an important problem to the capital city of Guinea (Conakry). The objective of this study was to identify socioeconomic and demographic factors associated with practice, knowledge, and safety behavior of family members regarding household waste management and to produce a remedial action plan. I found that no education background, income, and female individuals were independently associated with indiscriminate waste disposal. Unplanned residential area was an additional factor associated with indiscriminate waste disposal. I also found that the community residents had poor knowledge and unsafe behavior in relation to waste management. The promotion of environmental information and public education and implementation of community action programs on disease prevention and health promotion will enhance environmental friendliness and safety of the community. PMID:27092183

Factors Influencing Attitude, Safety Behavior, and Knowledge regarding Household Waste Management in Guinea: A Cross-Sectional Study.

PubMed

Mamady, Keita

2016-01-01

Waste indiscriminate disposal is recognized as an important cause of environmental pollution and is associated with health problems. Safe management and disposal of household waste are an important problem to the capital city of Guinea (Conakry). The objective of this study was to identify socioeconomic and demographic factors associated with practice, knowledge, and safety behavior of family members regarding household waste management and to produce a remedial action plan. I found that no education background, income, and female individuals were independently associated with indiscriminate waste disposal. Unplanned residential area was an additional factor associated with indiscriminate waste disposal. I also found that the community residents had poor knowledge and unsafe behavior in relation to waste management. The promotion of environmental information and public education and implementation of community action programs on disease prevention and health promotion will enhance environmental friendliness and safety of the community.

Effects of Bread with Nigella Sativa on Lipid Profiles, Apolipoproteins and Inflammatory Factor in Metabolic Syndrome Patients

PubMed Central

2016-01-01

Nigella sativa (N.sativa) has been used in traditional medicine and many studies have been performed in different communities in order to reveal the effects of it on medical disorders and chronic diseases. The aim of this study was to investigate the effects of bread with N. Sativa on lipid profiles, apolipoproteins, and inflammatory factors in metabolic syndrome (MetS) patients. A randomized, double-blind, cross-over and clinical trial was conducted in 51 MetS patients of both sexes with age group of 20-65 years old in Chaloos, north of Iran. Patients were randomly divided in two groups. In phase 1, intervention group (A, n = 27) received daily a bread with N. sativa and wheat bran and control group (B, n = 24) received the same bread without N. sativa for 2 months. After 2 weeks of wash out period, phase 2 was started with switch the intervention between two groups. Measuring of lipid profiles, apolipoproteins and inflammatory factor was performed for all patients before and after two phases. In this study, treatment, sequence and time effects of intervention were evaluated and revealed that consumption of bread with N. sativa has no significant treatment and time effects on triglyceride (TG), cholesterol (CHOL), low density lipoprotein (LDL), high density lipoprotein (HDL), apolipoprotein (APO)-A, APO-B and high-sensitivity C-reactive protein (p > 0.05). Sequence effect was significant on CHOL, LDL, APO-A, and APO-B (p < 0.05) but was not significant on other parameters (p > 0.05). Consumption of bread with N. sativa has no a significant effect on lipid profiles, apolipoproteins and inflammatory factor in MetS patients. PMID:27152298

Identification and expression profiles of the WRKY transcription factor family in Ricinus communis.

PubMed

Li, Hui-Liang; Zhang, Liang-Bo; Guo, Dong; Li, Chang-Zhu; Peng, Shi-Qing

2012-07-25

In plants, WRKY proteins constitute a large family of transcription factors. They are involved in many biological processes, such as plant development, metabolism, and responses to biotic and abiotic stresses. A large number of WRKY transcription factors have been reported from Arabidopsis, rice, and other higher plants. The recent publication of the draft genome sequence of castor bean (Ricinus communis) has allowed a genome-wide search for R. communis WRKY (RcWRKY) transcription factors and the comparison of these positively identified proteins with their homologs in model plants. A total of 47 WRKY genes were identified in the castor bean genome. According to the structural features of the WRKY domain, the RcWRKY are classified into seven main phylogenetic groups. Furthermore, putative orthologs of RcWRKY proteins in Arabidopsis and rice could now be assigned. An analysis of expression profiles of RcWRKY genes indicates that 47 WRKY genes display differential expressions either in their transcript abundance or expression patterns under normal growth conditions. Copyright © 2012 Elsevier B.V. All rights reserved.

Monitoring product safety in the postmarketing environment.

PubMed

Sharrar, Robert G; Dieck, Gretchen S

2013-10-01

The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

Creatine metabolism and safety profiles after six-week oral guanidinoacetic acid administration in healthy humans.

PubMed

Ostojic, Sergej M; Niess, Barbara; Stojanovic, Marko; Obrenovic, Milos

2013-01-01

Guanidinoacetic acid (GAA) is a natural precursor of creatine, yet the potential use of GAA as a nutritional additive for restoring creatine availability in humans has been limited by unclear efficacy and safety after exogenous GAA administration. The present study evaluated the effects of orally administered GAA on serum and urinary GAA, creatine and creatinine concentration, and on the occurrence of adverse events in healthy humans. Twenty-four healthy volunteers were randomized in a double-blind design to receive either GAA (2.4 grams daily) or placebo (PLA) by oral administration for 6 weeks. www.clinicaltrials.gov, identification number NCT01133899. Serum creatine and creatinine increased significantly from before to after administration in GAA-supplemented participants (P < 0.05). The proportion of participants who reported minor side effects was 58.3% in the GAA group and 45.5% in the placebo group (P = 0.68). A few participants experienced serum creatine levels above 70 µmol/L. Exogenous GAA is metabolized to creatine, resulting in a significant increase of fasting serum creatine after intervention. GAA had an acceptable side-effects profile with a low incidence of biochemical abnormalities.

Creatine Metabolism and Safety Profiles after Six-Week Oral Guanidinoacetic Acid Administration in Healthy Humans

PubMed Central

Ostojic, Sergej M.; Niess, Barbara; Stojanovic, Marko; Obrenovic, Milos

2013-01-01

Objectives; Guanidinoacetic acid (GAA) is a natural precursor of creatine, yet the potential use of GAA as a nutritional additive for restoring creatine availability in humans has been limited by unclear efficacy and safety after exogenous GAA administration. The present study evaluated the effects of orally administered GAA on serum and urinary GAA, creatine and creatinine concentration, and on the occurrence of adverse events in healthy humans. Methods and Results; Twenty-four healthy volunteers were randomized in a double-blind design to receive either GAA (2.4 grams daily) or placebo (PLA) by oral administration for 6 weeks. Clinical trial registration: www.clinicaltrials.gov, identification number NCT01133899. Serum creatine and creatinine increased significantly from before to after administration in GAA-supplemented participants (P < 0.05). The proportion of participants who reported minor side effects was 58.3% in the GAA group and 45.5% in the placebo group (P = 0.68). A few participants experienced serum creatine levels above 70 µmol/L. Conclusion; Exogenous GAA is metabolized to creatine, resulting in a significant increase of fasting serum creatine after intervention. GAA had an acceptable side-effects profile with a low incidence of biochemical abnormalities. PMID:23329885

An update of safety of clinically used atypical antipsychotics.

PubMed

Orsolini, L; Tomasetti, C; Valchera, A; Vecchiotti, R; Matarazzo, I; Vellante, F; Iasevoli, F; Buonaguro, E F; Fornaro, M; Fiengo, A L C; Martinotti, G; Mazza, M; Perna, G; Carano, A; De Bartolomeis, A; Di Giannantonio, M; De Berardis, D

2016-10-01

The atypical antipsychotic (APs) drugs have become the most widely used agents to treat a variety of psychoses because of their superiority with regard to safety and tolerability profile compared to conventional/'typical' APs. We aimed at providing a synthesis of most current evidence about the safety and tolerability profile of the most clinically used atypical APs so far marketed. Qualitative synthesis followed an electronic search made inquiring of the following databases: MEDLINE, Embase, PsycINFO and the Cochrane Library from inception until January 2016, combining free terms and MESH headings for the topics of psychiatric disorders and all atypical APs as following: ((safety OR adverse events OR side effects) AND (aripiprazole OR asenapine OR quetiapine OR olanzapine OR risperidone OR paliperidone OR ziprasidone OR lurasidone OR clozapine OR amisulpride OR iloperidone)). A critical issue in the treatment with atypical APs is represented by their metabolic side effect profile (e.g. weight gain, lipid and glycaemic imbalance, risk of diabetes mellitus and diabetic ketoacidosis) which may limit their use in particular clinical samples. Electrolyte imbalance, ECG abnormalities and cardiovascular adverse effects may recommend a careful baseline and periodic assessments.

Assessing medical students' perceptions of patient safety: the medical student safety attitudes and professionalism survey.

PubMed

Liao, Joshua M; Etchegaray, Jason M; Williams, S Tyler; Berger, David H; Bell, Sigall K; Thomas, Eric J

2014-02-01

To develop and test the psychometric properties of a survey to measure students' perceptions about patient safety as observed on clinical rotations. In 2012, the authors surveyed 367 graduating fourth-year medical students at three U.S. MD-granting medical schools. They assessed the survey's reliability and construct and concurrent validity. They examined correlations between students' perceptions of organizational cultural factors, organizational patient safety measures, and students' intended safety behaviors. They also calculated percent positive scores for cultural factors. Two hundred twenty-eight students (62%) responded. Analyses identified five cultural factors (teamwork culture, safety culture, error disclosure culture, experiences with professionalism, and comfort expressing professional concerns) that had construct validity, concurrent validity, and good reliability (Cronbach alphas > 0.70). Across schools, percent positive scores for safety culture ranged from 28% (95% confidence interval [CI], 13%-43%) to 64% (30%-98%), while those for teamwork culture ranged from 47% (32%-62%) to 74% (66%-81%). They were low for error disclosure culture (range: 10% [0%-20%] to 27% [20%-35%]), experiences with professionalism (range: 7% [0%-15%] to 23% [16%-30%]), and comfort expressing professional concerns (range: 17% [5%-29%] to 38% [8%-69%]). Each cultural factor correlated positively with perceptions of overall patient safety as observed in clinical rotations (r = 0.37-0.69, P < .05) and at least one safety behavioral intent item. This study provided initial evidence for the survey's reliability and validity and illustrated its applicability for determining whether students' clinical experiences exemplify positive patient safety environments.

Sun safety knowledge and practice in UK postal delivery workers.

PubMed

Houdmont, J; Davis, S; Griffiths, A

2016-06-01

Postal delivery workers spend a large proportion of their work time outdoors, placing them at increased risk of skin cancer. To date, no studies have examined occupational sun safety knowledge and practice within this group in the UK. To describe the occupational sun safety knowledge and practice of UK postal delivery workers and to investigate the association of demographic, personal and occupational factors with knowledge and practice in order to identify potential strategies for improving sun safety in this occupational group. Postal delivery workers completed a questionnaire that collected data on occupational sun safety knowledge and practice in addition to demographic, personal and workplace characteristics. One-way analysis of variances were applied to assess differences in knowledge and practice by these characteristics. A total of 1153 postal delivery workers completed the questionnaire, a 60% response rate. Thirty-three per cent reported receiving sun safety training within the previous 12 months. The majority of respondents reported correct knowledge on three of the six domains and good practice on four of the six behavioural domains. However, only one-fifth of respondents reported wearing sunglasses and ensuring a plentiful intake of water. Knowledge and practice differed significantly according to demographic, personal and workplace characteristics. There is a need to raise the profile of occupational skin cancer in this occupational group and to increase the priority given to occupational sun safety policies alongside targeted and tailored interventions, the effect of which can be evaluated. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine.

Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy.

PubMed

Klement, R J; Hoerner-Rieber, J; Adebahr, S; Andratschke, N; Blanck, O; Boda-Heggemann, J; Duma, M; Eble, M J; Eich, H C; Flentje, M; Gerum, S; Hass, P; Henkenberens, C; Hildebrandt, G; Imhoff, D; Kahl, K H; Klass, N D; Krempien, R; Lohaus, F; Petersen, C; Schrade, E; Wendt, T G; Wittig, A; Guckenberger, M

2018-03-03

Stereotactic body radiotherapy (SBRT) for oligometastatic disease is characterized by an excellent safety profile; however, experiences are mostly based on treatment of one single metastasis. It was the aim of this study to evaluate safety and efficacy of SBRT for multiple pulmonary metastases. This study is based on a retrospective database of the DEGRO stereotactic working group, consisting of 637 patients with 858 treatments. Cox regression and logistic regression were used to analyze the association between the number of SBRT treatments or the number and the timing of repeat SBRT courses with overall survival (OS) and the risk of early death. Out of 637 patients, 145 patients were treated for multiple pulmonary metastases; 88 patients received all SBRT treatments within one month whereas 57 patients were treated with repeat SBRT separated by at least one month. Median OS for the total patient population was 23.5 months and OS was not significantly influenced by the overall number of SBRT treatments or the number and timing of repeat SBRT courses. The risk of early death within 3 and 6 months was not increased in patients treated with multiple SBRT treatments, and no grade 4 or grade 5 toxicity was observed in these patients. In appropriately selected patients, synchronous SBRT for multiple pulmonary oligometastases and repeat SBRT may have a comparable safety and efficacy profile compared to SBRT for one single oligometastasis. Copyright © 2018 Elsevier B.V. All rights reserved.

The roles and functions of safety professionals in Taiwan: Comparing the perceptions of safety professionals and safety educators.

PubMed

Wu, Tsung-Chih

2011-10-01

The perspectives of both internal and external members have to be considered when developing safety curricula. This study discusses perceptional differences between safety educators (SEs) and safety professionals (SPs) regarding the function of SPs. The findings will serve as a reference framework for the establishment of core safety competencies and the development of safety curricula for SPs. 248 respondents, including both SEs and SPs, completed self-administered questionnaires, which included the 45-item safety function scale (SFS). Nine factors were extracted from the scale using exploratory factor analysis (EFA), namely inspection and research, regulatory tasks, emergency procedures and settlement of damage, management and financial affairs, culture change, problem identification and analysis, developing and implementing solutions, knowledge management, and training and communications. Descriptive statistical results indicated that SPs and SEs hold differing views on the rank of the frequency of safety functions. MANOVA results indicated that SPs' perceptions of developing and implementing solutions, training and communications, inspection and research, and management and financial affairs were significantly higher than that of SEs. On the other hand, SE's perceptions regarding participation in regulatory tasks were significantly higher than those of SPs. Based on these results, the author suggests that a clear communication channel should be established between universities and industry to reduce the gap between the perceptions of SEs and SPs. The results of the study are statistically and practically significant. In addition to serving as a reference for the development of safety curricula, the results are also conducive to the establishment of SP roles and functions. Ultimately the development of more suitable safety curricula would open up employment competition for students who graduate from safety-related programs. SPs, on the other hand, can correctly

Utilizing a Human Factors Nursing Worksystem Improvement Framework to Increase Nurses' Time at the Bedside and Enhance Safety.

PubMed

Probst, C Adam; Carter, Megan; Cadigan, Caton; Dalcour, Cortney; Cassity, Cindy; Quinn, Penny; Williams, Tiana; Montgomery, Donna Cook; Wilder, Claudia; Xiao, Yan

2017-02-01

The aim of this study is to increase nurses' time for direct patient care and improve safety via a novel human factors framework for nursing worksystem improvement. Time available for direct patient care influences outcomes, yet worksystem barriers prevent nurses adequate time at the bedside. A novel human factors framework was developed for worksystem improvement in 3 units at 2 facilities. Objectives included improving nurse efficiency as measured by time-and-motion studies, reducing missing medications and subsequent trips to medication rooms and improving medication safety. Worksystem improvement resulted in time savings of 16% to 32% per nurse per 12-hour shift. Requests for missing medications dropped from 3.2 to 1.3 per day. Nurse medication room trips were reduced by 30% and nurse-reported medication errors fell from a range of 1.2 to 0.8 and 6.3 to 4.0 per month. An innovative human factors framework for nursing worksystem improvement provided practical and high priority targets for interventions that significantly improved the nursing worksystem.

Definition, clinical profile, microbiological spectrum, and prognostic factors of early-onset prosthetic valve endocarditis.

PubMed

López, Javier; Revilla, Ana; Vilacosta, Isidre; Villacorta, Eduardo; González-Juanatey, Carlos; Gómez, Itziar; Rollán, María Jesús; San Román, José Alberto

2007-03-01

There is no agreement in the best cutoff time to distinguish between early- and late- onset prosthetic valve endocarditis (PVE). Our objectives are to define early-onset PVE according to the microbiological spectrum and to analyse the profile and short-term prognosis of this entity. The microbiological profile of 172 non-drug users, who were patients with PVE, were compared according to the time elapsed from surgery among 640 endocarditis diagnosed between 1996 and 2004. There were no differences in the microbiological profile of patients with PVE occurred within 2 months of valve replacement and those accounting between 2 and 12 months. The proportion of coagulase-negative Staphylococci (CNS) was higher during the first year post-intervention (37 vs. 18%, P = 0.005) and Streptococci viridans were more common after 1 year (18 vs. 1%, P = 0.001). The percentage of methicilin-resistant CNS strains was higher before 1 year (77 vs. 30%, P = 0.004). Early-onset PVE represented 38% of all episodes of PVE, CNS being the most frequent isolated microorganisms (37%), most of them methicilin resistant (77%). In-hospital mortality of patients who needed urgent surgery was 46% and elective surgery 25%. Overall, in-hospital mortality was 38% and no differences were seen between surgical and medical groups (32 vs. 45%, P = 0.30). Periannular complications were associated with higher in-hospital mortality (60 vs. 27%, P = 0.007). According to the microbiological profile, the most appropriate cutoff time to distinguish between early- and late-onset PVE was 1 year. Methicilin-resistant CNS are the most frequent pathogens and periannular complications, the only risk factor for in-hospital mortality.

Safety Psychology Applicating on Coal Mine Safety Management Based on Information System

NASA Astrophysics Data System (ADS)

Hou, Baoyue; Chen, Fei

In recent years, with the increase of intensity of coal mining, a great number of major accidents happen frequently, the reason mostly due to human factors, but human's unsafely behavior are affected by insecurity mental control. In order to reduce accidents, and to improve safety management, with the help of application security psychology, we analyse the cause of insecurity psychological factors from human perception, from personality development, from motivation incentive, from reward and punishment mechanism, and from security aspects of mental training , and put forward countermeasures to promote coal mine safety production,and to provide information for coal mining to improve the level of safety management.

Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.

PubMed

Gavin, Paul D; Simon, Lee S; Schlagheck, Thomas; Smith, Alisha J; Shakib, Sepehr

2017-07-01

To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM). Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h. Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed. A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application.

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

PubMed Central

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

2017-01-01

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. PMID:28350366

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

PubMed

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.

Calibration factors handbook : safety prediction models calibrated with Texas highway system.

DOT National Transportation Integrated Search

2009-10-01

Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...

Patient Safety Culture in Mutual Insurance Companies in Spain.

PubMed

Manzanera, Rafael; Mira, José Joaquín; Plana, Manel; Moya, Daniel; Guilabert, Mercedes; Ortner, Jordi

2017-02-22

The aim of the study was to assess the safety culture in a mutual insurance sector, searching for improvement opportunities. This sector offers health insurance for work-related injuries and occupational illnesses and represents an annual volume of patients corresponding to approximately 10% of the working population in Europe. A cross-sectional study was conducted to assess the safety culture in the mutual insurance sector in Spain. All physicians, nurses, and physiotherapists (N = 816) working in the organization in hospitals, outpatient clinics, and managerial settings were invited to reply to an online survey. A total of 499 professionals completed the questionnaire (response rate, 61%). Two dimensions were assessed: attitudinal (5 items) and instrumental (5 items). There were no differences between professional profiles or centers in the attitudinal (7.8; standard deviation, 1.3; 95% confidence interval, 7.6-7.9) or instrumental (8.5; standard deviation, 1.0; 95% confidence interval, 8.5-8.6) factors. The lowest level of implementation (<9 points) was related to the following: open disclosure after an adverse event (73%), having a quality and safety plan (75%), prioritizing the improvement of patient care (75%), and involving patients when making decisions on potential treatments (63%). Managers showed lower scores than the rest of professionals' groups (P < 0.05). This intent is to introduce a patient safety culture assessment in the mutual insurance companies. These results may encourage the implementation of quality and safety plans in this sector by paying more attention to attitudinal aspects.

The dread factor: how hazards and safety training influence learning and performance.

PubMed

Burke, Michael J; Salvador, Rommel O; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

Home literacy environment profiles of children with language impairment: associations with caregiver- and child-specific factors.

PubMed

Tambyraja, Sherine R; Schmitt, Mary Beth; Farquharson, Kelly; Justice, Laura M

2017-03-01

Numerous studies suggest a positive relationship between the home literacy environment (HLE) and children's language and literacy skills, yet very little research has focused on the HLE of children with language impairment (LI). Children with LI are at risk for reading difficulties; thus, understanding the nature and frequency of their home literacy interactions is warranted. To identify unique HLE profiles within a large sample of children with LI, and to determine relevant caregiver- and child-specific factors that predict children's profile membership. Participants were 195 kindergarten and first-grade children with LI who were receiving school-based language therapy. Caregivers completed a comprehensive questionnaire regarding their child's HLE, and the extent to which their child engaged in shared book reading, were taught about letters, initiated or asked to be read to, and chose to read independently. Caregivers also answered questions regarding the highest level of maternal education, caregiver history of reading difficulties, and caregiver reading habits. Children completed a language and literacy battery in the fall of their academic year. Latent profile analyses indicated a three-profile solution, representing high, average and low frequency of the selected HLE indicators. Multinomial regression further revealed that caregivers' own reading habits influenced children's profile membership, as did child age and language abilities. These results highlight the considerable variability in the frequency of home literacy interactions of children with LI. Future work examining relations between familial reading practices and literacy outcomes for children with LI is warranted. © 2016 Royal College of Speech and Language Therapists.

The Evaluation Of Therapeutic Efficacy and Safety Profile of Simvastatin Prodrug Micelles in a Closed Fracture Mouse Model

PubMed Central

Zhang, Yijia; Jia, Zhenshan; Yuan, Hongjiang; Dusad, Anand; Ren, Ke; Wei, Xin; Fehringer, Edward V.; Purdue, P. Edward; Daluiski, Aaron; Goldring, Steven R.; Wang, Dong

2016-01-01

Purpose To evaluate the therapeutic efficiency of a micellar prodrug formulation of simvastatin (SIM/SIM-mPEG) and explore its safety in a closed femoral fracture mouse model. Methods The amphiphilic macromolecular prodrug of simvastatin (SIM-mPEG) was synthesized and formulated together with free simvastatin into micelles. It was also labeled with a near infrared dye for in vivo imaging purpose. A closed femoral fracture mouse model was established using a three-point bending device. The mice with established closed femoral fracture were treated with SIM/SIM-mPEG micelle, using free simvastatin and saline as controls. The therapeutic efficacy of the micelles was evaluated using a high-resolution micro-CT. Serum biochemistry and histology analyses were performed to explore the potential toxicity of the micelle formulation. Results Near Infrared Fluorescence (NIRF) imaging confirmed the passive targeting of SIM/SIM-mPEG micelles to the bone lesion of the mice with closed femoral fracture. The micelle was found to promote fracture healing with an excellent safety profile. In addition, the accelerated healing of the femoral fracture also helped to prevent disuse-associated same-side tibia bone loss accompanying the femur fracture. Conclusion SIM/SIM-mPEG micelle was found to be an effective and safe treatment for closed femoral fracture repair in mice. The evidence obtained in this study suggests that it may have the potential to be translated into a novel therapy for clinical management of skeletal fractures and non-union. PMID:27164897

Cardiovascular safety of biologic therapies for the treatment of RA.

PubMed

Greenberg, Jeffrey D; Furer, Victoria; Farkouh, Michael E

2011-11-15

Cardiovascular disease represents a major source of extra-articular comorbidity in patients with rheumatoid arthritis (RA). A combination of traditional cardiovascular risk factors and RA-related factors accounts for the excess risk in RA. Among RA-related factors, chronic systemic inflammation has been implicated in the pathogenesis and progression of atherosclerosis. A growing body of evidence--mainly derived from observational databases and registries--suggests that specific RA therapies, including methotrexate and anti-TNF biologic agents, can reduce the risk of future cardiovascular events in patients with RA. The cardiovascular profile of other biologic therapies for the treatment of RA has not been adequately studied, including of investigational drugs that improve systemic inflammation but alter traditional cardiovascular risk factors. In the absence of large clinical trials adequately powered to detect differences in cardiovascular events between biologic drugs in RA, deriving firm conclusions on cardiovascular safety is challenging. Nevertheless, observational research using large registries has emerged as a promising approach to study the cardiovascular risk of emerging RA biologic therapies.

Safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis.

PubMed

Hagan, Matilda; Cross, Raymond K

2015-01-01

Vedolizumab is the latest FDA-approved anti-integrin therapy for treatment of moderate-to-severe inflammatory bowel disease (IBD). The safety and efficacy of vedolizumab have been studied in short-term clinical trials. This paper reviews the safety profile of vedolizumab compared with other biologics. It also highlights the mechanism of action of the medication. We discuss the current position of vedolizumab in our current algorithm for IBD management and comment on future prospects of the drug. Vedolizumab appears to be a safe and effective option in the treatment of moderate-to-severe IBD in the short term. Long-term observational studies and post-marketing safety data are needed to ascertain the long-term efficacy and side effect profile.

c-kit expression profile and regulatory factors during spermatogonial stem cell differentiation

PubMed Central

2013-01-01

Background It has been proven that c-kit is crucial for proliferation, migration, survival and maturation of spermatogenic cells. A periodic expression of c-kit is observed from primordial germ cells (PGCs) to spermatogenetic stem cells (SSCs), However, the expression profile of c-kit during the entire spermatogenesis process is still unclear. This study aims to reveal and compare c-kit expression profiles in the SSCs before and after the anticipated differentiation, as well as to examine its relationship with retinoic acid (RA) stimulation. Results We have found that there are more than 4 transcripts of c-kit expressed in the cell lines and in the testes. The transcripts can be divided into short and long categories. The long transcripts include the full-length canonical c-kit transcript and the 3′ end short transcript. Short transcripts include the 3.4 kb short transcript and several truncated transcripts (1.9-3.2 kb). In addition, the 3.4 kb transcript (starting from intron 9 and covering exons 10 ~ 21) is discovered to be specifically expressed in the spermatogonia. The extracellular domain of Kit is obtained in the spermatogonia stage, but the intracellular domain (50 kDa) is constantly expressed in both SSCs and spermatogonia. The c-kit expression profiles in the testis and the spermatogonial stem cell lines vary after RA stimulation. The wave-like changes of the quantitative expression pattern of c-kit (increase initially and decrease afterwards) during the induction process are similar to that of the in vivo male germ cell development process. Conclusions There are dynamic transcription and translation changes of c-kit before and after SSCs’ anticipated differentiation and most importantly, RA is a significant upstream regulatory factor for c-kit expression. PMID:24161026

[Self-rating of oral health according to the Oral Health Impact Profile and associated factors: a systematic review].

PubMed

Gabardo, Marilisa Carneiro Leão; Moysés, Simone Tetu; Moysés, Samuel Jorge

2013-06-01

To systematically evaluate the literature to investigate associations between social, demographic, economic, psychosocial, and behavioral factors and the self-perception of oral health measured using the Oral Health Impact Profile (OHIP). In this systematic review of the literature, the Preferred Reporting Items for Systematic Reviews (PRISMA) were adapted for the performance of a qualitative metasummary, without meta-analysis. Articles about oral health and associated factors with implications for quality of life were selected, with a focus on the tool for self-rating of the oral health-disease process, the OHIP. Pubmed/National Library of Medicine (NLM) and the Virtual Health Library (Biblioteca Virtual em Saúde - BVS/BIREME) were searched. Articles published between 2001 and 2011 were included. The following Medical Subject Headings (MeSH) were employed: oral health, quality of life, sickness impact profile, and socioeconomic factors. Of 57 articles identified, 20 met the inclusion criteria. The metasummary revealed that a poor self-perception of oral health was associated with unfavorable social, economic, demographic, and psychosocial factors, as well as with undesirable habits and poor clinical oral conditions. There is consensus in the literature about the influence of the investigated factors on the self-perception of oral health and on quality of life. The OHIP is an important aid for determining oral health needs and for developing strategies to control/reduce disease and promote oral health, with a consequent positive impact on quality of life.

Psychophysiology and posttraumatic stress disorder symptom profile in pregnant African-American women with trauma exposure.

PubMed

Michopoulos, Vasiliki; Rothbaum, Alex O; Corwin, Elizabeth; Bradley, Bekh; Ressler, Kerry J; Jovanovic, Tanja

2015-08-01

While female sex is a robust risk factor for posttraumatic stress disorder (PTSD), pregnant women are an understudied population in regards to PTSD symptom expression profiles. Because circulating hormones during pregnancy affect emotionality, we assessed whether pregnant women would have increased expression of the intermediate phenotypes of hyperarousal and fear-potentiated startle (FPS) compared to non-pregnant women. We examined PTSD symptom profiles in pregnant (n = 207) and non-pregnant women (n = 370). In a second study, FPS responses were assessed in 15 pregnant and 24 non-pregnant women. All participants were recruited from the obstetrics and gynecology clinic at a public hospital serving a primarily African-American, low socioeconomic status, inner-city population. Our results indicate that overall PTSD symptoms were not different between the groups of women. However, pregnant women reported being more hypervigilant (p = 0.036) than non-pregnant women. In addition, pregnant women showed increased FPS to a safety signal compared to non-pregnant women (p = 0.024). FPS to a safety signal in pregnant women was significantly correlated with PTSD hyperarousal symptoms (r = 0.731, p < 0.001). Furthermore, discrimination between danger and safety signals was present in non-pregnant women (p = 0.008), but not in pregnant women (p = 0.895). Together, these data suggest that pregnant women show clinical and psychophysiological hyperarousal compared to non-pregnant women, and support screening for PTSD and assessment of PTSD risk in pregnant women.

Sector-based VOCs emission factors and source profiles for the surface coating industry in the Pearl River Delta region of China.

PubMed

Zhong, Zhuangmin; Sha, Qing'e; Zheng, Junyu; Yuan, Zibing; Gao, Zongjiang; Ou, Jiamin; Zheng, Zhuoyun; Li, Cheng; Huang, Zhijiong

2017-04-01

Accurate depiction of VOCs emission characteristics is essential for the formulation of VOCs control strategies. As one of the continuous efforts in improving VOCs emission characterization in the Pearl River Delta (PRD) region, this study targeted on surface coating industry, the most important VOCs emission sources in the PRD. Sectors in analysis included shipbuilding coating, wood furniture coating, metal surface coating, plastic surface coating, automobile coating and fabric surface coating. Sector-based field measurement was conducted to characterize VOCs emission factors and source profiles in the PRD. It was found that the raw material-based VOCs emission factors for these six sectors ranged from 0.34 to 0.58kg VOCs per kg of raw materials (kg·kg -1 ) while the emission factors based on the production yield varied from 0.59kg to 13.72t VOCs for each production manufactured. VOCs emission factors of surface coating industry were therefore preferably calculated based on raw materials with low uncertainties. Source profiles differed greatly among different sectors. Aromatic was the largest group for shipbuilding coating, wood furniture coating, metal surface coating and automobile coating while the oxygenated VOCs (OVOCs) were the most abundant in the plastic and fabric surface coating sectors. The major species of aromatic VOCs in each of these six sectors were similar, mainly toluene and m/p-xylene, while the OVOCs varied among the different sectors. VOCs profiles in the three processes of auto industry, i.e., auto coating, auto drying and auto repairing, also showed large variations. The major species in these sectors in the PRD were similar with other places but the proportions of individual compounds were different. Some special components were also detected in the PRD region. This study highlighted the importance of updating local source profiles in a comprehensive and timely manner. Copyright © 2016 Elsevier B.V. All rights reserved.

Model equations for the Eiffel Tower profile: historical perspective and new results

NASA Astrophysics Data System (ADS)

Weidman, Patrick; Pinelis, Iosif

2004-07-01

Model equations for the shape of the Eiffel Tower are investigated. One model purported to be based on Eiffel's writing does not give a tower with the correct curvature. A second popular model not connected with Eiffel's writings provides a fair approximation to the tower's skyline profile of 29 contiguous panels. Reported here is a third model derived from Eiffel's concern about wind loads on the tower, as documented in his communication to the French Civil Engineering Society on 30 March 1885. The result is a nonlinear, integro-differential equation which is solved to yield an exponential tower profile. It is further verified that, as Eiffel wrote, "in reality the curve exterior of the tower reproduces, at a determined scale, the same curve of the moments produced by the wind". An analysis of the actual tower profile shows that it is composed of two piecewise continuous exponentials with different growth rates. This is explained by specific safety factors for wind loading that Eiffel & Company incorporated in the design of the free-standing tower. To cite this article: P. Weidman, I. Pinelis, C. R. Mecanique 332 (2004).