Sample records for safety goals phase

  1. Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

    PubMed

    Groves, Patricia S; Bunch, Jacinda L

    2018-05-18

    The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

  2. Methods and strategies for future reactor safety goals

    NASA Astrophysics Data System (ADS)

    Arndt, Steven Andrew

    There have been significant discussions over the past few years by the United States Nuclear Regulatory Commission (NRC), the Advisory Committee on Reactor Safeguards (ACRS), and others as to the adequacy of the NRC safety goals for use with the next generation of nuclear power reactors to be built in the United States. The NRC, in its safety goals policy statement, has provided general qualitative safety goals and basic quantitative health objectives (QHOs) for nuclear reactors in the United States. Risk metrics such as core damage frequency (CDF) and large early release frequency (LERF) have been used as surrogates for the QHOs. In its review of the new plant licensing policy the ACRS has looked at the safety goals, as has the NRC. A number of issues have been raised including what the Commission had in mind when it drafted the safety goals and QHOs, how risk from multiple reactors at a site should be combined for evaluation, how the combination of a new and old reactor at the same site should be evaluated, what the criteria for evaluating new reactors should be, and whether new reactors should be required to be safer than current generation reactors. As part of the development and application of the NRC safety goal policy statement the Commissioners laid out the expectations for the safety of a nuclear power plant but did not address the risk associated with current multi-unit sites, potential modular reactor sites, and hybrid sites that could contain current generation reactors, new passive reactors, and/or modular reactors. The NRC safety goals and the QHOs refer to a "nuclear power plant," but do not discuss whether a "plant" refers to only a single unit or all of the units on a site. There has been much discussion on this issue recently due to the development of modular reactors. Additionally, the risk of multiple reactor accidents on the same site has been largely ignored in the probabilistic risk assessments (PRAs) done to date, and in most risk

  3. Safer Systems: A NextGen Aviation Safety Strategic Goal

    NASA Technical Reports Server (NTRS)

    Darr, Stephen T.; Ricks, Wendell R.; Lemos, Katherine A.

    2008-01-01

    The Joint Planning and Development Office (JPDO), is charged by Congress with developing the concepts and plans for the Next Generation Air Transportation System (NextGen). The National Aviation Safety Strategic Plan (NASSP), developed by the Safety Working Group of the JPDO, focuses on establishing the goals, objectives, and strategies needed to realize the safety objectives of the NextGen Integrated Plan. The three goal areas of the NASSP are Safer Practices, Safer Systems, and Safer Worldwide. Safer Practices emphasizes an integrated, systematic approach to safety risk management through implementation of formalized Safety Management Systems (SMS) that incorporate safety data analysis processes, and the enhancement of methods for ensuring safety is an inherent characteristic of NextGen. Safer Systems emphasizes implementation of safety-enhancing technologies, which will improve safety for human-centered interfaces and enhance the safety of airborne and ground-based systems. Safer Worldwide encourages coordinating the adoption of the safer practices and safer systems technologies, policies and procedures worldwide, such that the maximum level of safety is achieved across air transportation system boundaries. This paper introduces the NASSP and its development, and focuses on the Safer Systems elements of the NASSP, which incorporates three objectives for NextGen systems: 1) provide risk reducing system interfaces, 2) provide safety enhancements for airborne systems, and 3) provide safety enhancements for ground-based systems. The goal of this paper is to expose avionics and air traffic management system developers to NASSP objectives and Safer Systems strategies.

  4. Research safety vehicle, Phase II. Volume I. Executive summary. Final report jul 75-dec 76

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

    Struble, D.

    1976-12-01

    Volume I summarizes the results of the Minicars Research Safety Vehicle Phase II program, as detailed in Volumes II and III. Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidentialmore » Task Force on Motor Vehicle Goals beyond 1980.« less

  5. A RE-LOOK AT THE US NRC SAFETY GOALS

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

    mubayi v.

    2013-09-22

    Since they were adopted in 1986, the US NRC’s Safety Goals have played a valuable role as a de facto risk acceptance criterion against which the predicted performance of a commercial nuclear power reactor can be evaluated and assessed. The current safety goals are cast in terms of risk metrics called quantitative health objectives (QHOs), limiting numerical values of the risks of the early and latent health effects of accidental releases of radioactivity to the offsite population. However, while demonstrating compliance with current safety goals has been an important step in assessing the acceptance of the risk posed by LWRs,more » new or somewhat different goals may be needed that go beyond the current early fatality and latent cancer fatality QHOs in assessing reactor risk. Natural phenomena such as hurricanes seem to be suitable candidates for establishing a background rate to derive a risk goal as their order of magnitude cost of damages is similar to those estimated in severe accident Level 3 PRAs done for nuclear power plants. This paper obtains a risk goal that could have a wider applicability, compared to the current QHOs, as a technology-neutral goal applicable to future reactors and multi-unit sites.« less

  6. Administrative goals and safety standards for hazard control on forested recreation sites

    Treesearch

    Lee A. Paine

    1973-01-01

    For efficient control of tree hazard on recreation sites, a specific administrative goal must be selected. A safety standard designed to achieve the selected goal and a uniform hazard-rating procedure will then promote a consistent level of safety at an acceptable cost. Safety standards can be established with the aid of data for past years, and dollar evaluations are...

  7. Food-safety educational goals for dietetics and hospitality students.

    PubMed

    Scheule, B

    2000-08-01

    To identify food-safety educational goals for dietetics and hospitality management students. Written questionnaires were used to identify educational goals and the most important food safety competencies for entry-level dietitians and foodservice managers. The sample included all directors of didactic programs in dietetics approved by the American Dietetic Association and baccalaureate-degree hospitality programs with membership in the Council on Hotel, Restaurant, and Institutional Education. Fifty-one percent of the directors responded. Descriptive statistics were calculated. chi 2 analysis and independent t tests were used to compare educators' responses for discrete and continuous variables, respectively. Exploratory factor analysis grouped statements about food safety competence. Internal consistency of factors was measured using Cronbach alpha. Thirty-four percent of dietetics programs and 70% of hospitality programs required or offered food safety certification. Dietetics educators reported multiple courses with food safety information, whereas hospitality educators identified 1 or 2 courses. In general, the educators rated food-safety competencies as very important or essential. Concepts related to Hazard Analysis and Critical Control Points (HAACP), irradiation, and pasteurization were rated less highly, compared with other items. Competencies related to reasons for outbreaks of foodborne illness were rated as most important. Food safety certification of dietitians and an increased emphasis on HAACP at the undergraduate level or during the practice component are suggested. Research is recommended to assess the level of food-safety competence expected by employers of entry-level dietitians and foodservice managers.

  8. Research safety vehicle. Phase II. Volume II. comprehensive technical results. Final report July 1975--December 1976

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

    DiNapoli, N.; Fitzpatrick, M.; Strother, C.

    1977-11-01

    Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidential Task Force on Motor Vehicle Goals beyond 1980.

  9. Patient safety goals for the proposed Federal Health Information Technology Safety Center.

    PubMed

    Sittig, Dean F; Classen, David C; Singh, Hardeep

    2015-03-01

    The Office of the National Coordinator for Health Information Technology is expected to oversee creation of a Health Information Technology (HIT) Safety Center. While its functions are still being defined, the center is envisioned as a public-private entity focusing on promotion of HIT related patient safety. We propose that the HIT Safety Center leverages its unique position to work with key administrative and policy stakeholders, healthcare organizations (HCOs), and HIT vendors to achieve four goals: (1) facilitate creation of a nationwide 'post-marketing' surveillance system to monitor HIT related safety events; (2) develop methods and governance structures to support investigation of major HIT related safety events; (3) create the infrastructure and methods needed to carry out random assessments of HIT related safety in complex HCOs; and (4) advocate for HIT safety with government and private entities. The convening ability of a federally supported HIT Safety Center could be critically important to our transformation to a safe and effective HIT enabled healthcare system. © The Author 2014. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Development of an Updated Societal-Risk Goal for Nuclear Power Safety

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

    Vicki Bier; Michael Corradini; Robert Youngblood

    2014-07-01

    This report briefly summarizes work done in FY 2013 on the subject LDRD. The working hypothesis is that societal disruption should be addressed in a safety goal. This is motivated by the point that the Fukushima disaster resulted in very little public dose, but enormous societal disruption; a goal that addressed societal disruption would fill a perceived gap in the US NRC safety goal structure. This year's work entailed analyzing the consequences of postulated accidents at various reactor sites in the US, specifically with a view to quantifying the number of people relocated and the duration of their relocation, tomore » see whether this makes sense as a measure of societal disruption.« less

  11. Specific features of goal setting in road traffic safety

    NASA Astrophysics Data System (ADS)

    Kolesov, V. I.; Danilov, O. F.; Petrov, A. I.

    2017-10-01

    Road traffic safety (RTS) management is inherently a branch of cybernetics and therefore requires clear formalization of the task. The paper aims at identification of the specific features of goal setting in RTS management under the system approach. The paper presents the results of cybernetic modeling of the cause-to-effect mechanism of a road traffic accident (RTA); in here, the mechanism itself is viewed as a complex system. A designed management goal function is focused on minimizing the difficulty in achieving the target goal. Optimization of the target goal has been performed using the Lagrange principle. The created working algorithms have passed the soft testing. The key role of the obtained solution in the tactical and strategic RTS management is considered. The dynamics of the management effectiveness indicator has been analyzed based on the ten-year statistics for Russia.

  12. The influence of multiple goals on driving behavior: the case of safety, time saving, and fuel saving.

    PubMed

    Dogan, Ebru; Steg, Linda; Delhomme, Patricia

    2011-09-01

    Due to the innate complexity of the task drivers have to manage multiple goals while driving and the importance of certain goals may vary over time leading to priority being given to different goals depending on the circumstances. This study aimed to investigate drivers' behavioral regulation while managing multiple goals during driving. To do so participants drove on urban and rural roads in a driving simulator while trying to manage fuel saving and time saving goals, besides the safety goals that are always present during driving. A between-subjects design was used with one group of drivers managing two goals (safety and fuel saving) and another group managing three goals (safety, fuel saving, and time saving) while driving. Participants were provided continuous feedback on the fuel saving goal via a meter on the dashboard. The results indicate that even when a fuel saving or time saving goal is salient, safety goals are still given highest priority when interactions with other road users take place and when interacting with a traffic light. Additionally, performance on the fuel saving goal diminished for the group that had to manage fuel saving and time saving together. The theoretical implications for a goal hierarchy in driving tasks and practical implications for eco-driving are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Safety performance of traffic phases and phase transitions in three phase traffic theory.

    PubMed

    Xu, Chengcheng; Liu, Pan; Wang, Wei; Li, Zhibin

    2015-12-01

    Crash risk prediction models were developed to link safety to various phases and phase transitions defined by the three phase traffic theory. Results of the Bayesian conditional logit analysis showed that different traffic states differed distinctly with respect to safety performance. The random-parameter logit approach was utilized to account for the heterogeneity caused by unobserved factors. The Bayesian inference approach based on the Markov Chain Monte Carlo (MCMC) method was used for the estimation of the random-parameter logit model. The proposed approach increased the prediction performance of the crash risk models as compared with the conventional logit model. The three phase traffic theory can help us better understand the mechanism of crash occurrences in various traffic states. The contributing factors to crash likelihood can be well explained by the mechanism of phase transitions. We further discovered that the free flow state can be divided into two sub-phases on the basis of safety performance, including a true free flow state in which the interactions between vehicles are minor, and a platooned traffic state in which bunched vehicles travel in successions. The results of this study suggest that a safety perspective can be added to the three phase traffic theory. The results also suggest that the heterogeneity between different traffic states should be considered when estimating the risks of crash occurrences on freeways. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Safety Verification of a Fault Tolerant Reconfigurable Autonomous Goal-Based Robotic Control System

    NASA Technical Reports Server (NTRS)

    Braman, Julia M. B.; Murray, Richard M; Wagner, David A.

    2007-01-01

    Fault tolerance and safety verification of control systems are essential for the success of autonomous robotic systems. A control architecture called Mission Data System (MDS), developed at the Jet Propulsion Laboratory, takes a goal-based control approach. In this paper, a method for converting goal network control programs into linear hybrid systems is developed. The linear hybrid system can then be verified for safety in the presence of failures using existing symbolic model checkers. An example task is simulated in MDS and successfully verified using HyTech, a symbolic model checking software for linear hybrid systems.

  15. How can leaders foster team learning? Effects of leader-assigned mastery and performance goals and psychological safety.

    PubMed

    Ashauer, Shirley A; Macan, Therese

    2013-01-01

    Learning and adapting to change are imperative as teams today face unprecedented change. Yet, an important part of learning involves challenging assumptions and addressing differences of opinion openly within a group--the kind of behaviors that pose the potential for embarrassment or threat. How can leaders foster an environment in which team members feel it is safe to take interpersonal risks in order to learn? In a study of 71 teams, we found that psychological safety and learning behavior were higher for teams with mastery than performance goal instructions or no goal instructions. Team psychological safety mediated the relationship between mastery and performance goal instructions and learning behavior. Findings contribute to our understanding of how leader-assigned goals are related to psychological safety and learning behavior in a team context, and suggest approaches to foster such processes.

  16. The Occupational Safety and Health Act: Its Goals and Its Achievements. Evaluative Studies Series.

    ERIC Educational Resources Information Center

    Smith, Robert Stewart

    The safety and health mandate of the Occupational Safety and Health Act of 1970 is examined in reference to its effectiveness in reducing injuries and its consistency with the goal of promoting general welfare. Chapter 1 describes the essential features of the act and its administration to date, and analyzes the mandate as revealed by legislative…

  17. Obtaining Valid Safety Data for Software Safety Measurement and Process Improvement

    NASA Technical Reports Server (NTRS)

    Basili, Victor r.; Zelkowitz, Marvin V.; Layman, Lucas; Dangle, Kathleen; Diep, Madeline

    2010-01-01

    We report on a preliminary case study to examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Our goal is to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. Our purpose was two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to identify potential risks due to incorrect application of the safety process, deficiencies in the safety process, or the lack of a defined process. One early outcome of this work was to show that there are structural deficiencies in collecting valid safety data that make software safety different from hardware safety. In our conclusions we present some of these deficiencies.

  18. Improving traffic safety culture in Iowa : phase II.

    DOT National Transportation Integrated Search

    2013-07-01

    Phase II of Improving Traffic Safety Culture in Iowa focuses on producing actions that will improve the traffic safety culture across the state, and involves collaboration among the three large public universities in Iowa: Iowa State University, Univ...

  19. Prescribing Warfarin Appropriately to Meet Patient Safety Goals

    PubMed Central

    Dharmarajan, Lekshmi; Dharmarajan, T.S.

    2008-01-01

    The anticoagulant warfarin is increasingly used in a variety of disorders associated with risk of thromboembolism. The drug is undoubtedly effective but is linked to numerous nutrient, disease, and drug interactions; safe use of warfarin therefore necessitates close patient monitoring, using the international normalized ratio. The predominant adverse effect is bleeding, and individuals respond to warfarin in different ways. Both high and subtherapeutic international normalized ratios warrant attention, whereas a high international normalized ratio, with or without bleeding, mandates prompt patient evaluation. The 2008 National Patient Safety Goals require medical institutions to develop processes to ensure the safe use and monitoring of anticoagulant use. Last August, the US Food and Drug Administration revised the prescribing information for warfarin to include genetic testing before initiating therapy, although this is still not covered by most health plans. PMID:25126243

  20. Occupational Safety. Hygiene Safety. Pre-Apprenticeship Phase 1 Training.

    ERIC Educational Resources Information Center

    Lane Community Coll., Eugene, OR.

    This self-paced student training module on hygiene safety is one of a number of modules developed for Pre-apprenticeship Phase 1 Training. Purpose of the module is to familiarize students with the different types of airborne contaminants--including noise--which may be health hazards and with the proper hygienic measures for dealing with them. The…

  1. Travtek Evaluation Safety Study

    DOT National Transportation Integrated Search

    1996-02-01

    One of the major evaluation goals of the TravTek operational test was to assess the safety impact of the TravTek system as implemented in Orlando, Florida during the 1 -year deployment phase. Also, the results of the TravTek operational test, with re...

  2. Comprehensive Lifecycle for Assuring System Safety

    NASA Technical Reports Server (NTRS)

    Knight, John C.; Rowanhill, Jonathan C.

    2017-01-01

    CLASS is a novel approach to the enhancement of system safety in which the system safety case becomes the focus of safety engineering throughout the system lifecycle. CLASS also expands the role of the safety case across all phases of the system's lifetime, from concept formation to decommissioning. As CLASS has been developed, the concept has been generalized to a more comprehensive notion of assurance becoming the driving goal, where safety is an important special case. This report summarizes major aspects of CLASS and contains a bibliography of papers that provide additional details.

  3. Occupational Safety. Hand Tools. Pre-Apprenticeship Phase 1 Training.

    ERIC Educational Resources Information Center

    Lane Community Coll., Eugene, OR.

    This self-paced student training module on safety when using hand tools is one of a number of modules developed for Pre-apprenticeship Phase 1 Training. Purpose of the module is to teach students the correct safety techniques for operating common hand- and arm-powered tools, including selection, maintenance, technique, and uses. The module may…

  4. The PAGES 2k Network, Phase 3: Introduction, Goals and Call for Participation

    NASA Astrophysics Data System (ADS)

    McGregor, Helen; Phipps, Steven; von Gunten, Lucien; Martrat, Belen; Linderholm, Lars; Abram, Nerilie; Bothe, Oliver; Neukom, Raphael; St. George, Scott; Evans, Michael; Kaufman, Darrell; Goosse, Hugues; Turney, Chris

    2017-04-01

    The past 2000 years (the "2k" interval) provides critical context for recent anthropogenic forcing of the climate, baseline information about Earth's natural climate variability, opportunities to improve the interpretation of proxy observations, and evaluation of climate models. The PAGES 2k Network (2008-2013 Phase 1; 2014-2016 Phase 2) built regional and global surface temperature reconstructions for terrestrial regions and the oceans, and used comparison with realistically forced simulations to identify mechanisms of climate variation on interannual to bicentennial time scales. The goals of Phase 3 (2017-2019), which launches in May 2017 at the PAGES Open Science Meeting, are to: 1) Further understand the mechanisms driving regional climate variability and change on interannual to centennial time scales (Theme: "Climate Variability, Modes and Mechanisms"); 2) Reduce uncertainties in the interpretation of observations imprinted in paleoclimatic archives by environmental sensors (Theme: "Methods and Uncertainties"); and 3) Identify and analyse the extent of agreement between reconstructions and climate model simulations (Theme: "Proxy and Model Understanding") Research will be organized as a linked network of well-defined projects and targeted manuscripts, identified and led by 2k members. The 2k projects will focus on specific scientific questions aligned with Phase 3 goals, rather than being defined along regional boundaries. An enduring element from earlier phases of PAGES 2k will be a culture of collegiality, transparency, and reciprocity. Phase 3 seeks to stimulate community based projects and facilitate collaboration of researchers from different regions and career stages, drawing on breadth and depth of the global PAGES 2k community; support end-to-end workflow transparency and open data and knowledge access; and develop collaborations with other research communities and engage with stakeholders. If you would like to participate in PAGES 2k Phase 3 or

  5. Statewide traffic safety study phase I : review of current traffic safety research, practice, analytical procedures and databases.

    DOT National Transportation Integrated Search

    2005-05-01

    This report synthesized the research findings of Phase I of the Statewide Traffic Safety Study of Louisiana, sponsored by the Louisiana Department of Transportation and Development. The objective of Phase I was to provide a comprehensive review of th...

  6. Integrated vehicle-based safety systems : third annual report.

    DOT National Transportation Integrated Search

    2009-10-01

    The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative : research program being conducted by an industry consortium led by the University of Michigan : Transportation Research Institute (UMTRI). The goal of ...

  7. Integrated Vehicle-Based Safety Systems Third Annual Report

    DOT National Transportation Integrated Search

    2009-10-01

    The Integrated Vehicle-Based Safety Systems (IVBSS) program is a five-year, two-phase cooperative research program being conducted by an industry consortium led by the University of Michigan Transportation Research Institute (UMTRI). The goal of the ...

  8. Safety and mobility impacts of winter weather : phase I.

    DOT National Transportation Integrated Search

    2011-08-01

    Highway agencies spend millions of dollars to ensure safe and efficient winter travel. However, the effectiveness of winter weather maintenance practices on safety and mobility are somewhat difficult to quantify. : Phase I of this project investigate...

  9. 3S (Safeguards, Security, Safety) based pyroprocessing facility safety evaluation plan

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

    Ku, J.H.; Choung, W.M.; You, G.S.

    The big advantage of pyroprocessing for the management of spent fuels against the conventional reprocessing technologies lies in its proliferation resistance since the pure plutonium cannot be separated from the spent fuel. The extracted materials can be directly used as metal fuel in a fast reactor, and pyroprocessing reduces drastically the volume and heat load of the spent fuel. KAERI has implemented the SBD (Safeguards-By-Design) concept in nuclear fuel cycle facilities. The goal of SBD is to integrate international safeguards into the entire facility design process since the very beginning of the design phase. This paper presents a safety evaluationmore » plan using a conceptual design of a reference pyroprocessing facility, in which 3S (Safeguards, Security, Safety)-By-Design (3SBD) concept is integrated from early conceptual design phase. The purpose of this paper is to establish an advanced pyroprocessing hot cell facility design concept based on 3SBD for the successful realization of pyroprocessing technology with enhanced safety and proliferation resistance.« less

  10. Safety Guided Design of Crew Return Vehicle in Concept Design Phase Using STAMP/STPA

    NASA Astrophysics Data System (ADS)

    Nakao, H.; Katahira, M.; Miyamoto, Y.; Leveson, N.

    2012-01-01

    In the concept development and design phase of a new space system, such as a Crew Vehicle, designers tend to focus on how to implement new technology. Designers also consider the difficulty of using the new technology and trade off several system design candidates. Then they choose an optimal design from the candidates. Safety should be a key aspect driving optimal concept design. However, in past concept design activities, safety analysis such as FTA has not used to drive the design because such analysis techniques focus on component failure and component failure cannot be considered in the concept design phase. The solution to these problems is to apply a new hazard analysis technique, called STAMP/STPA. STAMP/STPA defines safety as a control problem rather than a failure problem and identifies hazardous scenarios and their causes. Defining control flow is the essential in concept design phase. Therefore STAMP/STPA could be a useful tool to assess the safety of system candidates and to be part of the rationale for choosing a design as the baseline of the system. In this paper, we explain our case study of safety guided concept design using STPA, the new hazard analysis technique, and model-based specification technique on Crew Return Vehicle design and evaluate benefits of using STAMP/STPA in concept development phase.

  11. Connected vehicle pilot deployment program phase 1, safety management plan – Tampa (THEA).

    DOT National Transportation Integrated Search

    2016-04-01

    This document presents the Safety Management Plan for the THEA Connected Vehicle (CV) Pilot Deployment. The THEA CV Pilot Deployment goal is to advance and enable safe, interoperable, networked wireless communications among vehicles, the infrastructu...

  12. Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

    PubMed

    Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

    2016-11-23

    Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. Towards a Usability and Error "Safety Net": A Multi-Phased Multi-Method Approach to Ensuring System Usability and Safety.

    PubMed

    Kushniruk, Andre; Senathirajah, Yalini; Borycki, Elizabeth

    2017-01-01

    The usability and safety of health information systems have become major issues in the design and implementation of useful healthcare IT. In this paper we describe a multi-phased multi-method approach to integrating usability engineering methods into system testing to ensure both usability and safety of healthcare IT upon widespread deployment. The approach involves usability testing followed by clinical simulation (conducted in-situ) and "near-live" recording of user interactions with systems. At key stages in this process, usability problems are identified and rectified forming a usability and technology-induced error "safety net" that catches different types of usability and safety problems prior to releasing systems widely in healthcare settings.

  14. Overarching goals: a strategy for improving healthcare quality and safety?

    PubMed

    Nanji, Karen C; Ferris, Timothy G; Torchiana, David F; Meyer, Gregg S

    2013-03-01

    The management literature reveals that many successful organisations have strategic plans that include a bold 'stretch-goal' to stimulate progress over a ten-to-thirty-year period. A stretch goal is clear, compelling and easily understood. It serves as a unifying focal point for organisational efforts. The ambitiousness of such goals has been emphasised with the phrase Big Hairy Audacious Goal ('BHAG'). President Kennedy's proclamation in 1961 that 'this Nation should commit itself to achieving the goal, before this decade is out, of landing a man on the moon and returning him safely to earth' provides a famous example. This goal energised the US National Aeronautics and Space Administration, and it captured the attention of the American public and resulted in one of the largest accomplishments of any organisation. The goal set by Sony, a small, cash-strapped electronics company in the 1950s, to change the poor image of Japanese products around the world represents a classic BHAG. Few examples of quality goals that conform to the BHAG definition exist in the healthcare literature. However, the concept may provide a useful framework for organisations seeking to transform the quality of care they deliver. This review examines the merits and cautions of setting overarching quality goals to catalyse quality improvement efforts, and assists healthcare organisations with determining whether to adopt these goals.

  15. Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

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

    Pugliese, S.M.

    1977-02-01

    In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

  16. 76 FR 10524 - Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Parts 571 and 585 [Docket No. NHTSA-2011-0004] RIN 2127-AK23 Federal Motor Vehicle Safety Standards, Ejection Mitigation; Phase-In Reporting Requirements; Incorporation by Reference Correction In rule document 2011-547...

  17. Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

    PubMed

    Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

    2016-12-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  18. The interaction between dietary and life goals: using goal systems theory to explore healthy diet and life goals

    PubMed Central

    Turner-McGrievy, Gabrielle M.; Wright, Julie A.; Migneault, Jeffrey P.; Quintiliani, Lisa; Friedman, Robert H.

    2014-01-01

    Objective: To examine the types of life and dietary goals individuals report and how these goal domains interact as framed by goal systems theory. Methods: This work is a cross-sectional survey study. Measures included the incidence of common life and dietary goals and how these goals interact with and facilitate each other. Results: The results of a quantitative survey (n = 46 participants), which was informed by two focus groups (n = 17 participants), showed that participants are trying to achieve several different life (e.g. achieving financial success) and dietary goals (e.g. eating more fruits and vegetables, drinking more water, and losing weight) and that these two types of goals interact to both facilitate and conflict with each other. Having a life goal of exercising was significantly associated with healthy eating goals when compared with other life goals (p's < .05), suggesting these goals may be linked and help to facilitate one another. Being in the maintenance phase with the goal of healthy eating was associated with participants feeling like they were more successful in their other non-diet-related health goals (p < .05), suggesting maintenance of goals can facilitate success in achieving other goals. Conclusions: Life goals can have an impact on a person's ability to achieve and maintain dietary and other health goals. Health educators may help to facilitate long-term behavior change by examining a person's life goals as well as dietary goals. PMID:25750817

  19. The interaction between dietary and life goals: using goal systems theory to explore healthy diet and life goals.

    PubMed

    Turner-McGrievy, Gabrielle M; Wright, Julie A; Migneault, Jeffrey P; Quintiliani, Lisa; Friedman, Robert H

    2014-01-01

    Objective : To examine the types of life and dietary goals individuals report and how these goal domains interact as framed by goal systems theory. Methods : This work is a cross-sectional survey study. Measures included the incidence of common life and dietary goals and how these goals interact with and facilitate each other. Results : The results of a quantitative survey ( n  = 46 participants), which was informed by two focus groups ( n  = 17 participants), showed that participants are trying to achieve several different life (e.g. achieving financial success) and dietary goals (e.g. eating more fruits and vegetables, drinking more water, and losing weight) and that these two types of goals interact to both facilitate and conflict with each other. Having a life goal of exercising was significantly associated with healthy eating goals when compared with other life goals ( p 's < .05), suggesting these goals may be linked and help to facilitate one another. Being in the maintenance phase with the goal of healthy eating was associated with participants feeling like they were more successful in their other non-diet-related health goals ( p  < .05), suggesting maintenance of goals can facilitate success in achieving other goals. Conclusions : Life goals can have an impact on a person's ability to achieve and maintain dietary and other health goals. Health educators may help to facilitate long-term behavior change by examining a person's life goals as well as dietary goals.

  20. [Review: Patient safety as a national health goal: current state and essential fields of action for the German healthcare system].

    PubMed

    Hölscher, Uvo M; Gausmann, Peter; Haindl, Hans; Heidecke, Claus-Dieter; Hübner, Nils-Olaf; Lauer, Wolfgang; Lauterberg, Jörg; Skorning, Max; Thürmann, Petra A

    2014-01-01

    For some years patient safety has been an important topic for the design of the healthcare systems in many countries. In Germany we are still in the starting phase of this development. Here, patient safety is not a main focus for research and there is only little funding for these topics. Thus most findings on patient safety have been derived in foreign studies. Slowly, some find their way into the clinical routine in Germany. This paper summarises the state of development of patient safety from a trans-sectoral point of view and outlines essential fields of action for the German healthcare system. Copyright © 2014. Published by Elsevier GmbH.

  1. Final Report: Sensorpedia Phase 3

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

    Gorman, Bryan L; Resseguie, David R

    2011-02-01

    This report is a summary of the Oak Ridge National Laboratory s (ORNL s) Phase 3 development of Sensorpedia, a sensor information sharing platform. Sensorpedia is ORNL s Wikipedia for Sensors. The overall goal of Sensorpedia is to enable global scale sensor information sharing for scientific research, national security and defense, public health and safety, emergency preparedness and response, and general community awareness and outreach.

  2. Evaluation of a proposal to set a goal for the Virginia strategic highway safety plan of a forty percent reduction in traffic fatalities and injuries by 2010.

    DOT National Transportation Integrated Search

    2006-01-01

    The purpose of this study was to determine whether a 40% reduction in traffic fatalities and injuries by 2010 is a reasonable goal to include in Virginia's state-level strategic highway safety plan or whether such a goal is overly optimistic. To achi...

  3. Power Goals for NASA's Exploration Program

    NASA Technical Reports Server (NTRS)

    Jeevarajan, Judith A.

    2009-01-01

    Exciting Future Programs ahead for NASA. Power is needed for all Exploration vehicles and for the missions. For long term missions as in Lunar and Mars programs, safe, high energy/ultra high energy batteries are required. Safety is top priority for human-rated missions. Two-fault tolerance to catastrophic failures is required for human-rated safety To meet power safety goals -inherent cell safety may be required; it can lessen complexity of external protective electronics and prevents dependency on hardware that may also have limitations. Inherent cell safety will eliminate the need to carry out screening of all cells (X-rays, vibration, etc.)

  4. Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2

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

    NONE

    1994-10-01

    This document is the second volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of failure modes and effects analysis; accident analysis; operational safety requirements; quality assurance program; ES&H management program; environmental, safety, and health systems critical to safety; summary of waste-management program; environmental monitoring program; facility expansion, decontamination, and decommissioning; summary of emergency response plan; summary plan for employee training; summary plan for operating procedures; glossary; and appendices A and B.« less

  5. A comprehensive review of the Healthy People 2020 Occupational Safety And Health Objectives: Part 1. Tools for the occupational health nurse in goal attainment.

    PubMed

    Parks, Carol I; Chikotas, Noreen E; Olszewski, Kimberly

    2012-01-01

    This is the first part of a two-part series introducing Healthy People 2020 and the foundational categories that are linked to overarching goals and corresponding measures for progress within the Healthy People 2020 initiative. The two articles together will review the 10 objectives for occupational safety and health within the American workplace, provide a resource guide for occupational health nurses, and discuss MAP-IT, the suggested implementation format to reach the Healthy People 2020 goals. The articles are intended to inform occupational health nurses about the current agenda for safety and health of the U.S. work force as articulated in Healthy People 2020 and provide a foundation for better understanding the requirements of a safe work environment in 2020 and beyond. Copyright 2012, SLACK Incorporated.

  6. A comprehensive review of the healthy people 2020 occupational safety and health objectives: part 2. Tools for the occupational health nurse in goal attainment.

    PubMed

    Chikotas, Noreen E; Parks, Carol I; Olszewski, Kimberly

    2012-02-01

    This is the second part of a two-part series introducing Healthy People 2020 and the foundational categories that are linked to overarching goals and corresponding measures of progress within the Healthy People 2020 initiative. The two articles together review the 10 objectives for occupational safety and health within the American workplace, provide a resource guide for occupational health nurses, and discuss MAP-IT, the suggested implementation format to reach the Healthy People 2020 goals. The articles are intended to inform occupational health nurses about the current agenda for safety and health of the U.S. work force as articulated in Healthy People 2020 and provide a foundation for better understanding the requirements of a safe work environment in 2020 and beyond. Copyright 2012, SLACK Incorporated.

  7. Safety assessment for the postictal confusional phase following complex partial seizure.

    PubMed

    Tucker, C

    1985-06-01

    Misunderstanding of the postictal confusional state that follows the complex partial seizure has caused emotional and physical harm to patients. Concern about this phenomenon and its effects upon the patient prompted this study to explore, describe, and document one method of intervention to lessen these harmful effects. An evaluative descriptive research design was employed to assess patient safety during and after the postictal confusional phase following a complex partial seizure. A closed-structured questionnaire and participant observation were the methods used to collect data for this study. A Level of Safety Tool was specifically designed for this study.

  8. Timing of Formal Phase Safety Reviews for Large-Scale Integrated Hazard Analysis

    NASA Technical Reports Server (NTRS)

    Massie, Michael J.; Morris, A. Terry

    2010-01-01

    Integrated hazard analysis (IHA) is a process used to identify and control unacceptable risk. As such, it does not occur in a vacuum. IHA approaches must be tailored to fit the system being analyzed. Physical, resource, organizational and temporal constraints on large-scale integrated systems impose additional direct or derived requirements on the IHA. The timing and interaction between engineering and safety organizations can provide either benefits or hindrances to the overall end product. The traditional approach for formal phase safety review timing and content, which generally works well for small- to moderate-scale systems, does not work well for very large-scale integrated systems. This paper proposes a modified approach to timing and content of formal phase safety reviews for IHA. Details of the tailoring process for IHA will describe how to avoid temporary disconnects in major milestone reviews and how to maintain a cohesive end-to-end integration story particularly for systems where the integrator inherently has little to no insight into lower level systems. The proposal has the advantage of allowing the hazard analysis development process to occur as technical data normally matures.

  9. Goals and Strategies for the Human Lunar Reference Architecture

    NASA Technical Reports Server (NTRS)

    Seaman, Calvin H.

    2010-01-01

    The presentation examines common goals for human lunar exploration and strategic guidance. Three major sections include illustrative example goals, introduction to the GPoD campaign, and GPoD overview. The first section includes slides about strategic view of partnerships, the moon as a stepping stone and a uniquely preserved record, human-robotic partnership, innovative engagement, strategic considerations, and evaluation of campaigns against common goals. The second section examines campaigns considered, the philosophy of GPoD, GPoD campaign phase definitions, and GPoD design decision points. The third section examines lunar exploration capabilities, extended stay-relocation exploration mode, notional campaign destinations for GPoD, early robotics phase, development of the GPoD early robotics phase, polar exploration/system validation phase, polar relocatability phase, non-polar relocatability phase, long duration phase, and return to evaluation of campaigns.

  10. Goals Analysis Procedure Guidelines for Applying the Goals Analysis Process

    NASA Technical Reports Server (NTRS)

    Motley, Albert E., III

    2000-01-01

    One of the key elements to successful project management is the establishment of the "right set of requirements", requirements that reflect the true customer needs and are consistent with the strategic goals and objectives of the participating organizations. A viable set of requirements implies that each individual requirement is a necessary element in satisfying the stated goals and that the entire set of requirements, taken as a whole, is sufficient to satisfy the stated goals. Unfortunately, it is the author's experience that during project formulation phases' many of the Systems Engineering customers do not conduct a rigorous analysis of the goals and objectives that drive the system requirements. As a result, the Systems Engineer is often provided with requirements that are vague, incomplete, and internally inconsistent. To complicate matters, most systems development methodologies assume that the customer provides unambiguous, comprehensive and concise requirements. This paper describes the specific steps of a Goals Analysis process applied by Systems Engineers at the NASA Langley Research Center during the formulation of requirements for research projects. The objective of Goals Analysis is to identify and explore all of the influencing factors that ultimately drive the system's requirements.

  11. School Safety Study: Phase I.

    ERIC Educational Resources Information Center

    Arora, Alka

    This report summarizes findings from a study concerned with Arizona school safety. The survey component highlights safety-related policy information across 300 schools; the interview component highlights school-safety perceptions of 64 staff across 16 schools. Various policies and programs that respond to internal and external threats to school…

  12. Autonomous Flight Safety System Road Test

    NASA Technical Reports Server (NTRS)

    Simpson, James C.; Zoemer, Roger D.; Forney, Chris S.

    2005-01-01

    On February 3, 2005, Kennedy Space Center (KSC) conducted the first Autonomous Flight Safety System (AFSS) test on a moving vehicle -- a van driven around the KSC industrial area. A subset of the Phase III design was used consisting of a single computer, GPS receiver, and UPS antenna. The description and results of this road test are described in this report.AFSS is a joint KSC and Wallops Flight Facility project that is in its third phase of development. AFSS is an independent subsystem intended for use with Expendable Launch Vehicles that uses tracking data from redundant onboard sensors to autonomously make flight termination decisions using software-based rules implemented on redundant flight processors. The goals of this project are to increase capabilities by allowing launches from locations that do not have or cannot afford extensive ground-based range safety assets, to decrease range costs, and to decrease reaction time for special situations.

  13. Velocity, safety, or both? How do balance and strength of goal conflicts affect drivers' behaviour, feelings and physiological responses?

    PubMed

    Schmidt-Daffy, Martin; Brandenburg, Stefan; Beliavski, Alina

    2013-06-01

    Motivational models of driving behaviour agree that choice of speed is modulated by drivers' goals. Whilst it is accepted that some goals favour fast driving and others favour safe driving, little is known about the interplay of these conflicting goals. In the present study, two aspects of this interplay are investigated: the balance of conflict and the strength of conflict. Thirty-two participants completed several simulated driving runs in which fast driving was rewarded with a monetary gain if the end of the track was reached. However, unpredictably, some runs ended with the appearance of a deer. In these runs, fast driving was punished with a monetary loss. The ratio between the magnitudes of gains and losses varied in order to manipulate the balance of conflict. The absolute magnitudes of both gains and losses altered the strength of conflict. Participants drove slower, reported an increase in anxiety-related feelings, and showed indications of physiological arousal if there was more money at stake. In contrast, only marginal effects of varying the ratio between gains and losses were observed. Results confirm that the strength of a safety-velocity conflict is an important determinant of drivers' behaviour, feelings, and physiological responses. The lack of evidence for the balance of conflict playing a role suggests that in each condition, participants subjectively weighted the loss higher than the gain (loss aversion). It is concluded that the interplay of the subjective values that drivers attribute to objective incentives for fast and safe driving is a promising field for future research. Incorporating this knowledge into motivational theories of driving behaviour might improve their contribution to the design of adequate road safety measures. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. A Role of Phase-Resetting in Coordinating Large Scale Neural Networks During Attention and Goal-Directed Behavior

    PubMed Central

    Voloh, Benjamin; Womelsdorf, Thilo

    2016-01-01

    Short periods of oscillatory activation are ubiquitous signatures of neural circuits. A broad range of studies documents not only their circuit origins, but also a fundamental role for oscillatory activity in coordinating information transfer during goal directed behavior. Recent studies suggest that resetting the phase of ongoing oscillatory activity to endogenous or exogenous cues facilitates coordinated information transfer within circuits and between distributed brain areas. Here, we review evidence that pinpoints phase resetting as a critical marker of dynamic state changes of functional networks. Phase resets: (1) set a “neural context” in terms of narrow band frequencies that uniquely characterizes the activated circuits; (2) impose coherent low frequency phases to which high frequency activations can synchronize, identifiable as cross-frequency correlations across large anatomical distances; (3) are critical for neural coding models that depend on phase, increasing the informational content of neural representations; and (4) likely originate from the dynamics of canonical E-I circuits that are anatomically ubiquitous. These multiple signatures of phase resets are directly linked to enhanced information transfer and behavioral success. We survey how phase resets re-organize oscillations in diverse task contexts, including sensory perception, attentional stimulus selection, cross-modal integration, Pavlovian conditioning, and spatial navigation. The evidence we consider suggests that phase-resets can drive changes in neural excitability, ensemble organization, functional networks, and ultimately, overt behavior. PMID:27013986

  15. A primer for highway safety professionals : advancing pedestrian and bicyclist safety.

    DOT National Transportation Integrated Search

    2016-04-01

    Communities across the county are encouraging walking and biking to meet safety, health, livability, equity, and mobility goals. This primer is intended for highway safety professionals, including State Highway Safety Officials, as well as their part...

  16. Dynamic Safety Cases for Through-Life Safety Assurance

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh; Habli, Ibrahim

    2015-01-01

    We describe dynamic safety cases, a novel operationalization of the concept of through-life safety assurance, whose goal is to enable proactive safety management. Using an example from the aviation systems domain, we motivate our approach, its underlying principles, and a lifecycle. We then identify the key elements required to move towards a formalization of the associated framework.

  17. Generalized implementation of software safety policies

    NASA Technical Reports Server (NTRS)

    Knight, John C.; Wika, Kevin G.

    1994-01-01

    As part of a research program in the engineering of software for safety-critical systems, we are performing two case studies. The first case study, which is well underway, is a safety-critical medical application. The second, which is just starting, is a digital control system for a nuclear research reactor. Our goal is to use these case studies to permit us to obtain a better understanding of the issues facing developers of safety-critical systems, and to provide a vehicle for the assessment of research ideas. The case studies are not based on the analysis of existing software development by others. Instead, we are attempting to create software for new and novel systems in a process that ultimately will involve all phases of the software lifecycle. In this abstract, we summarize our results to date in a small part of this project, namely the determination and classification of policies related to software safety that must be enforced to ensure safe operation. We hypothesize that this classification will permit a general approach to the implementation of a policy enforcement mechanism.

  18. National Dam Safety Program. Brocton Reservoir (Inventory Number NY 785) , Lake Erie Basin, Chautauqua County, New York. Phase I Inspection Report

    DTIC Science & Technology

    1980-09-26

    Inspection Report Brocton Reservoir National Dam Safety Program Lake Erie Basin, Chautauqua County, New York 6. PERFORMING ORG. REPORT NUMBER Inventory No...LAKE ERIE BASIN BROCTON RESERVOIR I ’CHAUTAUQUA COUNTY, NEW YORK I INVENTORY NO. N.Y. 785 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAMI. I...Drawings I I I I I I I I I I PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAIM NAME OF DAM: Brocton Reservoir Inventory No. N.Y. 785 I STATE LOCATED

  19. Space-Based Telemetry and Range Safety Project Ku-Band and Ka-Band Phased Array Antenna

    NASA Technical Reports Server (NTRS)

    Whiteman, Donald E.; Valencia, Lisa M.; Birr, Richard B.

    2005-01-01

    The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to increase data rates and flexibility and decrease costs by using space-based communications assets for telemetry during launches and landings. Phase 1 used standard S-band antennas with the Tracking and Data Relay Satellite System to obtain a baseline performance. The selection process and available resources for Phase 2 resulted in a Ku-band phased array antenna system. Several development efforts are under way for a Ka-band phased array antenna system for Phase 3. Each phase includes test flights to demonstrate performance and capabilities. Successful completion of this project will result in a set of communications requirements for the next generation of launch vehicles.

  20. Offshore safety case approach and formal safety assessment of ships.

    PubMed

    Wang, J

    2002-01-01

    Tragic marine and offshore accidents have caused serious consequences including loss of lives, loss of property, and damage of the environment. A proactive, risk-based "goal setting" regime is introduced to the marine and offshore industries to increase the level of safety. To maximize marine and offshore safety, risks need to be modeled and safety-based decisions need to be made in a logical and confident way. Risk modeling and decision-making tools need to be developed and applied in a practical environment. This paper describes both the offshore safety case approach and formal safety assessment of ships in detail with particular reference to the design aspects. The current practices and the latest development in safety assessment in both the marine and offshore industries are described. The relationship between the offshore safety case approach and formal ship safety assessment is described and discussed. Three examples are used to demonstrate both the offshore safety case approach and formal ship safety assessment. The study of risk criteria in marine and offshore safety assessment is carried out. The recommendations on further work required are given. This paper gives safety engineers in the marine and offshore industries an overview of the offshore safety case approach and formal ship safety assessment. The significance of moving toward a risk-based "goal setting" regime is given.

  1. Disentangling self-management goal setting and action planning: A scoping review

    PubMed Central

    Daniëls, Ramon; van Bokhoven, Marloes Amantia; van der Weijden, Trudy; Beurskens, Anna

    2017-01-01

    Introduction The ongoing rise in the numbers of chronically ill people necessitates efforts for effective self-management. Goal setting and action planning are frequently used, as they are thought to support patients in changing their behavior. However, it remains unclear how goal setting and action planning in the context of self-management are defined in the scientific literature. This study aimed to achieve a better understanding of the various definitions used. Methods A scoping review was conducted, searching PubMed, Cinahl, PsychINFO and Cochrane. Inclusion and exclusion criteria were formulated to ensure the focus on goal setting/action planning and self-management. The literature was updated to December 2015; data selection and charting was done by two reviewers. A qualitative content analysis approach was used. Results Out of 9115 retrieved articles, 58 met the inclusion criteria. We created an overview of goal setting phases that were applied (preparation, formulation of goals, formulation of action plan, coping planning and follow-up). Although the phases we found are in accordance with commonly known frameworks for goal setting, it was striking that the majority of studies (n = 39, 67%) did not include all phases. We also prepared an overview of components and strategies for each goal setting phase. Interestingly, few strategies were found for the communication between patients and professionals about goals/action plans. Most studies (n = 35, 60%) focused goal setting on one single disease and on a predefined lifestyle behavior; nearly half of the articles (n = 27, 47%) reported a theoretical framework. Discussion The results might provide practical support for developers of interventions. Moreover, our results might encourage professionals to become more aware of the phases of the goal setting process and of strategies emphasizing on patient reflection. However, more research might be useful to examine strategies to facilitate communication about goals

  2. Impact of online education on intern behaviour around joint commission national patient safety goals: a randomised trial.

    PubMed

    Shaw, Tim J; Pernar, Luise I; Peyre, Sarah E; Helfrick, John F; Vogelgesang, Kaitlin R; Graydon-Baker, Erin; Chretien, Yves; Brown, Elizabeth J; Nicholson, James C; Heit, Jeremy J; Co, John Patrick T; Gandhi, Tejal

    2012-10-01

    To compare the effectiveness of two types of online learning methodologies for improving the patient-safety behaviours mandated in the Joint Commission National Patient Safety Goals (NPSG). This randomised controlled trial was conducted in 2010 at Massachusetts General Hospital and Brigham and Women's Hospital (BWH) in Boston USA. Incoming interns were randomised to either receive an online Spaced Education (SE) programme consisting of cases and questions that reinforce over time, or a programme consisting of an online slide show followed by a quiz (SQ). The outcome measures included NPSG-knowledge improvement, NPSG-compliant behaviours in a simulation scenario, self-reported confidence in safety and quality, programme acceptability and programme relevance. Both online learning programmes improved knowledge retention. On four out of seven survey items measuring satisfaction and self-reported confidence, the proportion of SE interns responding positively was significantly higher (p<0.05) than the fraction of SQ interns. SE interns demonstrated a mean 4.79 (36.6%) NPSG-compliant behaviours (out of 13 total), while SQ interns completed a mean 4.17 (32.0%) (p=0.09). Among those in surgical fields, SE interns demonstrated a mean 5.67 (43.6%) NPSG-compliant behaviours, while SQ interns completed a mean 2.33 (17.9%) (p=0.015). Focus group data indicates that SE was more contextually relevant than SQ, and significantly more engaging. While both online methodologies improved knowledge surrounding the NPSG, SE was more contextually relevant to trainees and was engaging. SE impacted more significantly on both self-reported confidence and the behaviour of surgical residents in a simulated scenario.

  3. A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase II: Final Report.

    ERIC Educational Resources Information Center

    Walker, Bonnie L.

    This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…

  4. A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

    PubMed

    Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

    2015-01-01

    The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.

  5. Ku- and Ka-Band Phased Array Antenna for the Space-Based Telemetry and Range Safety Project

    NASA Technical Reports Server (NTRS)

    Whiteman, Donald E.; Valencia, Lisa M.; Birr, Richard B.

    2005-01-01

    The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to increase data rates and flexibility and decrease costs by using space-based communications assets for telemetry during launches and landings. Phase 1 used standard S-band antennas with the Tracking and Data Relay Satellite System to obtain a baseline performance. The selection process and available resources for Phase 2 resulted in a Ku-band phased array antenna system. Several development efforts are under way for a Ka-band phased array antenna system for Phase 3. Each phase includes test flights to demonstrate performance and capabilities. Successful completion of this project will result in a set of communications requirements for the next generation of launch vehicles.

  6. Georgia Highway Safety 1997 fact book : a report on highway safety In Georgia

    DOT National Transportation Integrated Search

    1997-01-01

    The goal of this fact book is to present highway safety statistics and fact-based analysis that will increase public awareness on highway safety issues, and to provide information that will assist policy makers and highway safety advocates in making ...

  7. Impact of online education on intern behaviour around Joint Commission National Patient Safety Goals: A randomised trial

    PubMed Central

    TJ, Shaw; LIM, Pernar; SE, Peyre; JF, Helfrick; K, Vogelgesang; E, Graydon-Baker; Y, Chretien; EJ, Brown; J, Nicholson; JJ, Heit; JP, Co; TK, Gandhi

    2014-01-01

    Purpose To compare the effectiveness of 2 types of online learning methodologies for improving the patient-safety behaviours mandated in the Joint Commission National Patient Safety Goals (NPSG). Methods This randomized controlled trial was conducted in 2010 at Massachusetts General Hospital (MGH) and Brigham & Women’s Hospital (BWH) in Boston USA. Incoming interns were randomised to either receive an online Spaced Education program (SE) consisting of cases and questions that reinforce over time, or a program consisting of an online slide show followed by a quiz (SQ). The outcome measures included NPSG-knowledge improvement, NPSG-compliant behaviors in a simulation scenario, self reported confidence in safety and quality, program acceptability and program relevance. Results Both online learning programs improved knowledge retention. On four out of seven survey items measuring satisfaction and self reported confidence, the proportion of SE interns responding positively was significantly higher (p<0.05) than the fraction of SQ interns. SE interns demonstrated a mean 4.79 (36.6%) NPSG-compliant behaviors (out of 13 total), while SQ interns completed a mean 4.17 (32.0%) (p=0.09). Among those in surgical fields, SE interns demonstrated a mean 5.67 (43.6%) NPSG-compliant behaviors, while SQ interns completed a mean 2.33 (17.9%) (p=0.015). Focus group data indicates that SE was more contextually relevant than SQ and significantly more engaging. Conclusion While both online methodologies improved knowledge surrounding the NPSG, SE was more contextually relevant to trainees and engaging. SE impacted more significantly on both self reported confidence and the behaviour of surgical residents in a simulated scenario. PMID:22706930

  8. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

    PubMed Central

    2012-01-01

    Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement

  9. Patient Health Goals Elicited During Home Care Admission: A Categorization.

    PubMed

    Sockolow, Paulina; Radhakrishnan, Kavita; Chou, Edgar Y; Wojciechowicz, Christine

    2017-11-01

    Home care agencies are initiating "patient health goal elicitation" activities as part of home care admission planning. We categorized elicited goals and identified "clinically informative" goals at a home care agency. We examined patient goals that admitting clinicians documented in the point-of-care electronic health record; conducted content analysis on patient goal data to develop a coding scheme; grouped goal themes into codes; assigned codes to each goal; and identified goals that were in the patient voice. Of the 1,763 patient records, 16% lacked a goal; only 15 goals were in a patient's voice. Nurse and physician experts identified 12 of the 20 codes as clinically important accounting for 82% of goal occurrences. The most frequent goal documented was safety/falls (23%). Training and consistent communication of the intent and operationalization of patient goal elicitation may address the absence of patient voice and the less than universal recording of home care patients' goals.

  10. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

    USDA-ARS?s Scientific Manuscript database

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to ...

  11. Daily Goals Formulation and Enhanced Visualization of Mechanical Ventilation Variance Improves Mechanical Ventilation Score.

    PubMed

    Walsh, Brian K; Smallwood, Craig; Rettig, Jordan; Kacmarek, Robert M; Thompson, John; Arnold, John H

    2017-03-01

    The systematic implementation of evidence-based practice through the use of guidelines, checklists, and protocols mitigates the risks associated with mechanical ventilation, yet variation in practice remains prevalent. Recent advances in software and hardware have allowed for the development and deployment of an enhanced visualization tool that identifies mechanical ventilation goal variance. Our aim was to assess the utility of daily goal establishment and a computer-aided visualization of variance. This study was composed of 3 phases: a retrospective observational phase (baseline) followed by 2 prospective sequential interventions. Phase I intervention comprised daily goal establishment of mechanical ventilation. Phase II intervention was the setting and monitoring of daily goals of mechanical ventilation with a web-based data visualization system (T3). A single score of mechanical ventilation was developed to evaluate the outcome. The baseline phase evaluated 130 subjects, phase I enrolled 31 subjects, and phase II enrolled 36 subjects. There were no differences in demographic characteristics between cohorts. A total of 171 verbalizations of goals of mechanical ventilation were completed in phase I. The use of T3 increased by 87% from phase I. Mechanical ventilation score improved by 8.4% in phase I and 11.3% in phase II from baseline ( P = .032). The largest effect was in the low risk V T category, with a 40.3% improvement from baseline in phase I, which was maintained at 39% improvement from baseline in phase II ( P = .01). mechanical ventilation score was 9% higher on average in those who survived. Daily goal formation and computer-enhanced visualization of mechanical ventilation variance were associated with an improvement in goal attainment by evidence of an improved mechanical ventilation score. Further research is needed to determine whether improvements in mechanical ventilation score through a targeted, process-oriented intervention will lead to

  12. Safety Guided Design Based on Stamp/STPA for Manned Vehicle in Concept Design Phase

    NASA Astrophysics Data System (ADS)

    Ujiie, Ryo; Katahira, Masafumi; Miyamoto, Yuko; Umeda, Hiroki; Leveson, Nancy; Hoshino, Nobuyuki

    2013-09-01

    In manned vehicles, such as the Soyuz and the Space Shuttle, the crew and computer system cooperate to succeed in returning to the earth. While computers increase the functionality of system, they also increase the complexity of the interaction between the controllers (human and computer) and the target dynamics. In some cases, the complexity can produce a serious accident. To prevent such losses, traditional hazard analysis such as FTA has been applied to system development, however it can be used after creating a detailed system because it focuses on detailed component failures. As a result, it's more difficult to eliminate hazard cause early in the process when it is most feasible.STAMP/STPA is a new hazard analysis that can be applied from the early development phase, with the analysis being refined as more detailed decisions are made. In essence, the analysis and design decisions are intertwined and go hand-in-hand. We have applied STAMP/STPA to a concept design of a new JAXA manned vehicle and tried safety guided design of the vehicle. As a result of this trial, it has been shown that STAMP/STPA can be accepted easily by system engineers and the design has been made more sophisticated from a safety viewpoint. The result also shows that the consequences of human errors on system safety can be analysed in the early development phase and the system designed to prevent them. Finally, the paper will discuss an effective way to harmonize this safety guided design approach with system engineering process based on the result of this experience in this project.

  13. Benzocaine as a fish anesthetic: efficacy and safety for spawning-phase salmon

    USGS Publications Warehouse

    Gilderhus, P.A.

    1990-01-01

    The anesthetic benzocaine was tested for efficacy and safety for spawning-phase chinook salmon (Oncorhynchus tshawytscha) and Atlantic salmon (Salmo salar) at federal fish hatcheries. Tests were conducted in the existing hatchery water supplies (soft water; temperatures, 10–13 °C. Crystalline benzocaine was dissolved in ethanol (1 g/30 mL), and aliquots of that stock solution were added to the water in test tanks. Benzocaine concentrations of 25–30 mg/L anesthetized most fish in less than 3.5 min, and most fish recovered in less than 10 min after 15 min of exposure. Safety margins were narrow; both species tolerated 30 mg/L for about 20 min, but 25 min of exposure caused deaths. For 15 min exposures, concentrations of 35 mg/L for chinook salmon and 40 mg/L for Atlantic salmon were lethal.

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

    PubMed

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

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

  15. Comparing Three Models of Achievement Goals: Goal Orientations, Goal Standards, and Goal Complexes

    ERIC Educational Resources Information Center

    Senko, Corwin; Tropiano, Katie L.

    2016-01-01

    Achievement goal theory (Dweck, 1986) initially characterized mastery goals and performance goals as opposites in a good-bad dualism of student motivation. A later revision (Harackiewicz, Barron, & Elliot, 1998) contended that both goals can provide benefits and be pursued together. Perhaps both frameworks are correct: Their contrasting views…

  16. Treatment-naïve Gaucher disease patients achieve therapeutic goals and normalization with velaglucerase alfa by 4years in phase 3 trials.

    PubMed

    Zimran, Ari; Elstein, Deborah; Gonzalez, Derlis E; Lukina, Elena A; Qin, Yulin; Dinh, Quinn; Turkia, Hadhami Ben

    2018-02-01

    Gaucher disease is an inherited metabolic disease characterized by β-glucocerebrosidase deficiency and commonly treated with enzyme replacement therapy (ERT). The efficacy of ERT with velaglucerase alfa was assessed based on the achievement of published therapeutic goals and the normalization of disease parameters in 39 treatment-naïve patients with type 1 Gaucher disease, 6 to 62years of age, enrolled in phase 3 clinical trials. After 4years of ERT, therapeutic goals for thrombocytopenia and splenomegaly had been achieved in 100% of patients; goals for anemia and hepatomegaly had been achieved in 95% and 94% of patients, respectively. Consistent with the goal for bone mineral density, lumbar spine bone density improved in 87% of patients ≥18years of age. At year 4, compared with clinical ranges for healthy individuals, 86% of patients with a low baseline hemoglobin concentration had normalized, 60% with a low baseline platelet count had normalized, 67% with baseline splenomegaly had normalized, 58% with hepatomegaly had normalized, and lumbar spine bone density had normalized in 53% of adults. The decade-old therapeutic goals do not reflect the potential for normalization of clinical parameters in ERT-treated patients. Goals consistent with normalization or near-normalization should be considered. ClinicalTrials.gov identifiers: NCT00430625, NCT00553631, NCT00635427. Copyright © 2016 Shire Human Genetic Therapies, Inc. Published by Elsevier Inc. All rights reserved.

  17. MOTIVATION: Goals and Goal Setting

    ERIC Educational Resources Information Center

    Stratton, Richard K.

    2005-01-01

    Goal setting has great impact on a team's performance. Goals enable a team to synchronize their efforts to achieve success. In this article, the author talks about goals and goal setting. This articles complements Domain 5--Teaching and Communication (p.14) and discusses one of the benchmarks listed therein: "Teach the goal setting process and…

  18. Safety Goals at NASA: How Safe is Safe Enough and How to Get There

    NASA Technical Reports Server (NTRS)

    Stamatelatos, Michael

    2010-01-01

    NASA is developing and implementing safety improvements in all its activities including mission design, mission operations, and occupational safety. Decisions regarding where and how improvements are implemented to optimally enhance safety are discussed.

  19. Development of a software safety process and a case study of its use

    NASA Technical Reports Server (NTRS)

    Knight, John C.

    1993-01-01

    The goal of this research is to continue the development of a comprehensive approach to software safety and to evaluate the approach with a case study. The case study is a major part of the project, and it involves the analysis of a specific safety-critical system from the medical equipment domain. The particular application being used was selected because of the availability of a suitable candidate system. We consider the results to be generally applicable and in no way particularly limited by the domain. The research is concentrating on issues raised by the specification and verification phases of the software lifecycle since they are central to our previously-developed rigorous definitions of software safety. The theoretical research is based on our framework of definitions for software safety. In the area of specification, the main topics being investigated are the development of techniques for building system fault trees that correctly incorporate software issues and the development of rigorous techniques for the preparation of software safety specifications. The research results are documented. Another area of theoretical investigation is the development of verification methods tailored to the characteristics of safety requirements. Verification of the correct implementation of the safety specification is central to the goal of establishing safe software. The empirical component of this research is focusing on a case study in order to provide detailed characterizations of the issues as they appear in practice, and to provide a testbed for the evaluation of various existing and new theoretical results, tools, and techniques. The Magnetic Stereotaxis System is summarized.

  20. Educating for Safety.

    ERIC Educational Resources Information Center

    Rothe, J. Peter

    1991-01-01

    To enhance the chance for success in educating young drivers, there should be a balance between the content, structure, and goals of traffic safety programs and the normative rules governing young people's lives. Presents recommendations for safety education based on the notion of complementarity and using a multiperspective approach. (AF)

  1. Sun Safety at Work Canada: a multiple case-study protocol to develop sun safety and heat protection programs and policies for outdoor workers.

    PubMed

    Kramer, Desre M; Tenkate, Thomas; Strahlendorf, Peter; Kushner, Rivka; Gardner, Audrey; Holness, D Linn

    2015-07-10

    CAREX Canada has identified solar ultraviolet radiation (UV) as the second most prominent carcinogenic exposure in Canada, and over 75 % of Canadian outdoor workers fall within the highest exposure category. Heat stress also presents an important public health issue, particularly for outdoor workers. The most serious form of heat stress is heat stroke, which can cause irreversible damage to the heart, lungs, kidneys, and liver. Although the need for sun and heat protection has been identified, there is no Canada-wide heat and sun safety program for outdoor workers. Further, no prevention programs have addressed both skin cancer prevention and heat stress in an integrated approach. The aim of this partnered study is to evaluate whether a multi-implementation, multi-evaluation approach can help develop sustainable workplace-specific programs, policies, and procedures to increase the use of UV safety and heat protection. This 2-year study is a theory-driven, multi-site, non-randomized study design with a cross-case analysis of 13 workplaces across four provinces in Canada. The first phase of the study includes the development of workplace-specific programs with the support of the intensive engagement of knowledge brokers. There will be a three-points-in-time evaluation with process and impact components involving the occupational health and safety (OHS) director, management, and workers with the goal of measuring changes in workplace policies, procedures, and practices. It will use mixed methods involving semi-structured key informant interviews, focus groups, surveys, site observations, and UV dosimetry assessment. Using the findings from phase I, in phase 2, a web-based, interactive, intervention planning tool for workplaces will be developed, as will the intensive engagement of intermediaries such as industry decision-makers to link to policymakers about the importance of heat and sun safety for outdoor workers. Solar UV and heat are both health and safety hazards

  2. A Multidisciplinary Approach to Decommissioning Offshore Wells Using Stakeholder Engagement, Risk Identification, and the United Nations Sustainable Development Goals

    NASA Astrophysics Data System (ADS)

    Battalora, L.; Prasad, M.

    2017-12-01

    Context/PurposeThe typical oil and gas project lifecycle includes acquisition, exploration, drilling, production, and decommissioning phases. The oil and gas industry (Industry) has become proactive in identifying and mitigating health, safety, security, environment, and social responsibility risks during these phases as well as designing for sustainable development. With many fields reaching the end stages of the lifecycle, Industry is faced with the challenge of identifying and evaluating risks in the decommissioning phase. The level of challenge is increased when planning for the decommissioning of offshore wells. This paper describes tools that can be applied in the multidisciplinary design of the decommissioning program including use of the United Nations Sustainable Development Goals (SDGs). MethodsStakeholder engagement is key to a successful project. Typical stakeholders in an oil and gas project include the community, regulatory agencies, federal, state, and local governments, private investors, academia, and non-governmental organizations. Before engagement begins, stakeholders must be identified as well as their level of influence in the project. Relationships between stakeholders are "mapped" providing a better understanding of priorities and areas of concentration. Project risks are identified and ranked according to likelihood and impact. Mitigations are matched to risks. Sustainable development is implemented through acknowledgement of societal, economic, and environmental impacts in engineering design. InterpretationRecently, the United Nations Development Programme (UNDP), the International Finance Corporation (IFC) and IPIECA, the global oil and gas industry association for environmental and social issues, partnered to develop the publication, Mapping the oil and gas industry to the Sustainable Development Goals: An Atlas. SDGs have been linked to Industry operations and can serve as a guide for the offshore decommissioning phase Conclusion

  3. Preharvest food safety.

    PubMed

    Childers, A B; Walsh, B

    1996-07-23

    Preharvest food safety is essential for the protection of our food supply. The production and transport of livestock and poultry play an integral part in the safety of these food products. The goals of this safety assurance include freedom from pathogenic microorganisms, disease, and parasites, and from potentially harmful residues and physical hazards. Its functions should be based on hazard analysis and critical control points from producer to slaughter plant with emphasis on prevention of identifiable hazards rather than on removal of contaminated products. The production goal is to minimize infection and insure freedom from potentially harmful residues and physical hazards. The marketing goal is control of exposure to pathogens and stress. Both groups should have functional hazard analysis and critical control points management programs which include personnel training and certification of producers. These programs must cover production procedures, chemical usage, feeding, treatment practices, drug usage, assembly and transportation, and animal identification. Plans must use risk assessment principles, and the procedures must be defined. Other elements would include preslaughter certification, environmental protection, control of chemical hazards, live-animal drug-testing procedures, and identification of physical hazards.

  4. Autonomous Flight Safety System - Phase III

    NASA Technical Reports Server (NTRS)

    2008-01-01

    The Autonomous Flight Safety System (AFSS) is a joint KSC and Wallops Flight Facility project that uses tracking and attitude data from onboard Global Positioning System (GPS) and inertial measurement unit (IMU) sensors and configurable rule-based algorithms to make flight termination decisions. AFSS objectives are to increase launch capabilities by permitting launches from locations without range safety infrastructure, reduce costs by eliminating some downrange tracking and communication assets, and reduce the reaction time for flight termination decisions.

  5. Introduction: the goals of antimicrobial therapy.

    PubMed

    Song, Jae-Hoon

    2003-03-01

    Antimicrobial agents are generally evaluated in preclinical studies assessing in vitro activity, animal models demonstrating in vivo bacteriologic efficacy, and clinical trials primarily investigating safety and clinical efficacy. However, large sample sizes are required to detect any differences in outcomes between antimicrobials in clinical trials, and, generally, studies are powered to show only clinical equivalence. In addition, diagnosis is often based on clinical symptoms, rather than microbiological evidence of bacterial infection, and the patients most likely to have resistant pathogens are often excluded. Clinical efficacy can be achieved in some bacterial infections in which antimicrobials are suboptimal or even not prescribed. However, bacterial eradication maximizes clinical efficacy and may also reduce the development and spread of resistant organisms. The goal of antimicrobial therapy is, therefore, to eradicate bacteria at the site of infection. Bacterial eradication is not usually assessed as a primary endpoint within the limits of currently recommended clinical trial design. However, pharmacokinetic (PK) (serum concentration profiles, penetration to site of infection) and pharmacodynamic (PD) (susceptibility, concentration- versus time-dependent killing, post-antimicrobial effects) criteria can be used to predict bacteriologic efficacy. PK/PD predictions should be confirmed during all phases of antimicrobial development and throughout clinical use in response to changing patterns of resistance. A clear rationale for dose recommendations can be determined preclinically based on PK/PD parameters, and correlated with efficacy, safety and resistance endpoints in clinical trials. The duration of treatment and dose should be the shortest that will reliably eradicate the pathogen(s), and that is safe and well tolerated. Currently available agents vary significantly in their ability to achieve PK/PD parameters necessary for bacteriologic eradication

  6. The struggle of giving up personal goals: affective, physiological, and cognitive consequences of an action crisis.

    PubMed

    Brandstätter, Veronika; Herrmann, Marcel; Schüler, Julia

    2013-12-01

    A critical phase in goal striving occurs when setbacks accumulate and goal disengagement becomes an issue. This critical phase is conceptualized as an action crisis and assumed to be characterized by an intrapsychic conflict in which the individual becomes torn between further goal pursuit and goal disengagement. Our theorizing converges with Klinger's conceptualization of goal disengagement as a process, rather than a discrete event. Two longitudinal field studies tested and found support for the hypothesis that an action crisis not only compromises an individual's psychological and physiological well-being, but also dampens the cognitive evaluation of the respective goal. In Study 3, marathon runners experiencing an action crisis in their goal of running marathons showed a stronger cortisol secretion and a lower performance in the race 2 weeks later. Results are interpreted in terms of action-phase-specific mindsets with a focus on self-regulatory processes in goal disengagement.

  7. Five major NASA health and safety issues

    NASA Astrophysics Data System (ADS)

    Gavert, Raymond B.

    2000-01-01

    The goal has been set to establish NASA as number one in safety in the nation. This includes Systems and Mission Safety as well as Occupational Safety for all NASA employees and contractors on and off the job. There are five major health and safety issues important in the pursuit of being number one and they are: (1) Radiation (2) Hearing (3) Habitability/Toxicology (4) Extravehicular Activity (EVA) (5) Stress. The issues have features of accumulated injury since NASA's future missions involve long time human presence in space i.e., International Space Station operations and Mars missions. The objective of this paper is to discuss these five issues in terms of controlling risks and enhancing health and safety. Safety metrics are discussed in terms of the overall goal of NASA to be number one in safety. .

  8. Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2

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

    NONE

    1994-10-01

    This document is the third volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of appendices C through U of the report« less

  9. Making safety an integral part of 5S in healthcare.

    PubMed

    Ikuma, Laura H; Nahmens, Isabelina

    2014-01-01

    Healthcare faces major challenges with provider safety and rising costs, and many organizations are using Lean to instigate change. One Lean tool, 5S, is becoming popular for improving efficiency of physical work environments, and it can also improve safety. This paper demonstrates that safety is an integral part of 5S by examining five specific 5S events in acute care facilities. We provide two arguments for how safety is linked to 5S:1. Safety is affected by 5S events, regardless of whether safety is a specific goal and 2. Safety can and should permeate all five S's as part of a comprehensive plan for system improvement. Reports of 5S events from five departments in one health system were used to evaluate how changes made at each step of the 5S impacted safety. Safety was affected positively in each step of the 5S through initial safety goals and side effects of other changes. The case studies show that 5S can be a mechanism for improving safety. Practitioners may reap additional safety benefits by incorporating safety into 5S events through a safety analysis before the 5S, safety goals and considerations during the 5S, and follow-up safety analysis.

  10. Efficient runner safety assessment during early design phase and root cause analysis

    NASA Astrophysics Data System (ADS)

    Liang, Q. W.; Lais, S.; Gentner, C.; Braun, O.

    2012-11-01

    Fatigue related problems in Francis turbines, especially high head Francis turbines, have been published several times in the last years. During operation the runner is exposed to various steady and unsteady hydraulic loads. Therefore the analysis of forced response of the runner structure requires a combined approach of fluid dynamics and structural dynamics. Due to the high complexity of the phenomena and due to the limitation of computer power, the numerical prediction was in the past too expensive and not feasible for the use as standard design tool. However, due to continuous improvement of the knowledge and the simulation tools such complex analysis has become part of the design procedure in ANDRITZ HYDRO. This article describes the application of most advanced analysis techniques in runner safety check (RSC), including steady state CFD analysis, transient CFD analysis considering rotor stator interaction (RSI), static FE analysis and modal analysis in water considering the added mass effect, in the early design phase. This procedure allows a very efficient interaction between the hydraulic designer and the mechanical designer during the design phase, such that a risk of failure can be detected and avoided in an early design stage.The RSC procedure can also be applied to a root cause analysis (RCA) both to find out the cause of failure and to quickly define a technical solution to meet the safety criteria. An efficient application to a RCA of cracks in a Francis runner is quoted in this article as an example. The results of the RCA are presented together with an efficient and inexpensive solution whose effectiveness could be proven again by applying the described RSC technics. It is shown that, with the RSC procedure developed and applied as standard procedure in ANDRITZ HYDRO such a failure is excluded in an early design phase. Moreover, the RSC procedure is compatible with different commercial and open source codes and can be easily adapted to apply for

  11. Representation of Cognitive Reappraisal Goals in Frontal Gamma Oscillations

    PubMed Central

    Kang, Jae-Hwan; Jeong, Ji Woon; Kim, Hyun Taek; Kim, Sang Hee; Kim, Sung-Phil

    2014-01-01

    Recently, numerous efforts have been made to understand the neural mechanisms underlying cognitive regulation of emotion, such as cognitive reappraisal. Many studies have reported that cognitive control of emotion induces increases in neural activity of the control system, including the prefrontal cortex and the dorsal anterior cingulate cortex, and increases or decreases (depending upon the regulation goal) in neural activity of the appraisal system, including the amygdala and the insula. It has been hypothesized that information about regulation goals needs to be processed through interactions between the control and appraisal systems in order to support cognitive reappraisal. However, how this information is represented in the dynamics of cortical activity remains largely unknown. To address this, we investigated temporal changes in gamma band activity (35–55 Hz) in human electroencephalograms during a cognitive reappraisal task that was comprised of three reappraisal goals: to decease, maintain, or increase emotional responses modulated by affect-laden pictures. We examined how the characteristics of gamma oscillations, such as spectral power and large-scale phase synchronization, represented cognitive reappraisal goals. We found that left frontal gamma power decreased, was sustained, or increased when the participants suppressed, maintained, or amplified their emotions, respectively. This change in left frontal gamma power appeared during an interval of 1926 to 2453 ms after stimulus onset. We also found that the number of phase-synchronized pairs of gamma oscillations over the entire brain increased when participants regulated their emotions compared to when they maintained their emotions. These results suggest that left frontal gamma power may reflect cortical representation of emotional states modulated by cognitive reappraisal goals and gamma phase synchronization across whole brain regions may reflect emotional regulatory efforts to achieve these goals

  12. Representation of cognitive reappraisal goals in frontal gamma oscillations.

    PubMed

    Kang, Jae-Hwan; Jeong, Ji Woon; Kim, Hyun Taek; Kim, Sang Hee; Kim, Sung-Phil

    2014-01-01

    Recently, numerous efforts have been made to understand the neural mechanisms underlying cognitive regulation of emotion, such as cognitive reappraisal. Many studies have reported that cognitive control of emotion induces increases in neural activity of the control system, including the prefrontal cortex and the dorsal anterior cingulate cortex, and increases or decreases (depending upon the regulation goal) in neural activity of the appraisal system, including the amygdala and the insula. It has been hypothesized that information about regulation goals needs to be processed through interactions between the control and appraisal systems in order to support cognitive reappraisal. However, how this information is represented in the dynamics of cortical activity remains largely unknown. To address this, we investigated temporal changes in gamma band activity (35-55 Hz) in human electroencephalograms during a cognitive reappraisal task that was comprised of three reappraisal goals: to decease, maintain, or increase emotional responses modulated by affect-laden pictures. We examined how the characteristics of gamma oscillations, such as spectral power and large-scale phase synchronization, represented cognitive reappraisal goals. We found that left frontal gamma power decreased, was sustained, or increased when the participants suppressed, maintained, or amplified their emotions, respectively. This change in left frontal gamma power appeared during an interval of 1926 to 2453 ms after stimulus onset. We also found that the number of phase-synchronized pairs of gamma oscillations over the entire brain increased when participants regulated their emotions compared to when they maintained their emotions. These results suggest that left frontal gamma power may reflect cortical representation of emotional states modulated by cognitive reappraisal goals and gamma phase synchronization across whole brain regions may reflect emotional regulatory efforts to achieve these goals

  13. Posttest examination of Sodium Loop Safety Facility experiments. [LMFBR

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

    Holland, J.W.

    In-reactor, safety experiments performed in the Sodium Loop Safety Facility (SLSF) rely on comprehensive posttest examinations (PTE) to characterize the postirradiation condition of the cladding, fuel, and other test-subassembly components. PTE information and on-line instrumentation data, are analyzed to identify the sequence of events and the severity of the accident for each experiment. Following in-reactor experimentation, the SLSF loop and test assembly are transported to the Hot Fuel Examination Facility (HFEF) for initial disassembly. Goals of the HFEF-phase of the PTE are to retrieve the fuel bundle by dismantling the loop and withdrawing the test assembly, to assess the macro-conditionmore » of the fuel bundle by nondestructive examination techniques, and to prepare the fuel bundle for shipment to the Alpha-Gamma Hot Cell Facility (AGHCF) at Argonne National Laboratory.« less

  14. Explore The NASA Safety Center

    NASA Image and Video Library

    2015-07-01

    The NASA Safety Center (NSC) reports to NASA’s Office of Safety and Mission Assurance and supports the Safety and Mission Assurance (SMA) requirements of NASA’s portfolio of programs and projects. The NSC focuses on development of the personnel, processes and tools needed for the safe and successful achievement of NASA’s strategic goals.

  15. Safety Policy and Procedure Manual (Electronic Version)

    DOT National Transportation Integrated Search

    1997-08-18

    The state Secretary of Transportation has set a goal of zero accidents for the : North Carolina Department of Transportation (NCDOT). To guide the NCDOT towards : that goal, this safety manual sets for philosophy, goals, cardinal rules : (grounds for...

  16. "Evidence" Under a Magnifying Glass: Thoughts on Safety Argument Epistemology

    NASA Technical Reports Server (NTRS)

    Graydon, P. J.; Holloway, C. M.

    2015-01-01

    Common definitions of "safety case" emphasize that evidence is the basis of a safety argument, yet few widely referenced works explicitly define "evidence". Their examples suggest that similar things can be regarded as evidence. But the category evidence seems to contain (1) processes for finding things out, (2) information resulting from such processes, and (3) relevant documents. Moreover, any item of evidence could be replaced by further argument. Normative models of informal argumentation do not offer clear guidance on when a safety argument should cite evidence rather than appeal to a more detailed argument. Disciplines such as the law address the problem with a practical, domain-specific epistemology. In this paper, we explore these problems associated with evidence citations in safety arguments, identify goals for a theory of safety argument evidence and a practical safety argument epistemology, propose a model of safety evidence citation that advances the identified goals, and present a related extension to the Goal Structuring Notation (GSN).

  17. Motor vehicle safety : comprehensive state programs offer best opportunity for increasing use of safety belts

    DOT National Transportation Integrated Search

    1996-01-01

    This report describes the nation's progress in achieving goals for the use of safety belts in motor vehicles, assesses the strategies used most successfully by some states to increase the use of safety belts, and identifies federal strategies that co...

  18. Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2

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

    NONE

    1994-10-01

    This document is the first volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of an introduction, summary/conclusion, site description and assessment, description of facility, and description of operation.« less

  19. Development of Risk Assessment Matrix for NASA Engineering and Safety Center

    NASA Technical Reports Server (NTRS)

    Malone, Roy W., Jr.; Moses, Kelly

    2004-01-01

    This paper describes a study, which had as its principal goal the development of a sufficiently detailed 5 x 5 Risk Matrix Scorecard. The purpose of this scorecard is to outline the criteria by which technical issues can be qualitatively and initially prioritized. The tool using this score card has been proposed to be one of the information resources the NASA Engineering and Safety Center (NESC) takes into consideration when making decisions with respect to incoming information on safety concerns across the entire NASA agency. The contents of this paper discuss in detail each element of the risk matrix scorecard, definitions for those elements and the rationale behind the development of those definitions. This scorecard development was performed in parallel with the tailoring of the existing Futron Corporation Integrated Risk Management Application (IRMA) software tool. IRMA was tailored to fit NESC needs for evaluating incoming safety concerns and was renamed NESC Assessment Risk Management Application (NAFMA) which is still in developmental phase.

  20. Safety Panel Resources

    NASA Technical Reports Server (NTRS)

    Stewart, Christine E.

    2008-01-01

    The goal of this paper is to explore what resources are potentially available to safety panels and to provide some guidance on how to utilize those resources. While the examples used in this paper will concentrate on the Flight Equipment and Reliability Review Panel (FESRRP) and Extravehicular Activity (EVA) hardware that have come through that panel, as well as resources at Johnson Space Center, the paper will address how this applies to safety panels in general, and where possible cite examples for other safety panels.

  1. Key components of effective collaborative goal setting in the chronic care encounter.

    PubMed

    Bigi, Sarah

    2014-01-01

    Collaborative goal setting in patient-provider communication with chronic patients is the phase in which--after collecting the data regarding the patient's health--it is necessary to make a decision regarding the best therapy and behaviors the patient should adopt until the next encounter. Although it is considered a pivotal phase of shared decision making, there remain a few open questions regarding its components and its efficacy: What are the factors that improve or impede agreement on treatment goals and strategies?; What are the 'success conditions' of collaborative goal setting?; How can physicians effectively help patients make their preferences explicit and then co-construct with them informed preferences to help them reach their therapeutic goals? Using the theoretical framework of dialogue types, an approach developed in the field of Argumentation Theory, it will be possible to formulate hypotheses on the success conditions' and effects on patient commitment of collaborative goal setting.

  2. Telotristat ethyl in carcinoid syndrome: safety and efficacy in the TELECAST phase 3 trial.

    PubMed

    Pavel, Marianne; Gross, David J; Benavent, Marta; Perros, Petros; Srirajaskanthan, Raj; Warner, Richard R P; Kulke, Matthew H; Anthony, Lowell B; Kunz, Pamela L; Hörsch, Dieter; Weickert, Martin O; Lapuerta, Pablo; Jiang, Wenjun; Kassler-Taub, Kenneth; Wason, Suman; Fleming, Rosanna; Fleming, Douglas; Garcia-Carbonero, Rocio

    2018-03-01

    Telotristat ethyl, a tryptophan hydroxylase inhibitor, was efficacious and well tolerated in the phase 3 TELESTAR study in patients with carcinoid syndrome (CS) experiencing ≥4 bowel movements per day (BMs/day) while on somatostatin analogs (SSAs). TELECAST, a phase 3 companion study, assessed the safety and efficacy of telotristat ethyl in patients with CS (diarrhea, flushing, abdominal pain, nausea or elevated urinary 5-hydroxyindoleacetic acid (u5-HIAA)) with <4 BMs/day on SSAs (or ≥1 symptom or ≥4 BMs/day if not on SSAs) during a 12-week double-blind treatment period followed by a 36-week open-label extension (OLE). The primary safety and efficacy endpoints were incidence of treatment-emergent adverse events (TEAEs) and percent change from baseline in 24-h u5-HIAA at week 12. Patients ( N  = 76) were randomly assigned (1:1:1) to receive placebo or telotristat ethyl 250 mg or 500 mg 3 times per day (tid); 67 continued receiving telotristat ethyl 500 mg tid during the OLE. Through week 12, TEAEs were generally mild to moderate in severity; 5 (placebo), 1 (telotristat ethyl 250 mg) and 3 (telotristat ethyl 500 mg) patients experienced serious events, and the rate of TEAEs in the OLE was comparable. At week 12, significant reductions in u5-HIAA from baseline were observed, with Hodges-Lehmann estimators of median treatment differences from placebo of -54.0% (95% confidence limits, -85.0%, -25.1%, P  < 0.001) and -89.7% (95% confidence limits, -113.1%, -63.9%, P  < 0.001) for telotristat ethyl 250 mg and 500 mg. These results support the safety and efficacy of telotristat ethyl when added to SSAs in patients with CS diarrhea (ClinicalTrials.gov identifier: Nbib2063659). © 2018 The authors.

  3. Stories from the Sharp End: Case Studies in Safety Improvement

    PubMed Central

    McCarthy, Douglas; Blumenthal, David

    2006-01-01

    Motivated by pressure and a wish to improve, health care organizations are implementing programs to improve patient safety. This article describes six natural experiments in health care safety that show where the safety field is heading and opportunities for and barriers to improvement. All these programs identified organizational culture change as critical to making patients safer, differing chiefly in their methods of creating a patient safety culture. Their goal is a safety culture that promotes continuing innovation and improvement, transcending whatever particular safety methodology is used. Policymakers could help stimulate a culture of safety by linking regulatory goals to safety culture expectations, sponsoring voluntary learning collaborations, rewarding safety improvements, better using publicly reported data, encouraging consumer involvement, and supporting research and education. PMID:16529572

  4. The NASA Aviation Safety Program: Overview

    NASA Technical Reports Server (NTRS)

    Shin, Jaiwon

    2000-01-01

    In 1997, the United States set a national goal to reduce the fatal accident rate for aviation by 80% within ten years based on the recommendations by the Presidential Commission on Aviation Safety and Security. Achieving this goal will require the combined efforts of government, industry, and academia in the areas of technology research and development, implementation, and operations. To respond to the national goal, the National Aeronautics and Space Administration (NASA) has developed a program that will focus resources over a five year period on performing research and developing technologies that will enable improvements in many areas of aviation safety. The NASA Aviation Safety Program (AvSP) is organized into six research areas: Aviation System Modeling and Monitoring, System Wide Accident Prevention, Single Aircraft Accident Prevention, Weather Accident Prevention, Accident Mitigation, and Synthetic Vision. Specific project areas include Turbulence Detection and Mitigation, Aviation Weather Information, Weather Information Communications, Propulsion Systems Health Management, Control Upset Management, Human Error Modeling, Maintenance Human Factors, Fire Prevention, and Synthetic Vision Systems for Commercial, Business, and General Aviation aircraft. Research will be performed at all four NASA aeronautics centers and will be closely coordinated with Federal Aviation Administration (FAA) and other government agencies, industry, academia, as well as the aviation user community. This paper provides an overview of the NASA Aviation Safety Program goals, structure, and integration with the rest of the aviation community.

  5. Communicating and understanding the purpose of pediatric phase I cancer trials.

    PubMed

    Cousino, Melissa K; Zyzanski, Stephen J; Yamokoski, Amy D; Hazen, Rebecca A; Baker, Justin N; Noll, Robert B; Rheingold, Susan R; Geyer, J Russell; Alexander, Stewart C; Drotar, Dennis; Kodish, Eric D

    2012-12-10

    Quality informed consent should provide a clear understanding of the purpose of the research. Given the ethical challenges of pediatric phase I cancer trials, it is important to investigate physician-parent communication during informed consent conferences (ICCs) and parental understanding of the purpose of these studies. In the multisite Informed Consent in Pediatric Phase I Cancer Trials study, 85 ICCs for phase I research between June 2008 and May 2011 were directly observed, and 60 parents were subsequently interviewed. The scientific purpose was defined as composite understanding of drug safety, dose finding, and dose escalation. We determined the frequency with which physicians explained these and other phase I-related concepts during the ICC. Parent interviews were analyzed to determine understanding. The child was present at 83 of 85 ICCs. Only 32% of parents demonstrated substantial understanding of the scientific purpose of phase I cancer trials; 35% demonstrated little or no understanding. Parents of higher socioeconomic status and racial majority status were more likely to understand the scientific purpose. Factors associated with understanding included physician explanation of the goal of the applicable phase I protocol offered (explained in 85% of ICCs) and explanation of the dose cohorts (explained in 43% of ICCs). Physicians explained drug safety in 23% of ICCs, dose finding in 52% of ICCs, and dose escalation in 53% of ICCs. Many parents of children participating in phase I trials do not understand the purpose of these trials. Physician-parent communication about the purpose of phase I research is lacking during ICCs.

  6. NASA Aviation Safety Program Systems Analysis/Program Assessment Metrics Review

    NASA Technical Reports Server (NTRS)

    Louis, Garrick E.; Anderson, Katherine; Ahmad, Tisan; Bouabid, Ali; Siriwardana, Maya; Guilbaud, Patrick

    2003-01-01

    The goal of this project is to evaluate the metrics and processes used by NASA's Aviation Safety Program in assessing technologies that contribute to NASA's aviation safety goals. There were three objectives for reaching this goal. First, NASA's main objectives for aviation safety were documented and their consistency was checked against the main objectives of the Aviation Safety Program. Next, the metrics used for technology investment by the Program Assessment function of AvSP were evaluated. Finally, other metrics that could be used by the Program Assessment Team (PAT) were identified and evaluated. This investigation revealed that the objectives are in fact consistent across organizational levels at NASA and with the FAA. Some of the major issues discussed in this study which should be further investigated, are the removal of the Cost and Return-on-Investment metrics, the lack of the metrics to measure the balance of investment and technology, the interdependencies between some of the metric risk driver categories, and the conflict between 'fatal accident rate' and 'accident rate' in the language of the Aviation Safety goal as stated in different sources.

  7. Laboratory safety and the WHO World Alliance for Patient Safety.

    PubMed

    McCay, Layla; Lemer, Claire; Wu, Albert W

    2009-06-01

    Laboratory medicine has been a pioneer in the field of patient safety; indeed, the College of American Pathology first called attention to the issue in 1946. Delivering reliable laboratory results has long been considered a priority, as the data produced in laboratory medicine have the potential to critically influence individual patients' diagnosis and management. Until recently, most attention on laboratory safety has focused on the analytic stage of laboratory medicine. Addressing this stage has led to significant and impressive improvements in the areas over which laboratories have direct control. However, recent data demonstrate that pre- and post-analytical phases are at least as vulnerable to errors; to further improve patient safety in laboratory medicine, attention must now be focused on the pre- and post-analytic phases, and the concept of patient safety as a multi-disciplinary, multi-stage and multi-system concept better understood. The World Alliance for Patient Safety (WAPS) supports improvement of patient safety globally and provides a potential framework for considering the total testing process.

  8. A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase I: Final Report.

    ERIC Educational Resources Information Center

    Walker, Bonnie L.

    This report describes the development and pilot testing of a fire safety certification system for board and care operators and staff who serve clients with developmental disabilities. During Phase 1, training materials were developed, including a trainer's manual, a participant's coursebook a videotape, an audiotape, and a pre-/post test which was…

  9. National Dam Safety Program. Lake Muskoday Dam (Inventory Number N.Y. 341) Delaware River Basin, Sullivan County, New York. Phase I Inspection Report,

    DTIC Science & Technology

    1981-09-14

    DACW-51-81-C-0006 . PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT PROJECT. TASK AREA & WORK UNIT NUMBERS ~ Flaherty-Giauara Associates...olie It neceary and Idontily b block number) Dam Safety National Dam Safety Program Visual Inspection Lake Muskoday Dam Hydrology, Structural Stability...DELAWARE RIVER BASIN LAKE MUSKODAY DAM SULLIVAN COUNTY, NEW YORK INVENTORY No.NY341 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY PROGRAM J T C NEW YORK

  10. Safety and feasibility of achieving lower systolic blood pressure goals in persons with type 2 diabetes: the SANDS trial.

    PubMed

    Weir, Matthew R; Yeh, Fawn; Silverman, Angela; Devereux, Richard B; Galloway, James M; Henderson, Jeffrey A; Howard, William J; Russell, Marie; Wilson, Charlton; Ratner, Robert; Sorkin, John; Umans, Jason G; Fleg, Jerome L; Stylianou, Mario; Lee, Elisa; Howard, Barbara V

    2009-10-01

    The Stop Atherosclerosis in Native Diabetics Study (SANDS) was a randomized open-label clinical trial in type 2 diabetics designed to examine the effects of intensive reduction of blood pressure, aggressive vs standard goals (< or =115/75 mm Hg vs < or =130/80 mm Hg), and low-density lipoprotein (LDL) cholesterol on the composite outcome of change in carotid intimal-medial thickness and cardiovascular events. The study demonstrated that in conjunction with a lower LDL cholesterol target of 70 mg/dL, aggressive systolic blood pressure-lowering resulted in a reduction in carotid intimal-medial thickness and left ventricular mass without measurable differences in cardiovascular events. The blood pressure treatment algorithm included renin-angiotensin system blockade, with other agents added if necessary. The authors conclude that both standard and more aggressive systolic blood pressure reduction can be achieved with excellent safety and good tolerability in patients with type 2 diabetes mellitus.

  11. A Safety Index and Method for Flightdeck Evaluation

    NASA Technical Reports Server (NTRS)

    Latorella, Kara A.

    2000-01-01

    If our goal is to improve safety through machine, interface, and training design, then we must define a metric of flightdeck safety that is usable in the design process. Current measures associated with our notions of "good" pilot performance and ultimate safety of flightdeck performance fail to provide an adequate index of safe flightdeck performance for design evaluation purposes. The goal of this research effort is to devise a safety index and method that allows us to evaluate flightdeck performance holistically and in a naturalistic experiment. This paper uses Reason's model of accident causation (1990) as a basis for measuring safety, and proposes a relational database system and method for 1) defining a safety index of flightdeck performance, and 2) evaluating the "safety" afforded by flightdeck performance for the purpose of design iteration. Methodological considerations, limitations, and benefits are discussed as well as extensions to this work.

  12. Safety assessment tool for construction zone work phasing plans

    DOT National Transportation Integrated Search

    2016-05-01

    The Highway Safety Manual (HSM) is the compilation of national safety research that provides quantitative methods for : analyzing highway safety. The HSM presents crash modification functions related to freeway work zone characteristics such as : wor...

  13. Design for Reliability and Safety Approach for the New NASA Launch Vehicle

    NASA Technical Reports Server (NTRS)

    Safie, Fayssal M.; Weldon, Danny M.

    2007-01-01

    The United States National Aeronautics and Space Administration (NASA) is in the midst of a space exploration program intended for sending crew and cargo to the international Space Station (ISS), to the moon, and beyond. This program is called Constellation. As part of the Constellation program, NASA is developing new launch vehicles aimed at significantly increase safety and reliability, reduce the cost of accessing space, and provide a growth path for manned space exploration. Achieving these goals requires a rigorous process that addresses reliability, safety, and cost upfront and throughout all the phases of the life cycle of the program. This paper discusses the "Design for Reliability and Safety" approach for the NASA new launch vehicles, the ARES I and ARES V. Specifically, the paper addresses the use of an integrated probabilistic functional analysis to support the design analysis cycle and a probabilistic risk assessment (PRA) to support the preliminary design and beyond.

  14. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

    PubMed Central

    Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

    2015-01-01

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states. PMID:25569274

  15. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.

    PubMed

    Merenstein, Daniel J; Tan, Tina P; Molokin, Aleksey; Smith, Keisha Herbin; Roberts, Robert F; Shara, Nawar M; Mete, Mihriye; Sanders, Mary Ellen; Solano-Aguilar, Gloria

    2015-01-01

    Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

  16. Shuttle Safety Improvements

    NASA Technical Reports Server (NTRS)

    Henderson, Edward

    2001-01-01

    The Space Shuttle has been flying for over 20 years and based on the Orbiter design life of 100 missions it should be capable of flying at least 20 years more if we take care of it. The Space Shuttle Development Office established in 1997 has identified those upgrades needed to keep the Shuttle flying safely and efficiently until a new reusable launch vehicle (RLV) is available to meet the agency commitments and goals for human access to space. The upgrade requirements shown in figure 1 are to meet the program goals, support HEDS and next generation space transportation goals while protecting the country 's investment in the Space Shuttle. A major review of the shuttle hardware and processes was conducted in 1999 which identified key shuttle safety improvement priorities, as well as other system upgrades needed to reliably continue to support the shuttle miss ions well into the second decade of this century. The high priority safety upgrades selected for development and study will be addressed in this paper.

  17. Implementing Patient Safety Initiatives in Rural Hospitals

    ERIC Educational Resources Information Center

    Klingner, Jill; Moscovice, Ira; Tupper, Judith; Coburn, Andrew; Wakefield, Mary

    2009-01-01

    Implementation of patient safety initiatives can be costly in time and energy. Because of small volumes and limited resources, rural hospitals often are not included in nationally driven patient safety initiatives. This article describes the Tennessee Rural Hospital Patient Safety Demonstration project, whose goal was to strengthen capacity for…

  18. Tofacitinib, an oral Janus kinase inhibitor, in patients from Mexico with rheumatoid arthritis: Pooled efficacy and safety analyses from Phase 3 and LTE studies.

    PubMed

    Burgos-Vargas, Ruben; Cardiel, Mario; Xibillé, Daniel; Pacheco-Tena, César; Pascual-Ramos, Virginia; Abud-Mendoza, Carlos; Mahgoub, Ehab; Rahman, Mahboob; Fan, Haiyun; Rojo, Ricardo; García, Erika; Santana, Karina

    2017-05-25

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized efficacy and safety of tofacitinib in Mexican patients from RA Phase 3 and long-term extension (LTE) studies. Data from Mexican patients with RA and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were taken from four Phase 3 studies (pooled across studies) and one open-label LTE study of tofacitinib. Patients received tofacitinib 5 or 10mg twice daily, adalimumab (one Phase 3 study) or placebo (four Phase 3 studies) as monotherapy or in combination with conventional synthetic DMARDs. Efficacy up to Month 12 (Phase 3) and Month 36 (LTE) was assessed by American College of Rheumatology 20/50/70 response rates, Disease Activity Score (erythrocyte sedimentation rate), and Health Assessment Questionnaire-Disability Index. Safety, including incidence rates (IRs; patients with events/100 patient-years) for adverse events (AEs) of special interest, was assessed throughout the studies. 119 and 212 Mexican patients were included in the Phase 3 and LTE analyses, respectively. Tofacitinib-treated patients in Phase 3 had numerically greater improvements in efficacy responses versus placebo at Month 3. Efficacy was sustained in Phase 3 and LTE studies. IRs for AEs of special interest were similar to those with tofacitinib in the global and Latin American RA populations. In Mexican patients from the tofacitinib global RA program, tofacitinib efficacy was demonstrated up to Month 12 in Phase 3 studies and Month 36 in the LTE study, with a safety profile consistent with tofacitinib global population. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  19. Interruption of the Tower of London Task: Support for a Goal-Activation Approach

    ERIC Educational Resources Information Center

    Hodgetts, Helen M.; Jones, Dylan M.

    2006-01-01

    Unexpected interruptions introduced during the execution phase of simple Tower of London problems incurred a time cost when the interrupted goal was retrieved, and this cost was exacerbated the longer the goal was suspended. Furthermore, time taken to retrieve goals was greater following a more complex interruption, indicating the processing…

  20. Deep Borehole Disposal Safety Analysis.

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

    Freeze, Geoffrey A.; Stein, Emily; Price, Laura L.

    This report presents a preliminary safety analysis for the deep borehole disposal (DBD) concept, using a safety case framework. A safety case is an integrated collection of qualitative and quantitative arguments, evidence, and analyses that substantiate the safety, and the level of confidence in the safety, of a geologic repository. This safety case framework for DBD follows the outline of the elements of a safety case, and identifies the types of information that will be required to satisfy these elements. At this very preliminary phase of development, the DBD safety case focuses on the generic feasibility of the DBD concept.more » It is based on potential system designs, waste forms, engineering, and geologic conditions; however, no specific site or regulatory framework exists. It will progress to a site-specific safety case as the DBD concept advances into a site-specific phase, progressing through consent-based site selection and site investigation and characterization.« less

  1. A Phase I proof-of-concept and safety trial of sildenafil to treat cerebral vasospasm following subarachnoid hemorrhage.

    PubMed

    Washington, Chad W; Derdeyn, Colin P; Dhar, Rajat; Arias, Eric J; Chicoine, Michael R; Cross, DeWitte T; Dacey, Ralph G; Han, Byung Hee; Moran, Christopher J; Rich, Keith M; Vellimana, Ananth K; Zipfel, Gregory J

    2016-02-01

    Studies show that phosphodiesterase-V (PDE-V) inhibition reduces cerebral vasospasm (CVS) and improves outcomes after experimental subarachnoid hemorrhage (SAH). This study was performed to investigate the safety and effect of sildenafil (an FDA-approved PDE-V inhibitor) on angiographic CVS in SAH patients. A2-phase, prospective, nonrandomized, human trial was implemented. Subarachnoid hemorrhage patients underwent angiography on Day 7 to assess for CVS. Those with CVS were given 10 mg of intravenous sildenafil in the first phase of the study and 30 mg in the second phase. In both, angiography was repeated 30 minutes after infusion. Safety was assessed by monitoring neurological examination findings and vital signs and for the development of adverse reactions. For angiographic assessment, in a blinded fashion, pre- and post-sildenafil images were graded as "improvement" or "no improvement" in CVS. Unblinded measurements were made between pre- and post-sildenafil angiograms. Twelve patients received sildenafil; 5 patients received 10 mg and 7 received 30 mg. There were no adverse reactions. There was no adverse effect on heart rate or intracranial pressure. Sildenafil resulted in a transient decline in mean arterial pressure, an average of 17% with a return to baseline in an average of 18 minutes. Eight patients (67%) were found to have a positive angiographic response to sildenafil, 3 (60%) in the low-dose group and 5 (71%) in the high-dose group. The largest degree of vessel dilation was an average of 0.8 mm (range 0-2.1 mm). This corresponded to an average percentage increase in vessel diameter of 62% (range 0%-200%). The results from this Phase I safety and proof-of-concept trial assessing the use of intravenous sildenafil in patients with CVS show that sildenafil is safe and well tolerated in the setting of SAH. Furthermore, the angiographic data suggest that sildenafil has a positive impact on human CVS.

  2. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants.

    PubMed

    Martinon-Torres, Federico; Gimenez-Sanchez, Francisco; Bernaola-Iturbe, Enrique; Diez-Domingo, Javier; Jiang, Qin; Perez, John L

    2014-09-08

    Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in infants. A conserved, surface-exposed lipoprotein, LP2086 (a factor H-binding protein [fHBP]), is a promising MnB vaccine target. A bivalent, recombinant vaccine targeting the fHBP (rLP2086) of MnB was developed. This phase 1/2 clinical study was designed to assess the immunogenicity, safety, and tolerability of a 4-dose series of the rLP2086 vaccine at 20-, 60-, 120-, or 200-μg dose levels in vaccine-naive infants when given with routine childhood vaccines. The study was to consist of two phases: a single-blind sentinel phase and an open-label full enrollment phase. During the sentinel phase, randomization of subjects to the next higher dose was delayed pending a 14-day safety review of dose 1 of the preceding dose cohort. The full enrollment phase was to occur after completion of the sentinel phase. Local reactions were generally mild and adverse events infrequent; however, after only 46 infants were randomized into the study, fever rates were 64% and 90% in subjects receiving one 20- or 60-μg rLP2086 dose, respectively. Most fevers were <39.0°C. Only 2 subjects in the 20-μg group and 1 subject in the 60-μg group experienced fevers >39.0°C; no fevers were >40.0°C. Due to these high fever rates, the study was terminated early. No immunogenicity data were collected. This report discusses the safety and acceptability of rLP2086 in infants after one 20- or 60-μg dose. Due to the high fever rate experienced in the 20- and 60-μg groups, rLP2086 in the current formulation may not be acceptable for infants. Copyright © 2014. Published by Elsevier Ltd.

  3. Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

    PubMed

    Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David

    2017-03-01

    The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

  4. Goal motives and multiple-goal striving in sport and academia: A person-centered investigation of goal motives and inter-goal relations.

    PubMed

    Healy, Laura C; Ntoumanis, Nikos; Duda, Joan L

    2016-12-01

    This investigation extended the goal striving literature by examining motives for two goals being pursued simultaneously. Grounded in self-determination theory, we examined how student-athletes' motives for their sporting and academic goals were associated with inter-goal facilitation and interference. Cross-sectional survey. UK university student-athletes (n=204) identified their most important sporting and academic goals. They then rated their extrinsic, introjected, identified and intrinsic motives for these goals and completed questionnaires assessing inter-goal facilitation and interference. Using a person-centered approach via latent profile analysis, we identified three distinct profiles of goal motives. Auxiliary analyses showed that the profile with high identified motives for both goals reported greater inter-goal facilitation. Extending the previous literature, the findings demonstrate the benefits of autonomous motives when simultaneously pursing goals in sport and academia. Copyright © 2016. Published by Elsevier Ltd.

  5. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial.

    PubMed

    Cavalcanti, Alexandre B; Bozza, Fernando Augusto; Machado, Flavia R; Salluh, Jorge I F; Campagnucci, Valquiria Pelisser; Vendramim, Patricia; Guimaraes, Helio Penna; Normilio-Silva, Karina; Damiani, Lucas Petri; Romano, Edson; Carrara, Fernanda; Lubarino Diniz de Souza, Juliana; Silva, Aline Reis; Ramos, Grazielle Viana; Teixeira, Cassiano; Brandão da Silva, Nilton; Chang, Chung-Chou H; Angus, Derek C; Berwanger, Otavio

    2016-04-12

    The effectiveness of checklists, daily goal assessments, and clinician prompts as quality improvement interventions in intensive care units (ICUs) is uncertain. To determine whether a multifaceted quality improvement intervention reduces the mortality of critically ill adults. This study had 2 phases. Phase 1 was an observational study to assess baseline data on work climate, care processes, and clinical outcomes, conducted between August 2013 and March 2014 in 118 Brazilian ICUs. Phase 2 was a cluster randomized trial conducted between April and November 2014 with the same ICUs. The first 60 admissions of longer than 48 hours per ICU were enrolled in each phase. Intensive care units were randomized to a quality improvement intervention, including a daily checklist and goal setting during multidisciplinary rounds with follow-up clinician prompting for 11 care processes, or to routine care. In-hospital mortality truncated at 60 days (primary outcome) was analyzed using a random-effects logistic regression model, adjusted for patients' severity and the ICU's baseline standardized mortality ratio. Exploratory secondary outcomes included adherence to care processes, safety climate, and clinical events. A total of 6877 patients (mean age, 59.7 years; 3218 [46.8%] women) were enrolled in the baseline (observational) phase and 6761 (mean age, 59.6 years; 3098 [45.8%] women) in the randomized phase, with 3327 patients enrolled in ICUs (n = 59) assigned to the intervention group and 3434 patients in ICUs (n = 59) assigned to routine care. There was no significant difference in in-hospital mortality between the intervention group and the usual care group, with 1096 deaths (32.9%) and 1196 deaths (34.8%), respectively (odds ratio, 1.02; 95% CI, 0.82-1.26; P = .88). Among 20 prespecified secondary outcomes not adjusted for multiple comparisons, 6 were significantly improved in the intervention group (use of low tidal volumes, avoidance of heavy sedation, use of

  6. Identifying the most significant indicators of the total road safety performance index.

    PubMed

    Tešić, Milan; Hermans, Elke; Lipovac, Krsto; Pešić, Dalibor

    2018-04-01

    The review of the national and international literature dealing with the assessment of the road safety level has shown great efforts of the authors who tried to define the methodology for calculating the composite road safety index on a territory (region, state, etc.). The procedure for obtaining a road safety composite index of an area has been largely harmonized. The question that has not been fully resolved yet concerns the selection of indicators. There is a wide range of road safety indicators used to show a road safety situation on a territory. Road safety performance index (RSPI) obtained on the basis of a larger number of safety performance indicators (SPIs) enable decision makers to more precisely define the earlier goal- oriented actions. However, recording a broader comprehensive set of SPIs helps identify the strengths and weaknesses of a country's road safety system. Providing high quality national and international databases that would include comparable SPIs seems to be difficult since a larger number of countries dispose of a small number of identical indicators available for use. Therefore, there is a need for calculating a road safety performance index with a limited number of indicators (RSPI ln n ) which will provide a comparison of a sufficient quality, of as many countries as possible. The application of the Data Envelopment Analysis (DEA) method and correlative analysis has helped to check if the RSPI ln n is likely to be of sufficient quality. A strong correlation between the RSPI ln n and the RSPI has been identified using the proposed methodology. Based on this, the most contributing indicators and methodologies for gradual monitoring of SPIs, have been defined for each country analyzed. The indicator monitoring phases in the analyzed countries have been defined in the following way: Phase 1- the indicators relating to alcohol, speed and protective systems; Phase 2- the indicators relating to roads and Phase 3- the indicators relating to

  7. Optimization of safety on pavement preservation projects.

    DOT National Transportation Integrated Search

    2011-01-01

    To achieve a goal of reducing highway crash fatalities by 4% each year to improve roadway safety, the Georgia Department of Transportation (GDOT) is actively seeking opportunities to incorporate safety improvements into its current pavement preservat...

  8. Monitoring safety in a phase III real‐world effectiveness trial: use of novel methodology in the Salford Lung Study

    PubMed Central

    Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David

    2016-01-01

    Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors

  9. Human aspects of mission safety

    NASA Technical Reports Server (NTRS)

    Connors, Mary M.

    1989-01-01

    Recent discussions of psychology's involvement in spaceflight have emphasized its role in enhancing space living conditions and incresing crew productivity. While these goals are central to space missions, behavioral scientists should not lose sight of a more basic flight requirement - that of crew safety. This paper examines some of the processes employed in the American space program in support of crew safety and suggests that behavioral scientists could contribute to flight safety, both through these formal processes and through less formal methods. Various safety areas of relevance to behavioral scientists are discussed.

  10. Technical Guidance from the International Safety Framework for Nuclear Power Source Applications in Outer Space for Design and Development Phases

    NASA Astrophysics Data System (ADS)

    Summerer, Leopold

    2014-08-01

    In 2009, the International Safety Framework for Nuclear Power Source Applications in Outer Space [1] has been adopted, following a multi-year process that involved all major space faring nations in the frame of the International Atomic Energy Agency and the UN Committee on the Peaceful Uses of Outer Space. The safety framework reflects an international consensus on best practices. After the older 1992 Principles Relevant to the Use of Nuclear Power Sources in Outer Space, it is the second document at UN level dedicated entirely to space nuclear power sources.This paper analyses aspects of the safety framework relevant for the design and development phases of space nuclear power sources. While early publications have started analysing the legal aspects of the safety framework, its technical guidance has not yet been subject to scholarly articles. The present paper therefore focuses on the technical guidance provided in the safety framework, in an attempt to assist engineers and practitioners to benefit from these.

  11. Safety in the Science Classroom

    ERIC Educational Resources Information Center

    Online Submission, 2006

    2006-01-01

    The goal of this K-12 science safety resource is to bring together information needed by administrators, planners, teachers and support staff to help them make sound decisions regarding science safety. The document identifies areas for decision making and action at a variety of levels. It supports planning and action by providing information on…

  12. Dose escalation methods in phase I cancer clinical trials.

    PubMed

    Le Tourneau, Christophe; Lee, J Jack; Siu, Lillian L

    2009-05-20

    Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid accrual. Here we review dose escalation methods for phase I trials, including the rule-based and model-based dose escalation methods that have been developed to evaluate new anticancer agents. Toxicity has traditionally been the primary endpoint for phase I trials involving cytotoxic agents. However, with the emergence of molecularly targeted anticancer agents, potential alternative endpoints to delineate optimal biological activity, such as plasma drug concentration and target inhibition in tumor or surrogate tissues, have been proposed along with new trial designs. We also describe specific methods for drug combinations as well as methods that use a time-to-event endpoint or both toxicity and efficacy as endpoints. Finally, we present the advantages and drawbacks of the various dose escalation methods and discuss specific applications of the methods in developmental oncotherapeutics.

  13. Reliability and Maintainability Engineering - A Major Driver for Safety and Affordability

    NASA Technical Reports Server (NTRS)

    Safie, Fayssal M.

    2011-01-01

    The United States National Aeronautics and Space Administration (NASA) is in the midst of an effort to design and build a safe and affordable heavy lift vehicle to go to the moon and beyond. To achieve that, NASA is seeking more innovative and efficient approaches to reduce cost while maintaining an acceptable level of safety and mission success. One area that has the potential to contribute significantly to achieving NASA safety and affordability goals is Reliability and Maintainability (R&M) engineering. Inadequate reliability or failure of critical safety items may directly jeopardize the safety of the user(s) and result in a loss of life. Inadequate reliability of equipment may directly jeopardize mission success. Systems designed to be more reliable (fewer failures) and maintainable (fewer resources needed) can lower the total life cycle cost. The Department of Defense (DOD) and industry experience has shown that optimized and adequate levels of R&M are critical for achieving a high level of safety and mission success, and low sustainment cost. Also, lessons learned from the Space Shuttle program clearly demonstrated the importance of R&M engineering in designing and operating safe and affordable launch systems. The Challenger and Columbia accidents are examples of the severe impact of design unreliability and process induced failures on system safety and mission success. These accidents demonstrated the criticality of reliability engineering in understanding component failure mechanisms and integrated system failures across the system elements interfaces. Experience from the shuttle program also shows that insufficient Reliability, Maintainability, and Supportability (RMS) engineering analyses upfront in the design phase can significantly increase the sustainment cost and, thereby, the total life cycle cost. Emphasis on RMS during the design phase is critical for identifying the design features and characteristics needed for time efficient processing

  14. Effectiveness of high school safety belt instruction

    DOT National Transportation Integrated Search

    1982-12-01

    The Effectiveness of High School Safety Belt Instruction was developed during a two-phased project. In Phase I, Focus Group Activities were conducted to determine whether audiovisual safety belt instructional materials assembled by the National Highw...

  15. California Guide to Traffic Safety Education.

    ERIC Educational Resources Information Center

    California State Dept. of Education, Sacramento.

    The guide proposes an elementary through high school program encompassing many aspects of traffic safety. Chapter 1 presents definitions, instructional goals, behavioral objectives, and K-6 traffic safety concepts coupled with student performance indicators. Various elements of program administration are covered in Chapter 2. Chapter 3 includes…

  16. Toward a national core course in agricultural medicine and curriculum in agricultural safety and health: the "building capacity" consensus process.

    PubMed

    Rudolphi, Josie M; Donham, Kelley J

    2015-01-01

    ABSTRACT The agricultural industry poses specific hazards and risks to its workers. Since the 1970s, the University of Iowa has been establishing programs to educate rural health care and safety professionals who in turn provide education and occupational health and safety services to farm families and farm workers. This program has been well established in the state of Iowa as a program of Iowa's Center for Agricultural Safety and Health (I-CASH). However, the National 1989 Agriculture at Risk Report indicated there was a great need for agricultural medicine training beyond Iowa's borders. In order to help meet this need, Building Capacity: A National Resource of Agricultural Medicine Professionals was initiated as a project of the National Institute for Occupational Safety and Health (NIOSH)-funded Great Plains Center for Agricultural Health in 2006. Before the first phase of this project, a consensus process was conducted with a group of safety and health professionals to determine topics and learning objectives for the course. Over 300 students attended and matriculated the agricultural medicine course during first phase of the project (2007-2010). Beginning the second phase of the project (2012-2016), an expanded advisory committee (38 internationally recognized health and safety professionals) was convened to review the progress of the first phase, make recommendations for revisions to the required topics and competencies, and discuss updates to the second edition of the course textbook (Agricultural Medicine: Occupational and Environmental Health for the Health Professions). A formal consensus process was held and included an online survey and also a face-to-face meeting. The group was charged with the responsibility of developing the next version of this course by establishing best practices and setting an agenda with the long-term goal of developing a national course in agricultural medicine.

  17. Querying Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Naylor, Dwight; Pai, Ganesh

    2014-01-01

    Querying a safety case to show how the various stakeholders' concerns about system safety are addressed has been put forth as one of the benefits of argument-based assurance (in a recent study by the Health Foundation, UK, which reviewed the use of safety cases in safety-critical industries). However, neither the literature nor current practice offer much guidance on querying mechanisms appropriate for, or available within, a safety case paradigm. This paper presents a preliminary approach that uses a formal basis for querying safety cases, specifically Goal Structuring Notation (GSN) argument structures. Our approach semantically enriches GSN arguments with domain-specific metadata that the query language leverages, along with its inherent structure, to produce views. We have implemented the approach in our toolset AdvoCATE, and illustrate it by application to a fragment of the safety argument for an Unmanned Aircraft System (UAS) being developed at NASA Ames. We also discuss the potential practical utility of our query mechanism within the context of the existing framework for UAS safety assurance.

  18. Relationships between psychological safety climate facets and safety behavior in the rail industry: a dominance analysis.

    PubMed

    Morrow, Stephanie L; McGonagle, Alyssa K; Dove-Steinkamp, Megan L; Walker, Curtis T; Marmet, Matthew; Barnes-Farrell, Janet L

    2010-09-01

    The goals of this study were twofold: (1) to confirm a relationship between employee perceptions of psychological safety climate and safety behavior for a sample of workers in the rail industry and (2) to explore the relative strengths of relationships between specific facets of safety climate and safety behavior. Non-management rail maintenance workers employed by a large North American railroad completed a survey (n=421) regarding workplace safety perceptions and behaviors. Three facets of safety climate (management safety, coworker safety, and work-safety tension) were assessed as relating to individual workers' reported safety behavior. All three facets were significantly associated with safety behavior. Dominance analysis was used to assess the relative importance of each facet as related to the outcome, and work-safety tension evidenced the strongest relationship with safety behavior. Published by Elsevier Ltd.

  19. The Role and Quality of Software Safety in the NASA Constellation Program

    NASA Technical Reports Server (NTRS)

    Layman, Lucas; Basili, Victor R.; Zelkowitz, Marvin V.

    2010-01-01

    In this study, we examine software safety risk in the early design phase of the NASA Constellation spaceflight program. Obtaining an accurate, program-wide picture of software safety risk is difficult across multiple, independently-developing systems. We leverage one source of safety information, hazard analysis, to provide NASA quality assurance managers with information regarding the ongoing state of software safety across the program. The goal of this research is two-fold: 1) to quantify the relative importance of software with respect to system safety; and 2) to quantify the level of risk presented by software in the hazard analysis. We examined 154 hazard reports created during the preliminary design phase of three major flight hardware systems within the Constellation program. To quantify the importance of software, we collected metrics based on the number of software-related causes and controls of hazardous conditions. To quantify the level of risk presented by software, we created a metric scheme to measure the specificity of these software causes. We found that from 49-70% of hazardous conditions in the three systems could be caused by software or software was involved in the prevention of the hazardous condition. We also found that 12-17% of the 2013 hazard causes involved software, and that 23-29% of all causes had a software control. Furthermore, 10-12% of all controls were software-based. There is potential for inaccuracy in these counts, however, as software causes are not consistently scoped, and the presence of software in a cause or control is not always clear. The application of our software specificity metrics also identified risks in the hazard reporting process. In particular, we found a number of traceability risks in the hazard reports may impede verification of software and system safety.

  20. Application of the statistical process control method for prospective patient safety monitoring during the learning phase: robotic kidney transplantation with regional hypothermia (IDEAL phase 2a-b).

    PubMed

    Sood, Akshay; Ghani, Khurshid R; Ahlawat, Rajesh; Modi, Pranjal; Abaza, Ronney; Jeong, Wooju; Sammon, Jesse D; Diaz, Mireya; Kher, Vijay; Menon, Mani; Bhandari, Mahendra

    2014-08-01

    Traditional evaluation of the learning curve (LC) of an operation has been retrospective. Furthermore, LC analysis does not permit patient safety monitoring. To prospectively monitor patient safety during the learning phase of robotic kidney transplantation (RKT) and determine when it could be considered learned using the techniques of statistical process control (SPC). From January through May 2013, 41 patients with end-stage renal disease underwent RKT with regional hypothermia at one of two tertiary referral centers adopting RKT. Transplant recipients were classified into three groups based on the robotic training and kidney transplant experience of the surgeons: group 1, robot trained with limited kidney transplant experience (n=7); group 2, robot trained and kidney transplant experienced (n=20); and group 3, kidney transplant experienced with limited robot training (n=14). We employed prospective monitoring using SPC techniques, including cumulative summation (CUSUM) and Shewhart control charts, to perform LC analysis and patient safety monitoring, respectively. Outcomes assessed included post-transplant graft function and measures of surgical process (anastomotic and ischemic times). CUSUM and Shewhart control charts are time trend analytic techniques that allow comparative assessment of outcomes following a new intervention (RKT) relative to those achieved with established techniques (open kidney transplant; target value) in a prospective fashion. CUSUM analysis revealed an initial learning phase for group 3, whereas groups 1 and 2 had no to minimal learning time. The learning phase for group 3 varied depending on the parameter assessed. Shewhart control charts demonstrated no compromise in functional outcomes for groups 1 and 2. Graft function was compromised in one patient in group 3 (p<0.05) secondary to reasons unrelated to RKT. In multivariable analysis, robot training was significantly associated with improved task-completion times (p<0.01). Graft

  1. Hierarchical Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen W.; Whiteside, Iain J.

    2012-01-01

    We introduce hierarchical safety cases (or hicases) as a technique to overcome some of the difficulties that arise creating and maintaining industrial-size safety cases. Our approach extends the existing Goal Structuring Notation with abstraction structures, which allow the safety case to be viewed at different levels of detail. We motivate hicases and give a mathematical account of them as well as an intuition, relating them to other related concepts. We give a second definition which corresponds closely to our implementation of hicases in the AdvoCATE Assurance Case Editor and prove the correspondence between the two. Finally, we suggest areas of future enhancement, both theoretically and practically.

  2. Bertolette Selected as EHS Champion of Safety | Poster

    Cancer.gov

    Dan Bertolette has been selected as the most recent NCI at Frederick Champion of Safety, as part of the Champions of Safety Program sponsored by the Environment, Health, and Safety Program (EHS). The goal of the program, which began last year, is to raise awareness and promote a culture of safety by showing NCI at Frederick staff at work in their respective workplaces,

  3. Towards a Formal Basis for Modular Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Pai, Ganesh

    2015-01-01

    Safety assurance using argument-based safety cases is an accepted best-practice in many safety-critical sectors. Goal Structuring Notation (GSN), which is widely used for presenting safety arguments graphically, provides a notion of modular arguments to support the goal of incremental certification. Despite the efforts at standardization, GSN remains an informal notation whereas the GSN standard contains appreciable ambiguity especially concerning modular extensions. This, in turn, presents challenges when developing tools and methods to intelligently manipulate modular GSN arguments. This paper develops the elements of a theory of modular safety cases, leveraging our previous work on formalizing GSN arguments. Using example argument structures we highlight some ambiguities arising through the existing guidance, present the intuition underlying the theory, clarify syntax, and address modular arguments, contracts, well-formedness and well-scopedness of modules. Based on this theory, we have a preliminary implementation of modular arguments in our toolset, AdvoCATE.

  4. Guide for Maintaining Pedestrian Facilities for Enhanced Safety.

    DOT National Transportation Integrated Search

    2013-10-01

    A Guide for Maintaining Pedestrian Facilities for Enhanced Safety provides guidance for maintaining pedestrian facilities with the primary goal of increasing safety and mobility. The Guide addresses the needs for pedestrian facility maintenance; comm...

  5. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies

    PubMed Central

    Burri, Christian; Yeramian, Patrick D.; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Josenando, Théophilo; Bernhard, Sonja C.; Olson, Carol A.; Blum, Johannes; Tidwell, Richard R.; Pohlig, Gabriele

    2016-01-01

    Background Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. Methods The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Findings/Conclusion Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3. PMID:26881924

  6. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies.

    PubMed

    Burri, Christian; Yeramian, Patrick D; Allen, James L; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Bilenge, Constantin Miaka Mia; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Manuel, Francisco; Josenando, Théophilo; Bernhard, Sonja C; Olson, Carol A; Blum, Johannes; Tidwell, Richard R; Pohlig, Gabriele

    2016-02-01

    Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3.

  7. [Goals, goal attainment, and patient satisfaction in psychosomatic rehabilitation].

    PubMed

    Richter, Matthias; Schmid-Ott, Gerhard; Muthny, Fritz A

    2011-01-01

    The study assesses patient satisfaction and investigates the correlation between patient satisfaction and the setting and attainment of goals. Cross-sectional questionnaire-based assessment data were provided anonymously by 276 patients at the end of their inpatient stay in psychosomatic rehabilitation. Patient satisfaction as well as sociodemographic, disease-related, and outcome parameters including rehabilitation goals were assessed at the beginning of rehabilitation and their attainment at the end of rehabilitation. Goal-attainment scales based on factor analysis showed a high degree of goal-attainment with respect to "lifestyle and priorities" and "psychotherapeutic goals." Patient satisfaction correlated most significantly with the goal-attainment level at the end of rehabilitation (r=.62) and the subscale "attainment of psychotherapeutic goals" (r=.57). Nonattainment of goals (r=-.55) was more closely related with patient satisfaction than the attainment (r=.40). The results confirm the central role of goal-setting and goal-attainment in rehabilitation, and reveal the necessity of goal-setting assessment of goal-attainment in the process of rehabilitation.

  8. Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults' physical activity.

    PubMed

    Adams, Marc A; Hurley, Jane C; Todd, Michael; Bhuiyan, Nishat; Jarrett, Catherine L; Tucker, Wesley J; Hollingshead, Kevin E; Angadi, Siddhartha S

    2017-03-29

    Emerging interventions that rely on and harness variability in behavior to adapt to individual performance over time may outperform interventions that prescribe static goals (e.g., 10,000 steps/day). The purpose of this factorial trial was to compare adaptive vs. static goal setting and immediate vs. delayed, non-contingent financial rewards for increasing free-living physical activity (PA). A 4-month 2 × 2 factorial randomized controlled trial tested main effects for goal setting (adaptive vs. static goals) and rewards (immediate vs. delayed) and interactions between factors to increase steps/day as measured by a Fitbit Zip. Moderate-to-vigorous PA (MVPA) minutes/day was examined as a secondary outcome. Participants (N = 96) were mainly female (77%), aged 41 ± 9.5 years, and all were insufficiently active and overweight/obese (mean BMI = 34.1 ± 6.2). Participants across all groups increased by 2389 steps/day on average from baseline to intervention phase (p < .001). Participants receiving static goals showed a stronger increase in steps per day from baseline phase to intervention phase (2630 steps/day) than those receiving adaptive goals (2149 steps/day; difference = 482 steps/day, p = .095). Participants receiving immediate rewards showed stronger improvement (2762 step/day increase) from baseline to intervention phase than those receiving delayed rewards (2016 steps/day increase; difference = 746 steps/day, p = .009). However, the adaptive goals group showed a slower decrease in steps/day from the beginning of the intervention phase to the end of the intervention phase (i.e. less than half the rate) compared to the static goals group (-7.7 steps vs. -18.3 steps each day; difference = 10.7 steps/day, p < .001) resulting in better improvements for the adaptive goals group by study end. Rate of change over the intervention phase did not differ between reward groups. Significant goal phase x goal setting x reward interactions were

  9. State of Tennessee strategic highway safety plan

    DOT National Transportation Integrated Search

    2007-08-01

    The State of Tennessee's Strategic Highway Safety Plan was developed by the Tennessee Strategic Highway Safety Committee with the goal of reaching a 10% fatality rate reduction, based on CY 2002 data, by the end of CY 2008, with a projected saving of...

  10. Single and two-phase flows of shear-thinning media in safety valves.

    PubMed

    Moncalvo, D; Friedel, L

    2009-09-15

    This study is the first one in the scientific literature to investigate the liquid and two-phase flows of shear-thinning media, here aqueous solutions of polyvinylpyrrolidone, in a fully opened safety valve. In liquid flows the volume flux at the valve seat does not show any appreciable reduction when increasing the percental weight of polymer in the solution. This result may suggest that the viscous losses in the valve do not increase sensibly from the most aqueous to the most viscous solution. The authors explain it considering that in the region between the seat and the disk, where large pressure and velocity gradients occur, large shear rates are expected. On behalf of the rheological measurements, which show that both the pseudoplasticity and the zero-shear viscosity of the solutions increase with the polymer weight, the difference between the viscosities of the most viscous and those of the most aqueous solution is between the seat and the disk far less than that existing at zero-shear condition. Therefore, the effective viscous pressure drop of the safety valve, which occurs mostly in that region, must increase only modestly with the polymer percental weight in the solution. In two-phase flows the total mass flow rate at constant quality and constant relieving pressure increases remarkably with the polymer weight. The analogy with similar results in cocurrent pipe flows suggests that air entrainment causes large velocity gradients in the liquids and strains them to very large shear rates. It suggests also that a redistribution of the gas agglomerates within the liquid must be expected when increasing the polymer weight in the solutions. In fact, the gas agglomerates react to the larger viscous drag of the liquid by compressing their volume in order to exert a higher internal pressure. The reduction of the void fraction of the mixture at constant quality and constant relieving pressure imposes an increment in the total mass flow rate, since otherwise it would

  11. Market Analysis Identifies Community and School Education Goals.

    ERIC Educational Resources Information Center

    Lindle, Jane C.

    1989-01-01

    Principals must realize the positive effects that marketing can have on improving schools and building support for them. Market analysis forces clarification of the competing needs and interests present in the community. The four marketing phases are needs assessment, analysis, goal setting, and public relations and advertising. (MLH)

  12. In Pursuit of Goal Six: A Statewide Initiative To Improve School Safety.

    ERIC Educational Resources Information Center

    Yap, Kim O.; And Others

    National Education Goal Six calls for all schools to have safe environments conducive to teaching and learning by year 2000. In 1989, the Washington State Office of Superintendent of Public Instruction initiated the School Security Enhancement Program, which provides competitive grants to school districts to develop or improve school-based…

  13. The effectiveness of inking needle core prostate biopsies for preventing patient specimen identification errors: a technique to address Joint Commission patient safety goals in specialty laboratories.

    PubMed

    Raff, Lester J; Engel, George; Beck, Kenneth R; O'Brien, Andrea S; Bauer, Meagan E

    2009-02-01

    The elimination or reduction of medical errors has been a main focus of health care enterprises in the United States since the year 2000. Elimination of errors in patient and specimen identification is a key component of this focus and is the number one goal in the Joint Commission's 2008 National Patient Safety Goals Laboratory Services Program. To evaluate the effectiveness of using permanent inks to maintain specimen identity in sequentially submitted prostate needle biopsies. For a 12-month period, a grossing technician stained each prostate core with permanent ink developed for inking of pathology specimens. A different color was used for each patient, with all the prostate cores from all vials for a particular patient inked with the same color. Five colors were used sequentially: green, blue, yellow, orange, and black. The ink was diluted with distilled water to a consistency that allowed application of a thin, uniform coating of ink along the edges of the prostate core. The time required to ink patient specimens comprising different numbers of vials and prostate biopsies was timed. The number and type of inked specimen discrepancies were evaluated. The identified discrepancy rate for prostate biopsy patients was 0.13%. The discrepancy rate in terms of total number of prostate blocks was 0.014%. Diluted inks adhered to biopsy contours throughout tissue processing. The tissue showed no untoward reactions to the inks. Inking did not affect staining (histochemical or immunohistochemical) or pathologic evaluation. On average, inking prostate needle biopsies increases grossing time by 20%. Inking of all prostate core biopsies with colored inks, in sequential order, is an aid in maintaining specimen identity. It is a simple and effective method of addressing Joint Commission patient safety goals by maintaining specimen identity during processing of similar types of gross specimens. This technique may be applicable in other specialty laboratories and high

  14. Autonomous Flight Safety System September 27, 2005, Aircraft Test

    NASA Technical Reports Server (NTRS)

    Simpson, James C.

    2005-01-01

    This report describes the first aircraft test of the Autonomous Flight Safety System (AFSS). The test was conducted on September 27, 2005, near Kennedy Space Center (KSC) using a privately-owned single-engine plane and evaluated the performance of several basic flight safety rules using real-time data onboard a moving aerial vehicle. This test follows the first road test of AFSS conducted in February 2005 at KSC. AFSS is a joint KSC and Wallops Flight Facility (WEF) project that is in its third phase of development. AFSS is an independent subsystem intended for use with Expendable Launch Vehicles that uses tracking data from redundant onboard sensors to autonomously make flight termination decisions using software-based rules implemented on redundant flight processors. The goals of this project are to increase capabilities by allowing launches from locations that do not have or cannot afford extensive ground-based range safety assets, to decrease range costs, and to decrease reaction time for special situations. The mission rules are configured for each operation by the responsible Range Safety authorities and can be loosely categorized in four major categories: Parameter Threshold Violations, Physical Boundary Violations present position and instantaneous impact point (TIP), Gate Rules static and dynamic, and a Green-Time Rule. Examples of each of these rules were evaluated during this aircraft test.

  15. Programs That Support Safety and Security for the Transit Industry

    DOT National Transportation Integrated Search

    2001-03-01

    FTA's Office of Safety and Security (Office) directly supports the U.S. Department of Transportation's safety goals through a series of programs designed to maintain continuous improvement in the safety and security of our nation's transit systems. T...

  16. Development of a highway safety fundamental course.

    DOT National Transportation Integrated Search

    2015-05-01

    Although the need for road safety education was first recognized in the 1960s, it has become an increasingly urgent issue : in recent years. To fulfill the hefty goal set up by the AASHTO Highway Safety Strategy and by state DOTS, it is critical : to...

  17. The contribution of goal specificity to goal achievement in collaborative goal setting for the management of asthma.

    PubMed

    Smith, Lorraine; Alles, Chehani; Lemay, Kate; Reddel, Helen; Saini, Bandana; Bosnic-Anticevich, Sinthia; Emmerton, Lynne; Stewart, Kay; Burton, Debbie; Krass, Ines; Armour, Carol

    2013-01-01

    Goal setting was investigated as part of an implementation trial of an asthma management service (PAMS) conducted in 96 Australian community pharmacies. Patients and pharmacists identified asthma-related issues of concern to the patient and collaboratively set goals to address these. Although goal setting is commonly integrated into disease state management interventions, the nature of goals, and their contribution to goal attainment and health outcomes are not well understood. To identify and describe: 1) goals set collaboratively between adult patients with asthma and their pharmacist, 2) goal specificity and goal achievement, and 3) describe the relationships between specificity, achievement, asthma control and asthma-related quality of life. Measures of goal specificity, and goal achievement were developed and applied to patient data records. Goals set were thematically analyzed into goal domains. Proportions of goals set, goals achieved and their specificity were calculated. Correlational and regression analyses were undertaken to determine the relationships between goal specificity, goal achievement, asthma control and asthma-related quality of life. Data were drawn from 498 patient records. Findings showed that patients set a wide range and number of asthma-related goals (N = 1787) and the majority (93%) were either achieved or being working toward by the end of the study. Goal achievement was positively associated with specific and moderately specific goals, but not non-specific goals. However, on closer inspection, an inconsistent pattern of relationships emerged as a function of goal domain. Findings also showed that goal setting was associated with end-of-study asthma control but not to asthma-related quality of life. Pharmacists can help patients to set achievable and specific asthma management goals, and these have the potential to directly impact health outcomes such as asthma control. Goal specificity appears to be an important feature in the

  18. Safety and mobility impacts of winter weather - phase 3.

    DOT National Transportation Integrated Search

    2014-09-01

    Highway agencies spend millions of dollars to ensure safe and efficient winter travel. However, the effectiveness of winter-weather : maintenance practices on safety and mobility are somewhat difficult to quantify. Safety and Mobility Impacts of Wint...

  19. Get a taste of your goals: promoting motive-goal congruence through affect-focus goal fantasy.

    PubMed

    Job, Veronika; Brandstätter, Veronika

    2009-10-01

    Studies show that motive-goal congruence is an important predictor of well-being (Baumann, Kaschel, & Kuhl, 2005; Brunstein, Schultheiss, & Grässmann, 1998). However, little is known about the factors that promote congruence between implicit motives and goals. Relying on McClelland's (1985) concept of implicit motives and the theory of fantasy realization (Oettingen, 1999), we postulated that goal fantasies focusing on motive-specific affective incentives promote motive-congruent goal setting. This hypothesis was tested in 3 experimental studies. In Study 1 (n=46) and Study 2 (n=48), participants were asked to select goals in a hypothetical scenario. In Study 3 (n=179), they rated their commitment to personal goals for their actual life situation. The results of all 3 studies supported our hypothesis that participants who focus on motive-specific affective incentives in their goal fantasies set their goals in line with their corresponding implicit motive dispositions.

  20. Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies.

    PubMed

    Belkoff, L; Brock, G; Carrara, D; Neijber, A; Ando, M; Mitchel, J

    2018-02-01

    Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300 ng/dl at two consecutive measurements were included. Study duration was 9 months (000023: 3 months; 000077: 6 months). Starting dose of TG (46 mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050 ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6 months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (C max ) >1500 ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. C max >1500 ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce C max is warranted while maintaining the average steady state total testosterone concentration. © 2017 Blackwell Verlag GmbH.

  1. A Safety Run-in and Randomized Phase II Study of Cilengitide Combined with Chemoradiation for Newly Diagnosed Glioblastoma (NABTT 0306)

    PubMed Central

    Nabors, L. Burt; Mikkelsen, Tom; Hegi, Monika E.; Ye, Xiaubu; Batchelor, Tracy; Lesser, Glenn; Peereboom, David; Rosenfeld, Myrna R.; Olsen, Jeff; Brem, Steve; Fisher, Joy D.; Grossman, Stuart A.

    2012-01-01

    Background Cilengitide is a selective integrin inhibitor that is well tolerated and has demonstrated biological activity in patients with recurrent malignant glioma. The primary objectives of this randomized phase II trial were to determine safety and efficacy of cilengitide when combined with radiation and temozolomide for newly diagnosed glioblastoma (GBM) and to select a dose for comparative clinical testing. Methods A total of 112 patients were accrued. Eighteen patients received standard RT+TMZ with cilengitide in a safety run-in phase followed by a randomized phase II with ninety-four patients assigned to either 500 or 2000 mg dose groups. The trial was designed to estimate overall survival benefit when compared with the NABTT internal historical control or the published EORTC 26981 data. Results Cilengitide at all doses studied was well tolerated with radiation and temozolomide. The median survival was 19.7 months for all patients, 17.4 months for those receiving the 500 mg dose, 20.8 months for those receiving the 2000mg dose, 30 months for patients with methylated MGMT promoters and 17.4 months for unmethylated patients. For patients ages 70 and younger, the median survival and survival at 24 months was superior to that observed in the EORTC trial (20.7 months vs 14.6 months and 41% vs 27% (p=0.008) respectively). Conclusions Cilengitide is well tolerated when combined with standard chemoradiation and may improve survival for patients newly diagnosed with GBM regardless of MGMT status. From an efficacy and safety standpoint, future trials of this agent in this population should utilize the 2000 mg dose. PMID:22517399

  2. Autonomous Flight Safety System

    NASA Technical Reports Server (NTRS)

    Ferrell, Bob; Santuro, Steve; Simpson, James; Zoerner, Roger; Bull, Barton; Lanzi, Jim

    2004-01-01

    Autonomous Flight Safety System (AFSS) is an independent flight safety system designed for small to medium sized expendable launch vehicles launching from or needing range safety protection while overlying relatively remote locations. AFSS replaces the need for a man-in-the-loop to make decisions for flight termination. AFSS could also serve as the prototype for an autonomous manned flight crew escape advisory system. AFSS utilizes onboard sensors and processors to emulate the human decision-making process using rule-based software logic and can dramatically reduce safety response time during critical launch phases. The Range Safety flight path nominal trajectory, its deviation allowances, limit zones and other flight safety rules are stored in the onboard computers. Position, velocity and attitude data obtained from onboard global positioning system (GPS) and inertial navigation system (INS) sensors are compared with these rules to determine the appropriate action to ensure that people and property are not jeopardized. The final system will be fully redundant and independent with multiple processors, sensors, and dead man switches to prevent inadvertent flight termination. AFSS is currently in Phase III which includes updated algorithms, integrated GPS/INS sensors, large scale simulation testing and initial aircraft flight testing.

  3. Moving forward with safety culture.

    PubMed

    Weber, Michael

    2012-04-01

    Radiation safety and protection of people are shared goals of the Health Physics Society (HPS) and the U.S. Nuclear Regulatory Commission (NRC). A positive safety culture contributes to achieving radiation safety and protection of people, which are important to both the HPS and the NRC. Through unprecedented collaboration and engagement with diverse stakeholders, the NRC and the stakeholders developed a Safety Culture Policy Statement. The policy statement defines safety culture and describes the traits of a positive safety culture. Consideration of both safety and security issues and the interface of safety and security are underlying principles that support the policy. Examination of significant events, both within the nuclear industry and in society at large, illustrates how weaknesses in these traits can contribute to the occurrence and consequences of safety incidents, including serious injury and loss of life. With the policy statement in place, the NRC is moving forward with outreach and education about safety culture. Health physicists and other radiation safety specialists play an essential role in enhancing safety culture.

  4. Rehabilitation goal setting with community dwelling adults with acquired brain injury: a theoretical framework derived from clinicians' reflections on practice.

    PubMed

    Prescott, Sarah; Fleming, Jennifer; Doig, Emmah

    2017-06-11

    The aim of this study was to explore clinicians' experiences of implementing goal setting with community dwelling clients with acquired brain injury, to develop a goal setting practice framework. Grounded theory methodology was employed. Clinicians, representing six disciplines across seven services, were recruited and interviewed until theoretical saturation was achieved. A total of 22 clinicians were interviewed. A theoretical framework was developed to explain how clinicians support clients to actively engage in goal setting in routine practice. The framework incorporates three phases: a needs identification phase, a goal operationalisation phase, and an intervention phase. Contextual factors, including personal and environmental influences, also affect how clinicians and clients engage in this process. Clinicians use additional strategies to support clients with impaired self-awareness. These include structured communication and metacognitive strategies to operationalise goals. For clients with emotional distress, clinicians provide additional time and intervention directed at new identity development. The goal setting practice framework may guide clinician's understanding of how to engage in client-centred goal setting in brain injury rehabilitation. There is a predilection towards a client-centred goal setting approach in the community setting, however, contextual factors can inhibit implementation of this approach. Implications for Rehabilitation The theoretical framework describes processes used to develop achievable client-centred goals with people with brain injury. Building rapport is a core strategy to engage clients with brain injury in goal setting. Clients with self-awareness impairment benefit from additional metacognitive strategies to participate in goal setting. Clients with emotional distress may need additional time for new identity development.

  5. Model Transformation for a System of Systems Dependability Safety Case

    NASA Technical Reports Server (NTRS)

    Murphy, Judy; Driskell, Steve

    2011-01-01

    The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

  6. Measuring global water security towards sustainable development goals

    NASA Astrophysics Data System (ADS)

    Gain, Animesh K.; Giupponi, Carlo; Wada, Yoshihide

    2016-12-01

    Water plays an important role in underpinning equitable, stable and productive societies and ecosystems. Hence, United Nations recognized ensuring water security as one (Goal 6) of the seventeen sustainable development goals (SDGs). Many international river basins are likely to experience ‘low water security’ over the coming decades. Water security is rooted not only in the physical availability of freshwater resources relative to water demand, but also on social and economic factors (e.g. sound water planning and management approaches, institutional capacity to provide water services, sustainable economic policies). Until recently, advanced tools and methods are available for the assessment of water scarcity. However, quantitative and integrated—physical and socio-economic—approaches for spatial analysis of water security at global level are not available yet. In this study, we present a spatial multi-criteria analysis framework to provide a global assessment of water security. The selected indicators are based on Goal 6 of SDGs. The term ‘security’ is conceptualized as a function of ‘availability’, ‘accessibility to services’, ‘safety and quality’, and ‘management’. The proposed global water security index (GWSI) is calculated by aggregating indicator values on a pixel-by-pixel basis, using the ordered weighted average method, which allows for the exploration of the sensitivity of final maps to different attitudes of hypothetical policy makers. Our assessment suggests that countries of Africa, South Asia and Middle East experience very low water security. Other areas of high water scarcity, such as some parts of United States, Australia and Southern Europe, show better GWSI values, due to good performance of management, safety and quality, and accessibility. The GWSI maps show the areas of the world in which integrated strategies are needed to achieve water related targets of the SDGs particularly in the African and Asian continents.

  7. Measuring Global Water Security Towards Sustainable Development Goals

    NASA Technical Reports Server (NTRS)

    Gain, Animesh K.; Giupponi, Carlo; Wada, Yoshihide

    2016-01-01

    Water plays an important role in underpinning equitable, stable and productive societies and ecosystems. Hence, United Nations recognized ensuring water security as one (Goal 6) of the seventeen sustainable development goals (SDGs). Many international river basins are likely to experience 'low water security' over the coming decades. Water security is rooted not only in the physical availability of freshwater resources relative to water demand, but also on social and economic factors (e.g. sound water planning and management approaches, institutional capacity to provide water services, sustainable economic policies). Until recently, advanced tools and methods are available for the assessment of water scarcity. However, quantitative and integrated-physical and socio-economic-approaches for spatial analysis of water security at global level are not available yet. In this study, we present a spatial multi-criteria analysis framework to provide a global assessment of water security. The selected indicators are based on Goal 6 of SDGs. The term 'security' is conceptualized as a function of 'availability', 'accessibility to services', 'safety and quality', and 'management'. The proposed global water security index (GWSI) is calculated by aggregating indicator values on a pixel-by-pixel basis, using the ordered weighted average method, which allows for the exploration of the sensitivity of final maps to different attitudes of hypothetical policy makers. Our assessment suggests that countries of Africa, South Asia and Middle East experience very low water security. Other areas of high water scarcity, such as some parts of United States, Australia and Southern Europe, show better GWSI values, due to good performance of management, safety and quality, and accessibility. The GWSI maps show the areas of the world in which integrated strategies are needed to achieve water related targets of the SDGs particularly in the African and Asian continents.

  8. Safety first: Instrumentality for reaching safety determines attention allocation under threat.

    PubMed

    Vogt, Julia; Koster, Ernst H W; De Houwer, Jan

    2017-04-01

    Theories of attention to emotional information suggest that attentional processes prioritize threatening information. In this article, we suggest that attention will prioritize the events that are most instrumental to a goal in any given context, which in threatening situations is typically reaching safety. To test our hypotheses, we used an attentional cueing paradigm that contained cues signaling imminent threat (i.e., aversive noises) as well as cues that allowed participants to avoid threat (instrumental safety signals). Correct reactions to instrumental safety signals seemingly allowed participants to lower the presentation rate of the threat. Experiment 1 demonstrates that attention prioritizes instrumental safety signals over threat signals. Experiment 2 replicates this finding and additionally compares instrumental safety signals to other action-relevant signals controlling for action relevance as cause of the effects. Experiment 3 demonstrates that when actions toward threat signals permit to avoid threat, attention prioritizes threat signals. Taken together, these results support the view that instrumentality for reaching safety determines the allocation of attention under threat. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  9. Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer.

    PubMed

    Kumar, Nagi; Crocker, Theresa; Smith, Tiffany; Pow-Sang, Julio; Spiess, Philippe E; Egan, Kathleen; Quinn, Gwen; Schell, Michael; Sebti, Said; Kazi, Aslam; Chuang, Tian; Salup, Raoul; Helal, Mohamed; Zagaja, Gregory; Trabulsi, Edouard; McLarty, Jerry; Fazili, Tajammul; Williams, Christopher R; Schreiber, Fred; Slaton, Joel; Anderson, J Kyle

    2012-03-01

    The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety-four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Challenges and Potential Solutions to Meeting Accrual Goals in a Phase II Chemoprevention Trial for Prostate Cancer

    PubMed Central

    Kumar, Nagi; Crocker, Theresa; Smith, Tiffany; Pow-Sang, Julio; Spiess, Philippe E.; Egan, Kathleen; Quinn, Gwen; Schell, Michael; Sebti, Said; Kazi, Aslam; Chuang, Tian; Salup, Raoul; Helal, Mohamed; Zagaja, Gregory; Trabulsi, Edouard; McLarty, Jerry; Fazili, Tajammul; Williams, Christopher R.; Schreiber, Fred; Slaton, Joel; Anderson, J Kyle

    2011-01-01

    Objective The goal of this report is to describe the on going strategies, successes, challenges and solutions for recruitment in this multi-center, phase II chemoprevention trial targeting men at high risk for prostate cancer. Methods We developed and implemented a multi-center clinical trial in institutions with supportive infrastructure, lead by a recruitment team of experienced and committed physicians and clinical trial staff, implementing multi-media and community outreach strategies to meet recruitment goals. Screening logs were reviewed to identify trends as well as patient, protocol and infrastructure -related barriers impacting accrual and revisions to protocol implemented. Results Between January 2008 and February 2011 a total of 3547 individuals were prescreened with 94% (n=3092) determined to be ineligible based on diagnosis of cancer or benign biopsy results. Of these, 216 were considered eligible for further screening with 52% (n=113) declining to participate due to patient related factors and 14% (n=29) eliminated due to protocol-related criteria for exclusion. Ninety four (94) subjects consented to participate with 34% of these subjects (n=74) meeting all eligibility criteria to be randomized to receive study agent or placebo. Across all sites, 99% of the recruitment of subjects in this clinical trial is via physician recruitment and referral with less than 1% responding to other recruitment strategies. Conclusion A contemporary approach to subject recruitment and frequent evaluation is needed to assure responsiveness to emerging challenges to accrual and the evolving scientific literature. A focus on investing on improving systems for physician recruitment may be key to meeting recruitment target in chemoprevention trials. PMID:22101219

  11. U18 : Traffic signal safety (phase B).

    DOT National Transportation Integrated Search

    2009-08-01

    Efficiently scheduling traffic, particularly heavy vehicles, remains a key challenge in transportation engineering. This project has focused on the development of a novel trafficsignal-control methodology to improve the safety of heavy vehicles on...

  12. Patient Safety and the Malpractice System.

    PubMed

    Swift, James Q

    2017-05-01

    The cost of health care in the United States and malpractice insurance has escalated greatly over the past 30 years. In an ideal world, the goals of the tort system would be aligned with efforts at improving safety. In fact, there is little evidence that the tort system and the processes of risk management and informed consent have improved patient safety. This article explores the disunion between patient safety and the malpractice system. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. The Determination of Relevant Goals and Criteria Used to Select an Automated Patient Care Information System

    PubMed Central

    Chocholik, Joan K.; Bouchard, Susan E.; Tan, Joseph K. H.; Ostrow, David N.

    1999-01-01

    Objectives: To determine the relevant weighted goals and criteria for use in the selection of an automated patient care information system (PCIS) using a modified Delphi technique to achieve consensus. Design: A three-phase, six-round modified Delphi process was implemented by a ten-member PCIS selection task force. The first phase consisted of an exploratory round. It was followed by the second phase, of two rounds, to determine the selection goals and finally the third phase, of three rounds, to finalize the selection criteria. Results: Consensus on the goals and criteria for selecting a PCIS was measured during the Delphi process by reviewing the mean and standard deviation of the previous round's responses. After the study was completed, the results were analyzed using a limits-of-agreement indicator that showed strong agreement of each individual's responses between each of the goal determination rounds. Further analysis for variability in the group's response showed a significant movement to consensus after the first goal-determination iteration, with consensus reached on all goals by the end of the second iteration. Conclusion: The results indicated that the relevant weighted goals and criteria used to make the final decision for an automated PCIS were developed as a result of strong agreement among members of the PCIS selection task force. It is therefore recognized that the use of the Delphi process was beneficial in achieving consensus among clinical and nonclinical members in a relatively short time while avoiding a decision based on political biases and the “groupthink” of traditional committee meetings. The results suggest that improvements could be made in lessening the number of rounds by having information available through side conversations, by having other statistical indicators besides the mean and standard deviation available between rounds, and by having a content expert address questions between rounds. PMID:10332655

  14. The relationship between an effort goal and self-regulatory efficacy beliefs for division I football players.

    PubMed

    Gilson, Todd A; Heller, Emily A; Stults-Kolehmainen, Matthew A

    2013-10-01

    When training for sport, it can be argued that self-regulation-or how athletes attempt to learn new skills-is vital for success. However, self-regulation means little if athletes cannot apply it in the throes of adversity. Specifically, the confidence one has to use self-regulation skills (i.e., self-regulatory efficacy [SRE]) when faced with adverse conditions can contribute to positive or negative behavioral implications when examined in conjunction with an athlete's current goals. Therefore, the purpose of this study was twofold: (a) determine if athletes who hold an effort goal when training for sport will have higher SRE scores; and (b) assess the relationship between effort goals and SRE, as the strength of one's effort goal increases. In phase 1, interviews with 11 Division I athletes were conducted to determine the most salient dissuading conditions athletes experience when training for sport. This process resulted in 27 factors that were implemented into a questionnaire for phase 2. During this latter phase, 402 Division I football players (Mage = 20.1 years, SD = 1.3 years) completed a 2-part goal statement along with an SRE questionnaire. The results indicated that athletes who held a criterion effort goal related to training (n = 362) had significantly higher SRE scores when compared with athletes who did not report having an effort goal F(27,401) = 1.89, p < 0.01. Additionally, as athletes' effort goal increased, stronger SRE beliefs resulted for all dissuading conditions, with all p values <0.05. Based on these results, practitioners are encouraged to facilitate goal setting sessions early and often with athletes as a way to combat the negative effects of low SRE beliefs.

  15. Putting Safety in the Frame

    PubMed Central

    O’Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

    2015-01-01

    Current patient safety policy focuses nursing on patient care goals, often overriding nurses’ safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used “frames” built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses’ decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses’ frames question current policy and practice by challenging how nurses’ safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management. PMID:28462311

  16. Autonomous system for launch vehicle range safety

    NASA Astrophysics Data System (ADS)

    Ferrell, Bob; Haley, Sam

    2001-02-01

    The Autonomous Flight Safety System (AFSS) is a launch vehicle subsystem whose ultimate goal is an autonomous capability to assure range safety (people and valuable resources), flight personnel safety, flight assets safety (recovery of valuable vehicles and cargo), and global coverage with a dramatic simplification of range infrastructure. The AFSS is capable of determining current vehicle position and predicting the impact point with respect to flight restriction zones. Additionally, it is able to discern whether or not the launch vehicle is an immediate threat to public safety, and initiate the appropriate range safety response. These features provide for a dramatic cost reduction in range operations and improved reliability of mission success. .

  17. Space-Based Range Safety and Future Space Range Applications

    NASA Technical Reports Server (NTRS)

    Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

    2005-01-01

    The National Aeronautics and Space Administration (NASA) Space-Based Telemetry and Range Safety (STARS) study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety [global positioning system (GPS) metric tracking data, flight termination command and range safety data relay] and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California, USA) using the NASA Tracking and Data Relay Satellite System (TDRSS) as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit (RSU) provided real-time video for three days during the historic Global Flyer (Scaled Composites, Mojave, California, USA) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This paper discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

  18. Space-Based Range Safety and Future Space Range Applications

    NASA Technical Reports Server (NTRS)

    Whiteman, Donald E.; Valencia, Lisa M.; Simpson, James C.

    2005-01-01

    The National Aeronautics and Space Administration Space-Based Telemetry and Range Safety study is a multiphase project to demonstrate the performance, flexibility and cost savings that can be realized by using space-based assets for the Range Safety (global positioning system metric tracking data, flight termination command and range safety data relay) and Range User (telemetry) functions during vehicle launches and landings. Phase 1 included flight testing S-band Range Safety and Range User hardware in 2003 onboard a high-dynamic aircraft platform at Dryden Flight Research Center (Edwards, California) using the NASA Tracking and Data Relay Satellite System as the communications link. The current effort, Phase 2, includes hardware and packaging upgrades to the S-band Range Safety system and development of a high data rate Ku-band Range User system. The enhanced Phase 2 Range Safety Unit provided real-time video for three days during the historic GlobalFlyer (Scaled Composites, Mojave, California) flight in March, 2005. Additional Phase 2 testing will include a sounding rocket test of the Range Safety system and aircraft flight testing of both systems. Future testing will include a flight test on a launch vehicle platform. This report discusses both Range Safety and Range User developments and testing with emphasis on the Range Safety system. The operational concept of a future space-based range is also discussed.

  19. Another Approach to Enhance Airline Safety: Using Management Safety Tools

    NASA Technical Reports Server (NTRS)

    Lu, Chien-tsug; Wetmore, Michael; Przetak, Robert

    2006-01-01

    The ultimate goal of conducting an accident investigation is to prevent similar accidents from happening again and to make operations safer system-wide. Based on the findings extracted from the investigation, the "lesson learned" becomes a genuine part of the safety database making risk management available to safety analysts. The airline industry is no exception. In the US, the FAA has advocated the usage of the System Safety concept in enhancing safety since 2000. Yet, in today s usage of System Safety, the airline industry mainly focuses on risk management, which is a reactive process of the System Safety discipline. In order to extend the merit of System Safety and to prevent accidents beforehand, a specific System Safety tool needs to be applied; so a model of hazard prediction can be formed. To do so, the authors initiated this study by reviewing 189 final accident reports from the National Transportation Safety Board (NTSB) covering FAR Part 121 scheduled operations. The discovered accident causes (direct hazards) were categorized into 10 groups Flight Operations, Ground Crew, Turbulence, Maintenance, Foreign Object Damage (FOD), Flight Attendant, Air Traffic Control, Manufacturer, Passenger, and Federal Aviation Administration. These direct hazards were associated with 36 root factors prepared for an error-elimination model using Fault Tree Analysis (FTA), a leading tool for System Safety experts. An FTA block-diagram model was created, followed by a probability simulation of accidents. Five case studies and reports were provided in order to fully demonstrate the usefulness of System Safety tools in promoting airline safety.

  20. Therapeutic Immunization In HIV Infected Ugandans Receiving Stable Antiretroviral Treatment: A Phase I Safety Study4

    PubMed Central

    Kityo, Cissy; Bousheri, Stephanie; Akao, Juliette; Ssali, Francis; Byaruhanga, Rose; Ssewanyana, Isaac; Muloma, Prossy; Myalo, Sula; Magala, Rose; Lu, Yichen; Mugyenyi, Peter; Cao, Huyen

    2011-01-01

    Therapeutic immunizations in HIV infection may boost immunity during antiretroviral treatment. We report on the first therapeutic vaccine trial in Uganda, Africa. This open label Phase I trial was designed to assess the safety, tolerability and immunogenicity of a therapeutic HIV-1 vaccine candidate. Thirty HIV positive volunteers receiving a stable regimen of antiretroviral therapy with CD4 counts > 400 were recruited for the safety evaluation of LFn-p24C, a detoxified anthrax-derived polypeptide fused to the subtype C HIV gag protein p24. The vaccine was well tolerated and HIV RNA levels remained undetectable following three immunizations. CD4 counts in vaccine recipients were significantly higher compared to the control individuals after 12 months. HIV-specific responses were associated with higher gain in CD4 counts following LFn-p24C immunizations. Volunteers were subsequently asked to undergo a 30-day period of observed treatment interruption. 8/24 (30%) individuals showed no evidence of viral rebound during treatment interruption. All demonstrated prompt suppression of viral load following resumption of ART. Our data demonstrates the safety of LFn-p24C and suggests that adjunct therapeutic immunization may benefit select individuals in further boosting an immune response. PMID:21211581

  1. 75 FR 41531 - Brookwood-Sago Mine Safety Grants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... stated goals and current reporting period. objectives for improving safety. Conduct and report pre-test and post- test results of trainees. Course evaluations of trainer and training materials. The extent... pre-test and post- and improves safety. educational materials test results of the training materials...

  2. Safety through Education and Training.

    ERIC Educational Resources Information Center

    Thorburn, S.

    1990-01-01

    Addresses the need for safety education as a continuous process through elementary and secondary phases of education in the context of human risk within modern society. Discusses the teaching of safety subjects in civil engineering curriculum. (YP)

  3. From the school of nursing quality and safety officer: nursing students' use of safety reporting tools and their perception of safety issues in clinical settings.

    PubMed

    Cooper, Elizabeth

    2013-01-01

    Improved patient safety and quality are priority goals for nurses and schools of nursing. This article describes the innovative new role of quality and safety officer (QSO) developed by one university in response to the Quality and Safety Education for Nurses challenge to increase quality and safety education for prelicensure nursing students. The article also describes the results of a study conducted by the QSO, obtaining information from prelicensure nursing students about the use of safety tools and identifying the students' perceptions of safety issues, communication, and safety reporting in the clinical setting. Responses of 145 prelicensure nursing students suggest that it is difficult to get all errors and near-miss events reported. Barriers for nursing students are similar to the barriers nurses and physicians identify in reporting errors and near-miss events. The survey reveals that safety for the patient is the primary concern of the student nurse. Copyright © 2013 Elsevier Inc. All rights reserved.

  4. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster.

    PubMed

    Liedert, B; Bassus, S; Schneider, C K; Kalinke, U; Löwer, J

    2007-01-01

    This review summarizes scientific, ethical and regulatory aspects of Phase I clinical trials with monoclonal antibodies. The current standard requirements for pre-clinical testing and for clinical study design are presented. The scientific considerations discussed herein are generally applicable, the view on legal requirements for clinical trials refer to the German jurisdiction only. The adverse effects associated with the TGN1412 Phase I trial indicate that the predictive value of pre-clinical animal models requires reevaluation and that, in certain cases, some issues of clinical trial protocols such as dose fixing may need refinement or redesign. Concrete safety measures, which have been proposed as a consequence of the TGN1412 event include introduction of criteria for high-risk antibodies, sequential inclusion of trial participants and implementation of pre-Phase I studies where dose calculation is based on the pre-clinical No Effect Level instead of the No Observed Adverse Effect Level. The recently established European clinical trials database (EUDRACT Database) is a further safety tool to expedite the sharing of relevant information between scientific authorities.

  6. The closing phase of the psychoanalytic treatment of adults and the goals of psychoanalysis 'The search for truth about one's self'.

    PubMed

    Grinberg, L

    1980-01-01

    The purpose of this paper is to pose doubts and queries about the nature and objectives regarding our work. I am not contributing specific replies to these questions, but rather some ideas so that we may rethink what we are doing and why we are doing it. In the first place, I state the doubts which I have regarding the classical criteria and goals as being the expression of the essence of psychoanalysis. Perhaps we do not realize that we 'saturate' the development of the psychoanalytic relationship with the aprioristic idea of 'leading' our patients to achieve the therapeutic goals we have already fixed for them from the very beginning. We should question if these 'therapeutic objectives' correspond to what should be our 'psychoanalytic point of view', with its search for the truth about oneself regarding our goals. Psychoanalysis is a science with specific and singular characteristics which should not be confused or, indeed equated with medical science or any other natural science. In the second place, I would like to draw attention to the fact that when considering these criteria, the accent has been almost exclusively put on the personality of the analysand. I believe that it is important to take into account also that which concerns the personality of the analyst with his neurotic and/or psychotic remnant and the role which his counter-transference or his projective counter-identification plays and which can disturb his creative work. But I wish to stress, especially, the importance contained in the analyst-analysand interaction in order to understand better the vicissitudes of all which happens in the closing phase of analysis. The achievement of insight is one of the most important goals of psychoanalysis. The concept of insight is related to that knowledge which stems from the experiences of deep change and mental growth helping the patient to get near to 'being his own truth', with the need to accept the corresponding responsibility. It is important to

  7. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033

    PubMed Central

    Tran, Jonathan Q.; Rana, Jitesh; Barkhof, Frederik; Melamed, Isaac; Gevorkyan, Hakop; Wattjes, Mike P.; de Jong, Remko; Brosofsky, Kristin; Ray, Soma; Xu, Lei; Zhao, Jim; Parr, Edward

    2014-01-01

    Objective: To evaluate the safety, tolerability, and pharmacokinetics (PK) of BIIB033 (anti-LINGO-1 monoclonal antibody) in healthy volunteers and participants with multiple sclerosis (MS). Methods: In 2 separate randomized, placebo-controlled studies, single ascending doses (SAD; 0.1–100 mg/kg) of BIIB033 or placebo were administered via IV infusion or subcutaneous injection to 72 healthy volunteers, and multiple ascending doses (MAD; 0.3–100 mg/kg; 2 doses separated by 14 days) of BIIB033 or placebo were administered via IV infusion to 47 participants with relapsing-remitting or secondary progressive MS. Safety assessments included adverse event (AE) monitoring, neurologic examinations, conventional and nonconventional MRI, EEG, optical coherence tomography, retinal examinations, and evoked potentials. Serum and CSF PK as well as the immunogenicity of BIIB033 were also evaluated. Results: All 72 healthy volunteers and 47 participants with MS were included in the safety analyses. BIIB033 infusions were well tolerated. The frequency of AEs was similar between BIIB033 and placebo. There were no serious AEs or deaths. No clinically significant changes in any of the safety measures were observed. BIIB033 PK was similar between healthy volunteers and participants with MS. Doses of ≥10 mg/kg resulted in BIIB033 concentrations similar to or higher than the concentration associated with 90% of the maximum remyelination effect in rat remyelination studies. The incidence of anti-drug antibody production was low. Conclusions: The emerging safety, tolerability, and PK of BIIB033 support advancing BIIB033 into phase II clinical development as a potential treatment for CNS demyelination disorders. Classification of evidence: This study provides Class I evidence that BIIB033 is well tolerated and safe (serious adverse event rate 0%, 95% confidence interval 0–7.6%). PMID:25340070

  8. Predicting subsequent task performance from goal motivation and goal failure.

    PubMed

    Healy, Laura C; Ntoumanis, Nikos; Stewart, Brandon D; Duda, Joan L

    2015-01-01

    Recent research has demonstrated that the cognitive processes associated with goal pursuit can continue to interfere with unrelated tasks when a goal is unfulfilled. Drawing from the self-regulation and goal-striving literatures, the present study explored the impact of goal failure on subsequent cognitive and physical task performance. Furthermore, we examined if the autonomous or controlled motivation underpinning goal striving moderates the responses to goal failure. Athletes (75 male, 59 female, Mage = 19.90 years, SDage = 3.50) completed a cycling trial with the goal of covering a given distance in 8 min. Prior to the trial, their motivation was primed using a video. During the trial they were provided with manipulated performance feedback, thus creating conditions of goal success or failure. No differences emerged in the responses to goal failure between the primed motivation or performance feedback conditions. We make recommendations for future research into how individuals can deal with failure in goal striving.

  9. Achievement Goals, Reasons for Goal Pursuit, and Achievement Goal Complexes as Predictors of Beneficial Outcomes: Is the Influence of Goals Reducible to Reasons?

    ERIC Educational Resources Information Center

    Sommet, Nicolas; Elliot, Andrew J.

    2017-01-01

    In the present research, we proposed a systematic approach to disentangling the shared and unique variance explained by achievement goals, reasons for goal pursuit, and specific goal-reason combinations (i.e., achievement goal complexes). Four studies using this approach (involving nearly 1,800 participants) led to 3 basic sets of findings. First,…

  10. Pro-Social Goals in Achievement Situations: Amity Goal Orientation Enhances the Positive Effects of Mastery Goal Orientation.

    PubMed

    Levontin, Liat; Bardi, Anat

    2018-04-01

    Research has neglected the utility of pro-social goals within achievement situations. In this article, four studies demonstrate that amity goal orientation, promoting mutual success of oneself together with others, enhances the utility of mastery goal orientation. We demonstrate this in longitudinally predicting performance (Studies 1 and 2) and in maintaining motivation after a disappointing performance (Studies 3 and 4). The studies demonstrate the same interaction effect in academic and in work achievement contexts. Specifically, whereas amity goal orientation did not predict achievement on its own, it enhanced the positive effect of mastery goal orientation. Together, these studies establish the importance of amity goal orientation while also advancing our understanding of the effects of other achievement goal orientations. We suggest future directions in examining the utility of amity goals in other contexts.

  11. Self-Regulatory Responses to Unattainable Goals: The Role of Goal Motives

    PubMed Central

    Healy, Laura C.; Sedikides, Constantine; Smith, Alison L.; Duda, Joan L.

    2014-01-01

    Does motivation for goal pursuit predict how individuals will respond when confronted with unattainable goals? Two studies examined the role of autonomous and controlled motives when pursuing an unattainable goal without (Study 1) or with (Study 2) the opportunity to reengage in alternative goal pursuit. Autonomous motives positively predicted the cognitive ease of reengagement with an alternative goal when the current goal was perceived as unattainable, especially when participants realized goal unattainability relatively early during goal striving. Autonomous motives, however, were negative predictors of cognitive ease of disengagement from an unattainable goal. When faced with failure, autonomously motivated individuals are better off realizing early the goal unattainability. Otherwise, they will find it difficult to disengage cognitively from the pursued goal (despite reengaging cognitively in an alternative goal), possibly due to interfering rumination. PMID:25104918

  12. Developing a Highway Safety Fundamentals Course : Research Project Capsule

    DOT National Transportation Integrated Search

    2012-10-01

    Although the need for road : safety education was fi rst : recognized in the 1960s, : recently it has become an : increasingly urgent issue. To : fulfi ll the hefty goal set up by : the AASHTO Highway : Safety Strategy (cutting : traffi c fatalities ...

  13. Goals.

    ERIC Educational Resources Information Center

    Phillips, David A.; Phillips, Prudence

    1985-01-01

    Presents two discussions which focus on the rationale for and goals of teaching electrochemistry at high school and college levels. The first is "Electrochemistry" by Ronald Perkins and the second is "Goals in Teaching Electrochemistry" by J. T. Maloy. (JN)

  14. Flightdeck Automation Problems (FLAP) Model for Safety Technology Portfolio Assessment

    NASA Technical Reports Server (NTRS)

    Ancel, Ersin; Shih, Ann T.

    2014-01-01

    NASA's Aviation Safety Program (AvSP) develops and advances methodologies and technologies to improve air transportation safety. The Safety Analysis and Integration Team (SAIT) conducts a safety technology portfolio assessment (PA) to analyze the program content, to examine the benefits and risks of products with respect to program goals, and to support programmatic decision making. The PA process includes systematic identification of current and future safety risks as well as tracking several quantitative and qualitative metrics to ensure the program goals are addressing prominent safety risks accurately and effectively. One of the metrics within the PA process involves using quantitative aviation safety models to gauge the impact of the safety products. This paper demonstrates the role of aviation safety modeling by providing model outputs and evaluating a sample of portfolio elements using the Flightdeck Automation Problems (FLAP) model. The model enables not only ranking of the quantitative relative risk reduction impact of all portfolio elements, but also highlighting the areas with high potential impact via sensitivity and gap analyses in support of the program office. Although the model outputs are preliminary and products are notional, the process shown in this paper is essential to a comprehensive PA of NASA's safety products in the current program and future programs/projects.

  15. IMPLEMENTATION OF DEFENSE NUCLEAR FACILITY SAFETY BOARD RECOMMENDATION 2000-2 AT WIPP

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

    Jackson, K.; Wu, C.

    2002-02-26

    The Defense Nuclear Safeties Board (DNFSB) issued Recommendation 2000-2 on March 8, 2000, concerning the degrading conditions of vital safety systems, or systems important to nuclear safety, at DOE sites across the nation. The Board recommended that the DOE take action to assess the condition of its nuclear systems to ensure continued operational readiness of vital safety systems that are important for safely accomplishing the DOE's mission. To verify the readiness of vital safety systems, a two-phased approach was established. Phase I consisted of a qualitative assessment to approved criteria of the defined vital safety systems by operating contractor personnel,more » overseen by Federal field office personnel. Based on Phase I Assessment results, vital safety systems with significant deficiencies would be further assessed in Phase II, a more extensive quantitative assessment, by a contractor and Federal team, using a second set of criteria. In addition, Defense Nuclear Facility Safety Board Recommendation 2000-2 concluded that the degradation of confinement ventilation systems was of major concern, and issued a separate set of criteria to perform a Phase II Assessment on confinement ventilation systems.« less

  16. Efficacy and safety of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms, with an emphasis on contraceptive efficacy. A phase IV trial.

    PubMed

    Friedman, A J; Wheeler, J

    1991-04-01

    A phase IV trial evaluated the efficacy and safety of a monophasic oral contraceptive formulation, ethynodiol diacetate, 1 mg, plus ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) (Demulen 1/35). Nine hundred eighty-three community-based obstetrician-gynecologists treated a total of 7,759 patients with EDA 1 mg with EE 35 micrograms for one to eight months. Clinical evaluation forms on 6,382 patients were amenable to analysis for safety (including breakthrough bleeding, ovarian cyst formation and complexion changes); 5,412 patients were evaluable for efficacy (prevention of pregnancy), with a total of 21,440 cycles recorded. The study results were interpreted in terms of the impact on clinical management of oral contraceptive users and the methods, strengths and weaknesses of phase IV trials, particularly as they relate to confirmation of the results reported here.

  17. Special Education/Traffic Safety Education. Curriculum Guide.

    ERIC Educational Resources Information Center

    McBrayer, Clyde; Tidwell, Fred

    The curriculum guide for special education students is intended to serve as a supplement to the Washington 1980 State Traffice Safety Education Curriculum Guide. The guide is also correlated with two popular traffic safety texts. Each of the 21 modules contains a goal statement, a list of vocabulary words that might be difficult, a check sheet…

  18. Enhancing Productivity Through Feedback and Goal Setting. Final Report.

    ERIC Educational Resources Information Center

    Pritchard, Robert D.; And Others

    A field test was conducted to research the effects of feedback and goal-setting techniques on increasing productivity. Subjects were regular employees of two autonomous clerical-type units in a credit card and payment processing center of a Southwestern oil company. The study desiqn had three phases--baseline period and two experimental conditions…

  19. Taking up national safety alerts to improve patient safety in hospitals: The perspective of healthcare quality and risk managers.

    PubMed

    Pfeiffer, Yvonne; Schwappach, David

    2016-01-01

    National safety alert systems publish relevant information to improve patient safety in hospitals. However, the information has to be transformed into local action to have an effect on patient safety. We studied three research questions: How do Swiss healthcare quality and risk managers (qm/rm(1)) see their own role in learning from safety alerts issued by the Swiss national voluntary reporting and analysis system? What are their attitudes towards and evaluations of the alerts, and which types of improvement actions were fostered by the safety alerts? A survey was developed and applied to Swiss healthcare risk and quality managers, with a response rate of 39 % (n=116). Descriptive statistics are presented. The qm/rm disseminate and communicate with a broad variety of professional groups about the alerts. While most respondents felt that they should know the alerts and their contents, only a part of them felt responsible for driving organizational change based on the recommendations. However, most respondents used safety alerts to back up their own patient safety goals. The alerts were evaluated positively on various dimensions such as usefulness and were considered as standards of good practice by the majority of the respondents. A range of organizational responses was applied, with disseminating information being the most common. An active role is related to using safety alerts for backing up own patient safety goals. To support an active role of qm/rm in their hospital's learning from safety alerts, appropriate organizational structures should be developed. Furthermore, they could be given special information or training to act as an information hub on the issues discussed in the alerts. Copyright © 2016. Published by Elsevier GmbH.

  20. Operational and safety characteristics of lane widths : final report.

    DOT National Transportation Integrated Search

    2015-01-15

    The primary goal of this study was to investigate and assess the effect of lane widths on the safety and : operation of highways in South Carolina. Because of the many site conditions that affect safety and : operations on roadways, this type of rese...

  1. Traveler safety policy paper : TranPlan 21, amended in 2007

    DOT National Transportation Integrated Search

    2007-01-01

    This policy paper describes the current initiatives and potential policy goals and actions that the Montana Department of Transportation (MDT) could implement to improve public safety on the State's public roadways. these goals and actions were adopt...

  2. Setting goals, not just roles: Improving teamwork through goal-focused debriefing.

    PubMed

    Gardner, Aimee K; Kosemund, Matthew; Hogg, Deborah; Heymann, Abraham; Martinez, Joseph

    2017-02-01

    The role of goal setting within post-simulation debriefing is not well known. This study sought to examine how inclusion of group-level goals, individual-level goals, or no goals in the debriefing process impacts teamwork. Students participated in two high-fidelity team training scenarios. Between scenarios, teams were assigned to one of three debriefing groups: jointly creating five teamwork goals for the group to achieve (group-level goals); independently creating five teamwork goals for each individual to attain (individual-level goals); or no goals. Paired-samples t tests and one-way ANOVA with post-hoc Tukey tests were used to examine performance improvements and differences between groups. 86 MS3s participated in the training program across 22 groups. Percentage of items achieved on the teamwork tool from first to second scenario were 61.7±20.4 to 60.2±8.8 (no goals; ns), 59.8±14.0 to 76.8±7.0 (individual goals; p<0.01), and 62.5±9.5 to 67.0±10.0 (group goals; ns). Performance improvement in the individual goals group was significantly higher than the no goals group (p<0.05). Debriefing facilitators should encourage learners to focus on creating and achieving personal goals contributing to teamwork. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. A Two-Phase Pilot Study to Evaluate the Safety and Tolerability of an In Situ Polymerizing Collagen.

    PubMed

    Inglefield, Christopher; Rone-McCrate, Rebecca; Brooks, Robert; Zhu, Jiaxun; Grant, Sheila; DeVore, Dale P

    2017-09-01

    Demand for collagen-based fillers has declined primarily because of limited long-term clinical benefit and the introduction of hyaluronic acid compositions. In situ polymerizing collagen is a noncrosslinked solution of porcine collagen containing a collagenase shield that undergoes fibrillogenesis on injected into tissues forming a natural matrix. Conduct a prospective, single-center, dual-phase open-label study in 8 subjects to evaluate the safety, tolerability, and efficacy of the porcine collagen composition. In Phase I, potential hypersensitivity of the collagen composition was evaluated after skin testing in the back (men) or forearms of subjects (women). In Phase II, subjects showing no signs of hypersensitivity received collagen injections into the nasolabial area followed by evaluation at 1, 4, 8, and 12 weeks using the Global Aesthetic Improvement Scale. None of the subjects had signs of hypersensitivity and all continued in Phase II. The treating physician(s) reported no post-treatment adverse events. Improvement of the nasolabial fold was observed by the physicians and confirmed by assessment of high-resolution photographs and Global Aesthetic Improvement Scale scores over the 12-week treatment were maintained. In this pilot clinical study in situ polymerizing collagen was shown to be safe and effective throughout the 3-month study period.

  4. Safety management vs. picking leaves.

    PubMed

    Wright, D

    1991-09-01

    A safety program will generally have as its base a comprehensive written document made available for everyone in the organization. The document should indicate a positive commitment to safety by management. It should not be a "how to" guide, but rather a broad outline to establish responsibilities, goals, and methods. The safety manager is appointed in writing and answers to the highest level of management. As opposed to a "doer," the safety manager acts as a director and administrator of the safety program. This is accomplished through the advisory capacity of the safety program for solicited and unsolicited problems. The focus of the safety manager is on the system and how it contributes to safety problems, rather than individual problems. Management has the ultimate responsibility for safety. Their efforts should reflect a proactive attitude to correct problems in the system. In order to identify areas of interest, technically competent input from the safety manager should be required. The support of the safety program by top management determines the success of the program. Without a clear and firm commitment by the organization, safety will receive no more than lip service from the employees. The benefits of a proactive approach will be realized in the organization's ability to manage safety issues, rather than reacting to them.

  5. When goals collide: monitoring the goals of multiple characters.

    PubMed

    Magliano, Joseph P; Taylor, Holly A; Kim, Hyun-Jeong Joyce

    2005-12-01

    Most story plots contain multiple characters who are independent, interact, and often have conflicting goals. One would expect that narrative understanding would require monitoring of the goals, concerns, and situations of multiple agents. There is considerable evidence that understanders monitor the primary protagonist's goal plans (e.g., Suh & Trabasso, 1993). However, there is relatively little research on the extent to which understanders monitor the goals of multiple agents. We investigated the impact of characters' roles and prominence on the extent to which understanders monitor the goal plans of multiple characters in a feature length film. In Experiment 1, participants made situation change judgments, and in Experiment 2, they verbally described scenes. Both types of judgments indicated that viewers monitor the goals and plans of multiple agents but do so to a greater extent for characters more prominent to the plotline.

  6. Fire safety applications for spacecraft

    NASA Technical Reports Server (NTRS)

    Friedman, Robert; Olson, Sandra L.

    1989-01-01

    Fire safety for spacecraft is reviewed by first describing current practices, many of which are adapted directly from aircraft. Then, current analyses and experimental knowledge in low-gravity combustion, with implications for fire safety are discussed. In orbiting spacecraft, the detection and suppression of flames are strongly affected by the large reduction in buoyant flows under low gravity. Generally, combustion intensity is reduced in low gravity. There are some notable exceptions, however, one example being the strong enhancement of flames by low-velocity ventilation flows in space. Finally, the future requirements in fire safety, particularly the needs of long-duration space stations in fire prevention, detection, extinguishment, and atmospheric control are examined. The goal of spacecraft fire-safety investigations is the establishment of trade-offs that promote maximum safety without hampering the useful human and scientific activities in space.

  7. Quieter Cars and the Safety of Blind Pedestrians: Phase 1.

    DOT National Transportation Integrated Search

    2010-04-01

    The National Highway Traffic Safety Administration recognizes that quieter cars such as hybrid-electric vehicles in low-speed operation using their : electric motors, may introduce a safety issue for pedestrians who are blind. This study documents th...

  8. Analysis of chemistry textbook content and national science education standards in terms of air quality-related learning goals

    NASA Astrophysics Data System (ADS)

    Naughton, Wendy

    In this study's Phase One, representatives of nine municipal agencies involved in air quality education were interviewed and interview transcripts were analyzed for themes related to what citizens need to know or be able to do regarding air quality concerns. Based on these themes, eight air quality Learning Goal Sets were generated and validated via peer and member checks. In Phase Two, six college-level, liberal-arts chemistry textbooks and the National Science Education Standards (NSES) were analyzed for congruence with Phase One learning goals. Major categories of desired citizen understandings highlighted in agency interviews concerned air pollution sources, impact, detection, and transport. Identified cognitive skills focused on information-gathering and -evaluating skills, enabling informed decision-making. A content match was found between textbooks and air quality learning goals, but most textbooks fail to address learning goals that remediate citizen misconceptions and inabilities---particularly those with a "personal experience" focus. A partial match between NSES and air quality learning goals was attributed to differing foci: Researcher-derived learning goals deal specifically with air quality, while NSES focus is on "fundamental science concepts," not "many science topics." Analysis of findings within a situated cognition framework suggests implications for instruction and NSES revision.

  9. Bertolette Selected as EHS Champion of Safety | Poster

    Cancer.gov

    Dan Bertolette has been selected as the most recent NCI at Frederick Champion of Safety, as part of the Champions of Safety Program sponsored by the Environment, Health, and Safety Program (EHS). The goal of the program, which began last year, is to raise awareness and promote a culture of safety by showing NCI at Frederick staff at work in their respective workplaces, according to Terri Bray, director, EHS. “Since we have so many varied work environments here, safety often takes on a different look, according to workplace. We want to take the opportunity to show real people in real situations, to encourage safety everywhere,” Bray said.

  10. Teachers' goal orientations: Effects on classroom goal structures and emotions.

    PubMed

    Wang, Hui; Hall, Nathan C; Goetz, Thomas; Frenzel, Anne C

    2017-03-01

    Prior research has shown teachers' goal orientations to influence classroom goal structures (Retelsdorf et al., 2010, Learning and Instruction, 20, 30) and to also impact their emotions (Schutz et al., 2007, Emotion in education, Academic Press, Amsterdam, the Netherlands). However, empirical research evaluating possible causal ordering and mediation effects involving these variables in teachers is presently lacking. The present 6-month longitudinal study investigated the relations between varied motivational, behavioural, and emotional variables in practising teachers. More specifically, this study examined the reciprocal, longitudinal relations between teachers' achievement goals, classroom goal structures, and teaching-related emotions, as well as cumulative mediational models in which observed causal relations were evaluated. Participants were 495 practising teachers from Canada (86% female, M = 42 years). Teachers completed a web-based questionnaire at two time points assessing their instructional goals, perceived classroom goal structures, achievement emotions, and demographic items. Results from cross-lagged analyses and structural equation modelling showed teachers' achievement goals to predict their perceived classroom goal structures that, in turn, predicted their teaching-related emotions. The present results inform both Butler's (2012, Journal of Educational Psychology, 104, 726) theory on teachers' achievement goals and Frenzel's (2014, International handbook of emotions in education, Routledge, New York, NY) model of teachers' emotions in showing teachers' instructional goals to both directly predict their teaching-related emotions, as well as indirectly through the mediating effects of classroom goal structures. © 2016 The British Psychological Society.

  11. Safety evaluation of laninamivir octanoate hydrate through analysis of adverse events reported during early post-marketing phase vigilance.

    PubMed

    Nakano, Takashi; Okumura, Akihisa; Tanabe, Takuya; Niwa, Shimpei; Fukushima, Masato; Yonemochi, Rie; Eda, Hisano; Tsutsumi, Hiroyuki

    2013-06-01

    Abnormal behavior and delirium are common in children with influenza. While abnormal behavior and delirium are considered to be associated with influenza encephalopathy, an increased risk of such neuropsychiatric symptoms in patients receiving neuraminidase inhibitor treatment is suspected. Laninamivir octanoate hydrate, recently approved in Japan, is a long-acting neuraminidase inhibitor. It is important to establish a safety profile for laninamivir early, based on post-marketing experiences. Spontaneous safety reports collected in the early post-marketing phase vigilance were analyzed. Adverse events of interest such as abnormal behavior/delirium, dizziness/vertigo, respiratory disorders, shock/syncope, and any other serious events were intensively reviewed by the Safety Evaluation Committee. Abnormal behavior/delirium was a frequently reported event. Almost all the reported cases were considered to be due to influenza and not laninamivir. There were 32 cases of abnormal behavior/delirium that could lead to dangerous accidents, and these were observed more frequently in males and teenagers. Syncope probably related to the act of inhalation per se of laninamivir was reported during this survey. This safety review revealed that the safety profile of laninamivir for abnormal behavior/delirium and syncope was similar to that of other neuraminidase inhibitors. As stated in the labeling, teenage patients inhaling laninamivir should remain under constant parental supervision for at least 2 days and should be closely monitored for behavioral changes to prevent serious accidents associated with abnormal behavior/delirium. Furthermore, to avoid syncope because of inhalation, patients should be instructed to inhale in a relaxed sitting position.

  12. Aviation Safety/Automation Program Conference

    NASA Technical Reports Server (NTRS)

    Morello, Samuel A. (Compiler)

    1990-01-01

    The Aviation Safety/Automation Program Conference - 1989 was sponsored by the NASA Langley Research Center on 11 to 12 October 1989. The conference, held at the Sheraton Beach Inn and Conference Center, Virginia Beach, Virginia, was chaired by Samuel A. Morello. The primary objective of the conference was to ensure effective communication and technology transfer by providing a forum for technical interchange of current operational problems and program results to date. The Aviation Safety/Automation Program has as its primary goal to improve the safety of the national airspace system through the development and integration of human-centered automation technologies for aircraft crews and air traffic controllers.

  13. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Employees take a look at this NASCAR auto being displayed during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  14. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Center Director Roy Bridges talks to workers outside the Hazardous Maintenance Facility during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  15. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Employees gather around a demonstration by Florida Power and Light during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health- and safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  16. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    In an exhibit tent during Super Safety and Health Day at KSC, employees sample iced tea from a vendor. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health- and safety-related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  17. Achievement goals, social goals, and motivational regulations in physical education settings.

    PubMed

    Cecchini Estrada, José A; González González-Mesa, Carmen; Méndez-Giménez, Antonio; Fernández-Río, Javier

    2011-02-01

    This study examined the relationship between achievement and social goals, and explored how both goals affect students' level of informed self-determination in Physical Education. Participants were 395 high school students. Three scales were used to assess achievement, social goals, and motivation. Several hierarchical regression analyses revealed that mastery-approach goals were the greatest contributors to the individuals' levels of self-determination. Achievement and social goals were found to be separate predictors of students' levels of self-determination, and this highlights the importance of separating mastery and performance goals into avoidance and approach profiles. Girls reported significantly higher values than boys on responsibility, relationship, and mastery-avoidance goals, whereas boys scored higher on performance-approach goals. Researchers could use achievement and social goals to study students' motivation and achievement in Physical Education settings.

  18. Manned space flight nuclear system safety. Volume 6: Space base nuclear system safety plan

    NASA Technical Reports Server (NTRS)

    1972-01-01

    A qualitative identification of the steps required to assure the incorporation of radiological system safety principles and objectives into all phases of a manned space base program are presented. Specific areas of emphasis include: (1) radiological program management, (2) nuclear system safety plan implementation, (3) impact on program, and (4) summary of the key operation and design guidelines and requirements. The plan clearly indicates the necessity of considering and implementing radiological system safety recommendations as early as possible in the development cycle to assure maximum safety and minimize the impact on design and mission plans.

  19. Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

    Sharirli, M.; Rand, J.L.; Sasser, M.K.

    1992-01-01

    The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

  20. Limited-scope probabilistic safety analysis for the Los Alamos Meson Physics Facility (LAMPF)

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

    Sharirli, M.; Rand, J.L.; Sasser, M.K.

    1992-12-01

    The reliability of instrumentation and safety systems is a major issue in the operation of accelerator facilities. A probabilistic safety analysis was performed or the key safety and instrumentation systems at the Los Alamos Meson Physics Facility (LAMPF). in Phase I of this unique study, the Personnel Safety System (PSS) and the Current Limiters (XLs) were analyzed through the use of the fault tree analyses, failure modes and effects analysis, and criticality analysis. Phase II of the program was done to update and reevaluate the safety systems after the Phase I recommendations were implemented. This paper provides a brief reviewmore » of the studies involved in Phases I and II of the program.« less

  1. Inhibition of Fear by Learned Safety Signals: minisymposium review

    PubMed Central

    Fernando, Anushka B. P.; Kazama, Andy M.; Jovanovic, Tanja; Ostroff, Linnaea E.; Sangha, Susan

    2012-01-01

    Safety signals are learned cues that predict the non-occurrence of an aversive event. As such, safety signals are potent inhibitors of fear and stress responses. Investigations of safety signal learning have increased over the last few years due in part to the finding that traumatized persons are unable to utilize safety cues to inhibit fear, making it a clinically relevant phenotype. The goal of this review is to present recent advances relating to the neural and behavioral mechanisms of safety learning and expression in rodents, non-human primates and humans. PMID:23055481

  2. Safety evaluation of intersection conflict warning systems (ICWS), TechBrief

    DOT National Transportation Integrated Search

    2016-02-02

    The Federal Highway Administration (FHWA) organized 40 States to participate in the FHWA Evaluation of LowCost Safety Improvements Pooled Fund Study (ELCSI-PFS) as part of its strategic highway safety plan support effort. The goal of the ELCSI-PFS re...

  3. Goal Structured Notation in a Radiation Hardening Safety Case for COTS-Based Spacecraft

    NASA Technical Reports Server (NTRS)

    Witulski, Arthur; Austin, Rebekah; Reed, Robert; Karsai, Gabor; Mahadevan, Nag; Sierawski, Brian; Evans, John; LaBel, Ken

    2016-01-01

    A systematic approach is presented to constructing a radiation assurance case using Goal Structured Notation (GSN) for spacecraft containing COTS parts. The GSN paradigm is applied to an SRAM single-event upset experiment board designed to fly on a CubeSat November 2016. Construction of a radiation assurance case without use of hardened parts or extensive radiation testing is discussed.

  4. Relations between Classroom Goal Structures and Students' Goal Orientations in Mathematics Classes: When Is a Mastery Goal Structure Adaptive?

    ERIC Educational Resources Information Center

    Skaalvik, Einar M.; Federici, Roger A.

    2016-01-01

    The purpose of this study was to test possible interactions between mastery and performance goal structures in mathematics classrooms when predicting students' goal orientations. More specifically, we tested if the degree of performance goal structure moderated the associations between mastery goal structure and students' goal orientations.…

  5. Goal Contents and Goal Contexts: Experiments with Chinese Students

    ERIC Educational Resources Information Center

    Wang, Ze; Hu, Xiao Yong; Guo, Yong Yu

    2013-01-01

    Using samples of Chinese middle school students, the 2 experimental studies presented here examined the effects of goal content and goal context on test performance, free-choice engagement, and test anxiety within the framework of self-determination theory. Students' learning goals were induced as intrinsic or extrinsic with the learning contexts…

  6. National Dam Safety Program. Steeger Lake Dam (MO 11098), Upper Mississippi - Kaskaskia - St. Louis Basin, Jefferson County, Missouri. Phase 1 Inspection Report

    DTIC Science & Technology

    1980-11-01

    MISSOURPI 6 311-0 FOR: U. S. ARMY ENGINEER DISTRICT, ST. LOUIS CORPS OF ENGGINEERS -, NOVE4BER 1980 HS-8011 PHASE I REPORT NATIONAL DAM SAFETY...if the dam should fail, there may be loss of life, serious damage to homes, or extensive damage to agricultural, industrial and commercial facilities

  7. [Perceptions of classroom goal structures, personal achievement goal orientations, and learning strategies].

    PubMed

    Miki, Kaori; Yamauchi, Hirotsugu

    2005-08-01

    We examined the relations among students' perceptions of classroom goal structures (mastery and performance goal structures), students' achievement goal orientations (mastery, performance, and work-avoidance goals), and learning strategies (deep processing, surface processing and self-handicapping strategies). Participants were 323 5th and 6th grade students in elementary schools. The results from structural equation modeling indicated that perceptions of classroom mastery goal structures were associated with students' mastery goal orientations, which were in turn related positively to the deep processing strategies and academic achievement. Perceptions of classroom performance goal stractures proved associated with work avoidance-goal orientations, which were positively related to the surface processing and self-handicapping strategies. Two types of goal structures had a positive relation with students' performance goal orientations, which had significant positive effects on academic achievement. The results of this study suggest that elementary school students' perceptions of mastery goal structures are related to adaptive patterns of learning more than perceptions of performance goal structures are. The role of perceptions of classroom goal structure in promoting students' goal orientations and learning strategies is discussed.

  8. 77 FR 75443 - Draft Safety Culture Policy Statement: Request for Public Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... personal and organizational characteristics are present in a positive safety culture. A characteristic, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, particularly in goal...

  9. Working Safely at Some Times and Unsafely at Others: A Typology and Within-Person Process Model of Safety-Related Work Behaviors.

    PubMed

    Beus, Jeremy M; Taylor, William D

    2017-06-22

    Why do individuals choose to work safely in some instances and unsafely in others? Though this inherently within-person question is straightforward, the preponderance of between-person theory and research in the workplace safety literature is not equipped to answer it. Additionally, the limited way in which safety-related behaviors tend to be conceptualized further restricts understanding of why individuals vary in their safety-related actions. We use a goal-focused approach to conceptually address this question of behavioral variability and contribute to workplace safety research in 2 key ways. First, we establish an updated typology of safety-related behaviors that differentiates behaviors based on goal choice (i.e., safe vs. unsafe behaviors), goal-directedness (i.e., intentional vs. unintentional behaviors), and the means of goal pursuit (i.e., commission vs. omission and promotion vs. prevention-focused behaviors). Second, using an expectancy-value theoretical framework to explain variance in goal choice, we establish within-person propositions stating that safety-related goal choice and subsequent behaviors are a function of the target of safety-related behaviors, the instrumentality and resource requirement of behaviors, and the perceived severity, likelihood, and immediacy of the threats associated with behaviors. Taken together, we define what safety-related behaviors are, explain how they differ, and offer propositions concerning when and why they may vary within-persons. We explore potential between-person moderators of our theoretical propositions and discuss the practical implications of our typology and process model of safety-related behavior. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  10. The Selfish Goal

    PubMed Central

    Bargh, John A.; Green, Michelle; Fitzsimons, Gráinne

    2008-01-01

    Three experiments tested the hypothesis that consciously intended goal pursuits have unintended consequences for social judgment and behavior. From evolutionary theory (Dawkins 1976/2006) and empirical evidence of a nonconscious mode of goal pursuit (Bargh, 2005) we derive the hypothesis that most human goal pursuits are open-ended in nature: Once active, goals will operate on goal-relevant content in the environment, even if that content is not the intended focus of the conscious goal. Experiments 1 and 2 demonstrate that goals to evaluate a job applicant for either a waiter or crime reporter position also shape impressions of incidental bystanders in the situation, such that the bystander is later liked or disliked not on his own merits, but on how well his behavior matches the criteria consciously applied in evaluating the job applicant. Experiment 3 finds that a goal to help a specific target person spills over to influence actions toward incidental bystanders, but only while active. Implications of these findings for goal pursuit in everyday life are discussed. PMID:19081795

  11. Fundamentals of quality and safety in diagnostic radiology.

    PubMed

    Bruno, Michael A; Nagy, Paul

    2014-12-01

    The most fundamental aspects of quality and safety in radiology are reviewed, including a brief history of the quality and safety movement as applied to radiology, the overarching considerations of organizational culture, team building, choosing appropriate goals and metrics, and the radiologist's quality "tool kit." Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. The Perception, Level of Safety Satisfaction and Safety Feedback on Occupational Safety and Health Management among Hospital Staff Nurses in Sabah State Health Department.

    PubMed

    Cheah, Whye Lian; Giloi, Nelbon; Chang, Ching Thon; Lim, Jac Fang

    2012-07-01

    This study aimed to determine the perception and level of safety satisfaction of staff nurses with regards to Occupational Safety and Health (OSH) management practice in the Sabah Health Department, and to associate the OSH management dimensions, to Safety Satisfaction and Safety Feedback. A cross-sectional study using a validated self-administered questionnaire was conducted among randomly respondents. 135 nurses responded the survey. Mean (SD) score for each dimension ranged from 1.70 ± 0.68-4.04 ± 0.65, with Training and Competence dimension (mean [SD], 4.04 ± 0.65) had the highest while Safety Incidence was the least score (mean [SD], 1.70 ± 0.68). Both mean (SD) scores for Safety Satisfaction and Safety Feedback was high, 3.28 ± 0.51 and 3.57 ± 0.73, respectively. Pearson's correlation analysis indicated that all OSH dimensions had significant correlation with Safety Satisfaction and Safety Feedback (r coefficient ranged from 0.176-0.512) except for Safety Incidence. The overall perception of OSH management was rather low. Significant correlation between Safety Satisfaction and Safety Feedback and several dimensions, suggest that each organization to put in place the leaders who have appropriate leadership and supervisory skills and committed in providing staff training to improve staff's competency in OSH practice. In addition, clear goals, rules, and reporting system will help the organization to implement proper OSH management practice.

  13. Comparative study of goal contents and goal characteristics between medical and business students.

    PubMed

    Park, Soowon; Kim, Ji Eun; Lee, Jun-Young; Shin, Jongho

    2016-03-01

    Medical and business are one of the most popular majors among students, and both fields require intensive training to reach certain level of expertise. During the development of professionalism, goal can become a crucial role in psychological impetus. The purpose of this study is to compare goal contents, goal characteristics, and effect of goal characteristics on student's major satisfaction between medical and business. A total of 193 undergraduate students (97 medical students, 96 business students) answered survey questions including goal contents, goal characteristics (goal autonomy, goal attainability, social value of goal) and satisfaction on their majors. Qualitative analysis of goal contents and quantitative analysis of goal characteristics, and their effects on student major satisfaction were performed. Goal content analysis showed percentage of social concern goal was higher in medical students (25.8%) than business students (6.3%), whereas percentage of wealth goal was higher business students (24.0%) than medical students (3.1%). Among goal characteristics, goal attainability and social value of goal were higher in medical students than business students. In both groups, social value of goal was significantly predict major satisfaction. Goal contents and goal characteristics are different between medical and business students. Curriculum and educational interventions that concerning students' goal and developing programs to enhance students' social value of goal is necessary.

  14. National Dam Safety Program. Manalapan Lake Dam (NJ00293), Raritan River Basin, Manalapan Brook, Middlesex County, New Jersey. Phase I Inspection Report.

    DTIC Science & Technology

    1979-04-01

    NJ00293 1. OOVT ACCESSION NO. 4. TITLE (and Submit) Phase I Inspection Report National Dan Safety Program Manalapan Lake Dam Middlesea County...ssthoriistioa of set, Fsblic Lsw M- Ss7 . k brlsf assasaasat of ths ssa’s csssltlss is giwaa is ths frost of ths rsaort. oa wlsssl iaasostlaa, svallsbla

  15. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Vendor tents and displays filled the grounds in the Industrial Area as well as LC 39 Area during Super Safety and Health Day at KSC. Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  16. Comparative study of goal contents and goal characteristics between medical and business students

    PubMed Central

    Park, Soowon; Kim, Ji Eun; Lee, Jun-Young; Shin, Jongho

    2016-01-01

    Purpose: Medical and business are one of the most popular majors among students, and both fields require intensive training to reach certain level of expertise. During the development of professionalism, goal can become a crucial role in psychological impetus. The purpose of this study is to compare goal contents, goal characteristics, and effect of goal characteristics on student’s major satisfaction between medical and business. Methods: A total of 193 undergraduate students (97 medical students, 96 business students) answered survey questions including goal contents, goal characteristics (goal autonomy, goal attainability, social value of goal) and satisfaction on their majors. Qualitative analysis of goal contents and quantitative analysis of goal characteristics, and their effects on student major satisfaction were performed. Results: Goal content analysis showed percentage of social concern goal was higher in medical students (25.8%) than business students (6.3%), whereas percentage of wealth goal was higher business students (24.0%) than medical students (3.1%). Among goal characteristics, goal attainability and social value of goal were higher in medical students than business students. In both groups, social value of goal was significantly predict major satisfaction. Conclusion: Goal contents and goal characteristics are different between medical and business students. Curriculum and educational interventions that concerning students’ goal and developing programs to enhance students’ social value of goal is necessary. PMID:26838564

  17. Volunteering for early phase gene transfer research in Parkinson disease.

    PubMed

    Kim, S Y H; Holloway, R G; Frank, S; Beck, C A; Zimmerman, C; Wilson, R; Kieburtz, K

    2006-04-11

    For early phase trials of novel interventions-such as gene transfer for Parkinson disease (PD)--whose focus is primarily on safety and tolerability, it is important that participants have a realistic understanding of the goals of such research. Recently, some have expressed concern that patients with PD may have unrealistic expectations. The authors examined why patients with PD might volunteer for invasive early phase research by interviewing 92 patients with PD and comparing those who would (n = 46) and those who would not (n = 46) participate in a hypothetical phase I gene-transfer study. The two groups' demographic, clinical, functional, and quality of life measures, as well as their understanding of the research protocol, were similar. The groups did not differ on their perception of potential for personal benefit nor on the level of likelihood of benefit they saw as a precondition for volunteering. However, those willing to participate tended to perceive lower probability of risk, were tolerant of greater probability of risk, and were more optimistic about the phase I study's potential benefits to society. They also appeared more decisive and action-oriented than the unwilling group. It is likely that the decision whether to participate in early phase PD gene transfer studies will depend mostly on patients' attitudes regarding risk, optimism about science, and an action orientation, rather than on their clinical, functional, or demographic characteristics.

  18. 2009 National Safety Performance Function Summit

    DOT National Transportation Integrated Search

    2010-07-01

    The Illinois Department of Transportation (IDOT) and the Illinois Center for Transportation (ICT) sponsored and : hosted the first National Safety Performance Function Summit on July 29 and 30, 2009, in Chicago, Illinois. The : goal of this summit wa...

  19. Long-term 4-year safety of saxagliptin in drug-naive and metformin-treated patients with Type 2 diabetes.

    PubMed

    Rosenstock, J; Gross, J L; Aguilar-Salinas, C; Hissa, M; Berglind, N; Ravichandran, S; Fleming, D

    2013-12-01

    To evaluate the safety of saxagliptin ± metformin over 4 years in patients with Type 2 diabetes mellitus. Drug-naive (n = 401; study 11) or metformin-treated (n = 743; study 14) adults with HbA(1c) of 53-86 mmol/mol (7.0-10%) were enrolled in two randomized, placebo-controlled, double-blind trials of saxagliptin 2.5, 5 or 10 mg/day. Patients rescued during or completing 24 weeks of treatment could continue in a 42-month long-term blinded phase, for which the primary goal was assessment of safety and tolerability. Between-group efficacy was not evaluated in the long-term phase of study 11. Time to rescue or discontinuation because of inadequate glycaemic control, change from baseline in HbA(1c) and percentages of patients achieving HbA(1c) < 53 mmol/mol (< 7.0%) were assessed in study 14. No new safety findings were noted during the long-term phase. Most adverse events were mild or moderate, with slightly greater frequency of upper respiratory infections with saxagliptin. Hypoglycaemic event rates were similar with saxagliptin and placebo. In study 14, time to rescue or discontinuation because of inadequate glycaemic control was longer with saxagliptin plus metformin than for placebo plus metformin. From baseline to week 154, HbA(1c) decreased with saxagliptin but increased with placebo. Saxagliptin monotherapy or add-on to metformin is generally safe and well tolerated, with no increased risk of hypoglycaemia, for up to 4 years. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  20. Design for Reliability and Safety Approach for the NASA New Launch Vehicle

    NASA Technical Reports Server (NTRS)

    Safie, Fayssal, M.; Weldon, Danny M.

    2007-01-01

    The United States National Aeronautics and Space Administration (NASA) is in the midst of a space exploration program intended for sending crew and cargo to the international Space Station (ISS), to the moon, and beyond. This program is called Constellation. As part of the Constellation program, NASA is developing new launch vehicles aimed at significantly increase safety and reliability, reduce the cost of accessing space, and provide a growth path for manned space exploration. Achieving these goals requires a rigorous process that addresses reliability, safety, and cost upfront and throughout all the phases of the life cycle of the program. This paper discusses the "Design for Reliability and Safety" approach for the NASA new crew launch vehicle called ARES I. The ARES I is being developed by NASA Marshall Space Flight Center (MSFC) in support of the Constellation program. The ARES I consists of three major Elements: A solid First Stage (FS), an Upper Stage (US), and liquid Upper Stage Engine (USE). Stacked on top of the ARES I is the Crew exploration vehicle (CEV). The CEV consists of a Launch Abort System (LAS), Crew Module (CM), Service Module (SM), and a Spacecraft Adapter (SA). The CEV development is being led by NASA Johnson Space Center (JSC). Designing for high reliability and safety require a good integrated working environment and a sound technical design approach. The "Design for Reliability and Safety" approach addressed in this paper discusses both the environment and the technical process put in place to support the ARES I design. To address the integrated working environment, the ARES I project office has established a risk based design group called "Operability Design and Analysis" (OD&A) group. This group is an integrated group intended to bring together the engineering, design, and safety organizations together to optimize the system design for safety, reliability, and cost. On the technical side, the ARES I project has, through the OD

  1. Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study.

    PubMed

    Gutzmer, R; Rivoltini, L; Levchenko, E; Testori, A; Utikal, J; Ascierto, P A; Demidov, L; Grob, J J; Ridolfi, R; Schadendorf, D; Queirolo, P; Santoro, A; Loquai, C; Dreno, B; Hauschild, A; Schultz, E; Lesimple, T P; Vanhoutte, N; Salaun, B; Gillet, M; Jarnjak, S; De Sousa Alves, P M; Louahed, J; Brichard, V G; Lehmann, F F

    2016-01-01

    The PRAME tumour antigen is expressed in several tumour types but in few normal adult tissues. A dose-escalation phase I/II study (NCT01149343) assessed the safety, immunogenicity and clinical activity of the PRAME immunotherapeutic (recombinant PRAME protein (recPRAME) with the AS15 immunostimulant) in patients with advanced melanoma. Here, we report the phase I dose-escalation study segment. Patients with stage IV PRAME-positive melanoma were enrolled to 3 consecutive cohorts to receive up to 24 intramuscular injections of the PRAME immunotherapeutic. The RecPRAME dose was 20, 100 or 500 µg in cohorts 1, 2 and 3, respectively, with a fixed dose of AS15. Adverse events (AEs), including predefined dose-limiting toxicity (DLT) and the anti-PRAME humoral response (ELISA), were coprimary end points. Cellular immune responses were evaluated using in vitro assays. 66 patients were treated (20, 24 and 22 in the respective cohorts). AEs considered by the investigator to be causally related were mostly grade 1 or 2 injection site symptoms, fatigue, chills, fever and headache. Two DLTs (grade 3 brain oedema and proteinuria) were recorded in two patients in two cohorts (cohorts 2 and 3). All patients had detectable anti-PRAME antibodies after four immunisations. Percentages of patients with predefined PRAME-specific-CD4+T-cell responses after four immunisations were similar in each cohort. No CD8+ T-cell responses were detected. The PRAME immunotherapeutic had an acceptable safety profile and induced similar anti-PRAME-specific humoral and cellular immune responses in all cohorts. As per protocol, the phase II study segment was initiated to further evaluate the 500 µg PRAME immunotherapeutic dose. NCT01149343, Results.

  2. Goal commitment and the goal-setting process: conceptual clarification and empirical synthesis.

    PubMed

    Klein, H J; Wesson, M J; Hollenbeck, J R; Alge, B J

    1999-12-01

    Goals are central to current treatments of work motivation, and goal commitment is a critical construct in understanding the relationship between goals and task performance. Despite this importance, there is confusion about the role of goal commitment and only recently has this key construct received the empirical attention it warrants. This meta-analysis, based on 83 independent samples, updates the goal commitment literature by summarizing the accumulated evidence on the antecedents and consequences of goal commitment. Using this aggregate empirical evidence, the role of goal commitment in the goal-setting process is clarified and key areas for future research are identified.

  3. Industrial Student Apprenticeship: Understanding Health and Safety

    NASA Astrophysics Data System (ADS)

    Simanjuntak, M. V.; Abdullah, A. G.; Puspita, R. H.; Mahdan, D.; Kamaludin, M.

    2018-02-01

    The level of accident in industry is very high caused by lack of knowledge and awareness of workers toward the health and safety. Health and Safety are efforts to create a comfortable and productive atmosphere to accomplish a purpose or goal as maximum risk in the workplace. Vocational Education students must conduct training on business and industry, prior to that they should have a clear understanding on occupational health and safety. The purpose of this research is to analyze the understanding, preparation, and implementation of work health and safety of the students. Method used is descriptive method and data are collected using instrument, observation and interview. The result of study is conclusion of understanding occupational health and safety of vocational education students.

  4. Safety and pharmacokinetics of veliparib extended-release in patients with advanced solid tumors: a phase I study.

    PubMed

    Werner, Theresa L; Sachdev, Jasgit; Swisher, Elizabeth M; Gutierrez, Martin; Kittaneh, Muaiad; Stein, Mark N; Xiong, Hao; Dunbar, Martin; Sullivan, Danielle; Komarnitsky, Philip; McKee, Mark; Tan, Antoinette R

    2018-05-07

    The poly(ADP-ribose) polymerase-1/2 inhibitor veliparib is active against tumors deficient in homologous DNA damage repair. The pharmacokinetics and safety of veliparib extended-release (ER) were evaluated in patients with advanced solid tumors. This phase I study assessed veliparib-ER up to 800 mg once daily or 600 mg twice daily. Dose-limiting toxicities (DLTs), recommended phase II dose (RP2D), and maximum tolerated dose (MTD) were assessed in cycle 1 and safety/tolerability during continuous administration (28-day cycles). Seventy-one patients (n = 53 ovarian, n = 17 breast, n = 1 prostate carcinoma) received veliparib; 50 had deleterious breast cancer susceptibility (BRCA) gene mutations. Single-dose veliparib-ER 200 mg (fasting) led to 58% lower peak concentration and similar area under the concentration-time curve compared with veliparib immediate-release (IR). Three patients experienced DLTs (grade 2: asthenia; grade 3: nausea/vomiting, seizure). RP2D and MTD for veliparib-ER were 400 mg BID. The most frequent adverse events (AEs) were nausea (78.9%) and vomiting (50.7%). The most common grade 3/4 treatment-related AEs were as follows: thrombocytopenia (7.0%), nausea, and anemia (4.2% each). Overall, 12 (27.3%) patients with ovarian and 10 (62.5%) patients with breast carcinoma had a partial response. Veliparib-ER, versus veliparib-IR, exhibited an improved pharmacokinetic profile and was well tolerated in patients with ovarian and BRCA-mutated breast cancers. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  5. Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study.

    PubMed

    Sanga, Panna; Katz, Nathaniel; Polverejan, Elena; Wang, Steven; Kelly, Kathleen M; Haeussler, Juergen; Thipphawong, John

    2017-04-01

    To evaluate the long-term safety and efficacy of fulranumab in patients with knee or hip pain caused by moderate-to-severe chronic osteoarthritis (OA). In this phase II double-blind, placebo-controlled extension study, patients who were randomized in equal proportions to receive subcutaneous doses of either placebo or fulranumab (1 mg every 4 weeks, 3 mg every 8 weeks, 3 mg every 4 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks) in the 12-week double-blind efficacy phase and who completed this double-blind efficacy phase were eligible to continue the dosage throughout a 92-week double-blind extension phase, followed by a 24-week posttreatment follow-up period. Safety assessments included evaluation of treatment-emergent adverse events (TEAEs), pre-identified AEs of interest, and joint replacements. Efficacy assessments included changes from baseline to the end of the double-blind extension phase in scores on the patient's global assessment and the pain and physical function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index. Overall, 401 of the 423 patients who completed the 12-week double-blind efficacy phase entered the extension study. Long-term sustained improvements were observed in all efficacy parameters following fulranumab treatment (1 mg every 4 weeks, 3 mg every 4 weeks, and 10 mg every 8 weeks) as compared with placebo. Similar percentages of patients in both groups experienced TEAEs (88% taking placebo and 91% taking fulranumab; all phases). Across all fulranumab groups, arthralgia (21%) and OA (18%) (e.g., exacerbation of OA pain) were the most common TEAEs. The most common serious TEAEs were the requirement for knee (10%) and hip (7%) arthroplasty, with 80% occurring during the posttreatment follow-up period. Neurologic-related TEAEs (28%; all phases) were generally mild-to-moderate. Overall, 81 joint replacements were performed in 71 patients (8 [11%] receiving placebo and 63 [89%] receiving fulranumab); 15 patients

  6. Safety and Liability in the New Technology Laboratory

    ERIC Educational Resources Information Center

    Haynie, W. J., III

    2009-01-01

    All laboratories, even modern high-tech ones, have some degree of hazard potential. It is the teacher's responsibility to make the lab as safe as possible and to do all that is reasonable and prudent to prevent accidents. The teacher's goal should be to insure the safety of every student. This goal is met best via well-planned instruction and…

  7. Safety in earth orbit study. Volume 5: Space shuttle payloads: Safety requirements and guidelines on-orbit phase

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Safety requirements and guidelines are listed for the sortie module, upper stage vehicle, and space station for the earth orbit operations of the space shuttle program. The requirements and guidelines are for vehicle design, safety devices, warning devices, operational procedures, and residual hazards.

  8. Safety and long-term immunological effects of CryJ2-LAMP plasmid vaccine in Japanese red cedar atopic subjects: A phase I study.

    PubMed

    Su, Yan; Romeu-Bonilla, Eliezer; Anagnostou, Athanasia; Fitz-Patrick, David; Hearl, William; Heiland, Teri

    2017-12-02

    Japanese Red Cedar (JRC) pollen induced allergy affects one third of Japanese and the development of effective therapies remains an unachieved challenge. We designed a DNA vaccine encoding CryJ2 allergen from the JRC pollen and Lysosomal Associated Membrane Protein 1 (LAMP-1) to treat JRC allergy. These Phase IA and IB trials assessed safety and immunological effects of the investigational CryJ2-LAMP DNA vaccine in both non-sensitive and sensitive Japanese expatriates living in Honolulu, Hawaii. In the Phase IA trial, 6 JRC non-sensitive subjects and 9 JRC and/or Mountain Cedar (MC) sensitive subjects were given 4 vaccine doses (each 4mg/1ml) intramuscularly (IM) at 14-day intervals. Nine JRC and/or MC sensitive subjects were given 4 doses (2 mg/0.5 ml) IM at 14-day intervals. The safety and functional biomarkers were followed for 132 d. Following this, 17 of 24 subjects were recruited into the IB trial and received one booster dose (2 mg/0.5 ml) IM approximately 300 d after the first vaccination dose to which they were randomized in the first phase of the trial. All safety endpoints were met and all subjects tolerated CryJ2-LAMP vaccinations well. At the end of the IA trial, 10 out of 12 JRC sensitive and 6 out of 11 MC sensitive subjects experienced skin test negative conversion, possibly related to the CryJ2-LAMP vaccinations. Collectively, these data suggested that the CryJ2-LAMP DNA vaccine is safe and may be immunologically effective in treating JRC induced allergy.

  9. Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

    PubMed

    Suzuki, Kazuyuki; Endo, Ryujin; Takikawa, Yasuhiro; Moriyasu, Fuminori; Aoyagi, Yutaka; Moriwaki, Hisataka; Terai, Shuji; Sakaida, Isao; Sakai, Yoshiyuki; Nishiguchi, Shuhei; Ishikawa, Toru; Takagi, Hitoshi; Naganuma, Atsushi; Genda, Takuya; Ichida, Takafumi; Takaguchi, Koichi; Miyazawa, Katsuhiko; Okita, Kiwamu

    2018-05-01

    The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia. © 2017 The Japan Society of Hepatology.

  10. Improved truck safety at traffic signals (phase A).

    DOT National Transportation Integrated Search

    2008-01-01

    This project is developing new traffic signal control logic to improve the safety of heavy vehicles on high speed approaches to signalized intersections using wireless communications between the heavy vehicle and the traffic signal controller. The pr...

  11. Classroom Goal Structures, Social Achievement Goals, and Adjustment in Middle School

    ERIC Educational Resources Information Center

    Shim, Sungok Serena; Cho, YoonJung; Wang, Cen

    2013-01-01

    The current study investigated the mediating role of social achievement goals in the relation between classroom goal structures and academic engagement and social adjustment among 373 middle school students (52.8% female). Students' perceptions of classroom goal structures were measured in Fall; social achievement goals and academic and social…

  12. National Dam Safety Program. Lipps Lake Dam (MO 30214). Mississippi - Kaskaskia - St. Louis Basin, Cape Girardeau County, Missouri. Phase I Inspection Report.

    DTIC Science & Technology

    1980-10-01

    AD-A105 988 HOSKINSEWESTERN-SONOER EGGER INC LINCOLN NEM F/S 13/13 NATIONAL DA -M SAFETY PROGRAM. LI PS LAKE DAM (MO 3021 ). MISS! SS7 - TC(U...COMPLETING FORM i. REPORT NUMBER 12. GOVT ACCESSION NO. 3. RECIPIENT’S CATALOG NIOMBER 4. TITLE (and Subtitle) 5. TYPE OF REPORT & PERIOD COVERED Phase I Dam

  13. CENTERLINE RUMBLE STRIPS SAFETY IMPACT EVALUATION—PHASE 2

    DOT National Transportation Integrated Search

    2018-02-02

    Centerline rumble strips are used by various states as a low-cost countermeasure for mitigating cross-over crashes on two-way highways. This study performs a safety impact evaluation using an empirical Bayesian analysis. The researchers obtained a cr...

  14. Emotional suppression during personal goal pursuit impedes goal strivings and achievement.

    PubMed

    Low, Rachel S T; Overall, Nickola C; Hammond, Matthew D; Girme, Yuthika U

    2017-03-01

    Prior research indicates that emotional suppression exacerbates distress and reduces cognitive performance and self-control. We extend this prior work in the current studies by examining whether emotional suppression in specific goal-relevant contexts impedes people's goal strivings and progress. In Study 1, participants (N = 146) provided reports every 2 weeks across a 2-month period reporting the degree to which they engaged in emotional suppression during goal pursuit and reported important goal-related outcomes, including depressed mood, perceived support/closeness, goal effort, goal-related competence, and goal success. In Study 2, participants reported on the degree to which they engaged in emotional suppression while discussing a personal goal with their romantic partner (N = 100 heterosexual couples) and reported on the same outcomes as in Study 1 prior to, immediately following, and then 1 month after couples' discussions. In both studies, greater use of emotional suppression predicted increased depressed mood, reduced perceived support/closeness, and reduced goal effort, competence, and success across time. Corroborating individuals' self-reports, participants who engaged in emotional suppression were also perceived by their partners to experience greater depressed mood and lower feelings of support and closeness, and be less competent with regard to their goal (Study 2). The effects of emotional suppression were robust when controlling for a range of alternative explanations. These goal hindering effects are likely one important reason emotional suppression is linked with poorer psychological and health outcomes and extend our understanding of the detrimental impact that emotional suppression can have in people's everyday lives. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  15. Safety evaluation of lane and shoulder width combinations on rural, two-lane, undivided roads

    DOT National Transportation Integrated Search

    2009-06-01

    The Federal Highway Administration (FHWA) organized a pooled fund study of 26 States to evaluate low-cost safety strategies as part of its strategic highway safety effort. The goal of this study is to evaluate the safety effectiveness of various lane...

  16. Establishing research priorities for patient safety in emergency medicine: a multidisciplinary consensus panel.

    PubMed

    Plint, Amy C; Stang, Antonia S; Calder, Lisa A

    2015-01-01

    Patient safety in the context of emergency medicine is a relatively new field of study. To date, no broad research agenda for patient safety in emergency medicine has been established. The objective of this study was to establish patient safety-related research priorities for emergency medicine. These priorities would provide a foundation for high-quality research, important direction to both researchers and health-care funders, and an essential step in improving health-care safety and patient outcomes in the high-risk emergency department (ED) setting. A four-phase consensus procedure with a multidisciplinary expert panel was organized to identify, assess, and agree on research priorities for patient safety in emergency medicine. The 19-member panel consisted of clinicians, administrators, and researchers from adult and pediatric emergency medicine, patient safety, pharmacy, and mental health; as well as representatives from patient safety organizations. In phase 1, we developed an initial list of potential research priorities by electronically surveying a purposeful and convenience sample of patient safety experts, ED clinicians, administrators, and researchers from across North America using contact lists from multiple organizations. We used simple content analysis to remove duplication and categorize the research priorities identified by survey respondents. Our expert panel reached consensus on a final list of research priorities through an in-person meeting (phase 3) and two rounds of a modified Delphi process (phases 2 and 4). After phases 1 and 2, 66 unique research priorities were identified for expert panel review. At the end of phase 4, consensus was reached for 15 research priorities. These priorities represent four themes: (1) methods to identify patient safety issues (five priorities), (2) understanding human and environmental factors related to patient safety (four priorities), (3) the patient perspective (one priority), and (4) interventions for

  17. A uniform transit safety records system for the Commonwealth of Virginia.

    DOT National Transportation Integrated Search

    1981-01-01

    This study was conceived as the first phase of a three-phase program to develop a safety data base for intracity bus transit. It involved reviewing the state of the art of general transportation safety management, examining the current intracity bus ...

  18. Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial.

    PubMed

    Nel, Annaléne; Martins, Janine; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

    2018-01-01

    Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides.

  19. Safety of a silicone elastomer vaginal ring as potential microbicide delivery method in African women: A Phase 1 randomized trial

    PubMed Central

    Nel, Annaléne; Bekker, Linda-Gail; Ramjee, Gita; Masenga, Gileard; Rees, Helen; van Niekerk, Neliëtte

    2018-01-01

    Background Women in sub-Saharan Africa are in urgent need of female-initiated human immunodeficiency virus (HIV) preventative methods. Vaginal rings are one dosage form in development for delivery of HIV microbicides. However, African women have limited experience with vaginal rings. Objectives This Phase I, randomized, crossover trial assessed and compared the safety, acceptability and adherence of a silicone elastomer placebo vaginal ring, intended as a microbicide delivery method, inserted for a 12-week period in healthy, HIV-negative, sexually active women in South Africa and Tanzania. Methods 170 women, aged 18 to 35 years were enrolled with 88 women randomized to Group A, using a placebo vaginal ring for 12 weeks followed by a 12-week safety observation period. 82 women were randomized to Group B and observed for safety first, followed by a placebo vaginal ring for 12 weeks. Safety was assessed by clinical laboratory assessments, pelvic/colposcopy examinations and adverse events. Possible carry-over effect was addressed by ensuring no signs or symptoms of genital irritation at crossover. Results No safety concerns were identified for any safety variables assessed during the trial. No serious adverse events were reported considered related to the placebo vaginal ring. Vaginal candidiasis was the most common adverse event occurring in 11% of participants during each trial period. Vaginal discharge (2%), vaginal odour (2%), and bacterial vaginitis (2%) were assessed as possibly or probably related to the vaginal ring. Thirty-four percent of participants had sexually transmitted infections (STIs) at screening, compared to 12% of participants who tested positive for STIs at crossover and the final trial visit. Three participants (2%) tested HIV positive during the trial. Conclusions The silicone elastomer vaginal ring had no safety concerns, demonstrating a profile favorable for further development for topical release of antiretroviral-based microbicides. PMID

  20. The Perception, Level of Safety Satisfaction and Safety Feedback on Occupational Safety and Health Management among Hospital Staff Nurses in Sabah State Health Department

    PubMed Central

    Cheah, Whye Lian; Giloi, Nelbon; Chang, Ching Thon; Lim, Jac Fang

    2012-01-01

    Background: This study aimed to determine the perception and level of safety satisfaction of staff nurses with regards to Occupational Safety and Health (OSH) management practice in the Sabah Health Department, and to associate the OSH management dimensions, to Safety Satisfaction and Safety Feedback. Methods: A cross-sectional study using a validated self-administered questionnaire was conducted among randomly respondents. Results: 135 nurses responded the survey. Mean (SD) score for each dimension ranged from 1.70 ± 0.68–4.04 ± 0.65, with Training and Competence dimension (mean [SD], 4.04 ± 0.65) had the highest while Safety Incidence was the least score (mean [SD], 1.70 ± 0.68). Both mean (SD) scores for Safety Satisfaction and Safety Feedback was high, 3.28 ± 0.51 and 3.57 ± 0.73, respectively. Pearson’s correlation analysis indicated that all OSH dimensions had significant correlation with Safety Satisfaction and Safety Feedback (r coefficient ranged from 0.176–0.512) except for Safety Incidence. Conclusion: The overall perception of OSH management was rather low. Significant correlation between Safety Satisfaction and Safety Feedback and several dimensions, suggest that each organization to put in place the leaders who have appropriate leadership and supervisory skills and committed in providing staff training to improve staff’s competency in OSH practice. In addition, clear goals, rules, and reporting system will help the organization to implement proper OSH management practice. PMID:23610550

  1. Preclinical study and phase I clinical safety evaluation of recombinant Mycobacterium tuberculosis ESAT6 protein.

    PubMed

    Du, Wei-Xin; Chen, Bao-Wen; Lu, Jin-Biao; Gao, Meng-Qiu; Shen, Xiao-Bing; Yang, Lei; Su, Cheng; Wang, Guo-Zhi; Sun, Qing-feng; Xu, Miao

    2013-05-15

    To investigate the ability of rESAT6 to identify different mycobacteria-sensitized guinea pigs and its safety in preclinical and phase I clinical study. Guinea pigs were sensitized with different Mycobacteria. After sensitization, all animals were intradermally injected with rESAT6 and either PPD or PPD-B. At 24 h after the injection, the erythema of the injection sites were measured using a double-blind method. For the preclinical safety study, different doses of rESAT6 and BSA were given 3 times intramuscularly to guinea pigs. On day 14 after the final immunization, the guinea pigs were intravenously injected with the same reagents in the hind legs and the allergic reactions were observed. A single-center, randomized, open phase I clinical trial was employed. The skin test was conducted in 32 healthy volunteers aged 19-65 years with 0.1 µg, 0.5 µg, and 1 µg rESAT6. Physical examination and laboratory tests were performed before and after the skin test and adverse reactions were monitored. The volunteers' local and systemic adverse reactions and adverse events were recorded for 7 days. Positive PPD or PPD-B skin tests were observed in all Mycobacteria-sensitized guinea pigs; the diameters of erythema were all >10 mm. The rESAT6 protein induced a positive skin test result in the guinea pigs sensitized with MTB, M. bovis, M. africanum and M. kansasii; the diameters of erythema were 14.7±2.0, 9.3±3.8, 18.7±2.4, and 14.8±4.2 mm, respectively. A negative skin test result was detected in BCG-vaccinated and other NTM-sensitized guinea pigs. The rESAT6 caused no allergic symptoms, but many allergic reactions, such as cough, dyspnea, and even death, were observed in the guinea pigs who were administered BSA. During the phase I clinical trial, no adverse reactions were found in the 0.1 µg rESAT6 group, but in the 0.5 µg rESAT6 group 2 volunteers reported pain and 1 reported itching, and in the 1 µg rESAT6 group there was 1 case of pain, 1 case of itching, and 1

  2. Safety interventions on the labor and delivery unit.

    PubMed

    Kacmar, Rachel M

    2017-06-01

    The present review highlights recent advances in efforts to improve patient safety on labor and delivery units and well tolerated care for pregnant patients in general. Recent studies in obstetric patient safety have a broad focus but repetitive themes for interdisciplinary training include: simulating critical events, having open multidisciplinary communication, frequent reviews of cases of maternal morbidity, and implementing maternal early warning systems. The National Partnership for Maternal Safety is also active in promoting care bundles across many topics on maternal safety. A culture of safety is the goal for all obstetric units. Achieving that ideal requires multidisciplinary collaboration, frequent reassessment for areas of improvement, and a culture of openness to change when improvement opportunities arise.

  3. Career Goals in Young Adults: Personal Resources, Goal Appraisals, Attitudes, and Goal Management Strategies

    ERIC Educational Resources Information Center

    Haratsis, Jessica M.; Hood, Michelle; Creed, Peter A.

    2015-01-01

    We tested a model based on the dual-process framework that assessed the relationships among personal resources, career goal appraisals, career attitudes, and career goal management, which have not been previously assessed together. The model (tested on a sample of 486 young adults: 74% female, M[subscript]age = 22 years) proposed that personal…

  4. Transsexualism and Flight Safety

    DTIC Science & Technology

    1987-05-08

    Security Classification) Transsexualism and Flight Safety 12. PERSONAL AUTHOR(S) Clements, Thomas I. and Wicks, Roland E. 13a. TYPE OF REPORT 13b. TIME... transsexual pilot with questionable judgment affecting flight safety is reported. The definition, etiology, and presenting symptoms are discussed. Three...involve all the phases of therapy and can be significant. Though the transsexual tends to have more episodes of anxiety and depression than the norm

  5. Developing safety performance measures for roundabout applications in the state of Oregon.

    DOT National Transportation Integrated Search

    2013-04-01

    This report documents the research effort to quantify the safety performance of roundabouts in the State of Oregon. : The primary goal of this research is to provide the Oregon Department of Transportation (ODOT) with safety : performance functions (...

  6. Analyzing Software Requirements Errors in Safety-Critical, Embedded Systems

    NASA Technical Reports Server (NTRS)

    Lutz, Robyn R.

    1993-01-01

    This paper analyzes the root causes of safety-related software errors in safety-critical, embedded systems. The results show that software errors identified as potentially hazardous to the system tend to be produced by different error mechanisms than non- safety-related software errors. Safety-related software errors are shown to arise most commonly from (1) discrepancies between the documented requirements specifications and the requirements needed for correct functioning of the system and (2) misunderstandings of the software's interface with the rest of the system. The paper uses these results to identify methods by which requirements errors can be prevented. The goal is to reduce safety-related software errors and to enhance the safety of complex, embedded systems.

  7. Users' participation in nursing care: an element of the Theory of Goal Attainment.

    PubMed

    da Silva, Rodrigo Nogueira; Ferreira, Márcia de Assunção

    2016-02-01

    Users' participation in care has been acknowledged as a key factor to improve health services. To analyze the Theory of Goal Attainment and to discuss the explicit and implicit relations between the Theory and the phenomenon of users' participation in nursing care. Theoretical analysis of the Theory of Goal Attainment. The analysis phase of the Framework for Analysis and Evaluation of Nursing Theories was applied. Then, the explicit and implicit relations between the Theory and the phenomenon of users' participation were analyzed. Users' participation in nursing care is an element of the Theory of Goal Attainment, although limited to the goal setting and the means to achieve them. The choice for users' participation in care is a right defended in health policies around the world. The Theory of Goal Attainment is an appropriate guide to nurses in defense of users' participation in nursing care.

  8. Sensor technology for hazardous cargo transportation safety.

    DOT National Transportation Integrated Search

    2013-08-01

    The overall goal of this research project was to develop oxidant vapor detection devices that can be : used to ensure the safety of hazardous freight transportation systems. Two nanotechnology-based : systems originally developed for improvised explo...

  9. The nonconscious cessation of goal pursuit: when goals and negative affect are coactivated.

    PubMed

    Aarts, Henk; Custers, Ruud; Holland, Rob W

    2007-02-01

    Extending on the recent investigation into the implicit affective processes underlying motivation and decision making, 5 studies examined the role of negative affect in moderating goal priming effects. Specifically, experimental effects on measures that typify motivational qualities of goal systems, such as keeping a goal at a heightened level of mental accessibility and exerting effort to work for a goal and experiencing desire to attain the goal, showed that the motivation and resultant operation of social goals cease when these goals are primed in temporal proximity of negatively valenced information. These goal cessation effects resulting from the mere coactivation of a goal and negative affect are discussed against the background of present research on nonconscious goal pursuit and the role of accessibility and desirability in the regulation of automatic goal-directed behavior. ((c) 2007 APA, all rights reserved).

  10. Goal-Directed and Goal-Less Imitation in Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Wild, Kelly S.; Poliakoff, Ellen; Jerrison, Andrew; Gowen, Emma

    2012-01-01

    To investigate how people with Autism are affected by the presence of goals during imitation, we conducted a study to measure movement kinematics and eye movements during the imitation of goal-directed and goal-less hand movements. Our results showed that a control group imitated changes in movement kinematics and increased the level that they…

  11. Evaluating the Cardiovascular Safety of Nonsteroidal Anti-Inflammatory Drugs.

    PubMed

    Antman, Elliott M

    2017-05-23

    Some drugs used to treat noncardiovascular conditions may adversely impact the cardiovascular status of individuals both with and without known cardiovascular disease. When the US Food and Drug Administration judges the potential cardiovascular safety signal to be of sufficient concern, it may require the pharmaceutical manufacturer of the drug in question to conduct a postmarketing (phase 4) randomized controlled trial (RCT). Although historically many phase 4 RCTs focused on efficacy (using a superiority design), contemporary phase 4 RCTs often are focused on safety and use a noninferiority design. The choices made by investigators during the planning stage of a postmarketing phase 4 RCT dedicated to the evaluation of cardiovascular safety can influence the ability to compare the standard and test agents. Multiple factors reflecting the conduct of a phase 4 RCT for a general medical condition may influence interpretation of a cardiovascular safety signal. The higher the rates of failure to adhere to the protocol and dropout from the study, the greater the risk of bias. Trials evaluating the cardiovascular safety of nonsteroidal anti-inflammatory drugs (NSAIDs) when used for arthritis are difficult to conduct and even more challenging to interpret. Concerns include the comparison of drug regimens that do not provide comparable analgesic efficacy and problems with adherence to the protocol and retention in the study. On the basis of phase 4 RCTs of NSAIDs to date, it appears that a comparatively low dose of celecoxib administered to low-risk subjects is associated with approximately the same cardiovascular risk as NSAIDs with less cyclooxygenase-2 inhibitory activity, but at the cost of not controlling arthritic pain as effectively. © 2017 American Heart Association, Inc.

  12. OECD/NEA expert group on uncertainty analysis for criticality safety assessment: Results of benchmark on sensitivity calculation (phase III)

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

    Ivanova, T.; Laville, C.; Dyrda, J.

    2012-07-01

    The sensitivities of the k{sub eff} eigenvalue to neutron cross sections have become commonly used in similarity studies and as part of the validation algorithm for criticality safety assessments. To test calculations of the sensitivity coefficients, a benchmark study (Phase III) has been established by the OECD-NEA/WPNCS/EG UACSA (Expert Group on Uncertainty Analysis for Criticality Safety Assessment). This paper presents some sensitivity results generated by the benchmark participants using various computational tools based upon different computational methods: SCALE/TSUNAMI-3D and -1D, MONK, APOLLO2-MORET 5, DRAGON-SUSD3D and MMKKENO. The study demonstrates the performance of the tools. It also illustrates how model simplificationsmore » impact the sensitivity results and demonstrates the importance of 'implicit' (self-shielding) sensitivities. This work has been a useful step towards verification of the existing and developed sensitivity analysis methods. (authors)« less

  13. National child safety seat distribution program evaluation

    DOT National Transportation Integrated Search

    1999-03-01

    The National Child Safety Seat Distribution Program (NCSS) was a multi-year, multi-phase program intended to distribute $8 million in child safety seats to low-income and special needs children in all fifty states. Non-profit organizations that recei...

  14. Academic goals in surgery.

    PubMed

    Bleier, Joshua I S; Kann, Brian

    2013-12-01

    The development of an academic surgical career can be an overwhelming prospect, and one that is not intuitive. Establishing a structured plan and support structure is critical to success. Starting a successful academic surgical career begins with defining one's academic goals within several broad categories: personal goals, academic goals, research goals, educational goals, and financial goals. Learning the art of self-promotion is the means by which many of these goals are achieved. It is important to realize that achieving these goals requires a delicate personal balance between work and home life, and the key ways in which to achieve success require establishment of well thought-out goals, a reliable support structure, realistic and clear expectations, and frequent re-evaluation.

  15. An irreplaceable safety culture.

    PubMed

    Render, Marta L; Hirschhorn, Larry

    2005-01-01

    Intensive care unit (ICU) clinicians are sources of errors and of resilience. When they learn how to juggle many competing goals, remain vigilant, and tell safety stories--all in the context of changing technologies and demand--they can create safe settings of care. Other strategies (eg, using computerized tools and implementing safety procedures) are important, but alone they are not sufficient. An ICU needs a safety culture that is rooted in a committed leadership, the acknowledgment that error is inevitable, a reporting system, and continuous learning. The all too common norm, "no harm no foul," is an obstacle. ICU leaders can use a campaign strategy to spread the safety practices that sustain a safety culture. They should attend to the political, marketing, and military aspects of such campaigns and recognize that people's time and attention are limited and built projects from existing ongoing pilots. Pilots can compete for people's attention; it has pull when it exemplifies a moral idea, simplifies work, and gives the health care professional more control and feedback. Under these conditions, the campaign will release individuals' passions and add energy and insight to the campaign itself.

  16. Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis.

    PubMed

    van de Kerkhof, Peter C M; Griffiths, Christopher E M; Reich, Kristian; Leonardi, Craig L; Blauvelt, Andrew; Tsai, Tsen-Fang; Gong, Yankun; Huang, Jiaqing; Papavassilis, Charis; Fox, Todd

    2016-07-01

    Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis. We reviewed safety data from the secukinumab psoriasis phase II/III program. Data were pooled from 10 phase II/III secukinumab psoriasis studies. Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). There was a limited number of patients in comparator groups and the exposure to placebo was short. Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  17. Goals of Care or Goals of Trust? How Family Members Perceive Goals for Dying Nursing Home Residents.

    PubMed

    Rosemond, Cherie; Hanson, Laura C; Zimmerman, Sheryl

    2017-04-01

    Dementia affects more than 5 million Americans, and is a leading cause of death. Family members of nursing home (NH) residents with advanced dementia report difficulty making decisions about care toward the end of life. As part of a randomized trial testing an intervention to improve decision making, this qualitative study aimed to understand how family decision makers experienced goal-based decision making in advance of the death of their relative. This qualitative study was conducted as part of the goals of care clinical trial. Study participants (n = 16) were family decision makers in North Carolina whose relative with advanced dementia died after participating in the goals of care intervention. Semi-structured interviews were analyzed using a qualitative description approach. Family members' experience of decision making and death differed based on the presence or absence of trusting relationships with NH staff. Family members who reported trust described a positive end-of-life experience and less need for prescribed goals of care discussions. In the absence of trust, family members reported that goals of care discussions were ignored by staff or created confusion. Among family members of persons who recently died from dementia in NHs, expressions of trust in staff were strongly related to perceptions of decision making about goals of care. Although goals of care discussions may potentially promote communication to earn trust, the presence of pre-existing trust ultimately influenced the decision making and end-of-life experiences of residents and families.

  18. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.

    PubMed

    O'Neil, Patrick M; Aroda, Vanita R; Astrup, Arne; Kushner, Robert; Lau, David C W; Wadden, Thomas A; Brett, Jason; Cancino, Ana-Paula; Wilding, John P H

    2017-11-01

    Liraglutide, a GLP-1 receptor agonist, regulates appetite via receptors in the brain. Because of concerns regarding the potential of centrally-acting anti-obesity medications to affect mental health, pooled neuropsychiatric safety data from all phase 2 and 3a randomized, double-blind trials with liraglutide 3.0 mg were evaluated post hoc. Data from the liraglutide weight-management programme were pooled. Across trials, individuals with a body mass index ≥30 or ≥27 kg/m 2 with weight-related comorbidities were randomized to once-daily subcutaneous liraglutide 3.0 mg (n = 3384) or placebo (n = 1941), both with a 500 kcal/d deficit diet, plus exercise. Adverse events related to neuropsychiatric safety were collected in all trials. Additionally, in the phase 3a trials, validated mental-health questionnaires were prospectively and systematically administered. In the pooled analysis of 5325 randomized and exposed individuals, rates of depression (2.1 vs 2.1 events/100 person-years) and anxiety (1.9 vs 1.7 events/100 person-years) through adverse event reporting were similarly low in liraglutide and placebo groups. Nine (0.3%) individuals receiving liraglutide and 2 (0.1%) receiving placebo reported adverse events of suicidal ideation or behaviour. In phase 3a trials, mean baseline Patient Health Questionnaire-9 scores of 2.8 ± 3.0 vs 2.9 ± 3.1 for liraglutide vs placebo improved to 1.8 ± 2.7 vs 1.9 ± 2.7, respectively, at treatment end; 34/3291 individuals (1.0%) receiving liraglutide 3.0 mg vs 19/1843 (1.0%) receiving placebo reported suicidal ideation on the Columbia-Suicide Severity Rating Scale. Results of this exploratory pooled analysis provide no cause for concern regarding the neuropsychiatric safety of treatment with liraglutide 3.0 mg in patients similar to those included in the examined trials. Although there was a small numerical imbalance in suicidal ideation with liraglutide through adverse event reporting, no

  19. Mars Observer: Phase 0 safety review data package

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The Mars Observer Program has as its primary objectives a study of the geochemistry, atmospheric dynamics, atmosphere/surface interactions, seasonal variations, and magnetic field characteristics of Mars. The Mars Observer Spacecraft, safety critical spacecraft subsystems, ground support equipment, ground operations scenario, requirements matrix, and equipment specifications are described.

  20. Setting quality and safety priorities in a target-rich environment: an academic medical center's challenge.

    PubMed

    Mort, Elizabeth A; Demehin, Akinluwa A; Marple, Keith B; McCullough, Kathryn Y; Meyer, Gregg S

    2013-08-01

    Hospitals are continually challenged to provide safer and higher-quality patient care despite resource constraints. With an ever-increasing range of quality and safety targets at the national, state, and local levels, prioritization is crucial in effective institutional quality goal setting and resource allocation.Organizational goal-setting theory is a performance improvement methodology with strong results across many industries. The authors describe a structured goal-setting process they have established at Massachusetts General Hospital for setting annual institutional quality and safety goals. Begun in 2008, this process has been conducted on an annual basis. Quality and safety data are gathered from many sources, both internal and external to the hospital. These data are collated and classified, and multiple approaches are used to identify the most pressing quality issues facing the institution. The conclusions are subject to stringent internal review, and then the top quality goals of the institution are chosen. Specific tactical initiatives and executive owners are assigned to each goal, and metrics are selected to track performance. A reporting tool based on these tactics and metrics is used to deliver progress updates to senior hospital leadership.The hospital has experienced excellent results and strong organizational buy-in using this effective, low-cost, and replicable goal-setting process. It has led to improvements in structural, process, and outcomes aspects of quality.

  1. Sounding rocket and balloon flight safety philosophy and methodologies

    NASA Technical Reports Server (NTRS)

    Beyma, R. J.

    1986-01-01

    NASA's sounding rocket and balloon goal is to successfully and safely perform scientific research. This is reflected in the design, planning, and conduct of sounding rocket and balloon operations. The purpose of this paper is to acquaint the sounding rocket and balloon scientific community with flight safety philosophy and methodologies, and how range safety affects their programs. This paper presents the flight safety philosophy for protecting the public against the risk created by the conduct of sounding rocket and balloon operations. The flight safety criteria used to implement this philosophy are defined and the methodologies used to calculate mission risk are described.

  2. Reduced Specificity of Personal Goals and Explanations for Goal Attainment in Major Depression

    PubMed Central

    Dickson, Joanne M.; Moberly, Nicholas J.

    2013-01-01

    Objectives Overgeneralization has been investigated across many domains of cognitive functioning in major depression, including the imagination of future events. However, it is unknown whether this phenomenon extends to representations of personal goals, which are important in structuring long-term behaviour and providing meaning in life. Furthermore, it is not clear whether depressed individuals provide less specific explanations for and against goal attainment. Method Clinically depressed individuals and controls generated personally important approach and avoidance goals, and then generated explanations why they would and would not achieve these goals. Goals and causal explanations were subsequently coded as either specific or general. Results Compared to controls, depressed individuals did not generate significantly fewer goals or causal explanations for or against goal attainment. However, compared to controls, depressed individuals generated less specific goals, less specific explanations for approach (but not avoidance) goal attainment, and less specific explanations for goal nonattainment. Significance Our results suggest that motivational deficits in depression may stem partly from a reduction in the specificity of personal goal representations and related cognitions that support goal-directed behaviour. Importantly, the findings have the potential to inform the ongoing development of psychotherapeutic approaches in the treatment of depression. PMID:23691238

  3. Nuclear safety for the space exploration initiative

    NASA Technical Reports Server (NTRS)

    Dix, Terry E.

    1991-01-01

    The results of a study to identify potential hazards arising from nuclear reactor power systems for use on the lunar and Martian surfaces, related safety issues, and resolutions of such issues by system design changes, operating procedures, and other means are presented. All safety aspects of nuclear reactor power systems from prelaunch ground handling to eventual disposal were examined consistent with the level of detail for SP-100 reactor design at the 1988 System Design Review and for launch vehicle and space transport vehicle designs and mission descriptions as defined in the 90-day Space Exploration Initiative (SEI) study. Information from previous aerospace nuclear safety studies was used where appropriate. Safety requirements for the SP-100 space nuclear reactor system were compiled. Mission profiles were defined with emphasis on activities after low earth orbit insertion. Accident scenarios were then qualitatively defined for each mission phase. Safety issues were identified for all mission phases with the aid of simplified event trees. Safety issue resolution approaches of the SP-100 program were compiled. Resolution approaches for those safety issues not covered by the SP-100 program were identified. Additionally, the resolution approaches of the SP-100 program were examined in light of the moon and Mars missions.

  4. What barriers thwart postpartum women's physical activity goals during a 12-month intervention? A process evaluation of the Nā Mikimiki Project.

    PubMed

    Albright, Cheryl L; Saiki, Kara; Steffen, Alana D; Woekel, Erica

    2015-01-01

    Approximately 70% of new mothers do not meet national guidelines for moderate-to-vigorous physical activity (MVPA). The Nā Mikimiki ("the active ones") Project (2008-2011) was designed to increase MVPA among women with infants 2-12 months old. Participants' barriers to exercising and achievement of specific MVPA goals were discussed during telephone counseling calls over 12 months. Healthy, inactive women (n = 115, mean age = 31 ± 5 years, infants' mean age = 5.5 ± 3 months; 80% racial/ethnic minorities) received a total of 17 calls over 12 months in three phases. During Phase 1 weekly calls were made for a month, in Phase 2 biweekly calls were made for 2 months, and in Phase 3 monthly calls were made for 9 months. Across all phases, the most frequent barriers to achieving MVPA goals were: time/too busy (25%), sick child (11%), and illness (10%). Goals for MVPA minutes per week were achieved or surpassed 40.6% of the time during weekly calls, 39.9% during biweekly calls, and 42.0% during monthly calls. The least likely MVPA goals to be achieved (p < 0.04) were those which the woman encountered and for which she failed to overcome the barriers she had previously anticipated would impair her improvement of MVPA. This process evaluation demonstrated that telephone counseling somewhat facilitated the resolution of barriers and achievement of MVPA goals; thus, if clinical settings adopted such methods, chronic disease risks could be reduced in this vulnerable population of new mothers.

  5. Safety evaluation of curve warning speed signs.

    DOT National Transportation Integrated Search

    2011-06-01

    This report presents a review of a research effort to evaluate the safety implications of advisory speeds at horizontal curve locations on Oregon rural two-lane highways. The primary goals of this research effort were to characterize driving operatio...

  6. Safety assessment in plant layout design using indexing approach: implementing inherent safety perspective. Part 1 - guideword applicability and method description.

    PubMed

    Tugnoli, Alessandro; Khan, Faisal; Amyotte, Paul; Cozzani, Valerio

    2008-12-15

    Layout planning plays a key role in the inherent safety performance of process plants since this design feature controls the possibility of accidental chain-events and the magnitude of possible consequences. A lack of suitable methods to promote the effective implementation of inherent safety in layout design calls for the development of new techniques and methods. In the present paper, a safety assessment approach suitable for layout design in the critical early phase is proposed. The concept of inherent safety is implemented within this safety assessment; the approach is based on an integrated assessment of inherent safety guideword applicability within the constraints typically present in layout design. Application of these guidewords is evaluated along with unit hazards and control devices to quantitatively map the safety performance of different layout options. Moreover, the economic aspects related to safety and inherent safety are evaluated by the method. Specific sub-indices are developed within the integrated safety assessment system to analyze and quantify the hazard related to domino effects. The proposed approach is quick in application, auditable and shares a common framework applicable in other phases of the design lifecycle (e.g. process design). The present work is divided in two parts: Part 1 (current paper) presents the application of inherent safety guidelines in layout design and the index method for safety assessment; Part 2 (accompanying paper) describes the domino hazard sub-index and demonstrates the proposed approach with a case study, thus evidencing the introduction of inherent safety features in layout design.

  7. Goals and everyday problem solving: manipulating goal preferences in young and older adults.

    PubMed

    Hoppmann, Christiane A; Blanchard-Fields, Fredda

    2010-11-01

    In the present study, we examined the link between goal and problem-solving strategy preferences in 130 young and older adults using hypothetical family problem vignettes. At baseline, young adults preferred autonomy goals, whereas older adults preferred generative goals. Imagining an expanded future time perspective led older adults to show preferences for autonomy goals similar to those observed in young adults but did not eliminate age differences in generative goals. Autonomy goals were associated with more self-focused instrumental problem solving, whereas generative goals were related to more other-focused instrumental problem solving in the no-instruction and instruction conditions. Older adults were better at matching their strategies to their goals than young adults were. This suggests that older adults may become better at selecting their strategies in accordance with their goals. Our findings speak to a contextual approach to everyday problem solving by showing that goals are associated with the selection of problem-solving strategies.

  8. Safety and tolerability of the γ-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease.

    PubMed

    Coric, Vladimir; van Dyck, Christopher H; Salloway, Stephen; Andreasen, Niels; Brody, Mark; Richter, Ralph W; Soininen, Hilkka; Thein, Stephen; Shiovitz, Thomas; Pilcher, Gary; Colby, Susan; Rollin, Linda; Dockens, Randy; Pachai, Chahin; Portelius, Erik; Andreasson, Ulf; Blennow, Kaj; Soares, Holly; Albright, Charles; Feldman, Howard H; Berman, Robert M

    2012-11-01

    To assess the safety, tolerability, and pharmacokinetic and pharmacodynamic effects of the -secretase inhibitor avagacestat in patients with mild to moderate Alzheimer disease (AD). Randomized, double-blind, placebo-controlled,24-week phase 2 study. Global, multicenter trial. A total of 209 outpatients with mild to moderate AD were randomized into the double-blind treatment phase. The median age of the patients was 75 years,58.9% were APOE ε4 carriers, and baseline measures of disease severity were similar among groups. Avagacestat, 25, 50, 100, or 125 mg daily,or placebo administered orally daily. Safety and tolerability of avagacestat. Discontinuation rates for the 25-mg and 50-mg doses of avagacestat were comparable with placebo but were higher in the 100-mg and 125-mg dose groups.Trends for worsening cognition, as measured by change from baseline Alzheimer Disease Assessment Scale cognitive subscale score, were observed in the 100-mg and125-mg dose groups. Treatment-emergent serious adverse events were similar across placebo and treatment groups. The most common reason for discontinuation was adverse events, predominantly gastrointestinal anddermatologic. Other adverse events occurring more frequentlyin patients undergoing treatment included reversibleglycosuria (without associated serum glucose changes), nonmelanoma skin cancer, and asymptomaticmagnetic resonance imaging findings. Exploratory cerebrospinal fluid amyloid isoforms and tau biomarker analysis demonstrated dose-dependent but not statistically significant reductions in a small subset of patients. Avagacestat dosed at 25 and 50 mg daily was relatively well tolerated and had low discontinuation rates. The 100-mg and 125-mg dose arms were poorly tolerated with trends for cognitive worsening. Exploratory cerebrospinal fluid biomarker substudies provide preliminary support for -secretase target engagement,but additional studies are warranted to better characterize pharmacodynamic effects at the 25- and

  9. Psychological "gel" to bind individuals' goal pursuit: gratitude facilitates goal contagion.

    PubMed

    Jia, Lile; Tong, Eddie M W; Lee, Li Neng

    2014-08-01

    Past research demonstrates that gratitude affects individuals' self-regulation of behavior primarily through engendering a prosocial tendency. Based on theories proposing that gratitude plays an unique role in fostering communal relationship (e.g., Algoe, 2012), we propose that gratitude can have an incidental effect in facilitating goal contagion: automatically inferring and adopting the goal implied by a social other's behavior. This hypothesis is supported in 3 studies. In Study 1, after being exposed to the behaviors of a social target that implied either a cooperative or a competitive goal, individuals adopted the respective goal and behaved accordingly in a Resource Dilemma Task. This occurred, however, only when they were feeling gratitude and not when they were feeling joy or a neutral mood. In Study 2, after being exposed to a social target's behavior that implied the goal to make money, people feeling gratitude, as compared to those feeling pride or a neutral mood, strove for a future opportunity to earn money. Study 3 further demonstrated that individuals' goal striving behavior was mediated by a heightened level of goal activation. Finally, it was found that gratitude facilitated goal contagion only when the social target was a member of participants' own social group. Through this mechanism, gratitude, thus, seems to bind one's self-regulation with those of social others. Theoretical and practical implications of this new perspective are discussed.

  10. A TIERED APPROACH TO LIFE STAGES TESTING FOR AGRICULTURAL CHEMICAL SAFETY ASSESSMENT

    EPA Science Inventory

    A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studie...

  11. Safety Studies for Use of Adipose Tissue‐Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial

    PubMed Central

    Riester, Scott M.; Denbeigh, Janet M.; Lin, Yang; Jones, Dakota L.; de Mooij, Tristan; Lewallen, Eric A.; Nie, Hai; Paradise, Christopher R.; Radel, Darcie J.; Dudakovic, Amel; Camilleri, Emily T.; Larson, Dirk R.; Qu, Wenchun; Krych, Aaron J.; Frick, Matthew A.; Im, Hee‐Jeong; Dietz, Allan B.; Smith, Jay

    2016-01-01

    Abstract Adipose‐derived mesenchymal stem cells (AMSCs) offer potential as a therapeutic option for clinical applications in musculoskeletal regenerative medicine because of their immunomodulatory functions and capacity for trilineage differentiation. In preparation for a phase I clinical trial using AMSCs to treat patients with osteoarthritis, we carried out preclinical studies to assess the safety of human AMSCs within the intra‐articular joint space. Culture‐expanded human AMSCs grown in human platelet‐lysate were delivered via intra‐articular injections into normal healthy rabbit knees and knees at risk for the development of osteoarthritis after bilateral medial anterior hemimeniscectomy. Treatment outcomes and safety were evaluated by assessing the general health, function, and behavior of the animals. Joint tissues were analyzed by x‐ray, magnetic resonance imaging, and histopathology. Intra‐articular AMSC therapy was well tolerated in this study. We did not observe adverse systemic reactions, nor did we find evidence of damage to intra‐articular joint tissues. Thus, the data generated in this study show a favorable safety profile for AMSCs within the joint space in support of a phase I clinical trial evaluating the clinical utility of AMSCs to treat osteoarthritis. Stem Cells Translational Medicine 2017;6:910–922 PMID:28297568

  12. Achievement goals, self-handicapping, and performance: a 2 x 2 achievement goal perspective.

    PubMed

    Ntoumanis, Nikos; Thøgersen-Ntoumani, Cecilie; Smith, Alison L

    2009-11-01

    Elliot and colleagues (2006) examined the effects of experimentally induced achievement goals, proposed by the trichotomous model, on self-handicapping and performance in physical education. Our study replicated and extended the work of Elliot et al. by experimentally promoting all four goals proposed by the 2 x 2 model (Elliot & McGregor, 2001), measuring the participants' own situational achievement goals, using a relatively novel task, and testing the participants in a group setting. We used a randomized experimental design with four conditions that aimed to induce one of the four goals advanced by the 2 x 2 model. The participants (n = 138) were undergraduates who engaged in a dart-throwing task. The results pertaining to self-handicapping partly replicated Elliot and colleagues' findings by showing that experimentally promoted performance-avoidance goals resulted in less practice. In contrast, the promotion of mastery-avoidance goals did not result in less practice compared with either of the approach goals. Dart-throwing performance did not differ among the four goal conditions. Personal achievement goals did not moderate the effects of experimentally induced goals on self-handicapping and performance. The extent to which mastery-avoidance goals are maladaptive is discussed, as well as the interplay between personal and experimentally induced goals.

  13. Towards patient safety in anaesthesia.

    PubMed

    Cooper, J B

    1994-07-01

    The anaesthesia specialty has focused on the safety of the patient and examination of untoward outcomes. Serious injuries are now rare in medically advanced countries. Still, anaesthesia deaths and complications are important because the anaesthetic itself has no intended therapeutic effect. Safety is a never-ending battle that requires continued effort because many forces have the potential to diminish whatever progress is made. This paper describes the modern movement in anaesthesia patient safety--the reasons it started, the major foci and explanations for why anaesthesia seems now to be safer than at any time in history. The American legal system, critical incident studies, studies of malpractice claims and large-scale studies of anaesthesia outcomes played a role in increasing the awareness of the need to enhance anaesthesia safety. Many efforts are believed to have contributed to improvements in the safety of anaesthesia: improved training of anaesthesia clinicians, new pharmaceuticals, new technologies for monitoring (especially pulse oximetry and capnography), standards for monitoring and other aspects of anaesthesia care, safety enhancements in anaesthesia equipment and the implementation of quality assurance and risk management programmes. The creation of the Anesthesia Patient Safety Foundation in the United States and a similar organization in Australia have helped to bring about awareness of safety issues and to support study of patient safety. Ultimately, the motto of the Anesthesia Patient Safety Foundation should be the goal of all anaesthesia professionals: "That no patient shall be harmed by anaesthesia".

  14. The business case for patient safety.

    PubMed

    Hwang, Raymond W; Herndon, James H

    2007-04-01

    Recent trends have focused attention on improving patient safety in the United States healthcare system. Lapses in patient safety create undue, often preventable, morbidity. These include adverse drug events, adverse surgical events and nosocomial infections. From an organizational perspective, these events are both inefficient and expensive. Many safe practices and quality enhancing improvements, such as computer provider order entry, proper infection surveillance, telemedicine intensive care, and registered nurse staffing are in fact cost-effective. However, in order to fully achieve higher quality, better adverse event reporting and a culture of safety must first be developed. Increased provider recognition, models of success, public awareness and consumer demand are propelling improvements. As we will outline in this review of the current literature, the business case for patient safety is a compelling one, offering substantial economic incentives for achieving the necessary goal of improved patient outcomes.

  15. Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

    PubMed

    Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

    2017-08-30

    Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

  16. Research Needs in Fire Safety for the Human Exploration and Utilization of Space

    NASA Technical Reports Server (NTRS)

    Ruff, Gary A.

    2003-01-01

    This viewgraph presentation provides information on developments in spacecraft fire safety research. The presentation includes an overview of the previous Spacecraft Fire Safety Workshop, from 1986, and the influences since then of bioastronautics on combustion science and fire safety. The presentation then gives of overview of the current conference, stating goals and giving a schedule.

  17. STS safety approval process for small self-contained payloads

    NASA Technical Reports Server (NTRS)

    Gum, Mary A.

    1988-01-01

    The safety approval process established by the National Aeronautics and Space Administration for Get Away Special (GAS) payloads is described. Although the designing organization is ultimately responsible for the safe operation of its payload, the Get Away Special team at the Goddard Space Flight Center will act as advisors while iterative safety analyses are performed and the Safety Data Package inputs are submitted. This four phase communications process will ultimately give NASA confidence that the GAS payload is safe, and successful completion of the Phase 3 package and review will clear the way for flight aboard the Space Transportation System orbiter.

  18. Efficacy and safety of intravenous belimumab in Japanese patients with systemic lupus erythematosus: a subgroup analysis of a Phase 3 randomized placebo-controlled trial.

    PubMed

    Tanaka, Yoshiya; Bass, Damon; Chu, Myron; Egginton, Sally; Ji, Beulah; Struemper, Herbert; Roth, David

    2018-05-24

    To assess the efficacy and safety of intravenous belimumab plus standard systemic lupus erythematosus (SLE) therapy (SoC) in Japanese patients with SLE. A Phase 3, multicenter, double-blind, placebo-controlled, 52-week study (BEL 113750; NCT01345253) in patients with SLE, randomized 2:1 to belimumab 10 mg/kg plus SoC or placebo plus SoC to Week 48. Sixty of 707 randomized patients were enrolled from study centers in Japan (belimumab, n = 39; placebo, n = 21). In this cohort, more patients achieved SLE Responder Index 4 response at Week 52 in the belimumab group compared with placebo (46.2% [18/39] vs 25.0% [5/20]; odds ratio, 2.57 [95% confidence interval: 0.78, 8.47]; p = 0.1204). Fewer patients receiving belimumab experienced a severe flare through Week 52, with longer median time to flare compared with placebo. More patients with baseline prednisone dose >7.5 mg/day receiving belimumab had a dose reduction of ≥25% from baseline to ≤7.5 mg/day during Weeks 40 to 52, compared with placebo. No new safety issues were identified within the Japanese cohort. In Japanese patients with SLE, belimumab improved disease activity, with efficacy and safety results similar and consistent to the pivotal Phase 3 trials, suggesting that belimumab is a potential treatment option in this population.

  19. Goal setting.

    PubMed

    Levin, Roger P

    2003-11-01

    I would not tell any individual what his or her goals should be or what the picture of one's life should look like. I strongly believe in human potential, and I love to see people achieve more of the things that are important to them. The Goal Curves exercise is probably one of the most powerful methodologies used to help individuals get the most out of their lives while enjoying every day; this exercise leads to much greater individual success. However, for it to be effective, one needs to develop his or her goals and then review and act on them on a regular basis.

  20. Goal Orientations of General Chemistry Students via the Achievement Goal Framework

    ERIC Educational Resources Information Center

    Lewis, Scott E.

    2018-01-01

    The Achievement Goal Framework describes students' goal orientations as: task-based, focusing on the successful completion of the task; self-based, evaluating performance relative to one's own past performance; or other-based, evaluating performance relative to the performance of others. Goal orientations have been used to explain student success…

  1. Goal Setting in Principal Evaluation: Goal Quality and Predictors of Achievement

    ERIC Educational Resources Information Center

    Sinnema, Claire E. L.; Robinson, Viviane M. J.

    2012-01-01

    This article draws on goal-setting theory to investigate the goals set by experienced principals during their performance evaluations. While most goals were about teaching and learning, they tended to be vaguely expressed and only partially achieved. Five predictors (commitment, challenge, learning, effort, and support) explained a significant…

  2. Renovating and Reconstructing in Phases--Specifying Phased Construction.

    ERIC Educational Resources Information Center

    Bunzick, John

    2002-01-01

    Discusses planning for phased school construction projects, including effects on occupancy (for example, construction adjacent to occupied space, construction procedure safety zones near occupied areas, and code-complying means of egress), effects on building systems (such as heating and cooling equipment and power distribution), and contract…

  3. Implementation of a patient safety program at a tertiary health system: A longitudinal analysis of interventions and serious safety events.

    PubMed

    Cropper, Douglas P; Harb, Nidal H; Said, Patricia A; Lemke, Jon H; Shammas, Nicolas W

    2018-04-01

    We hypothesize that implementation of a safety program based on high reliability organization principles will reduce serious safety events (SSE). The safety program focused on 7 essential elements: (a) safety rounding, (b) safety oversight teams, (c) safety huddles, (d) safety coaches, (e) good catches/safety heroes, (f) safety education, and (g) red rule. An educational curriculum was implemented focusing on changing high-risk behaviors and implementing critical safety policies. All unusual occurrences were captured in the Midas system and investigated by risk specialists, the safety officer, and the chief medical officer. A multidepartmental committee evaluated these events, and a root cause analysis (RCA) was performed. Events were tabulated and serious safety event (SSE) recorded and plotted over time. Safety success stories (SSSs) were also evaluated over time. A steady drop in SSEs was seen over 9 years. Also a rise in SSSs was evident, reflecting on staff engagement in the program. The parallel change in SSEs, SSSs, and the implementation of various safety interventions highly suggest that the program was successful in achieving its goals. A safety program based on high-reliability organization principles and made a core value of the institution can have a significant positive impact on reducing SSEs. © 2018 American Society for Healthcare Risk Management of the American Hospital Association.

  4. Goal-directed visual attention drives health goal priming: An eye-tracking experiment.

    PubMed

    van der Laan, Laura N; Papies, Esther K; Hooge, Ignace T C; Smeets, Paul A M

    2017-01-01

    Several lab and field experiments have shown that goal priming interventions can be highly effective in promoting healthy food choices. Less is known, however, about the mechanisms by which goal priming affects food choice. This experiment tested the hypothesis that goal priming affects food choices through changes in visual attention. Specifically, it was hypothesized that priming with the dieting goal steers attention toward goal-relevant, low energy food products, which, in turn, increases the likelihood of choosing these products. In this eye-tracking experiment, 125 participants chose between high and low energy food products in a realistic online supermarket task while their eye movements were recorded with an eye-tracker. One group was primed with a health and dieting goal, a second group was exposed to a control prime, and a third group was exposed to no prime at all. The health goal prime increased low energy food choices and decreased high energy food choices. Furthermore, the health goal prime resulted in proportionally longer total dwell times on low energy food products, and this effect mediated the goal priming effect on choices. The findings suggest that the effect of priming on consumer choice may originate from an increase in attention for prime-congruent items. This study supports the effectiveness of health goal priming interventions in promoting healthy eating and opens up directions for research on other behavioral interventions that steer attention toward healthy foods. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  5. Measuring and improving patient safety through health information technology: The Health IT Safety Framework

    PubMed Central

    Singh, Hardeep

    2016-01-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

  6. Improving patient safety culture in general practice: an interview study

    PubMed Central

    Verbakel, Natasha J; de Bont, Antoinette A; Verheij, Theo JM; Wagner, Cordula; Zwart, Dorien LM

    2015-01-01

    Background When improving patient safety a positive safety culture is key. As little is known about improving patient safety culture in primary care, this study examined whether administering a culture questionnaire with or without a complementary workshop could be used as an intervention for improving safety culture. Aim To gain insight into how two interventions affected patient safety culture in everyday practice. Design and setting After conducting a randomised control trial of two interventions, this was a qualitative study conducted in 30 general practices to aid interpretation of the previous quantitative findings. Method Interviews were conducted at practice locations (n = 27) with 24 GPs and 24 practice nurses. The theory of communities of practice — in particular, its concepts of a domain, a community, and a practice — was used to interpret the findings by examining which elements were or were not present in the participating practices. Results Communal awareness of the problem was only raised after getting together and discussing patient safety. The combination of a questionnaire and workshop enhanced the interaction of team members and nourished team feelings. This shared experience also helped them to understand and develop tools and language for daily practice. Conclusion In order for patient safety culture to improve, the safety culture questionnaire was more successful when accompanied by a practice workshop. Initial discussion and negotiation of shared goals during the workshop fuelled feelings of coherence and belonging to a community wishing to learn about enhancing patient safety. Team meetings and day-to-day interactions enhanced further liaison and sharing, making patient safety a common and conscious goal. PMID:26622035

  7. National Dam Safety Program. Lakeview Estates Dam (MO 11004), Mississippi - Kaskaskia - St. Louis Basin, Warren County, Missouri. Phase I Inspection Report.

    DTIC Science & Technology

    1979-09-01

    ificatiozh Distributon/ Availabilit oe LAKEVIEW ESTATES DAM WARREN COUNTY, MISSOURI MISSOURI INVENTORY NO. 11004 PHASE I INSPECTION REPORT NATIONAL DAM SAFETY...and *impounds less than 1,000 acre-feet of water . Our inspection and evaluation indicates that the spill- way of Lakeview Estates Dam does not meet...not be measured because of high reservoir level, scalloping near the crest and a berm just under the water surface. Limestone riprap in sizes from sand

  8. Achieving compatibility of state and federal safety requirements : a report to the Secretary of Transportation.

    DOT National Transportation Integrated Search

    1990-08-01

    The Commercial Motor Vehicle Safety Regulatory Review Panel (Safety : Panel) has prepared this report in response to Sections 207, 208, and 209 of : the Motor Carrier Safety Act of 1984 (Public Law 98-554). A major goal of the : 1984 Act was to achie...

  9. Pharmacological mechanism-based drug safety assessment and prediction.

    PubMed

    Abernethy, D R; Woodcock, J; Lesko, L J

    2011-06-01

    Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

  10. Aviation safety/automation program overview

    NASA Technical Reports Server (NTRS)

    Morello, Samuel A.

    1990-01-01

    The goal is to provide a technology base leading to improved safety of the national airspace system through the development and integration of human-centered automation technologies for aircraft crews and air traffic controllers. Information on the problems, specific objectives, human-automation interaction, intelligent error-tolerant systems, and air traffic control/cockpit integration is given in viewgraph form.

  11. Safety and immunogenicity of a live attenuated mumps vaccine: a phase I clinical trial.

    PubMed

    Liang, Yan; Ma, Jingchen; Li, Changgui; Chen, Yuguo; Liu, Longding; Liao, Yun; Zhang, Ying; Jiang, Li; Wang, Xuan-Yi; Che, Yanchun; Deng, Wei; Li, Hong; Cui, Xiaoyu; Ma, Na; Ding, Dong; Xie, Zhongping; Cui, Pingfang; Ji, Qiuyan; Wang, JingJing; Zhao, Yuliang; Wang, Junzhi; Li, Qihan

    2014-01-01

    Mumps, a communicable, acute and previously well-controlled disease, has had recent and occasional resurgences in some areas. A randomized, double-blind, controlled and multistep phase I study of an F-genotype attenuated mumps vaccine produced in human diploid cells was conducted. A total of 300 subjects were enrolled and divided into 4 age groups: 16-60 years, 5-16 years, 2-5 years and 8-24 months. The groups were immunized with one injection per subject. Three different doses of the F-genotype attenuated mumps vaccine, A (3.5 ± 0.25 logCCID50), B (4.25 ± 0.25 logCCID50) and C (5.0 ± 0.25 logCCID50), as well as a placebo control and a positive control of a licensed A-genotype vaccine (S79 strain) were used. The safety and immunogenicity of this vaccine were compared with those of the controls. The safety evaluation suggested that mild adverse reactions were observed in all groups. No serious adverse event (SAE) was reported throughout the trial. The immunogenicity test showed a similar seroconversion rate of the neutralizing and ELISA antibody in the 2- to 5-year-old and 8- to 24-month-old groups compared with the seroconversion rate in the positive control. The GMT of the neutralizing anti-F-genotype virus antibodies in the vaccine groups was slightly higher than that in the positive control group. The F-genotype attenuated mumps vaccine evaluated in this clinical trial was demonstrated to be safe and have effective immunogenicity vs. control.

  12. [Power of personal goal sharing--treatment plan using personal goal maps for patients with mental disorders].

    PubMed

    Zhao, Yueren

    2011-01-01

    , which help us along the Trust Path. The more patients and staff trust and understand each other the easier it is to climb up the Initial Treatment Path. We need to build up trustful relations so we can share personal goals and make a proper assessment and diagnosis, and talk about the safety, efficacy, cost and suitability of the initial treatment. Secondly, we need to take a rest and make more plans for the Recovery Path. It is on this path that we decide on comprehensive treatment together. We may be able to improve the patient's cognitive functions by using atypical anti-psychotic agents. We can then give them information, instructions and warnings about medicine usage so the patient is able to understand their condition. It is only after the patient can understand these things fully and act positively that we can start to climb the final path, the Achievement Path. We should review the suitability and efficacy of the treatment again, and it is at this stage that the mountain guide steps back and watches the mountain climber take the final steps towards the mountain peak goal. Lastly, the patient will feel elation and a sense of fulfillment and self-pride, and no doubt will be ready to look for the next mountain peak to climb. In order for you to enjoy the benefits at the clinical scene, all you need is a piece of paper, a pen, and a limitless imagination for better personal goal sharing. At Meisei hospital we promote the 'Minotake Team Approach', which calls for flexible management so we hospital staff can help each other as professionals. We treat patients as individuals using words and expressions they understand (such as local dialect and nonmedical terms), and give them access to easy to understand resources such as leaflets delivered by universities or pharmaceutical companies. We ask our staff to act naturally with the patients, and to just do what they can do to help the patients work towards their personal goals.

  13. Development of a highway incident management operational and training guide : phase II.

    DOT National Transportation Integrated Search

    2014-08-01

    The overall goal of both phases of this project was to reduce responder fatalities and injuries, as well as to prevent : secondary crashes, especially those involving incident responders. The phases of this project worked toward this goal : by creati...

  14. Applying successfully proven measures in roadway safety to reduce harmful collisions in SC.

    DOT National Transportation Integrated Search

    2017-06-06

    The overall goal of this research was to identify proven successful safety programs used in other states and assess the potential for safety improvement if similar programs were implemented in South Carolina. The research team not only sought out eng...

  15. Safety Effectiveness of Regulatory Headlight Signs in Wyoming - Phase 1 : Interim Report - Phase 2

    DOT National Transportation Integrated Search

    2016-01-01

    Although Daytime Running Lights (DRLs) may have a significant impact on increasing vehicle conspicuity during different times of the day, their effect on overall safety is still up for debate. A recent study by the U.S. Department of Transportation (...

  16. Super Safety and Health Day at KSC

    NASA Technical Reports Server (NTRS)

    2000-01-01

    During Super Safety and Health Day at KSC, two employees were recognized for submitting winning entries in the theme and logo/poster contests. At left, Center Director Roy Bridges congratulates Dave Earhart with United Space Alliance (USA) for his winning logo; at right, Brig. Gen. Ronald D. Pettit congratulates David Koval with Space Gateway Support (SGS) for his winning theme, '''Safety and Health: A Working Relationship.''' Safety Day is a full day of NASA-sponsored, KSC and 45th Space Wing events involving a number of health and safety related activities: Displays, vendors, technical paper sessions, panel discussions, a keynote speaker, etc. The entire Center and Wing stand down to participate in the planned events. Safety Day is held annually to proactively increase awareness in safety and health among the government and contractor workforce population. The first guiding principle at KSC is '''Safety and Health First.''' KSC's number one goal is to '''Assure sound, safe and efficient practices and processes are in place for privatized/commercialized launch site processing.'''

  17. Improving tractor safety warnings: readability is missing.

    PubMed

    Tebeaux, E

    2010-07-01

    Research on tractor safety has not focused on user manuals. This study focuses on tractor operator manuals, specifically safety warnings, selected from the files of the Tractor Test facility at University of Nebraska-Lincoln. Analysis of many common warnings, based on readability and legibility research, shows that many warnings contain excessive information, confusing visuals and safety icons, poor document design, and illegible typefaces. The result is unreadable warnings that do not communicate quickly and correctly, and discourage readers rather than clarify critical information. Many tractor operator warnings are cluttered, "over-written," and contain information needed to protect the manufacturer rather than to inform operators. What is needed is a careful analysis and revision of many safety warnings with the goal of encouraging operators to read the warnings and follow their message.

  18. Longterm Safety and Efficacy of Subcutaneous Abatacept in Patients with Rheumatoid Arthritis: 5-year Results from a Phase IIIb Trial.

    PubMed

    Genovese, Mark C; Pacheco-Tena, César; Covarrubias, Arturo; Leon, Gustavo; Mysler, Eduardo; Keiserman, Mauro; Valente, Robert M; Nash, Peter; Simon-Campos, J Abraham; Box, Jane; Legerton, Clarence W; Nasonov, Evgeny; Durez, Patrick; Elegbe, Ayanbola; Wong, Robert; Li, Xiaohui; Banerjee, Subhashis; Alten, Rieke

    2018-04-15

    To assess 5-year safety, tolerability, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate (MTX)-refractory patients with rheumatoid arthritis (RA). The Abatacept Comparison of sub[QU]cutaneous versus intravenous in Inadequate Responders to methotrexatE (ACQUIRE) phase IIIb, randomized, double-dummy, multinational trial compared efficacy and safety of SC and intravenous (IV) ABA in patients with RA. In the initial 6-month double-blind (DB) period, patients received IV or SC ABA, plus MTX, and in the subsequent open-label longterm extension (LTE) period, all patients received SC ABA (125 mg/wk). The final 5-year safety, tolerability, and efficacy analyses are reported. Of 1385 patients who completed the DB period, 1372 entered LTE and 945 (68.8%) completed ≥ 5 years of treatment. During LTE, 97 (7.1%) patients discontinued treatment because of an adverse event (AE). Incidence rate (IR; event/100 patient-yrs of exposure; based on LTE data, 95% CI) for AE of interest were the following: serious AE 7.73 (6.96-8.58), infection 38.60 (36.24-41.12), serious infection 1.68 (1.35-2.07), malignancies 1.09 (0.84-1.42), and autoimmune disorders 1.33 (1.05-1.69), and were stable over time. No association between immunogenicity and either worsening of ABA safety or loss of efficacy was noted. Efficacy in the LTE was consistent with the DB period and was maintained to the end of the study. These 5-year data establish that SC ABA (125 mg/wk) has a consistent safety profile and durable efficacy for longterm treatment of patients with RA who had an inadequate response to MTX.

  19. Advanced Parkinson's disease effect on goal-directed and habitual processes involved in visuomotor associative learning

    PubMed Central

    Hadj-Bouziane, Fadila; Benatru, Isabelle; Brovelli, Andrea; Klinger, Hélène; Thobois, Stéphane; Broussolle, Emmanuel; Boussaoud, Driss; Meunier, Martine

    2013-01-01

    The present behavioral study re-addresses the question of habit learning in Parkinson's disease (PD). Patients were early onset, non-demented, dopa-responsive, candidates for surgical treatment, similar to those we found earlier as suffering greater dopamine depletion in the putamen than in the caudate nucleus. The task was the same conditional associative learning task as that used previously in monkeys and healthy humans to unveil the striatum involvement in habit learning. Sixteen patients and 20 age- and education-matched healthy control subjects learned sets of 3 visuo-motor associations between complex patterns and joystick displacements during two testing sessions separated by a few hours. We distinguished errors preceding vs. following the first correct response to compare patients' performance during the earliest phase of learning dominated by goal-directed actions with that observed later on, when responses start to become habitual. The disease significantly retarded both learning phases, especially in patients under 60 years of age. However, only the late phase deficit was disease severity-dependent and persisted on the second testing session. These findings provide the first corroboration in Parkinson patients of two ideas well-established in the animal literature. The first is the idea that associating visual stimuli to motor acts is a form of habit learning that engages the striatum. It is confirmed here by the global impairment in visuo-motor learning induced by PD. The second idea is that goal-directed behaviors are predominantly caudate-dependent whereas habitual responses are primarily putamen-dependent. At the advanced PD stages tested here, dopamine depletion is greater in the putamen than in the caudate nucleus. Accordingly, the late phase of learning corresponding to the emergence of habitual responses was more vulnerable to the disease than the early phase dominated by goal-directed actions. PMID:23386815

  20. Dynamics of multiple-goal pursuit.

    PubMed

    Louro, Maria J; Pieters, Rik; Zeelenberg, Marcel

    2007-08-01

    The authors propose and test a model of multiple-goal pursuit that specifies how individuals allocate effort among multiple goals over time. The model predicts that whether individuals decide to step up effort, coast, abandon the current goal, or switch to pursue another goal is determined jointly by the emotions that flow from prior goal progress and the proximity to future goal attainment, and proximally determined by changes in expectancies about goal attainment. Results from a longitudinal diary study and 2 experiments show that positive and negative goal-related emotions can have diametrically opposing effects on goal-directed behavior, depending on the individual's proximity to goal attainment. The findings resolve contrasting predictions about the influence of positive and negative emotions in volitional behavior, critically amend the goal gradient hypothesis, and provide new insights into the dynamics and determinants of multiple-goal pursuit.

  1. The Armstrong Institute: An Academic Institute for Patient Safety and Quality Improvement, Research, Training, and Practice.

    PubMed

    Pronovost, Peter J; Holzmueller, Christine G; Molello, Nancy E; Paine, Lori; Winner, Laura; Marsteller, Jill A; Berenholtz, Sean M; Aboumatar, Hanan J; Demski, Renee; Armstrong, C Michael

    2015-10-01

    Academic medical centers (AMCs) could advance the science of health care delivery, improve patient safety and quality improvement, and enhance value, but many centers have fragmented efforts with little accountability. Johns Hopkins Medicine, the AMC under which the Johns Hopkins University School of Medicine and the Johns Hopkins Health System are organized, experienced similar challenges, with operational patient safety and quality leadership separate from safety and quality-related research efforts. To unite efforts and establish accountability, the Armstrong Institute for Patient Safety and Quality was created in 2011.The authors describe the development, purpose, governance, function, and challenges of the institute to help other AMCs replicate it and accelerate safety and quality improvement. The purpose is to partner with patients, their loved ones, and all interested parties to end preventable harm, continuously improve patient outcomes and experience, and eliminate waste in health care. A governance structure was created, with care mapped into seven categories, to oversee the quality and safety of all patients treated at a Johns Hopkins Medicine entity. The governance has a Patient Safety and Quality Board Committee that sets strategic goals, and the institute communicates these goals throughout the health system and supports personnel in meeting these goals. The institute is organized into 13 functional councils reflecting their behaviors and purpose. The institute works daily to build the capacity of clinicians trained in safety and quality through established programs, advance improvement science, and implement and evaluate interventions to improve the quality of care and safety of patients.

  2. Science Goal Monitor: Science Goal Driven Automation for NASA Missions

    NASA Technical Reports Server (NTRS)

    Koratkar, Anuradha; Grosvenor, Sandy; Jung, John; Pell, Melissa; Matusow, David; Bailyn, Charles

    2004-01-01

    Infusion of automation technologies into NASA s future missions will be essential because of the need to: (1) effectively handle an exponentially increasing volume of scientific data, (2) successfully meet dynamic, opportunistic scientific goals and objectives, and (3) substantially reduce mission operations staff and costs. While much effort has gone into automating routine spacecraft operations to reduce human workload and hence costs, applying intelligent automation to the science side, i.e., science data acquisition, data analysis and reactions to that data analysis in a timely and still scientifically valid manner, has been relatively under-emphasized. In order to introduce science driven automation in missions, we must be able to: capture and interpret the science goals of observing programs, represent those goals in machine interpretable language; and allow spacecrafts onboard systems to autonomously react to the scientist's goals. In short, we must teach our platforms to dynamically understand, recognize, and react to the scientists goals. The Science Goal Monitor (SGM) project at NASA Goddard Space Flight Center is a prototype software tool being developed to determine the best strategies for implementing science goal driven automation in missions. The tools being developed in SGM improve the ability to monitor and react to the changing status of scientific events. The SGM system enables scientists to specify what to look for and how to react in descriptive rather than technical terms. The system monitors streams of science data to identify occurrences of key events previously specified by the scientist. When an event occurs, the system autonomously coordinates the execution of the scientist s desired reactions. Through SGM, we will improve om understanding about the capabilities needed onboard for success, develop metrics to understand the potential increase in science returns, and develop an operational prototype so that the perceived risks associated

  3. 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.

  4. Getting by, getting back, and getting on: Matching mental health services to consumers' recovery goals.

    PubMed

    Yarborough, Bobbi Jo H; Yarborough, Micah T; Janoff, Shannon L; Green, Carla A

    2016-06-01

    The goal of this study was to better understand mental health recovery from the point of view of mental health consumers to identify opportunities for practice improvements that closely align services with consumer goals and consumer-preferred outcomes. As part of an exploratory study of recovery, semistructured interviews were conducted with 177 integrated health plan members diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or affective psychosis. Transcripts of in-depth interviews were coded using Atlas.ti, and definitions of recovery were further subcoded. A qualitative analysis using a modified grounded theory approach and constant comparative method identified common themes and less common but potentially important recovery-related experiences and perspectives. Three primary and 2 cross-cutting themes emerged. "Getting by" meant coping and meeting basic needs. "Getting back" meant learning to live with mental illness. "Getting on" meant living a life where mental illness was no longer prominent. Regaining control and recouping losses were cross-cutting themes. Mental health recovery is complex and dynamic; individuals' recovery goals can be expected to change over time. Person-centered care must accommodate changing consumer priorities, services must be flexible and responsive, and outcomes need to match consumers' objectives. Clinicians can assist in (a) identifying recovery goals, (b) monitoring progress toward and recognizing movement away from goals, (c) tailoring support to different phases/stages, and (d) supporting transitions between phases/stages. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  5. The Art World's Concept of Negative Space Applied to System Safety Management

    NASA Technical Reports Server (NTRS)

    Goodin, James Ronald (Ronnie)

    2005-01-01

    Tools from several different disciplines can improve system safety management. This paper relates the Art World with our system safety world, showing useful art schools of thought applied to system safety management, developing an art theory-system safety bridge. This bridge is then used to demonstrate relations with risk management, the legal system, personnel management and basic management (establishing priorities). One goal of this presentation/paper is simply to be a fun diversion from the many technical topics presented during the conference.

  6. Emotional exhaustion and workload predict clinician-rated and objective patient safety

    PubMed Central

    Welp, Annalena; Meier, Laurenz L.; Manser, Tanja

    2015-01-01

    Aims: To investigate the role of clinician burnout, demographic, and organizational characteristics in predicting subjective and objective indicators of patient safety. Background: Maintaining clinician health and ensuring safe patient care are important goals for hospitals. While these goals are not independent from each other, the interplay between clinician psychological health, demographic and organizational variables, and objective patient safety indicators is poorly understood. The present study addresses this gap. Method: Participants were 1425 physicians and nurses working in intensive care. Regression analysis (multilevel) was used to investigate the effect of burnout as an indicator of psychological health, demographic (e.g., professional role and experience) and organizational (e.g., workload, predictability) characteristics on standardized mortality ratios, length of stay and clinician-rated patient safety. Results: Clinician-rated patient safety was associated with burnout, trainee status, and professional role. Mortality was predicted by emotional exhaustion. Length of stay was predicted by workload. Contrary to our expectations, burnout did not predict length of stay, and workload and predictability did not predict standardized mortality ratios. Conclusion: At least in the short-term, clinicians seem to be able to maintain safety despite high workload and low predictability. Nevertheless, burnout poses a safety risk. Subjectively, burnt-out clinicians rated safety lower, and objectively, units with high emotional exhaustion had higher standardized mortality ratios. In summary, our results indicate that clinician psychological health and patient safety could be managed simultaneously. Further research needs to establish causal relationships between these variables and support to the development of managerial guidelines to ensure clinicians’ psychological health and patients’ safety. PMID:25657627

  7. Interpersonal coordination tendencies supporting the creation/prevention of goal scoring opportunities in futsal.

    PubMed

    Vilar, Luís; Araújo, Duarte; Davids, Keith; Travassos, Bruno; Duarte, Ricardo; Parreira, João

    2014-01-01

    Research on 1vs1 sub-phases in team sports has shown how one player coordinates his/her actions with his/her opponent and the location of a target/goal to attain performance objectives. In this study, we extended this approach to analysis of 5vs5 competitive performance in the team sport of futsal to provide a performance analysis framework that explains how players coordinate their actions to create/prevent opportunities to score goals. For this purpose, we recorded all 10 futsal matches of the 2009 Lusophony Games held in Lisbon. We analysed the displacement trajectories of a shooting attacker and marking defender in plays ending in a goal, a goalkeeper's save, and a defender's interception, at four specific moments during performance: (1) assisting attacker's ball reception and (2) moment of passing, (3) shooter's ball reception, and (4), shot on goal. Statistical analysis showed that when a goal was scored, the defender's angle to the goal and to the attacker tended to decrease, the attacker was able to move to the same distance to the goal alongside the defender, and the attacker was closer to the defender and moving at the same velocity (at least) as the defender. This study identified emergent patterns of coordination between attackers and defenders under key competitive task constraints, such as the location of the goal, which supported successful performance in futsal.

  8. Towards an effective co-operation between companies and occupational safety and health services.

    PubMed

    van der Drift, Dorine Willy

    2002-01-01

    In the Dutch Working Conditions Act, every employer is required to organize preventive occupational safety and health services (OSH-Services). The OSH-Services need to have a certification that can be compared with ISO-9000. This article is focused on the question: How can companies and OSH-Services co-operate more effectively to obtain a better OSH management system inside the companies? To answer this question, TNO has developed an approach to support organisations in the health care branch to obtain a better service from their OSH-Service. TNO has chosen to focus on supporting the companies, because of the recognition that the effectiveness of OSH-Services has been found in effects on their customers, the companies. As a result of the research project a stepwise approach with several tools was developed. After the development phase, parts of the approach and the tools were used in several other consultancy projects. Evaluative studies have not been performed yet. However, from the development activities and several consultancy projects some remarkable evaluative findings can be given. The approach can be useful for companies and OSH-Services to make their goals and expectations more explicit. The approach also helps to make the management of companies clear that their own behaviour is relevant to the achievement of their goals in occupational health and safety policy, in addition to the services provided by the OSH-Service and their professionals. The approach cannot fulfil the possible need for qualification of OSH professionals. However, the approach can make the OSH professionals clear in what way they have qualification needs.

  9. Usability Methods for Ensuring Health Information Technology Safety: Evidence-Based Approaches. Contribution of the IMIA Working Group Health Informatics for Patient Safety.

    PubMed

    Borycki, E; Kushniruk, A; Nohr, C; Takeda, H; Kuwata, S; Carvalho, C; Bainbridge, M; Kannry, J

    2013-01-01

    Issues related to lack of system usability and potential safety hazards continue to be reported in the health information technology (HIT) literature. Usability engineering methods are increasingly used to ensure improved system usability and they are also beginning to be applied more widely for ensuring the safety of HIT applications. These methods are being used in the design and implementation of many HIT systems. In this paper we describe evidence-based approaches to applying usability engineering methods. A multi-phased approach to ensuring system usability and safety in healthcare is described. Usability inspection methods are first described including the development of evidence-based safety heuristics for HIT. Laboratory-based usability testing is then conducted under artificial conditions to test if a system has any base level usability problems that need to be corrected. Usability problems that are detected are corrected and then a new phase is initiated where the system is tested under more realistic conditions using clinical simulations. This phase may involve testing the system with simulated patients. Finally, an additional phase may be conducted, involving a naturalistic study of system use under real-world clinical conditions. The methods described have been employed in the analysis of the usability and safety of a wide range of HIT applications, including electronic health record systems, decision support systems and consumer health applications. It has been found that at least usability inspection and usability testing should be applied prior to the widespread release of HIT. However, wherever possible, additional layers of testing involving clinical simulations and a naturalistic evaluation will likely detect usability and safety issues that may not otherwise be detected prior to widespread system release. The framework presented in the paper can be applied in order to develop more usable and safer HIT, based on multiple layers of evidence.

  10. Stay Alive--Simulation for Situational Safety Awareness

    NASA Technical Reports Server (NTRS)

    Ruder, Michelle

    2008-01-01

    STAY ALIVE is an idea for a safety awareness simulation prototype, powered by gaming technology, that would make safety training enlightening, engaging and fun. Recalling initial instructions and using situational awareness principles, participants would escape a fire by choosing the appropriate door. Escape times would be measured while stressors increased. This presentation describes how STAY ALIVE utilizes first person point of view (PoV), a generic scenario, immersion- and presence-enhancing design, and ease of distribution to provide more people opportunity to realize, review, analyze and practice effective awareness behaviors. The goals for this prototype include facilitating interest in first-person PoV safety training and eliciting further suggestions on prevention technologies.

  11. Manned space flight nuclear system safety. Volume 3: Reactor system preliminary nuclear safety analysis. Part 3: Nuclear Safety Analysis Document (NSAD)

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Nuclear safety analysis as applied to a space base mission is presented. The nuclear safety analysis document summarizes the mission and the credible accidents/events which may lead to nuclear hazards to the general public. The radiological effects and associated consequences of the hazards are discussed in detail. The probability of occurrence is combined with the potential number of individuals exposed to or above guideline values to provide a measure of accident and total mission risk. The overall mission risk has been determined to be low with the potential exposure to or above 25 rem limited to less than 4 individuals per every 1000 missions performed. No radiological risk to the general public occurs during the prelaunch phase at KSC. The most significant risks occur from prolonged exposure to reactor debris following land impact generally associated with the disposal phase of the mission where fission product inventories can be high.

  12. Identifying behaviour patterns of construction safety using system archetypes.

    PubMed

    Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

    2015-07-01

    Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. Health Sector Reform in the Kurdistan Region - Iraq: Financing Reform, Primary Care, and Patient Safety.

    PubMed

    Anthony, C Ross; Moore, Melinda; Hilborne, Lee H; Mulcahy, Andrew W

    2014-12-30

    In 2010, the Kurdistan Regional Government asked the RAND Corporation to help guide reform of the health care system in the Kurdistan Region of Iraq. The overarching goal of reform was to help establish a health system that would provide high-quality services efficiently to everyone to prevent, treat, and manage physical and mental illnesses and injuries. This article summarizes the second phase of RAND's work, when researchers analyzed three distinct but intertwined health policy issue areas: development of financing policy, implementation of early primary care recommendations, and evaluation of quality and patient safety. For health financing, the researchers reviewed the relevant literature, explored the issue in discussions with key stakeholders, developed and assessed various policy options, and developed plans or approaches to overcome barriers and achieve stated policy objectives. In the area of primary care, they developed and helped to implement a new management information system. In the area of quality and patient safety, they reviewed relevant literature, discussed issues and options with health leaders, and recommended an approach toward incremental implementation.

  14. Proceedings of the international meeting on thermal nuclear reactor safety. Vol. 1

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

    None

    Separate abstracts are included for each of the papers presented concerning current issues in nuclear power plant safety; national programs in nuclear power plant safety; radiological source terms; probabilistic risk assessment methods and techniques; non LOCA and small-break-LOCA transients; safety goals; pressurized thermal shocks; applications of reliability and risk methods to probabilistic risk assessment; human factors and man-machine interface; and data bases and special applications.

  15. Goals are not selfish.

    PubMed

    von Hippel, William; von Hippel, Frank A

    2014-04-01

    The metaphor of selfish goals is misguided. Organisms can be considered vessels that further the interests of their genes, but not vessels that further the interests of their goals. Although goals can act at cross-purposes to each other and to longevity, such trade-offs are predicted by evolutionary theory. The metaphor of selfish goals provides no purchase on this problem.

  16. Putting Safety in the Frame: Nurses' Sensemaking at Work.

    PubMed

    O'Keeffe, Valerie Jean; Thompson, Kirrilly Rebecca; Tuckey, Michelle Rae; Blewett, Verna Lesley

    2015-01-01

    Current patient safety policy focuses nursing on patient care goals, often overriding nurses' safety. Without understanding how nurses construct work health and safety (WHS), patient and nurse safety cannot be reconciled. Using ethnography, we examine social contexts of safety, studying 72 nurses across five Australian hospitals making decisions during patient encounters. In enacting safe practice, nurses used "frames" built from their contextual experiences to guide their behavior. Frames are produced by nurses, and they structure how nurses make sense of their work. Using thematic analysis, we identify four frames that inform nurses' decisions about WHS: (a) communicating builds knowledge, (b) experiencing situations guides decisions, (c) adapting procedures streamlines work, and (d) team working promotes safe working. Nurses' frames question current policy and practice by challenging how nurses' safety is positioned relative to patient safety. Recognizing these frames can assist the design and implementation of effective WHS management.

  17. Safety and immunogenicity of the M72/AS01E candidate tuberculosis vaccine in adults with tuberculosis: A phase II randomised study.

    PubMed

    Gillard, Paul; Yang, Pan-Chyr; Danilovits, Manfred; Su, Wei-Juin; Cheng, Shih-Lung; Pehme, Lea; Bollaerts, Anne; Jongert, Erik; Moris, Philippe; Ofori-Anyinam, Opokua; Demoitié, Marie-Ange; Castro, Marcela

    2016-09-01

    Previous studies have shown that the M72/AS01E candidate tuberculosis vaccine is immunogenic with a clinically acceptable safety profile in healthy and Mycobacterium tuberculosis-infected adults. This phase II, observer-blind, randomised study compared the safety, reactogenicity, and immunogenicity of M72/AS01E in 3 cohorts: tuberculosis-naïve adults (n = 80), adults previously treated for tuberculosis (n = 49), and adults who have completed the intensive phase of tuberculosis treatment (n = 13). In each cohort, 18-59-year-old adults were randomised (1:1) to receive two doses of M72/AS01E (n = 71) or placebo (n = 71) and followed-up until six months post-dose 2. Safety and reactogenicity were assessed as primary objective. Recruitment in the study ended prematurely because of a high incidence of large injection site redness/swelling reactions in M72/AS01E-vaccinated adults undergoing tuberculosis treatment. No additional clinically relevant adverse events were observed, except one possibly vaccine-related serious adverse event (hypersensitivity in a tuberculosis-treated-M72/AS01E participant). Robust and persistent M72-specific humoral and polyfunctional CD4(+) T-cell-mediated immune responses were observed post-M72/AS01E vaccination in each cohort. In conclusion, the M72/AS01E vaccine was immunogenic in adults previously or currently treated for tuberculosis, but further analyses are needed to explain the high local reactogenicity in adults undergoing tuberculosis treatment. ClinicalTrials.gov: NCT01424501. Copyright © 2016 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.

  18. Goal-setting in clinical medicine.

    PubMed

    Bradley, E H; Bogardus, S T; Tinetti, M E; Inouye, S K

    1999-07-01

    The process of setting goals for medical care in the context of chronic disease has received little attention in the medical literature, despite the importance of goal-setting in the achievement of desired outcomes. Using qualitative research methods, this paper develops a theory of goal-setting in the care of patients with dementia. The theory posits several propositions. First, goals are generated from embedded values but are distinct from values. Goals vary based on specific circumstances and alternatives whereas values are person-specific and relatively stable in the face of changing circumstances. Second, goals are hierarchical in nature, with complex mappings between general and specific goals. Third, there are a number of factors that modify the goal-setting process, by affecting the generation of goals from values or the translation of general goals to specific goals. Modifying factors related to individuals include their degree of risk-taking, perceived self-efficacy, and acceptance of the disease. Disease factors that modify the goal-setting process include the urgency and irreversibility of the medical condition. Pertinent characteristics of the patient-family-clinician interaction include the level of participation, control, and trust among patients, family members, and clinicians. The research suggests that the goal-setting process in clinical medicine is complex, and the potential for disagreements regarding goals substantial. The nature of the goal-setting process suggests that explicit discussion of goals for care may be necessary to promote effective patient-family-clinician communication and adequate care planning.

  19. Safety, tolerability, and immunogenicity of the novel antituberculous vaccine RUTI: randomized, placebo-controlled phase II clinical trial in patients with latent tuberculosis infection.

    PubMed

    Nell, Andre S; D'lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

    2014-01-01

    To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV-) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/-): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV- status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future trials, preceded by an extended safety clinical

  20. Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection

    PubMed Central

    Nell, Andre S.; D’lom, Eva; Bouic, Patrick; Sabaté, Montserrat; Bosser, Ramon; Picas, Jordi; Amat, Mercè; Churchyard, Gavin; Cardona, Pere-Joan

    2014-01-01

    Objectives To evaluate the safety, tolerability and immunogenicity of three different doses (5, 25 and 50 µg) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection. Methods and Findings Double-blind, randomized, placebo-controlled Phase II Clinical Trial (95 patients randomized). Three different RUTI doses and placebo were tested, randomized both in HIV-positive (n = 47) and HIV-negative subjects (n = 48), after completion of one month isoniazid (INH) pre-vaccination. Each subject received two vaccine administrations, 28 Days apart. Five patients withdrew and 90 patients completed the study. Assessment of safety showed no deaths during study. Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized; causality was assessed as very likely and by the end of the study the outcome had resolved. All the patients except 5 (21%) patients of the placebo group (3 HIV+ and 2 HIV−) reported at least one adverse event (AE) during the study. The most frequently occurring AEs among RUTI recipients were (% in HIV+/−): injection site reactions [erythema (91/92), induration (94/92), local nodules (46/25), local pain (66/75), sterile abscess (6/6), swelling (74/83), ulcer (20/11), headache (17/22) and nasopharyngitis (20/5)]. These events were mostly mild and well tolerated. Overall, a polyantigenic response was observed, which differed by HIV− status. The best polyantigenic response was obtained when administrating 25 µg RUTI, especially in HIV-positive subjects which was not increased after the second inoculation. Conclusion This Phase II clinical trial demonstrates reasonable tolerability of RUTI. The immunogenicity profile of RUTI vaccine in LTBI subjects, even being variable among groups, allows us considering one single injection of one of the highest doses in future

  1. Goal-Function Tree Modeling for Systems Engineering and Fault Management

    NASA Technical Reports Server (NTRS)

    Patterson, Jonathan D.; Johnson, Stephen B.

    2013-01-01

    provide formal connectivity between the nominal (SE), and off-nominal (SHM and FM) aspects of functions and designs. This paper describes a formal modeling approach to the initial phases of the development process that integrates the nominal and off-nominal perspectives in a model that unites SE goals and functions of with the failure to achieve goals and functions (SHM/FM). This methodology and corresponding model, known as a Goal-Function Tree (GFT), provides a means to represent, decompose, and elaborate system goals and functions in a rigorous manner that connects directly to design through use of state variables that translate natural language requirements and goals into logical-physical state language. The state variable-based approach also provides the means to directly connect FM to the design, by specifying the range in which state variables must be controlled to achieve goals, and conversely, the failures that exist if system behavior go out-of-range. This in turn allows for the systems engineers and SHM/FM engineers to determine which state variables to monitor, and what action(s) to take should the system fail to achieve that goal. In sum, the GFT representation provides a unified approach to early-phase SE and FM development. This representation and methodology has been successfully developed and implemented using Systems Modeling Language (SysML) on the NASA Space Launch System (SLS) Program. It enabled early design trade studies of failure detection coverage to ensure complete detection coverage of all crew-threatening failures. The representation maps directly both to FM algorithm designs, and to failure scenario definitions needed for design analysis and testing. The GFT representation provided the basis for mapping of abort triggers into scenarios, both needed for initial, and successful quantitative analyses of abort effectiveness (detection and response to crew-threatening events).

  2. Enforcing Job Safety; A Union View of OSHA

    ERIC Educational Resources Information Center

    Wood, Michael

    1975-01-01

    A primary shortcoming of the Occupational Safety and Health Act of 1970 is that it provides the employer with too many phases of postponement of responsibility. However, positive administrative action has included organized labor's entry into all levels of job safety and health activities. (MW)

  3. Supervisors Guidebook: Driver and Traffic Safety Education.

    ERIC Educational Resources Information Center

    Aaron, James E.; And Others

    Intended for those responsible to organize, oversee, and evaluate a school's comprehensive traffic safety education program, this Illinois State guide contains nine major sections and appendixes. An introduction presents philosophy and status of the Illinois program, general goals and objectives, notes on relevant professional associations, and…

  4. Safety effects of exclusive and concurrent signal phasing for pedestrian crossing.

    PubMed

    Zhang, Yaohua; Mamun, Sha A; Ivan, John N; Ravishanker, Nalini; Haque, Khademul

    2015-10-01

    This paper describes the estimation of pedestrian crash count and vehicle interaction severity prediction models for a sample of signalized intersections in Connecticut with either concurrent or exclusive pedestrian phasing. With concurrent phasing, pedestrians cross at the same time as motor vehicle traffic in the same direction receives a green phase, while with exclusive phasing, pedestrians cross during their own phase when all motor vehicle traffic on all approaches is stopped. Pedestrians crossing at each intersection were observed and classified according to the severity of interactions with motor vehicles. Observation intersections were selected to represent both types of signal phasing while controlling for other physical characteristics. In the nonlinear mixed models for interaction severity, pedestrians crossing on the walk signal at an exclusive signal experienced lower interaction severity compared to those crossing on the green light with concurrent phasing; however, pedestrians crossing on a green light where an exclusive phase was available experienced higher interaction severity. Intersections with concurrent phasing have fewer total pedestrian crashes than those with exclusive phasing but more crashes at higher severity levels. It is recommended that exclusive pedestrian phasing only be used at locations where pedestrians are more likely to comply. Copyright © 2015. Published by Elsevier Ltd.

  5. National Dam Safety Program. Diascund Reservoir Dam. Inventory Number: VA-12703. New Kent County, Virginia. Phase I Inspection Report.

    DTIC Science & Technology

    1979-03-01

    iIIASQJII I ~SO~O1R I ~1Location: ~ r ~oi i ~air caurny, VII~INIA ~Inventory Number: VA .!:L.12703 1 - ,~ / ~ L~] PHASE I INSPECTION REPORT ‘ (9AT1ON...ak.lr.Sl sst tsd I ., MIoek 30. St ~~1l vwt ft... R p ert) - IS. SUPPLEMENTARY NOTES Copies are obtainable froB National Technica l Information...Service , Springfield , Virginia 22151 IL KEY BeRGS (C.” ~~ :. isua &~~ U 11 U4 SY i I ~~UU1)’ by block r ~~b.r) - Dam - VA National Darn Safety Program

  6. USDOT guidance summary for connected vehicle deployments : safety management.

    DOT National Transportation Integrated Search

    2016-07-01

    This document provides guidance material in regards to safety management plan for the CV Pilots DeploymentConcept Development Phase. This guidance provides key concepts and references in developing the SafetyManagement Plan in Task 4, lists relevant ...

  7. Towards Measurement of Confidence in Safety Cases

    NASA Technical Reports Server (NTRS)

    Denney, Ewen; Paim Ganesh J.; Habli, Ibrahim

    2011-01-01

    Arguments in safety cases are predominantly qualitative. This is partly attributed to the lack of sufficient design and operational data necessary to measure the achievement of high-dependability targets, particularly for safety-critical functions implemented in software. The subjective nature of many forms of evidence, such as expert judgment and process maturity, also contributes to the overwhelming dependence on qualitative arguments. However, where data for quantitative measurements is systematically collected, quantitative arguments provide far more benefits over qualitative arguments, in assessing confidence in the safety case. In this paper, we propose a basis for developing and evaluating integrated qualitative and quantitative safety arguments based on the Goal Structuring Notation (GSN) and Bayesian Networks (BN). The approach we propose identifies structures within GSN-based arguments where uncertainties can be quantified. BN are then used to provide a means to reason about confidence in a probabilistic way. We illustrate our approach using a fragment of a safety case for an unmanned aerial system and conclude with some preliminary observations

  8. Teachers' Goal Orientations: Effects on Classroom Goal Structures and Emotions

    ERIC Educational Resources Information Center

    Wang, Hui; Hall, Nathan C.; Goetz, Thomas; Frenzel, Anne C.

    2017-01-01

    Background: Prior research has shown teachers' goal orientations to influence classroom goal structures (Retelsdorf "et al.," 2010, "Learning and Instruction, 20," 30) and to also impact their emotions (Schutz "et al.," 2007, "Emotion in Education," Academic Press, Amsterdam, the Netherlands). However,…

  9. Development of the Oregon traffic safety data archive : phases 1 and 2.

    DOT National Transportation Integrated Search

    2012-03-01

    "This report describes the preliminary work to develop the Oregon Traffic Safety Data Archive (OrTSDA). The mission of OrTSDA is to build : the knowledge base of traffic safety data in Oregon. The archive hopes to become a valuable traffic safe...

  10. The Effects of Pain Intensity on Goal Schemas and Goal Pursuit: A Daily Diary Study

    PubMed Central

    Karoly, Paul; Okun, Morris A.; Enders, Craig; Tennen, Howard

    2014-01-01

    Objective Although the adverse effects of chronic pain on work productivity and daily life pursuits are clear, the within-person dynamics of pain, goal cognition, and engagement in work-related and lifestyle goals remain uncharted. This study investigated the impact of pain intensity (assessed on three occasions each day) and goal-related schematic thinking (ratings of importance, planning, and goal pursuit opportunities, assessed only in the morning) on afternoon and evening work and lifestyle goal pursuit. Methods A community sample of working adults with chronic pain (N =131) were screened and interviewed about their work and lifestyle goals and completed a 21-day telephonic diary. Hierarchical linear modeling was used to estimate within-person and between-person effects. Results At the within-person level, morning pain intensity was inversely related to schematic cognition concerning work and lifestyle goals, whereas, at the between-person level, morning pain intensity varied positively with schematic thinking about work goals as well with afternoon life-style goal pursuit. At both the between- and within- analytic levels, morning goal schemas were positively associated with the pursuit of each type of goal in the afternoon and again in the evening. Moreover, positive carry-over effects of morning goal schemas on next day afternoon goal pursuit were observed. Conclusions Whereas morning pain intensity exhibited inconsistent effects across analytic levels, morning goal-related schematic thinking consistently predicted goal pursuit across analytic levels, type of goal, and time of day. These findings have implications for treatment and prevention of pain’s potentially deleterious effects on workplace and lifestyle goals. PMID:25180547

  11. NASA Range Safety Annual Report 2007

    NASA Technical Reports Server (NTRS)

    Dumont, Alan G.

    2007-01-01

    As always, Range Safety has been involved in a number of exciting and challenging activities and events. Throughout the year, we have strived to meet our goal of protecting the public, the workforce, and property during range operations. During the past year, Range Safety was involved in the development, implementation, and support of range safety policy. Range Safety training curriculum development was completed this year and several courses were presented. Tailoring exercises concerning the Constellation Program were undertaken with representatives from the Constellation Program, the 45th Space Wing, and the Launch Constellation Range Safety Panel. Range Safety actively supported the Range Commanders Council and it subgroups and remained involved in updating policy related to flight safety systems and flight safety analysis. In addition, Range Safety supported the Space Shuttle Range Safety Panel and addressed policy concerning unmanned aircraft systems. Launch operations at Kennedy Space Center, the Eastern and Western ranges, Dryden Flight Research Center, and Wallops Flight Facility were addressed. Range Safety was also involved in the evaluation of a number of research and development efforts, including the space-based range (formerly STARS), the autonomous flight safety system, the enhanced flight termination system, and the joint advanced range safety system. Flight safety system challenges were evaluated. Range Safety's role in the Space Florida Customer Assistance Service Program for the Eastern Range was covered along with our support for the Space Florida Educational Balloon Release Program. We hope you have found the web-based format both accessible and easy to use. Anyone having questions or wishing to have an article included in the 2008 Range Safety Annual Report should contact Alan Dumont, the NASA Range Safety Program Manager located at the Kennedy Space Center, or Michael Dook at NASA Headquarters.

  12. Phase I (Safety) Study of Autologous Tolerogenic Dendritic Cells in Type 1 Diabetic Patients

    PubMed Central

    Giannoukakis, Nick; Phillips, Brett; Finegold, David; Harnaha, Jo; Trucco, Massimo

    2011-01-01

    OBJECTIVE The safety of dendritic cells to selectively suppress autoimmunity, especially in type 1 diabetes, has never been ascertained. We investigated the safety of autologous dendritic cells, stabilized into an immunosuppressive state, in established adult type 1 diabetic patients. RESEARCH DESIGN AND METHODS A randomized, double-blind, phase I study was conducted. A total of 10, otherwise generally healthy, insulin-requiring type 1 diabetic patients between 18 and 60 years of age, without any other known or suspected health conditions, received autologous dendritic cells, unmanipulated or engineered ex vivo toward an immunosuppressive state. Ten million cells were administered intradermally in the abdomen once every 2 weeks for a total of four administrations. The primary end point determined the proportion of patients with adverse events on the basis of the physician’s global assessment, hematology, biochemistry, and immune monitoring for a period of 12 months. RESULTS The dendritic cells were safely tolerated. There were no discernible adverse events in any patient throughout the study. Other than a significant increase in the frequency of peripheral B220+ CD11c− B cells, mainly seen in the recipients of engineered dendritic cells during the dendritic cell administration period, there were no statistically relevant differences in other immune populations or biochemical, hematological, and immune biomarkers compared with baseline. CONCLUSIONS Treatment with autologous dendritic cells, in a native state or directed ex vivo toward a tolerogenic immunosuppressive state, is safe and well tolerated. Dendritic cells upregulated the frequency of a potentially beneficial B220+ CD11c− B-cell population, at least in type 1 diabetes autoimmunity. PMID:21680720

  13. A phased approach to clinical testing: criteria for progressing from Phase I to Phase II to Phase III studies.

    PubMed

    André, F E; Foulkes, M A

    1998-01-01

    The overall intent of clinical testing is to establish, in a series of phased studies, the clinical tolerance and acceptable "safety" of the candidate vaccine, as well as the type, level and persistence of the immune response after its inoculation, to a representative target population, according to a convenient administration schedule. The final stages involve the direct or indirect demonstration of protective efficacy, if possible in the population(s) for which the vaccine is intended. In addition, consistency of production must be demonstrated. At all these stages, the amount of prior information from preclinical and other studies affects and informs the objectives and design of subsequent studies. Progression from one testing phase to the next is dependent upon attaining the pre-set objectives of each series of studies. The precise objectives to be met will be decided on a case-by-case basis. The earliest assessments in humans (Phase I) involve evaluation of short-term clinical tolerance as measured by local and general reactogenicity, and gross assessments of immunogenicity, in a small number of highly selected individuals in an idealised situation. The selection of "optimal" dose and schedule are the result of further dose-ranging investigations (Phase II), involving more volunteers, with longer, more detailed follow-up assessments. It is at this stage that the accumulated evidence on its immunogenicity profile should be sufficient to assess whether or not the vaccine is worthy of further development. The next level of investigation (Phase III) aims to measure with greater precision the vaccine protective efficacy in the intended target population(s) by comparison of infection and/or disease attack rates in vaccine and placebo recipients. In consistency studies different production lots, manufactured at commercial scale, are tested to demonstrate consistency of manufacture. Additional bridging studies to establish similarity of lots at different production

  14. Propulsion Health Monitoring for Enhanced Safety

    NASA Technical Reports Server (NTRS)

    Butz, Mark G.; Rodriguez, Hector M.

    2003-01-01

    This report presents the results of the NASA contract Propulsion System Health Management for Enhanced Safety performed by General Electric Aircraft Engines (GE AE), General Electric Global Research (GE GR), and Pennsylvania State University Applied Research Laboratory (PSU ARL) under the NASA Aviation Safety Program. This activity supports the overall goal of enhanced civil aviation safety through a reduction in the occurrence of safety-significant propulsion system malfunctions. Specific objectives are to develop and demonstrate vibration diagnostics techniques for the on-line detection of turbine rotor disk cracks, and model-based fault tolerant control techniques for the prevention and mitigation of in-flight engine shutdown, surge/stall, and flameout events. The disk crack detection work was performed by GE GR which focused on a radial-mode vibration monitoring technique, and PSU ARL which focused on a torsional-mode vibration monitoring technique. GE AE performed the Model-Based Fault Tolerant Control work which focused on the development of analytical techniques for detecting, isolating, and accommodating gas-path faults.

  15. 49 CFR 585.2 - Phase-in reports.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Phase-in reports. 585.2 Section 585.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PHASE-IN REPORTING REQUIREMENTS General § 585.2 Phase-in reports. Each report submitted to NHTSA...

  16. Self-regulation of health behavior: social psychological approaches to goal setting and goal striving.

    PubMed

    Mann, Traci; de Ridder, Denise; Fujita, Kentaro

    2013-05-01

    The goal of this article is to review and highlight the relevance of social psychological research on self-regulation for health-related theory and practice. We first review research on goal setting, or determining which goals to pursue and the criteria to determine whether one has succeeded. We discuss when and why people adopt goals, what properties of goals increase the likelihood of their attainment, and why people abandon goals. We then review research on goal striving, which includes the planning and execution of actions that lead to goal attainment, and the processes that people use to shield their goals from being disrupted by other competing goals, temptations, or distractions. We describe four types of strategies that people use when pursuing goals. We find that self-regulation entails the operation of a number of psychological mechanisms, and that there is no single solution that will help all people in all situations. We recommend a number of strategies that can help people to more effectively set and attain health-related goals. We conclude that enhancing health behavior requires a nuanced understanding and sensitivity to the varied, dynamic psychological processes involved in self-regulation, and that health is a prototypical and central domain in which to examine the relevance of these theoretical models for real behavior. We discuss the implications of this research for theory and practice in health-related domains. PsycINFO Database Record (c) 2013 APA, all rights reserved.

  17. Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

    PubMed

    Singh, Hardeep; Sittig, Dean F

    2016-04-01

    Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

  18. How vaccine safety can become political--the example of polio in Nigeria.

    PubMed

    Clements, Christopher J; Greenough, Paul; Shull, Diana

    2006-01-01

    Vaccine safety is increasingly a major aspect of immunization programmes. Parents are becoming more aware of safety issues relating to vaccines their babies might receive. As a consequence, public health initiatives have had to take note of pressures brought to bear by individual parents and groups. Now we document a new phase in vaccine safety where it has been used to achieve political objectives. In 1988, the World Health Assembly declared its intention to eradicate poliomyelitis from the globe by the year 2000. This goal had to be postponed to 2005 for a number of reasons. Although the progress has been spectacular in achieving eradication in almost all nations and areas, the goal has been tantalizingly elusive. But arguably the most difficult country from which to eradicate the virus has been Nigeria. Over the past two years, tension has arisen in the north against immunizing against polio using the oral polio vaccine (OPV). Although this vaccine has been used in every other country in the world including other Muslim states, some religious leaders in the north found reason in August 2003 to advise their followers not to have their children vaccinated with OPV. Subsequent to this boycott, which the Kano governor had endorsed for a year and then ended in July 2004, cases of polio occurred in African nations previously free of the virus, and the DNA finger-print of the virus indicated it had come from Nigeria. In other words, Nigeria became a net exporter of polio virus to its African neighbours and beyond. Now the disease has spread to a dozen formerly polio-free countries, including Sudan and Indonesia. We show that, while the outward manifestations of the northern Nigerian intransigence were that of distrust of vaccine, the underlying problem was actually part of a longstanding dispute about political and religious power vis a vis Abuja. It is unlikely that polio transmission will be interrupted by 2005 if this dispute is allowed to run its course.

  19. Overview of safety research

    NASA Technical Reports Server (NTRS)

    Enders, J. H.

    1978-01-01

    Aircraft safety is reviewed by first establishing a perspective of air transportation accidents as a function of calendar year, geographic area, and phase of flight, and then by describing the threats to safety and NASA research underway in the three representative areas of engine operational problems, meteorological phenomena, and fire. Engine rotor burst protection, aircraft nacelle fire extinguishment, the aircraft-weather interface, severe weather wind shears and turbulence, clear air turbulence, and lightning are among the topics covered. Fire impact management through fire resistant materials technology development is emphasized.

  20. Forest management practices and the occupational safety and health administration logging standard

    Treesearch

    John R. Myers; David Elton Fosbroke

    1995-01-01

    The Occupational Safety and Health Administration (OSHA) has established safety and health regulations for the logging industry. These new regulations move beyond the prior OSHA pulpwood harvesting standard by including sawtimber harvesting operations. Because logging is a major tool used by forest managers to meet silvicultural goals, managers must be aware of what...

  1. Defining the pharmaceutical system to support proactive drug safety.

    PubMed

    Lewis, Vicki R; Hernandez, Angelica; Meadors, Margaret

    2013-02-01

    The military, aviation, nuclear, and transportation industries have transformed their safety records by using a systems approach to safety and risk mitigation. This article creates a preliminary model of the U.S. pharmaceutical system using available literature including academic publications, policies, and guidelines established by regulatory bodies and drug industry trade publications. Drawing from the current literature, the goals, roles, and individualized processes of pharmaceutical subsystems will be defined. Defining the pharmaceutical system provides a vehicle to assess and address known problems within the system, and provides a means to conduct proactive risk analyses, which would create significant pharmaceutical safety advancement.

  2. Goal Conflict and Goal Commitment among Campus Parking Administrators in Higher Education

    ERIC Educational Resources Information Center

    McKinney, David R.

    2014-01-01

    The purpose of this study was to determine the degree to which campus parking administrators in public higher education perceive they are experiencing goal conflict and the degree to which they differ in commitment to goals related to generating revenue and goals related to academics and service. The study also sought to determine the relationship…

  3. DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY

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

    D. A. MC CLURE; C. A. NELSON; R. L. BOUDRIE

    2001-04-01

    This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamosmore » National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety.« less

  4. A single-arm, multicenter, safety-monitoring, phase IV study of icotinib in treating advanced non-small cell lung cancer (NSCLC).

    PubMed

    Hu, Xingsheng; Han, Baohui; Gu, Aiqin; Zhang, Yiping; Jiao, Shun Chang; Wang, Chang-Li; He, Jintao; Jia, Xueke; Zhang, Li; Peng, Jiewen; Wu, Meina; Ying, Kejing; Wang, Junye; Ma, Kewei; Zhang, Shucai; You, Changxuan; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

    2014-11-01

    The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  5. Safety and activity of temsirolimus and bevacizumab in patients with advanced renal cell carcinoma previously treated with tyrosine kinase inhibitors: a phase 2 consortium study.

    PubMed

    Merchan, Jaime R; Qin, Rui; Pitot, Henry; Picus, Joel; Liu, Glenn; Fitch, Tom; Maples, William J; Flynn, Patrick J; Fruth, Briant F; Erlichman, Charles

    2015-03-01

    Bevacizumab or temsirolimus regimens have clinical activity in the first-line treatment of advanced renal cell carcinoma (RCC). This phase I/II trial was conducted to determine the safety of combining both agents and its efficacy in RCC patients who progressed on at least one prior anti-VEGF receptor tyrosine kinase inhibitor (RTKI) agent. In the phase I portion, eligible patients were treated with temsirolimus (25 mg IV weekly) and escalating doses of IV bevacizumab (level 1 = 5 mg/kg; level 2 = 10 mg/kg) every other week. The primary endpoint for the phase II portion (RTKI resistant patients) was the 6-month progression-free rate. Secondary endpoints were response rate, toxicity evaluation, and PFS and OS. Maximum tolerated dose was not reached at the maximum dose administered in 12 phase I patients. Forty evaluable patients were treated with the phase II recommended dose (temsirolimus 25 mg IV weekly and bevacizumab 10 mg/kg IV every 2 weeks). The 6-month progression-free rate was 40 % (16/40 pts). Median PFS was 5.9 (4-7.8) months, and median OS was 20.6 (11.5-23.7) months. Partial response, stable disease, and progressive disease were seen in 23, 63, and 14 % of patients, respectively. Most common grade 3-4 AEs included fatigue (17.8 %), hypertriglyceridemia (11.1 %), stomatitis (8.9 %), proteinuria (8.9 %), abdominal pain (6.7 %), and anemia (6.7 %). Baseline levels of serum sFLT-1 and VEGF-A were inversely correlated with PFS and OS, respectively. Temsirolimus and bevacizumab is a feasible combination in patients with advanced RCC previously exposed to oral anti-VEGF agents. The safety and efficacy results warrant further confirmatory studies in this patient population.

  6. SAFETY AND ACTIVITY OF TEMSIROLIMUS AND BEVACIZUMAB IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA PREVIOUSLY TREATED WITH TYROSINE KINASE INHIBITORS: A PHASE 2 CONSORTIUM STUDY

    PubMed Central

    Merchan, Jaime R.; Qin, Rui; Pitot, Henry; Picus, Joel; Liu, Glenn; Fitch, Tom; Maples, William J.; Flynn, Patrick J.; Fruth, Briant F.; Erlichman, Charles

    2015-01-01

    Purpose Bevacizumab or Temsirolimus regimens have clinical activity in the first line treatment of advanced renal cell carcinoma (RCC). This phase I/II trial was conducted to determine the safety of combining both agents and its efficacy in RCC patients who progressed on at least one prior anti-VEGF receptor tyrosine kinase inhibitor (RTKI) agent. Methods In the phase I portion, eligible patients were treated with Temsirolimus (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. The primary endpoint for the phase II portion (RTKI resistant patients) was the 6-month progression free rate. Secondary endpoints were response rate, toxicity evaluation, PFS and OS. Results MTD was not reached at the maximum dose administered in 12 phase I patients. Forty evaluable patients were treated with the phase II recommended dose (Temsirolimus 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). The 6-month progression free rate was 40% (16/40 pts). Median PFS was 5.9 (4-7.8) months, and median OS was 20.6 (11.5-23.7) months. Partial response/stable/progressive disease were seen in 23%/63%/14% of patients. Most common grade 3-4 AEs included fatigue (17.8%), hypertriglyceridemia (11.1%), stomatitis (8.9%), proteinuria (8.9%), abdominal pain (6.7%), and anemia (6.7%). Baseline levels of serum sFLT-1 and VEGF-A were inversely correlated with PFS and OS, respectively. Conclusions Temsirolimus and Bevacizumab is a feasible combination in patients with advanced RCC previously exposed to oral anti-VEGF agents. The safety and efficacy results warrant further confirmatory studies in this patient population. PMID:25556030

  7. Does monitoring goal progress promote goal attainment? A meta-analysis of the experimental evidence.

    PubMed

    Harkin, Benjamin; Webb, Thomas L; Chang, Betty P I; Prestwich, Andrew; Conner, Mark; Kellar, Ian; Benn, Yael; Sheeran, Paschal

    2016-02-01

    Control theory and other frameworks for understanding self-regulation suggest that monitoring goal progress is a crucial process that intervenes between setting and attaining a goal, and helps to ensure that goals are translated into action. However, the impact of progress monitoring interventions on rates of behavioral performance and goal attainment has yet to be quantified. A systematic literature search identified 138 studies (N = 19,951) that randomly allocated participants to an intervention designed to promote monitoring of goal progress versus a control condition. All studies reported the effects of the treatment on (a) the frequency of progress monitoring and (b) subsequent goal attainment. A random effects model revealed that, on average, interventions were successful at increasing the frequency of monitoring goal progress (d+ = 1.98, 95% CI [1.71, 2.24]) and promoted goal attainment (d+ = 0.40, 95% CI [0.32, 0.48]). Furthermore, changes in the frequency of progress monitoring mediated the effect of the interventions on goal attainment. Moderation tests revealed that progress monitoring had larger effects on goal attainment when the outcomes were reported or made public, and when the information was physically recorded. Taken together, the findings suggest that monitoring goal progress is an effective self-regulation strategy, and that interventions that increase the frequency of progress monitoring are likely to promote behavior change. (c) 2016 APA, all rights reserved).

  8. Evaluation of the effectiveness of child safety restraints

    DOT National Transportation Integrated Search

    1987-03-01

    The goals of the study were to better establish the relationsips between proper and improper usage of safety seats in crashes and the resulting injury levels and mechanisms and to establish measures of the distance from home that the children were wh...

  9. A Synthetic Vision Preliminary Integrated Safety Analysis

    NASA Technical Reports Server (NTRS)

    Hemm, Robert; Houser, Scott

    2001-01-01

    This report documents efforts to analyze a sample of aviation safety programs, using the LMI-developed integrated safety analysis tool to determine the change in system risk resulting from Aviation Safety Program (AvSP) technology implementation. Specifically, we have worked to modify existing system safety tools to address the safety impact of synthetic vision (SV) technology. Safety metrics include reliability, availability, and resultant hazard. This analysis of SV technology is intended to be part of a larger effort to develop a model that is capable of "providing further support to the product design and development team as additional information becomes available". The reliability analysis portion of the effort is complete and is fully documented in this report. The simulation analysis is still underway; it will be documented in a subsequent report. The specific goal of this effort is to apply the integrated safety analysis to SV technology. This report also contains a brief discussion of data necessary to expand the human performance capability of the model, as well as a discussion of human behavior and its implications for system risk assessment in this modeling environment.

  10. Site Safety and Health Plan (Phase 3) for the treatability study for in situ vitrification at Seepage Pit 1 in Waste Area Grouping 7, Oak Ridge National Laboratory, Oak Ridge, TN

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

    Spalding, B.P.; Naney, M.T.

    1995-06-01

    This plan is to be implemented for Phase III ISV operations and post operations sampling. Two previous project phases involving site characterization have been completed and required their own site specific health and safety plans. Project activities will take place at Seepage Pit 1 in Waste Area Grouping 7 at ORNL, Oak Ridge, Tennessee. Purpose of this document is to establish standard health and safety procedures for ORNL project personnel and contractor employees in performance of this work. Site activities shall be performed in accordance with Energy Systems safety and health policies and procedures, DOE orders, Occupational Safety and Healthmore » Administration Standards 29 CFR Part 1910 and 1926; applicable United States Environmental Protection Agency requirements; and consensus standards. Where the word ``shall`` is used, the provisions of this plan are mandatory. Specific requirements of regulations and orders have been incorporated into this plan in accordance with applicability. Included from 29 CFR are 1910.120 Hazardous Waste Operations and Emergency Response; 1910.146, Permit Required - Confined Space; 1910.1200, Hazard Communication; DOE Orders requirements of 5480.4, Environmental Protection, Safety and Health Protection Standards; 5480.11, Radiation Protection; and N5480.6, Radiological Control Manual. In addition, guidance and policy will be followed as described in the Environmental Restoration Program Health and Safety Plan. The levels of personal protection and the procedures specified in this plan are based on the best information available from reference documents and site characterization data. Therefore, these recommendations represent the minimum health and safety requirements to be observed by all personnel engaged in this project.« less

  11. Achieving the Goals. Goal 4: Teacher Education and Professional Development.

    ERIC Educational Resources Information Center

    Department of Education, Washington, DC.

    Goal 4 of the National Education Goals envisions that teachers will have access to programs for the continued improvement of their professional skills. This book examines what federal agencies are doing to enhance teacher preparation, presents information on career-long development, and offers program descriptions and contact names. The first…

  12. Bus operator safety : critical issues examination and model practices.

    DOT National Transportation Integrated Search

    2014-01-01

    In this study, researchers at the National Center for Transit Research performed a multi-topic comprehensive : examination of bus operator-related critical safety and personal security issues. The goals of this research : effort were to: : 1. Identif...

  13. Evolution of International Space Station Program Safety Review Processes and Tools

    NASA Technical Reports Server (NTRS)

    Ratterman, Christian D.; Green, Collin; Guibert, Matt R.; McCracken, Kristle I.; Sang, Anthony C.; Sharpe, Matthew D.; Tollinger, Irene V.

    2013-01-01

    The International Space Station Program at NASA is constantly seeking to improve the processes and systems that support safe space operations. To that end, the ISS Program decided to upgrade their Safety and Hazard data systems with 3 goals: make safety and hazard data more accessible; better support the interconnection of different types of safety data; and increase the efficiency (and compliance) of safety-related processes. These goals are accomplished by moving data into a web-based structured data system that includes strong process support and supports integration with other information systems. Along with the data systems, ISS is evolving its submission requirements and safety process requirements to support the improved model. In contrast to existing operations (where paper processes and electronic file repositories are used for safety data management) the web-based solution provides the program with dramatically faster access to records, the ability to search for and reference specific data within records, reduced workload for hazard updates and approval, and process support including digital signatures and controlled record workflow. In addition, integration with other key data systems provides assistance with assessments of flight readiness, more efficient review and approval of operational controls and better tracking of international safety certifications. This approach will also provide new opportunities to streamline the sharing of data with ISS international partners while maintaining compliance with applicable laws and respecting restrictions on proprietary data. One goal of this paper is to outline the approach taken by the ISS Progrm to determine requirements for the new system and to devise a practical and efficient implementation strategy. From conception through implementation, ISS and NASA partners utilized a user-centered software development approach focused on user research and iterative design methods. The user-centered approach used on

  14. 30 CFR 75.806 - Connection of single-phase loads.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Connection of single-phase loads. 75.806 Section 75.806 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Underground High-Voltage Distribution...

  15. National Dam Safety Program. Lac Marseilles Dam (MO 30282), Mississippi - Kaskaskia - St. Louis Basin, St. Francois County, Missouri. Phase I Inspection Report.

    DTIC Science & Technology

    1981-01-01

    thereof in such quantity as will yield 50 pounds of nitrogen per acre. In the case of 33 per cent amonium nitrate , the above provisions will be interpreted...Dam Safety, Lake, Dam Inspection, Private Dams S& ASTRACT (Ct0- m -. d Idenuutyl by block number) This report was prepared under the National...may be obtained from the Office of the Chief of Engineer., Washington, D . C., 20314. The purpose of a Phase I investigation is not to provide a

  16. Goal Engagement during the School-Work Transition: Beneficial for All, Particularly for Girls

    ERIC Educational Resources Information Center

    Haase, Claudia M.; Heckhausen, Jutta; Koller, Olaf

    2008-01-01

    The school-to-work transition presents a substantial regulatory challenge for youth in modern societies. Based on the action-phase model of developmental regulation, we investigated the effects of goal engagement on transition outcomes in a high-density longitudinal study of noncollege-bound German adolescents (N = 362). Career-related goal…

  17. Student Goals: Psychological Perspectives

    ERIC Educational Resources Information Center

    Muirhead, Brent; Little, Jennifer

    2008-01-01

    The paper will discuss research insights into student academic goals. Cognitive psychologists have found that effective goal setting procedures involves establishing specific and challenging learning objectives. Students who set difficult goals must be persistent while facing the risk of potential failure that could diminish their intrinsic…

  18. Promoting Health and Safety. Skills for Independent Living.

    ERIC Educational Resources Information Center

    Agran, Martin, Ed.; And Others

    This guidebook provides behavioral-instructional strategies for teaching essential personal safety skills and promoting overall well-being to persons with developmental disabilities. Case studies demonstrate these strategies in practice, and detailed curriculum goals are included to guide intervention efforts. To ensure that learners both…

  19. Older adults' influence in family care: how do daughters and aging parents navigate differences in care goals?

    PubMed

    Heid, Allison R; Zarit, Steven H; Van Haitsma, Kimberly

    2016-01-01

    This study seeks to address how older adults influence their daily care when their preferences conflict with those of their adult daughter caregivers. Using a sample of 10 dyads (N = 20) of an older adult and adult daughter, we utilize content analysis strategies to analyze in-depth, semi-structured interview data with QSR NVIVO to investigate how older adults influence their care, how daughters respond to such efforts of influence, and how dyads navigate differences in care goals. When there is agreement in goals, dyads report tasks going well and both individuals' requests are honored. When there are differences in care goals, daughters most frequently reason with their older parents, while parents walk away or 'let go' of their requests. Daughters report making decisions for their parents for health or safety-related needs. However, all dyads discuss differences in care goals, whereby parents are perceived as insisting, resisting, or persisting in care. Findings illustrate complex patterns of responses by families when navigating differences in daily care goals that carry important implications for research and the development of dyadic-based family interventions.

  20. Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease: Randomized Phase 2b Safety and Efficacy Trial

    PubMed Central

    Lambert, Paul R.; Carey, John; Mikulec, Anthony A.; LeBel, Carl

    2016-01-01

    Objective: To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease. Study Design: Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months. Setting: Fifty-two academic and community otolaryngology centers. Patients: One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive. Intervention: Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo. Main Outcome Measures: Efficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry). Results: Primary endpoint (change from baseline in vertigo rate at Month 3) was not statistically significant (placebo [−43%], OTO-104 [−61%], P = 0.067). Improvements with OTO-104 were observed in prospectively defined secondary endpoints number of days with definitive vertigo, (Month 2 [P = 0.035], Month 3 [P = 0.030]), vertigo severity (Months 2–3, P = 0.046) and daily vertigo counts (Month 2, P = 0.042), and in some Short Form-36 (SF-36) subscales (Month 2 bodily pain P = 0.039, vitality P = 0.045, social functioning P = 0.025). No difference in tinnitus loudness or tinnitus handicap inventory (THI-25) was observed. OTO-104 was well tolerated; no negative impact on safety compared with placebo. Persistent tympanic membrane perforation was observed in two OTO-104 treated patients at study end. Conclusion: OTO-104 was well-tolerated, did not significantly affect change from baseline in vertigo rate, but did reduce number definitive vertigo days, vertigo severity, and average daily vertigo count compared with placebo during Month 3. Results provide insight into analyzing for a vertigo treatment effect and support advancing OTO-104 into Phase 3 clinical trials for the treatment of Ménière's disease symptoms. PMID:27749754

  1. Directory of aerospace safety specialized information sources

    NASA Technical Reports Server (NTRS)

    Fullerton, E. A.; Rubens, L. S.

    1973-01-01

    A directory is presented to make available to the aerospace safety community a handbook of organizations and experts in specific, well-defined areas of safety technology. It is designed for the safety specialist as an aid for locating both information sources and individual points of contact (experts) in engineering related fields. The file covers sources of data in aerospace design, tests, as well as information in hazard and failure cause identification, accident analysis, materials characteristics, and other related subject areas. These 171 organizations and their staff members, hopefully, should provide technical information in the form of documentation, data and consulting expertise. These will be sources that have assembled and collated their information, so that it will be useful in the solution of engineering problems. One of the goals of the project in the United States that have and are willing to share data of value to the aerospace safety community.

  2. The goal of making friends for youth with disabilities: creating a goal menu.

    PubMed

    Gerhardt, S; McCallum, A; McDougall, C; Keenan, S; Rigby, P

    2015-11-01

    Clinicians working with youth with disabilities have acknowledged making friends as a commonly identified client goal. Clinicians find this goal difficult to address, as there are no measures that provide a breakdown of making friends into functional steps. In addition, research on friendship has traditionally focused on characteristics and quality of friendships rather than the friend-making process as a whole. A goal menu, comprised of a variety of steps that address the goal of making friends, would provide guidance to clinicians challenged with this goal in practice. To develop an understanding of the friend-making process as a first step towards the development of a goal menu for the goal of making friends. A literature review, youth focus group and expert clinician semi-structured interviews and consultation were used to generate a comprehensive data set. Established qualitative methods were used to sort and group the data into categories. A thematic analysis of the categories was performed. Analysis revealed four themes integral to the friend-making process: person factors influencing friend-making, making friend-making a priority, opportunity for friend-making and motivation to make friends. An additional theme identified as occasionally involved in the process was a little bit of luck in making friends. The themes generated by this research indicate that actionable target areas exist for the somewhat abstract notion of friend-making and the authors recommend that clinicians explore beyond person factors when addressing the goal of making friends. As a next step, the identified themes will provide the foundation for a goal menu, ultimately enabling clinicians to address the goal of making friends in a more efficient and effective manner. © 2015 John Wiley & Sons Ltd.

  3. ProgrammingRationalAgents in GOAL

    NASA Astrophysics Data System (ADS)

    Hindriks, Koen V.

    The agent programming language GOAL is a high-level programming language to program rational agents that derive their choice of action from their beliefsand goals. The language provides the basic building blocks to design and implementrationalagents by meansofa setofprogramming constructs. These programming constructs allow and facilitate the manipulation of an agent’sbeliefs and goals and to structure its decision-making. GOAL agents are called rational because they satisfy a numberof basic rationality constraints and because they decide to perform actions to further their goals based uponareasoning scheme derived from practical reasoning. The programming concepts of belief and goal incorporated into GOAL provide the basis for this form of reasoning and are similarto their common sense counterparts used everyday to explain the actions that we perform. In addition, GOAL provides the means for agents to focus their attention on specic goals and to communicate at the knowledge level. This provides an intuitive basis for writing high-level agent programs. At the same time these concepts and programming constructs have a well-dened, formal semantics. The formal semantics provides the basis for deninga verication framework for GOAL for verifying and reasoning about GOAL agents whichis similar to some of the wellknownagent logics introduced in the literature.

  4. Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial.

    PubMed

    Mendonça-da-Silva, Iran; Magela Tavares, Antônio; Sachett, Jacqueline; Sardinha, José Felipe; Zaparolli, Lilian; Gomes Santos, Maria Fátima; Lacerda, Marcus; Monteiro, Wuelton Marcelo

    2017-11-01

    In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability. This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms. Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial. ISRCTNregistry: ISRCTN12845255; DOI: 10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255).

  5. Stability and Change in Social Goals as Related to Goal Structures and Engagement in School

    ERIC Educational Resources Information Center

    Madjar, Nir

    2017-01-01

    The current studies explored (a) the extended external validity of social-goal-orientation framework; (b) the mediating role of social goals between classroom goal structures and students' engagement; and (c) whether changes in social goals can be explained by classroom goal structures and engagement. Study 1 was cross-sectional (N = 317), and…

  6. Nuclear Safety. Technical progress journal, April--June 1996: Volume 37, No. 2

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

    Muhlheim, M D

    1996-01-01

    This journal covers significant issues in the field of nuclear safety. Its primary scope is safety in the design, construction, operation, and decommissioning of nuclear power reactors worldwide and the research and analysis activities that promote this goal, but it also encompasses the safety aspects of the entire nuclear fuel cycle, including fuel fabrication, spent-fuel processing and handling, nuclear waste disposal, the handling of fissionable materials and radioisotopes, and the environmental effects of all these activities.

  7. Major accident prevention through applying safety knowledge management approach.

    PubMed

    Kalatpour, Omid

    2016-01-01

    Many scattered resources of knowledge are available to use for chemical accident prevention purposes. The common approach to management process safety, including using databases and referring to the available knowledge has some drawbacks. The main goal of this article was to devise a new emerged knowledge base (KB) for the chemical accident prevention domain. The scattered sources of safety knowledge were identified and scanned. Then, the collected knowledge was formalized through a computerized program. The Protégé software was used to formalize and represent the stored safety knowledge. The domain knowledge retrieved as well as data and information. This optimized approach improved safety and health knowledge management (KM) process and resolved some typical problems in the KM process. Upgrading the traditional resources of safety databases into the KBs can improve the interaction between the users and knowledge repository.

  8. An organizational process for promoting home fire safety in two community settings.

    PubMed

    Lehna, Carlee; Twyman, Stephanie; Fahey, Erin; Coty, Mary-Beth; Williams, Joe; Scrivener, Drane; Wishnia, Gracie; Myers, John

    2017-02-01

    The purpose of this study was to describe the home fire safety quality improvement model designed to aid organizations in achieving institutional program goals. The home fire safety model was developed from community-based participatory research (CBPR) applying training-the-trainer methods and is illustrated by an institutional case study. The model is applicable to other types of organizations to improve home fire safety in vulnerable populations. Utilizing the education model leaves trained employees with guided experience to build upon, adapt, and modify the home fire safety intervention to more effectively serve their clientele, promote safety, and meet organizational objectives. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  9. Corrections in Grasp Posture in Response to Modifications of Action Goals

    PubMed Central

    Hughes, Charmayne M. L.; Seegelke, Christian; Spiegel, Marnie Ann; Oehmichen, Corinna; Hammes, Julia; Schack, Thomas

    2012-01-01

    There is ample evidence that people plan their movements to ensure comfortable final grasp postures at the end of a movement. The end-state comfort effect has been found to be a robust constraint during unimanual movements, and leads to the inference that goal-postures are represented and planned prior to movement initiation. The purpose of this study was to examine whether individuals make appropriate corrections to ensure comfortable final goal postures when faced with an unexpected change in action goal. Participants reached for a horizontal cylinder and placed the left or right end of the object into the target disk. As soon as the participant began to move, a secondary stimuli was triggered, which indicated whether the intended action goal had changed or not. Confirming previous research, participants selected initial grasp postures that ensured end-state comfort during non-perturbed trials. In addition, participants made appropriate on-line corrections to their reach-to-grasp movements to ensure end-state comfort during perturbed trials. Corrections in grasp posture occurred early or late in the reach-to-grasp phase. The results indicate that individuals plan their movements to afford comfort at the end of the movement, and that grasp posture planning is controlled via both feedforward and feedback mechanisms. PMID:22970119

  10. Goal setting in psychotherapy: the relevance of approach and avoidance goals for treatment outcome.

    PubMed

    Wollburg, Eileen; Braukhaus, Christoph

    2010-07-01

    The present study is the first aimed at investigating the influence of goal definition on treatment outcome in a sample of depressed patients. Data from 657 inpatients admitted to a psychosomatic clinic in Germany being treated in a cognitive-behavioral therapy program were analyzed. Treatment goals were identified as either approach or avoidance, and the sample was classified accordingly. Patients who identified approach goals only were placed in the approach group, and those who identified at least one avoidance goal were placed in the avoidance group. Results showed that framing goals using avoidance terms was associated with less symptomatic improvement but did not affect goal attainment. Findings from this research should be utilized in practice not only for process management such as individual treatment planning but also to control outcome quality. Furthermore, goal definition should be considered as a control variable in research on depression.

  11. Safety and economic impact of Texas travel information centers.

    DOT National Transportation Integrated Search

    2014-12-01

    The overall goal of this research was to develop a methodology and gather sufficient data to quantify the : impact of Texas Travel Information Center staff and services on the safety of travelers on Texas roadways. : Researchers used data and analyti...

  12. Patient Safety Reporting Systems: Sustained Quality Improvement Using a Multidisciplinary Team and “Good Catch” Awards

    PubMed Central

    Herzer, Kurt R.; Mirrer, Meredith; Xie, Yanjun; Steppan, Jochen; Li, Matthew; Jung, Clinton; Cover, Renee; Doyle, Peter A.; Mark, Lynette J.

    2014-01-01

    Background Since 1999, hospitals have made substantial commitments to healthcare quality and patient safety through individual initiatives of executive leadership involvement in quality, investments in safety culture, education and training for medical students and residents in quality and safety, the creation of patient safety committees, and implementation of patient safety reporting systems. Cohesive quality and safety approaches have become comprehensive programs to identify and mitigate hazards that could harm patients. This article moves to the next level with an intense refocusing of attention on one of the individual components of a comprehensive program--the patient safety reporting system—with a goal of maximized usefulness of the reports and long-term sustainability of quality improvements arising from them. Methods A six-phase framework was developed to deal with patient safety hazards: identify, report, analyze, mitigate, reward, and follow up. Unique features of this process included a multidisciplinary team to review reports, mitigate hazards, educate and empower providers, recognize the identifying/reporting individuals or groups with “Good Catch” awards, and follow up to determine if quality improvements were sustained over time. Results To date, 29 patient safety hazards have gone through this process with “Good Catch” awards being granted at our institution. These awards were presented at various times over the past 4 years since the process began in 2008. Follow-up revealed that 86% of the associated quality improvements have been sustained over time since the awards were given. We present the details of two of these “Good Catch” awards: vials of heparin with an unusually high concentration of the drug that posed a potential overdose hazard and a rapid infusion device that resisted practitioner control. Conclusion A multidisciplinary team's analysis and mitigation of hazards identified in a patient safety reporting system, positive

  13. Developing Probabilistic Safety Performance Margins for Unknown and Underappreciated Risks

    NASA Technical Reports Server (NTRS)

    Benjamin, Allan; Dezfuli, Homayoon; Everett, Chris

    2015-01-01

    Probabilistic safety requirements currently formulated or proposed for space systems, nuclear reactor systems, nuclear weapon systems, and other types of systems that have a low-probability potential for high-consequence accidents depend on showing that the probability of such accidents is below a specified safety threshold or goal. Verification of compliance depends heavily upon synthetic modeling techniques such as PRA. To determine whether or not a system meets its probabilistic requirements, it is necessary to consider whether there are significant risks that are not fully considered in the PRA either because they are not known at the time or because their importance is not fully understood. The ultimate objective is to establish a reasonable margin to account for the difference between known risks and actual risks in attempting to validate compliance with a probabilistic safety threshold or goal. In this paper, we examine data accumulated over the past 60 years from the space program, from nuclear reactor experience, from aircraft systems, and from human reliability experience to formulate guidelines for estimating probabilistic margins to account for risks that are initially unknown or underappreciated. The formulation includes a review of the safety literature to identify the principal causes of such risks.

  14. Organizational climate determinants of resident safety culture in nursing homes.

    PubMed

    Arnetz, Judith E; Zhdanova, Ludmila S; Elsouhag, Dalia; Lichtenberg, Peter; Luborsky, Mark R; Arnetz, Bengt B

    2011-12-01

    In recent years, there has been an increasing focus on the role of safety culture in preventing costly adverse events, such as medication errors and falls, among nursing home residents. However, little is known regarding critical organizational determinants of a positive safety culture in nursing homes. The aim of this study was to identify organizational climate predictors of specific aspects of the staff-rated resident safety culture (RSC) in a sample of nursing homes. Staff at 4 Michigan nursing homes responded to a self-administered questionnaire measuring organizational climate and RSC. Multiple regression analyses were used to identify organizational climate factors that predicted the safety culture dimensions nonpunitive response to mistakes, communication about incidents, and compliance with procedures.  The organizational climate factors efficiency and work climate predicted nonpunitive response to mistakes (p < .001 for both scales) and compliance with procedures (p < .05 and p < .001 respectively). Work stress was an inverse predictor of compliance with procedures (p < .05). Goal clarity was the only significant predictor of communication about incidents (p < .05). Efficiency, work climate, work stress, and goal clarity are all malleable organizational factors that could feasibly be the focus of interventions to improve RSC. Future studies will examine whether these results can be replicated with larger samples.

  15. Determining Safety Inspection Thresholds for Employee Incentives Programs on Construction Sites

    PubMed Central

    Sparer, Emily; Dennerlein, Jack

    2017-01-01

    The goal of this project was to evaluate approaches of determining the numerical value of a safety inspection score that would activate a reward in an employee safety incentive program. Safety inspections are a reflection of the physical working conditions at a construction site and provide a safety score that can be used in incentive programs to reward workers. Yet it is unclear what level of safety should be used when implementing this kind of program. This study explored five ways of grouping safety inspection data collected during 19 months at Harvard University-owned construction projects. Each approach grouped the data by one of the following: owner, general contractor, project, trade, or subcontractor. The median value for each grouping provided the threshold score. These five approaches were then applied to data from a completed project in order to calculate the frequency and distribution of rewards in a monthly safety incentive program. The application of each approach was evaluated qualitatively for consistency, competitiveness, attainability, and fairness. The owner-specific approach resulted in a threshold score of 96.3% and met all of the qualitative evaluation goals. It had the most competitive reward distribution (only 1/3 of the project duration) yet it was also attainable. By treating all workers equally and maintaining the same value throughout the project duration, this approach was fair and consistent. The owner-based approach for threshold determination can be used by owners or general contractors when creating leading indicator incentives programs and by researchers in future studies on incentive program effectiveness. PMID:28638178

  16. Achievement goals affect metacognitive judgments

    PubMed Central

    Ikeda, Kenji; Yue, Carole L.; Murayama, Kou; Castel, Alan D.

    2017-01-01

    The present study examined the effect of achievement goals on metacognitive judgments, such as judgments of learning (JOLs) and metacomprehension judgments, and actual recall performance. We conducted five experiments manipulating the instruction of achievement goals. In each experiment, participants were instructed to adopt mastery-approach goals (i.e., develop their own mental ability through a memory task) or performance-approach goals (i.e., demonstrate their strong memory ability through getting a high score on a memory task). The results of Experiments 1 and 2 showed that JOLs of word pairs in the performance-approach goal condition tended to be higher than those in the mastery-approach goal condition. In contrast, cued recall performance did not differ between the two goal conditions. Experiment 3 also demonstrated that metacomprehension judgments of text passages were higher in the performance-approach goal condition than in the mastery-approach goals condition, whereas test performance did not differ between conditions. These findings suggest that achievement motivation affects metacognitive judgments during learning, even when achievement motivation does not influence actual performance. PMID:28983496

  17. Materials-related issues in the safety and licensing of nuclear fusion facilities

    NASA Astrophysics Data System (ADS)

    Taylor, N.; Merrill, B.; Cadwallader, L.; Di Pace, L.; El-Guebaly, L.; Humrickhouse, P.; Panayotov, D.; Pinna, T.; Porfiri, M.-T.; Reyes, S.; Shimada, M.; Willms, S.

    2017-09-01

    Fusion power holds the promise of electricity production with a high degree of safety and low environmental impact. Favourable characteristics of fusion as an energy source provide the potential for this very good safety and environmental performance. But to fully realize the potential, attention must be paid in the design of a demonstration fusion power plant (DEMO) or a commercial power plant to minimize the radiological hazards. These hazards arise principally from the inventory of tritium and from materials that become activated by neutrons from the plasma. The confinement of these radioactive substances, and prevention of radiation exposure, are the primary goals of the safety approach for fusion, in order to minimize the potential for harm to personnel, the public, and the environment. The safety functions that are implemented in the design to achieve these goals are dependent on the performance of a range of materials. Degradation of the properties of materials can lead to challenges to key safety functions such as confinement. In this paper the principal types of material that have some role in safety are recalled. These either represent a potential source of hazard or contribute to the amelioration of hazards; in each case the related issues are reviewed. The resolution of these issues lead, in some instances, to requirements on materials specifications or to limits on their performance.

  18. Self-regulation of goal setting: turning free fantasies about the future into binding goals.

    PubMed

    Oettingen, G; Pak, H; Schnetter, K

    2001-05-01

    Fantasy realization theory states that when people contrast their fantasies about a desired future with reflections on present reality, a necessity to act is induced that leads to the activation and use of relevant expectations. Strong goal commitment arises in light of favorable expectations, and weak goal commitment arises in light of unfavorable expectations. To the contrary, when people only fantasize about a desired future or only reflect on present reality, expectancy-independent moderate goal commitment emerges. Four experiments pertaining to various life domains supported these hypotheses. Strength of goal commitment was assessed in cognitive (e.g., making plans), affective (e.g., felt attachment), and behavioral terms (e.g., effort expenditure, quality of performance). Implications for theories on goal setting and goal striving are discussed.

  19. From goal motivation to goal progress: the mediating role of coping in the Self-Concordance Model.

    PubMed

    Gaudreau, Patrick; Carraro, Natasha; Miranda, Dave

    2012-01-01

    The present studies examined the mediating role of self-regulatory mechanisms in the relationship between goal motivation and goal progress in the Self-Concordance Model. First, a systematic review, using meta-analytical path analysis, supported the mediating role of effort and action planning in the positive association between autonomous goal motivation and goal progress. Second, results from two additional empirical studies, using structural equation modeling, lent credence to the mediating role of coping in the relationship between goal motivation and goal progress of university students. Autonomous goal motivation was positively associated with task-oriented coping, which predicted greater goal progress during midterm exams (Study 1, N=702) and at the end of the semester in a different sample (Study 2, N=167). Controlled goal motivation was associated with greater disengagement-oriented coping (Study 1 and Study 2) and lesser use of task-oriented coping (Study 2), which reduced goal progress. These results held up after controlling for perceived stress (Study 2). Our findings highlight the importance of coping in the "inception-to-attainment" goal process because autonomous goal motivation indirectly rather than directly predicts goal progress of university students through their usage of task-oriented coping.

  20. Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

    PubMed

    Kapur, Ajay; Potters, Louis

    2012-01-01

    The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed

  1. Closed medical negligence claims can drive patient safety and reduce litigation.

    PubMed

    Pegalis, Steven E; Bal, B Sonny

    2012-05-01

    Medical liability reform is viewed by many physician groups as a means of reducing medical malpractice litigation and lowering healthcare costs. However, alternative approaches such as closed medical negligence claims data may also achieve these goals. We asked whether information gleaned from closed claims related to medical negligence could promote patient safety and reduce costs related to medical liability. Specifically, we investigated whether physician groups have examined such data to identify error patterns and to then institute specific patient treatment protocols. We searched for medical societies that have systematically examined closed medical negligence claims in their specialty to develop specific standards of physician conduct. We then searched the medical literature for published evidence of the efficacy, if any, related to the patient safety measures thus developed. Anesthesia and obstetric physician societies have successfully targeted costs and related concerns arising from medical malpractice lawsuits by using data from closed claims to develop patient safety and treatment guidelines. In both specialties, after institution of safety measures derived from closed medical negligence claims, the incidence and costs related to medical malpractice decreased and physician satisfaction improved. Tort reform, in the form of legislatively prescribed limits on damages arising from lawsuits, is not the only means of addressing the incidence and costs related to medical malpractice litigation. As the experience of anesthesia and obstetric physicians has demonstrated, safety guidelines derived from analyzing past medical malpractice litigation can achieve the same goals while also promoting patient safety.

  2. Establishing Community College Goals.

    ERIC Educational Resources Information Center

    Leeson, Marjorie

    In 1975, Delta College began a project to prepare a set of institutional goals and a mission statement for consideration and adoption by the college Senate and Board of Trustees, and to identify those goals that should take priority over the following five years. All areas of the college were represented on the goal development committee, and to…

  3. Rilonacept for gout flare prevention in patients receiving uric acid-lowering therapy: results of RESURGE, a phase III, international safety study.

    PubMed

    Sundy, John S; Schumacher, H Ralph; Kivitz, Alan; Weinstein, Steven P; Wu, Richard; King-Davis, Shirletta; Evans, Robert R

    2014-08-01

    To evaluate the safety and efficacy of once-weekly subcutaneous rilonacept 160 mg for prevention of gout flares in patients initiating or continuing urate-lowering therapy (ULT). This phase III study was conducted in the United States, South Africa, Europe, and Asia. Adults (n = 1315, 18-80 yrs) with gout, who were initiating or continuing ULT, were randomized to treatment with weekly subcutaneous injections of rilonacept 160 mg or placebo for 16 weeks followed by a 4-week safety followup. The primary endpoint was safety, assessed by adverse events (AE) and laboratory values. Efficacy was a secondary endpoint. Demographic and clinical characteristics were similar between treatments; predominantly male (87.8%), mean age 52.7 ± 11.3 years. Patients with ≥ 1 AE were 66.6% with rilonacept versus 59.1% placebo, with slightly more AE-related withdrawals with rilonacept (4.7% vs 3.0%) because of the greater incidence of injection site reactions (15.2% rilonacept, 3.3% placebo). Serious AE were similar in both groups, as were serious infections (0.9% placebo, 0.5% rilonacept); no tuberculosis or opportunistic infections occurred. Most common AE were headache, arthralgia, injection site erythema, accidental overdose, and pain in extremity. Of the 6 deaths, only 1 in the placebo group was considered treatment-related. At Week 16, rilonacept resulted in 70.3% fewer gout flares per patient (p < 0.0001), fewer patients with ≥ 1 and ≥ 2 gout flares (p < 0.0001), and 64.9% fewer gout flare days (p < 0.0001) relative to placebo. Weekly subcutaneous administration of rilonacept 160 mg showed no new safety signals. The safety profile was consistent with previous studies. Rilonacept also significantly reduced the risk of gout flares. Clinicaltrials.gov identifier NCT00856206; EudraCT No. 2008-007784-16.

  4. Predicting race performance in triathlon: the role of perfectionism, achievement goals, and personal goal setting.

    PubMed

    Stoeber, Joachim; Uphill, Mark A; Hotham, Sarah

    2009-04-01

    The question of how perfectionism affects performance is highly debated. Because empirical studies examining perfectionism and competitive sport performance are missing, the present research investigated how perfectionism affected race performance and what role athletes' goals played in this relationship in two prospective studies with competitive triathletes (Study 1: N = 112; Study 2: N = 321). Regression analyses showed that perfectionistic personal standards, high performance-approach goals, low performance-avoidance goals, and high personal goals predicted race performance beyond athletes' performance level. Moreover, the contrast between performance-avoidance and performance-approach goals mediated the relationship between perfectionistic personal standards and performance, whereas personal goal setting mediated the relationship between performance-approach goals and performance. The findings indicate that perfectionistic personal standards do not undermine competitive performance, but are associated with goals that help athletes achieve their best possible performance.

  5. Students' Achievement Goal Orientations and Their Behavioral and Emotional Engagement: Co-Examining the Role of Perceived School Goal Structures and Parent Goals during Adolescence

    ERIC Educational Resources Information Center

    Gonida, Eleftheria N.; Voulala, Katerina; Kiosseoglou, Grigoris

    2009-01-01

    The role of perceived school goal structures and parent goals in predicting adolescents' goal orientations and their behavioral and emotional engagement in the classroom was examined in the present study. Surveys were given to a sample of 271 seventh- and ninth-grade students. Path analyses showed that (a) perceived school mastery goal structures…

  6. A relational leadership perspective on unit-level safety climate.

    PubMed

    Thompson, Debra N; Hoffman, Leslie A; Sereika, Susan M; Lorenz, Holly L; Wolf, Gail A; Burns, Helen K; Minnier, Tamra E; Ramanujam, Rangaraj

    2011-11-01

    This study compared nursing staff perceptions of safety climate in clinical units characterized by high and low ratings of leader-member exchange (LMX) and explored characteristics that might account for differences. Frontline nursing leaders' actions are critical to ensure patient safety. Specific leadership behaviors to achieve this goal are underexamined. The LMX perspective has shown promise in nonhealthcare settings as a means to explain safety climate perceptions. Cross-sectional survey of staff (n = 711) and unit directors from 34 inpatient units in an academic medical center was conducted. Significant differences were found between high and low LMX scoring units on supervisor safety expectations, organizational learning-continuous improvement, total communication, feedback and communication about errors, and nonpunitive response to errors. The LMX perspective can be used to identify differences in perceptions of safety climate among nursing staff. Future studies are needed to identify strategies to improve staff safety attitudes and behaviors. Copyright © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins

  7. Preliminary Results Obtained in Integrated Safety Analysis of NASA Aviation Safety Program Technologies

    NASA Technical Reports Server (NTRS)

    Reveley, Mary S.

    2003-01-01

    The goal of the NASA Aviation Safety Program (AvSP) is to develop and demonstrate technologies that contribute to a reduction in the aviation fatal accident rate by a factor of 5 by the year 2007 and by a factor of 10 by the year 2022. Integrated safety analysis of day-to-day operations and risks within those operations will provide an understanding of the Aviation Safety Program portfolio. Safety benefits analyses are currently being conducted. Preliminary results for the Synthetic Vision Systems (SVS) and Weather Accident Prevention (WxAP) projects of the AvSP have been completed by the Logistics Management Institute under a contract with the NASA Glenn Research Center. These analyses include both a reliability analysis and a computer simulation model. The integrated safety analysis method comprises two principal components: a reliability model and a simulation model. In the reliability model, the results indicate how different technologies and systems will perform in normal, degraded, and failed modes of operation. In the simulation, an operational scenario is modeled. The primary purpose of the SVS project is to improve safety by providing visual-flightlike situation awareness during instrument conditions. The current analyses are an estimate of the benefits of SVS in avoiding controlled flight into terrain. The scenario modeled has an aircraft flying directly toward a terrain feature. When the flight crew determines that the aircraft is headed toward an obstruction, the aircraft executes a level turn at speed. The simulation is ended when the aircraft completes the turn.

  8. Phased Retrofits in Existing Homes in Florida Phase I: Shallow and Deep Retrofits

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

    D. Parker; Sutherland, K.; Chasar, D.

    2016-02-01

    The U.S. Department of Energy (DOE) Building America program, in collaboration with Florida Power and Light (FPL), conducted a phased residential energy-efficiency retrofit program. This research sought to establish impacts on annual energy and peak energy reductions from the technologies applied at two levels of retrofit - shallow and deep, with savings levels approaching the Building America program goals of reducing whole-house energy use by 40%. Under the Phased Deep Retrofit (PDR) project, we have installed phased, energy-efficiency retrofits in a sample of 56 existing, all-electric homes. End-use savings and economic evaluation results from the phased measure packages and singlemore » measures are summarized in this report.« less

  9. 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.

  10. 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

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

    PubMed

    Choudhry, Rafiq M

    2014-09-01

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

  12. Performance Based Traffic Safety Education Course. Two-Phase Program.

    ERIC Educational Resources Information Center

    Washington State Board of Education, Olympia.

    This course for high school highway traffic safety education is intended to help students learn to make good driving decisions. It consists of twenty-one modules--ten sequenced, two not in specific sequence but intended to be completed in the earlier part of the course, and nine non-sequenced modules. Each module begins with an outline providing…

  13. Nuclear Safety. Technical progress journal, January--March 1994: Volume 35, No. 1

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

    Silver, E G

    1994-01-01

    This is a journal that covers significant issues in the field of nuclear safety. Its primary scope is safety in the design, construction, operation, and decommissioning of nuclear power reactors worldwide and the research and analysis activities that promote this goal, but it also encompasses the safety aspects of the entire nuclear fuel cycle, including fuel fabrication, spent-fuel processing and handling, and nuclear waste disposal, the handling of fissionable materials and radioisotopes, and the environmental effects of all these activities.

  14. MISSION: Mission and Safety Critical Support Environment. Executive overview

    NASA Technical Reports Server (NTRS)

    Mckay, Charles; Atkinson, Colin

    1992-01-01

    For mission and safety critical systems it is necessary to: improve definition, evolution and sustenance techniques; lower development and maintenance costs; support safe, timely and affordable system modifications; and support fault tolerance and survivability. The goal of the MISSION project is to lay the foundation for a new generation of integrated systems software providing a unified infrastructure for mission and safety critical applications and systems. This will involve the definition of a common, modular target architecture and a supporting infrastructure.

  15. An overview of the safety pharmacology society strategic plan.

    PubMed

    Pugsley, M K; Authier, S; Koerner, J E; Redfern, W S; Markgraf, C G; Brabham, T; Correll, K; Soloviev, M V; Botchway, A; Engwall, M; Traebert, M; Valentin, J-P; Mow, T J; Greiter-Wilke, A; Leishman, D J; Vargas, H M

    2018-01-09

    Safety Pharmacology studies are conducted to characterize the confidence by which biologically active new chemical entities (NCE) may be anticipated as safe. Non-clinical safety pharmacology studies aim to detect and characterize potentially undesirable pharmacodynamic activities using an array of in silico, in vitro and in vivo animal models. While a broad spectrum of methodological innovation and advancement of the science occurs within the Safety Pharmacology Society, the society also focuses on partnerships with health authorities and technology providers and facilitates interaction with organizations of common interest such as pharmacology, physiology, neuroscience, cardiology and toxicology. Education remains a primary emphasis for the society through content derived from regional and annual meetings, webinars and publication of its works it seeks to inform the general scientific and regulatory community. In considering the future of safety pharmacology the society has developed a strategy to successfully navigate forward and not be mired in stagnation of the discipline. Strategy can be defined in numerous ways but generally involves establishing and setting goals, determining what actions are needed to achieve those goals, and mobilizing resources within the society to accomplish the actions. The discipline remains in rapid evolution and its coverage is certain to expand to provide better guidance for more systems in the next few years. This overview from the Safety Pharmacology Society will outline the strategic plan from 2016 to 2018 and beyond and provide insight into the future of the discipline which builds upon a previous strategic plan established in 2009. Copyright © 2018 Elsevier Inc. All rights reserved.

  16. Long-term safety and efficacy of canakinumab in cryopyrin-associated periodic syndrome: results from an open-label, phase III pivotal study in Japanese patients.

    PubMed

    Yokota, Shumpei; Imagawa, Tomoyuki; Nishikomori, Ryuta; Takada, Hidetoshi; Abrams, Ken; Lheritier, Karine; Heike, Toshio; Hara, Toshiro

    2017-01-01

    To assess the long-term safety and efficacy of canakinumab in Japanese patients with cryopyrin-associated periodic syndrome (CAPS). In this open-label phase 3 study, Japanese patients aged ≥2 years with CAPS received canakinumab 2-8 mg/kg subcutaneously every 8 weeks. The duration of the core treatment phase was 24 weeks followed by 22 months extension phase. The primary objective was the proportion of patients free of clinical and serologic relapse at week 24. The study enrolled 19 Japanese patients (median age, 14 years; range, 2-48 years) with CAPS [MWS, 7 (36.8%); NOMID, 12 (63.2%)] for a median of 109 weeks. Fifteen patients (79%) achieved a complete response by day 15, 18 (94.7%) by week 24 and all by week 48. At the end of the study, 18 (95%) were free from relapse and 11 (57.9%) were assessed as having no disease activity by the PGA. Thirteen (68%) patients (MWS, 4; NOMID, 9) had their canakinumab dose increased during the trial. All patients experienced at least one adverse event (AE), the most common being infections (100%) and 5 (26.3%) reported serious AEs. No deaths were reported and the only patient who discontinued the study early withdrew consent. Regular canakinumab treatment every 8 weeks at dose levels from 2-8 mg/kg, based on the clinical need, represents a successful strategy to induce rapid and complete response while maintain long-term disease control in Japanese patients with CAPS. The safety profile of canakinumab was consistent with that observed from previous studies.

  17. Personal goals as predictors of intended classroom goals: comparing elementary and secondary school pre-service teachers.

    PubMed

    Daniels, Lia M; Frenzel, Anne C; Stupnisky, Robert H; Stewart, Tara L; Perry, Raymond P

    2013-09-01

    The literature documents fewer classroom mastery goal structures in secondary school compared to elementary. However, little is known about how personal achievement goals may influence classroom goal structures. This is especially true at the level of pre-service teachers. Our objective was to investigate if pre-service teachers' personal goals predicted their intended classroom goal structures. Participants were 125 elementary and 175 secondary school pre-service teachers from two Western Canadian universities. Structural equation modelling was used to examine if the structural relationships and latent means of personal and intended classroom goal structures differed for elementary and secondary school pre-service teachers. The results revealed that personal goals predicted the goal structures that pre-service teachers intended to establish; however, the relationships and means differed between elementary and secondary school pre-service teachers. Specifically, personal mastery-approach goals positively predicted classroom mastery goals much more strongly at the elementary than the secondary level. Furthermore, elementary pre-service teachers had significantly higher latent mean scores on personal mastery-approach goals than their secondary counterparts. It seems possible that the currently documented differences between classroom goal structures noted for elementary compared to secondary school may be based on the personal goals endorsed as pre-service teachers. The results are further discussed in terms of alignment with research on practising teachers' personal and classroom goals and implications for teacher education. © 2012 The British Psychological Society.

  18. Overview of physics goals for OP1.2a on Wendelstein 7-X

    NASA Astrophysics Data System (ADS)

    Pedersen, Thomas Sunn; W7-X Team

    2017-10-01

    Wendelstein 7-X achieved, and in many cases exceeded, the pre-defined goals for its first operation phase, OP1.1. Results include core values of Te = 8 keV, Ti = 2 keV and ne>3*1019 m-3 and confinement times of 100-150 ms. The next operation phase, OP1.2a, scheduled to start in fall 2017, features a much more elaborate set of plasma-facing components. 10 inertially cooled graphite test divertor units (TDU) have been installed, as have graphite tiles on all the heat shields and baffles. Upgrades have also been made to heating systems, diagnostics, and particle fueling systems. This will allow for significantly increased pulse lengths, heating power and plasma performance, in particular, higher plasma density, and higher ion temperatures, thereby enabling a much more detailed investigation of the W7-X optimization and significantly higher triple products than achieved in OP1.1. The robustness of the TDU allows for an aggressive exploration of divertor operation scenarios in this phase. The main goals and plans, and, if available, first results of OP1.2a will be presented. This work has been carried out within the framework of the EUROfusion Consortium and has received funding from the Euratom research and training programme 2014-2018 under Grant agreement No 633053.

  19. Social Goals and Well-Being

    ERIC Educational Resources Information Center

    King, Ronnel B.

    2017-01-01

    Students have various social reasons for doing well in school (social-academic goals). However, most studies have focused on competence-oriented achievement goals with little attention paid to social-academic goals. This study aims to examine the role of social-academic goals in students' general well-being (Study 1) and socioemotional functioning…

  20. Motivation of employers to encourage their employees to use safety belts (Phase 1)

    DOT National Transportation Integrated Search

    1982-05-01

    For the purpose of motivating employers to encourage their employees to use safety belts, a manual for employers, "The Profit in Safety Belts: A View for Employers", is developed. The manual brings to the attention of employers the various cost eleme...

  1. Goal striving, goal attainment, and well-being: adapting and testing the self-concordance model in sport.

    PubMed

    Smith, Alison; Ntoumanis, Nikos; Duda, Joan

    2007-12-01

    Grounded in self-determination theory (Deci & Ryan, 1985) and the self-concordance model (Sheldon & Elliot, 1999), this study examined the motivational processes underlying goal striving in sport as well as the role of perceived coach autonomy support in the goal process. Structural equation modeling with a sample of 210 British athletes showed that autonomous goal motives positively predicted effort, which, in turn, predicted goal attainment. Goal attainment was positively linked to need satisfaction, which, in turn, predicted psychological well-being. Effort and need satisfaction were found to mediate the associations between autonomous motives and goal attainment and between attainment and well-being, respectively. Controlled motives negatively predicted well-being, and coach autonomy support positively predicted both autonomous motives and need satisfaction. Associations of autonomous motives with effort were not reducible to goal difficulty, goal specificity, or goal efficacy. These findings support the self-concordance model as a framework for further research on goal setting in sport.

  2. Albiglutide for the treatment of type 2 diabetes mellitus: An integrated safety analysis of the HARMONY phase 3 trials.

    PubMed

    Ahrén, Bo; Carr, Molly C; Murphy, Karen; Perkins, Christopher; Rendell, Marc; Mallory, Jason; Wilson, Timothy; Johnson, Susan

    2017-04-01

    Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) stimulate the incretin system and lower glycaemic parameters in type 2 diabetes mellitus (T2DM). This analysis of clinical studies of up to 3years evaluated the safety of albiglutide, a GLP-1 RA, in people with T2DM. Integrated safety analysis included seven phase-3 T2DM studies of albiglutide compared with placebo and/or active comparators (a dipeptidyl peptidase-4 inhibitor, GLP-1 RA, insulin, sulphonylurea, and thiazolidinedione). Studies of 32months (HARMONY 7), 1year (HARMONY 6), and 3years (HARMONY 1-5), reported similar rates of adverse events (AEs) (84.8%, 82.3%), and serious AEs (13.1%, 12.9%) between albiglutide and all comparators, respectively. AEs that did not differ between the groups included symptomatic or severe hypoglycaemia as well as nausea (12.0%, 11.3%) and vomiting (5.3%, 4.7%) for albiglutide and all comparators, respectively. According to the Medical Dictionary for Regulatory Activities preferred terms, only diarrhoea (13.7%, 9.9%), injection-site reaction (9.0%, 2.0%), and peripheral oedema (4.5%, 6.8%) had at least 2% difference between the albiglutide and all-comparator groups. In a similar integrated analysis, pancreatitis occurred more often with albiglutide (0.3%, 0.1%). Renal and cardiac function did not differ between the two groups. In an integrated analysis of seven phase 3 clinical trials, albiglutide-treated patients experienced frequencies of AEs (including cardiovascular and renal) similar to the all-comparators group treated with other T2DM medications or placebo. Albiglutide treatment was associated with higher rates of diarrhoea and injection-site reactions, but not increased nausea and vomiting, versus all comparators. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Alcohol myopia and goal commitment

    PubMed Central

    Sevincer, A. Timur; Oettingen, Gabriele

    2014-01-01

    According to alcohol myopia theory, acute alcohol consumption leads people to disproportionally focus on the salient rather than the peripheral aspects of a situation. We summarize various studies exploring how myopic processes resulting from acute alcohol intake affect goal commitment. After consuming alcohol student participants felt strongly committed to an important personal goal even though they had low expectations of successfully attaining the goal. However, once intoxicated participants were sober again (i.e., not myopic anymore) they failed to act on their goal commitment. In line with alcohol myopia theory, strong goal commitment as a result of alcohol intake was mediated by intoxicated (vs. sober) participants disproportionally focusing on the desirability rather than the feasibility of their goal. Further supporting alcohol myopia theory, when the low feasibility of attaining a particular goal was experimentally made salient (either explicitly or implicitly by subliminal priming), intoxicated participants felt less committed than those who consumed a placebo. We discuss these effects of acute alcohol intake in the context of research on the effects of chronic alcohol consumption on goal commitment. PMID:24624106

  4. Safety analysis in test facility design

    NASA Astrophysics Data System (ADS)

    Valk, A.; Jonker, R. J.

    1990-09-01

    The application of safety analysis techniques as developed in, for example nuclear and petrochemical industry, can be very beneficial in coping with the increasing complexity of modern test facility installations and their operations. To illustrate the various techniques available and their phasing in a project, an overview of the most commonly used techniques is presented. Two case studies are described: the hazard and operability study techniques and safety zoning in relation to the possible presence of asphyxiating atmospheres.

  5. Revenue sources for financing transportation safety activities in Virginia : phase two, state sources.

    DOT National Transportation Integrated Search

    1980-01-01

    Senate Bill 85, an action of the 1978 General Assembly, amended the Code of Virginia to provide, in part, that the Division of Highway Safety be succeeded by the newly created Department of Transportation Safety effective July 1, 1978. In its Declara...

  6. Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial

    PubMed Central

    Mendonça-da-Silva, Iran; Magela Tavares, Antônio; Sachett, Jacqueline; Sardinha, José Felipe; Zaparolli, Lilian; Gomes Santos, Maria Fátima; Lacerda, Marcus

    2017-01-01

    Background In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability. Methods and findings This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms. Conclusions/Significance Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial. Trial registration ISRCTNregistry: ISRCTN12845255; DOI: 10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255). PMID:29176824

  7. Safety and efficacy of first-line bevacizumab with chemotherapy in Asian patients with advanced nonsquamous NSCLC: results from the phase IV MO19390 (SAiL) study.

    PubMed

    Tsai, Chun-Ming; Au, Joseph Siu-kie; Chang, Gee-Chen; Cheng, Ashley Chi-kin; Zhou, Caicun; Wu, Yi-long

    2011-06-01

    First-line treatment with bevacizumab combined with chemotherapy has been shown to improve outcomes in patients with advanced, nonsquamous non-small cell lung cancer (NSNSCLC) in phase III clinical trials. SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a preplanned subanalysis of Asian patients enrolled in SAiL. Patients with untreated, locally advanced, metastatic or recurrent NSNSCLC received bevacizumab 7.5 or 15 mg/kg every 3 weeks plus chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression. Eligibility criteria for SAiL permitted enrolment of a broad patient population. The primary end point was safety; secondary end points included time to disease progression and overall survival. The Asian intent-to-treat population comprised 314 of the 2212 patients enrolled in the SAiL trial. In the Asian subanalysis, patients received a median of nine cycles of bevacizumab, and the median follow-up was 16.4 months. The incidence of clinically significant adverse events (grade ≥3) of special interest was relatively low in this population (15.6% overall); proteinuria (7.6%), hypertension (4.8%), and bleeding (2.5%) were the most common. A total of five adverse events related to bevacizumab were reported as grade 5. Disease control rate was 94.1%, median time to disease progression was 8.3 months, and median overall survival was 18.9 months. The safety and efficacy of first-line bevacizumab-based treatment in Asian patients with advanced NSNSCLC is consistent with that demonstrated in phase III studies and in the overall SAiL population. There were no new safety signals.

  8. Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

    PubMed

    Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

    2018-02-01

    Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

  9. A phase I/II randomized, controlled, clinical trial for assessment of the efficacy and safety of β-D-mannuronic acid in rheumatoid arthritis patients.

    PubMed

    Ahmadi, Hossein; Jamshidi, Ahmad Reza; Gharibdoost, Farhad; Mahmoudi, Mahdi; Rastkari, Noushin; Mostafaei, Shayan; Fattahi, Mohammad Javad; Vojdanian, Mahdi; Cuzzocrea, Salvatore; Rehm, Bernd H A; Matsuo, Hidenori; Hosseini, Mostafa; Aghazadeh, Zahra; Mortazavi-Jahromi, Seyed Shahabeddin; Mirshafiey, Abbas

    2018-06-01

    Following the potent efficacy of β-D-mannuronic acid (M2000) in phase I/II trial in ankylosing spondylitis patients, the present clinical trial was conducted to evaluate the efficacy, safety, and tolerability of this novel drug in rheumatoid arthritis (RA) patients who had inadequate response to conventional therapy. The study was a 12-week randomized, controlled, phase I/II clinical trial with two treatment arms: M2000 and conventional treatment. Patients who had RA according to the modified American College of Rheumatology (ACR) criteria, with active disease at baseline also inadequate response to conventional therapy, were enrolled in this study. M2000 was administrated at a dose of two capsules (500 mg) per day orally during a period of 12 weeks. The primary endpoint was the proportion of patients fulfilling the ACR 20% improvement criteria after 12 weeks of M2000 therapy. Moreover, the patients were also followed up for safety. There were no statistically significant differences between treatment and conventional groups at baseline characteristics. The ACR20 response rate was significantly higher among M2000-treated patients than conventional-treated control, so that 74% of patients in treatment group showed an ACR20 response after 12 weeks of M2000 therapy (74 versus 16%; P = 0.011). 10% of M2000-treated patients and 57.1% of conventional-treated patient's adverse events occurred during this study. Treatment with M2000 in combination with conventional therapy showed a significantly superior efficacy along with a high safety profile compared to conventional-treated patients. Thereby, M2000 might be suggested as a suitable option in the treatment of RA.

  10. A conceptual framework for road safety and mobility applied to cycling safety.

    PubMed

    Schepers, Paul; Hagenzieker, Marjan; Methorst, Rob; van Wee, Bert; Wegman, Fred

    2014-01-01

    Scientific literature lacks a model which combines exposure to risk, risk, and the relationship between them. This paper presents a conceptual road safety framework comprising mutually interacting factors for exposure to risk resulting from travel behaviour (volumes, modal split, and distribution of traffic over time and space) and for risk (crash and injury risk). The framework's three determinants for travel behaviour are locations of activities; resistances (generalized transport costs); needs, opportunities, and abilities. Crash and injury risks are modelled by the three 'safety pillars': infrastructure, road users and the vehicles they use. Creating a link in the framework between risk and exposure is important because of the 'non-linear relationship' between them, i.e. risk tends to decrease as exposure increases. Furthermore, 'perceived' risk (a type of travel resistance) plays a role in mode choice, i.e. the perception that a certain type of vehicle is unsafe can be a deterrent to its use. This paper uses theories to explain how the elements in the model interact. Cycling is an area where governments typically have goals for both mobility and safety. To exemplify application of the model, the paper uses the framework to link research on cycling (safety) to land use and infrastructure. The model's value lies in its ability to identify potential consequences of measures and policies for both exposure and risk. This is important from a scientific perspective and for policy makers who often have objectives for both mobility and safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Malleability in communal goals and beliefs influences attraction to stem careers: evidence for a goal congruity perspective.

    PubMed

    Diekman, Amanda B; Clark, Emily K; Johnston, Amanda M; Brown, Elizabeth R; Steinberg, Mia

    2011-11-01

    The goal congruity perspective posits that 2 distinct social cognitions predict attraction to science, technology, engineering, or mathematics (STEM) fields. First, individuals may particularly value communal goals (e.g., working with or helping others), due to either chronic individual differences or the salience of these goals in particular contexts. Second, individuals hold beliefs about the activities that facilitate or impede these goals, or goal affordance stereotypes. Women's tendency to endorse communal goals more highly than do men, along with consensual stereotypes that STEM careers impede communal goals, intersect to produce disinterest in STEM careers. We provide evidence for the foundational predictions that gender differences emerge primarily on communal rather than agentic goals (Studies 1a and 3) and that goal affordance stereotypes reflect beliefs that STEM careers are relatively dissociated from communal goals (Studies 1b and 1c). Most critically, we provide causal evidence that activated communal goals decrease interest in STEM fields (Study 2) and that the potential for a STEM career to afford communal goals elicits greater positivity (Study 3). These studies thus provide a novel demonstration that understanding communal goals and goal affordance stereotypes can lend insight into attitudes toward STEM pursuits.

  12. Some evidence for the usefulness of an optimal foraging theory perspective on goal conflict and goal facilitation.

    PubMed

    Tomasik, Martin J; Knecht, Michaela; Freund, Alexandra M

    2017-12-01

    Based on optimal foraging theory, we propose a metric that allows evaluating the goodness of goal systems, that is, systems comprising multiple goals with facilitative and conflicting interrelations. This optimal foraging theory takes into account expectancy and value, as well as opportunity costs, of foraging. Applying this approach to goal systems provides a single index of goodness of a goal system for goal striving. Three quasi-experimental studies (N = 277, N = 145, and N = 210) provide evidence for the usefulness of this approach for goal systems comprising between 3 to 10 goals. Results indicate that persons with a more optimized goal-system are more conscientious and open to new experience, are more likely to represent their goals in terms of means (i.e., adopt a process focus), and are more satisfied and engaged with their goals. Persons with a suboptimal goal system tend to switch their goals more often and thereby optimize their goal system. We discuss limitations as well as possible future directions of this approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  13. Goal Setting as Teacher Development Practice

    ERIC Educational Resources Information Center

    Camp, Heather

    2017-01-01

    This article explores goal setting as a teacher development practice in higher education. It reports on a study of college teacher goal setting informed by goal setting theory. Analysis of study participants' goal setting practices and their experiences with goal pursuit offers a framework for thinking about the kinds of goals teachers might set…

  14. CenteringPregnancy-Africa: a pilot of group antenatal care to address Millennium Development Goals.

    PubMed

    Patil, Crystal L; Abrams, Elizabeth T; Klima, Carrie; Kaponda, Chrissie P N; Leshabari, Sebalda C; Vonderheid, Susan C; Kamanga, Martha; Norr, Kathleen F

    2013-10-01

    severe health worker shortages and resource limitations negatively affect quality of antenatal care (ANC) throughout sub-Saharan Africa. Group ANC, specifically CenteringPregnancy (CP), may offer an innovative approach to enable midwives to offer higher quality ANC. our overarching goal was to prepare to conduct a clinical trial of CenteringPregnancy-Africa (CP-Africa) in Malawi and Tanzania. In Phase 1, our goal was to determine the acceptability of CP as a model for ANC in both countries. In Phase 2, our objective was to develop CP-Africa session content consistent with the Essential Elements of CP model and with national standards in both Malawi and Tanzania. In Phase 3, our objective was to pilot CP-Africa in Malawi to determine whether sessions could be conducted with fidelity to the Centering process. Phases 1 and 2 took place in Malawi and Tanzania. Phase 3, the piloting of two sessions of CP-Africa, occurred at two sites in Malawi: a district hospital and a small clinic. we used an Action Research approach to promote partnerships among university researchers, the Centering Healthcare Institute, health care administrators, health professionals and women attending ANC to develop CP-Africa session content and pilot this model of group ANC. for Phases 1 and 2, members of the Ministries of Health, health professionals and pregnant women in Malawi and Tanzania were introduced to and interviewed about CP. In Phase 2, we finalised CP-Africa content and trained 13 health professionals in the Centering Healthcare model. In Phase 3, we conducted a small pilot with 24 pregnant women (12 at each site). participants enthusiastically embraced CP-Africa as an acceptable model of ANC health care delivery. The CP-Africa content met both CP and national standards. The pilot established that the CP model could be implemented with process fidelity to the 13 Essential Elements. Several implementation challenges and strategies to address these challenges were identified

  15. CENTERING PREGANCY- AFRICA: A PILOT OF GROUP ANTENATAL CARE TO ADDRESS MILLENIUM DEVELOPMENT GOALS

    PubMed Central

    Patil, Crystal L.; Abrams, Elizabeth T.; Klima, Carrie; Kaponda, Chrissie P.N.; Leshabari, Sebalda C.; Vonderheid, Susan C.; Kamaga, Martha; Norr, Kathleen F.

    2013-01-01

    Background Severe health worker shortages and resource limitations negatively affect quality of antenatal care (ANC) throughout sub-Saharan Africa. Group ANC, specifically CenteringPregnancy (CP), may offer an innovative approach to enable midwives to offer higher quality ANC. Objective Our overarching goal was to prepare to conduct a clinical trial of CenteringPregnancy – Africa (CP-Africa) in Malawi and Tanzania. In Phase 1, our goal was to determine the acceptability of CP as model for ANC in both countries. In Phase 2, our objective was to develop CP-Africa session content consistent with the Essential Elements of CP model and with national standards in both Malawi and Tanzania. In Phase 3, our objective was to pilot CP-Africa in Malawi to determine whether sessions could be conducted with fidelity to the Centering process. Setting Phase 1 and 2 took place in Malawi and Tanzania. Phase 3, the piloting of two sessions of CP-Africa, occurred at two sites in Malawi: a district hospital and a small clinic. Design We used an Action Research approach to promote partnerships among university researchers, the Centering Healthcare Institute, healthcare administrators, health professionals and women attending ANC to develop CP-Africa session content and pilot this model of group ANC. Participants For Phases 1 and 2, members of the Ministries of Health, health professionals and pregnant women in Malawi and Tanzania were introduced to and interviewed about CP. In Phase 2, we finalized CP-Africa content and trained thirteen health professionals in the Centering Healthcare model. In Phase 3, we conducted a small pilot with 24 pregnant women (12 at each site). Measurements and Findings Participants enthusiastically embraced CP-Africa as an acceptable model of ANC healthcare delivery. The CP-Africa content met both CP and national standards. The pilot established that the CP model could be implemented with process fidelity to the 13 Essential Elements. Several implementation

  16. New Institutional Theory and a Culture of Safety in Agriculture.

    PubMed

    Janssen, Brandi; Nonnenmann, Matthew W

    2017-01-01

    Health and safety professionals often call for an improved safety culture in agriculture. Such a shift would result in agricultural practices that prioritize safe work habits and see safety as both an effective means to improve production and a goal worth pursuing in its own right. This article takes an anthropological approach and demonstrates the potential for new institutional theory to conceptualize broader cultural change in agriculture. New institutional theory examines the roles of organizations and the ways that they inform and support broad social institutions. Using preliminary data from the agricultural lending industry in Iowa and integrated poultry production in Texas, this article considers the ability of these organizations to contribute to systemic change and an improved culture of safety in agriculture.

  17. New Institutional Theory and a Culture of Safety in Agriculture

    PubMed Central

    Janssen, Brandi; Nonnenmann, Matthew W.

    2017-01-01

    Health and safety professionals often call for an improved safety culture in agriculture. Such a shift would result in agricultural practices that prioritize safe work habits and see safety as both an effective means to improve production and a goal worth pursuing in its own right. This article takes an anthropological approach and demonstrates the potential for new institutional theory to conceptualize broader cultural change in agriculture. New institutional theory examines the roles of organizations and the ways that they inform and support broad social institutions. Using preliminary data from the agricultural lending industry in Iowa and integrated poultry production in Texas, this article considers the ability of these organizations to contribute to systemic change and an improved culture of safety in agriculture. PMID:27754778

  18. The development of a patient-specific method for physiotherapy goal setting: a user-centered design.

    PubMed

    Stevens, Anita; Köke, Albère; van der Weijden, Trudy; Beurskens, Anna

    2018-08-01

    To deliver client-centered care, physiotherapists need to identify the patients' individual treatment goals. However, practical tools for involving patients in goal setting are lacking. The purpose of this study was to improve the frequently used Patient-Specific Complaints instrument in Dutch physiotherapy, and to develop it into a feasible method to improve physiotherapy goal setting. An iterative user-centered design was conducted in co-creation with the physiotherapists and patients, in three phases. Their needs and preferences were identified by means of group meetings and questionnaires. The new method was tested in several field tests in physiotherapy practices. Four main objectives for improvement were formulated: clear instructions for the administration procedure, targeted use across the physiotherapy process, client-activating communication skills, and a client-centered attitude of the physiotherapist. A theoretical goal-setting framework and elements of shared decision making were integrated into the new-called, Patient-Specific Goal-setting method, together with a practical training course. The user-centered approach resulted in a goal-setting method that is fully integrated in the physiotherapy process. The new goal-setting method contributes to a more structured approach to goal setting and enables patient participation and goal-oriented physiotherapy. Before large-scale implementation, its feasibility in physiotherapy practice needs to be investigated. Implications for rehabilitation Involving patients and physiotherapists in the development and testing of a goal-setting method, increases the likelihood of its feasibility in practice. The integration of a goal-setting method into the physiotherapy process offers the opportunity to focus more fully on the patient's goals. Patients should be informed about the aim of every step of the goal-setting process in order to increase their awareness and involvement. Training physiotherapists to use a patient

  19. Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

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

    Brown, Nicholas R.; Pointer, William David; Sieger, Matt

    2016-04-01

    The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

  20. Educational Goals and National Development

    ERIC Educational Resources Information Center

    Umapathy, K. Setty

    1974-01-01

    Discusses educational goals in ancient India, western education in India, educational goals in free India, goals and national development, and the problem of poverty and equal distribution of national gains. (Author/PG)

  1. Professional conceptualisation and accomplishment of patient safety in mental healthcare: an ethnographic approach

    PubMed Central

    2011-01-01

    Background This study seeks to broaden current understandings of what patient safety means in mental healthcare and how it is accomplished. We propose a qualitative observational study of how safety is produced or not produced in the complex context of everyday professional mental health practice. Such an approach intentionally contrasts with much patient safety research which assumes that safety is achieved and improved through top-down policy directives. We seek instead to understand and articulate the connections and dynamic interactions between people, materials, and organisational, legal, moral, professional and historical safety imperatives as they come together at particular times and places to perform safe or unsafe practice. As such we advocate an understanding of patient safety 'from the ground up'. Methods/Design The proposed project employs a six-phase data collection framework in two mental health settings: an inpatient unit and a community team. The first four phases comprise multiple modes of focussed, unobtrusive observation of professionals at work, to enable us to trace the conceptualisation and enactment of safety as revealed in dialogue and narrative, use of artefacts and space, bodily activity and patterns of movement, and in the accomplishment of specific work tasks. An interview phase and a social network analysis phase will subsequently be conducted to offer comparative perspectives on the observational data. This multi-modal and holistic approach to studying patient safety will complement existing research, which is dominated by instrumentalist approaches to discovering factors contributing to error, or developing interventions to prevent or manage adverse events. Discussion This ethnographic research framework, informed by the principles of practice theories and in particular actor-network ideas, provides a tool to aid the understanding of patient safety in mental healthcare. The approach is novel in that it seeks to articulate an 'anatomy

  2. Medication safety infrastructure in critical-access hospitals in Florida.

    PubMed

    Winterstein, Almut G; Hartzema, Abraham G; Johns, Thomas E; De Leon, Jessica M; McDonald, Kathie; Henshaw, Zak; Pannell, Robert

    2006-03-01

    The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

  3. Intranet-based safety documentation in management of major hazards and occupational health and safety.

    PubMed

    Leino, Antti

    2002-01-01

    In the European Union, Council Directive 96/82/EC requires operators producing, using, or handling significant amounts of dangerous substances to improve their safety management systems in order to better manage the major accident potentials deriving from human error. A new safety management system for the Viikinmäki wastewater treatment plant in Helsinki, Finland, was implemented in this study. The system was designed to comply with both the new safety liabilities and the requirements of OHSAS 18001 (British Standards Institute, 1999). During the implementation phase experiences were gathered from the development processes in this small organisation. The complete documentation was placed in the intranet of the plant. Hyperlinks between documents were created to ensure convenience of use. Documentation was made accessible for all workers from every workstation.

  4. 30 CFR 75.905 - Connection of single-phase loads.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Alternating Current Circuits § 75.905 Connection of single-phase loads. [Statutory Provisions] Single-phase... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Connection of single-phase loads. 75.905 Section 75.905 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE...

  5. 30 CFR 75.905 - Connection of single-phase loads.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Alternating Current Circuits § 75.905 Connection of single-phase loads. [Statutory Provisions] Single-phase... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Connection of single-phase loads. 75.905 Section 75.905 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE...

  6. Exploratory Analyses of the Effects of Managerial Support and Feedback Consequences on Behavioral Safety Maintenance

    ERIC Educational Resources Information Center

    Cooper, M. Dominic

    2006-01-01

    Reviews indicate management commitment is vital to maintain behavioral safety processes. Similarly, the impact of observation frequency on safety behaviors is thought to be important. An employee-driven process which encompassed behavioral observations, goal-setting, and feedback was implemented in a paper mill with 55 workgroups using a…

  7. Teaching Students to Attain Annual Transition Goals Using the Take Action Goal Attainment Lessons

    ERIC Educational Resources Information Center

    Martin, Jodie D.; Martin, James E.; Osmani, Kimberly J.

    2014-01-01

    This study used the Take Action goal attainment lesson package and assistive technology to teach nine high school students with mild to moderate disabilities to attain annual transition goals. The Take Action lessons increased students' goal attainment knowledge, and this knowledge generalized to improved Plan Organizers, and slightly increased…

  8. A safety roadmap for future plastics and composites intensive vehicles

    DOT National Transportation Integrated Search

    2007-11-01

    This report summarizes the approach, activities, and results of a study to evaluate the potential safety benefits of Plastics and Composites Intensive Vehicles (PCIVs) to enable their deployment by 2020. The main goals were to review and assess the s...

  9. Understanding adolescent development: implications for driving safety.

    PubMed

    Keating, Daniel P

    2007-01-01

    The implementation of Graduated Driver Licensing (GDL) programs has significantly improved the crash and fatality rates of novice teen drivers, but these rates remain unacceptably high. A review of adolescent development research was undertaken to identify potential areas of improvement. Research support for GDL was found to be strong, particularly regarding early acquisition of expertise in driving safety (beyond driving skill), and to limitations that reduce opportunities for distraction. GDL regimes are highly variable, and no US jurisdictions have implemented optimal regimes. Expanding and improving GDL to enhance acquisition of expertise and self-regulation are indicated for implementation and for applied research. Driver training that effectively incorporates safety goals along with driving skill is another target. The insurance industry will benefit from further GDL enhancements. Benefits may accrue to improved driver training, improved simulation devices during training, and automated safety feedback instrumentation.

  10. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial.

    PubMed

    Sun, Hong; Dodick, David W; Silberstein, Stephen; Goadsby, Peter J; Reuter, Uwe; Ashina, Messoud; Saper, Joel; Cady, Roger; Chon, Yun; Dietrich, Julie; Lenz, Robert

    2016-04-01

    The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention. In this multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, patients aged 18-60 years with 4 to 14 migraine days per month were enrolled at 59 headache and clinical research centres in North America and Europe, and randomly assigned in a 3:2:2:2 ratio to monthly subcutaneous placebo, AMG 334 7 mg, AMG 334 21 mg, or AMG 334 70 mg using a sponsor-generated randomisation sequence centrally executed by an interactive voice response or interactive web response system. Study site personnel, patients, and the sponsor study personnel were masked to the treatment assignment. The primary endpoint was the change in monthly migraine days from baseline to the last 4 weeks of the 12-week double-blind treatment phase. The primary endpoint was calculated using the least squares mean at each timepoint from a generalised linear mixed-effect model for repeated measures. Safety endpoints were adverse events, clinical laboratory values, vital signs, and anti-AMG 334 antibodies. The study is registered with ClinicalTrials.gov, number NCT01952574. An open-label extension phase of up to 256 weeks is ongoing and will assess the long-term safety of AMG 334. From Aug 6, 2013, to June 30, 2014, 483 patients were randomly assigned to placebo (n=160), AMG 334 7 mg (n=108), AMG 334 21 mg (n=108), or AMG 334 70 mg (n=107). The mean change in monthly migraine days at week 12 was -3·4 (SE 0·4) days with AMG 334 70 mg versus -2·3 (0·3) days with placebo (difference -1·1 days [95% CI -2·1 to -0·2], p=0·021). The mean reductions in monthly migraine days with the 7 mg (-2·2 [SE 0·4]) and the 21 mg (-2·4 [0·4]) doses were not significantly different from that with placebo. Adverse events were recorded in 82 (54

  11. 76 FR 58281 - Magnetic Resonance Imaging Safety; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    ... announcing a public workshop entitled: ``Magnetic Resonance Imaging (MRI) Safety Public Workshop.'' The... (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment. DATES: The public workshop will be held on October 25, 2011...

  12. Preparing for the update of New Hampshire’s strategic highway safety plan.

    DOT National Transportation Integrated Search

    2015-01-01

    NHDOTs objectives in requesting the peer exchange were to: Build a sustainable SHSP by energizing existing and developing cooperative partnerships among highway safety stakeholders; Strengthen the goals, strategies, and performance trackin...

  13. Evaluation of Patient Safety Indicators in Semnan City Hospitals by Using the Patient Safety Friendly Hospital Initiative (PSFHI).

    PubMed

    Babamohamadi, Hassan; Nemati, Roghayeh Khabiri; Nobahar, Monir; Keighobady, Seifullah; Ghazavi, Soheila; Izadi-Sabet, Farideh; Najafpour, Zhila

    2016-08-01

    Nowadays, patient safety issue is among one of the main concerns of the hospital policy worldwide. This study aimed to evaluate the patient safety status in hospitals affiliated to Semnan city, using the WHO model for Patient Safety Friendly Hospital Initiatives (PSFHI) in summer 2014. That was a cross sectional descriptive study that addressed patient safety , which explained the current status of safety in the Semnan hospitals using by instrument of Patient safety friendly initiative standards (PSFHI). Data was collected from 5 hospitals in Semnan city during four weeks in May 2014. The finding of 5 areas examined showed that some components in critical standards had disadvantages. Critical standards of hospitals including areas of leadership and administration, patient and public involvement and safe evidence-based clinical practice, safe environment with and lifetime education in a safe and secure environment were analyzed. The domain of patient and public involvement obtained the lowest mean score and the domain of safe environment obtained the highest mean score in the surveyed hospitals. All the surveyed hospitals had a poor condition regarding standards based on patient safety. Further, the identified weak points are almost the same in the hospitals. Therefore, In order to achieve a good level of all aspects of the protocol, the goals should be considered in the level of strategic planning at hospitals. An effective execution of patient safety creatively may depend on the legal infrastructure and enforcement of standards by hospital management, organizational liability to expectation of patients, safety culture in hospitals.

  14. Traffic safety in the U.S.: re-examining major opportunities.

    PubMed

    Sivak, Michael; Luoma, Juha; Flannagan, Michael J; Bingham, C Raymond; Eby, David W; Shope, Jean T

    2007-01-01

    This article examines five major road-safety risk factors: exceeding posted speed limits, not using safety belts, driving while intoxicated, nighttime driving, and young drivers. The importance of each of these factors is documented, known effective countermeasures (both policy and technology based) are discussed, and impediments to the implementation of these countermeasures in the United States are examined. Based on current understanding of the five major risk factors, and of the available countermeasures, there appear to be a variety of opportunities to make substantial gains in road safety using existing knowledge. The limited implementation of a variety of known countermeasures therefore appears to be inconsistent with high-level, strategic goals to improve road safety. Consequently, a recommendation is made to comprehensively re-examine the balance between the countermeasures discussed in this article and economic, mobility, and privacy concerns. IMPACT ON PUBLIC SAFETY: Such a re-examination is likely to result in broad support for these countermeasures, with a consequent major improvement in road safety.

  15. Joint FAM/Line Management Assessment Report on LLNL Machine Guarding Safety Program

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

    Armstrong, J. J.

    2016-07-19

    The LLNL Safety Program for Machine Guarding is implemented to comply with requirements in the ES&H Manual Document 11.2, "Hazards-General and Miscellaneous," Section 13 Machine Guarding (Rev 18, issued Dec. 15, 2015). The primary goal of this LLNL Safety Program is to ensure that LLNL operations involving machine guarding are managed so that workers, equipment and government property are adequately protected. This means that all such operations are planned and approved using the Integrated Safety Management System to provide the most cost effective and safest means available to support the LLNL mission.

  16. Examining hospital pharmacists' goals for medication counseling within the communication accommodation theoretical framework.

    PubMed

    Chevalier, Bernadette A M; Watson, Bernadette M; Barras, Michael A; Cottrell, William Neil

    2016-01-01

    Medication counseling opportunities are key times for pharmacists to speak to patients about their medications and any changes made during their hospital stay. Communication Accommodation Theory (CAT) posits that an individual's goals drive their communication behavior. The way in which pharmacists communicate with patients may be determined by the goals they set for these medication counseling sessions. To examine hospital pharmacists' goals in patient medication counseling within the CAT framework. Hospital pharmacist focus groups were held in two teaching hospitals. Interested pharmacists attended a focus group designed to elicit their goals in patient medication counseling. Focus groups were audio recorded and transcribed verbatim. NVivo(®) software was used to assist in coding and organization. The codes were reviewed for reliability by pharmacists independent of the focus groups. An inductive thematic analysis was applied to the data. Six 1 h focus groups were conducted with a total of 24 pharmacists participating. Saturation of information was achieved after four focus groups. Greater than 80% consensus was achieved for reliability of the identified codes. Patient-centered themes constructed from these codes were to build rapport, to empower patients and to improve patients' experience, health and safety. Exemplars provided by pharmacists for the goals of building rapport and empowering patients were aligned with five CAT communication behaviors (approximation, interpretability, discourse management, emotional expression and interpersonal control). Patient-centered goals described by hospital pharmacists for medication counseling aligned well with CAT behaviors necessary for effective communication. Further research using the CAT framework to examine the effectiveness of hospital pharmacist-patient exchanges that include both participants' perspectives is required to better understand how well pharmacists communicate with patients. Copyright © 2015

  17. Exploring the state of health and safety management system performance measurement in mining organizations.

    PubMed

    Haas, Emily Joy; Yorio, Patrick

    2016-03-01

    Complex arguments continue to be articulated regarding the theoretical foundation of health and safety management system (HSMS) performance measurement. The culmination of these efforts has begun to enhance a collective understanding. Despite this enhanced theoretical understanding, however, there are still continuing debates and little consensus. The goal of the current research effort was to empirically explore common methods to HSMS performance measurement in mining organizations. The purpose was to determine if value and insight could be added into the ongoing approaches of the best ways to engage in health and safety performance measurement. Nine site-level health and safety management professionals were provided with 133 practices corresponding to 20 HSMS elements, each fitting into the plan, do, check, act phases common to most HSMS. Participants were asked to supply detailed information as to how they (1) assess the performance of each practice in their organization, or (2) would assess each practice if it were an identified strategic imperative. Qualitative content analysis indicated that the approximately 1200 responses provided could be described and categorized into interventions , organizational performance , and worker performance . A discussion of how these categories relate to existing indicator frameworks is provided. The analysis also revealed divergence in two important measurement issues; (1) quantitative vs qualitative measurement and reporting; and (2) the primary use of objective or subjective metrics. In lieu of these findings we ultimately recommend a balanced measurement and reporting approach within the three metric categories and conclude with suggestions for future research.

  18. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

  19. Cortico-basal ganglia networks subserving goal-directed behavior mediated by conditional visuo-goal association

    PubMed Central

    Hoshi, Eiji

    2013-01-01

    Action is often executed according to information provided by a visual signal. As this type of behavior integrates two distinct neural representations, perception and action, it has been thought that identification of the neural mechanisms underlying this process will yield deeper insights into the principles underpinning goal-directed behavior. Based on a framework derived from conditional visuomotor association, prior studies have identified neural mechanisms in the dorsal premotor cortex (PMd), dorsolateral prefrontal cortex (dlPFC), ventrolateral prefrontal cortex (vlPFC), and basal ganglia (BG). However, applications resting solely on this conceptualization encounter problems related to generalization and flexibility, essential processes in executive function, because the association mode involves a direct one-to-one mapping of each visual signal onto a particular action. To overcome this problem, we extend this conceptualization and postulate a more general framework, conditional visuo-goal association. According to this new framework, the visual signal identifies an abstract behavioral goal, and an action is subsequently selected and executed to meet this goal. Neuronal activity recorded from the four key areas of the brains of monkeys performing a task involving conditional visuo-goal association revealed three major mechanisms underlying this process. First, visual-object signals are represented primarily in the vlPFC and BG. Second, all four areas are involved in initially determining the goals based on the visual signals, with the PMd and dlPFC playing major roles in maintaining the salience of the goals. Third, the cortical areas play major roles in specifying action, whereas the role of the BG in this process is restrictive. These new lines of evidence reveal that the four areas involved in conditional visuomotor association contribute to goal-directed behavior mediated by conditional visuo-goal association in an area-dependent manner. PMID:24155692

  20. Professional environment and patient safety in emergency departments.

    PubMed

    Lambrou, Persefoni; Papastavrou, Evridiki; Merkouris, Anastasios; Middleton, Nicos

    2015-04-01

    The purpose of this study was to examine nurses' and physicians' perceptions of professional environment and its association with patient safety in public emergency departments in Cyprus. A total of 224 professionals (174 nurses and 50 physicians) participated (rr = 81%). Data were collected using the "Revised Professional Practice Environment" (RPPE) instrument and the Safety Climate Domain of the "Emergency Medical Services Safety Attitudes Questionnaire" (EMS-SAQ). The mean overall score of RPPE was 2.79 (SD = 0.30), among physicians 2.84 (SD = 0.25) and nurses 2.73 (SD = 0.33) (P-value = 0.07). Statistically significant differences were observed between the two study groups regarding "staff relationships", "motivation" and "cultural sensitivity" (P-values < 0.05). No significant differences were observed as regards EMS-SAQ (3.25 vs. 3.16 respectively; P-value = 0.28). All 8 components of the RPPE exhibited significant association with patient safety. Linear and stepwise regression analyses showed that "leadership" explains 28% of the variance of safety. This relationship suggests improvements in professional environment with the ultimate goal of improving patient safety. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. A trial of an all-terrain vehicle safety education video in a community-based hunter education program.

    PubMed

    Williams, Robert S; Graham, James; Helmkamp, James C; Dick, Rhonda; Thompson, Tonya; Aitken, Mary E

    2011-01-01

    All-terrain vehicle (ATV) injury is an increasingly serious problem, particularly among rural youth. There have been repeated calls for ATV safety education, but little study regarding optimal methods or content for such education. The purpose of this study was to determine if an ATV safety video was effective in increasing ATV safety knowledge when used in a community-based statewide hunter education program. During the baseline phase, surveys focusing on ATV safety were distributed to students in the Arkansas hunter safety program in 2006. In the intervention phase a year later, an ATV safety video on DVD was provided for use in required hunter education courses across Arkansas. The same survey was administered to hunter education students before and after the course. In the baseline phase, 1,641 precourse and 1,374 postcourse surveys were returned and analyzed. In the intervention phase, 708 precourse and 694 postcourse surveys were completed. Student knowledge of ATV safety after watching the video was higher than in preintervention classes. Knowledge of appropriate helmet usage increased from 95% to 98.8% (P < .0001). Awareness of the importance of not carrying a passenger behind the driver increased from 59.5% to 91.1% (P < .0001). Awareness of importance of hands-on ATV rider training increased from 82.1% to 92.4% (P < .0001). A brief ATV safety video used in a hunter education course increased ATV safety knowledge on most measures. A statewide hunter education program appears to be a useful venue for ATV safety education. © 2010 National Rural Health Association.

  2. Spent Nuclear Fuel (SNF) project Integrated Safety Management System phase I and II Verification Review Plan

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

    CARTER, R.P.

    1999-11-19

    The U.S. Department of Energy (DOE) commits to accomplishing its mission safely. To ensure this objective is met, DOE issued DOE P 450.4, Safety Management System Policy, and incorporated safety management into the DOE Acquisition Regulations ([DEAR] 48 CFR 970.5204-2 and 90.5204-78). Integrated Safety Management (ISM) requires contractors to integrate safety into management and work practices at all levels so that missions are achieved while protecting the public, the worker, and the environment. The contractor is required to describe the Integrated Safety Management System (ISMS) to be used to implement the safety performance objective.

  3. Goals of telephone nursing work--the managers' perspectives: a qualitative study on Swedish Healthcare Direct.

    PubMed

    Kaminsky, Elenor; Carlsson, Marianne; Holmström, Inger K; Larsson, Jan; Fredriksson, Mio

    2014-04-24

    Swedish Healthcare Direct (SHD) receives 6 million calls yearly and aims at increased public sense of security and healthcare efficiency. Little is known about what SHD managers perceive as the primary goals of telephone nursing (TN) work and how the organisation matches goals of health promotion and equitable healthcare, so important in Swedish healthcare legislation. The aim of the study was to explore and describe what the SHD managers perceive as the goals of TN work and how the managers view health promotion and implementation of equitable healthcare with gender as example at SHD. The study was qualitative using an exploratory and descriptive design. All 23 managers employed at SHD were interviewed and data analysis used deductive directed content analysis. The findings reveal four themes describing the goals of TN work as recommended by the SHD managers. These are: 'create feelings of trust', 'achieve patient safety', 'assess, refer and give advice', and 'teach the caller'. Most of the managers stated that health promotion should not be included in the goals, whereas equitable healthcare was viewed as an important issue. Varying suggestions for implementing equitable healthcare were given. The interviewed managers mainly echoed the organisational goals of TN work. The managers' expressed goal of teaching lacked the caller learning components highlighted by telenurses in previous research. The fact that health promotion was not seen as important indicates a need for SHD to clarify its goals as the organisation is part of the Swedish healthcare system, where health promotion should always permeate work. Time used for health promotion and dialogues in a gender equitable manner at SHD is well invested as it will save time elsewhere in the health care system, thereby facing one of the challenges of European health systems.

  4. It's Not Just Your Goal, but Also Who You Know: How the Cognitive Associations among Goals and Relationships Influence Goal Detection in Social Interaction

    ERIC Educational Resources Information Center

    Palomares, Nicholas A.

    2009-01-01

    An experiment tested a theoretical framework for goal detection in dyadic interactions of close friends and unacquainted strangers wherein one conversationalist pursued a goal unbeknownst to a detector. The extent to which pursuers' conversation goal was cognitively associated with the dyad's relational type was manipulated. As hypothesized,…

  5. Efficacy and Safety of Lubiprostone in Patients with Opioid-Induced Constipation: Phase 3 Study Results and Pooled Analysis of the Effect of Concomitant Methadone Use on Clinical Outcomes.

    PubMed

    Spierings, Egilius L H; Drossman, Douglas A; Cryer, Byron; Mazen Jamal, M; Losch-Beridon, Taryn; Mareya, Shadreck M; Wang, Martin

    2018-06-01

    The efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain were evaluated in a randomized, double-blind, placebo-controlled study. These data were also pooled with those from two similar phase 3 studies to explore the effects of methadone on treatment response. In the primary study, adults with OIC (fewer than three spontaneous bowel movements [SBMs] per week) were randomized to receive lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary end point was a change from baseline in the frequency of SBMs at week 8 in patients without a prior dose reduction. For the pooled analysis, the efficacy of lubiprostone was compared with placebo in patients receiving methadone or nonmethadone opioids. Responders were defined as patients with nine or more weeks of nonmissing SBM data who had one or more additional SBMs per week from baseline for each week that data were available and three or more SBMs per week for nine or more weeks. In the primary study, the change from baseline at week 8 in SBM frequency was similar in the lubiprostone and placebo groups (P = 0.842). In the pooled analysis, the response rate was significantly higher with lubiprostone treatment vs placebo for patients receiving nonmethadone opioids (P = 0.002) but was similar between lubiprostone treatment and placebo in patients receiving methadone (P = 0.692). The safety profile of lubiprostone was unaffected by methadone use. The phase 3 study did not meet its primary efficacy end point. However, analysis of pooled data from all phase 3 studies in the OIC clinical development program, stratified by methadone opioid usage, confirmed that lubiprostone is effective for treatment of OIC in patients taking nonmethadone opioids; no safety concerns were identified based on the type of opioid used.

  6. Goal-Function Tree Modeling for Systems Engineering and Fault Management

    NASA Technical Reports Server (NTRS)

    Johnson, Stephen B.; Breckenridge, Jonathan T.

    2013-01-01

    provide formal connectivity between the nominal (SE), and off-nominal (SHM and FM) aspects of functions and designs. This paper describes a formal modeling approach to the initial phases of the development process that integrates the nominal and off-nominal perspectives in a model that unites SE goals and functions of with the failure to achieve goals and functions (SHM/FM).

  7. 49 CFR 350.101 - What is the Motor Carrier Safety Assistance Program (MCSAP)?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... involving commercial motor vehicles (CMV). The goal of the MCSAP is to reduce CMV-involved accidents, fatalities, and injuries through consistent, uniform, and effective CMV safety programs. Investing grant...

  8. 49 CFR 350.101 - What is the Motor Carrier Safety Assistance Program (MCSAP)?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... involving commercial motor vehicles (CMV). The goal of the MCSAP is to reduce CMV-involved accidents, fatalities, and injuries through consistent, uniform, and effective CMV safety programs. Investing grant...

  9. 49 CFR 350.101 - What is the Motor Carrier Safety Assistance Program (MCSAP)?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... involving commercial motor vehicles (CMV). The goal of the MCSAP is to reduce CMV-involved accidents, fatalities, and injuries through consistent, uniform, and effective CMV safety programs. Investing grant...

  10. 49 CFR 350.101 - What is the Motor Carrier Safety Assistance Program (MCSAP)?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... involving commercial motor vehicles (CMV). The goal of the MCSAP is to reduce CMV-involved accidents, fatalities, and injuries through consistent, uniform, and effective CMV safety programs. Investing grant...

  11. 49 CFR 350.101 - What is the Motor Carrier Safety Assistance Program (MCSAP)?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... involving commercial motor vehicles (CMV). The goal of the MCSAP is to reduce CMV-involved accidents, fatalities, and injuries through consistent, uniform, and effective CMV safety programs. Investing grant...

  12. 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.

  13. Surveying Student Goals to Aid Institutional Effectiveness: Student Goals Survey Research Report.

    ERIC Educational Resources Information Center

    Freeman, Robin Mark; And Others

    A survey was conducted at Vista College to determine the educational and occupational goals of students enrolled in the Environmental Energy Technology Program. A seven-item survey was distributed in class over a five-semester period, soliciting information on academic and employment goals, current employment status, interest in networking with…

  14. Design principles for enhancing phase sensitivity and suppressing phase fluctuations simultaneously in biochemical oscillatory systems.

    PubMed

    Fei, Chenyi; Cao, Yuansheng; Ouyang, Qi; Tu, Yuhai

    2018-04-12

    Biological systems need to function accurately in the presence of strong noise and at the same time respond sensitively to subtle external cues. Here we study design principles in biochemical oscillatory circuits to achieve these two seemingly incompatible goals. We show that energy dissipation can enhance phase sensitivity linearly by driving the phase-amplitude coupling and increase timing accuracy by suppressing phase diffusion. Two general design principles in the key underlying reaction loop formed by two antiparallel pathways are found to optimize oscillation performance with a given energy budget: balancing the forward-to-backward flux ratio between the two pathways to reduce phase diffusion and maximizing the net flux of the phase-advancing pathway relative to that of the phase-retreating pathway to enhance phase sensitivity. Experimental evidences consistent with these design principles are found in the circadian clock of cyanobacteria. Future experiments to test the predicted dependence of phase sensitivity on energy dissipation are proposed.

  15. Something's got to give: the effects of dual-goal difficulty, goal progress, and expectancies on resource allocation.

    PubMed

    Schmidt, Aaron M; Dolis, Chad M

    2009-05-01

    The current study developed and tested a model of the interplay among goal difficulty, goal progress, and expectancy over time in influencing resource allocation toward competing demands. The results provided broad support for the theoretical model. As predicted, dual-goal expectancy-the perceived likelihood of meeting both goals in competition-played a central role, moderating the relationship between relative goal progress and resource allocation. Dual-goal difficulty was also found to exert an important influence on multiple-goal self-regulation. Although it did not influence total productivity across both tasks combined, it did combine with other model components to influence the relative emphasis of one task over another. These results suggest that the cumulative demands placed by multiple difficult goals may exceed individuals' perceived capabilities and may lead to partial or total abandonment of 1 goal to ensure attainment of the other. The model helps shed light on some of the conflicting theoretical propositions and empirical results obtained in prior work. Implications for theory and research regarding multiple-goal self-regulation are discussed. (c) 2009 APA, all rights reserved.

  16. Resident Self-Assessment and Learning Goal Development: Evaluation of Resident-Reported Competence and Future Goals.

    PubMed

    Li, Su-Ting T; Paterniti, Debora A; Tancredi, Daniel J; Burke, Ann E; Trimm, R Franklin; Guillot, Ann; Guralnick, Susan; Mahan, John D

    2015-01-01

    To determine incidence of learning goals by competency area and to assess which goals fall into competency areas with lower self-assessment scores. Cross-sectional analysis of existing deidentified American Academy of Pediatrics' PediaLink individualized learning plan data for the academic year 2009-2010. Residents self-assessed competencies in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas and wrote learning goals. Textual responses for goals were mapped to 6 ACGME competency areas, future practice, or personal attributes. Adjusted mean differences and associations were estimated using multiple linear and logistic regression. A total of 2254 residents reported 6078 goals. Residents self-assessed their systems-based practice (51.8) and medical knowledge (53.0) competencies lowest and professionalism (68.9) and interpersonal and communication skills (62.2) highest. Residents were most likely to identify goals involving medical knowledge (70.5%) and patient care (50.5%) and least likely to write goals on systems-based practice (11.0%) and professionalism (6.9%). In logistic regression analysis adjusting for postgraduate year (PGY), gender, and degree type (MD/DO), resident-reported goal area showed no association with the learner's relative self-assessment score for that competency area. In the conditional logistic regression analysis, with each learner serving as his or her own control, senior residents (PGY2/3+s) who rated themselves relatively lower in a competency area were more likely to write a learning goal in that area than were PGY1s. Senior residents appear to develop better skills and/or motivation to explicitly turn self-assessed learning gaps into learning goals, suggesting that individualized learning plans may help improve self-regulated learning during residency. Copyright © 2015 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  17. Growth goals, maturity, and well-being.

    PubMed

    Bauer, Jack J; McAdams, Dan P

    2004-01-01

    In 2 studies (125 college students and 51 adults), 2 forms of growth goals (exploratory and intrinsic) were compared with 2 forms of personality development (social-cognitive maturity and social-emotional well-being). Participants whose narratives of major life goals emphasized conceptual exploration were especially likely to have high levels of maturity (measured as ego development; J. Loevinger, 1976), whereas those whose goals emphasized intrinsic interests (K. M. Sheldon & T. Kasser, 1995) were especially likely to have high levels of well-being. Participants who had coherent hierarchies of growth goals on the levels of major life goals and everyday goals were especially likely to have high levels of personality development. Finally, growth goals accounted for some relationships between age and personality development. Growth goals are discussed in terms of intentional self-development and specific developmental paths. (c) 2003 APA

  18. Safety results from a phase III study (TURANDOT trial by CECOG) of first-line bevacizumab in combination with capecitabine or paclitaxel for HER-2-negative locally recurrent or metastatic breast cancer.

    PubMed

    Lang, I; Inbar, M J; Kahán, Z; Greil, R; Beslija, S; Stemmer, S M; Kaufman, B; Zvirbule, Z; Steger, G G; Messinger, D; Brodowicz, T; Zielinski, C

    2012-11-01

    We report safety data from a randomised, phase III study (CECOG/BC.1.3.005) evaluating first-line bevacizumab plus paclitaxel or capecitabine for locally recurrent or metastatic breast cancer. Patients aged ≥18 years with human epidermal growth factor receptor-2-negative breast adenocarcinoma were randomised to Arm A: bevacizumab 10 mg/kg days 1 and 15; paclitaxel 90 mg/m(2) days 1, 8, and 15, every 4 weeks; or Arm B: bevacizumab 15 mg/kg day 1; capecitabine 1000 mg/m(2) b.i.d., days 1-14, every 3 weeks, until disease progression, unacceptable toxicity or consent withdrawal. A post hoc interim safety analysis included 561 patients (Arm A: 284, Arm B: 277). The regimens demonstrated similar frequencies of all-grade and serious adverse events (SAEs), but different safety profiles. Treatment-related events occurred in 85.2% (Arm A) and 78.0% (Arm B) of patients. Fatigue was most common in Arm A (30.6% versus 23.5% Arm B), and hand-foot syndrome (HFS) most common in Arm B (49.5% versus 2.5% Arm A). Diarrhoea (Arm A: 0.4%, Arm B: 1.4%) and pulmonary embolism (Arm A: 0.7%, Arm B: 1.1%) were the most frequently reported SAEs. These findings are in-line with safety data for bevacizumab plus paclitaxel or capecitabine, reported in previous phase III trials. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. An Organizational Learning Framework for Patient Safety.

    PubMed

    Edwards, Marc T

    Despite concerted effort to improve quality and safety, high reliability remains a distant goal. Although this likely reflects the challenge of organizational change, persistent controversy over basic issues suggests that weaknesses in conceptual models may contribute. The essence of operational improvement is organizational learning. This article presents a framework for identifying leverage points for improvement based on organizational learning theory and applies it to an analysis of current practice and controversy. Organizations learn from others, from defects, from measurement, and from mindfulness. These learning modes correspond with contemporary themes of collaboration, no blame for human error, accountability for performance, and managing the unexpected. The collaborative model has dominated improvement efforts. Greater attention to the underdeveloped modes of organizational learning may foster more rapid progress in patient safety by increasing organizational capabilities, strengthening a culture of safety, and fixing more of the process problems that contribute to patient harm.

  20. Efficacy and Safety of Secukinumab in Elderly Subjects with Moderate to Severe Plaque Psoriasis: A Pooled Analysis of Phase III Studies.

    PubMed

    Körber, Andreas; Papavassilis, Charis; Bhosekar, Vaishali; Reinhardt, Maximilian

    2018-02-01

    Psoriasis is a chronic inflammatory skin disease, affecting patients of a wide age range, including elderly patients. Elderly patients can respond differently to drug treatments and can be more vulnerable to adverse reactions. There are limited data on biologic therapies for psoriasis in elderly subjects. Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has proven significant efficacy in the treatment of moderate to severe psoriasis. A post-hoc analysis of three phase III trials (ERASURE, FIXTURE and CLEAR) was performed to evaluate the efficacy and safety of secukinumab in elderly subjects. Studies were multicentre, randomized, parallel-group, double-blind, 52-week phase III trials in subjects with moderate to severe plaque psoriasis. For efficacy analyses, 67 elderly subjects (≥ 65 years) treated with secukinumab 300 mg were compared with 841 younger subjects (18-64 years). Psoriasis Area and Severity Index (PASI), Dermatological Life Quality Index (DLQI) and safety were analysed. Elderly subjects had higher baseline frequencies of cardiovascular and metabolic disorders. Secukinumab efficacy in elderly subjects was comparable to that in younger subjects throughout 52 weeks of treatment. PASI 75 response was reached by 81.8% of elderly subjects and 79.4% of younger subjects at Week 52. Similar rates of DLQI 0/1 response were observed. The total rate of adverse events was similar between elderly and younger subjects. Secukinumab at the recommended dose (300 mg) is effective and acceptably safe in subjects aged ≥ 65 years with moderate to severe psoriasis, with quality-of-life benefits, despite an increased prevalence of cardiovascular and metabolic comorbidities in this population.

  1. A systematic review of goal directed fluid therapy: rating of evidence for goals and monitoring methods.

    PubMed

    Wilms, Heath; Mittal, Anubhav; Haydock, Matthew D; van den Heever, Marc; Devaud, Marcello; Windsor, John A

    2014-04-01

    To review the literature on goal directed fluid therapy and evaluate the quality of evidence for each combination of goal and monitoring method. A search of major digital databases and hand search of references was conducted. All studies assessing the clinical utility of a specific fluid therapy goal or set of goals using any monitoring method were included. Data was extracted using a pre-determined pro forma and papers were evaluated using GRADE principles to assess evidence quality. Eighty-one papers met the inclusion criteria, investigating 31 goals and 22 methods for monitoring fluid therapy in 13052 patients. In total there were 118 different goal/method combinations. Goals with high evidence quality were central venous lactate and stroke volume index. Goals with moderate quality evidence were sublingual microcirculation flow, the oxygen extraction ratio, cardiac index, cardiac output, and SVC collapsibility index. This review has highlighted the plethora of goals and methods for monitoring fluid therapy. Strikingly, there is scant high quality evidence, in particular for non-invasive G/M combinations in non-operative and non-intensive care settings. There is an urgent need to address this research gap, which will be helped by methodologies to compare utility of G/M combinations. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Goals and everyday problem solving: examining the link between age-related goals and problem-solving strategy use.

    PubMed

    Hoppmann, Christiane A; Coats, Abby Heckman; Blanchard-Fields, Fredda

    2008-07-01

    Qualitative interviews on family and financial problems from 332 adolescents, young, middle-aged, and older adults, demonstrated that developmentally relevant goals predicted problem-solving strategy use over and above problem domain. Four focal goals concerned autonomy, generativity, maintaining good relationships with others, and changing another person. We examined both self- and other-focused problem-solving strategies. Autonomy goals were associated with self-focused instrumental problem solving and generative goals were related to other-focused instrumental problem solving in family and financial problems. Goals of changing another person were related to other-focused instrumental problem solving in the family domain only. The match between goals and strategies, an indicator of problem-solving adaptiveness, showed that young individuals displayed the greatest match between autonomy goals and self-focused problem solving, whereas older adults showed a greater match between generative goals and other-focused problem solving. Findings speak to the importance of considering goals in investigations of age-related differences in everyday problem solving.

  3. Investigative safety science as a competitive advantage for Pharma.

    PubMed

    Moggs, Jonathan; Moulin, Pierre; Pognan, Francois; Brees, Dominique; Leonard, Michele; Busch, Steve; Cordier, Andre; Heard, David J; Kammüller, Michael; Merz, Michael; Bouchard, Page; Chibout, Salah-Dine

    2012-09-01

    Following a US National Academy of Sciences report in 2007 entitled "Toxicity Testing of the 21st Century: a Vision and a Strategy," significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. The purpose of this review is to outline why investigative safety science is a competitive advantage for the pharmaceutical industry. The article discusses the essential goals for modern investigative toxicologists including: cross-species target biology; molecular pathways of toxicity; and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, the article emphasizes the importance of investigating unanticipated clinical safety signals through a combination of mechanistic preclinical studies and/or molecular characterization of clinical samples from affected organs. The traditional boundaries between pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: i) identifying translational safety biomarkers; ii) identifying new drug targets/indications; and iii) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

  4. Labor education programs in health and safety.

    PubMed

    Wallerstein, N; Baker, R

    1994-01-01

    Labor health and safety programs encourage workers to take an active part in making the workplace safe. The authors describe the growing need for preparing workers to participate in prevention efforts, the role of training in addressing this need, educational principles and traditions that contribute to empowerment education, and a step-by-step process that is required to achieve the goals of worker involvement and empowerment.

  5. Evaluation of surface, microstructure and phase modifications on various tungsten grades induced by pulsed plasma loading

    NASA Astrophysics Data System (ADS)

    Vilémová, M.; Pala, Z.; Jäger, A.; Matějíček, J.; Chernyshova, M.; Kowalska-Strzęciwilk, E.; Tonarová, D.; Gribkov, V. A.

    2016-03-01

    Progress in the field of nuclear fusion requires the development of a new generation of tungsten materials that are expected to meet specific property, lifetime and safety requirements. Pursuing this goal, the new materials must be properly tested in a wide range of conditions including cases where material is brought to the molten stage, such as with large fusion plasma instabilities. In this study, two prospective candidates from the family of dispersion strengthened (DS) tungsten materials, i.e., W-1%Y2O3 and W-2.5%TiC, were subjected to extreme heat loading exerted by the deuterium plasma generator PF6. The study focuses on the interaction of the tungsten matrix with the dispersed particles during material melting. The materials underwent significant changes in microstructure and phase content. Among the most serious was the loss of TiC particles and void formation in W-2.5%TiC and phase change of polymorphic Y2O3 particles in W-1% Y2O3.

  6. Effectively Using IEP Goal Banks

    ERIC Educational Resources Information Center

    Kowalski, Ellen; McCall, Renee; Aiello, Rocco; Lieberman, Lauren

    2009-01-01

    For students with disabilities, annual goals are the nuts and bolts of the everyday program outlined in their individualized education program (IEP). According to the Individuals with Disabilities Education Improvement Act (IDEA) of 2004, a present level of performance with measurable annual goals must be outlined in a student's IEP. Goals should…

  7. The impact of goal setting and goal orientation on performance during a clerkship surgical skills training program.

    PubMed

    Gardner, Aimee K; Diesen, Diana L; Hogg, Deborah; Huerta, Sergio

    2016-02-01

    The purpose of this study was to integrate relevant goal-setting theory and to identify if trainees' goal orientations have an impact on the assigned goals-performance relationship. Trainees attended 1 of the 3 goal-training activities (do your best, performance, or learning goals) for knot tying (KT) and camera navigation (CN) during the 3rd-year clerkship rotation. Questionnaires and pretests and/or post-tests were completed. One twenty-seven 3rd-year medical students (age: 25 ± 2.6; 54% women) participated in the training program. Pretraining to post-training performance changes were significant for all groups on both tasks (P < .01), but the increase was significantly greater (P < .01) for the learning goals group (do your best: KTΔ = 2.14, CNΔ = 1.69; performance: KTΔ = 2.49, CNΔ = 2.24; learning: KTΔ = 3.04 CNΔ = 2.76). Correlations between goal orientations and improvement were examined, revealing a unique role of goal orientation for performance improvement. These data indicate that consideration of goal type and trainee goal orientation must be considered during curriculum development to maximize educational value. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Drug safety evaluation of defibrotide.

    PubMed

    Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

    2013-01-01

    Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

  9. Highway safety data : costs, quality, and strategies for improvement, final report.

    DOT National Transportation Integrated Search

    1998-01-01

    The goal of this project was to analyze the collection and management of highway safety data by identifying issues and costs, and proposing means of resolving those issues and reducing the costs. Initial emphasis addressed known elements of the highw...

  10. Highway Safety Data : costs, quality, and strategies for improvement : research report

    DOT National Transportation Integrated Search

    1998-01-01

    The goal of this project was to analyze the collection and management of highway safety data by identifying issues and costs, and proposing means of resolving those issues and reducing the costs. Initial emphasis addressed known elements of the highw...

  11. Electronic clinical safety reporting system: a benefits evaluation.

    PubMed

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  12. Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.

    PubMed

    Schadendorf, Dirk; Wolchok, Jedd D; Hodi, F Stephen; Chiarion-Sileni, Vanna; Gonzalez, Rene; Rutkowski, Piotr; Grob, Jean-Jacques; Cowey, C Lance; Lao, Christopher D; Chesney, Jason; Robert, Caroline; Grossmann, Kenneth; McDermott, David; Walker, Dana; Bhore, Rafia; Larkin, James; Postow, Michael A

    2017-12-01

    Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.

  13. Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials

    PubMed Central

    Schadendorf, Dirk; Wolchok, Jedd D.; Hodi, F. Stephen; Chiarion-Sileni, Vanna; Gonzalez, Rene; Rutkowski, Piotr; Grob, Jean-Jacques; Cowey, C. Lance; Lao, Christopher D.; Chesney, Jason; Robert, Caroline; Grossmann, Kenneth; McDermott, David; Walker, Dana; Bhore, Rafia; Larkin, James

    2017-01-01

    Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs (P = .97). Median overall survival had not been reached in either group (P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy. PMID:28841387

  14. Safety and tolerability review of lorcaserin in clinical trials.

    PubMed

    Greenway, F L; Shanahan, W; Fain, R; Ma, T; Rubino, D

    2016-10-01

    Lorcaserin is a novel selective serotonin 2C receptor agonist indicated by the US Food and Drug Administration for chronic weight management in adults with obesity or overweight with ≥1 comorbidity. The safety and efficacy of lorcaserin were established during two Phase III clinical trials in patients without diabetes (BLOOM and BLOSSOM) and one Phase III clinical trial in patients with type 2 diabetes (BLOOM-DM). Headache was the most common adverse event experienced by patients during all Phase III trials. Additional adverse events occurring in >5% of patients receiving lorcaserin included dizziness, fatigue, nausea, dry mouth and constipation in patients without diabetes, and hypoglycaemia, back pain, cough and fatigue in patients with diabetes. In a pooled analysis of echocardiographic data collected during the three lorcaserin Phase III trials, the incidence of FDA-defined valvulopathy was similar in patients taking lorcaserin and the placebo. Here, the safety profile of lorcaserin at the FDA-approved dose of 10 mg twice daily is reviewed using data from the lorcaserin Phase III programme, with a focus on theoretical adverse events commonly associated with agonists of the serotonin receptor family. Based on the lorcaserin Phase III clinical trial data, lorcaserin is safe and well tolerated in the indicated patient populations. © 2016 World Obesity.

  15. The use of safety restraint systems in Virginia by occupants under 16 years of age : the 1999 survey results.

    DOT National Transportation Integrated Search

    2000-01-01

    The Virginia Transportation Research Council has been monitoring the use of child safety restraint systems in Virginia since 1983 through child safety seat surveys conducted annually (with the exception of 1995). The principal goal of the survey has ...

  16. Goal Fluency, Pessimism and Disengagement in Depression

    PubMed Central

    Dickson, Joanne M.; Moberly, Nicholas J.; O’Dea, Christian; Field, Matt

    2016-01-01

    Despite the development of prominent theoretical models of goal motivation and its importance in daily life, research has rarely examined goal dysregulation processes in clinical depression. Here we aimed to investigate problematic aspects of goal regulation in clinically depressed adults, relative to controls. Depressed participants (n = 42) were recruited from two Improving Access to Psychological Therapy clinics in north-west England. Control participants (n = 51) were recruited from the same region. Participants generated personal approach goals (e.g., improve my marathon time) and avoidance goals (e.g., avoid getting upset over little things) and completed self-report measures of goal attainment likelihood and depressive symptoms. Participants also completed a measure of ease of disengagement from unattainable goals and re-engagement with new goals. Compared to controls, depressed participants reported fewer approach goals (but not more avoidance goals), rated their approach goal (rewarding) outcomes as less likely to happen and avoidance goal (threatening) outcomes as more likely to happen. Depressed participants also reported greater ease of disengagement from unattainable goals and more difficulty re-engaging with new goals than controls. Our findings extend current knowledge of the psychopathology of depression from a goal regulation perspective, suggesting that pessimism around goal pursuit accompanies fewer approach goal pursuits and a general tendency to disengage when difficulties are encountered. PMID:27902708

  17. National Dam Safety Program. J. Bristow Lake Dam (MO 30985), Mississippi - Kaskaskia - St. Louis River Basin, Crawford County, Missouri. Phase I Inspection Report.

    DTIC Science & Technology

    1980-08-01

    8217 m’-* k TOW LAKE DAM -- CRAWFORD COUNTY, MISSOURI * ~MO 30MS PHASE 1 INSPECTION REPORT NATIONAL DAM SAFETY PROGRAM Unkd Ska AnviV €Ow" of Ifntineers I...REPORT NUMBER Crawford County, Missouri 7. AUTHOR() 1 . CONTRACT OR GRANT NUMBER(@) Anderson Engineering, Inc. D6ACW4 3-8j-C-#73 9. PERFORMING ORGANIZATION...oF 1 MOV SS IS O~LET’E 𔄃UNCLASSIFIED SECUFITY CLASSIFICATION OF THIS PAGE (When Dote Entered) SI ’ SECURITY CLASSIFICATION OF THIS PAOR(3SOM DOS a

  18. Personal Finance. Common Curriculum Goals.

    ERIC Educational Resources Information Center

    Oregon State Dept. of Education, Salem.

    This document provides the common curriculum goals for the state of Oregon in personal finance, an area of study that relates basic economic concepts and practices to the financial concerns of consumers. These goals were designed to define what should be taught in all public school settings. The common curriculum goals in personal finance are…

  19. Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study.

    PubMed

    Czito, Brian G; Deming, Dustin A; Jameson, Gayle S; Mulcahy, Mary F; Vaghefi, Houman; Dudley, Matthew W; Holen, Kyle D; DeLuca, Angela; Mittapalli, Rajendar K; Munasinghe, Wijith; He, Lei; Zalcberg, John R; Ngan, Samuel Y; Komarnitsky, Philip; Michael, Michael

    2017-06-01

    Further optimisation of present standard chemoradiation is needed in patients with locally advanced rectal cancer. Veliparib, an oral poly(ADP-ribose) polymerase inhibitor, has been shown to enhance the antitumour activity of chemotherapy and radiotherapy in preclinical models. We aimed to establish the maximum tolerated dose and establish the recommended phase 2 dose of veliparib combined with neoadjuvant capecitabine and radiotherapy. This phase 1b, open-label, multicentre, dose-escalation study was done at six hospitals (one in Australia and five in the USA). Patients were eligible if they were aged 18 years or more and were newly diagnosed with stage II to III locally advanced, resectable adenocarcinoma of the rectum with a distal tumour border of less than 12 cm from anal verge. Patients were ineligible if they had received anticancer therapy or surgery (except colostomy or ileostomy) 28 days or less before the first dose of study drug, previous pelvic radiotherapy, or previous treatment with poly (ADP-ribose) polymerase inhibitors. Enrolled patients received capecitabine (825 mg/m 2 orally twice daily) with radiotherapy (50·4 Gy in 1·8 Gy fractions daily, approximately 5 days consecutively per week for about 5·5 weeks). Veliparib (20-400 mg orally twice daily) was administered daily starting on day 2 of week 1 and continuing until 2 days after radiotherapy completion. Patients underwent total mesorectal excision 5-10 weeks after radiotherapy completion. The primary objectives were to establish the maximum tolerated dose and recommended phase 2 dose of veliparib plus capecitabine and radiotherapy, with an exposure-adjusted continual reassessment methodology. Efficacy and safety analyses were done per protocol. The reported study has completed accrual and all analyses are final. This trial is registered with ClinicalTrials.gov, number NCT01589419. Between June 12, 2012, and Jan 13, 2015, 32 patients received veliparib (22 in the dose-escalation group; ten in

  20. Different Goals for Different Folks: A Cross-Cultural Study of Achievement Goals across Nine Cultures

    ERIC Educational Resources Information Center

    King, Ronnel B.; McInerney, Dennis M.; Nasser, Ramzi

    2017-01-01

    Goals are important predictors of key educational outcomes. However, most of the research on goal theory has been conducted in Western societies. In this study we examine how different types of goals (mastery, performance, social, and extrinsic) derived from personal investment theory are associated with key learning outcomes across nine cultural…

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