Preventing Harm in the ICU-Building a Culture of Safety and Engaging Patients and Families.

PubMed

Thornton, Kevin C; Schwarz, Jennifer J; Gross, A Kendall; Anderson, Wendy G; Liu, Kathleen D; Romig, Mark C; Schell-Chaple, Hildy; Pronovost, Peter J; Sapirstein, Adam; Gropper, Michael A; Lipshutz, Angela K M

2017-09-01

Preventing harm remains a persistent challenge in the ICU despite evidence-based practices known to reduce the prevalence of adverse events. This review seeks to describe the critical role of safety culture and patient and family engagement in successful quality improvement initiatives in the ICU. We review the evidence supporting the impact of safety culture and provide practical guidance for those wishing to implement initiatives aimed at improving safety culture and more effectively integrate patients and families in such efforts. Literature review using PubMed including evaluation of key studies assessing large-scale quality improvement efforts in the ICU, impact of safety culture on patient outcomes, methodologies for quality improvement commonly used in healthcare, and patient and family engagement. Print and web-based resources from leading patient safety organizations were also searched. Our group completed a review of original studies, review articles, book chapters, and recommendations from leading patient safety organizations. Our group determined by consensus which resources would best inform this review. A strong safety culture is associated with reduced adverse events, lower mortality rates, and lower costs. Quality improvement efforts have been shown to be more effective and sustainable when paired with a strong safety culture. Different methodologies exist for quality improvement in the ICU; a thoughtful approach to implementation that engages frontline providers and administrative leadership is essential for success. Efforts to substantively include patients and families in the processes of quality improvement work in the ICU should be expanded. Efforts to establish a culture of safety and meaningfully engage patients and families should form the foundation for all safety interventions in the ICU. This review describes an approach that integrates components of several proven quality improvement methodologies to enhance safety culture in the ICU and highlights opportunities to include patients and families.

A risk-based decision support framework for selection of appropriate safety measure system for underground coal mines.

PubMed

Samantra, Chitrasen; Datta, Saurav; Mahapatra, Siba Sankar

2017-03-01

In the context of underground coal mining industry, the increased economic issues regarding implementation of additional safety measure systems, along with growing public awareness to ensure high level of workers safety, have put great pressure on the managers towards finding the best solution to ensure safe as well as economically viable alternative selection. Risk-based decision support system plays an important role in finding such solutions amongst candidate alternatives with respect to multiple decision criteria. Therefore, in this paper, a unified risk-based decision-making methodology has been proposed for selecting an appropriate safety measure system in relation to an underground coal mining industry with respect to multiple risk criteria such as financial risk, operating risk, and maintenance risk. The proposed methodology uses interval-valued fuzzy set theory for modelling vagueness and subjectivity in the estimates of fuzzy risk ratings for making appropriate decision. The methodology is based on the aggregative fuzzy risk analysis and multi-criteria decision making. The selection decisions are made within the context of understanding the total integrated risk that is likely to incur while adapting the particular safety system alternative. Effectiveness of the proposed methodology has been validated through a real-time case study. The result in the context of final priority ranking is seemed fairly consistent.

Applying ethnography to the study of context in healthcare quality and safety.

PubMed

Leslie, Myles; Paradis, Elise; Gropper, Michael A; Reeves, Scott; Kitto, Simon

2014-02-01

Translating and scaling healthcare quality improvement (QI) and patient safety interventions remains a significant challenge. Context has been identified as a major factor in this. QI and patient safety research have begun to focus on context, with ethnography seen as a promising methodology for understanding the professional, organisational and cultural aspects of context. While ethnography is used to investigate the context of a variety of QI and safety interventions, the challenges inherent in effectively importing a qualitative methodology and its social science practitioners into this work have been largely unexamined. We explain ethnography as a research practice grounded in theory and dependent on observations gathered and interpreted in particular ways. We then review the approach of health services literature to evaluating this sort of qualitative research. Although the study of context is an interest shared by both social scientists and healthcare QI and safety researchers, we identify three key points at which those 'exporting' ethnography as a methodology and those 'importing' it to deal with QI and safety challenges may diverge. We describe perspectival divergences on the methodology's mission, form and scale. At the level of mission we demonstrate how ethnography has been adapted to a 'describe and feed back' role in the service of QI. At the level of form, we show how the long-term embedded observation at the heart of ethnography can be adapted only so far to accommodate QI interests if both data quality and ethical standards are to be upheld. Finally, at the level of scale, we demonstrate one ethnographic study design that balances breadth of exposure with depth of experience in its observations and so generates a particular type of scalable findings. The effective export of ethnography into QI and safety research requires discussion and negotiation between social scientific and health services research perspectives, as well as creative approaches to producing self-reflexive data that will allow clinicians to understand their own context and so improve their own processes.

Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

PubMed

Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

2017-10-01

The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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.

Lunar mission safety and rescue: Hazards analysis and safety requirements

NASA Technical Reports Server (NTRS)

1971-01-01

The results are presented of the hazards analysis which was concerned only with hazards to personnel and not with loss of equipment or property. Hazards characterization includes the definition of a hazard, the hazard levels, and the hazard groups. The analysis methodology is described in detail. The methodology was used to prepare the top level functional flow diagrams, to perform the first level hazards assessment, and to develop a list of conditions and situations requiring individual hazard studies. The 39 individual hazard study results are presented in total.

Design strategies from sexual exploitation and sex work studies among women and girls: Methodological considerations in a hidden and vulnerable population.

PubMed

Gerassi, Lara; Edmond, Tonya; Nichols, Andrea

2017-06-01

The study of sex trafficking, prostitution, sex work, and sexual exploitation is associated with many methodological issues and challenges. Researchers' study designs must consider the many safety issues related to this vulnerable and hidden population. Community advisory boards and key stakeholder involvement are essential to study design to increase safety of participants, usefulness of study aims, and meaningfulness of conclusions. Nonrandomized sampling strategies are most often utilized when studying exploited women and girls, which have the capacity to provide rich data and require complex sampling and recruitment methods. This article reviews the current methodological issues when studying this marginalized population as well as strategies to address challenges while working with the community in order to bring about social change. The authors also discuss their own experiences in collaborating with community organizations to conduct research in this field.

Design strategies from sexual exploitation and sex work studies among women and girls: Methodological considerations in a hidden and vulnerable population

PubMed Central

Gerassi, Lara; Edmond, Tonya; Nichols, Andrea

2016-01-01

The study of sex trafficking, prostitution, sex work, and sexual exploitation is associated with many methodological issues and challenges. Researchers’ study designs must consider the many safety issues related to this vulnerable and hidden population. Community advisory boards and key stakeholder involvement are essential to study design to increase safety of participants, usefulness of study aims, and meaningfulness of conclusions. Nonrandomized sampling strategies are most often utilized when studying exploited women and girls, which have the capacity to provide rich data and require complex sampling and recruitment methods. This article reviews the current methodological issues when studying this marginalized population as well as strategies to address challenges while working with the community in order to bring about social change. The authors also discuss their own experiences in collaborating with community organizations to conduct research in this field. PMID:28824337

Methodological and Ethical Issues in Pediatric Medication Safety Research.

PubMed

Carpenter, Delesha; Gonzalez, Daniel; Retsch-Bogart, George; Sleath, Betsy; Wilfond, Benjamin

2017-09-01

In May 2016, the Eshelman School of Pharmacy at The University of North Carolina at Chapel Hill convened the PharmSci conference to address the topic of "methodological and ethical issues in pediatric medication safety research." A multidisciplinary group of experts representing a diverse array of perspectives, including those of the US Food and Drug Administration, children's hospitals, and academia, identified important considerations for pediatric medication safety research and opportunities to advance the field. This executive summary describes current challenges that clinicians and researchers encounter related to pediatric medication safety research and identifies innovative and ethically sound methodologies to address these challenges to improve children's health. This article addresses 5 areas: (1) pediatric drug development and drug trials; (2) conducting comparative effectiveness research in pediatric populations; (3) child and parent engagement on study teams; (4) improving communication with children and parents; and (5) assessing child-reported outcomes and adverse drug events. Copyright © 2017 by the American Academy of Pediatrics.

Evaluation of analytical methodology for hydrocarbons in high pressure air and nitrogen systems. [data aquisition

NASA Technical Reports Server (NTRS)

1977-01-01

Information regarding the safety limits of hydrocarbons in liquid and gaseous oxygen, the steps taken for hydrocarbon removal from liquified gases, and the analysis of the contaminants was searched and the results are presented. The safety of hydrocarbons in gaseous systems was studied, and the latest hydrocarbon test equipment and methodology is reviewed. A detailed sampling and analysis plan is proposed to evaluate high pressure GN2 and LOX systems.

Roadway safety analysis methodology for Utah : final report.

DOT National Transportation Integrated Search

2016-12-01

This research focuses on the creation of a three-part Roadway Safety Analysis methodology that applies and automates the cumulative work of recently-completed roadway safety research. The first part is to prepare the roadway and crash data for analys...

Reliability Modeling Methodology for Independent Approaches on Parallel Runways Safety Analysis

NASA Technical Reports Server (NTRS)

Babcock, P.; Schor, A.; Rosch, G.

1998-01-01

This document is an adjunct to the final report An Integrated Safety Analysis Methodology for Emerging Air Transport Technologies. That report presents the results of our analysis of the problem of simultaneous but independent, approaches of two aircraft on parallel runways (independent approaches on parallel runways, or IAPR). This introductory chapter presents a brief overview and perspective of approaches and methodologies for performing safety analyses for complex systems. Ensuing chapter provide the technical details that underlie the approach that we have taken in performing the safety analysis for the IAPR concept.

Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

DOT National Transportation Integrated Search

1980-06-01

This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

Improving Safety, Quality and Efficiency through the Management of Emerging Processes: The TenarisDalmine Experience

ERIC Educational Resources Information Center

Bonometti, Patrizia

2012-01-01

Purpose: The aim of this contribution is to describe a new complexity-science-based approach for improving safety, quality and efficiency and the way it was implemented by TenarisDalmine. Design/methodology/approach: This methodology is called "a safety-building community". It consists of a safety-behaviour social self-construction…

Indian reservation safety improvement program : a methodology and case study.

DOT National Transportation Integrated Search

2015-11-01

Improving roadway safety on Indian reservations requires a comprehensive approach. Limited : resources, lack of crash data, and few cross-jurisdictions coordination has made it difficult for : Native American communities to address their roadway safe...

A Case Study of Measuring Process Risk for Early Insights into Software Safety

NASA Technical Reports Server (NTRS)

Layman, Lucas; Basili, Victor; Zelkowitz, Marvin V.; Fisher, Karen L.

2011-01-01

In this case study, we examine software safety risk in three flight hardware systems in NASA's Constellation spaceflight program. We applied our Technical and Process Risk Measurement (TPRM) methodology to the Constellation hazard analysis process to quantify the technical and process risks involving software safety in the early design phase of these projects. We analyzed 154 hazard reports and collected metrics to measure the prevalence of software in hazards and the specificity of descriptions of software causes of hazardous conditions. We found that 49-70% of 154 hazardous conditions 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. The application of the TPRM methodology identified process risks in the application of the hazard analysis process itself that may lead to software safety risk.

Reviewing methodologically disparate data: a practical guide for the patient safety research field.

PubMed

Brown, Katrina F; Long, Susannah J; Athanasiou, Thanos; Vincent, Charles A; Kroll, J Simon; Sevdalis, Nick

2012-02-01

This article addresses key questions frequently asked by researchers conducting systematic reviews in patient safety. This discipline is relatively young, and asks complex questions about complex aspects of health care delivery and experience, therefore its studies are typically methodologically heterogeneous, non-randomized and complex; but content rich and highly relevant to practice. Systematic reviews are increasingly necessary to drive forward practice and research in this area, but the data do not always lend themselves to 'standard' review methodologies. This accessible 'how-to' article demonstrates that data diversity need not preclude high-quality systematic reviews. It draws together information from published guidelines and experience within our multidisciplinary patient safety research group to provide entry-level advice for the clinician-researcher new to systematic reviewing, to non-biomedical research data or to both. It offers entry-level advice, illustrated with detailed practical examples, on defining a research question, creating a comprehensive search strategy, selecting articles for inclusion, assessing study quality, extracting data, synthesizing data and evaluating the impact of your review. The article concludes with a comment on the vital role of robust systematic reviews in the continuing advancement of the patient safety field. © 2010 Blackwell Publishing Ltd.

Analytical Utility of Campylobacter Methodologies

USDA-ARS?s Scientific Manuscript database

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF, or the Committee) was asked to address the analytical utility of Campylobacter methodologies in preparation for an upcoming United States Food Safety and Inspection Service (FSIS) baseline study to enumerate Campylobacter...

Bayesian methodology incorporating expert judgment for ranking countermeasure effectiveness under uncertainty: example applied to at grade railroad crossings in Korea.

PubMed

Washington, Simon; Oh, Jutaek

2006-03-01

Transportation professionals are sometimes required to make difficult transportation safety investment decisions in the face of uncertainty. In particular, an engineer may be expected to choose among an array of technologies and/or countermeasures to remediate perceived safety problems when: (1) little information is known about the countermeasure effects on safety; (2) information is known but from different regions, states, or countries where a direct generalization may not be appropriate; (3) where the technologies and/or countermeasures are relatively untested, or (4) where costs prohibit the full and careful testing of each of the candidate countermeasures via before-after studies. The importance of an informed and well-considered decision based on the best possible engineering knowledge and information is imperative due to the potential impact on the numbers of human injuries and deaths that may result from these investments. This paper describes the formalization and application of a methodology to evaluate the safety benefit of countermeasures in the face of uncertainty. To illustrate the methodology, 18 countermeasures for improving safety of at grade railroad crossings (AGRXs) in the Republic of Korea are considered. Akin to "stated preference" methods in travel survey research, the methodology applies random selection and laws of large numbers to derive accident modification factor (AMF) densities from expert opinions. In a full Bayesian analysis framework, the collective opinions in the form of AMF densities (data likelihood) are combined with prior knowledge (AMF density priors) for the 18 countermeasures to obtain 'best' estimates of AMFs (AMF posterior credible intervals). The countermeasures are then compared and recommended based on the largest safety returns with minimum risk (uncertainty). To the author's knowledge the complete methodology is new and has not previously been applied or reported in the literature. The results demonstrate that the methodology is able to discern anticipated safety benefit differences across candidate countermeasures. For the 18 at grade railroad crossings considered in this analysis, it was found that the top three performing countermeasures for reducing crashes are in-vehicle warning systems, obstacle detection systems, and constant warning time systems.

A Review of Interventions To Increase Driving Safety among Teenage Drivers.

ERIC Educational Resources Information Center

Mattox, John R., II

Young drivers across the United States represent a persistent traffic safety problem. Many interventions have been imposed on these drivers but few studies have evaluated the impact of these interventions on risky behaviors or traffic safety measures. To fill this gap, a review was undertaken to examine the most rigorous methodological evaluations…

75 FR 9232 - Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

... for assessing progress in food safety and associated methodological issues and to discuss potential.... The FoodNet also conducts special studies to determine risk factors for acquiring those illnesses... production, studies on the prevalence of specific pathogens in specific classes of food, and studies of...

Promoting quality and safety in women's health through the use of transdisciplinary clinical simulation educational modules: methodology and a pilot trial.

PubMed

Montgomery, Kymberlee; Morse, Catherine; Smith-Glasgow, Mary Ellen; Posmontier, Bobbie; Follen, Michele

2012-02-01

This manuscript presents the methodology used to assess the impact of a clinical simulation module used for training providers specializing in women's health. The methodology presented here will be used for a quantitative study in the future. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Systems Analysis of NASA Aviation Safety Program: Final Report

NASA Technical Reports Server (NTRS)

Jones, Sharon M.; Reveley, Mary S.; Withrow, Colleen A.; Evans, Joni K.; Barr, Lawrence; Leone, Karen

2013-01-01

A three-month study (February to April 2010) of the NASA Aviation Safety (AvSafe) program was conducted. This study comprised three components: (1) a statistical analysis of currently available civilian subsonic aircraft data from the National Transportation Safety Board (NTSB), the Federal Aviation Administration (FAA), and the Aviation Safety Information Analysis and Sharing (ASIAS) system to identify any significant or overlooked aviation safety issues; (2) a high-level qualitative identification of future safety risks, with an assessment of the potential impact of the NASA AvSafe research on the National Airspace System (NAS) based on these risks; and (3) a detailed, top-down analysis of the NASA AvSafe program using an established and peer-reviewed systems analysis methodology. The statistical analysis identified the top aviation "tall poles" based on NTSB accident and FAA incident data from 1997 to 2006. A separate examination of medical helicopter accidents in the United States was also conducted. Multiple external sources were used to develop a compilation of ten "tall poles" in future safety issues/risks. The top-down analysis of the AvSafe was conducted by using a modification of the Gibson methodology. Of the 17 challenging safety issues that were identified, 11 were directly addressed by the AvSafe program research portfolio.

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Effectiveness of Occupational Health and Safety Training: A Systematic Review with Meta-Analysis

ERIC Educational Resources Information Center

Ricci, Federico; Chiesi, Andrea; Bisio, Carlo; Panari, Chiara; Pelosi, Annalisa

2016-01-01

Purpose: This meta-analysis aims to verify the efficacy of occupational health and safety (OHS) training in terms of knowledge, attitude and beliefs, behavior and health. Design/methodology/approach: The authors included studies published in English (2007-2014) selected from ten databases. Eligibility criteria were studies concerned with the…

Development of Flight Safety Prediction Methodology for U. S. Naval Safety Center. Revision 1

DTIC Science & Technology

1970-02-01

Safety Center. The methodology develoned encompassed functional analysis of the F-4J aircraft, assessment of the importance of safety- sensitive ... Sensitivity ... ....... . 4-8 V 4.5 Model Implementation ........ ......... . 4-10 4.5.1 Functional Analysis ..... ........... . 4-11 4. 5. 2 Major...Function Sensitivity Assignment ........ ... 4-13 i 4.5.3 Link Dependency Assignment ... ......... . 4-14 4.5.4 Computer Program for Sensitivity

The National Aviation Operational Monitoring Service (NAOMS): A Documentation of the Development of a Survey Methodology

NASA Technical Reports Server (NTRS)

Connors, Mary M.; Mauro, Robert; Statler, Irving C.

2012-01-01

The National Aviation Operational Monitoring Service (NAOMS) was a research project under NASA s Aviation Safety Program during the years from 2000 to 2005. The purpose of this project was to develop a methodology for gaining reliable information on changes over time in the rates-of-occurrence of safety-related events as a means of assessing the safety of the national airspace. The approach was a scientifically designed survey of the operators of the aviation system concerning their safety-related experiences. This report presents the results of the methodology developed and a demonstration of the NAOMS concept through a survey of nearly 20,000 randomly selected air-carrier pilots. Results give evidence that the NAOMS methodology can provide a statistically sound basis for evaluating trends of incidents that could compromise safety. The approach and results are summarized in the report and supporting documentation and complete analyses of results are presented in 14 appendices.

Integrating teamwork, clinician occupational well-being and patient safety - development of a conceptual framework based on a systematic review.

PubMed

Welp, Annalena; Manser, Tanja

2016-07-19

There is growing evidence that teamwork in hospitals is related to both patient outcomes and clinician occupational well-being. Furthermore, clinician well-being is associated with patient safety. Despite considerable research activity, few studies include all three concepts, and their interrelations have not yet been investigated systematically. To advance our understanding of these potentially complex interrelations we propose an integrative framework taking into account current evidence and research gaps identified in a systematic review. We conducted a literature search in six major databases (Medline, PsycArticles, PsycInfo, Psyndex, ScienceDirect, and Web of Knowledge). Inclusion criteria were: peer reviewed papers published between January 2000 and June 2015 investigating a statistical relationship between at least two of the three concepts; teamwork, patient safety, and clinician occupational well-being in hospital settings, including practicing nurses and physicians. We assessed methodological quality using a standardized rating system and qualitatively appraised and extracted relevant data, such as instruments, analyses and outcomes. The 98 studies included in this review were highly diverse regarding quality, methodology and outcomes. We found support for the existence of independent associations between teamwork, clinician occupational well-being and patient safety. However, we identified several conceptual and methodological limitations. The main barrier to advancing our understanding of the causal relationships between teamwork, clinician well-being and patient safety is the lack of an integrative, theory-based, and methodologically thorough approach investigating the three concepts simultaneously and longitudinally. Based on psychological theory and our findings, we developed an integrative framework that addresses these limitations and proposes mechanisms by which these concepts might be linked. Knowledge about the mechanisms underlying the relationships between these concepts helps to identify avenues for future research, aimed at benefiting clinicians and patients by using the synergies between teamwork, clinician occupational well-being and patient safety.

Predictors of Safety Training Transfer Support as In-Role Behavior of Occupational Health and Safety Professionals

ERIC Educational Resources Information Center

Freitas, Ana Cristina; Silva, Sílvia Agostinho; Santos, Catarina Marques

2017-01-01

Purpose: The purpose of this study is to identify individual and contextual influences on in-house safety trainers' role orientation toward the transfer of training (TT). Design/methodology/approach: The authors tested a model where felt-responsibility for TT mediates the influence of job resources (i.e. autonomy, access to resources, access to…

A Predictive Safety Management System Software Package Based on the Continuous Hazard Tracking and Failure Prediction Methodology

NASA Technical Reports Server (NTRS)

Quintana, Rolando

2003-01-01

The goal of this research was to integrate a previously validated and reliable safety model, called Continuous Hazard Tracking and Failure Prediction Methodology (CHTFPM), into a software application. This led to the development of a safety management information system (PSMIS). This means that the theory or principles of the CHTFPM were incorporated in a software package; hence, the PSMIS is referred to as CHTFPM management information system (CHTFPM MIS). The purpose of the PSMIS is to reduce the time and manpower required to perform predictive studies as well as to facilitate the handling of enormous quantities of information in this type of studies. The CHTFPM theory encompasses the philosophy of looking at the concept of safety engineering from a new perspective: from a proactive, than a reactive, viewpoint. That is, corrective measures are taken before a problem instead of after it happened. That is why the CHTFPM is a predictive safety because it foresees or anticipates accidents, system failures and unacceptable risks; therefore, corrective action can be taken in order to prevent all these unwanted issues. Consequently, safety and reliability of systems or processes can be further improved by taking proactive and timely corrective actions.

Safety and economic impacts of converting two-way frontage roads to one-way : methodology and findings.

DOT National Transportation Integrated Search

2011-01-01

In the research documented here, researchers develop information to communicate the safety and : economic impacts of converting frontage roads from two-way to one-way. Researchers studied five : locations in Texas where frontage roads were converted ...

Physical Activity and Safety From Crime Among Adults: A Systematic Review.

PubMed

da Silva, Inacio C; Payne, Valerie L; Hino, Adriano Akira; Varela, Andrea Ramirez; Reis, Rodrigo S; Ekelund, Ulf; Hallal, Pedro C

2016-06-01

The aim of this study was to review the evidence to date on the association between physical activity and safety from crime. Articles with adult populations of 500+ participants investigating the association between physical activity and safety from crime were included. A methodological quality assessment was conducted using an adapted version of the Downs and Black checklist. The literature search identified 15,864 articles. After assessment of titles, abstracts and full-texts, 89 articles were included. Most articles (84.3%) were derived from high-income countries and only 3 prospective articles were identified. Articles presented high methodological quality. In 38 articles (42.7%), at least one statistically significant association in the expected direction was reported (ie, safety from crime was positively associated with physical activity). Nine articles (10.1%) found an association in the unexpected direction and 42 (47.2%) did not find statistically significant associations. The results did not change when we analyzed articles separately by sex, age, type of measurement, or domains of physical activity evaluated. The current evidence, mostly based on cross-sectional studies, suggests a lack of association between physical activity and safety from crime. Prospective studies and natural experiments are needed, particularly in areas with wide crime variability.

Transcranial Direct Current Stimulation in Epilepsy.

PubMed

San-Juan, Daniel; Morales-Quezada, León; Orozco Garduño, Adolfo Josué; Alonso-Vanegas, Mario; González-Aragón, Maricarmen Fernández; Espinoza López, Dulce Anabel; Vázquez Gregorio, Rafael; Anschel, David J; Fregni, Felipe

2015-01-01

Transcranial direct current stimulation (tDCS) is an emerging non-invasive neuromodulation therapy in epilepsy with conflicting results in terms of efficacy and safety. Review the literature about the efficacy and safety of tDCS in epilepsy in humans and animals. We searched studies in PubMed, MedLine, Scopus, Web of Science and Google Scholar (January 1969 to October 2013) using the keywords 'transcranial direct current stimulation' or 'tDCS' or 'brain polarization' or 'galvanic stimulation' and 'epilepsy' in animals and humans. Original articles that reported tDCS safety and efficacy in epileptic animals or humans were included. Four review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions, PRISMA guidelines and Jadad Scale. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies. We analyzed 9 articles with different methodologies (3 animals/6 humans) with a total of 174 stimulated individuals; 109 animals and 65 humans. In vivo and in vitro animal studies showed that direct current stimulation can successfully induce suppression of epileptiform activity without neurological injury and 4/6 (67%) clinical studies showed an effective decrease in epileptic seizures and 5/6 (83%) reduction of inter-ictal epileptiform activity. All patients tolerated tDCS well. tDCS trials have demonstrated preliminary safety and efficacy in animals and patients with epilepsy. Further larger studies are needed to define the best stimulation protocols and long-term follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.

A systematic review of patient tracking systems for use in the pediatric emergency department.

PubMed

Dobson, Ian; Doan, Quynh; Hung, Geoffrey

2013-01-01

Patient safety is of great importance in the pediatric emergency department (PED). The combination of acutely and critically ill patients and high patient volumes creates a need for systems to support physicians in making accurate and timely diagnoses. Electronic patient tracking systems can potentially improve PED safety by reducing overcrowding and enhancing security. To enhance our understanding of current electronic tracking technologies, how they are implemented in a clinical setting, and resulting effect on patient care outcomes including patient safety. Nine databases were searched. Two independent reviewers identified articles that contained reference to patient tracking technologies in pediatrics or emergency medicine. Quantitative studies were assessed independently for methodological strength by two reviewers using an external assessment tool. Of 2292 initial articles, 22 were deemed relevant. Seventeen were qualitative, and the remaining five quantitative articles were assessed as being methodologically weak. Existing patient tracking systems in the ED included: infant monitoring/abduction prevention; barcode identification; radiofrequency identification (RFID)- or infrared (IR)-based patient tracking. Twenty articles supported the use of tracking technology to enhance patient safety or improve efficiency. One article failed to support the use of IR patient sensors due to study design flaws. Support exists for the use of barcode-, IR-, and RFID-based patient tracking systems to improve ED patient safety and efficiency. A lack of methodologically strong studies indicates a need for further evidence-based support for the implementation of patient tracking technology in a clinical or research setting. Copyright © 2013 Elsevier Inc. All rights reserved.

RPP-PRT-58489, Revision 1, One Systems Consistent Safety Analysis Methodologies Report. 24590-WTP-RPT-MGT-15-014

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

Gupta, Mukesh; Niemi, Belinda; Paik, Ingle

2015-09-02

In 2012, One System Nuclear Safety performed a comparison of the safety bases for the Tank Farms Operations Contractor (TOC) and Hanford Tank Waste Treatment and Immobilization Plant (WTP) (RPP-RPT-53222 / 24590-WTP-RPT-MGT-12-018, “One System Report of Comparative Evaluation of Safety Bases for Hanford Waste Treatment and Immobilization Plant Project and Tank Operations Contract”), and identified 25 recommendations that required further evaluation for consensus disposition. This report documents ten NSSC approved consistent methodologies and guides and the results of the additional evaluation process using a new set of evaluation criteria developed for the evaluation of the new methodologies.

Alcohol abuse and traffic safety : a study of fatalities, DWI offenders, alcoholics, and court-related treatment approaches

DOT National Transportation Integrated Search

1970-06-26

Author's abstract: Methodology and conclusions on the role of the abusive use of alcohol in traffic safety were developed through three related projects. Project I is a case-history investigation of 616 traffic fatalities from metropolitan Wayne Coun...

Advanced biosensing methodologies developed for evaluating performance quality and safety of emerging biophotonics technologies and medical devices (Conference Presentation)

NASA Astrophysics Data System (ADS)

Ilev, Ilko K.; Walker, Bennett; Calhoun, William; Hassan, Moinuddin

2016-03-01

Biophotonics is an emerging field in modern biomedical technology that has opened up new horizons for transfer of state-of-the-art techniques from the areas of lasers, fiber optics and biomedical optics to the life sciences and medicine. This field continues to vastly expand with advanced developments across the entire spectrum of biomedical applications ranging from fundamental "bench" laboratory studies to clinical patient "bedside" diagnostics and therapeutics. However, in order to translate these technologies to clinical device applications, the scientific and industrial community, and FDA are facing the requirement for a thorough evaluation and review of laser radiation safety and efficacy concerns. In many cases, however, the review process is complicated due the lack of effective means and standard test methods to precisely analyze safety and effectiveness of some of the newly developed biophotonics techniques and devices. There is, therefore, an immediate public health need for new test protocols, guidance documents and standard test methods to precisely evaluate fundamental characteristics, performance quality and safety of these technologies and devices. Here, we will overview our recent developments of novel test methodologies for safety and efficacy evaluation of some emerging biophotonics technologies and medical devices. These methodologies are based on integrating the advanced features of state-of-the-art optical sensor technologies and approaches such as high-resolution fiber-optic sensing, confocal and optical coherence tomography imaging, and infrared spectroscopy. The presentation will also illustrate some methodologies developed and implemented for testing intraocular lens implants, biochemical contaminations of medical devices, ultrahigh-resolution nanoscopy, and femtosecond laser therapeutics.

Crash Simulation and Animation: 'A New Approach for Traffic Safety Analysis'

DOT National Transportation Integrated Search

2001-02-01

This researchs objective is to present a methodology to supplement the conventional traffic safety analysis techniques. This methodology aims at using computer simulation to animate and visualize crash occurrence at high-risk locations. This methodol...

Systematic review of the evidence related to mandated nurse staffing ratios in acute hospitals.

PubMed

Olley, Richard; Edwards, Ian; Avery, Mark; Cooper, Helen

2018-04-17

Objective The purpose of this systematic review was to evaluate and summarise available research on nurse staffing methods and relate these to outcomes under three overarching themes of: (1) management of clinical risk, quality and safety; (2) development of a new or innovative staffing methodology; and (3) equity of nursing workload. Methods The PRISMA method was used. Relevant articles were located by searching via the Griffith University Library electronic catalogue, including articles on PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Medline. Only English language publications published between 1 January 2010 and 30 April 2016 focusing on methodologies in acute hospital in-patient units were included in the present review. Results Two of the four staffing methods were found to have evidenced-based articles from empirical studies within the parameters set for inclusion. Of the four staffing methodologies searched, supply and demand returned 10 studies and staffing ratios returned 11. Conclusions There is a need to develop an evidence-based nurse-sensitive outcomes measure upon which staffing for safety, quality and workplace equity, as well as an instrument that reliability and validly projects nurse staffing requirements in a variety of clinical settings. Nurse-sensitive indicators reflect elements of patient care that are directly affected by nursing practice In addition, these measures must take into account patient satisfaction, workload and staffing, clinical risks and other measures of the quality and safety of care and nurses' work satisfaction. i. What is known about the topic? Nurse staffing is a controversial topic that has significant patient safety, quality of care, human resources and financial implications. In acute care services, nursing accounts for approximately 70% of salaries and wages paid by health services budgets, and evidence as to the efficacy and effectiveness of any staffing methodology is required because it has workforce and industrial relations implications. Although there is significant literature available on the topic, there is a paucity of empirical evidence supporting claims of increased patient safety in the acute hospital setting, but some evidence exists relating to equity of workload for nurses. What does this paper add? This paper provides a contemporary qualitative analysis of empirical evidence using PRISMA methodology to conduct a systematic review of the available literature. It demonstrates a significant research gap to support claims of increased patient safety in the acute hospital setting. The paper calls for greatly improved datasets upon which research can be undertaken to determine any associations between mandated patient to nurse ratios and other staffing methodologies and patient safety and quality of care. What are the implications for practitioners? There is insufficient contemporary research to support staffing methodologies for appropriate staffing, balanced workloads and quality, safe care. Such research would include the establishment of nurse-sensitive patient outcomes measures, and more robust datasets are needed for empirical analysis to produce such evidence.

Narrative review of the UK Patient Safety Research Portfolio.

PubMed

Waring, Justin; Rowley, Emma; Dingwall, Robert; Palmer, Cecily; Murcott, Toby

2010-01-01

The UK Patient Safety Research Portfolio (PSRP) commissioned 38 studies investigating the threats to patient safety in various clinical settings and evaluating safety-related service interventions. This paper reviews 27 of these studies, drawing out emergent and cross-cutting themes in terms of theory, research methods and thematic findings. Given the diversity of PSRP studies, the paper takes a narrative approach that allows for qualitative description, interpretation and synthesis of the studies and their findings. The theoretical review shows the majority of PSRP studies draw upon a patient safety 'orthodoxy', developed from the concepts and models associated with the human factors approach. The methodological review shows that a diverse range of research designs and techniques have been utilized. Although many follow in the 'scientific' tradition, interpretative, mixed and innovative methods have been integral to research. The thematic review of findings highlights significant contributions to knowledge in the areas of 'people', 'organizations', and 'technology'. As well as identifying the various sources of risk in the organization and delivery of patient care, the studies also evaluate and make recommendations about service change and improvement. The PSRP has provided the foundations for significant theoretical, methodological and empirical advances in the area of patient safety. The findings and recommendations make important contributions to policy formulation and implementation as well as professional and managerial practice. Through this body of research the PSRP has supported the formation and growth of a thriving research community across academic, policy and professional communities.

The Study of the Relationship between Probabilistic Design and Axiomatic Design Methodology. Volume 2

NASA Technical Reports Server (NTRS)

Onwubiko, Chin-Yere; Onyebueke, Landon

1996-01-01

The structural design, or the design of machine elements, has been traditionally based on deterministic design methodology. The deterministic method considers all design parameters to be known with certainty. This methodology is, therefore, inadequate to design complex structures that are subjected to a variety of complex, severe loading conditions. A nonlinear behavior that is dependent on stress, stress rate, temperature, number of load cycles, and time is observed on all components subjected to complex conditions. These complex conditions introduce uncertainties; hence, the actual factor of safety margin remains unknown. In the deterministic methodology, the contingency of failure is discounted; hence, there is a use of a high factor of safety. It may be most useful in situations where the design structures are simple. The probabilistic method is concerned with the probability of non-failure performance of structures or machine elements. It is much more useful in situations where the design is characterized by complex geometry, possibility of catastrophic failure, sensitive loads and material properties. Also included: Comparative Study of the use of AGMA Geometry Factors and Probabilistic Design Methodology in the Design of Compact Spur Gear Set.

A Practical Risk Assessment Methodology for Safety-Critical Train Control Systems

DOT National Transportation Integrated Search

2009-07-01

This project proposes a Practical Risk Assessment Methodology (PRAM) for analyzing railroad accident data and assessing the risk and benefit of safety-critical train control systems. This report documents in simple steps the algorithms and data input...

NASA's post-Challenger safety program - Themes and thrusts

NASA Technical Reports Server (NTRS)

Rodney, G. A.

1988-01-01

The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.

A systematic review on the effectiveness of school and community-based injury prevention programmes on risk behaviour and injury risk in 8-12 year old children.

PubMed

Nauta, Joske; van Mechelen, Willem; Otten, René H J; Verhagen, Evert A L M

2014-03-01

To review existing literature on the effectiveness of community-based and school-based physical activity related injury prevention programmes implemented to increase safety behaviour and decrease injury risk in 8-12 year old children, considering the methodological quality of the studies. A systematic review with quality assessment. A systematic search was performed using the CINAHL, Cochrane, EMBASE, PubMed and Sportdiscus databases. Inclusion criteria included the following: children aged 8-12 years; school- or community-based injury prevention programmes; an outcome defined as number of injuries, injury incidence or safety behaviour; published in an English language journal. Methodological quality was assessed for all included studies. The search yielded 5377 records, of which 11 were included in the review; four studies were considered as being of high quality. The focus of studies that were included was on the use of safety devices (8), pedestrian safety (2) and physical activity-related injury prevention (1). For safety device use, short term effects of school- and community-based interventions are promising for 8-12 year olds. Results regarding sustainability of the effect are inconsistent. A mediating effect on the distribution of safety devices was observed. Both financial and non-financial barriers seemed to prevent participants from purchasing a safety device. The short term effects for school- and community-based interventions using safety devices for 8-12 year olds are promising. More high quality research is, however warranted, preferably shifting focus from safety behaviour change to actual physical activity injury reduction. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

National Institute for Occupational Safety and Health Oversight: OMB Involvement in VDT Study. Hearing before the Subcommittee on Health and Safety of the Committee on Education and Labor. House of Representatives, Ninety-Ninth Congress, Second Session (June 4, 1986).

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. House Committee on Education and Labor.

This hearing addressed the issue of whether the delays in producing a proposed National Institute for Occupational and Safety Health (NIOSH) study on the possible health hazards associated with video display terminals (VDTs) are due to concerns about scientific methodology or unwarranted interference by the Office of Management and Budget (OMB).…

A literature review of safety culture.

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

Cole, Kerstan Suzanne; Stevens-Adams, Susan Marie; Wenner, Caren A.

2013-03-01

Workplace safety has been historically neglected by organizations in order to enhance profitability. Over the past 30 years, safety concerns and attention to safety have increased due to a series of disastrous events occurring across many different industries (e.g., Chernobyl, Upper Big-Branch Mine, Davis-Besse etc.). Many organizations have focused on promoting a healthy safety culture as a way to understand past incidents, and to prevent future disasters. There is an extensive academic literature devoted to safety culture, and the Department of Energy has also published a significant number of documents related to safety culture. The purpose of the current endeavormore » was to conduct a review of the safety culture literature in order to understand definitions, methodologies, models, and successful interventions for improving safety culture. After reviewing the literature, we observed four emerging themes. First, it was apparent that although safety culture is a valuable construct, it has some inherent weaknesses. For example, there is no common definition of safety culture and no standard way for assessing the construct. Second, it is apparent that researchers know how to measure particular components of safety culture, with specific focus on individual and organizational factors. Such existing methodologies can be leveraged for future assessments. Third, based on the published literature, the relationship between safety culture and performance is tenuous at best. There are few empirical studies that examine the relationship between safety culture and safety performance metrics. Further, most of these studies do not include a description of the implementation of interventions to improve safety culture, or do not measure the effect of these interventions on safety culture or performance. Fourth, safety culture is best viewed as a dynamic, multi-faceted overall system composed of individual, engineered and organizational models. By addressing all three components of safety culture, organizations have a better chance of understanding, evaluating, and making positive changes towards safety within their own organization.« less

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

Microbial food safety in Ghana: a meta-analysis.

PubMed

Saba, Courage K S; Gonzalez-Zorn, Bruno

2012-12-16

Food safety is a crucial factor in the growth of developing countries worldwide. In this study, we present a meta-analysis of microbiological food safety publications from Ghana. The search words "Ghana food safety", "Ghana food research", and "Ghana food bacteria" were used to search for microbiological food safety publications with related abstracts or titles in PubMed, published between 1997 and 2009. We obtained 183 research articles, from which we excluded articles concerning ready-to-eat microbial fermented foods and waterborne microorganisms as well as articles without abstracts. The criteria used for analysis of these publications were based on an assessment of methodological soundness previously developed for use in the medical field, with some modifications incorporated. The most predominant bacteria in Ghanain foods are Enterobacter spp., Citrobacter spp., Klebsiella spp. and Escherichia spp., which were found to be present in 65%, 50%, 46% and 38% respectively, of the food samples considered in the studies analysed. The most contaminated food samples were macaroni, salad, and milk. Although the methodological quality of the articles was generally sound, most of them did not give directions for future research. Several did not state possible reasons for differences between studies. The microbiological food contamination in Ghana is alarming. However, we found that the downward trend in publications of microbial food safety articles is appalling. Hence a concerted effort in research on food safety is needed in Ghana to help curb the incidence of preventable food-borne disease.

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

Integrated vehicle-based safety systems heavy truck field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the heavy-truck field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michiga...

Integrated vehicle-based safety systems light-vehicle field operational test, methodology and results report.

DOT National Transportation Integrated Search

2010-12-01

"This document presents the methodology and results from the light-vehicle field operational test conducted as part of the Integrated Vehicle-Based Safety Systems program. These findings are the result of analyses performed by the University of Michi...

The outcomes of recent patient safety education interventions for trainee physicians and medical students: a systematic review

PubMed Central

Kirkman, Matthew A; Sevdalis, Nick; Arora, Sonal; Baker, Paul; Vincent, Charles; Ahmed, Maria

2015-01-01

Objective To systematically review the latest evidence for patient safety education for physicians in training and medical students, updating, extending and improving on a previous systematic review on this topic. Design A systematic review. Data sources Embase, Ovid Medline and PsycINFO databases. Study selection Studies including an evaluation of patient safety training interventions delivered to trainees/residents and medical students published between January 2009 and May 2014. Data extraction The review was performed using a structured data capture tool. Thematic analysis also identified factors influencing successful implementation of interventions. Results We identified 26 studies reporting patient safety interventions: 11 involving students and 15 involving trainees/residents. Common educational content included a general overview of patient safety, root cause/systems-based analysis, communication and teamwork skills, and quality improvement principles and methodologies. The majority of courses were well received by learners, and improved patient safety knowledge, skills and attitudes. Moreover, some interventions were shown to result in positive behaviours, notably subsequent engagement in quality improvement projects. No studies demonstrated patient benefit. Availability of expert faculty, competing curricular/service demands and institutional culture were important factors affecting implementation. Conclusions There is an increasing trend for developing educational interventions in patient safety delivered to trainees/residents and medical students. However, significant methodological shortcomings remain and additional evidence of impact on patient outcomes is needed. While there is some evidence of enhanced efforts to promote sustainability of such interventions, further work is needed to encourage their wider adoption and spread. PMID:25995240

An integrated quality function deployment and capital budgeting methodology for occupational safety and health as a systems thinking approach: the case of the construction industry.

PubMed

Bas, Esra

2014-07-01

In this paper, an integrated methodology for Quality Function Deployment (QFD) and a 0-1 knapsack model is proposed for occupational safety and health as a systems thinking approach. The House of Quality (HoQ) in QFD methodology is a systematic tool to consider the inter-relationships between two factors. In this paper, three HoQs are used to consider the interrelationships between tasks and hazards, hazards and events, and events and preventive/protective measures. The final priority weights of events are defined by considering their project-specific preliminary weights, probability of occurrence, and effects on the victim and the company. The priority weights of the preventive/protective measures obtained in the last HoQ are fed into a 0-1 knapsack model for the investment decision. Then, the selected preventive/protective measures can be adapted to the task design. The proposed step-by-step methodology can be applied to any stage of a project to design the workplace for occupational safety and health, and continuous improvement for safety is endorsed by the closed loop characteristic of the integrated methodology. Copyright © 2013 Elsevier Ltd. All rights reserved.

Seniors Falls Investigative Methodology (SFIM): A Systems Approach to the Study of Falls in Seniors

ERIC Educational Resources Information Center

Zecevic, Aleksandra A.; Salmoni, Alan W.; Lewko, John H.; Vandervoort, Anthony A.

2007-01-01

An in-depth understanding of human factors and human error is lacking in current research on seniors' falls. Additional knowledge is needed to understand why seniors are falling. The purpose of this article is to describe the adapting of the Integrated Safety Investigation Methodology (ISIM) (used for investigating transportation and industrial…

Systems cost/performance analysis (study 2.3). Volume 2: Systems cost/performance model. [unmanned automated payload programs and program planning

NASA Technical Reports Server (NTRS)

Campbell, B. H.

1974-01-01

A methodology which was developed for balanced designing of spacecraft subsystems and interrelates cost, performance, safety, and schedule considerations was refined. The methodology consists of a two-step process: the first step is one of selecting all hardware designs which satisfy the given performance and safety requirements, the second step is one of estimating the cost and schedule required to design, build, and operate each spacecraft design. Using this methodology to develop a systems cost/performance model allows the user of such a model to establish specific designs and the related costs and schedule. The user is able to determine the sensitivity of design, costs, and schedules to changes in requirements. The resulting systems cost performance model is described and implemented as a digital computer program.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

PubMed

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

PubMed

Ma, Haijun; Russek-Cohen, Estelle; Izem, Rima; Marchenko, Olga V; Jiang, Qi

2018-03-01

Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources. In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle. Some challenges and statistical strategies for medical product safety evaluation are discussed. Examples of safety issues identified in different periods, that is, premarketing and postmarketing, are discussed to illustrate how different sources are used in the safety signal identification and the iterative process of safety assessment. The examples highlighted range from commonly used pediatric vaccine given to healthy children to medical products primarily used to treat a medical condition in adults. These case studies illustrate that different products may require different approaches, and once a signal is discovered, it could impact future safety assessments. Many challenges still remain in this area despite advances in methodologies, infrastructure, public awareness, international harmonization, and regulatory enforcement. Innovations in safety assessment methodologies are pressing in order to make the medical product development process more efficient and effective, and the assessment of medical product marketing approval more streamlined and structured. Health care payers, providers, and patients may have different perspectives when weighing in on clinical, financial and personal needs when therapies are being evaluated.

Participatory approach to improving safety, health and working conditions in informal economy workplaces in Cambodia.

PubMed

Kawakami, Tsuyoshi; Tong, Leng; Kannitha, Yi; Sophorn, Tun

2011-01-01

The present study aimed to improve safety and health in informal economy workplaces such as home workplaces, small construction sites, and rural farms in Cambodia by using "participatory" approach. The government, workers' and employers' organizations and NGOs jointly assisted informal economy workers in improving safety and health by using participatory training methodologies. The steps taken were: (1) to collect existing good practices in safety and health in Cambodia; (2) to develop new participatory training programmes for home workers and small construction sites referring to ILO's WISE training programme, and (3) to train government officers, workers, employers and NGOs as safety and health trainers. The participatory training programmes developed consisted of action-checklists associated with illustrations, good example photo sheets, and texts explaining practical, low-cost improvement measures. The established safety and health trainers reached many informal economy workers through their human networks, and trained them by using the developed participatory training programmes. More than 3,000 informal economy workers were trained and they implemented improvements by using low-cost methods. Participatory training methodologies and active cooperation between the government, workers, employers and NGOs made it possible to provide practical training for those involved in the informal economy workplaces.

A Methodology for Validating Safety Heuristics Using Clinical Simulations: Identifying and Preventing Possible Technology-Induced Errors Related to Using Health Information Systems

PubMed Central

Borycki, Elizabeth; Kushniruk, Andre; Carvalho, Christopher

2013-01-01

Internationally, health information systems (HIS) safety has emerged as a significant concern for governments. Recently, research has emerged that has documented the ability of HIS to be implicated in the harm and death of patients. Researchers have attempted to develop methods that can be used to prevent or reduce technology-induced errors. Some researchers are developing methods that can be employed prior to systems release. These methods include the development of safety heuristics and clinical simulations. In this paper, we outline our methodology for developing safety heuristics specific to identifying the features or functions of a HIS user interface design that may lead to technology-induced errors. We follow this with a description of a methodological approach to validate these heuristics using clinical simulations. PMID:23606902

Behavioral Self-Monitoring of Safety and Productivity in the Workplace: A Methodological Primer and Quantitative Literature Review

ERIC Educational Resources Information Center

Olson, Ryan; Winchester, Jamey

2008-01-01

Workplace applications of behavioral self-monitoring (BSM) methods have been studied periodically for over 35 years, yet the literature has never been systematically reviewed. Recent occupational safety interventions including BSM resulted in relatively large behavior changes. Moreover, BSM methods are functional for addressing a broad range of…

System cost/performance analysis (study 2.3). Volume 1: Executive summary

NASA Technical Reports Server (NTRS)

Kazangey, T.

1973-01-01

The relationships between performance, safety, cost, and schedule parameters were identified and quantified in support of an overall effort to generate program models and methodology that provide insight into a total space vehicle program. A specific space vehicle system, the attitude control system (ACS), was used, and a modeling methodology was selected that develops a consistent set of quantitative relationships among performance, safety, cost, and schedule, based on the characteristics of the components utilized in candidate mechanisms. These descriptive equations were developed for a three-axis, earth-pointing, mass expulsion ACS. A data base describing typical candidate ACS components was implemented, along with a computer program to perform sample calculations. This approach, implemented on a computer, is capable of determining the effect of a change in functional requirements to the ACS mechanization and the resulting cost and schedule. By a simple extension of this modeling methodology to the other systems in a space vehicle, a complete space vehicle model can be developed. Study results and recommendations are presented.

Economic evaluation in patient safety: a literature review of methods.

PubMed

de Rezende, Bruna Alves; Or, Zeynep; Com-Ruelle, Laure; Michel, Philippe

2012-06-01

Patient safety practices, targeting organisational changes for improving patient safety, are implemented worldwide but their costs are rarely evaluated. This paper provides a review of the methods used in economic evaluation of such practices. International medical and economics databases were searched for peer-reviewed publications on economic evaluations of patient safety between 2000 and 2010 in English and French. This was complemented by a manual search of the reference lists of relevant papers. Grey literature was excluded. Studies were described using a standardised template and assessed independently by two researchers according to six quality criteria. 33 articles were reviewed that were representative of different patient safety domains, data types and evaluation methods. 18 estimated the economic burden of adverse events, 3 measured the costs of patient safety practices and 12 provided complete economic evaluations. Healthcare-associated infections were the most common subject of evaluation, followed by medication-related errors and all types of adverse events. Of these, 10 were selected that had adequately fulfilled one or several key quality criteria for illustration. This review shows that full cost-benefit/utility evaluations are rarely completed as they are resource intensive and often require unavailable data; some overcome these difficulties by performing stochastic modelling and by using secondary sources. Low methodological transparency can be a problem for building evidence from available economic evaluations. Investing in the economic design and reporting of studies with more emphasis on defining study perspectives, data collection and methodological choices could be helpful for strengthening our knowledge base on practices for improving patient safety.

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

An object-oriented approach to risk and reliability analysis : methodology and aviation safety applications.

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

Dandini, Vincent John; Duran, Felicia Angelica; Wyss, Gregory Dane

2003-09-01

This article describes how features of event tree analysis and Monte Carlo-based discrete event simulation can be combined with concepts from object-oriented analysis to develop a new risk assessment methodology, with some of the best features of each. The resultant object-based event scenario tree (OBEST) methodology enables an analyst to rapidly construct realistic models for scenarios for which an a priori discovery of event ordering is either cumbersome or impossible. Each scenario produced by OBEST is automatically associated with a likelihood estimate because probabilistic branching is integral to the object model definition. The OBEST methodology is then applied to anmore » aviation safety problem that considers mechanisms by which an aircraft might become involved in a runway incursion incident. The resulting OBEST model demonstrates how a close link between human reliability analysis and probabilistic risk assessment methods can provide important insights into aviation safety phenomenology.« less

Development and application of a safety assessment methodology for waste disposals

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

Little, R.H.; Torres, C.; Schaller, K.H.

1996-12-31

As part of a European Commission funded research programme, QuantiSci (formerly the Environmental Division of Intera Information Technologies) and Instituto de Medio Ambiente of the Centro de Investigaciones Energeticas Medioambientales y Tecnologicas (IMA/CIEMAT) have developed and applied a comprehensive, yet practicable, assessment methodology for post-disposal safety assessment of land-based disposal facilities. This Safety Assessment Comparison (SACO) Methodology employs a systematic approach to the collection, evaluation and use of waste and disposal system data. It can be used to assess engineered barrier performance, the attenuating properties of host geological formations, and the long term impacts of a facility on the environmentmore » and human health, as well as allowing the comparison of different disposal options for radioactive, mixed and non-radioactive wastes. This paper describes the development of the methodology and illustrates its use.« less

The role of safety signals in fear extinction: An analogue study.

PubMed

Restrepo-Castro, Juan C; Castro-Camacho, Leonidas; Javier Labrador, Francisco

2017-12-01

Safety signals are conditioned inhibitory stimuli that indicate the absence of unconditioned stimuli. It is not clear whether the presence of safety signals is detrimental or beneficial in extinction-based interventions. The purpose of this study was to evaluate the effect of safety signals on autonomic and expectancy fear-related responses. Following the conditional discrimination paradigm (AX +, BX-), undergraduate students (N = 48) underwent an aversive conditioning procedure, while safety signals were experimentally created. Participants were randomly assigned to one of two conditions during extinction: presence or absence of safety signals. Significant reductions of fear-related responses were found in both groups. Expectancy measures showed that the presence of safety signals did not interfere with reduction of fear related responses at follow-up. The analogue nature of the study affects its ecological validity. There are some methodological issues. Safety signals did not interfere with extinction learning. Attention may be a mechanism associated with the maintenance of fear responses. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance.

PubMed

Lu, Ellen; Wang, Bing Wei; Guimond, Colleen; Synnes, Anne; Sadovnick, A Dessa; Dahlgren, Leanne; Traboulsee, Anthony; Tremlett, Helen

2013-03-01

When contemplating a pregnancy, women treated for multiple sclerosis (MS) with a disease-modifying drug must decide to discontinue their medication before conception or risk exposing their unborn child to potential drug toxicity. Few studies exist as reference for patients and physicians, and of those available, the majority are less than ideal due to real-world constraints, ethical issues and methodological shortcomings. The authors provide a brief summary of existing animal and human data with current recommendations regarding the safety of IFN-β, glatiramer acetate, natalizumab, mitoxantrone, fingolimod and teriflunomide during pregnancy and lactation in women with MS. We also assess the quality, strengths and limitations of the existing studies including challenges with study design. The investigation of outcomes such as spontaneous abortion and congenital anomalies are highlighted with potential methodological improvements for future studies on drug safety in pregnancy suggested. The authors explore the pharmacokinetics and pharmacodynamics of the MS disease-modifying drugs for their possible mechanistic role in fetal harm and discuss the potential role of clinical trials. Future pharmacovigilance studies should continue to pursue multicenter collaboration with an emphasis on appropriate study design.

The 12th International Conference on Computer Safety, Reliability and Security

DTIC Science & Technology

1993-10-29

then used [10]. The adequacy of the proposed methodology is shown through the design and the validation of a simple control system: a train set example...satisfying the safety condition. 4 Conclusions In this paper we have presented a methodology which can be used for the design of safety-critical systems...has a Burner but no Detector (or the Detector is permanently non -active). The PA: G1 for this design is shown in Fig 3a. The probability matrices are

Novel thermal management system design methodology for power lithium-ion battery

NASA Astrophysics Data System (ADS)

Nieto, Nerea; Díaz, Luis; Gastelurrutia, Jon; Blanco, Francisco; Ramos, Juan Carlos; Rivas, Alejandro

2014-12-01

Battery packs conformed by large format lithium-ion cells are increasingly being adopted in hybrid and pure electric vehicles in order to use the energy more efficiently and for a better environmental performance. Safety and cycle life are two of the main concerns regarding this technology, which are closely related to the cell's operating behavior and temperature asymmetries in the system. Therefore, the temperature of the cells in battery packs needs to be controlled by thermal management systems (TMSs). In the present paper an improved design methodology for developing TMSs is proposed. This methodology involves the development of different mathematical models for heat generation, transmission, and dissipation and their coupling and integration in the battery pack product design methodology in order to improve the overall safety and performance. The methodology is validated by comparing simulation results with laboratory measurements on a single module of the battery pack designed at IK4-IKERLAN for a traction application. The maximum difference between model predictions and experimental temperature data is 2 °C. The models developed have shown potential for use in battery thermal management studies for EV/HEV applications since they allow for scalability with accuracy and reasonable simulation time.

Data Safety Monitoring Boards and Other Study Methodologies that Address Subject Safety in "High-Risk" Therapeutic Trials in Youths

ERIC Educational Resources Information Center

Carandang, Carlo; Santor, Darcy; Gardner, David M.; Carrey, Normand; Kutcher, Stan

2007-01-01

The underlying proposition for any experimental/therapeutic trial is the uncertainty that the risks of treatment will be outweighed by its benefits. For some therapeutic interventions (e.g., exercise programs, vitamin supplementation), the potential for treatment-emergent adverse events may prima facie be low or negligible, whereas for others…

Demonstration of a Safety Analysis on a Complex System

NASA Technical Reports Server (NTRS)

Leveson, Nancy; Alfaro, Liliana; Alvarado, Christine; Brown, Molly; Hunt, Earl B.; Jaffe, Matt; Joslyn, Susan; Pinnell, Denise; Reese, Jon; Samarziya, Jeffrey;

Advanced Crash Avoidance Technologies (ACAT) Program - Final Report of the Volvo-Ford-UMTRI Project: Safety Impact Methodology for Lane Departure Warning - Method Development and Estimation of Benefits

DOT National Transportation Integrated Search

2010-10-01

The Volvo-Ford-UMTRI project: Safety Impact Methodology (SIM) for Lane Departure Warning is part of the U.S. Department of Transportation's Advanced Crash Avoidance Technologies (ACAT) program. The project developed a basic analytical framework for e...

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

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

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Safety impacts of bicycle infrastructure: A critical review.

PubMed

DiGioia, Jonathan; Watkins, Kari Edison; Xu, Yanzhi; Rodgers, Michael; Guensler, Randall

2017-06-01

This paper takes a critical look at the present state of bicycle infrastructure treatment safety research, highlighting data needs. Safety literature relating to 22 bicycle treatments is examined, including findings, study methodologies, and data sources used in the studies. Some preliminary conclusions related to research efficacy are drawn from the available data and findings in the research. While the current body of bicycle safety literature points toward some defensible conclusions regarding the safety and effectiveness of certain bicycle treatments, such as bike lanes and removal of on-street parking, the vast majority treatments are still in need of rigorous research. Fundamental questions arise regarding appropriate exposure measures, crash measures, and crash data sources. This research will aid transportation departments with regard to decisions about bicycle infrastructure and guide future research efforts toward understanding safety impacts of bicycle infrastructure. Copyright © 2017 Elsevier Ltd and National Safety Council. All rights reserved.

Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

ERIC Educational Resources Information Center

National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues,"…

Toward an Application Guide for Safety Integrity Level Allocation in Railway Systems.

PubMed

Ouedraogo, Kiswendsida Abel; Beugin, Julie; El-Koursi, El-Miloudi; Clarhaut, Joffrey; Renaux, Dominique; Lisiecki, Frederic

2018-02-02

The work in the article presents the development of an application guide based on feedback and comments stemming from various railway actors on their practices of SIL allocation to railway safety-related functions. The initial generic methodology for SIL allocation has been updated to be applied to railway rolling stock safety-related functions in order to solve the SIL concept application issues. Various actors dealing with railway SIL allocation problems are the intended target of the methodology; its principles will be summarized in this article with a focus on modifications and precisions made in order to establish a practical guide for railway safety authorities. The methodology is based on the flowchart formalism used in CSM (common safety method) European regulation. It starts with the use of quantitative safety requirements, particularly tolerable hazard rates (THR). THR apportioning rules are applied. On the one hand, the rules are related to classical logical combinations of safety-related functions preventing hazard occurrence. On the other hand, to take into account technical conditions (last safety weak link, functional dependencies, technological complexity, etc.), specific rules implicitly used in existing practices are defined for readjusting some THR values. SIL allocation process based on apportioned and validated THR values is finally illustrated through the example of "emergency brake" subsystems. Some specific SIL allocation rules are also defined and illustrated. © 2018 Society for Risk Analysis.

Methodology Application: Logistic Regression the Using CODES Data

DOT National Transportation Integrated Search

1996-09-06

Congress directed the Secretary of Transportation, through the Intermodal : Surface Transportation Efficiency Act (ISTEA) of 1991, to carry out a study or : studies to determine the impact of safety belt and motorcycle helmet use. In : order to carry...

Development of guidance for states transitioning to new safety analysis tools

NASA Astrophysics Data System (ADS)

Alluri, Priyanka

With about 125 people dying on US roads each day, the US Department of Transportation heightened the awareness of critical safety issues with the passage of SAFETEA-LU (Safe Accountable Flexible Efficient Transportation Equity Act---a Legacy for Users) legislation in 2005. The legislation required each of the states to develop a Strategic Highway Safety Plan (SHSP) and incorporate data-driven approaches to prioritize and evaluate program outcomes: Failure to do so resulted in funding sanctioning. In conjunction with the legislation, research efforts have also been progressing toward the development of new safety analysis tools such as IHSDM (Interactive Highway Safety Design Model), SafetyAnalyst, and HSM (Highway Safety Manual). These software and analysis tools are comparatively more advanced in statistical theory and level of accuracy, and have a tendency to be more data intensive. A review of the 2009 five-percent reports and excerpts from the nationwide survey revealed astonishing facts about the continuing use of traditional methods including crash frequencies and rates for site selection and prioritization. The intense data requirements and statistical complexity of advanced safety tools are considered as a hindrance to their adoption. In this context, this research aims at identifying the data requirements and data availability for SafetyAnalyst and HSM by working with both the tools. This research sets the stage for working with the Empirical Bayes approach by highlighting some of the biases and issues associated with the traditional methods of selecting projects such as greater emphasis on traffic volume and regression-to-mean phenomena. Further, the not-so-obvious issue with shorter segment lengths, which effect the results independent of the methods used, is also discussed. The more reliable and statistically acceptable Empirical Bayes methodology requires safety performance functions (SPFs), regression equations predicting the relation between crashes and exposure for a subset of roadway network. These SPFs, specific to a region and the analysis period are often unavailable. Calibration of already existing default national SPFs to the state's data could be a feasible solution, but, how well the state's data is represented is a legitimate question. With this background, SPFs were generated for various classifications of segments in Georgia and compared against the national default SPFs used in SafetyAnalyst calibrated to Georgia data. Dwelling deeper into the development of SPFs, the influence of actual and estimated traffic data on the fit of the equations is also studied questioning the accuracy and reliability of traffic estimations. In addition to SafetyAnalyst, HSM aims at performing quantitative safety analysis. Applying HSM methodology to two-way two-lane rural roads, the effect of using multiple CMFs (Crash Modification Factors) is studied. Lastly, data requirements, methodology, constraints, and results are compared between SafetyAnalyst and HSM.

The development of a methodology for transportation safety planning in Virginia.

DOT National Transportation Integrated Search

1980-01-01

Senate Bill 85, passed by the General Assembly in 1978, renamed the former Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to assume control over safety activities in all modes of transportation. T...

10 CFR 70.62 - Safety program and integrated safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... conclusion of each failure investigation of an item relied on for safety or management measure. (b) Process... methodology being used. (3) Requirements for existing licensees. Individuals holding an NRC license on...

Deriving and Validating a Road Safety Performance Indicator for Vehicle Fleet Passive Safety

PubMed Central

Page, Marianne; Rackliff, Lucy

2006-01-01

Road safety performance indicators (RSPI) are policy tools which describe the extent of insecure operational safety conditions within traffic systems. This study describes the production of an RSPI which represents the presence within a country’s vehicle fleet, of vehicles that may not effectively protect an occupant in a collision. This work is highly original, as it uses the entire vehicle database of European Union Member States in order to estimate the average level of passive safety offered by the entire fleet in each country. The EuroNCAP safety ratings and vehicle age of each vehicle in each fleet have been obtained to calculate the RSPI. The methodology used could be adopted as an international standard. PMID:16968645

A conceptual framework to development of construction safety culture in Indonesia

NASA Astrophysics Data System (ADS)

Armyn Machfudiyanto, Rossy; Latief, Yusuf

2017-12-01

Working accidents in the construction industry are among the highest in the world, affecting the three levels of both macro (National) mezzo (Enterprise) and micro (Projects) that need to be integrated in building a safety culture. The purpose of this research is to develop a conceptual framework in improving safety culture in the construction industry in Indonesia. The methodology was developed using literature study and deductive analysis which then performed expert validation to ensure the concept developed. The result of this research is that policy and institution as input to build safety culture which need to be followed up with increasing of company maturity which have implication to safety performance and construction project performance.

A methodology to model causal relationships on offshore safety assessment focusing on human and organizational factors.

PubMed

Ren, J; Jenkinson, I; Wang, J; Xu, D L; Yang, J B

2008-01-01

Focusing on people and organizations, this paper aims to contribute to offshore safety assessment by proposing a methodology to model causal relationships. The methodology is proposed in a general sense that it will be capable of accommodating modeling of multiple risk factors considered in offshore operations and will have the ability to deal with different types of data that may come from different resources. Reason's "Swiss cheese" model is used to form a generic offshore safety assessment framework, and Bayesian Network (BN) is tailored to fit into the framework to construct a causal relationship model. The proposed framework uses a five-level-structure model to address latent failures within the causal sequence of events. The five levels include Root causes level, Trigger events level, Incidents level, Accidents level, and Consequences level. To analyze and model a specified offshore installation safety, a BN model was established following the guideline of the proposed five-level framework. A range of events was specified, and the related prior and conditional probabilities regarding the BN model were assigned based on the inherent characteristics of each event. This paper shows that Reason's "Swiss cheese" model and BN can be jointly used in offshore safety assessment. On the one hand, the five-level conceptual model is enhanced by BNs that are capable of providing graphical demonstration of inter-relationships as well as calculating numerical values of occurrence likelihood for each failure event. Bayesian inference mechanism also makes it possible to monitor how a safety situation changes when information flow travel forwards and backwards within the networks. On the other hand, BN modeling relies heavily on experts' personal experiences and is therefore highly domain specific. "Swiss cheese" model is such a theoretic framework that it is based on solid behavioral theory and therefore can be used to provide industry with a roadmap for BN modeling and implications. A case study of the collision risk between a Floating Production, Storage and Offloading (FPSO) unit and authorized vessels caused by human and organizational factors (HOFs) during operations is used to illustrate an industrial application of the proposed methodology.

Brake testing methodology study : driver effects testing

DOT National Transportation Integrated Search

1999-03-01

The National Highway Traffic Safety Administration (NHTSA) is exploring the feasibility of developing brake tests to measure brake system performance of light vehicles. Developing test procedures requires controlling test variability so that measured...

Effect of Cycling Skills on Bicycle Safety and Comfort Associated with Bicycle Infrastructure and Environment

DOT National Transportation Integrated Search

2017-08-31

This study seeks to improve the methodology for determining the relationship between cycling dynamic performance and roadway environment characteristics across different bicyclists' skill levels. To achieve the goal of this study, an Instrumented Pro...

Open-type ferry safety system design for using LNG fuel

NASA Astrophysics Data System (ADS)

Pagonis, D. N.; Livanos, G.; Theotokatos, G.; Peppa, S.; Themelis, N.

2016-12-01

In this feasibility study, we investigate the viability of using Liquefied Natural Gas (LNG) fuel in an open type Ro-Ro passenger ferry and the associated potential challenges with regard to the vessel safety systems. We recommend an appropriate methodology for converting existing ships to run on LNG fuel, discuss all the necessary modifications to the ship's safety systems, and also evaluate the relevant ship evacuation procedures. We outline the basic requirements with which the ship already complies for each safety system and analyze the additional restrictions that must be taken into consideration for the use of LNG fuel. Appropriate actions are recommended. Furthermore, we carry out a hazard identification study. Overall, we clearly demonstrate the technical feasibility of the investigated scenario. Minimal modifications to the ship's safety systems are required to comply with existing safety rules for this specific type of ship.

Passenger rail vehicle safety assessment methodology. Volume I, Summary of safe performance limits.

DOT National Transportation Integrated Search

2000-04-01

This report presents a methodology based on computer simulation that asseses the safe dyamic performance limits of commuter passenger vehicles. The methodology consists of determining the critical design parameters and characteristic properties of bo...

[Operating Room Nurses' Experiences of Securing for Patient Safety].

PubMed

Park, Kwang Ok; Kim, Jong Kyung; Kim, Myoung Sook

2015-10-01

This study was done to evaluate the experience of securing patient safety in hospital operating rooms. Experiential data were collected from 15 operating room nurses through in-depth interviews. The main question was "Could you describe your experience with patient safety in the operating room?". Qualitative data from the field and transcribed notes were analyzed using Strauss and Corbin's grounded theory methodology. The core category of experience with patient safety in the operating room was 'trying to maintain principles of patient safety during high-risk surgical procedures'. The participants used two interactional strategies: 'attempt continuous improvement', 'immersion in operation with sharing issues of patient safety'. The results indicate that the important factors for ensuring the safety of patients in the operating room are manpower, education, and a system for patient safety. Successful and safe surgery requires communication, teamwork and recognition of the importance of patient safety by the surgical team.

How effective is drug testing as a workplace safety strategy? A systematic review of the evidence.

PubMed

Pidd, Ken; Roche, Ann M

2014-10-01

The growing prevalence of workplace drug testing and the narrow scope of previous reviews of the evidence base necessitate a comprehensive review of research concerning the efficacy of drug testing as a workplace strategy. A systematic qualitative review of relevant research published between January 1990 and January 2013 was undertaken. Inclusion criteria were studies that evaluated the effectiveness of drug testing in deterring employee drug use or reducing workplace accident or injury rates. Methodological adequacy was assessed using a published assessment tool specifically designed to assess the quality of intervention studies. A total of 23 studies were reviewed and assessed, six of which reported on the effectiveness of testing in reducing employee drug use and 17 which reported on occupational accident or injury rates. No studies involved randomised control trials. Only one study was assessed as demonstrating strong methodological rigour. That study found random alcohol testing reduced fatal accidents in the transport industry. The majority of studies reviewed contained methodological weaknesses including; inappropriate study design, limited sample representativeness, the use of ecological data to evaluate individual behaviour change and failure to adequately control for potentially confounding variables. This latter finding is consistent with previous reviews and indicates the evidence base for the effectiveness of testing in improving workplace safety is at best tenuous. Better dissemination of the current evidence in relation to workplace drug testing is required to support evidence-informed policy and practice. There is also a pressing need for more methodologically rigorous research to evaluate the efficacy and utility of drug testing. Copyright © 2014 Elsevier Ltd. All rights reserved.

Independent evaluation of the transit retrofit package safety applications : final report.

DOT National Transportation Integrated Search

2015-02-01

This report presents the methodology and results of the independent evaluation of retrofit safety packages installed on transit vehicles in the : Safety Pilot Model Deploymentpart of the United States Department of Transportations Intelligent T...

[Definition of "Safety and Hygiene Packages" as a management model for the Hospital Hygiene Service (HHS)].

PubMed

Raponi, Matteo; Damiani, Gianfranco; Vincenti, Sara; Wachocka, Malgorzata; Boninti, Federica; Bruno, Stefania; Quaranta, Gianluigi; Moscato, Umberto; Boccia, Stefania; Ficarra, Maria Giovanna; Specchia, Maria Lucia; Posteraro, Brunella; Berloco, Filippo; Celani, Fabrizio; Ricciardi, Walter; Laurenti, Patrizia

2014-01-01

The purpose of this research is to identify and formalize the Hospital Hygiene Service activities and products, evaluating them in a cost accounting management view. The ultimate aim, is to evaluate the financial adverse events prevention impact, in an Hospital Hygiene Service management. A three step methodology based on affinity grouping activities, was employed. This methodology led us to identify 4 action areas, with 23 related productive processes, and 86 available safety packages. Owing to this new methodology, we was able to implement a systematic evaluation of the furnished services.

Space Station man-machine automation trade-off analysis

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.; Bard, J.; Feinberg, A.

1985-01-01

The man machine automation tradeoff methodology presented is of four research tasks comprising the autonomous spacecraft system technology (ASST) project. ASST was established to identify and study system level design problems for autonomous spacecraft. Using the Space Station as an example spacecraft system requiring a certain level of autonomous control, a system level, man machine automation tradeoff methodology is presented that: (1) optimizes man machine mixes for different ground and on orbit crew functions subject to cost, safety, weight, power, and reliability constraints, and (2) plots the best incorporation plan for new, emerging technologies by weighing cost, relative availability, reliability, safety, importance to out year missions, and ease of retrofit. A fairly straightforward approach is taken by the methodology to valuing human productivity, it is still sensitive to the important subtleties associated with designing a well integrated, man machine system. These subtleties include considerations such as crew preference to retain certain spacecraft control functions; or valuing human integration/decision capabilities over equivalent hardware/software where appropriate.

Independent evaluation of light-vehicle safety applications based on vehicle-to-vehicle communications used in the 2012-2013 safety pilot model deployment

DOT National Transportation Integrated Search

2015-12-01

This report presents the methodology and results of the independent evaluation of safety applications for passenger vehicles in the 2012-2013 Safety Pilot Model Deployment, part of the United States Department of Transportations Intelligent Transp...

Developing Methodologies for Evaluating the Earthquake Safety of Existing Buildings.

ERIC Educational Resources Information Center

Bresler, B.; And Others

This report contains four papers written during an investigation of methods for evaluating the safety of existing school buildings under Research Applied to National Needs (RANN) grants. In "Evaluation of Earthquake Safety of Existing Buildings," by B. Bresler, preliminary ideas on the evaluation of the earthquake safety of existing…

Photovoltaic system criteria documents. Volume 5: Safety criteria for photovoltaic applications

NASA Technical Reports Server (NTRS)

Koenig, John C.; Billitti, Joseph W.; Tallon, John M.

1979-01-01

Methodology is described for determining potential safety hazards involved in the construction and operation of photovoltaic power systems and provides guidelines for the implementation of safety considerations in the specification, design and operation of photovoltaic systems. Safety verification procedures for use in solar photovoltaic systems are established.

Development of a methodology for assessing the safety of embedded software systems

NASA Technical Reports Server (NTRS)

Garrett, C. J.; Guarro, S. B.; Apostolakis, G. E.

1993-01-01

A Dynamic Flowgraph Methodology (DFM) based on an integrated approach to modeling and analyzing the behavior of software-driven embedded systems for assessing and verifying reliability and safety is discussed. DFM is based on an extension of the Logic Flowgraph Methodology to incorporate state transition models. System models which express the logic of the system in terms of causal relationships between physical variables and temporal characteristics of software modules are analyzed to determine how a certain state can be reached. This is done by developing timed fault trees which take the form of logical combinations of static trees relating the system parameters at different point in time. The resulting information concerning the hardware and software states can be used to eliminate unsafe execution paths and identify testing criteria for safety critical software functions.

Are automatic systems the future of motorcycle safety? A novel methodology to prioritize potential safety solutions based on their projected effectiveness.

PubMed

Gil, Gustavo; Savino, Giovanni; Piantini, Simone; Baldanzini, Niccolò; Happee, Riender; Pierini, Marco

2017-11-17

Motorcycle riders are involved in significantly more crashes per kilometer driven than passenger car drivers. Nonetheless, the development and implementation of motorcycle safety systems lags far behind that of passenger cars. This research addresses the identification of the most effective motorcycle safety solutions in the context of different countries. A knowledge-based system of motorcycle safety (KBMS) was developed to assess the potential for various safety solutions to mitigate or avoid motorcycle crashes. First, a set of 26 common crash scenarios was identified from the analysis of multiple crash databases. Second, the relative effectiveness of 10 safety solutions was assessed for the 26 crash scenarios by a panel of experts. Third, relevant information about crashes was used to weigh the importance of each crash scenario in the region studied. The KBMS method was applied with an Italian database, with a total of more than 1 million motorcycle crashes in the period 2000-2012. When applied to the Italian context, the KBMS suggested that automatic systems designed to compensate for riders' or drivers' errors of commission or omission are the potentially most effective safety solution. The KBMS method showed an effective way to compare the potential of various safety solutions, through a scored list with the expected effectiveness of each safety solution for the region to which the crash data belong. A comparison of our results with a previous study that attempted a systematic prioritization of safety systems for motorcycles (PISa project) showed an encouraging agreement. Current results revealed that automatic systems have the greatest potential to improve motorcycle safety. Accumulating and encoding expertise in crash analysis from a range of disciplines into a scalable and reusable analytical tool, as proposed with the use of KBMS, has the potential to guide research and development of effective safety systems. As the expert assessment of the crash scenarios is decoupled from the regional crash database, the expert assessment may be reutilized, thereby allowing rapid reanalysis when new crash data become available. In addition, the KBMS methodology has potential application to injury forecasting, driver/rider training strategies, and redesign of existing road infrastructure.

2007 motor vehicle occupant safety survey. Volume 1, Methodology report

DOT National Transportation Integrated Search

2008-07-01

The 2007 Motor Vehicle Occupant Safety Survey was the sixth in a series of periodic national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration (NHTSA). Data collection was conducted by Sc...

2003 motor vehicle occupant safety survey. Volume 1, Methodology report

DOT National Transportation Integrated Search

2003-09-01

The 2003 Motor Vehicle Occupant Safety Survey was the fifth in a series of biennial national telephone surveys on occupant protection issues conducted for the National Highway Traffic Safety Administration. The survey used two questionnaires, each ad...

A methodology to quantitatively evaluate the safety of a glazing robot.

PubMed

Lee, Seungyeol; Yu, Seungnam; Choi, Junho; Han, Changsoo

2011-03-01

A new construction method using robots is spreading widely among construction sites in order to overcome labour shortages and frequent construction accidents. Along with economical efficiency, safety is a very important factor for evaluating the use of construction robots in construction sites. However, the quantitative evaluation of safety is difficult compared with that of economical efficiency. In this study, we suggested a safety evaluation methodology by defining the 'worker' and 'work conditions' as two risk factors, defining the 'worker' factor as posture load and the 'work conditions' factor as the work environment and the risk exposure time. The posture load evaluation reflects the risk of musculoskeletal disorders which can be caused by work posture and the risk of accidents which can be caused by reduced concentration. We evaluated the risk factors that may cause various accidents such as falling, colliding, capsizing, and squeezing in work environments, and evaluated the operational risk by considering worker exposure time to risky work environments. With the results of the evaluations for each factor, we calculated the general operational risk and deduced the improvement ratio in operational safety by introducing a construction robot. To verify these results, we compared the safety of the existing human manual labour and the proposed robotic labour construction methods for manipulating large glass panels. Copyright © 2010 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Effects of efforts to optimise morbidity and mortality rounds to serve contemporary quality improvement and educational goals: a systematic review.

PubMed

Smaggus, Andrew; Mrkobrada, Marko; Marson, Alanna; Appleton, Andrew

2018-01-01

The quality and safety movement has reinvigorated interest in optimising morbidity and mortality (M&M) rounds. We performed a systematic review to identify effective means of updating M&M rounds to (1) identify and address quality and safety issues, and (2) address contemporary educational goals. Relevant databases (Medline, Embase, PubMed, Education Resource Information Centre, Cumulative Index to Nursing and Allied Health Literature, Healthstar, and Global Health) were searched to identify primary sources. Studies were included if they (1) investigated an intervention applied to M&M rounds, (2) reported outcomes relevant to the identification of quality and safety issues, or educational outcomes relevant to quality improvement (QI), patient safety or general medical education and (3) included a control group. Study quality was assessed using the Medical Education Research Study Quality Instrument and Newcastle-Ottawa Scale-Education instruments. Given the heterogeneity of interventions and outcome measures, results were analysed thematically. The final analysis included 19 studies. We identified multiple effective strategies (updating objectives, standardising elements of rounds and attaching rounds to a formal quality committee) to optimise M&M rounds for a QI/safety purpose. These efforts were associated with successful integration of quality and safety content into rounds, and increased implementation of QI interventions. Consistent effects on educational outcomes were difficult to identify, likely due to the use of methodologies ill-fitted for educational research. These results are encouraging for those seeking to optimise the quality and safety mission of M&M rounds. However, the inability to identify consistent educational effects suggests the investigation of M&M rounds could benefit from additional methodologies (qualitative, mixed methods) in order to understand the complex mechanisms driving learning at M&M rounds. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Method for Evaluating the Safety Impacts of Air Traffic Automation

NASA Technical Reports Server (NTRS)

Kostiuk, Peter; Shapiro, Gerald; Hanson, Dave; Kolitz, Stephan; Leong, Frank; Rosch, Gene; Bonesteel, Charles

1998-01-01

This report describes a methodology for analyzing the safety and operational impacts of emerging air traffic technologies. The approach integrates traditional reliability models of the system infrastructure with models that analyze the environment within which the system operates, and models of how the system responds to different scenarios. Products of the analysis include safety measures such as predicted incident rates, predicted accident statistics, and false alarm rates; and operational availability data. The report demonstrates the methodology with an analysis of the operation of the Center-TRACON Automation System at Dallas-Fort Worth International Airport.

Risk-Based Explosive Safety Analysis

DTIC Science & Technology

2016-11-30

safety siting of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed...liquids or propellants . 15. SUBJECT TERMS N/A 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a. NAME OF...of energetic liquids and propellants can be greatly aided by the use of risk-based methodologies. The low probability of exposed personnel and the

Safety Climate and Occupational Stress According to Occupational Accidents Experience and Employment Type in Shipbuilding Industry of Korea.

PubMed

Kim, Kyung Woo; Park, Sung Jin; Lim, Hae Sun; Cho, Hm Hak

2017-09-01

Safety climate and occupational stress are related with occupational accident. The present study tried to identify the differences in safety climate and occupational stress according to occupational accidents experience and employment type (e.g., direct workers and subcontract workers). In this study, we conducted a survey using safety climate scale and Korean Occupational Stress Scale and classified the participants into four groups: direct workers working for accident-free departments, direct workers working for accident departments, subcontract workers working for accident-free departments, and subcontract workers working for accident departments for 2 years within the same workplace in the shipbuilding industry. The direct workers and subcontract workers showed diverse results in subscales of safety climate and occupational stress. This result is supported by existing studies; however, further study is necessary for more supporting evidence and elaborative methodological approach. The necessity of management for safety climate and psychosocial factor such as occupational stress for both direct workers and subcontract workers as a whole is suggested by this study.

Criteria for the Research Institute for Fragrance Materials, Inc. (RIFM) safety evaluation process for fragrance ingredients.

PubMed

Api, A M; Belsito, D; Bruze, M; Cadby, P; Calow, P; Dagli, M L; Dekant, W; Ellis, G; Fryer, A D; Fukayama, M; Griem, P; Hickey, C; Kromidas, L; Lalko, J F; Liebler, D C; Miyachi, Y; Politano, V T; Renskers, K; Ritacco, G; Salvito, D; Schultz, T W; Sipes, I G; Smith, B; Vitale, D; Wilcox, D K

2015-08-01

The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

[Social network analysis: a method to improve safety in healthcare organizations].

PubMed

Marqués Sánchez, Pilar; González Pérez, Marta Eva; Agra Varela, Yolanda; Vega Núñez, Jorge; Pinto Carral, Arrate; Quiroga Sánchez, Enedina

2013-01-01

Patient safety depends on the culture of the healthcare organization involving relationships between professionals. This article proposes that the study of these relations should be conducted from a network perspective and using a methodology called Social Network Analysis (SNA). This methodology includes a set of mathematical constructs grounded in Graph Theory. With the SNA we can know aspects of the individual's position in the network (centrality) or cohesion among team members. Thus, the SNA allows to know aspects related to security such as the kind of links that can increase commitment among professionals, how to build those links, which nodes have more prestige in the team in generating confidence or collaborative network, which professionals serve as intermediaries between the subgroups of a team to transmit information or smooth conflicts, etc. Useful aspects in stablishing a safety culture. The SNA would analyze the relations among professionals, their level of communication to communicate errors and spontaneously seek help and coordination between departments to participate in projects that enhance safety. Thus, they related through a network, using the same language, a fact that helps to build a culture. In summary, we propose an approach to safety culture from a SNA perspective that would complement other commonly used methods.

Benefits of public roadside safety rest areas in Texas : technical report.

DOT National Transportation Integrated Search

2011-05-01

The objective of this investigation was to develop a benefit-cost analysis methodology for safety rest areas in : Texas and to demonstrate its application in select corridors throughout the state. In addition, this project : considered novel safety r...

[IBEAS design: adverse events prevalence in Latin American hospitals].

PubMed

Aranaz-Andrés, J M; Aibar-Remón, C; Limón-Ramírez, R; Amarilla, A; Restrepo, F R; Urroz, O; Sarabia, O; Inga, R; Santivañez, A; Gonseth-García, J; Larizgoitia-Jauregui, I; Agra-Varela, Y; Terol-García, E

2011-01-01

To describe the methodological characteristics of the IBEAS study: adverse events prevalence in Latin American hospitals, with the aim of analysing the magnitude, significance and impact of adverse events (AE); to identify the main problems associated with patient safety AE; to increase the capacity of professionals involved in patient safety; and the setting up of patient safety agendas in the participating countries. A patient safety study launched in 35 Latin American hospitals through the analysis of AE in 5 countries: Argentina, Colombia, Costa Rica, Mexico and Peru, using a cross-sectional study using a review of clinical records as the main method. The implications of using a cross-sectional design when studying AE are described, in terms of resources required, internal validity and usefulness related to risk management. The cross-sectional design seems an efficient methodology in terms of time and resources spent, as well as being easy to carry out. Although the cross-sectional design does not review the all hospital episodes, it is able to provide a reliable estimate of prevalence and to support a surveillance system. Because of a possible survival bias, it is likely that the AE which led to hospital admissions will be overestimated, as well as the health related infections or those adverse events which are difficult to identify if the patient is not examined (e.g. contusions). Communication with the ward staff (if the patient is still hospitalised) help in finding the causality and their prevention. Copyright © 2010 SECA. Published by Elsevier Espana. All rights reserved.

ASCERTAINMENT OF ON-ROAD SAFETY ERRORS BASED ON VIDEO REVIEW

PubMed Central

Dawson, Jeffrey D.; Uc, Ergun Y.; Anderson, Steven W.; Dastrup, Elizabeth; Johnson, Amy M.; Rizzo, Matthew

2011-01-01

Summary Using an instrumented vehicle, we have studied several aspects of the on-road performance of healthy and diseased elderly drivers. One goal from such studies is to ascertain the type and frequency of driving safety errors. Because the judgment of such errors is somewhat subjective, we applied a taxonomy system of 15 general safety error categories and 76 specific safety error types. We also employed and trained professional driving instructors to review the video data of the on-road drives. In this report, we illustrate our rating system on a group of 111 drivers, ages 65 to 89. These drivers made errors in 13 of the 15 error categories, comprising 42 of the 76 error types. A mean (SD) of 35.8 (12.8) safety errors per drive were noted, with 2.1 (1.7) of them being judged as serious. Our methodology may be useful in applications such as intervention studies, and in longitudinal studies of changes in driving abilities in patients with declining cognitive ability. PMID:24273753

Safety Capital: The Management of Organizational Knowledge on Occupational Health and Safety

ERIC Educational Resources Information Center

Nunez, Imanol; Villanueva, Mikel

2011-01-01

Purpose: The concept of Safety Capital was developed by analyzing the creation and composition of the Intellectual Capital embedded in Occupational Health and Safety (OHS) systems. The paper aims to address this relationship. Design/methodology/approach: By drawing a theoretical link for the relationship between OHS activities and intellectual…

Methodological guidelines for developing accident modification functions.

PubMed

Elvik, Rune

2015-07-01

This paper proposes methodological guidelines for developing accident modification functions. An accident modification function is a mathematical function describing systematic variation in the effects of road safety measures. The paper describes ten guidelines. An example is given of how to use the guidelines. The importance of exploratory analysis and an iterative approach in developing accident modification functions is stressed. The example shows that strict compliance with all the guidelines may be difficult, but represents a level of stringency that should be strived for. Currently the main limitations in developing accident modification functions are the small number of good evaluation studies and the often huge variation in estimates of effect. It is therefore still not possible to develop accident modification functions for very many road safety measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

A novel integrated approach for the hazardous radioactive dust source terms estimation in future nuclear fusion power plants.

PubMed

Poggi, L A; Malizia, A; Ciparisse, J F; Gaudio, P

2016-10-01

An open issue still under investigation by several international entities working on the safety and security field for the foreseen nuclear fusion reactors is the estimation of source terms that are a hazard for the operators and public, and for the machine itself in terms of efficiency and integrity in case of severe accident scenarios. Source term estimation is a crucial key safety issue to be addressed in the future reactors safety assessments, and the estimates available at the time are not sufficiently satisfactory. The lack of neutronic data along with the insufficiently accurate methodologies used until now, calls for an integrated methodology for source term estimation that can provide predictions with an adequate accuracy. This work proposes a complete methodology to estimate dust source terms starting from a broad information gathering. The wide number of parameters that can influence dust source term production is reduced with statistical tools using a combination of screening, sensitivity analysis, and uncertainty analysis. Finally, a preliminary and simplified methodology for dust source term production prediction for future devices is presented.

Studies to determine the effectiveness of longitudinal channelizing devices in work zones.

DOT National Transportation Integrated Search

2011-01-01

This report describes the methodology and results of analyses performed to determine whether the following longitudinal : channelizing device (LCD) applications improve the traffic safety and operations of work zones relative to the use of standard :...

Cyber-Informed Engineering: The Need for a New Risk Informed and Design Methodology

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

Price, Joseph Daniel; Anderson, Robert Stephen

Current engineering and risk management methodologies do not contain the foundational assumptions required to address the intelligent adversary’s capabilities in malevolent cyber attacks. Current methodologies focus on equipment failures or human error as initiating events for a hazard, while cyber attacks use the functionality of a trusted system to perform operations outside of the intended design and without the operator’s knowledge. These threats can by-pass or manipulate traditionally engineered safety barriers and present false information, invalidating the fundamental basis of a safety analysis. Cyber threats must be fundamentally analyzed from a completely new perspective where neither equipment nor human operationmore » can be fully trusted. A new risk analysis and design methodology needs to be developed to address this rapidly evolving threatscape.« less

[Legislation and inspection for the health and safety of workers. Efficacy and limits].

PubMed

Tozzi, G A

2009-01-01

To provide information regarding Occupational Health and Safety (OHS) Inspections in Europe. The dynamics that are transforming regulatory subsystems and complementary inspection services are described. Simplification initiatives, the limits and difficulties of applying the different models of Health and Safety Management Systems are discussed. Examples are given on how to evaluate legislation and technical standards during planning and enforcement. Different approaches for studying characteristics, methodologies and efficacy in practice of OHS Inspection are provided. Targeted inspections need to respond to the needs of enterprises and workers. Impartiality must be guaranteed and workers' participation should be facilitated.

A Guide to the Application of Probability Risk Assessment Methodology and Hazard Risk Frequency Criteria as a Hazard Control for the Use of the Mobile Servicing System on the International Space Station

NASA Astrophysics Data System (ADS)

D'silva, Oneil; Kerrison, Roger

2013-09-01

A key feature for the increased utilization of space robotics is to automate Extra-Vehicular manned space activities and thus significantly reduce the potential for catastrophic hazards while simultaneously minimizing the overall costs associated with manned space. The principal scope of the paper is to evaluate the use of industry standard accepted Probability risk/safety assessment (PRA/PSA) methodologies and Hazard Risk frequency Criteria as a hazard control. This paper illustrates the applicability of combining the selected Probability risk assessment methodology and hazard risk frequency criteria, in order to apply the necessary safety controls that allow for the increased use of the Mobile Servicing system (MSS) robotic system on the International Space Station. This document will consider factors such as component failure rate reliability, software reliability, and periods of operation and dormancy, fault tree analyses and their effects on the probability risk assessments. The paper concludes with suggestions for the incorporation of existing industry Risk/Safety plans to create an applicable safety process for future activities/programs

[A preliminary mapping methodology for occupational hazards and biomechanical risk evaluation: presentation of a simple, computerized tool kit for ergonomic hazards identification and risk assessment].

PubMed

Colombini, Daniela; Occhipinti, E; Di Leone, G

2011-01-01

During the last Congress of the International Ergonomics Association (IEA), Beijing, August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization. The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists. According to the ISO standard 11228 series and the new Draft CD ISO 12259-2009: Application document guides for the potential user, our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel). The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).

Safety assessment on pedestrian crossing environments using MLS data.

PubMed

Soilán, Mario; Riveiro, Belén; Sánchez-Rodríguez, Ana; Arias, Pedro

2018-02-01

In the framework of infrastructure analysis and maintenance in an urban environment, it is important to address the safety of every road user. This paper presents a methodology for the evaluation of several safety indicators on pedestrian crossing environments using geometric and radiometric information extracted from 3D point clouds collected by a Mobile Mapping System (MMS). The methodology is divided in four main modules which analyze the accessibility of the crossing area, the presence of traffic lights and traffic signs, and the visibility between a driver and a pedestrian on the proximities of a pedestrian crossing. The outputs of the analysis are exported to a Geographic Information System (GIS) where they are visualized and can be further processed in the context of city management. The methodology has been tested on approximately 30 pedestrian crossings in cluttered urban environments of two different cities. Results show that MMS are a valid mean to assess the safety of a specific urban environment, regarding its geometric conditions. Remarkable results are presented on traffic light classification, with a global F-score close to 95%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Optimization of coupled multiphysics methodology for safety analysis of pebble bed modular reactor

NASA Astrophysics Data System (ADS)

Mkhabela, Peter Tshepo

The research conducted within the framework of this PhD thesis is devoted to the high-fidelity multi-physics (based on neutronics/thermal-hydraulics coupling) analysis of Pebble Bed Modular Reactor (PBMR), which is a High Temperature Reactor (HTR). The Next Generation Nuclear Plant (NGNP) will be a HTR design. The core design and safety analysis methods are considerably less developed and mature for HTR analysis than those currently used for Light Water Reactors (LWRs). Compared to LWRs, the HTR transient analysis is more demanding since it requires proper treatment of both slower and much longer transients (of time scale in hours and days) and fast and short transients (of time scale in minutes and seconds). There is limited operation and experimental data available for HTRs for validation of coupled multi-physics methodologies. This PhD work developed and verified reliable high fidelity coupled multi-physics models subsequently implemented in robust, efficient, and accurate computational tools to analyse the neutronics and thermal-hydraulic behaviour for design optimization and safety evaluation of PBMR concept The study provided a contribution to a greater accuracy of neutronics calculations by including the feedback from thermal hydraulics driven temperature calculation and various multi-physics effects that can influence it. Consideration of the feedback due to the influence of leakage was taken into account by development and implementation of improved buckling feedback models. Modifications were made in the calculation procedure to ensure that the xenon depletion models were accurate for proper interpolation from cross section tables. To achieve this, the NEM/THERMIX coupled code system was developed to create the system that is efficient and stable over the duration of transient calculations that last over several tens of hours. Another achievement of the PhD thesis was development and demonstration of full-physics, three-dimensional safety analysis methodology for the PBMR to provide reference solutions. Investigation of different aspects of the coupled methodology and development of efficient kinetics treatment for the PBMR were carried out, which accounts for all feedback phenomena in an efficient manner. The OECD/NEA PBMR-400 coupled code benchmark was used as a test matrix for the proposed investigations. The integrated thermal-hydraulics and neutronics (multi-physics) methods were extended to enable modeling of a wider range of transients pertinent to the PBMR. First, the effect of the spatial mapping schemes (spatial coupling) was studied and quantified for different types of transients, which resulted in implementation of improved mapping methodology based on user defined criteria. The second aspect that was studied and optimized is the temporal coupling and meshing schemes between the neutronics and thermal-hydraulics time step selection algorithms. The coupled code convergence was achieved supplemented by application of methods to accelerate it. Finally, the modeling of all feedback phenomena in PBMRs was investigated and a novel treatment of cross-section dependencies was introduced for improving the representation of cross-section variations. The added benefit was that in the process of studying and improving the coupled multi-physics methodology more insight was gained into the physics and dynamics of PBMR, which will help also to optimize the PBMR design and improve its safety. One unique contribution of the PhD research is the investigation of the importance of the correct representation of the three-dimensional (3-D) effects in the PBMR analysis. The performed studies demonstrated that explicit 3-D modeling of control rod movement is superior and removes the errors associated with the grey curtain (2-D homogenized) approximation.

Cookbooks in U.S. history: How do they reflect food safety from 1896 to 2014?

PubMed

Almanza, Barbara A; Byrd, Karen S; Behnke, Carl; Ma, Jing; Ge, Li

2017-09-01

Historical cookbooks as a source of recipes and food preparation information would be expected to document advancements in food safety related to kitchen equipment, cleaning, foodborne illness knowledge, and consumer education materials. In turn, this food safety information might be expected to contribute to consumers' food safety behaviors. Using both quantitative and qualitative research methodology, this study assessed how food safety information in cookbooks changed and how quickly advancements were incorporated. Faster assimilation into cookbooks was associated with kitchen equipment, educational resources (hotlines and websites), and foodborne illness outbreaks. The rate of incorporation of education materials was moderate. Cleaning advances were the slowest to be incorporated. Modern cookbooks published after the 1980's rapidly evolved with advances in food safety knowledge. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving timeliness and efficiency in the referral process for safety net providers: application of the Lean Six Sigma methodology.

PubMed

Deckard, Gloria J; Borkowski, Nancy; Diaz, Deisell; Sanchez, Carlos; Boisette, Serge A

2010-01-01

Designated primary care clinics largely serve low-income and uninsured patients who present a disproportionate number of chronic illnesses and face great difficulty in obtaining the medical care they need, particularly the access to specialty physicians. With limited capacity for providing specialty care, these primary care clinics generally refer patients to safety net hospitals' specialty ambulatory care clinics. A large public safety net health system successfully improved the effectiveness and efficiency of the specialty clinic referral process through application of Lean Six Sigma, an advanced process-improvement methodology and set of tools driven by statistics and engineering concepts.

Exploring inattention and distraction in the SafetyNet Accident Causation Database.

PubMed

Talbot, Rachel; Fagerlind, Helen; Morris, Andrew

2013-11-01

Distraction and inattention are considered to be very important and prevalent factors in the causation of road accidents. There have been many recent research studies which have attempted to understand the circumstances under which a driver becomes distracted or inattentive and how distraction/inattention can be prevented. Both factors are thought to have become more important in recent times partly due to the evolution of in-vehicle information and communication technology. This study describes a methodology that was developed to understand when factors such as distraction and inattention may have been contributors to crashes and also describes some of the consequences of distraction and inattention in terms of subsequent driver actions. The study uses data relating to distraction and inattention from the SafetyNet Accident Causation Database. This database was formulated as part of the SafetyNet project to address the lack of representative in-depth accident causation data within the European Union. Data were collected in 6 European countries using 'on-scene' and 'nearly on-scene' crash investigation methodologies. 32% of crashes recorded in the database, involved at least one driver, rider or pedestrian, who was determined to be 'Inattentive' or 'Distracted'. 212 of the drivers were assigned 'Distraction' and 140 drivers were given the code 'Inattention'. It was found that both distraction and inattention often lead to missed observations within the driving task and consequently 'Timing' or 'Direction' become critical events in the aetiology of crashes. In addition, the crash types and outcomes may differ according to the type and nature of the distraction and inattention as determined by the in-depth investigations. The development of accident coding methodology is described in this study as is its evolution into the Driver Reliability and Error Analysis Model (DREAM) version 3.0. Copyright © 2012 Elsevier Ltd. All rights reserved.

Drug research methodology. Volume 1, The alcohol-highway safety experience and its applicability to other drugs

DOT National Transportation Integrated Search

1980-03-01

This report presents the findings of a workshop concerning the alcohol and highway safety experience, which includes research efforts to define the drinking-driving problem and societal responses to reduce the increased highway safety risk attributab...

Work zone safety : physical and behavioral barriers in accident prevention.

DOT National Transportation Integrated Search

2014-05-01

This report discusses the usefulness of creating a work zone traffic safety culture as a methodology to improve the overall : safety of both work zone personnel and the traveling public in Missouri. As part of this research, the existing MoDOT : Work...

Work zone safety : physical and behavioral barriers in accident prevention.

DOT National Transportation Integrated Search

2014-05-01

This report discusses the usefulness of creating a work zone traffic safety culture as a methodology to improve the overall : safety of both work zone personnel and the traveling public in Missouri. As part of this research, the existing MoDOT : w : ...

Training and Action for Patient Safety: Embedding Interprofessional Education for Patient Safety within an Improvement Methodology

ERIC Educational Resources Information Center

Slater, Beverley L.; Lawton, Rebecca; Armitage, Gerry; Bibby, John; Wright, John

2012-01-01

Introduction: Despite an explosion of interest in improving safety and reducing error in health care, one important aspect of patient safety that has received little attention is a systematic approach to education and training for the whole health care workforce. This article describes an evaluation of an innovative multiprofessional, team-based…

An approach to evaluating reactive airborne wind shear systems

NASA Technical Reports Server (NTRS)

Gibson, Joseph P., Jr.

1992-01-01

An approach to evaluating reactive airborne windshear detection systems was developed to support a deployment study for future FAA ground-based windshear detection systems. The deployment study methodology assesses potential future safety enhancements beyond planned capabilities. The reactive airborne systems will be an integral part of planned windshear safety enhancements. The approach to evaluating reactive airborne systems involves separate analyses for both landing and take-off scenario. The analysis estimates the probability of effective warning considering several factors including NASA energy height loss characteristics, reactive alert timing, and a probability distribution for microburst strength.

29 CFR 1926.64 - Process safety management of highly hazardous chemicals.

Code of Federal Regulations, 2011 CFR

2011-07-01

... analysis methodology being used. (5) The employer shall establish a system to promptly address the team's... the decision as to the appropriate PHA methodology to use. All PHA methodologies are subject to... be developed in conjunction with the process hazard analysis in sufficient detail to support the...

29 CFR 1926.64 - Process safety management of highly hazardous chemicals.

Code of Federal Regulations, 2010 CFR

2010-07-01

... analysis methodology being used. (5) The employer shall establish a system to promptly address the team's... the decision as to the appropriate PHA methodology to use. All PHA methodologies are subject to... be developed in conjunction with the process hazard analysis in sufficient detail to support the...

Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

PubMed

Anderson, Devon E; Watts, Bradley V

2013-09-01

Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

The development of an inherent safety approach to the prevention of domino accidents.

PubMed

Cozzani, Valerio; Tugnoli, Alessandro; Salzano, Ernesto

2009-11-01

The severity of industrial accidents in which a domino effect takes place is well known in the chemical and process industry. The application of an inherent safety approach for the prevention of escalation events leading to domino accidents was explored in the present study. Reference primary scenarios were analyzed and escalation vectors were defined. Inherent safety distances were defined and proposed as a metric to express the intensity of the escalation vectors. Simple rules of thumb were presented for a preliminary screening of these distances. Swift reference indices for layout screening with respect to escalation hazard were also defined. Two case studies derived from existing layouts of oil refineries were selected to understand the potentialities coming from the application in the methodology. The results evidenced that the approach allows a first comparative assessment of the actual domino hazard in a layout, and the identification of critical primary units with respect to escalation events. The methodology developed also represents a useful screening tool to identify were to dedicate major efforts in the design of add-on measures, optimizing conventional passive and active measures for the prevention of severe domino accidents.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

PubMed

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Collaborative Learning Network Approach to Improvement: The CUSP Learning Network.

PubMed

Weaver, Sallie J; Lofthus, Jennifer; Sawyer, Melinda; Greer, Lee; Opett, Kristin; Reynolds, Catherine; Wyskiel, Rhonda; Peditto, Stephanie; Pronovost, Peter J

2015-04-01

Collaborative improvement networks draw on the science of collaborative organizational learning and communities of practice to facilitate peer-to-peer learning, coaching, and local adaption. Although significant improvements in patient safety and quality have been achieved through collaborative methods, insight regarding how collaborative networks are used by members is needed. Improvement Strategy: The Comprehensive Unit-based Safety Program (CUSP) Learning Network is a multi-institutional collaborative network that is designed to facilitate peer-to-peer learning and coaching specifically related to CUSP. Member organizations implement all or part of the CUSP methodology to improve organizational safety culture, patient safety, and care quality. Qualitative case studies developed by participating members examine the impact of network participation across three levels of analysis (unit, hospital, health system). In addition, results of a satisfaction survey designed to evaluate member experiences were collected to inform network development. Common themes across case studies suggest that members found value in collaborative learning and sharing strategies across organizational boundaries related to a specific improvement strategy. The CUSP Learning Network is an example of network-based collaborative learning in action. Although this learning network focuses on a particular improvement methodology-CUSP-there is clear potential for member-driven learning networks to grow around other methods or topic areas. Such collaborative learning networks may offer a way to develop an infrastructure for longer-term support of improvement efforts and to more quickly diffuse creative sustainment strategies.

Utilization of the Seniors Falls Investigation Methodology to identify system-wide causes of falls in community-dwelling seniors.

PubMed

Zecevic, Aleksandra A; Salmoni, Alan W; Lewko, John H; Vandervoort, Anthoney A; Speechley, Mark

2009-10-01

As a highly heterogeneous group, seniors live in complex environments influenced by multiple physical and social structures that affect their safety. Until now, the major approach to falls research has been person centered. However, in industrial settings, the individuals involved in an accident are seen as the inheritors of system defects. The objective of the present study was to investigate safety deficiencies that contributed to falls in community-dwelling seniors using a systems approach. The investigations were conducted using the Seniors Falls Investigation Methodology (SFIM), an adapted version of a method used to examine transportation accidents, such as airplane crashes. Fifteen seniors, who experienced a fall or near fall, participated in multiple case studies. A cross-case synthesis was used to summarize findings and identify common patterns of causes and safety deficiencies. Falls and near falls are a result of latent unsafe conditions, and unsafe acts and decisions combined in a diverse set of circumstances. If not identified and removed, these unsafe conditions can cause falls for other seniors. This study provided compelling evidence that causes of falling are systemic and develop over time. It demonstrated that the systems approach is needed to expand the focus from the individual to multilayered organizational and supervisory causes. The SFIM demonstrated capability to identify causes of falls that will allow better prevention and management programs, hence advancing seniors' safety. SFIM shows great potential for implementation in organized settings, such as hospitals and long-term care homes.

Hospital safety climate and safety behavior: A social exchange perspective.

PubMed

Ancarani, Alessandro; Di Mauro, Carmela; Giammanco, Maria D

Safety climate is considered beneficial to the improvement of hospital safety outcomes. Nevertheless, the relations between two of its key constituents, namely those stemming from leader-subordinate relations and coworker support for safety, are still to be fully ascertained. This article uses the theoretical lens of Social Exchange Theory to study the joint impact of leader-member exchange in the safety sphere and coworker support for safety on safety-related behavior at the hospital ward level. Social exchange constructs are further related to the existence of a shame-/blame-free environment, seen as a potential antecedent of safety behavior. A cross-sectional study including 166 inpatients in hospital wards belonging to 10 public hospitals in Italy was undertaken to test the hypotheses developed. Hypothesized relations have been analyzed through a fully mediated multilevel structural equation model. This methodology allows studying behavior at the individual level, while keeping into account the heterogeneity among hospital specialties. Results suggest that the linkage between leader support for safety and individual safety behavior is mediated by coworker support on safety issues and by the creation of a shame-free environment. These findings call for the creation of a safety climate in which managerial efforts should be directed not only to the provision of new safety resources and the enforcement of safety rules but also to the encouragement of teamwork and freedom to report errors as ways to foster the capacity of the staff to communicate, share, and learn from each other.

Development of a lane change risk index using vehicle trajectory data.

PubMed

Park, Hyunjin; Oh, Cheol; Moon, Jaepil; Kim, Seongho

2018-01-01

Surrogate safety measures (SSMs) have been widely used to evaluate crash potential, which is fundamental for the development of effective safety countermeasures. Unlike existing SSMs, which are mainly focused on the evaluation of longitudinal vehicle maneuvering leading to rear-end crashes, this study proposes a new method for estimating crash risk while a subject vehicle changes lanes, referred to as the lane change risk index (LCRI). A novel feature of the proposed methodology is its incorporation of the amount of exposure time to potential crash and the expected crash severity level by applying a fault tree analysis (FTA) to the evaluation framework. Vehicle interactions between a subject vehicle and adjacent vehicles in the starting lane and the target lane are evaluated in terms of crash potential during lane change. Vehicle trajectory data obtained from a traffic stream, photographed using a drone flown over a freeway segment, is used to investigate the applicability of the proposed methodology. This study compares the characteristics of compulsory and discretionary lane changes observed in a work zone section and a general section of a freeway using the LCRI. It is expected that the outcome of this study will be valuable in evaluating the effectiveness of various traffic operations and control strategies in terms of lane change safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety performance functions.

DOT National Transportation Integrated Search

2014-10-01

This project developed safety performance functions for roadway segments and intersections for two-lane rural highways in : Pennsylvania. The statistical modeling methodology was consistent with that used in the first edition of the American : Associ...

49 CFR 385.3 - Definitions and acronyms.

Code of Federal Regulations, 2010 CFR

2010-10-01

... applicable FMCSRs. RSPA means the Research and Special Programs Administration. Safety fitness determination... the Safety Fitness Rating Methodology (SFRM) set forth in Appendix B to this part and based on the...

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

PubMed

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

2016-01-01

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

Safety Assessment for a Surface Repository in the Chernobyl Exclusion Zone - Methodology for Assessing Disposal under Intervention Conditions - 13476

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

Haverkamp, B.; Krone, J.; Shybetskyi, I.

The Radioactive Waste Disposal Facility (RWDF) Buryakovka was constructed in 1986 as part of the intervention measures after the accident at Chernobyl NPP (ChNPP). Today, RWDF Buryakovka is still being operated but its maximum capacity is nearly reached. Plans for enlargement of the facility exist since more than 10 years but have not been implemented yet. In the framework of an European Commission Project DBE Technology GmbH prepared a safety analysis report of the facility in its current state (SAR) and a preliminary safety analysis report (PSAR) based on the planned enlargement. Due to its history RWDF Buryakovka does notmore » fully comply with today's best international practices and the latest Ukrainian regulations in this area. The most critical aspects are its inventory of long-lived radionuclides, and the non-existent multi-barrier waste confinement system. A significant part of the project was dedicated, therefore, to the development of a methodology for the safety assessment taking into consideration the facility's special situation and to reach an agreement with all stakeholders involved in the later review and approval procedure of the safety analysis reports. Main aspect of the agreed methodology was to analyze the safety, not strictly based on regulatory requirements but on the assessment of the actual situation of the facility including its location within the Exclusion Zone. For both safety analysis reports, SAR and PSAR, the assessment of the long-term safety led to results that were either within regulatory limits or within the limits allowing for a specific situational evaluation by the regulator. (authors)« less

Tracer methodology: an appropriate tool for assessing compliance with accreditation standards?

PubMed

Bouchard, Chantal; Jean, Olivier

2017-10-01

Tracer methodology has been used by Accreditation Canada since 2008 to collect evidence on the quality and safety of care and services, and to assess compliance with accreditation standards. Given the importance of this methodology in the accreditation program, the objective of this study is to assess the quality of the methodology and identify its strengths and weaknesses. A mixed quantitative and qualitative approach was adopted to evaluate consistency, appropriateness, effectiveness and stakeholder synergy in applying the methodology. An online questionnaire was sent to 468 Accreditation Canada surveyors. According to surveyors' perceptions, tracer methodology is an effective tool for collecting useful, credible and reliable information to assess compliance with Qmentum program standards and priority processes. The results show good coherence between methodology components (appropriateness of the priority processes evaluated, activities to evaluate a tracer, etc.). The main weaknesses are the time constraints faced by surveyors and management's lack of cooperation during the evaluation of tracers. The inadequate amount of time allowed for the methodology to be applied properly raises questions about the quality of the information obtained. This study paves the way for a future, more in-depth exploration of the identified weaknesses to help the accreditation organization make more targeted improvements to the methodology. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Studies to determine the effectiveness of automated flagger assistance devices and school crossing devices.

DOT National Transportation Integrated Search

2012-01-01

This report describes the methodology and results of analyses performed to determine motorist understanding, as well as : the operational and safety effectiveness, of automated flagger assistance devices (AFADs) relative to the use of flaggers at lan...

Independent Evaluation of Heavy-Truck Safety Applications Based on Vehicle-to-Vehicle and Vehicle-to-Infrastructure Communications Used in the Safety Pilot Model Deployment

DOT National Transportation Integrated Search

2016-01-01

This report presents the methodology and results of the independent evaluation of heavy trucks (HTs) in the Safety Pilot Model Deployment (SPMD); part of the United States Department of Transportations Intelligent Transportation Systems research p...

Methodology for safety optimization of highway cross-sections for horizontal curves with restricted sight distance.

PubMed

Ibrahim, Shewkar E; Sayed, Tarek; Ismail, Karim

2012-11-01

Several earlier studies have noted the shortcomings with existing geometric design guides which provide deterministic standards. In these standards the safety margin of the design output is generally unknown and there is little knowledge of the safety implications of deviating from the standards. To mitigate these shortcomings, probabilistic geometric design has been advocated where reliability analysis can be used to account for the uncertainty in the design parameters and to provide a mechanism for risk measurement to evaluate the safety impact of deviations from design standards. This paper applies reliability analysis for optimizing the safety of highway cross-sections. The paper presents an original methodology to select a suitable combination of cross-section elements with restricted sight distance to result in reduced collisions and consistent risk levels. The purpose of this optimization method is to provide designers with a proactive approach to the design of cross-section elements in order to (i) minimize the risk associated with restricted sight distance, (ii) balance the risk across the two carriageways of the highway, and (iii) reduce the expected collision frequency. A case study involving nine cross-sections that are parts of two major highway developments in British Columbia, Canada, was presented. The results showed that an additional reduction in collisions can be realized by incorporating the reliability component, P(nc) (denoting the probability of non-compliance), in the optimization process. The proposed approach results in reduced and consistent risk levels for both travel directions in addition to further collision reductions. Copyright © 2012 Elsevier Ltd. All rights reserved.

ARAMIS project: a comprehensive methodology for the identification of reference accident scenarios in process industries.

PubMed

Delvosalle, Christian; Fievez, Cécile; Pipart, Aurore; Debray, Bruno

2006-03-31

In the frame of the Accidental Risk Assessment Methodology for Industries (ARAMIS) project, this paper aims at presenting the work carried out in the part of the project devoted to the definition of accident scenarios. This topic is a key-point in risk assessment and serves as basis for the whole risk quantification. The first result of the work is the building of a methodology for the identification of major accident hazards (MIMAH), which is carried out with the development of generic fault and event trees based on a typology of equipment and substances. The term "major accidents" must be understood as the worst accidents likely to occur on the equipment, assuming that no safety systems are installed. A second methodology, called methodology for the identification of reference accident scenarios (MIRAS) takes into account the influence of safety systems on both the frequencies and possible consequences of accidents. This methodology leads to identify more realistic accident scenarios. The reference accident scenarios are chosen with the help of a tool called "risk matrix", crossing the frequency and the consequences of accidents. This paper presents both methodologies and an application on an ethylene oxide storage.

Safety evaluation methodology for advanced coal extraction systems

NASA Technical Reports Server (NTRS)

Zimmerman, W. F.

1981-01-01

Qualitative and quantitative evaluation methods for coal extraction systems were developed. The analysis examines the soundness of the design, whether or not the major hazards have been eliminated or reduced, and how the reduction would be accomplished. The quantitative methodology establishes the approximate impact of hazards on injury levels. The results are weighted by peculiar geological elements, specialized safety training, peculiar mine environmental aspects, and reductions in labor force. The outcome is compared with injury level requirements based on similar, safer industries to get a measure of the new system's success in reducing injuries. This approach provides a more detailed and comprehensive analysis of hazards and their effects than existing safety analyses.

Using Risk Assessment Methodologies to Meet Management Objectives

NASA Technical Reports Server (NTRS)

DeMott, D. L.

2015-01-01

Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures.

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...

Lecture Notes on Criticality Safety Validation Using MCNP & Whisper

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

Brown, Forrest B.; Rising, Michael Evan; Alwin, Jennifer Louise

Training classes for nuclear criticality safety, MCNP documentation. The need for, and problems surrounding, validation of computer codes and data area considered first. Then some background for MCNP & Whisper is given--best practices for Monte Carlo criticality calculations, neutron spectra, S(α,β) thermal neutron scattering data, nuclear data sensitivities, covariance data, and correlation coefficients. Whisper is computational software designed to assist the nuclear criticality safety analyst with validation studies with the Monte Carlo radiation transport package MCNP. Whisper's methodology (benchmark selection – C k's, weights; extreme value theory – bias, bias uncertainty; MOS for nuclear data uncertainty – GLLS) and usagemore » are discussed.« less

Application of Mls Data to the Assessment of Safety-Related Features in the Surrounding Area of Automatically Detected Pedestrian Crossings

NASA Astrophysics Data System (ADS)

Soilán, M.; Riveiro, B.; Sánchez-Rodríguez, A.; González-deSantos, L. M.

2018-05-01

During the last few years, there has been a huge methodological development regarding the automatic processing of 3D point cloud data acquired by both terrestrial and aerial mobile mapping systems, motivated by the improvement of surveying technologies and hardware performance. This paper presents a methodology that, in a first place, extracts geometric and semantic information regarding the road markings within the surveyed area from Mobile Laser Scanning (MLS) data, and then employs it to isolate street areas where pedestrian crossings are found and, therefore, pedestrians are more likely to cross the road. Then, different safety-related features can be extracted in order to offer information about the adequacy of the pedestrian crossing regarding its safety, which can be displayed in a Geographical Information System (GIS) layer. These features are defined in four different processing modules: Accessibility analysis, traffic lights classification, traffic signs classification, and visibility analysis. The validation of the proposed methodology has been carried out in two different cities in the northwest of Spain, obtaining both quantitative and qualitative results for pedestrian crossing classification and for each processing module of the safety assessment on pedestrian crossing environments.

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

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

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

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

Safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults on anti-retroviral therapy in Uganda (COSTOP trial): Design.

PubMed

Anywaine, Zacchaeus; Abaasa, Andrew; Levin, Jonathan; Kasirye, Ronnie; Kamali, Anatoli; Grosskurth, Heiner; Munderi, Paula; Nunn, Andrew

2015-07-01

Cotrimoxazole (CTX) prophylaxis is recommended by the World Health Organisation for HIV infected persons. However, once HIV infected patients have commenced ART in resource limited settings, the benefits of continued CTX prophylaxis are not known. The few studies that investigated the safety of discontinuing CTX prophylaxis in these settings had limitations due to their design. COSTOP is a randomised double blind placebo controlled non-inferiority trial among HIV infected Ugandan adults stabilised on anti-retroviral treatment (ART). Participants with CD4 count of 250 or more cells/mm(3) are randomised to two arms: the intervention arm in which CTX is discontinued and the control arm in which CTX prophylaxis is continued. The study aims to assess whether the intervention regimen is not inferior, with respect to the incidence of pre-defined CTX-preventable events, to the control regimen and superior with respect to the incidence of haematological adverse events. Studies that have previously evaluated the safety of discontinuing CTX prophylaxis among HIV infected adults in resource limited settings have provided moderate to low quality evidence owing in part to methodological limitations. COSTOP is designed and conducted with sufficient rigour to answer this question. The results of the trial will assist in guiding policy recommendations. This paper describes the design and methodological considerations important for the conduct of CTX cessation studies. Copyright © 2015. Published by Elsevier Inc.

Railroad safety program, task 2

NASA Technical Reports Server (NTRS)

1983-01-01

Aspects of railroad safety and the preparation of a National Inspection Plan (NIP) for rail safety improvement are examined. Methodology for the allocation of inspection resources, preparation of a NIP instruction manual, and recommendations for future NIP, are described. A statistical analysis of regional rail accidents is presented with causes and suggested preventive measures included.

Calibration of the Highway Safety Manual and development of new safety performance functions for rural multilane highways in Kansas : technical summary.

DOT National Transportation Integrated Search

2016-10-01

Rural roads account for 90.3% of the 140,476 total centerline miles of roadways : in Kansas. In recent years, rural fatal crashes have accounted for about 66% : of all fatal crashes. The Highway Safety Manual (HSM) provides models and : methodologies...

Safety assessment of adjuvanted vaccines: Methodological considerations

PubMed Central

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

2015-01-01

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

Fragility Analysis of Concrete Gravity Dams

NASA Astrophysics Data System (ADS)

Tekie, Paulos B.; Ellingwood, Bruce R.

2002-09-01

Concrete gravity dams are an important part ofthe nation's infrastructure. Many dams have been in service for over 50 years, during which time important advances in the methodologies for evaluation of natural phenomena hazards have caused the design-basis events to be revised upwards, in some cases significantly. Many existing dams fail to meet these revised safety criteria and structural rehabilitation to meet newly revised criteria may be costly and difficult. A probabilistic safety analysis (PSA) provides a rational safety assessment and decision-making tool managing the various sources of uncertainty that may impact dam performance. Fragility analysis, which depicts fl%e uncertainty in the safety margin above specified hazard levels, is a fundamental tool in a PSA. This study presents a methodology for developing fragilities of concrete gravity dams to assess their performance against hydrologic and seismic hazards. Models of varying degree of complexity and sophistication were considered and compared. The methodology is illustrated using the Bluestone Dam on the New River in West Virginia, which was designed in the late 1930's. The hydrologic fragilities showed that the Eluestone Dam is unlikely to become unstable at the revised probable maximum flood (PMF), but it is likely that there will be significant cracking at the heel ofthe dam. On the other hand, the seismic fragility analysis indicated that sliding is likely, if the dam were to be subjected to a maximum credible earthquake (MCE). Moreover, there will likely be tensile cracking at the neck of the dam at this level of seismic excitation. Probabilities of relatively severe limit states appear to be only marginally affected by extremely rare events (e.g. the PMF and MCE). Moreover, the risks posed by the extreme floods and earthquakes were not balanced for the Bluestone Dam, with seismic hazard posing a relatively higher risk.

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

PubMed

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

2013-12-01

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

Probabilistic design of fibre concrete structures

NASA Astrophysics Data System (ADS)

Pukl, R.; Novák, D.; Sajdlová, T.; Lehký, D.; Červenka, J.; Červenka, V.

2017-09-01

Advanced computer simulation is recently well-established methodology for evaluation of resistance of concrete engineering structures. The nonlinear finite element analysis enables to realistically predict structural damage, peak load, failure, post-peak response, development of cracks in concrete, yielding of reinforcement, concrete crushing or shear failure. The nonlinear material models can cover various types of concrete and reinforced concrete: ordinary concrete, plain or reinforced, without or with prestressing, fibre concrete, (ultra) high performance concrete, lightweight concrete, etc. Advanced material models taking into account fibre concrete properties such as shape of tensile softening branch, high toughness and ductility are described in the paper. Since the variability of the fibre concrete material properties is rather high, the probabilistic analysis seems to be the most appropriate format for structural design and evaluation of structural performance, reliability and safety. The presented combination of the nonlinear analysis with advanced probabilistic methods allows evaluation of structural safety characterized by failure probability or by reliability index respectively. Authors offer a methodology and computer tools for realistic safety assessment of concrete structures; the utilized approach is based on randomization of the nonlinear finite element analysis of the structural model. Uncertainty of the material properties or their randomness obtained from material tests are accounted in the random distribution. Furthermore, degradation of the reinforced concrete materials such as carbonation of concrete, corrosion of reinforcement, etc. can be accounted in order to analyze life-cycle structural performance and to enable prediction of the structural reliability and safety in time development. The results can serve as a rational basis for design of fibre concrete engineering structures based on advanced nonlinear computer analysis. The presented methodology is illustrated on results from two probabilistic studies with different types of concrete structures related to practical applications and made from various materials (with the parameters obtained from real material tests).

Safety risk assessment for vertical concrete formwork activities in civil engineering construction.

PubMed

López-Arquillos, Antonio; Rubio-Romero, Juan Carlos; Gibb, Alistair G F; Gambatese, John A

2014-01-01

The construction sector has one of the worst occupational health and safety records in Europe. Of all construction tasks, formwork activities are associated with a high frequency of accidents and injuries. This paper presents an investigation of the activities and related safety risks present in vertical formwork for in-situ concrete construction in the civil engineering sector. Using the methodology of staticized groups, twelve activities and ten safety risks were identified and validated by experts. Every safety risk identified in this manner was quantified for each activity using binary methodology according to the frequency and severity scales developed in prior research. A panel of experts was selected according to the relevant literature on staticized groups. The results obtained show that the activities with the highest risk in vertical formwork tasks are: Plumbing and leveling of forms, cutting of material, handling materials with cranes, and climbing or descending ladders. The most dangerous health and safety risks detected were falls from height, cutting and overexertion. The research findings provide construction practitioners with further evidence of the hazardous activities associated with concrete formwork construction and a starting point for targeting worker health and safety programmes.

A Narrative Review of High-Quality Literature on the Effects of Resident Duty Hours Reforms.

PubMed

Lin, Henry; Lin, Emery; Auditore, Stephanie; Fanning, Jon

2016-01-01

To summarize current high-quality studies evaluating the effect and efficacy of resident duty hours reforms (DHRs) on patient safety and resident education and well-being. The authors searched PubMed and Medline in August 2012 and again in May 2013 for literature (1987-2013) about the effects of DHRs. They assessed the quality of articles using the Medical Education Research Study Quality Instrument (MERSQI) scoring system. They considered randomized controlled trials (RCTs), partial RCTs, and all studies with a MERSQI score ≥ 14 to be "high-quality" methodology studies. A total of 72 high-quality studies met inclusion criteria. Most studies showed no change or slight improvement in mortality and complication rates after DHRs. Resident well-being was generally improved, but there was a perceived negative impact on education (knowledge acquisition, skills, and cognitive performance) following DHRs. Eleven high-quality studies assessed the impact of DHR interventions; all reported a neutral to positive impact. Seven high-quality studies assessed costs associated with DHRs and demonstrated an increase in hospital costs. The results of most studies that allow enough time for DHR interventions to take effect suggest a benefit to patient safety and resident well-being, but the effect on the quality of training remains unknown. Additional methodologically sound studies on the impact of DHRs are necessary. Priorities for future research include approaches to optimizing education and clinical proficiency and studies on the effect of intervention strategies on both education and patient safety. Such studies will provide additional information to help improve duty hours policies.

Methodologic limitations of prescription opioid safety research and recommendations for improving the evidence base.

PubMed

Ranapurwala, Shabbar I; Naumann, Rebecca B; Austin, Anna E; Dasgupta, Nabarun; Marshall, Stephen W

2018-06-03

The ongoing opioid epidemic has claimed more than a quarter million Americans' lives over the past 15 years. The epidemic began with an escalation of prescription opioid deaths and has now evolved to include secondary waves of illicit heroin and fentanyl deaths, while the deaths due to prescription opioid overdoses are still increasing. In response, the Centers for Disease Control and Prevention (CDC) moved to limit opioid prescribing with the release of opioid prescribing guidelines for chronic noncancer pain in March 2016. The guidelines represent a logical and timely federal response to this growing crisis. However, CDC acknowledged that the evidence base linking opioid prescribing to opioid use disorders and overdose was grades 3 and 4. Motivated by the need to strengthen the evidence base, this review details limitations of the opioid safety studies cited in the CDC guidelines with a focus on methodological limitations related to internal and external validity. Internal validity concerns were related to poor confounding control, variable misclassification, selection bias, competing risks, and potential competing interventions. External validity concerns arose from the use of limited source populations, historical data (in a fast-changing epidemic), and issues with handling of cancer and acute pain patients' data. We provide a nonexhaustive list of 7 recommendations to address these limitations in future opioid safety studies. Strengthening the opioid safety evidence base will aid any future revisions of the CDC guidelines and enhance their prevention impact. Copyright © 2018 John Wiley & Sons, Ltd.

Indian reservation safety improvement program : a methodology and case study.

DOT National Transportation Integrated Search

2013-10-01

The need to reduce fatal and injury crashes on Tribal lands has been recognized for years. The U.S. has : realized a decline in fatal crashes over the past several years but fatal crashes continue to increase on : Tribal lands. Little progress has be...

Hospital Nurses' Work Environment Characteristics and Patient Safety Outcomes: A Literature Review.

PubMed

Lee, Seung Eun; Scott, Linda D

2018-01-01

This integrative literature review assesses the relationship between hospital nurses' work environment characteristics and patient safety outcomes and recommends directions for future research based on examination of the literature. Using an electronic search of five databases, 18 studies published in English between 1999 and 2016 were identified for review. All but one study used a cross-sectional design, and only four used a conceptual/theoretical framework to guide the research. No definition of work environment was provided in most studies. Differing variables and instruments were used to measure patient outcomes, and findings regarding the effects of work environment on patient outcomes were inconsistent. To clarify the relationship between nurses' work environment characteristics and patient safety outcomes, researchers should consider using a longitudinal study design, using a theoretical foundation, and providing clear operational definitions of concepts. Moreover, given the inconsistent findings of previous studies, they should choose their measurement methodologies with care.

RISMC Toolkit and Methodology Research and Development Plan for External Hazards Analysis

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

Coleman, Justin Leigh

This report includes the description and development plan for a Risk Informed Safety Margins Characterization (RISMC) toolkit and methodology that will evaluate multihazard risk in an integrated manner to support the operating nuclear fleet.

Safety of High Speed Guided Ground Transportation Systems: Work Breakdown Structure

DOT National Transportation Integrated Search

1994-11-30

This report provides a systems approach to the assessment, evaluation and application of high-speed guided ground transportation (HSGGT) safety criteria and : presents one potential methodology by combining a work breakdown structure (WBS) : approach...

Estimation of potential safety benefits for pedestrian crash avoidance/mitigation systems.

DOT National Transportation Integrated Search

2017-04-01

This report presents and exercises a methodology to estimate the effectiveness and potential safety benefits of production pedestrian crash avoidance/mitigation systems. The analysis focuses on light vehicles moving forward and striking a pedestrian ...

[Demonstrating patient safety requires acceptance of a broader scientific palette].

PubMed

Leistikow, I

2017-01-01

It is high time the medical community recognised that patient-safety research can be assessed using other scientific methods than the traditional medical ones. There is often a fundamental mismatch between the methodology of patient-safety research and the methodology used to assess the quality of this research. One example is research into the reliability and validity of record review as a method for detecting adverse events. This type of research is based on logical positivism, while record review itself is based on social constructivism. Record review does not lead to "one truth": adverse events are not measured on the basis of the records themselves, but by weighing the probability of certain situations being classifiable as adverse events. Healthcare should welcome behavioural and social sciences to its scientific palette. Restricting ourselves to the randomised control trial paradigm is short-sighted and dangerous; it deprives patients of much-needed improvements in safety.

Chemical plant innovative safety investments decision-support methodology.

PubMed

Reniers, G L L; Audenaert, A

2009-01-01

This article examines the extent to which investing in safety during the creation of a new chemical installation proves profitable. The authors propose a management supporting cost-benefit model that identifies and evaluates investments in safety within a chemical company. This innovative model differentiates between serious accidents and less serious accidents, thus providing an authentic image of prevention-related costs and benefits. In classic cost-benefit analyses, which do not make such differentiations, only a rudimentary image of potential profitability resulting from investments in safety is obtained. The resulting management conclusions that can be drawn from such classical analyses are of a very limited nature. The proposed model, however, is applied to a real case study and the proposed investments in safety at an appointed chemical installation are weighed against the estimated hypothetical benefits resulting from the preventive measures to be installed at the installation. In the case-study carried out in question, it would appear that the proposed prevention investments are justified. Such an economic exercise may be very important to chemical corporations trying to (further) improve their safety investments.

Design Development Test and Evaluation (DDT and E) Considerations for Safe and Reliable Human Rated Spacecraft Systems

NASA Technical Reports Server (NTRS)

Miller, James; Leggett, Jay; Kramer-White, Julie

2008-01-01

A team directed by the NASA Engineering and Safety Center (NESC) collected methodologies for how best to develop safe and reliable human rated systems and how to identify the drivers that provide the basis for assessing safety and reliability. The team also identified techniques, methodologies, and best practices to assure that NASA can develop safe and reliable human rated systems. The results are drawn from a wide variety of resources, from experts involved with the space program since its inception to the best-practices espoused in contemporary engineering doctrine. This report focuses on safety and reliability considerations and does not duplicate or update any existing references. Neither does it intend to replace existing standards and policy.

Baccalaureate nursing students' perspectives of peer tutoring in simulation laboratory, a Q methodology study.

PubMed

Li, Ting; Petrini, Marcia A; Stone, Teresa E

2018-02-01

The study aim was to identify the perceived perspectives of baccalaureate nursing students toward the peer tutoring in the simulation laboratory. Insight into the nursing students' experiences and baseline data related to their perception of peer tutoring will assist to improve nursing education. Q methodology was applied to explore the students' perspectives of peer tutoring in the simulation laboratory. A convenience P-sample of 40 baccalaureate nursing students was used. Fifty-eight selected Q statements from each participant were classified into the shape of a normal distribution using an 11-point bipolar scale form with a range from -5 to +5. PQ Method software analyzed the collected data. Three discrete factors emerged: Factor I ("Facilitate or empower" knowledge acquisition), Factor II ("Safety Net" Support environment), and Factor III ("Mentoring" learn how to learn). The findings of this study support and indicate that peer tutoring is an effective supplementary strategy to promote baccalaureate students' knowledge acquisition, establishing a supportive safety net and facilitating their abilities to learn in the simulation laboratory. Copyright © 2017 Elsevier Ltd. All rights reserved.

75 FR 81165 - Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-27

... number of studies have shown a correlation between higher job risk and higher wages, suggesting that... & Aldy (2003) conducted an analysis of studies that use a willingness-to-pay methodology to estimate the...). Although MSHA is using the Viscusi & Aldy (2003) study as the basis for monetizing the expected benefits of...

Recent advances in the management of neuropsychiatric symptoms in dementia.

PubMed

Forlenza, Orestes V; Loureiro, Júlia Cunha; Pais, Marcos Vasconcelos; Stella, Florindo

2017-03-01

The present article addresses intriguing questions related to the clinical intervention in distinct neuropsychiatric syndromes of patients with dementia. We reviewed 154 articles published between 2015 and 2016 targeting psychopharmacological and nonpharmacological interventions, and safety-tolerability concerns. We selected 115 articles addressing the purpose of this study. Of these, 33 were chosen because they were dedicated to subtopics: agitation (42), depression (33), apathy (18), sleep disorders/anxiety (8), and psychosis (4). Clinical studies using both pharmacological (70) and nonpharmacological (37) interventions were considered; others were included for theoretical support. Regarding the methodological design, we found double-blind RCTs (17), single-blinded RCTs (4), open-label studies (18), case reports (5), cross-sectional or cohort studies (25), epidemiological papers (2), and expert reviews (44). This observation raises concerns about the overall methodological adequacy of a substantial proportion of studies in this field, which limits the potential of generalization of the findings. Finally, 18 studies were designed to determine safety-tolerability issues of psychotropic medications (6 were discussed). Effective and well tolerated treatment of neuropsychiatric syndromes in dementia remains a critically unsolved challenge. We understand that this is an extremely important area of research, and critically required to guide clinical decisions in geriatric neuropsychiatry.

Contributions of the sandwich doctoral program to methodological approaches: an experience report.

PubMed

Lorenzini, Elisiane; Oelke, Nelly Donszelmann; Marck, Patricia Beryl; Dall'Agnol, Clarice Maria

2016-06-01

Objective To share our experience on theoretical and methodological insights we have gained as researchers working together during the Sandwich Doctoral Program. Method This is a descriptive experience report. Results We have incorporated restoration thinking into a study on patient safety culture and will enhance knowledge translation by applying principles of deliberative dialogue to increase the uptake and implementation of research results. Conclusion Incorporating new approaches in Brazilian nursing research plays a key role in achieving international participation and visibility in different areas of nursing knowledge.

The safety climate in primary care (SAP-C) study: study protocol for a randomised controlled feasibility study.

PubMed

Lydon, Sinéad; Cupples, Margaret E; Hart, Nigel; Murphy, Andrew W; Faherty, Aileen; O'Connor, Paul

2016-01-01

Research on patient safety has focused largely on secondary care settings, and there is a dearth of knowledge relating to safety culture or climate, and safety climate improvement strategies, in the context of primary care. This is problematic given the high rates of usage of primary care services and the myriad of opportunities for clinical errors daily. The current research programme aimed to assess the effectiveness of an intervention derived from the Scottish Patient Safety Programme in Primary Care. The intervention consists of safety climate measurement and feedback and patient chart audit using the trigger review method. The purpose of this paper is to describe the background to this research and to present the methodology of this feasibility study in preparation for a future definitive RCT. The SAP-C study is a feasibility study employing a randomised controlled pretest-posttest design that will be conducted in 10 general practices in the Republic of Ireland and Northern Ireland. Five practices will receive the safety climate intervention over a 9-month period. The five practices in the control group will continue care as usual but will complete the GP-SafeQuest safety climate questionnaire at baseline (month 1) and at the terminus of the intervention (month 9). The outcomes of the study include process evaluation metrics (i.e. rates of participant recruitment and retention, rates of completion of safety climate measures, qualitative data regarding participants' perceptions of the intervention's potential efficacy, acceptability, and sustainability), patient safety culture in intervention and control group practices at posttest, and instances of undetected patient harm identified through patient chart audit using the trigger review method. The planned study investigates an intervention to improve safety climate in Irish primary care settings. The resulting data may inform our knowledge of the frequency of undetected patient safety incidents in primary care, may contribute to improved patient safety practices in primary care settings, and may inform future research on patient safety improvement initiatives.

Vessel traffic safety in busy waterways: A case study of accidents in western shenzhen port.

PubMed

Mou, J M; Chen, P F; He, Y X; Yip, Tsz Leung; Li, W H; Tang, J; Zhang, H Z

2016-08-03

Throughout the world, busy waterways near large ports witness heavy vessel traffic in recent decades. The waterways are characterized by high risk in terms of loss of life, property, and pollution to environment. To facilitate maritime safety management with satisfactory efficiency and efficacy, the authors propose a framework of safety indexes to evaluate the risk level in busy waterways according to the accident severity, fatality rate and special indicators of maritime transportation. The safety indexes consist of Safety Evaluation Index (SEI) and Safety Warning Index (SWI), and are derived from the proposed risk criteria of Chinese vessel traffic. As a case study, data on vessel traffic accidents reported in the Western Shenzhen Port, South China from 1995 to 2015 are analyzed. The actual risk level of this area during the period is calculated under the framework. The implementation of the safety indexes indicate that the risk criteria and safety indexes are practicable and effective for the vessel traffic management. The methodology based on long-term accident data can significantly support the risk analysis in the macroscopic perspective for busy ports and waterways, such that SWI can act as threshold to trigger actions, while SEI can act as an indicator to measure safety status. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safety and reliability analysis in a polyvinyl chloride batch process using dynamic simulator-case study: Loss of containment incident.

PubMed

Rizal, Datu; Tani, Shinichi; Nishiyama, Kimitoshi; Suzuki, Kazuhiko

2006-10-11

In this paper, a novel methodology in batch plant safety and reliability analysis is proposed using a dynamic simulator. A batch process involving several safety objects (e.g. sensors, controller, valves, etc.) is activated during the operational stage. The performance of the safety objects is evaluated by the dynamic simulation and a fault propagation model is generated. By using the fault propagation model, an improved fault tree analysis (FTA) method using switching signal mode (SSM) is developed for estimating the probability of failures. The timely dependent failures can be considered as unavailability of safety objects that can cause the accidents in a plant. Finally, the rank of safety object is formulated as performance index (PI) and can be estimated using the importance measures. PI shows the prioritization of safety objects that should be investigated for safety improvement program in the plants. The output of this method can be used for optimal policy in safety object improvement and maintenance. The dynamic simulator was constructed using Visual Modeler (VM, the plant simulator, developed by Omega Simulation Corp., Japan). A case study is focused on the loss of containment (LOC) incident at polyvinyl chloride (PVC) batch process which is consumed the hazardous material, vinyl chloride monomer (VCM).

14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

Code of Federal Regulations, 2013 CFR

2013-01-01

... approach provides an equivalent level of safety. If a Federal launch range performs the launch operator's... FAA will measure any proposed alternative analysis approach. This appendix also identifies the... control systems; (ix) Steering misalignment; and (x) Winds. (2) Each three-sigma trajectory must account...

Calibration of the highway safety manual and development of new safety performance functions for rural multilane highways in Kansas : final report.

DOT National Transportation Integrated Search

2016-10-01

Rural roads account for 90.3% of the 140,476 total centerline miles of roadways in Kansas. In recent years, rural fatal crashes have accounted for about 66% of all fatal crashes. The Highway Safety Manual (HSM) provides models and methodologies for a...

14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

Code of Federal Regulations, 2012 CFR

2012-01-01

... approach provides an equivalent level of safety. If a Federal launch range performs the launch operator's... FAA will measure any proposed alternative analysis approach. This appendix also identifies the... control systems; (ix) Steering misalignment; and (x) Winds. (2) Each three-sigma trajectory must account...

14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

Code of Federal Regulations, 2010 CFR

2010-01-01

... approach provides an equivalent level of safety. If a Federal launch range performs the launch operator's... FAA will measure any proposed alternative analysis approach. This appendix also identifies the... control systems; (ix) Steering misalignment; and (x) Winds. (2) Each three-sigma trajectory must account...

14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

Code of Federal Regulations, 2014 CFR

2014-01-01

... approach provides an equivalent level of safety. If a Federal launch range performs the launch operator's... FAA will measure any proposed alternative analysis approach. This appendix also identifies the... control systems; (ix) Steering misalignment; and (x) Winds. (2) Each three-sigma trajectory must account...

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

PubMed

Zink, Richard C; Marchenko, Olga; Sanchez-Kam, Matilde; Ma, Haijun; Jiang, Qi

2018-03-01

There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation. In this manuscript, we review the challenges associated with the analysis of safety endpoints and describe the safety data that are available to influence the design and analysis of premarket clinical trials. We share our recommendations for the statistical and graphical methodologies necessary to appropriately analyze, report, and interpret safety outcomes, and we discuss the advantages and disadvantages of safety data obtained from clinical trials compared to other sources. Clinical trials are an important source of safety data that contribute to the totality of safety information available to generate evidence for regulators, sponsors, payers, physicians, and patients. This work is a result of the efforts of the American Statistical Association Biopharmaceutical Section Safety Working Group.

Review article: the role of practice guidelines and evidence-based medicine in perioperative patient safety.

PubMed

Crosby, Edward

2013-02-01

The purpose of this narrative review is to discuss the impact of clinical practice guidelines on the outcomes of care and patient safety. The care provided to patients has a high degree of variability, including some care that is discordant with available evidence. This inconsistency has implications for patient safety as some patients receive care that is unlikely beneficial yet may be harmful, while others are denied care that would clearly be helpful. The medical literature is expanding at an alarming rate; its quality and reliability is often poor; study methodology is frequently suboptimal, and reversal is common, even among frequently cited articles. For decades, specialty societies and other agencies have been providing clinical practice guidelines to assist physicians with the integration of evidence into clinical decision-making. Implementation of guidelines has been variable, and their goals are often not achieved due to failed uptake and application. The reasons for this shortcoming are complex and some explanations are valid. Many guidelines have not been evidence-based and many have been methodologically unsound. Physician autonomy likely also plays an important role in guideline uptake; an updated concept of autonomy that embraces appropriate guidelines is long overdue. Under certain conditions, guidelines can add value to care and improve outcomes; they need to be evidence-based, methodologically sound, and appropriately applied to patients and clinical scenarios. Simply summarizing evidence in a guideline is an inadequate process. To achieve the benefit of guidelines, implementation strategies need to be robust.

Communication and teamwork in patient care: how much can we learn from aviation?

PubMed

Lyndon, Audrey

2006-01-01

To identify evidence on the role of assertiveness and teamwork and the application of aviation industry techniques to improve patient safety for inpatient obstetric care. Studies limited to research with humans in English language retrieved from CINAHL, PubMed, Social Science Abstracts, and Social Sciences Citation Index, and references from reviewed articles. A total of 13 studies were reviewed, including 5 studies of teamwork, communication, and safety attitudes in aviation; 2 studies comparing these factors in aviation and health care; and 6 studies of assertive behavior and decision making by nurses. Studies lacking methodological rigor or focusing on medication errors and deviant behavior were excluded. Pilot attitudes regarding interpersonal interaction on the flight deck predicted effective performance and were amenable to behavior-based training to improve team performance. Nursing knowledge was inconsistently accessed in decision making. Findings regarding nurse assertiveness were mixed. Adaptation of training concepts and safety methods from other fields will have limited impact on perinatal safety without an examination of the contextual experiences of nurses and other health care providers in working to prevent patient harm.

Passenger rail vehicle safety assessment methodology. Volume II, Detailed analyses and simulation results.

DOT National Transportation Integrated Search

2000-04-01

This report presents detailed analytic tools and results on dynamic response which are used to develop the safe dynamic performance limits of commuter passenger vehicles. The methodology consists of determining the critical parameters and characteris...

Applied Use of Safety Event Occurrence Control Charts of Harm and Non-Harm Events: A Case Study.

PubMed

Robinson, Susan N; Neyens, David M; Diller, Thomas

Most hospitals use occurrence reporting systems that facilitate identifying serious events that lead to root cause investigations. Thus, the events catalyze improvement efforts to mitigate patient harm. A serious limitation is that only a few of the occurrences are investigated. A challenge is leveraging the data to generate knowledge. The goal is to present a methodology to supplement these incident assessment efforts. The framework affords an enhanced understanding of patient safety through the use of control charts to monitor non-harm and harm incidents simultaneously. This approach can identify harm and non-harm reporting rates and also can facilitate monitoring occurrence trends. This method also can expedite identifying changes in workflow, processes, or safety culture. Although unable to identify root causes, this approach can identify changes in near real time. This approach also supports evaluating safety or policy interventions that may not be observable in annual safety climate surveys.

Target crashes and safety benefits estimation methodology for pedestrian crash avoidance/mitigation systems

DOT National Transportation Integrated Search

2014-04-01

Through the analysis of national crash databases from the National Highway Traffic Safety Administration, pre-crash scenarios are identified, prioritized, and described for the development of objective tests for pedestrian crash avoidance/mitigation ...

Where Our Children Learn Matters. A Report on the Virginia School Facilities Impact Study.

ERIC Educational Resources Information Center

Duke, Daniel; Griesdorn, Jacqueline

2001-01-01

Describes the methodology, findings, and recommendations of a survey to determine how overcrowded and deteriorating facilities affect learning and teaching. Survey questions sought information about lost instructional time, instructional effectiveness, available curricular options, student health and safety, and the pressure on facilities…

Professional Competence Enhancement via Postgraduate Post-Experience Learning and Development

ERIC Educational Resources Information Center

Chivers, Geoffrey

2007-01-01

Purpose: The purpose of this paper is to determine the ways in which postgraduate study in vocational fields supports the development of advanced competences amongst mid-career professionals. Design/methodology/approach: The extensive written communications between health and safety professionals taking a postgraduate course in health and safety…

Emotions, Coping and Learning in Error Situations in the Workplace

ERIC Educational Resources Information Center

Rausch, Andreas; Seifried, Jürgen; Harteis, Christian

2017-01-01

Purpose: This paper aims to investigate the complex relationship between emotions, coping approaches and learning in error situations in the workplace. The study also examines the influence of individual error orientation, as well as psychological safety, and team learning behaviour as contextual factors. Design/methodology/approach: To measure…

Economic Evaluation of Occupational Safety and Health Interventions From the Employer Perspective

PubMed Central

Grimani, Aikaterini; Bergström, Gunnar; Casallas, Martha Isabel Riaño; Aboagye, Emmanuel; Jensen, Irene; Lohela-Karlsson, Malin

2018-01-01

Objectives: The aim of this systematic review was to evaluate the cost-effectiveness of occupational safety and health interventions from the employer perspective. Methods: A comprehensive literature search (2005 to 2016) in five electronic databases was conducted. Pre-2005 studies were identified from the reference lists of previous studies and systematic reviews, which have similar objective to those of this search. Results: A total of 19 randomized controlled trials and quasi-experimental studies were included, targeting diverse health problems in a number of settings. Few studies included organizational-level interventions. When viewed in relation to the methodological quality and the sufficiency of economic evidence, five of 11 cost-effective occupational safety and health (OSH) interventions appear to be promising. Conclusion: The present systematic review highlights the need for high-quality economic evidence to evaluate the cost-effectiveness of OSH interventions, especially at organizational-level, in all areas of worker health. PMID:29112631

Prioritization Methodology for Chemical Replacement

NASA Technical Reports Server (NTRS)

Cruit, W.; Schutzenhofer, S.; Goldberg, B.; Everhart, K.

1993-01-01

This project serves to define an appropriate methodology for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weigh the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results are being implemented as a guideline for consideration for current NASA propulsion systems.

A review of the current state-of-the-art methodology for handling bias and uncertainty in performing criticality safety evaluations. Final report

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

Disney, R.K.

1994-10-01

The methodology for handling bias and uncertainty when calculational methods are used in criticality safety evaluations (CSE`s) is a rapidly evolving technology. The changes in the methodology are driven by a number of factors. One factor responsible for changes in the methodology for handling bias and uncertainty in CSE`s within the overview of the US Department of Energy (DOE) is a shift in the overview function from a ``site`` perception to a more uniform or ``national`` perception. Other causes for change or improvement in the methodology for handling calculational bias and uncertainty are; (1) an increased demand for benchmark criticalsmore » data to expand the area (range) of applicability of existing data, (2) a demand for new data to supplement existing benchmark criticals data, (3) the increased reliance on (or need for) computational benchmarks which supplement (or replace) experimental measurements in critical assemblies, and (4) an increased demand for benchmark data applicable to the expanded range of conditions and configurations encountered in DOE site restoration and remediation.« less

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

PubMed

Ward, Denham S; Williams, Mark R; Berkenbosch, John W; Bhatt, Maala; Carlson, Douglas; Chappell, Phillip; Clark, Randall M; Constant, Isabelle; Conway, Aaron; Cravero, Joseph; Dahan, Albert; Dexter, Franklin; Dionne, Raymond; Dworkin, Robert H; Gan, Tong J; Gozal, David; Green, Steven; Irwin, Michael G; Karan, Suzanne; Kochman, Michael; Lerman, Jerrold; Lightdale, Jenifer R; Litman, Ronald S; Mason, Keira P; Miner, James; O'Connor, Robert E; Pandharipande, Pratik; Riker, Richard R; Roback, Mark G; Sessler, Daniel I; Sexton, Anne; Tobin, Joseph R; Turk, Dennis C; Twersky, Rebecca S; Urman, Richard D; Weiss, Mark; Wunsch, Hannah; Zhao-Wong, Anna

2018-05-17

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Orion GN&C Fault Management System Verification: Scope And Methodology

NASA Technical Reports Server (NTRS)

Brown, Denise; Weiler, David; Flanary, Ronald

2016-01-01

In order to ensure long-term ability to meet mission goals and to provide for the safety of the public, ground personnel, and any crew members, nearly all spacecraft include a fault management (FM) system. For a manned vehicle such as Orion, the safety of the crew is of paramount importance. The goal of the Orion Guidance, Navigation and Control (GN&C) fault management system is to detect, isolate, and respond to faults before they can result in harm to the human crew or loss of the spacecraft. Verification of fault management/fault protection capability is challenging due to the large number of possible faults in a complex spacecraft, the inherent unpredictability of faults, the complexity of interactions among the various spacecraft components, and the inability to easily quantify human reactions to failure scenarios. The Orion GN&C Fault Detection, Isolation, and Recovery (FDIR) team has developed a methodology for bounding the scope of FM system verification while ensuring sufficient coverage of the failure space and providing high confidence that the fault management system meets all safety requirements. The methodology utilizes a swarm search algorithm to identify failure cases that can result in catastrophic loss of the crew or the vehicle and rare event sequential Monte Carlo to verify safety and FDIR performance requirements.

Hazard identification and pre-map with a simple specific tool: synthesis of application experience in handicrafts in various productive sectors.

PubMed

Colombini, Daniela; Occhipinti, Enrico; Peluso, Raffaele; Montomoli, Loretta

2012-01-01

In August 2009, an international group was founded with the task of developing a "toolkit for MSD prevention" under the IEA and in collaboration with the World Health Organization.According to the ISO standard 11228 series and the new Draft ISO TR 12259 "Application document guides for the potential user", our group developed a preliminary "mapping" methodology of occupational hazards in the craft industry, supported by software (Excel®, free download on: www.epmresearch.org).The possible users of toolkits are: members of health and safety committees; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers providing basic occupational health services; occupational health and safety specialists.The proposed methodology, using specific key enters and quick assessment criteria, allows a simple ergonomics hazards identification and risk estimation to be made. It is thus possible to decide for which occupational hazards a more exhaustive risk assessment will be necessary and which occupational consultant should be involved (occupational physician, safety engineer, industrial hygienist, etc.).The methodology has been applied in different situations of small and medium craftsmanship Italian enterprises: leather goods, food, technical dental work, production of artistic ceramics and stained glass, beekeeping activities. The results are synthetically reported and discussed in this paper.

Evaluation of countermeasures for red light running by traffic simulator-based surrogate safety measures.

PubMed

Lee, Changju; So, Jaehyun Jason; Ma, Jiaqi

2018-01-02

The conflicts among motorists entering a signalized intersection with the red light indication have become a national safety issue. Because of its sensitivity, efforts have been made to investigate the possible causes and effectiveness of countermeasures using comparison sites and/or before-and-after studies. Nevertheless, these approaches are ineffective when comparison sites cannot be found, or crash data sets are not readily available or not reliable for statistical analysis. Considering the random nature of red light running (RLR) crashes, an inventive approach regardless of data availability is necessary to evaluate the effectiveness of each countermeasure face to face. The aims of this research are to (1) review erstwhile literature related to red light running and traffic safety models; (2) propose a practical methodology for evaluation of RLR countermeasures with a microscopic traffic simulation model and surrogate safety assessment model (SSAM); (3) apply the proposed methodology to actual signalized intersection in Virginia, with the most prevalent scenarios-increasing the yellow signal interval duration, installing an advance warning sign, and an RLR camera; and (4) analyze the relative effectiveness by RLR frequency and the number of conflicts (rear-end and crossing). All scenarios show a reduction in RLR frequency (-7.8, -45.5, and -52.4%, respectively), but only increasing the yellow signal interval duration results in a reduced total number of conflicts (-11.3%; a surrogate safety measure of possible RLR-related crashes). An RLR camera makes the greatest reduction (-60.9%) in crossing conflicts (a surrogate safety measure of possible angle crashes), whereas increasing the yellow signal interval duration results in only a 12.8% reduction of rear-end conflicts (a surrogate safety measure of possible rear-end crash). Although increasing the yellow signal interval duration is advantageous because this reduces the total conflicts (a possibility of total RLR-related crashes), each countermeasure shows different effects by RLR-related conflict types that can be referred to when making a decision. Given that each intersection has different RLR crash issues, evaluated countermeasures are directly applicable to enhance the cost and time effectiveness, according to the situation of the target intersection. In addition, the proposed methodology is replicable at any site that has a dearth of crash data and/or comparison sites in order to test any other countermeasures (both engineering and enforcement countermeasures) for RLR crashes.

Improving Patient Safety Culture in Primary Care: A Systematic Review.

PubMed

Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

2016-09-01

Patient safety culture, described as shared values, attitudes and behavior of staff in a health-care organization, gained attention as a subject of study as it is believed to be related to the impact of patient safety improvements. However, in primary care, it is yet unknown, which effect interventions have on the safety culture. To review literature on the use of interventions that effect patient safety culture in primary care. Searches were performed in PubMed, EMBASE, CINAHL, and PsychINFO on March 4, 2013. Terms defining safety culture were combined with terms identifying intervention and terms indicating primary care. Inclusion followed if the intervention effected patient safety culture, and effect measures were reported. The search yielded 214 articles from which two were eligible for inclusion. Both studies were heterogeneous in their interventions and outcome; we present a qualitative summary. One study described the implementation of an electronic medical record system in general practices as part of patient safety improvements. The other study facilitated 2 workshops for general practices, one on risk management and another on significant event audit. Results showed signs of improvement, but the level of evidence was low because of the design and methodological problems. These studies in general practice provide a first understanding of improvement strategies and their effect in primary care. As the level of evidence was low, no clear preference can be determined. Further research is needed to help practices make an informed choice for an intervention.

National survey of drinking and driving attitudes and behaviors : 2008. Volume 3, methodology report

DOT National Transportation Integrated Search

2010-08-01

This report presents the details of the methodology used for the 2008 National Survey of Drinking and Driving Attitudes and Behaviors conducted by Gallup, Inc. for : the National Highway Traffic Safety Administration (NHTSA). This survey represents t...

Deployment of a tool for measuring freeway safety performance.

DOT National Transportation Integrated Search

2011-12-01

This project updated and deployed a freeway safety performance measurement tool, building upon a previous project that developed the core methodology. The tool evaluates the cumulative risk over time of an accident or a particular kind of accident. T...

Alcohol and Traffic Safety.

ERIC Educational Resources Information Center

Dickman, Frances Baker, Ed.

1988-01-01

Seven papers discuss current issues and applied social research concerning alcohol traffic safety. Prevention, policy input, methodology, planning strategies, anti-drinking/driving programs, social-programmatic orientations of Mothers Against Drunk Driving, Kansas Driving Under the Influence Law, New Jersey Driving While Impaired Programs,…

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...

Safety belt and motorcycle helmet use in Virginia : the December 2003 update.

DOT National Transportation Integrated Search

2004-01-01

The Virginia Transportation Research Council has been collecting safety belt use data in Virginia since 1974. Beginning in 1992, the data gathering methodology was changed to a statistically valid probability-based sampling plan in accordance with fe...

The Driver Behaviour Questionnaire as accident predictor; A methodological re-meta-analysis.

PubMed

Af Wåhlberg, A E; Barraclough, P; Freeman, J

2015-12-01

The Manchester Driver Behaviour Questionnaire (DBQ) is the most commonly used self-report tool in traffic safety research and applied settings. It has been claimed that the violation factor of this instrument predicts accident involvement, which was supported by a previous meta-analysis. However, that analysis did not test for methodological effects, or include unpublished results. The present study re-analysed studies on prediction of accident involvement from DBQ factors, including lapses, and many unpublished effects. Tests of various types of dissemination bias and common method variance were undertaken. Outlier analysis showed that some effects were probably not reliable data, but excluding them did not change the results. For correlations between violations and crashes, tendencies for published effects to be larger than unpublished ones and for effects to decrease over time were observed, but were not significant. Also, using the mean of accidents as proxy for effect indicated that studies where effects for violations are not reported have smaller effect sizes. These differences indicate dissemination bias. Studies using self-reported accidents as dependent variables had much larger effects than those using recorded accident data. Also, zero-order correlations were larger than partial correlations controlled for exposure. Similarly, violations/accidents effects were strong only when there was also a strong correlation between accidents and exposure. Overall, the true effect is probably very close to zero (r<.07) for violations versus traffic accident involvement, depending upon which tendencies are controlled for. Methodological factors and dissemination bias have inflated the published effect sizes of the DBQ. Strong evidence of various artefactual effects is apparent. A greater level of care should be taken if the DBQ continues to be used in traffic safety research. Also, validation of self-reports should be more comprehensive in the future, taking into account the possibility of common method variance. Copyright © 2015 Elsevier Ltd and National Safety Council. All rights reserved.

Projecting effects of improvements in passive safety of the New Zealand light vehicle fleet.

PubMed

Keall, Michael; Newstead, Stuart; Jones, Wayne

2007-09-01

In the year 2000, as part of the process for setting New Zealand road safety targets, a projection was made for a reduction in social cost of 15.5 percent associated with improvements in crashworthiness, which is a measure of the occupant protection of the light passenger vehicle fleet. Since that document was produced, new estimates of crashworthiness have become available, allowing for a more accurate projection. The objective of this paper is to describe a methodology for projecting changes in casualty rates associated with passive safety features and to apply this methodology to produce a new prediction. The shape of the age distribution of the New Zealand light passenger vehicle fleet was projected to 2010. Projected improvements in crashworthiness and associated reductions in social cost were also modeled based on historical trends. These projections of changes in the vehicle fleet age distribution and of improvements in crashworthiness together provided a basis for estimating the future performance of the fleet in terms of secondary safety. A large social cost reduction of about 22 percent for 2010 compared to the year 2000 was predicted due to the expected huge impact of improvements in passive vehicle features on road trauma in New Zealand. Countries experiencing improvements in their vehicle fleets can also expect significant reductions in road injury compared to a less crashworthy passenger fleet. Such road safety gains can be analyzed using some of the methodology described here.

The effects of organizational commitment and structural empowerment on patient safety culture.

PubMed

Horwitz, Sujin K; Horwitz, Irwin B

2017-03-20

Purpose The purpose of this paper is to investigate the relationship between patient safety culture and two attitudinal constructs: affective organizational commitment and structural empowerment. In doing so, the main and interaction effects of the two constructs on the perception of patient safety culture were assessed using a cohort of physicians. Design/methodology/approach Affective commitment was measured with the Organizational Commitment Questionnaire, whereas structural empowerment was assessed with the Conditions of Work Effectiveness Questionnaire-II. The abbreviated versions of these surveys were administered to a cohort of 71 post-doctoral medical residents. For the data analysis, hierarchical regression analyses were performed for the main and interaction effects of affective commitment and structural empowerment on the perception of patient safety culture. Findings A total of 63 surveys were analyzed. The results revealed that both affective commitment and structural empowerment were positively related to patient safety culture. A potential interaction effect of the two attitudinal constructs on patient safety culture was tested but no such effect was detected. Research limitations/implications This study suggests that there are potential benefits of promoting affective commitment and structural empowerment for patient safety culture in health care organizations. By identifying the positive associations between the two constructs and patient safety culture, this study provides additional empirical support for Kanter's theoretical tenet that structural and organizational support together helps to shape the perceptions of patient safety culture. Originality/value Despite the wide recognition of employee empowerment and commitment in organizational research, there has still been a paucity of empirical studies specifically assessing their effects on patient safety culture in health care organizations. To the authors' knowledge, this study is the first empirical study to examine the relationship between structural empowerment as proposed by Kanter and the culture of patient safety using physicians.

Comparison of two drug safety signals in a pharmacovigilance data mining framework.

PubMed

Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

2016-04-01

Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database. © The Author(s) 2012.

14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

Code of Federal Regulations, 2011 CFR

2011-01-01

... time duration of the turn and must show increments not to exceed one second. The series of tumble turns... FAA will measure any proposed alternative analysis approach. This appendix also identifies the... approach provides an equivalent level of safety. If a Federal launch range performs the launch operator's...

Matrix Game Methodology - Support to V2010 Olympic Marine Security Planners

DTIC Science & Technology

2011-02-01

OMOC was called the Integrated Safety /Security Matrix Game – Marine III, and was held 16-17 June 2009. This was the most extensive and complex of...Protection Matrix Game Marine Two .................................................. 12 3.3 Integrated Safety /Security Matrix Game – Marine III...Integrated Safety /Security Matrix Game – Marine III Scenarios........................... 53 ISSMG Marine III – Team Groupings

K Basin Hazard Analysis

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

PECH, S.H.

This report describes the methodology used in conducting the K Basins Hazard Analysis, which provides the foundation for the K Basins Final Safety Analysis Report. This hazard analysis was performed in accordance with guidance provided by DOE-STD-3009-94, Preparation Guide for U. S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports and implements the requirements of DOE Order 5480.23, Nuclear Safety Analysis Report.

Sociotechnical approaches to workplace safety: Research needs and opportunities.

PubMed

Robertson, Michelle M; Hettinger, Lawrence J; Waterson, Patrick E; Noy, Y Ian; Dainoff, Marvin J; Leveson, Nancy G; Carayon, Pascale; Courtney, Theodore K

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety.

Prioritization methodology for chemical replacement

NASA Technical Reports Server (NTRS)

Goldberg, Ben; Cruit, Wendy; Schutzenhofer, Scott

1995-01-01

This methodology serves to define a system for effective prioritization of efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semi quantitative approach derived from quality function deployment techniques (QFD Matrix). QFD is a conceptual map that provides a method of transforming customer wants and needs into quantitative engineering terms. This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives.

'Emerging technologies for the changing global market' - Prioritization methodology for chemical replacement

NASA Technical Reports Server (NTRS)

Cruit, Wendy; Schutzenhofer, Scott; Goldberg, Ben; Everhart, Kurt

1993-01-01

This project served to define an appropriate methodology for effective prioritization of technology efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semiquantitative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results will be implemented as a guideline for consideration for current NASA propulsion systems.

Title: Studies on drug switchability showed heterogeneity in methodological approaches: a scoping review.

PubMed

Belleudi, Valeria; Trotta, Francesco; Vecchi, Simona; Amato, Laura; Addis, Antonio; Davoli, Marina

2018-05-16

Several drugs share the same therapeutic indication, including those undergoing patent expiration. Concerns on the interchangeability are frequent in clinical practice, challenging the evaluation of switchability through observational research. To conduct a scoping review of observational studies on drug switchability to identify methodological strategies adopted to deal with bias and confounding. We searched PubMed, EMBASE, and Web of Science (updated 1/31/2017) to identify studies evaluating switchability in terms of effectiveness/safety outcomes or compliance. Three reviewers independently screened studies extracting all characteristics. Strategies to address confounding, particularly, previous drug use and switching reasons were considered. All findings were summarized in descriptive analyses. Thirty-two studies, published in the last 10 years, met the inclusion criteria. Epilepsy, cardiovascular and rheumatology were the most frequently represented clinical areas. 75% of the studies reported data on effectiveness/safety outcomes. The most frequent study design was cohort (65.6%) followed by case-control (21.9%) and self-controlled (12.5%). Case-control and case-crossover studies showed homogeneous methodological strategies to deal with bias and confounding. Among cohort studies, the confounding associated with previous drug use was addressed introducing variables in multivariate model (47.3%) or selecting only adherent patients (14.3%). Around 30% of cohort studies did not report reasons for switching. In the remaining 70%, clinical parameters or previous occurrence of outcomes were measured to identify switching connected with lack of effectiveness or adverse events. This study represents a starting point for researchers and administrators who are approaching the investigation and assessment of issues related to interchangeability of drugs. Copyright © 2018. Published by Elsevier Inc.

76 FR 71431 - Civil Penalty Calculation Methodology

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-17

... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Civil Penalty Calculation... is currently evaluating its civil penalty methodology. Part of this evaluation includes a forthcoming... civil penalties. UFA takes into account the statutory penalty factors under 49 U.S.C. 521(b)(2)(D). The...

Methodology Development for Passive Component Reliability Modeling in a Multi-Physics Simulation Environment

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

Aldemir, Tunc; Denning, Richard; Catalyurek, Umit

Reduction in safety margin can be expected as passive structures and components undergo degradation with time. Limitations in the traditional probabilistic risk assessment (PRA) methodology constrain its value as an effective tool to address the impact of aging effects on risk and for quantifying the impact of aging management strategies in maintaining safety margins. A methodology has been developed to address multiple aging mechanisms involving large numbers of components (with possibly statistically dependent failures) within the PRA framework in a computationally feasible manner when the sequencing of events is conditioned on the physical conditions predicted in a simulation environment, suchmore » as the New Generation System Code (NGSC) concept. Both epistemic and aleatory uncertainties can be accounted for within the same phenomenological framework and maintenance can be accounted for in a coherent fashion. The framework accommodates the prospective impacts of various intervention strategies such as testing, maintenance, and refurbishment. The methodology is illustrated with several examples.« less

Landslide hazard analysis for pipelines: The case of the Simonette river crossing

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

Grivas, D.A.; Schultz, B.C.; O`Neil, G.

1995-12-31

The overall objective of this study is to develop a probabilistic methodology to analyze landslide hazards and their effects on the safety of buried pipelines. The methodology incorporates a range of models that can accommodate differences in the ground movement modes and the amount and type of information available at various site locations. Two movement modes are considered, namely (a) instantaneous (catastrophic) slides, and (b) gradual ground movement which may result in cumulative displacements over the pipeline design life (30--40 years) that are in excess of allowable values. Probabilistic analysis is applied in each case to address the uncertainties associatedmore » with important factors that control slope stability. Availability of information ranges from relatively well studied, instrumented installations to cases where data is limited to what can be derived from topographic and geologic maps. The methodology distinguishes between procedures applied where there is little information and those that can be used when relatively extensive data is available. important aspects of the methodology are illustrated in a case study involving a pipeline located in Northern Alberta, Canada, in the Simonette river valley.« less

Hydration: certain basic aspects for developing technical and scientific parameters into the nutrition knowledge

PubMed

Perales-García, Aránzazu; Estévez-Martínez, Isabel; Urrialde, Rafael

2016-07-12

Introduction: Hydration is defined as the water intake coming from food and beverages. Its study has become an area by itself, within the nutrition field. Meaning that in 2010 the European Food Safety Authority (EFSA) approved the water intake recommendations, but the study of this topic implies a rigorous methodology, which represents several issues. Objective: Showing as a glance the main methodological issues in hydration studies. Material and methods: Bibliographic revision of scientific literature. Results: The main methodological issues presented are: sample selection (investigation field and sample design), selection of the method to evaluate hydration status (dilution techniques, bioelectrical impedance, plasmatic and urinary indicators, changes in body composition, water losses and clinic symptoms) selection of the method to evaluate water intake (biomarker, questionnaires, informatics programs, smartphone use, 24-h register, dietary history and food frequency questionnaire), and the main sources of hydration. Conclusions: Hydration status should be understood as a routine model, with daily frequency, according to gender, age, physical activity and environmental conditions. Furthermore, the correct design of the methodology has a special importance in order to take into account all the aspects

An assessment of the safety performance of farm vehicles subject to exemptions under MAP-21.

DOT National Transportation Integrated Search

2016-05-01

This report presents the methodology and findings from an analysis conducted by the Federal Motor Carrier Safety Administrations (FMCSAs) Office of Analysis, Research, and Technology, with support from the Office of Field Operations, in respons...

Integrated Vehicle-Based Safety Systems (IVBSS) Light Vehicle Field Operational Test Independent Evaluation

DOT National Transportation Integrated Search

2011-10-01

This report presents the methodology and results of the independent evaluation of a prototype integrated crash warning system for : light vehicles as part of the Integrated Vehicle-Based Safety Systems initiative of the United States Department of : ...

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Intra-Articular Cellular Therapy for Osteoarthritis and Focal Cartilage Defects of the Knee: A Systematic Review of the Literature and Study Quality Analysis.

PubMed

Chahla, Jorge; Piuzzi, Nicolas S; Mitchell, Justin J; Dean, Chase S; Pascual-Garrido, Cecilia; LaPrade, Robert F; Muschler, George F

2016-09-21

Intra-articular cellular therapy injections constitute an appealing strategy that may modify the intra-articular milieu or regenerate cartilage in the settings of osteoarthritis and focal cartilage defects. However, little consensus exists regarding the indications for cellular therapies, optimal cell sources, methods of preparation and delivery, or means by which outcomes should be reported. We present a systematic review of the current literature regarding the safety and efficacy of cellular therapy delivered by intra-articular injection in the knee that provided a Level of Evidence of III or higher. A total of 420 papers were screened. Methodological quality was assessed using a modified Coleman methodology score. Only 6 studies (4 Level II and 2 Level III) met the criteria to be included in this review; 3 studies were on treatment of osteoarthritis and 3 were on treatment of focal cartilage defects. These included 4 randomized controlled studies without blinding, 1 prospective cohort study, and 1 retrospective therapeutic case-control study. The studies varied widely with respect to cell sources, cell characterization, adjuvant therapies, and assessment of outcomes. Outcome was reported in a total of 300 knees (124 in the osteoarthritis studies and 176 in the cartilage defect studies). Mean follow-up was 21.0 months (range, 12 to 36 months). All studies reported improved outcomes with intra-articular cellular therapy and no major adverse events. The mean modified Coleman methodology score was 59.1 ± 16 (range, 32 to 82). The studies of intra-articular cellular therapy injections for osteoarthritis and focal cartilage defects in the human knee suggested positive results with respect to clinical improvement and safety. However, the improvement was modest and a placebo effect cannot be disregarded. The overall quality of the literature was poor, and the methodological quality was fair, even among Level-II and III studies. Effective clinical assessment and optimization of injection therapies will demand greater attention to study methodology, including blinding; standardized quantitative methods for cell harvesting, processing, characterization, and delivery; and standardized reporting of clinical and structural outcomes. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

A systems-based food safety evaluation: an experimental approach.

PubMed

Higgins, Charles L; Hartfield, Barry S

2004-11-01

Food establishments are complex systems with inputs, subsystems, underlying forces that affect the system, outputs, and feedback. Building on past exploration of the hazard analysis critical control point concept and Ludwig von Bertalanffy General Systems Theory, the National Park Service (NPS) is attempting to translate these ideas into a realistic field assessment of food service establishments and to use information gathered by these methods in efforts to improve food safety. Over the course of the last two years, an experimental systems-based methodology has been drafted, developed, and tested by the NPS Public Health Program. This methodology is described in this paper.

Color-coding and human factors engineering to improve patient safety characteristics of paper-based emergency department clinical documentation.

PubMed

Kobayashi, Leo; Boss, Robert M; Gibbs, Frantz J; Goldlust, Eric; Hennedy, Michelle M; Monti, James E; Siegel, Nathan A

2011-01-01

Investigators studied an emergency department (ED) physical chart system and identified inconsistent, small font labeling; a single-color scheme; and an absence of human factors engineering (HFE) cues. A case study and description of the methodology with which surrogate measures of chart-related patient safety were studied and subsequently used to reduce latent hazards are presented. Medical records present a challenge to patient safety in EDs. Application of HFE can improve specific aspects of existing medical chart organization systems as they pertain to patient safety in acute care environments. During 10 random audits over 5 consecutive days (573 data points), 56 (9.8%) chart binders (range 0.0-23%) were found to be either misplaced or improperly positioned relative to other chart binders; 12 (21%) were in the critical care area. HFE principles were applied to develop an experimental chart binder system with alternating color-based chart groupings, simple and prominent identifiers, and embedded visual cues. Post-intervention audits revealed significant reductions in chart binder location problems overall (p < 0.01), for Urgent Care A and B pods (6.4% to 1.2%; p < 0.05), Fast Track C pod (19.3% to 0.0%; p < 0.05) and Behavioral/Substance Abuse D pod (15.7% to 0.0%; p < 0.05) areas of the ED. The critical care room area did not display an improvement (11.4% to 13.2%; p = 0.40). Application of HFE methods may aid the development, assessment, and modification of acute care clinical environments through evidence-based design methodologies and contribute to safe patient care delivery.

Space-planning and structural solutions of low-rise buildings: Optimal selection methods

NASA Astrophysics Data System (ADS)

Gusakova, Natalya; Minaev, Nikolay; Filushina, Kristina; Dobrynina, Olga; Gusakov, Alexander

2017-11-01

The present study is devoted to elaboration of methodology used to select appropriately the space-planning and structural solutions in low-rise buildings. Objective of the study is working out the system of criteria influencing the selection of space-planning and structural solutions which are most suitable for low-rise buildings and structures. Application of the defined criteria in practice aim to enhance the efficiency of capital investments, energy and resource saving, create comfortable conditions for the population considering climatic zoning of the construction site. Developments of the project can be applied while implementing investment-construction projects of low-rise housing at different kinds of territories based on the local building materials. The system of criteria influencing the optimal selection of space-planning and structural solutions of low-rise buildings has been developed. Methodological basis has been also elaborated to assess optimal selection of space-planning and structural solutions of low-rise buildings satisfying the requirements of energy-efficiency, comfort and safety, and economical efficiency. Elaborated methodology enables to intensify the processes of low-rise construction development for different types of territories taking into account climatic zoning of the construction site. Stimulation of low-rise construction processes should be based on the system of approaches which are scientifically justified; thus it allows enhancing energy efficiency, comfort, safety and economical effectiveness of low-rise buildings.

Attendance and Substance Use Outcomes for the Seeking Safety Program: Sometimes Less Is More

ERIC Educational Resources Information Center

Hien, Denise A.; Morgan-Lopez, Antonio A.; Campbell, Aimee N. C.; Saavedra, Lissette M.; Wu, Elwin; Cohen, Lisa; Ruglass, Lesia; Nunes, Edward V.

2012-01-01

Objective: This study uses data from the largest effectiveness trial to date on treatment of co-occurring posttraumatic stress and substance use disorders, using advances in statistical methodology for modeling treatment attendance and membership turnover in rolling groups. Method: Women receiving outpatient substance abuse treatment (N = 353)…

Pressures, Stresses, Anxieties, and On-Job Safety of the School Superintendent.

ERIC Educational Resources Information Center

Chand, Krishan

Identification of the causes of job stress for public school superintendents, with a focus on personal-experiential and task variables, is the purpose of this study. Methodology involved a mail survey of 1,531 randomly selected superintendents. Canonical correlation analysis (CCA) and multiple regression correlation (MCR) analysis were used to…

Report of an exploratory study: Safety and liability considerations for photovoltaic modules/panels

NASA Technical Reports Server (NTRS)

Weinstein, A. S.; Meeker, D. G.

1981-01-01

An overview of legal issues as they apply to design, manufacture and use of photovoltaic module/array devices is provided and a methodology is suggested for use of the design stage of these products to minimize or eliminate perceived hazards. Questions are posed to stimulate consideration of this area.

Collaboration and patient safety at an emergency department - a qualitative case study.

PubMed

Pedersen, Anna Helene Meldgaard; Rasmussen, Kurt; Grytnes, Regine; Nielsen, Kent Jacob

2018-03-19

Purpose The purpose of this paper is to examine how conflicts about collaboration between staff at different departments arose during the establishment of a new emergency department and how these conflicts affected the daily work and ultimately patient safety at the emergency department. Design/methodology/approach This qualitative single case study draws on qualitative semi-structured interviews and participant observation. The theoretical concepts "availability" and "receptiveness" as antecedents for collaboration will be applied in the analysis. Findings Close collaboration between departments was an essential precondition for the functioning of the new emergency department. The study shows how a lack of antecedents for collaboration affected the working relation and communication between employees and departments, which spurred negative feelings and reproduced conflicts. This situation was seen as a potential threat for the safety of the emergency patients. Research limitations/implications This study presents a single case study, at a specific point in time, and should be used as an illustrative example of how contextual and situational factors affect the working environment and through that patient safety. Originality/value Few studies provide an in-depth investigation of what actually takes place when collaboration between professional groups goes wrong and escalates, and how problems in collaboration may affect patient safety.

Influence of organizational factors on safety

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

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

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

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2012 CFR

2012-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

10 CFR 851.21 - Hazard identification and assessment.

Code of Federal Regulations, 2011 CFR

2011-01-01

.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety..., biological, and safety workplace hazards using recognized exposure assessment and testing methodologies and... hazards and the established controls within 90 days after identifying such hazards. The Head of DOE Field...

Safety of railroad passenger vehicle dynamics : OMNISIM simulation and test correlations for passenger rail cars

DOT National Transportation Integrated Search

2002-07-01

The purpose of the work is to validate the safety assessment methodology previously developed for passenger rail vehicle dynamics, which requires the application of simulation tools as well as testing of vehicles under different track scenarios. This...

Developing a Methodology for Eliciting Subjective Probability Estimates During Expert Evaluations of Safety Interventions: Application for Bayesian Belief Networks

NASA Technical Reports Server (NTRS)

Wiegmann, Douglas A.a

2005-01-01

The NASA Aviation Safety Program (AvSP) has defined several products that will potentially modify airline and/or ATC operations, enhance aircraft systems, and improve the identification of potential hazardous situations within the National Airspace System (NAS). Consequently, there is a need to develop methods for evaluating the potential safety benefit of each of these intervention products so that resources can be effectively invested to produce the judgments to develop Bayesian Belief Networks (BBN's) that model the potential impact that specific interventions may have. Specifically, the present report summarizes methodologies for improving the elicitation of probability estimates during expert evaluations of AvSP products for use in BBN's. The work involved joint efforts between Professor James Luxhoj from Rutgers University and researchers at the University of Illinois. The Rutgers' project to develop BBN's received funding by NASA entitled "Probabilistic Decision Support for Evaluating Technology Insertion and Assessing Aviation Safety System Risk." The proposed project was funded separately but supported the existing Rutgers' program.

Joint Test Protocol: Environmentally Friendly Zirconium Oxide Pretreatment Demonstration

DTIC Science & Technology

2013-12-01

coatings . Loss of paint adhesion is the primary failure mode on aluminum and steel. 3.7.3 Test Methodology The test methodology for pencil hardness...conversion pretreatment coatings . Loss of paint adhesion is the primary failure mode on aluminum and steel. 3.8.3 Test Methodology The test...SUPPLEMENTARY NOTES 14. ABSTRACT There is a need to implement innovative and cost- effective replacement technologies to address the multiple health, safety

Exposure to fall hazards and safety climate in the aircraft maintenance industry.

PubMed

Neitzel, Richard L; Seixas, Noah S; Harris, Michael J; Camp, Janice

2008-01-01

Falls represent a significant occupational hazard, particularly in industries with dynamic work environments. This paper describes rates of noncompliance with fall hazard prevention requirements, perceived safety climate and worker knowledge and beliefs, and the association between fall exposure and safety climate measures in commercial aircraft maintenance activities. Walkthrough observations were conducted on aircraft mechanics at two participating facilities (Sites A and B) to ascertain the degree of noncompliance. Mechanics at each site completed questionnaires concerning fall hazard knowledge, personal safety beliefs, and safety climate. Questionnaire results were summarized into safety climate and belief scores by workgroup and site. Noncompliance rates observed during walkthroughs were compared to the climate-belief scores, and were expected to be inversely associated. Important differences were seen in fall safety performance between the sites. The study provided a characterization of aircraft maintenance fall hazards, and also demonstrated the effectiveness of an objective hazard assessment methodology. Noncompliance varied by height, equipment used, location of work on the aircraft, shift, and by safety system. Although the expected relationship between safety climate and noncompliance was seen for site-average climate scores, workgroups with higher safety climate scores had greater observed noncompliance within Site A. Overall, use of engineered safety systems had a significant impact on working safely, while safety beliefs and climate also contributed, though inconsistently. The results of this study indicate that safety systems are very important in reducing noncompliance with fall protection requirements in aircraft maintenance facilities. Site-level fall safety compliance was found to be related to safety climate, although an unexpected relationship between compliance and safety climate was seen at the workgroup level within site. Finally, observed fall safety compliance was found to differ from self-reported compliance.

Correlation between safety climate and contractor safety assessment programs in construction

PubMed Central

Sparer, EH1; Murphy, LA; Taylor, KM; Dennerlein, Jt

2015-01-01

Background Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Methods 401 construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. Results There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers’ safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. Conclusions A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. PMID:24038403

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma.

PubMed

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-09-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans.

Feasibility and Safety of RNA-transfected CD20-specific Chimeric Antigen Receptor T Cells in Dogs with Spontaneous B Cell Lymphoma

PubMed Central

Panjwani, M Kazim; Smith, Jenessa B; Schutsky, Keith; Gnanandarajah, Josephine; O'Connor, Colleen M; Powell, Daniel J; Mason, Nicola J

2016-01-01

Preclinical murine models of chimeric antigen receptor (CAR) T cell therapy are widely applied, but are greatly limited by their inability to model the complex human tumor microenvironment and adequately predict safety and efficacy in patients. We therefore sought to develop a system that would enable us to evaluate CAR T cell therapies in dogs with spontaneous cancers. We developed an expansion methodology that yields large numbers of canine T cells from normal or lymphoma-diseased dogs. mRNA electroporation was utilized to express a first-generation canine CD20-specific CAR in expanded T cells. The canine CD20 (cCD20) CAR expression was efficient and transient, and electroporated T cells exhibited antigen-specific interferon-gamma (IFN-γ) secretion and lysed cCD20+ targets. In a first-in-canine study, autologous cCD20-ζ CAR T cells were administered to a dog with relapsed B cell lymphoma. Treatment was well tolerated and led to a modest, but transient, antitumor activity, suggesting that stable CAR expression will be necessary for durable clinical remissions. Our study establishes the methodologies necessary to evaluate CAR T cell therapy in dogs with spontaneous malignancies and lays the foundation for use of outbred canine cancer patients to evaluate the safety and efficacy of next-generation CAR therapies and their optimization prior to translation into humans. PMID:27401141

Concerns related to Safety Management of Engineered Nanomaterials in research environment

NASA Astrophysics Data System (ADS)

Groso, A.; Meyer, Th

2013-04-01

Since the rise of occupational safety and health research on nanomaterials a lot of progress has been made in generating health effects and exposure data. However, when detailed quantitative risk analysis is in question, more research is needed, especially quantitative measures of workers exposure and standards to categorize toxicity/hazardousness data. In the absence of dose-response relationships and quantitative exposure measurements, control banding (CB) has been widely adopted by OHS community as a pragmatic tool in implementing a risk management strategy based on a precautionary approach. Being in charge of health and safety in a Swiss university, where nanomaterials are largely used and produced, we are also faced with the challenge related to nanomaterials' occupational safety. In this work, we discuss the field application of an in-house risk management methodology similar to CB as well as some other methodologies. The challenges and issues related to the process will be discussed. Since exact data on nanomaterials hazardousness are missing for most of the situations, we deduce that the outcome of the analysis for a particular process is essentially the same with a simple methodology that determines only exposure potential and the one taking into account the hazardousness of ENPs. It is evident that when reliable data on hazardousness factors (as surface chemistry, solubility, carcinogenicity, toxicity etc.) will be available, more differentiation will be possible in determining the risk for different materials. On the protective measures side, all CB methodologies are inclined to overprotection side, only that some of them suggest comprehensive protective/preventive measures and others remain with basic advices. The implementation and control of protective measures in research environment will also be discussed.

77 FR 52110 - Agency Response to Public Comments of Safety Measurement System Changes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... University of Michigan Transportation Research Institute ( http://csa.fmcsa.dot.gov/Documents/Evaluation-of... the revised methodology have a 3.9% greater future crash rate and 3.6% greater future HM violation rate than those previously identified for intervention using the existing SMS methodology. Details...

Evaluation of a Propolis Water Extract Using a Reliable RP-HPLC Methodology and In Vitro and In Vivo Efficacy and Safety Characterisation

PubMed Central

Rocha, Bruno Alves; Bueno, Paula Carolina Pires; Vaz, Mirela Mara de Oliveira Lima Leite; Nascimento, Andresa Piacezzi; Ferreira, Nathália Ursoli; Moreno, Gabriela de Padua; Rodrigues, Marina Rezende; Costa-Machado, Ana Rita de Mello; Barizon, Edna Aparecida; Campos, Jacqueline Costa Lima; de Oliveira, Pollyanna Francielli; Acésio, Nathália de Oliveira; Martins, Sabrina de Paula Lima; Tavares, Denise Crispim; Berretta, Andresa Aparecida

2013-01-01

Since the beginning of propolis research, several groups have studied its antibacterial, antifungal, and antiviral properties. However, most of these studies have only employed propolis ethanolic extract (PEE) leading to little knowledge about the biological activities of propolis water extract (PWE). Based on this, in a previous study, we demonstrated the anti-inflammatory and immunomodulatory activities of PWE. In order to better understand the equilibrium between effectiveness and toxicity, which is essential for a new medicine, the characteristics of PWE were analyzed. We developed and validated an RP-HPLC method to chemically characterize PWE and PEE and evaluated the in vitro antioxidant/antimicrobial activity for both extracts and the safety of PWE via determining genotoxic potential using in vitro and in vivo mammalian micronucleus assays. We have concluded that the proposed analytical methodology was reliable, and both extracts showed similar chemical composition. The extracts presented antioxidant and antimicrobial effects, while PWE demonstrated higher antioxidant activity and more efficacious for the most of the microorganisms tested than PEE. Finally, PWE was shown to be safe using micronucleus assays. PMID:23710228

Enhancing and generalizing the two-level screening approach incorporating the Highway Safety Manual (HSM) methods, phase 2.

DOT National Transportation Integrated Search

2016-04-01

This project aims at developing a novel methodology to identify traffic safety hotspots and hot zones for at the macroscopic : and microscopic levels. In order to achieve these objectives, the following tasks were performed. The research team : follo...

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool.

PubMed

Ho, Robin S T; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel Y S; Chung, Vincent C H

2015-01-08

Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. To assess the methodological quality of MAs on COPD treatments. A cross-sectional study on MAs of COPD trials. MAs published during 2000-2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods.

Methodological quality of meta-analyses on treatments for chronic obstructive pulmonary disease: a cross-sectional study using the AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool

PubMed Central

Ho, Robin ST; Wu, Xinyin; Yuan, Jinqiu; Liu, Siya; Lai, Xin; Wong, Samuel YS; Chung, Vincent CH

2015-01-01

Background: Meta-analysis (MA) of randomised trials is considered to be one of the best approaches for summarising high-quality evidence on the efficacy and safety of treatments. However, methodological flaws in MAs can reduce the validity of conclusions, subsequently impairing the quality of decision making. Aims: To assess the methodological quality of MAs on COPD treatments. Methods: A cross-sectional study on MAs of COPD trials. MAs published during 2000–2013 were sampled from the Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Methodological quality was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. Results: Seventy-nine MAs were sampled. Only 18% considered the scientific quality of primary studies when formulating conclusions and 49% used appropriate meta-analytic methods to combine findings. The problems were particularly acute among MAs on pharmacological treatments. In 48% of MAs the authors did not report conflict of interest. Fifty-eight percent reported harmful effects of treatment. Publication bias was not assessed in 65% of MAs, and only 10% had searched non-English databases. Conclusions: The methodological quality of the included MAs was disappointing. Consideration of scientific quality when formulating conclusions should be made explicit. Future MAs should improve on reporting conflict of interest and harm, assessment of publication bias, prevention of language bias and use of appropriate meta-analytic methods. PMID:25569783

Ergonomic initiatives at Inmetro: measuring occupational health and safety.

PubMed

Drucker, L; Amaral, M; Carvalheira, C

2012-01-01

This work studies biomechanical hazards to which the workforce of Instituto Nacional de Metrologia, Qualidade e Tecnologia Industrial (Inmetro) is exposed. It suggests a model for ergonomic evaluation of work, based on the concepts of resilience engineering which take into consideration the institute's ability to manage risk and deal with its consequences. Methodology includes the stages of identification, inventory, analysis, and risk management. Diagnosis of the workplace uses as parameters the minimal criteria stated in Brazilian legislation. The approach has several prospectives and encompasses the points of view of public management, safety engineering, physical therapy and ergonomics-oriented design. The suggested solution integrates all aspects of the problem: biological, psychological, sociological and organizational. Results obtained from a pilot Project allow to build a significant sample of Inmetro's workforce, identifying problems and validating the methodology employed as a tool to be applied to the whole institution. Finally, this work intends to draw risk maps and support goals and methods based on resiliency engineering to assess environmental and ergonomic risk management.

The use of mental models in chemical risk protection: developing a generic workplace methodology.

PubMed

Cox, Patrick; Niewöhmer, Jörg; Pidgeon, Nick; Gerrard, Simon; Fischhoff, Baruch; Riley, Donna

2003-04-01

We adopted a comparative approach to evaluate and extend a generic methodology to analyze the different sets of beliefs held about chemical hazards in the workplace. Our study mapped existing knowledge structures about the risks associated with the use of perchloroethylene and rosin-based solder flux in differing workplaces. "Influence diagrams" were used to represent beliefs held by chemical experts; "user models" were developed from data elicited from open-ended interviews with the workplace users of the chemicals. The juxtaposition of expert and user understandings of chemical risks enabled us to identify knowledge gaps and misunderstandings and to reinforce appropriate sets of safety beliefs and behavior relevant to chemical risk communications. By designing safety information to be more relevant to the workplace context of users, we believe that employers and employees may gain improved knowledge about chemical hazards in the workplace, such that better chemical risk management, self-protection, and informed decision making develop over time.

Progressive failure methodologies for predicting residual strength and life of laminated composites

NASA Technical Reports Server (NTRS)

Harris, Charles E.; Allen, David H.; Obrien, T. Kevin

1991-01-01

Two progressive failure methodologies currently under development by the Mechanics of Materials Branch at NASA Langley Research Center are discussed. The damage tolerance/fail safety methodology developed by O'Brien is an engineering approach to ensuring adequate durability and damage tolerance by treating only delamination onset and the subsequent delamination accumulation through the laminate thickness. The continuum damage model developed by Allen and Harris employs continuum damage laws to predict laminate strength and life. The philosophy, mechanics framework, and current implementation status of each methodology are presented.

Ergonomics, safety, and resilience in the helicopter offshore transportation system of Campos Basin.

PubMed

Gomes, José Orlando; Huber, Gilbert J; Borges, Marcos R S; de Carvalho, Paulo Victor R

2015-01-01

Air transportation of personnel to offshore oil platforms is one of the major hazards of this kind of endeavor. Pilot performance is a key factor in the safety of the transportation system. This study seeks to identify the ergonomic factors present in pilots' activities that may in some way compromise or enhance their performance, the constraints and affordances which they are subject to; and where possible to link these to their associated risk factors. Methodology adopted in this project studies work in its context. It is a merging of Activity Analysis (Guerin et al. 2001) of European tradition with Cognitive Task Analysis (CTA - www.ctaresource.com) articulated with the recent approaches to cognitive systems engineering developed by Professors David Woods and Erik Hollnagel. Fifty-five hours of field interviews provided the input for analysis. Sixteen ergonomic constraints were identified, some cognitive, some physical, all considered relevant by the research subjects and expert advisers. Although the safety record of the personnel transportation system studied is considered acceptable, there is low hanging fruit to be picked which can help improve the system's safety.

The health and safety concerns of immigrant women workers in the Toronto sportswear industry.

PubMed

Gannagé, C M

1999-01-01

Immigrant women's conditions of work have worsened with new government and managerial strategies to restructure the Canadian apparel industry. Changes in occupational health and safety legislation have both given and taken away tools that immigrant women workers could use to improve the quality of their working lives. The author outlines a methodology for eliciting the health and safety concerns of immigrant women workers.

Researching safety culture: deliberative dialogue with a restorative lens.

PubMed

Lorenzini, Elisiane; Oelke, Nelly D; Marck, Patricia Beryl; Dall'agnol, Clarice Maria

2017-10-01

Safety culture is a key component of patient safety. Many patient safety strategies in health care have been adapted from high-reliability organizations (HRO) such as aviation. However, to date, attempts to transform the cultures of health care settings through HRO approaches have had mixed results. We propose a methodological approach for safety culture research, which integrates the theory and practice of restoration science with the principles and methods of deliberative dialogue to support active engagement in critical reflection and collective debate. Our aim is to describe how these two innovative approaches in health services research can be used together to provide a comprehensive effective method to study and implement change in safety culture. Restorative research in health care integrates socio-ecological theory of complex adaptive systems concepts with collaborative, place-sensitive study of local practice contexts. Deliberative dialogue brings together all stakeholders to collectively develop solutions on an issue to facilitate change. Together these approaches can be used to actively engage people in the study of safety culture to gain a better understanding of its elements. More importantly, we argue that the synergistic use of these approaches offers enhanced potential to move health care professionals towards actionable strategies to improve patient safety within today's complex health care systems. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

SU-E-T-785: Using Systems Engineering to Design HDR Skin Treatment Operation for Small Lesions to Enhance Patient Safety

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

Saw, C; Baikadi, M; Peters, C

2015-06-15

Purpose: Using systems engineering to design HDR skin treatment operation for small lesions using shielded applicators to enhance patient safety. Methods: Systems engineering is an interdisciplinary field that offers formal methodologies to study, design, implement, and manage complex engineering systems as a whole over their life-cycles. The methodologies deal with human work-processes, coordination of different team, optimization, and risk management. The V-model of systems engineering emphasize two streams, the specification and the testing streams. The specification stream consists of user requirements, functional requirements, and design specifications while the testing on installation, operational, and performance specifications. In implementing system engineering tomore » this project, the user and functional requirements are (a) HDR unit parameters be downloaded from the treatment planning system, (b) dwell times and positions be generated by treatment planning system, (c) source decay be computer calculated, (d) a double-check system of treatment parameters to comply with the NRC regulation. These requirements are intended to reduce human intervention to improve patient safety. Results: A formal investigation indicated that the user requirements can be satisfied. The treatment operation consists of using the treatment planning system to generate a pseudo plan that is adjusted for different shielded applicators to compute the dwell times. The dwell positions, channel numbers, and the dwell times are verified by the medical physicist and downloaded into the HDR unit. The decayed source strength is transferred to a spreadsheet that computes the dwell times based on the type of applicators and prescribed dose used. Prior to treatment, the source strength, dwell times, dwell positions, and channel numbers are double-checked by the radiation oncologist. No dosimetric parameters are manually calculated. Conclusion: Systems engineering provides methodologies to effectively design the HDR treatment operation that minimize human intervention and improve patient safety.« less

Sociotechnical approaches to workplace safety: Research needs and opportunities

PubMed Central

Robertson, Michelle M.; Hettinger, Lawrence J.; Waterson, Patrick E.; Ian Noy, Y.; Dainoff, Marvin J.; Leveson, Nancy G.; Carayon, Pascale; Courtney, Theodore K.

2015-01-01

The sociotechnical systems perspective offers intriguing and potentially valuable insights into problems associated with workplace safety. While formal sociotechnical systems thinking originated in the 1950s, its application to the analysis and design of sustainable, safe working environments has not been fully developed. To that end, a Hopkinton Conference was organised to review and summarise the state of knowledge in the area and to identify research priorities. A group of 26 international experts produced collaborative articles for this special issue of Ergonomics, and each focused on examining a key conceptual, methodological and/or theoretical issue associated with sociotechnical systems and safety. In this concluding paper, we describe the major conference themes and recommendations. These are organised into six topic areas: (1) Concepts, definitions and frameworks, (2) defining research methodologies, (3) modelling and simulation, (4) communications and decision-making, (5) sociotechnical attributes of safe and unsafe systems and (6) potential future research directions for sociotechnical systems research. Practitioner Summary: Sociotechnical complexity, a characteristic of many contemporary work environments, presents potential safety risks that traditional approaches to workplace safety may not adequately address. In this paper, we summarise the investigations of a group of international researchers into questions associated with the application of sociotechnical systems thinking to improve worker safety. PMID:25728246

Making the Hubble Space Telescope servicing mission safe

NASA Technical Reports Server (NTRS)

Bahr, N. J.; Depalo, S. V.

1992-01-01

The implementation of the HST system safety program is detailed. Numerous safety analyses are conducted through various phases of design, test, and fabrication, and results are presented to NASA management for discussion during dedicated safety reviews. Attention is given to the system safety assessment and risk analysis methodologies used, i.e., hazard analysis, fault tree analysis, and failure modes and effects analysis, and to how they are coupled with engineering and test analysis for a 'synergistic picture' of the system. Some preliminary safety analysis results, showing the relationship between hazard identification, control or abatement, and finally control verification, are presented as examples of this safety process.

A methodology for model-based development and automated verification of software for aerospace systems

NASA Astrophysics Data System (ADS)

Martin, L.; Schatalov, M.; Hagner, M.; Goltz, U.; Maibaum, O.

Today's software for aerospace systems typically is very complex. This is due to the increasing number of features as well as the high demand for safety, reliability, and quality. This complexity also leads to significant higher software development costs. To handle the software complexity, a structured development process is necessary. Additionally, compliance with relevant standards for quality assurance is a mandatory concern. To assure high software quality, techniques for verification are necessary. Besides traditional techniques like testing, automated verification techniques like model checking become more popular. The latter examine the whole state space and, consequently, result in a full test coverage. Nevertheless, despite the obvious advantages, this technique is rarely yet used for the development of aerospace systems. In this paper, we propose a tool-supported methodology for the development and formal verification of safety-critical software in the aerospace domain. The methodology relies on the V-Model and defines a comprehensive work flow for model-based software development as well as automated verification in compliance to the European standard series ECSS-E-ST-40C. Furthermore, our methodology supports the generation and deployment of code. For tool support we use the tool SCADE Suite (Esterel Technology), an integrated design environment that covers all the requirements for our methodology. The SCADE Suite is well established in avionics and defense, rail transportation, energy and heavy equipment industries. For evaluation purposes, we apply our approach to an up-to-date case study of the TET-1 satellite bus. In particular, the attitude and orbit control software is considered. The behavioral models for the subsystem are developed, formally verified, and optimized.

Impact of reconstruction strategies on system performance measures : maximizing safety and mobility while minimizing life-cycle costs : final report, December 8, 2008.

DOT National Transportation Integrated Search

2008-12-08

The objective of this research is to develop a general methodological framework for planning and : evaluating the effectiveness of highway reconstruction strategies on the systems performance : measures, in particular safety, mobility, and the tot...

Drug research methodology. Volume 2, The identification of drugs of interest in highway safety

DOT National Transportation Integrated Search

1980-03-01

This report presents findings of a workshop on the identification of drugs that should be the focus of near-term highway safety research. Drugs of interest are those that have a potential to increase the likelihood of traffic crashes and their attend...

The Failure of Zero Tolerance

ERIC Educational Resources Information Center

Skiba, Russell J.

2014-01-01

There is no doubt that the safety of children in schools and in communities is paramount. Incidents of school violence in the United States have motivated researchers and practitioners to explore and employ effective methodologies and strategies to promote safety in classrooms and schools. Still, issues of disruptive behavior top the list of…

ADA access to passenger vessels : finding safety equivalence solutions for weathertight doors with coamings : Phase 2 : a risk management approach to reconfiguration design solutions

DOT National Transportation Integrated Search

2005-03-01

This report examines a risk management methodology to provide for both marine safety and disability access at weathertight doors into passenger accommodation spaces on U.S. passenger vessels. The Architectural and Transportation Barriers Compliance B...

Systematic Review of Breastfeeding and Herbs

PubMed Central

Budzynska, Katarzyna; Gardner, Zoë E.; Dugoua, Jean-Jacques; Low Dog, Tieraona

2012-01-01

Abstract Objectives Despite popular and historical use, there has been little modern research conducted to determine the safety and efficacy of herb use during breastfeeding. The purpose of this study was to systematically review the clinical literature on herbal medicine and lactation. Methods The databases PubMed, CAB Abstracts, Cochrane Central Register of Controlled Trials, HealthSTAR, Cumulative Index to Nursing and Allied Health Literature, and Reprotox were systematically searched for human trials from 1970 until 2010. Reference lists from relevant articles were hand-searched. Results Thirty-two studies met the inclusion criteria. Clinical studies were divided into three categories: survey studies (n=11), safety studies (n=8), and efficacy studies (n=13). Six studies were randomized controlled trials. The most common herbs studied were St. John's wort (Hypericum perforatum L.) (n=3), garlic (Allium sativum L.) extract (n=2), and senna (Cassia senna L.) (n=2). Studies were very heterogeneous with regard to study design, herbal intervention, and outcome measures. Overall, poor methodological quality predominated among the studies. Conclusions Our review concludes that further research is needed to assess the prevalence, efficacy, and safety of commonly used herbs during breastfeeding. PMID:22686865

Discrete Abstractions of Hybrid Systems: Verification of Safety and Application to User-Interface Design

NASA Technical Reports Server (NTRS)

Oishi, Meeko; Tomlin, Claire; Degani, Asaf

2003-01-01

Human interaction with complex hybrid systems involves the user, the automation's discrete mode logic, and the underlying continuous dynamics of the physical system. Often the user-interface of such systems displays a reduced set of information about the entire system. In safety-critical systems, how can we identify user-interface designs which do not have adequate information, or which may confuse the user? Here we describe a methodology, based on hybrid system analysis, to verify that a user-interface contains information necessary to safely complete a desired procedure or task. Verification within a hybrid framework allows us to account for the continuous dynamics underlying the simple, discrete representations displayed to the user. We provide two examples: a car traveling through a yellow light at an intersection and an aircraft autopilot in a landing/go-around maneuver. The examples demonstrate the general nature of this methodology, which is applicable to hybrid systems (not fully automated) which have operational constraints we can pose in terms of safety. This methodology differs from existing work in hybrid system verification in that we directly account for the user's interactions with the system.

Safety impact of engineering treatments on undivided rural roads.

PubMed

Pérez, I

2006-01-01

This article presents an evaluation of the safety impacts of four engineering treatments implemented in the Autonomous Community of Madrid (Spain): highway upgrading; updating and improvement of traffic signing; repainting of pavement markings and pavement resurfacings. This evaluation was carried out using the Empirical Bayes method with a comparison group. The functioning of a methodology to test the significance of the safety impact is described. The results show that highway upgrading has a positive and significant safety impact, while the updating and improvement of traffic signing, the repainting of road markings and pavement resurfacings do not exhibit a significant impact on safety.

Influence Map Methodology for Evaluating Systemic Safety Issues

NASA Technical Reports Server (NTRS)

2008-01-01

"Raising the bar" in safety performance is a critical challenge for many organizations, including Kennedy Space Center. Contributing-factor taxonomies organize information about the reasons accidents occur and therefore are essential elements of accident investigations and safety reporting systems. Organizations must balance efforts to identify causes of specific accidents with efforts to evaluate systemic safety issues in order to become more proactive about improving safety. This project successfully addressed the following two problems: (1) methods and metrics to support the design of effective taxonomies are limited and (2) influence relationships among contributing factors are not explicitly modeled within a taxonomy.

A methodology for overall consequence modeling in chemical industry.

PubMed

Arunraj, N S; Maiti, J

2009-09-30

Risk assessment in chemical process industry is a very important issue for safeguarding human and the ecosystem from damages caused to them. Consequence assessment is an integral part of risk assessment. However, the commonly used consequence estimation methods involve time-consuming complex mathematical models and simple assimilation of losses without considering all the consequence factors. This lead to the deterioration of quality of estimated risk value. So, the consequence modeling has to be performed in detail considering all major losses with optimal time to improve the decisive value of risk. The losses can be broadly categorized into production loss, assets loss, human health and safety loss, and environment loss. In this paper, a conceptual framework is developed to assess the overall consequence considering all the important components of major losses. Secondly, a methodology is developed for the calculation of all the major losses, which are normalized to yield the overall consequence. Finally, as an illustration, the proposed methodology is applied to a case study plant involving benzene extraction. The case study result using the proposed consequence assessment scheme is compared with that from the existing methodologies.

Management of the aging of critical safety-related concrete structures in light-water reactor plants

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

Naus, D.J.; Oland, C.B.; Arndt, E.G.

1990-01-01

The Structural Aging Program has the overall objective of providing the USNRC with an improved basis for evaluating nuclear power plant safety-related structures for continued service. The program consists of a management task and three technical tasks: materials property data base, structural component assessment/repair technology, and quantitative methodology for continued-service determinations. Objectives, accomplishments, and planned activities under each of these tasks are presented. Major program accomplishments include development of a materials property data base for structural materials as well as an aging assessment methodology for concrete structures in nuclear power plants. Furthermore, a review and assessment of inservice inspection techniquesmore » for concrete materials and structures has been complete, and work on development of a methodology which can be used for performing current as well as reliability-based future condition assessment of concrete structures is well under way. 43 refs., 3 tabs.« less

Time series modeling in traffic safety research.

PubMed

Lavrenz, Steven M; Vlahogianni, Eleni I; Gkritza, Konstantina; Ke, Yue

2018-08-01

The use of statistical models for analyzing traffic safety (crash) data has been well-established. However, time series techniques have traditionally been underrepresented in the corresponding literature, due to challenges in data collection, along with a limited knowledge of proper methodology. In recent years, new types of high-resolution traffic safety data, especially in measuring driver behavior, have made time series modeling techniques an increasingly salient topic of study. Yet there remains a dearth of information to guide analysts in their use. This paper provides an overview of the state of the art in using time series models in traffic safety research, and discusses some of the fundamental techniques and considerations in classic time series modeling. It also presents ongoing and future opportunities for expanding the use of time series models, and explores newer modeling techniques, including computational intelligence models, which hold promise in effectively handling ever-larger data sets. The information contained herein is meant to guide safety researchers in understanding this broad area of transportation data analysis, and provide a framework for understanding safety trends that can influence policy-making. Copyright © 2017 Elsevier Ltd. All rights reserved.

Distributed improvisation: a systems perspective of improvisation 'epics' by led outdoor activity leaders.

PubMed

Trotter, Margaret J; Salmon, Paul M; Goode, Natassia; Lenné, Michael G

2018-02-01

Improvisation represents the spontaneous and real-time conception and execution of a novel response to an unanticipated situation. In order to benefit from the positive safety potential of this phenomenon, it is necessary to understand what influences its appropriateness and effectiveness. This study has applied the system-based methodology Impromaps to analysing accounts of improvisation aimed at mitigating adverse safety outcomes. These accounts were obtained from led outdoor activity (LOA) leaders through critical decision method interviews. Influencing factors and interactions have been identified across all system levels. The factors most influential to leaders' ability to improvise are 'Policy, procedures and rules', 'Organisation culture', 'Training', 'Role responsibilities', 'Communication/instruction/demonstration', 'Situation awareness', 'Leader experience', 'Mental simulation', 'Equipment, clothing & PPE' and 'Terrain/physical environment'. To enhance the likelihood of effective, appropriate improvisation, LOA providers are recommended to focus on higher level factors over which they are able to exert greater control. Practitioner Summary: To enhance resilience in safety-critical situations, organisations need to understand what influences appropriate, effective improvisation. To elucidate this, the Impromaps methodology is applied to in-depth interview data. The Impromap affords a graphical depiction of the influencing factors and interactions across the system, providing a basis for the development of interventions.

Tyre-road grip coefficient assessment - Part II: online estimation using instrumented vehicle, extended Kalman filter, and neural network

NASA Astrophysics Data System (ADS)

Luque, Pablo; Mántaras, Daniel A.; Fidalgo, Eloy; Álvarez, Javier; Riva, Paolo; Girón, Pablo; Compadre, Diego; Ferran, Jordi

2013-12-01

The main objective of this work is to determine the limit of safe driving conditions by identifying the maximal friction coefficient in a real vehicle. The study will focus on finding a method to determine this limit before reaching the skid, which is valuable information in the context of traffic safety. Since it is not possible to measure the friction coefficient directly, it will be estimated using the appropriate tools in order to get the most accurate information. A real vehicle is instrumented to collect information of general kinematics and steering tie-rod forces. A real-time algorithm is developed to estimate forces and aligning torque in the tyres using an extended Kalman filter and neural networks techniques. The methodology is based on determining the aligning torque; this variable allows evaluation of the behaviour of the tyre. It transmits interesting information from the tyre-road contact and can be used to predict the maximal tyre grip and safety margin. The maximal grip coefficient is estimated according to a knowledge base, extracted from computer simulation of a high detailed three-dimensional model, using Adams® software. The proposed methodology is validated and applied to real driving conditions, in which maximal grip and safety margin are properly estimated.

Multi-sectoral action for child safety-a European study exploring implicated sectors.

PubMed

Scholtes, Beatrice; Schröder-Bäck, Peter; Förster, Katharina; MacKay, Morag; Vincenten, Joanne; Brand, Helmut

2017-06-01

Injury to children in Europe, resulting in both death and disability, constitutes a significant burden on individuals, families and society. Inequalities between high and low-income countries are growing. The World Health Organisation Health 2020 strategy calls for inter-sectoral collaboration to address injury in Europe and advocates the whole of government and whole of society approaches to wicked problems. In this study we explore which sectors (e.g. health, transport, education) are relevant for four domains of child safety (intentional injury, water, road and home safety). We used the organigraph methodology, originally developed to demonstrate how organizations work, to describe the governance of child safety interventions. Members of the European Child Safety Alliance, working in the field of child safety in 24 European countries, drew organigraphs of evidence-based interventions. They included the different actors involved and the processes between them. We analyzed the organigraphs by counting the actors presented and categorizing them into sectors using a pre-defined analysis framework. We received 44 organigraphs from participants in 24 countries. Twenty-seven sectors were identified across the four domains. Nine of the 27 identified sectors were classified as 'core sectors' (education, health, home affairs, justice, media, recreation, research, social/welfare services and consumers). This study reveals the multi-sectoral nature of child safety in practice. It provides information for stakeholders working in child safety to help them implement inter-sectoral child safety interventions taking a whole-of-government and whole-of-society approach to health governance. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Applications of Tutoring Systems in Specialized Subject Areas: An Analysis of Skills, Methodologies, and Results.

ERIC Educational Resources Information Center

Heron, Timothy E.; Welsch, Richard G.; Goddard, Yvonne L.

2003-01-01

This article reviews how tutoring systems have been applied across specialized subject areas (e.g., music, horticulture, health and safety, social interactions). It summarizes findings, provides an analysis of skills learned within each tutoring system, identifies the respective methodologies, and reports relevant findings, implications, and…

Correlation between safety climate and contractor safety assessment programs in construction.

PubMed

Sparer, Emily H; Murphy, Lauren A; Taylor, Kathryn M; Dennerlein, Jack T

2013-12-01

Contractor safety assessment programs (CSAPs) measure safety performance by integrating multiple data sources together; however, the relationship between these measures of safety performance and safety climate within the construction industry is unknown. Four hundred and one construction workers employed by 68 companies on 26 sites and 11 safety managers employed by 11 companies completed brief surveys containing a nine-item safety climate scale developed for the construction industry. CSAP scores from ConstructSecure, Inc., an online CSAP database, classified these 68 companies as high or low scorers, with the median score of the sample population as the threshold. Spearman rank correlations evaluated the association between the CSAP score and the safety climate score at the individual level, as well as with various grouping methodologies. In addition, Spearman correlations evaluated the comparison between manager-assessed safety climate and worker-assessed safety climate. There were no statistically significant differences between safety climate scores reported by workers in the high and low CSAP groups. There were, at best, weak correlations between workers' safety climate scores and the company CSAP scores, with marginal statistical significance with two groupings of the data. There were also no significant differences between the manager-assessed safety climate and the worker-assessed safety climate scores. A CSAP safety performance score does not appear to capture safety climate, as measured in this study. The nature of safety climate in construction is complex, which may be reflective of the challenges in measuring safety climate within this industry. Am. J. Ind. Med. 56:1463-1472, 2013. © 2013 Wiley Periodicals, Inc. © 2013 Wiley Periodicals, Inc.

Massive parallelization of serial inference algorithms for a complex generalized linear model

PubMed Central

Suchard, Marc A.; Simpson, Shawn E.; Zorych, Ivan; Ryan, Patrick; Madigan, David

2014-01-01

Following a series of high-profile drug safety disasters in recent years, many countries are redoubling their efforts to ensure the safety of licensed medical products. Large-scale observational databases such as claims databases or electronic health record systems are attracting particular attention in this regard, but present significant methodological and computational concerns. In this paper we show how high-performance statistical computation, including graphics processing units, relatively inexpensive highly parallel computing devices, can enable complex methods in large databases. We focus on optimization and massive parallelization of cyclic coordinate descent approaches to fit a conditioned generalized linear model involving tens of millions of observations and thousands of predictors in a Bayesian context. We find orders-of-magnitude improvement in overall run-time. Coordinate descent approaches are ubiquitous in high-dimensional statistics and the algorithms we propose open up exciting new methodological possibilities with the potential to significantly improve drug safety. PMID:25328363

Reactor Safety Gap Evaluation of Accident Tolerant Components and Severe Accident Analysis

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

Farmer, Mitchell T.; Bunt, R.; Corradini, M.

The overall objective of this study was to conduct a technology gap evaluation on accident tolerant components and severe accident analysis methodologies with the goal of identifying any data and/or knowledge gaps that may exist, given the current state of light water reactor (LWR) severe accident research, and additionally augmented by insights obtained from the Fukushima accident. The ultimate benefit of this activity is that the results can be used to refine the Department of Energy’s (DOE) Reactor Safety Technology (RST) research and development (R&D) program plan to address key knowledge gaps in severe accident phenomena and analyses that affectmore » reactor safety and that are not currently being addressed by the industry or the Nuclear Regulatory Commission (NRC).« less

Evaluating the abuse potential of opioids and abuse-deterrent -opioid formulations: A review of clinical study methodology.

PubMed

Setnik, Beatrice; Schoedel, Kerri A; Levy-Cooperman, Naama; Shram, Megan; Pixton, Glenn C; Roland, Carl L

With the development of opioid abuse-deterrent formulations (ADFs), there is a need to conduct well-designed human abuse potential studies to evaluate the effectiveness of their deterrent properties. Although these types of studies have been conducted for many years, largely to evaluate inherent abuse potential of a molecule and inform drug scheduling, methodological approaches have varied across studies. The focus of this review is to describe current "best practices" and methodological adaptations required to assess abuse-deterrent opioid formulations for regulatory submissions. A literature search was conducted in PubMed® to review methodological approaches (study conduct and analysis) used in opioid human abuse potential studies. Search terms included a combination of "opioid," "opiate," "abuse potential," "abuse liability," "liking," AND "pharmacodynamic," and only studies that evaluated single doses of opioids in healthy, nondependent individuals with or without prior opioid experience were included. Seventy-one human abuse potential studies meeting the prespecified criteria were identified, of which 21 studies evaluated a purported opioid ADF. Based on these studies, key methodological considerations were reviewed and summarized according to participant demographics, study prequalification, comparator and dose selection, route of administration and drug manipulation, study blinding, outcome measures and training, safety, and statistical analyses. The authors recommend careful consideration of key elements (eg, a standardized definition of a "nondependent recreational user"), as applicable, and offer key principles and "best practices" when conducting human abuse potential studies for opioid ADFs. Careful selection of appropriate study conditions is dependent on the type of ADF technology being evaluated.

Multimorbidity and Patient Safety Incidents in Primary Care: A Systematic Review and Meta-Analysis

PubMed Central

Panagioti, Maria; Stokes, Jonathan; Esmail, Aneez; Coventry, Peter; Cheraghi-Sohi, Sudeh; Alam, Rahul; Bower, Peter

2015-01-01

Background Multimorbidity is increasingly prevalent and represents a major challenge in primary care. Patients with multimorbidity are potentially more likely to experience safety incidents due to the complexity of their needs and frequency of their interactions with health services. However, rigorous syntheses of the link between patient safety incidents and multimorbidity are not available. This review examined the relationship between multimorbidity and patient safety incidents in primary care. Methods We followed our published protocol (PROSPERO registration number: CRD42014007434). Medline, Embase and CINAHL were searched up to May 2015. Study design and quality were assessed. Odds ratios (OR) and 95% confidence intervals (95% CIs) were calculated for the associations between multimorbidity and two categories of patient safety outcomes: ‘active patient safety incidents’ (such as adverse drug events and medical complications) and ‘precursors of safety incidents’ (such as prescription errors, medication non-adherence, poor quality of care and diagnostic errors). Meta-analyses using random effects models were undertaken. Results Eighty six relevant comparisons from 75 studies were included in the analysis. Meta-analysis demonstrated that physical-mental multimorbidity was associated with an increased risk for ‘active patient safety incidents’ (OR = 2.39, 95% CI = 1.40 to 3.38) and ‘precursors of safety incidents’ (OR = 1.69, 95% CI = 1.36 to 2.03). Physical multimorbidity was associated with an increased risk for active safety incidents (OR = 1.63, 95% CI = 1.45 to 1.80) but was not associated with precursors of safety incidents (OR = 1.02, 95% CI = 0.90 to 1.13). Statistical heterogeneity was high and the methodological quality of the studies was generally low. Conclusions The association between multimorbidity and patient safety is complex, and varies by type of multimorbidity and type of safety incident. Our analyses suggest that multimorbidity involving mental health may be a key driver of safety incidents, which has important implication for the design and targeting of interventions to improve safety. High quality studies examining the mechanisms of patient safety incidents in patients with multimorbidity are needed, with the goal of promoting effective service delivery and ameliorating threats to safety in this group of patients. PMID:26317435

[Application of root cause analysis in healthcare].

PubMed

Hsu, Tsung-Fu

2007-12-01

The main purpose of this study was to explore various aspects of root cause analysis (RCA), including its definition, rationale concept, main objective, implementation procedures, most common analysis methodology (fault tree analysis, FTA), and advantages and methodologic limitations in regard to healthcare. Several adverse events that occurred at a certain hospital were also analyzed by the author using FTA as part of this study. RCA is a process employed to identify basic and contributing causal factors underlying performance variations associated with adverse events. The rationale concept of RCA offers a systemic approach to improving patient safety that does not assign blame or liability to individuals. The four-step process involved in conducting an RCA includes: RCA preparation, proximate cause identification, root cause identification, and recommendation generation and implementation. FTA is a logical, structured process that can help identify potential causes of system failure before actual failures occur. Some advantages and significant methodologic limitations of RCA were discussed. Finally, we emphasized that errors stem principally from faults attributable to system design, practice guidelines, work conditions, and other human factors, which induce health professionals to make negligence or mistakes with regard to healthcare. We must explore the root causes of medical errors to eliminate potential RCA system failure factors. Also, a systemic approach is needed to resolve medical errors and move beyond a current culture centered on assigning fault to individuals. In constructing a real environment of patient-centered safety healthcare, we can help encourage clients to accept state-of-the-art healthcare services.

Patients' and families' perspectives of patient safety at the end of life: a video-reflexive ethnography study.

PubMed

Collier, Aileen; Sorensen, Ros; Iedema, Rick

2016-02-01

The aim of this study was to investigate patients' and families' perspectives of safety and quality in the setting of a life-limiting illness. Data reported here were generated from a qualitative study using video-reflexive ethnographic methodology. Data were collected over 18 months and generated through participant observation, shadowing of clinicians, field-interviews and semi-structured interviews with patients and families. The study was conducted at two hospital sites in Sydney, Australia and in patients' homes. Patients with an advanced life-limiting illness (n = 29) ranging in age between 27 and 89 years and family members (n = 5) participated in the study. Patient safety remains important to dying patients and families. For dying people, iatrogenic harm is not regarded as 'one off' incidents. Rather, harm is experienced as a result of an unfolding series of negative events. Critically, iatrogenic harm is emotional, social and spiritual and not solely technical-clinical misadventure and is inextricably linked with feeling unsafe. Thus, patient safety extends beyond narrowly defined technical-clinical parameters to include interpersonal safety. Current approaches to patient safety do not address fully the needs of dying patients and their families. Patients and their families regard poor communication with and by health professionals to be harmful in and of itself. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Effectiveness and safety of acupuncture in the treatment of Parkinson's disease: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Noh, Hyeonseok; Kwon, Seungwon; Cho, Seung-Yeon; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Park, Seong-Uk

2017-10-01

This study aimed to examine the effectiveness and safety of acupuncture in the treatment of Parkinson's disease (PD). English, Chinese, and Korean electronic databases were searched up to June 2016. Randomized controlled trials (RCTs) were eligible. The methodological quality was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using RevMan 5.3. In total, 42 studies involving 2625 participants were systematically reviewed. Participants treated using combined acupuncture and conventional medication (CM) showed significant improvements in total Unified PD Rating Scale (UPDRS), UPDRS I, UPDRS II, UPDRS III, and the Webster scale compared to those treated using CM alone. The combination of electroacupuncture and CM was significantly superior to CM alone in total UPDRS, UPDRS I, UPDRS II, and UPDRS IV. Similarly, the combination of scalp electroacupuncture, acupuncture, and CM was significantly more effective than CM alone in total UPDRS. However, our meta-analysis showed that the combination of electroacupuncture and CM was not significantly more effective than CM alone in UPDRS III, the Webster, and the Tension Assessment Scale. The results also failed to show that acupuncture was significantly more effective than placebo acupuncture in total UPDRS. Overall, the methodological quality of the RCTs was low. No serious adverse events were reported. We found that acupuncture might be a safe and useful adjunctive treatment for patients with PD. However, because of methodological flaws in the included studies, conclusive evidence is still lacking. More rigorous and well-designed placebo-controlled trials should be conducted. Copyright © 2017 Elsevier Ltd. All rights reserved.

Trial-Based Economic Evaluations in Occupational Health

PubMed Central

van Wier, Marieke F.; Tompa, Emile; Bongers, Paulien M.; van der Beek, Allard J.; van Tulder, Maurits W.; Bosmans, Judith E.

2014-01-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions. PMID:24854249

Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

PubMed

van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

2014-06-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.

Recommendations for Safe Separation Distances from the Kennedy Space Center (KSC) Vehicle Assembly Building (VAB) Using a Heat-Flux-Based Analytical Approach (Abridged)

NASA Technical Reports Server (NTRS)

Cragg, Clinton H.; Bowman, Howard; Wilson, John E.

2011-01-01

The NASA Engineering and Safety Center (NESC) was requested to provide computational modeling to support the establishment of a safe separation distance surrounding the Kennedy Space Center (KSC) Vehicle Assembly Building (VAB). The two major objectives of the study were 1) establish a methodology based on thermal flux to determine safe separation distances from the Kennedy Space Center's (KSC's) Vehicle Assembly Building (VAB) with large numbers of solid propellant boosters containing hazard division 1.3 classification propellants, in case of inadvertent ignition; and 2) apply this methodology to the consideration of housing eight 5-segment solid propellant boosters in the VAB. The results of the study are contained in this report.

Use of COTS Batteries on ISS and Shuttle: Payload Safety and Mission Success

NASA Technical Reports Server (NTRS)

Jeevarajan, Judith A.

2004-01-01

Contents: Current program requirements; Challenges with COTS batteries; manned vehicle COTS methodology in use; List of typical flight COTS batteries; Energy content and toxicity; Hazards, failure modes and controls for different battery chemistries; JSC test details; List of incidents from Consumer Protection Safety Commission; Conclusions ans recommendations.

Aircraft Survivability. Spring 2009

DTIC Science & Technology

2009-01-01

transport and civil General Aviation (GA) aircraft by mitigating impact injury and keeping the occupants conscious and able to evacuate quickly. The AmSafe...representatives from the Federal Aviation Agency (FAA), the National Transportation Safety Board (NTSB), National Aeronautics & Space Administration...NASA), and the National Highway Transportation Safety Administration (NHTSA) to address and identify combat and mishap expertise, methodologies

How Organisations Learn from Safety Incidents: A Multifaceted Problem

ERIC Educational Resources Information Center

Lukic, Dane; Margaryan, Anoush; Littlejohn, Allison

2010-01-01

Purpose: This paper seeks to review current approaches to learning from health and safety incidents in the workplace. The aim of the paper is to identify the diversity of approaches and analyse them in terms of learning aspects. Design/methodology/approach: A literature review was conducted searching for terms incident/accident/near…

Health and safety impacts of nuclear, geothermal, and fossil-fuel electric generation in California. Volume 9. Methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities

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

Nero, A.V.; Quinby-Hunt, M.S.

1977-01-01

This report sets forth methodologies for review of the health and safety aspects of proposed nuclear, geothermal, and fossil-fuel sites and facilities for electric power generation. The review is divided into a Notice of Intention process and an Application for Certification process, in accordance with the structure to be used by the California Energy Resources Conservation and Development Commission, the first emphasizing site-specific considerations, the second examining the detailed facility design as well. The Notice of Intention review is divided into three possible stages: an examination of emissions and site characteristics, a basic impact analysis, and an assessment of publicmore » impacts. The Application for Certification review is divided into five possible stages: a review of the Notice of Intention treatment, review of the emission control equipment, review of the safety design, review of the general facility design, and an overall assessment of site and facility acceptability.« less

Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically.

PubMed

Bragazzi, Nicola Luigi; Watad, Abdulla; Amital, Howard; Shoenfeld, Yehuda

2017-10-09

Since Jenner, vaccines and vaccinations have stirred a hot, highly polarized debate, leading to contrasting positions and feelings, ranging from acritical enthusiasm to blind denial. On the one hand, we find anti-vaccination movements which divulge and disseminate misleading information, myths, prejudices, and even frauds, with the main aim of denying that vaccination practices represent a major public health measure, being effective in controlling infectious diseases and safeguarding the wellbeing of entire communities. Recently, the authors of many vaccine safety investigations are being personally criticized rather than the actual science being methodologically assessed and critiqued. Unfortunately, this could result in making vaccine safety science a "hazardous occupation". Critiques should focus on the science and not on the authors and on the scientists that publish reasonably high-quality science suggesting a problem with a given vaccine. These scientists require adequate professional protection so there are not disincentives to publish and to carry out researches in the field. The issues for vaccine safety are not dissimilar to other areas such as medical errors and drug safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

Investigation of the impact of low cost traffic engineering measures on road safety in urban areas.

PubMed

Yannis, George; Kondyli, Alexandra; Georgopoulou, Xenia

2014-01-01

This paper investigates the impact of low cost traffic engineering measures (LCTEMs) on the improvement of road safety in urban areas. A number of such measures were considered, such as speed humps, woonerfs, raised intersections and other traffic calming measures, which have been implemented on one-way, one-lane roads in the Municipality of Neo Psychiko in the Greater Athens Area. Data were analysed using the before-and-after safety analysis methodology with large control group. The selected control group comprised of two Municipalities in the Athens Greater Area, which present similar road network and land use characteristics with the area considered. The application of the methodology showed that the total number of crashes presented a statistically significant reduction, which can be possibly attributed to the introduction of LCTEMs. This reduction concerns passenger cars and single-vehicle crashes and is possibly due to the behavioural improvement of drivers of 25 years old or more. The results of this research are very useful for the identification of the appropriate low cost traffic engineering countermeasures for road safety problems in urban areas.

The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial.

PubMed

Tian, Jinzhou; Shi, Jing; Wei, Mingqing; Qin, Renan; Ni, Jingnian; Zhang, Xuekai; Li, Ting; Wang, Yongyan

2016-06-08

Vascular dementia (VaD) is the second most common subtype of dementia after Alzheimer's disease (AD). Currently, there are no medications approved for treating patients with VaD. Fufangdanshen (FFDS) tablets (Radix Salviae miltiorrhizae formula tablets) are a traditional Chinese medicine that has been reported to improve memory. However, the existing evidence for FFDS tablets in clinical practice derives from methodologically flawed studies. To further investigate the safety, tolerability, and efficacy of FFDS tables in the treatment of mild to moderate VaD, we designed and reported the methodology for a 24-week randomized, double-blind, parallel, multicenter study. This ongoing study is a double-blind, randomized, parallel placebo-controlled trial. A total of 240 patients with mild to moderate VaD will be enrolled. After a 2-week run-in period, the eligible patients will be randomized to receive either three FFDS or placebo tablets three times per day for 24 weeks, with a follow-up 12 weeks after the last treatment. The primary efficacy measurement will be the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician Interview-Based Impression of Change (CIBIC-plus). The secondary efficacy measurements will include the Mini Mental State Examination (MMSE) and activities of daily living (ADL). Adverse events will also be reported. This randomized trial will be the first rigorous study on the efficacy and safety of FFDS tablets for treating cognitive symptoms in patients with VaD using a rational design. ClinicalTrials.gov: NCT01761227 . Registered on 2 January 2013.

A Monte-Carlo simulation analysis for evaluating the severity distribution functions (SDFs) calibration methodology and determining the minimum sample-size requirements.

PubMed

Shirazi, Mohammadali; Reddy Geedipally, Srinivas; Lord, Dominique

2017-01-01

Severity distribution functions (SDFs) are used in highway safety to estimate the severity of crashes and conduct different types of safety evaluations and analyses. Developing a new SDF is a difficult task and demands significant time and resources. To simplify the process, the Highway Safety Manual (HSM) has started to document SDF models for different types of facilities. As such, SDF models have recently been introduced for freeway and ramps in HSM addendum. However, since these functions or models are fitted and validated using data from a few selected number of states, they are required to be calibrated to the local conditions when applied to a new jurisdiction. The HSM provides a methodology to calibrate the models through a scalar calibration factor. However, the proposed methodology to calibrate SDFs was never validated through research. Furthermore, there are no concrete guidelines to select a reliable sample size. Using extensive simulation, this paper documents an analysis that examined the bias between the 'true' and 'estimated' calibration factors. It was indicated that as the value of the true calibration factor deviates further away from '1', more bias is observed between the 'true' and 'estimated' calibration factors. In addition, simulation studies were performed to determine the calibration sample size for various conditions. It was found that, as the average of the coefficient of variation (CV) of the 'KAB' and 'C' crashes increases, the analyst needs to collect a larger sample size to calibrate SDF models. Taking this observation into account, sample-size guidelines are proposed based on the average CV of crash severities that are used for the calibration process. Copyright © 2016 Elsevier Ltd. All rights reserved.

A performance improvement plan to increase nurse adherence to use of medication safety software.

PubMed

Gavriloff, Carrie

2012-08-01

Nurses can protect patients receiving intravenous (IV) medication by using medication safety software to program "smart" pumps to administer IV medications. After a patient safety event identified inconsistent use of medication safety software by nurses, a performance improvement team implemented the Deming Cycle performance improvement methodology. The combined use of improved direct care nurse communication, programming strategies, staff education, medication safety champions, adherence monitoring, and technology acquisition resulted in a statistically significant (p < .001) increase in nurse adherence to using medication safety software from 28% to above 85%, exceeding national benchmark adherence rates (Cohen, Cooke, Husch & Woodley, 2007; Carefusion, 2011). Copyright © 2012 Elsevier Inc. All rights reserved.

Researching Reflexively With Patients and Families: Two Studies Using Video-Reflexive Ethnography to Collaborate With Patients and Families in Patient Safety Research.

PubMed

Collier, Aileen; Wyer, Mary

2016-06-01

Patient safety research has to date offered few opportunities for patients and families to be actively involved in the research process. This article describes our collaboration with patients and families in two separate studies, involving end-of-life care and infection control in acute care. We used the collaborative methodology of video-reflexive ethnography, which has been primarily used with clinicians, to involve patients and families as active participants and collaborators in our research. The purpose of this article is to share our experiences and findings that iterative researcher reflexivity in the field was critical to the progress and success of each study. We present and analyze the complexities of reflexivity-in-the-field through a framework of multilayered reflexivity. We share our lessons here for other researchers seeking to actively involve patients and families in patient safety research using collaborative visual methods. © The Author(s) 2015.

Methodological Issues in Trials of Complementary and Alternative Medicine Interventions

PubMed Central

Sikorskii, Alla; Wyatt, Gwen; Victorson, David; Faulkner, Gwen; Rahbar, Mohammad Hossein

2010-01-01

Background Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and health care providers. Well-designed randomized clinical trials (RCTs) of CAM therapy interventions can inform both clinical research and practice. Objectives To review important issues that affect the design of RCTs for CAM interventions. Methods Using the methods component of the Consolidated Standards for Reporting Trials (CONSORT) as a guiding framework, and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed. Discussion Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and improving the well-being of patients. PMID:19918155

Analysis of La Dehesa paleo-landslide. Central Pre-Andes of Argentina

NASA Astrophysics Data System (ADS)

Tapia Baldis, Carla; Rothis, Luis Martín; Perucca, Laura; Esper Angillieri, María; Vargas, Horacio; Ponce, David; Allis, Carlos

2018-04-01

The main objective of this paper is to consider the influence of Quaternary faults as likely triggering factor for rockslides occurrence in the Central Pre-Andes, a region with intense shallow seismic activity. A rockslide deposit was selected as study case, placed in the western flank of La Dehesa and Talacasto (DT) range (31°3‧37″ S and 68°46‧ 8″ W). Applied methodology includes the characterization of main discontinuities, reconstruction of the topography using a high-resolution digital elevation model, safety factor calculation along the sliding surface and, Newmark displacements estimation for three different hypothetical seismic scenarios, recreated from existing neotectonic local information. Equilibrium-limit method's results confirm that study case, La Dehesa rockslide (LDR), had a stable and safe slope's configuration under static conditions. However, a seismic horizontal coefficient between 0.2 and 0.3 decreases safety factor below the safety threshold. Newmark's displacements for different seismic reconstructed scenarios varies between 4.1 and 15.9 cm, values that agreed with a coherent failure process, likely triggered by Pleistocene to Holocene seismogenic sources in Central Pre-Andes. LDR trigger could be assigned mainly to an earthquake related to La Dehesa Quaternary fault (LDF) activity; however, similar movements produced by neighboring faults should not be discarded. LDR triggering related to climatic conditions is despised. Finally, the methodology presented in this work is easy to reproduce and may be applied to other rockslides located in the mountainous areas of the Central Pre-Andes of Argentina.

Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

PubMed

Kaiser, Lee D; Melemed, Allen S; Preston, Alaknanda J; Chaudri Ross, Hilary A; Niedzwiecki, Donna; Fyfe, Gwendolyn A; Gough, Jacqueline M; Bushnell, William D; Stephens, Cynthia L; Mace, M Kelsey; Abrams, Jeffrey S; Schilsky, Richard L

2010-12-01

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications. Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials. A total of 107,884 adverse events and 136,608 concomitant medication records were reviewed for the analysis. Of these, four grade 1 to 2 and nine grade 3 and higher events were identified as drug effects that were not included in the previously established safety profiles and could potentially have been missed using subsampling. These events were frequently detected in subsamples of 400 patients or larger. Furthermore, none of the concomitant medication records contributed to labeling changes for the supplemental indications. Our study found that applying the optimized methodologic approach, described herein, has a high probability of detecting new drug safety signals. Focusing data collection on signals that cause physicians to modify or discontinue treatment ensures that safety issues of the highest concern for patients and regulators are captured and has significant potential to relieve strain on the clinical trials system.

Safety surrogate histograms (SSH): A novel real-time safety assessment of dilemma zone related conflicts at signalized intersections.

PubMed

Ghanipoor Machiani, Sahar; Abbas, Montasir

2016-11-01

Drivers' indecisiveness in dilemma zones (DZ) could result in crash-prone situations at signalized intersections. DZ is to the area ahead of an intersection in which drivers encounter a dilemma regarding whether to stop or proceed through the intersection when the signal turns yellow. An improper decision to stop by the leading driver, combined with the following driver deciding to go, can result in a rear-end collision, unless the following driver recognizes a collision is imminent and adjusts his or her behavior at or shortly after the onset of yellow. Considering the significance of DZ-related crashes, a comprehensive safety measure is needed to characterize the level of safety at signalized intersections. In this study, a novel safety surrogate measure was developed utilizing real-time radar field data. This new measure, called safety surrogate histogram (SSH), captures the degree and frequency of DZ-related conflicts at each intersection approach. SSH includes detailed information regarding the possibility of crashes, because it is calculated based on the vehicles conflicts. An example illustrating the application of the new methodology at two study sites in Virginia is presented and discussed, and a comparison is provided between SSH and other DZ-related safety surrogate measures mentioned in the literature. The results of the study reveal the efficacy of the SSH as complementary to existing surrogate measures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Methodological quality of systematic reviews on influenza vaccination.

PubMed

Remschmidt, Cornelius; Wichmann, Ole; Harder, Thomas

2014-03-26

There is a growing body of evidence on the risks and benefits of influenza vaccination in various target groups. Systematic reviews are of particular importance for policy decisions. However, their methodological quality can vary considerably. To investigate the methodological quality of systematic reviews on influenza vaccination (efficacy, effectiveness, safety) and to identify influencing factors. A systematic literature search on systematic reviews on influenza vaccination was performed, using MEDLINE, EMBASE and three additional databases (1990-2013). Review characteristics were extracted and the methodological quality of the reviews was evaluated using the assessment of multiple systematic reviews (AMSTAR) tool. U-test, Kruskal-Wallis test, chi-square test, and multivariable linear regression analysis were used to assess the influence of review characteristics on AMSTAR-score. Fourty-six systematic reviews fulfilled the inclusion criteria. Average methodological quality was high (median AMSTAR-score: 8), but variability was large (AMSTAR range: 0-11). Quality did not differ significantly according to vaccination target group. Cochrane reviews had higher methodological quality than non-Cochrane reviews (p=0.001). Detailed analysis showed that this was due to better study selection and data extraction, inclusion of unpublished studies, and better reporting of study characteristics (all p<0.05). In the adjusted analysis, no other factor, including industry sponsorship or journal impact factor had an influence on AMSTAR score. Systematic reviews on influenza vaccination showed large differences regarding their methodological quality. Reviews conducted by the Cochrane collaboration were of higher quality than others. When using systematic reviews to guide the development of vaccination recommendations, the methodological quality of a review in addition to its content should be considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Effectiveness and Safety of Manual Therapy on Pain and Disability in Older Persons With Chronic Low Back Pain: A Systematic Review.

PubMed

de Luca, Katie E; Fang, Sheng Hung; Ong, Justin; Shin, Ki-Soo; Woods, Samuel; Tuchin, Peter J

2017-09-01

The aim of this study was to perform a systematic review of the literature of the effectiveness and safety of manual therapy interventions on pain and disability in older persons with chronic low back pain (LBP). A literature search of 4 electronic databases was performed (PubMed, EMBASE, OVID, and CINAHL). Inclusion criteria included randomized controlled trials of manual therapy interventions on older persons who had chronic LBP. Effectiveness was determined by extracting and examining outcomes for pain and disability, with safety determined by the report of adverse events. The PEDro scale was used for quality assessment of eligible studies. The search identified 405 articles, and 38 full-text articles were assessed. Four studies met the inclusion criteria. All trials were of good methodologic quality and had a low risk of bias. The included studies provided moderate evidence supporting the use of manual therapy to reduce pain levels and alleviate disability. A limited number of studies have investigated the effectiveness and safety of manual therapy in the management of older people with chronic LBP. The current evidence to make firm clinical recommendations is limited. Research with appropriately designed trials to investigate the effectiveness and safety of manual therapy interventions in older persons with chronic LBP is required. Copyright © 2017. Published by Elsevier Inc.

A Methodology for Quantifying Certain Design Requirements During the Design Phase

NASA Technical Reports Server (NTRS)

Adams, Timothy; Rhodes, Russel

2005-01-01

A methodology for developing and balancing quantitative design requirements for safety, reliability, and maintainability has been proposed. Conceived as the basis of a more rational approach to the design of spacecraft, the methodology would also be applicable to the design of automobiles, washing machines, television receivers, or almost any other commercial product. Heretofore, it has been common practice to start by determining the requirements for reliability of elements of a spacecraft or other system to ensure a given design life for the system. Next, safety requirements are determined by assessing the total reliability of the system and adding redundant components and subsystems necessary to attain safety goals. As thus described, common practice leaves the maintainability burden to fall to chance; therefore, there is no control of recurring costs or of the responsiveness of the system. The means that have been used in assessing maintainability have been oriented toward determining the logistical sparing of components so that the components are available when needed. The process established for developing and balancing quantitative requirements for safety (S), reliability (R), and maintainability (M) derives and integrates NASA s top-level safety requirements and the controls needed to obtain program key objectives for safety and recurring cost (see figure). Being quantitative, the process conveniently uses common mathematical models. Even though the process is shown as being worked from the top down, it can also be worked from the bottom up. This process uses three math models: (1) the binomial distribution (greaterthan- or-equal-to case), (2) reliability for a series system, and (3) the Poisson distribution (less-than-or-equal-to case). The zero-fail case for the binomial distribution approximates the commonly known exponential distribution or "constant failure rate" distribution. Either model can be used. The binomial distribution was selected for modeling flexibility because it conveniently addresses both the zero-fail and failure cases. The failure case is typically used for unmanned spacecraft as with missiles.

Comparison between low-cost marker-less and high-end marker-based motion capture systems for the computer-aided assessment of working ergonomics.

PubMed

Patrizi, Alfredo; Pennestrì, Ettore; Valentini, Pier Paolo

2016-01-01

The paper deals with the comparison between a high-end marker-based acquisition system and a low-cost marker-less methodology for the assessment of the human posture during working tasks. The low-cost methodology is based on the use of a single Microsoft Kinect V1 device. The high-end acquisition system is the BTS SMART that requires the use of reflective markers to be placed on the subject's body. Three practical working activities involving object lifting and displacement have been investigated. The operational risk has been evaluated according to the lifting equation proposed by the American National Institute for Occupational Safety and Health. The results of the study show that the risk multipliers computed from the two acquisition methodologies are very close for all the analysed activities. In agreement to this outcome, the marker-less methodology based on the Microsoft Kinect V1 device seems very promising to promote the dissemination of computer-aided assessment of ergonomics while maintaining good accuracy and affordable costs. PRACTITIONER’S SUMMARY: The study is motivated by the increasing interest for on-site working ergonomics assessment. We compared a low-cost marker-less methodology with a high-end marker-based system. We tested them on three different working tasks, assessing the working risk of lifting loads. The two methodologies showed comparable precision in all the investigations.

77 FR 39521 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... Methodology for Boiling Water Reactors, June 2011. To support use of Topical Report ANP-10307PA, Revision 0... the NRC's E-Filing system does not support unlisted software, and the NRC Meta System Help Desk will... Water Reactors with AREVA Topical Report ANP- 10307PA, Revision 0, ``AREVA MCPR Safety Limit Methodology...

Health Risk Behaviors of African American Adolescents with Mild Mental Retardation: Prevalence Depends on Measurement Method.

ERIC Educational Resources Information Center

Pack, Robert P.; Browne, Dorothy; Wallander, Jan L.

1998-01-01

Health risk behaviors (substance use, violence, suicide, and car safety) of 194 African American urban adolescents with mild mental retardation were measured using either a confidential individual interview or an anonymous group survey. The survey methodology resulted in disclosure of more risk behaviors than the interview methodology. Elevated…

SCI Hazard Report Methodology

NASA Technical Reports Server (NTRS)

Mitchell, Michael S.

2010-01-01

This slide presentation reviews the methodology in creating a Source Control Item (SCI) Hazard Report (HR). The SCI HR provides a system safety risk assessment for the following Ares I Upper Stage Production Contract (USPC) components (1) Pyro Separation Systems (2) Main Propulsion System (3) Reaction and Roll Control Systems (4) Thrust Vector Control System and (5) Ullage Settling Motor System components.

Safety in construction--a comprehensive description of the characteristics of high safety standards in construction work, from the combined perspective of supervisors and experienced workers.

PubMed

Törner, Marianne; Pousette, Anders

2009-01-01

The often applied engineering approach to safety management in the construction industry needs to be supplemented by organizational measures and measures based on how people conceive and react to their social environment. This requires in-depth knowledge of the broad preconditions for high safety standards in construction. The aim of the study was to comprehensively describe the preconditions and components of high safety standards in the construction industry from the perspective of both experienced construction workers and first-line managers. Five worker safety representatives and 19 first-line managers were interviewed, all strategically selected from within a large Swedish construction project. Phenomenographic methodology was used for data acquisition and analysis and to categorize the information. Nine informants verified the results. The study identified four main categories of work safety preconditions and components: (1) Project characteristics and nature of the work, which set the limits of safety management; (2) Organization and structures, with the subcategories planning, work roles, procedures, and resources; (3) Collective values, norms, and behaviors, with the subcategories climate and culture, and interaction and cooperation; and (4) Individual competence and attitudes, with the subcategories knowledge, ability and experience, and individual attitudes. The results comprehensively describe high safety standards in construction, incorporating organizational, group, individual, and technical aspects. High-quality interaction between different organizational functions and hierarchical levels stood out as important aspects of safety. The results are discussed in relation to previous research into safety and into the social-psychological preconditions for other desired outcomes in occupational settings. The results can guide construction companies in planning and executing construction projects to a high safety standard.

Emerging technologies for the changing global market

NASA Technical Reports Server (NTRS)

Cruit, Wendy; Schutzenhofer, Scott; Goldberg, Ben; Everhart, Kurt

1993-01-01

This project served to define an appropriate methodology for effective prioritization of technology efforts required to develop replacement technologies mandated by imposed and forecast legislation. The methodology used is a semi-quantative approach derived from quality function deployment techniques (QFD Matrix). This methodology aims to weight the full environmental, cost, safety, reliability, and programmatic implications of replacement technology development to allow appropriate identification of viable candidates and programmatic alternatives. The results will be implemented as a guideline for consideration for current NASA propulsion systems.

An evaluation of NASA's program in human factors research: Aircrew-vehicle system interaction

NASA Technical Reports Server (NTRS)

1982-01-01

Research in human factors in the aircraft cockpit and a proposed program augmentation were reviewed. The dramatic growth of microprocessor technology makes it entirely feasible to automate increasingly more functions in the aircraft cockpit; the promise of improved vehicle performance, efficiency, and safety through automation makes highly automated flight inevitable. An organized data base and validated methodology for predicting the effects of automation on human performance and thus on safety are lacking and without such a data base and validated methodology for analyzing human performance, increased automation may introduce new risks. Efforts should be concentrated on developing methods and techniques for analyzing man machine interactions, including human workload and prediction of performance.

Fear conditioning and extinction across development: Evidence from human studies and animal models☆

PubMed Central

Shechner, Tomer; Hong, Melanie; Britton, Jennifer C.; Pine, Daniel S.; Fox, Nathan A.

2015-01-01

The ability to differentiate danger and safety through associative processes emerges early in life. Understanding the mechanisms underlying associative learning of threat and safety can clarify the processes that shape development of normative fears and pathological anxiety. Considerable research has used fear conditioning and extinction paradigms to delineate underlying mechanisms in animals and human adults; however, little is known about these mechanisms in children and adolescents. The current paper summarizes the empirical data on the development of fear conditioning and extinction. It reviews methodological considerations and future directions for research on fear conditioning and extinction in pediatric populations. PMID:24746848

Assessment of cognitive safety in clinical drug development

PubMed Central

Roiser, Jonathan P.; Nathan, Pradeep J.; Mander, Adrian P.; Adusei, Gabriel; Zavitz, Kenton H.; Blackwell, Andrew D.

2016-01-01

Cognitive impairment is increasingly recognised as an important potential adverse effect of medication. However, many drug development programmes do not incorporate sensitive cognitive measurements. Here, we review the rationale for cognitive safety assessment, and explain several basic methodological principles for measuring cognition during clinical drug development, including study design and statistical analysis, from Phase I through to postmarketing. The crucial issue of how cognition should be assessed is emphasized, especially the sensitivity of measurement. We also consider how best to interpret the magnitude of any identified effects, including comparison with benchmarks. We conclude by discussing strategies for the effective communication of cognitive risks. PMID:26610416

A simulation-optimization model for Stone column-supported embankment stability considering rainfall effect

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

Deb, Kousik, E-mail: kousik@civil.iitkgp.ernet.in; Dhar, Anirban, E-mail: anirban@civil.iitkgp.ernet.in; Purohit, Sandip, E-mail: sandip.purohit91@gmail.com

Landslide due to rainfall has been and continues to be one of the most important concerns of geotechnical engineering. The paper presents the variation of factor of safety of stone column-supported embankment constructed over soft soil due to change in water level for an incessant period of rainfall. A combined simulation-optimization based methodology has been proposed to predict the critical surface of failure of the embankment and to optimize the corresponding factor of safety under rainfall conditions using an evolutionary genetic algorithm NSGA-II (Non-Dominated Sorted Genetic Algorithm-II). It has been observed that the position of water table can be reliablymore » estimated with varying periods of infiltration using developed numerical method. The parametric study is presented to study the optimum factor of safety of the embankment and its corresponding critical failure surface under the steady-state infiltration condition. Results show that in case of floating stone columns, period of infiltration has no effect on factor of safety. Even critical failure surfaces for a particular floating column length remain same irrespective of rainfall duration.« less

Parametric Criticality Safety Calculations for Arrays of TRU Waste Containers

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

Gough, Sean T.

The Nuclear Criticality Safety Division (NCSD) has performed criticality safety calculations for finite and infinite arrays of transuranic (TRU) waste containers. The results of these analyses may be applied in any technical area onsite (e.g., TA-54, TA-55, etc.), as long as the assumptions herein are met. These calculations are designed to update the existing reference calculations for waste arrays documented in Reference 1, in order to meet current guidance on calculational methodology.

Methodological variations and their effects on reported medication administration error rates.

PubMed

McLeod, Monsey Chan; Barber, Nick; Franklin, Bryony Dean

2013-04-01

Medication administration errors (MAEs) are a problem, yet methodological variation between studies presents a potential barrier to understanding how best to increase safety. Using the UK as a case-study, we systematically summarised methodological variations in MAE studies, and their effects on reported MAE rates. Nine healthcare databases were searched for quantitative observational MAE studies in UK hospitals. Methodological variations were analysed and meta-analysis of MAE rates performed using studies that used the same definitions. Odds ratios (OR) were calculated to compare MAE rates between intravenous (IV) and non-IV doses, and between paediatric and adult doses. We identified 16 unique studies reporting three MAE definitions, 44 MAE subcategories and four different denominators. Overall adult MAE rates were 5.6% of a total of 21 533 non-IV opportunities for error (OE) (95% CI 4.6% to 6.7%) and 35% of a total of 154 IV OEs (95% CI 2% to 68%). MAEs were five times more likely in IV than non-IV doses (pooled OR 5.1; 95% CI 3.5 to 7.5). Including timing errors of ±30 min increased the MAE rate from 27% to 69% of 320 IV doses in one study. Five studies were unclear as to whether the denominator included dose omissions; omissions accounted for 0%-13% of IV doses and 1.8%-5.1% of non-IV doses. Wide methodological variations exist even within one country, some with significant effects on reported MAE rates. We have made recommendations for future MAE studies; these may be applied both within and outside the UK.

Online interviewing with interpreters in humanitarian contexts

PubMed Central

Chiumento, Anna; Rahman, Atif; Frith, Lucy

2018-01-01

ABSTRACT Purpose: Recognising that one way to address the logistical and safety considerations of research conducted in humanitarian emergencies is to use internet communication technologies to facilitate interviews online, this article explores some practical and methodological considerations inherent to qualitative online interviewing. Method: Reflections from a case study of a multi-site research project conducted in post-conflict countries are presented.  Synchronous online cross-language qualitative interviews were conducted in one country.  Although only a small proportion of interviews were conducted online (six out of 35), it remains important to critically consider the impact upon data produced in this way. Results: A range of practical and methodological considerations are discussed, illustrated with examples.  Results suggest that whilst online interviewing has methodological and ethical potential and versatility, there are inherent practical challenges in settings with poor internet and electricity infrastructure.  Notable methodological limitations include barriers to building rapport due to partial visual and non-visual cues, and difficulties interpreting pauses or silences. Conclusions: Drawing upon experiences in this case study, strategies for managing the practical and methodological limitations of online interviewing are suggested, alongside recommendations for supporting future research practice.  These are intended to act as a springboard for further reflection, and operate alongside other conceptual frameworks for online interviewing. PMID:29532739

Online interviewing with interpreters in humanitarian contexts.

PubMed

Chiumento, Anna; Machin, Laura; Rahman, Atif; Frith, Lucy

2018-12-01

Recognising that one way to address the logistical and safety considerations of research conducted in humanitarian emergencies is to use internet communication technologies to facilitate interviews online, this article explores some practical and methodological considerations inherent to qualitative online interviewing. Reflections from a case study of a multi-site research project conducted in post-conflict countries are presented.  Synchronous online cross-language qualitative interviews were conducted in one country.  Although only a small proportion of interviews were conducted online (six out of 35), it remains important to critically consider the impact upon data produced in this way. A range of practical and methodological considerations are discussed, illustrated with examples.  Results suggest that whilst online interviewing has methodological and ethical potential and versatility, there are inherent practical challenges in settings with poor internet and electricity infrastructure.  Notable methodological limitations include barriers to building rapport due to partial visual and non-visual cues, and difficulties interpreting pauses or silences. Drawing upon experiences in this case study, strategies for managing the practical and methodological limitations of online interviewing are suggested, alongside recommendations for supporting future research practice.  These are intended to act as a springboard for further reflection, and operate alongside other conceptual frameworks for online interviewing.

A Systematic Overview of Reviews for Complementary and Alternative Therapies in the Treatment of the Fibromyalgia Syndrome

PubMed Central

Häuser, Winfried; Dobos, Gustav; Langhorst, Jost

2015-01-01

Objectives. This systematic overview of reviews aimed to summarize evidence and methodological quality from systematic reviews of complementary and alternative medicine (CAM) for the fibromyalgia syndrome (FMS). Methods. The PubMed/MEDLINE, Cochrane Library, and Scopus databases were screened from their inception to Sept 2013 to identify systematic reviews and meta-analyses of CAM interventions for FMS. Methodological quality of reviews was rated using the AMSTAR instrument. Results. Altogether 25 systematic reviews were found; they investigated the evidence of CAM in general, exercised-based CAM therapies, manipulative therapies, Mind/Body therapies, acupuncture, hydrotherapy, phytotherapy, and homeopathy. Methodological quality of reviews ranged from lowest to highest possible quality. Consistently positive results were found for tai chi, yoga, meditation and mindfulness-based interventions, hypnosis or guided imagery, electromyogram (EMG) biofeedback, and balneotherapy/hydrotherapy. Inconsistent results concerned qigong, acupuncture, chiropractic interventions, electroencephalogram (EEG) biofeedback, and nutritional supplements. Inconclusive results were found for homeopathy and phytotherapy. Major methodological flaws included missing details on data extraction process, included or excluded studies, study details, and adaption of conclusions based on quality assessment. Conclusions. Despite a growing body of scientific evidence of CAM therapies for the management of FMS systematic reviews still show methodological flaws limiting definite conclusions about their efficacy and safety. PMID:26246841

A Systematic Overview of Reviews for Complementary and Alternative Therapies in the Treatment of the Fibromyalgia Syndrome.

PubMed

Lauche, Romy; Cramer, Holger; Häuser, Winfried; Dobos, Gustav; Langhorst, Jost

2015-01-01

Objectives. This systematic overview of reviews aimed to summarize evidence and methodological quality from systematic reviews of complementary and alternative medicine (CAM) for the fibromyalgia syndrome (FMS). Methods. The PubMed/MEDLINE, Cochrane Library, and Scopus databases were screened from their inception to Sept 2013 to identify systematic reviews and meta-analyses of CAM interventions for FMS. Methodological quality of reviews was rated using the AMSTAR instrument. Results. Altogether 25 systematic reviews were found; they investigated the evidence of CAM in general, exercised-based CAM therapies, manipulative therapies, Mind/Body therapies, acupuncture, hydrotherapy, phytotherapy, and homeopathy. Methodological quality of reviews ranged from lowest to highest possible quality. Consistently positive results were found for tai chi, yoga, meditation and mindfulness-based interventions, hypnosis or guided imagery, electromyogram (EMG) biofeedback, and balneotherapy/hydrotherapy. Inconsistent results concerned qigong, acupuncture, chiropractic interventions, electroencephalogram (EEG) biofeedback, and nutritional supplements. Inconclusive results were found for homeopathy and phytotherapy. Major methodological flaws included missing details on data extraction process, included or excluded studies, study details, and adaption of conclusions based on quality assessment. Conclusions. Despite a growing body of scientific evidence of CAM therapies for the management of FMS systematic reviews still show methodological flaws limiting definite conclusions about their efficacy and safety.

Effects of digital countdown timer on intersection safety and efficiency: A systematic review.

PubMed

Fu, Chuanyun; Zhang, Yaping; Qi, Weiwei; Cheng, Shaowu

2016-01-01

To investigate the available evidence referring to the effectiveness of digital countdown timers (DCTs) in improving the safety and operational efficiency of signalized intersection. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement guidelines. Relevant literature was searched from electronic databases using key terms. Based on study selection and methodological quality assessment, 14 studies were included in the review. Findings of the studies were synthesized in a narrative analysis. Three types of DCT had different effects on intersection safety and operational efficiency. Green signal countdown timers (GSCTs) reduced red light violations, type I dilemma zone distributions, and rear-end collision likelihood but increased crossing after yellow onset and had mixed impacts on type II dilemma zone distributions and intersection capacity. In contrast, red signal countdown timers (RSCTs) increased intersection capacity, although their effectiveness in reducing red light violations dissipated over time. Likewise, continuous countdown timers (CCTs) significantly enhanced intersection capacity but had mixed influences on red light violations and crossing after yellow onset. Due to the limited and inconsistent evidence regarding DCTs' effects on intersection safety and efficiency, it is not sufficient to recommend any type of DCT to be installed at signalized intersections to improve safety and operational efficiency. Nevertheless, it is apparent that both RSCTs and CCTs enhance intersection capacity, though their impacts on intersection safety are unclear. Future studies need to further verify those anticipated safe and operational benefits of DCTs with enriched field observation data.

Investigating surety methodologies for cognitive systems.

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

Caudell, Thomas P.; Peercy, David Eugene; Mills, Kristy

2006-11-01

Advances in cognitive science provide a foundation for new tools that promise to advance human capabilities with significant positive impacts. As with any new technology breakthrough, associated technical and non-technical risks are involved. Sandia has mitigated both technical and non-technical risks by applying advanced surety methodologies in such areas as nuclear weapons, nuclear reactor safety, nuclear materials transport, and energy systems. In order to apply surety to the development of cognitive systems, we must understand the concepts and principles that characterize the certainty of a system's operation as well as the risk areas of cognitive sciences. This SAND report documentsmore » a preliminary spectrum of risks involved with cognitive sciences, and identifies some surety methodologies that can be applied to potentially mitigate such risks. Some potential areas for further study are recommended. In particular, a recommendation is made to develop a cognitive systems epistemology framework for more detailed study of these risk areas and applications of surety methods and techniques.« less

Quantum Dots Applied to Methodology on Detection of Pesticide and Veterinary Drug Residues.

PubMed

Zhou, Jia-Wei; Zou, Xue-Mei; Song, Shang-Hong; Chen, Guan-Hua

2018-02-14

The pesticide and veterinary drug residues brought by large-scale agricultural production have become one of the issues in the fields of food safety and environmental ecological security. It is necessary to develop the rapid, sensitive, qualitative and quantitative methodology for the detection of pesticide and veterinary drug residues. As one of the achievements of nanoscience, quantum dots (QDs) have been widely used in the detection of pesticide and veterinary drug residues. In these methodology studies, the used QD-signal styles include fluorescence, chemiluminescence, electrochemical luminescence, photoelectrochemistry, etc. QDs can also be assembled into sensors with different materials, such as QD-enzyme, QD-antibody, QD-aptamer, and QD-molecularly imprinted polymer sensors, etc. Plenty of study achievements in the field of detection of pesticide and veterinary drug residues have been obtained from the different combinations among these signals and sensors. They are summarized in this paper to provide a reference for the QD application in the detection of pesticide and veterinary drug residues.

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

PubMed

Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

2017-05-03

The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

Methodological development for selection of significant predictors explaining fatal road accidents.

PubMed

Dadashova, Bahar; Arenas-Ramírez, Blanca; Mira-McWilliams, José; Aparicio-Izquierdo, Francisco

2016-05-01

Identification of the most relevant factors for explaining road accident occurrence is an important issue in road safety research, particularly for future decision-making processes in transport policy. However model selection for this particular purpose is still an ongoing research. In this paper we propose a methodological development for model selection which addresses both explanatory variable and adequate model selection issues. A variable selection procedure, TIM (two-input model) method is carried out by combining neural network design and statistical approaches. The error structure of the fitted model is assumed to follow an autoregressive process. All models are estimated using Markov Chain Monte Carlo method where the model parameters are assigned non-informative prior distributions. The final model is built using the results of the variable selection. For the application of the proposed methodology the number of fatal accidents in Spain during 2000-2011 was used. This indicator has experienced the maximum reduction internationally during the indicated years thus making it an interesting time series from a road safety policy perspective. Hence the identification of the variables that have affected this reduction is of particular interest for future decision making. The results of the variable selection process show that the selected variables are main subjects of road safety policy measures. Published by Elsevier Ltd.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence.

PubMed

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-08-18

Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in 'patient safety' and 'economic analyses' has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. CRD42017057853. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Patient complaints in healthcare systems: a systematic review and coding taxonomy

PubMed Central

Reader, Tom W; Gillespie, Alex; Roberts, Jane

2014-01-01

Background Patient complaints have been identified as a valuable resource for monitoring and improving patient safety. This article critically reviews the literature on patient complaints, and synthesises the research findings to develop a coding taxonomy for analysing patient complaints. Methods The PubMed, Science Direct and Medline databases were systematically investigated to identify patient complaint research studies. Publications were included if they reported primary quantitative data on the content of patient-initiated complaints. Data were extracted and synthesised on (1) basic study characteristics; (2) methodological details; and (3) the issues patients complained about. Results 59 studies, reporting 88 069 patient complaints, were included. Patient complaint coding methodologies varied considerably (eg, in attributing single or multiple causes to complaints). In total, 113 551 issues were found to underlie the patient complaints. These were analysed using 205 different analytical codes which when combined represented 29 subcategories of complaint issue. The most common issues complained about were ‘treatment’ (15.6%) and ‘communication’ (13.7%). To develop a patient complaint coding taxonomy, the subcategories were thematically grouped into seven categories, and then three conceptually distinct domains. The first domain related to complaints on the safety and quality of clinical care (representing 33.7% of complaint issues), the second to the management of healthcare organisations (35.1%) and the third to problems in healthcare staff–patient relationships (29.1%). Conclusions Rigorous analyses of patient complaints will help to identify problems in patient safety. To achieve this, it is necessary to standardise how patient complaints are analysed and interpreted. Through synthesising data from 59 patient complaint studies, we propose a coding taxonomy for supporting future research and practice in the analysis of patient complaint data. PMID:24876289

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

[OCCUPATIONAL HEALTH RISK ASSESSMENT AND MANAGEMENT IN WORKERS IN IMPROVEMENT OF NATIONAL POLICY IN OCCUPATIONAL HYGIENE AND SAFETY].

PubMed

Shur, P Z; Zaĭtseva, N V; Alekseev, V B; Shliapnikov, D M

2015-01-01

In accordance with the international documents in the field of occupational safety and hygiene, the assessment and minimization of occupational risks is a key instrument for the health maintenance of workers. One of the main ways to achieve it is the minimization of occupational risks. Correspondingly, the instrument for the implementation of this method is the methodology of analysis of occupational risks. In Russian Federation there were the preconditions for the formation of the system for the assessment and management of occupational risks. As the target of the national (state) policy in the field of occupational safety in accordance with ILO Conventions it can be offered the prevention of accidents and injuries to health arising from work or related with it, minimizing the causes of hazards inherent in the working environment, as far as it is reasonably and practically feasible. Global trend ofusing the methodology of the assessment and management of occupational risks to life and health of citizens requires the improvement of national policies in the field of occupational hygiene and safety. Achieving an acceptable level of occupational risk in the formation of national policy in the field of occupational hygiene and safety can be considered as one of the main tasks.

Assessment of research and development (R and D) needs in LPG safety and environmental control

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

DeSteese, J.G.

1982-05-01

The report characterizes the LPG industry covering all operations from production to end use, reviews current knowledge of LPG release phenomenology, summarizes the status of current LPG release prevention and control methodology, and identifies any remaining safety and environmental problems and recommends R and D strategies that may mitigate these problems. (ACR)

76 FR 37799 - DOE Final Decision in Response to Recommendation 2010-1 of the Defense Nuclear Facilities Safety...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-28

... the public, workers, and the environment. For example, the Board clarified that use of the term.... Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as a safe harbor methodology..., our workers, and the environment at all of our facilities. We share your conviction that a clear set...

Knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings: a systematic review.

PubMed

Tarabay, Rami; El Rassi, Rola; Dakik, Abeer; Harb, Alain; Ballout, Rami A; Diab, Batoul; Khamassi, Selma; Akl, Elie A

2016-07-13

Adopting technologies such as injection safety devices in healthcare settings can enhance injection safety. Developing guidelines for appropriate adoption of such technologies need to consider factors beyond evidence for their health effects. The objective of this study is to systematically review the published literature for evidence among healthcare workers and patients about knowledge, attitudes, beliefs, values, preferences, and feasibility in relation to the use of injection safety devices in healthcare settings. We included both qualitative and quantitative studies conducted with the general public, patients, and healthcare workers, administrators, or policy makers. We searched MEDLINE, EMBASE, CINHAL and CENTRAL. We used a duplicate and independent approach to title and abstract screening, full text screening, data abstraction and risk of bias assessment. Out of a total of 6568 identified citations, we judged fourteen studies as eligible for this systematic review. All these studies were surveys, conducted with healthcare workers in high-income countries. We did not identify any qualitative study, or a study of the general public, patients, healthcare administrators or policy makers. We did not identify any study assessing knowledge, or values assigned to outcomes relevant to injection safety devices. Each of the included studies suffered from methodological limitations, which lowers our confidence in their findings. Based on the findings of six studies, the injection safety devices were generally perceived as easy to use and as an improvement compared with conventional syringes. Some of these studies reported few technical problems while using the devices. In three studies assessing perceived safety, the majority of participants judged the devices as safe. Two studies reported positive perceptions of healthcare workers regarding patient tolerance of these injection safety devices. One study found that less than half the nurses felt comfortable using the insulin pens. Findings from four studies assessing preference and satisfaction were not consistent. This systematic review identified evidence that injection safety devices are generally perceived as easy to use, safe, and tolerated by patients. There were few reports of technical problems while using the devices and some discomfort by nurses using the insulin pens.

Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens

PubMed Central

Packer, Mark

2016-01-01

The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL), and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.). Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594)=1.33; P=0.18). The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks. PMID:27354760

Meta-analysis and review: effectiveness, safety, and central port design of the intraocular collamer lens.

PubMed

Packer, Mark

2016-01-01

The purpose of this review is to summarize relevant data from publications appearing in the peer-reviewed scientific literature over the past decade since US Food and Drug Administration approval of the implantable collamer lens (ICL), and, in particular, to review studies relating to sizing methodology, safety, and effectiveness, as well as more recent studies reporting clinical outcomes of the V4c Visian ICL with KS Aquaport, VICMO. A literature search was conducted using two databases, PubMed.gov and Science.gov, to identify all articles published after 2005 related to the Visian ICL (STAAR Surgical, Inc.). Articles were examined for their relevance to sizing methodology, clinical safety, and effectiveness, and the references cited in each article were also searched for additional relevant publications. The literature review revealed that all currently reported methods of determining the best-fit size of the ICL achieve similarly satisfactory results in terms of vault, the safe distance between the crystalline lens and the ICL. Specifically, meta-analysis demonstrated that sulcus-to-sulcus and white-to-white measurement-based sizing methods do not result in clinically meaningful nor statistically significant differences in vault (two-sample two-sided t-test using pooled mean and standard deviations; t (2,594)=1.33; P=0.18). The reported rates of complications related to vault are very low, except in two case series where additional risk factors such as higher levels of myopia and older age impacted the incidence of cataract. On the basis of preclinical studies and initial clinical reports, with up to 5 years of follow-up, the new VICMO central port design holds promise for further reduction of complications. Given its safety record and the significant improvement in vision and quality of life that the ICL makes possible, the benefits of ICL implantation outweigh the risks.

Systematic review of economic analyses in patient safety: a protocol designed to measure development in the scope and quality of evidence

PubMed Central

Carter, Alexander W; Mandavia, Rishi; Mayer, Erik; Marti, Joachim; Mossialos, Elias; Darzi, Ara

2017-01-01

Introduction Recent avoidable failures in patient care highlight the ongoing need for evidence to support improvements in patient safety. According to the most recent reviews, there is a dearth of economic evidence related to patient safety. These reviews characterise an evidence gap in terms of the scope and quality of evidence available to support resource allocation decisions. This protocol is designed to update and improve on the reviews previously conducted to determine the extent of methodological progress in economic analyses in patient safety. Methods and analysis A broad search strategy with two core themes for original research (excluding opinion pieces and systematic reviews) in ‘patient safety’ and ‘economic analyses’ has been developed. Medline, Econlit and National Health Service Economic Evaluation Database bibliographic databases will be searched from January 2007 using a combination of medical subject headings terms and research-derived search terms (see table 1). The method is informed by previous reviews on this topic, published in 2012. Screening, risk of bias assessment (using the Cochrane collaboration tool) and economic evaluation quality assessment (using the Drummond checklist) will be conducted by two independent reviewers, with arbitration by a third reviewer as needed. Studies with a low risk of bias will be assessed using the Drummond checklist. High-quality economic evaluations are those that score >20/35. A qualitative synthesis of evidence will be performed using a data collection tool to capture the study design(s) employed, population(s), setting(s), disease area(s), intervention(s) and outcome(s) studied. Methodological quality scores will be compared with previous reviews where possible. Effect size(s) and estimate uncertainty will be captured and used in a quantitative synthesis of high-quality evidence, where possible. Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, presentations and social media. Trial registration number CRD42017057853. PMID:28821527

The TRIPOD e-learning Platform for the Training of Earthquake Safety Assessment

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

Coppari, S.; Di Pasquale, G.; Goretti, A.

2008-07-08

The paper summarizes the results of the in progress EU Project titled TRIPOD (Training Civil Engineers on Post-Earthquake Safety Assessment of Damaged Buildings), funded under the Leonardo Da Vinci program. The main theme of the project is the development of a methodology and a learning platform for the training of technicians involved in post-earthquake building safety inspections. In the event of a catastrophic earthquake, emergency building inspections constitute a major undertaking with severe social impact. Given the inevitable chaotic conditions and the urgent need of a great number of specialized individuals to carry out inspections, past experience indicates that inspectionmore » teams are often formed in an adhoc manner, under stressful conditions, at a varying levels of technical expertise and experience, sometime impairing the reliability and consistency of the inspection results. Furthermore each Country has its own building damage and safety assessment methodology, developed according to its experience, laws, building technology and seismicity. This holds also for the partners participating to the project (Greece, Italy, Turkey, Cyprus), that all come from seismically sensitive Mediterranean countries. The project aims at alleviating the above shortcomings by designing and developing a training methodology and e-platform, forming a complete training program targeted at inspection engineers, specialized personnel and civil protection agencies. The e-learning platform will provide flexible and friendly authoring mechanisms, self-teaching and assessment capabilities, course and trainee management, etc. Courses will be also made available as stand-alone multimedia applications on CD and in the form of a complete pocket handbook. Moreover the project will offer the possibility of upgrading different experiences and practices: a first step towards the harmonization of methodologies and tools of different Countries sharing similar problems. Finally, through wide dissemination activities, the final aim of the project is to ensure the deployment and the integration into existing earthquake mitigation policies and vocational training schemes.« less

The TRIPOD e-learning Platform for the Training of Earthquake Safety Assessment

NASA Astrophysics Data System (ADS)

Coppari, S.; Di Pasquale, G.; Goretti, A.; Papa, F.; Papa, S.; Paoli, G.; Pizza, A. G.; Severino, M.

2008-07-01

The paper summarizes the results of the in progress EU Project titled TRIPOD (Training Civil Engineers on Post-Earthquake Safety Assessment of Damaged Buildings), funded under the Leonardo Da Vinci program. The main theme of the project is the development of a methodology and a learning platform for the training of technicians involved in post-earthquake building safety inspections. In the event of a catastrophic earthquake, emergency building inspections constitute a major undertaking with severe social impact. Given the inevitable chaotic conditions and the urgent need of a great number of specialized individuals to carry out inspections, past experience indicates that inspection teams are often formed in an adhoc manner, under stressful conditions, at a varying levels of technical expertise and experience, sometime impairing the reliability and consistency of the inspection results. Furthermore each Country has its own building damage and safety assessment methodology, developed according to its experience, laws, building technology and seismicity. This holds also for the partners participating to the project (Greece, Italy, Turkey, Cyprus), that all come from seismically sensitive Mediterranean countries. The project aims at alleviating the above shortcomings by designing and developing a training methodology and e-platform, forming a complete training program targeted at inspection engineers, specialized personnel and civil protection agencies. The e-learning platform will provide flexible and friendly authoring mechanisms, self-teaching and assessment capabilities, course and trainee management, etc. Courses will be also made available as stand-alone multimedia applications on CD and in the form of a complete pocket handbook. Moreover the project will offer the possibility of upgrading different experiences and practices: a first step towards the harmonization of methodologies and tools of different Countries sharing similar problems. Finally, through wide dissemination activities, the final aim of the project is to ensure the deployment and the integration into existing earthquake mitigation policies and vocational training schemes.

Defining a reference set to support methodological research in drug safety.

PubMed

Ryan, Patrick B; Schuemie, Martijn J; Welebob, Emily; Duke, Jon; Valentine, Sarah; Hartzema, Abraham G

2013-10-01

Methodological research to evaluate the performance of methods requires a benchmark to serve as a referent comparison. In drug safety, the performance of analyses of spontaneous adverse event reporting databases and observational healthcare data, such as administrative claims and electronic health records, has been limited by the lack of such standards. To establish a reference set of test cases that contain both positive and negative controls, which can serve the basis for methodological research in evaluating methods performance in identifying drug safety issues. Systematic literature review and natural language processing of structured product labeling was performed to identify evidence to support the classification of drugs as either positive controls or negative controls for four outcomes: acute liver injury, acute kidney injury, acute myocardial infarction, and upper gastrointestinal bleeding. Three-hundred and ninety-nine test cases comprised of 165 positive controls and 234 negative controls were identified across the four outcomes. The majority of positive controls for acute kidney injury and upper gastrointestinal bleeding were supported by randomized clinical trial evidence, while the majority of positive controls for acute liver injury and acute myocardial infarction were only supported based on published case reports. Literature estimates for the positive controls shows substantial variability that limits the ability to establish a reference set with known effect sizes. A reference set of test cases can be established to facilitate methodological research in drug safety. Creating a sufficient sample of drug-outcome pairs with binary classification of having no effect (negative controls) or having an increased effect (positive controls) is possible and can enable estimation of predictive accuracy through discrimination. Since the magnitude of the positive effects cannot be reliably obtained and the quality of evidence may vary across outcomes, assumptions are required to use the test cases in real data for purposes of measuring bias, mean squared error, or coverage probability.

Quality, risk management and patient safety: the challenge of effective integration.

PubMed

França, Margarida

2008-01-01

Nowadays we observe the development of three waves of intervention and change within healthcare services: quality management, risk management and patient safety. The Patient Safety movement has been launched at international level as a consequence of the Institute of Medicine's report--To Err is Human, and today patient safety constitutes one basic dimension of health quality subjected to the direct intervention of supranational entities (WHO, EU) and Member States' Governments. The objective of this paper is to raise awareness about the value of quality improvement (QI) methodologies and tools to sustainable healthcare quality outcomes.

Minutes of the Explosives Safety Seminar (20th) Held at OMNI international Hotel, Norfolk, Virginia on 24-26 August 1982. Volume I

DTIC Science & Technology

1982-08-01

between one that provides for total protection of life and property and one that per- mits operators to conduct activities in a " laisse - faire " manner...Workers. AD-PO00 456 General Risk Analysis Methodological Implications to Explosives Risk Management Systems. AD-PO0O 457 Risk Analysis for Explosives...THE EFFECTS OF THE HEALTH AND SAFETY AT WORK ACT, 1974, ON MILITARY EXPLOSIVES SAFETY MANAGEMENT IN THE UNITED KINGDOM ........................ 7 Air

A Framework for Reliability and Safety Analysis of Complex Space Missions

NASA Technical Reports Server (NTRS)

Evans, John W.; Groen, Frank; Wang, Lui; Austin, Rebekah; Witulski, Art; Mahadevan, Nagabhushan; Cornford, Steven L.; Feather, Martin S.; Lindsey, Nancy

2017-01-01

Long duration and complex mission scenarios are characteristics of NASA's human exploration of Mars, and will provide unprecedented challenges. Systems reliability and safety will become increasingly demanding and management of uncertainty will be increasingly important. NASA's current pioneering strategy recognizes and relies upon assurance of crew and asset safety. In this regard, flexibility to develop and innovate in the emergence of new design environments and methodologies, encompassing modeling of complex systems, is essential to meet the challenges.

Review of quality assessment tools for the evaluation of pharmacoepidemiological safety studies

PubMed Central

Neyarapally, George A; Hammad, Tarek A; Pinheiro, Simone P; Iyasu, Solomon

2012-01-01

Objectives Pharmacoepidemiological studies are an important hypothesis-testing tool in the evaluation of postmarketing drug safety. Despite the potential to produce robust value-added data, interpretation of findings can be hindered due to well-recognised methodological limitations of these studies. Therefore, assessment of their quality is essential to evaluating their credibility. The objective of this review was to evaluate the suitability and relevance of available tools for the assessment of pharmacoepidemiological safety studies. Design We created an a priori assessment framework consisting of reporting elements (REs) and quality assessment attributes (QAAs). A comprehensive literature search identified distinct assessment tools and the prespecified elements and attributes were evaluated. Primary and secondary outcome measures The primary outcome measure was the percentage representation of each domain, RE and QAA for the quality assessment tools. Results A total of 61 tools were reviewed. Most tools were not designed to evaluate pharmacoepidemiological safety studies. More than 50% of the reviewed tools considered REs under the research aims, analytical approach, outcome definition and ascertainment, study population and exposure definition and ascertainment domains. REs under the discussion and interpretation, results and study team domains were considered in less than 40% of the tools. Except for the data source domain, quality attributes were considered in less than 50% of the tools. Conclusions Many tools failed to include critical assessment elements relevant to observational pharmacoepidemiological safety studies and did not distinguish between REs and QAAs. Further, there is a lack of considerations on the relative weights of different domains and elements. The development of a quality assessment tool would facilitate consistent, objective and evidence-based assessments of pharmacoepidemiological safety studies. PMID:23015600

Software-Based Safety Systems in Space - Learning from other Domains

NASA Astrophysics Data System (ADS)

Klicker, M.; Putzer, H.

2012-01-01

Increasing complexity and new emerging capabilities for manned and unmanned missions have been the hallmark of the past decades of space exploration. One of the drivers in this process was the ever increasing use of software and software-intensive systems to implement system functions necessary to the capabilities needed. The course of technological evolution suggests that this development will continue well into the future with a number of challenges for the safety community some of which shall be discussed in this paper. The current state of the art reveals a number of problems with developing and assessing safety critical software which explains the reluctance of the space community to rely on software-based safety measures to mitigate hazards. Among others, usually lack of trustworthy evidence of software integrity in all foreseeable situations and the difficulties to integrate software in the traditional safety analysis framework are cited. Experience from other domains and recent developments in modern software development methodologies and verification techniques are analysed for the suitability for space systems and an avionics architectural framework (see STANAG 4626) for the implementation of safety critical software is proposed. This is shown to create among other features the possibility of numerous degradation modes enhancing overall system safety and interoperability of computerized space systems. It also potentially simplifies international cooperation on a technical level by introducing a higher degree of compatibility. As software safety cannot be tested or argued into a system in hindsight, the development process and especially the architecture chosen are essential to establish safety properties for the software used to implement safety functions. The core of the safety argument revolves around the separation of different functions and software modules from each other by minimal coupling of functions and credible separation mechanisms in the architecture combined with rigorous development methodologies for the software itself.

Handling and safety enhancement of race cars using active aerodynamic systems

NASA Astrophysics Data System (ADS)

Diba, Fereydoon; Barari, Ahmad; Esmailzadeh, Ebrahim

2014-09-01

A methodology is presented in this work that employs the active inverted wings to enhance the road holding by increasing the downward force on the tyres. In the proposed active system, the angles of attack of the vehicle's wings are adjusted by using a real-time controller to increase the road holding and hence improve the vehicle handling. The handling of the race car and safety of the driver are two important concerns in the design of race cars. The handling of a vehicle depends on the dynamic capabilities of the vehicle and also the pneumatic tyres' limitations. The vehicle side-slip angle, as a measure of the vehicle dynamic safety, should be narrowed into an acceptable range. This paper demonstrates that active inverted wings can provide noteworthy dynamic capabilities and enhance the safety features of race cars. Detailed analytical study and formulations of the race car nonlinear model with the airfoils are presented. Computer simulations are carried out to evaluate the performance of the proposed active aerodynamic system.

A methodology for accident analysis of fusion breeder blankets and its application to helium-cooled lead–lithium blanket

DOE PAGES

Panayotov, Dobromir; Poitevin, Yves; Grief, Andrew; ...

2016-09-23

'Fusion for Energy' (F4E) is designing, developing, and implementing the European Helium-Cooled Lead-Lithium (HCLL) and Helium-Cooled Pebble-Bed (HCPB) Test Blanket Systems (TBSs) for ITER (Nuclear Facility INB-174). Safety demonstration is an essential element for the integration of these TBSs into ITER and accident analysis is one of its critical components. A systematic approach to accident analysis has been developed under the F4E contract on TBS safety analyses. F4E technical requirements, together with Amec Foster Wheeler and INL efforts, have resulted in a comprehensive methodology for fusion breeding blanket accident analysis that addresses the specificity of the breeding blanket designs, materials,more » and phenomena while remaining consistent with the approach already applied to ITER accident analyses. Furthermore, the methodology phases are illustrated in the paper by its application to the EU HCLL TBS using both MELCOR and RELAP5 codes.« less

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

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

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

Systematic and progressive implementation of the centers of excellence for rheumatoid arthritis: a methodological proposal.

PubMed

Santos-Moreno, Pedro; Caballero-Uribe, Carlo V; Massardo, Maria Loreto; Maldonado, Claudio Galarza; Soriano, Enrique R; Pineda, Carlos; Cardiel, Mario; Benavides, Juan Alberto; Beltrán, Paula Andrea

2017-12-01

The implementation of excellence centers in specific diseases has been gaining recognition in the field of health; specifically in rheumatoid arthritis, where the prognosis of the disease is related to an early diagnosis and a timely intervention, it is necessary that the provision of health services is developed in an environment of quality, opportunity, and safety with the highest standards of care. A methodology that allows this implementation in such a way that is achievable by the most of the care centers is a priority to achieve a better attention to populations with this disease. In this paper, we propose a systematic and progressive methodology that will help all the institutions to develop successful models without faltering in the process. The expected impact on public health is defined by a better effective coverage of high-quality treatments, obtaining better health outcomes with safety and accessibility that reduces the budgetary impact for the health systems of our countries.

System engineering toolbox for design-oriented engineers

NASA Technical Reports Server (NTRS)

Goldberg, B. E.; Everhart, K.; Stevens, R.; Babbitt, N., III; Clemens, P.; Stout, L.

1994-01-01

This system engineering toolbox is designed to provide tools and methodologies to the design-oriented systems engineer. A tool is defined as a set of procedures to accomplish a specific function. A methodology is defined as a collection of tools, rules, and postulates to accomplish a purpose. For each concept addressed in the toolbox, the following information is provided: (1) description, (2) application, (3) procedures, (4) examples, if practical, (5) advantages, (6) limitations, and (7) bibliography and/or references. The scope of the document includes concept development tools, system safety and reliability tools, design-related analytical tools, graphical data interpretation tools, a brief description of common statistical tools and methodologies, so-called total quality management tools, and trend analysis tools. Both relationship to project phase and primary functional usage of the tools are also delineated. The toolbox also includes a case study for illustrative purposes. Fifty-five tools are delineated in the text.

Verification methodology for fault-tolerant, fail-safe computers applied to maglev control computer systems. Final report, July 1991-May 1993

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

Lala, J.H.; Nagle, G.A.; Harper, R.E.

1993-05-01

The Maglev control computer system should be designed to verifiably possess high reliability and safety as well as high availability to make Maglev a dependable and attractive transportation alternative to the public. A Maglev control computer system has been designed using a design-for-validation methodology developed earlier under NASA and SDIO sponsorship for real-time aerospace applications. The present study starts by defining the maglev mission scenario and ends with the definition of a maglev control computer architecture. Key intermediate steps included definitions of functional and dependability requirements, synthesis of two candidate architectures, development of qualitative and quantitative evaluation criteria, and analyticalmore » modeling of the dependability characteristics of the two architectures. Finally, the applicability of the design-for-validation methodology was also illustrated by applying it to the German Transrapid TR07 maglev control system.« less

USING A RISK-BASED METHODOLOGY FOR THE TRANSFER OF RADIOACTIVE MATERIAL WITHIN THE SAVANNAH RIVER SITE BOUNDARY

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

Loftin, B; Watkins, R; Loibl, M

2010-06-03

Shipment of radioactive materials (RAM) is discussed in the Code of Federal Regulations in parts of both 49 CFR and 10 CFR. The regulations provide the requirements and rules necessary for the safe shipment of RAM across public highways, railways, waterways, and through the air. These shipments are sometimes referred to as in-commerce shipments. Shipments of RAM entirely within the boundaries of Department of Energy sites, such as the Savannah River Site (SRS), can be made using methodology allowing provisions to maintain equivalent safety while deviating from the regulations for in-commerce shipments. These onsite shipments are known as transfers atmore » the SRS. These transfers must follow the requirements approved in a site-specific Transportation Safety Document (TSD). The TSD defines how the site will transfer materials so that they have equivalence to the regulations. These equivalences are documented in an Onsite Safety Assessment (OSA). The OSA can show how a particular packaging used onsite is equivalent to that which would be used for an in-commerce shipment. This is known as a deterministic approach. However, when a deterministic approach is not viable, the TSD allows for a risk-based OSA to be written. These risk-based assessments show that if a packaging does not provide the necessary safety to ensure that materials are not released (during normal or accident conditions) then the worst-case release of materials does not result in a dose consequence worse than that defined for the SRS. This paper will discuss recent challenges and successes using this methodology at the SRS.« less

The safety of St John's wort (Hypericum perforatum) in pregnancy and lactation: A systematic review of rodent studies.

PubMed

Avila, Catharine; Whitten, Dawn; Evans, Sue

2018-04-30

Herbal products are popular among women during the perinatal period. St John's wort (SJW), Hypericum perforatum, is a common remedy for mild depression, a problem prevalent in this population. Although the safety of herbal products must be investigated, ethical issues constrain intervention studies in humans. Hence, animal studies often inform clinical decisions. The objective of this study is to systematically review rodent studies assessing the safety of SJW during the perinatal period. A literature search to November 10, 2017, identified 10 rodent studies that met a priori inclusion criteria. Study quality was evaluated according to both the Systematic Review Centre for Laboratory animal Experimentation tool for assessing bias and recommendations for appropriate reporting of herbal medicine research. Significant methodological limitations were found in each of the studies reviewed. These limitations include the lack of botanical verification and omission of extract characterization, inadequate explanation of dosage rationale, and absence of bias limiting protocols. Critical appraisal with contemporary tools indicates that each of the reviewed studies lacks appropriate rigour, rendering the results unreliable. Despite this, these papers are used in the rationale for recommending or contraindicating SJW during pregnancy and lactation. Copyright © 2018 John Wiley & Sons, Ltd.

[Working hypothesis of simplified techniques for the first mapping of occupational hazards in handicraft. First part: ergonomics hazards].

PubMed

Colombini, D; Di Leone, G; Occhipinti, E; Montomoli, L; Ruschioni, A; Giambartolomei, M; Ardissone, S; Fanti, M; Pressiani, S; Placci, M; Cerbai, M; Preite, S

2009-01-01

During the last Congress of the International Ergonomics Association (IEA), Beijing - China August 2009, in collaboration with World Health Organization an international group for developing a "toolkit for MSD prevention" was founded. Possible users of toolkits are: members of a health and safety committee; health and safety representatives; line supervisors; foremen; workers; government representatives; health workers implementing basic occupational health services; occupational health and safety specialists. According with ISO standard 11228 series and their ISO Application document for the Key enters and Quick Assessment (green/red conditions), our group developed a first mapping methodology of occupational hazards in handicraft, working with the support of the information technology (Excel). This methodology, utilizing specific key enters and quick evaluation, allows a simple risk estimation. So it is possible to decide for which occupational hazards will be necessary an exhaustive assessment and to which professional consultant it is better to direct them to (worker's doctor, engineer, chemical, etc.).

Methodological proposal for occupational health and safety actions in research laboratories with nanotechnologies activities.

PubMed

Andrade, Luís Renato Balbão; Amaral, Fernando Gonçalves

2012-01-01

Nanotechnologies is a multidisciplinary set of techniques to manipulate matter on nanoscale level, more precisely particles below 100 nm whose characteristic due to small size is essentially different from those found in macro form materials. Regarding to these new properties of the materials there are knowledge gaps about the effects of these particles on human organism and the environment. Although it still being considered emerging technology it is growing increasingly fast as well as the number of products using nanotechnologies in some production level and so the number of researchers involved with the subject. Given this scenario and based on literature related, a comprehensive methodology for health and safety at work for researching laboratories with activities in nanotechnologies was developed, based on ILO structure guidelines for safety and health at work system on which a number of nanospecific recommendations were added to. The work intends to offer food for thought on controlling risks associated to nanotechnologies.

Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy.

PubMed

Skjæret, Nina; Nawaz, Ather; Morat, Tobias; Schoene, Daniel; Helbostad, Jorunn Lægdheim; Vereijken, Beatrix

2016-01-01

There has been a rapid increase in research on the use of virtual reality (VR) and gaming technology as a complementary tool in exercise and rehabilitation in the elderly population. Although a few recent studies have evaluated their efficacy, there is currently no in-depth description and discussion of different game technologies, physical functions targeted, and safety issues related to older adults playing exergames. This integrative review provides an overview of the technologies and games used, progression, safety measurements and associated adverse events, adherence to exergaming, outcome measures used, and their effect on physical function. We undertook systematic searches of SCOPUS and PubMed databases. Key search terms included "game", "exercise", and "aged", and were adapted to each database. To be included, studies had to involve older adults aged 65 years or above, have a pre-post training or intervention design, include ICT-implemented games with weight-bearing exercises, and have outcome measures that included physical activity variables and/or clinical tests of physical function. Sixty studies fulfilled the inclusion criteria. The studies had a broad range of aims and intervention designs and mostly focused on community-dwelling healthy older adults. The majority of the studies used commercially available gaming technologies that targeted a number of different physical functions. Most studies reported that they had used some form of safety measure during intervention. None of the studies reported serious adverse events. However, only 21 studies (35%) reported on whether adverse events occurred. Twenty-four studies reported on adherence, but only seven studies (12%) compared adherence to exergaming with other forms of exercise. Clinical measures of balance were the most frequently used outcome measures. PEDro scores indicated that most studies had several methodological problems, with only 4 studies fulfilling 6 or more criteria out of 10. Several studies found positive effects of exergaming on balance and gait, while none reported negative effects. Exergames show promise as an intervention to improve physical function in older adults, with few reported adverse events. As there is large variability between studies in terms of intervention protocols and outcome measures, as well as several methodological limitations, recommendations for both practice and further research are provided in order to successfully establish exergames as an exercise and rehabilitation tool for older adults. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Eighteen years of recommendations to prevent industrial chemical incidents: results and lessons learned of the US Chemical Safety Board.

PubMed

Tinney, V A; Anenberg, S C; Kaszniak, M; Robinson, B

2016-10-01

The US Chemical Safety Board (CSB), a federal agency that investigates significant chemical incidents and hazards, is interested in determining the impact of the recommendations resulting from its investigations, and how to better more effective recommendations to prevent chemical incidents. This is a descriptive study of the US Chemical Safety Board's safety recommendations. The CSB coded and analysed its safety recommendations according to potential impact on reducing incidents, implementation status, purpose and recipient type. As of March 31, 2015, the CSB has issued 733 recommendations, 75% (548) of which are closed and 25% (185) of which remain open. For recommendations categorised as having high, medium, and low impact, 38% (78), 76% (160), and 78% (245) were implemented, respectively. CSB recommendations have led to important and lasting safety changes through regulations, industry guidance and voluntary consensus standards, and individual companies; however, coding recommendations by potential impact do not fully capture the influence of CSB recommendations. While this methodology serves as a preliminary way to determine the effect of recommendations, further data are needed to determine the extent to which these safety changes have reduced the frequency or severity of industrial accidents. Copyright © 2016 The Royal Society for Public Health. All rights reserved.

Evaluation of a safety training program in three food service companies.

PubMed

Sinclair, Raymond C; Smith, Randall; Colligan, Michael; Prince, Mary; Nguyen, Trang; Stayner, Leslie

2003-01-01

Outcome measures for safety training effectiveness research often do not include measures such as occupational injury experience. Effectiveness mediators also receive sparse attention. A new safety training curriculum was delivered to workers in a stratified random sample of food service facilities across three companies. A similar group of facilities received usual training. We collected post-test measures of demographic variables, safety knowledge, perceptions of transfer of training climate, and workers' compensation claim data for one year after the initial training activities. Knowledge test scores were apparently higher in the new-training units than in the usual-training units. Some demographic variables were inconsistently associated with these differences. Evidence for reduction of the injury rate associated with the new training was observed from two companies but only approached significance for one company. A second company revealed a similar but non-significant trend. Knowledge scores were not significantly associated with lower injury rates. We found evidence that safety training increases knowledge and reduces injuries. We found almost no evidence of effects of training effectiveness mediators, including no relationship between safety knowledge and injury experience. Methodological issues related to conducting a large study may have influenced these results. Although safety training leads to greater knowledge and, in some cases, reduced occupational injuries, the influence of mediating variables remains to be fully explained.

An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

PubMed

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

Elaboration and Validation of the Medication Prescription Safety Checklist 1

PubMed Central

Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena

2017-01-01

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128

An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

PubMed Central

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

RiskSOAP: Introducing and applying a methodology of risk self-awareness in road tunnel safety.

PubMed

Chatzimichailidou, Maria Mikela; Dokas, Ioannis M

2016-05-01

Complex socio-technical systems, such as road tunnels, can be designed and developed with more or less elements that can either positively or negatively affect the capability of their agents to recognise imminent threats or vulnerabilities that possibly lead to accidents. This capability is called risk Situation Awareness (SA) provision. Having as a motive the introduction of better tools for designing and developing systems that are self-aware of their vulnerabilities and react to prevent accidents and losses, this paper introduces the Risk Situation Awareness Provision (RiskSOAP) methodology to the field of road tunnel safety, as a means to measure this capability in this kind of systems. The main objective is to test the soundness and the applicability of RiskSOAP to infrastructure, which is advanced in terms of technology, human integration, and minimum number of safety requirements imposed by international bodies. RiskSOAP is applied to a specific road tunnel in Greece and the accompanying indicator is calculated twice, once for the tunnel design as defined by updated European safety standards and once for the 'as-is' tunnel composition, which complies with the necessary safety requirements, but calls for enhancing safety according to what EU and PIARC further suggest. The derived values indicate the extent to which each tunnel version is capable of comprehending its threats and vulnerabilities based on its elements. The former tunnel version seems to be more enhanced both in terms of it risk awareness capability and safety as well. Another interesting finding is that despite the advanced tunnel safety specifications, there is still room for enriching the safe design and maintenance of the road tunnel. Copyright © 2016 Elsevier Ltd. All rights reserved.

Identification and description of randomized controlled trials and systematic reviews on patient safety published in medical journals.

PubMed

Barajas-Nava, Leticia Andrea; Calvache, José Andrés; López-Alcalde, Jesús; Solà, Ivan; Cosp, Xavier Bonfill

2013-06-01

To identify and describe randomized controlled trials (RCTs) and systematic reviews (SRs) on patient safety published from 1973 onward. We handsearched a total of 12 medical journals published in English with contents related to patient safety to identify RCTs and SRs published between 1973 and the end of 2010. The results obtained from this search were complemented with an additional search in MEDLINE. The documents were classified by area of specialty or service in which the intervention was applied, level of preventive action, and type of patient safety incident, the latter in accordance with the International Classification for Patient Safety proposed by the World Health Organization (WHO). The main features of the identified studies are also described. A total of 787 issues of 12 journals published between 1973 and 2010 were handsearched. This procedure yielded 10,162 references, of which, 131 corresponded to RCTs and 127 to SRs. A parallel MEDLINE search identified only about two-thirds of these articles. Of all the studies identified, 83 RCTs and 64 SRs addressed interventions related to patient safety. The types of incident related to patient safety that were included most often in RCTs involved the clinical process, and for SRs, those related to resources/organizational management. On average, only 3.5 RCTs and 3.4 SRs were published per year, many of which had significant deficiencies in the reported information, such as, for instance, a lack of details on the methodology used. The number of RCTs and SRs on patient safety published in specialized journals is scarce. No studies on interventions to improve the safety of the handling of blood and derivatives, infections related to health care, nutrition, or infrastructure were identified as a result of our search. Handsearching plays a key role in the identification of all the clinical trials that could be included in SRs on patient safety interventions. Knowing the content of RCTs and SRs published on patient safety can better target future research.

14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

Code of Federal Regulations, 2012 CFR

2012-01-01

... operator clearly and convincingly demonstrates that an alternative approach provides an equivalent level of... firing times of the stages, fuel flow rates, contributions from the wind weighting safety system employed... each stage of flight. (iv) Thrust as a function of time. (v) Propellant weight as a function of time...

14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

Code of Federal Regulations, 2010 CFR

2010-01-01

... operator clearly and convincingly demonstrates that an alternative approach provides an equivalent level of... firing times of the stages, fuel flow rates, contributions from the wind weighting safety system employed... each stage of flight. (iv) Thrust as a function of time. (v) Propellant weight as a function of time...

14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

Code of Federal Regulations, 2011 CFR

2011-01-01

... operator clearly and convincingly demonstrates that an alternative approach provides an equivalent level of... firing times of the stages, fuel flow rates, contributions from the wind weighting safety system employed... each stage of flight. (iv) Thrust as a function of time. (v) Propellant weight as a function of time...

14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

Code of Federal Regulations, 2013 CFR

2013-01-01

... operator clearly and convincingly demonstrates that an alternative approach provides an equivalent level of... firing times of the stages, fuel flow rates, contributions from the wind weighting safety system employed... each stage of flight. (iv) Thrust as a function of time. (v) Propellant weight as a function of time...

14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

Code of Federal Regulations, 2014 CFR

2014-01-01

... operator clearly and convincingly demonstrates that an alternative approach provides an equivalent level of... firing times of the stages, fuel flow rates, contributions from the wind weighting safety system employed... each stage of flight. (iv) Thrust as a function of time. (v) Propellant weight as a function of time...

Risk-based process safety assessment and control measures design for offshore process facilities.

PubMed

Khan, Faisal I; Sadiq, Rehan; Husain, Tahir

2002-09-02

Process operation is the most hazardous activity next to the transportation and drilling operation on an offshore oil and gas (OOG) platform. Past experiences of onshore and offshore oil and gas activities have revealed that a small mis-happening in the process operation might escalate to a catastrophe. This is of especial concern in the OOG platform due to the limited space and compact geometry of the process area, less ventilation, and difficult escape routes. On an OOG platform, each extra control measure, which is implemented, not only occupies space on the platform and increases congestion but also adds extra load to the platform. Eventualities in the OOG platform process operation can be avoided through incorporating the appropriate control measures at the early design stage. In this paper, the authors describe a methodology for risk-based process safety decision making for OOG activities. The methodology is applied to various offshore process units, that is, the compressor, separators, flash drum and driers of an OOG platform. Based on the risk potential, appropriate safety measures are designed for each unit. This paper also illustrates that implementation of the designed safety measures reduces the high Fatal accident rate (FAR) values to an acceptable level.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

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

PubMed

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

2005-07-01

This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (p<0.0001). Response rate was significantly higher in the OGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

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

Dobromir Panayotov; Andrew Grief; Brad J. Merrill

'Fusion for Energy' (F4E) develops designs and implements the European Test Blanket Systems (TBS) in ITER - Helium-Cooled Lithium-Lead (HCLL) and Helium-Cooled Pebble-Bed (HCPB). Safety demonstration is an essential element for the integration of TBS in ITER and accident analyses are one of its critical segments. A systematic approach to the accident analyses had been acquired under the F4E contract on TBS safety analyses. F4E technical requirements and AMEC and INL efforts resulted in the development of a comprehensive methodology for fusion breeding blanket accident analyses. It addresses the specificity of the breeding blankets design, materials and phenomena and atmore » the same time is consistent with the one already applied to ITER accident analyses. Methodology consists of several phases. At first the reference scenarios are selected on the base of FMEA studies. In the second place elaboration of the accident analyses specifications we use phenomena identification and ranking tables to identify the requirements to be met by the code(s) and TBS models. Thus the limitations of the codes are identified and possible solutions to be built into the models are proposed. These include among others the loose coupling of different codes or code versions in order to simulate multi-fluid flows and phenomena. The code selection and issue of the accident analyses specifications conclude this second step. Furthermore the breeding blanket and ancillary systems models are built on. In this work challenges met and solutions used in the development of both MELCOR and RELAP5 codes models of HCLL and HCPB TBSs will be shared. To continue the developed models are qualified by comparison with finite elements analyses, by code to code comparison and sensitivity studies. Finally, the qualified models are used for the execution of the accident analyses of specific scenario. When possible the methodology phases will be illustrated in the paper by limited number of tables and figures. Description of each phase and its results in detail as well the methodology applications to EU HCLL and HCPB TBSs will be published in separate papers. The developed methodology is applicable to accident analyses of other TBSs to be tested in ITER and as well to DEMO breeding blankets.« less

Full Bayesian evaluation of the safety effects of reducing the posted speed limit in urban residential area.

PubMed

Islam, Md Tazul; El-Basyouny, Karim

2015-07-01

Full Bayesian (FB) before-after evaluation is a newer approach than the empirical Bayesian (EB) evaluation in traffic safety research. While a number of earlier studies have conducted univariate and multivariate FB before-after safety evaluations and compared the results with the EB method, often contradictory conclusions have been drawn. To this end, the objectives of the current study were to (i) perform a before-after safety evaluation using both the univariate and multivariate FB methods in order to enhance our understanding of these methodologies, (ii) perform the EB evaluation and compare the results with those of the FB methods and (iii) apply the FB and EB methods to evaluate the safety effects of reducing the urban residential posted speed limit (PSL) for policy recommendation. In addition to three years of crash data for both the before and after periods, traffic volume, road geometry and other relevant data for both the treated and reference sites were collected and used. According to the model goodness-of-fit criteria, the current study found that the multivariate FB model for crash severities outperformed the univariate FB models. Moreover, in terms of statistical significance of the safety effects, the EB and FB methods led to opposite conclusions when the safety effects were relatively small with high standard deviation. Therefore, caution should be taken in drawing conclusions from the EB method. Based on the FB method, the PSL reduction was found effective in reducing crashes of all severities and thus is recommended for improving safety on urban residential collector roads. Copyright © 2015 Elsevier Ltd. All rights reserved.

A systematic review of occupational health and safety interventions with economic analyses.

PubMed

Tompa, Emile; Dolinschi, Roman; de Oliveira, Claire; Irvin, Emma

2009-09-01

We reviewed the occupational health and safety intervention literature to synthesize evidence on financial merits of such interventions. A literature search included journal databases, existing systematic reviews, and studies identified by content experts. Studies meeting inclusion criteria were assessed for quality. Evidence was synthesized within industry-intervention type clusters. We found strong evidence that ergonomic and other musculoskeletal injury prevention interventions in manufacturing and warehousing are worth undertaking in terms of their financial merits. We also found strong evidence that multisector disability management interventions are worth undertaking. While the economic evaluation of interventions in this literature warrants further expansion, we found a sufficient number of studies to identify strong, moderate, and limited evidence in certain industry-intervention clusters. The review also provided insights into how the methodological quality of economic evaluations in this literature could be improved.

Applying the AcciMap methodology to investigate the tragic Sewol Ferry accident in South Korea.

PubMed

Lee, Samuel; Moh, Young Bo; Tabibzadeh, Maryam; Meshkati, Najmedin

2017-03-01

This study applies the AcciMap methodology, which was originally proposed by Professor Jens Rasmussen (1997), to the analysis of the tragic Sewol Ferry accident in South Korea on April 16, 2014, which killed 304 mostly young people and is considered as a national disaster in that country. This graphical representation, by incorporating associated socio-technical factors into an integrated framework, provides a big-picture to illustrate the context in which an accident occurred as well as the interactions between different levels of the studied system that resulted in that event. In general, analysis of past accidents within the stated framework can define the patterns of hazards within an industrial sector. Such analysis can lead to the definition of preconditions for safe operations, which is a main focus of proactive risk management systems. In the case of the Sewol Ferry accident, a lot of the blame has been placed on the Sewol's captain and its crewmembers. However, according to this study, which relied on analyzing all available sources published in English and Korean, the disaster is the result of a series of lapses and disregards for safety across different levels of government and regulatory bodies, Chonghaejin Company, and the Sewol's crewmembers. The primary layers of the AcciMap framework, which include the political environment and non-proactive governmental body; inadequate regulations and their lax oversight and enforcement; poor safety culture; inconsideration of human factors issues; and lack of and/or outdated standard operating and emergency procedures were not only limited to the maritime industry in South Korea, and the Sewol Ferry accident, but they could also subject any safety-sensitive industry anywhere in the world. Copyright © 2016 Elsevier Ltd. All rights reserved.

Application of hazard analysis and critical control point methodology and risk-based grading to consumer food safety surveys.

PubMed

Røssvoll, Elin Halbach; Ueland, Øydis; Hagtvedt, Therese; Jacobsen, Eivind; Lavik, Randi; Langsrud, Solveig

2012-09-01

Traditionally, consumer food safety survey responses have been classified as either "right" or "wrong" and food handling practices that are associated with high risk of infection have been treated in the same way as practices with lower risks. In this study, a risk-based method for consumer food safety surveys has been developed, and HACCP (hazard analysis and critical control point) methodology was used for selecting relevant questions. We conducted a nationally representative Web-based survey (n = 2,008), and to fit the self-reported answers we adjusted a risk-based grading system originally developed for observational studies. The results of the survey were analyzed both with the traditional "right" and "wrong" classification and with the risk-based grading system. The results using the two methods were very different. Only 5 of the 10 most frequent food handling violations were among the 10 practices associated with the highest risk. These 10 practices dealt with different aspects of heat treatment (lacking or insufficient), whereas the majority of the most frequent violations involved storing food at room temperature for too long. Use of the risk-based grading system for survey responses gave a more realistic picture of risks associated with domestic food handling practices. The method highlighted important violations and minor errors, which are performed by most people and are not associated with significant risk. Surveys built on a HACCP-based approach with risk-based grading will contribute to a better understanding of domestic food handling practices and will be of great value for targeted information and educational activities.

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.

Safety Case Development as an Information Modelling Problem

NASA Astrophysics Data System (ADS)

Lewis, Robert

This paper considers the benefits from applying information modelling as the basis for creating an electronically-based safety case. It highlights the current difficulties of developing and managing large document-based safety cases for complex systems such as those found in Air Traffic Control systems. After a review of current tools and related literature on this subject, the paper proceeds to examine the many relationships between entities that can exist within a large safety case. The paper considers the benefits to both safety case writers and readers from the future development of an ideal safety case tool that is able to exploit these information models. The paper also introduces the idea that the safety case has formal relationships between entities that directly support the safety case argument using a methodology such as GSN, and informal relationships that provide links to direct and backing evidence and to supporting information.

Quantitative EEG neurofeedback for the treatment of pediatric attention-deficit/hyperactivity disorder, autism spectrum disorders, learning disorders, and epilepsy.

PubMed

Hurt, Elizabeth; Arnold, L Eugene; Lofthouse, Nicholas

2014-07-01

Neurofeedback (NF) using surface electroencephalographic signals has been used to treat various child psychiatric disorders by providing patients with video/audio information about their brain's electrical activity in real-time. Research data are reviewed and clinical recommendations are made regarding NF treatment of youth with attention deficit/hyperactivity disorder, autism, learning disorders, and epilepsy. Most NF studies are limited by methodological issues, such as failure to use or test the validity of a full-blind or sham NF. The safety of NF treatment has not been thoroughly investigated in youth or adults, although clinical experience suggests reasonable safety. Copyright © 2014 Elsevier Inc. All rights reserved.

Fear conditioning and extinction across development: evidence from human studies and animal models.

PubMed

Shechner, Tomer; Hong, Melanie; Britton, Jennifer C; Pine, Daniel S; Fox, Nathan A

2014-07-01

The ability to differentiate danger and safety through associative processes emerges early in life. Understanding the mechanisms underlying associative learning of threat and safety can clarify the processes that shape development of normative fears and pathological anxiety. Considerable research has used fear conditioning and extinction paradigms to delineate underlying mechanisms in animals and human adults; however, little is known about these mechanisms in children and adolescents. The current paper summarizes the empirical data on the development of fear conditioning and extinction. It reviews methodological considerations and future directions for research on fear conditioning and extinction in pediatric populations. Copyright © 2014 Elsevier B.V. All rights reserved.

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

PubMed

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

2017-01-01

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

Safety and Health Hazard Observations in Hmong Farming Operations

PubMed Central

Neitzel, R. L.; Krenz, J.; de Castro, A. B.

2014-01-01

Agricultural workers have a high risk of occupational injuries, illnesses, and fatalities. However, there are very few standardized tools available to assess safety and health in agricultural operations. Additionally, there are a number of groups of agricultural workers, including Hmong refugees and immigrants, for which virtually no information on safety and health conditions is available. This study developed an observation-based methodology for systematically evaluating occupational health and safety hazards in agriculture, and pilot-tested this on several small-scale Hmong farming operations. Each observation assessed of range of safety and health hazards (e.g., musculoskeletal hazards, dust and pollen, noise, and mechanical hazards), as well as on factors such as type of work area, presence of personal protective equipment, and weather conditions. Thirty-six observations were collected on nine farms. The most common hazards observed were bending at the back and lifting <50 pounds. Use of sharp tools without adequate guarding mechanisms, awkward postures, repetitive hand motions, and lifting >50 pounds were also common. The farming activities observed involved almost no power equipment, and no pesticide or chemical handling was observed. The use of personal protective equipment was uncommon. The results of this assessment agreed well with a parallel study of perceived safety and health hazards among Hmong agricultural workers. This study suggests that small-scale Hmong farming operations involve a variety of hazards, and that occupational health interventions may be warranted in this community. The study also demonstrates the utility of standardized assessment tools and mixed-method approaches to hazard evaluation. PMID:24911689

Efficacy and safety of Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham for menopausal women: A systematic review of clinical trials and the way forward.

PubMed

Kongkaew, Chuenjid; Scholfield, Norman C; Dhippayom, Teerapon; Dilokthornsakul, Piyameth; Saokaew, Surasak; Chaiyakunapruk, Nathorn

2018-04-24

Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed. International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines. Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores. The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance. Copyright © 2018 Elsevier B.V. All rights reserved.

Assessment of Integrated Pedestrian Protection Systems with Autonomous Emergency Braking (AEB) and Passive Safety Components.

PubMed

Edwards, Mervyn; Nathanson, Andrew; Carroll, Jolyon; Wisch, Marcus; Zander, Oliver; Lubbe, Nils

2015-01-01

Autonomous emergency braking (AEB) systems fitted to cars for pedestrians have been predicted to offer substantial benefit. On this basis, consumer rating programs-for example, the European New Car Assessment Programme (Euro NCAP)-are developing rating schemes to encourage fitment of these systems. One of the questions that needs to be answered to do this fully is how the assessment of the speed reduction offered by the AEB is integrated with the current assessment of the passive safety for mitigation of pedestrian injury. Ideally, this should be done on a benefit-related basis. The objective of this research was to develop a benefit-based methodology for assessment of integrated pedestrian protection systems with AEB and passive safety components. The method should include weighting procedures to ensure that it represents injury patterns from accident data and replicates an independently estimated benefit of AEB. A methodology has been developed to calculate the expected societal cost of pedestrian injuries, assuming that all pedestrians in the target population (i.e., pedestrians impacted by the front of a passenger car) are impacted by the car being assessed, taking into account the impact speed reduction offered by the car's AEB (if fitted) and the passive safety protection offered by the car's frontal structure. For rating purposes, the cost for the assessed car is normalized by comparing it to the cost calculated for a reference car. The speed reductions measured in AEB tests are used to determine the speed at which each pedestrian in the target population will be impacted. Injury probabilities for each impact are then calculated using the results from Euro NCAP pedestrian impactor tests and injury risk curves. These injury probabilities are converted into cost using "harm"-type costs for the body regions tested. These costs are weighted and summed. Weighting factors were determined using accident data from Germany and Great Britain and an independently estimated AEB benefit. German and Great Britain versions of the methodology are available. The methodology was used to assess cars with good, average, and poor Euro NCAP pedestrian ratings, in combination with a current AEB system. The fitment of a hypothetical A-pillar airbag was also investigated. It was found that the decrease in casualty injury cost achieved by fitting an AEB system was approximately equivalent to that achieved by increasing the passive safety rating from poor to average. Because the assessment was influenced strongly by the level of head protection offered in the scuttle and windscreen area, a hypothetical A-pillar airbag showed high potential to reduce overall casualty cost. A benefit-based methodology for assessment of integrated pedestrian protection systems with AEB has been developed and tested. It uses input from AEB tests and Euro NCAP passive safety tests to give an integrated assessment of the system performance, which includes consideration of effects such as the change in head impact location caused by the impact speed reduction given by the AEB.

Traditional Chinese medicine for knee osteoarthritis: An overview of systematic review.

PubMed

Yang, Min; Jiang, Li; Wang, Qing; Chen, Hao; Xu, Guihua

2017-01-01

Traditional Chinese medicine (TCM) has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown. To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs) on TCM for knee osteoarthritis. Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach. Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from "very low" to "low," mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes. TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice.

Oral Huangqi Formulae for Stable Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis

PubMed Central

Wu, Lei; Chen, Yuanbin; Xu, Yinji; Guo, Xinfeng; Li, Xiaoyan; Zhang, Anthony Lin; May, Brian H.; Xue, Charlie Changli; Wen, Zehuai; Lin, Lin

2013-01-01

Objective. To evaluate the efficacy and safety of oral Huangqi formulae for the treatment of stable COPD. Methods. The major databases were searched until September 2010 and supplemented with a manual search. Randomized controlled trials (RCTs) of oral Huangqi formulae that reported on lung function, St. George's Respiratory Questionnaire, symptom improvement and/or frequency of exacerbations were extracted by two reviewers. The Cochrane tool was used for the assessment of risk of bias in the included trials. Data were analyzed with RevMan 5.1.2 software. Results. 25 RCTs (1,661 participants) were included. Compared with conventional therapy (CT) alone, oral Huangqi formulae plus CT increased FEV1, and a similar result was found comparing Huangqi formulae with no treatment. Improvements in SGRQ total score, COPD-related symptoms and reduction of frequency of exacerbations were found in patients receiving Huangqi formulae plus CT compared to those receiving CT alone or CT plus placebo. No serious adverse events were reported. However, there were some methodological inadequacies in the included studies. Conclusions. The benefits of Huangqi formulae for stable COPD were promising, but its efficacy and safety have not been established due to methodological weakness and possible bias in the reported results. Further rigorously designed studies are warranted. PMID:23606889

Methodology to develop crash modification functions for road safety treatments with fully specified and hierarchical models.

PubMed

Chen, Yongsheng; Persaud, Bhagwant

2014-09-01

Crash modification factors (CMFs) for road safety treatments are developed as multiplicative factors that are used to reflect the expected changes in safety performance associated with changes in highway design and/or the traffic control features. However, current CMFs have methodological drawbacks. For example, variability with application circumstance is not well understood, and, as important, correlation is not addressed when several CMFs are applied multiplicatively. These issues can be addressed by developing safety performance functions (SPFs) with components of crash modification functions (CM-Functions), an approach that includes all CMF related variables, along with others, while capturing quantitative and other effects of factors and accounting for cross-factor correlations. CM-Functions can capture the safety impact of factors through a continuous and quantitative approach, avoiding the problematic categorical analysis that is often used to capture CMF variability. There are two formulations to develop such SPFs with CM-Function components - fully specified models and hierarchical models. Based on sample datasets from two Canadian cities, both approaches are investigated in this paper. While both model formulations yielded promising results and reasonable CM-Functions, the hierarchical model was found to be more suitable in retaining homogeneity of first-level SPFs, while addressing CM-Functions in sub-level modeling. In addition, hierarchical models better capture the correlations between different impact factors. Copyright © 2014 Elsevier Ltd. All rights reserved.

Air-kerma evaluation at the maze entrance of HDR brachytherapy facilities.

PubMed

Pujades, M C; Granero, D; Vijande, J; Ballester, F; Perez-Calatayud, J; Papagiannis, P; Siebert, F A

2014-12-01

In the absence of procedures for evaluating the design of brachytherapy (BT) facilities for radiation protection purposes, the methodology used for external beam radiotherapy facilities is often adapted. The purpose of this study is to adapt the NCRP 151 methodology for estimating the air-kerma rate at the door in BT facilities. Such methodology was checked against Monte Carlo (MC) techniques using the code Geant4. Five different facility designs were studied for (192)Ir and (60)Co HDR applications to account for several different bunker layouts.For the estimation of the lead thickness needed at the door, the use of transmission data for the real spectra at the door instead of the ones emitted by (192)Ir and (60)Co will reduce the lead thickness by a factor of five for (192)Ir and ten for (60)Co. This will significantly lighten the door and hence simplify construction and operating requirements for all bunkers.The adaptation proposed in this study to estimate the air-kerma rate at the door depends on the complexity of the maze: it provides good results for bunkers with a maze (i.e. similar to those used for linacs for which the NCRP 151 methodology was developed) but fails for less conventional designs. For those facilities, a specific Monte Carlo study is in order for reasons of safety and cost-effectiveness.

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

Grabaskas, David; Brunett, Acacia J.; Passerini, Stefano

GE Hitachi Nuclear Energy (GEH) and Argonne National Laboratory (Argonne) participated in a two year collaboration to modernize and update the probabilistic risk assessment (PRA) for the PRISM sodium fast reactor. At a high level, the primary outcome of the project was the development of a next-generation PRA that is intended to enable risk-informed prioritization of safety- and reliability-focused research and development. A central Argonne task during this project was a reliability assessment of passive safety systems, which included the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedbacks of the metal fuel core. Both systems were examinedmore » utilizing a methodology derived from the Reliability Method for Passive Safety Functions (RMPS), with an emphasis on developing success criteria based on mechanistic system modeling while also maintaining consistency with the Fuel Damage Categories (FDCs) of the mechanistic source term assessment. This paper provides an overview of the reliability analyses of both systems, including highlights of the FMEAs, the construction of best-estimate models, uncertain parameter screening and propagation, and the quantification of system failure probability. In particular, special focus is given to the methodologies to perform the analysis of uncertainty propagation and the determination of the likelihood of violating FDC limits. Additionally, important lessons learned are also reviewed, such as optimal sampling methodologies for the discovery of low likelihood failure events and strategies for the combined treatment of aleatory and epistemic uncertainties.« less

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety.

PubMed

Waterson, Patrick; Robertson, Michelle M; Cooke, Nancy J; Militello, Laura; Roth, Emilie; Stanton, Neville A

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a 'roadmap' for future work.

7T: Physics, safety, and potential clinical applications.

PubMed

Kraff, Oliver; Quick, Harald H

2017-12-01

With more than 60 installed magnetic resonance imaging (MRI) systems worldwide operating at a magnetic field strength of 7T or higher, ultrahigh-field (UHF) MRI has been established as a platform for clinically oriented research in recent years. Profound technical and methodological developments have helped overcome the inherent physical challenges of UHF radiofrequency (RF) signal homogenization in the human body. The ongoing development of dedicated RF coil arrays was pivotal in realizing UHF body MRI, beyond mere brain imaging applications. Another precondition to clinical application of 7T MRI is the safety testing of implants and the establishment of safety concepts. Against this backdrop, 7T MRI and MR spectroscopy (MRS) recently have demonstrated capabilities and potentials for clinical diagnostics in a variety of studies. This article provides an overview of the immanent physical challenges of 7T UHF MRI and discusses recent technical solutions and safety concepts. Furthermore, recent clinically oriented studies are highlighted that span a broad application spectrum from 7T UHF brain to body MRI. 4 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1573-1589. © 2017 International Society for Magnetic Resonance in Medicine.

Occupational Safety and Related Impacts on Health  and the Environment.

PubMed

Watterson, Andrew

2016-10-05

The inter-relationship between safety, health and the 'environment' is a complex and at times a relatively neglected topic. In this issue, 'safety' is often viewed by contributors as 'health and safety' and includes occupationally-related ill health as well as injury or harm to employees and the wider public. 'Environment' is also interpreted in the widest sense covering both physical and work environments with upstream work hazards presenting risks to downstream communities. The focus is very much on exploring and where possible addressing the challenges, some old and some facing workers in a range of public and private settings and also at times their nearby communities. The 19 papers in the issue cover public and private sectors, global and very local populations, macro-theoretical perspectives, large epidemiological and some single factory or hospital site small case studies. A number of the papers are just beginning to explore and draw out for the first time the risks from hazards in their part of the world. The methodologies adopted also range from lab-based studies through ergonomic assessments and interventions to therapeutic approaches.

76 FR 5719 - Pattern of Violations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-02

... safety and health record of each mine rather than on a strictly quantitative comparison of mines to... several reservations, given the methodological difficulties involved in estimating the compensating wage...

Regulatory and Safety Requirements for Food Cultures

PubMed Central

Laulund, Svend; Wind, Anette; Derkx, Patrick M. F.; Zuliani, Véronique

2017-01-01

The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product. PMID:28545249

DASHBOARDS & CONTROL CHARTS EXPERIENCES IN IMPROVING SAFETY AT HANFORD WASHINGTON

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

PREVETTE, S.S.

2006-02-27

The aim of this paper is to demonstrate the integration of safety methodology, quality tools, leadership, and teamwork at Hanford and their significant positive impact on safe performance of work. Dashboards, Leading Indicators, Control charts, Pareto Charts, Dr. W. Edward Deming's Red Bead Experiment, and Dr. Deming's System of Profound Knowledge have been the principal tools and theory of an integrated management system. Coupled with involved leadership and teamwork, they have led to significant improvements in worker safety and protection, and environmental restoration at one of the nation's largest nuclear cleanup sites.

The Evaluation of the North Carolina K-9 Traffic Safety Curriculum: Methodology, Findings, and Recommendations.

ERIC Educational Resources Information Center

Padgett, Susan S.

The evaluation of the traffic safety curriculum as presented to K-9 students in North Carolina focused on three areas: (1) the extent to which students acquired the information included in the curriculum, (2) the extent to which students showed a change in their actual pedestrian and bicyclist behavior, and (3) the extent to which teachers made…

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

PubMed

Frosini, Francesco; Miniati, Roberto; Grillone, Saverio; Dori, Fabrizio; Gentili, Guido Biffi; Belardinelli, Andrea

2016-11-14

The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

A Systematic Review of Primary Care Safety Climate Survey Instruments: Their Origins, Psychometric Properties, Quality, and Usage.

PubMed

Curran, Ciara; Lydon, Sinéad; Kelly, Maureen; Murphy, Andrew; Walsh, Chloe; OʼConnor, Paul

2018-06-01

Safety climate (SC) measurement is a common and feasible method of proactive safety assessment in primary care. However, there is no consensus on which instrument is "best" to use. The aim of the study was to identify the origins, psychometric properties, quality, and SC domains measured by survey instruments used to assess SC in primary care settings. Systematic searches were conducted using Medline, Embase, CINAHL, and PsycInfo in February 2016. English-language, peer-reviewed studies that reported the development and/or use of a SC survey in a primary care setting were included. Two reviewers independently extracted data (survey characteristics, origins, and psychometric properties) from studies and applied the Quality Assessment Tool for Studies with Diverse Designs to assess methodological rigour. Safety climate domains within surveys were deductively analyzed and categorized into common healthcare SC themes. Seventeen SC surveys were identified, of which 16 had been adapted from 2 main U.S. hospital-based surveys. Only 1 survey was developed de novo for a primary care setting. The quantity and quality of psychometric testing varied considerably across the surveys. Management commitment to safety was the most frequently measured SC theme (87.5%). Workload was infrequently measured (25%). Valid and reliable instruments, which are context specific to the healthcare environment for intentional use, are essential to accurately assess SC. Key recommendations include further establishing the construct and criterion-related validity of existing instruments as opposed to developing additional surveys.

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

PubMed Central

Pinheiro, Simone P.; Rivera, Donna R.; Graham, David J.; Freedman, Andrew N.; Major, Jacqueline M.; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C.; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2017-01-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. PMID:27663208

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.

PubMed

Pinheiro, Simone P; Rivera, Donna R; Graham, David J; Freedman, Andrew N; Major, Jacqueline M; Penberthy, Lynne; Levenson, Mark; Bradley, Marie C; Wong, Hui-Lee; Ouellet-Hellstrom, Rita

2016-11-01

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting. Published by Elsevier Inc.

Pediatric microdose and microtracer studies using 14C in Europe.

PubMed

Turner, M A; Mooij, M G; Vaes, W H J; Windhorst, A D; Hendrikse, N H; Knibbe, C A J; Kõrgvee, L T; Maruszak, W; Grynkiewicz, G; Garner, R C; Tibboel, D; Park, B K; de Wildt, S N

2015-09-01

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientific challenges. One barrier to the evaluation of medicines for children is a lack of innovative methodologies that have been adapted to the needs of children. This article presents our successful experience of pediatric microdose and microtracer studies using (14) C-labeled probes in Europe to illustrate the strengths and limitations of these approaches. © 2015 ASCPT.

The effects of a lean transition on process times, patients and employees.

PubMed

Simons, Pascale; Backes, Huub; Bergs, Jochen; Emans, Davy; Johannesma, Madelon; Jacobs, Maria; Marneffe, Wim; Vandijck, Dominique

2017-03-13

Purpose Treatment delays must be avoided, especially in oncology, to assure sustainable high-quality health care and increase the odds of survival. The purpose of this paper is to hypothesize that waiting times would decrease and patients and employees would benefit, when specific lean interventions are incorporated in an organizational improvement approach. Design/methodology/approach In 2013, 15 lean interventions were initiated to improve flow in a single radiotherapy institute. Process/waiting times, patient satisfaction, safety, employee satisfaction, and absenteeism were evaluated using a mixed methods methodology (2010-2014). Data from databases, surveys, and interviews were analyzed by time series analysis, χ 2 , multi-level regression, and t-tests. Findings Median waiting/process times improved from 20.2 days in 2012 to 16.3 days in 2014 ( p<0.001). The percentage of palliative patients for which waiting times had exceeded Dutch national norms (ten days) improved from 35 (six months in 2012: pre-intervention) to 16 percent (six months in 2013-2014: post-intervention; p<0.01), and the percentage exceeding national objectives (seven days) from 22 to 17 percent ( p=0.44). For curative patients, exceeding of norms (28 days) improved from 17 (2012) to 8 percent (2013-2014: p=0.05), and for the objectives (21 days) from 18 to 10 percent ( p<0.01). Reported safety incidents decreased 47 percent from 2009 to 2014, whereas safety culture, awareness, and intention to solve problems improved. Employee satisfaction improved slightly, and absenteeism decreased from 4.6 (2010) to 2.7 percent (2014; p<0.001). Originality/value Combining specific lean interventions with an organizational improvement approach improved waiting times, patient safety, employee satisfaction, and absenteeism on the short term. Continuing evaluation of effects should study the improvements sustainability.

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 trauma management. This will help achieve the standardization of indicators including data collection procedures and selection of the key list of indicators that need to be monitored. Based on the results, it has been concluded that the use of the most contributing indicators will make it possible to assess the level of road safety on a territory, with an acceptable quality score by focusing on the low-ranked countries. A smaller set of significant indicators defined in this manner can serve for a fast and simple understanding of a road safety situation and assessment of effects of measures undertaken. Also, this universal index approach is applicable in cases when a broader comprehensive set of indicators is analyzed, which provides a more accurate identification of weaker points and rank the countries in a more meaningful way. Copyright © 2018 Elsevier Ltd. All rights reserved.

Maca (Lepidium meyenii) for treatment of menopausal symptoms: A systematic review.

PubMed

Lee, Myeong Soo; Shin, Byung-Cheul; Yang, Eun Jin; Lim, Hyun-Ja; Ernst, Edzard

2011-11-01

Maca (Lepidium meyenii), an Andean plant of the brassica (mustard) family has been used for centuries in the Andes as an adaptogenic plant to manage anemia, infertility and female hormone balance. The aim of this review was to assess the evidence for and against the effectiveness of the maca plant as a treatment for menopausal symptoms. We searched 17 databases from their inception up to June 2011 and included all randomized clinical trials (RCTs) that compared any type of maca-based intervention to a placebo for the treatment of menopausal symptoms. All studies were assessed for methodological quality using the Cochrane 'risk of bias' assessment tool. Four RCTs met all inclusion criteria. These RCTs tested the effects of maca on menopausal symptoms in healthy perimenopausal, early postmenopausal, and late postmenopausal women. Using the Kupperman Menopausal Index and the Greene Climacteric Score, all RCTs demonstrated favorable effects of maca. There have been very few rigorous trials of maca for menopausal symptoms. The results of our systematic review provide limited evidence for the effectiveness of maca as a treatment for menopausal symptoms. However, the total number of trials, the total sample size, and the average methodological quality of the primary studies, were too limited to draw firm conclusions. Furthermore, the safety has not been proved yet. Therefore, the efficacy and safety should be tested in larger studies. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Quality of reporting in clinical trials of preharvest food safety interventions and associations with treatment effect.

PubMed

Sargeant, Jan M; Saint-Onge, Jacqueline; Valcour, James; Thompson, Adam; Elgie, Robyn; Snedeker, Kate; Marcynuk, Pasha

2009-10-01

Randomized controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. Therefore, it is important that RCTs are conducted with methodological rigor to prevent biased results and report results in a manner that allows the reader to evaluate internal and external validity. Most human health journals now require manuscripts to meet the Consolidated Standards of Reporting Trials (CONSORT) criteria for reporting of RCTs. Our objective was to evaluate preharvest food safety trials using a modification of the CONSORT criteria to assess methodological quality and completeness of reporting, and to investigate associations between reporting and treatment effects. One hundred randomly selected trials were evaluated using a modified CONSORT statement. The majority of the selected trials (84%) used a deliberate disease challenge, with the remainder representing natural pathogen exposure. There were widespread deficiencies in the reporting of many trial features. Randomization, double blinding, and the number of subjects lost to follow-up were reported in only 46%, 0%, and 43% of trials, respectively. The inclusion criteria for study subjects were only described in 16% of trials, and the number of animals housed together was only stated in 52% of the trials. Although 91 trials had more than one outcome, no trials specified the primary outcome of interest. There were significant bivariable associations between the proportion of positive treatment effects and failure to report the number of subjects lost to follow-up, the number of animals housed together in a group, the level of treatment allocation, and possible study limitations. The results suggest that there are substantive deficiencies in reporting of preharvest food safety trials, and that these deficiencies may be associated with biased treatment effects. The creation and adoption of standards for reporting in preharvest food safety trials will help to ensure the inclusion of important trial details in all publications.

Interventions for postoperative pain in children: An overview of systematic reviews.

PubMed

Boric, Krste; Dosenovic, Svjetlana; Jelicic Kadic, Antonia; Batinic, Marijan; Cavar, Marija; Urlic, Marjan; Markovina, Nikolina; Puljak, Livia

2017-09-01

The aim of this study was to conduct an overview of systematic reviews that summarizes the results about efficacy and safety from randomized controlled trials involving the various strategies used for postoperative pain management in children. We searched the Cochrane Database of Systematic Reviews, CINAHL, Database of Reviews of Effect, Embase, MEDLINE, and PsycINFO from the earliest date to January 24, 2016. This overview included 45 systematic reviews that evaluated interventions for postoperative pain in children. Out of 45 systematic reviews that investigated various interventions for postoperative pain in children, 19 systematic reviews (42%) presented conclusive evidence of efficacy. Positive conclusive evidence was reported in 18 systematic reviews (40%) for the efficacy of diclofenac, ketamine, caudal analgesia, dexmedetomidine, music therapy, corticosteroid, epidural analgesia, paracetamol, and/or nonsteroidal anti-inflammatory drugs and transversus abdominis plane block. Only one systematic review reported conclusive evidence of equal efficacy that involved a comparison of dexmedetomidine vs morphine and fentanyl. Safety of interventions was reported as conclusive in 14 systematic reviews (31%), with positive conclusive evidence for dexmedetomidine, corticosteroid, epidural analgesia, transversus abdominis plane block, and clonidine. Seven systematic reviews reported equal conclusive safety for epidural infusion, diclofenac intravenous vs ketamine added to opioid analgesia, bupivacaine, ketamine, paracetamol, and dexmedetomidine vs intravenous infusions of various opioid analgesics, oral suspension and suppository of diclofenac, only opioid, normal saline, no treatment, placebo, and midazolam. Negative conclusive statement for safety was reported in one systematic review for caudal analgesia vs noncaudal regional analgesia. More than half of systematic reviews included in this overview were rated as having medium methodological quality. Of 45 included systematic reviews, 10 were Cochrane reviews and they had higher methodological quality than non-Cochrane reviews. As evidence concerning efficacy and safety is inconclusive for most of the analyzed interventions, our review points out the need for more rigorous trials concerning pain management in children. © 2017 John Wiley & Sons Ltd.

Nano-Evaluris: an inhalation and explosion risk evaluation method for nanoparticle use. Part I: description of the methodology

NASA Astrophysics Data System (ADS)

Bouillard, Jacques X.; Vignes, Alexis

2014-02-01

In this paper, an inhalation health and explosion safety risk assessment methodology for nanopowders is described. Since toxicological threshold limit values are still unknown for nanosized substances, detailed risk assessment on specific plants may not be carried out. A simple approach based on occupational hazard/exposure band expressed in mass concentrations is proposed for nanopowders. This approach is consolidated with an iso surface toxicological scaling method, which has the merit, although incomplete, to provide concentration threshold levels for which new metrological instruments should be developed for proper air monitoring in order to ensure safety. Whenever the processing or use of nanomaterials is introducing a risk to the worker, a specific nano pictogram is proposed to inform the worker. Examples of risk assessment of process equipment (i.e., containment valves) processing various nanomaterials are provided. Explosion risks related to very reactive nanomaterials such as aluminum nanopowders can be assessed using this new analysis methodology adapted to nanopowders. It is nevertheless found that to formalize and extend this approach, it is absolutely necessary to develop new relevant standard apparatuses and to qualify individual and collective safety barriers with respect to health and explosion risks. In spite of these uncertainties, it appears, as shown in the second paper (Part II) that health and explosion risks, evaluated for given MWCNTs and aluminum nanoparticles, remain manageable in their continuous fabrication mode, considering current individual and collective safety barriers that can be put in place. The authors would, however, underline that peculiar attention must be paid to non-continuous modes of operations, such as process equipment cleaning steps, that are often under-analyzed and are too often forgotten critical steps needing vigilance in order to minimize potential toxic and explosion risks.

Why system safety programs can fail

NASA Technical Reports Server (NTRS)

Hammer, W.

1971-01-01

Factors that cause system safety programs to fail are discussed from the viewpoint that in general these programs have not achieved their intended aims. The one item which is considered to contribute most to failure of a system safety program is a poor statement of work which consists of ambiguity, lack of clear definition, use of obsolete requirements, and pure typographical errors. It is pointed out that unless safety requirements are stated clearly, and where they are readily apparent as firm requirements, some of them will be overlooked by designers and contractors. The lack of clarity is stated as being a major contributing factor in system safety program failure and usually evidenced in: (1) lack of clear requirements by the procuring activity, (2) lack of clear understanding of system safety by other managers, and (3) lack of clear methodology to be employed by system safety engineers.

The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management

PubMed Central

Patel, Teresa; Fisher, Stanley P.

2016-01-01

Objective This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. Methods The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. Results Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest‐ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. Conclusions The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success. PMID:27477689

Improving patient safety in Libya: insights from a British health system perspective.

PubMed

Elmontsri, Mustafa; Almashrafi, Ahmed; Dubois, Elizabeth; Banarsee, Ricky; Majeed, Azeem

2018-04-16

Purpose Patient safety programmes aim to make healthcare safe for both patients and health professionals. The purpose of this paper is to explore the UK's patient safety improvement programmes over the past 15 years and explore what lessons can be learnt to improve Libyan healthcare patient safety. Design/methodology/approach Publications focusing on UK patient safety were searched in academic databases and content analysed. Findings Several initiatives have been undertaken over the past 15 years to improve British healthcare patient safety. Many stakeholders are involved, including regulatory and professional bodies, educational providers and non-governmental organisations. Lessons can be learnt from the British journey. Practical implications Developing a national patient safety strategy for Libya, which reflects context and needs is paramount. Above all, Libyan patient safety programmes should reference internationally approved guidelines, evidence, policy and learning from Britain's unique experience. Originality/value This review examines patient safety improvement strategies adopted in Britain to help developing country managers to progress local strategies based on lessons learnt from Britain's unique experience.

Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.

PubMed

Sahota, Tarjinder; Danhof, Meindert; Della Pasqua, Oscar

2016-05-01

Despite ongoing efforts to better understand the mechanisms underlying safety and toxicity, ~30% of the attrition in drug discovery and development is still due to safety concerns. Changes in current practice regarding the assessment of safety and toxicity are required to reduce late stage attrition and enable effective development of novel medicines. This review focuses on the implications of empirical evidence generation for the evaluation of safety and toxicity during drug development. A shift in paradigm is needed to (i) ensure that pharmacological concepts are incorporated into the evaluation of safety and toxicity; (ii) facilitate the integration of historical evidence and thereby the translation of findings across species as well as between in vitro and in vivo experiments and (iii) promote the use of experimental protocols tailored to address specific safety and toxicity questions. Based on historical examples, we highlight the challenges for the early characterisation of the safety profile of a new molecule and discuss how model-based methodologies can be applied for the design and analysis of experimental protocols. Issues relative to the scientific rationale are categorised and presented as a hierarchical tree describing the decision-making process. Focus is given to four different areas, namely, optimisation, translation, analytical construct and decision criteria. From a methodological perspective, the relevance of quantitative methods for estimation and extrapolation of risk from toxicology and safety pharmacology experimental protocols, such as points of departure and potency, is discussed in light of advancements in population and Bayesian modelling techniques (e.g. non-linear mixed effects modelling). Their use in the evaluation of pharmacokinetics (PK) and pharmacokinetic-pharmacodynamic relationships (PKPD) has enabled great insight into the dose rationale for medicines in humans, both in terms of efficacy and adverse events. Comparable benefits can be anticipated for the assessment of safety and toxicity profile of novel molecules. © The Author 2016. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluation of glucose controllers in virtual environment: methodology and sample application.

PubMed

Chassin, Ludovic J; Wilinska, Malgorzata E; Hovorka, Roman

2004-11-01

Adaptive systems to deliver medical treatment in humans are safety-critical systems and require particular care in both the testing and the evaluation phase, which are time-consuming, costly, and confounded by ethical issues. The objective of the present work is to develop a methodology to test glucose controllers of an artificial pancreas in a simulated (virtual) environment. A virtual environment comprising a model of the carbohydrate metabolism and models of the insulin pump and the glucose sensor is employed to simulate individual glucose excursions in subjects with type 1 diabetes. The performance of the control algorithm within the virtual environment is evaluated by considering treatment and operational scenarios. The developed methodology includes two dimensions: testing in relation to specific life style conditions, i.e. fasting, post-prandial, and life style (metabolic) disturbances; and testing in relation to various operating conditions, i.e. expected operating conditions, adverse operating conditions, and system failure. We define safety and efficacy criteria and describe the measures to be taken prior to clinical testing. The use of the methodology is exemplified by tuning and evaluating a model predictive glucose controller being developed for a wearable artificial pancreas focused on fasting conditions. Our methodology to test glucose controllers in a virtual environment is instrumental in anticipating the results of real clinical tests for different physiological conditions and for different operating conditions. The thorough testing in the virtual environment reduces costs and speeds up the development process.

Workload in community pharmacies in the UK and its impact on patient safety and pharmacists' well-being: a review of the evidence.

PubMed

Hassell, Karen; Seston, Elizabeth Mary; Schafheutle, Ellen Ingrid; Wagner, Andrew; Eden, Martin

2011-11-01

New contractual frameworks for community pharmacy are believed to have increased workload for pharmacists; too much work has been implicated in high profile cases of dispensing errors leading to patient harm, and concerns about pharmacists' well-being. A review was undertaken to ascertain whether community pharmacists' workload has increased and whether links between workload and patient safety and pharmacists' well-being have been established. We searched Scopus; EMBASE; MEDLINE; PubMed; CINAHL; PsychINFO; ASSIA; E-pic, and International Pharmaceutical Abstracts for research published between 1989 and 2010 containing data on UK community pharmacy workload, and on its consequences when workload was found to be a determinant of either patient or pharmacist outcomes. Researchers assessed retrieved material against inclusion and exclusion criteria and synthesised findings using a data extraction form. Fifteen studies were retrieved that met the inclusion criteria. A number of methodological weaknesses were identified: studies categorised work tasks and workload differently making comparisons over time or between studies difficult; most studies were small scale or conducted in specific localities, or lacked sufficient methodological information to rule out bias; studies that control for possible confounders are rare. The reviewed research suggests that community pharmacists still spend the majority of their time involved in activities associated with the dispensing of prescriptions. There is some evidence that community pharmacists' workload has increased since the introduction of the new contracts in England and Wales, especially around the core activity of dispensing prescriptions and medicines use reviews. There is also some evidence to suggest a link between heavy workload and aspects of pharmacists' well-being but there is no robust evidence indicating threats to patient safety caused by their having too much work to do. More high quality research is required to examine what constitutes too much work, the impact of high workload, and associations with other work place factors. © 2011 Blackwell Publishing Ltd.

Data and methods for studying commercial motor vehicle driver fatigue, highway safety and long-term driver health.

PubMed

Stern, Hal S; Blower, Daniel; Cohen, Michael L; Czeisler, Charles A; Dinges, David F; Greenhouse, Joel B; Guo, Feng; Hanowski, Richard J; Hartenbaum, Natalie P; Krueger, Gerald P; Mallis, Melissa M; Pain, Richard F; Rizzo, Matthew; Sinha, Esha; Small, Dylan S; Stuart, Elizabeth A; Wegman, David H

2018-03-09

This article summarizes the recommendations on data and methodology issues for studying commercial motor vehicle driver fatigue of a National Academies of Sciences, Engineering, and Medicine study. A framework is provided that identifies the various factors affecting driver fatigue and relating driver fatigue to crash risk and long-term driver health. The relevant factors include characteristics of the driver, vehicle, carrier and environment. Limitations of existing data are considered and potential sources of additional data described. Statistical methods that can be used to improve understanding of the relevant relationships from observational data are also described. The recommendations for enhanced data collection and the use of modern statistical methods for causal inference have the potential to enhance our understanding of the relationship of fatigue to highway safety and to long-term driver health. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

PubMed

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

2013-12-01

Scandinavian countries such as Sweden implemented the occupational health and safety (OHS) measures in the European Directive 89/391/EEC earlier than other European counties, including Spain. In fact, statistics on workplace accident rates reveal that between 2004 and 2009, there were considerably fewer accidents in Sweden than in Spain. The objective of the research described in this paper was to reduce workplace accidents and to improve OHS management in Spain by exploring the OHS practices in Sweden. For this purpose, an exploratory comparative study was conducted, which focused on the effectiveness of the EU directive in both countries. The study included a cross-sectional analysis of workplace accident rates and other contextual indicators in both national contexts. A case study of 14 Swedish and Spanish companies identified 14 differences in the preventive practices implemented. These differences were then assessed with a Delphi study to evaluate their contribution to the reduction of workplace accidents and their potential for improving health and safety management in Spain. The results showed that there was agreement concerning 12 of the 14 practices. Finally, we discuss opportunities of improvement in Spanish companies so that they can make their risk management practices more effective. The findings of this comparative study on the implementation of the European Directive 89/391/EEC in both Sweden and Spain have revealed health and safety managerial practices which, if properly implemented, could contribute to improved work conditions and accident statistics of Spanish companies. In particular, the results suggest that Spanish employers, safety managers, external prevention services, safety deputies and Labour Inspectorates should consider implementing streamlined internal preventive management, promoting the integration of prevention responsibilities to the chain of command, and preventing health and safety management from becoming a mere exchange of documents. The authors also encourage future research studies to use the methodology presented to compare and assess the European Directive 89/391/EEC implementation in other European countries. © 2013.

A strategic approach for Water Safety Plans implementation in Portugal.

PubMed

Vieira, Jose M P

2011-03-01

Effective risk assessment and risk management approaches in public drinking water systems can benefit from a systematic process for hazards identification and effective management control based on the Water Safety Plan (WSP) concept. Good results from WSP development and implementation in a small number of Portuguese water utilities have shown that a more ambitious nationwide strategic approach to disseminate this methodology is needed. However, the establishment of strategic frameworks for systematic and organic scaling-up of WSP implementation at a national level requires major constraints to be overcome: lack of legislation and policies and the need for appropriate monitoring tools. This study presents a framework to inform future policy making by understanding the key constraints and needs related to institutional, organizational and research issues for WSP development and implementation in Portugal. This methodological contribution for WSP implementation can be replicated at a global scale. National health authorities and the Regulator may promote changes in legislation and policies. Independent global monitoring and benchmarking are adequate tools for measuring the progress over time and for comparing the performance of water utilities. Water utilities self-assessment must include performance improvement, operational monitoring and verification. Research and education and resources dissemination ensure knowledge acquisition and transfer.

Final Report - Regulatory Considerations for Adaptive Systems

NASA Technical Reports Server (NTRS)

Wilkinson, Chris; Lynch, Jonathan; Bharadwaj, Raj

2013-01-01

This report documents the findings of a preliminary research study into new approaches to the software design assurance of adaptive systems. We suggest a methodology to overcome the software validation and verification difficulties posed by the underlying assumption of non-adaptive software in the requirementsbased- testing verification methods in RTCA/DO-178B and C. An analysis of the relevant RTCA/DO-178B and C objectives is presented showing the reasons for the difficulties that arise in showing satisfaction of the objectives and suggested additional means by which they could be satisfied. We suggest that the software design assurance problem for adaptive systems is principally one of developing correct and complete high level requirements and system level constraints that define the necessary system functional and safety properties to assure the safe use of adaptive systems. We show how analytical techniques such as model based design, mathematical modeling and formal or formal-like methods can be used to both validate the high level functional and safety requirements, establish necessary constraints and provide the verification evidence for the satisfaction of requirements and constraints that supplements conventional testing. Finally the report identifies the follow-on research topics needed to implement this methodology.

A system methodology for optimization design of the structural crashworthiness of a vehicle subjected to a high-speed frontal crash

NASA Astrophysics Data System (ADS)

Xia, Liang; Liu, Weiguo; Lv, Xiaojiang; Gu, Xianguang

2018-04-01

The structural crashworthiness design of vehicles has become an important research direction to ensure the safety of the occupants. To effectively improve the structural safety of a vehicle in a frontal crash, a system methodology is presented in this study. The surrogate model of Online support vector regression (Online-SVR) is adopted to approximate crashworthiness criteria and different kernel functions are selected to enhance the accuracy of the model. The Online-SVR model is demonstrated to have the advantages of solving highly nonlinear problems and saving training costs, and can effectively be applied for vehicle structural crashworthiness design. By combining the non-dominated sorting genetic algorithm II and Monte Carlo simulation, both deterministic optimization and reliability-based design optimization (RBDO) are conducted. The optimization solutions are further validated by finite element analysis, which shows the effectiveness of the RBDO solution in the structural crashworthiness design process. The results demonstrate the advantages of using RBDO, resulting in not only increased energy absorption and decreased structural weight from a baseline design, but also a significant improvement in the reliability of the design.

Assessment of a French scenario with the INPRO methodology

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

Vasile, A.; Fiorini, G.L.; Cazalet, J.

2006-07-01

This paper presents the French contribution to the Joint Study of the IAEA International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO). It concerns the application of the INPRO methodology to a French scenario, on the transition from present LWRs to EPRs in a first phase and to 4. generation fast reactors in a second phase during the 21. century. The scenario also considers the renewal of the present fuel cycle facilities by the third and the fourth generation ones. Present practice of plutonium recycling in PWR is replaced by the middle of the century by a global recyclingmore » of actinides, uranium, plutonium and minor actinides in fast reactors. The status and the evolution of the INPRO criteria and the corresponding indicators during the studied period are analyzed for each of the six considered areas: economics, safety, environment, waste management, proliferation resistance and infrastructure. Improvements on economic and safety are expected for both the EPR and the 4. generation systems having these improvements among their basic goals. The use of fast reactors and global recycling of actinides leads to a significant improvement on environment indicators and in particular on the natural resources utilization. The envisaged waste management policy results in significant reductions on mass, thermal loads and radiotoxicity of the final waste which only contains fission products. The use of fuels that do not relay on enriched uranium and separated plutonium increases the proliferation resistance characteristics of the future fuel cycle. The paper summarizes also some recommendations on the data, codes and methods used to support the continuous improvement of the INPRO methodology and help future assessors. (authors)« less

Hotspots identification and ranking for road safety improvement: an alternative approach.

PubMed

Coll, Bronagh; Moutari, Salissou; Marshall, Adele H

2013-10-01

During the last decade, the concept of composite performance index, brought from economic and business statistics, has become a popular practice in the field of road safety, namely for the identification and classification of worst performing areas or time slots also known as hotspots. The overall quality of a composite index depends upon the complexity of phenomena of interest as well as the relevance of the methodological approach used to aggregate the various indicators into a single composite index. However, current aggregation methods used to estimate the composite road safety performance index suffer from various deficiencies at both the theoretical and operational level; these include the correlation and compensability between indicators, the weighting of the indicators as well as their high "degree of freedom" which enables one to readily manipulate them to produce desired outcomes (Munda and Nardo, 2003, 2005, 2009). The objective of this study is to contribute to the ongoing research effort on the estimation of road safety composite index for hotspots' identification and ranking. The aggregation method for constructing the composite road safety performance index introduced in this paper, strives to minimize the aforementioned deficiencies of the current approaches. Furthermore, this new method can be viewed as an intelligent decision support system for road safety performance evaluation, in order to prioritize interventions for road safety improvement. Copyright © 2013 Elsevier Ltd. All rights reserved.

The translation of sports injury prevention and safety promotion knowledge: insights from key intermediary organisations.

PubMed

Bekker, Sheree; Paliadelis, Penny; Finch, Caroline F

2017-03-28

A recognised research-to-practice gap exists in the health research field of sports injury prevention and safety promotion. There is a need for improved insight into increasing the relevancy, accessibility and legitimacy of injury prevention and safety promotion research knowledge for sport settings. The role of key organisations as intermediaries in the process of health knowledge translation for sports settings remains under-explored, and this paper aims to determine, and describe, the processes of knowledge translation undertaken by a set of key organisations in developing and distributing injury prevention and safety promotion resources. The National Guidance for Australian Football Partnerships and Safety (NoGAPS) project provided the context for this study. Representatives from five key NoGAPS organisations participated in individual face-to-face interviews about organisational processes of knowledge translation. A qualitative descriptive methodology was used to analyse participants' descriptions of knowledge translation activities undertaken at their respective organisations. Several themes emerged around health knowledge translation processes and considerations, including (1) identifying a need for knowledge translation, (2) developing and disseminating resources, and (3) barriers and enablers to knowledge translation. This study provides insight into the processes that key organisations employ when developing and disseminating injury prevention and safety promotion resources within sport settings. The relevancy, accessibility and legitimacy of health research knowledge is foregrounded, with a view to increasing the influence of research on the development of health-related resources suitable for community sport settings.

Effects of Metric Change on Safety in the Workplace for Selected Occupations.

DTIC Science & Technology

1982-04-21

a measurement, or misccmuni- cation of the measurement between workers. The factor comon to each case is based on the human learning theory, which...SENSITIVE OCCUPATIONS w/ NMGM UNJUMT MATS& & DECISION REOUISEUUUTS SKATED TO UE1ASIUS19ENT HAZARDOUS OCCUPATIONS ALL OCCUPATIONS II. STUDY METHODOLOGY... Motors Waukegan, Illinois 60085 Dr. Jams Johnson Department of Heal th and Human Services 8120 Hillcrest Drive Manassas, Virginia 22111 Mr. Darrell

[Comparative evaluation of neurovirulence of domestic and foreign live mumps vaccine].

PubMed

Maksimova, O A; Popov, V F; Bektimirov, T A; Grigor'eva, L V; Iunasova, T N; Kaplunova, O P; Sharova, O K

2001-01-01

Morphological and immunofluorescent study of changes in the central nervous system of monkeys with mumps was carried out in order to determine the criteria of neurovirulence of different mumps virus strains. Quantitative evaluation showed a lower residual neurovirulence of L-3 strain vs. Jeryl Lynn and Urabe Am9 strains. Use of new methodological approaches to evaluation of mumps vaccine strain neurovirulence will improve the safety control of live mumps vaccines.

[Integral methodologic approach to occupational health maintenance for oil industry workers in North-West Siberia (exemplified by JSC "Novosibirsknephtegaz" model)].

PubMed

Logvinenko, I I; Voevoda, M I; Samadova, D T; Kulinich, V N; Kopylova, O S

2011-01-01

The authors analyzed work conditions and health of workers in oil-extracting industry of Novosibirsk region. Findings are that work safety system based on workplace certification concerning work conditions and on occupational safety activities certification is the most important component in primary prevention of occupational hazardous effects on life and health of workers during the occupational activities.

Ethnomedical survey and safety evaluation of traditional eye medicines used in Misungwi district, Tanzania

PubMed Central

Maregesi, Sheila M.; Messo, Charles W.; Mathias, Juma

2017-01-01

Aim: This study aimed at documenting products used as traditional eye medicine (TEM) in Misungwi district, Tanzania, and performing preliminary analysis on safety status. Methodology: Ethnomedical study was conducted in Misungwi district. Information was sourced by face-to-face interview with traditional healers, traditional medicine vendors, and knowledgeable people guided by a well-structured questionnaire. Safety was evaluated by determining pH using pH meter and mineral analysis using the Delta, Portable X-ray fluorescence equipment, and qualitative chemical tests. Results: A total of 23 TEM products were recorded from botanical (79%) and zoological (21%) sources including animal excreta. Liquid preparation ranked highest among dosage forms. Safety evaluation showed that only one product possessed the pH value of 7.4 as recommended for topical ophthalmic medicines. Fourteen minerals were detected and quantified in three samples; some of these minerals are known for their negative effects to the eyes, of medical interest is strontium used for the management of benign eye tumors. Information providers were unaware of health risks associated with the use of TEM. Conclusion: This study has revealed the common use of TEM in Misungwi district. The majority of the products are from the botanical source. Although literature provides supporting data for the application to some of the recorded TEM, safety evaluation by pH and mineral analysis in this study have indicated possible ophthalmological medical problems that could result from using such products. Extensive scientific studies including animal experiments and identification of bioactive compounds are essential to develop safe TEMs. PMID:28163964

The 2007 Projected Impacts to Clark County and Local Government Public Safety Agencies Resulting from the Transportation of High- Level Nuclear Waste to Yucca Mountain

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

Mushkatel, A.H.; Conway, P.H.D.S.; Navis, I.

2008-07-01

This paper focuses on projecting fiscal impacts to public safety agencies from the proposed high-level nuclear waste repository at Yucca Mountain, Nevada. The efforts made by Clark County Nevada, to develop a fiscal model of impacts for public safety agencies are described in this paper. In addition, the scenarios used in the study are discussed, as well as a discussion of the plume models provided for each community's scenario that result from the efforts of the National Atmospheric Release Advisory Center (NARAC). Some of the difficulties in constructing a fiscal model of impacts for the entire 24 year high-level nuclearmore » waste transportation shipping campaign are identified, and a refined methodology is provided to accomplish this task. Finally, a comparison of the fiscal impact projections for public safety agencies that Clark County developed in 2001, 2005 are discussed, and the fiscal impact cost projections for the entire 24 year transportation campaign are provided. (authors)« less

Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review

PubMed Central

Krauth, David; Woodruff, Tracey J.

2013-01-01

Background: Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking. Objective: We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies. Method: We searched Medline (January 1966–November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument. Discussion: Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability. Conclusion: Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument. Citation: Krauth D, Woodruff TJ, Bero L. 2013. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect 121:985–992 (2013); http://dx.doi.org/10.1289/ehp.1206389 PMID:23771496

Risk-Informed External Hazards Analysis for Seismic and Flooding Phenomena for a Generic PWR

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

Parisi, Carlo; Prescott, Steve; Ma, Zhegang

This report describes the activities performed during the FY2017 for the US-DOE Light Water Reactor Sustainability Risk-Informed Safety Margin Characterization (LWRS-RISMC), Industry Application #2. The scope of Industry Application #2 is to deliver a risk-informed external hazards safety analysis for a representative nuclear power plant. Following the advancements occurred during the previous FYs (toolkits identification, models development), FY2017 focused on: increasing the level of realism of the analysis; improving the tools and the coupling methodologies. In particular the following objectives were achieved: calculation of buildings pounding and their effects on components seismic fragility; development of a SAPHIRE code PRA modelsmore » for 3-loops Westinghouse PWR; set-up of a methodology for performing static-dynamic PRA coupling between SAPHIRE and EMRALD codes; coupling RELAP5-3D/RAVEN for performing Best-Estimate Plus Uncertainty analysis and automatic limit surface search; and execute sample calculations for demonstrating the capabilities of the toolkit in performing a risk-informed external hazards safety analyses.« less

Eigenvalue Contributon Estimator for Sensitivity Calculations with TSUNAMI-3D

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

Rearden, Bradley T; Williams, Mark L

2007-01-01

Since the release of the Tools for Sensitivity and Uncertainty Analysis Methodology Implementation (TSUNAMI) codes in SCALE [1], the use of sensitivity and uncertainty analysis techniques for criticality safety applications has greatly increased within the user community. In general, sensitivity and uncertainty analysis is transitioning from a technique used only by specialists to a practical tool in routine use. With the desire to use the tool more routinely comes the need to improve the solution methodology to reduce the input and computational burden on the user. This paper reviews the current solution methodology of the Monte Carlo eigenvalue sensitivity analysismore » sequence TSUNAMI-3D, describes an alternative approach, and presents results from both methodologies.« less

A safety culture assessment by mixed methods at a public maternity and infant hospital in China

PubMed Central

Listyowardojo, Tita Alissa; Yan, Xiaoling; Leyshon, Stephen; Ray-Sannerud, Bobbie; Yu, Xin Yan; Zheng, Kai; Duan, Tao

2017-01-01

Objective To assess safety culture at a public maternity hospital in Shanghai, China, using a sequential mixed methods approach. The study was part of a bigger study looking at the application of the mixed methods approach to assess safety culture in health care in different organizations and countries. Methodology A mixed methods approach was utilized by first distributing the Safety Attitudes Questionnaire measuring six safety culture dimensions and five independent items to all hospital staff (n=1482) working in 18 departments at a single hospital. Afterward, semistructured interviews were conducted using convenience sampling, where 48 hospital staff from nine departments at the same hospital were individually interviewed. Results The survey received a response rate of 96%. The survey findings show significant differences between the hospital departments in almost all safety culture dimensions and independent items. Similarly, the interview findings revealed that there were different, competing priorities between departments perceived to result in a reduced quality of collaboration and bottlenecks in care delivery. Another major finding was that staff who worked more hours per week would perceive working conditions significantly more negatively. Issues related to working conditions were also the most common concerns discussed in the interviews, especially the issue on high workload. High workload was also reflected in the fact that 91.45% of survey respondents reported that they worked 40 hours or longer per week. Finally, interview findings complemented survey findings, thus providing a more complete and accurate picture of safety culture. Conclusion Hospital leaders need to prioritize interventions focused on improving the quality of cross-department collaboration and reducing workload. A mixed methods assessment of safety culture provides more meaningful, targeted results, enabling leaders to prioritize and tailor improvement efforts to increase the impact of an intervention. PMID:28740399

Estimating intrapartum-related perinatal mortality rates for booked home births: when the 'best' available data are not good enough.

PubMed

Gyte, G; Dodwell, M; Newburn, M; Sandall, J; Macfarlane, A; Bewley, S

2009-06-01

To critically appraise a recent study on the safety of home birth (Mori R, Dougherty M, Whittle M. BJOG 2008;115:554) and assess its contribution to the debate about risks and benefits of planned home birth for women at low risk of complications. Critical appraisal of a published paper. England and Wales. Home births from 1994-2003 and all women giving birth in the same time period. Six members of a multidisciplinary group appraised the paper independently. Comments were collated and synthesised. Assessment of: overall methodology; assumptions used in estimating figures; methods used for calculations; conclusions drawn from the results and reliability and consistency of data. Although there were some positive aspects to the study, there were weaknesses in design and an inaccurate estimate of risk. Our evidence suggests that the conclusions drawn did not reflect the results and the methodological weaknesses found in the study rendered both the results and conclusions invalid. On the basis of our critical appraisal, the study does not contribute to the existing evidence about the safety of home birth to inform decision-making or provision of care. The limitations could have been identified by the peer review process and the problems were compounded by an inaccurate press release. Great care needs to be taken by journals to ensure the accuracy of information before dissemination to the scientific community, clinicians and the public. These data should not have been used to inform national guidelines.

Cannabis for therapeutic purposes and public health and safety: a systematic and critical review.

PubMed

Sznitman, Sharon R; Zolotov, Yuval

2015-01-01

The use of Cannabis for Therapeutic Purposes (CTP) has recently become legal in many places. These policy and legal modifications may be related to changes in cannabis perceptions, availability and use and in the way cannabis is grown and sold. This may in turn have effects on public health and safety. To better understand the potential effects of CTP legalization on public health and safety, the current paper synthesizes and critically discusses the relevant literature. Twenty-eight studies were identified by a comprehensive search strategy, and their characteristics and main findings were systematically reviewed according to the following content themes: CTP and illegal cannabis use; CTP and other public health issues; CTP, crime and neighbourhood disadvantage. The research field is currently limited by a lack of theoretical and methodological rigorous studies. The review shows that the most prevalent theme of investigation so far has been the relation between CTP and illegal cannabis use. In addition, the literature review shows that there is an absence of evidence to support many common concerns related to detrimental public health and safety effects of CTP legalization. Although lack of evidence provides some reassurance that CTP legalization may not have posed a substantial threat to public health and safety, this conclusion needs to be examined in light of the limitations of studies conducted so far. Furthermore, as CTP policy continues to evolve, including incorporation of greater commercialization, it is possible that the full effects of CTP legalization have yet to take place. Ensuring study quality will allow future research to better investigate the complex role that CTP plays in relation to society at large, and public health and safety in particular. Copyright © 2014 Elsevier B.V. All rights reserved.

The use of meta-analysis or research synthesis to combine driving simulation or naturalistic study results on driver distraction.

PubMed

Caird, Jeff K; Johnston, Katherine A; Willness, Chelsea R; Asbridge, Mark

2014-06-01

Three important and inter-related topics are addressed in this paper. First, the importance of meta-analysis and research synthesis methods to combine studies on traffic safety, in general, and on driver distraction, in particular, is briefly reviewed. Second, naturalistic, epidemiologic, and driving simulation studies on driver distraction are used to illustrate convergent and divergent results that have accumulated thus far in this domain of research. In particular, mobile phone conversation, passenger presence, and text messaging naturalistic studies use meta-analyses and research syntheses to illustrate important patterns of results that are in need of more in-depth study. Third, a number of driver distraction study limitations such as poorly defined dependent variables, lack of methodological detail, and omission of statistical information prevent the integration of many studies into meta-analyses. In addition, the overall quality of road safety studies suffers from these same limitations and suggestions for improvement are made to guide researchers and reviewers. Practical Applications. The use of research synthesis and meta-analysis provide comprehensive estimates of the impact of distractions on driving performance, which can be used to guide public policy and future research. Copyright © 2014 National Safety Council and Elsevier Ltd. All rights reserved.

Development of an Integrated Team Training Design and Assessment Architecture to Support Adaptability in Healthcare Teams

DTIC Science & Technology

2017-10-01

to patient safety by addressing key methodological and conceptual gaps in healthcare simulation-based team training. The investigators are developing...primary outcome of Aim 1a is a conceptually and methodologically sound training design architecture that supports the development and integration of team...should be delivered. This subtask was delayed by approximately 1 month and is now completed. Completed Evaluation of existing experimental dataset to

Preparedness of fire safety in underground train station: Comparison between train operators in Malaysia with other operators from the developed countries

NASA Astrophysics Data System (ADS)

Tajedi, Noor Aqilah A.; Sukor, Nur Sabahiah A.; Ismail, Mohd Ashraf M.; Shamsudin, Shahrul A.

2017-10-01

The purpose of this paper is to compare the fire evacuation plan and preparation at the underground train stations in the different countries. The methodology for this study was using the extended questionnaire survey to investigate the Rapid Rail Sdn Bhd, Malaysia's fire safety plan and preparation at the underground train stations. There were four sections in the questionnaire which included (i) background of the respondents, (ii) the details on the train stations, safety instruction and fire evacuation exercises (iii) technical systems, installation and equipment at the underground stations and (iv) procedures and technical changes related to fire safety that had been applied by the operators. Previously, the respondents from the different train operator services in the developed countries had completed the questionnaires. This paper extends the response from the Rapid Rail Sdn Bhd to compare the emergency procedures and preparation for fire event with the developed countries. As a result, this study found that the equipment and facilities that provided at the underground train stations that operated by Rapid Rail are relevant for fire safety procedures and needs. The main advantage for Rapid Rail is the underground stations were designed with two or more entrances/exits that may perform better evacuation compare to one main entrance/exit train stations in the other developed countries.

Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients.

PubMed

Ghahramanlou-Holloway, Marjan; Brown, Gregory K; Currier, Glenn W; Brenner, Lisa; Knox, Kerry L; Grammer, Geoffrey; Carreno-Ponce, Jaime T; Stanley, Barbara

2014-09-01

Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18-24 months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap. Published by Elsevier Inc.

NASA's Software Safety Standard

NASA Technical Reports Server (NTRS)

Ramsay, Christopher M.

2005-01-01

NASA (National Aeronautics and Space Administration) relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft (manned or unmanned) launched that did not have a computer on board that provided vital command and control services. Despite this growing dependence on software control and monitoring, there has been no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Led by the NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard (STD-18l9.13B) has recently undergone a significant update in an attempt to provide that consistency. This paper will discuss the key features of the new NASA Software Safety Standard. It will start with a brief history of the use and development of software in safety critical applications at NASA. It will then give a brief overview of the NASA Software Working Group and the approach it took to revise the software engineering process across the Agency.

Methodology for Prototyping Increased Levels of Automation for Spacecraft Rendezvous Functions

NASA Technical Reports Server (NTRS)

Hart, Jeremy J.; Valasek, John

2007-01-01

The Crew Exploration Vehicle necessitates higher levels of automation than previous NASA vehicles, due to program requirements for automation, including Automated Rendezvous and Docking. Studies of spacecraft development often point to the locus of decision-making authority between humans and computers (i.e. automation) as a prime driver for cost, safety, and mission success. Therefore, a critical component in the Crew Exploration Vehicle development is the determination of the correct level of automation. To identify the appropriate levels of automation and autonomy to design into a human space flight vehicle, NASA has created the Function-specific Level of Autonomy and Automation Tool. This paper develops a methodology for prototyping increased levels of automation for spacecraft rendezvous functions. This methodology is used to evaluate the accuracy of the Function-specific Level of Autonomy and Automation Tool specified levels of automation, via prototyping. Spacecraft rendezvous planning tasks are selected and then prototyped in Matlab using Fuzzy Logic techniques and existing Space Shuttle rendezvous trajectory algorithms.

A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

NASA Astrophysics Data System (ADS)

Tabibzadeh, Maryam

According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test misinterpretation. Finally, a rational decision making model is introduced to quantify a section of the developed conceptual framework in the previous step and analyze the impact of different decision making biases on negative pressure test results. Along with the corroborating findings of previous studies, the analysis of the developed conceptual framework in this paper indicates that organizational factors are root causes of accumulated errors and questionable decisions made by personnel or management. Further analysis of this framework identifies procedural issues, economic pressure, and personnel management issues as the organizational factors with the highest influence on misinterpreting a negative pressure test. It is noteworthy that the captured organizational factors in the introduced conceptual framework are not only specific to the scope of the NPT. Most of these organizational factors have been identified as not only the common contributing causes of other offshore drilling accidents but also accidents in other oil and gas related operations as well as high-risk operations in other industries. In addition, the proposed rational decision making model in this research introduces a quantitative structure for analysis of the results of a conducted NPT. This model provides a structure and some parametric derived formulas to determine a cut-off point value, which assists personnel in accepting or rejecting an implemented negative pressure test. Moreover, it enables analysts to assess different decision making biases involved in the process of interpreting a conducted negative pressure test as well as the root organizational factors of those biases. In general, although the proposed integrated research methodology in this dissertation is developed for the risk assessment of human and organizational factors contributions in negative pressure test misinterpretation, it can be generalized and be potentially useful for other well control situations, both offshore and onshore; e.g. fracking. In addition, this methodology can be applied for the analysis of any high-risk operations, in not only the oil and gas industry but also in other industries such as nuclear power plants, aviation industry, and transportation sector.

Contribution of European research to risk analysis.

PubMed

Boenke, A

2001-12-01

The European Commission's, Quality of Life Research Programme, Key Action 1-Health, Food & Nutrition is mission-oriented and aims, amongst other things, at providing a healthy, safe and high-quality food supply leading to reinforced consumer confidence in the safety, of European food. Its objectives also include the enhancing of the competitiveness of the European food supply. Key Action 1 is currently supporting a number of different types of European collaborative projects in the area of risk analysis. The objectives of these projects range from the development and validation of prevention strategies including the reduction of consumers risks; development and validation of new modelling approaches, harmonization of risk assessment principles methodologies and terminology; standardization of methods and systems used for the safety evaluation of transgenic food; providing of tools for the evaluation of human viral contamination of shellfish and quality control; new methodologies for assessing the potential of unintended effects of genetically modified (genetically modified) foods; development of a risk assessment model for Cryptosporidium parvum related to the food and water industries, to the development of a communication platform for genetically modified organism, producers, retailers, regulatory authorities and consumer groups to improve safety assessment procedures, risk management strategies and risk communication; development and validation of new methods for safety testing of transgenic food; evaluation of the safety and efficacy of iron supplementation in pregnant women, evaluation of the potential cancer-preventing activity of pro- and pre-biotic ('synbiotic') combinations in human volunteers. An overview of these projects is presented here.

A hybrid design methodology for structuring an Integrated Environmental Management System (IEMS) for shipping business.

PubMed

Celik, Metin

2009-03-01

The International Safety Management (ISM) Code defines a broad framework for the safe management and operation of merchant ships, maintaining high standards of safety and environmental protection. On the other hand, ISO 14001:2004 provides a generic, worldwide environmental management standard that has been utilized by several industries. Both the ISM Code and ISO 14001:2004 have the practical goal of establishing a sustainable Integrated Environmental Management System (IEMS) for shipping businesses. This paper presents a hybrid design methodology that shows how requirements from both standards can be combined into a single execution scheme. Specifically, the Analytic Hierarchy Process (AHP) and Fuzzy Axiomatic Design (FAD) are used to structure an IEMS for ship management companies. This research provides decision aid to maritime executives in order to enhance the environmental performance in the shipping industry.

Simulation as a surgical teaching model.

PubMed

Ruiz-Gómez, José Luis; Martín-Parra, José Ignacio; González-Noriega, Mónica; Redondo-Figuero, Carlos Godofredo; Manuel-Palazuelos, José Carlos

2018-01-01

Teaching of surgery has been affected by many factors over the last years, such as the reduction of working hours, the optimization of the use of the operating room or patient safety. Traditional teaching methodology fails to reduce the impact of these factors on surgeońs training. Simulation as a teaching model minimizes such impact, and is more effective than traditional teaching methods for integrating knowledge and clinical-surgical skills. Simulation complements clinical assistance with training, creating a safe learning environment where patient safety is not affected, and ethical or legal conflicts are avoided. Simulation uses learning methodologies that allow teaching individualization, adapting it to the learning needs of each student. It also allows training of all kinds of technical, cognitive or behavioural skills. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Development of ergonomics audits for bagging, haul truck and maintenance and repair operations in mining.

PubMed

Dempsey, Patrick G; Pollard, Jonisha; Porter, William L; Mayton, Alan; Heberger, John R; Gallagher, Sean; Reardon, Leanna; Drury, Colin G

2017-12-01

The development and testing of ergonomics and safety audits for small and bulk bag filling, haul truck and maintenance and repair operations in coal preparation and mineral processing plants found at surface mine sites is described. The content for the audits was derived from diverse sources of information on ergonomics and safety deficiencies including: analysis of injury, illness and fatality data and reports; task analysis; empirical laboratory studies of particular tasks; field studies and observations at mine sites; and maintenance records. These diverse sources of information were utilised to establish construct validity of the modular audits that were developed for use by mine safety personnel. User and interrater reliability testing was carried out prior to finalising the audits. The audits can be implemented using downloadable paper versions or with a free mobile NIOSH-developed Android application called ErgoMine. Practitioner Summary: The methodology used to develop ergonomics audits for three types of mining operations is described. Various sources of audit content are compared and contrasted to serve as a guide for developing ergonomics audits for other occupational contexts.

Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception.

PubMed

Mishell, Daniel R; Guillebaud, John; Westhoff, Carolyn; Nelson, Anita L; Kaunitz, Andrew M; Trussell, James; Davis, Ann Jeanette

2007-01-01

Initially approved for use in the United States nearly 50 years ago, oral hormonal contraceptives containing both estrogen and progestin have undergone steady improvements in safety and convenience. Concurrent with improvements in safety associated with decreasing doses of both steroids, there has been an increased incidence of unscheduled bleeding and spotting. There exist no standards regarding data collection techniques and methods, and reporting and analysis of bleeding and spotting events during combined hormonal contraceptive (CHC) trials. For the regulatory review of hormonal contraceptives, data regarding the incidence of bleeding and spotting events are not included in either of the traditional categories of efficacy and safety. Standardization of methods for collecting and analyzing data about cycle control in all clinical trials of CHCs is long overdue. Until such standards are developed and implemented, clinicians need to familiarize themselves with the techniques used in each study in order to provide correct information to their patients about the frequency of bleeding and spotting associated with different formulations and delivery systems.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Do prescription stimulants increase the risk of adverse cardiovascular events?: A systematic review

PubMed Central

2012-01-01

Background There is increasing concern that prescription stimulants may be associated with adverse cardiovascular events such as stroke, myocardial infarction, and sudden death. Public health concerns are amplified by increasing use of prescription stimulants among adults. Methods The objective of this study was to conduct a systematic review of the evidence of an association between prescription stimulant use and adverse cardiovascular outcomes. PUBMED, MEDLINE, EMBASE and Google Scholar searches were conducted using key words related to these topics (MESH): ADHD; Adults; Amphetamine; Amphetamines; Arrhythmias, Cardiac; Cardiovascular Diseases; Cardiovascular System; Central Nervous Stimulants; Cerebrovascular; Cohort Studies; Case–control Studies; Death; Death, Sudden, Cardiac; Dextroamphetamine; Drug Toxicity; Methamphetamine; Methylphenidate; Myocardial Infarction; Stimulant; Stroke; Safety. Eligible studies were population-based studies of children, adolescents, or adults using prescription stimulant use as the independent variable and a hard cardiovascular outcome as the dependent variable. Results Ten population-based observational studies which evaluated prescription stimulant use with cardiovascular outcomes were reviewed. Six out of seven studies in children and adolescents did not show an association between stimulant use and adverse cardiovascular outcomes. In contrast, two out of three studies in adults found an association. Conclusions Findings of an association between prescription stimulant use and adverse cardiovascular outcomes are mixed. Studies of children and adolescents suggest that statistical power is limited in available study populations, and the absolute risk of an event is low. More suggestive of a safety signal, studies of adults found an increased risk for transient ischemic attack and sudden death/ventricular arrhythmia. Interpretation was limited due to differences in population, cardiovascular outcome selection/ascertainment, and methodology. Accounting for confounding and selection biases in these studies is of particular concern. Future studies should address this and other methodological issues. PMID:22682429

Traditional Chinese medicine for knee osteoarthritis: An overview of systematic review

PubMed Central

Wang, Qing; Chen, Hao

2017-01-01

Background Traditional Chinese medicine (TCM) has been accepted as a complementary therapy for knee osteoarthritis. However, the efficacy and safety of the intervention were still conflicting and uncertain. Meanwhile, the quality of methodology and evidence in the field was unknown. Objective To summarize the characteristics and critically evaluate the quality of methodology, as well as the evidence of systematic reviews (SRs) on TCM for knee osteoarthritis. Methods Five electronic databases were searched from inception to April 2016. The methodological quality of the included studies was assessed by AMSTAR and ROBIS. The quality of the evidence was determined using the GRADE approach. Results Ten SRs were included. The conclusions suggest that TCM provides potential benefits for patients with knee osteoarthritis. These benefits include pain relief, functional improvement, and presence of few adverse events. Limitations of the methodological quality mainly included the lack of a-priori protocol or protocol registration and incomprehensive literature search. A list of excluded studies was also not provided. The overall quality of evidence in the SRs was poor, ranging from “very low” to “low,” mainly because of the serious risk of bias of original trials, inconsistencies, and imprecision in the outcomes. Conclusions TCM generally appears to be effective for knee osteoarthritis treatment. However, the evidence is not robust enough because of the methodological flaws in SRs. Hence, these conclusions on available SRs should be treated with caution for clinical practice. PMID:29267324

The impact of airport characteristics on airport surface accidents and incidents.

PubMed

Wilke, Sabine; Majumdar, Arnab; Ochieng, Washington Y

2015-06-01

Airport surface safety and in particular runway and taxiway safety is acknowledged globally as one of aviation's greatest challenges. To improve this key area of aviation safety, it is necessary to identify and understand the causal and contributing factors on safety occurrences. While the contribution of human factors, operations, and procedures has been researched extensively, the impact of the airport and its associated characteristics itself has received little or no attention. This paper introduces a novel methodology for risk and hazard assessment of airport surface operations, and models the relationships between airport characteristics, and (a) the rate of occurrences, (b) the severity of occurrences, and (c) the causal factors underlying occurrences. The results show for the first time how the characteristics of airports, and in particular its infrastructure and operations, influence the safety of surface operations. Copyright © 2015 Elsevier Ltd. and National Safety Council. Published by Elsevier Ltd. All rights reserved.

Mindfulness Meditation for Substance Use Disorders: A Systematic Review

PubMed Central

Zgierska, Aleksandra; Rabago, David; Chawla, Neharika; Kushner, Kenneth; Koehler, Robert; Marlatt, Allan

2009-01-01

Relapse is common in substance use disorders (SUDs), even among treated individuals. The goal of this article was to systematically review the existing evidence on mindfulness meditation-based interventions (MM) for SUDs. The comprehensive search for and review of literature found over 2,000 abstracts and resulted in 25 eligible manuscripts (22 published, 3 unpublished: 8 RCTs, 7 controlled non-randomized, 6 non-controlled prospective, 2 qualitative studies, 1 case report). When appropriate, methodological quality, absolute risk reduction, number needed to treat, and effect size (ES) were assessed. Overall, although preliminary evidence suggests MM efficacy and safety, conclusive data for MM as a treatment of SUDs are lacking. Significant methodological limitations exist in most studies. Further, it is unclear which persons with SUDs might benefit most from MM. Future trials must be of sufficient sample size to answer a specific clinical question and should target both assessment of effect size and mechanisms of action. PMID:19904664

Evaluation Studies of Robotic Rollators by the User Perspective: A Systematic Review.

PubMed

Werner, Christian; Ullrich, Phoebe; Geravand, Milad; Peer, Angelika; Hauer, Klaus

2016-01-01

Robotic rollators enhance the basic functions of established devices by technically advanced physical, cognitive, or sensory support to increase autonomy in persons with severe impairment. In the evaluation of such ambient assisted living solutions, both the technical and user perspectives are important to prove usability, effectiveness and safety, and to ensure adequate device application. The aim of this systematic review is to summarize the methodology of studies evaluating robotic rollators with focus on the user perspective and to give recommendations for future evaluation studies. A systematic literature search up to December 31, 2014, was conducted based on the Cochrane Review methodology using the electronic databases PubMed and IEEE Xplore. Articles were selected according to the following inclusion criteria: evaluation studies of robotic rollators documenting human-robot interaction, no case reports, published in English language. Twenty-eight studies were identified that met the predefined inclusion criteria. Large heterogeneity in the definitions of the target user group, study populations, study designs and assessment methods was found across the included studies. No generic methodology to evaluate robotic rollators could be identified. We found major methodological shortcomings related to insufficient sample descriptions and sample sizes, and lack of appropriate, standardized and validated assessment methods. Long-term use in habitual environment was also not evaluated. Apart from the heterogeneity, methodological deficits in most of the identified studies became apparent. Recommendations for future evaluation studies include: clear definition of target user group, adequate selection of subjects, inclusion of other assistive mobility devices for comparison, evaluation of the habitual use of advanced prototypes, adequate assessment strategy with established, standardized and validated methods, and statistical analysis of study results. Assessment strategies may additionally focus on specific functionalities of the robotic rollators allowing an individually tailored assessment of innovative features to document their added value. © 2016 S. Karger AG, Basel.

Applying Systems Thinking to Law Enforcement Safety: Recommendation for a Comprehensive Safety Management Framework

DTIC Science & Technology

2015-12-01

Occupational Injuries COPS Community Oriented Policing Services CRM Crew Resource Management DA Department of the Army FEMA Federal Emergency...establishes composite risk management ( CRM ), also known as crew resource management, “as the Army’s principal risk reduction methodology and assures...regulatory and statutory compliance.”106 CRM , also utilized by other branches within the military and by the aviation industry, is intended “to minimize

Third year nursing students' viewpoints about circumstances which threaten safety in the clinical setting.

PubMed

Montgomery, Phyllis; Killam, Laura; Mossey, Sharolyn; Heerschap, Corey

2014-02-01

Evidence emphasizes that learners, educators, clinicians, programs, and organizations share the responsibility for establishing and maintaining safety throughout undergraduate nursing education. Increased knowledge about students' perceptions of threats to safety in the clinical setting may guide educators' efforts to promote the development of safe novice practitioners while preserving patient safety. The purpose of this study was to describe third year nursing students' viewpoints of the circumstances which threaten safety in the clinical setting. Using Q methodology, 34 third year Bachelor of Science in Nursing students sorted 43 theoretical statement cards. Each card identified a statement describing a threat to safety in the clinical setting. These statements were generated through a review of nursing literature and consultation with experts in nursing education. Centroid factor analysis and varimax rotation identified viewpoints regarding circumstances that most threaten safety. Three discrete viewpoints and one consensus perspective constituted students' description of threatened safety. The discrete viewpoints were labeled lack of readiness, misdirected practices, and negation of professional boundaries. There was consensus that it is most unsafe in the clinical setting when novices fail to consolidate an integrated cognitive, behavioral, and ethical identity. This unifying perspective was labeled non-integration. Third year nursing students and their educators are encouraged to be mindful of the need to ensure readiness prior to entry into the clinical setting. In the clinical setting, the learning of prepared students must be guided by competent educators. Finally, both students and their educators must respect professional boundaries to promote safety for students and patients. © 2013.

Methodology for clinical trials involving patients with cancer who have febrile neutropenia: updated guidelines of the Immunocompromised Host Society/Multinational Association for Supportive Care in Cancer, with emphasis on outpatient studies.

PubMed

Feld, Ronald; Paesmans, Marianne; Freifeld, Alison G; Klastersky, Jean; Pizzo, Philip A; Rolston, Kenneth V I; Rubenstein, Edward; Talcott, James A; Walsh, Thomas J

2002-12-15

Two multinational organizations, the Immunocompromised Host Society and the Multinational Association for Supportive Care in Cancer, have produced for investigators and regulatory bodies a set of guidelines on methodology for clinical trials involving patients with febrile neutropenia. The guidelines suggest that response (i.e., success of initial empirical antibiotic therapy without any modification) be determined at 72 h and again on day 5, and the reasons for modification should be stated. Blinding and stratification are to be encouraged, as should statistical consideration of trials specifically designed for showing equivalence. Patients enrolled in outpatient studies should be selected by use of a validated risk model, and patients should be carefully monitored after discharge from the hospital. Response and safety parameters should be recorded along with readmission rates. If studies use these guidelines, comparisons between studies will be simpler and will lead to further improvements in patient therapy.

[Methodological problems of noninfectious epidemiology and hygiene under chemical pollution of the environment].

PubMed

Rusakov, N V

In modern conditions the base of the assurance of the safety of human being from harmful factors of environment is the hygienic rationing for the latters. The use of this methodological principle led to the considerable decline in the level of chemical pollution of environment objects. However tens of millions of Russians are exposed to the impact of chemicals above admissible hygienic level. There was noted the high prevalence and mortality rate due to noninfectious diseases of the population. The hygienic science needs to develop and introduce methodology of personification prevention on protection of the person against chemical environmental pollution.

The efficacy and feasibility of aquatic physiotherapy for people with Parkinson's disease: a systematic review.

PubMed

Terrens, Aan Fleur; Soh, Sze-Ee; Morgan, Prue Elizabeth

2017-08-09

To critically evaluate the literature regarding the efficacy and feasibility of aquatic physiotherapy in people with Parkinson's disease. Relevant studies were identified through searches in nine health-related databases. Two independent reviewers assessed study quality using either the PEDro scale or a customised tool for safety and feasibility. Database searches yielded 88 articles, of which 10 met the inclusion criteria. Studies varied greatly in methodology, quality, interventions and outcome measures. Study quality was generally low in items reporting on safety precautions, adverse events, attrition, and adherence. Results suggest that aquatic physiotherapy may have a positive effect on motor symptoms, quality of life and balance. Aquatic physiotherapy may improve aspects of motor performance, quality of life and balance in people with Parkinson's disease, however, it remains unclear whether it is a safe and feasible treatment modality. The development of standardised outcome measures for people with Parkinson's disease (unified Parkinson's disease rating scale and Parkinson's disease questionnaire-39) would aid study comparability and validate study outcomes. As safety criteria was grossly underreported, guidelines for mandatory reporting of safety criteria are essential to make conclusions regarding the feasibility of aquatic physiotherapy for people with Parkinson's disease. Implications for Rehabilitation Aquatic physiotherapy may be a beneficial treatment modality for people with Parkinson's disease. A minimum data set that includes the unified Parkinson's disease rating scale and Parkinson's disease questionnaire 39 is required to aid future meta-analysis and to allow more definitive conclusions to be made regarding aquatic physiotherapy for people with Parkinson's disease. People with Parkinson's disease are a vulnerable population, where safety within an aquatic physiotherapy program needs to be well documented and addressed.

Identifying associations between pig pathologies using a multi-dimensional machine learning methodology.

PubMed

Sanchez-Vazquez, Manuel J; Nielen, Mirjam; Edwards, Sandra A; Gunn, George J; Lewis, Fraser I

2012-08-31

Abattoir detected pathologies are of crucial importance to both pig production and food safety. Usually, more than one pathology coexist in a pig herd although it often remains unknown how these different pathologies interrelate to each other. Identification of the associations between different pathologies may facilitate an improved understanding of their underlying biological linkage, and support the veterinarians in encouraging control strategies aimed at reducing the prevalence of not just one, but two or more conditions simultaneously. Multi-dimensional machine learning methodology was used to identify associations between ten typical pathologies in 6485 batches of slaughtered finishing pigs, assisting the comprehension of their biological association. Pathologies potentially associated with septicaemia (e.g. pericarditis, peritonitis) appear interrelated, suggesting on-going bacterial challenges by pathogens such as Haemophilus parasuis and Streptococcus suis. Furthermore, hepatic scarring appears interrelated with both milk spot livers (Ascaris suum) and bacteria-related pathologies, suggesting a potential multi-pathogen nature for this pathology. The application of novel multi-dimensional machine learning methodology provided new insights into how typical pig pathologies are potentially interrelated at batch level. The methodology presented is a powerful exploratory tool to generate hypotheses, applicable to a wide range of studies in veterinary research.

Biomimetics in the design of a robotic exoskeleton for upper limb therapy

NASA Astrophysics Data System (ADS)

Baniqued, Paul Dominick E.; Dungao, Jade R.; Manguerra, Michael V.; Baldovino, Renann G.; Abad, Alexander C.; Bugtai, Nilo T.

2018-02-01

Current methodologies in designing robotic exoskeletons for upper limb therapy simplify the complex requirements of the human anatomy. As a result, such devices tend to compromise safety and biocompatibility with the intended user. However, a new design methodology uses biological analogues as inspiration to address these technical issues. This approach follows that of biomimetics, a design principle that uses the extraction and transfer of useful information from natural morphologies and processes to solve technical design issues. In this study, a biomimetic approach in the design of a 5-degree-of-freedom robotic exoskeleton for upper limb therapy was performed. A review of biomimetics was first discussed along with its current contribution to the design of rehabilitation robots. With a proposed methodological framework, the design for an upper limb robotic exoskeleton was generated using CATIA software. The design was inspired by the morphology of the bones and the muscle force transmission of the upper limbs. Finally, a full design assembly presented had integrated features extracted from the biological analogue. The successful execution of a biomimetic design methodology made a case in providing safer and more biocompatible robots for rehabilitation.

Evaluation of Enhanced Risk Monitors for Use on Advanced Reactors

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

Ramuhalli, Pradeep; Veeramany, Arun; Bonebrake, Christopher A.

This study provides an overview of the methodology for integrating time-dependent failure probabilities into nuclear power reactor risk monitors. This prototypic enhanced risk monitor (ERM) methodology was evaluated using a hypothetical probabilistic risk assessment (PRA) model, generated using a simplified design of a liquid-metal-cooled advanced reactor (AR). Component failure data from industry compilation of failures of components similar to those in the simplified AR model were used to initialize the PRA model. Core damage frequency (CDF) over time were computed and analyzed. In addition, a study on alternative risk metrics for ARs was conducted. Risk metrics that quantify the normalizedmore » cost of repairs, replacements, or other operations and management (O&M) actions were defined and used, along with an economic model, to compute the likely economic risk of future actions such as deferred maintenance based on the anticipated change in CDF due to current component condition and future anticipated degradation. Such integration of conventional-risk metrics with alternate-risk metrics provides a convenient mechanism for assessing the impact of O&M decisions on safety and economics of the plant. It is expected that, when integrated with supervisory control algorithms, such integrated-risk monitors will provide a mechanism for real-time control decision-making that ensure safety margins are maintained while operating the plant in an economically viable manner.« less

Defining the methodological challenges and opportunities for an effective science of sociotechnical systems and safety

PubMed Central

Waterson, Patrick; Robertson, Michelle M.; Cooke, Nancy J.; Militello, Laura; Roth, Emilie; Stanton, Neville A.

2015-01-01

An important part of the application of sociotechnical systems theory (STS) is the development of methods, tools and techniques to assess human factors and ergonomics workplace requirements. We focus in this paper on describing and evaluating current STS methods for workplace safety, as well as outlining a set of six case studies covering the application of these methods to a range of safety contexts. We also describe an evaluation of the methods in terms of ratings of their ability to address a set of theoretical and practical questions (e.g. the degree to which methods capture static/dynamic aspects of tasks and interactions between system levels). The outcomes from the evaluation highlight a set of gaps relating to the coverage and applicability of current methods for STS and safety (e.g. coverage of external influences on system functioning; method usability). The final sections of the paper describe a set of future challenges, as well as some practical suggestions for tackling these. Practitioner Summary: We provide an up-to-date review of STS methods, a set of case studies illustrating their use and an evaluation of their strengths and weaknesses. The paper concludes with a ‘roadmap’ for future work. PMID:25832121

Structural health monitoring methodology for aircraft condition-based maintenance

NASA Astrophysics Data System (ADS)

Saniger, Jordi; Reithler, Livier; Guedra-Degeorges, Didier; Takeda, Nobuo; Dupuis, Jean Pierre

2001-06-01

Reducing maintenance costs while keeping a constant level of safety is a major issue for Air Forces and airlines. The long term perspective is to implement condition based maintenance to guarantee a constant safety level while decreasing maintenance costs. On this purpose, the development of a generalized Structural Health Monitoring System (SHMS) is needed. The objective of such a system is to localize the damages and to assess their severity, with enough accuracy to allow low cost corrective actions. The present paper describes a SHMS based on acoustic emission technology. This choice was driven by its reliability and wide use in the aerospace industry. The described SHMS uses a new learning methodology which relies on the generation of artificial acoustic emission events on the structure and an acoustic emission sensor network. The calibrated acoustic emission events picked up by the sensors constitute the knowledge set that the system relies on. With this methodology, the anisotropy of composite structures is taken into account, thus avoiding the major cause of errors of classical localization methods. Moreover, it is adaptive to different structures as it does not rely on any particular model but on measured data. The acquired data is processed and the event's location and corrected amplitude are computed. The methodology has been demonstrated and experimental tests on elementary samples presented a degree of accuracy of 1cm.

Rail-Highway Crossing Resource Allocation Model

DOT National Transportation Integrated Search

1981-04-01

This report describes a methodology developed at the Transportation Systems Center for the Federal Railroad Administration and the Federal Highway Administration to aid in determining the most effective allocation of funds to improve safety at rail-h...

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and evaluating the results of such studies. Copyright © 2010 Elsevier B.V. All rights reserved.

A design and implementation methodology for diagnostic systems

NASA Technical Reports Server (NTRS)

Williams, Linda J. F.

1988-01-01

A methodology for design and implementation of diagnostic systems is presented. Also discussed are the advantages of embedding a diagnostic system in a host system environment. The methodology utilizes an architecture for diagnostic system development that is hierarchical and makes use of object-oriented representation techniques. Additionally, qualitative models are used to describe the host system components and their behavior. The methodology architecture includes a diagnostic engine that utilizes a combination of heuristic knowledge to control the sequence of diagnostic reasoning. The methodology provides an integrated approach to development of diagnostic system requirements that is more rigorous than standard systems engineering techniques. The advantages of using this methodology during various life cycle phases of the host systems (e.g., National Aerospace Plane (NASP)) include: the capability to analyze diagnostic instrumentation requirements during the host system design phase, a ready software architecture for implementation of diagnostics in the host system, and the opportunity to analyze instrumentation for failure coverage in safety critical host system operations.

Risk-based requirements management framework with applications to assurance cases

NASA Astrophysics Data System (ADS)

Feng, D.; Eyster, C.

The current regulatory approach for assuring device safety primarily focuses on compliance with prescriptive safety regulations and relevant safety standards. This approach, however, does not always lead to a safe system design even though safety regulations and standards have been met. In the medical device industry, several high profile recalls involving infusion pumps have prompted the regulatory agency to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. Assurance cases have been used in safety-critical systems for some time. Most assurance cases, if not all, in literature today are developed in an ad hoc fashion, independent from risk management and requirement development. An assurance case is a resource-intensive endeavor that requires additional effort and documentation from equipment manufacturers. Without a well-organized requirements infrastructure in place, such “ additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, the authors present a Risk-Based Requirements and Assurance Management (RBRAM) methodology. The RBRAM is an elaborate framework that combines Risk-Based Requirements Management (RBRM) with assurance case methods. Such an integrated framework can help manufacturers leverage an existing risk management to present a comprehensive assurance case with minimal additional effort while providing a supplementary means to reexamine the integrity of the system design in terms of the mission objective. Although the example used is from the medical industry, the authors believe that the RBRAM methodology underlines the fundamental principle of risk management, and offers a simple, yet effective framework applicable to aerospace industry, perhaps, to any industry.

New Tools for Measuring and Improving Patient Safety in Canadian Hospitals.

PubMed

D'Silva, Jennifer; Amuah, Joseph Emmanuel; Sovran, Vanessa; MacLaurin, Anne; Rodgers, Jennifer; Johnson, Tracy; Leeb, Kira; Kossey, Sandi

2017-01-01

The Canadian Institute for Health Information (CIHI) and the Canadian Patient Safety Institute (CPSI) have collaborated on a new measure of patient safety, along with a resource of evidence-informed practices. This measure captures four broad categories of harm in acute care hospitals, consisting of 31 clinical groups selected by clinicians. Analysis showed that harm was experienced in 1 of 18 hospital stays in Canada in 2014ߝ2015 and that no single category accounted for the majority of harmful events. Although CIHI and CPSI continue to work with hospitals and experts to further refine the methodology, the measure and associated Improvement Resource are useful new tools for monitoring and identifying harm, and have the potential to improve patient safety.

Developing a theoretical foundation to change road user behavior and improve traffic safety: Driving under the influence of cannabis (DUIC).

PubMed

Ward, Nicholas J; Schell, William; Kelley-Baker, Tara; Otto, Jay; Finley, Kari

2018-05-19

This study explored a theoretical model to assess the influence of culture on willingness and intention to drive under the influence of cannabis (DUIC). This model is expected to guide the design of strategies to change future DUIC behavior in road users. This study used a survey methodology to obtain a nationally representative sample (n = 941) from the AmeriSpeak Panel. Survey items were designed to measure aspects of a proposed definition of traffic safety culture and a predictive model of its relationship to DUIC. Although the percentage of reported past DUIC behaviors was relatively low (8.5%), this behavior is still a significant public health issue-especially for younger drivers (18-29 years), who reported more DUIC than expected. Findings suggest that specific cultural components (attitudes, norms) reliably predict past DUIC behavior, general DUIC willingness, and future DUIC intention. Most DUIC behavior appears to be deliberate, related significantly to willingness and intention. Intention and willingness both appear to fully moderate the relationship between traffic safety culture and DUIC behavior. This study explored a theoretical model to understand road user behavior involving drug (cannabis)-impaired driving as a significant risk factor for traffic safety. By understanding the cultural factors that increase DUIC behavior, we can create strategies to transform this culture and sustain safer road user behavior.

Perceived risk and modal choice: risk compensation in transportation systems.

PubMed

Noland, R B

1995-08-01

A transportation mode choice analysis is performed that examines behavioral responses to perceived risk in the choice of mode for daily commute trips. This methodology provides a technique for examining, by means of disaggregate individual level data, risk-compensating effects in transportation systems. Various measures of perceived risk are examined for explaining modal choice. Other studies have described how safety regulations have resulted in increases in "driving intensity." This study defines one component of driving intensity to be the increased probability of commuting by automobile. The results show that modal shifts occur when risk perceptions for a given mode are reduced. To demonstrate potential risk-compensating effects within the transportation system, an estimate of changes in accident fatalities due to commuting is derived using rough estimates of fatalities per person-mile travelled. It is shown that a given change in the perceived risk of commuting by automobile results in a less than proportionate change in net commuting fatalities. The relative magnitude is dependent on how objective reductions in risk translate into perceived reductions in risk. This study also shows that perceived safety improvements in bicycle transportation have an aggregate elasticity value that is greater than one. This means that bicycle safety improvements attract proportionately more people to bicycle commuting (i.e. a 10% increase in safety results in a greater than 10% increase in the share of people bicycle commuting).

Obstetric Safety and Quality.

PubMed

Pettker, Christian M; Grobman, William A

2015-07-01

Obstetric safety and quality is an emerging and important topic not only as a result of the pressures of patient and regulatory expectations, but also because of the genuine interest of caregivers to reduce harm, improve outcomes, and optimize care. Although each seeks to improve care by using scientific approaches beyond human physiology and pathophysiology, patient safety methodologies seek to avoid preventable adverse events, whereas health care quality projects aim to achieve the best possible outcomes. It is well-documented that an increasingly complex medical system controlled by human workers is a circumstance subject to recurrent failure. A safety culture encourages a proactive approach to mitigate failure before, during, and after it occurs. This article highlights the key concepts in health care safety and quality and reviews the background of the quality improvement sciences with particular emphasis on obstetric outcomes and quality measures.

Structural Design Methodology Based on Concepts of Uncertainty

NASA Technical Reports Server (NTRS)

Lin, K. Y.; Du, Jiaji; Rusk, David

2000-01-01

In this report, an approach to damage-tolerant aircraft structural design is proposed based on the concept of an equivalent "Level of Safety" that incorporates past service experience in the design of new structures. The discrete "Level of Safety" for a single inspection event is defined as the compliment of the probability that a single flaw size larger than the critical flaw size for residual strength of the structure exists, and that the flaw will not be detected. The cumulative "Level of Safety" for the entire structure is the product of the discrete "Level of Safety" values for each flaw of each damage type present at each location in the structure. Based on the definition of "Level of Safety", a design procedure was identified and demonstrated on a composite sandwich panel for various damage types, with results showing the sensitivity of the structural sizing parameters to the relative safety of the design. The "Level of Safety" approach has broad potential application to damage-tolerant aircraft structural design with uncertainty.

Current evidence of percutaneous nucleoplasty for the cervical herniated disk: a systematic review.

PubMed

Wullems, Jorgen A; Halim, Willy; van der Weegen, Walter

2014-07-01

Although percutaneous cervical nucleoplasty (PCN) has been shown to be both safe and effective, its application is still debated. PCN applied in disk herniation has not been systematically reviewed before, resulting in a limited insight into its effectiveness and safety, and the quality of available evidence. Therefore, we systematically reviewed the evidence on the efficacy and safety of PCN in patients with a (contained) herniated disk. MEDLINE, EMBASE, and the Cochrane Library (Central Register of Controlled Trials) were searched for randomized controlled trials (RCTs) and nonrandomized studies using the following keywords: "Nucleoplasty," "Cervical," "Hernia," "Herniation," "Prolapse," "Protrusion," "Intervertebral disk," and "Percutaneous disk decompression." First, all articles were appraised for methodological quality, and then, RCTs were graded for the level of evidence according a best-evidence synthesis, because a meta-analysis was not possible. Finally, the RCTs' applicability and clinical relevance also was assessed. Of 75 identified abstracts, 10 full-text articles were included (3 RCTs and 7 nonrandomized studies). These studies represented a total of 1021 patients: 823 patients (≥ 892 disks) were treated by PCN. All studies showed low methodological quality, except for two. The level of evidence of the RCTs was graded as moderate, with low to moderate applicability and clinical relevance. All included studies showed PCN to be an effective and safe procedure in the treatment of (contained) herniated disks at short-, mid-, and long-term follow-up. However, the level of evidence is moderate and shows only low to moderate applicability and clinical relevance. © 2013 World Institute of Pain.

Systematic review of clinical trials assessing pharmacological properties of Salvia species on memory, cognitive impairment and Alzheimer's disease.

PubMed

Miroddi, Marco; Navarra, Michele; Quattropani, Maria C; Calapai, Fabrizio; Gangemi, Sebastiano; Calapai, Gioacchino

2014-06-01

Salvia officinalis L. and Salvia lavandulaefolia L. have a longstanding use as traditional herbal remedies that can enhance memory and improve cognitive functions. Pharmacological actions of S. officinalis and S. lavandulaefolia on healthy subjects and on patients suffering of cognitive decline have been investigated. Aim of this review was to summarize published clinical trials assessing effectiveness and safety of S. officinalis and S. lavandulaefolia in the enhancement of cognitive performance in healthy subjects and neurodegenerative illnesses. Furthermore, to purchase a more complete view on safety of S. officinalis and S. lavandulaefolia, we collected and discussed articles regarding toxicity and adverse reactions. Eight clinical studies investigating on acute effects of S. officinalis on healthy subjects were included in the review. Six studies investigated on the effects of S. officinalis and S. lavandaeluaefolia on cognitive performance in healthy subjects. The two remaining were carried out to study the effects of sage on Azheimer's disease. Our review shows that S. officinalis and S. lavandulaefolia exert beneficial effects by enhancing cognitive performance both in healthy subjects and patients with dementia or cognitive impairment and is safe for this indication. Unfortunately, promising beneficial effects are debased by methodological issues, use of different herbal preparations (extracts, essential oil, use of raw material), lack of details on herbal products used. We believe that sage promising effects need further higher methodological standard clinical trials. © 2014 John Wiley & Sons Ltd.

An alternative methodology for interpretation and reporting of hand hygiene compliance data.

PubMed

DiDiodato, Giulio

2012-05-01

Since 2009, all hospitals in Ontario have been mandated to publicly report health care provider compliance with hand hygiene opportunities (http://www.health.gov.on.ca/patient_safety/index.html). Hand hygiene compliance (HHC) is reported for 2 of the 4 moments during the health care provider-patient encounter. This study analyzes the HHC data by using an alternative methodology for interpretation and reporting. Annualized HHC data were available for fiscal years 2009 and 2010 for each of the 5 hospital corporations (6 sites) in the North Simcoe Muskoka Local Health Integration Network. The weighted average for HHC was used to estimate the overall observed rate for HHC for each hospital and reporting period. Using Bayes' probability theorem, this estimate was used to predict the probability that any patient would experience HHC for at least 75% of hand hygiene moments. This probability was categorized as excellent (≥75%), above average (50%-74%), below average (25%-49%), or poor (<25%). The results were reported using a balanced scorecard display. The overall observed rates for HHC ranged from 50% to 87% (mean, 75% ± 11%, P = .079). Using the alternative methodology for reporting, 6 of the 12 reporting periods would be categorized as excellent, 1 as above average, 2 as below average, and 3 as poor. Population-level HHC data can be converted to patient-level risk information. Reporting this information to the public may increase the value and understandability of this patient safety indicator. Copyright © 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

[Improving inpatient pharmacoterapeutic process by Lean Six Sigma methodology].

PubMed

Font Noguera, I; Fernández Megía, M J; Ferrer Riquelme, A J; Balasch I Parisi, S; Edo Solsona, M D; Poveda Andres, J L

2013-01-01

Lean Six Sigma methodology has been used to improve care processes, eliminate waste, reduce costs, and increase patient satisfaction. To analyse the results obtained with Lean Six Sigma methodology in the diagnosis and improvement of the inpatient pharmacotherapy process during structural and organisational changes in a tertiary hospital. 1.000 beds tertiary hospital. prospective observational study. The define, measure, analyse, improve and control (DMAIC), were deployed from March to September 2011. An Initial Project Charter was updated as results were obtained. 131 patients with treatments prescribed within 24h after admission and with 4 drugs. safety indicators (medication errors), and efficiency indicators (complaints and time delays). Proportion of patients with a medication error was reduced from 61.0% (25/41 patients) to 55.7% (39/70 patients) in four months. Percentage of errors (regarding the opportunities for error) decreased in the different phases of the process: Prescription: from 5.1% (19/372 opportunities) to 3.3% (19/572 opportunities); Preparation: from 2.7% (14/525 opportunities) to 1.3% (11/847 opportunities); and administration: from 4.9% (16/329 opportunities) to 3.0% (13/433 opportunities). Nursing complaints decreased from 10.0% (2119/21038 patients) to 5.7% (1779/31097 patients). The estimated economic impact was 76,800 euros saved. An improvement in the pharmacotherapeutic process and a positive economic impact was observed, as well as enhancing patient safety and efficiency of the organization. Standardisation and professional training are future Lean Six Sigma candidate projects. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

Principles of Safety Pharmacology

PubMed Central

Pugsley, M K; Authier, S; Curtis, M J

2008-01-01

Safety Pharmacology is a rapidly developing discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment. The aim of Safety Pharmacology is to characterize the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects using continuously evolving methodology. Unlike toxicology, Safety Pharmacology includes within its remit a regulatory requirement to predict the risk of rare lethal events. This gives Safety Pharmacology its unique character. The key issues for Safety Pharmacology are detection of an adverse effect liability, projection of the data into safety margin calculation and finally clinical safety monitoring. This article sets out to explain the drivers for Safety Pharmacology so that the wider pharmacology community is better placed to understand the discipline. It concludes with a summary of principles that may help inform future resolution of unmet needs (especially establishing model validation for accurate risk assessment). Subsequent articles in this issue of the journal address specific aspects of Safety Pharmacology to explore the issues of model choice, the burden of proof and to highlight areas of intensive activity (such as testing for drug-induced rare event liability, and the challenge of testing the safety of so-called biologics (antibodies, gene therapy and so on.). PMID:18604233

Enacting corporate governance of healthcare safety and quality: a dramaturgy of hospital boards in England.

PubMed

Freeman, Tim; Millar, Ross; Mannion, Russell; Davies, Huw

2016-02-01

The governance of patient safety is a challenging concern for all health systems. Yet, while the role of executive boards receives increased scrutiny, the area remains theoretically and methodologically underdeveloped. Specifically, we lack a detailed understanding of the performative aspects at play: what board members say and do to discharge their accountabilities for patient safety. This article draws on qualitative data from overt non-participant observation of four NHS hospital Foundation Trust boards in England. Applying a dramaturgical framework to explore scripting, setting, staging and performance, we found important differences between case study sites in the performative dimensions of processing and interpretation of infection control data. We detail the practices associated with these differences--the legitimation of current performance, the querying of data classification, and the naming and shaming of executives--to consider their implications. © 2015 The Authors. Sociology of Health & Illness published by John Wiley & Sons Ltd on behalf of Foundation for SHIL.

Environmental benefits and concerns on safety: communicating latest results on nanotechnology safety research-the project DaNa2.0.

PubMed

Kühnel, D; Marquardt, C; Nau, K; Krug, H F; Paul, F; Steinbach, C

2017-04-01

The use of nanotechnology and advanced materials promises to revolutionise many areas of technology and improve our daily life. In that respect, many positive effects on the environment are expected, either directly, by developing new technologies for remediation, filtering techniques or energy generation, or indirectly, by e.g. saving resources due to lower consumption of raw materials, or lower energy and fuel consumption due to reduced weight of vehicles. However, such beneficial effects of new technologies are often confronted by concerns regarding the safety of novel substances or materials. During the past 10 years, great effort has been put into research on potential hazards of nanomaterials towards environmental organisms. As the methodology for reliable assessment of nanomaterials was immature, many studies reporting contradictory results have been published, hindering both risk assessment for nanomaterials, as well as the knowledge communication to all involved stakeholders. Thus, DaNa 2.0 serves as a platform to implement trusted knowledge on nanomaterials for an objective discussion.

Proceedings of the High Consequence Operations Safety Symposium

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

Not Available

1994-12-01

Many organizations face high consequence safety situations where unwanted stimuli due to accidents, catastrophes, or inadvertent human actions can cause disasters. In order to improve interaction among such organizations and to build on each others` experience, preventive approaches, and assessment techniques, the High Consequence Operations Safety Symposium was held July 12--14, 1994 at Sandia National Laboratories, Albuquerque, New Mexico. The symposium was conceived by Dick Schwoebel, Director of the SNL Surety Assessment Center. Stan Spray, Manager of the SNL System Studies Department, planned strategy and made many of the decisions necessary to bring the concept to fruition on a shortmore » time scale. Angela Campos and about 60 people worked on the nearly limitless implementation and administrative details. The initial symposium (future symposia are planned) was structured around 21 plenary presentations in five methodology-oriented sessions, along with a welcome address, a keynote address, and a banquet address. Poster papers addressing the individual session themes were available before and after the plenary sessions and during breaks.« less

NAVIGATING A QUALITY ROUTE TO A NATIONAL SAFETY AWARD

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

PREVETTE SS

Deming quality methodologies applied to safety are recognized with the National Safety Council's annual Robert W. Campbell Award. Over the last ten years, the implementation of Statistical Process Control and quality methodologies at the U.S. Department of Energy's Hanford Site have contributed to improved safety. Improvements attributed to Statistical Process Control are evidenced in Occupational Safety and Health records and documented through several articles in Quality Progress and the American Society of Safety Engineers publication, Professional Safety. Statistical trending of safety, quality, and occurrence data continues to playa key role in improving safety and quality at what has been calledmore » the world's largest environmental cleanup project. DOE's Hanford Site played a pivotal role in the nation's defense beginning in the 1940s, when it was established as part of the Manhattan Project. After more than 50 years of producing material for nuclear weapons, Hanford, which covers 586 square miles in southeastern Washington state, is now focused on three outcomes: (1) Restoring the Columbia River corridor for multiple uses; (2) Transitioning the central plateau to support long-term waste management; and (3) Putting DOE assets to work for the future. The current environmental cleanup mission faces challenges of overlapping technical, political, regulatory, environmental, and cultural interests. From Oct. 1, 1996 through Sept. 30, 2008, Fluor Hanford was a prime contractor to the Department of Energy's Richland Operations Office. In this role, Fluor Hanford managed several major cleanup activities that included dismantling former nuclear-processing facilities, cleaning up the Site's contaminated groundwater, retrieving and processing transuranic waste for shipment and disposal off-site, maintaining the Site's infrastructure, providing security and fire protection, and operating the Volpentest HAMMER Training and Education Center. On October 1,2008, a transition occurred that changed Fluor's role at Hanford. Fluor's work at Hanford was split in two with the technical scope being assumed by the CH2M HILL Plateau Remediation Company (CHPRC) CHPRC is now spearheading much of the cleanup work associated with former nuclear-processing facilities, contaminated groundwater, and transuranic waste. Fluor is an integrated subcontractor to CH PRC in this effort. In addition, at the time of this writing, while the final outcome is being determined for the new Mission Support Contract, Fluor Hanford has had its contract extended to provide site-wide services that include security, fire protection, infrastructure, and operating the HAMMER facility. The emphasis has to be on doing work safely, delivering quality work, controlling costs, and meeting deadlines. Statistical support is provided by Fluor to the PRC, within Fluor Hanford, and to a third contractor, Washington Closure Hanford, which is tasked with cleaning up approximately 210 square miles designated as the Columbia River corridor along the outer edge of the Hanford Site. The closing months of Fluor Hanford's 12 year contract were busy, characterized by special events that capped its work as a prime cleanup contractor, transitions of work scope and personnel, and the completion numerous activities. At this time, Fluor's work and approach to safety were featured in state and national forums. A 'Blockbuster' presentation at the Washington State Governor's Industrial Safety Conference in September 2008 featured Fluor Hanford's Chief Operating Officer, a company Safety Representative, and me. Simultaneously, an award ceremony in Anaheim, Calif. recognized Fluor Hanford as the winner of the 2008 Robert W. Campbell Award. The Robert W. Campbell Award is co-sponsored by Exxon Mobil Corporation and the National Safety Council. Named after a pioneer of industrial safety, the Campbell Award recognizes organizations that demonstrate how integration of environmental, health and safety (EHS) management into business operations is a cornerstone of their corporate success. Fluor Hanford received the award for corporations with more than 1,000 employees. Campbell Award winners undergo rigorous assessments that include site visits and comprehensive evaluations of their commitment to, and implementation of, EHS practices. Award winners work with an international partnership of 21 organizations to develop case studies that illustrate their superior EHS programs and best practices, for use by top business and engineering schools worldwide. Quality methodologies in place at Fluor Hanford played a key role in the award process. Fluor Hanford's integrated use of Statistical Process Control and Pareto Charts for analyzing and displaying EHS performance were viewed favorably by the award judges.« less

Safety analysis of urban arterials at the meso level.

PubMed

Li, Jia; Wang, Xuesong

2017-11-01

Urban arterials form the main structure of street networks. They typically have multiple lanes, high traffic volume, and high crash frequency. Classical crash prediction models investigate the relationship between arterial characteristics and traffic safety by treating road segments and intersections as isolated units. This micro-level analysis does not work when examining urban arterial crashes because signal spacing is typically short for urban arterials, and there are interactions between intersections and road segments that classical models do not accommodate. Signal spacing also has safety effects on both intersections and road segments that classical models cannot fully account for because they allocate crashes separately to intersections and road segments. In addition, classical models do not consider the impact on arterial safety of the immediately surrounding street network pattern. This study proposes a new modeling methodology that will offer an integrated treatment of intersections and road segments by combining signalized intersections and their adjacent road segments into a single unit based on road geometric design characteristics and operational conditions. These are called meso-level units because they offer an analytical approach between micro and macro. The safety effects of signal spacing and street network pattern were estimated for this study based on 118 meso-level units obtained from 21 urban arterials in Shanghai, and were examined using CAR (conditional auto regressive) models that corrected for spatial correlation among the units within individual arterials. Results showed shorter arterial signal spacing was associated with higher total and PDO (property damage only) crashes, while arterials with a greater number of parallel roads were associated with lower total, PDO, and injury crashes. The findings from this study can be used in the traffic safety planning, design, and management of urban arterials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cartilage-Repair Innovation at a Standstill: Methodologic and Regulatory Pathways to Breaking Free.

PubMed

Lyman, Stephen; Nakamura, Norimasa; Cole, Brian J; Erggelet, Christoph; Gomoll, Andreas H; Farr, Jack

2016-08-03

Articular cartilage defects strongly predispose patients to developing early joint degeneration and osteoarthritis, but for more than 15 years, no new cartilage-repair technologies that we know of have been approved by the U.S. Food and Drug Administration. Many studies examining novel approaches to cartilage repair, including cell, tissue, or matrix-based techniques, have shown great promise, but completing randomized controlled trials (RCTs) to establish safety and efficacy has been challenging, providing a major barrier to bringing these innovations into clinical use. In this article, we review reasons that surgical innovations are not well-suited for testing through RCTs. We also discuss how analytical methods for reducing bias, such as propensity scoring, make prospective observational studies a potentially viable alternative for testing the safety and efficacy of cartilage-repair and other novel therapies, offering the real possibility of therapeutic innovation. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Estimation of integrated public risks for nonseismic external events affecting the Savannah River Site

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

Durant, W.S.; robinette, R.J.; Kirchner, J.R.

1994-03-01

In essence, this study was envisioned as the ``combination`` of existing accident dose and risk calculations from safety analyses of individual facilities. However, because of the extended time period over which the safety analyses were prepared, calculational assumptions and methodologies differed between the analyses. The scope of this study therefore included the standardization of assumptions and calculations as necessary to insure that the analytical logic was consistent for all the facilities. Each of the nonseismic external events considered in the analyses are addressed in individual sections in this report. In Section 2, extreme straight-line winds are examined. Section 3 addressesmore » tornadoes, and Section 4 addresses other external events [floods, other extreme weather events (lightning, hail, and extremes in temperature or precipitation), vehicle impact, accidents involving adjacent facilities, aircraft impact, and meteorite impact]. Section 5 provides a summary of the general conclusions of the report.« less

Overview of the "epigenetic end points in toxicologic pathology and relevance to human health" session of the 2014 Society Of Toxicologic Pathology Annual Symposium.

PubMed

Hoenerhoff, Mark J; Hartke, James

2015-01-01

The theme of the Society of Toxicologic Pathology 2014 Annual Symposium was "Translational Pathology: Relevance of Toxicologic Pathology to Human Health." The 5th session focused on epigenetic end points in biology, toxicity, and carcinogenicity, and how those end points are relevant to human exposures. This overview highlights the various presentations in this session, discussing integration of epigenetics end points in toxicologic pathology studies, investigating the role of epigenetics in product safety assessment, epigenetic changes in cancers, methodologies to detect them, and potential therapies, chromatin remodeling in development and disease, and epigenomics and the microbiome. The purpose of this overview is to discuss the application of epigenetics to toxicologic pathology and its utility in preclinical or mechanistic based safety, efficacy, and carcinogenicity studies. © 2014 by The Author(s).

An Investigation of Health and Safety Measures in a Hydroelectric Power Plant.

PubMed

Acakpovi, Amevi; Dzamikumah, Lucky

2016-12-01

Occupational risk management is known as a catalyst in generating superior returns for all stakeholders on a sustainable basis. A number of companies in Ghana implemented health and safety measures adopted from international companies to ensure the safety of their employees. However, there exist great threats to employees' safety in these companies. The purpose of this paper is to investigate the level of compliance of Occupational Health and Safety management systems and standards set by international and local legislation in power producing companies in Ghana. The methodology is conducted by administering questionnaires and in-depth interviews as measuring instruments. A random sampling technique was applied to 60 respondents; only 50 respondents returned their responses. The questionnaire was developed from a literature review and contained questions and items relevant to the initial research problem. A factor analysis was also carried out to investigate the influence of some variables on safety in general. Results showed that the significant factors that influence the safety of employees at the hydroelectric power plant stations are: lack of training and supervision, non-observance of safe work procedures, lack of management commitment, and lack of periodical check on machine operations. The study pointed out the safety loopholes and therefore helped improve the health and safety measures of employees in the selected company by providing effective recommendations. The implementation of the proposed recommendations in this paper, would lead to the prevention of work-related injuries and illnesses of employees as well as property damage and incidents in hydroelectric power plants. The recommendations may equally be considered as benchmark for the Safety and Health Management System with international standards.

Collaborating with nurse leaders to develop patient safety practices.

PubMed

Kanerva, Anne; Kivinen, Tuula; Lammintakanen, Johanna

2017-07-03

Purpose The organisational level and leadership development are crucial elements in advancing patient safety, because patient safety weaknesses are often caused by system failures. However, little is known about how frontline leader and director teams can be supported to develop patient safety practices. The purpose of this study is to describe the patient safety development process carried out by nursing leaders and directors. The research questions were: how the chosen development areas progressed in six months' time and how nursing leaders view the participatory development process. Design/methodology/approach Participatory action research was used to engage frontline nursing leaders and directors into developing patient safety practices. Semi-structured group interviews ( N = 10) were used in data collection at the end of a six-month action cycle, and data were analysed using content analysis. Findings The participatory development process enhanced collaboration and gave leaders insights into patient safety as a part of the hospital system and their role in advancing it. The chosen development areas advanced to different extents, with the greatest improvements in those areas with simple guidelines to follow and in which the leaders were most participative. The features of high-reliability organisation were moderately identified in the nursing leaders' actions and views. For example, acting as a change agent to implement patient safety practices was challenging. Participatory methods can be used to support leaders into advancing patient safety. However, it is important that the participants are familiar with the method, and there are enough facilitators to steer development processes. Originality/value Research brings more knowledge of how leaders can increase their effectiveness in advancing patient safety and promoting high-reliability organisation features in the healthcare organisation.

Hazard Analysis and Safety Requirements for Small Drone Operations: To What Extent Do Popular Drones Embed Safety?

PubMed

Plioutsias, Anastasios; Karanikas, Nektarios; Chatzimihailidou, Maria Mikela

2018-03-01

Currently, published risk analyses for drones refer mainly to commercial systems, use data from civil aviation, and are based on probabilistic approaches without suggesting an inclusive list of hazards and respective requirements. Within this context, this article presents: (1) a set of safety requirements generated from the application of the systems theoretic process analysis (STPA) technique on a generic small drone system; (2) a gap analysis between the set of safety requirements and the ones met by 19 popular drone models; (3) the extent of the differences between those models, their manufacturers, and the countries of origin; and (4) the association of drone prices with the extent they meet the requirements derived by STPA. The application of STPA resulted in 70 safety requirements distributed across the authority, manufacturer, end user, or drone automation levels. A gap analysis showed high dissimilarities regarding the extent to which the 19 drones meet the same safety requirements. Statistical results suggested a positive correlation between drone prices and the extent that the 19 drones studied herein met the safety requirements generated by STPA, and significant differences were identified among the manufacturers. This work complements the existing risk assessment frameworks for small drones, and contributes to the establishment of a commonly endorsed international risk analysis framework. Such a framework will support the development of a holistic and methodologically justified standardization scheme for small drone flights. © 2017 Society for Risk Analysis.

Waste collection in developing countries - Tackling occupational safety and health hazards at their source

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

Bleck, Daniela, E-mail: bleck.daniela@baua.bund.de; Wettberg, Wieland, E-mail: wettberg.wieland@baua.bund.de

2012-11-15

Waste management procedures in developing countries are associated with occupational safety and health risks. Gastro-intestinal infections, respiratory and skin diseases as well as muscular-skeletal problems and cutting injuries are commonly found among waste workers around the globe. In order to find efficient, sustainable solutions to reduce occupational risks of waste workers, a methodological risk assessment has to be performed and counteractive measures have to be developed according to an internationally acknowledged hierarchy. From a case study in Addis Ababa, Ethiopia suggestions for the transferral of collected household waste into roadside containers are given. With construction of ramps to dump collectedmore » household waste straight into roadside containers and an adaptation of pushcarts and collection procedures, the risk is tackled at the source.« less