Using a familiar risk comparison within a risk ladder to improve risk understanding by low numerates: a study of visual attention.

PubMed

Keller, Carmen

2011-07-01

Previous experimental research provides evidence that a familiar risk comparison within a risk ladder is understood by low- and high-numerate individuals. It especially helps low numerates to better evaluate risk. In the present study, an eye tracker was used to capture individuals' visual attention to a familiar risk comparison, such as the risk associated with smoking. Two parameters of information processing-efficiency and level-were derived from visual attention. A random sample of participants from the general population (N= 68) interpreted a given risk level with the help of the risk ladder. Numeracy was negatively correlated with overall visual attention on the risk ladder (r(s) =-0.28, p= 0.01), indicating that the lower the numeracy, the more the time spent looking at the whole risk ladder. Numeracy was positively correlated with the efficiency of processing relevant frequency (r(s) = 0.34, p < 0.001) and relevant textual information (r(s) = 0.34, p < 0.001), but not with the efficiency of processing relevant comparative information and numerical information. There was a significant negative correlation between numeracy and the level of processing of relevant comparative risk information (r(s) =-0.21, p < 0.01), indicating that low numerates processed the comparative risk information more deeply than the high numerates. There was no correlation between numeracy and perceived risk. These results add to previous experimental research, indicating that the smoking risk comparison was crucial for low numerates to evaluate and understand risk. Furthermore, the eye-tracker method is promising for studying information processing and improving risk communication formats. © 2011 Society for Risk Analysis.

Case Study: University of Anyplace: Strategic Legal Risk Review.

ERIC Educational Resources Information Center

Hall, John T.; Ferguson, Rowan

2000-01-01

Considers legal issues and risks faced by a fictional American university as it seeks to establish an operation based in London. Addresses the first step in the process of risk management, the risk review exercise, and provides an explanation of the legal issues involved to allow progression to the second stage in the process (evaluation of the…

Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

PubMed

Stocker, Elena; Toschkoff, Gregor; Sacher, Stephan; Khinast, Johannes G

2014-11-20

The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. Copyright © 2014. Published by Elsevier B.V.

Zika Virus in Ontario: Evaluating a Rapid Risk Assessment Tool for Emerging Infectious Disease Threats.

PubMed

Van Meer, Ryan; Hohenadel, Karin; Fitzgerald-Husek, Alanna; Warshawsky, Bryna; Sider, Doug; Schwartz, Brian; Nelder, Mark P

To determine the Ontario-specific risk of local and travel-related Zika virus transmission in the context of a public health emergency of international concern, Public Health Ontario (PHO) completed a rapid risk assessment (RRA) on January 29, 2016, using a newly developed RRA guidance tool. The RRA concluded that risk of local mosquito-borne transmission was low, with a high risk of imported cases through travel. The RRA was updated 3 times based on predetermined triggers. An independent evaluation assessed both the application of the RRA guidance tool (process evaluation) and the usefulness of the RRA (outcome evaluation). We conducted face-to-face, semi-structured interviews with 7 individuals who participated in the creation or review of the Zika virus RRA and 4 end-users at PHO and the Ministry of Health and Long-Term Care. An inductive thematic analysis of responses was undertaken, whereby themes were directly informed by the data. The process evaluation determined that most steps outlined in the RRA guidance tool were adhered to, including forming a cross-functional writing team, clarifying the scope and describing context, completing the RRA summary report, and updating the RRA based on predefined triggers. The outcome evaluation found that end-users judged the Zika virus RRA as evidence-informed, useful, consistent, and timely. The evaluation established that the locally tailored guidance tool, adapted from national and international approaches to RRAs, facilitated a systematic, evidence-informed, and timely formal RRA process at PHO for the Zika virus RRA, which met the needs of end-users. Based on the evaluation, PHO will modify future RRAs by incorporating some flexibility into the literature review process to support timeliness of the RRA, explicitly describing the limitations of studies used to inform the RRA, and refining risk algorithms to better suit emerging infectious disease threats. It is anticipated that these refinements will improve upon the timely assessment of novel or reemerging infectious diseases.

Guidelines for developing NASA (National Aeronautics and Space Administration) ADP security risk management plans

NASA Technical Reports Server (NTRS)

Tompkins, F. G.

1983-01-01

This report presents guidance to NASA Computer security officials for developing ADP security risk management plans. The six components of the risk management process are identified and discussed. Guidance is presented on how to manage security risks that have been identified during a risk analysis performed at a data processing facility or during the security evaluation of an application system.

Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist.

PubMed

Radawski, Christine; Morrato, Elaine; Hornbuckle, Kenneth; Bahri, Priya; Smith, Meredith; Juhaeri, Juhaeri; Mol, Peter; Levitan, Bennett; Huang, Han-Yao; Coplan, Paul; Li, Hu

2015-12-01

Optimizing a therapeutic product's benefit-risk profile is an on-going process throughout the product's life cycle. Different, yet related, benefit-risk assessment strategies and frameworks are being developed by various regulatory agencies, industry groups, and stakeholders. This paper summarizes current best practices and discusses the role of the pharmacoepidemiologist in these activities, taking a life-cycle approach to integrated Benefit-Risk Assessment, Communication, and Evaluation (BRACE). A review of the medical and regulatory literature was performed for the following steps involved in therapeutic benefit-risk optimization: benefit-risk evidence generation; data integration and analysis; decision making; regulatory and policy decision making; benefit-risk communication and risk minimization; and evaluation. Feedback from International Society for Pharmacoepidemiology members was solicited on the role of the pharmacoepidemiologist. The case example of natalizumab is provided to illustrate the cyclic nature of the benefit-risk optimization process. No single, globally adopted benefit-risk assessment process exists. The BRACE heuristic offers a way to clarify research needs and to promote best practices in a cyclic and integrated manner and highlight the critical importance of cross-disciplinary input. Its approach focuses on the integration of BRACE activities for risk minimization and optimization of the benefit-risk profile. The activities defined in the BRACE heuristic contribute to the optimization of the benefit-risk profile of therapeutic products in the clinical world at both the patient and population health level. With interdisciplinary collaboration, pharmacoepidemiologists are well suited for bringing in methodology expertise, relevant research, and public health perspectives into the BRACE process. Copyright © 2015 John Wiley & Sons, Ltd.

Metal Vapor Arcing Risk Assessment Tool

NASA Technical Reports Server (NTRS)

Hill, Monika C.; Leidecker, Henning W.

2010-01-01

The Tin Whisker Metal Vapor Arcing Risk Assessment Tool has been designed to evaluate the risk of metal vapor arcing and to help facilitate a decision toward a researched risk disposition. Users can evaluate a system without having to open up the hardware. This process allows for investigating components at risk rather than spending time and money analyzing every component. The tool points to a risk level and provides direction for appropriate action and documentation.

The Feasibility of Embedding Data Collection into the Routine Service Delivery of a Multi-Component Program for High-Risk Young People.

PubMed

Knight, Alice; Havard, Alys; Shakeshaft, Anthony; Maple, Myfanwy; Snijder, Mieke; Shakeshaft, Bernie

2017-02-20

There is little evidence about how to improve outcomes for high-risk young people, of whom Indigenous young people are disproportionately represented, due to few evaluation studies of interventions. One way to increase the evidence is to have researchers and service providers collaborate to embed evaluation into the routine delivery of services, so program delivery and evaluation occur simultaneously. This study aims to demonstrate the feasibility of integrating best-evidence measures into the routine data collection processes of a service for high-risk young people, and identify the number and nature of risk factors experienced by participants. The youth service is a rural based NGO comprised of multiple program components: (i) engagement activities; (ii) case management; (iii) diversionary activities; (iv) personal development; and (v) learning and skills. A best-evidence assessment tool was developed by staff and researchers and embedded into the service's existing intake procedure. Assessment items were organised into demographic characteristics and four domains of risk: education and employment; health and wellbeing; substance use; and crime. Descriptive data are presented and summary risk variables were created for each domain of risk. A count of these summary variables represented the number of co-occurring risks experienced by each participant. The feasibility of this process was determined by the proportion of participants who completed the intake assessment and provided research consent. This study shows 85% of participants completed the assessment tool demonstrating that data on participant risk factors can feasibly be collected by embedding a best-evidence assessment tool into the routine data collection processes of a service. The most prevalent risk factors were school absence, unemployment, suicide ideation, mental distress, substance use, low levels of physical activity, low health service utilisation, and involvement in crime or with the juvenile justice system. All but one participant experienced at least two co-occurring domains of risk, and the majority of participants (58%) experienced co-occurring risk across four domains. This is the first study to demonstrate that best-evidence measures can feasibly be embedded into the routine data collection processes of a service for high-risk young people. This process allows services to tailor their activities to the most prevalent risks experienced by participants, and monitor these risks over time. Replication of this process in other services would improve the quality of services, facilitate more high quality evaluations of services, and contribute evidence on how to improve outcomes for high-risk young people.

Risk Assessment of Groundwater Contamination: A Multilevel Fuzzy Comprehensive Evaluation Approach Based on DRASTIC Model

PubMed Central

Zhang, Yan; Zhong, Ming

2013-01-01

Groundwater contamination is a serious threat to water supply. Risk assessment of groundwater contamination is an effective way to protect the safety of groundwater resource. Groundwater is a complex and fuzzy system with many uncertainties, which is impacted by different geological and hydrological factors. In order to deal with the uncertainty in the risk assessment of groundwater contamination, we propose an approach with analysis hierarchy process and fuzzy comprehensive evaluation integrated together. Firstly, the risk factors of groundwater contamination are identified by the sources-pathway-receptor-consequence method, and a corresponding index system of risk assessment based on DRASTIC model is established. Due to the complexity in the process of transitions between the possible pollution risks and the uncertainties of factors, the method of analysis hierarchy process is applied to determine the weights of each factor, and the fuzzy sets theory is adopted to calculate the membership degrees of each factor. Finally, a case study is presented to illustrate and test this methodology. It is concluded that the proposed approach integrates the advantages of both analysis hierarchy process and fuzzy comprehensive evaluation, which provides a more flexible and reliable way to deal with the linguistic uncertainty and mechanism uncertainty in groundwater contamination without losing important information. PMID:24453883

Do Italian Companies Manage Work-Related Stress Effectively? A Process Evaluation in Implementing the INAIL Methodology

PubMed Central

Di Tecco, Cristina; Ronchetti, Matteo; Ghelli, Monica; Russo, Simone; Persechino, Benedetta

2015-01-01

Studies on Intervention Process Evaluation are attracting growing attention in the literature on interventions linked to stress and the wellbeing of workers. There is evidence that some elements relating to the process and content of an intervention may have a decisive role in implementing it by facilitating or hindering the effectiveness of the results. This study aimed to provide a process evaluation on interventions to assess and manage risks related to work-related stress using a methodological path offered by INAIL. The final sample is composed of 124 companies participating to an interview on aspects relating to each phase of the INAIL methodological path put in place to implement the intervention. INAIL methodology has been defined as useful in the process of assessing and managing the risks related to work-related stress. Some factors related to the process (e.g., implementation of a preliminary phase, workers' involvement, and use of external consultants) showed a role in significant differences that emerged in the levels of risk, particularly in relation to findings from the preliminary assessment. Main findings provide information on the key aspects of process and content that are useful in implementing an intervention for assessing and managing risks related to work-related stress. PMID:26504788

Do Italian Companies Manage Work-Related Stress Effectively? A Process Evaluation in Implementing the INAIL Methodology.

PubMed

Di Tecco, Cristina; Ronchetti, Matteo; Ghelli, Monica; Russo, Simone; Persechino, Benedetta; Iavicoli, Sergio

2015-01-01

Studies on Intervention Process Evaluation are attracting growing attention in the literature on interventions linked to stress and the wellbeing of workers. There is evidence that some elements relating to the process and content of an intervention may have a decisive role in implementing it by facilitating or hindering the effectiveness of the results. This study aimed to provide a process evaluation on interventions to assess and manage risks related to work-related stress using a methodological path offered by INAIL. The final sample is composed of 124 companies participating to an interview on aspects relating to each phase of the INAIL methodological path put in place to implement the intervention. INAIL methodology has been defined as useful in the process of assessing and managing the risks related to work-related stress. Some factors related to the process (e.g., implementation of a preliminary phase, workers' involvement, and use of external consultants) showed a role in significant differences that emerged in the levels of risk, particularly in relation to findings from the preliminary assessment. Main findings provide information on the key aspects of process and content that are useful in implementing an intervention for assessing and managing risks related to work-related stress.

Methodology for an occupational risk assessment: an evaluation of four processes for the fabrication of photovoltaic cells.

PubMed

Ungers, L J; Moskowitz, P D; Owens, T W; Harmon, A D; Briggs, T M

1982-02-01

Determining occupational health and safety risks posed by emerging technologies is difficult because of limited statistics. Nevertheless, estimates of such risks must be constructed to permit comparison of various technologies to identify the most attractive processes. One way to estimate risks is to use statistics on related industries. Based on process labor requirements and associated occupational health data, risks to workers and to society posed by an emerging technology can be calculated. Using data from the California semiconductor industry, this study applies a five-step occupational risk assessment procedure to four processes for the fabrication of photovoltaic cells. The validity of the occupational risk assessment method is discussed.

Constellation Mission Operation Working Group: ESMO Maneuver Planning Process Review

NASA Technical Reports Server (NTRS)

Moyer, Eric

2015-01-01

The Earth Science Mission Operation (ESMO) Project created an Independent Review Board to review our Conjunction Risk evaluation process and Maneuver Planning Process to identify improvements that safely manages mission conjunction risks, maintains ground track science requirements, and minimizes overall hours expended on High Interest Events (HIE). The Review Board is evaluating the current maneuver process which requires support by multiple groups. In the past year, there have been several changes to the processes although many prior and new concerns exist. This presentation will discuss maneuver process reviews and Board comments, ESMO assessment and path foward, ESMO future plans, recent changes and concerns.

The role of risk communication planning in the release of the oral rabies vaccine in New Jersey: An evaluation

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

Pflugh, K.K.

1995-12-01

Communicating health risk information is a complicated task. Citizen reaction to such information is difficult to predict, which makes it hard to plan an appropriate response. Research indicates that the way citizens respond to risk information often depends on whether the risk is familiar or unfamiliar, whether it is seen as imposed on them, whether it is man made or natural, or whether they have control over the risk. Potentially controversial cases that deal with delivering risk information have a special need for a well planned communication effort. Natural resource issues with an impact on public health are no exception.more » In New Jersey, a proposal to release an experimental bioengineered oral rabies vaccine for raccoons to test the effectiveness of the vaccine in halting the spread of rabies into an as yet unaffected area met with widespread public support and approval due in large part to the use of a unique risk communication planning process. This paper will describe the risk communication planning process used to gain public support and approval for release of oral rabies raccoon vaccine while focusing on the evaluation component of the process. The seven step process includes setting goals, profiling the issue or information gathering, audience identification and assessment, message development, method selection, implementation of the strategy and evaluation and follow-up. The goal of the evaluation component was to determine the effectiveness of the public information campaign on citizen`s knowledge of the field trial nearly three years after the initial announcement. In addition, it sought to learn citizen interest in maintaining the rabies free barrier that was created by the field trial using funds from local taxes. This evaluation includes the results of a mailed survey to 280 citizens, local officials and professional organizations. Finally, this paper will discuss the implications for future outreach efforts dealing complicated technical issues.« less

Flexible, secure agent development framework

DOEpatents

Goldsmith,; Steven, Y [Rochester, MN

2009-04-07

While an agent generator is generating an intelligent agent, it can also evaluate the data processing platform on which it is executing, in order to assess a risk factor associated with operation of the agent generator on the data processing platform. The agent generator can retrieve from a location external to the data processing platform an open site that is configurable by the user, and load the open site into an agent substrate, thereby creating a development agent with code development capabilities. While an intelligent agent is executing a functional program on a data processing platform, it can also evaluate the data processing platform to assess a risk factor associated with performing the data processing function on the data processing platform.

Risk evaluation of highway engineering project based on the fuzzy-AHP

NASA Astrophysics Data System (ADS)

Yang, Qian; Wei, Yajun

2011-10-01

Engineering projects are social activities, which integrate with technology, economy, management and organization. There are uncertainties in each respect of engineering projects, and it needs to strengthen risk management urgently. Based on the analysis of the characteristics of highway engineering, and the study of the basic theory on risk evaluation, the paper built an index system of highway project risk evaluation. Besides based on fuzzy mathematics principle, analytical hierarchy process was used and as a result, the model of the comprehensive appraisal method of fuzzy and AHP was set up for the risk evaluation of express way concessionary project. The validity and the practicability of the risk evaluation of expressway concessionary project were verified after the model was applied to the practice of a project.

Impact of stress and mitigating information on evaluations, attributions, affect, disciplinary choices, and expectations of compliance in mothers at high and low risk for child physical abuse.

PubMed

De Paúl, Joaquín; Asla, Nagore; Pérez-Albéniz, Alicia; de Cádiz, Bárbara Torres-Gómez

2006-08-01

The objective is to know if high-risk mothers for child physical abuse differ in their evaluations, attributions, negative affect, disciplinary choices for children's behavior, and expectations of compliance. The effect of a stressor and the introduction of mitigating information are analyzed. Forty-seven high-risk and 48 matched low-risk mothers participated in the study. Mothers' information processing and disciplinary choices were examined using six vignettes depicting a child engaging in different transgressions. A four-factor design with repeated measures on the last two factors was used. High-risk mothers reported more hostile intent, global and internal attributions, more use of power assertion discipline, and less induction. A risk group by child transgression interaction and a risk group by mitigating information interaction were found. Results support the social information-processing model of child physical abuse, which suggests that high-risk mothers process child-related information differently and use more power assertive and less inductive disciplinary techniques.

User embracement with risk classification in an emergency care unit: an evaluative study.

PubMed

Hermida, Patrícia Madalena Vieira; Nascimento, Eliane Regina Pereira do; Echevarría-Guanilo, Maria Elena; Brüggemann, Odaléa Maria; Malfussi, Luciana Bihain Hagemann de

2018-01-01

Objective Describing the evaluation of the Structure, Process and Outcome of User Embracement with Risk Classification of an Emergency Care Unit from the perspective of physicians and nurses. Method An evaluative, descriptive, quantitative study developed in Santa Catarina. Data were collected using a validated and adapted instrument consisting of 21 items distributed in the dimensions of Structure (facilities), Process (activities and relationships in providing care) and Outcome (care effects). In the analysis, descriptive statistics and the Mean Ranking and Mean Score calculations were applied. Results The sample consisted of 37 participants. From the 21 evaluated items, 11 (52.4%) had a Mean Ranking between 3 and 4, and none of them reached the maximum ranking (5 points). "Prioritization of severe cases" and "Primary care according to the severity of the case" reached a higher Mean Ranking (4.5), while "Flowchart discussion" had the lowest Ranking (2.1). The dimensions of Structure, Process and Outcome reached mean scores of 23.9, 21.9 and 25.5, respectively, indicating a Precarious evaluation (17.5 to 26.1 points). Conclusion User Embracement with Risk Classification is precarious, especially regarding the Process which obtained a lower satisfaction level from the participants.

Evaluation of Risk Management Strategies for a Low-Cost, High-Risk Project

NASA Technical Reports Server (NTRS)

Shishko, Robert; Jorgensen, Edward J.

1996-01-01

This paper summarizes work in progress to define and implement a risk management process tailored to a low-cost, high-risk, NASA mission -the Microrover Flight Experiment (MFEX, commonly called the Mars microrover).

Managing fear in public health campaigns: a theory-based formative evaluation process.

PubMed

Cho, Hyunyi; Witte, Kim

2005-10-01

The HIV/AIDS infection rate of Ethiopia is one of the world's highest. Prevention campaigns should systematically incorporate and respond to at-risk population's existing beliefs, emotions, and perceived barriers in the message design process to effectively promote behavior change. However, guidelines for conducting formative evaluation that are grounded in proven risk communication theory and empirical data analysis techniques are hard to find. This article provides a five-step formative evaluation process that translates theory and research for developing effective messages for behavior change. Guided by the extended parallel process model, the five-step process helps message designers manage public's fear surrounding issues such as HIV/AIDS. An entertainment education project that used the process to design HIV/AIDS prevention messages for Ethiopian urban youth is reported. Data were collected in five urban regions of Ethiopia and analyzed according to the process to develop key messages for a 26-week radio soap opera.

Reference manual for toxicity and exposure assessment and risk characterization. CERCLA Baseline Risk Assessment

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

NONE

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, 1980) (CERCLA or Superfund) was enacted to provide a program for identifying and responding to releases of hazardous substances into the environment. The Superfund Amendments and Reauthorization Act (SARA, 1986) was enacted to strengthen CERCLA by requiring that site clean-ups be permanent, and that they use treatments that significantly reduce the volume, toxicity, or mobility of hazardous pollutants. The National Oil and Hazardous Substances Pollution Contingency Plan (NCP) (USEPA, 1985; USEPA, 1990) implements the CERCLA statute, presenting a process for (1) identifying and prioritizing sites requiring remediation and (2) assessing themore » extent of remedial action required at each site. The process includes performing two studies: a Remedial Investigation (RI) to evaluate the nature, extent, and expected consequences of site contamination, and a Feasibility Study (FS) to select an appropriate remedial alternative adequate to reduce such risks to acceptable levels. An integral part of the RI is the evaluation of human health risks posed by hazardous substance releases. This risk evaluation serves a number of purposes within the overall context of the RI/FS process, the most essential of which is to provide an understanding of ``baseline`` risks posed by a given site. Baseline risks are those risks that would exist if no remediation or institutional controls are applied at a site. This document was written to (1) guide risk assessors through the process of interpreting EPA BRA policy and (2) help risk assessors to discuss EPA policy with regulators, decision makers, and stakeholders as it relates to conditions at a particular DOE site.« less

Neural mechanisms underlying urgent and evaluative behaviors: An fMRI study on the interaction of automatic and controlled processes.

PubMed

Megías, Alberto; Navas, Juan Francisco; Petrova, Dafina; Cándido, Antonio; Maldonado, Antonio; Garcia-Retamero, Rocio; Catena, Andrés

2015-08-01

Dual-process theories have dominated the study of risk perception and risk-taking over the last two decades. However, there is a lack of objective brain-level evidence supporting the two systems of processing in every-day risky behavior. To address this issue, we propose the dissociation between evaluative and urgent behaviors as evidence of dual processing in risky driving situations. Our findings show a dissociation of evaluative and urgent behavior both at the behavioral and neural level. fMRI data showed an increase of activation in areas implicated in motor programming, emotional processing, and visuomotor integration in urgent behavior compared to evaluative behavior. These results support a more automatic processing of risk in urgent tasks, relying mainly on heuristics and experiential appraisal. The urgent task, which is characterized by strong time pressure and the possibility for negative consequences among others factors, creates a suitable context for the experiential-affective system to guide the decision-making process. Moreover, we observed greater frontal activation in the urgent task, suggesting the participation of cognitive control in safe behaviors. The findings of this research are relevant for the study of the neural mechanisms underlying dual process models in risky perception and decision-making, especially because of their proximity to everyday activities. © 2015 Wiley Periodicals, Inc.

[Auditory processing evaluation in children born preterm].

PubMed

Gallo, Júlia; Dias, Karin Ziliotto; Pereira, Liliane Desgualdo; Azevedo, Marisa Frasson de; Sousa, Elaine Colombo

2011-01-01

To verify the performance of children born preterm on auditory processing evaluation, and to correlate the data with behavioral hearing assessment carried out at 12 months of age, comparing the results to those of auditory processing evaluation of children born full-term. Participants were 30 children with ages between 4 and 7 years, who were divided into two groups: Group 1 (children born preterm), and Group 2 (children born full-term). The auditory processing results of Group 1 were correlated to data obtained from the behavioral auditory evaluation carried out at 12 months of age. The results were compared between groups. Subjects in Group 1 presented at least one risk indicator for hearing loss at birth. In the behavioral auditory assessment carried out at 12 months of age, 38% of the children in Group 1 were at risk for central auditory processing deficits, and 93.75% presented auditory processing deficits on the evaluation. Significant differences were found between the groups for the temporal order test, the PSI test with ipsilateral competitive message, and the speech-in-noise test. The delay in sound localization ability was associated to temporal processing deficits. Children born preterm have worse performance in auditory processing evaluation than children born full-term. Delay in sound localization at 12 months is associated to deficits on the physiological mechanism of temporal processing in the auditory processing evaluation carried out between 4 and 7 years.

Documentation Protocols to Generate Risk Indicators Regarding Degradation Processes for Cultural Heritage Risk Evaluation

NASA Astrophysics Data System (ADS)

Kioussi, A.; Karoglou, M.; Bakolas, A.; Labropoulos, K.; Moropoulou, A.

2013-07-01

Sustainable maintenance and preservation of cultural heritage assets depends highly on its resilience to external or internal alterations and to various hazards. Risk assessment of a heritage asset's can be defined as the identification of all potential hazards affecting it and the evaluation of the asset's vulnerability (building materials and building structure conservation state).Potential hazards for cultural heritage are complex and varying. The risk of decay and damage associated with monuments is not limited to certain long term natural processes, sudden events and human impact (macroscale of the heritage asset) but is also a function of the degradation processes within materials and structural elements due to physical and chemical procedures. Obviously, these factors cover different scales of the problem. The deteriorating processes in materials may be triggered by external influences or caused because of internal chemical and/or physical variations of materials properties and characteristics. Therefore risk evaluation should be dealt in the direction of revealing the specific active decay and damage mechanism both in mesoscale [type of decay and damage] and microscale [decay phenomenon mechanism] level. A prerequisite for risk indicators identification and development is the existence of an organised source of comparable and interoperable data about heritage assets under observation. This unified source of information offers a knowledge based background of the asset's vulnerability through the diagnosis of building materials' and building structure's conservation state, through the identification of all potential hazards affecting these and through mapping of its possible alterations during its entire life-time. In this framework the identification and analysis of risks regarding degradation processes for the development of qualitative and quantitative indicators can be supported by documentation protocols. The data investigated by such protocols help identify the parameters needed for the assessment of the preservation state of a monument and its monitoring through its entire lifetime. The main tool for detecting these indicators is a diagnostic methodology based on appropriate standards that reveals the actual degradation processes responsible of the asset's vulnerability. It is very important that the integration between the material's diagnosis and the overall documentation is taken into consideration in order to identify the required levels of protection and preventive conservation for heritage assets depending on the most frequent local risks. The ranging of risks is therefore necessary according to their importance in each area. Documentation protocols provide with a specific diagnostic tool for materials characterization, decay diagnosis, evaluation process of former conservation materials and interventions, standard procedures for monitoring and control as well as data documentation based on specific guidelines and standards. Implementation and analysis of a "standardised" diagnostic study will reveal the main risks due to degradation processes affecting the heritage asset to be subsequently recorded in order to result into risk indicators. The development of risk indicators regarding degradation processes is the basic step towards uptaking efficient management, preventive conservation and strategic planning for heritage assets against various threats. These risk indicators could be further elaborated according to the activities of inspection, diagnosis and intervention works, offering scientific support to the decision making process for cultural heritage preventive conservation and overall protection.

Assessment Methodology for Process Validation Lifecycle Stage 3A.

PubMed

Sayeed-Desta, Naheed; Pazhayattil, Ajay Babu; Collins, Jordan; Chen, Shu; Ingram, Marzena; Spes, Jana

2017-07-01

The paper introduces evaluation methodologies and associated statistical approaches for process validation lifecycle Stage 3A. The assessment tools proposed can be applied to newly developed and launched small molecule as well as bio-pharma products, where substantial process and product knowledge has been gathered. The following elements may be included in Stage 3A: number of 3A batch determination; evaluation of critical material attributes, critical process parameters, critical quality attributes; in vivo in vitro correlation; estimation of inherent process variability (IPV) and PaCS index; process capability and quality dashboard (PCQd); and enhanced control strategy. US FDA guidance on Process Validation: General Principles and Practices, January 2011 encourages applying previous credible experience with suitably similar products and processes. A complete Stage 3A evaluation is a valuable resource for product development and future risk mitigation of similar products and processes. Elements of 3A assessment were developed to address industry and regulatory guidance requirements. The conclusions made provide sufficient information to make a scientific and risk-based decision on product robustness.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

PubMed

Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

2014-09-01

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

Implementation of cold risk management in occupational safety, occupational health and quality practices. Evaluation of a development process and its effects at the finnish maritime administration.

PubMed

Risikko, Tanja; Remes, Jouko; Hassi, Juhani

2008-01-01

Cold is a typical environmental risk factor in outdoor work in northern regions. It should be taken into account in a company's occupational safety, health and quality systems. A development process for improving cold risk management at the Finnish Maritime Administration (FMA) was carried out by FMA and external experts. FMA was to implement it. Three years after the development phase, the outcomes and implementation were evaluated. The study shows increased awareness about cold work and few concrete improvements. Concrete improvements in occupational safety and health practices could be seen in the pilot group. However, organization-wide implementation was insufficient, the main reasons being no organization-wide practices, unclear process ownership, no resources and a major reorganization process. The study shows a clear need for expertise supporting implementation. The study also presents a matrix for analyzing the process.

Developing Statistical Models to Assess Transplant Outcomes Using National Registries: The Process in the United States.

PubMed

Snyder, Jon J; Salkowski, Nicholas; Kim, S Joseph; Zaun, David; Xiong, Hui; Israni, Ajay K; Kasiske, Bertram L

2016-02-01

Created by the US National Organ Transplant Act in 1984, the Scientific Registry of Transplant Recipients (SRTR) is obligated to publicly report data on transplant program and organ procurement organization performance in the United States. These reports include risk-adjusted assessments of graft and patient survival, and programs performing worse or better than expected are identified. The SRTR currently maintains 43 risk adjustment models for assessing posttransplant patient and graft survival and, in collaboration with the SRTR Technical Advisory Committee, has developed and implemented a new systematic process for model evaluation and revision. Patient cohorts for the risk adjustment models are identified, and single-organ and multiorgan transplants are defined, then each risk adjustment model is developed following a prespecified set of steps. Model performance is assessed, the model is refit to a more recent cohort before each evaluation cycle, and then it is applied to the evaluation cohort. The field of solid organ transplantation is unique in the breadth of the standardized data that are collected. These data allow for quality assessment across all transplant providers in the United States. A standardized process of risk model development using data from national registries may enhance the field.

Estimation and evaluation of management options to control and/or reduce the risk of not complying with commercial sterility.

PubMed

Pujol, Laure; Albert, Isabelle; Magras, Catherine; Johnson, Nicholas Brian; Membré, Jeanne-Marie

2015-11-20

In a previous study, a modular process risk model, from the raw material reception to the final product storage, was built to estimate the risk of a UHT-aseptic line of not complying with commercial sterility (Pujol et al., 2015). This present study was focused on demonstrating how the model (updated version with uncertainty and variability separated and 2(nd) order Monte Carlo procedure run) could be used to assess quantitatively the influence of management options. This assessment was done in three steps: pinpoint which process step had the highest influence on the risk, identify which management option(s) could be the most effective to control and/or reduce the risk, and finally evaluate quantitatively the influence of changing process setting(s) on the risk. For Bacillus cereus, it was identified that during post-process storage in an aseptic tank, there was potentially an air re-contamination due to filter efficiency loss (efficiency loss due to successive in-place sterilizations after cleaning operations), followed by B. cereus growth. Two options were then evaluated: i) reducing by one fifth of the number of filter sterilizations before renewing the filters, ii) designing new UHT-aseptic lines without an aseptic tank, i.e. without a storage period after the thermal process and before filling. Considering the uncertainty in the model, it was not possible to confirm whether these options had a significant influence on the risk associated with B. cereus. On the other hand, for Geobacillus stearothermophilus, combinations of heat-treatment time and temperature enabling the control or reduction in risk by a factor of ca. 100 were determined; for ease of operational implementation, they were presented graphically in the form of iso-risk curves. For instance, it was established that a heat treatment of 138°C for 31s (instead of 138°C for 25s) enabled a reduction in risk to 18×10(-8) (95% CI=[10; 34]×10(-8)), instead of 578×10(-8) (95% CI=[429; 754]×10(-8)) initially. In conclusion, a modular risk model, as the one exemplified here with a UHT-aseptic line, is a valuable tool in process design and operation, bringing definitive quantitative elements into the decision making process. Copyright © 2015 Elsevier B.V. All rights reserved.

Report: Fiscal Year 2013 Federal Information Security Management Act Report

EPA Pesticide Factsheets

Report #14-P-0033, November 26, 2013. The EPA’s network and data could be exploited without processes to evaluate risks and timely remediate vulnerabilities. Data processed by EPA contractors could be at risk because adequate controls may not be in place.

Cumulative Assessment of Risk from Pesticides

EPA Pesticide Factsheets

EPA protects human health and the environment by evaluating the risk associated with pesticides before allowing them to be used in the United States. Learn about the tools and processes used in risk assessment for pesticides.

Pesticide Science and Assessing Pesticide Risks

EPA Pesticide Factsheets

EPA protects human health and the environment by evaluating the risk associated with pesticides before allowing them to be used in the United States. Learn about the tools and processes used in risk assessment for pesticides.

Assessing Human Health Risk from Pesticides

EPA Pesticide Factsheets

EPA protects human health and the environment by evaluating the risk associated with pesticides before allowing them to be used in the United States. Learn about the tools and processes used in risk assessment for pesticides.

Feasibility of screening patients for emotional risk factors before in vitro fertilization in daily clinical practice: a process evaluation.

PubMed

Van Dongen, A J C M; Kremer, J A M; Van Sluisveld, N; Verhaak, C M; Nelen, W L D M

2012-12-01

Is patient screening for emotional risk factors before starting IVF treatment feasible? Introduction of screening for emotional risk factors by a validated instrument (SCREENIVF) in couples treated by IVF or ICSI is feasible, indicated by a moderate to high and stable uptake rate, a high acceptance of the process of SCREENIVF, and a high acceptability of the presented risk profile by the patients. SCREENIVF is a validated screening tool to identify women at risk for emotional maladjustment preceding the start of their IVF/ICSI treatment. This was a prospective cohort study, including data of two cohorts of patients (304 and 342 patients), with a duration of 3 months per cohort. For the first cohort, we sent a process evaluation to 210 patients and it was completed by 91 patients. All 304 patients (male and female) who started IVF/ICSI between 1 December 2009 and 28 February 2010 in our tertiary IVF clinic were eligible. The uptake rate of SCREENIVF was assessed as the response rate to the screening questionnaire. One year later, we re-assessed the uptake rate in 342 new patients to assess the stability of the uptake rate. A non-responder assessment in patients who did not complete SCREENIVF was carried out. Finally, patients' characteristics and their experiences with SCREENIVF as well as their consequent actions were assessed by an additional process evaluation questionnaire sent some months later to 210 patients. The uptake rate of SCREENIVF was 78-80%. One-third of the responders were found to be at risk for emotional maladjustment, which was comparable with previous studies using SCREENIVF. Of 27 non-responders to SCREENIVF, 41% explained non-response by 'no actual need for psychological help' and 19% forgot to complete the screening. The response rate to the process evaluation was 43% (n = 91). Of these, 90% found the screening was useful, and almost all patients were positive about the SCREENIVF questionnaire. Furthermore, 93% recognized themselves in the risk profile based on SCREENIVF. Of the patients at risk, 21% reported planning to seek professional help, but 46% of the at-risk patients experienced travelling distance as an obstacle to seek psychological help. We concluded that screening patients for emotional risk factors is feasible. In future, psychosocial care offered by the Internet may be promising in meeting the barrier of travelling distance. People were asked to fill in SCREENIVF for clinical purposes pretreatment. There might be a selection bias in the people who did not fill in SCREENIVF, which may be due to already existing psychological problems or language problems. The low response rate of the process evaluation questionnaire and the mono-centre evaluation may be confounders and may have influenced our analysis opportunities. The generalizability of this data is unknown with respect to other ethnic groups. Furthermore, more research is needed to evaluate psychosocial factors in male partners. Future research should also focus on the barriers and facilitators for help-seeking behaviour. There was no funding for this study and no conflict of interest.

Low-thrust mission risk analysis, with application to a 1980 rendezvous with the comet Encke

NASA Technical Reports Server (NTRS)

Yen, C. L.; Smith, D. B.

1973-01-01

A computerized failure process simulation procedure is used to evaluate the risk in a solar electric space mission. The procedure uses currently available thrust-subsystem reliability data and performs approximate simulations of the thrust sybsystem burn operation, the system failure processes, and the retargeting operations. The method is applied to assess the risks in carrying out a 1980 rendezvous mission to the comet Encke. Analysis of the results and evaluation of the effects of various risk factors on the mission show that system component failure rates are the limiting factors in attaining a high mission relability. It is also shown that a well-designed trajectory and system operation mode can be used effectively to partially compensate for unreliable thruster performance.

Risk Assessment for Stonecutting Enterprises

NASA Astrophysics Data System (ADS)

Aleksandrova, A. J.; Timofeeva, S. S.

2017-04-01

Working conditions at enterprises and artisanal workshops for the processing of jewelry and ornamental stones were considered. The main stages of the technological process for processing of stone raw materials were shown; dangerous processes in the extraction of stone and its processing were identified. The characteristic of harmful and dangerous production factors affecting stonecutters is given. It was revealed that the most dangerous are the increased level of noise and vibration, as well as chemical reagents. The results of a special assessment of the working conditions of stone-cutting plant workers are studied. Professions with high professional risk were identified; an analysis of occupational risks and occupational injuries was carried out. Risk assessment was produced by several methods; professions with high and medium risk indicators were identified by results of the evaluation. The application of risk assessment methods was given the possibility to justify rational measures reducing risks to the lowest possible level. The received quantitative indicators of risk of workers of the stone-cutting enterprises are the result of this work.

EVALUATION OF PHYSIOLOGY COMPUTER MODELS, AND THE FEASIBILITY OF THEIR USE IN RISK ASSESSMENT.

EPA Science Inventory

This project will evaluate the current state of quantitative models that simulate physiological processes, and the how these models might be used in conjunction with the current use of PBPK and BBDR models in risk assessment. The work will include a literature search to identify...

Red and Processed Meat Consumption Increases Risk for Non-Hodgkin Lymphoma

PubMed Central

Yang, Li; Dong, Jianming; Jiang, Shenghua; Shi, Wenyu; Xu, Xiaohong; Huang, Hongming; You, Xuefen; Liu, Hong

2015-01-01

Abstract The association between consumption of red and processed meat and non-Hodgkin lymphoma (NHL) remains unclear. We performed a meta-analysis of the published observational studies to explore this relationship. We searched databases in MEDLINE and EMBASE to identify observational studies which evaluated the association between consumption of red and processed meat and risk of NHL. Quality of included studies was evaluated using Newcastle-Ottawa Quality Assessment Scale (NOS). Random-effects models were used to calculate summary relative risk (SRR) and the corresponding 95% confidence interval (CI). We identified a total of 16 case–control and 4 prospective cohort studies, including 15,189 subjects with NHL. The SRR of NHL comparing the highest and lowest categories were 1.32 (95% CI: 1.12–1.55) for red meat and 1.17 (95% CI: 1.07–1.29) for processed meat intake. Stratified analysis indicated that a statistically significant risk association between consumption of red and processed meat and NHL risk was observed in case–control studies, but not in cohort studies. The SRR was 1.11 (95% CI: 1.04–1.18) for per 100 g/day increment in red meat intake and 1.28 (95% CI: 1.08–1.53) for per 50 g/day increment in processed meat intake. There was evidence of a nonlinear association for intake of processed meat, but not for intake of red meat. Findings from our meta-analysis indicate that consumption of red and processed meat may be related to NHL risk. More prospective epidemiological studies that control for important confounders and focus on the NHL risk related with different levels of meat consumption are required to clarify this association. PMID:26559248

Evaluation of risk and benefit in thermal effusivity sensor for monitoring lubrication process in pharmaceutical product manufacturing.

PubMed

Uchiyama, Jumpei; Kato, Yoshiteru; Uemoto, Yoshifumi

2014-08-01

In the process design of tablet manufacturing, understanding and control of the lubrication process is important from various viewpoints. A detailed analysis of thermal effusivity data in the lubrication process was conducted in this study. In addition, we evaluated the risk and benefit in the lubrication process by a detailed investigation. It was found that monitoring of thermal effusivity detected mainly the physical change of bulk density, which was changed by dispersal of the lubricant and the coating powder particle by the lubricant. The monitoring of thermal effusivity was almost the monitoring of bulk density, thermal effusivity could have a high correlation with tablet hardness. Moreover, as thermal effusivity sensor could detect not only the change of the conventional bulk density but also the fractional change of thermal conductivity and thermal capacity, two-phase progress of lubrication process could be revealed. However, each contribution of density, thermal conductivity, or heat capacity to thermal effusivity has the risk of fluctuation by formulation. After carefully considering the change factor with the risk to be changed by formulation, thermal effusivity sensor can be a useful tool for monitoring as process analytical technology, estimating tablet hardness and investigating the detailed mechanism of the lubrication process.

Risk Evaluation of Railway Coal Transportation Network Based on Multi Level Grey Evaluation Model

NASA Astrophysics Data System (ADS)

Niu, Wei; Wang, Xifu

2018-01-01

The railway transport mode is currently the most important way of coal transportation, and now China’s railway coal transportation network has become increasingly perfect, but there is still insufficient capacity, some lines close to saturation and other issues. In this paper, the theory and method of risk assessment, analytic hierarchy process and multi-level gray evaluation model are applied to the risk evaluation of coal railway transportation network in China. Based on the example analysis of Shanxi railway coal transportation network, to improve the internal structure and the competitiveness of the market.

Assessment and Control of Spacecraft Charging Risks on the International Space Station

NASA Technical Reports Server (NTRS)

Koontz, Steve; Valentine, Mark; Keeping, Thomas; Edeen, Marybeth; Spetch, William; Dalton, Penni

2004-01-01

The International Space Station (ISS) operates in the F2 region of Earth's ionosphere, orbiting at altitudes ranging from 350 to 450 km at an inclination of 51.6 degrees. The relatively dense, cool F2 ionospheric plasma suppresses surface charging processes much of the time, and the flux of relativistic electrons is low enough to preclude deep dielectric charging processes. The most important spacecraft charging processes in the ISS orbital environment are: 1) ISS electrical power system interactions with the F2 plasma, 2) magnetic induction processes resulting from flight through the geomagnetic field and, 3) charging processes that result from interaction with auroral electrons at high latitude. Recently, the continuing review and evaluation of putative ISS charging hazards required by the ISS Program Office revealed that ISS charging could produce an electrical shock hazard to the ISS crew during extravehicular activity (EVA). ISS charging risks are being evaluated in an ongoing measurement and analysis campaign. The results of ISS charging measurements are combined with a recently developed model of ISS charging (the Plasma Interaction Model) and an exhaustive analysis of historical ionospheric variability data (ISS Ionospheric Specification) to evaluate ISS charging risks using Probabilistic Risk Assessment (PRA) methods. The PRA combines estimates of the frequency of occurrence and severity of the charging hazards with estimates of the reliability of various hazard controls systems, as required by NASA s safety and risk management programs, to enable design and selection of a hazard control approach that minimizes overall programmatic and personnel risk. The PRA provides a quantitative methodology for incorporating the results of the ISS charging measurement and analysis campaigns into the necessary hazard reports, EVA procedures, and ISS flight rules required for operating ISS in a safe and productive manner.

A model study of the Haihe river passenger ferry risk based on AHP

NASA Astrophysics Data System (ADS)

Du, Jinyin; Xu, Yanming; Du, Chunzhi; Jin, Zhenhua

2017-05-01

The core function of maritime is water safety supervision, whose emphasis and difficulty is ferry. In combination with the practical situation of Haihe river passenger ferry operation management, this paper analyzes Haihe river passenger ferry risk from four aspects "human, machinery, environment and management", and establishes the ferry risk index system. By using AHP (Analytic Hierarchy Process), the ferry risk evaluation model is established. By using the ferry model, the application of Ferry Zhengyanfa7 in Tianjin Haihe river crossing is evaluated, whose safety situation is verified to be between "relatively high risk" and "high risk".

Determining Risk - How to Evaluate the Environmental Effects of Marine and Hydrokinetic Energy Development

NASA Astrophysics Data System (ADS)

Copping, A. E.; Blake, K.; Zdanski, L.

2011-12-01

As marine and hydrokinetic (MHK) energy development projects progress towards early deployments in the U.S., the process of determining the risks to aquatic animals, habitats, and ecosystem processes from these engineered systems continues to be a significant barrier to efficient siting and permitting. Understanding the risk of MHK installations requires that the two elements of risk - consequence and probability - be evaluated. However, standard risk assessment methodologies are not easily applied to MHK interactions with marine and riverine environment as there are few data that describe the interaction of stressors (MHK devices, anchors, foundations, mooring lines and power cables) and receptors (aquatic animals, habitats and ecosystem processes). The number of possible combinations and permutations of stressors and receptors in MHK systems is large: there are many different technologies designed to harvest energy from the tides, waves and flowing rivers; each device is planned for a specific waterbody that supports an endemic ecosystem of animals and habitats, tied together by specific physical and chemical processes. With few appropriate analogue industries in the oceans and rivers, little information on the effects of these technologies on the living world is available. Similarly, without robust data sets of interactions, mathematical probability models are difficult to apply. Pacific Northwest National Laboratory scientists are working with MHK developers, researchers, engineers, and regulators to rank the consequences of planned MHK projects on living systems, and exploring alternative methodologies to estimate probabilities of these encounters. This paper will present the results of ERES, the Environmental Risk Evaluation System, which has been used to rank consequences for major animal groups and habitats for five MHK projects that are in advanced stages of development and/or early commercial deployment. Probability analyses have been performed for high priority stressor/receptor interactions where data are adaptable from other industries. In addition, a methodology for evaluating the probability of encounter, and therefore risk, to an endangered marine mammal from tidal turbine blades will be presented.

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

Glantz, C.S.; DiMassa, F.V.; Pelto, P.J.

The Western Area Power Administration (Western) views environmental protection and compliance as a top priority as it manages the construction, operation, and maintenance of its vast network of transmission lines, substations, and other facilities. A recent Department of Energy audit of Western`s environmental management activities recommends that Western adopt a formal environmental risk program. To accomplish this goal, Western, in conjunction with Pacific Northwest Laboratory, is in the process of developing a centrally coordinated environmental risk program. This report presents the results of this design effort, and indicates the direction in which Western`s environmental risk program is heading. Western`s environmentalmore » risk program will consist of three main components: risk communication, risk assessment, and risk management/decision making. Risk communication is defined as an exchange of information on the potential for threats to human health, public safety, or the environment. This information exchange provides a mechanism for public involvement, and also for the participation in the risk assessment and management process by diverse groups or offices within Western. The objective of risk assessment is to evaluate and rank the relative magnitude of risks associated with specific environmental issues that are facing Western. The evaluation and ranking is based on the best available scientific information and judgment and serves as input to the risk management process. Risk management takes risk information and combines it with relevant non-risk factors (e.g., legal mandates, public opinion, costs) to generate risk management options. A risk management tool, such as decision analysis, can be used to help make risk management choices.« less

A review of risk management process in construction projects of developing countries

NASA Astrophysics Data System (ADS)

Bahamid, R. A.; Doh, S. I.

2017-11-01

In the construction industry, risk management concept is a less popular technique. There are three main stages in the systematic approach to risk management in construction industry. These stages include: a) risk response; b) risk analysis and evaluation; and c) risk identification. The high risk related to construction business affects each of its participants; while operational analysis and management of construction related risks remain an enormous task to practitioners of the industry. This paper tends towards reviewing the existing literature on construction project risk managements in developing countries specifically on risk management process. The literature lacks ample risk management process approach capable of capturing risk impact on diverse project objectives. This literature review aims at discovering the frequently used techniques in risk identification and analysis. It also attempts to identify response to clarifying the different classifications of risk sources in the existing literature of developing countries, and to identify the future research directions on project risks in the area of construction in developing countries.

BIG DARBY CREEK WATERSHED

EPA Science Inventory

What is an ecological risk assessment?

Middle Platte River Watershed

EPA Science Inventory

What is an ecological risk assessment?

An ecological risk assessment evaluates the potential adverse effects of human activities on the plants and animals that make up ecosystems. The risk assessment process provides a way to develop, organize and present sc...

Guidance on Cumulative Risk Assessment of Pesticide Chemicals that have a Common Mechanism of Toxicity

EPA Pesticide Factsheets

This document provides guidance to OPP scientists for evaluating and estimating the potential human risks associated with such multichemical and multipathway exposures to pesticides. This process is referred to as cumulative risk assessment.

EPA's Policy on Evaluating Risk to Children

EPA Pesticide Factsheets

It is the policy of EPA to consider the risks to infants and children consistently and explicitly as a part of risk assessments generated during its decision making process, including the setting of standards to protect public health and the environment.

Three methods for integration of environmental risk into the benefit-risk assessment of veterinary medicinal products.

PubMed

Chapman, Jennifer L; Porsch, Lucas; Vidaurre, Rodrigo; Backhaus, Thomas; Sinclair, Chris; Jones, Glyn; Boxall, Alistair B A

2017-12-15

Veterinary medicinal products (VMPs) require, as part of the European Union (EU) authorization process, consideration of both risks and benefits. Uses of VMPs have multiple risks (e.g., risks to the animal being treated, to the person administering the VMP) including risks to the environment. Environmental risks are not directly comparable to therapeutic benefits; there is no standardized approach to compare both environmental risks and therapeutic benefits. We have developed three methods for communicating and comparing therapeutic benefits and environmental risks for the benefit-risk assessment that supports the EU authorization process. Two of these methods support independent product evaluation (i.e., a summative classification and a visual scoring matrix classification); the other supports a comparative evaluation between alternative products (i.e., a comparative classification). The methods and the challenges to implementing a benefit-risk assessment including environmental risk are presented herein; how these concepts would work in current policy is discussed. Adaptability to scientific and policy development is considered. This work is an initial step in the development of a standardized methodology for integrated decision-making for VMPs. Copyright © 2017 Elsevier B.V. All rights reserved.

OPPT workplan risk assessment for antimony trioxide (CASRN ...

EPA Pesticide Factsheets

This assessment will focus on the ecological hazards that may be associated with ATO use in flame retardants. Because ATO’s use in PET plastics was previously evaluated and determined to present minimal concerns for human health and the environment (EU, 2008), this use scenario will not be evaluated here. Human health risks have been evaluated previously and will be summarized in this assessment. EPA anticipates issuing draft risk assessments for public review and comment as they are completed. At the conclusion of the review process, if an assessment of specific uses indicates significant risk, EPA will evaluate and pursue appropriate risk reduction actions, as warranted. If an assessment indicates no significant risk, EPA will conclude its current work on assessment of those specified targeted uses of that chemical. Over time, additional chemicals will be added to the work plan as more data are developed and more chemicals screened.

Cognitive Processes Underlying Women's Risk Judgments: Associations with Sexual Victimization History and Rape Myth Acceptance

ERIC Educational Resources Information Center

Yeater, Elizabeth A.; Treat, Teresa A.; Viken, Richard J.; McFall, Richard M.

2010-01-01

Objective: This study evaluated the effects of sexual victimization history, rape myth acceptance, implicit attention, and recent learning on the cognitive processes underlying undergraduate women's explicit risk judgments. Method: Participants were 194 undergraduate women between 18 and 24 years of age. The sample was ethnically diverse and…

A risk-based auditing process for pharmaceutical manufacturers.

PubMed

Vargo, Susan; Dana, Bob; Rangavajhula, Vijaya; Rönninger, Stephan

2014-01-01

The purpose of this article is to share ideas on developing a risk-based model for the scheduling of audits (both internal and external). Audits are a key element of a manufacturer's quality system and provide an independent means of evaluating the manufacturer's or the supplier/vendor's compliance status. Suggestions for risk-based scheduling approaches are discussed in the article. Pharmaceutical manufacturers are required to establish and implement a quality system. The quality system is an organizational structure defining responsibilities, procedures, processes, and resources that the manufacturer has established to ensure quality throughout the manufacturing process. Audits are a component of the manufacturer's quality system and provide a systematic and an independent means of evaluating the manufacturer's overall quality system and compliance status. Audits are performed at defined intervals for a specified duration. The intention of the audit process is to focus on key areas within the quality system and may not cover all relevant areas during each audit. In this article, the authors provide suggestions for risk-based scheduling approaches to aid pharmaceutical manufacturers in identifying the key focus areas for an audit.

[Development and clinical evaluation of an anesthesia information management system].

PubMed

Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

2010-09-21

To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

[Risk management--a new aspect of quality assessment in intensive care medicine: first results of an analysis of the DIVI's interdisciplinary quality assessment research group].

PubMed

Stiletto, R; Röthke, M; Schäfer, E; Lefering, R; Waydhas, Ch

2006-10-01

Patient security has become one of the major aspects of clinical management in recent years. The crucial point in research was focused on malpractice. In contradiction to the economic process in non medical fields, the analysis of errors during the in-patient treatment time was neglected. Patient risk management can be defined as a structured procedure in a clinical unit with the aim to reduce harmful events. A risk point model was created based on a Delphi process and founded on the DIVI data register. The risk point model was evaluated in clinically working ICU departments participating in the register data base. The results of the risk point evaluation will be integrated in the next data base update. This might be a step to improve the reliability of the register to measure quality assessment in the ICU.

Environmental risk communication as an educational process

NASA Astrophysics Data System (ADS)

Schottenfeld, Faith

The purpose of this study was to explore the dynamics of the environmental risk communication process. The goal was to look at the totality of the process by examining the different components: entry to communication (what brings people into the process), maintenance of communication (behaviors of participants, pathways to successful risk communication, barriers to successful risk communication, characteristics of the dialogue) and outcomes of risk communication (what has been learned, what moves the process to social action, what else can come of the process). Interviews and critical incidents were used to explore the experiences of risk communicators in four different practice settings: academia, industry/trade groups, community-based organizations and government. Twenty-four people completed critical incident stories and sixteen participated in in-depth interviews. Data were coded and analyzed for themes. Findings illustrated that successful risk communication results from a deliberative, or purposeful process. This process includes a systematic approach to identifying and inviting people to participate, while considering specific motivating factors that affect participation. Risk communication is maintained by creating and nurturing structured forums for dialogue by acknowledging the varying perspectives of the people who participate and the contextual settings of environmental risks. The result of effective dialogue may range from increased knowledge, to transformative learning to social action and policy change. The researcher recommended that a multi-disciplinary team including risk communicators, adult educators and scientists can work most effectively to plan, implement and evaluate a risk communication process.

Application of a hazard and operability study method to hazard evaluation of a chemical unit of the power station.

PubMed

Habibi, E; Zare, M; Barkhordari, A; Mirmohammadi, Sj; Halvani, Ghh

2008-12-28

The aim of this study was to identify the hazards, evaluate their risk factors and determine the measure for promotion of the process and reduction of accidents in the chemical unit of the power station. In this case and qualitative study, HAZOP technique was used to recognize the hazards and problems of operations on the chemical section at power station. Totally, 126 deviations were documented with various causes and consequences. Ranking and evaluation of identified risks indicate that the majority of deviations were categorized as "acceptable" and less than half of that were "unacceptable". The highest calculated risk level (1B) related to both the interruption of acid entry to the discharge pumps and an increased density of the acid. About 27% of the deviations had the lowest risk level (4B). The identification of hazards by HAZOP indicates that it could, systemically, assess and criticize the process of consumption or production of acid and alkali in the chemical unit of power plant.

The NASA Continuous Risk Management Process

NASA Technical Reports Server (NTRS)

Pokorny, Frank M.

2004-01-01

As an intern this summer in the GRC Risk Management Office, I have become familiar with the NASA Continuous Risk Management Process. In this process, risk is considered in terms of the probability that an undesired event will occur and the impact of the event, should it occur (ref., NASA-NPG: 7120.5). Risk management belongs in every part of every project and should be ongoing from start to finish. Another key point is that a risk is not a problem until it has happened. With that in mind, there is a six step cycle for continuous risk management that prevents risks from becoming problems. The steps are: identify, analyze, plan, track, control, and communicate & document. Incorporated in the first step are several methods to identify risks such as brainstorming and using lessons learned. Once a risk is identified, a risk statement is made on a risk information sheet consisting of a single condition and one or more consequences. There can also be a context section where the risk is explained in more detail. Additionally there are three main goals of analyzing a risk, which are evaluate, classify, and prioritize. Here is where a value is given to the attributes of a risk &e., probability, impact, and timeframe) based on a multi-level classification system (e.g., low, medium, high). It is important to keep in mind that the definitions of these levels are probably different for each project. Furthermore the risks can be combined into groups. Then, the risks are prioritized to see what risk is necessary to mitigate first. After the risks are analyzed, a plan is made to mitigate as many risks as feasible. Each risk should be assigned to someone in the project with knowledge in the area of the risk. Then the possible approaches to choose from are: research, accept, watch, or mitigate. Next, all risks, mitigated or not, are tracked either individually or in groups. As the plan is executed, risks are re-evaluated, and the attribute values are adjusted as necessary. Metrics are established and monitored as tools for risk tracking. Also a trigger or threshold should be set on the metric data that indicates when an action is needed. Results of this tracking are usually evaluated and reported in a relevant format at weekly or monthly meetings. Choosing controls is the subsequent step, which involves the effects of the tracking. The three basic controls are: close, continue tracking, and re- plan. Finally communicate & document is the last step, but occurs throughout the process. It is vital that main risks, plans, changes, and progress are known by everyone in the project. A good way to keep everyone updated and inform other projects of common issues is by thoroughly documenting project risks. NASA sees value in risk management and believes that projects have greater probability or success by using the NASA Continuous Risk Management Process.

HIERARCHIAL DESIGN AND EVALUATION OF PROCESSES TO GENERATE WASTE-RECYCLED FEEDS

EPA Science Inventory

Hierarchical Design and Evaluation of Processes to Generate
Waste-Recycled Feeds

Raymond L. Smith
U.S. Environmental Protection Agency
Office of Research and Development
National Risk Management Research Laboratory
26 W. Martin Luther King Drive
Cincinna...

Research and Evaluations of the Health Aspects of Disasters, Part IX: Risk-Reduction Framework.

PubMed

Birnbaum, Marvin L; Daily, Elaine K; O'Rourke, Ann P; Loretti, Alessandro

2016-06-01

A disaster is a failure of resilience to an event. Mitigating the risks that a hazard will progress into a destructive event, or increasing the resilience of a society-at-risk, requires careful analysis, planning, and execution. The Disaster Logic Model (DLM) is used to define the value (effects, costs, and outcome(s)), impacts, and benefits of interventions directed at risk reduction. A Risk-Reduction Framework, based on the DLM, details the processes involved in hazard mitigation and/or capacity-building interventions to augment the resilience of a community or to decrease the risk that a secondary event will develop. This Framework provides the structure to systematically undertake and evaluate risk-reduction interventions. It applies to all interventions aimed at hazard mitigation and/or increasing the absorbing, buffering, or response capacities of a community-at-risk for a primary or secondary event that could result in a disaster. The Framework utilizes the structure provided by the DLM and consists of 14 steps: (1) hazards and risks identification; (2) historical perspectives and predictions; (3) selection of hazard(s) to address; (4) selection of appropriate indicators; (5) identification of current resilience standards and benchmarks; (6) assessment of the current resilience status; (7) identification of resilience needs; (8) strategic planning; (9) selection of an appropriate intervention; (10) operational planning; (11) implementation; (12) assessments of outputs; (13) synthesis; and (14) feedback. Each of these steps is a transformation process that is described in detail. Emphasis is placed on the role of Coordination and Control during planning, implementation of risk-reduction/capacity building interventions, and evaluation. Birnbaum ML , Daily EK , O'Rourke AP , Loretti A . Research and evaluations of the health aspects of disasters, part IX: Risk-Reduction Framework. Prehosp Disaster Med. 2016;31(3):309-325.

An approach for environmental risk assessment of engineered nanomaterials using Analytical Hierarchy Process (AHP) and fuzzy inference rules.

PubMed

Topuz, Emel; van Gestel, Cornelis A M

2016-01-01

The usage of Engineered Nanoparticles (ENPs) in consumer products is relatively new and there is a need to conduct environmental risk assessment (ERA) to evaluate their impacts on the environment. However, alternative approaches are required for ERA of ENPs because of the huge gap in data and knowledge compared to conventional pollutants and their unique properties that make it difficult to apply existing approaches. This study aims to propose an ERA approach for ENPs by integrating Analytical Hierarchy Process (AHP) and fuzzy inference models which provide a systematic evaluation of risk factors and reducing uncertainty about the data and information, respectively. Risk is assumed to be the combination of occurrence likelihood, exposure potential and toxic effects in the environment. A hierarchy was established to evaluate the sub factors of these components. Evaluation was made with fuzzy numbers to reduce uncertainty and incorporate the expert judgements. Overall score of each component was combined with fuzzy inference rules by using expert judgements. Proposed approach reports the risk class and its membership degree such as Minor (0.7). Therefore, results are precise and helpful to determine the risk management strategies. Moreover, priority weights calculated by comparing the risk factors based on their importance for the risk enable users to understand which factor is effective on the risk. Proposed approach was applied for Ag (two nanoparticles with different coating) and TiO2 nanoparticles for different case studies. Results verified the proposed benefits of the approach. Copyright © 2016 Elsevier Ltd. All rights reserved.

Proposal for a new categorization of aseptic processing facilities based on risk assessment scores.

PubMed

Katayama, Hirohito; Toda, Atsushi; Tokunaga, Yuji; Katoh, Shigeo

2008-01-01

Risk assessment of aseptic processing facilities was performed using two published risk assessment tools. Calculated risk scores were compared with experimental test results, including environmental monitoring and media fill run results, in three different types of facilities. The two risk assessment tools used gave a generally similar outcome. However, depending on the tool used, variations were observed in the relative scores between the facilities. For the facility yielding the lowest risk scores, the corresponding experimental test results showed no contamination, indicating that these ordinal testing methods are insufficient to evaluate this kind of facility. A conventional facility having acceptable aseptic processing lines gave relatively high risk scores. The facility showing a rather high risk score demonstrated the usefulness of conventional microbiological test methods. Considering the significant gaps observed in calculated risk scores and in the ordinal microbiological test results between advanced and conventional facilities, we propose a facility categorization based on risk assessment. The most important risk factor in aseptic processing is human intervention. When human intervention is eliminated from the process by advanced hardware design, the aseptic processing facility can be classified into a new risk category that is better suited for assuring sterility based on a new set of criteria rather than on currently used microbiological analysis. To fully benefit from advanced technologies, we propose three risk categories for these aseptic facilities.

Research on Liquidity Risk Evaluation of Chinese A-Shares Market Based on Extension Theory

NASA Astrophysics Data System (ADS)

Bai-Qing, Sun; Peng-Xiang, Liu; Lin, Zhang; Yan-Ge, Li

This research defines the liquidity risk of stock market in matter-element theory and affair-element theory, establishes the indicator system of the forewarning for liquidity risks,designs the model and the process of early warning using the extension set method, extension dependent function and the comprehensive evaluation model. And the paper studies empirically A-shares market through the data of 1A0001, which prove that the model can better describe liquidity risk of China’s A-share market. At last, it gives the corresponding policy recommendations.

Risk Evaluation in the Pre-Phase A Conceptual Design of Spacecraft

NASA Technical Reports Server (NTRS)

Fabisinski, Leo L., III; Maples, Charlotte Dauphne

2010-01-01

Typically, the most important decisions in the design of a spacecraft are made in the earliest stages of its conceptual design the Pre-Phase A stages. It is in these stages that the greatest number of design alternatives is considered, and the greatest number of alternatives is rejected. The focus of Pre-Phase A conceptual development is on the evaluation and comparison of whole concepts and the larger-scale systems comprising those concepts. This comparison typically uses general Figures of Merit (FOMs) to quantify the comparative benefits of designs and alternative design features. Along with mass, performance, and cost, risk should be one of the major FOMs in evaluating design decisions during the conceptual design phases. However, risk is often given inadequate consideration in conceptual design practice. The reasons frequently given for this lack of attention to risk include: inadequate mission definition, lack of rigorous design requirements in early concept phases, lack of fidelity in risk assessment methods, and under-evaluation of risk as a viable FOM for design evaluation. In this paper, the role of risk evaluation in early conceptual design is discussed. The various requirements of a viable risk evaluation tool at the Pre-Phase A level are considered in light of the needs of a typical spacecraft design study. A technique for risk identification and evaluation is presented. The application of the risk identification and evaluation approach to the conceptual design process is discussed. Finally, a computational tool for risk profiling is presented and applied to assess the risk for an existing Pre-Phase A proposal. The resulting profile is compared to the risks identified for the proposal by other means.

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.

PubMed

Lentine, Krista L; Kasiske, Bertram L; Levey, Andrew S; Adams, Patricia L; Alberú, Josefina; Bakr, Mohamed A; Gallon, Lorenzo; Garvey, Catherine A; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L; Taler, Sandra J; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G; Cheung, Michael; Garg, Amit X

2017-08-01

The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a "proof-in-concept" risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided.In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1-S109.

FMEA of manual and automated methods for commissioning a radiotherapy treatment planning system.

PubMed

Wexler, Amy; Gu, Bruce; Goddu, Sreekrishna; Mutic, Maya; Yaddanapudi, Sridhar; Olsen, Lindsey; Harry, Taylor; Noel, Camille; Pawlicki, Todd; Mutic, Sasa; Cai, Bin

2017-09-01

To evaluate the level of risk involved in treatment planning system (TPS) commissioning using a manual test procedure, and to compare the associated process-based risk to that of an automated commissioning process (ACP) by performing an in-depth failure modes and effects analysis (FMEA). The authors collaborated to determine the potential failure modes of the TPS commissioning process using (a) approaches involving manual data measurement, modeling, and validation tests and (b) an automated process utilizing application programming interface (API) scripting, preloaded, and premodeled standard radiation beam data, digital heterogeneous phantom, and an automated commissioning test suite (ACTS). The severity (S), occurrence (O), and detectability (D) were scored for each failure mode and the risk priority numbers (RPN) were derived based on TG-100 scale. Failure modes were then analyzed and ranked based on RPN. The total number of failure modes, RPN scores and the top 10 failure modes with highest risk were described and cross-compared between the two approaches. RPN reduction analysis is also presented and used as another quantifiable metric to evaluate the proposed approach. The FMEA of a MTP resulted in 47 failure modes with an RPN ave of 161 and S ave of 6.7. The highest risk process of "Measurement Equipment Selection" resulted in an RPN max of 640. The FMEA of an ACP resulted in 36 failure modes with an RPN ave of 73 and S ave of 6.7. The highest risk process of "EPID Calibration" resulted in an RPN max of 576. An FMEA of treatment planning commissioning tests using automation and standardization via API scripting, preloaded, and pre-modeled standard beam data, and digital phantoms suggests that errors and risks may be reduced through the use of an ACP. © 2017 American Association of Physicists in Medicine.

The role of risk perception in making flood risk management more effective

NASA Astrophysics Data System (ADS)

Buchecker, M.; Salvini, G.; Di Baldassarre, G.; Semenzin, E.; Maidl, E.; Marcomini, A.

2013-11-01

Over the last few decades, Europe has suffered from a number of severe flood events and, as a result, there has been a growing interest in probing alternative approaches to managing flood risk via prevention measures. A literature review reveals that, although in the last decades risk evaluation has been recognized as key element of risk management, and risk assessment methodologies (including risk analysis and evaluation) have been improved by including social, economic, cultural, historical and political conditions, the theoretical schemes are not yet applied in practice. One main reason for this shortcoming is that risk perception literature is mainly of universal and theoretical nature and cannot provide the necessary details to implement a comprehensive risk evaluation. This paper therefore aims to explore a procedure that allows the inclusion of stakeholders' perceptions of prevention measures in risk assessment. It proposes to adopt methods of risk communication (both one-way and two-way communication) in risk assessment with the final aim of making flood risk management more effective. The proposed procedure not only focuses on the effect of discursive risk communication on risk perception, and on achieving a shared assessment of the prevention alternatives, but also considers the effects of the communication process on perceived uncertainties, accepted risk levels, and trust in the managing institutions. The effectiveness of this combined procedure has been studied and illustrated using the example of the participatory flood prevention assessment process on the Sihl River in Zurich, Switzerland. The main findings of the case study suggest that the proposed procedure performed well, but that it needs some adaptations for it to be applicable in different contexts and to allow a (semi-) quantitative estimation of risk perception to be used as an indicator of adaptive capacity.

Food-chain contamination evaluations in ecological risk assessments

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

Linder, G.

Food-chain models have become increasingly important within the ecological risk assessment process. This is the case particularly when acute effects are not readily apparent, or the contaminants of concern are not readily detoxified, have a high likelihood for partitioning into lipids, or have specific target organs or tissues that may increase their significance in evaluating their potential adverse effects. An overview of food-chain models -- conceptual, theoretical, and empirical -- will be considered through a series of papers that will focus on their application within the ecological risk assessment process. Whether a food-chain evaluation is being developed to address relativelymore » simple questions related to chronic effects of toxicants on target populations, or whether a more complex food-web model is being developed to address questions related to multiple-trophic level transfers of toxicants, the elements within the food chain contamination evaluation can be generalized to address the mechanisms of toxicant accumulation in individual organisms. This can then be incorporated into more elaborate models that consider these organismal-level processes within the context of a species life-history or community-level responses that may be associated with long-term exposures.« less

Risk of Infection After Allograft Anterior Cruciate Ligament Reconstruction: Are Nonprocessed Allografts More Likely to Get Infected? A Cohort Study of Over 10,000 Allografts.

PubMed

Yu, Anthony; Prentice, Heather A; Burfeind, William E; Funahashi, Tadashi; Maletis, Gregory B

2018-03-01

Allograft tissue is frequently used in anterior cruciate ligament reconstruction (ACLR). It is often irradiated and/or chemically processed to decrease the risk of disease transmission, but some tissue is aseptically harvested without further processing. Irradiated and chemically processed allograft tissue appears to have a higher risk of revision, but whether this processing decreases the risk of infection is not clear. To determine the incidence of deep surgical site infection after ACLR with allograft in a large community-based sample and to evaluate the association of allograft processing and the risk of deep infection. Cohort study; Level of evidence, 3. The authors conducted a cohort study using the Kaiser Permanente Anterior Cruciate Ligament Reconstruction Registry. Primary isolated unilateral ACLR with allograft were identified from February 1, 2005 to September 30, 2015. Ninety-day postoperative deep infections were identified via an electronic screening algorithm and then validated through chart review. Logistic regression was used to evaluate the likelihood of 90-day postoperative deep infection per allograft processing method: processed (graft treated chemically and/or irradiated) or nonprocessed (graft not irradiated or chemically processed). Of 10,190 allograft cases, 8425 (82.7%) received a processed allograft, and 1765 (17.3%) received a nonprocessed allograft. There were 15 (0.15%) deep infections during the study period: 4 (26.7%) coagulase-negative Staphylococcus, 4 (26.7%) methicillin-sensitive Staphylococcus aureus, 1 (6.7%) Peptostreptococcus micros, and 6 (40.0%) with no growth. There was no difference in the likelihood for 90-day deep infection for processed versus nonprocessed allografts (odds ratio = 1.36, 95% CI = 0.31-6.04). The overall incidence of deep infection after ACLR with allograft tissue was very low (0.15%), suggesting that the methods currently employed by tissue banks to minimize the risk of infection are effective. In this cohort, no difference in the likelihood of infection between processed and nonprocessed allografts could be identified.

A systematic review of training interventions addressing sexual violence against marginalized at-risk groups of women.

PubMed

Kouta, Christiana; Pithara, Christalla; Zobnina, Anna; Apostolidou, Zoe; Christodoulou, Josie; Papadakaki, Maria; Chliaoutakis, Joannes

2015-12-01

Women from marginalized groups working in occupations such as domestic work are at increased risk for sexual violence. Scarce evidence exists about training interventions targeting such groups. The article aims to identify community and workplace-based training interventions aiming to increase capacity among marginalized at-risk women to deal with sexual violence. A systematic review was applied. Inclusion criteria were English language published between 2003 and 2013; reporting on delivery and/or evaluation; focusing on any form of sexual violence; delivered to professionals, affected or at-risk women; targeting migrant, at-risk women or domestic workers. Data were extracted on the setting, content, evaluation process and target population. Four studies which focused on prevention or responding to sexual violence were included. One study provided sexual violence training to vulnerable female and one provided a HIV prevention intervention to marginalized women. Learning objectives included increasing knowledge around issues of sexual violence and/or gender and human rights, prevention and response strategies. Two studies aimed to train trainers. All studies conducted an outcome evaluation and two a process evaluation. It seems there is a gap on participatory empowerment training for marginalized women. Community train-the-trainer interventions are imperative to protect themselves and deal with the risk of sexual violence. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evaluating Computer-Based Assessment in a Risk-Based Model

ERIC Educational Resources Information Center

Zakrzewski, Stan; Steven, Christine; Ricketts, Chris

2009-01-01

There are three purposes for evaluation: evaluation for action to aid the decision making process, evaluation for understanding to further enhance enlightenment and evaluation for control to ensure compliance to standards. This article argues that the primary function of evaluation in the "Catherine Wheel" computer-based assessment (CBA)…

Presenting health risk information in different formats: the effect on participants' cognitive and emotional evaluation and decisions.

PubMed

Timmermans, Daniëlle R M; Ockhuysen-Vermey, Caroline F; Henneman, Lidewij

2008-12-01

Effective communication of health risks plays an important role in enabling patients to make adequate decisions. There is little--though contradictory--evidence to indicate which format is most effective for communicating risks, and which risk format is preferred by counselees. In an experiment, subjects were presented health scenarios and risk information in different formats (percentages, frequencies, and population figures) and asked to evaluate the risks and make a decision based on these. Different risk formats had different effects on respondents' evaluation of the health risks presented. Contrary to our expectation, population figures were not evaluated as being the easiest format for all decision problems. Population figures were shown to have the biggest affective impact, and risks presented as population figures were also evaluated as significantly greater than the risks presented in other formats. The format of the presented risks influenced their decision in only one out of four decision-making situations, although in a second situation there was a similar trend. This study suggests that the risk format plays a role in the decision-making process, although it remains unclear which format is the most effective in terms of understanding. More experimental studies based on a theoretical analysis of the factors that promote effective risk communication are needed in the general population as well as in clinical settings with patients actually experiencing the risks and making the decisions.

An Analysis of Department of Energy Cost Proposal Process and Effectiveness

DTIC Science & Technology

2011-10-11

processes to mitigate and manage risk , rather than derive upfront assessment and quantification of proposal risk (DoE, 2008a). The proposal...2. GM 2- Enhance the Federal Contract and Project Management Workforce Substantially Complete 3. GM 3 - Improve Project Risk Assessment ...proposal, contract proposal evaluation, risk , cost analysis = = ^Åèìáëáíáçå=oÉëÉ~êÅÜ=mêçÖê~ã= do^ar^qb=p`elli=lc=_rpfkbpp=C=mr_if`=mlif`v - ii

Risk Management in Biologics Technology Transfer.

PubMed

Toso, Robert; Tsang, Jonathan; Xie, Jasmina; Hohwald, Stephen; Bain, David; Willison-Parry, Derek

Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer. © PDA, Inc. 2016.

Evaluation of rail test frequencies using risk analysis

DOT National Transportation Integrated Search

2009-03-03

Several industries now use risk analysis to develop : inspection programs to ensure acceptable mechanical integrity : and reliability. These industries include nuclear and electric : power generation, oil refining, gas processing, onshore and : offsh...

Automated identification and predictive tools to help identify high-risk heart failure patients: pilot evaluation.

PubMed

Evans, R Scott; Benuzillo, Jose; Horne, Benjamin D; Lloyd, James F; Bradshaw, Alejandra; Budge, Deborah; Rasmusson, Kismet D; Roberts, Colleen; Buckway, Jason; Geer, Norma; Garrett, Teresa; Lappé, Donald L

2016-09-01

Develop and evaluate an automated identification and predictive risk report for hospitalized heart failure (HF) patients. Dictated free-text reports from the previous 24 h were analyzed each day with natural language processing (NLP), to help improve the early identification of hospitalized patients with HF. A second application that uses an Intermountain Healthcare-developed predictive score to determine each HF patient's risk for 30-day hospital readmission and 30-day mortality was also developed. That information was included in an identification and predictive risk report, which was evaluated at a 354-bed hospital that treats high-risk HF patients. The addition of NLP-identified HF patients increased the identification score's sensitivity from 82.6% to 95.3% and its specificity from 82.7% to 97.5%, and the model's positive predictive value is 97.45%. Daily multidisciplinary discharge planning meetings are now based on the information provided by the HF identification and predictive report, and clinician's review of potential HF admissions takes less time compared to the previously used manual methodology (10 vs 40 min). An evaluation of the use of the HF predictive report identified a significant reduction in 30-day mortality and a significant increase in patient discharges to home care instead of to a specialized nursing facility. Using clinical decision support to help identify HF patients and automatically calculating their 30-day all-cause readmission and 30-day mortality risks, coupled with a multidisciplinary care process pathway, was found to be an effective process to improve HF patient identification, significantly reduce 30-day mortality, and significantly increase patient discharges to home care. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

WORKSHOP ON ENVIRONMENTALLY CONSCIOUS CHEMICAL PROCESS DESIGN

EPA Science Inventory

To encourage the consideration of environmental issues during chemical process design, the USEPA has developed techniques and software tools to evaluate the relative environmental impact of a chemical process. These techniques and tools aid in the risk management process by focus...

Enhancing the ecological risk assessment process.

PubMed

Dale, Virginia H; Biddinger, Gregory R; Newman, Michael C; Oris, James T; Suter, Glenn W; Thompson, Timothy; Armitage, Thomas M; Meyer, Judith L; Allen-King, Richelle M; Burton, G Allen; Chapman, Peter M; Conquest, Loveday L; Fernandez, Ivan J; Landis, Wayne G; Master, Lawrence L; Mitsch, William J; Mueller, Thomas C; Rabeni, Charles F; Rodewald, Amanda D; Sanders, James G; van Heerden, Ivor L

2008-07-01

The Ecological Processes and Effects Committee of the US Environmental Protection Agency Science Advisory Board conducted a self-initiated study and convened a public workshop to characterize the state of the ecological risk assessment (ERA), with a view toward advancing the science and application of the process. That survey and analysis of ERA in decision making shows that such assessments have been most effective when clear management goals were included in the problem formulation; translated into information needs; and developed in collaboration with decision makers, assessors, scientists, and stakeholders. This process is best facilitated when risk managers, risk assessors, and stakeholders are engaged in an ongoing dialogue about problem formulation. Identification and acknowledgment of uncertainties that have the potential to profoundly affect the results and outcome of risk assessments also improves assessment effectiveness. Thus we suggest 1) through peer review of ERAs be conducted at the problem formulation stage and 2) the predictive power of risk-based decision making be expanded to reduce uncertainties through analytical and methodological approaches like life cycle analysis. Risk assessment and monitoring programs need better integration to reduce uncertainty and to evaluate risk management decision outcomes. Postdecision audit programs should be initiated to evaluate the environmental outcomes of risk-based decisions. In addition, a process should be developed to demonstrate how monitoring data can be used to reduce uncertainties. Ecological risk assessments should include the effects of chemical and nonchemical stressors at multiple levels of biological organization and spatial scale, and the extent and resolution of the pertinent scales and levels of organization should be explicitly considered during problem formulation. An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence. In addition, tools for cumulative risk assessment should be developed because contaminants are often released into stressed environments.

Controls on the Environmental Fate of Compounds Controlled by Coupled Hydrologic and Reactive Processes

NASA Astrophysics Data System (ADS)

Hixson, J.; Ward, A. S.; McConville, M.; Remucal, C.

2017-12-01

Current understanding of how compounds interact with hydrologic processes or reactive processes have been well established. However, the environmental fate for compounds that interact with hydrologic AND reactive processes is not well known, yet critical in evaluating environmental risk. Evaluations of risk are often simplified to homogenize processes in space and time and to assess processes independently of one another. However, we know spatial heterogeneity and time-variable reactivities complicate predictions of environmental transport and fate, and is further complicated by the interaction of these processes, limiting our ability to accurately predict risk. Compounds that interact with both systems, such as photolytic compounds, require that both components are fully understood in order to predict transport and fate. Release of photolytic compounds occurs through both unintentional releases and intentional loadings. Evaluating risks associated with unintentional releases and implementing best management practices for intentional releases requires an in-depth understanding of the sensitivity of photolytic compounds to external controls. Lampricides, such as 3-trifluoromethyl-4-nitrophenol (TFM), are broadly applied in the Great Lakes system to control the population of invasive sea lamprey. Over-dosing can yield fish kills and other detrimental impacts. Still, planning accounts for time of passage and dilution, but not the interaction of the physical and chemical systems (i.e., storage in the hyporheic zone and time-variable decay rates). In this study, we model a series of TFM applications to test the efficacy of dosing as a function of system characteristics. Overall, our results demonstrate the complexity associated with photo-sensitive compounds through stream-hyporheic systems, and highlight the need to better understand how physical and chemical systems interact to control transport and fate in the environment.

The neural bases underlying social risk perception in purchase decisions.

PubMed

Yokoyama, Ryoichi; Nozawa, Takayuki; Sugiura, Motoaki; Yomogida, Yukihito; Takeuchi, Hikaru; Akimoto, Yoritaka; Shibuya, Satoru; Kawashima, Ryuta

2014-05-01

Social considerations significantly influence daily purchase decisions, and the perception of social risk (i.e., the anticipated disapproval of others) is crucial in dissuading consumers from making purchases. However, the neural basis for consumers' perception of social risk remains undiscovered, and this novel study clarifies the relevant neural processes. A total of 26 volunteers were scanned while they evaluated purchase intention of products (purchase intention task) and their anticipation of others' disapproval for possessing a product (social risk task), using functional magnetic resonance imaging (fMRI). The fMRI data from the purchase intention task was used to identify the brain region associated with perception of social risk during purchase decision making by using subjective social risk ratings for a parametric modulation analysis. Furthermore, we aimed to explore if there was a difference between participants' purchase decisions and their explicit evaluations of social risk, with reference to the neural activity associated with social risk perception. For this, subjective social risk ratings were used for a parametric modulation analysis on fMRI data from the social risk task. Analysis of the purchase intention task revealed a significant positive correlation between ratings of social risk and activity in the anterior insula, an area of the brain that is known as part of the emotion-related network. Analysis of the social risk task revealed a significant positive correlation between ratings of social risk and activity in the temporal parietal junction and the medial prefrontal cortex, which are known as theory-of-mind regions. Our results suggest that the anterior insula processes consumers' social risk implicitly to prompt consumers not to buy socially unacceptable products, whereas ToM-related regions process such risk explicitly in considering the anticipated disapproval of others. These findings may prove helpful in understanding the mental processes involved in purchase decisions. Copyright © 2014 Elsevier Inc. All rights reserved.

INTERPRETING SPONTANEOUS RENAL LESIONS IN SAFETY AND RISK ASSESSMENT

EPA Science Inventory

Interpreting Spontaneous Renal Lesions in Safety and Risk Assessment
Douglas C. Wolf, D.V.M., Ph.D.

Introduction

Risk assessment is a process whereby the potential adverse health effects from exposure to a xenobiotic are predicted after evaluation of the availab...

Decision-Making for Systemic Water Risks: Insights From a Participatory Risk Assessment Process in Vietnam

NASA Astrophysics Data System (ADS)

Wyrwoll, Paul R.; Grafton, R. Quentin; Daniell, Katherine A.; Chu, Hoang Long; Ringler, Claudia; Lien, Le Thi Ha; Khoi, Dang Kim; Do, Thang Nam; Tuan, Nguyen Do Anh

2018-03-01

Systemic threats to food-energy-environment-water systems require national policy responses. Yet complete control of these complex systems is impossible and attempts to mitigate systemic risks can generate unexpected feedback effects. Perverse outcomes from national policy can emerge from the diverse responses of decision-makers across different levels and scales of resource governance. Participatory risk assessment processes can help planners to understand subnational dynamics and ensure that policies do not undermine the resilience of social-ecological systems and infrastructure networks. Researchers can play an important role in participatory processes as both technical specialists and brokers of stakeholder knowledge on the feedbacks generated by systemic risks and policy decisions. Here, we evaluate the use of causal modeling and participatory risk assessment to develop national policy on systemic water risks. We present an application of the Risks and Options Assessment for Decision-Making (ROAD) process to a district of Vietnam where national agricultural water reforms are being piloted. The methods and results of this project provide general insights about how to support resilient decision-making, including the transfer of knowledge across administrative levels, identification of feedback effects, and the effective implementation of risk assessment processes.

Inflammatory markers in relation to body composition, physical activity and assessment of nutritional status of the adolescents.

PubMed

Neves Miranda, Valter Paulo; Gouveia Peluzio, Maria do Carmo; Rodrigues de Faria, Eliana; Castro Franceschini, Sylvia do Carmo; Eloiza Priore, Silvia

2015-05-01

The evaluation of inflammatory markers during adolescence can monitor different stages and manifestation of chronic diseases in adulthood. The control of the subclinical inflammation process through changes in lifestyle, especially in the practice of physical activity and dietary education can mitigate the effects of risk factors that trigger the process of atherosclerosis. To do a critical review regarding inflammatory markers as a risk factor of cardiovascular disease in relation to body composition, physical activity and assessment of nutritional status of adolescents. A literature review was performed in the following electronic databases: PUBMED, SCIELO and CONCHRANE COLLECTION. The following associated terms were used "inflammation AND cardiovascular diseases AND nutritional status OR body composition OR physical activity". There were topics created for the discussion of subjects: obesity and risk factors for cardiovascular disease during adolescence; expression of inflammatory markers in adolescence; development of cardiovascular disease with inflammatory markers, and finally, inflammatory markers, physical activity and nutritional evaluation. It was observed that the inflammatory markers may manifest in adolescence and be related to risk factors for cardiovascular diseases. Physical activity and nutritional evaluation featured as non-pharmacological measures to control the incidence of inflammatory markers and cardiovascular risk factor. Intervention studies may clarify how the adoption of a more proper lifestyle can influence the inflammatory process. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Evaluation of work posture and quantification of fatigue by Rapid Entire Body Assessment (REBA)

NASA Astrophysics Data System (ADS)

Rizkya, I.; Syahputri, K.; Sari, R. M.; Anizar; Siregar, I.

2018-02-01

Work related musculoskeletal disorders (MSDs), poor body postures, and low back injuries are the most common problems occurring in many industries including small-medium industries. This study presents assessment and evaluation of ergonomic postures of material handling worker. That evaluation was carried out using REBA (Rapid Entire Body Assessment). REBA is a technique to quantize the fatigue experienced by the worker while manually lifting loads. Fatigue due to abnormal work posture leads to complaints of labor-perceived pain. REBA methods were used to an assessment of working postures for the existing process by a procedural analysis of body postures involved. This study shows that parts of the body have a high risk of work are the back, neck, and upper arms with REBA score 9, so action should be taken as soon as possible. Controlling actions were implemented to those process with high risk then substantial risk reduction was achieved.

[Quality assurance of hospital medical records as a risk management tool].

PubMed

Terranova, Giuseppina; Cortesi, Elisabetta; Briani, Silvia; Giannini, Raffaella

2006-01-01

A retrospective analysis of hospital medical records was performed jointly by the Medicolegal department of the Pistoia Local Health Unit N. 3 and by the management of the SS. Cosma and Damiano di Pescia Hospital. Evaluation was based on ANDEM criteria, JCAHO standards, and the 1992 discharge abstract guidelines of the Italian Health Ministry. In the first phase of the study, data were collected and processed for each hospital ward and then discussed with clinicians and audited. After auditing, appropriate actions were agreed upon for correcting identified problems. Approximately one year later a second smaller sample of medical records was evaluated and a higher compliance rate with the established corrective actions was found in all wards for all data categories. In this study the evaluation of medical records can be considered in the wider context of risk management, a multidisciplinary process directed towards identifying and monitoring risk through the use of appropriate quality indicators.

Human System Risk Management - Tools of our Trade

NASA Technical Reports Server (NTRS)

Ott, C. Mark

2009-01-01

The risk of infectious disease to select individuals has historically been difficult to predict in either spaceflight or on Earth with health care efforts relying on broad-based prevention and post-infection treatment. Over the past 10 years, quantitative microbial risk assessment evaluations have evolved to formalize the assessment process and quantify the risk. This process of hazard identification, exposure assessment, dose-response assessment, and risk characterization has been applied by the water and food safety industries to address the public health impacts associated with the occurrence of and human exposure to pathogens in water and food for the development of preventive strategies for microbial disease. NASA is currently investigating the feasibility of using these techniques to better understand the risks to astronauts and refine their microbiological requirements. To assess these techniques, NASA began an evaluation of the potable water system on the International Space Station to determine how the microbial risk from water consumption during flight differed from terrestrial sources, such as municipal water systems. The ultimate goal of this work is to optimize microbial requirements which would minimize unnecessary cargo and use of crew time, while still protecting the health of the crew. Successful demonstration of this risk assessment framework with the water system holds the potential to maximize the use of available resources during spaceflight missions and facilitate investigations into the evaluation of other routes of infection, such as through the spaceflight foods system.

Exposure assessment and risk management of engineered nanoparticles: Investigation in semiconductor wafer processing

NASA Astrophysics Data System (ADS)

Shepard, Michele N.

Engineered nanomaterials (ENMs) are currently used in hundreds of commercial products and industrial processes, with more applications being investigated. Nanomaterials have unique properties that differ from bulk materials. While these properties may enable technological advancements, the potential risks of ENMs to people and the environment are not yet fully understood. Certain low solubility nanoparticles are more toxic than their bulk material, such that existing occupational exposure limits may not be sufficiently protective for workers. Risk assessments are currently challenging due to gaps in data on the numerous emerging materials and applications as well as method uncertainties and limitations. Chemical mechanical planarization (CMP) processes with engineered nanoparticle abrasives are used for research and commercial manufacturing applications in the semiconductor and related industries. Despite growing use, no published studies addressed occupational exposures to nanoparticles associated with CMP or risk assessment and management practices for these scenarios. Additional studies are needed to evaluate potential sources of workplace exposure or emission, as well as to help test and refine assessment methods. This research was conducted to: identify the lifecycle stages and potential exposure sources for ENMs in CMP processes; characterize worker exposure; determine recommended engineering controls and compare risk assessment models. The study included workplace air and surface sampling and an evaluation of qualitative risk banding approaches. Exposure assessment results indicated the potential for worker contact with ENMs on workplace surfaces but did not identify nanoparticles readily dispersed in air during work tasks. Some increases in respirable particle concentrations were identified, but not consistently. Measured aerosol concentrations by number and mass were well below current reference values for poorly soluble low toxicity nanoparticles. From application and evaluation of qualitative risk assessment approaches, differences in control banding models and results were identified, although output generally agreed with conclusions from air sampling as to whether an upgrade in site engineering controls was recommended. This research helped to improve understanding of potential worker exposures to ENMs in CMP processes, as well as the methods for risk assessment and management of metal oxide nanoparticles in occupational environments.

The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

PubMed

Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S

2015-01-01

A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program evaluations in LMICs.

The Quality of Clinical Maternal and Neonatal Healthcare – A Strategy for Identifying ‘Routine Care Signal Functions’

PubMed Central

Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S.

2015-01-01

Background A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the ‘EmOC signal functions’, a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. Methods We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Results Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants’ adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. Conclusion The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program evaluations in LMICs. PMID:25875252

System Theoretic Frameworks for Mitigating Risk Complexity in the Nuclear Fuel Cycle

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

Williams, Adam David; Mohagheghi, Amir H.; Cohn, Brian

In response to the expansion of nuclear fuel cycle (NFC) activities -- and the associated suite of risks -- around the world, this project evaluated systems-based solutions for managing such risk complexity in multimodal and multi-jurisdictional international spent nuclear fuel (SNF) transportation. By better understanding systemic risks in SNF transportation, developing SNF transportation risk assessment frameworks, and evaluating these systems-based risk assessment frameworks, this research illustrated interdependency between safety, security, and safeguards risks is inherent in NFC activities and can go unidentified when each "S" is independently evaluated. Two novel system-theoretic analysis techniques -- dynamic probabilistic risk assessment (DPRA) andmore » system-theoretic process analysis (STPA) -- provide integrated "3S" analysis to address these interdependencies and the research results suggest a need -- and provide a way -- to reprioritize United States engagement efforts to reduce global nuclear risks. Lastly, this research identifies areas where Sandia National Laboratories can spearhead technical advances to reduce global nuclear dangers.« less

Simulation technology used for risky assessment in deep exploration project in China

NASA Astrophysics Data System (ADS)

jiao, J.; Huang, D.; Liu, J.

2013-12-01

Deep exploration has been carried out in China for five years in which various heavy duty instruments and equipments are employed for gravity, magnetic, seismic and electromagnetic data prospecting as well as ultra deep drilling rig established for obtaining deep samples, and so on. The deep exploration is a large and complex system engineering crossing multiple subjects with great investment. It is necessary to employ advanced technical means technology for verification, appraisal, and optimization of geographical prospecting equipment development. To reduce risk of the application and exploration, efficient and allegeable management concept and skills have to be enhanced in order to consolidate management measure and workflow to benefit the ambitious project. Therefore, evidence, prediction, evaluation and related decision strategies have to be taken into accouter simultaneously to meet practical scientific requests and technique limits and extendable attempts. Simulation technique is then proposed as a tool that can be used to carry out dynamic test on actual or imagined system. In practice, it is necessary to combine the simulation technique with the instruments and equipment to accomplish R&D tasks. In this paper, simulation technique is introduced into the R&D process of heavy-duty equipment and high-end engineering project technology. Based on the information provided by a drilling group recently, a digital model is constructed by combination of geographical data, 3d visualization, database management, and visual reality technologies together. It result in push ahead a R&D strategy, in which data processing , instrument application, expected result and uncertainty, and even operation workflow effect environment atmosphere are simulated systematically or simultaneously, in order to obtain an optimal consequence as well as equipment updating strategy. The simulation technology is able to adjust, verify, appraise and optimize the primary plan due to changing in the real world or process, which can provide new insight to the equipment to meet requests from application and construction process and facilitates by means of direct perception and understanding of installation, debugging and experimental process of key equipment for deep exploration. Finally, the objective of project cost conservation and risk reduction can be reasonably approached. Risk assessment can be used to quantitatively evaluate the possible degree of the impact. During the research and development stage, information from the installation, debugging and simulation demonstration of the experiment process of the key instrument and equipment are used to evaluate the fatigue and safety of the device. It needs fully understanding the controllable and uncontrollable risk factors during the process, and then adjusting and improving the unsafe risk factors in the risk assessment and prediction. With combination with professional Geo software to process and interpret the environment to obtain evaluation parameters, simulation modeling is more likely close to exploration target which need more details of evaluations. From micro and macro comprehensive angles to safety and risk assessment can be achieved to satisfy the purpose of reducing the risk of equipment development, and to avoid unnecessary loss on the way of the development.

A risk-based approach to management of leachables utilizing statistical analysis of extractables.

PubMed

Stults, Cheryl L M; Mikl, Jaromir; Whelehan, Oliver; Morrical, Bradley; Duffield, William; Nagao, Lee M

2015-04-01

To incorporate quality by design concepts into the management of leachables, an emphasis is often put on understanding the extractable profile for the materials of construction for manufacturing disposables, container-closure, or delivery systems. Component manufacturing processes may also impact the extractable profile. An approach was developed to (1) identify critical components that may be sources of leachables, (2) enable an understanding of manufacturing process factors that affect extractable profiles, (3) determine if quantitative models can be developed that predict the effect of those key factors, and (4) evaluate the practical impact of the key factors on the product. A risk evaluation for an inhalation product identified injection molding as a key process. Designed experiments were performed to evaluate the impact of molding process parameters on the extractable profile from an ABS inhaler component. Statistical analysis of the resulting GC chromatographic profiles identified processing factors that were correlated with peak levels in the extractable profiles. The combination of statistically significant molding process parameters was different for different types of extractable compounds. ANOVA models were used to obtain optimal process settings and predict extractable levels for a selected number of compounds. The proposed paradigm may be applied to evaluate the impact of material composition and processing parameters on extractable profiles and utilized to manage product leachables early in the development process and throughout the product lifecycle.

Impact of the Diagnostic Process on Parents of Infants and Preschool Children. Final Report.

ERIC Educational Resources Information Center

Tice, Terrence N.; Hanson, Janice L.

In an investigation of the impact of the psychological/educational diagnostic process on the parents of young children at risk for developmental delay, 18 families completed questionnaires and were interviewed concerning their child's evaluation. Transcribed interviews conducted 1-2 weeks after the evaluation and 4 months after the evaluations…

Process Evaluation of a Parenting Program for Low-Income Families in South Africa

ERIC Educational Resources Information Center

Lachman, Jamie M.; Kelly, Jane; Cluver, Lucie; Ward, Catherine L.; Hutchings, Judy; Gardner, Frances

2018-01-01

Objective: This mixed-methods process evaluation examined the feasibility of a parenting program delivered by community facilitators to reduce the risk of child maltreatment in low-income families with children aged 3-8 years in Cape Town, South Africa (N = 68). Method: Quantitative measures included attendance registers, fidelity checklists,…

78 FR 15931 - Sunshine Act Meeting; Request for Comments on Draft Evaluation of Recommended Practice on Fatigue...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... Evaluation of Recommended Practice on Fatigue Risk Management Systems for Personnel in the Refining and... and Health Administration: 2001-05-I-DE-1 (Process Safety Management coverage of atmospheric storage tanks); 2005-04-I-TX-9 (Process Safety Management requirement for organizational management of change...

An Introduction to the Mission Risk Diagnostic for Incident Management Capabilities (MRD-IMC)

DTIC Science & Technology

2014-05-01

objectives. Analysts applying the MRD- IMC evaluate a set of systemic risk factors (called drivers) to aggregate decision-making data and provide decision...function is in position to achieve its mission and objective(s) [Alberts 2012]. To accomplish this goal, analysts applying the MRD- IMC evaluate a...005 | 3 evaluation of IM processes and capabilities. The MRD- IMC comprises the following three core tasks: 1. Identify the mission and objective(s

Assessment of environmental risk for red mud storage facility in China: a case study in Shandong Province.

PubMed

Wen, Zhi-Chao; Ma, Shu-Hua; Zheng, Shi-Li; Zhang, Yi; Liang, Yan

2016-06-01

Red mud storage facility (RM-SF) pollution remains a serious problem in China mainly due to the RM's huge quantity, little recyclability, and high alkalinity. And, there is also a risk of dam failure because almost all RM-SFs are processed by damming. In order to address this challenge and improve the level of risk management, it is necessary to evaluate the environmental risk of RM-SFs systematically. So, this paper firstly designs a comprehensive evaluation index system with a three-level evaluation index in the terms of RM characteristics, RM-SF characteristics, ambient environment of RM-SF, the management of RM-SF, and the application aspect of RM by the analytic hierarchy process (AHP) method. Then, a case of RM-SF from a typical alumina production enterprise is studied according to this system, as is assisted by several experts from different fields when determining the weights of all indicators. The results show that the risk of selected RM-SF primarily depends on the former factors, that is, RM and RM-SF characteristics, while the contributions of the other factors are quite smaller.

The application of risk management in sport.

PubMed

Fuller, Colin; Drawer, Scott

2004-01-01

The process of risk management can be implemented as part of a best practice management system within the sport and leisure sector. The process enables risk factors that might lead to injuries to be identified and the levels of risk associated with activities to be estimated and evaluated. This information can be utilised proactively by sports governing bodies and participants to identify preventive and therapeutic interventions in order to reduce the frequency of occurrence and/or severity of injuries within their sports. The acceptability of risk within specific sports, however, is dependent on the perceptions of the participants involved. Copyright 2004 Adis Data Information BV

Can preferences in information processing aid in understanding suicide risk among emerging adults?

PubMed

Cramer, Robert J; Bryson, Claire N; Gardner, Brett O; Webber, Wesley B

2016-07-01

The present study evaluated emerging adult (n = 192 college students) preferences in information processing (PIP), defined by the need for affect (NFA) and need for cognition (NFC), as they may be associated with suicide risk. The following were direct indicators of elevated suicide risk: presence of lifetime exposure to suicide (i.e., lifetime yes/no), elevated depressive symptoms, and greater NFA avoidance. Two different interactions resulted in elevated suicide risk: high depressive symptoms and high NFA avoidance, and high NFC and high NFA. Present results concerning PIP hold the potential to inform suicide risk assessment and prevention efforts among young adults.

An evaluation of a risk-based environmental regulation in Brazil: Limitations to risk management of hazardous installations

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

Naime, Andre, E-mail: andre.naime.ibama@gmail.com

The environmental regulation of hazardous projects with risk-based decision-making processes can lead to a deficient management of human exposure to technological hazards. Such an approach for regulation is criticized for simplifying the complexity of decisions involving the economic, social, and environmental aspects of the installation and operation of hazardous facilities in urban areas. Results of a Brazilian case study indicate that oil and gas transmission pipelines may represent a threat to diverse communities if the relationship between such linear projects and human populations is overlooked by regulatory bodies. Results also corroborate known challenges to the implementation of EIA processes andmore » outline limitations to an effective environmental and risk management. Two preliminary topics are discussed to strengthen similar regulatory practices. Firstly, an effective integration between social impact assessment and risk assessment in EIA processes to have a more comprehensive understanding of the social fabric. Secondly, the advancement of traditional management practices for hazardous installations to pursue a strong transition from assessment and evaluation to management and control and to promote an effective interaction between land-use planning and environmental regulation.« less

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.

Comparative risk analysis of technological hazards (a review).

PubMed Central

Kates, R W; Kasperson, J X

1983-01-01

Hazards are threats to people and what they value and risks are measures of hazards. Comparative analyses of the risks and hazards of technology can be dated to Starr's 1969 paper [Starr, C. (1969) Science 165, 1232-1238] but are rooted in recent trends in the evolution of technology, the identification of hazard, the perception of risk, and the activities of society. These trends have spawned an interdisciplinary quasi profession with new terminology, methodology, and literature. A review of 54 English-language monographs and book-length collections, published between 1970 and 1983, identified seven recurring themes: (i) overviews of the field of risk assessment, (ii) efforts to estimate and quantify risk, (iii) discussions of risk acceptability, (iv) perception, (v) analyses of regulation, (vi) case studies of specific technological hazards, and (vii) agenda for research. Within this field, science occupies a unique niche, for many technological hazards transcend the realm of ordinary experience and require expert study. Scientists can make unique contributions to each area of hazard management but their primary contribution is the practice of basic science. Beyond that, science needs to further risk assessment by understanding the more subtle processes of hazard creation and by establishing conventions for estimating risk and for presenting and handling uncertainty. Scientists can enlighten the discussion of tolerable risk by setting risks into comparative contexts, by studying the process of evaluation, and by participating as knowledgeable individuals, but they cannot decide the issue. Science can inform the hazard management process by broadening the range of alternative control actions and modes of implementation and by devising methods to evaluate their effectiveness. PMID:6580625

Study Sensitivity: Evaluating the Ability to Detect Effects in Systematic Reviews of Chemical Exposures

PubMed Central

Cooper, Glinda S.; Lunn, Ruth M.; Ågerstrand, Marlene; Glenn, Barbara S.; Kraft, Andrew D.; Luke, April M.; Ratcliffe, Jennifer M.

2016-01-01

A critical step in systematic reviews of potential health hazards is the structured evaluation of the strengths and weaknesses of the included studies; risk of bias is a term often used to represent this process, specifically with respect to the evaluation of systematic errors that can lead to inaccurate (biased) results (i.e. focusing on internal validity). Systematic review methods developed in the clinical medicine arena have been adapted for use in evaluating environmental health hazards; this expansion raises questions about the scope of risk of bias tools and the extent to which they capture the elements that can affect the interpretation of results from environmental and occupational epidemiology studies and in vivo animal toxicology studies, (the studies typically available for assessment of risk of chemicals). One such element, described here as “sensitivity”, is a measure of the ability of a study to detect a true effect or hazard. This concept is similar to the concept of the sensitivity of an assay; an insensitive study may fail to show a difference that truly exists, leading to a false conclusion of no effect. Factors relating to study sensitivity should be evaluated in a systematic manner with the same rigor as the evaluation of other elements within a risk of bias framework. We discuss the importance of this component for the interpretation of individual studies, examine approaches proposed or in use to address it, and describe how it relates to other evaluation components. The evaluation domains contained within a risk of bias tool can include, or can be modified to include, some features relating to study sensitivity; the explicit inclusion of these sensitivity criteria with the same rigor and at the same stage of study evaluation as other bias-related criteria can improve the evaluation process. In some cases, these and other features may be better addressed through a separate sensitivity domain. The combined evaluation of risk of bias and sensitivity can be used to identify the most informative studies, to evaluate the confidence of the findings from individual studies and to identify those study elements that may help to explain heterogeneity across the body of literature. PMID:27156196

[Outsourcing in long-term care: a risk management approach].

PubMed

Guimarães, Cristina Machado; Carvalho, José Crespo de

2012-05-01

This article seeks to investigate outsourcing decisions in supply chain management of healthcare organizations, namely the motives and constraints behind the decision, the selection criteria for activities to be outsourced to third parties, the type of possible agreements, and the impact of this decision on the organization per se. A case study of the start-up phase of a Long-term Care unit with an innovative approach and high levels of customization was conducted to understand the outsourcing process in a start-up context (not in the standard context of organizational change) and a risk evaluation matrix was created for outsourcing activities in order to define and implement a performance monitoring process. This study seeks to understand how to evaluate and assess the risks of an outsourcing strategy and proposes a monitoring model using risk management tools. It was shown that the risk management approach can be a solution for monitoring outsourcing in the organizational start-up phase. Conclusions concerning dissatisfaction with the results of outsourcing strategies adopted are also presented.

Proposal of a risk-factor-based analytical approach for integrating occupational health and safety into project risk evaluation.

PubMed

Badri, Adel; Nadeau, Sylvie; Gbodossou, André

2012-09-01

Excluding occupational health and safety (OHS) from project management is no longer acceptable. Numerous industrial accidents have exposed the ineffectiveness of conventional risk evaluation methods as well as negligence of risk factors having major impact on the health and safety of workers and nearby residents. Lack of reliable and complete evaluations from the beginning of a project generates bad decisions that could end up threatening the very existence of an organization. This article supports a systematic approach to the evaluation of OHS risks and proposes a new procedure based on the number of risk factors identified and their relative significance. A new concept called risk factor concentration along with weighting of risk factor categories as contributors to undesirable events are used in the analytical hierarchy process multi-criteria comparison model with Expert Choice(©) software. A case study is used to illustrate the various steps of the risk evaluation approach and the quick and simple integration of OHS at an early stage of a project. The approach allows continual reassessment of criteria over the course of the project or when new data are acquired. It was thus possible to differentiate the OHS risks from the risk of drop in quality in the case of the factory expansion project. Copyright © 2011 Elsevier Ltd. All rights reserved.

Using a Systematic Conceptual Model for a Process Evaluation of a Middle School Obesity Risk-Reduction Nutrition Curriculum Intervention: Choice, Control & Change

PubMed Central

Lee, Heewon; Contento, Isobel R.; Koch, Pamela

2012-01-01

Objective To use and review a conceptual model of process evaluation and to examine the implementation of a nutrition education curriculum, Choice, Control & Change, designed to promote dietary and physical activity behaviors that reduce obesity risk. Design A process evaluation study based on a systematic conceptual model. Setting Five middle schools in New York City. Participants 562 students in 20 classes and their science teachers (n=8). Main Outcome Measures Based on the model, teacher professional development, teacher implementation, and student reception were evaluated. Also measured were teacher characteristics, teachers’ curriculum evaluation, and satisfaction with teaching the curriculum. Analysis Descriptive statistics and Spearman’s Rho Correlation for quantitative analysis and content analysis for qualitative data were used. Results Mean score of the teacher professional development evaluation was 4.75 on a 5-point scale. Average teacher implementation rate was 73%, and student reception rate was 69%. Ongoing teacher support was highly valued by teachers. Teachers’ satisfaction with teaching the curriculum was highly correlated with students’ satisfaction (p <.05). Teachers’ perception of amount of student work was negatively correlated with implementation and with student satisfaction (p<.05). Conclusions and implications Use of a systematic conceptual model and comprehensive process measures improves understanding of the implementation process and helps educators to better implement interventions as designed. PMID:23321021

Using a systematic conceptual model for a process evaluation of a middle school obesity risk-reduction nutrition curriculum intervention: choice, control & change.

PubMed

Lee, Heewon; Contento, Isobel R; Koch, Pamela

2013-03-01

To use and review a conceptual model of process evaluation and to examine the implementation of a nutrition education curriculum, Choice, Control & Change, designed to promote dietary and physical activity behaviors that reduce obesity risk. A process evaluation study based on a systematic conceptual model. Five middle schools in New York City. Five hundred sixty-two students in 20 classes and their science teachers (n = 8). Based on the model, teacher professional development, teacher implementation, and student reception were evaluated. Also measured were teacher characteristics, teachers' curriculum evaluation, and satisfaction with teaching the curriculum. Descriptive statistics and Spearman ρ correlation for quantitative analysis and content analysis for qualitative data were used. Mean score of the teacher professional development evaluation was 4.75 on a 5-point scale. Average teacher implementation rate was 73%, and the student reception rate was 69%. Ongoing teacher support was highly valued by teachers. Teacher satisfaction with teaching the curriculum was highly correlated with student satisfaction (P < .05). Teacher perception of amount of student work was negatively correlated with implementation and with student satisfaction (P < .05). Use of a systematic conceptual model and comprehensive process measures improves understanding of the implementation process and helps educators to better implement interventions as designed. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A neural network model for credit risk evaluation.

PubMed

Khashman, Adnan

2009-08-01

Credit scoring is one of the key analytical techniques in credit risk evaluation which has been an active research area in financial risk management. This paper presents a credit risk evaluation system that uses a neural network model based on the back propagation learning algorithm. We train and implement the neural network to decide whether to approve or reject a credit application, using seven learning schemes and real world credit applications from the Australian credit approval datasets. A comparison of the system performance under the different learning schemes is provided, furthermore, we compare the performance of two neural networks; with one and two hidden layers following the ideal learning scheme. Experimental results suggest that neural networks can be effectively used in automatic processing of credit applications.

Consumption of meat and fish and risk of lung cancer: results from the European Prospective Investigation into Cancer and Nutrition.

PubMed

Linseisen, Jakob; Rohrmann, Sabine; Bueno-de-Mesquita, Bas; Büchner, Frederike L; Boshuizen, Hendriek C; Agudo, Antonio; Gram, Inger Torhild; Dahm, Christina C; Overvad, Kim; Egeberg, Rikke; Tjønneland, Anne; Boeing, Heiner; Steffen, Annika; Kaaks, Rudolf; Lukanova, Annekatrin; Berrino, Franco; Palli, Domenico; Panico, Salvatore; Tumino, Rosario; Ardanaz, Eva; Dorronsoro, Miren; Huerta, José-Maria; Rodríguez, Laudina; Sánchez, María-José; Rasmuson, Torgny; Hallmans, Göran; Manjer, Jonas; Wirfält, Elisabet; Engeset, Dagrun; Skeie, Guri; Katsoulis, Michael; Oikonomou, Eleni; Trichopoulou, Antonia; Peeters, Petra H M; Khaw, Kay-Tee; Wareham, Nicholas; Allen, Naomi; Key, Tim; Brennan, Paul; Romieu, Isabelle; Slimani, Nadia; Vergnaud, Anne-Claire; Xun, Wei W; Vineis, Paolo; Riboli, Elio

2011-06-01

Evidence from case-control studies, but less so from cohort studies, suggests a positive association between meat intake and risk of lung cancer. Therefore, this association was evaluated in the frame of the European Prospective Investigation into Cancer and Nutrition, EPIC. Data from 478,021 participants, recruited from 10 European countries, who completed a dietary questionnaire in 1992-2000 were evaluated; 1,822 incident primary lung cancer cases were included in the present evaluation. Relative risk estimates were calculated for categories of meat intake using multi-variably adjusted Cox proportional hazard models. In addition, the continuous intake variables were calibrated by means of 24-h diet recall data to account for part of the measurement error. There were no consistent associations between meat consumption and the risk of lung cancer. Neither red meat (RR = 1.06, 95% CI 0.89-1.27 per 50 g intake/day; calibrated model) nor processed meat (RR = 1.13, 95% CI 0.95-1.34 per 50 g/day; calibrated model) was significantly related to an increased risk of lung cancer. Also, consumption of white meat and fish was not associated with the risk of lung cancer. These findings do not support the hypothesis that a high intake of red and processed meat is a risk factor for lung cancer.

Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT).

PubMed

Yu, Esther Yee Tak; Wan, Eric Yuk Fai; Chan, Karina Hiu Yen; Wong, Carlos King Ho; Kwok, Ruby Lai Ping; Fong, Daniel Yee Tak; Lam, Cindy Lo Kuen

2015-06-19

There is some evidence to support a risk-stratified, multi-disciplinary approach to manage patients with hypertension in primary care. The aim of this study is to evaluate the quality of care (QOC) of a multi-disciplinary Risk Assessment and Management Programme for Hypertension (RAMP-HT) for hypertensive patients in busy government-funded primary care clinics in Hong Kong. The objectives are to develop an evidence-based, structured and comprehensive evaluation framework on quality of care, to enhance the QOC of the RAMP-HT through an audit spiral of two evaluation cycles and to determine the effectiveness of the programme in reducing cardiovascular disease (CVD) risk. A longitudinal study is conducted using the Action Learning and Audit Spiral methodologies to measure whether pre-set target standards of care intended by the RAMP-HT are achieved. A structured evaluation framework on the quality of structure, process and outcomes of care has been developed based on the programme objectives and literature review in collaboration with the programme workgroup and health service providers. Each participating clinic is invited to complete a structure of care evaluation questionnaire in each evaluation cycle. The data of all patients who have enrolled into the RAMP-HT in the pre-defined evaluation periods are used for the evaluation of the process and outcomes of care in each evaluation cycle. For evaluation of the effectiveness of RAMP-HT, the primary outcomes including blood pressure (both systolic and diastolic), low-density lipoprotein cholesterol and estimated 10-year CVD risk of RAMP-HT participants are compared to those of hypertensive patients in usual care without RAMP-HT. The QOC and effectiveness of the RAMP-HT in improving clinical and patient-reported outcomes for patients with hypertension in normal primary care will be determined. Possible areas for quality enhancement and standards of good practice will be established to inform service planning and policy decision making.

Evaluating Risk Communication After the Fukushima Disaster Based on Nudge Theory.

PubMed

Murakami, Michio; Tsubokura, Masaharu

2017-03-01

Using nudge theory and some examples of risk communication that followed the Fukushima disaster, this article discusses the influences and justifications of risk communication, in addition to how risk communication systems are designed. To assist people in making decisions based on their own value systems, we provide three suggestions, keeping in mind that people can be influenced (ie, "nudged") depending on how risk communication takes place: (1) accumulate knowledge on the process of evaluating how the method of risk communication and a system's default design could impact people; (2) clarify the purpose and outcomes of risk communication; and (3) see what risk communication might be ethically unjustifiable. Quantitative studies on risk communication and collective narratives will provide some ideas for how to design better risk communication systems and to help people make decisions. Furthermore, we have shown examples of unjustifiable risk communication.

Soils Project Risk-Based Corrective Action Evaluation Process with ROTC 1 and ROTC 2, Revision 0

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

Matthews, Patrick; Sloop, Christina

2012-04-01

This document formally defines and clarifies the NDEP-approved process the NNSA/NSO Soils Activity uses to fulfill the requirements of the FFACO and state regulations. This process is used to establish FALs in accordance with the risk-based corrective action (RBCA) process stipulated in Chapter 445 of the Nevada Administrative Code (NAC) as described in the ASTM International (ASTM) Method E1739-95 (NAC, 2008; ASTM, 1995). It is designed to provide a set of consistent standards for chemical and radiological corrective actions.

Modeling Research Project Risks with Fuzzy Maps

ERIC Educational Resources Information Center

Bodea, Constanta Nicoleta; Dascalu, Mariana Iuliana

2009-01-01

The authors propose a risks evaluation model for research projects. The model is based on fuzzy inference. The knowledge base for fuzzy process is built with a causal and cognitive map of risks. The map was especially developed for research projects, taken into account their typical lifecycle. The model was applied to an e-testing research…

Efficiency and Accuracy in Thermal Simulation of Powder Bed Fusion of Bulk Metallic Glass

NASA Astrophysics Data System (ADS)

Lindwall, J.; Malmelöv, A.; Lundbäck, A.; Lindgren, L.-E.

2018-05-01

Additive manufacturing by powder bed fusion processes can be utilized to create bulk metallic glass as the process yields considerably high cooling rates. However, there is a risk that reheated material set in layers may become devitrified, i.e., crystallize. Therefore, it is advantageous to simulate the process to fully comprehend it and design it to avoid the aforementioned risk. However, a detailed simulation is computationally demanding. It is necessary to increase the computational speed while maintaining accuracy of the computed temperature field in critical regions. The current study evaluates a few approaches based on temporal reduction to achieve this. It is found that the evaluated approaches save a lot of time and accurately predict the temperature history.

Risk management frameworks for human health and environmental risks.

PubMed

Jardine, Cindy; Hrudey, Steve; Shortreed, John; Craig, Lorraine; Krewski, Daniel; Furgal, Chris; McColl, Stephen

2003-01-01

A comprehensive analytical review of the risk assessment, risk management, and risk communication approaches currently being undertaken by key national, provincial/state, territorial, and international agencies was conducted. The information acquired for review was used to identify the differences, commonalities, strengths, and weaknesses among the various approaches, and to identify elements that should be included in an effective, current, and comprehensive approach applicable to environmental, human health and occupational health risks. More than 80 agencies, organizations, and advisory councils, encompassing more than 100 risk documents, were examined during the period from February 2000 until November 2002. An overview was made of the most important general frameworks for risk assessment, risk management, and risk communication for human health and ecological risk, and for occupational health risk. In addition, frameworks for specific applications were reviewed and summarized, including those for (1)contaminated sites; (2) northern contaminants; (3) priority substances; (4) standards development; (5) food safety; (6) medical devices; (7) prescription drug use; (8) emergency response; (9) transportation; (10) risk communication. Twelve frameworks were selected for more extensive review on the basis of representation of the areas of human health, ecological, and occupational health risk; relevance to Canadian risk management needs; representation of comprehensive and well-defined approaches; generalizability with their risk areas; representation of "state of the art" in Canada, the United States, and/or internationally; and extent of usage of potential usage within Canada. These 12 frameworks were: 1. Framework for Environmental Health Risk Management (US Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997). 2. Health Risk Determination: The Challenge of Health Protection (Health and Welfare Canada, 1990). 3. Health Canada Decision-Making Framework for Identifying, Assessing and Managing Health Risks (Health Canada, 2000). 4. Canadian Environmental Protection Act: Human Health Risk Assessment of Priority Substances(Health Canada, 1994). 5. CSA-Q8550 Risk Management: Guidelines for Decision-Makers (Canada Standards Association, 1997). 6. Risk Assessment in the Federal Government: Managing the Process (US National Research Council, 1983). 7. Understanding Risk: Informing Decisions in a Democratic Society (US National Research Council, 1996). 8. Environmental Health Risk Assessment (enHealth Council of Australia, 2002). 9. A Framework for Ecological Risk Assessment (CCME, 1996). 10. Ecological Risk Assessments of Priority Substances Under the Canadian Environmental Protection Act (Environment Canada, 1996).11. Guidelines for Ecological Risk Assessment (US EPA, 1998b). 12. Proposed Model for Occupational Health Risk Assessment and Management (Rampal & Sadhra, 1999). Based on the extensive review of these frameworks, seven key elements that should be included in a comprehensive framework for human health, ecological, and occupational risk assessment and management were identified: 1. Problem formulation stage. 2. Stakeholder involvement. 3. Communication. 4. Quantitative risk assessment components. 5. Iteration and evaluation. 6. Informed decision making. 7. Flexibility. On the basis of this overarching approach to risk management, the following "checklist" to ensure a good risk management decision is proposed: - Make sure you're solving the right problem. - Consider the problem and the risk within the full context of the situation, using a broad perspective. - Acknowledge, incorporate, and balance the multiple dimensions of risk. - Ensure the highest degree of reliability for all components of the risk management process. - Involve interested and effected parties from the outset of the process. - Commit to honest and open communication between all parties. - Employ continuous evaluation throughout the process (formative, process, and outcome evaluation), and be prepared to change the decision if new information becomes available. Comprehensive and sound principles are critical to providing structure and integrity to risk management frameworks. Guiding principles are intended to provide an ethical grounding for considering the many factors involved in risk management decision making. Ten principles are proposed to guide risk management decision making. The first four principles were adapted and modified from Hattis (1996) along with the addition of two more principles by Hrudey (2000). These have been supplemented by another four principles to make the 10 presented. The principles are based in fundamental ethical principles and values. These principles are intended to be aspirational rather than prescriptive--their application requires flexibility and practical judgement. Risk management is inherently a process in search of balance among competing interests and concerns. Each risk management decision will be "balancing act" of competing priorities, and trade-offs may sometimes have to be made between seemingly conflicting principles. The 10 decision-making principles, with the corresponding ethical principle in italics are: 1. Do more good than harm (beneficence, nonmalificence).- The ultimate goal of good risk management is to prevent or minimize risk, or to "do good" as much as possible. 2. Fair process of decision making (fairness, natural justice). - Risk management must be just, equitable, impartial, unbiased, dispassionate, and objective as far as possible given the circumstances of each situation. 3. Ensure an equitable distribution of risk (equity). - An equitable process of risk management would ensure fair outcomes and equal treatment of all concerned through an equal distribution of benefits and burdens (includes the concept of distributive justice, i.e., equal opportunities for all individuals). 4. Seek optimal use of limited risk management resources (utility). - Optimal risk management demands using limited resources where they will achieve the most risk reduction of overall benefit. 5. Promise no more risk management that can be delivered (honesty).- Unrealistic expectations of risk management can be avoided with honest and candid public accounting of what we know and don't know, and what we can and can't do using risk assessment and risk management. 6. Impose no more risk that you would tolerate yourself (the Golden Rule). - The Golden Rule is important in risk management because it forces decision makers to abandon complete detachment from their decisions so they may understand the perspectives of those affected. 7. Be cautious in the face of uncertainty ("better safe than sorry"). - Risk management must adopt a cautious approach when faced with a potentially serous risk, even if the evidence is uncertain. 8. Foster informed risk decision making for all stakeholders (autonomy). - Fostering autonomous decision making involves both providing people with the opportunity to participate, and full and honest disclosure of all the information required for informed decisions. 9. Risk management processes must be flexible and evolutionary to be open to new knowledge and understanding (evolution, evaluation, iterative process). - The incorporation of new evidence requires that risk management be a flexible, evolutionary, and iterative process, and that evaluation is employed at the beginning and througthout the process. 10. the complete elimination fo risk is not possible (life is not risk free).- Risk is pervasive in our society, and cannot be totally eliminated despite an oft-expressed public desire for "zero risk". However, the level of risk that may ve tolerable by any individual is dependent on values of beliefs, as well as scientific information. Each agency must continue to employ a process that meets the needs of their specific application of risk management. A single approach cannot satisfy the diverse areas to which risk decisions are being applied. However, with increasing experience in the application of the approaches, we are evolving to a common understanding of the essential elements and principles required for successful risk assessment, risk management, and risk communication. Risk management will continue to be a balancing act of competing priorities and needs. Flexibility and good judgement are ultimately the key to successfully making appropriate risk decisions.

IMPROVING THE TMDL PROCESS USING WATERSHED RISK ASSESSMENT PRINCIPLES

EPA Science Inventory

Watershed ecological risk assessment (WERA) evaluates potential causal relationships between multiple sources and stressors and impacts on valued ecosystem components. This has many similarities tothe placed-based analuses that are undertaken to develop total maximum daily loads...

Train integrity detection risk analysis based on PRISM

NASA Astrophysics Data System (ADS)

Wen, Yuan

2018-04-01

GNSS based Train Integrity Monitoring System (TIMS) is an effective and low-cost detection scheme for train integrity detection. However, as an external auxiliary system of CTCS, GNSS may be influenced by external environments, such as uncertainty of wireless communication channels, which may lead to the failure of communication and positioning. In order to guarantee the reliability and safety of train operation, a risk analysis method of train integrity detection based on PRISM is proposed in this article. First, we analyze the risk factors (in GNSS communication process and the on-board communication process) and model them. Then, we evaluate the performance of the model in PRISM based on the field data. Finally, we discuss how these risk factors influence the train integrity detection process.

Risk as a Driver for Innovation

NASA Technical Reports Server (NTRS)

Davis, Jeff; Fogarty, Jennifer; Perchonok, Michele; Zapp, Neal; Ferebee, Melvin; Edwards, J. Michelle

2010-01-01

The Space Life Sciences directorate (SLSD) and Human Research Program (HRP) at NASA Johnson Space Center has implemented a system for managing human systems risks. These risks are defined as the health and performance risks posed to crew during and after spaceflight. Identification and evaluation of these risks has led to the identification of gaps in knowledge about the risks as well as gaps in technology needed to mitigate them. Traditional routes of closing technology gaps have, in some cases, proven to be too slow when a solution was required quickly. Therefore, certain gaps were used to drive the development of "challenges" for the scientific community. Partnering with open innovation service providers such as InnoCentive and Yet2.com, SLSD and HRP have decreased the amount of time from identification of a need to the evaluation of a solution. Although not all proposed solutions will result in a risk mitigation strategy or tool, the process has allowed faster evaluation of proposed solutions providing the researcher the ability to move to another possible solution if the first does not sufficiently address the problem. Moreover, this process engages the community outside of NASA and broadens the population from which to draw solutions. In the traditional grant funding structure, only those in the specific field will apply for the grant. However, using open innovation, solutions can come from individuals in many different fields. This can expand the general view of a field (way of thinking within a field) and the application of solutions form new fields while providing a pathway for the acquisition of novel solutions or refinements of current mitigations. Identification of the human systems risks has helped drive the development and evaluation of innovative solutions as well as engaging a broader scientific audience in working with NASA.

Implementing Organizational Physical Activity and Healthy Eating Strategies on Paid Time: Process Evaluation of the UCLA WORKING Pilot Study

ERIC Educational Resources Information Center

Hopkins, Jammie M.; Glenn, Beth A.; Cole, Brian L.; McCarthy, William; Yancey, Antronette

2012-01-01

Integrating organizationally targeted wellness strategies into the routine conduct of business has shown promise in engaging captive audiences at highest risk of obesity and obesity-related health consequences. This paper presents a process evaluation of the implementation of the University of California, Los Angeles, Working Out Regularly Keeps…

Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks.

PubMed

Lu, Yao; Teng, Fang; Zhou, Jie; Wen, Aiqing; Bi, Yutian

2013-12-01

The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. The failure modes and effects occurring throughout the whole process of blood transfusion were studied. Each failure mode was evaluated using three scores: severity of effect (S), likelihood of occurrence (O), and probability of detection (D). Risk priority numbers (RPNs) were calculated by multiplying the S, O, and D scores. The plan-do-check-act cycle was also used for continuous improvement. Analysis has showed that failure modes with the highest RPNs, and therefore the greatest risk, were insufficient preoperative assessment of the blood product requirement (RPN, 245), preparation time before infusion of more than 30 minutes (RPN, 240), blood transfusion reaction occurring during the transfusion process (RPN, 224), blood plasma abuse (RPN, 180), and insufficient and/or incorrect clinical information on request form (RPN, 126). After implementation of preventative measures and reassessment, a reduction in RPN was detected with each risk. The failure mode with the second highest RPN, namely, preparation time before infusion of more than 30 minutes, was shown in detail to prove the efficiency of this tool. FMEA evaluation model is a useful tool in proactively analyzing and reducing the risks associated with the blood transfusion procedure. © 2013 American Association of Blood Banks.

IT security evaluation - “hybrid” approach and risk of its implementation

NASA Astrophysics Data System (ADS)

Livshitz, I. I.; Neklyudov, A. V.; Lontsikh, P. A.

2018-05-01

It is relevant to evolve processes of evaluation of the IT security nowadays. Creating and application of the common evaluation approaches for an IT component, which are processed by the governmental and civil organizations, are still not solving problem. It is suggested to create a more precise and complex assessment tool for an IT security – the “hybrid” method of the IT security evaluation for a particular object, which is based on a range of adequate assessment tools.

CFD for evaluation and treatment planning of aneurysms: review of proposed clinical uses and their challenges.

PubMed

Chung, Bongjae; Cebral, Juan Raul

2015-01-01

Computational fluid dynamics (CFD) has been used for several years to identify mechanical risk factors associated with aneurysmal evolution and rupture as well as to understand flow characteristics before and after surgical treatments in order to help the clinical decision making process. We used the keywords, "CFD" and "aneurysms" to search recent publications since about 2000, and categorized them into (i) studies of rupture risk factors and (ii) investigations of pre- and post-evaluations of surgical treatment with devices like coils and flow diverters (FD). This search enables us to examine the current status of CFD as a clinical tool and to determine if CFD can potentially become an important part of the routine clinical practice for the evaluation and treatment of aneurysms in near future. According to previous reports, it has been argued that CFD has become a quite robust non-invasive tool for the evaluation of surgical devices, especially in the early stages of device design and it has also been applied successfully to the study of rupture risk assessment. However, we find that due to the large number of pre-processing inputs further efforts of validation and reproducibility of CFD with larger clinical datasets are still essential to identify standardized mechanical risk factors. As a result, we identify the following needs to have a robust CFD tool for clinical use: (i) more reliability tests through validation studies, (ii) analyses of larger generalized clinical datasets to find converging universal risk parameters, (iii) fluid structure interaction (FSI) analyses to better understand the detailed vascular remodeling processes associated with aneurysm growth, evolution and rupture, and (iv) better coordinated and organized communications and collaborations between engineers and clinicians.

Application of risk-based multiple criteria decision analysis for selection of the best agricultural scenario for effective watershed management.

PubMed

Javidi Sabbaghian, Reza; Zarghami, Mahdi; Nejadhashemi, A Pouyan; Sharifi, Mohammad Bagher; Herman, Matthew R; Daneshvar, Fariborz

2016-03-01

Effective watershed management requires the evaluation of agricultural best management practice (BMP) scenarios which carefully consider the relevant environmental, economic, and social criteria involved. In the Multiple Criteria Decision-Making (MCDM) process, scenarios are first evaluated and then ranked to determine the most desirable outcome for the particular watershed. The main challenge of this process is the accurate identification of the best solution for the watershed in question, despite the various risk attitudes presented by the associated decision-makers (DMs). This paper introduces a novel approach for implementation of the MCDM process based on a comparative neutral risk/risk-based decision analysis, which results in the selection of the most desirable scenario for use in the entire watershed. At the sub-basin level, each scenario includes multiple BMPs with scores that have been calculated using the criteria derived from two cases of neutral risk and risk-based decision-making. The simple additive weighting (SAW) operator is applied for use in neutral risk decision-making, while the ordered weighted averaging (OWA) and induced OWA (IOWA) operators are effective for risk-based decision-making. At the watershed level, the BMP scores of the sub-basins are aggregated to calculate each scenarios' combined goodness measurements; the most desirable scenario for the entire watershed is then selected based on the combined goodness measurements. Our final results illustrate the type of operator and risk attitudes needed to satisfy the relevant criteria within the number of sub-basins, and how they ultimately affect the final ranking of the given scenarios. The methodology proposed here has been successfully applied to the Honeyoey Creek-Pine Creek watershed in Michigan, USA to evaluate various BMP scenarios and determine the best solution for both the stakeholders and the overall stream health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Guide to Considering Children's Health When Developing EPA Actions: Implementing Executive Order 13045 and EPA's Policy on Evaluating Health Risks to Children

EPA Pesticide Factsheets

Recommendations on integrating children's health considerations into EPA's Action Development Process (ADP). Also how to identify economically significant actions, disproportionate risk, and developing the Analytical Blueprint.

78 FR 22551 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... is needed for the design, implementation, and evaluation of public health programs. New mobile... could make smartphones ideal for the ongoing research, surveillance, and evaluation of risk behaviors... feasibility study to evaluate the process of conducting Web surveys by smartphone [[Page 22552

KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors

PubMed Central

Lentine, Krista L.; Kasiske, Bertram L.; Levey, Andrew S.; Adams, Patricia L.; Alberú, Josefina; Bakr, Mohamed A.; Gallon, Lorenzo; Garvey, Catherine A.; Guleria, Sandeep; Li, Philip Kam-Tao; Segev, Dorry L.; Taler, Sandra J.; Tanabe, Kazunari; Wright, Linda; Zeier, Martin G.; Cheung, Michael; Garg, Amit X.

2017-01-01

Abstract The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant studies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive approach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses were undertaken to produce a “proof-in-concept” risk-prediction model for kidney failure to support a framework for quantitative risk assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the simultaneous consideration of each candidate's profile of demographic and health characteristics. The processes and framework for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk prediction and novel approaches to estimating donation-attributable risks, are also provided. In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017;101(Suppl 8S):S1–S109. PMID:28742762

IT Operational Risk Measurement Model Based on Internal Loss Data of Banks

NASA Astrophysics Data System (ADS)

Hao, Xiaoling

Business operation of banks relies increasingly on information technology (IT) and the most important role of IT is to guarantee the operational continuity of business process. Therefore, IT Risk management efforts need to be seen from the perspective of operational continuity. Traditional IT risk studies focused on IT asset-based risk analysis and risk-matrix based qualitative risk evaluation. In practice, IT risk management practices of banking industry are still limited to the IT department and aren't integrated into business risk management, which causes the two departments to work in isolation. This paper presents an improved methodology for dealing with IT operational risk. It adopts quantitative measurement method, based on the internal business loss data about IT events, and uses Monte Carlo simulation to predict the potential losses. We establish the correlation between the IT resources and business processes to make sure risk management of IT and business can work synergistically.

Event-related potentials show taste and risk effects on food evaluation.

PubMed

Ma, Qingguo; Wang, Cuicui; Wu, Yifan; Wang, Xiaoyi

2014-07-09

Tastes and claims about unhealthy food are important factors that affect consumption. This study investigated the correlation of the event-related potential (ERP) of the evaluation of processing of food information with the task of positive judgment. Given the information on possible diseases that arise with food consumption, sweet-tasting food elicited more conflict than salty food, and this conflict was reflected by a negative ERP component at 250-500 ms (N400). Moreover, the late positive wave at 500-800 ms that was evoked by presentation of food with the names of chronic diseases that could arise from the consumption of such food was larger than that evoked when acute diseases were presented. Sweet-tasting food caused a more intense conflict with disease-related risk than salty food, and chronic diseases aroused a stronger emotional fear than acute diseases. These findings provide new insights into the N400 component and the neurocognitive processes of evaluating food combined with taste and risk information.

Information Presentation in Decision and Risk Analysis: Answered, Partly Answered, and Unanswered Questions.

PubMed

Keller, L Robin; Wang, Yitong

2017-06-01

For the last 30 years, researchers in risk analysis, decision analysis, and economics have consistently proven that decisionmakers employ different processes for evaluating and combining anticipated and actual losses, gains, delays, and surprises. Although rational models generally prescribe a consistent response, people's heuristic processes will sometimes lead them to be inconsistent in the way they respond to information presented in theoretically equivalent ways. We point out several promising future research directions by listing and detailing a series of answered, partly answered, and unanswered questions. © 2016 Society for Risk Analysis.

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

PubMed

Sorrentino, Patricia

2016-01-01

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Assessment of Risk Evaluation and Mitigation Strategies in Oncology: Summary of the Oncology Risk Evaluation and Mitigation Strategies Workshop

PubMed Central

Frame, James N.; Jacobson, Joseph O.; Vogel, Wendy H.; Griffith, Niesha; Wariabharaj, Darshan; Garg, Rekha; Zon, Robin; Stephens, Cyntha L.; Bialecki, Alison M.; Bruinooge, Suanna S.; Allen, Steven L.

2013-01-01

To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder presentations and topical panel discussions addressed REMS program development, implementation processes, and practice experiences, as well as oncology drug safety processes. A draft REMS decision tool prepared by the ASCO REMS Steering Committee was presented for group discussion with facilitated, goal-oriented feedback. The workshop identified several unintended consequences resulting from current oncology REMS: (1) the release of personal health information to drug sponsors as a condition for gaining access to a needed drug; (2) risk information that is not tailored—and therefore not accessible—to all literacy levels; (3) exclusive focus on drug risk, thereby affecting patient-provider treatment discussion; (4) REMS elements that do not consider existing, widely practiced oncology safety standards, professional training, and experience; and (5) administrative burdens that divert the health care team from direct patient care activities and, in some cases, could limit patient access to important therapies. Increased provider and professional society participation should form the basis of ongoing and future REMS standardization discussions with the FDA to work toward overall improvement of risk communication. PMID:23814522

The role of the anterior cingulate cortex in women's sexual decision making.

PubMed

Rupp, Heather A; James, Thomas W; Ketterson, Ellen D; Sengelaub, Dale R; Janssen, Erick; Heiman, Julia R

2009-01-02

Women's sexual decision making is a complex process balancing the potential rewards of conception and pleasure against the risks of possible low paternal care or sexually transmitted infection. Although neural processes underlying social decision making are suggested to overlap with those involved in economic decision making, the neural systems associated with women's sexual decision making are unknown. Using fMRI, we measured the brain activation of 12 women while they viewed photos of men's faces. Face stimuli were accompanied by information regarding each man's potential risk as a sexual partner, indicated by a written description of the man's number of previous sexual partners and frequency of condom use. Participants were asked to evaluate how likely they would be to have sex with the man depicted. Women reported that they would be more likely to have sex with low compared to high risk men. Stimuli depicting low risk men also elicited stronger activation in the anterior cingulate cortex (ACC), midbrain, and intraparietal sulcus, possibly reflecting an influence of sexual risk on women's attraction, arousal, and attention during their sexual decision making. Activation in the ACC was positively correlated with women's subjective evaluations of sex likelihood and response times during their evaluations of high, but not low risk men. These findings provide evidence that neural systems involved in sexual decision making in women overlap with those described previously to underlie nonsexual decision making.

Risk-Based Contaminated Land Investigation and Assessment

NASA Astrophysics Data System (ADS)

Davis, Donald R.

With increasing frequency, problems of environmental contamination are being analyzed from a risk perspective. Risk-Based Contaminated Land Investigation and Assessment is written for those who wish to present the results of their examination of contaminated land in terms of risk.The opening chapters introduce the concepts of risk analysis for contaminated land. Risk management and the risk assessment process are based on a source-pathway-target framework. Readers are warned against an “over-reliance on the identification of contaminants rather than the potential pathways by which targets may be exposed to these hazards.” In the risk management framework presented in this book, risk evaluation and resultant decision making are seen as part of both the risk assessment and risk reduction process. The sharp separation of risk assessment from risk management as seen in the National Academy of Sciences' (NAS) risk assessment paradigm is not advocatedsemi; perhaps this is because the NAS' concern was regulatory decision while the book's concern is the assessment of a specific site.

ECOLOGICAL RISK ASSESSMENT: PROTECTING NORTHWEST ANADROMOUS SALMONID STOCKS

EPA Science Inventory

Ecological risk assessment is usually defined as the process that evaluates the likelihood that adverse ecological effects are occurring, or may occur, as a result of exposure to one or mare stressors. he basic concept, while straightforward, is difficult to apply. trong reaction...

A dynamic process of health risk assessment for business continuity management during the World Exposition Shanghai, China, 2010.

PubMed

Sun, Xiaodong; Keim, Mark; Dong, Chen; Mahany, Mollie; Guo, Xiang

2014-01-01

Reports of health issues related to mass gatherings around the world have indicated a potential for public health and medical emergencies to occur on a scale that could place a significant impact on business continuity for national and international organisations. This paper describes a risk assessment process for business continuity management that was performed as part of the planning efforts related to the World Expo 2010 Shanghai China (Expo), the world's largest mass gathering to date. Altogether, 73 million visitors attended the Expo, generating over US$2bn of revenue. During 2008 to 2010, the Shanghai Municipal Center for Disease Control and Prevention performed a dynamic series of four disaster risk assessments before and during the Expo. The purpose of this assessment process was to identify, analyse and evaluate risks for public health security during different stages of the Expo. This paper describes an overview of the novel approach for this multiple and dynamic process of assessment of health security risk for ensuring business continuity.

Study on Failure of Third-Party Damage for Urban Gas Pipeline Based on Fuzzy Comprehensive Evaluation.

PubMed

Li, Jun; Zhang, Hong; Han, Yinshan; Wang, Baodong

2016-01-01

Focusing on the diversity, complexity and uncertainty of the third-party damage accident, the failure probability of third-party damage to urban gas pipeline was evaluated on the theory of analytic hierarchy process and fuzzy mathematics. The fault tree of third-party damage containing 56 basic events was built by hazard identification of third-party damage. The fuzzy evaluation of basic event probabilities were conducted by the expert judgment method and using membership function of fuzzy set. The determination of the weight of each expert and the modification of the evaluation opinions were accomplished using the improved analytic hierarchy process, and the failure possibility of the third-party to urban gas pipeline was calculated. Taking gas pipelines of a certain large provincial capital city as an example, the risk assessment structure of the method was proved to conform to the actual situation, which provides the basis for the safety risk prevention.

Evaluating the operational risks of biomedical waste using failure mode and effects analysis.

PubMed

Chen, Ying-Chu; Tsai, Pei-Yi

2017-06-01

The potential problems and risks of biomedical waste generation have become increasingly apparent in recent years. This study applied a failure mode and effects analysis to evaluate the operational problems and risks of biomedical waste. The microbiological contamination of biomedical waste seldom receives the attention of researchers. In this study, the biomedical waste lifecycle was divided into seven processes: Production, classification, packaging, sterilisation, weighing, storage, and transportation. Twenty main failure modes were identified in these phases and risks were assessed based on their risk priority numbers. The failure modes in the production phase accounted for the highest proportion of the risk priority number score (27.7%). In the packaging phase, the failure mode 'sharp articles not placed in solid containers' had the highest risk priority number score, mainly owing to its high severity rating. The sterilisation process is the main difference in the treatment of infectious and non-infectious biomedical waste. The failure modes in the sterilisation phase were mainly owing to human factors (mostly related to operators). This study increases the understanding of the potential problems and risks associated with biomedical waste, thereby increasing awareness of how to improve the management of biomedical waste to better protect workers, the public, and the environment.

Risk assessment techniques with applicability in marine engineering

NASA Astrophysics Data System (ADS)

Rudenko, E.; Panaitescu, F. V.; Panaitescu, M.

2015-11-01

Nowadays risk management is a carefully planned process. The task of risk management is organically woven into the general problem of increasing the efficiency of business. Passive attitude to risk and awareness of its existence are replaced by active management techniques. Risk assessment is one of the most important stages of risk management, since for risk management it is necessary first to analyze and evaluate risk. There are many definitions of this notion but in general case risk assessment refers to the systematic process of identifying the factors and types of risk and their quantitative assessment, i.e. risk analysis methodology combines mutually complementary quantitative and qualitative approaches. Purpose of the work: In this paper we will consider as risk assessment technique Fault Tree analysis (FTA). The objectives are: understand purpose of FTA, understand and apply rules of Boolean algebra, analyse a simple system using FTA, FTA advantages and disadvantages. Research and methodology: The main purpose is to help identify potential causes of system failures before the failures actually occur. We can evaluate the probability of the Top event.The steps of this analize are: the system's examination from Top to Down, the use of symbols to represent events, the use of mathematical tools for critical areas, the use of Fault tree logic diagrams to identify the cause of the Top event. Results: In the finally of study it will be obtained: critical areas, Fault tree logical diagrams and the probability of the Top event. These results can be used for the risk assessment analyses.

La Conchita Landslide Risk Assessment

NASA Astrophysics Data System (ADS)

Kropp, A.; Johnson, L.; Magnusen, W.; Hitchcock, C. S.

2009-12-01

Following the disastrous landslide in La Conchita in 2005 that resulted in ten deaths, the State of California selected our team to prepare a risk assessment for a committee of key stakeholders. The stakeholders represented the State of California, Ventura County, members of the La Conchita community, the railroad, and the upslope ranch owner (where the slide originated); a group with widely varying views and interests. Our team was charged with characterizing the major hazards, developing a series of mitigation concepts, evaluating the benefits and costs of mitigation, and gathering stakeholder input throughout the process. Two unique elements of the study were the methodologies utilized for the consequence assessment and for the decision-making framework. La Conchita is exposed to multiple slope hazards, each with differing geographical distributions, as well as depth and velocity characteristics. Three consequence matrices were developed so that the potential financial losses, structural vulnerabilities, and human safety exposure could be evaluated. The matrices utilized semi-quantitative loss evaluations (both financial and life safety) based on a generalized understanding of likely vulnerability and hazard characteristics. The model provided a quantitative estimate of cumulative losses over a 50-year period, including losses of life based on FEMA evaluation criteria. Conceptual mitigation options and loss estimates were developed to provide a range of risk management solutions that were feasible from a cost-benefit standpoint. A decision tree approach was adopted to focus on fundamental risk management questions rather than on specific outcomes since the committee did not have a consensus view on the preferred solution. These questions included: 1. Over what time period can risks be tolerated before implementation of decisions? 2. Whose responsibility is it to identify a workable risk management solution? 3. Who will own the project? The decision tree developed for assessment can also be used in the reverse direction to evaluate a project impasse or to evaluate owners and time-frames associated with a particular risk management outcome. Although the processes developed were specific to the La Conchita study, we believe that they are applicable elsewhere for localized multi-hazard assessments and/or committee-led risk management efforts.

Process monitoring in intensive care with the use of cumulative expected minus observed mortality and risk-adjusted P charts.

PubMed

Cockings, Jerome G L; Cook, David A; Iqbal, Rehana K

2006-02-01

A health care system is a complex adaptive system. The effect of a single intervention, incorporated into a complex clinical environment, may be different from that expected. A national database such as the Intensive Care National Audit & Research Centre (ICNARC) Case Mix Programme in the UK represents a centralised monitoring, surveillance and reporting system for retrospective quality and comparative audit. This can be supplemented with real-time process monitoring at a local level for continuous process improvement, allowing early detection of the impact of both unplanned and deliberately imposed changes in the clinical environment. Demographic and UK Acute Physiology and Chronic Health Evaluation II (APACHE II) data were prospectively collected on all patients admitted to a UK regional hospital between 1 January 2003 and 30 June 2004 in accordance with the ICNARC Case Mix Programme. We present a cumulative expected minus observed (E-O) plot and the risk-adjusted p chart as methods of continuous process monitoring. We describe the construction and interpretation of these charts and show how they can be used to detect planned or unplanned organisational process changes affecting mortality outcomes. Five hundred and eighty-nine adult patients were included. The overall death rate was 0.78 of predicted. Calibration showed excess survival in ranges above 30% risk of death. The E-O plot confirmed a survival above that predicted. Small transient variations were seen in the slope that could represent random effects, or real but transient changes in the quality of care. The risk-adjusted p chart showed several observations below the 2 SD control limits of the expected mortality rate. These plots provide rapid analysis of risk-adjusted performance suitable for local application and interpretation. The E-O chart provided rapid easily visible feedback of changes in risk-adjusted mortality, while the risk-adjusted p chart allowed statistical evaluation. Local analysis of risk-adjusted mortality data with an E-O plot and a risk-adjusted p chart is feasible and allows the rapid detection of changes in risk-adjusted outcome of intensive care patients. This complements the centralised national database, which is more archival and comparative in nature.

Modeling perceptions of climatic risk in crop production.

PubMed

Reinmuth, Evelyn; Parker, Phillip; Aurbacher, Joachim; Högy, Petra; Dabbert, Stephan

2017-01-01

In agricultural production, land-use decisions are components of economic planning that result in the strategic allocation of fields. Climate variability represents an uncertainty factor in crop production. Considering yield impact, climatic influence is perceived during and evaluated at the end of crop production cycles. In practice, this information is then incorporated into planning for the upcoming season. This process contributes to attitudes toward climate-induced risk in crop production. In the literature, however, the subjective valuation of risk is modeled as a risk attitude toward variations in (monetary) outcomes. Consequently, climatic influence may be obscured by political and market influences so that risk perceptions during the production process are neglected. We present a utility concept that allows the inclusion of annual risk scores based on mid-season risk perceptions that are incorporated into field-planning decisions. This approach is exemplified and implemented for winter wheat production in the Kraichgau, a region in Southwest Germany, using the integrated bio-economic simulation model FarmActor and empirical data from the region. Survey results indicate that a profitability threshold for this crop, the level of "still-good yield" (sgy), is 69 dt ha-1 (regional mean Kraichgau sample) for a given season. This threshold governs the monitoring process and risk estimators. We tested the modeled estimators against simulation results using ten projected future weather time series for winter wheat production. The mid-season estimators generally proved to be effective. This approach can be used to improve the modeling of planning decisions by providing a more comprehensive evaluation of field-crop response to climatic changes from an economic risk point of view. The methodology further provides economic insight in an agrometeorological context where prices for crops or inputs are lacking, but farmer attitudes toward risk should still be included in the analysis.

Modeling perceptions of climatic risk in crop production

PubMed Central

Parker, Phillip; Aurbacher, Joachim; Högy, Petra; Dabbert, Stephan

2017-01-01

In agricultural production, land-use decisions are components of economic planning that result in the strategic allocation of fields. Climate variability represents an uncertainty factor in crop production. Considering yield impact, climatic influence is perceived during and evaluated at the end of crop production cycles. In practice, this information is then incorporated into planning for the upcoming season. This process contributes to attitudes toward climate-induced risk in crop production. In the literature, however, the subjective valuation of risk is modeled as a risk attitude toward variations in (monetary) outcomes. Consequently, climatic influence may be obscured by political and market influences so that risk perceptions during the production process are neglected. We present a utility concept that allows the inclusion of annual risk scores based on mid-season risk perceptions that are incorporated into field-planning decisions. This approach is exemplified and implemented for winter wheat production in the Kraichgau, a region in Southwest Germany, using the integrated bio-economic simulation model FarmActor and empirical data from the region. Survey results indicate that a profitability threshold for this crop, the level of “still-good yield” (sgy), is 69 dt ha-1 (regional mean Kraichgau sample) for a given season. This threshold governs the monitoring process and risk estimators. We tested the modeled estimators against simulation results using ten projected future weather time series for winter wheat production. The mid-season estimators generally proved to be effective. This approach can be used to improve the modeling of planning decisions by providing a more comprehensive evaluation of field-crop response to climatic changes from an economic risk point of view. The methodology further provides economic insight in an agrometeorological context where prices for crops or inputs are lacking, but farmer attitudes toward risk should still be included in the analysis. PMID:28763471

Estimating and controlling workplace risk: an approach for occupational hygiene and safety professionals.

PubMed

Toffel, Michael W; Birkner, Lawrence R

2002-07-01

The protection of people and physical assets is the objective of health and safety professionals and is accomplished through the paradigm of anticipation, recognition, evaluation, and control of risks in the occupational environment. Risk assessment concepts are not only used by health and safety professionals, but also by business and financial planners. Since meeting health and safety objectives requires financial resources provided by business and governmental managers, the hypothesis addressed here is that health and safety risk decisions should be made with probabilistic processes used in financial decision-making and which are familiar and recognizable to business and government planners and managers. This article develops the processes and demonstrates the use of incident probabilities, historic outcome information, and incremental impact analysis to estimate risk of multiple alternatives in the chemical process industry. It also analyzes how the ethical aspects of decision-making can be addressed in formulating health and safety risk management plans. It is concluded that certain, easily understood, and applied probabilistic risk assessment methods used by business and government to assess financial and outcome risk have applicability to improving workplace health and safety in three ways: 1) by linking the business and health and safety risk assessment processes to securing resources, 2) by providing an additional set of tools for health and safety risk assessment, and 3) by requiring the risk assessor to consider multiple risk management alternatives.

Process evaluation of the implementation of scorecard-based antenatal risk assessment, care pathways and interdisciplinary consultation: the Healthy Pregnancy 4 All study.

PubMed

Vos, A A; van Voorst, S F; Posthumus, A G; Waelput, A J M; Denktaş, S; Steegers, E A P

2017-09-01

To evaluate the implementation of a complex intervention in the antenatal healthcare field in 14 Dutch municipalities. The intervention consisted of the implementation of a systematic scorecard-based risk assessment in pregnancy, subsequent patient-tailored care pathways, and consultations of professionals from different medical and social disciplines. Saunders's seven-step method was used for the development of a programme implementation monitoring plan, with specific attention to the setting and context of the programme. Data were triangulated from multiple sources, and prespecified criteria were applied to examine the evidence for implementation. Six out of 11 municipalities (54%) met the implementation criteria for the entire risk assessment programme, whereas three municipalities (27%) met the criteria if the three components of implementation were analysed separately. A process evaluation of implementation of a complex intervention is possible. The results can be used to improve understanding of the associations between specific programme elements and programme outcomes on effectiveness of the intervention. Additionally, the results are important for formative purposes to assess how future implementation of antenatal risk assessment can be improved in comparable contexts. Copyright © 2017. Published by Elsevier Ltd.

A risk analysis for production processes with disposable bioreactors.

PubMed

Merseburger, Tobias; Pahl, Ina; Müller, Daniel; Tanner, Markus

2014-01-01

: Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.

The ECETOC approach to targeted risk assessment; lessons and experiences relevant to REACH.

PubMed

Money, Chris D; Jacobi, Sylvia; Penman, Mike G; Rodriguez, Carlos; De Rooij, Christ; Veenstra, Gauke

2007-12-01

ECETOC has been developed an approach by which the health and environmental risks arising from the supply and use of chemicals can be quickly and reliably evaluated by chemical suppliers. The approach has been available as a web-based tool since 2004. During the development and implementation of the approach, ECETOC has consulted widely so that the approach is seen to meet the required levels of science while also meeting the differing needs of affected stakeholders. The consultation process has yielded a number of findings in terms of the considerations necessary for implementing successful risk-informed decision-making in a multi-stakeholder environment. Concurrently, as the European Commission's REACH legislative package has begun to take shape, it has also become apparent that the approach has a number of potential applications for aiding the process of risk assessment under REACH. This paper reviews these experiences within the broader context of the expectations that REACH places on chemical manufacturers and suppliers. In particular, it highlights the key role that REACH Exposure Scenarios have for evaluating, managing and communicating chemical risks.

Study sensitivity: Evaluating the ability to detect effects in systematic reviews of chemical exposures.

PubMed

Cooper, Glinda S; Lunn, Ruth M; Ågerstrand, Marlene; Glenn, Barbara S; Kraft, Andrew D; Luke, April M; Ratcliffe, Jennifer M

2016-01-01

A critical step in systematic reviews of potential health hazards is the structured evaluation of the strengths and weaknesses of the included studies; risk of bias is a term often used to represent this process, specifically with respect to the evaluation of systematic errors that can lead to inaccurate (biased) results (i.e. focusing on internal validity). Systematic review methods developed in the clinical medicine arena have been adapted for use in evaluating environmental health hazards; this expansion raises questions about the scope of risk of bias tools and the extent to which they capture the elements that can affect the interpretation of results from environmental and occupational epidemiology studies and in vivo animal toxicology studies, (the studies typically available for assessment of risk of chemicals). One such element, described here as "sensitivity", is a measure of the ability of a study to detect a true effect or hazard. This concept is similar to the concept of the sensitivity of an assay; an insensitive study may fail to show a difference that truly exists, leading to a false conclusion of no effect. Factors relating to study sensitivity should be evaluated in a systematic manner with the same rigor as the evaluation of other elements within a risk of bias framework. We discuss the importance of this component for the interpretation of individual studies, examine approaches proposed or in use to address it, and describe how it relates to other evaluation components. The evaluation domains contained within a risk of bias tool can include, or can be modified to include, some features relating to study sensitivity; the explicit inclusion of these sensitivity criteria with the same rigor and at the same stage of study evaluation as other bias-related criteria can improve the evaluation process. In some cases, these and other features may be better addressed through a separate sensitivity domain. The combined evaluation of risk of bias and sensitivity can be used to identify the most informative studies, to evaluate the confidence of the findings from individual studies and to identify those study elements that may help to explain heterogeneity across the body of literature. Copyright © 2016. Published by Elsevier Ltd.

Screening for Reading Problems: The Utility of SEARCH.

ERIC Educational Resources Information Center

Morrison, Delmont; And Others

1988-01-01

The accuracy of SEARCH for identifying children at risk for developing learning disabilities was evaluated with 1,107 kindergarten children. Children identified as at risk were of average intelligence. SEARCH scores were significantly correlated with sequential and simultaneous information processing skills. SEARCH predicted adequacy of…

Integrating Human Factors into Space Vehicle Processing for Risk Management

NASA Technical Reports Server (NTRS)

Woodbury, Sarah; Richards, Kimberly J.

2008-01-01

This presentation will discuss the multiple projects performed in United Space Alliance's Human Engineering Modeling and Performance (HEMAP) Lab, improvements that resulted from analysis, and the future applications of the HEMAP Lab for risk assessment by evaluating human/machine interaction and ergonomic designs.

Reframing climate change assessments around risk: recommendations for the US National Climate Assessment

DOE PAGES

Weaver, C. P.; Moss, Richard H.; Ebi, Kristie L.; ...

2017-07-21

Climate change is a risk management challenge for society, with uncertain but potentially severe outcomes affecting natural and human systems, across generations. Managing climate-related risks will be more difficult without a base of knowledge and practice aimed at identifying and evaluating specific risks, and their likelihood and consequences, as well as potential actions to promote resilience in the face of these risks. Here, we suggest three improvements to the process of conducting climate change assessments to better characterize risk and inform risk management actions.

Reframing climate change assessments around risk: recommendations for the US National Climate Assessment

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

Weaver, C. P.; Moss, Richard H.; Ebi, Kristie L.

Climate change is a risk management challenge for society, with uncertain but potentially severe outcomes affecting natural and human systems, across generations. Managing climate-related risks will be more difficult without a base of knowledge and practice aimed at identifying and evaluating specific risks, and their likelihood and consequences, as well as potential actions to promote resilience in the face of these risks. Here, we suggest three improvements to the process of conducting climate change assessments to better characterize risk and inform risk management actions.

Microbiological Quantitative Risk Assessment

NASA Astrophysics Data System (ADS)

Dominguez, Silvia; Schaffner, Donald W.

The meat and poultry industry faces ongoing challenges due to the natural association of pathogens of concern (e.g., Salmonella, Campylobacter jejuni, Escherichia coli O157:H7) with a variety of domesticated food animals. In addition, pathogens such as Listeria monocytogenes pose a significant cross-contamination risk during further meat and poultry processing, distribution, and storage. Furthermore, the meat and poultry industries are constantly changing with the addition of new products, use of new raw materials, and targeting of new consumer populations, each of which may give rise to potential new risks. National and international regulations are increasingly using a “risk-based” approach to food safety (where the regulatory focus is driven by the magnitude of the risk), so risk assessment is becoming a valuable tool to systematically organize and evaluate the potential public health risk posed by food processing operations.

EVALUATION OF COLLIER COUNTY, FLORIDA LANDFILL MINING DEMONSTRATION

EPA Science Inventory

This report describes the landfill mining process as demonstrated under the U.S. EPA, Risk Reduction Engineering Laboratory's Municipal Waste Innovative Technology Evaluation (MITE) Program by the Collier County (Florida) Solid Waste Management Department. Landfill mining is the ...

EVALUATION OF THE COLLIER COUNTY, FLORIDA LANDFILL MINING DEMONSTRATION

EPA Science Inventory

This report describes the landfill mining process as demonstrated under the U.S. EPA, Risk Reduction Engineering Laboratory's Municipal Waste Innovative Technology Evaluation (MITE) Program by the Collier County (Florida) Solid Waste Management Department. Landfill mining is the ...

Risk-based evaluation of commercial motor vehicle roadside violations : process and results

DOT National Transportation Integrated Search

2010-09-01

This report provides an analytic framework for evaluating the Atlanta Congestion Reduction Demonstration (CRD) under the United States Department of Transportation (U.S. DOT) Urban Partnership Agreement (UPA) and CRD Programs. The Atlanta CRD project...

An evaluation of Computational Fluid dynamics model for flood risk analysis

NASA Astrophysics Data System (ADS)

Di Francesco, Silvia; Biscarini, Chiara; Montesarchio, Valeria

2014-05-01

This work presents an analysis of the hydrological-hydraulic engineering requisites for Risk evaluation and efficient flood damage reduction plans. Most of the research efforts have been dedicated to the scientific and technical aspects of risk assessment, providing estimates of possible alternatives and of the risk associated. In the decision making process for mitigation plan, the contribute of scientist is crucial, due to the fact that Risk-Damage analysis is based on evaluation of flow field ,of Hydraulic Risk and on economical and societal considerations. The present paper will focus on the first part of process, the mathematical modelling of flood events which is the base for all further considerations. The evaluation of potential catastrophic damage consequent to a flood event and in particular to dam failure requires modelling of the flood with sufficient detail so to capture the spatial and temporal evolutions of the event, as well of the velocity field. Thus, the selection of an appropriate mathematical model to correctly simulate flood routing is an essential step. In this work we present the application of two 3D Computational fluid dynamics models to a synthetic and real case study in order to evaluate the correct evolution of flow field and the associated flood Risk . The first model is based on a opensource CFD platform called openFoam. Water flow is schematized with a classical continuum approach based on Navier-Stokes equation coupled with Volume of fluid (VOF) method to take in account the multiphase character of river bottom-water- air systems. The second model instead is based on the Lattice Boltzmann method, an innovative numerical fluid dynamics scheme based on Boltzmann's kinetic equation that represents the flow dynamics at the macroscopic level by incorporating a microscopic kinetic approach. Fluid is seen as composed by particles that can move and collide among them. Simulation results from both models are promising and congruent to experimental results available in literature, thought the LBM model requires less computational effort respect to the NS one.

BeWell24: development and process evaluation of a smartphone "app" to improve sleep, sedentary, and active behaviors in US Veterans with increased metabolic risk.

PubMed

Buman, Matthew P; Epstein, Dana R; Gutierrez, Monica; Herb, Christine; Hollingshead, Kevin; Huberty, Jennifer L; Hekler, Eric B; Vega-López, Sonia; Ohri-Vachaspati, Punam; Hekler, Andrea C; Baldwin, Carol M

2016-09-01

Lifestyle behaviors across the 24-h spectrum (i.e., sleep, sedentary, and active behaviors) drive metabolic risk. We describe the development and process evaluation of BeWell24, a multicomponent smartphone application (or "app") that targets behavior change in these interdependent behaviors. A community-embedded iterative design framework was used to develop the app. An 8-week multiphase optimization strategy design study was used to test the initial efficacy of the sleep, sedentary, and exercise components of the app. Process evaluation outcomes included objectively measured app usage statistics (e.g., minutes of usage, self-monitoring patterns), user experience interviews, and satisfaction ratings. Participants (N = 26) logged approximately 60 % of their sleep, sedentary, and exercise behaviors, which took 3-4 min/day to complete. Usage of the sleep and sedentary components peaked at week 2 and remained high throughout the intervention. Exercise component use was low. User experiences were mixed, and overall satisfaction was modest.

Evaluating robustness in rank-based risk assessments of freshwater ecosystems

USGS Publications Warehouse

Mattson, K.M.; Angermeier, Paul

2007-01-01

Conservation planning aims to protect biodiversity by sustainng the natural physical, chemical, and biological processes within representative ecosystems. Often data to measure these components are inadequate or unavailable. The impact of human activities on ecosystem processes complicates integrity assessments and might alter ecosystem organization at multiple spatial scales. Freshwater conservation targets, such as populations and communities, are influenced by both intrinsic aquatic properties and the surrounding landscape, and locally collected data might not accurately reflect potential impacts. We suggest that changes in five major biotic drivers—energy sources, physical habitat, flow regime, water quality, and biotic interactions—might be used as surrogates to inform conservation planners of the ecological integrity of freshwater ecosystems. Threats to freshwater systems might be evaluated based on their impact to these drivers to provide an overview of potential risk to conservation targets. We developed a risk-based protocol, the Ecological Risk Index (ERI), to identify watersheds with least/most risk to conservation targets. Our protocol combines risk-based components, specifically the frequency and severity of human-induced stressors, with biotic drivers and mappable land- and water-use data to provide a summary of relative risk to watersheds. We illustrate application of our protocol with a case study of the upper Tennessee River basin, USA. Differences in risk patterns among the major drainages in the basin reflect dominant land uses, such as mining and agriculture. A principal components analysis showed that localized, moderately severe threats accounted for most of the threat composition differences among our watersheds. We also found that the relative importance of threats is sensitive to the spatial grain of the analysis. Our case study demonstrates that the ERI is useful for evaluating the frequency and severity of ecosystemwide risk, which can inform local and regional conservation planning.

A spatial assessment framework for evaluating flood risk under extreme climates.

PubMed

Chen, Yun; Liu, Rui; Barrett, Damian; Gao, Lei; Zhou, Mingwei; Renzullo, Luigi; Emelyanova, Irina

2015-12-15

Australian coal mines have been facing a major challenge of increasing risk of flooding caused by intensive rainfall events in recent years. In light of growing climate change concerns and the predicted escalation of flooding, estimating flood inundation risk becomes essential for understanding sustainable mine water management in the Australian mining sector. This research develops a spatial multi-criteria decision making prototype for the evaluation of flooding risk at a regional scale using the Bowen Basin and its surroundings in Queensland as a case study. Spatial gridded data, including climate, hydrology, topography, vegetation and soils, were collected and processed in ArcGIS. Several indices were derived based on time series of observations and spatial modeling taking account of extreme rainfall, evapotranspiration, stream flow, potential soil water retention, elevation and slope generated from a digital elevation model (DEM), as well as drainage density and proximity extracted from a river network. These spatial indices were weighted using the analytical hierarchy process (AHP) and integrated in an AHP-based suitability assessment (AHP-SA) model under the spatial risk evaluation framework. A regional flooding risk map was delineated to represent likely impacts of criterion indices at different risk levels, which was verified using the maximum inundation extent detectable by a time series of remote sensing imagery. The result provides baseline information to help Bowen Basin coal mines identify and assess flooding risk when making adaptation strategies and implementing mitigation measures in future. The framework and methodology developed in this research offers the Australian mining industry, and social and environmental studies around the world, an effective way to produce reliable assessment on flood risk for managing uncertainty in water availability under climate change. Copyright © 2015. Published by Elsevier B.V.

Application of quality risk management to set viable environmental monitoring frequencies in biotechnology processing and support areas.

PubMed

Sandle, Tim

2012-01-01

Environmental monitoring programs are essential for pharmaceutical facilities in order to assess the level of environmental control. For biotechnology facilities there is little advice as to the frequency at which viable environmental monitoring should be conducted. This paper outlines an approach, based on the principles of quality risk management, for the development of a framework from which monitoring frequencies can be determined. This involved the identification of common hazards and the evaluation those hazards in terms of the severity of contamination and the probability of contamination occurring. These elements of risk were evaluated for different cleanrooms and the relative risks ranked. Once the risk scores were calculated, the methods for detecting risks within the cleanrooms were assessed. Risk filtering was then used to group different cleanrooms based on their relative risks and detection methods against predetermined monitoring frequencies. Through use of case study examples, the paper presents the model and describes how appropriate frequencies for the environmental monitoring of cleanrooms can be set. Cleanrooms in which biotechnology pharmaceutical processing takes place are subject to environmental monitoring. The frequency at which such monitoring should be performed can be difficult to determine. This paper uses quality risk assessment methods to construct a framework for determining monitoring frequencies and illustrates the suitability of the framework through a case study.

Rationales for regulatory activity

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

Perhac, R.M.

1997-02-01

The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

Quantitative risk assessment of Cryptosporidium in tap water in Ireland.

PubMed

Cummins, E; Kennedy, R; Cormican, M

2010-01-15

Cryptosporidium species are protozoan parasites associated with gastro-intestinal illness. Following a number of high profile outbreaks worldwide, it has emerged as a parasite of major public health concern. A quantitative Monte Carlo simulation model was developed to evaluate the annual risk of infection from Cryptosporidium in tap water in Ireland. The assessment considers the potential initial contamination levels in raw water, oocyst removal and decontamination events following various process stages, including coagulation/flocculation, sedimentation, filtration and disinfection. A number of scenarios were analysed to represent potential risks from public water supplies, group water schemes and private wells. Where surface water is used additional physical and chemical water treatment is important in terms of reducing the risk to consumers. The simulated annual risk of illness for immunocompetent individuals was below 1 x 10(-4) per year (as set by the US EPA) except under extreme contamination events. The risk for immunocompromised individuals was 2-3 orders of magnitude greater for the scenarios analysed. The model indicates a reduced risk of infection from tap water that has undergone microfiltration, as this treatment is more robust in the event of high contamination loads. The sensitivity analysis highlighted the importance of watershed protection and the importance of adequate coagulation/flocculation in conventional treatment. The frequency of failure of the treatment process is the most important parameter influencing human risk in conventional treatment. The model developed in this study may be useful for local authorities, government agencies and other stakeholders to evaluate the likely risk of infection given some basic input data on source water and treatment processes used. Copyright 2009 Elsevier B.V. All rights reserved.

Analysis and Risk Evaluation on the Case of Alteration, Revitalization and Conversion of a Historic Building in Gdańsk

NASA Astrophysics Data System (ADS)

Grzyl, Beata; Kristowski, Adam; Miszewska-Urbańska, Emilia

2017-10-01

Each investment plan, including the one concerning a building, is exposed to the consequences of various types of threats taking place. Therefore, in the case of some large-scale, atypical and complicated building ventures, some actions included in the procedure of risk management should be taken (identifications, analysis, measurements, control and supervision of the risk). This will allow for the risk to be eliminated or limited. While preparing a building venture, an investor does not possess full information about the course of events on each stage of investment completion. The identification of the above-mentioned unknowns, subjecting them to quantification and specifying the method of dealing with them, allows an investor to increase the effectiveness of the intended plan. The enterprise discussed in this article and analyzed in the context of risk, concerns alteration, revitalization and conversion for office purposes of two buildings located in Gdańsk at 1 and 2 Lastadia Street. These buildings are situated on the area of historical urban layout of Gdańsk, in the northern-eastern part of Stare Przedmieście District (Old Suburb), about 800 meters south from Dlugi Targ Street and 200 meters west from The Old Motława River. The investor is “Gdańskie Melioracje Ltd.”, a limited liability company, which belongs to the Council of Gdańsk. In order to increase the effectiveness of the intended investment venture, while organizing the investment process, the investor commissioned preparation of an analysis and risk evaluation connected with the above-mentioned intention. Based on an on-site visit, the opinions of experts, who have been involved in the process of the preparation of the investment, studies of the available monographies about the technical condition of the buildings at 1 and 2 Lastadia Street and their own experiences, the authors identified 54 types of relevant risks, which have been systematized into 10 subject groups (among others- investor’s risk due to the designing process, location of the investment, third party or investor business activity, force majeure, political, legal, financial, technical). The scope of the study includes the identification, analysis and risk evaluation connected with planning and completion of alteration, revitalization and conversion of a historic building located at 2 Lastadia Street for the office purposes. The risk has been analyzed from the investor’s perspective. The authors used a method of preliminary analysis and risk evaluation PHA (Preliminary Hazard Analysis) and the expert method.

SU-E-T-128: Applying Failure Modes and Effects Analysis to a Risk-Based Quality Management for Stereotactic Radiosurgery in Brazil

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

Teixeira, F; Universidade do Estado do Rio de Janeiro, Rio De Janeiro, RJ; Almeida, C de

2015-06-15

Purpose: The goal of the present work was to evaluate the process maps for stereotactic radiosurgery (SRS) treatment at three radiotherapy centers in Brazil and apply the FMEA technique to evaluate similarities and differences, if any, of the hazards and risks associated with these processes. Methods: A team, consisting of professionals from different disciplines and involved in the SRS treatment, was formed at each center. Each team was responsible for the development of the process map, and performance of FMEA and FTA. A facilitator knowledgeable in these techniques led the work at each center. The TG100 recommended scales were usedmore » for the evaluation of hazard and severity for each step for the major process “treatment planning”. Results: Hazard index given by the Risk Priority Number (RPN) is found to range from 4–270 for various processes and the severity (S) index is found to range from 1–10. The RPN values > 100 and severity value ≥ 7 were chosen to flag safety improvement interventions. Number of steps with RPN ≥100 were found to be 6, 59 and 45 for the three centers. The corresponding values for S ≥ 7 are 24, 21 and 25 respectively. The range of RPN and S values for each center belong to different process steps and failure modes. Conclusion: These results show that interventions to improve safety is different for each center and it is associated with the skill level of the professional team as well as the technology used to provide radiosurgery treatment. The present study will very likely be a model for implementation of risk-based prospective quality management program for SRS treatment in Brazil where currently there are 28 radiotherapy centers performing SRS. A complete FMEA for SRS for these three radiotherapy centers is currently under development.« less

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

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

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

Quality Attribute Techniques Framework

NASA Astrophysics Data System (ADS)

Chiam, Yin Kia; Zhu, Liming; Staples, Mark

The quality of software is achieved during its development. Development teams use various techniques to investigate, evaluate and control potential quality problems in their systems. These “Quality Attribute Techniques” target specific product qualities such as safety or security. This paper proposes a framework to capture important characteristics of these techniques. The framework is intended to support process tailoring, by facilitating the selection of techniques for inclusion into process models that target specific product qualities. We use risk management as a theory to accommodate techniques for many product qualities and lifecycle phases. Safety techniques have motivated the framework, and safety and performance techniques have been used to evaluate the framework. The evaluation demonstrates the ability of quality risk management to cover the development lifecycle and to accommodate two different product qualities. We identify advantages and limitations of the framework, and discuss future research on the framework.

Importance Of Quality Control in Reducing System Risk, a Lesson Learned From The Shuttle and a Recommendation for Future Launch Vehicles

NASA Technical Reports Server (NTRS)

Safie, Fayssal M.; Messer, Bradley P.

2006-01-01

This paper presents lessons learned from the Space Shuttle return to flight experience and the importance of these lessons learned in the development of new the NASA Crew Launch Vehicle (CLV). Specifically, the paper discusses the relationship between process control and system risk, and the importance of process control in improving space vehicle flight safety. It uses the External Tank (ET) Thermal Protection System (TPS) experience and lessons learned from the redesign and process enhancement activities performed in preparation for Return to Flight after the Columbia accident. The paper also, discusses in some details, the Probabilistic engineering physics based risk assessment performed by the Shuttle program to evaluate the impact of TPS failure on system risk and the application of the methodology to the CLV.

Evaluation of generic types of drilling fluid using a risk-based analytic hierarchy process.

PubMed

Sadiq, Rehan; Husain, Tahir; Veitch, Brian; Bose, Neil

2003-12-01

The composition of drilling muds is based on a mixture of clays and additives in a base fluid. There are three generic categories of base fluid--water, oil, and synthetic. Water-based fluids (WBFs) are relatively environmentally benign, but drilling performance is better with oil-based fluids (OBFs). The oil and gas industry developed synthetic-based fluids (SBFs), such as vegetable esters, olefins, ethers, and others, which provide drilling performance comparable to OBFs, but with lower environmental and occupational health effects. The primary objective of this paper is to present a methodology to guide decision-making in the selection and evaluation of three generic types of drilling fluids using a risk-based analytic hierarchy process (AHP). In this paper a comparison of drilling fluids is made considering various activities involved in the life cycle of drilling fluids. This paper evaluates OBFs, WBFs, and SBFs based on four major impacts--operations, resources, economics, and liabilities. Four major activities--drilling, discharging offshore, loading and transporting, and disposing onshore--cause the operational impacts. Each activity involves risks related to occupational injuries (safety), general public health, environmental impact, and energy use. A multicriteria analysis strategy was used for the selection and evaluation of drilling fluids using a risk-based AHP. A four-level hierarchical structure is developed to determine the final relative scores, and the SBFs are found to be the best option.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-01-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Risk assessment of supply chain for pharmaceutical excipients with AHP-fuzzy comprehensive evaluation.

PubMed

Li, Maozhong; Du, Yunai; Wang, Qiyue; Sun, Chunmeng; Ling, Xiang; Yu, Boyang; Tu, Jiasheng; Xiong, Yerong

2016-04-01

As the essential components in formulations, pharmaceutical excipients directly affect the safety, efficacy, and stability of drugs. Recently, safety incidents of pharmaceutical excipients posing seriously threats to the patients highlight the necessity of controlling the potential risks. Hence, it is indispensable for the industry to establish an effective risk assessment system of supply chain. In this study, an AHP-fuzzy comprehensive evaluation model was developed based on the analytic hierarchy process and fuzzy mathematical theory, which quantitatively assessed the risks of supply chain. Taking polysorbate 80 as the example for model analysis, it was concluded that polysorbate 80 for injection use is a high-risk ingredient in the supply chain compared to that for oral use to achieve safety application in clinic, thus measures should be taken to control and minimize those risks.

Middle Man Concept for In-Orbit Collision Risks Mitigation, CAESAR and CARA Examples

NASA Technical Reports Server (NTRS)

Moury, Monique; Newman, Lauri K.; Laporte, Francois

2014-01-01

This paper describes the conjunction analysis which has to be performed using data provided by JSpOC. This description not only demonstrates that Collision Avoidance is a 2- step process (close approach detection followed by risk evaluation for collision avoidance decision) but also leads to the conclusion that there is a need for a Middle Man role. After describing the Middle Man concept, this paper introduces two examples with their similarities and particularities: the American civil space effort delivered by the NASA CARA team (Conjunction Assessment Risk Analysis) and the French response CAESAR (Conjunction Assessment and Evaluation Service: Alerts and Recommendations). For both, statistics are presented and feedbacks discussed. All together, around 80 satellites are served by CARA and/or CAESAR. Both processes regularly evolve in order either to follow JSpOC upgrades or to improve analysis according to experience acquired during the past years.

[Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

PubMed

Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

2011-10-01

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments.

PubMed

Heinemann, Jack A; Agapito-Tenfen, Sarah Zanon; Carman, Judy A

2013-05-01

Changing the nature, kind and quantity of particular regulatory-RNA molecules through genetic engineering can create biosafety risks. While some genetically modified organisms (GMOs) are intended to produce new regulatory-RNA molecules, these may also arise in other GMOs not intended to express them. To characterise, assess and then mitigate the potential adverse effects arising from changes to RNA requires changing current approaches to food or environmental risk assessments of GMOs. We document risk assessment advice offered to government regulators in Australia, New Zealand and Brazil during official risk evaluations of GM plants for use as human food or for release into the environment (whether for field trials or commercial release), how the regulator considered those risks, and what that experience teaches us about the GMO risk assessment framework. We also suggest improvements to the process. Copyright © 2013 Elsevier Ltd. All rights reserved.

Assessing the potential impact of non-proprietary drug copies on quality of medicine and treatment in patients with relapsing multiple sclerosis: the experience with fingolimod.

PubMed

Correale, Jorge; Chiquete, Erwin; Milojevic, Snezana; Frider, Nadina; Bajusz, Imre

2014-01-01

Fingolimod is a once-daily oral treatment for relapsing multiple sclerosis, the proprietary production processes of which are tightly controlled, owing to its susceptibility to contamination by impurities, including genotoxic impurities. Many markets produce nonproprietary medicines; assessing their efficacy and safety is difficult as regulators may approve nonproprietary drugs without bioequivalence data, genotoxic evaluation, or risk management plans (RMPs). This assessment is especially important for fingolimod given its solubility/bioavailability profile, genotoxicity risk, and low-dose final product (0.5 mg). This paper presents an evaluation of the quality of proprietary and nonproprietary fingolimod variants. Proprietary fingolimod was used as a reference substance against which eleven nonproprietary fingolimod copies were assessed. The microparticle size distribution of each compound was assessed by laser light diffraction, and inorganic impurity content by sulfated ash testing. Heavy metals content was quantified using inductively coupled plasma optical emission spectrometry, and levels of unspecified impurities by high-performance liquid chromatography. Solubility was assessed in a range of solvents at different pH values. Key information from the fingolimod RMP is also presented. Nonproprietary fingolimod variants exhibited properties out of proprietary or internationally accepted specifications, including differences in particle size distribution and levels of impurities such as heavy metals. For microparticle size and heavy metals, all tested fingolimod copies were out-of-specification by several-fold magnitudes. Proprietary fingolimod has a well-defined RMP, highlighting known and potential mid- to long-term safety risks, and risk-minimization and pharmacovigilance procedures. Nonproprietary fingolimod copies produced by processes less well controlled than or altered from proprietary production processes may reduce product reproducibility and quality, potentially presenting risks to patients. Safety data and risk-minimization strategies for proprietary fingolimod may not apply to the nonproprietary fingolimod copies evaluated here. Market authorization of nonproprietary fingolimod copies should require an appropriate RMP to minimize risks to patients.

Smarten

NASA Astrophysics Data System (ADS)

Metcalfe, C.; Bennett, E.; Chappell, M.; Steevens, J.; Depledge, M.; Goss, G.; Goudey, S.; Kaczmar, S.; O'Brien, N.; Picado, A.; Ramadan, A. B.

Traditional risk assessment procedures are inadequate for predicting the ecological risks associated with the release of nanomaterials (NM) into the environment. The root of the problem lies in an inadequate application of solid phase chemical principles (e.g. particle size, shape, functionality) for the risk assessment of NMs. Thus, the "solubility" paradigm used to evaluate the risks associated with other classes of contaminants must be replaced by a "dispersivity" paradigm for evaluating the risks associated with NM. The pace of development of NM will exceed the capacity to conduct adequate risk assessments using current methods and approaches. Each NM product will be available in a variety of size classes and with different surface functionalizations; probably requiring multiple risk assessments for each NM. The "SMARTEN" approach to risk assessment involves having risk assessors play a more proactive role in evaluating all aspects of the NM life cycle and in making decisions to develop lower risk NM products. Improved problem formulation could come from considering the chemical, physical and biological properties of NMs. New effects assessment techniques are needed to evaluate cellular binding and uptake potential, such as biological assays for binding to macromolecules or organelles, phagocytic activity, and active/passive uptake processes. Tests should be developed to evaluate biological effects with multiple species across a range of trophic levels. Despite our best efforts to assess the risks associated with NM, previous experience indicates that some NM products will enter the environment and cause biological effects. Therefore, risk assessors should support programs for reconnaissance and surveillance to detect the impacts of NM before irreversible damage occurs. New analytical tools are needed for surveillance, including sensors for detecting NMs, passive sampling systems, and improved methods for separation and characterization of NMs in environmental matrices, as well as biomarker techniques to evaluate exposure to NMs. Risk assessors should use this information to refine data quality, determine future risk assessment objectives and to communicate interim conclusions to a wide group of stakeholders.1

A comprehensive Network Security Risk Model for process control networks.

PubMed

Henry, Matthew H; Haimes, Yacov Y

2009-02-01

The risk of cyber attacks on process control networks (PCN) is receiving significant attention due to the potentially catastrophic extent to which PCN failures can damage the infrastructures and commodity flows that they support. Risk management addresses the coupled problems of (1) reducing the likelihood that cyber attacks would succeed in disrupting PCN operation and (2) reducing the severity of consequences in the event of PCN failure or manipulation. The Network Security Risk Model (NSRM) developed in this article provides a means of evaluating the efficacy of candidate risk management policies by modeling the baseline risk and assessing expectations of risk after the implementation of candidate measures. Where existing risk models fall short of providing adequate insight into the efficacy of candidate risk management policies due to shortcomings in their structure or formulation, the NSRM provides model structure and an associated modeling methodology that captures the relevant dynamics of cyber attacks on PCN for risk analysis. This article develops the NSRM in detail in the context of an illustrative example.

Evaluation of Human Reliability in Selected Activities in the Railway Industry

NASA Astrophysics Data System (ADS)

Sujová, Erika; Čierna, Helena; Molenda, Michał

2016-09-01

The article focuses on evaluation of human reliability in the human - machine system in the railway industry. Based on a survey of a train dispatcher and of selected activities, we have identified risk factors affecting the dispatcher`s work and the evaluated risk level of their influence on the reliability and safety of preformed activities. The research took place at the authors` work place between 2012-2013. A survey method was used. With its help, authors were able to identify selected work activities of train dispatcher's risk factors that affect his/her work and the evaluated seriousness of its influence on the reliability and safety of performed activities. Amongst the most important finding fall expressions of unclear and complicated internal regulations and work processes, a feeling of being overworked, fear for one's safety at small, insufficiently protected stations.

From "At Risk" to "At Promise": An Evaluation of an Early Reading First Project

ERIC Educational Resources Information Center

Zoll, Susan Marie

2012-01-01

This study demonstrates the impact of an Early Reading First intervention on preschool children's language and literacy development using an ex post facto, causal-comparative research design. The project's professional development model was evaluated to produce a process and outcome evaluation to answer two overarching research questions: (1) What…

A Conceptual Framework for the Evaluation of Emergency Risk Communications

PubMed Central

Lin, Leesa; Gamhewage, Gaya M.

2017-01-01

Objectives. To articulate a conceptual framework in support of evaluation activities in emergency risk communications (ERC). Methods. The framework proposed is based on a systematic review of the scientific literature (2001–2016) combined with data derived from a series of semistructured interviews with experts and practitioners in ERC, and it is designed to support local, national, and international public health organizations in implementing evaluation studies in ERC. Results. We identified a list of ERC outcomes from the full-text review of 152 articles and categorized these into 3 groups, depending upon the level at which the outcome was measured: (1) information environment, (2) population, and (3) public health system. We analyzed interviewees’ data from 18 interviews to identify practices and processes related to the effectiveness of ERC and included these as key structural components and processes in the developed evaluation framework. Conclusions. Researchers and public health practitioners interested in the evaluation of ERC can use the conceptual framework described in this article to guide the development of evaluation studies and methods for assessing communication outcomes related to public health emergencies. PMID:28892436

A Conceptual Framework for the Evaluation of Emergency Risk Communications.

PubMed

Savoia, Elena; Lin, Leesa; Gamhewage, Gaya M

2017-09-01

To articulate a conceptual framework in support of evaluation activities in emergency risk communications (ERC). The framework proposed is based on a systematic review of the scientific literature (2001-2016) combined with data derived from a series of semistructured interviews with experts and practitioners in ERC, and it is designed to support local, national, and international public health organizations in implementing evaluation studies in ERC. We identified a list of ERC outcomes from the full-text review of 152 articles and categorized these into 3 groups, depending upon the level at which the outcome was measured: (1) information environment, (2) population, and (3) public health system. We analyzed interviewees' data from 18 interviews to identify practices and processes related to the effectiveness of ERC and included these as key structural components and processes in the developed evaluation framework. Researchers and public health practitioners interested in the evaluation of ERC can use the conceptual framework described in this article to guide the development of evaluation studies and methods for assessing communication outcomes related to public health emergencies.

High-Risk Infants: Auditory Processing Deficits in Later Childhood.

ERIC Educational Resources Information Center

Gilbride, Kathleen E.; And Others

To determine whether deficits warranting intervention are present in the later functioning of high-risk infants, 22 premature infants who experienced asphyxia or chronic lung disease (CLD) but who had no gross developmental abnormalities were evaluated. Assessments of auditory perception and receptive language ability were made during later…

Systems Toxicology: The Future of Risk Assessment.

PubMed

Sauer, John Michael; Hartung, Thomas; Leist, Marcel; Knudsen, Thomas B; Hoeng, Julia; Hayes, A Wallace

2015-01-01

Risk assessment, in the context of public health, is the process of quantifying the probability of a harmful effect to individuals or populations from human activities. With increasing public health concern regarding the potential risks associated with chemical exposure, there is a need for more predictive and accurate approaches to risk assessment. Developing such an approach requires a mechanistic understanding of the process by which xenobiotic substances perturb biological systems and lead to toxicity. Supplementing the shortfalls of traditional risk assessment with mechanistic biological data has been widely discussed but not routinely implemented in the evaluation of chemical exposure. These mechanistic approaches to risk assessment have been generally referred to as systems toxicology. This Symposium Overview article summarizes 4 talks presented at the 35th Annual Meeting of the American College of Toxicology. © The Author(s) 2015.

Quality Risk Management: Putting GMP Controls First.

PubMed

O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

2012-01-01

This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.

The formulary process from a risk management perspective.

PubMed

Raber, Jack H

2010-06-01

During their evolution over the past 6 decades, hospital formularies have become more than a list of drugs that an institution keeps in stock. Today, an agent under formulary consideration must be examined not only in light of its relative efficacy, safety, and acquisition cost, but consideration must also be given to the potential indirect costs that accompany its use. Federal regulations have, for some drugs, added layers of administrative actions that must be followed to ensure their appropriate use. Examples of this are risk evaluation and mitigation strategies (REMS) and duties that may be implied or expressly addressed in the black-box warnings associated with some classes of agents and, in isolated instances, specific drugs within a given class. Regulatory interpretation of these programs and warnings has often led to the expectation that the institution providing the agent will implement effective protocols and procedures to minimize the risk of adverse events to a patient in addition to or in accordance with required programs such as REMS. The consequences for failing to meet this expectation can lead to regulatory sanctions; the potential also exists for liability exposure. Risk management principles apply to all levels of the decision-making process for evaluating a new agent for formulary inclusion or when reevaluating an agent's formulary status. Pharmacists play an important role in mitigating these risks by carefully evaluating every agent from a broader perspective.

Evaluation of a peer-led drug abuse risk reduction project for runaway/homeless youths.

PubMed

Fors, S W; Jarvis, S

1995-01-01

The purpose of this study was to evaluate the Drug Prevention in Youth risk reduction program that was implemented in shelters for runaway/homeless youths in the Southeastern United States. The program focuses on knowledge, attitudes and skills that can help this group of high risk young people minimize the serious negative consequences of drug abuse. An evaluation strategy was developed so comparisons could be made between peer-led, adult-led and non-intervention groups. Dependent samples t tests and least squares ANCOVAS were used to measure pretest-posttest differences both within and between groups. Results indicate that the peer-led groups were more successful than the other two groups, and that program effects were the most powerful with the youngest group of shelter clients. Process evaluation revealed important factors related to group leader training and group management. It is concluded that well-trained and motivated peer/near peer leaders have particularly valuable contributions to make with regard to drug abuse risk reduction for shelter clients.

Using formative research to lay the foundation for community level HIV prevention efforts: an example from the AIDS Community Demonstration Projects.

PubMed Central

Higgins, D L; O'Reilly, K; Tashima, N; Crain, C; Beeker, C; Goldbaum, G; Elifson, C S; Galavotti, C; Guenther-Grey, C

1996-01-01

The AIDS Community Demonstration Projects provided community-level HIV prevention interventions to historically hard-to-reach groups at high risk for HIV infection. The projects operated under a common research protocol which encompassed formative research, intervention delivery, process evaluation, and outcome evaluation. A formative research process specifically focusing on intervention development was devised to assist project staff in identifying, prioritizing, accessing, and understanding the intervention target groups. This process was central to the creation of interventions that were acceptable and unique to the target populations. Intended to be rapid, the process took 6 months to complete. Drawn from the disciplines of anthropology, community psychology, sociology, and public health, the formative research process followed distinct steps which included (a) defining the populations at high-risk for HIV; (b) gathering information about these populations through interviews with persons who were outside of, but who had contact with, the target groups (such as staff from the health department and alcohol and drug treatment facilities, as well as persons who interacted in an informal manner with the target groups, such as clerks in neighborhood grocery stores and bartenders); (c) interviewing people with access to the target populations (gatekeepers), and conducting observations in areas where these high-risk groups were reported to gather (from previous interviews); (d) interviewing members of these groups at high risk for HIV infection or transmission; and (e) systematically integrating information throughout the process. Semistructured interview schedules were used for all data collection in this process. This standardized systematic method yielded valuable information about the focal groups in each demonstration project site. The method, if adopted by others, would assist community intervention specialists in developing interventions that are culturally appropriate and meaningful to their respective target populations. PMID:8862154

Development of NASA's Accident Precursor Analysis Process Through Application on the Space Shuttle Orbiter

NASA Technical Reports Server (NTRS)

Maggio, Gaspare; Groen, Frank; Hamlin, Teri; Youngblood, Robert

2010-01-01

Accident Precursor Analysis (APA) serves as the bridge between existing risk modeling activities, which are often based on historical or generic failure statistics, and system anomalies, which provide crucial information about the failure mechanisms that are actually operative in the system. APA docs more than simply track experience: it systematically evaluates experience, looking for under-appreciated risks that may warrant changes to design or operational practice. This paper presents the pilot application of the NASA APA process to Space Shuttle Orbiter systems. In this effort, the working sessions conducted at Johnson Space Center (JSC) piloted the APA process developed by Information Systems Laboratories (ISL) over the last two years under the auspices of NASA's Office of Safety & Mission Assurance, with the assistance of the Safety & Mission Assurance (S&MA) Shuttle & Exploration Analysis Branch. This process is built around facilitated working sessions involving diverse system experts. One important aspect of this particular APA process is its focus on understanding the physical mechanism responsible for an operational anomaly, followed by evaluation of the risk significance of the observed anomaly as well as consideration of generalizations of the underlying mechanism to other contexts. Model completeness will probably always be an issue, but this process tries to leverage operating experience to the extent possible in order to address completeness issues before a catastrophe occurs.

Towards Rapid Re-Certification Using Formal Analysis

DTIC Science & Technology

2015-07-22

profiles will help ensure that information assurance requirements are commensurate with risk and scalable based on an application’s changing external...20 Scalability Evaluation .......................................................................................................... 22...agility in certification processes. Software re-certification processes require significant expenditure in order to provide evidence of information

PCBs: Cancer Dose-Response Assessment and Application to Environmental Mixtures (1996)

EPA Science Inventory

This report updates the cancer dose-response assessment for polychlorinated biphenyls (PCBs) and shows how information on toxicity, disposition, and environmental processes can be considered together to evaluate health risks from PCB mixtures in the environment. Processes that ch...

Predicting Parent-Child Aggression Risk: Cognitive Factors and Their Interaction With Anger.

PubMed

Rodriguez, Christina M

2018-02-01

Several cognitive elements have previously been proposed to elevate risk for physical child abuse. To predict parent-child aggression risk, the current study evaluated the role of approval of parent-child aggression, perceptions of children as poorly behaved, and discipline attributions. Several dimensions of attributions specifically tied to parents' discipline practices were targeted. In addition, anger experienced during discipline episodes was considered a potential moderator of these cognitive processes. Using a largely multiple-indicator approach, a sample of 110 mothers reported on these cognitive and affective aspects that may occur when disciplining their children as well as responding to measures of parent-child aggression risk. Findings suggest that greater approval of parent-child aggression, negative perceptions of their child's behavior, and discipline attributions independently predicted parent-child aggression risk, with anger significantly interacting with mothers' perception of their child as more poorly behaved to exacerbate their parent-child aggression risk. Of the discipline attribution dimensions evaluated, mothers' sense of external locus of control and believing their child deserved their discipline were related to increase parent-child aggression risk. Future work is encouraged to comprehensively evaluate how cognitive and affective components contribute and interact to increase risk for parent-child aggression.

A risk assessment methodology using intuitionistic fuzzy set in FMEA

NASA Astrophysics Data System (ADS)

Chang, Kuei-Hu; Cheng, Ching-Hsue

2010-12-01

Most current risk assessment methods use the risk priority number (RPN) value to evaluate the risk of failure. However, conventional RPN methodology has been criticised as having five main shortcomings as follows: (1) the assumption that the RPN elements are equally weighted leads to over simplification; (2) the RPN scale itself has some non-intuitive statistical properties; (3) the RPN elements have many duplicate numbers; (4) the RPN is derived from only three factors mainly in terms of safety; and (5) the conventional RPN method has not considered indirect relations between components. To address the above issues, an efficient and comprehensive algorithm to evaluate the risk of failure is needed. This article proposes an innovative approach, which integrates the intuitionistic fuzzy set (IFS) and the decision-making trial and evaluation laboratory (DEMATEL) approach on risk assessment. The proposed approach resolves some of the shortcomings of the conventional RPN method. A case study, which assesses the risk of 0.15 µm DRAM etching process, is used to demonstrate the effectiveness of the proposed approach. Finally, the result of the proposed method is compared with the listing approaches of risk assessment methods.

Automating the evaluation of flood damages: methodology and potential gains

NASA Astrophysics Data System (ADS)

Eleutério, Julian; Martinez, Edgar Daniel

2010-05-01

The evaluation of flood damage potential consists of three main steps: assessing and processing data, combining data and calculating potential damages. The first step consists of modelling hazard and assessing vulnerability. In general, this step of the evaluation demands more time and investments than the others. The second step of the evaluation consists of combining spatial data on hazard with spatial data on vulnerability. Geographic Information System (GIS) is a fundamental tool in the realization of this step. GIS software allows the simultaneous analysis of spatial and matrix data. The third step of the evaluation consists of calculating potential damages by means of damage-functions or contingent analysis. All steps demand time and expertise. However, the last two steps must be realized several times when comparing different management scenarios. In addition, uncertainty analysis and sensitivity test are made during the second and third steps of the evaluation. The feasibility of these steps could be relevant in the choice of the extent of the evaluation. Low feasibility could lead to choosing not to evaluate uncertainty or to limit the number of scenario comparisons. Several computer models have been developed over time in order to evaluate the flood risk. GIS software is largely used to realise flood risk analysis. The software is used to combine and process different types of data, and to visualise the risk and the evaluation results. The main advantages of using a GIS in these analyses are: the possibility of "easily" realising the analyses several times, in order to compare different scenarios and study uncertainty; the generation of datasets which could be used any time in future to support territorial decision making; the possibility of adding information over time to update the dataset and make other analyses. However, these analyses require personnel specialisation and time. The use of GIS software to evaluate the flood risk requires personnel with a double professional specialisation. The professional should be proficient in GIS software and in flood damage analysis (which is already a multidisciplinary field). Great effort is necessary in order to correctly evaluate flood damages, and the updating and the improvement of the evaluation over time become a difficult task. The automation of this process should bring great advance in flood management studies over time, especially for public utilities. This study has two specific objectives: (1) show the entire process of automation of the second and third steps of flood damage evaluations; and (2) analyse the induced potential gains in terms of time and expertise needed in the analysis. A programming language is used within GIS software in order to automate hazard and vulnerability data combination and potential damages calculation. We discuss the overall process of flood damage evaluation. The main result of this study is a computational tool which allows significant operational gains on flood loss analyses. We quantify these gains by means of a hypothetical example. The tool significantly reduces the time of analysis and the needs for expertise. An indirect gain is that sensitivity and cost-benefit analyses can be more easily realized.

SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment

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

Harry, T; University of California, San Diego, La Jolla, CA; Manger, R

Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this workmore » was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA critical failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.« less

Pesticide Reevaluation

EPA Pesticide Factsheets

Learn about the process for periodically evaluating registered pesticides to ensure they meet current science standards for risk assessment, as required by the Federal Insecticide Fungicide and Rodenticide Act.

What Do Trainers Need to Know to Train Higher-Order Thinking Skills

DTIC Science & Technology

2017-11-01

decision - making , perceptual processing , and information processing (U.S. Department of the Army, TRADOC, 2011; 2014). Current Army training...counteract this risk, we may offload aspects of the evaluative process using techniques—like the Military Decision Making Process — that tend to frame... decision -makers collect information and the influences of internal and external factors on the

Summary

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

Powell, Danny H; Elwood Jr, Robert H

2011-01-01

An effective risk assessment system is needed to address the threat posed by an active or passive insider who, acting alone or in collusion, could attempt diversion or theft of nuclear material. The material control and accountability (MC&A) system effectiveness tool (MSET) is a self-assessment or inspection tool utilizing probabilistic risk assessment (PRA) methodology to calculate the system effectiveness of a nuclear facility's material protection, control, and accountability (MPC&A) system. The MSET process is divided into four distinct and separate parts: (1) Completion of the questionnaire that assembles information about the operations of every aspect of the MPC&A system; (2)more » Conversion of questionnaire data into numeric values associated with risk; (3) Analysis of the numeric data utilizing the MPC&A fault tree and the SAPHIRE computer software; and (4) Self-assessment using the MSET reports to perform the effectiveness evaluation of the facility's MPC&A system. The process should lead to confirmation that mitigating features of the system effectively minimize the threat, or it could lead to the conclusion that system improvements or upgrades are necessary to achieve acceptable protection against the threat. If the need for system improvements or upgrades is indicated when the system is analyzed, MSET provides the capability to evaluate potential or actual system improvements or upgrades. A facility's MC&A system can be evaluated at a point in time. The system can be reevaluated after upgrades are implemented or after other system changes occur. The total system or specific subareas within the system can be evaluated. Areas of potential system improvement can be assessed to determine where the most beneficial and cost-effective improvements should be made. Analyses of risk importance factors show that sustainability is essential for optimal performance and reveals where performance degradation has the greatest impact on total system risk. The risk importance factors show the amount of risk reduction achievable with potential upgrades and the amount of risk reduction achieved after upgrades are completed. Applying the risk assessment tool gives support to budget prioritization by showing where budget support levels must be sustained for MC&A functions most important to risk. Results of the risk assessment are also useful in supporting funding justifications for system improvements that significantly reduce system risk. The functional model, the system risk assessment tool, and the facility evaluation questionnaire are valuable educational tools for MPC&A personnel. These educational tools provide a framework for ongoing dialogue between organizations regarding the design, development, implementation, operation, assessment, and sustainability of MPC&A systems. An organization considering the use of MSET as an analytical tool for evaluating the effectiveness of its MPC&A system will benefit from conducting a complete MSET exercise at an existing nuclear facility.« less

State of the art in benefit-risk analysis: consumer perception.

PubMed

Ueland, Ø; Gunnlaugsdottir, H; Holm, F; Kalogeras, N; Leino, O; Luteijn, J M; Magnússon, S H; Odekerken, G; Pohjola, M V; Tijhuis, M J; Tuomisto, J T; White, B C; Verhagen, H

2012-01-01

Benefit and risk perception with respect to food consumption, have been a part of human daily life from beginning of time. In today's society the food chain is long with many different types of actors and low degree of transparency. Making informed food choices where knowledge of benefits and risks is part of the decision making process are therefore complicated for consumers. Thus, to understand how consumers perceive benefits and risks of foods, their importance in relation to quality evaluations are aspects that need to be addressed. The objective of this paper is to discuss state of the art in understanding consumer perceptions of benefits and risks of foods in order to improve understanding of consumer behaviour in the food domain. Risks may be associated with both acute and long term consequences, some of which may have serious effects. Perceived risks are connected to morbidity and mortality along two dimensions relating to unknown risk, and to which extent the risk is dreaded by the consumer. Unfamiliar, uncertain, unknown, uncontrollable, and severe consequences are some factors associated with risk perception. Novel food processing techniques, for instance, score high on several of these parameters and are consequently regarded with suspicion and perceived as risky by consumers. On a daily basis, benefits of foods and food consumption are more important in most consumers' minds than risks. Benefits are often associated with food's ability to assuage hunger, and to provide pleasure through eating and socialising. In addition, two main categories of benefits that are important for acceptance of product innovations are health and environmental benefits. Benefit and risk perception of foods seem to be inversely correlated, so when something is perceived as being highly beneficial, it is correspondingly perceived as having low risk. However, slightly different paths are used in the formation of these perceptions; benefit perception is based on heuristics and experience, while risk perception is to a larger extent the result of cognitive information processing. Consumers are particularly conservative when it comes to perception and acceptance of foods compared to other products. Benefit-risk evaluations tend to be skewed towards acceptance of all that is traditional and well-known (benefits), and rejection or suspicion towards anything that is novel or highly processed (risks) regardless of actual risk. Knowledge of how consumers perceive benefits and risks of foods, may contribute to understanding benefit-risk perception in other areas related to personal, societal or environmental perspectives. Copyright © 2011 Elsevier Ltd. All rights reserved.

Potential Genetic Risk Factors for Chronic TMD: Genetic Associations from the OPPERA Case Control Study

PubMed Central

Smith, Shad B.; Maixner, Dylan; Greenspan, Joel; Dubner, Ron; Fillingim, Roger; Ohrbach, Richard; Knott, Charles; Slade, Gary; Bair, Eric; Gibson, Dustin G.; Zaykin, Dmitri V.; Weir, Bruce; Maixner, William; Diatchenko, Luda

2011-01-01

Genetic factors play a role in the etiology of persistent pain conditions, putatively by modulating underlying processes such as nociceptive sensitivity, psychological well-being, inflammation, and autonomic response. However, to date, only a few genes have been associated with temporomandibular disorders (TMD). This study evaluated 358 genes involved in pain processes, comparing allelic frequencies between 166 cases with chronic TMD and 1442 controls enrolled in the OPPERA (Orofacial Pain: Prospective Evaluation and Risk Assessment) study cooperative agreement. To enhance statistical power, 182 TMD cases and 170 controls from a similar study were included in the analysis. Genotyping was performed using the Pain Research Panel, an Affymetrix gene chip representing 3295 single nucleotide polymorphisms, including ancestry-informative markers that were used to adjust for population stratification. Adjusted associations between genetic markers and TMD case status were evaluated using logistic regression. The OPPERA findings provided evidence supporting previously-reported associations between TMD and two genes: HTR2A and COMT. Other genes were revealed as potential new genetic risk factors for TMD, including NR3C1, CAMK4, CHRM2, IFRD1, and GRK5. While these findings need to be replicated in independent cohorts, the genes potentially represent important markers of risk for TMD and they identify potential targets for therapeutic intervention. PMID:22074755

Study on Failure of Third-Party Damage for Urban Gas Pipeline Based on Fuzzy Comprehensive Evaluation

PubMed Central

Li, Jun; Zhang, Hong; Han, Yinshan; Wang, Baodong

2016-01-01

Focusing on the diversity, complexity and uncertainty of the third-party damage accident, the failure probability of third-party damage to urban gas pipeline was evaluated on the theory of analytic hierarchy process and fuzzy mathematics. The fault tree of third-party damage containing 56 basic events was built by hazard identification of third-party damage. The fuzzy evaluation of basic event probabilities were conducted by the expert judgment method and using membership function of fuzzy set. The determination of the weight of each expert and the modification of the evaluation opinions were accomplished using the improved analytic hierarchy process, and the failure possibility of the third-party to urban gas pipeline was calculated. Taking gas pipelines of a certain large provincial capital city as an example, the risk assessment structure of the method was proved to conform to the actual situation, which provides the basis for the safety risk prevention. PMID:27875545

Blood Sugar, Your Pancreas, and Unicorns: The Development of Health Education Materials for Youth With Prediabetes.

PubMed

Yazel-Smith, Lisa G; Pike, Julie; Lynch, Dustin; Moore, Courtney; Haberlin, Kathryn; Taylor, Jennifer; Hannon, Tamara S

2018-05-01

The obesity epidemic has led to an increase in prediabetes in youth, causing a serious public health concern. Education on diabetes risk and initiation of lifestyle change are the primary treatment modalities. There are few existing age-appropriate health education tools to address diabetes prevention for high-risk youth. To develop an age-appropriate health education tool(s) to help youth better understand type 2 diabetes risk factors and the reversibility of risk. Health education tool development took place in five phases: exploration, design, analysis, refinement, and process evaluation. The project resulted in (1) booklet designed to increase knowledge of risk, (2) meme generator that mirrors the booklet graphics and allows youth to create their own meme based on their pancreas' current mood, (3) environmental posters for clinic, and (4) brief self-assessment that acts as a conversation starter for the health educators. Patients reported high likability and satisfaction with the health education tools, with the majority of patients giving the materials an "A" rating. The process evaluation indicated a high level of fidelity and related measures regarding how the health education tools were intended to be used and how they were actually used in the clinic setting.

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Implementation of Systematic Review Tools in IRIS | Science ...

EPA Pesticide Factsheets

Currently, the number of chemicals present in the environment exceeds the ability of public health scientists to efficiently screen the available data in order to produce well-informed human health risk assessments in a timely manner. For this reason, the US EPA’s Integrated Risk Information System (IRIS) program has started implementing new software tools into the hazard characterization workflow. These automated tools aid in multiple phases of the systematic review process including scoping and problem formulation, literature search, and identification and screening of available published studies. The increased availability of these tools lays the foundation for automating or semi-automating multiple phases of the systematic review process. Some of these software tools include modules to facilitate a structured approach to study quality evaluation of human and animal data, although approaches are generally lacking for assessing complex mechanistic information, in particular “omics”-based evidence tools are starting to become available to evaluate these types of studies. We will highlight how new software programs, online tools, and approaches for assessing study quality can be better integrated to allow for a more efficient and transparent workflow of the risk assessment process as well as identify tool gaps that would benefit future risk assessments. Disclaimer: The views expressed here are those of the authors and do not necessarily represent the view

A surety engineering framework to reduce cognitive systems risks.

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

Caudell, Thomas P.; Peercy, David Eugene; Caldera, Eva O.

Cognitive science research investigates the advancement of human cognition and neuroscience capabilities. Addressing risks associated with these advancements can counter potential program failures, legal and ethical issues, constraints to scientific research, and product vulnerabilities. Survey results, focus group discussions, cognitive science experts, and surety researchers concur technical risks exist that could impact cognitive science research in areas such as medicine, privacy, human enhancement, law and policy, military applications, and national security (SAND2006-6895). This SAND report documents a surety engineering framework and a process for identifying cognitive system technical, ethical, legal and societal risks and applying appropriate surety methods to reducemore » such risks. The framework consists of several models: Specification, Design, Evaluation, Risk, and Maturity. Two detailed case studies are included to illustrate the use of the process and framework. Several Appendices provide detailed information on existing cognitive system architectures; ethical, legal, and societal risk research; surety methods and technologies; and educing information research with a case study vignette. The process and framework provide a model for how cognitive systems research and full-scale product development can apply surety engineering to reduce perceived and actual risks.« less

DTREEv2, a computer-based support system for the risk assessment of genetically modified plants.

PubMed

Pertry, Ine; Nothegger, Clemens; Sweet, Jeremy; Kuiper, Harry; Davies, Howard; Iserentant, Dirk; Hull, Roger; Mezzetti, Bruno; Messens, Kathy; De Loose, Marc; de Oliveira, Dulce; Burssens, Sylvia; Gheysen, Godelieve; Tzotzos, George

2014-03-25

Risk assessment of genetically modified organisms (GMOs) remains a contentious area and a major factor influencing the adoption of agricultural biotech. Methodologically, in many countries, risk assessment is conducted by expert committees with little or no recourse to databases and expert systems that can facilitate the risk assessment process. In this paper we describe DTREEv2, a computer-based decision support system for the identification of hazards related to the introduction of GM-crops into the environment. DTREEv2 structures hazard identification and evaluation by means of an Event-Tree type of analysis. The system produces an output flagging identified hazards and potential risks. It is intended to be used for the preparation and evaluation of biosafety dossiers and, as such, its usefulness extends to researchers, risk assessors and regulators in government and industry. Copyright © 2013 Elsevier B.V. All rights reserved.

Risk analysis within environmental impact assessment of proposed construction activity

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

Zeleňáková, Martina; Zvijáková, Lenka

Environmental impact assessment is an important process, prior to approval of the investment plan, providing a detailed examination of the likely and foreseeable impacts of proposed construction activity on the environment. The objective of this paper is to develop a specific methodology for the analysis and evaluation of environmental impacts of selected constructions – flood protection structures using risk analysis methods. The application of methodology designed for the process of environmental impact assessment will develop assumptions for further improvements or more effective implementation and performance of this process. The main objective of the paper is to improve the implementation ofmore » the environmental impact assessment process. Through the use of risk analysis methods in environmental impact assessment process, the set objective has been achieved. - Highlights: This paper is informed by an effort to develop research with the aim of: • Improving existing qualitative and quantitative methods for assessing the impacts • A better understanding of relations between probabilities and consequences • Methodology for the EIA of flood protection constructions based on risk analysis • Creative approaches in the search for environmentally friendly proposed activities.« less

Determining an appropriate integrated assessment model of tourism safety risk within the Changbai Mountain Scenic Area

NASA Astrophysics Data System (ADS)

Zhou, Lijun; Liu, Jisheng

2017-03-01

Tourism safety is gradually gaining more attention due to the rapid development of the tourism industry in China. Changbai Mountain is one of the most famous mountainous scenic areas in Northeast Asia. Assessment on Changbai Mountain scenic area’s tourism safety risk could do a favor in detecting influence factor of tourism safety risk and classifying tourism safety risk rank, thereby reducing and preventing associated tourism safety risks. This paper uses the Changbai Mountain scenic area as the study subject. By the means of experts scoring and analytic hierarchy process on quantified relevant evaluation indicator, the grid GIS method is used to vectorize the relevant data within a 1000m grid. It respectively analyzes main indicators associated tourism safety risk in Changbai Mountain scenic area, including hazard, exposure, vulnerability and ability to prevent and mitigate disasters. The integrated tourism safety risk model is used to comprehensively evaluate tourism safety risk in Changbai Mountain scenic area.

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.

Risk Analysis for Unintentional Slide Deployment During Airline Operations.

PubMed

Ayra, Eduardo S; Insua, David Ríos; Castellanos, María Eugenia; Larbi, Lydia

2015-09-01

We present a risk analysis undertaken to mitigate problems in relation to the unintended deployment of slides under normal operations within a commercial airline. This type of incident entails relevant costs for the airline industry. After assessing the likelihood and severity of its consequences, we conclude that such risks need to be managed. We then evaluate the effectiveness of various countermeasures, describing and justifying the chosen ones. We also discuss several issues faced when implementing and communicating the proposed measures, thus fully illustrating the risk analysis process. © 2015 Society for Risk Analysis.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: towards a global multi-step design space.

PubMed

Eon-duval, Alex; Valax, Pascal; Solacroup, Thomas; Broly, Hervé; Gleixner, Ralf; Strat, Claire L E; Sutter, James

2012-10-01

The article describes how Quality by Design principles can be applied to the drug substance manufacturing process of an Fc fusion protein. First, the quality attributes of the product were evaluated for their potential impact on safety and efficacy using risk management tools. Similarly, process parameters that have a potential impact on critical quality attributes (CQAs) were also identified through a risk assessment. Critical process parameters were then evaluated for their impact on CQAs, individually and in interaction with each other, using multivariate design of experiment techniques during the process characterisation phase. The global multi-step Design Space, defining operational limits for the entire drug substance manufacturing process so as to ensure that the drug substance quality targets are met, was devised using predictive statistical models developed during the characterisation study. The validity of the global multi-step Design Space was then confirmed by performing the entire process, from cell bank thawing to final drug substance, at its limits during the robustness study: the quality of the final drug substance produced under different conditions was verified against predefined targets. An adaptive strategy was devised whereby the Design Space can be adjusted to the quality of the input material to ensure reliable drug substance quality. Finally, all the data obtained during the process described above, together with data generated during additional validation studies as well as manufacturing data, were used to define the control strategy for the drug substance manufacturing process using a risk assessment methodology. Copyright © 2012 Wiley-Liss, Inc.

Review of ecological-based risk management approaches used at five Army Superfund sites.

PubMed

Poucher, Sherri L; Tracey, Gregory A; Johnson, Mark S; Haines, Laurie B

2012-04-01

Factors used in environmental remedial decision making concerning ecological risk are not well understood or necessarily consistent. Recent Records of Decision (RODs) for Army CERCLA sites were reviewed to select case studies where remedial management occurred in response to ecological risks. Thirty-four Army RODs were evaluated representing decisions promulgated between 1996 and 2004. Five were selected based on assessments that remedial actions were clearly linked to concern for ecological receptors. The Ecological Risk Assessment (ERA) approach and the subsequent risk management process were reviewed for each site. The case studies demonstrated that the ERA findings, as well as critical management decisions regarding interpretation of identified ecological risks, were determinants of remedial action objectives. Decisions regarding the selection of remedial alternatives were based on a set of criteria prescribed by Superfund requirements and guidance. Remedial alternative evaluations require protection of human health and the environment, but protective conditions were determined using different methods at each site. Examining the remedial management process for the 5 case study sites revealed that uncertainty in the risk assessment and decisions regarding appropriate spatial scales for both risk assessment and remediation were important factors influencing remedial action decisions. The case reviews also revealed that levels of documentation were variable from site to site. In the future, more detailed documentation of decision criteria and the development of criteria that consider the resilience of the site will result in more technically defensible ecological risk management. Copyright © 2011 SETAC.

Using Role-Play for Expert Science Communication with Professional Stakeholders in Flood Risk Management

ERIC Educational Resources Information Center

McEwen, Lindsey; Stokes, Alison; Crowley, Kate; Roberts, Carolyn

2014-01-01

This paper explores role-play pedagogies in learning and communicating about cutting-edge flood science by flood risk management professionals in local government. It outlines role-play process/structure and evaluates participant perceptions of their learning experiences. Issues were impacts of prior role-play experience on attitudes brought to…

Risk management, financial evaluation and funding for wastewater and stormwater reuse projects.

PubMed

Furlong, Casey; De Silva, Saman; Gan, Kein; Guthrie, Lachlan; Considine, Robert

2017-04-15

This paper has considered risk management, financial evaluation and funding in seven Australian wastewater and stormwater reuse projects. From the investigated case studies it can be seen that responsible parties have generally been well equipped to identify potential risks. In relation to financial evaluation methods some serious discrepancies, such as time periods for analysis, and how stormwater benefits are valued, have been identified. Most of the projects have required external, often National Government, funding to proceed. As National funding is likely to become less common in the future, future reuse projects may need to be funded internally by the water industry. In order to enable this the authors propose that the industry requires (1) a standard project evaluation process, and (2) an infrastructure funders' forum (or committee) with representation from both utilities and regulators, in order to compare and prioritise future reuse projects against each other. Copyright © 2017 Elsevier Ltd. All rights reserved.

An Evaluation of Performance-Based Tests Designed to Improve Naval Aviation Selection.

DTIC Science & Technology

1991-08-01

Qualification Test AQT/FAR 8z Flight Aptitude Rating 3 Complex Visual CVT Information Processing 3 Risk RISK 3 Absolute Difference ADHT & Horizontal...01329* .01852 1077 6 CVT .03752* .05064 557 3 ADHT .03432* .03289 499 8 RISK .03369* .05028 337 2 MB .01814 .02479 544 5 PMT/DLT .00987 .01037 641 7 *p...to differences in age, sex, accession source, college major, prior flight hours, or intelligence. From Table 2 we see that the CVT, ADHT , and the RISK

Safety assessment, detection and traceability, and societal aspects of genetically modified foods. European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). Concluding remarks.

PubMed

Kuiper, H A; König, A; Kleter, G A; Hammes, W P; Knudsen, I

2004-07-01

The most important results from the EU-sponsored ENTRANSFOOD Thematic Network project are reviewed, including the design of a detailed step-wise procedure for the risk assessment of foods derived from genetically modified crops based on the latest scientific developments, evaluation of topical risk assessment issues, and the formulation of proposals for improved risk management and public involvement in the risk analysis process. Copyright 2004 Elsevier Ltd.

Management of high-risk perioperative systems.

PubMed

Dain, Steven

2006-06-01

The perioperative system is a complex system that requires people, materials, and processes to come together in a highly ordered and timely manner. However, when working in this high-risk system, even well-organized, knowledgeable, vigilant, and well-intentioned individuals will eventually make errors. All systems need to be evaluated on a continual basis to reduce the risk of errors, make errors more easily recognizable, and provide methods for error mitigation. A simple approach to risk management that may be applied in clinical medicine is discussed.

Relationship between productivity, quality and musculoskeletal disorder risk among deboning workers in a Chilean salmon industry.

PubMed

Ilardi, Juan S

2012-01-01

The purpose of this ergonomic investigation is to establish a relationship between quality, productivity and risk of musculoskeletal disorder (MSD) in manual bone-removal process in the salmon fish industry. The method consists in a follow up study of 14 workers in a lane that processes salmon steak. Time between each steak (work cycle), quality of the steak's meat through inspection of deepness and length of the gapping generated by the manual bone-removal process and risk for musculoskeletal disorders through OCRA method were considered for this study. IMC and musculoskeletal Nordic Questionnaire of Kourinka were applied to the workers evaluated. Fourteen women worker's completed the evaluation, age 37.67 ± 8.1, with 65.27 ± 34.41 months of experience, with an IMC of 27.18 ± 3.87 (1.52 ± 0.057 meters of height) at the time of the evaluation. Time for deboning per steak averaged 38 ± 14 seconds with 68.33 ± 14.79 steaks per hour per worker. In quality terms, 74% of the steaks were qualified as "premium steaks" and 26% as "grade or industrial" (lower category and cheapest price). OCRA index for the right hand average 13.79 ± 4.59 and 3.59 ± 0.41 for the left hand. From Nordic questionnaire 80% of the workers manifested musculoskeletal symptoms in the right hand/wrist, followed up by shoulder with 60% of the workers and arm/elbow with over 50%. There was no statistically significant relationship between productivity and quality of the steak after manual bone removal process and between quality and MSD risk. However, there was a statistically significant relationship between productivity and MSD risk (p<0.05). Discussion around the results allows to see complementary results that did have strong correlation between MSD risk and the presence of lower grade salmon steaks and between areas that present musculoskeletal symptoms (MSS) and the intensity of the MSS (p<0.05). The results showed that further research is needed to validate these relationships, due to the increasing demands of health-care services from this productive sector, considering its importance for this region.

Use of evidential reasoning and AHP to assess regional industrial safety

PubMed Central

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China’s fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others. PMID:29795593

Direct potable reuse microbial risk assessment methodology: Sensitivity analysis and application to State log credit allocations.

PubMed

Soller, Jeffrey A; Eftim, Sorina E; Nappier, Sharon P

2018-01-01

Understanding pathogen risks is a critically important consideration in the design of water treatment, particularly for potable reuse projects. As an extension to our published microbial risk assessment methodology to estimate infection risks associated with Direct Potable Reuse (DPR) treatment train unit process combinations, herein, we (1) provide an updated compilation of pathogen density data in raw wastewater and dose-response models; (2) conduct a series of sensitivity analyses to consider potential risk implications using updated data; (3) evaluate the risks associated with log credit allocations in the United States; and (4) identify reference pathogen reductions needed to consistently meet currently applied benchmark risk levels. Sensitivity analyses illustrated changes in cumulative annual risks estimates, the significance of which depends on the pathogen group driving the risk for a given treatment train. For example, updates to norovirus (NoV) raw wastewater values and use of a NoV dose-response approach, capturing the full range of uncertainty, increased risks associated with one of the treatment trains evaluated, but not the other. Additionally, compared to traditional log-credit allocation approaches, our results indicate that the risk methodology provides more nuanced information about how consistently public health benchmarks are achieved. Our results indicate that viruses need to be reduced by 14 logs or more to consistently achieve currently applied benchmark levels of protection associated with DPR. The refined methodology, updated model inputs, and log credit allocation comparisons will be useful to regulators considering DPR projects and design engineers as they consider which unit treatment processes should be employed for particular projects. Published by Elsevier Ltd.

Use of evidential reasoning and AHP to assess regional industrial safety.

PubMed

Chen, Zhichao; Chen, Tao; Qu, Zhuohua; Yang, Zaili; Ji, Xuewei; Zhou, Yi; Zhang, Hui

2018-01-01

China's fast economic growth contributes to the rapid development of its urbanization process, and also renders a series of industrial accidents, which often cause loss of life, damage to property and environment, thus requiring the associated risk analysis and safety control measures to be implemented in advance. However, incompleteness of historical failure data before the occurrence of accidents makes it difficult to use traditional risk analysis approaches such as probabilistic risk analysis in many cases. This paper aims to develop a new methodology capable of assessing regional industrial safety (RIS) in an uncertain environment. A hierarchical structure for modelling the risks influencing RIS is first constructed. The hybrid of evidential reasoning (ER) and Analytical Hierarchy Process (AHP) is then used to assess the risks in a complementary way, in which AHP is hired to evaluate the weight of each risk factor and ER is employed to synthesise the safety evaluations of the investigated region(s) against the risk factors from the bottom to the top level in the hierarchy. The successful application of the hybrid approach in a real case analysis of RIS in several major districts of Beijing (capital of China) demonstrates its feasibility as well as provides risk analysts and safety engineers with useful insights on effective solutions to comprehensive risk assessment of RIS in metropolitan cities. The contribution of this paper is made by the findings on the comparison of risk levels of RIS at different regions against various risk factors so that best practices from the good performer(s) can be used to improve the safety of the others.

Involvement and Influence of Healthcare Providers, Family Members, and Other Mutation Carriers in the Cancer Risk Management Decision-Making Process of BRCA1 and BRCA2 Mutation Carriers.

PubMed

Puski, Athena; Hovick, Shelly; Senter, Leigha; Toland, Amanda Ewart

2018-03-29

Deciding between increased cancer screening or prophylactic surgery and the timing of such procedures can be a difficult and complex process for women with BRCA mutations. There are gaps in our understanding of involvement of others in the decision-making process for women with BRCA mutations. This study evaluated the management decision-making process of women with BRCA mutations, focusing on the involvement of others. Grounded theory was used to analyze and code risk management decision-making information from interviews with 20 BRCA mutation carriers. Unaffected at-risk participants with a BRCA mutation, those under age 40, and those with no children described having a difficult time making risk management decisions. Physicians were an integral part of the decision-making process by providing decisional support and management recommendations. Family members and other mutation carriers filled similar yet distinct roles by providing experiential information as well as decisional and emotional support for carriers. Participants described genetic counselors as short-term providers of risk information and management recommendations. The study findings suggest that unaffected at-risk women, women under 40, and those who do not have children may benefit from additional support and information during the decision-making process. Genetic counselors are well trained to help women through this process and connect them with resources, and may be under-utilized in long-term follow-up for women with a BRCA mutation.

Radiation risk from CT: implications for cancer screening.

PubMed

Albert, Jeffrey M

2013-07-01

The cancer risks associated with patient exposure to radiation from medical imaging have become a major topic of debate. The higher doses necessary for technologies such as CT and the increasing utilization of these technologies further increase medical radiation exposure to the population. Furthermore, the use of CT for population-based cancer screening continues to be explored for common malignancies such as lung cancer and colorectal cancer. Given the known carcinogenic effects of ionizing radiation, this warrants evaluation of the balance between the benefit of early cancer detection and the risk of screening-induced malignancy. This report provides a brief review of the process of radiation carcino-genesis and the literature evaluating the risk of malignancy from CT, with a focus on the risks and benefits of CT for cancer screening. The available data suggest a small but real risk of radiation-induced malignancy from CT that could become significant at the population level with widespread use of CT-based screening. However, a growing body of literature suggests that the benefits of CT screening for lung cancer in high-risk patients and CT colonography for colorectal cancer may significantly outweigh the radiation risk. Future studies evaluating the benefits of CT screening should continue to consider potential radiation risks.

Historical Relationship Between Performance Assessment for Radioactive Waste Disposal and Other Types of Risk Assessment in the United States

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

RECHARD,ROBERT P.

This paper describes the evolution of the process for assessing the hazards of a geologic disposal system for radioactive waste and, similarly, nuclear power reactors, and the relationship of this process with other assessments of risk, particularly assessments of hazards from manufactured carcinogenic chemicals during use and disposal. This perspective reviews the common history of scientific concepts for risk assessment developed to the 1950s. Computational tools and techniques developed in the late 1950s and early 1960s to analyze the reliability of nuclear weapon delivery systems were adopted in the early 1970s for probabilistic risk assessment of nuclear power reactors, amore » technology for which behavior was unknown. In turn, these analyses became an important foundation for performance assessment of nuclear waste disposal in the late 1970s. The evaluation of risk to human health and the environment from chemical hazards is built upon methods for assessing the dose response of radionuclides in the 1950s. Despite a shared background, however, societal events, often in the form of legislation, have affected the development path for risk assessment for human health, producing dissimilarities between these risk assessments and those for nuclear facilities. An important difference is the regulator's interest in accounting for uncertainty and the tools used to evaluate it.« less

Failure mode and effects analysis: A community practice perspective.

PubMed

Schuller, Bradley W; Burns, Angi; Ceilley, Elizabeth A; King, Alan; LeTourneau, Joan; Markovic, Alexander; Sterkel, Lynda; Taplin, Brigid; Wanner, Jennifer; Albert, Jeffrey M

2017-11-01

To report our early experiences with failure mode and effects analysis (FMEA) in a community practice setting. The FMEA facilitator received extensive training at the AAPM Summer School. Early efforts focused on department education and emphasized the need for process evaluation in the context of high profile radiation therapy accidents. A multidisciplinary team was assembled with representation from each of the major department disciplines. Stereotactic radiosurgery (SRS) was identified as the most appropriate treatment technique for the first FMEA evaluation, as it is largely self-contained and has the potential to produce high impact failure modes. Process mapping was completed using breakout sessions, and then compiled into a simple electronic format. Weekly sessions were used to complete the FMEA evaluation. Risk priority number (RPN) values > 100 or severity scores of 9 or 10 were considered high risk. The overall time commitment was also tracked. The final SRS process map contained 15 major process steps and 183 subprocess steps. Splitting the process map into individual assignments was a successful strategy for our group. The process map was designed to contain enough detail such that another radiation oncology team would be able to perform our procedures. Continuous facilitator involvement helped maintain consistent scoring during FMEA. Practice changes were made responding to the highest RPN scores, and new resulting RPN scores were below our high-risk threshold. The estimated person-hour equivalent for project completion was 258 hr. This report provides important details on the initial steps we took to complete our first FMEA, providing guidance for community practices seeking to incorporate this process into their quality assurance (QA) program. Determining the feasibility of implementing complex QA processes into different practice settings will take on increasing significance as the field of radiation oncology transitions into the new TG-100 QA paradigm. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Applications of Living Fire PRA models to Fire Protection Significance Determination Process in Taiwan

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

De-Cheng, Chen; Chung-Kung, Lo; Tsu-Jen, Lin

2004-07-01

The living fire probabilistic risk assessment (PRA) models for all three operating nuclear power plants (NPPs) in Taiwan had been established in December 2000. In that study, a scenario-based PRA approach was adopted to systematically evaluate the fire and smoke hazards and associated risks. Using these fire PRA models developed, a risk-informed application project had also been completed in December 2002 for the evaluation of cable-tray fire-barrier wrapping exemption. This paper presents a new application of the fire PRA models to fire protection issues using the fire protection significance determination process (FP SDP). The fire protection issues studied may involvemore » the selection of appropriate compensatory measures during the period when an automatic fire detection or suppression system in a safety-related fire zone becomes inoperable. The compensatory measure can either be a 24-hour fire watch or an hourly fire patrol. The living fire PRA models were used to estimate the increase in risk associated with the fire protection issue in terms of changes in core damage frequency (CDF) and large early release frequency (LERF). In compliance with SDP at-power and the acceptance guidelines specified in RG 1.174, the fire protection issues in question can be grouped into four categories; red, yellow, white and green, in accordance with the guidelines developed for FD SDP. A 24-hour fire watch is suggested only required for the yellow condition, while an hourly fire patrol may be adopted for the white condition. More limiting requirement is suggested for the red condition, but no special consideration is needed for the green condition. For the calculation of risk measures, risk impacts from any additional fire scenarios that may have been introduced, as well as more severe initiating events and fire damages that may accompany the fire protection issue should be considered carefully. Examples are presented in this paper to illustrate the evaluation process. (authors)« less

Suitability of biomarkers of biological effects (BOBEs) for assessing the likelihood of reducing the tobacco related disease risk by new and innovative tobacco products: A literature review.

PubMed

Scherer, Gerhard

2018-04-01

The health risk of tobacco smoking can best be avoided or reduced by not taking up or quitting the habit. The use of new and innovative tobacco (NTPs, e.g. electronic cigarettes) can either be an aid for smoking cessation or, for those who are not able or willing to quit, an alternative for smoking conventional tobacco products. Before the use of an NTP can be regarded as an effective approach in tobacco harm reduction (THR), the implicated risk has to be evaluated by suitable toxicological methods such as the analysis of the chemical composition as well as assessment of detrimental effects in animal and in vitro studies. In human (clinical) studies, the NTP-related exposure to toxicants and early biological effects can be assessed by the determination of suitable biomarkers. In this review, the suitability of established and newly developed biomarkers of biological effect (BOBEs) for the indicated purpose is evaluated according to five criteria, including the association to diseases, reported difference in BOBE levels between smokers and non-smokers, dose-response relationships, reversibility and kinetics after smoking cessation. Furthermore, the effect size and the resulting sample size required in clinical studies were estimated and considered in the BOBE evaluation process. It is concluded that the rating process presented is useful for selecting BOBEs suitable for risk evaluation of NTPs in clinical and other human studies. Copyright © 2018 Elsevier Inc. All rights reserved.

Red and processed meat intake and risk of breast cancer: a meta-analysis of prospective studies.

PubMed

Guo, Jingyu; Wei, Wei; Zhan, Lixing

2015-05-01

Epidemiological studies regarding the association between red and processed meat intake and the risk of breast cancer have yielded inconsistent results. Therefore, we conducted an updated and comprehensive meta-analysis which included 14 prospective studies to evaluate the association of red and processed meat intake with breast cancer risk. Relevant prospective cohort studies were identified by searching PubMed through October 31, 2014, and by reviewing the reference lists of retrieved articles. Study-specific relative risk (RR) estimates were pooled using a random-effects model. Fourteen prospective studies on red meat (involving 31,552 cases) and 12 prospective studies on processed meat were included in the meta-analysis. The summary RRs (95 % CI) of breast cancer for the highest versus the lowest categories were 1.10 (1.02, 1.19) for red meat, and 1.08 (1.01, 1.15) for processed meat. The estimated summary RRs (95 % CI) were 1.11 (1.05, 1.16) for an increase of 120 g/day of red meat, and 1.09 (1.03, 1.16) for an increase of 50 g/day of processed meat. Our findings indicate that increased intake of red and processed meat is associated with an increased risk of breast cancer. Further research with well-designed cohort or interventional studies is needed to confirm the association.

Participatory evaluation and process use within a social aid organization for at-risk families and youth.

PubMed

Jacob, Steve; Ouvrard, Laurence; Bélanger, Jean-François

2011-05-01

Participatory evaluation has been developing over the last several years, particularly in the social sector. Concurrently, research on the effects of evaluation has evolved significantly. Recently, one type of result has been the object of particular attention: the effects and lessons directly attributable to the evaluative process, or process use. Analyses generally underline the direct link between participatory approaches and this type of result. However, few empirical studies testing this concept are available. Our analysis aims to enrich evaluative research on this theme and is founded on a case study of a participatory evaluation project on practices carried out in a social services organization (Centre Jeunesse de Québec--Institut universitaire [Québec Youth Centre--University Institute, Canada]). The results of our analysis show that the evaluative process favours participant learning and has had several direct and indirect effects on the practices of the involved clinical teams. The results also demonstrate the existence of a link between the intensity of actor participation (individuals, groups) and process use. Both constraining factors and factors favourable to participation and the development of the evaluative process are identified, and avenues for improvement are suggested to accentuate the effects of process use. Copyright © 2010 Elsevier Ltd. All rights reserved.

Institutional facilitators and barriers to local public health preparedness planning for vulnerable and at-risk populations.

PubMed

Bevc, Christine A; Simon, Matthew C; Montoya, Tanya A; Horney, Jennifer A

2014-01-01

Numerous institutional facilitators and barriers to preparedness planning exist at the local level for vulnerable and at-risk populations. Findings of this evaluation study contribute to ongoing practice-based efforts to improve response services and address public health preparedness planning and training as they relate to vulnerable and at-risk populations. From January 2012 through June 2013, we conducted a multilevel, mixed-methods evaluation study of the North Carolina Preparedness and Emergency Response Research Center's Vulnerable & At-Risk Populations Resource Guide, an online tool to aid local health departments' (LHDs') preparedness planning efforts. We examined planning practices across multiple local, regional, and state jurisdictions utilizing user data, follow-up surveys, and secondary data. To identify potential incongruities in planning, we compared respondents' reported populations of interest with corresponding census data to determine whether or not there were differences in planning priorities. We used data collected from evaluation surveys to identify key institutional facilitators and barriers associated with planning for at-risk populations, including challenges to conducting assessments and lack of resources. Results identified both barriers within institutional culture and disconnects between planning priorities and evidence-based identification of vulnerable and at-risk populations, including variation in the planning process, partnerships, and perceptions. Our results highlight the important role of LHDs in preparedness planning and the potential implications associated with organizational and bureaucratic impediments to planning implementation. A more in-depth understanding of the relationships among public institutions and the levels of preparedness that contribute to the conditions and processes that generate vulnerability is needed.

Quantitative modelling of amyloidogenic processing and its influence by SORLA in Alzheimer's disease.

PubMed

Schmidt, Vanessa; Baum, Katharina; Lao, Angelyn; Rateitschak, Katja; Schmitz, Yvonne; Teichmann, Anke; Wiesner, Burkhard; Petersen, Claus Munck; Nykjaer, Anders; Wolf, Jana; Wolkenhauer, Olaf; Willnow, Thomas E

2012-01-04

The extent of proteolytic processing of the amyloid precursor protein (APP) into neurotoxic amyloid-β (Aβ) peptides is central to the pathology of Alzheimer's disease (AD). Accordingly, modifiers that increase Aβ production rates are risk factors in the sporadic form of AD. In a novel systems biology approach, we combined quantitative biochemical studies with mathematical modelling to establish a kinetic model of amyloidogenic processing, and to evaluate the influence by SORLA/SORL1, an inhibitor of APP processing and important genetic risk factor. Contrary to previous hypotheses, our studies demonstrate that secretases represent allosteric enzymes that require cooperativity by APP oligomerization for efficient processing. Cooperativity enables swift adaptive changes in secretase activity with even small alterations in APP concentration. We also show that SORLA prevents APP oligomerization both in cultured cells and in the brain in vivo, eliminating the preferred form of the substrate and causing secretases to switch to a less efficient non-allosteric mode of action. These data represent the first mathematical description of the contribution of genetic risk factors to AD substantiating the relevance of subtle changes in SORLA levels for amyloidogenic processing as proposed for patients carrying SORL1 risk alleles.

Quantitative modelling of amyloidogenic processing and its influence by SORLA in Alzheimer's disease

PubMed Central

Schmidt, Vanessa; Baum, Katharina; Lao, Angelyn; Rateitschak, Katja; Schmitz, Yvonne; Teichmann, Anke; Wiesner, Burkhard; Petersen, Claus Munck; Nykjaer, Anders; Wolf, Jana; Wolkenhauer, Olaf; Willnow, Thomas E

2012-01-01

The extent of proteolytic processing of the amyloid precursor protein (APP) into neurotoxic amyloid-β (Aβ) peptides is central to the pathology of Alzheimer's disease (AD). Accordingly, modifiers that increase Aβ production rates are risk factors in the sporadic form of AD. In a novel systems biology approach, we combined quantitative biochemical studies with mathematical modelling to establish a kinetic model of amyloidogenic processing, and to evaluate the influence by SORLA/SORL1, an inhibitor of APP processing and important genetic risk factor. Contrary to previous hypotheses, our studies demonstrate that secretases represent allosteric enzymes that require cooperativity by APP oligomerization for efficient processing. Cooperativity enables swift adaptive changes in secretase activity with even small alterations in APP concentration. We also show that SORLA prevents APP oligomerization both in cultured cells and in the brain in vivo, eliminating the preferred form of the substrate and causing secretases to switch to a less efficient non-allosteric mode of action. These data represent the first mathematical description of the contribution of genetic risk factors to AD substantiating the relevance of subtle changes in SORLA levels for amyloidogenic processing as proposed for patients carrying SORL1 risk alleles. PMID:21989385

Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.

PubMed

Jenke, Dennis

2015-01-01

An accelerating trend in the pharmaceutical industry is the use of plastic components in systems used to produce an active pharmaceutical ingredient or a finished drug product. If the active pharmaceutical ingredient, the finished drug product, or any solution used to generate them (for example, a process stream such as media, buffers, eluents, and the like) is contacted by a plastic component at any time during the production process, substances leached from the component may accumulate in the active pharmaceutical ingredient or finished drug product, affecting its safety and/or efficacy. In this article the author develops and justifies a semi-quantitative risk evaluation matrix that is used to determine the amount and rigor of component testing necessary and appropriate to establish that the component is chemically suitable for its intended use. By considering key properties of the component, the contact medium, the contact conditions, and the active pharmaceutical ingredient's or finished drug product's clinical conditions of use, use of the risk evaluation matrix produces a risk score whose magnitude reflects the accumulated risk that the component will interact with the contact solution to such an extent that component-related extractables will accumulate in the active pharmaceutical ingredient or finished drug product as leachables at levels sufficiently high to adversely affect user safety. The magnitude of the risk score establishes the amount and rigor of the testing that is required to select and qualify the component, and such testing is broadly grouped into three categories: baseline assessment, general testing, and full testing (extractables profiling). Production suites used to generate pharmaceuticals can include plastic components. It is possible that substances in the components could leach into manufacturing solutions and accumulate in the pharmaceutical product. In this article the author develops and justifies a semi-quantitative risk evaluation matrix that can be used to determine the amount and rigor of component testing that may be necessary and appropriate to establish that the component is suitable for its intended use. Use of the risk evaluation matrix allows a user of a component to determine the type and amount of testing that should be performed to establish the patient safety risk associated with using that component in order to manufacture an active pharmaceutical ingredient or a finished drug product. © PDA, Inc. 2015.

Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

PubMed

McMillan, Matthew T; Soi, Sameer; Asbun, Horacio J; Ball, Chad G; Bassi, Claudio; Beane, Joal D; Behrman, Stephen W; Berger, Adam C; Bloomston, Mark; Callery, Mark P; Christein, John D; Dixon, Elijah; Drebin, Jeffrey A; Castillo, Carlos Fernandez-Del; Fisher, William E; Fong, Zhi Ven; House, Michael G; Hughes, Steven J; Kent, Tara S; Kunstman, John W; Malleo, Giuseppe; Miller, Benjamin C; Salem, Ronald R; Soares, Kevin; Valero, Vicente; Wolfgang, Christopher L; Vollmer, Charles M

2016-08-01

To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P < 0.00001) and octreotide (odds ratio 3.30, P < 0.00001). When adjusting for risk, performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

Development of the Damage Potential resulting from Avalanche Risks, Case Study Galtür (Tyrol, Austria)

NASA Astrophysics Data System (ADS)

Keiler, M.

2003-04-01

Reports on catastrophes with high damage caused by natural hazards seem to have increased in number recently. A new trend in dealing with these natural processes leads to the integration of risk into natural hazards evaluations and approaches of integral risk management. The risk resulting from natural hazards can be derived from the combination of parameters of physical processes (intensity and recurrence probability) and damage potential (probability of presence and expected damage value). Natural hazard research focuses mainly on the examination, modelling and estimation of individual geomorphological processes as well as on future developments caused by climate change. Even though damage potential has been taken into account more frequently, quantifying statements are still missing. Due to the changes of the socio-economic structures in mountain regions (urban sprawl, population growth, increased mobility and tourism) these studies are mandatory. This study presents a conceptual method that records the damage potential (probability of physical presence, evaluation of buildings) and shows the development of the damage potential resulting from avalanches since 1950. The study area is the community of Galtür, Austria. 36 percent of the existing buildings are found in officially declared avalanche hazard zones. The majority of these buildings are either agricultural or accommodation facilities. Additionally, the effects of physical planning and/or technical measures on the spatial development of the potential damage are illustrated. The results serve to improve risk determination and point out an unnoticed increase of damage potential and risk in apparently safe settlement areas.

Development of the e-Baby serious game with regard to the evaluation of oxygenation in preterm babies: contributions of the emotional design.

PubMed

Fonseca, Luciana Mara Monti; Dias, Danielle Monteiro Vilela; Góes, Fernanda Dos Santos Nogueira; Seixas, Carlos Alberto; Scochi, Carmen Gracinda Silvan; Martins, José Carlos Amado; Rodrigues, Manuel Alves

2014-09-01

The present study aimed to describe the development process of a serious game that enables users to evaluate the respiratory process in a preterm infant based on an emotional design model. The e-Baby serious game was built to feature the simulated environment of an incubator, in which the user performs a clinical evaluation of the respiratory process in a virtual preterm infant. The user learns about the preterm baby's history, chooses the tools for the clinical evaluation, evaluates the baby, and determines whether his/her evaluation is appropriate. The e-Baby game presents phases that contain respiratory process impairments of higher or lower complexity in the virtual preterm baby. Included links give the user the option of recording the entire evaluation procedure and sharing his/her performance on a social network. e-Baby integrates a Clinical Evaluation of the Preterm Baby course in the Moodle virtual environment. This game, which evaluates the respiratory process in preterm infants, could support a more flexible, attractive, and interactive teaching and learning process that includes simulations with features very similar to neonatal unit realities, thus allowing more appropriate training for clinical oxygenation evaluations in at-risk preterm infants. e-Baby allows advanced user-technology-educational interactions because it requires active participation in the process and is emotionally integrated.

Risk factors for invasive fungal disease in critically ill adult patients: a systematic review.

PubMed

Muskett, Hannah; Shahin, Jason; Eyres, Gavin; Harvey, Sheila; Rowan, Kathy; Harrison, David

2011-01-01

Over 5,000 cases of invasive Candida species infections occur in the United Kingdom each year, and around 40% of these cases occur in critical care units. Invasive fungal disease (IFD) in critically ill patients is associated with increased morbidity and mortality at a cost to both the individual and the National Health Service. In this paper, we report the results of a systematic review performed to identify and summarise the important risk factors derived from published multivariable analyses, risk prediction models and clinical decision rules for IFD in critically ill adult patients to inform the primary data collection for the Fungal Infection Risk Evaluation Study. An internet search was performed to identify articles which investigated risk factors, risk prediction models or clinical decisions rules for IFD in critically ill adult patients. Eligible articles were identified in a staged process and were assessed by two investigators independently. The methodological quality of the reporting of the eligible articles was assessed using a set of questions addressing both general and statistical methodologies. Thirteen articles met the inclusion criteria, of which eight articles examined risk factors, four developed a risk prediction model or clinical decision rule and one evaluated a clinical decision rule. Studies varied in terms of objectives, risk factors, definitions and outcomes. The following risk factors were found in multiple studies to be significantly associated with IFD: surgery, total parenteral nutrition, fungal colonisation, renal replacement therapy, infection and/or sepsis, mechanical ventilation, diabetes, and Acute Physiology and Chronic Health Evaluation II (APACHE II) or APACHE III score. Several other risk factors were also found to be statistically significant in single studies only. Risk factor selection process and modelling strategy also varied across studies, and sample sizes were inadequate for obtaining reliable estimates. This review shows a number of risk factors to be significantly associated with the development of IFD in critically ill adults. Methodological limitations were identified in the design and conduct of studies in this area, and caution should be used in their interpretation.

Risk factors for invasive fungal disease in critically ill adult patients: a systematic review

PubMed Central

2011-01-01

Introduction Over 5,000 cases of invasive Candida species infections occur in the United Kingdom each year, and around 40% of these cases occur in critical care units. Invasive fungal disease (IFD) in critically ill patients is associated with increased morbidity and mortality at a cost to both the individual and the National Health Service. In this paper, we report the results of a systematic review performed to identify and summarise the important risk factors derived from published multivariable analyses, risk prediction models and clinical decision rules for IFD in critically ill adult patients to inform the primary data collection for the Fungal Infection Risk Evaluation Study. Methods An internet search was performed to identify articles which investigated risk factors, risk prediction models or clinical decisions rules for IFD in critically ill adult patients. Eligible articles were identified in a staged process and were assessed by two investigators independently. The methodological quality of the reporting of the eligible articles was assessed using a set of questions addressing both general and statistical methodologies. Results Thirteen articles met the inclusion criteria, of which eight articles examined risk factors, four developed a risk prediction model or clinical decision rule and one evaluated a clinical decision rule. Studies varied in terms of objectives, risk factors, definitions and outcomes. The following risk factors were found in multiple studies to be significantly associated with IFD: surgery, total parenteral nutrition, fungal colonisation, renal replacement therapy, infection and/or sepsis, mechanical ventilation, diabetes, and Acute Physiology and Chronic Health Evaluation II (APACHE II) or APACHE III score. Several other risk factors were also found to be statistically significant in single studies only. Risk factor selection process and modelling strategy also varied across studies, and sample sizes were inadequate for obtaining reliable estimates. Conclusions This review shows a number of risk factors to be significantly associated with the development of IFD in critically ill adults. Methodological limitations were identified in the design and conduct of studies in this area, and caution should be used in their interpretation. PMID:22126425

ELECTRA © Launch and Re-Entry Safety Analysis Tool

NASA Astrophysics Data System (ADS)

Lazare, B.; Arnal, M. H.; Aussilhou, C.; Blazquez, A.; Chemama, F.

2010-09-01

French Space Operation Act gives as prime objective to National Technical Regulations to protect people, properties, public health and environment. In this frame, an independent technical assessment of French space operation is delegated to CNES. To perform this task and also for his owns operations CNES needs efficient state-of-the-art tools for evaluating risks. The development of the ELECTRA© tool, undertaken in 2007, meets the requirement for precise quantification of the risks involved in launching and re-entry of spacecraft. The ELECTRA© project draws on the proven expertise of CNES technical centers in the field of flight analysis and safety, spaceflight dynamics and the design of spacecraft. The ELECTRA© tool was specifically designed to evaluate the risks involved in the re-entry and return to Earth of all or part of a spacecraft. It will also be used for locating and visualizing nominal or accidental re-entry zones while comparing them with suitable geographic data such as population density, urban areas, and shipping lines, among others. The method chosen for ELECTRA© consists of two main steps: calculating the possible reentry trajectories for each fragment after the spacecraft breaks up; calculating the risks while taking into account the energy of the fragments, the population density and protection afforded by buildings. For launch operations and active re-entry, the risk calculation will be weighted by the probability of instantaneous failure of the spacecraft and integrated for the whole trajectory. ELECTRA©’s development is today at the end of the validation phase, last step before delivery to users. Validation process has been performed in different ways: numerical application way for the risk formulation; benchmarking process for casualty area, level of energy of the fragments entries and level of protection housing module; best practices in space transportation industries concerning dependability evaluation; benchmarking process for world population repartition leading to the choice of a worldwide used model called GPW V3. Then, the complementary part for validation has been numerous system tests, most of them by comparison with already existing tools, operationally used for example into the European Space port in French Guyana. The purpose of this article is to review the method and models chosen by CNES for describing physical phenomena and the results of validation process including comparison with other risk assessment tools.

Coordinating activities between NOAA and other agencies.

PubMed

Fritz, A T; Buchman, M F

1997-11-01

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) mandate protection of public health, welfare, and the environment at Superfund hazardous waste sites. The NCP requires lead response agenciesto integrate baseline risk assessments into the remedial process that "assess threats to the environment." EPA policy statements direct regional offices to perform thorough, consistent ecological risk assessments, and stress the importance of coordination and technical consultation with the natural resource trustees. As a Federal natural trustee, the National Oceanic and Atmospheric Administration's (NOAA) role and responsibilities within the CERCLA process also are defined and mandated by Federal law. NOAA is responsible for identifying sites in the coastal zone that may affect natural resources, evaluating injury to trust resources, and providing technical advice on assessments and remedial and restoration alternatives. Statutes require lead cleanup agencies and trustee agencies to notify and coordinate with each other during CERCLA response. Over the past ten years, NOAA has gained valuable experience and technical expertise in environmental assessments and in evaluating contaminated aquatic environments. NOAA fulfills its responsibilities through an effective network of Coastal Resource Coordinators (CRCs) who can rapidly respond to local technical requirements and priorities, and coordinate effectively with technical and trustee representatives. In addition to CRCs, an interdisciplinary support group provides technical expertise in the scientific disciplines required to respond to the needs of regional activities. NOAA provides CRCs to coastal EPA regional offices for technical support, and to act as liaisons with Federal and state natural resource trustee agencies. The CRCs help EPA and other lead response agencies identify and assess risks to coastal resources from hazardous waste sites and to develop cost-effective strategies to minimize those risks. Notification of trustees of potential natural resource injuries and coordination of subsequent investigations helps Federal and state trustees to carry out their responsibilities effectively. Trustees' early involvement in the scoping of ecological risk assessments ensures that assessments and the entire remedial process adequately evaluate the risk to trust resources. Coordination throughout the process makes it easier to develop cost-effective and protective remedies that enhance the recovery of natural resources. Examples of NOAA's successful coordination and cooperative ecological risk assessments will be presented in brief case studies for both EPA and Department of Defense (DOD) lead sites.

Automated Scoring in Context: Rapid Assessment for Placed Students

ERIC Educational Resources Information Center

Klobucar, Andrew; Elliot, Norbert; Deess, Perry; Rudniy, Oleksandr; Joshi, Kamal

2013-01-01

This study investigated the use of automated essay scoring (AES) to identify at-risk students enrolled in a first-year university writing course. An application of AES, the "Criterion"[R] Online Writing Evaluation Service was evaluated through a methodology focusing on construct modelling, response processes, disaggregation, extrapolation,…

32 CFR 211.9 - Mitigation Options.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 2 2013-07-01 2013-07-01 false Mitigation Options. 211.9 Section 211.9 National... MISSION COMPATIBILITY EVALUATION PROCESS Project Evaluation Procedures § 211.9 Mitigation Options. (a) In discussing mitigation to avoid an unacceptable risk to the national security of the United States, the DoD...

32 CFR 211.9 - Mitigation options.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Mitigation options. 211.9 Section 211.9 National... MISSION COMPATIBILITY EVALUATION PROCESS Project Evaluation Procedures § 211.9 Mitigation options. (a) In discussing mitigation to avoid an unacceptable risk to the national security of the United States, the DoD...

32 CFR 211.9 - Mitigation Options.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 2 2012-07-01 2012-07-01 false Mitigation Options. 211.9 Section 211.9 National... MISSION COMPATIBILITY EVALUATION PROCESS Project Evaluation Procedures § 211.9 Mitigation Options. (a) In discussing mitigation to avoid an unacceptable risk to the national security of the United States, the DoD...

A unified framework for evaluating the risk of re-identification of text de-identification tools.

PubMed

Scaiano, Martin; Middleton, Grant; Arbuckle, Luk; Kolhatkar, Varada; Peyton, Liam; Dowling, Moira; Gipson, Debbie S; El Emam, Khaled

2016-10-01

It has become regular practice to de-identify unstructured medical text for use in research using automatic methods, the goal of which is to remove patient identifying information to minimize re-identification risk. The metrics commonly used to determine if these systems are performing well do not accurately reflect the risk of a patient being re-identified. We therefore developed a framework for measuring the risk of re-identification associated with textual data releases. We apply the proposed evaluation framework to a data set from the University of Michigan Medical School. Our risk assessment results are then compared with those that would be obtained using a typical contemporary micro-average evaluation of recall in order to illustrate the difference between the proposed evaluation framework and the current baseline method. We demonstrate how this framework compares against common measures of the re-identification risk associated with an automated text de-identification process. For the probability of re-identification using our evaluation framework we obtained a mean value for direct identifiers of 0.0074 and a mean value for quasi-identifiers of 0.0022. The 95% confidence interval for these estimates were below the relevant thresholds. The threshold for direct identifier risk was based on previously used approaches in the literature. The threshold for quasi-identifiers was determined based on the context of the data release following commonly used de-identification criteria for structured data. Our framework attempts to correct for poorly distributed evaluation corpora, accounts for the data release context, and avoids the often optimistic assumptions that are made using the more traditional evaluation approach. It therefore provides a more realistic estimate of the true probability of re-identification. This framework should be used as a basis for computing re-identification risk in order to more realistically evaluate future text de-identification tools. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Risk management and post-marketing surveillance of CNS drugs.

PubMed

Henningfield, Jack E; Schuster, Charles R

2009-12-01

Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings.

PubMed

Hanlon, Paul; Brorby, Gregory P; Krishan, Mansi

2016-05-01

Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework in the form of a decision tree developed by the ILSI North America Technical Committee on Food and Chemical Safety to a panel of experts, and they discussed the importance of communicating the value of such a process to the larger scientific community and, ultimately, the public. The outcome of the workshop was a decision tree that can be used by the scientific community and could form the basis of a global approach to assessing the risks associated with mitigation of process-formed compounds. © The Author(s) 2016.

A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food

PubMed Central

Brorby, Gregory P.; Krishan, Mansi

2016-01-01

Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework in the form of a decision tree developed by the ILSI North America Technical Committee on Food and Chemical Safety to a panel of experts, and they discussed the importance of communicating the value of such a process to the larger scientific community and, ultimately, the public. The outcome of the workshop was a decision tree that can be used by the scientific community and could form the basis of a global approach to assessing the risks associated with mitigation of process-formed compounds. PMID:27102178

Informed consent and decision-making about adult-to-adult living donor liver transplantation: a systematic review of empirical research.

PubMed

Gordon, Elisa J; Daud, Amna; Caicedo, Juan Carlos; Cameron, Kenzie A; Jay, Colleen; Fryer, Jonathan; Beauvais, Nicole; Skaro, Anton; Baker, Talia

2011-12-27

Adult-to-adult living donor liver transplantation (LDLT) is a complex procedure that poses serious health risks to and provides no direct health benefit for the donor. Because of this uneven risk-benefit ratio, ensuring donor autonomy through informed consent is critical. To assess the current knowledge pertaining to informed consent for LDLT, we conducted a systematic review of the empirical literature on donors' decision-making process, comprehension about risks and outcomes, and information needs for LDLT. Of the 1423 identified articles, 24 met final review criteria, representing the perspective of approximately 2789 potential and actual donors. As donors' decisions to donate often occur before evaluation, they often make uninformed decisions. The review found that 88% to 95% of donors reported understanding information clinicians disclosed about risks and benefits. However, donors reported unmet information needs, knowledge gaps regarding risks, and unanticipated complications. Few donors reported feeling pressure to donate. Most studies were limited by cultural differences, small sample sizes, inconsistent measures, and poor methodological approaches. This systematic review suggests that informed consent for LDLT is sub-optimal as donors do not adequately appreciate disclosed information during the informed consent process, despite United Network for Organ Sharing/CMS regulations requiring formal psychological evaluation of donor candidates. Interventions are needed to improve donor-clinician communication during the LDLT informed consent process such as through the use of comprehension assessment tools and e-health educational tools that leverage adult learning theory to effectively convey LDLT outcome data.

Heavy metals in soil at a waste electrical and electronic equipment processing area in China.

PubMed

Gu, Weihua; Bai, Jianfeng; Yao, Haiyan; Zhao, Jing; Zhuang, Xuning; Huang, Qing; Zhang, Chenglong; Wang, JingWei

2017-11-01

For the objective of evaluating the contamination degree of heavy metals and analysing its variation trend in soil at a waste electrical and electronic equipment processing area in Shanghai, China, evaluation methods, which include single factor index method, geo-accumulation index method, comprehensive pollution index method, and potential ecological risk index method, were adopted in this study. The results revealed that the soil at a waste electrical and electronic equipment processing area was polluted by arsenic, cadmium, copper, lead, zinc, and chromium. It also demonstrated that the concentrations of heavy metals were increased over time. Exceptionally, the average value of the metalloid (arsenic) was 73.31 mg kg -1 in 2014, while it was 58.31 mg kg -1 in the first half of 2015, and it was 2.93 times and 2.33 times higher than that of the Chinese Environmental Quality Standard for Soil in 2014 and the first half of 2015, respectively. The sequences of the contamination degree of heavy metals in 2014 and the first half of 2015 were cadmium > lead > copper > chromium > zinc and cadmium > lead > chromium > zinc > copper. From the analysis of the potential ecological risk index method, arsenic and cadmium had higher ecological risk than other heavy metals. The integrated ecological risk index of heavy metals (cadmium, copper, lead, zinc, and chromium) and metalloid (arsenic) was 394.10 in 2014, while it was 656.16 in the first half of 2015, thus documenting a strong ecological risk.

Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

PubMed

Wright, Curtis; Schnoll, Sidney; Bernstein, David

2008-10-01

Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

PubMed

Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

2015-01-01

Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

Dissociable neural processes during risky decision-making in individuals with Internet-gaming disorder.

PubMed

Liu, Lu; Xue, Gui; Potenza, Marc N; Zhang, Jin-Tao; Yao, Yuan-Wei; Xia, Cui-Cui; Lan, Jing; Ma, Shan-Shan; Fang, Xiao-Yi

2017-01-01

Risk-taking is purported to be central to addictive behaviors. However, for Internet gaming disorder (IGD), a condition conceptualized as a behavioral addiction, the neural processes underlying impaired decision-making (risk evaluation and outcome processing) related to gains and losses have not been systematically investigated. Forty-one males with IGD and 27 healthy comparison (HC) male participants were recruited, and the cups task was used to identify neural processes associated with gain- and loss-related risk- and outcome-processing in IGD. During risk evaluation, the IGD group, compared to the HC participants, showed weaker modulation for experienced risk within the bilateral dorsolateral prefrontal cortex (DLPFC) ( t  = - 4.07; t  = - 3.94; P FWE  < 0.05) and inferior parietal lobule (IPL) ( t  = - 4.08; t  = - 4.08; P FWE  < 0.05) for potential losses. The modulation of the left DLPFC and bilateral IPL activation were negatively related to addiction severity within the IGD group ( r  = - 0.55; r  = - 0.61; r  = - 0.51; P FWE  < 0.05). During outcome processing, the IGD group presented greater responses for the experienced reward within the ventral striatum, ventromedial prefrontal cortex, and orbitofrontal cortex (OFC) ( t  = 5.04, P FWE  < 0.05) for potential gains, as compared to HC participants. Within the IGD group, the increased reward-related activity in the right OFC was positively associated with severity of IGD ( r  = 0.51, P FWE  < 0.05). These results provide a neurobiological foundation for decision-making deficits in individuals with IGD and suggest an imbalance between hypersensitivity for reward and weaker risk experience and self-control for loss. The findings suggest a biological mechanism for why individuals with IGD may persist in game-seeking behavior despite negative consequences, and treatment development strategies may focus on targeting these neural pathways in this population.

Ecotoxicological evaluation of diesel-contaminated soil before and after a bioremediation process.

PubMed

Molina-Barahona, L; Vega-Loyo, L; Guerrero, M; Ramírez, S; Romero, I; Vega-Jarquín, C; Albores, A

2005-02-01

Evaluation of contaminated sites is usually performed by chemical analysis of pollutants in soil. This is not enough either to evaluate the environmental risk of contaminated soil nor to evaluate the efficiency of soil cleanup techniques. Information on the bioavailability of complex mixtures of xenobiotics and degradation products cannot be totally provided by chemical analytical data, but results from bioassays can integrate the effects of pollutants in complex mixtures. In the preservation of human health and environment quality, it is important to assess the ecotoxicological effects of contaminated soils to obtain a better evaluation of the healthiness of this system. The monitoring of a diesel-contaminated soil and the evaluation of a bioremediation technique conducted on a microcosm scale were performed by a battery of ecotoxicological tests including phytotoxicity, Daphnia magna, and nematode assays. In this study we biostimulated the native microflora of soil contaminated with diesel by adding nutrients and crop residue (corn straw) as a bulking agent and as a source of microorganisms and nutrients; in addition, moisture was adjusted to enhance diesel removal. The bioremediation process efficiency was evaluated directly by an innovative, simple phytotoxicity test system and the diesel extracts by Daphnia magna and nematode assays. Contaminated soil samples were revealed to have toxic effects on seed germination, seedling growth, and Daphnia survival. After biostimulation, the diesel concentration was reduced by 50.6%, and the soil samples showed a significant reduction in phytotoxicity (9%-15%) and Daphnia assays (3-fold), confirming the effectiveness of the bioremediation process. Results from our microcosm study suggest that in addition to the evaluation of the bioremediation processes efficiency, toxicity testing is different with organisms representative of diverse phylogenic levels. The integration of analytical, toxicological and bioremediation data is necessary to properly assess the ecological risk of bioremediation processes. (c) 2005 Wiley Periodicals, Inc.

State-of-the-Science Workshop Report: Issues and Approaches in Low Dose–Response Extrapolation for Environmental Health Risk Assessment

EPA Science Inventory

Low-dose extrapolation model selection for evaluating the health effects of environmental pollutants is a key component of the risk assessment process. At a workshop held in Baltimore, MD, on April 23-24, 2007, and sponsored by U.S. Environmental Protection Agency (EPA) and Johns...

A New Process for Organizing Assessments of Social, Economic, and Environmental Outcomes: Case Study of Wildland Fire Management in the USA

EPA Science Inventory

Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders, and analysts to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypothe...

A new process for organizing assessments of social, economic and environmental outcomes: case study of wildland fire management in the U.S.A.

EPA Science Inventory

Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders and analysis to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypothes...

Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal

PubMed Central

Kimmelman, Jonathan; Henderson, Valerie C.

2015-01-01

Abstract Moral evaluation of risk/benefit in early phase studies requires assessing the clinical promise of a candidate intervention using preclinical evidence. Yet there is little to guide ethics committees, investigators, sponsors or other stakeholders morally charged with making these assessments (“evaluators”). In what follows, we draw on published guidelines for preclinical study design to develop a structured process for assessing the clinical promise of new interventions. In the first step, evaluators gather all relevant preclinical studies, assess the magnitude of treatment effects, and determine clinical promise in light of various threats to valid clinical inference. In the second step, evaluators adjust assessments of clinical promise from preclinical studies by examining how other agents in the same reference class-and supported by similar evidence- have fared in clinical development. Assessments of clinical promise can then be fed into moral evaluation of risk and benefit in early phase trials. Though our approach has limitations, it offers a systematic and transparent method for assessing risk/benefit in early phase trials of novel interventions. PMID:26463620

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

Leetaru, Hannes

This report describes a process and provides seed information for identifying and evaluating risks pertinent to a hypothetical carbon dioxide (CO{sub 2}) capture and sequestration (CCS) project. In the envisioned project, the target sequestration reservoir rock is the Potosi Formation of the Knox Supergroup. The Potosi is identified as a potential target formation because (1) at least locally, it contains vuggy to cavernous layers that have very high porosity, and (2) it is present in areas where the deeper Mt. Simon Sandstone (a known potential reservoir unit) is absent or nonporous. The key report content is discussed in Section 3.3,more » which describes two lists of Features, Events, and Processes (FEPs) that should be considered during the design stage of such a project. These lists primarily highlight risk elements particular to the establishment of the Potosi as the target formation in general. The lists are consciously incomplete with respect to risk elements that would be relevant for essentially all CCS projects regardless of location or geology. In addition, other risk elements specific to a particular future project site would have to be identified. Sources for the FEPs and scenarios listed here include the iconic Quintessa FEPs list developed for the International Energy Agency Greenhouse Gas (IEAGHG) Programme; previous risk evaluation projects executed by Schlumberger Carbon Services; and new input solicited from experts currently working on aspects of CCS in the Knox geology. The projects used as sources of risk information are primarily those that have targeted carbonate reservoir rocks similar in age, stratigraphy, and mineralogy to the Knox-Potosi. Risks of using the Potosi Formation as the target sequestration reservoir for a CCS project include uncertainties about the levels of porosity and permeability of that rock unit; the lateral consistency and continuity of those properties; and the ability of the project team to identify suitable (i.e., persistently porous and permeable) injection depths within the overall formation. Less direct implications include the vertical position of the Potosi within the rock column and the absence of a laterally extensive shale caprock immediately overlying the Potosi. Based on modeling work done partly in association with this risk report, risks that should also be evaluated include the ability of available methods to predict and track the development of a CO{sub 2} plume as it migrates away from the injection point(s). The geologic and hydrodynamic uncertainties present risks that are compounded at the stage of acquiring necessary drilling and injection permits. It is anticipated that, in the future, a regional geologic study or CO{sub 2}-emitter request may identify a small specific area as a prospective CCS project site. At that point, the FEPs lists provided in this report should be evaluated by experts for their relative levels of risk. A procedure for this evaluation is provided. The higher-risk FEPs should then be used to write project-specific scenarios that may themselves be evaluated for risk. Then, actions to reduce and to manage risk can be described and undertaken. The FEPs lists provided as Appendix 2 should not be considered complete, as potentially the most important risks are ones that have not yet been thought of. But these lists are intended to include the most important risk elements pertinent to a Potosi-target CCS project, and they provide a good starting point for diligent risk identification, evaluation, and management.« less

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

Hnottavange-Telleen, Ken; Leetaru, Hannes

This report describes a process and provides seed information for identifying and evaluating risks pertinent to a hypothetical carbon dioxide (CO2) capture and sequestration (CCS) project. In the envisioned project, the target sequestration reservoir rock is the Potosi Formation of the Knox Supergroup. The Potosi is identified as a potential target formation because (1) at least locally, it contains vuggy to cavernous layers that have very high porosity, and (2) it is present in areas where the deeper Mt. Simon Sandstone (a known potential reservoir unit) is absent or nonporous. The key report content is discussed in Section 3.3, whichmore » describes two lists of Features, Events, and Processes (FEPs) that should be considered during the design stage of such a project. These lists primarily highlight risk elements particular to the establishment of the Potosi as the target formation in general. The lists are consciously incomplete with respect to risk elements that would be relevant for essentially all CCS projects regardless of location or geology. In addition, other risk elements specific to a particular future project site would have to be identified. Sources for the FEPs and scenarios listed here include the iconic Quintessa FEPs list developed for the International Energy Agency Greenhouse Gas (IEAGHG) Programme; previous risk evaluation projects executed by Schlumberger Carbon Services; and new input solicited from experts currently working on aspects of CCS in the Knox geology. The projects used as sources of risk information are primarily those that have targeted carbonate reservoir rocks similar in age, stratigraphy, and mineralogy to the Knox-Potosi. Risks of using the Potosi Formation as the target sequestration reservoir for a CCS project include uncertainties about the levels of porosity and permeability of that rock unit; the lateral consistency and continuity of those properties; and the ability of the project team to identify suitable (i.e., persistently porous and permeable) injection depths within the overall formation. Less direct implications include the vertical position of the Potosi within the rock column and the absence of a laterally extensive shale caprock immediately overlying the Potosi. Based on modeling work done partly in association with this risk report, risks that should also be evaluated include the ability of available methods to predict and track the development of a CO2 plume as it migrates away from the injection point(s). The geologic and hydrodynamic uncertainties present risks that are compounded at the stage of acquiring necessary drilling and injection permits. It is anticipated that, in the future, a regional geologic study or CO2-emitter request may identify a small specific area as a prospective CCS project site. At that point, the FEPs lists provided in this report should be evaluated by experts for their relative levels of risk. A procedure for this evaluation is provided. The higher-risk FEPs should then be used to write project-specific scenarios that may themselves be evaluated for risk. Then, actions to reduce and to manage risk can be described and undertaken. The FEPs lists provided as Appendix 2 should not be considered complete, as potentially the most important risks are ones that have not yet been thought of. But these lists are intended to include the most important risk elements pertinent to a Potosi-target CCS project, and they provide a good starting point for diligent risk identification, evaluation, and management.« less

Ensemble of trees approaches to risk adjustment for evaluating a hospital's performance.

PubMed

Liu, Yang; Traskin, Mikhail; Lorch, Scott A; George, Edward I; Small, Dylan

2015-03-01

A commonly used method for evaluating a hospital's performance on an outcome is to compare the hospital's observed outcome rate to the hospital's expected outcome rate given its patient (case) mix and service. The process of calculating the hospital's expected outcome rate given its patient mix and service is called risk adjustment (Iezzoni 1997). Risk adjustment is critical for accurately evaluating and comparing hospitals' performances since we would not want to unfairly penalize a hospital just because it treats sicker patients. The key to risk adjustment is accurately estimating the probability of an Outcome given patient characteristics. For cases with binary outcomes, the method that is commonly used in risk adjustment is logistic regression. In this paper, we consider ensemble of trees methods as alternatives for risk adjustment, including random forests and Bayesian additive regression trees (BART). Both random forests and BART are modern machine learning methods that have been shown recently to have excellent performance for prediction of outcomes in many settings. We apply these methods to carry out risk adjustment for the performance of neonatal intensive care units (NICU). We show that these ensemble of trees methods outperform logistic regression in predicting mortality among babies treated in NICU, and provide a superior method of risk adjustment compared to logistic regression.

PO*WW*ER mobile treatment unit process hazards analysis

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

Richardson, R.B.

1996-06-01

The objective of this report is to demonstrate that a thorough assessment of the risks associated with the operation of the Rust Geotech patented PO*WW*ER mobile treatment unit (MTU) has been performed and documented. The MTU was developed to treat aqueous mixed wastes at the US Department of Energy (DOE) Albuquerque Operations Office sites. The MTU uses evaporation to separate organics and water from radionuclides and solids, and catalytic oxidation to convert the hazardous into byproducts. This process hazards analysis evaluated a number of accident scenarios not directly related to the operation of the MTU, such as natural phenomena damagemore » and mishandling of chemical containers. Worst case accident scenarios were further evaluated to determine the risk potential to the MTU and to workers, the public, and the environment. The overall risk to any group from operation of the MTU was determined to be very low; the MTU is classified as a Radiological Facility with low hazards.« less

Categorizing sources of risk and the estimated magnitude of risk.

PubMed

Aragonés, Juan Ignacio; Moyano, Emilio; Talayero, Fernando

2008-05-01

The social perception of risk is considered a multidimensional task, yet little attention has been paid to the cognitive components that organize sources of risk, despite their having been discovered in various research studies. This study attempts to concretely analyze the cultural dimension involved in those processes. In the first phase, we tried to discover to what extent sources of risk are organized into the same categories by people from different countries. In order to do so, two groups of participants were formed: 60 Spanish psychology students and 60 Chilean psychology students classified 43 sources of risk into different groups according to the criteria they found appropriate. The two samples classified risk into identical groups: acts of violence, drugs, electricity and home appliances, household chemicals, chemicals in the environment, public construction projects, transportation, sports, and natural disasters. In a second study, 100 Spanish and 84 Chilean students were asked to evaluate the magnitude of the damage incurred by 17 sources of risk. In both groups, it was observed that the evaluation of damage resulting from each source of risk was affected by its category.

Multi-Criteria Decision Making for a Spatial Decision Support System on the Analysis of Changing Risk

NASA Astrophysics Data System (ADS)

Olyazadeh, Roya; van Westen, Cees; Bakker, Wim H.; Aye, Zar Chi; Jaboyedoff, Michel; Derron, Marc-Henri

2014-05-01

Natural hazard risk management requires decision making in several stages. Decision making on alternatives for risk reduction planning starts with an intelligence phase for recognition of the decision problems and identifying the objectives. Development of the alternatives and assigning the variable by decision makers to each alternative are employed to the design phase. Final phase evaluates the optimal choice by comparing the alternatives, defining indicators, assigning a weight to each and ranking them. This process is referred to as Multi-Criteria Decision Making analysis (MCDM), Multi-Criteria Evaluation (MCE) or Multi-Criteria Analysis (MCA). In the framework of the ongoing 7th Framework Program "CHANGES" (2011-2014, Grant Agreement No. 263953) of the European Commission, a Spatial Decision Support System is under development, that has the aim to analyse changes in hydro-meteorological risk and provide support to selecting the best risk reduction alternative. This paper describes the module for Multi-Criteria Decision Making analysis (MCDM) that incorporates monetary and non-monetary criteria in the analysis of the optimal alternative. The MCDM module consists of several components. The first step is to define criteria (or Indicators) which are subdivided into disadvantages (criteria that indicate the difficulty for implementing the risk reduction strategy, also referred to as Costs) and advantages (criteria that indicate the favorability, also referred to as benefits). In the next step the stakeholders can use the developed web-based tool for prioritizing criteria and decision matrix. Public participation plays a role in decision making and this is also planned through the use of a mobile web-version where the general local public can indicate their agreement on the proposed alternatives. The application is being tested through a case study related to risk reduction of a mountainous valley in the Alps affected by flooding. Four alternatives are evaluated in this case study namely: construction of defense structures, relocation, implementation of an early warning system and spatial planning regulations. Some of the criteria are determined partly in other modules of the CHANGES SDSS, such as the costs for implementation, the risk reduction in monetary values, and societal risk. Other criteria, which could be environmental, economic, cultural, perception in nature, are defined by different stakeholders such as local authorities, expert organizations, private sector, and local public. In the next step, the stakeholders weight the importance of the criteria by pairwise comparison and visualize the decision matrix, which is a matrix based on criteria versus alternatives values. Finally alternatives are ranked by Analytic Hierarchy Process (AHP) method. We expect that this approach will help the decision makers to ease their works and reduce their costs, because the process is more transparent, more accurate and involves a group decision. In that way there will be more confidence in the overall decision making process. Keywords: MCDM, Analytic Hierarchy Process (AHP), SDSS, Natural Hazard Risk Management

Integrating public risk perception into formal natural hazard risk assessment

NASA Astrophysics Data System (ADS)

Plattner, Th.; Plapp, T.; Hebel, B.

2006-06-01

An urgent need to take perception into account for risk assessment has been pointed out by relevant literature, its impact in terms of risk-related behaviour by individuals is obvious. This study represents an effort to overcome the broadly discussed question of whether risk perception is quantifiable or not by proposing a still simple but applicable methodology. A novel approach is elaborated to obtain a more accurate and comprehensive quantification of risk in comparison to present formal risk evaluation practice. A consideration of relevant factors enables a explicit quantification of individual risk perception and evaluation. The model approach integrates the effective individual risk reff and a weighted mean of relevant perception affecting factors PAF. The relevant PAF cover voluntariness of risk-taking, individual reducibility of risk, knowledge and experience, endangerment, subjective damage rating and subjective recurrence frequency perception. The approach assigns an individual weight to each PAF to represent its impact magnitude. The quantification of these weights is target-group-dependent (e.g. experts, laypersons) and may be effected by psychometric methods. The novel approach is subject to a plausibility check using data from an expert-workshop. A first model application is conducted by means of data of an empirical risk perception study in Western Germany to deduce PAF and weight quantification as well as to confirm and evaluate model applicbility and flexibility. Main fields of application will be a quantification of risk perception by individual persons in a formal and technical way e.g. for the purpose of risk communication issues in illustrating differing perspectives of experts and non-experts. For decision making processes this model will have to be applied with caution, since it is by definition not designed to quantify risk acceptance or risk evaluation. The approach may well explain how risk perception differs, but not why it differs. The formal model generates only "snap shots" and considers neither the socio-cultural nor the historical context of risk perception, since it is a highly individualistic and non-contextual approach.

DE-CERTS: A Decision Support System for a Comparative Evaluation Method for Risk Management Methodologies and Tools

DTIC Science & Technology

1991-09-01

iv III. THE ANALYTIC HIERARCHY PROCESS ..... ........ 15 A. INTRODUCTION ...... ................. 15 B. THE AHP PROCESS ...... ................ 16 C...INTRODUCTION ...... ................. 26 B. IMPLEMENTATION OF CERTS USING AHP ........ .. 27 1. Consistency ...... ................ 29 2. User Interface...the proposed technique into a Decision Support System. Expert Choice implements the Analytic Hierarchy Process ( AHP ), an approach to multi- criteria

Observations on the Use of SCAN To Identify Children at Risk for Central Auditory Processing Disorder.

ERIC Educational Resources Information Center

Emerson, Maria F.; And Others

1997-01-01

The SCAN: A Screening Test for Auditory Processing Disorders was administered to 14 elementary children with a history of otitis media and 14 typical children, to evaluate the validity of the test in identifying children with central auditory processing disorder. Another experiment found that test results differed based on the testing environment…

Workflow for Criticality Assessment Applied in Biopharmaceutical Process Validation Stage 1.

PubMed

Zahel, Thomas; Marschall, Lukas; Abad, Sandra; Vasilieva, Elena; Maurer, Daniel; Mueller, Eric M; Murphy, Patrick; Natschläger, Thomas; Brocard, Cécile; Reinisch, Daniela; Sagmeister, Patrick; Herwig, Christoph

2017-10-12

Identification of critical process parameters that impact product quality is a central task during regulatory requested process validation. Commonly, this is done via design of experiments and identification of parameters significantly impacting product quality (rejection of the null hypothesis that the effect equals 0). However, parameters which show a large uncertainty and might result in an undesirable product quality limit critical to the product, may be missed. This might occur during the evaluation of experiments since residual/un-modelled variance in the experiments is larger than expected a priori. Estimation of such a risk is the task of the presented novel retrospective power analysis permutation test. This is evaluated using a data set for two unit operations established during characterization of a biopharmaceutical process in industry. The results show that, for one unit operation, the observed variance in the experiments is much larger than expected a priori, resulting in low power levels for all non-significant parameters. Moreover, we present a workflow of how to mitigate the risk associated with overlooked parameter effects. This enables a statistically sound identification of critical process parameters. The developed workflow will substantially support industry in delivering constant product quality, reduce process variance and increase patient safety.

Emotional reactions to alcohol-related words: Differences between low- and high-risk drinkers.

PubMed

Gantiva, Carlos; Delgado, Rafael; Romo-González, Tania

2015-11-01

Research that has examined responses to alcohol-related words in drinkers has mostly linked such responses to memory, attentional, and perceptual bias. However, studies of emotional processing in alcoholics have not received much attention. The main goal of the present study was to identify the features and differences of emotional responses to alcohol-related words in low- and high-risk drinkers. A total of 149 low-risk drinkers and 125 high-risk drinkers evaluated five alcohol-related words and 15 words from the Affective Norms for English Words in the dimensions of valence, arousal, and dominance using the Self-Assessment Manikin. The results indicated that high-risk drinkers evaluated alcohol-related words as more appetitive and arousing. These results, together with findings in the attention and memory research literature, suggest that alcohol-related words can serve as conditioned cues in alcohol consumption. Copyright © 2015 Elsevier Ltd. All rights reserved.

Participatory ergonomics: co-developing interventions to reduce the risk of musculoskeletal symptoms in business drivers.

PubMed

Gyi, Diane; Sang, Katherine; Haslam, Cheryl

2013-01-01

The participatory process within four case study organisations with a target population of high mileage business drivers is described. The aim was to work with drivers and their managers to co-develop intervention activities to raise awareness of musculoskeletal health in drivers, including use of the car as a mobile office and manual handling from the car. Train-the-trainer sessions were delivered in each organisation, along with the co-production of training materials. The effectiveness of these activities were evaluated using three sources of data: post-intervention questionnaires, interviews with organisation 'champions' and observations from the research team's diaries. The approach raised management awareness of the risks to drivers and was successful in affecting change, and as such, participatory research should consider the early stages of a project as part of any intervention activities. The research team also reflect on conducting applied longitudinal research in the field. Raising awareness of the risks of musculoskeletal disorders in drivers who work from their vehicle is important. This paper reflects on research in the field and provides guidance on the participatory process and evaluating intervention activities. The participatory process was successful in affecting change at management level.

Evaluation of wholesale electric power market rules and financial risk management by agent-based simulations

NASA Astrophysics Data System (ADS)

Yu, Nanpeng

As U.S. regional electricity markets continue to refine their market structures, designs and rules of operation in various ways, two critical issues are emerging. First, although much experience has been gained and costly and valuable lessons have been learned, there is still a lack of a systematic platform for evaluation of the impact of a new market design from both engineering and economic points of view. Second, the transition from a monopoly paradigm characterized by a guaranteed rate of return to a competitive market created various unfamiliar financial risks for various market participants, especially for the Investor Owned Utilities (IOUs) and Independent Power Producers (IPPs). This dissertation uses agent-based simulation methods to tackle the market rules evaluation and financial risk management problems. The California energy crisis in 2000-01 showed what could happen to an electricity market if it did not go through a comprehensive and rigorous testing before its implementation. Due to the complexity of the market structure, strategic interaction between the participants, and the underlying physics, it is difficult to fully evaluate the implications of potential changes to market rules. This dissertation presents a flexible and integrative method to assess market designs through agent-based simulations. Realistic simulation scenarios on a 225-bus system are constructed for evaluation of the proposed PJM-like market power mitigation rules of the California electricity market. Simulation results show that in the absence of market power mitigation, generation company (GenCo) agents facilitated by Q-learning are able to exploit the market flaws and make significantly higher profits relative to the competitive benchmark. The incorporation of PJM-like local market power mitigation rules is shown to be effective in suppressing the exercise of market power. The importance of financial risk management is exemplified by the recent financial crisis. In this dissertation, basic financial risk management concepts relevant for wholesale electric power markets are carefully explained and illustrated. In addition, the financial risk management problem in wholesale electric power markets is generalized as a four-stage process. Within the proposed financial risk management framework, the critical problem of financial bilateral contract negotiation is addressed. This dissertation analyzes a financial bilateral contract negotiation process between a generating company and a load-serving entity in a wholesale electric power market with congestion managed by locational marginal pricing. Nash bargaining theory is used to model a Pareto-efficient settlement point. The model predicts negotiation results under varied conditions and identifies circumstances in which the two parties might fail to reach an agreement. Both analysis and agent-based simulation are used to gain insight regarding how relative risk aversion and biased price estimates influence negotiated outcomes. These results should provide useful guidance to market participants in their bilateral contract negotiation processes.

An Educational Implementation Process Staff Survey: Lessons Learned.

PubMed

Delmore, Barbara; Kent, Martha

2018-05-01

To evaluate the education process for the effective use of the Munro Pressure Ulcer Risk Assessment Scale by practicing perioperative staff at an urban tertiary medical center. Given that pressure injury formation is tied to the surgical process, there is a need for a pressure injury risk assessment scale that addresses the uniqueness of the perioperative process. Participants were staff who worked in the surgical admissions area, the main operating room, and the main postanesthesia care unit. The authors' facility was 1 of 8 participants in a multisite study. Each site was required to educate staff using standard written instructions and an instructional webinar. However, sites were also encouraged to consider any other methods that would successfully engage the staff in the learning process. After the education process, staff were surveyed and asked to evaluate the educational interventions. Findings indicated that the staff did not prefer written instructions alone but rather preferred a combination of different learning modalities and media to assist them in using the Munro Scale effectively. This article discusses the strategies required to engage staff in the implementation process of this scale, the barriers encountered during this implementation, and the implications for perioperative nursing using this scale. The lessons learned from conducting this research provided insight into engaging and educating the adult learner in a new process.

The German clinical risk management survey for hospitals: Implementation levels and areas for improvement in 2015.

PubMed

Manser, Tanja; Frings, Janina; Heuser, Gregory; Mc Dermott, Fiona

2016-01-01

Despite the growing recognition of the need to implement systematic approaches for managing the risks associated with healthcare, few studies have investigated the level of implementation for clinical risk management (CRM) at a national level. Therefore, this study aimed to assess the current level of CRM implementation in German hospitals and to explore differences across hospital types. From March to June 2015, persons responsible for CRM in 2,617 hospitals and rehabilitation clinics in Germany were invited to participate in a voluntary online survey assessing the level of implementation for various aspects of CRM: CRM strategy, structures and processes; risk assessment (risk identification, risk analysis, risk evaluation) with a focus on incident reporting systems; risk mitigation measures; and risk monitoring and reporting. 572 hospitals participated in the survey (response rate 22 %). Most of these hospitals had a formalised, binding CRM strategy (72 %). 66 % had a centralised and 34 % a decentralised CRM structure. We also found that, despite a broad range of risk assessment methods being applied, there was a lack of integration of risk information from different data sources. Hospitals also reported a high level of implementation of critical incident reporting systems with a strong preference for local (74 %) over transorganisational systems. This study provides relevant data to inform targeted interventions concerning CRM implementation at a national level and to consider the specific context of different types of hospitals more carefully in this process. The approach to CRM assessment illustrated in this article could be the basis of a system for monitoring CRM over time and, thus, for evaluating the impact of strategy decisions at the policy level on CRM development. Copyright © 2016. Published by Elsevier GmbH.

Summary of evidence-based guideline update: Evaluation and management of concussion in sports

PubMed Central

Giza, Christopher C.; Kutcher, Jeffrey S.; Ashwal, Stephen; Barth, Jeffrey; Getchius, Thomas S.D.; Gioia, Gerard A.; Gronseth, Gary S.; Guskiewicz, Kevin; Mandel, Steven; Manley, Geoffrey; McKeag, Douglas B.; Thurman, David J.; Zafonte, Ross

2013-01-01

Objective: To update the 1997 American Academy of Neurology (AAN) practice parameter regarding sports concussion, focusing on 4 questions: 1) What factors increase/decrease concussion risk? 2) What diagnostic tools identify those with concussion and those at increased risk for severe/prolonged early impairments, neurologic catastrophe, or chronic neurobehavioral impairment? 3) What clinical factors identify those at increased risk for severe/prolonged early postconcussion impairments, neurologic catastrophe, recurrent concussions, or chronic neurobehavioral impairment? 4) What interventions enhance recovery, reduce recurrent concussion risk, or diminish long-term sequelae? The complete guideline on which this summary is based is available as an online data supplement to this article. Methods: We systematically reviewed the literature from 1955 to June 2012 for pertinent evidence. We assessed evidence for quality and synthesized into conclusions using a modified Grading of Recommendations Assessment, Development and Evaluation process. We used a modified Delphi process to develop recommendations. Results: Specific risk factors can increase or decrease concussion risk. Diagnostic tools to help identify individuals with concussion include graded symptom checklists, the Standardized Assessment of Concussion, neuropsychological assessments, and the Balance Error Scoring System. Ongoing clinical symptoms, concussion history, and younger age identify those at risk for postconcussion impairments. Risk factors for recurrent concussion include history of multiple concussions, particularly within 10 days after initial concussion. Risk factors for chronic neurobehavioral impairment include concussion exposure and APOE ε4 genotype. Data are insufficient to show that any intervention enhances recovery or diminishes long-term sequelae postconcussion. Practice recommendations are presented for preparticipation counseling, management of suspected concussion, and management of diagnosed concussion. PMID:23508730

Investigations regarding the evaluation of specific intellectual property production risks within Quality Management System

NASA Astrophysics Data System (ADS)

Pakocs, R.; Lupulescu, N. B.

2016-11-01

This paper is a theoretical research concerning methods for risk assessment of specific intellectual property production risks that are identified in the product achievement stage within the Quality Management System. In order to realize this, we will start by identifying the specific intellectual property production risks and by proposing some new calculating formulas for minimalizing their negative effects. The theoretical model proposed assessment of specific intellectual property production risks, will be realized based on 3 hypothetical situations. This study intends to reduce the intellectual property risks identified in the production process of commercial societies that have an industrial profile.

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process.

PubMed

Kothari, Bhaveshkumar H; Fahmy, Raafat; Claycamp, H Gregg; Moore, Christine M V; Chatterjee, Sharmista; Hoag, Stephen W

2017-05-01

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.

Exposure to major volatile organic compounds and carbonyls in European indoor environments and associated health risk.

PubMed

Sarigiannis, Dimosthenis A; Karakitsios, Spyros P; Gotti, Alberto; Liakos, Ioannis L; Katsoyiannis, Athanasios

2011-05-01

This paper summarizes recent data on the occurrence of major organic compounds (benzene, toluene, xylenes, styrene, acetaldehyde, formaldehyde, naphthalene, limonene, α-pinene and ammonia, classified by the European Commission's INDEX strategy report as the priority pollutants to be regulated) and evaluates accordingly cancer and non-cancer risks posed by indoor exposure in dwellings and public buildings in European Union (EU) countries. The review process indicated that significant differences in indoor air quality exist within and among the countries where data were available, indicating corresponding differences in sources and emission strength of airborne chemicals, identified or not. Conservative exposure limits were not exceeded for non-carcinogenic effects, except for formaldehyde; for carcinogenic agents the estimated risks were up to three orders of magnitude higher than the one (10(-6)) proposed as acceptable by risk management bodies. However, the risk assessment evaluation process faces crucial difficulties, either due to the relative paucity of indoor air quality measurements in many EU countries, or by the lack of sampling consistency in the already existing studies, indicating the need for additional measurements of indoor air quality following a harmonized sampling and analytical protocol. Additionally, uncertainties embodied in the cancer potency factors and exposure limit values impose further difficulties in substance prioritization and risk management. Copyright © 2011 Elsevier Ltd. All rights reserved.

Establishing a proactive safety and health risk management system in the fire service.

PubMed

Poplin, Gerald S; Pollack, Keshia M; Griffin, Stephanie; Day-Nash, Virginia; Peate, Wayne F; Nied, Ed; Gulotta, John; Burgess, Jefferey L

2015-04-19

Formalized risk management (RM) is an internationally accepted process for reducing hazards in the workplace, with defined steps including hazard scoping, risk assessment, and implementation of controls, all within an iterative process. While required for all industry in the European Union and widely used elsewhere, the United States maintains a compliance-based regulatory structure, rather than one based on systematic, risk-based methodologies. Firefighting is a hazardous profession, with high injury, illness, and fatality rates compared with other occupations, and implementation of RM programs has the potential to greatly improve firefighter safety and health; however, no descriptions of RM implementation are in the peer-reviewed literature for the North American fire service. In this paper we describe the steps used to design and implement the RM process in a moderately-sized fire department, with particular focus on prioritizing and managing injury hazards during patient transport, fireground, and physical exercise procedures. Hazard scoping and formalized risk assessments are described, in addition to the identification of participatory-led injury control strategies. Process evaluation methods were conducted to primarily assess the feasibility of voluntarily instituting the RM approach within the fire service setting. The RM process was well accepted by the fire department and led to development of 45 hazard specific-interventions. Qualitative data documenting the implementation of the RM process revealed that participants emphasized the: value of the RM process, especially the participatory bottom-up approach; usefulness of the RM process for breaking down tasks to identify potential risks; and potential of RM for reducing firefighter injury. As implemented, this risk-based approach used to identify and manage occupational hazards and risks was successful and is deemed feasible for U.S. (and other) fire services. While several barriers and challenges do exist in the implementation of any intervention such as this, recommendations for adopting the process are provided. Additional work will be performed to determine the effectiveness of select controls strategies that were implemented; however participants throughout the organizational structure perceived the RM process to be of high utility while researchers also found the process improved the awareness and engagement in actively enhancing worker safety and health.

Development and preliminary validation of an index for indicating the risks of the design of working hours to health and wellbeing.

PubMed

Schomann, Carsten; Giebel, Ole; Nachreiner, Friedhelm

2006-01-01

BASS 4, a computer program for the design and evaluation of workings hours, is an example of an ergonomics-based software tool that can be used by safety practitioners at the shop floor with regard to legal, ergonomic, and economic criteria. Based on experiences with this computer program, a less sophisticated Working-Hours-Risk Index for assessing the quality of work schedules (including flexible work hours) to indicate risks to health and wellbeing has been developed to provide a quick and easy applicable tool for legally required risk assessments. The results of a validation study show that this risk index seems to be a promising indicator for predicting risks of health complaints and wellbeing. The purpose of the Risk Index is to simplify the evaluation process at the shop floor and provide some more general information about the quality of a work schedule that can be used for triggering preventive interventions. Such a risk index complies with practitioners' expectations and requests for easy, useful, and valid instruments.

Clinical evaluation of a new pressure ulcer risk assessment instrument, the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE T).

PubMed

Coleman, Susanne; Smith, Isabelle L; McGinnis, Elizabeth; Keen, Justin; Muir, Delia; Wilson, Lyn; Stubbs, Nikki; Dealey, Carol; Brown, Sarah; Nelson, E Andrea; Nixon, Jane

2018-02-01

To test the psychometric properties and clinical usability of a new Pressure Ulcer Risk Assessment Instrument including inter-rater and test-retest reliability, convergent validity and data completeness. Methodological and practical limitations associated with traditional Pressure Ulcer Risk Assessment Instruments, prompted a programme to work to develop a new instrument, as part of the National Institute for Health Research funded, Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056). Observational field test. For this clinical evaluation 230 patients were purposefully sampled across four broad levels of pressure ulcer risk with representation from four secondary care and four community NHS Trusts in England. Blinded and simultaneous paired (ward/community nurse and expert nurse) PURPOSE-T assessments were undertaken. Follow-up retest was undertaken by the expert nurse. Field notes of PURPOSE-T use were collected. Data were collected October 2012-January 2013. The clinical evaluation demonstrated "very good" (kappa) inter-rater and test-retest agreement for PURPOSE-T assessment decision overall. The percentage agreement for "problem/no problem" was over 75% for the main risk factors. Convergent validity demonstrated moderate to high associations with other measures of similar constructs. The PURPOSE-T evaluation facilitated the initial validation and clinical usability of the instrument and demonstrated that PURPOSE-T is suitable of use in clinical practice. Further study is needed to evaluate the impact of using the instrument on care processes and outcomes. © 2017 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

Framework for Optimizing the Evaluation of Data From Contaminated Soil in Sweden

EPA Science Inventory

The Swedish guidelines for the evaluation of data for the purpose of a risk assessment at contaminated sites are of a qualitative character, as opposed to the USEPA’s Data Quality Objective Process. In Sweden, this can sometimes be a problem because the demands on data quality ar...

Advanced Booster Composite Case/Polybenzimidazole Nitrile Butadiene Rubber Insulation Development

NASA Technical Reports Server (NTRS)

Gentz, Steve; Taylor, Robert; Nettles, Mindy

2015-01-01

The NASA Engineering and Safety Center (NESC) was requested to examine processing sensitivities (e.g., cure temperature control/variance, debonds, density variations) of polybenzimidazole nitrile butadiene rubber (PBI-NBR) insulation, case fiber, and resin systems and to evaluate nondestructive evaluation (NDE) and damage tolerance methods/models required to support human-rated composite motor cases. The proposed use of composite motor cases in Blocks IA and II was expected to increase performance capability through optimizing operating pressure and increasing propellant mass fraction. This assessment was to support the evaluation of risk reduction for large booster component development/fabrication, NDE of low mass-to-strength ratio material structures, and solid booster propellant formulation as requested in the Space Launch System NASA Research Announcement for Advanced Booster Engineering Demonstration and/or Risk Reduction. Composite case materials and high-energy propellants represent an enabling capability in the Agency's ability to provide affordable, high-performing advanced booster concepts. The NESC team was requested to provide an assessment of co- and multiple-cure processing of composite case and PBI-NBR insulation materials and evaluation of high-energy propellant formulations.

Systematic review of HIV prevention interventions in China: a health communication perspective.

PubMed

Xiao, Zhiwen; Noar, Seth M; Zeng, Lily

2014-02-01

To examine whether communication strategies and principles have been utilized in the HIV prevention intervention programs conducted in China. Comprehensive literature searches were conducted using PsycINFO, Medline, and Academic Search Complete with combinations of a number of keywords. Studies were included if they (1) were conducted in China and published prior to October 2011; (2) tested interventions promoting HIV/sexual risk reduction; and (3) reported empirical outcome evaluations on HIV knowledge, condom use and other condom-related variables. Data on 11 dimensions were extracted and analyzed, including formative research, theory, message targeting, messenger and channels, process evaluation, evaluation design, outcome measures. The majority of the 45 intervention studies were not theory-based, did not report conducting formative research or process evaluation, used pretest-posttest control group designs, combined nonmedia channels, printed and visual materials, and employed HIV knowledge and condom use as outcome measures. Many HIV prevention interventions in China have been successful in reducing HIV risk-related outcomes. This literature has its weaknesses; however, the current review illuminates gaps in the literature and points to important future directions for research.

The safer clinical systems project in renal care.

PubMed

Weale, Andy R

2013-09-01

Current systems in place in healthcare are designed to detect harm after it has happened (e.g critical incident reports) and make recommendations based on an assessment of that event. Safer Clinical Systems, a Health Foundation funded project, is designed to proactively search for risk within systems, rather than being reactive to harm. The aim of the Safer Clinical Systems project in Renal Care was to reduce the risks associated with shared care for patients who are undergoing surgery but are looked after peri-operatively by nephrology teams on nephrology wards. This report details our findings of the diagnostic phase of Safer Clinical Systems: the proactive search for risk. We have evaluated the current system of care using a set of risk evaluation and process mapping tools (Failure Modes and Effects Analysis (FMEA) and Hierarchical Task Analysis HTA). We have engaged staff with the process mapping and risk assessment tools. We now understand our system and understand where the highest risk tasks are undertaken during a renal in-patient stay during which a patient has an operation. These key tasks occur across the perioperaive period and are not confined to one aspect of care. A measurement strategy and intervention plan have been designed around these tasks. Safer Clinical Systems has identified high risk, low reliability tasks in our system. We look forward to fully reporting these data in 2014. © 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Windstorm damage in Boundary Waters Canoe Area Wilderness (Minnesota, USA): Evaluating landscape-level risk factors

Treesearch

W. Keith Moser; Mark D. Nelson

2009-01-01

Ecosystem management requires an understanding of disturbance processes and their influence on forests. One of these disturbances is damage due to severe wind events. In an ideal model, assessing risk of windstorm damage to a forested ecosystem entails defining tree-, stand-, and landscape-level factors that influence response and recovery. Data are not always...

Quantitative assessment of building fire risk to life safety.

PubMed

Guanquan, Chu; Jinhua, Sun

2008-06-01

This article presents a quantitative risk assessment framework for evaluating fire risk to life safety. Fire risk is divided into two parts: probability and corresponding consequence of every fire scenario. The time-dependent event tree technique is used to analyze probable fire scenarios based on the effect of fire protection systems on fire spread and smoke movement. To obtain the variation of occurrence probability with time, Markov chain is combined with a time-dependent event tree for stochastic analysis on the occurrence probability of fire scenarios. To obtain consequences of every fire scenario, some uncertainties are considered in the risk analysis process. When calculating the onset time to untenable conditions, a range of fires are designed based on different fire growth rates, after which uncertainty of onset time to untenable conditions can be characterized by probability distribution. When calculating occupant evacuation time, occupant premovement time is considered as a probability distribution. Consequences of a fire scenario can be evaluated according to probability distribution of evacuation time and onset time of untenable conditions. Then, fire risk to life safety can be evaluated based on occurrence probability and consequences of every fire scenario. To express the risk assessment method in detail, a commercial building is presented as a case study. A discussion compares the assessment result of the case study with fire statistics.

A quantitative risk assessment model to evaluate effective border control measures for rabies prevention.

PubMed

Weng, Hsin-Yi; Wu, Pei-I; Yang, Ping-Cheng; Tsai, Yi-Lun; Chang, Chao-Chin

2010-01-01

Border control is the primary method to prevent rabies emergence. This study developed a quantitative risk model incorporating stochastic processes to evaluate whether border control measures could efficiently prevent rabies introduction through importation of cats and dogs using Taiwan as an example. Both legal importation and illegal smuggling were investigated. The impacts of reduced quarantine and/or waiting period on the risk of rabies introduction were also evaluated. The results showed that Taiwan's current animal importation policy could effectively prevent rabies introduction through legal importation of cats and dogs. The median risk of a rabid animal to penetrate current border control measures and enter Taiwan was 5.33 x 10(-8) (95th percentile: 3.20 x 10(-7)). However, illegal smuggling may pose Taiwan to the great risk of rabies emergence. Reduction of quarantine and/or waiting period would affect the risk differently, depending on the applied assumptions, such as increased vaccination coverage, enforced custom checking, and/or change in number of legal importations. Although the changes in the estimated risk under the assumed alternatives were not substantial except for completely abolishing quarantine, the consequences of rabies introduction may yet be considered to be significant in a rabies-free area. Therefore, a comprehensive benefit-cost analysis needs to be conducted before recommending these alternative measures.

Empirical evaluation of sufficient similarity in dose-response for environmental risk assessment of a mixture of 11 pyrethroids.

EPA Science Inventory

Chemical mixtures in the environment are often the result of a dynamic process. When dose-response data are available on random samples throughout the process, equivalence testing can be used to determine whether the mixtures are sufficiently similar based on a pre-specified biol...

Integrating human and ecological risk assessment: application to the cyanobacterial harmful algal bloom problem.

PubMed

Orme-Zavaleta, Jennifer; Munns, Wayne R

2008-01-01

Environmental and public health policy continues to evolve in response to new and complex social, economic and environmental drivers. Globalization and centralization of commerce, evolving patterns of land use (e.g., urbanization, deforestation), and technological advances in such areas as manufacturing and development of genetically modified foods have created new and complex classes of stressors and risks (e.g., climate change, emergent and opportunist disease, sprawl, genomic change). In recognition of these changes, environmental risk assessment and its use are changing from stressor-endpoint specific assessments used in command and control types of decisions to an integrated approach for application in community-based decisions. As a result, the process of risk assessment and supporting risk analyses are evolving to characterize the human-environment relationship. Integrating risk paradigms combine the process of risk estimation for humans, biota, and natural resources into one assessment to improve the information used in environmental decisions (Suter et al. 2003b). A benefit to this approach includes a broader, system-wide evaluation that considers the interacting effects of stressors on humans and the environment, as well the interactions between these entities. To improve our understanding of the linkages within complex systems, risk assessors will need to rely on a suite of techniques for conducting rigorous analyses characterizing the exposure and effects relationships between stressors and biological receptors. Many of the analytical techniques routinely employed are narrowly focused and unable to address the complexities of an integrated assessment. In this paper, we describe an approach to integrated risk assessment, and discuss qualitative community modeling and Probabilistic Relational Modeling techniques that address these limitations and evaluate their potential for use in an integrated risk assessment of cyanobacteria.

Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

PubMed

Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

2013-12-01

Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %).

Decision Making Under Objective Risk Conditions-a Review of Cognitive and Emotional Correlates, Strategies, Feedback Processing, and External Influences.

PubMed

Schiebener, Johannes; Brand, Matthias

2015-06-01

While making decisions under objective risk conditions, the probabilities of the consequences of the available options are either provided or calculable. Brand et al. (Neural Networks 19:1266-1276, 2006) introduced a model describing the neuro-cognitive processes involved in such decisions. In this model, executive functions associated with activity in the fronto-striatal loop are important for developing and applying decision-making strategies, and for verifying, adapting, or revising strategies according to feedback. Emotional rewards and punishments learned from such feedback accompany these processes. In this literature review, we found support for the role of executive functions, but also found evidence for the importance of further cognitive abilities in decision making. Moreover, in addition to reflective processing (driven by cognition), decisions can be guided by impulsive processing (driven by anticipation of emotional reward and punishment). Reflective and impulsive processing may interact during decision making, affecting the evaluation of available options, as both processes are affected by feedback. Decision-making processes are furthermore modulated by individual attributes (e.g., age), and external influences (e.g., stressors). Accordingly, we suggest a revised model of decision making under objective risk conditions.

Drug interactions evaluation: An integrated part of risk assessment of therapeutics

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

Zhang, Lei; Reynolds, Kellie S.; Zhao, Ping

2010-03-01

Pharmacokinetic drug interactions can lead to serious adverse events or decreased drug efficacy. The evaluation of a new molecular entity's (NME's) drug-drug interaction potential is an integral part of risk assessment during drug development and regulatory review. Alteration of activities of enzymes or transporters involved in the absorption, distribution, metabolism, or excretion of a new molecular entity by concomitant drugs may alter drug exposure, which can impact response (safety or efficacy). The recent Food and Drug Administration (FDA) draft drug interaction guidance ( (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf)) highlights the methodologies and criteria that may be used to guide drug interaction evaluation by industrymore » and regulatory agencies and to construct informative labeling for health practitioner and patients. In addition, the Food and Drug Administration established a 'Drug Development and Drug Interactions' website to provide up-to-date information regarding evaluation of drug interactions ( (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm080499.htm)). This review summarizes key elements in the FDA drug interaction guidance and new scientific developments that can guide the evaluation of drug-drug interactions during the drug development process.« less

Real-Time Optimal Flood Control Decision Making and Risk Propagation Under Multiple Uncertainties

NASA Astrophysics Data System (ADS)

Zhu, Feilin; Zhong, Ping-An; Sun, Yimeng; Yeh, William W.-G.

2017-12-01

Multiple uncertainties exist in the optimal flood control decision-making process, presenting risks involving flood control decisions. This paper defines the main steps in optimal flood control decision making that constitute the Forecast-Optimization-Decision Making (FODM) chain. We propose a framework for supporting optimal flood control decision making under multiple uncertainties and evaluate risk propagation along the FODM chain from a holistic perspective. To deal with uncertainties, we employ stochastic models at each link of the FODM chain. We generate synthetic ensemble flood forecasts via the martingale model of forecast evolution. We then establish a multiobjective stochastic programming with recourse model for optimal flood control operation. The Pareto front under uncertainty is derived via the constraint method coupled with a two-step process. We propose a novel SMAA-TOPSIS model for stochastic multicriteria decision making. Then we propose the risk assessment model, the risk of decision-making errors and rank uncertainty degree to quantify the risk propagation process along the FODM chain. We conduct numerical experiments to investigate the effects of flood forecast uncertainty on optimal flood control decision making and risk propagation. We apply the proposed methodology to a flood control system in the Daduhe River basin in China. The results indicate that the proposed method can provide valuable risk information in each link of the FODM chain and enable risk-informed decisions with higher reliability.

Risk-based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses.

PubMed

Qiu, Jinshu; Li, Kim; Miller, Karen; Raghani, Anil

2015-01-01

The purpose of this article is to recommend a risk-based strategy for determining clearance testing requirements of the process reagents used in manufacturing biopharmaceutical products. The strategy takes account of four risk factors. Firstly, the process reagents are classified into two categories according to their safety profile and history of use: generally recognized as safe (GRAS) and potential safety concern (PSC) reagents. The clearance testing of GRAS reagents can be eliminated because of their safe use historically and process capability to remove these reagents. An estimated safety margin (Se) value, a ratio of the exposure limit to the estimated maximum reagent amount, is then used to evaluate the necessity for testing the PSC reagents at an early development stage. The Se value is calculated from two risk factors, the starting PSC reagent amount per maximum product dose (Me), and the exposure limit (Le). A worst-case scenario is assumed to estimate the Me value, that is common. The PSC reagent of interest is co-purified with the product and no clearance occurs throughout the entire purification process. No clearance testing is required for this PSC reagent if its Se value is ≥1; otherwise clearance testing is needed. Finally, the point of the process reagent introduction to the process is also considered in determining the necessity of the clearance testing for process reagents. How to use the measured safety margin as a criterion for determining PSC reagent testing at process characterization, process validation, and commercial production stages are also described. A large number of process reagents are used in the biopharmaceutical manufacturing to control the process performance. Clearance testing for all of the process reagents will be an enormous analytical task. In this article, a risk-based strategy is described to eliminate unnecessary clearance testing for majority of the process reagents using four risk factors. The risk factors included in the strategy are (i) safety profile of the reagents, (ii) the starting amount of the process reagents used in the manufacturing process, (iii) the maximum dose of the product, and (iv) the point of introduction of the process reagents in the process. The implementation of the risk-based strategy can eliminate clearance testing for approximately 90% of the process reagents used in the manufacturing processes. This science-based strategy allows us to ensure patient safety and meet regulatory agency expectations throughout the product development life cycle. © PDA, Inc. 2015.

Mapping mass movement processes using terrestrial LIDAR: a swift mechanism for hazard and disaster risk assessment

NASA Astrophysics Data System (ADS)

Garnica-Peña, Ricardo; Murillo-García, Franny; Alcántara-Ayala, Irasema

2014-05-01

The impact of disasters associated with mass movement processes has increased in the past decades. Either triggered by earthquakes, volcanic activity or rainfall, mass movement processes have affected people, infrastructure, economic activities and the environment in different parts of the world. Extensive damage is particularly linked to rainfall induced landslides due to the occurrence of tropical storms, hurricanes, and the combination of different meteorological phenomenon on exposed vulnerable communities. Therefore, landslide susceptibility analysis, hazard and risk assessments are considered as significant mechanisms to lessen the impact of disasters. Ideally, these procedures ought to be carried out before disasters take place. However, under intense or persistent periods of rainfall, the evaluation of potentially unstable slopes becomes a critical issue. Such evaluations are constrained by the availability of resources, capabilities and scientific and technological tools. Among them, remote sensing has proved to be a valuable tool to evaluate areas affected by mass movement processes during the post-disaster stage. Nonetheless, the high cost of imagery acquisition inhibits their wide use. High resolution topography field surveys consequently, turn out to be an essential approach to address landslide evaluation needs. In this work, we present the evaluation and mapping of a series of mass movement processes induced by hurricane Ingrid in September, 2013, in Teziutlán, Puebla, México, a municipality situated 265 km Northeast of Mexico City. Geologically, Teziutlán is characterised by the presence, in the North, of siltstones and conglomerates of the Middle Jurassic, whereas the central and Southern sectors consist of volcanic deposits of various types: andesitic tuffs of Tertiary age, and basalts, rhyolitic tuffs and ignimbrites from the Quaternary. Major relief structures are formed by the accumulation of volcanic material; lava domes, partially buried volcanic cones, and slopes of pyroclastic deposits. Additionally, there are mountains and elevations of metamorphic and intrusive origin. The predominant hillslope materials in Teziutlán are poorly consolidated pyroclastic flows that favour rapid water saturation and enhance slope instability. Rainfall induced landslides in this region are not uncommon. Their consequences were particularly severe in the years 1999, 2005 and 2013. Rainfall derived from hurricane Ingrid in September, 2013, triggered 41 landslides on populated areas of Teziutlán, and involved 3 human losses and the evacuation of 139 people. Reoccurrence of landsliding in this area, where vulnerability levels of communities is high, certainly implies the need of establishing strategies for disaster risk reduction, among which, the use of terrestrial LIDAR can be regarded as a swift mechanism for landslide susceptibility, hazard and disaster risk assessments.

Urinary lithogenesis risk tests: comparison of a commercial kit and a laboratory prototype test.

PubMed

Grases, Félix; Costa-Bauzá, Antonia; Prieto, Rafel M; Arrabal, Miguel; De Haro, Tomás; Lancina, Juan A; Barbuzano, Carmen; Colom, Sergi; Riera, Joaquín; Perelló, Joan; Isern, Bernat; Sanchis, Pilar; Conte, Antonio; Barragan, Fernando; Gomila, Isabel

2011-11-01

Renal stone formation is a multifactorial process depending in part on urine composition. Other parameters relate to structural or pathological features of the kidney. To date, routine laboratory estimation of urolithiasis risk has been based on determination of urinary composition. This process requires collection of at least two 24 h urine samples, which is tedious for patients. The most important feature of urinary lithogenic risk is the balance between various urinary parameters, although unknown factors may be involved. The objective of this study was to compare data obtained using a commercial kit with those of a laboratory prototype, using a multicentre approach, to validate the utility of these methods in routine clinical practice. A simple new commercial test (NefroPlus®; Sarstedt AG & Co., Nümbrecht, Germany) evaluating the capacity of urine to crystallize calcium salts, and thus permitting detection of patients at risk for stone development, was compared with a prototype test previously described by this group. Urine of 64 volunteers produced during the night was used in these comparisons. The commercial test was also used to evaluate urine samples of 83 subjects in one of three hospitals. Both methods were essentially in complete agreement (98%) with respect to test results. The multicentre data were: sensitivity 94.7%; specificity 76.9%; positive predictive value (lithogenic urine) 90.0%; negative predictive value (non-lithogenic urine) 87.0%; test efficacy 89.2%. The new commercial NefroPlus test offers fast and cheap evaluation of the overall risk of development of urinary calcium-containing calculi.

Adapting existing natural language processing resources for cardiovascular risk factors identification in clinical notes.

PubMed

Khalifa, Abdulrahman; Meystre, Stéphane

2015-12-01

The 2014 i2b2 natural language processing shared task focused on identifying cardiovascular risk factors such as high blood pressure, high cholesterol levels, obesity and smoking status among other factors found in health records of diabetic patients. In addition, the task involved detecting medications, and time information associated with the extracted data. This paper presents the development and evaluation of a natural language processing (NLP) application conceived for this i2b2 shared task. For increased efficiency, the application main components were adapted from two existing NLP tools implemented in the Apache UIMA framework: Textractor (for dictionary-based lookup) and cTAKES (for preprocessing and smoking status detection). The application achieved a final (micro-averaged) F1-measure of 87.5% on the final evaluation test set. Our attempt was mostly based on existing tools adapted with minimal changes and allowed for satisfying performance with limited development efforts. Copyright © 2015 Elsevier Inc. All rights reserved.

Validating and determining the weight of items used for evaluating clinical governance implementation based on analytic hierarchy process model.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Vafaee Najar, Ali; Meraji, Marziye; Ebrahimipour, Hossein

2015-04-08

The purpose of implementing a system such as Clinical Governance (CG) is to integrate, establish and globalize distinct policies in order to improve quality through increasing professional knowledge and the accountability of healthcare professional toward providing clinical excellence. Since CG is related to change, and change requires money and time, CG implementation has to be focused on priority areas that are in more dire need of change. The purpose of the present study was to validate and determine the significance of items used for evaluating CG implementation. The present study was descriptive-quantitative in method and design. Items used for evaluating CG implementation were first validated by the Delphi method and then compared with one another and ranked based on the Analytical Hierarchy Process (AHP) model. The items that were validated for evaluating CG implementation in Iran include performance evaluation, training and development, personnel motivation, clinical audit, clinical effectiveness, risk management, resource allocation, policies and strategies, external audit, information system management, research and development, CG structure, implementation prerequisites, the management of patients' non-medical needs, complaints and patients' participation in the treatment process. The most important items based on their degree of significance were training and development, performance evaluation, and risk management. The least important items included the management of patients' non-medical needs, patients' participation in the treatment process and research and development. The fundamental requirements of CG implementation included having an effective policy at national level, avoiding perfectionism, using the expertise and potentials of the entire country and the coordination of this model with other models of quality improvement such as accreditation and patient safety. © 2015 by Kerman University of Medical Sciences.

ePORT, NASA's Computer Database Program for System Safety Risk Management Oversight (Electronic Project Online Risk Tool)

NASA Technical Reports Server (NTRS)

Johnson, Paul W.

2008-01-01

ePORT (electronic Project Online Risk Tool) provides a systematic approach to using an electronic database program to manage a program/project risk management processes. This presentation will briefly cover the standard risk management procedures, then thoroughly cover NASA's Risk Management tool called ePORT. This electronic Project Online Risk Tool (ePORT) is a web-based risk management program that provides a common framework to capture and manage risks, independent of a programs/projects size and budget. It is used to thoroughly cover the risk management paradigm providing standardized evaluation criterion for common management reporting, ePORT improves Product Line, Center and Corporate Management insight, simplifies program/project manager reporting, and maintains an archive of data for historical reference.

Fall risk assessment and prevention.

PubMed

Kline, Nancy E; Davis, Mary Elizabeth; Thom, Bridgette

2011-02-01

Patient falls are a common cause of morbidity and are the leading cause of injury deaths in adults age 65 years and older. Injuries sustained as result of falls in a cancer hospital are often severe, regardless of patient age, due to the nature of the underlying cancer. Falls are a nursing-sensitive indicator and nurses are in a unique position to assess, design, implement, and evaluate programs for fall risk reduction. We analyzed our nursing processes related to falls and fall prevention in conjunction with an evidence-based review, a research study to improve our fall risk-assessment process, and development of a comprehensive fall-reduction program. This article outlines how our institution developed a fall risk assessment for the oncology patient population, and utilized this assessment in a comprehensive nursing approach to fall prevention in both inpatient and outpatient settings.

Screening for Chemical Contributions to Breast Cancer Risk: A Case Study for Chemical Safety Evaluation

PubMed Central

Ackerman, Janet M.; Dairkee, Shanaz H.; Fenton, Suzanne E.; Johnson, Dale; Navarro, Kathleen M.; Osborne, Gwendolyn; Rudel, Ruthann A.; Solomon, Gina M.; Zeise, Lauren; Janssen, Sarah

2015-01-01

Background Current approaches to chemical screening, prioritization, and assessment are being reenvisioned, driven by innovations in chemical safety testing, new chemical regulations, and demand for information on human and environmental impacts of chemicals. To conceptualize these changes through the lens of a prevalent disease, the Breast Cancer and Chemicals Policy project convened an interdisciplinary expert panel to investigate methods for identifying chemicals that may increase breast cancer risk. Methods Based on a review of current evidence, the panel identified key biological processes whose perturbation may alter breast cancer risk. We identified corresponding assays to develop the Hazard Identification Approach for Breast Carcinogens (HIA-BC), a method for detecting chemicals that may raise breast cancer risk. Finally, we conducted a literature-based pilot test of the HIA-BC. Results The HIA-BC identifies assays capable of detecting alterations to biological processes relevant to breast cancer, including cellular and molecular events, tissue changes, and factors that alter susceptibility. In the pilot test of the HIA-BC, chemicals associated with breast cancer all demonstrated genotoxic or endocrine activity, but not necessarily both. Significant data gaps persist. Conclusions This approach could inform the development of toxicity testing that targets mechanisms relevant to breast cancer, providing a basis for identifying safer chemicals. The study identified important end points not currently evaluated by federal testing programs, including altered mammary gland development, Her2 activation, progesterone receptor activity, prolactin effects, and aspects of estrogen receptor β activity. This approach could be extended to identify the biological processes and screening methods relevant for other common diseases. Citation Schwarzman MR, Ackerman JM, Dairkee SH, Fenton SE, Johnson D, Navarro KM, Osborne G, Rudel RA, Solomon GM, Zeise L, Janssen S. 2015. Screening for chemical contributions to breast cancer risk: a case study for chemical safety evaluation. Environ Health Perspect 123:1255–1264; http://dx.doi.org/10.1289/ehp.1408337 PMID:26032647

Subject-enabled analytics model on measurement statistics in health risk expert system for public health informatics.

PubMed

Chung, Chi-Jung; Kuo, Yu-Chen; Hsieh, Yun-Yu; Li, Tsai-Chung; Lin, Cheng-Chieh; Liang, Wen-Miin; Liao, Li-Na; Li, Chia-Ing; Lin, Hsueh-Chun

2017-11-01

This study applied open source technology to establish a subject-enabled analytics model that can enhance measurement statistics of case studies with the public health data in cloud computing. The infrastructure of the proposed model comprises three domains: 1) the health measurement data warehouse (HMDW) for the case study repository, 2) the self-developed modules of online health risk information statistics (HRIStat) for cloud computing, and 3) the prototype of a Web-based process automation system in statistics (PASIS) for the health risk assessment of case studies with subject-enabled evaluation. The system design employed freeware including Java applications, MySQL, and R packages to drive a health risk expert system (HRES). In the design, the HRIStat modules enforce the typical analytics methods for biomedical statistics, and the PASIS interfaces enable process automation of the HRES for cloud computing. The Web-based model supports both modes, step-by-step analysis and auto-computing process, respectively for preliminary evaluation and real time computation. The proposed model was evaluated by computing prior researches in relation to the epidemiological measurement of diseases that were caused by either heavy metal exposures in the environment or clinical complications in hospital. The simulation validity was approved by the commercial statistics software. The model was installed in a stand-alone computer and in a cloud-server workstation to verify computing performance for a data amount of more than 230K sets. Both setups reached efficiency of about 10 5 sets per second. The Web-based PASIS interface can be used for cloud computing, and the HRIStat module can be flexibly expanded with advanced subjects for measurement statistics. The analytics procedure of the HRES prototype is capable of providing assessment criteria prior to estimating the potential risk to public health. Copyright © 2017 Elsevier B.V. All rights reserved.

Preparation of a flood-risk environmental index: case study of eight townships in Changhua County, Taiwan.

PubMed

Peng, Szu-Hsien

2018-02-26

To evaluate flood-prone areas, correlation analysis of flooding factors for the quantitative evaluation of hazard degree was determined to assist in further disaster prevention management. This study used flood-prone areas in 35 villages over eight townships (Changhua, Huatan, Yuanlin, Xiushui, Puyan, Hemei, Dacun, and Erlin) in Changhua County as research samples. Linear combination was used to evaluate flood-prone environmental indices, and an expert questionnaire was designed by using the analytic hierarchy process and the Delphi method to determine the weights of factors. These factors were then used to calculate the eigenvector of a pairwise comparison matrix to obtain the weights for the risk assessment criteria. Through collection of disaster cases, with particular focus on specifically protected areas where flooding has occurred or is likely to occur, public adaptation and response capabilities were evaluated by using an interview questionnaire that contains the items of perceived disaster risk, resource acquisition capability, adaptation capability, and environment understanding and disaster prevention education. Overlays in a geographic information system were used to analyze the flood-risk degree in villages and to construct a distribution map that contains flood-prone environment indices. The results can assist local governments in understanding the risk degree of various administrative areas to aid them in developing effective mitigation plans.

Integrating diverse scientific and practitioner knowledge in ecological risk analysis: a case study of biodiversity risk assessment in South Africa.

PubMed

Dana, G V; Kapuscinski, A R; Donaldson, J S

2012-05-15

Ecological risk analysis (ERA) is a structured evaluation of threats to species, natural communities, and ecosystem processes from pollutants and toxicants and more complicated living stressors such as invasive species, genetically modified organisms, and biological control agents. Such analyses are typically conducted by a narrowly-focused group of scientific experts using technical information. We evaluate whether the inclusion of more diverse experts and practitioners in ERA improved the ecological knowledge base about South African biodiversity and the potential impacts of genetically modified (GM) crops. We conducted two participatory ERA workshops in South Africa, analyzing potential impacts of GM maize on biodiversity. The first workshop involved only four biological scientists, who were joined by 18 diverse scientists and practitioners in the second, and we compared the ERA process and results between the two using descriptive statistics and semi-structured interview responses. The addition of diverse experts and practitioners led to a more comprehensive understanding of biological composition of the agro-ecosystem and a more ecologically relevant set of hazards, but impeded hazard prioritization and the generation of precise risk assessment values. Results suggest that diverse participation can improve the scoping or problem formulation of the ERA, by generating an ecologically robust set of information on which to base the subsequent, more technical risk assessment. The participatory ERA process also increased the transparency of the ERA by exposing the logic and rationale for decisions made at each step. Copyright © 2011 Elsevier Ltd. All rights reserved.

Prototype development of a web-based participative decision support platform in risk management

NASA Astrophysics Data System (ADS)

Aye, Zar Chi; Olyazadeh, Roya; Jaboyedoff, Michel; Derron, Marc-Henri

2014-05-01

This paper discusses the proposed background architecture and prototype development of an internet-based decision support system (DSS) in the field of natural hazards and risk management using open-source geospatial software and web technologies. It is based on a three-tier, client-server architecture with the support of boundless (opengeo) framework and its client side SDK application environment using customized gxp components and data utility classes. The main purpose of the system is to integrate the workflow of risk management systematically with the diverse involvement of stakeholders from different organizations dealing with natural hazards and risk for evaluation of management measures through the active online participation approach. It aims to develop an adaptive user friendly, web-based environment that allows the users to set up risk management strategies based on actual context and data by integrating web-GIS and DSS functionality associated with process flow and other visualization tools. Web-GIS interface has been integrated within the DSS to deliver maps and provide certain geo-processing capabilities on the web, which can be easily accessible and shared by different organizations located in case study sites of the project. This platform could be envisaged not only as a common web-based platform for the centralized sharing of data such as hazard maps, elements at risk maps and additional information but also to ensure an integrated platform of risk management where the users could upload data, analyze risk and identify possible alternative scenarios for risk reduction especially for floods and landslides, either quantitatively or qualitatively depending on the risk information provided by the stakeholders in case study regions. The level of involvement, access to and interaction with the provided functionality of the system varies depending on the roles and responsibilities of the stakeholders, for example, only the experts (planners, geological services, etc.) can have access to the alternative definition component to formulate the risk reduction measures. The development of such a participative platform would finally lead to an integrated risk management approach highlighting the needs to deal with involved experts and civil society in the decision-making process for evaluation of risk management measures through the active participation approach. The system will be applied and evaluated in four case study areas of the CHANGES project in Europe: Romania, North Eastern Italy, French Alps and Poland. However, the framework of the system is designed in a generic way so as to be applicable in other regions to achieve the high adaptability and flexibility of the system. The research has been undertaken as a part of the CHANGES project funded by the European Commission's 7th framework program.

Depression and Anxiety During Pregnancy: Evaluating the Literature in Support of Clinical Risk-Benefit Decision-Making.

PubMed

Dalke, Katharine Baratz; Wenzel, Amy; Kim, Deborah R

2016-06-01

Depression and anxiety during pregnancy are common, and patients and providers are faced with complex decisions regarding various treatment modalities. A structured discussion of the risks and benefits of options with the patient and her support team is recommended to facilitate the decision-making process. This clinically focused review, with emphasis on the last 3 years of published study data, evaluates the major risk categories of medication treatments, namely pregnancy loss, physical malformations, growth impairment, behavioral teratogenicity, and neonatal toxicity. Nonpharmacological treatment options, including neuromodulation and psychotherapy, are also briefly reviewed. Specific recommendations, drawn from the literature and the authors' clinical experience, are also offered to help guide the clinician in decision-making.

Risk based inspection for atmospheric storage tank

NASA Astrophysics Data System (ADS)

Nugroho, Agus; Haryadi, Gunawan Dwi; Ismail, Rifky; Kim, Seon Jin

2016-04-01

Corrosion is an attack that occurs on a metallic material as a result of environment's reaction.Thus, it causes atmospheric storage tank's leakage, material loss, environmental pollution, equipment failure and affects the age of process equipment then finally financial damage. Corrosion risk measurement becomesa vital part of Asset Management at the plant for operating any aging asset.This paper provides six case studies dealing with high speed diesel atmospheric storage tank parts at a power plant. A summary of the basic principles and procedures of corrosion risk analysis and RBI applicable to the Process Industries were discussed prior to the study. Semi quantitative method based onAPI 58I Base-Resource Document was employed. The risk associated with corrosion on the equipment in terms of its likelihood and its consequences were discussed. The corrosion risk analysis outcome used to formulate Risk Based Inspection (RBI) method that should be a part of the atmospheric storage tank operation at the plant. RBI gives more concern to inspection resources which are mostly on `High Risk' and `Medium Risk' criteria and less on `Low Risk' shell. Risk categories of the evaluated equipment were illustrated through case study analysis outcome.

Risk assessment in the 21st century: roadmap and matrix.

PubMed

Embry, Michelle R; Bachman, Ammie N; Bell, David R; Boobis, Alan R; Cohen, Samuel M; Dellarco, Michael; Dewhurst, Ian C; Doerrer, Nancy G; Hines, Ronald N; Moretto, Angelo; Pastoor, Timothy P; Phillips, Richard D; Rowlands, J Craig; Tanir, Jennifer Y; Wolf, Douglas C; Doe, John E

2014-08-01

Abstract The RISK21 integrated evaluation strategy is a problem formulation-based exposure-driven risk assessment roadmap that takes advantage of existing information to graphically represent the intersection of exposure and toxicity data on a highly visual matrix. This paper describes in detail the process for using the roadmap and matrix. The purpose of this methodology is to optimize the use of prior information and testing resources (animals, time, facilities, and personnel) to efficiently and transparently reach a risk and/or safety determination. Based on the particular problem, exposure and toxicity data should have sufficient precision to make such a decision. Estimates of exposure and toxicity, bounded by variability and/or uncertainty, are plotted on the X- and Y-axes of the RISK21 matrix, respectively. The resulting intersection is a highly visual representation of estimated risk. Decisions can then be made to increase precision in the exposure or toxicity estimates or declare that the available information is sufficient. RISK21 represents a step forward in the goal to introduce new methodologies into 21st century risk assessment. Indeed, because of its transparent and visual process, RISK21 has the potential to widen the scope of risk communication beyond those with technical expertise.

Update on Risk Reduction Activities for a Liquid Advanced Booster for NASA's Space Launch System

NASA Technical Reports Server (NTRS)

Crocker, Andy; Graham, Bart

2016-01-01

Dynetics has designed innovative structure assemblies; manufactured them using Friction Stir Welding (FSW) to leverage NASA investments in tools, facilities, and processes; conducted proof and burst testing, demonstrating viability of design/build processes Dynetics/AR has applied state-of-the-art manufacturing and processing techniques to the heritage F-1, reducing risk for engine development Dynetics/AR has also made progress on technology demonstrations for ORSC cycle engine, which offers affordability and performance for both NASA and other launch vehicles Full-scale integrated oxidizer-rich test article. Testing will evaluate performance and combustion stability characteristics. Contributes to technology maturation for ox-rich staged combustion engines.

The knowledge value-chain of genetic counseling for breast cancer: an empirical assessment of prediction and communication processes.

PubMed

Amara, Nabil; Blouin-Bougie, Jolyane; Jbilou, Jalila; Halilem, Norrin; Simard, Jacques; Landry, Réjean

2016-01-01

The aim of this paper is twofold: to analyze the genetic counseling process for breast cancer with a theoretical knowledge transfer lens and to compare generalists, medical specialists, and genetic counselors with regards to their genetic counseling practices. This paper presents the genetic counseling process occurring within a chain of value-adding activities of four main stages describing health professionals' clinical practices: (1) evaluation, (2) investigation, (3) information, and (4) decision. It also presents the results of a cross-sectional study based on a Canadian medical doctors and genetic counselors survey (n = 176) realized between July 2012 and March 2013. The statistical exercise included descriptive statistics, one-way ANOVA and post-hoc tests. The results indicate that even though all types of health professionals are involved in the entire process of genetic counseling for breast cancer, genetic counselors are more involved in the evaluation of breast cancer risk, while medical doctors are more active in the decision toward breast cancer risk management strategies. The results secondly demonstrate the relevance and the key role of genetic counselors in the care provided to women at-risk of familial breast cancer. This paper presents an integrative framework to understand the current process of genetic counseling for breast cancer in Canada, and to shed light on how and where health professionals contribute to the process. It also offers a starting point for assessing clinical practices in genetic counseling in order to establish more clearly where and to what extent efforts should be undertaken to implement future genetic services.

Evaluation of performance of footwear and flooring systems in combination with personnel using voltage probability analysis

NASA Astrophysics Data System (ADS)

Smallwood, Jeremy; Swenson, David E.

2011-06-01

Evaluation of electrostatic performance of footwear and flooring in combination is necessary in applications such as electrostatic discharge (ESD) control in electronics manufacture, evaluation of equipment for avoidance of factory process electrostatic ignition risks and avoidance of electrostatic shocks to personnel in working environments. Typical standards use a walking test in which the voltage produced on a subject is evaluated by identification and measurement of the magnitude of the 5 highest "peaks" and "valleys" of the recorded voltage waveform. This method does not lend itself to effective analysis of the risk that the voltage will exceed a hazard threshold. This paper shows the advantages of voltage probability analysis and recommends that the method is adopted for use in future standards.

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

A pragmatic randomised controlled trial of the Welsh National Exercise Referral Scheme: protocol for trial and integrated economic and process evaluation.

PubMed

Murphy, Simon; Raisanen, Larry; Moore, Graham; Edwards, Rhiannon Tudor; Linck, Pat; Williams, Nefyn; Ud Din, Nafees; Hale, Janine; Roberts, Chris; McNaish, Elaine; Moore, Laurence

2010-06-18

The benefits to health of a physically active lifestyle are well established and there is evidence that a sedentary lifestyle plays a significant role in the onset and progression of chronic disease. Despite a recognised need for effective public health interventions encouraging sedentary people with a medical condition to become more active, there are few rigorous evaluations of their effectiveness. Following NICE guidance, the Welsh national exercise referral scheme was implemented within the context of a pragmatic randomised controlled trial. The randomised controlled trial, with nested economic and process evaluations, recruited 2,104 inactive men and women aged 16+ with coronary heart disease (CHD) risk factors and/or mild to moderate depression, anxiety or stress. Participants were recruited from 12 local health boards in Wales and referred directly by health professionals working in a range of health care settings. Consenting participants were randomised to either a 16 week tailored exercise programme run by qualified exercise professionals at community sports centres (intervention), or received an information booklet on physical activity (control). A range of validated measures assessing physical activity, mental health, psycho-social processes and health economics were administered at 6 and 12 months, with the primary 12 month outcome measure being 7 day Physical Activity Recall. The process evaluation explored factors determining the effectiveness or otherwise of the scheme, whilst the economic evaluation determined the relative cost-effectiveness of the scheme in terms of public spending. Evaluation of such a large scale national public health intervention presents methodological challenges in terms of trial design and implementation. This study was facilitated by early collaboration with social research and policy colleagues to develop a rigorous design which included an innovative approach to patient referral and trial recruitment, a comprehensive process evaluation examining intervention delivery and an integrated economic evaluation. This will allow a unique insight into the feasibility, effectiveness and cost effectiveness of a national exercise referral scheme for participants with CHD risk factors or mild to moderate anxiety, depression, or stress and provides a potential model for future policy evaluations. Current Controlled Trials ISRCTN47680448.

Detection of Cardiovascular Disease Risk's Level for Adults Using Naive Bayes Classifier.

PubMed

Miranda, Eka; Irwansyah, Edy; Amelga, Alowisius Y; Maribondang, Marco M; Salim, Mulyadi

2016-07-01

The number of deaths caused by cardiovascular disease and stroke is predicted to reach 23.3 million in 2030. As a contribution to support prevention of this phenomenon, this paper proposes a mining model using a naïve Bayes classifier that could detect cardiovascular disease and identify its risk level for adults. The process of designing the method began by identifying the knowledge related to the cardiovascular disease profile and the level of cardiovascular disease risk factors for adults based on the medical record, and designing a mining technique model using a naïve Bayes classifier. Evaluation of this research employed two methods: accuracy, sensitivity, and specificity calculation as well as an evaluation session with cardiologists and internists. The characteristics of cardiovascular disease are identified by its primary risk factors. Those factors are diabetes mellitus, the level of lipids in the blood, coronary artery function, and kidney function. Class labels were assigned according to the values of these factors: risk level 1, risk level 2 and risk level 3. The evaluation of the classifier performance (accuracy, sensitivity, and specificity) in this research showed that the proposed model predicted the class label of tuples correctly (above 80%). More than eighty percent of respondents (including cardiologists and internists) who participated in the evaluation session agree till strongly agreed that this research followed medical procedures and that the result can support medical analysis related to cardiovascular disease. The research showed that the proposed model achieves good performance for risk level detection of cardiovascular disease.

Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

PubMed

Baron, Patrick; Frattaroli, Shannon

2016-01-01

The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain.

Blunted feedback processing during risk-taking in adolescents with features of problematic Internet use.

PubMed

Yau, Yvonne H C; Potenza, Marc N; Mayes, Linda C; Crowley, Michael J

2015-06-01

While the conceptualization of problematic Internet use (PIU) as a "behavioral addiction" resembling substance-use disorders is debated, the neurobiological underpinnings of PIU remain understudied. This study examined whether adolescents displaying features of PIU (at-risk PIU; ARPIU) are more impulsive and exhibit blunted responding in the neural mechanisms underlying feedback processing and outcome evaluation during risk-taking. Event-related potentials (ERPs) elicited by positive (i.e. reward) and negative (i.e. loss) feedback were recorded during performance on a modified version of the Balloon Analogue Risk Task (BART) among ARPIU (n=39) and non-ARPIU subjects (n=27). Compared to non-ARPIU, ARPIU adolescents displayed higher levels of urgency and lack of perseverance on the UPPS Impulsive Behavior Scale. Although no between-group difference in BART performance was observed, ERPs demonstrated overall decreased sensitivity to feedback in ARPIU compared to non-ARPIU adolescents, as indexed by blunted feedback-related negativity (FRN) and P300 amplitudes to both negative and positive feedback. The present study provides evidence for feedback processing during risk-taking as a neural correlate of ARPIU. Given recent concerns regarding the growing prevalence of PIU as a health concern, future work should examine the extent to which feedback processing may represent a risk factor for PIU, a consequence of PIU, or possibly both. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluating supplier quality performance using fuzzy analytical hierarchy process

NASA Astrophysics Data System (ADS)

Ahmad, Nazihah; Kasim, Maznah Mat; Rajoo, Shanmugam Sundram Kalimuthu

2014-12-01

Evaluating supplier quality performance is vital in ensuring continuous supply chain improvement, reducing the operational costs and risks towards meeting customer's expectation. This paper aims to illustrate an application of Fuzzy Analytical Hierarchy Process to prioritize the evaluation criteria in a context of automotive manufacturing in Malaysia. Five main criteria were identified which were quality, cost, delivery, customer serviceand technology support. These criteria had been arranged into hierarchical structure and evaluated by an expert. The relative importance of each criteria was determined by using linguistic variables which were represented as triangular fuzzy numbers. The Center of Gravity defuzzification method was used to convert the fuzzy evaluations into their corresponding crisps values. Such fuzzy evaluation can be used as a systematic tool to overcome the uncertainty evaluation of suppliers' performance which usually associated with human being subjective judgments.

Development and Evaluation of the American College of Surgeons NSQIP Pediatric Surgical Risk Calculator.

PubMed

Kraemer, Kari; Cohen, Mark E; Liu, Yaoming; Barnhart, Douglas C; Rangel, Shawn J; Saito, Jacqueline M; Bilimoria, Karl Y; Ko, Clifford Y; Hall, Bruce L

2016-11-01

There is an increased desire among patients and families to be involved in the surgical decision-making process. A surgeon's ability to provide patients and families with patient-specific estimates of postoperative complications is critical for shared decision making and informed consent. Surgeons can also use patient-specific risk estimates to decide whether or not to operate and what options to offer patients. Our objective was to develop and evaluate a publicly available risk estimation tool that would cover many common pediatric surgical procedures across all specialties. American College of Surgeons NSQIP Pediatric standardized data from 67 hospitals were used to develop a risk estimation tool. Surgeons enter 18 preoperative variables (demographics, comorbidities, procedure) that are used in a logistic regression model to predict 9 postoperative outcomes. A surgeon adjustment score is also incorporated to adjust for any additional risk not accounted for in the 18 risk factors. A pediatric surgical risk calculator was developed based on 181,353 cases covering 382 CPT codes across all specialties. It had excellent discrimination for mortality (c-statistic = 0.98), morbidity (c-statistic = 0.81), and 7 additional complications (c-statistic > 0.77). The Hosmer-Lemeshow statistic and graphic representations also showed excellent calibration. The ACS NSQIP Pediatric Surgical Risk Calculator was developed using standardized and audited multi-institutional data from the ACS NSQIP Pediatric, and it provides empirically derived, patient-specific postoperative risks. It can be used as a tool in the shared decision-making process by providing clinicians, families, and patients with useful information for many of the most common operations performed on pediatric patients in the US. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Summary of evidence-based guideline update: evaluation and management of concussion in sports: report of the Guideline Development Subcommittee of the American Academy of Neurology.

PubMed

Giza, Christopher C; Kutcher, Jeffrey S; Ashwal, Stephen; Barth, Jeffrey; Getchius, Thomas S D; Gioia, Gerard A; Gronseth, Gary S; Guskiewicz, Kevin; Mandel, Steven; Manley, Geoffrey; McKeag, Douglas B; Thurman, David J; Zafonte, Ross

2013-06-11

To update the 1997 American Academy of Neurology (AAN) practice parameter regarding sports concussion, focusing on 4 questions: 1) What factors increase/decrease concussion risk? 2) What diagnostic tools identify those with concussion and those at increased risk for severe/prolonged early impairments, neurologic catastrophe, or chronic neurobehavioral impairment? 3) What clinical factors identify those at increased risk for severe/prolonged early postconcussion impairments, neurologic catastrophe, recurrent concussions, or chronic neurobehavioral impairment? 4) What interventions enhance recovery, reduce recurrent concussion risk, or diminish long-term sequelae? The complete guideline on which this summary is based is available as an online data supplement to this article. We systematically reviewed the literature from 1955 to June 2012 for pertinent evidence. We assessed evidence for quality and synthesized into conclusions using a modified Grading of Recommendations Assessment, Development and Evaluation process. We used a modified Delphi process to develop recommendations. Specific risk factors can increase or decrease concussion risk. Diagnostic tools to help identify individuals with concussion include graded symptom checklists, the Standardized Assessment of Concussion, neuropsychological assessments, and the Balance Error Scoring System. Ongoing clinical symptoms, concussion history, and younger age identify those at risk for postconcussion impairments. Risk factors for recurrent concussion include history of multiple concussions, particularly within 10 days after initial concussion. Risk factors for chronic neurobehavioral impairment include concussion exposure and APOE ε4 genotype. Data are insufficient to show that any intervention enhances recovery or diminishes long-term sequelae postconcussion. Practice recommendations are presented for preparticipation counseling, management of suspected concussion, and management of diagnosed concussion.

Integration of Biosafety into Core Facility Management

PubMed Central

Fontes, Benjamin

2013-01-01

This presentation will discuss the implementation of biosafety policies for small, medium and large core laboratories with primary shared objectives of ensuring the control of biohazards to protect core facility operators and assure conformity with applicable state and federal policies, standards and guidelines. Of paramount importance is the educational process to inform core laboratories of biosafety principles and policies and to illustrate the technology and process pathways of the core laboratory for biosafety professionals. Elevating awareness of biohazards and the biosafety regulatory landscape among core facility operators is essential for the establishment of a framework for both project and material risk assessment. The goal of the biohazard risk assessment process is to identify the biohazard risk management parameters to conduct the procedure safely and in compliance with applicable regulations. An evaluation of the containment, protective equipment and work practices for the procedure for the level of risk identified is facilitated by the establishment of a core facility registration form for work with biohazards and other biological materials with potential risk. The final step in the biocontainment process is the assumption of Principal Investigator role with full responsibility for the structure of the site-specific biosafety program plan by core facility leadership. The presentation will provide example biohazard protocol reviews and accompanying containment measures for core laboratories at Yale University.

75 FR 61148 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-04

... Evaluation and testing within a risk management process 2-100 ASTM E1372-95 (2003) Standard Test Method...) Standard Title, Type of Test Method for Agar Diffusion Cell standard , Relevant Culture Screening for... Biological evaluation of medical devices - Office(s) and Part 3: Tests for genotoxicity, Division(s...

Evaluating Knowledge, Attitudinal, and Behavioral Change Effects from a Multinational HIV/AIDS Education Program for Youth

ERIC Educational Resources Information Center

Hardre, Patricia L.; Garcia, Fe; Apamo, Peter; Mutheu, Lucy; Ndege, Monica; Bois, Iderle

2010-01-01

This project tracked the mid-term evaluation processes, practices, and products of a multinational program to reduce at-risk behaviors for HIV/AIDS among children in Kenya, Tanzania, and Haiti. It focused on participant and community perceptions; program effectiveness in promoting abstinence and monogamy decisions; and factors supporting ongoing…

Economic Evaluation of the Information Security Levels Achieved by Electric Energy Providers in North Arctic Region

NASA Astrophysics Data System (ADS)

Sushko, O. P.; Kaznin, A. A.; Babkin, A. V.; Bogdanov, D. A.

2017-10-01

The study we are conducting involves the analysis of information security levels achieved by energy providers operating in the North Arctic Region. We look into whether the energy providers’ current information security levels meet reliability standards and determine what further actions may be needed for upgrading information security in the context of the digital transformation that the world community is undergoing. When developing the information security systems for electric energy providers or selecting the protection means for them, we are governed by the fact that the assets to be protected are process technologies. While information security risk can be assessed using different methods, the evaluation of the economic damage from these risks appears to be a difficult task. The most probable and harmful risks we have identified when evaluating the electric energy providers’ information security will be used by us as variables. To provide the evaluation, it is necessary to calculate the costs relating to elimination of the risks identified. The final stage of the study will involve the development of an operation algorithm for the North Arctic Region’s energy provider’s business information protection security system - a set of information security services, and security software and hardware.

Evaluation of biologic occupational risk control practices: quality indicators development and validation.

PubMed

Takahashi, Renata Ferreira; Gryschek, Anna Luíza F P L; Izumi Nichiata, Lúcia Yasuko; Lacerda, Rúbia Aparecida; Ciosak, Suely Itsuko; Gir, Elucir; Padoveze, Maria Clara

2010-05-01

There is growing demand for the adoption of qualification systems for health care practices. This study is aimed at describing the development and validation of indicators for evaluation of biologic occupational risk control programs. The study involved 3 stages: (1) setting up a research team, (2) development of indicators, and (3) validation of the indicators by a team of specialists recruited to validate each attribute of the developed indicators. The content validation method was used for the validation, and a psychometric scale was developed for the specialists' assessment. A consensus technique was used, and every attribute that obtained a Content Validity Index of at least 0.75 was approved. Eight indicators were developed for the evaluation of the biologic occupational risk prevention program, with emphasis on accidents caused by sharp instruments and occupational tuberculosis prevention. The indicators included evaluation of the structure, process, and results at the prevention and biologic risk control levels. The majority of indicators achieved a favorable consensus regarding all validated attributes. The developed indicators were considered validated, and the method used for construction and validation proved to be effective. Copyright (c) 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

A Computer-Based Network for Writing Process Instruction of At-Risk Community College Students: A Second Year Evaluation.

ERIC Educational Resources Information Center

Balajthy, Ernest

In its second year of operation (1988-1989 academic year), the Electronic Writing Center (EWC) of the Union County College in Cranford, New Jersey has expanded its capabilities and the amount of service it provides to at-risk students through the Computers in the Curricula Project. Major changes include: (1) increased numbers of classes and…

Resolving conflict creatively: evaluating the developmental effects of a school-based violence prevention program in neighborhood and classroom context.

PubMed

Aber, J L; Jones, S M; Brown, J L; Chaudry, N; Samples, F

1998-01-01

This study evaluated the short-term impact of a school-based violence prevention initiative on developmental processes thought to place children at risk for future aggression and violence and examined the influence of classroom and neighborhood contexts on the effectiveness of the violence prevention initiative. Two waves of developmental data (fall and spring) were analyzed from the 1st year of the evaluation of the Resolving Conflict Creatively Program (RCCP), which includes 5053 children from grades two to six from 11 elementary schools in New York City. Three distinct profiles of exposure to the intervention were derived from Management Information System (MIS) data on between classroom differences in teacher Training and Coaching in RCCP, Classroom Instruction in RCCP, and percentages of students who are Peer Mediators. Developmental processes that place children at risk were found to increase over the course of the school year. Children whose teachers had a moderate amount of training and coaching from RCCP and who taught many lessons showed significantly slower growth in aggression-related processes, and less of a decrease in competence-related processes, compared to children whose teachers taught few or no lessons. Contrary to expectation, children whose teachers had a higher level of training and coaching in the RCCP but taught few lessons showed significantly faster growth over time in aggressive cognitions and behaviors. The impact of the intervention on children's social cognitions (but not on their interpersonal behaviors) varied by context. Specifically the positive effect of High Lessons was dampened for children in high-risk classrooms and neighborhoods. Implications for future research on developmental psychopathology in context and for the design of preventive interventions are discussed.

Northwest Climate Risk Assessment

NASA Astrophysics Data System (ADS)

Mote, P.; Dalton, M. M.; Snover, A. K.

2012-12-01

As part of the US National Climate Assessment, the Northwest region undertook a process of climate risk assessment. This process included an expert evaluation of previously identified impacts, their likelihoods, and consequences, and engaged experts from both academia and natural resource management practice (federal, tribal, state, local, private, and non-profit) in a workshop setting. An important input was a list of 11 risks compiled by state agencies in Oregon and similar adaptation efforts in Washington. By considering jointly the likelihoods, consequences, and adaptive capacity, participants arrived at an approximately ranked list of risks which was further assessed and prioritized through a series of risk scoring exercises to arrive at the top three climate risks facing the Northwest: 1) changes in amount and timing of streamflow related to snowmelt, causing far-reaching ecological and socioeconomic consequences; 2) coastal erosion and inundation, and changing ocean acidity, combined with low adaptive capacity in the coastal zone to create large risks; and 3) the combined effects of wildfire, insect outbreaks, and diseases will cause large areas of forest mortality and long-term transformation of forest landscapes.

Risk Acceptance Personality Paradigm: How We View What We Don't Know We Don't Know

NASA Technical Reports Server (NTRS)

Massie, Michael J.; Morris, A. Terry

2011-01-01

The purpose of integrated hazard analyses, probabilistic risk assessments, failure modes and effects analyses, fault trees and many other similar tools is to give managers of a program some idea of the risks associated with their program. All risk tools establish a set of undesired events and then try to evaluate the risk to the program by assessing the severity of the undesired event and the likelihood of that event occurring. Some tools provide qualitative results, some provide quantitative results and some do both. However, in the end the program manager and his/her team must decide which risks are acceptable and which are not. Even with a wide array of analysis tools available, risk acceptance is often a controversial and difficult decision making process. And yet, today's space exploration programs are moving toward more risk based design approaches. Thus, risk identification and good risk assessment is becoming even more vital to the engineering development process. This paper explores how known and unknown information influences risk-based decisions by looking at how the various parts of our personalities are affected by what they know and what they don't know. This paper then offers some criteria for consideration when making risk-based decisions.

Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

PubMed

Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

2013-09-01

The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

Evaluation of Computational Method of High Reynolds Number Slurry Flow for Caverns Backfilling

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

Bettin, Giorgia

2015-05-01

The abandonment of salt caverns used for brining or product storage poses a significant environmental and economic risk. Risk mitigation can in part be address ed by the process of backfilling which can improve the cavern geomechanical stability and reduce the risk o f fluid loss to the environment. This study evaluate s a currently available computational tool , Barracuda, to simulate such process es as slurry flow at high Reynolds number with high particle loading . Using Barracuda software, a parametric sequence of simu lations evaluated slurry flow at Re ynolds number up to 15000 and loading up tomore » 25%. Li mitations come into the long time required to run these simulation s due in particular to the mesh size requirement at the jet nozzle. This study has found that slurry - jet width and centerline velocities are functions of Re ynold s number and volume fractio n The solid phase was found to spread less than the water - phase with a spreading rate smaller than 1 , dependent on the volume fraction. Particle size distribution does seem to have a large influence on the jet flow development. This study constitutes a first step to understand the behavior of highly loaded slurries and their ultimate application to cavern backfilling.« less

Sleep Problems in Preschoolers and Maternal Depressive Symptoms: An Evaluation of Mother- and Child-Driven Effects

ERIC Educational Resources Information Center

Ystrom, Hilde; Nilsen, Wendy; Hysing, Mari; Sivertsen, Børge; Ystrom, Eivind

2017-01-01

Child sleep problems are associated with maternal depressive symptoms. It is unclear to what extent the association is due to direct effects or common risk factors for mother and child. Direct effects could represent child-driven processes, where child sleep problems influence maternal depressive symptoms, or mother-driven processes, where…

A risk assessment of direct and indirect exposure to emissions from a proposed hazardous waste incinerator in Puerto Rico

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

Hallinger, K.; Huggins, A.; Warner, L.

1995-12-31

An Indirect Exposure Assessment (IEA) was conducted, under USEPA`s RCRA Combustion Strategy, as part of the Part B permitting process for a proposed hazardous waste incinerator. The IEA involved identification of constituents of concern, emissions estimations, air dispersion and deposition modeling, evaluation of site-specific exposure pathways/scenarios, and food chain modeling in order to evaluate potential human health and environmental risks. The COMPDEP model was used to determine ambient ground level concentrations and dry and wet deposition rates of constituents of concern. The air modeling results were input into 50th percentile (Central) and 95th percentile (High-End) exposure scenarios which evaluated directmore » exposure via inhalation, dermal contact, and soil ingestion pathways, and indirect exposure through the food chain. The indirect pathway analysis considered the accumulation of constituents in plants and animals used as food sources by local inhabitants. Local food consumption data obtained from the Puerto Rico USDA were combined with realistic present-day and future-use exposure scenarios such as residential use, pineapple farming, and subsistence farming to obtain a comprehensive evaluation of risk, Overall risk was calculated using constituent doses and toxicity factors associated with the various routes of exposure. Risk values for each exposure pathway were summed to determine total carcinogenic and non-carcinogenic hazard to exposed individuals. A population risk assessment was also conducted in order to assess potential risks to the population surrounding the facility. Results of the assessment indicated no acute effects from constituents of concern, and a high-end excess lifetime cancer risk of approximately 6 in a million with dioxins (as 2,3,7,8-TCDD) and arsenic dominating the risk estimate.« less

Evidence-based guidelines for fall prevention in Korea

PubMed Central

Kim, Kwang-Il; Jung, Hye-Kyung; Kim, Chang Oh; Kim, Soo-Kyung; Cho, Hyun-Ho; Kim, Dae Yul; Ha, Yong-Chan; Hwang, Sung-Hee; Won, Chang Won; Lim, Jae-Young; Kim, Hyun Jung; Kim, Jae Gyu

2017-01-01

Falls and fall-related injuries are common in older populations and have negative effects on quality of life and independence. Falling is also associated with increased morbidity, mortality, nursing home admission, and medical costs. Korea has experienced an extreme demographic shift with its population aging at the fastest pace among developed countries, so it is important to assess fall risks and develop interventions for high-risk populations. Guidelines for the prevention of falls were first developed by the Korean Association of Internal Medicine and the Korean Geriatrics Society. These guidelines were developed through an adaptation process as an evidence-based method; four guidelines were retrieved via systematic review and the Appraisal of Guidelines for Research and Evaluation II process, and seven recommendations were developed based on the Grades of Recommendation, Assessment, Development, and Evaluation framework. Because falls are the result of various factors, the guidelines include a multidimensional assessment and multimodal strategy. The guidelines were developed for primary physicians as well as patients and the general population. They provide detailed recommendations and concrete measures to assess risk and prevent falls among older people. PMID:28049285

Risk mitigation process for utilization of commercial off-the-shelf (COTS) parts in CCD camera for military applications

NASA Astrophysics Data System (ADS)

Ahmad, Anees; Batcheldor, Scott; Cannon, Steven C.; Roberts, Thomas E.

2002-09-01

This paper presents the lessons learned during the design and development of a high performance cooled CCD camera for military applications utilizing common commercial off the shelf (COTS) parts. Our experience showed that concurrent evaluation and testing of high risk COTS must be performed to assess their performance over the required temperature range and other special product requirements such as fuel vapor compatibility, EMI and shock susceptibility, etc. Technical, cost and schedule risks for COTS parts must also be carefully evaluated. The customer must be involved in the selection and evaluation of such parts so that the performance limitations of the selected parts are clearly understood. It is equally important to check with vendors on the availability and obsolescence of the COTS parts being considered since the electronic components are often replaced by newer, better and cheaper models in a couple of years. In summary, this paper addresses the major benefits and risks associated with using commercial and industrial parts in military products, and suggests a risk mitigation approach to ensure a smooth development phase, and predictable performance from the end product.

[Spatiotemporal dynamic fuzzy evaluation of wetland environmental pollution risk in Dayang estuary of Liaoning Province, Northeast China based on remote sensing].

PubMed

Sun, Yong-Guang; Zhao, Dong-Zhi; Zhang, Feng-Shou; Wei, Bao-Quan; Chu, Jia-Lan; Su, Xiu

2012-11-01

Based on the aerial image data of Dayang estuary in 2008, and by virtue of Analytic Hierarchy Process (AHP) , remote sensing technology, and GIS spatial analysis, a spatiotemporal evaluation was made on the comprehensive level of wetland environmental pollution risk in Dayang estuary, with the impacts of typical human activities on the dynamic variation of this comprehensive level discussed. From 1958 to 2008, the comprehensive level of the environmental pollution risk in study area presented an increasing trend. Spatially, this comprehensive level declined from land to ocean, and showed a zonal distribution. Tourism development activities unlikely led to the increase of the comprehensive level, while human inhabitation, transportation, and aquaculture would exacerbate the risk of environmental pollution. This study could provide reference for the sea area use planning, ecological function planning, and pollutants control of estuary region.

HIV Prevention for Adults With Criminal Justice Involvement: A Systematic Review of HIV Risk-Reduction Interventions in Incarceration and Community Settings

PubMed Central

Dumont, Dora; Operario, Don

2014-01-01

We summarized and appraised evidence regarding HIV prevention interventions for adults with criminal justice involvement. We included randomized and quasi-randomized controlled trials that evaluated an HIV prevention intervention, enrolled participants with histories of criminal justice involvement, and reported biological or behavioral outcomes. We used Cochrane methods to screen 32 271 citations from 16 databases and gray literature. We included 37 trials enrolling n = 12 629 participants. Interventions were 27 psychosocial, 7 opioid substitution therapy, and 3 HIV-testing programs. Eleven programs significantly reduced sexual risk taking, 4 reduced injection drug risks, and 4 increased testing. Numerous interventions may reduce HIV-related risks among adults with criminal justice involvement. Future research should consider process evaluations, programs involving partners or families, and interventions integrating biomedical, psychosocial, and structural approaches. PMID:25211725

Blending technology and teamwork for successful management of product recalls.

PubMed

Frush, Karen; Pleasants, Jane; Shulby, Gail; Hendrix, Barbara; Berson, Brooke; Gordon, Cynthia; Cuffe, Michael S

2009-12-01

Patient safety programs have been developed in many hospitals to reduce the risk of harm to patients. Proactive, real-time, and retrospective risk-reduction strategies should be implemented in hospitals, but patient safety leaders should also be cognizant of the risks associated with thousands of products that enter the hospital through the supply chain. A growing number of recalls and alerts related to these products are received by health care facilities each year, through a recall process that is fraught with challenges. Despite the best efforts of health care providers, weaknesses and gaps in the process lead to delays, fragmentation, and disruptions, thus extending the number of days patients may be at risk from potentially faulty or misused products. To address these concerns, Duke Medicine, which comprises an academic medical center, two community hospitals, outlying clinics, physicians' offices, and home health and hospice, implemented a Web-based recall management system. Within three months, the time required to receive, deliver, and close alerts decreased from 43 days to 2.74 days. To maximize the effectiveness of the recall management process, a team of senior Duke Medicine leaders was established to evaluate the impact of product recalls and alerts on patient safety, to evaluate response action plans, and to provide oversight of patient and provider communication strategies. Alerts are now communicated more effectively and responded to in a more consistent and global manner. This comprehensive approach to product recalls is a critical component of a broader Duke Medicine strategy to improve patient safety.

More Than Fear Induction: Toward an Understanding of People's Motivation to Be Well-Prepared for Emergencies in Flood-Prone Areas.

PubMed

de Boer, Joop; Botzen, W J Wouter; Terpstra, Teun

2015-03-01

This article examines the extent and manner to which evaluations of flood-related precautions are affected by an individual's motivation and perception of context. It argues that the relationship between risk perception and flood risk preparedness can be fruitfully specified in terms of vulnerability and efficacy if these concepts are put into the perspective of prevention-focused motivation. This relationship was empirically examined in a risk communication experiment in a delta area of the Netherlands (n = 1,887). Prevention-focused motivation was induced by contextualized risk information. The results showed that prevention-focused individuals were more sensitive to the relevance of potential precautions for satisfying their needs in the context they found themselves in. The needs included, but were not limited to, fear reduction. Due to the heterogeneity of the residents, the evaluations reflected individual differences in the intensity and the selectivity of precautionary processes. Four types of persons could be distinguished according to their evaluation of precautionary measures: a high-scoring minority, two more selective types, and a low-scoring minority. For policymakers and risk communicators it is vital to consider the nature of prevention motivation and the context in which it is likely to be high. © 2015 Society for Risk Analysis.

Fruit and vegetable intakes and risk of colorectal cancer and incident and recurrent adenomas in the PLCO cancer screening trial.

PubMed

Kunzmann, Andrew T; Coleman, Helen G; Huang, Wen-Yi; Cantwell, Marie M; Kitahara, Cari M; Berndt, Sonja I

2016-04-15

The roles of fruits and vegetables in colorectal cancer development are unclear. Few prospective studies have assessed the association with adenoma, a known precursor to colorectal cancer. Our aim was to evaluate the association between fruit and vegetable intake and colorectal cancer development by evaluating the risk of incident and recurrent colorectal adenoma and colorectal cancer. Study participants were identified from the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Fruit and vegetable intake was measured using a self-reported dietary questionnaire. Total fruit and vegetable intake was not associated with reduced incident or recurrent adenoma risk overall, but a protective association was observed for multiple adenomas (Odds ratio 3rd tertile vs. 1st tertile = 0.61, 95% confidence interval (CI): 0.38, 1.00). Higher fruit and vegetable intakes were associated with a borderline reduced risk of colorectal cancer (Hazard ratio (HR) 3rd tertile vs. 1st tertile = 0.82, 95% CI: 0.67, 1.01), which reached significance amongst individuals with high processed meat intakes (HR = 0.74, 95% CI: 0.55, 0.99). Our results suggest that increased fruit and vegetable intake may protect against multiple adenoma development and may reduce the detrimental effects of high processed meat intakes on colorectal cancer risk. © 2015 UICC.

Analytical Hierarchy Process modeling for malaria risk zones in Vadodara district, Gujarat

NASA Astrophysics Data System (ADS)

Bhatt, B.; Joshi, J. P.

2014-11-01

Malaria epidemic is one of the complex spatial problems around the world. According to WHO, an estimated 6, 27, 000 deaths occurred due to malaria in 2012. In many developing nations with diverse ecological regions, it is still a large cause of human mortality. Owing to the incompleteness of epidemiological data and their spatial origin, the quantification of disease incidence burdening basic public health planning is a major constrain especially in developing countries. The present study focuses on the integrated Geospatial and Multi-Criteria Evaluation (AHP) technique to determine malaria risk zones. The study is conducted in Vadodara district, including 12 Taluka among which 4 Taluka are predominantly tribal. The influence of climatic and physical environmental factors viz., rainfall, hydro geomorphology; drainage, elevation, and land cover are used to score their share in the evaluation of malariogenic condition. This was synthesized on the basis of preference over each factor and the total weights of each data and data layer were computed and visualized. The district was divided into three viz., high, moderate and low risk zones .It was observed that a geographical area of 1885.2sq.km comprising 30.3% fall in high risk zone. The risk zones identified on the basis of these parameters and assigned weights shows a close resemblance with ground condition. As the API distribution for 2011overlaid corresponds to the risk zones identified. The study demonstrates the significance and prospect of integrating Geospatial tools and Analytical Hierarchy Process for malaria risk zones and dynamics of malaria transmission.

Impact of model-based risk analysis for liver surgery planning.

PubMed

Hansen, C; Zidowitz, S; Preim, B; Stavrou, G; Oldhafer, K J; Hahn, H K

2014-05-01

A model-based risk analysis for oncologic liver surgery was described in previous work (Preim et al. in Proceedings of international symposium on computer assisted radiology and surgery (CARS), Elsevier, Amsterdam, pp. 353–358, 2002; Hansen et al. Int I Comput Assist Radiol Surg 4(5):469–474, 2009). In this paper, we present an evaluation of this method. To prove whether and how the risk analysis facilitates the process of liver surgery planning, an explorative user study with 10 liver experts was conducted. The purpose was to compare and analyze their decision-making. The results of the study show that model-based risk analysis enhances the awareness of surgical risk in the planning stage. Participants preferred smaller resection volumes and agreed more on the safety margins’ width in case the risk analysis was available. In addition, time to complete the planning task and confidence of participants were not increased when using the risk analysis. This work shows that the applied model-based risk analysis may influence important planning decisions in liver surgery. It lays a basis for further clinical evaluations and points out important fields for future research.

Advantages and Disadvantages of Physiological Assessment For Next Generation Control Room Design

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

Tuan Q. Tran; Ronald L. Boring; Donald D. Dudenhoeffer

2007-08-01

Abstract - We propose using non-obtrusive physiological assessment (e.g., eye tracking,) to assess human information processing errors (e.g., loss of vigilance) and limitations (e.g., workload) for advanced energy systems early in the design process. This physiological approach for assessing risk will circumvent many limitations of current risk methodologies such as subjective rating (e.g., rater’s biases) and performance modeling (e.g., risk assessment is scripted and is based upon the individual modeler’s judgment). Key uses will be to evaluate (early in the design process) novel control room equipment and configurations as well as newly developed automated systems that will inevitably place amore » high information load on operators. The physiological risk assessment tool will allow better precision in pinpointing problematic design issues and will provide a “real-time” assessment of risk. Furthermore, this physiological approach would extend the state-of-the-art of human reliability methods from a “static” measure to more “dynamic.” This paper will discuss a broad range of the current popular online performance gauges as well as its advantages and disadvantages for use in next generation control room.« less

Multi-hazard risk analysis for management strategies

NASA Astrophysics Data System (ADS)

Kappes, M.; Keiler, M.; Bell, R.; Glade, T.

2009-04-01

Risk management is very often operating in a reactive way, responding to an event, instead of proactive starting with risk analysis and building up the whole process of risk evaluation, prevention, event management and regeneration. Since damage and losses from natural hazards raise continuously more and more studies, concepts (e.g. Switzerland or South Tyrol-Bolozano) and software packages (e.g. ARMAGEDOM, HAZUS or RiskScape) are developed to guide, standardize and facilitate the risk analysis. But these approaches focus on different aspects and are mostly closely adapted to the situation (legislation, organization of the administration, specific processes etc.) of the specific country or region. We propose in this study the development of a flexible methodology for multi-hazard risk analysis, identifying the stakeholders and their needs, processes and their characteristics, modeling approaches as well as incoherencies occurring by combining all these different aspects. Based on this concept a flexible software package will be established consisting of ArcGIS as central base and being complemented by various modules for hazard modeling, vulnerability assessment and risk calculation. Not all modules will be developed newly but taken from the current state-of-the-art and connected or integrated into ArcGIS. For this purpose two study sites, Valtellina in Italy and Bacelonnette in France, were chosen and the hazards types debris flows, rockfalls, landslides, avalanches and floods are planned to be included in the tool for a regional multi-hazard risk analysis. Since the central idea of this tool is its flexibility this will only be a first step, in the future further processes and scales can be included and the instrument thus adapted to any study site.

Remedial Action Assessment System: A computer-based methodology for conducting feasibility studies

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

White, M.K.; Buelt, J.L.; Stottlemyre, J.A.

1991-02-01

Because of the complexity and number of potential waste sites facing the US Department of Energy (DOE) for potential cleanup, DOE is supporting the development of a computer-based methodology to streamline the remedial investigation/feasibility study process. The Remedial Action Assessment System (RAAS), can be used for screening, linking, and evaluating established technology processes in support of conducting feasibility studies. It is also intended to do the same in support of corrective measures studies. The user interface employs menus, windows, help features, and graphical information while RAAS is in operation. Object-oriented programming is used to link unit processes into sets ofmore » compatible processes that form appropriate remedial alternatives. Once the remedial alternatives are formed, the RAAS methodology can evaluate them in terms of effectiveness, implementability, and cost. RAAS will access a user-selected risk assessment code to determine the reduction of risk after remedial action by each recommended alternative. The methodology will also help determine the implementability of the remedial alternatives at a site and access cost estimating tools to provide estimates of capital, operating, and maintenance costs. This paper presents the characteristics of two RAAS prototypes currently being developed. These include the RAAS Technology Information System, which accesses graphical, tabular and textual information about technologies, and the main RAAS methodology, which screens, links, and evaluates remedial technologies. 4 refs., 3 figs., 1 tab.« less

A quantitative risk assessment model to evaluate effective border control measures for rabies prevention

PubMed Central

Weng, Hsin-Yi; Wu, Pei-I; Yang, Ping-Cheng; Tsai, Yi-Lun; Chang, Chao-Chin

2009-01-01

Border control is the primary method to prevent rabies emergence. This study developed a quantitative risk model incorporating stochastic processes to evaluate whether border control measures could efficiently prevent rabies introduction through importation of cats and dogs using Taiwan as an example. Both legal importation and illegal smuggling were investigated. The impacts of reduced quarantine and/or waiting period on the risk of rabies introduction were also evaluated. The results showed that Taiwan’s current animal importation policy could effectively prevent rabies introduction through legal importation of cats and dogs. The median risk of a rabid animal to penetrate current border control measures and enter Taiwan was 5.33 × 10−8 (95th percentile: 3.20 × 10−7). However, illegal smuggling may pose Taiwan to the great risk of rabies emergence. Reduction of quarantine and/or waiting period would affect the risk differently, depending on the applied assumptions, such as increased vaccination coverage, enforced custom checking, and/or change in number of legal importations. Although the changes in the estimated risk under the assumed alternatives were not substantial except for completely abolishing quarantine, the consequences of rabies introduction may yet be considered to be significant in a rabies-free area. Therefore, a comprehensive benefit-cost analysis needs to be conducted before recommending these alternative measures. PMID:19822125

A Risk Management Framework to Characterize Black Swan Risks: A Case Study of Lightning Effects on Insensitive High Explosives

NASA Astrophysics Data System (ADS)

Sanders, Gary A.

Effective and efficient risk management processes include the use of high fidelity modeling and simulation during the concept exploration phase as part of the technology and risk assessment activities, with testing and evaluation tasks occurring in later design development phases. However, some safety requirements and design architectures may be dominated by the low probability/high consequence "Black Swan" vulnerabilities that require very early testing to characterize and efficiently mitigate. Failure to address these unique risks has led to catastrophic systems failures including the space shuttle Challenger, Deepwater Horizon, Fukushima nuclear reactor, and Katrina dike failures. Discovering and addressing these risks later in the design and development process can be very costly or even lead to project cancellation. This paper examines the need for risk management process adoption of early hazard phenomenology testing to inform the technical risk assessment, requirements definition and conceptual design. A case study of the lightning design vulnerability of the insensitive high explosives being used in construction, mining, demolition, and defense industries will be presented to examine the impact of this vulnerability testing during the concept exploration phase of the design effort. While these insensitive high explosives are far less sensitive to accidental initiation by fire, impact, friction or even electrical stimuli, their full range of sensitivities have not been characterized and ensuring safe engineering design and operations during events such as lightning storms requires vulnerability testing during the risk assessment phase.

Commentary: IARC Monographs Program and public health under siege by corporate interests.

PubMed

Infante, Peter F; Melnick, Ronald; Vainio, Harri; Huff, James

2018-04-01

The International Agency for Research on Cancer (IARC) evaluates causes of cancer with help from independent international experts in an open and transparent manner. Countries, research and regulatory agencies, and other organizations adopt IARC evaluations for communication of human cancer hazards, and for strategies to prevent cancer. Scientists worldwide endorse IARC cancer evaluations and process. Those with economic interests, however, challenge IARC's cancer evaluations, most recently for glyphosate and red and processed meats, and are conducting a campaign including intervention from US Congressional Representatives to discredit IARC's review process and to undermine financial support-a campaign intimidating to IARC and Working Group members. Challenges to scientific interpretations serve to advance science and should be resolved by scientific experts who do not have conflicts of interest. Such interference does not bode well for the free flow of scientific information that informs and protects the public from risks of cancer. © 2018 Wiley Periodicals, Inc.

Identifying Falls Risk Screenings Not Documented with Administrative Codes Using Natural Language Processing

PubMed Central

Zhu, Vivienne J; Walker, Tina D; Warren, Robert W; Jenny, Peggy B; Meystre, Stephane; Lenert, Leslie A

2017-01-01

Quality reporting that relies on coded administrative data alone may not completely and accurately depict providers’ performance. To assess this concern with a test case, we developed and evaluated a natural language processing (NLP) approach to identify falls risk screenings documented in clinical notes of patients without coded falls risk screening data. Extracting information from 1,558 clinical notes (mainly progress notes) from 144 eligible patients, we generated a lexicon of 38 keywords relevant to falls risk screening, 26 terms for pre-negation, and 35 terms for post-negation. The NLP algorithm identified 62 (out of the 144) patients who falls risk screening documented only in clinical notes and not coded. Manual review confirmed 59 patients as true positives and 77 patients as true negatives. Our NLP approach scored 0.92 for precision, 0.95 for recall, and 0.93 for F-measure. These results support the concept of utilizing NLP to enhance healthcare quality reporting. PMID:29854264

QUANTITATIVE PROCEDURES FOR NEUROTOXICOLOGY RISK ASSESSMENT

EPA Science Inventory

In this project, previously published information on biologically based dose-response model for brain development was used to quantitatively evaluate critical neurodevelopmental processes, and to assess potential chemical impacts on early brain development. This model has been ex...

A Spike Cocktail Approach to Improve Microbial Performance Monitoring for Water Reuse.

PubMed

Zimmerman, Brian D; Korajkic, Asja; Brinkman, Nichole E; Grimm, Ann C; Ashbolt, Nicholas J; Garland, Jay L

  Water reuse, via either centralized treatment of traditional wastewater or decentralized treatment and on-site reuse, is becoming an increasingly important element of sustainable water management. Despite advances in waterborne pathogen detection methods, low and highly variable pathogen levels limit their utility for routine evaluation of health risks in water reuse systems. Therefore, there is a need to improve our understanding of the linkage between pathogens and more readily measured process indicators during treatment. This paper describes an approach for constructing spiking experiments to relate the behavior of viral, bacterial, and protozoan pathogens with relevant process indicators. General issues are reviewed, and the spiking protocol is applied as a case study example to improve microbial performance monitoring and health risk evaluation in a water reuse system. This approach provides a foundation for the development of novel approaches to improve real or near-real time performance monitoring of water recycling systems.

Remote Sensing and Modeling of Landslides: Detection, Monitoring and Risk Evaluation

NASA Technical Reports Server (NTRS)

Kirschbaum, Dalia; Fukuoka, Hiroshi

2012-01-01

Landslides are one of the most pervasive hazards in the world, resulting in more fatalities and economic damage than is generally recognized_ Occurring over an extensive range of lithologies, morphologies, hydrologies, and climates, mass movements can be triggered by intense or prolonged rainfall, seismicity, freeze/thaw processes, and antbropogertic activities, among other factors. The location, size, and timing of these processes are characteristically difficult to predict and assess because of their localized spatial scales, distribution, and complex interactions between rainfall infiltration, hydromechanical properties of the soil, and the underlying surface composition. However, the increased availability, accessibility, and resolution of remote sensing data offer a new opportunity to explore issues of landslide susceptibility, hazard, and risk over a variety of spatial scales. This special issue presents a series of papers that investigate the sources, behavior, and impacts of different mass movement types using a diverse set of data sources and evaluation methodologies.

Risk Management Interventions to Reduce Injuries and Maximize Economic Benefits in U.S. Mining.

PubMed

Griffin, Stephanie C; Bui, David P; Gowrisankaran, Gautam; Lutz, Eric A; He, Charles; Hu, Chengcheng; Burgess, Jefferey L

2018-03-01

Risk management (RM) is a cyclical process of identifying and ranking risks, implementing controls, and evaluating their effectiveness. This study aims to identify effective RM interventions in the U.S. mining industry. RM interventions were identified in four companies representing metal, aggregate, and coal mining sectors. Injury rates were determined using Mine Safety and Health Administration (MSHA) data and changes in injury rates identified through change point analysis. Program implementation costs and associated changes in injury costs were evaluated for select interventions. Six of 20 RM interventions were associated with a decline in all injuries and one with a reduction in lost-time injuries, all with a positive return on investment. Reductions in injuries and associated costs were observed following implementation of a limited number of specific RM interventions.

Evaluating Process Effectiveness to Reduce Risk

NASA Technical Reports Server (NTRS)

Shepherd, Christena C.

2017-01-01

It is well documented that government agencies do not have the same incentive as the private sector to focus on process effectiveness and continual improvement of those processes. It is also well documented whenever government agencies fail to deliver efficient, effective, consistent, and fair services to the citizens. In spite of the various "reinventing government" and "effectiveness initiatives" of the past decades, and in spite of the efforts on the part of many agencies to improve, government in general still lags behind industry in creating a culture of effective processes and systems. While the tragic events that unfolded recently in Flint, Michigan, teach us that running government "like a business" does not always take the needs of the citizenry into account, there are many lessons and techniques from the private sector that government agencies can use to improve. The incentive to improve, while mandated by various administrations1, needs to come from within the workforce, in order to effectively take root. The best, most effective incentive is to reduce, control or eliminate risk. Government agencies face some of the same risks as the private sector, while some are unique. While ISO 310002 has been around since 2009, risk has taken on increased visibility within the private sector with the advent of the emphasis on risk-based thinking in ISO 9001:20153. The relationship between risk-based thinking and effective processes is simple and direct. Those processes that are well thought out and standardized (i.e. Plan-Do-Check-Act), will have taken into account the applicable policy, statutory, regulatory, safety, quality and technical parameters, which may not occur to someone performing the process with minimal experience or training; and thus protect the employees, the public and the agency from statutory and regulatory violations; delay in providing services; non-delivery of services; harm to public or employee safety and health; cost overruns; breaches in security; loss of confidence in government; failure of publicly funded projects; damage to the environment; ethics violations, and the list goes on; with local, national and even international consequences. The Plan-Do-Check-Act process, also known as the "process approach" can be used at any time to establish and standardize a process, and it can also be used to check periodically for "process creep" (i.e., informal, unauthorized changes that have occurred over time), any necessary updates and improvements. While ISO 9001 compliance is not mandated for all government agencies, if interpreted correctly, it can be useful in establishing a framework and implementing effective management systems and processes.4 Another method that can be used to evaluate effectiveness is the scorecard definitions in Mallory's Process Management Standard5 as a basis for evaluating work on the process level on effective, and continuously improved and improving processes. With processes on the lower end of the scale, agencies are vulnerable to a great many risks, with employees and managers making up many of the rules as they go, leading to the above listed negative results. Without clear guidance for nominal operations, off-nominal situations can, and do, increase the likelihood of chaos. In an increasingly technical environment, with inter-agency communication and collaboration becoming the norm, agencies need to come to grips with the fact that processes can become rapidly outdated, and that the technical community should take on an increased role in the maturation of the agency's processes. Industry has long known that effective processes are also efficient, and process improvement methods such as Kaizen, Lean, Six Sigma, 5S, and mistake proofing lead to increased productivity, improved quality, and decreased cost. Again, government agencies have different concerns, but inefficiencies and mistakes can have dire and wide reaching consequences for the public that they serve. While no one goes to work planning to cause harm, it is up to agencies to establish upper level systems, which make establishment and compliance with processes possible. Again, Mallory provides us with a Systems Management Standard6, similar to the Process Management Standard, with a scale of 0-5 for systems effectiveness and maturity. Deming determined that "eighty-five percent of the reasons for failure are deficiencies in the systems and process rather than the employee. The role of management is to change the process rather than badgering individual employees to do better." 7 It is not just the working level employees who need effective processes, but the mid-and upper level managers as well. A disciplined management culture sets the tone for the employees, aids both routine and off-nominal decision-making, and incorporates risk -based thinking into the systems and processes as a matter of normal activity. Figure 1, illustrates the relationship between ineffective and effective processes and risk, through the use of the "stoplight" colors that are commonly used to show serious situations (red), situations which may be improving or deteriorating depending on trends (yellow), and situations that are under control and continuously improved (green).

Supporting virtual enterprise design by a web-based information model

NASA Astrophysics Data System (ADS)

Li, Dong; Barn, Balbir; McKay, Alison; de Pennington, Alan

2001-10-01

Development of IT and its applications have led to significant changes in business processes. To pursue agility, flexibility and best service to customers, enterprises focus on their core competence and dynamically build relationships with partners to form virtual enterprises as customer driven temporary demand chains/networks. Building the networked enterprise needs responsively interactive decisions instead of a single-direction partner selection process. Benefits and risks in the combination should be systematically analysed, and aggregated information about value-adding abilities and risks of networks needs to be derived from interactions of all partners. In this research, a hierarchical information model to assess partnerships for designing virtual enterprises was developed. Internet technique has been applied to the evaluation process so that interactive decisions can be visualised and made responsively during the design process. The assessment is based on the process which allows each partner responds to requirements of the virtual enterprise by planning its operational process as a bidder. The assessment is then produced by making an aggregated value to represent prospect of the combination of partners given current bidding. Final design is a combination of partners with the greatest total value-adding capability and lowest risk.

Use of failure mode, effect and criticality analysis to improve safety in the medication administration process.

PubMed

Rodriguez-Gonzalez, Carmen Guadalupe; Martin-Barbero, Maria Luisa; Herranz-Alonso, Ana; Durango-Limarquez, Maria Isabel; Hernandez-Sampelayo, Paloma; Sanjurjo-Saez, Maria

2015-08-01

To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index. This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized. Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility. FMECA is a useful approach that can improve the medication administration process. © 2015 John Wiley & Sons, Ltd.

Identification and assessment of common errors in the admission process of patients in Isfahan Fertility and Infertility Center based on "failure modes and effects analysis".

PubMed

Dehghan, Ashraf; Abumasoudi, Rouhollah Sheikh; Ehsanpour, Soheila

2016-01-01

Infertility and errors in the process of its treatment have a negative impact on infertile couples. The present study was aimed to identify and assess the common errors in the reception process by applying the approach of "failure modes and effects analysis" (FMEA). In this descriptive cross-sectional study, the admission process of fertility and infertility center of Isfahan was selected for evaluation of its errors based on the team members' decision. At first, the admission process was charted through observations and interviewing employees, holding multiple panels, and using FMEA worksheet, which has been used in many researches all over the world and also in Iran. Its validity was evaluated through content and face validity, and its reliability was evaluated through reviewing and confirmation of the obtained information by the FMEA team, and eventually possible errors, causes, and three indicators of severity of effect, probability of occurrence, and probability of detection were determined and corrective actions were proposed. Data analysis was determined by the number of risk priority (RPN) which is calculated by multiplying the severity of effect, probability of occurrence, and probability of detection. Twenty-five errors with RPN ≥ 125 was detected through the admission process, in which six cases of error had high priority in terms of severity and occurrence probability and were identified as high-risk errors. The team-oriented method of FMEA could be useful for assessment of errors and also to reduce the occurrence probability of errors.

Identification and assessment of common errors in the admission process of patients in Isfahan Fertility and Infertility Center based on “failure modes and effects analysis”

PubMed Central

Dehghan, Ashraf; Abumasoudi, Rouhollah Sheikh; Ehsanpour, Soheila

2016-01-01

Background: Infertility and errors in the process of its treatment have a negative impact on infertile couples. The present study was aimed to identify and assess the common errors in the reception process by applying the approach of “failure modes and effects analysis” (FMEA). Materials and Methods: In this descriptive cross-sectional study, the admission process of fertility and infertility center of Isfahan was selected for evaluation of its errors based on the team members’ decision. At first, the admission process was charted through observations and interviewing employees, holding multiple panels, and using FMEA worksheet, which has been used in many researches all over the world and also in Iran. Its validity was evaluated through content and face validity, and its reliability was evaluated through reviewing and confirmation of the obtained information by the FMEA team, and eventually possible errors, causes, and three indicators of severity of effect, probability of occurrence, and probability of detection were determined and corrective actions were proposed. Data analysis was determined by the number of risk priority (RPN) which is calculated by multiplying the severity of effect, probability of occurrence, and probability of detection. Results: Twenty-five errors with RPN ≥ 125 was detected through the admission process, in which six cases of error had high priority in terms of severity and occurrence probability and were identified as high-risk errors. Conclusions: The team-oriented method of FMEA could be useful for assessment of errors and also to reduce the occurrence probability of errors. PMID:28194208

How to Assess the Biomechanical Risk Levels in Beekeeping.

PubMed

Maina, G; Rossi, F; Baracco, A

2016-01-01

Beekeepers are at particular risk of developing work-related musculoskeletal disorders, but many of the studies lack detailed exposure assessment. To evaluate the biomechanical overload exposure in a specific farming activity, a multitasking model has been developed through the characterization of 37 basic operational tasks typical of the beekeeping activity. The Occupational Repetitive Actions (OCRA) Checklist and the National Institute for Occupational Safety and Health (NIOSH) Lifting Index methodologies have been applied to these elementary tasks to evaluate the exposure, and the resulting risk indices have been time-weighted averaged. Finally, an easy access, computer-assisted toolkit has been developed to help the beekeepers in the biomechanical risk assessment process. The risk of biomechanical overload for the upper limbs ranges from acceptable (maintenance and recovery of woody material and honey packaging with dosing machine tasks) to high (distribution of the top supers) risk level. The risk for back injury is always borderline in women and increases with exposure time, whereas it ranges from acceptable to borderline in men. The definition of the biomechanical risk levels allows for planning of corrective actions aimed at preventing and reducing the risk of musculoskeletal disorders through engineering, administrative, and behavioral interventions. The methodology can be used for risk assessment in other mainly manual agricultural activities.

The use of failure mode and effects analysis to construct an effective disposal and prevention mechanism for infectious hospital waste

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

Ho, Chao Chung, E-mail: ho919@pchome.com.tw; Liao, Ching-Jong

Highlights: > This study is based on a real case in a regional teaching hospital in Taiwan. > We use Failure mode and effects analysis (FMEA) as the evaluation method. > We successfully identify the risk factors of infectious waste disposal. > We propose plans for the detection of exceptional cases of infectious waste. - Abstract: In recent times, the quality of medical care has been continuously improving in medical institutions wherein patient-centred care has been emphasized. Failure mode and effects analysis (FMEA) has also been promoted as a method of basic risk management and as part of total qualitymore » management (TQM) for improving the quality of medical care and preventing mistakes. Therefore, a study was conducted using FMEA to evaluate the potential risk causes in the process of infectious medical waste disposal, devise standard procedures concerning the waste, and propose feasible plans for facilitating the detection of exceptional cases of infectious waste. The analysis revealed the following results regarding medical institutions: (a) FMEA can be used to identify the risk factors of infectious waste disposal. (b) During the infectious waste disposal process, six items were scored over 100 in the assessment of uncontrolled risks: erroneous discarding of infectious waste by patients and their families, erroneous discarding by nursing staff, erroneous discarding by medical staff, cleaning drivers pierced by sharp articles, cleaning staff pierced by sharp articles, and unmarked output units. Therefore, the study concluded that it was necessary to (1) provide education and training about waste classification to the medical staff, patients and their families, nursing staff, and cleaning staff; (2) clarify the signs of caution; and (3) evaluate the failure mode and strengthen the effects.« less

Modeling and managing risk early in software development

NASA Technical Reports Server (NTRS)

Briand, Lionel C.; Thomas, William M.; Hetmanski, Christopher J.

1993-01-01

In order to improve the quality of the software development process, we need to be able to build empirical multivariate models based on data collectable early in the software process. These models need to be both useful for prediction and easy to interpret, so that remedial actions may be taken in order to control and optimize the development process. We present an automated modeling technique which can be used as an alternative to regression techniques. We show how it can be used to facilitate the identification and aid the interpretation of the significant trends which characterize 'high risk' components in several Ada systems. Finally, we evaluate the effectiveness of our technique based on a comparison with logistic regression based models.

Risk analysis for biological hazards: What we need to know about invasive species

USGS Publications Warehouse

Stohlgren, T.J.; Schnase, J.L.

2006-01-01

Risk analysis for biological invasions is similar to other types of natural and human hazards. For example, risk analysis for chemical spills requires the evaluation of basic information on where a spill occurs; exposure level and toxicity of the chemical agent; knowledge of the physical processes involved in its rate and direction of spread; and potential impacts to the environment, economy, and human health relative to containment costs. Unlike typical chemical spills, biological invasions can have long lag times from introduction and establishment to successful invasion, they reproduce, and they can spread rapidly by physical and biological processes. We use a risk analysis framework to suggest a general strategy for risk analysis for invasive species and invaded habitats. It requires: (1) problem formation (scoping the problem, defining assessment endpoints); (2) analysis (information on species traits, matching species traits to suitable habitats, estimating exposure, surveys of current distribution and abundance); (3) risk characterization (understanding of data completeness, estimates of the “potential” distribution and abundance; estimates of the potential rate of spread; and probable risks, impacts, and costs); and (4) risk management (containment potential, costs, and opportunity costs; legal mandates and social considerations and information science and technology needs).

My friends have a word for it: Event-related potentials evidence of how social risk inhibits purchase intention.

PubMed

Shang, Qian; Pei, Guanxiong; Jin, Jia

2017-03-16

Social risk refers to the potential disapproval from significant others (especially family or friends), and it is crucial in dissuading consumers from making decisions to purchase. The current study explored the neural process underlying how social risk influenced people's purchase intention. Event-related potentials (ERPs) were employed to investigate the electrophysiological process when subjects evaluated their purchase intention for products with social risk factors. The behavioral data showed that the social risk condition inhibited people's purchase intention compared to the control condition. Neurophysiologically, larger anterior N2 amplitude was induced by the social risk condition in contrast with the control condition. We suggest that this anterior N2 may reflect the cognitive control or conflict monitoring. It may be that the participant has to regulate the conflict between an internal desire to purchase the item and the discordant information obtained from the social risk sentence, which would pressure the participant to not purchase the item in accord with social norms. These findings will be helpful in understanding the neural basis of social risk perception during purchase decisions. Copyright © 2017 Elsevier B.V. All rights reserved.

[Evaluating the Significance of Odor Gas Released During the Directly Drying Process of Sludge: Based on the Multi-index Integrated Assessment Method].

PubMed

Ding, Wen-jie; Chen, Wen-he; Deng, Ming-jia; Luo, Hui; Li, Lin; Liu, Jun-xin

2016-02-15

Co-processing of sewage sludge using the cement kiln can realize sludge harmless treatment, quantity reduction, stabilization and reutilization. The moisture content should be reduced to below 30% to meet the requirement of combustion. Thermal drying is an effective way for sludge desiccation. Odors and volatile organic compounds are generated and released during the sludge drying process, which could lead to odor pollution. The main odor pollutants were selected by the multi-index integrated assessment method. The concentration, olfactory threshold, threshold limit value, smell security level and saturated vapor pressure were considered as indexes based on the related regulations in China and foreign countries. Taking the pollution potential as the evaluation target, and the risk index and odor emission intensity as evaluation indexes, the odor pollution potential rated evaluation model of the pollutants was built according to the Weber-Fechner law. The aim of the present study is to form the rating evaluation method of odor potential pollution capacity suitable for the directly drying process of sludge.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

Hey girlfriend: an evaluation of AIDS prevention among women in the sex industry.

PubMed

Dorfman, L E; Derish, P A; Cohen, J B

1992-01-01

Increasingly, acquired immunodeficiency syndrome (AIDS) prevention programs have been developed to reach and influence street-based populations. Standard methods of evaluation do not fit the conditions of such programs. This article describes a process and outcome evaluation of an AIDS prevention program for sex workers in which qualitative and quantitative methods were combined in order to mediate research problems endemic to street-based populations. Methods included epidemiological questionnaires, open-ended interviews with participants, and ethnographic field notes. Process evaluation findings show that field staff who were indigenous to the neighborhood and population readily gained access to the community of sex workers and simultaneously became role models for positive behavior change. Outcome findings show that sex workers do feel at risk for AIDS, but usually from clients rather than from husbands or boyfriends. Accordingly, they use condoms more frequently with clients than with steady partners. Increasing condom use among sex workers with their steady partners remains an important challenge for AIDS prevention. Combining qualitative and quantitative research data provided a more comprehensive assessment of how to reach sex workers with effective AIDS risk reduction messages than either method could have provided alone.

Underwriting: a key to healthy capitation agreements.

PubMed

Dameron, T H; Fessler, J C

1996-09-01

In some markets, healthcare providers in integrated delivery systems have been assuming full-risk capitated contracts. Some of these contracts have been profitable, but others have produced inconsistent financial results. These results may reflect inadequate underwriting practices. For providers and HMO insurers to establish financially successful capitation agreements, they must develop and audit an underwriting process to evaluate the health risk of the population entering the managed care system.

Radiation hazards in scoliosis management

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

Drummond, D.; Ranallo, F.; Lonstein, J.

1983-10-01

Safe radiography in scoliosis management is based on a sound knowledge of 1) the radiographic imaging process, 2) the degree of risk to the patient from radiation exposure, and 3) the radiographic requirements to both evaluate and follow patients with spine deformity. This paper is a current review of the subject and work done at the authors' centers. It includes recommendations for reducing the radiation risk while maintaining necessary diagnostic information.

Molecular epidemiology: new rules for new tools?

PubMed

Merlo, Domenico Franco; Sormani, Maria Pia; Bruzzi, Paolo

2006-08-30

Molecular epidemiology combines biological markers and epidemiological observations in the study of the environmental and genetic determinants of cancer and other diseases. The potential advantages associated with biomarkers are manifold and include: (a) increased sensitivity and specificity to carcinogenic exposures; (b) more precise evaluation of the interplay between genetic and environmental determinants of cancer; (c) earlier detection of carcinogenic effects of exposure; (d) characterization of disease subtypes-etiologies patterns; (e) evaluation of primary prevention measures. These, in turn, may translate into better tools for etiologic research, individual risk assessment, and, ultimately, primary and secondary prevention. An area that has not received sufficient attention concerns the validation of these biomarkers as surrogate endpoints for cancer risk. Validation of a candidate biomarker's surrogacy is the demonstration that it possesses the properties required for its use as a substitute for a true endpoint. The principles underlying the validation process underwent remarkable developments and discussion in therapeutic research. However, the challenges posed by the application of these principles to epidemiological research, where the basic tool for this validation (i.e., the randomized study) is seldom possible, have not been thoroughly explored. The validation process of surrogacy must be applied rigorously to intermediate biomarkers of cancer risk before using them as risk predictors at the individual as well as at the population level.

Hyperspectral remote sensing and GIS techniques application for the evaluation and monitoring of interactions between natural risks and industrial hazards

NASA Astrophysics Data System (ADS)

Marino, Alessandra; Ludovisi, Giancarlo; Moccaldi, Antonio; Damiani, Fiorenzo

2001-02-01

The aim of this paper is to outline the potential of imaging spectroscopy and GIS techniques as tool for the management of data rich environments, as complex fluvial areas, exposed to geological, geomorphological, and hydrogeological risks. The area of study, the Pescara River Basin is characterized by the presence of important industrial sites and by the occurrence of floods, landslides and seismic events. Data were collected, during a specific flight, using an hyperspectral MIVIS sensor. Images have been processed in order to obtain updated and accurate land-cover and land-use maps that have been inserted in a specific GIS database and integrated with further information like lithology, geological structure, geomorphology, hydrogeological features, productive plants location and characters. The processing of data layers was performed, using a dedicated software, through typical GIS operators like indexing, recording, matrix analysis, proximity analysis. The interactions between natural risks, industrial installations, agricultural areas, water resources and urban settlements have been analyzed. This allowed the creation and processing of thematic layers like vulnerability, risk and impact maps.

Microfinance institutions and a coastal community's disaster risk reduction, response, and recovery process: a case study of Hatiya, Bangladesh.

PubMed

Parvin, Gulsan Ara; Shaw, Rajib

2013-01-01

Several researchers have examined the role of microfinance institutions (MFIs) in poverty alleviation, but the part that they play in disaster risk reduction remains unaddressed. Through an empirical study of Hatiya Island, one of the most vulnerable coastal communities of Bangladesh, this research evaluates perceptions of MFI support for the disaster risk reduction, response, and recovery process. The findings reveal no change in relation to risk reduction and income and occupation aspects for more than one-half of the clients of MFIs. In addition, only 26 per cent of them have witnessed less damage as a result of being members of MFIs. One can argue, though, that the longer the membership time period the better the disaster preparedness, response, and recovery process. The outcomes of this study could help to guide the current efforts of MFIs to enhance the ability of coastal communities to prepare for and to recover from disasters efficiently and effectively. © 2013 The Author(s). Journal compilation © Overseas Development Institute, 2013.

Grand Junction projects office mixed-waste treatment program, VAC*TRAX mobile treatment unit process hazards analysis

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

Bloom, R.R.

1996-04-01

The objective of this report is to demonstrate that a thorough assessment of the risks associated with the operation of the Rust Geotech patented VAC*TRAX mobile treatment unit (MTU) has been performed and documented. The MTU was developed to treat mixed wastes at the US Department of Energy (DOE) Albuquerque Operations Office sites. The MTU uses an indirectly heated, batch vacuum dryer to thermally desorb organic compounds from mixed wastes. This process hazards analysis evaluated 102 potential hazards. The three significant hazards identified involved the inclusion of oxygen in a process that also included an ignition source and fuel. Changesmore » to the design of the MTU were made concurrent with the hazard identification and analysis; all hazards with initial risk rankings of 1 or 2 were reduced to acceptable risk rankings of 3 or 4. The overall risk to any population group from operation of the MTU was determined to be very low; the MTU is classified as a Radiological Facility with low hazards.« less

The impact of fear appeals on processing and acceptance of action recommendations.

PubMed

de Hoog, Natascha; Stroebe, Wolfgang; de Wit, John B F

2005-01-01

A stage model of processing of fear-arousing communications was tested in an experiment that examined the impact of vulnerability to a severe health risk, the quality of the arguments supporting a protective action recommendation, and the source to which the recommendation was attributed, on processing and acceptance of the recommendation. Argument quality influenced attitudes toward the recommendation (but not intention to act), and this effect was mediated by negative thoughts about the recommendation. Vulnerability influenced intention to act (but not attitudes), and this effect was mediated by perceived threat and positive thoughts about the recommendation. The pattern of findings suggests that although vulnerability to a severe health risk induces biased processing of the recommendation, biased processing is restricted to intentions and does not compromise the evaluation of the recommendation. The theoretical and practical implications of these findings are discussed.

A Preliminary Anthropometry Standard for Australian Army Equipment Evaluation

DTIC Science & Technology

2014-08-01

UNCLASSIFIED Authors Mark Edwards Land Division Mark Edwards holds an undergraduate degree in Industrial Design , a Masters in Ergonomics ...equipment. Given that a built system is not a requirement of the processes described, this standard can also be used early in the design process to de...risk the design process. It must be noted that the data provided in this report are representative of the 2012 ADF Army population. The impacts

Systemic inflammation as a predictor of brain aging: Contributions of physical activity, metabolic risk, and genetic risk.

PubMed

Corlier, Fabian; Hafzalla, George; Faskowitz, Joshua; Kuller, Lewis H; Becker, James T; Lopez, Oscar L; Thompson, Paul M; Braskie, Meredith N

2018-05-15

Inflammatory processes may contribute to risk for Alzheimer's disease (AD) and age-related brain degeneration. Metabolic and genetic risk factors, and physical activity may, in turn, influence these inflammatory processes. Some of these risk factors are modifiable, and interact with each other. Understanding how these processes together relate to brain aging will help to inform future interventions to treat or prevent cognitive decline. We used brain magnetic resonance imaging (MRI) to scan 335 older adult humans (mean age 77.3 ± 3.4 years) who remained non-demented for the duration of the 9-year longitudinal study. We used structural equation modeling (SEM) in a subset of 226 adults to evaluate whether measures of baseline peripheral inflammation (serum C-reactive protein levels; CRP), mediated the baseline contributions of genetic and metabolic risk, and physical activity, to regional cortical thickness in AD-relevant brain regions at study year 9. We found that both baseline metabolic risk and AD risk variant apolipoprotein E ε4 (APOE4), modulated baseline serum CRP. Higher baseline CRP levels, in turn, predicted thinner regional cortex at year 9, and mediated an effect between higher metabolic risk and thinner cortex in those regions. A higher polygenic risk score composed of variants in immune-associated AD risk genes (other than APOE) was associated with thinner regional cortex. However, CRP levels did not mediate this effect, suggesting that other mechanisms may be responsible for the elevated AD risk. We found interactions between genetic and environmental factors and structural brain health. Our findings support the role of metabolic risk and peripheral inflammation in age-related brain decline. Copyright © 2018 Elsevier Inc. All rights reserved.

Can a pharmacy intervention improve the metabolic risks of mental health patients? Evaluation of a novel collaborative service.

PubMed

Maulavizada, Husna; Emmerton, Lynne; Hattingh, Hendrika Laetitia

2016-04-26

The pressure on healthcare services worldwide has driven the incorporation of disease state management services within community pharmacies in developed countries. Pharmacists are recognised as the most accessible healthcare professionals, and the incorporation of these services facilitates patient care. In Australia, the opportunity to manage pharmacy patients with mental illness has been underutilised, despite the existence of service models for other chronic conditions. This paper is an independent evaluation of a novel service developed by a community pharmacy in Perth, Western Australia. The service represents collaboration between a nurse practitioner and community pharmacy staff in the management of mental health patients with metabolic risks. We applied practice service standards for Australian community pharmacies to develop an evaluation framework for this novel service. This was followed by semi-structured interviews with staff members at the study pharmacy to explore service processes and procedures. Descriptive analysis of interviews was supplemented with analysis of patients' biometric data. All data were evaluated against the developed framework. The evaluation framework comprised 13 process, 5 outcomes, and 11 quality indicators. Interview data from eight staff members and biometric data from 20 community-dwelling mental health patients taking antipsychotics were evaluated against the framework. Predominantly, patients were managed by the pharmacy's nurse practitioner, with medication management provided by pharmacists. Patients' biometric measurements comprised weight, blood pressure, blood glucose levels, lipid profiles and management of obesity, smoking, hypertension and diabetes. Positive outcomes observed in the patient data included weight loss, smoking cessation, and improved blood pressure, blood glucose and lipid levels. The developed framework allowed effective evaluation of the service, and may be applicable to other pharmacy services. The metabolic clinic met key process, quality and outcomes indicators. The positive patient outcomes may assist in securing further funding.

Risk management perspective for climate service development - Results from a study on Finnish organizations

NASA Astrophysics Data System (ADS)

Harjanne, Atte; Haavisto, Riina; Tuomenvirta, Heikki; Gregow, Hilppa

2017-10-01

Weather, climate and climate change can cause significant risks to businesses and public administration. However, understanding these processes can also create opportunities. Information can help to manage these risks and opportunities, but in order to do so, it must be in line with how risk management and decision making works. To better understand how climate risks and opportunities are reflected in different organizational processes and what types of information is needed and used, we conducted a study on the perceptions and management of weather and climate risks in Finnish organizations and on their use of weather and climate information. In addition, we collected feedback on how the existing climate information tools should be developed. Data on climate risk management was collected in an online survey and in one full-day workshop. The survey was aimed to the Finnish public and private organizations who use weather and climate data and altogether 118 responses were collected. The workshop consisted of two parts: weather and climate risk management processes in general and the development of the current information tools to further address user needs.

We found that climate risk management in organizations is quite diverse and often de-centralized and that external experts are considered the most useful sources of information. Consequently, users emphasize the need for networks of expertise and sector-specific information tools. Creating such services requires input and information sharing from the user side as well. Better temporal and spatial accuracy is naturally asked for, but users also stressed the need for transparency when it comes to communicating uncertainties, and the availability and up-to-datedness of information. Our results illustrate that weather and climate risks compete and blend in with other risks and changes perceived by the organizations and supporting information is sought from different types of sources. Thus the design and evaluation of climate services should take into account the context of existing and developing processes in organizational risk management.

Bimodal fuzzy analytic hierarchy process (BFAHP) for coronary heart disease risk assessment.

PubMed

Sabahi, Farnaz

2018-04-04

Rooted deeply in medical multiple criteria decision-making (MCDM), risk assessment is very important especially when applied to the risk of being affected by deadly diseases such as coronary heart disease (CHD). CHD risk assessment is a stochastic, uncertain, and highly dynamic process influenced by various known and unknown variables. In recent years, there has been a great interest in fuzzy analytic hierarchy process (FAHP), a popular methodology for dealing with uncertainty in MCDM. This paper proposes a new FAHP, bimodal fuzzy analytic hierarchy process (BFAHP) that augments two aspects of knowledge, probability and validity, to fuzzy numbers to better deal with uncertainty. In BFAHP, fuzzy validity is computed by aggregating the validities of relevant risk factors based on expert knowledge and collective intelligence. By considering both soft and statistical data, we compute the fuzzy probability of risk factors using the Bayesian formulation. In BFAHP approach, these fuzzy validities and fuzzy probabilities are used to construct a reciprocal comparison matrix. We then aggregate fuzzy probabilities and fuzzy validities in a pairwise manner for each risk factor and each alternative. BFAHP decides about being affected and not being affected by ranking of high and low risks. For evaluation, the proposed approach is applied to the risk of being affected by CHD using a real dataset of 152 patients of Iranian hospitals. Simulation results confirm that adding validity in a fuzzy manner can accrue more confidence of results and clinically useful especially in the face of incomplete information when compared with actual results. Applying the proposed BFAHP on CHD risk assessment of the dataset, it yields high accuracy rate above 85% for correct prediction. In addition, this paper recognizes that the risk factors of diastolic blood pressure in men and high-density lipoprotein in women are more important in CHD than other risk factors. Copyright © 2018 Elsevier Inc. All rights reserved.

Remotely Sensed Quantitative Drought Risk Assessment in Vulnerable Agroecosystems

NASA Astrophysics Data System (ADS)

Dalezios, N. R.; Blanta, A.; Spyropoulos, N. V.

2012-04-01

Hazard may be defined as a potential threat to humans and their welfare and risk (or consequence) as the probability of a hazard occurring and creating loss. Drought is considered as one of the major natural hazards with significant impact to agriculture, environment, economy and society. This paper deals with drought risk assessment, which the first step designed to find out what the problems are and comprises three distinct steps, namely risk identification, risk management which is not covered in this paper, there should be a fourth step to address the need for feedback and to take post-audits of all risk assessment exercises. In particular, quantitative drought risk assessment is attempted by using statistical methods. For the qualification of drought, the Reconnaissance Drought Index (RDI) is employed, which is a new index based on hydrometeorological parameters, such as precipitation and potential evapotranspiration. The remotely sensed estimation of RDI is based on NOA-AVHRR satellite data for a period of 20 years (1981-2001). The study area is Thessaly, central Greece, which is a drought-prone agricultural region characterized by vulnerable agriculture. Specifically, the undertaken drought risk assessment processes are specified as follows: 1. Risk identification: This step involves drought quantification and monitoring based on remotely sensed RDI and extraction of several features such as severity, duration, areal extent, onset and end time. Moreover, it involves a drought early warning system based on the above parameters. 2. Risk estimation: This step includes an analysis of drought severity, frequency and their relationships. 3. Risk evaluation: This step covers drought evaluation based on analysis of RDI images before and after each drought episode, which usually lasts one hydrological year (12month). The results of these three-step drought assessment processes are considered quite satisfactory in a drought-prone region such as Thessaly in central Greece. Moreover, remote sensing has proven very effective in delineating spatial variability and features in drought monitoring and assessment.

Out-Life Characteristics of IM7/977-3 Composites

NASA Technical Reports Server (NTRS)

Miller, Sandi G.; Sutter, James K.; Hou, Tan-Hung; Scheiman, Daniel A.; Martin, Richard E.; Maryanski, Michael; Schlea, Michelle; Gardner, John M.; Schiferl, Zack R.

2010-01-01

The capability to manufacture large structures leads to weight savings and reduced risk relative to joining smaller components. However, manufacture of increasingly large composite components is pushing the out-time limits of epoxy/ carbon fiber prepreg. IM7/977-3 is an autoclave processable prepreg material, commonly used in aerospace structures. The out-time limit is reported as 30 days by the manufacturer. The purpose of this work was to evaluate the material processability and composite properties of 977-3 resin and IM7/977-3 prepreg that had been aged at room temperature for up to 60 days. The effects of room temperature aging on the thermal and visco-elastic properties of the materials were investigated. Neat resin was evaluated by differential scanning calorimetry to characterize thermal properties and change in activation energy of cure. Neat resin was also evaluated by rheometry to characterize its processability in composite fabrication. IM7/977-3 prepreg was evaluated by dynamic mechanical analysis to characterize the curing behavior. Prepreg tack was also evaluated over 60 days. The overall test results suggested that IM7/977-3 was a robust material that offered quality laminates throughout this aging process when processed by autoclave.

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

DeRosa, C.T.; Choudhury, H.; Schoeny, R.S.

Risk assessment can be thought of as a conceptual approach to bridge the gap between the available data and the ultimate goal of characterizing the risk or hazard associated with a particular environmental problem. To lend consistency to and to promote quality in the process, the US Environmental Protection Agency (EPA) published Guidelines for Risk Assessment of Carcinogenicity, Developmental Toxicity, Germ Cell Mutagenicity and Exposure Assessment, and Risk Assessment of Chemical Mixtures. The guidelines provide a framework for organizing the information, evaluating data, and for carrying out the risk assessment in a scientifically plausible manner. In the absence of sufficientmore » scientific information or when abundant data are available, the guidelines provide alternative methodologies that can be employed in the risk assessment. 4 refs., 3 figs., 2 tabs.« less

Risk assessment guidance for Superfund: Volume 1 -- Human health evaluation manual. Supplement to Part A: Community involvement in Superfund risk assessments

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

NONE

1999-03-01

The purpose of the guidance document is to provide the site team--risk assessor, remedial project manager (RPM), and community involvement coordinator--with information to improve community involvement in the Superfund risk assessment process. Specifically, the document: provides suggestions for how Superfund staff and community members can work together during the early stages of Superfund cleanup; identifies where, within the framework of the human health risk assessment methodology, community input can augment and improve EPA`s estimates of exposure and risk; recommends questions the site team should ask the community; and illustrates why community involvement is valuable during the human health assessment atmore » Superfund sites.« less

Operationalization Of The Professional Risks Assessment Activity

NASA Astrophysics Data System (ADS)

Ivascu, Victoria Larisa; Cirjaliu, Bianca; Draghici, Anca

2015-07-01

Professional risks assessment approach (integration of analysis and evaluation processes) is linked with the general concerns of nowadays companies for their employees' health and safety assurances, in the context of organizations sustainable development. The paper presents an approach for the operationalization of the professional risk assessment activity in companies through the implementation and use of the OnRisk platform (this have been tested in some industrial companies). The short presentation of the relevant technical reports and statistics on OSH management at the European Union level underlines the need for the development of a professional risks assessment. Finally, there have been described the designed and developed OnRisk platform as a web platform together with some case studies that have validate the created tool.

Delineating risk zones and evaluation of shelter centres for flood disaster management along the Pahang River Basin, Malaysia

PubMed Central

Isahak, Anizan; Siwar, Chamhuri; Ismail, Shaharuddin M.; Hanafi, Zulkifli; Zainuddin, Mohd S.

2018-01-01

Shelter centres are important locations to safeguard people from helpless situations and are an integral part of disaster risk reduction (DRR), particularly for flood DRR. The establishment of shelter centres, and their design based on scientific assessment, is crucial. Yet, they are very much related to the geographic location, socio-economic conditions and the livelihoods of the affected communities. However, many parts of the developing world are still lagging behind in ensuring such scientific design. Considering the flood disaster in 2014 that affected the residents living along the Pahang River Basin, in this study we delineate the communities at risk and evaluate the existing shelter centres to determine how they reduce people’s vulnerability to the risks associated with rural and urban landscapes. We used spatial analysis tools to delineate risk zones and to evaluate existing evacuation systems. A flood disaster risk map was produced to determine which communities are living with risks. Subsequently, the distribution of shelter centres examined whether they are able to support people living at the flood risk zones. These centres were also evaluated using a set of international guidelines for effective disaster shelters. This reveals that the number of shelter centres is not adequate. The designation and designing of shelter centres are not being done scientifically. The maps produced here have a lot of potential to support disaster management decisions, in particular site selection and the prioritisation of centres. The study concludes with a set of guidelines and recommendations for structural and non-structural measures, such as alternative livelihoods and the potential of ecotourism, which may improve the resilience among flood-affected communities; and the decision-making process for the overall flood DRR initiatives.

Dietary protein intakes and risk of ulcerative colitis.

PubMed

Rashvand, Samaneh; Somi, Mohammad Hossein; Rashidkhani, Bahram; Hekmatdoost, Azita

2015-01-01

The incidence of ulcerative colitis (UC) is rising in populations with western-style diet, rich in fat and protein, and low in fruits and vegetables. In the present study, we aimed to evaluate the association between dietary protein intakes and the risk of developing incident UC. Sixty two cases of UC and 124 controls were studied using country-specific food frequency questionnaire (FFQ). Group comparisons by each factor were done using χ2 test, and significance level was set at α= 0.05. Logistic regression adjusted for potential confounding variables was carried out. Univariate analysis suggested positive associations between processed meat, red meat and organ meat with risk of ulcerative colitis. Comparing highest versus lowest categories of consumption, multivariate conditional logistic regression analysis accounting for potential confounding variables indicated that patients who consumed a higher amount of processed meat were at a higher risk for developing UC (P value for trend= 0.02). Similarly, patients who consumed higher amounts of red meat were at a higher risk for UC (P value for trend= 0.01). The highest tertile of intake of organ meat was associated with an increased risk of ulcerative colitis with a statistically significant trend across tertiles (P value for trend= 0.01) when adjusted. In this case-control study we observed that higher consumptions of processed meat, red meat and organ meat were associated with increased risk for UC.

Where do we go from here? Interim analysis to forge ahead in violence prevention.

PubMed

Dicker, Rochelle A; Jaeger, Sebastian; Knudson, Mary M; Mackersie, Robert C; Morabito, Diane J; Antezana, Javier; Texada, Michael

2009-12-01

The severity and disparity of interpersonal violent injury is staggering. Fifty-three per 100,000 African Americans (AA) die of homicide yearly, 20 per 100,000 in Latinos, whereas the rate is 3 per 100,000 in Caucasians. With the ultimate goal of reducing injury recidivism, which now stands at 35% to 50%, we have designed and implemented a hospital-based, case-managed violence prevention program uniquely applicable to trauma centers. The Wraparound Project (WP) seizes the "teachable moment" after injury to implement culturally competent case management (CM) and shepherd clients through risk reduction resources with city and community partners. The purpose of this study was to perform a detailed intermediate evaluation of this multi-modal violence prevention program. We hypothesized that this evaluation would demonstrate feasibility and early programmatic efficacy. We looked to identify areas of programmatic weakness that, if corrected, could strengthen the project and enhance its effectiveness. We performed intermediate evaluation on the 18-month-old program. We selected the Centers for Disease Control and Prevention-recommended instrument used for unintentional injury prevention programs and applied it to the WP. The four sequential stages in this methodology are formative, process, impact, and outcome. To test feasibility of WP, we used process evaluation. To evaluate intermediate goals of risk reduction and early efficacy, we used impact evaluation. Four hundred thirty-five people met screening criteria. The two case managers were able to make contact and screen 73% of gun shot victims, and 57% of stab wound victims. Of those not seen, 48% were in the hospital for 6 h/wk with the client. Forty-one percent of the time, they spent 3 hours to 6 hours. Seventeen of 18 people who required >6 hours had two to three needs. Attrition rate is only 4%. The table demonstrates percent success thus far in providing risk reduction resources. WP case managers served high-risk clients by developing trust, credibility, and a risk reduction plan. Cultural competency has been vital. Six of seven major needs were successfully addressed at least 50% of the time. The value of reporting these results has led WP to gain credibility with municipal stakeholders, who have now agreed to fund a third CM position. Intermediate evaluation provided a framework in our effort to achieve the ultimate goal of reducing recidivism through culturally competent CM and risk factor modification.

Increased Risk of Revision After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Allografts Compared With Autografts.

PubMed

Maletis, Gregory B; Chen, Jason; Inacio, Maria C S; Love, Rebecca M; Funahashi, Tadashi T

2017-05-01

The use of allograft tissue for anterior cruciate ligament reconstruction (ACLR) remains controversial. To compare the risk of aseptic revision between bone-patellar tendon-bone (BPTB) autografts and BPTB allografts. Cohort study; Level of evidence, 2. A retrospective cohort study of prospectively collected data was conducted using the Kaiser Permanente ACLR Registry. A cohort of patients who underwent primary unilateral ACLR with BPTB autografts and BPTB allografts was identified. Aseptic revision was the endpoint. The type of graft and allograft processing method (nonprocessed, <1.8-Mrad, and ≥1.8-Mrad irradiation) were the exposures of interest evaluated. Age (≤21 and ≥22 years) was evaluated as an effect modifier. Analyses were adjusted for age, sex, and race. Kaplan-Meier curves and Cox proportional hazards models were employed. Hazard ratios (HRs) and 95% CIs are provided. The BPTB cohort consisted of 5586 patients: 3783 (67.7%) were male, 2359 (42.2%) were white, 1029 (18.4%) had allografts (nonprocessed: 155; <1.8 Mrad: 525; ≥1.8 Mrad: 288), and 4557 (81.6%) had autografts. The median age was 34.9 years (interquartile range [IQR], 25.4-44.0) for allograft cases and 22.0 years (IQR, 17.6-30.0) for autograft cases. The estimated cumulative revision rate at 2 years was 4.1% (95% CI, 2.9%-5.9%) for allografts and 1.7% (95% CI, 1.3%-2.2%) for autografts. BPTB allografts had a significantly higher adjusted risk of revision than BPTB autografts (HR, 4.54; 95% CI, 3.03-6.79; P < .001). This higher risk of revision was consistent with all allograft processing methods when compared with autografts and was also consistently higher in patients with allografts regardless of age. When BPTB allograft tissue was used for ACLR, an overall 4.54 times adjusted higher risk of revision was observed compared with surgery performed with a BPTB autograft. Whether the tissue was irradiated with either high- or low-dose radiation, chemically processed, or not processed at all made little difference in the risk of revision. The differences in the revision risk were also consistent in younger and older patients. Surgeons and patients should be aware of the increased risk of revision when a BPTB allograft is used for ACLR.

Risk evaluation and mitigation strategies: a focus on belatacept.

PubMed

Sam, Teena; Gabardi, Steven; Tichy, Eric M

2013-03-01

To review the elements and components of the risk evaluation and mitigation strategies (REMS) for the costimulation blocker belatacept and associated implications for health care providers working with transplant recipients. The MEDLINE and EMBASE databases (January 1990 to March 2012) were searched by using risk evaluation and mitigation strategies, REMS, belatacept, and organ transplant as search terms (individual organs were also searched). Retrieved articles were supplemented with analysis of information obtained from the Federal Register, the Food and Drug Administration, and the manufacturer of belatacept. REMS are risk-management strategies implemented to ensure that a product's benefits outweigh its known safety risks. Although belatacept offers a novel strategy in maintenance immunosuppression and was associated with superior renal function compared with cyclosporine in phase 2 and 3 trials, belatacept is also associated with increased risk of posttransplant lymphoproliferative disorder and central nervous system infections. The Food and Drug Administration required development of a REMS program as part of belatacept's approval process to ensure safe and appropriate use of the medication and optimization of its risk-benefit profile. Elements of the belatacept REMS include a medication guide that must be dispensed with each infusion and a communication plan. In the management of a complex population of patients, it is essential that those who care for transplant recipients, and patients, recognize the implications of potential and known risks of belatacept. The REMS program aims to facilitate careful selection and education of patients and vigilant monitoring.

Developing and evaluating an automated appendicitis risk stratification algorithm for pediatric patients in the emergency department.

PubMed

Deleger, Louise; Brodzinski, Holly; Zhai, Haijun; Li, Qi; Lingren, Todd; Kirkendall, Eric S; Alessandrini, Evaline; Solti, Imre

2013-12-01

To evaluate a proposed natural language processing (NLP) and machine-learning based automated method to risk stratify abdominal pain patients by analyzing the content of the electronic health record (EHR). We analyzed the EHRs of a random sample of 2100 pediatric emergency department (ED) patients with abdominal pain, including all with a final diagnosis of appendicitis. We developed an automated system to extract relevant elements from ED physician notes and lab values and to automatically assign a risk category for acute appendicitis (high, equivocal, or low), based on the Pediatric Appendicitis Score. We evaluated the performance of the system against a manually created gold standard (chart reviews by ED physicians) for recall, specificity, and precision. The system achieved an average F-measure of 0.867 (0.869 recall and 0.863 precision) for risk classification, which was comparable to physician experts. Recall/precision were 0.897/0.952 in the low-risk category, 0.855/0.886 in the high-risk category, and 0.854/0.766 in the equivocal-risk category. The information that the system required as input to achieve high F-measure was available within the first 4 h of the ED visit. Automated appendicitis risk categorization based on EHR content, including information from clinical notes, shows comparable performance to physician chart reviewers as measured by their inter-annotator agreement and represents a promising new approach for computerized decision support to promote application of evidence-based medicine at the point of care.

Process-based Cost Estimation for Ramjet/Scramjet Engines

NASA Technical Reports Server (NTRS)

Singh, Brijendra; Torres, Felix; Nesman, Miles; Reynolds, John

2003-01-01

Process-based cost estimation plays a key role in effecting cultural change that integrates distributed science, technology and engineering teams to rapidly create innovative and affordable products. Working together, NASA Glenn Research Center and Boeing Canoga Park have developed a methodology of process-based cost estimation bridging the methodologies of high-level parametric models and detailed bottoms-up estimation. The NASA GRC/Boeing CP process-based cost model provides a probabilistic structure of layered cost drivers. High-level inputs characterize mission requirements, system performance, and relevant economic factors. Design alternatives are extracted from a standard, product-specific work breakdown structure to pre-load lower-level cost driver inputs and generate the cost-risk analysis. As product design progresses and matures the lower level more detailed cost drivers can be re-accessed and the projected variation of input values narrowed, thereby generating a progressively more accurate estimate of cost-risk. Incorporated into the process-based cost model are techniques for decision analysis, specifically, the analytic hierarchy process (AHP) and functional utility analysis. Design alternatives may then be evaluated not just on cost-risk, but also user defined performance and schedule criteria. This implementation of full-trade study support contributes significantly to the realization of the integrated development environment. The process-based cost estimation model generates development and manufacturing cost estimates. The development team plans to expand the manufacturing process base from approximately 80 manufacturing processes to over 250 processes. Operation and support cost modeling is also envisioned. Process-based estimation considers the materials, resources, and processes in establishing cost-risk and rather depending on weight as an input, actually estimates weight along with cost and schedule.

A new process for organizing assessments of social, economic, and environmental outcomes: case study of wildland fire management in the USA

Treesearch

Randall JF Bruins; Wayne R Jr. Munns; Stephen J Botti; Steve Brink; David Cleland; Larry Kapustka; Danny Lee; al. et

2010-01-01

Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders, and analysts to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypotheses about adverse ecological effects, select assessment endpoints, and develop an analysis...

How normative interpretations of climate risk assessment affect local decision-making: an exploratory study at the city scale in Cork, Ireland.

PubMed

McDermott, T K J; Surminski, S

2018-06-13

Urban areas already suffer substantial losses in both economic and human terms from climate-related disasters. These losses are anticipated to grow substantially, in part as a result of the impacts of climate change. In this paper, we investigate the process of translating climate risk data into action for the city level. We apply a commonly used decision-framework as our backdrop and explore where in this process climate risk assessment and normative political judgements intersect. We use the case of flood risk management in Cork city in Ireland to investigate what is needed for translating risk assessment into action at the local city level. Evidence presented is based on focus group discussions at two stakeholder workshops, and a series of individual meetings and phone-discussions with stakeholders involved in local decision-making related to flood risk management and adaptation to climate change, in Ireland. Respondents were chosen on the basis of their expertise or involvement in the decision-making processes locally and nationally. Representatives of groups affected by flood risk and flood risk management and climate adaptation efforts were also included. The Cork example highlights that, despite ever more accurate data and an increasing range of theoretical approaches available to local decision-makers, it is the normative interpretation of this information that determines what action is taken. The use of risk assessments for decision-making is a process that requires normative decisions, such as setting 'acceptable risk levels' and identifying 'adequate' protection levels, which will not succeed without broader buy-in and stakeholder participation. Identifying and embracing those normative views up-front could strengthen the urban adaptation process-this may, in fact, turn out to be the biggest advantage of climate risk assessment: it offers an opportunity to create a shared understanding of the problem and enables an informed evaluation and discussion of remedial action.This article is part of the theme issue 'Advances in risk assessment for climate change adaptation policy'. © 2018 The Author(s).

How normative interpretations of climate risk assessment affect local decision-making: an exploratory study at the city scale in Cork, Ireland

NASA Astrophysics Data System (ADS)

McDermott, T. K. J.; Surminski, S.

2018-06-01

Urban areas already suffer substantial losses in both economic and human terms from climate-related disasters. These losses are anticipated to grow substantially, in part as a result of the impacts of climate change. In this paper, we investigate the process of translating climate risk data into action for the city level. We apply a commonly used decision-framework as our backdrop and explore where in this process climate risk assessment and normative political judgements intersect. We use the case of flood risk management in Cork city in Ireland to investigate what is needed for translating risk assessment into action at the local city level. Evidence presented is based on focus group discussions at two stakeholder workshops, and a series of individual meetings and phone-discussions with stakeholders involved in local decision-making related to flood risk management and adaptation to climate change, in Ireland. Respondents were chosen on the basis of their expertise or involvement in the decision-making processes locally and nationally. Representatives of groups affected by flood risk and flood risk management and climate adaptation efforts were also included. The Cork example highlights that, despite ever more accurate data and an increasing range of theoretical approaches available to local decision-makers, it is the normative interpretation of this information that determines what action is taken. The use of risk assessments for decision-making is a process that requires normative decisions, such as setting `acceptable risk levels' and identifying `adequate' protection levels, which will not succeed without broader buy-in and stakeholder participation. Identifying and embracing those normative views up-front could strengthen the urban adaptation process-this may, in fact, turn out to be the biggest advantage of climate risk assessment: it offers an opportunity to create a shared understanding of the problem and enables an informed evaluation and discussion of remedial action. This article is part of the theme issue `Advances in risk assessment for climate change adaptation policy'.

Public perceptions of the risks of an unfamiliar technology: The case of using nuclear energy sources for space missions

NASA Astrophysics Data System (ADS)

Maharik, Michael

This thesis addresses the public perception of the risk of a technology not widely known to laypeople. Its aims were (1) to characterize public perceptions of the risk of using nuclear energy in space and decisions related to this risk, and (2) to extend the 'mental model' methodology to studying public perception of unfamiliar, risky technologies. A model of the physical processes capable of creating risks from using nuclear energy sources in space was first constructed. Then, knowledge and beliefs related to this topic were elicited from three different groups of people. The generality of the findings was examined in a constructive replication with environmentally-oriented people. The possibility of involving the public in decision-making processes related to engineering macro-design was then investigated. Finally, a communication regarding these risk processes was developed and evaluated in an experiment comparing it with communications produced by NASA. Although they included large portions of the expert model, people's beliefs also had gaps and misconceptions. Respondents often used scientific terms without a clear understanding of what they meant. Respondents' mental models sometimes contained scattered and inconsistent entries. The impact of pre-existing mental models was clearly seen. Different groups of people had different patterns of knowledge and beliefs. Nevertheless, respondents expressed reasonable and coherent opinions on choices among engineering options. The CMU brochure, derived from the study of readers' existing mental models, provided a better risk communication tool than NASA's material, reflecting primarily experts' perspective. The better performance of subjects reading either brochure generally reflected adding knowledge on issues that they had not previously known, rather than correcting wrong beliefs. The communication study confirmed a hypothesis that improving knowledge on risk processes related to the use of a technology causes a more favorable attitude towards that technology. Recommendations related to the design and targeting of risk communication, and to public participation in decision-making on using new and risky technologies, are derived. Additional studies that will elicit laypeople's definitions of risk related to specific technologies, and link their detailed understanding of risk-development processes to the perceived dimensions of risk, are suggested.

Communication of scientific uncertainty: international case studies on the development of folate and vitamin D Dietary Reference Values.

PubMed

Brown, Kerry A; de Wit, Liesbeth; Timotijevic, Lada; Sonne, Anne-Mette; Lähteenmäki, Liisa; Brito Garcia, Noé; Jeruszka-Bielak, Marta; Sicińska, Ewa; Moore, Alana N; Lawrence, Mark; Raats, Monique M

2015-06-01

Transparent evidence-based decision making has been promoted worldwide to engender trust in science and policy making. Yet, little attention has been given to transparency implementation. The degree of transparency (focused on how uncertain evidence was handled) during the development of folate and vitamin D Dietary Reference Values was explored in three a priori defined areas: (i) value request; (ii) evidence evaluation; and (iii) final values. Qualitative case studies (semi-structured interviews and desk research). A common protocol was used for data collection, interview thematic analysis and reporting. Results were coordinated via cross-case synthesis. Australia and New Zealand, Netherlands, Nordic countries, Poland, Spain and UK. Twenty-one interviews were conducted in six case studies. Transparency of process was not universally observed across countries or areas of the recommendation setting process. Transparency practices were most commonly seen surrounding the request to develop reference values (e.g. access to risk manager/assessor problem formulation discussions) and evidence evaluation (e.g. disclosure of risk assessor data sourcing/evaluation protocols). Fewer transparency practices were observed to assist with handling uncertainty in the evidence base during the development of quantitative reference values. Implementation of transparency policies may be limited by a lack of dedicated resources and best practice procedures, particularly to assist with the latter stages of reference value development. Challenges remain regarding the best practice for transparently communicating the influence of uncertain evidence on the final reference values. Resolving this issue may assist the evolution of nutrition risk assessment and better inform the recommendation setting process.

Parenting and youth sexual risk in context: The role of community factors.

PubMed

Goodrum, Nada M; Armistead, Lisa P; Tully, Erin C; Cook, Sarah L; Skinner, Donald

2017-06-01

Black South African youth are disproportionately affected by HIV, and risky sexual behaviors increase youths' vulnerability to infection. U.S.-based research has highlighted several contextual influences on sexual risk, but these processes have not been examined in a South African context. In a convenience sample of Black South African caregivers and their 10-14-year-old youth (M age  = 11.7, SD = 1.4; 52.5% female), we examined the relation between parenting and youth sexual risk within the context of community-level processes, including neighborhood quality and maternal social support. Hypotheses were evaluated using structural equation modeling. Results revealed that better neighborhood quality and more social support predicted positive parenting, which in turn predicted less youth sexual risk. There was a significant indirect effect from neighborhood quality to youth sexual risk via parenting. Results highlight the importance of the community context in parenting and youth sexual risk in this understudied sample. HIV prevention-interventions should be informed by these contextual factors. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

PubMed Central

Morrato, Elaine H; Smith, Meredith Y

2015-01-01

Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, pharmaceutical companies have been slow to recognize and embrace the significant potential these programs offer in terms of enhancing trust with health care professionals and patients, and for providing a mechanism for bringing products to the market that might not otherwise have been approved. Pitfalls of the current drug development process include risk minimization programs that are not data driven; missed opportunities to incorporate pragmatic methods and market-based insights, outmoded tools and data sources, lack of rapid evaluative learning to support timely adaption, lack of systematic approaches for patient engagement, and questions on staffing and organizational infrastructure. We propose better integration of risk minimization with clinical drug development and commercialization work streams throughout the product lifecycle. We articulate a vision and propose broad adoption of organizational models for incorporating risk minimization expertise into the drug development process. Three organizational models are discussed and compared: outsource/external vendor, embedded risk management specialist model, and Center of Excellence. PMID:25750537

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

PubMed

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

[Process design in high-reliability organizations].

PubMed

Sommer, K-J; Kranz, J; Steffens, J

2014-05-01

Modern medicine is a highly complex service industry in which individual care providers are linked in a complicated network. The complexity and interlinkedness is associated with risks concerning patient safety. Other highly complex industries like commercial aviation have succeeded in maintaining or even increasing its safety levels despite rapidly increasing passenger figures. Standard operating procedures (SOPs), crew resource management (CRM), as well as operational risk evaluation (ORE) are historically developed and trusted parts of a comprehensive and systemic safety program. If medicine wants to follow this quantum leap towards increased patient safety, it must intensively evaluate the results of other high-reliability industries and seek step-by-step implementation after a critical assessment.

Risks of beryllium disease related to work processes at a metal, alloy, and oxide production plant.

PubMed

Kreiss, K; Mroz, M M; Zhen, B; Wiedemann, H; Barna, B

1997-08-01

To describe relative hazards in sectors of the beryllium industry, risk factors of beryllium disease and sensitisation related to work process were sought in a beryllium manufacturing plant producing pure metal, oxide, alloys, and ceramics. All 646 active employees were interviewed; beryllium sensitisation was ascertained with the beryllium lymphocyte proliferation blood test on 627 employees; clinical evaluation and bronchoscopy were offered to people with abnormal test results; and industrial hygiene measurements related to work processes taken in 1984-93 were reviewed. 59 employees (9.4%) had abnormal blood tests, 47 of whom underwent bronchoscopy. 24 new cases of beryllium disease were identified, resulting in a beryllium disease prevalence of 4.6%, including five known cases (29/632). Employees who had worked in ceramics had the highest prevalence of beryllium disease (9.0%). Employees in the pebble plant (producing beryllium metal) who had been employed after 1983 also had increased risk, with a prevalence of beryllium disease of 6.4%, compared with 1.3% of other workers hired in the same period, and a prevalence of abnormal blood tests of 19.2%. Logistic regression modelling confirmed these two risk factors for beryllium disease related to work processes and the dependence on time of the risk at the pebble plant. The pebble plant was not associated with the highest gravimetric industrial hygiene measurements available since 1984. Further characterisation of exposures in beryllium metal production may be important to understanding how beryllium exposures confer high contemporary risk of beryllium disease.

Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

PubMed Central

Baron, Patrick; Frattaroli, Shannon

2016-01-01

The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

Decision Making and Ratio Processing in Patients with Mild Cognitive Impairment.

PubMed

Pertl, Marie-Theres; Benke, Thomas; Zamarian, Laura; Delazer, Margarete

2015-01-01

Making advantageous decisions is important in everyday life. This study aimed at assessing how patients with mild cognitive impairment (MCI) make decisions under risk. Additionally, it investigated the relationship between decision making, ratio processing, basic numerical abilities, and executive functions. Patients with MCI (n = 22) were compared with healthy controls (n = 29) on a complex task of decision making under risk (Game of Dice Task-Double, GDT-D), on two tasks evaluating basic decision making under risk, on a task of ratio processing, and on several neuropsychological background tests. Patients performed significantly lower than controls on the GDT-D and on ratio processing, whereas groups performed comparably on basic decision tasks. Specifically, in the GDT-D, patients obtained lower net scores and lower mean expected values, which indicate a less advantageous performance relative to that of controls. Performance on the GDT-D correlated significantly with performance in basic decision tasks, ratio processing, and executive-function measures when the analysis was performed on the whole sample. Patients with MCI make sub-optimal decisions in complex risk situations, whereas they perform at the same level as healthy adults in simple decision situations. Ratio processing and executive functions have an impact on the decision-making performance of both patients and healthy older adults. In order to facilitate advantageous decisions in complex everyday situations, information should be presented in an easily comprehensible form and cognitive training programs for patients with MCI should focus--among other abilities--on executive functions and ratio processing.

Tools and Metrics for Environmental Sustainability

EPA Science Inventory

Within the U.S. Environmental Protection Agency’s Office of Research and Development the National Risk Management Research Laboratory has been developing tools to help design and evaluate chemical processes with a life cycle perspective. These tools include the Waste Reduction (...

Cancer Dose-Response Assessment for Polychlorinated Biphenyls (PCBs) and Application to Environmental Mixtures

EPA Pesticide Factsheets

This report updates the cancer dose-response assessment for PCBs and shows how information on toxicity, disposition, and environmental processes can be considered together to evaluate health risks from PCB mixtures in the environment.

Advective and diffusive dermal processes for estimating terrestrial amphibian pesticide exposure

EPA Science Inventory

Background/Question/Methods Dermal exposure presents a potentially significant but understudied route for pesticide uptake in terrestrial amphibians. Historically, evaluation of pesticide risk to both amphibians and reptiles has been achieved by comparing ingestion and inhalat...

BIOMARKERS OF EXPOSURE, EFFECT AND SUSCEPTIBILITY IN FISHES

EPA Science Inventory

Understanding basic mechanisms of toxicological processes is integral to assessment of risk, In aquatic toxicology, however, the mechanistic evaluation of environmental chemicals is a much younger area of investigation than in mammalian systems and only recently has received sig...

Exploring the benefits and challenges of establishing a DRI-like process for bioactives.

PubMed

Lupton, Joanne R; Atkinson, Stephanie A; Chang, Namsoo; Fraga, Cesar G; Levy, Joseph; Messina, Mark; Richardson, David P; van Ommen, Ben; Yang, Yuexin; Griffiths, James C; Hathcock, John

2014-04-01

Bioactives can be defined as: "Constituents in foods or dietary supplements, other than those needed to meet basic human nutritional needs, which are responsible for changes in health status" (Office of Disease Prevention and Health Promotion, Office of Public Health and Science, Department of Health and Human Services in Fed Reg 69:55821-55822, 2004). Although traditional nutrients, such as vitamins, minerals, protein, essential fatty acids and essential amino acids, have dietary reference intake (DRI) values, there is no such evaluative process for bioactives. For certain classes of bioactives, substantial scientific evidence exists to validate a relationship between their intake and enhanced health conditions or reduced risk of disease. In addition, the study of bioactives and their relationship to disease risk is a growing area of research supported by government, academic institutions, and food and supplement manufacturers. Importantly, consumers are purchasing foods containing bioactives, yet there is no evaluative process in place to let the public know how strong the science is behind the benefits or the quantitative amounts needed to achieve these beneficial health effects. This conference, Bioactives: Qualitative Nutrient Reference Values for Life-stage Groups?, explored why it is important to have a DRI-like process for bioactives and challenges for establishing such a process.

A Spike Cocktail Approach to Improve Microbial Performance ...

EPA Pesticide Factsheets

Water reuse, via either centralized treatment of traditional wastewater or decentralized treatment and on-site reuse, is becoming an increasingly important element of sustainable water management. Despite advances in waterborne pathogen detection methods, low and highly variable pathogen levels limit their utility for routine evaluation of health risks in water reuse systems. Therefore, there is a need to improve our understanding of the linkage between pathogens and more readily measured process indicators during treatment. This paper describes an approach for constructing spiking experiments to relate the behavior of viral, bacterial, and protozoan pathogens with relevant process indicators. General issues are reviewed, and the spiking protocol is applied as a case study example to improve microbial performance monitoring and health risk evaluation in a water reuse system. This approach provides a foundation for the development of novel approaches to improve real or near-real time performance monitoring of water recycling systems. This manuscrupt details an approach for developing "spike cocktail", a mixture of microorganisms that can be used to evaluate the performance of engineered and natural systems.

Our trial to develop a risk assessment tool for CO2 geological storage (GERAS-CO2GS)

NASA Astrophysics Data System (ADS)

Tanaka, A.; Sakamoto, Y.; Komai, T.

2012-12-01

We will introduce our researches about to develop a risk assessment tool named 'GERAS-CO2GS' (Geo-environmental Risk Assessment System, CO2 Geological Storage Risk Assessment System) for 'Carbon Dioxide Geological Storage (Geological CCS)'. It aims to facilitate understanding of size of impact of risks related with upper migration of injected CO2. For gaining public recognition about feasibility of Geological CCS, quantitative estimation of risks is essential, to let public knows the level of the risk: whether it is negligible or not. Generally, in preliminary hazard analysis procedure, potential hazards could be identified within Geological CCS's various facilities such as: reservoir, cap rock, upper layers, CO2 injection well, CO2 injection plant and CO2 transport facilities. Among them, hazard of leakage of injected C02 is crucial, because it is the clue to estimate risks around a specific injection plan in terms of safety, environmental protection effect and economy. Our risk assessment tool named GERAS-CO2GS evaluates volume and rate of retention and leakage of injected CO2 in relation with fractures and/or faults, and then it estimates impact of seepages on the surface of the earth. GERAS-CO2GS has four major processing segments: (a) calculation of CO2 retention and leakage volume and rate, (b) data processing of CO2 dispersion on the surface and ambient air, (c) risk data definition and (d) evaluation of risk. Concerning to the injection site, we defined a model, which is consisted from an injection well and a geological strata model: which involves a reservoir, a cap rock, an upper layer, faults, seabed, sea, the surface of the earth and the surface of the sea. For retention rate of each element of CO2 injection site model, we use results of our experimental and numerical studies on CO2 migration within reservoirs and faults with specific lithological conditions. For given CO2 injection rate, GERAS-CO2GS calculates CO2 retention and leakage of each segment of injection site model. It also evaluates dispersion of CO2 on the surface of the earth and ambient air, and displays evaluated risk level on Goole earth contour of risk levels with color classification. As regard with numerical estimation of CO2's surface dispersion, we use ADMER 2.5 (Atmospheric Dispersion Model for Exposure and Risk Assessment, AIST), which assesses ambient dispersion of materials using real observed atmospheric data such as wind direction and temperatures by meteorological observatory. As far as our simulations, it is obvious that cause of Lake Nyos type accident is owes its maar topography of the lake and the volume and duration of the CO2 outburst (about 1 km3). It's unlikely to cause similar happenings in geological CCS site, because there are significant difference amount of CO2 and topography. At this moment, GERAS-CO2GS is prototype system. We are going to extend GERAS-CO2GS functions and evaluate risks of further risk scenarios. Concerning to the route of seabed to sea and the surface of the sea, we hope to implement outer research findings into our logics. In the course of further research, we are going to develop GERAS-CO2GS will be able to estimate broader risks, and to contribute to the efforts for legislations and standards of CO2 Geological storage.

[Evidence based risk assessment of coronary heart disease].

PubMed

Filzmaier, K

2010-06-01

Coronary heart disease (CHD) poses a special challenge for risk assessments. Various kinds of diagnostic or therapeutic procedures, concomitant diseases, risk factors and symptoms need to be connected logically in order to assess the risk of each individual applicant. "Reinsurance manuals" are available to risk assessors in life insurance for this purpose. Using these manuals, the risk assessor can calculate the risk loadings for applicants with specific pre-existing conditions, e.g., CHD. Various tasks thus fall to the reinsurer, which must be able to give grounds for the increased risk loadings, provide the manuals with a process-oriented structure and simultaneously support the primary insurer's business objectives via an intelligent risk assessment. Taking CHD as an example, the following article explains how these tasks can be solved with the aid of medical and mathematical approaches, and how the insurability of applicants with CHD can be extended via the re-evaluation of risks.

Reducing Physical Risk Factors in Construction Work Through a Participatory Intervention: Protocol for a Mixed-Methods Process Evaluation.

PubMed

Ajslev, Jeppe; Brandt, Mikkel; Møller, Jeppe Lykke; Skals, Sebastian; Vinstrup, Jonas; Jakobsen, Markus Due; Sundstrup, Emil; Madeleine, Pascal; Andersen, Lars Louis

2016-05-26

Previous research has shown that reducing physical workload among workers in the construction industry is complicated. In order to address this issue, we developed a process evaluation in a formative mixed-methods design, drawing on existing knowledge of the potential barriers for implementation. We present the design of a mixed-methods process evaluation of the organizational, social, and subjective practices that play roles in the intervention study, integrating technical measurements to detect excessive physical exertion measured with electromyography and accelerometers, video documentation of working tasks, and a 3-phased workshop program. The evaluation is designed in an adapted process evaluation framework, addressing recruitment, reach, fidelity, satisfaction, intervention delivery, intervention received, and context of the intervention companies. Observational studies, interviews, and questionnaires among 80 construction workers organized in 20 work gangs, as well as health and safety staff, contribute to the creation of knowledge about these phenomena. At the time of publication, the process of participant recruitment is underway. Intervention studies are challenging to conduct and evaluate in the construction industry, often because of narrow time frames and ever-changing contexts. The mixed-methods design presents opportunities for obtaining detailed knowledge of the practices intra-acting with the intervention, while offering the opportunity to customize parts of the intervention.

Ecological risk assessment of depleted uranium in the environment at Aberdeen Proving Ground

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

Clements, W.H.; Kennedy, P.L.; Myers, O.B.

1993-01-01

A preliminary ecological risk assessment was conducted to evaluate the effects of depleted uranium (DU) in the Aberdeen Proving Ground (APG) ecosystem and its potential for human health effects. An ecological risk assessment of DU should include the processes of hazard identification, dose-response assessment, exposure assessment, and risk characterization. Ecological risk assessments also should explicitly examine risks incurred by nonhuman as well as human populations, because risk assessments based only on human health do not always protect other species. To begin to assess the potential ecological risk of DU release to the environment we modeled DU transport through the principalmore » components of the aquatic ecosystem at APG. We focused on the APG aquatic system because of the close proximity of the Chesapeake Bay and concerns about potential impacts on this ecosystem. Our objective in using a model to estimate environmental fate of DU is to ultimately reduce the uncertainty about predicted ecological risks due to DU from APG. The model functions to summarize information on the structure and functional properties of the APG aquatic system, to provide an exposure assessment by estimating the fate of DU in the environment, and to evaluate the sources of uncertainty about DU transport.« less

Ecological risk assessment of depleted uranium in the environment at Aberdeen Proving Ground. Annual report, 1991

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

Clements, W.H.; Kennedy, P.L.; Myers, O.B.

1993-03-01

A preliminary ecological risk assessment was conducted to evaluate the effects of depleted uranium (DU) in the Aberdeen Proving Ground (APG) ecosystem and its potential for human health effects. An ecological risk assessment of DU should include the processes of hazard identification, dose-response assessment, exposure assessment, and risk characterization. Ecological risk assessments also should explicitly examine risks incurred by nonhuman as well as human populations, because risk assessments based only on human health do not always protect other species. To begin to assess the potential ecological risk of DU release to the environment we modeled DU transport through the principalmore » components of the aquatic ecosystem at APG. We focused on the APG aquatic system because of the close proximity of the Chesapeake Bay and concerns about potential impacts on this ecosystem. Our objective in using a model to estimate environmental fate of DU is to ultimately reduce the uncertainty about predicted ecological risks due to DU from APG. The model functions to summarize information on the structure and functional properties of the APG aquatic system, to provide an exposure assessment by estimating the fate of DU in the environment, and to evaluate the sources of uncertainty about DU transport.« less

Wellness motivation in cardiac rehabilitation: the role of self-knowledge in cardiovascular risk modification.

PubMed

Fleury, Julie; Sedikides, Constantine

2007-08-01

Understanding the factors that motivate behavioral change is central to health promotion efforts. We used qualitative descriptive methods in an effort to understand the role of self-knowledge in the process of risk factor modification. The sample consisted of 17 men and 7 women with diagnosed coronary heart disease, who were attempting to initiate and sustain programs of cardiovascular risk modification. Participants described self-knowledge in terms of three contextually situated patterns: representational, evaluative, and behavioral action. Results reinforce the motivational role of the self and highlight the importance of understanding dimensions of self-knowledge relevant to cardiovascular risk reduction.

Sodium Bearing Waste Processing Alternatives Analysis

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

Murphy, James Anthony; Palmer, Brent J; Perry, Keith Joseph

2003-12-01

A multidisciplinary team gathered to develop a BBWI recommendation to DOE-ID on the processing alternatives for the sodium bearing waste in the INTEC Tank Farm. Numerous alternatives were analyzed using a rigorous, systematic approach. The data gathered were evaluated through internal and external peer reviews for consistency and validity. Three alternatives were identified to be top performers: Risk-based Calcination, MACT to WIPP Calcination and Cesium Ion Exchange. A dual-path through early Conceptual design is recommended for MACT to WIPP Calcination and Cesium Ion Exchange since Risk-based Calcination does not require design. If calcination alternatives are not considered based on givingmore » Type of Processing criteria significantly greater weight, the CsIX/TRUEX alternative follows CsIX in ranking. However, since CsIX/TRUEX shares common uncertainties with CsIX, reasonable backups, which follow in ranking, are the TRUEX and UNEX alternatives. Key uncertainties must be evaluated by the decision-makers to choose one final alternative. Those key uncertainties and a path forward for the technology roadmapping of these alternatives is provided.« less

Risks for respiratory and gastric cancer in wood-working occupations in Denmark.

PubMed

Olsen, J H; Møller, H; Jensen, O M

1988-01-01

Cases of cancer notified to the Danish Cancer Registry during the period 1970 to 1984 in the age groups 16 to 66 years have been linked to information on employment kept on file in the nationwide Supplementary Pension Fund since 1964. Industrial hygienists classified industrial groups as defined by the Pension Fund with regard to exposure to wood dust, and a list of industries with major exposure to wood dust was defined. The risk for cancer of the respiratory system and the gastrointestinal tract was evaluated by means of a proportional cancer incidence analysis. A fourfold increase in risk for sinonasal cancer was found among men involved in the manufacture of wooden furniture, and a twofold increase in risk for gastric cancer was seen in all of the component industries of basic wood-processing. In contrast, no excess of gastric cancer could be detected in men working in the manufacture of wooden building materials and wooden furniture, and a risk below unity was seen for those in carpentry and joinery. The elevated risk for gastric cancer in some wood-processing industries is probably due to social factors also common to men in agriculture and manufacturing. The absence of an increased risk for gastric cancer in trades in which a high risk for sinonasal cancer is seen indicates that wood dust is not of aetiological importance for gastric cancer. No excess of total lung cancer or of the adenocarcinoma subtype was seen in any of the wood-processing industries.

Applying Risk Prediction Models to Optimize Lung Cancer Screening: Current Knowledge, Challenges, and Future Directions.

PubMed

Sakoda, Lori C; Henderson, Louise M; Caverly, Tanner J; Wernli, Karen J; Katki, Hormuzd A

2017-12-01

Risk prediction models may be useful for facilitating effective and high-quality decision-making at critical steps in the lung cancer screening process. This review provides a current overview of published lung cancer risk prediction models and their applications to lung cancer screening and highlights both challenges and strategies for improving their predictive performance and use in clinical practice. Since the 2011 publication of the National Lung Screening Trial results, numerous prediction models have been proposed to estimate the probability of developing or dying from lung cancer or the probability that a pulmonary nodule is malignant. Respective models appear to exhibit high discriminatory accuracy in identifying individuals at highest risk of lung cancer or differentiating malignant from benign pulmonary nodules. However, validation and critical comparison of the performance of these models in independent populations are limited. Little is also known about the extent to which risk prediction models are being applied in clinical practice and influencing decision-making processes and outcomes related to lung cancer screening. Current evidence is insufficient to determine which lung cancer risk prediction models are most clinically useful and how to best implement their use to optimize screening effectiveness and quality. To address these knowledge gaps, future research should be directed toward validating and enhancing existing risk prediction models for lung cancer and evaluating the application of model-based risk calculators and its corresponding impact on screening processes and outcomes.

[Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

PubMed

Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

2017-12-01

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

Baseline risk assessment of ground water contamination at the uranium mill tailings site near Durango, Colorado

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

Not Available

1995-02-01

This risk assessment evaluates the possibility of health and environmental risks from contaminated ground water at the uranium mill tailings site near Durango, Colorado. The former uranium processing site`s contaminated soil and material were removed and placed at a disposal site located in Body Canyon, Colorado, during 1986--1991 by the US Departments of Energy`s Uranium Mill Tailings Remedial Action (UMTRA) Project. Currently, the UMTRA Project is evaluating the nature and extent of ground water contamination at the site. This risk assessment follows an approach similar to that used by the US Environmental Protection Agency. The first step is to determinemore » what site-related contaminants are found in ground water samples. The next step in the risk assessment is to determine how much of these contaminants people might ingest if they got their drinking water from a well on the site. In accordance with standard practice for this type of risk assessment, the highest contaminant concentrations from the most contaminated wells are used. The risk assessment then explains the possible health problems that could result from this amount of contamination.« less

Risk assessment of Salmonella in Danish meatballs produced in the catering sector.

PubMed

Møller, Cleide O de A; Nauta, Maarten J; Schaffner, Donald W; Dalgaard, Paw; Christensen, Bjarke B; Hansen, Tina B

2015-03-02

A modular process risk model approach was used to assess health risks associated with Salmonella spp. after consumption of the Danish meatball product (frikadeller) produced with fresh pork in a catering unit. Meatball production and consumption were described as a series of processes (modules), starting from 1.3kg meat pieces through conversion to 70g meatballs, followed by a dose response model to assess the risk of illness from consumption of these meatballs. Changes in bacterial prevalence, concentration, and unit size were modelled within each module. The risk assessment was built using observational data and models that were specific for Salmonella spp. in meatballs produced in the catering sector. Danish meatballs are often pan-fried followed by baking in an oven before consumption, in order to reach the core temperature of 75°C recommended by the Danish Food Safety Authority. However, in practice this terminal heat treatment in the oven may be accidentally omitted. Eleven production scenarios were evaluated with the model, to test the impact of heat treatments and cooling rates at different room temperatures. The risk estimates revealed that a process comprising heat treatment of meatballs to core temperatures higher than 70°C, and subsequent holding at room temperatures lower than 20°C, for no longer than 3.5h, were very effective in Salmonella control. The current Danish Food Safety Authority recommendation of cooking to an internal temperature of 75°C is conservative, at least with respect to Salmonella risk. Survival and growth of Salmonella during cooling of meatballs not heat treated in oven had a significant impact on the risk estimates, and therefore, cooling should be considered a critical step during meatball processing. Copyright © 2014. Published by Elsevier B.V.

Safe use of vaccines and vaccine compliance with food safety requirements.

PubMed

Grein, K; Papadopoulos, O; Tollis, M

2007-08-01

Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

The Relative Impact of Climate Change on the Extinction Risk of Tree Species in the Montane Tropical Andes.

PubMed

Tejedor Garavito, Natalia; Newton, Adrian C; Golicher, Duncan; Oldfield, Sara

2015-01-01

There are widespread concerns that anthropogenic climate change will become a major cause of global biodiversity loss. However, the potential impact of climate change on the extinction risk of species remains poorly understood, particularly in comparison to other current threats. The objective of this research was to examine the relative impact of climate change on extinction risk of upper montane tree species in the tropical Andes, an area of high biodiversity value that is particularly vulnerable to climate change impacts. The extinction risk of 129 tree species endemic to the region was evaluated according to the IUCN Red List criteria, both with and without the potential impacts of climate change. Evaluations were supported by development of species distribution models, using three methods (generalized additive models, recursive partitioning, and support vector machines), all of which produced similarly high AUC values when averaged across all species evaluated (0.82, 0.86, and 0.88, respectively). Inclusion of climate change increased the risk of extinction of 18-20% of the tree species evaluated, depending on the climate scenario. The relative impact of climate change was further illustrated by calculating the Red List Index, an indicator that shows changes in the overall extinction risk of sets of species over time. A 15% decline in the Red List Index was obtained when climate change was included in this evaluation. While these results suggest that climate change represents a significant threat to tree species in the tropical Andes, they contradict previous suggestions that climate change will become the most important cause of biodiversity loss in coming decades. Conservation strategies should therefore focus on addressing the multiple threatening processes currently affecting biodiversity, rather than focusing primarily on potential climate change impacts.

The Relative Impact of Climate Change on the Extinction Risk of Tree Species in the Montane Tropical Andes

PubMed Central

Tejedor Garavito, Natalia; Newton, Adrian C.; Golicher, Duncan; Oldfield, Sara

2015-01-01

There are widespread concerns that anthropogenic climate change will become a major cause of global biodiversity loss. However, the potential impact of climate change on the extinction risk of species remains poorly understood, particularly in comparison to other current threats. The objective of this research was to examine the relative impact of climate change on extinction risk of upper montane tree species in the tropical Andes, an area of high biodiversity value that is particularly vulnerable to climate change impacts. The extinction risk of 129 tree species endemic to the region was evaluated according to the IUCN Red List criteria, both with and without the potential impacts of climate change. Evaluations were supported by development of species distribution models, using three methods (generalized additive models, recursive partitioning, and support vector machines), all of which produced similarly high AUC values when averaged across all species evaluated (0.82, 0.86, and 0.88, respectively). Inclusion of climate change increased the risk of extinction of 18–20% of the tree species evaluated, depending on the climate scenario. The relative impact of climate change was further illustrated by calculating the Red List Index, an indicator that shows changes in the overall extinction risk of sets of species over time. A 15% decline in the Red List Index was obtained when climate change was included in this evaluation. While these results suggest that climate change represents a significant threat to tree species in the tropical Andes, they contradict previous suggestions that climate change will become the most important cause of biodiversity loss in coming decades. Conservation strategies should therefore focus on addressing the multiple threatening processes currently affecting biodiversity, rather than focusing primarily on potential climate change impacts. PMID:26177097

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients

PubMed Central

2012-01-01

Background Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. Method/design For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework. Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. Discussion The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making. PMID:23216708

Evaluation of the quality of care of a multi-disciplinary risk factor assessment and management programme (RAMP) for diabetic patients.

PubMed

Fung, Colman S C; Chin, Weng Yee; Dai, Daisy S K; Kwok, Ruby L P; Tsui, Eva L H; Wan, Yuk Fai; Wong, Wendy; Wong, Carlos K H; Fong, Daniel Y T; Lam, Cindy L K

2012-12-05

Type 2 Diabetes Mellitus (DM) is a common chronic disease associated with multiple clinical complications. Management guidelines have been established which recommend a risk-stratified approach to managing these patients in primary care. This study aims to evaluate the quality of care (QOC) and effectiveness of a multi-disciplinary risk assessment and management programme (RAMP) for type 2 diabetic patients attending government-funded primary care clinics in Hong Kong. The evaluation will be conducted using a structured and comprehensive evidence-based evaluation framework. For evaluation of the quality of care, a longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the pre-set target standards for criteria related to the structure and process of care are achieved. Each participating clinic will be invited to complete a Structure of Care Questionnaire evaluating pre-defined indicators which reflect the setting in which care is delivered, while process of care will be evaluated against the pre-defined indicators in the evaluation framework.Effectiveness of the programme will be evaluated in terms of clinical outcomes, service utilization outcomes, and patient-reported outcomes. A cohort study will be conducted on all eligible diabetic patients who have enrolled into RAMP for more than one year to compare their clinical and public service utilization outcomes of RAMP participants and non-participants. Clinical outcome measures will include HbA1c, blood pressure (both systolic and diastolic), lipids (low-density lipoprotein cholesterol) and future cardiovascular diseases risk prediction; and public health service utilization rate will include general and specialist outpatient, emergency department attendances, and hospital admissions annually within 5 years. For patient-reported outcomes, a total of 550 participants and another 550 non-participants will be followed by telephone to monitor quality of life, patient enablement, global rating of change in health and private health service utilization at baseline, 6, 12, 36 and 60 months. The quality of care and effectiveness of the RAMP in enhancing the health for patients with type 2 diabetes will be determined. Possible areas for quality enhancement will be identified and standards of good practice can be established. The information will be useful in guiding service planning and policy decision making.

Application of a web-based Decision Support System in risk management

NASA Astrophysics Data System (ADS)

Aye, Zar Chi; Jaboyedoff, Michel; Derron, Marc-Henri

2013-04-01

Increasingly, risk information is widely available with the help of advanced technologies such as earth observation satellites, global positioning technologies, coupled with hazard modeling and analysis, and geographical information systems (GIS). Even though it exists, no effort will be put into action if it is not properly presented to the decision makers. These information need to be communicated clearly and show its usefulness so that people can make better informed decision. Therefore, communicating available risk information has become an important challenge and decision support systems have been one of the significant approaches which can help not only in presenting risk information to the decision makers but also in making efficient decisions while reducing human resources and time needed. In this study, the conceptual framework of an internet-based decision support system is presented to highlight its importance role in risk management framework and how it can be applied in case study areas chosen. The main purpose of the proposed system is to facilitate the available risk information in risk reduction by taking into account of the changes in climate, land use and socio-economic along with the risk scenarios. It allows the users to formulate, compare and select risk reduction scenarios (mainly for floods and landslides) through an enhanced participatory platform with diverse stakeholders' involvement in the decision making process. It is based on the three-tier (client-server) architecture which integrates web-GIS plus DSS functionalities together with cost benefit analysis and other supporting tools. Embedding web-GIS provides its end users to make better planning and informed decisions referenced to a geographical location, which is the one of the essential factors in disaster risk reduction programs. Different risk reduction measures of a specific area (local scale) will be evaluated using this web-GIS tool, available risk scenarios obtained from Probabilistic Risk Assessment (PRA) model and the knowledge collected from experts. The visualization of the risk reduction scenarios can also be shared among the users on the web to support the on-line participatory process. In addition, cost-benefit ratios of the different risk reduction scenarios can be prepared in order to serve as inputs for high-level decision makers. The most appropriate risk reduction scenarios will be chosen using Multi-Criteria Evaluation (MCE) method by weighting different parameters according to the preferences and criteria defined by the users. The role of public participation has been changing from one-way communication between authorities, experts, stakeholders and citizens towards more intensive two-way interaction. Involving the affected public and interest groups can enhance the level of legitimacy, transparency, and confidence in the decision making process. Due to its important part in decision making, online participatory tool is included in the DSS in order to allow the involved stakeholders interactively in risk reduction and be aware of the existing vulnerability conditions of the community. Moreover, it aims to achieve a more transparent and better informed decision-making process. The system is under in progress and the first tools implemented will be presented showing the wide possibilities of new web technologies which can have a great impact on the decision making process. It will be applied in four pilot areas in Europe: French Alps, North Eastern Italy, Romania and Poland. Nevertheless, the framework will be designed and implemented in a way to be applicable in any other regions.

Energetic dose: Beyond fire and flint?

USGS Publications Warehouse

Linder, G.; Rattner, B.; Cohen, J.

2000-01-01

Nutritional and bioenergetic interactions influence exposure to environmental chemicals and may affect the risk realized when wildlife are exposed in the field. Here, food-chain analysis focuses on prairie voles (Microtus ochrogaster) and the evaluation of chemical risks associated with paraquat following 10-d dietary exposures. Reproductive effects were measured in 60-d trials that followed exposures to paraquat-tainted feed: control (untainted feed); 21 mg paraquat/kg feed; 63 mg paraquat/kg feed; and feed-restricted control (untainted feed restricted to 60% baseline consumption). Reproductive success was evaluated in control and treated breeding pairs, and a preliminary bioenergetics analysis was completed in parallel to derive exposure dose. Although reproductive performance differed among groups, feed-restriction appeared to be the dominant treatment effect observed in these 10-d feeding exposure/limited reproductive trials. Exposure dose ranged from 3.70-3.76 to 9.41-11.51 mg parquat/kg BW/day at 21 and 63 mg paraquat/kg feed stock exposures, respectively. Energetic doses as ug paraquat/kcal yielded preliminary estimates of energetic costs associated with paraquat exposure, and were similar within treatments for both sexes, ranging from 4.2-5.5 and 13.1-15.0 ug paraquat/kcal for voles exposed to 21 mg/kg feed stock and 63 mg/kg feed stock, respectively. Given the increasing likelihood that environmental chemicals will be found in wildlife habitat at 'acceptable levels', the critical role that wildlife nutrition plays in evaluating ecological risks should be fully integrated into the assessment process. Tools applied to the analysis of risk must gain higher resolution than the relatively crude methods we currently bring to the process.

WE-B-BRC-01: Current Methodologies in Risk Assessment

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

Rath, F.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-03: Risk in the Context of Medical Imaging

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

Samei, E.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-00: Concepts in Risk-Based Assessment

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

NONE

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-02: Risk Analysis and Incident Learning

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

Fraass, B.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

An Evaluation of Immediate Outcomes and Fidelity of a Drug Abuse Prevention Program in Continuation High Schools: Project towards No Drug Abuse (TND)

ERIC Educational Resources Information Center

Lisha, Nadra E.; Sun, Ping; Rohrbach, Louise A.; Spruijt-Metz, Donna; Unger, Jennifer B.; Sussman, Steve

2012-01-01

The present study provides an implementation fidelity, process, and immediate outcomes evaluation of Project Towards No Drug Abuse (TND), a drug prevention program targeting continuation high school youth (n = 1426) at risk for drug abuse. A total of 24 schools participated in three randomized conditions: TND Only, TND and motivational…

Evaluation of potential effects of federal land management alternatives on trends of salmonids and their habitats in the interior Columbia River basin.

Treesearch

Bruce Rieman; James T. Peterson; James Clayton; Philip Howell; Russell Thurow; William Thompson; Danny Lee

2001-01-01

Aquatic species throughout the interior Columbia River basin are at risk. Evaluation of the potential effects of federal land management on aquatic ecosystems across this region is an important but challenging task. Issues include the size and complexity of the systems, uncertainty in important processes and existing states, flexibility and consistency in the...

Multi-factor evaluation indicator method for the risk assessment of atmospheric and oceanic hazard group due to the attack of tropical cyclones

NASA Astrophysics Data System (ADS)

Qi, Peng; Du, Mei

2018-06-01

China's southeast coastal areas frequently suffer from storm surge due to the attack of tropical cyclones (TCs) every year. Hazards induced by TCs are complex, such as strong wind, huge waves, storm surge, heavy rain, floods, and so on. The atmospheric and oceanic hazards cause serious disasters and substantial economic losses. This paper, from the perspective of hazard group, sets up a multi-factor evaluation method for the risk assessment of TC hazards using historical extreme data of concerned atmospheric and oceanic elements. Based on the natural hazard dynamic process, the multi-factor indicator system is composed of nine natural hazard factors representing intensity and frequency, respectively. Contributing to the indicator system, in order of importance, are maximum wind speed by TCs, attack frequency of TCs, maximum surge height, maximum wave height, frequency of gusts ≥ Scale 8, rainstorm intensity, maximum tidal range, rainstorm frequency, then sea-level rising rate. The first four factors are the most important, whose weights exceed 10% in the indicator system. With normalization processing, all the single-hazard factors are superposed by multiplying their weights to generate a superposed TC hazard. The multi-factor evaluation indicator method was applied to the risk assessment of typhoon-induced atmospheric and oceanic hazard group in typhoon-prone southeast coastal cities of China.

Safety evaluation model of urban cross-river tunnel based on driving simulation.

PubMed

Ma, Yingqi; Lu, Linjun; Lu, Jian John

2017-09-01

Currently, Shanghai urban cross-river tunnels have three principal characteristics: increased traffic, a high accident rate and rapidly developing construction. Because of their complex geographic and hydrological characteristics, the alignment conditions in urban cross-river tunnels are more complicated than in highway tunnels, so a safety evaluation of urban cross-river tunnels is necessary to suggest follow-up construction and changes in operational management. A driving risk index (DRI) for urban cross-river tunnels was proposed in this study. An index system was also constructed, combining eight factors derived from the output of a driving simulator regarding three aspects of risk due to following, lateral accidents and driver workload. Analytic hierarchy process methods and expert marking and normalization processing were applied to construct a mathematical model for the DRI. The driving simulator was used to simulate 12 Shanghai urban cross-river tunnels and a relationship was obtained between the DRI for the tunnels and the corresponding accident rate (AR) via a regression analysis. The regression analysis results showed that the relationship between the DRI and the AR mapped to an exponential function with a high degree of fit. In the absence of detailed accident data, a safety evaluation model based on factors derived from a driving simulation can effectively assess the driving risk in urban cross-river tunnels constructed or in design.

76 FR 28481 - Carolina Power & Light Company; Brunswick Steam Electric Plant, Units 1 and 2; Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-17

... to public health and safety; (2) performing health physics or chemistry duties required as a member... SSCs that a risk-informed evaluation process has shown to be significant to public health and safety...

CHARACTERIZING SOILS FOR HAZAROUDS WASTE SITE ASSESSMENTS

EPA Science Inventory

The purpose of this paper is to provide guidance to Remedial Project Managers (RPM) and On-Scene Coordinators (OSC) concerning soil characterization data types required for decision-making in the CERCLA RI/FS process related to risk assessment and remedial alternative evaluation ...

Inflammatory Bowel Disease (IBD) and Pregnancy

MedlinePlus

... may be at an increased risk for having Vitamin K deficiency. Vitamin K is important in the blood clotting process. Women with IBD should have their nutritional status evaluated by their health care provider prior to and ... supplements may be necessary. What medications ...

Methods for Evaluating the Performance and Human Stress-Factors of Percussive Riveting

NASA Astrophysics Data System (ADS)

Ahn, Jonathan Y.

The aerospace industry automates portions of their manufacturing and assembly processes. However, mechanics still remain vital to production, especially in areas where automated machines cannot fit, or have yet to match the quality of human craftsmanship. One such task is percussive riveting. Because percussive riveting is associated with a high risk of injury, these tool must be certified prior to release. The major contribution of this thesis is to develop a test bench capable of percussive riveting for ergonomic evaluation purposes. The major issues investigated are: (i) automate the tool evaluation method to be repeatable; (ii) demonstrate use of displacement and force sensors; and (iii) correlate performance and risk exposure of percussive tools. A test bench equipped with servomotors and pneumatic cylinders to control xyz-position of a rivet gun and bucking bar simultaneously, is used to explore this evaluation approach.

IARC monographs: 40 years of evaluating carcinogenic hazards to humans.

PubMed

Pearce, Neil; Blair, Aaron; Vineis, Paolo; Ahrens, Wolfgang; Andersen, Aage; Anto, Josep M; Armstrong, Bruce K; Baccarelli, Andrea A; Beland, Frederick A; Berrington, Amy; Bertazzi, Pier Alberto; Birnbaum, Linda S; Brownson, Ross C; Bucher, John R; Cantor, Kenneth P; Cardis, Elisabeth; Cherrie, John W; Christiani, David C; Cocco, Pierluigi; Coggon, David; Comba, Pietro; Demers, Paul A; Dement, John M; Douwes, Jeroen; Eisen, Ellen A; Engel, Lawrence S; Fenske, Richard A; Fleming, Lora E; Fletcher, Tony; Fontham, Elizabeth; Forastiere, Francesco; Frentzel-Beyme, Rainer; Fritschi, Lin; Gerin, Michel; Goldberg, Marcel; Grandjean, Philippe; Grimsrud, Tom K; Gustavsson, Per; Haines, Andy; Hartge, Patricia; Hansen, Johnni; Hauptmann, Michael; Heederik, Dick; Hemminki, Kari; Hemon, Denis; Hertz-Picciotto, Irva; Hoppin, Jane A; Huff, James; Jarvholm, Bengt; Kang, Daehee; Karagas, Margaret R; Kjaerheim, Kristina; Kjuus, Helge; Kogevinas, Manolis; Kriebel, David; Kristensen, Petter; Kromhout, Hans; Laden, Francine; Lebailly, Pierre; LeMasters, Grace; Lubin, Jay H; Lynch, Charles F; Lynge, Elsebeth; 't Mannetje, Andrea; McMichael, Anthony J; McLaughlin, John R; Marrett, Loraine; Martuzzi, Marco; Merchant, James A; Merler, Enzo; Merletti, Franco; Miller, Anthony; Mirer, Franklin E; Monson, Richard; Nordby, Karl-Cristian; Olshan, Andrew F; Parent, Marie-Elise; Perera, Frederica P; Perry, Melissa J; Pesatori, Angela Cecilia; Pirastu, Roberta; Porta, Miquel; Pukkala, Eero; Rice, Carol; Richardson, David B; Ritter, Leonard; Ritz, Beate; Ronckers, Cecile M; Rushton, Lesley; Rusiecki, Jennifer A; Rusyn, Ivan; Samet, Jonathan M; Sandler, Dale P; de Sanjose, Silvia; Schernhammer, Eva; Costantini, Adele Seniori; Seixas, Noah; Shy, Carl; Siemiatycki, Jack; Silverman, Debra T; Simonato, Lorenzo; Smith, Allan H; Smith, Martyn T; Spinelli, John J; Spitz, Margaret R; Stallones, Lorann; Stayner, Leslie T; Steenland, Kyle; Stenzel, Mark; Stewart, Bernard W; Stewart, Patricia A; Symanski, Elaine; Terracini, Benedetto; Tolbert, Paige E; Vainio, Harri; Vena, John; Vermeulen, Roel; Victora, Cesar G; Ward, Elizabeth M; Weinberg, Clarice R; Weisenburger, Dennis; Wesseling, Catharina; Weiderpass, Elisabete; Zahm, Shelia Hoar

2015-06-01

Recently, the International Agency for Research on Cancer (IARC) Programme for the Evaluation of Carcinogenic Risks to Humans has been criticized for several of its evaluations, and also for the approach used to perform these evaluations. Some critics have claimed that failures of IARC Working Groups to recognize study weaknesses and biases of Working Group members have led to inappropriate classification of a number of agents as carcinogenic to humans. The authors of this Commentary are scientists from various disciplines relevant to the identification and hazard evaluation of human carcinogens. We examined criticisms of the IARC classification process to determine the validity of these concerns. Here, we present the results of that examination, review the history of IARC evaluations, and describe how the IARC evaluations are performed. We concluded that these recent criticisms are unconvincing. The procedures employed by IARC to assemble Working Groups of scientists from the various disciplines and the techniques followed to review the literature and perform hazard assessment of various agents provide a balanced evaluation and an appropriate indication of the weight of the evidence. Some disagreement by individual scientists to some evaluations is not evidence of process failure. The review process has been modified over time and will undoubtedly be altered in the future to improve the process. Any process can in theory be improved, and we would support continued review and improvement of the IARC processes. This does not mean, however, that the current procedures are flawed. The IARC Monographs have made, and continue to make, major contributions to the scientific underpinning for societal actions to improve the public's health.

Overview of prohibited and permitted plant regulatory listing systems

USGS Publications Warehouse

Westbrooks, Randy G.; Tasker, Alan V.

2011-01-01

Pest risk analysis is a process that evaluates the risks involved with a proposed species to help determine whether it should be permitted or denied entry into a country, and how the risks could be managed if it is imported. The prohibited listing approach was developed in the late 1800s and early 1900s in response to outbreaks of plant and animals pests such as foot and mouth disease of livestock, Mediterranean fruitfly (Ceratitis capitata Wiedemann), and Gypsy moth (Lymantria dispar L.). Under this approach, selected species of concern are evaluated to determine if they should be regulated for entry. Under the permitted listing approach that was first used on a national level in Australia in the 1990s, all species that are proposed for introduction are assessed to determine if they should be regulated.

Nanoparticle risk management and cost evaluation: a general framework

NASA Astrophysics Data System (ADS)

Fleury, Dominique; Bomfim, João A. S.; Metz, Sébastien; Bouillard, Jacques X.; Brignon, Jean-Marc

2011-07-01

Industrial production of nano-objects has been growing fast during the last decade and a wide range of products containing nanoparticles (NPs) is proposed to the public in various markets (automotive, electronics, textiles...). The issues encountered in monitoring the presence of nano-objects in any media cause a major difficulty for controlling the risk associated to the production stage. It is therefore very difficult to assess the efficiency of prevention and mitigation solutions, which potentially leads to overestimate the level of the protection barriers that are recommended. The extra costs in adding nano-objects to the process, especially that of nanosafety, must be estimated and optimized to ensure the competitiveness of the future production lines and associated products. The risk management and cost evaluation methods presented herein have been designed for application in a pilot production line of injection-moulded nanocomposites.

IRIS Toxicological Review of Tetrahydrofuran (THF) ...

EPA Pesticide Factsheets

EPA is releasing the draft report, Toxicological Review of Tetrahydrofuran, that was distributed to Federal agencies and White House Offices for comment during the Science Discussion step of the IRIS Assessment Development Process. Comments received from other Federal agencies and White House Offices are provided below with external peer review panel comments. EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for tetrahydrofuran. IRIS is an EPA database containing Agency scientific positions on potential adverse human health effects that may result from chronic (or lifetime) exposure to chemicals in the environment. IRIS contains chemical-specific summaries of qualitative and quantitative health information in support of two steps of the risk assessment paradigm, i.e., hazard identification and dose-response evaluation. IRIS assessments are used in combination with specific situational exposure assessment information to evaluate potential public health risk associated with environmental contaminants.

Combining web-based tools for transparent evaluation of data for risk assessment: developmental effects of bisphenol A on the mammary gland as a case study.

PubMed

Molander, Linda; Hanberg, Annika; Rudén, Christina; Ågerstrand, Marlene; Beronius, Anna

2017-03-01

Different tools have been developed that facilitate systematic and transparent evaluation and handling of toxicity data in the risk assessment process. The present paper sets out to explore the combined use of two web-based tools for study evaluation and identification of reliable data relevant to health risk assessment. For this purpose, a case study was performed using in vivo toxicity studies investigating low-dose effects of bisphenol A on mammary gland development. The reliability of the mammary gland studies was evaluated using the Science in Risk Assessment and Policy (SciRAP) criteria for toxicity studies. The Health Assessment Workspace Collaborative (HAWC) was used for characterizing and visualizing the mammary gland data in terms of type of effects investigated and reported, and the distribution of these effects within the dose interval. It was then investigated whether there was any relationship between study reliability and the type of effects reported and/or their distribution in the dose interval. The combination of the SciRAP and HAWC tools allowed for transparent evaluation and visualization of the studies investigating developmental effects of BPA on the mammary gland. The use of these tools showed that there were no apparent differences in the type of effects and their distribution in the dose interval between the five studies assessed as most reliable and the whole data set. Combining the SciRAP and HAWC tools was found to be a useful approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

A QRM Discussion of Microbial Contamination of Non-sterile Drug Products, Using FDA and EMA Warning Letters Recorded between 2008 and 2016.

PubMed

Santos, Ana M C; Doria, Mara S; Meirinhos-Soares, Luís; Almeida, António J; Menezes, José C

2018-01-01

Microbial quality control of non-sterile drug products has been a concern to regulatory agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted if such events occur. To better manage risk and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in non-sterile drug products manufacturing, be able to evaluate their potential impact on final product quality, and apply mitigation actions. Herein we discuss the most likely root causes involved in microbial contaminations referenced in warning letters issued by US health authorities and non-compliance reports issued by European health authorities over a period of several years. The quality risk management tools proposed were applied to the data gathered from those databases, and a generic risk ranking was provided based on a panel of non-sterile drug product manufacturers that was assembled and given the opportunity to perform the risk assessments. That panel identified gaps and defined potential mitigation actions, based on their own experience of potential risks expected for their processes. Major findings clearly indicate that the manufacturers affected by the warning letters should focus their attention on process improvements and microbial control strategies, especially those related to microbial analysis and raw material quality control. Additionally, the WLs considered frequently referred to failures in quality-related issues, which indicates that the quality commitment should be reinforced at most companies to avoid microbiological contaminations. LAY ABSTRACT: Microbial contamination of drug products affects the quality of non-sterile drug products produced by numerous manufacturers, representing a major risk to patients. It is necessary to understand the microbial hazards involved in the manufacturing process and evaluate their impact on final product quality so that effective prevention strategies can be implemented. A risk-based classification of most likely root causes for microbial contamination found in the warning letters issued by the US Food and Drug Administration and the European Medicines Agency is proposed. To validate the likely root causes extracted from the warning letters, a subject matter expert panel made of several manufacturers was formed and consulted. A quality risk management approach to assess microbiological contamination of non-sterile drug products is proposed for the identification of microbial hazards involved in the manufacturing process. To enable ranking of microbial contamination risks, quality risk management metrics related to criticality and overall risk were applied. The results showed that manufacturers of non-sterile drug products should improve their microbial control strategy, with special attention to quality controls of raw materials, primary containers, and closures. Besides that, they should invest in a more robust quality system and culture. As a start, manufacturers may consider investigating their specific microbiological risks, adressing their sites' own microbial ecology, type of manufacturing processes, and dosage form characteristics, as these may lead to increased contamination risks. Authorities should allow and enforce innovative, more comprehensive, and more effective approaches to in-process contamination monitoring and controls. © PDA, Inc. 2018.

Integration of care for hypertension and diabetes: a scoping review assessing the evidence from systematic reviews and evaluating reporting.

PubMed

Yiu, Kristy C; Rohwer, Anke; Young, Taryn

2018-06-20

With the rise in pre-mature mortality rate from non-communicable disease (NCD), there is a need for evidence-based interventions. We evaluated existing systematic reviews on effectiveness of integration of healthcare services, in particular with focus on delivery of care designed to improve health and process outcomes in people with multi-morbidity, where at least one of the conditions was diabetes or hypertension. We searched MEDLINE, EMBASE, Cochrane Library, and Health Evidence to November 8, 2016 and consulted experts. One review author screened titles, abstracts and two review authors independently screened short listed full-texts and selected reviews for inclusion. We considered systematic reviews evaluating integration of care, compared to usual care, for people with multi-morbidity. One review author extracted data and another author verified it. Two review authors independently evaluated risk of bias using ROBIS and AMSTAR. Inter-rater reliability was analysed for ROBIS and AMSTAR using Cohen's kappa and percent agreement. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used to assess reporting. We identified five systematic reviews on integration of care. Four reviews focused on comorbid diabetes and depression and two covered hypertension and comorbidities of cardiovascular disease, depression, or diabetes. Interventions were poorly described. The health outcomes evaluated included risk of all-cause mortality, measures of depression, cholesterol levels, HbA1c levels, effect of depression on HbA1c levels, symptom improvement, systolic blood pressure, and hypertension control. Process outcomes included access and utilisation of healthcare services, costs, and quality of care. Overall, three reviews had a low and medium risk of bias according to ROBIS and AMSTAR respectively, while two reviews had high risk of bias as judged by both ROBIS and AMSTAR. Findings have demonstrated that collaborative care in general resulted in better health and process outcomes when compared to usual care for both depression and diabetes and hypertension and diabetes. Several knowledge gaps were identified on integration of care for comorbidities with diabetes and/or hypertension: limited research on this topic for hypertension, limited reviews that included primary studies based in low-middle income countries, and limited reviews on collaborative care for communicable and NCDs.

Improving the Impact and Implementation of Disaster Education: Programs for Children Through Theory-Based Evaluation.

PubMed

Johnson, Victoria A; Ronan, Kevin R; Johnston, David M; Peace, Robin

2016-11-01

A main weakness in the evaluation of disaster education programs for children is evaluators' propensity to judge program effectiveness based on changes in children's knowledge. Few studies have articulated an explicit program theory of how children's education would achieve desired outcomes and impacts related to disaster risk reduction in households and communities. This article describes the advantages of constructing program theory models for the purpose of evaluating disaster education programs for children. Following a review of some potential frameworks for program theory development, including the logic model, the program theory matrix, and the stage step model, the article provides working examples of these frameworks. The first example is the development of a program theory matrix used in an evaluation of ShakeOut, an earthquake drill practiced in two Washington State school districts. The model illustrates a theory of action; specifically, the effectiveness of school earthquake drills in preventing injuries and deaths during disasters. The second example is the development of a stage step model used for a process evaluation of What's the Plan Stan?, a voluntary teaching resource distributed to all New Zealand primary schools for curricular integration of disaster education. The model illustrates a theory of use; specifically, expanding the reach of disaster education for children through increased promotion of the resource. The process of developing the program theory models for the purpose of evaluation planning is discussed, as well as the advantages and shortcomings of the theory-based approaches. © 2015 Society for Risk Analysis.

Evaluation of agricultural nonpoint source pollution potential risk over China with a Transformed-Agricultural Nonpoint Pollution Potential Index method.

PubMed

Yang, Fei; Xu, Zhencheng; Zhu, Yunqiang; He, Chansheng; Wu, Genyi; Qiu, Jin Rong; Fu, Qiang; Liu, Qingsong

2013-01-01

Agricultural nonpoint source (NPS) pollution has been the most important threat to water environment quality. Understanding the spatial distribution of NPS pollution potential risk is important for taking effective measures to control and reduce NPS pollution. A Transformed-Agricultural Nonpoint Pollution Potential Index (T-APPI) model was constructed for evaluating the national NPS pollution potential risk in this study; it was also combined with remote sensing and geographic information system techniques for evaluation on the large scale and at 1 km2 spatial resolution. This model considers many factors contributing to the NPS pollution as the original APPI model, summarized as four indicators of the runoff, sediment production, chemical use and the people and animal load. These four indicators were analysed in detail at 1 km2 spatial resolution throughout China. The T-APPI model distinguished the four indicators into pollution source factors and transport process factors; it also took their relationship into consideration. The studied results showed that T-APPI is a credible and convenient method for NPS pollution potential risk evaluation. The results also indicated that the highest NPS pollution potential risk is distributed in the middle-southern Jiangsu province. Several other regions, including the North China Plain, Chengdu Basin Plain, Jianghan Plain, cultivated lands in Guangdong and Guangxi provinces, also showed serious NPS pollution potential. This study can provide a scientific reference for predicting the future NPS pollution risk throughout China and may be helpful for taking reasonable and effective measures for preventing and controlling NPS pollution.

Environmental Risk Assessment System for Phosphogypsum Tailing Dams

PubMed Central

Sun, Xin; Tang, Xiaolong; Yi, Honghong; Li, Kai; Zhou, Lianbi; Xu, Xianmang

2013-01-01

This paper may be of particular interest to the readers as it provides a new environmental risk assessment system for phosphogypsum tailing dams. In this paper, we studied the phosphogypsum tailing dams which include characteristics of the pollution source, environmental risk characteristics and evaluation requirements to identify the applicable environmental risk assessment methods. Two analytical methods, that is, the analytic hierarchy process (AHP) and fuzzy logic, were used to handle the complexity of the environmental and nonquantitative data. Using our assessment method, different risk factors can be ranked according to their contributions to the environmental risk, thereby allowing the calculation of their relative priorities during decision making. Thus, environmental decision-makers can use this approach to develop alternative management strategies for proposed, ongoing, and completed PG tailing dams. PMID:24382947

Environmental risk assessment system for phosphogypsum tailing dams.

PubMed

Sun, Xin; Ning, Ping; Tang, Xiaolong; Yi, Honghong; Li, Kai; Zhou, Lianbi; Xu, Xianmang

2013-01-01

This paper may be of particular interest to the readers as it provides a new environmental risk assessment system for phosphogypsum tailing dams. In this paper, we studied the phosphogypsum tailing dams which include characteristics of the pollution source, environmental risk characteristics and evaluation requirements to identify the applicable environmental risk assessment methods. Two analytical methods, that is, the analytic hierarchy process (AHP) and fuzzy logic, were used to handle the complexity of the environmental and nonquantitative data. Using our assessment method, different risk factors can be ranked according to their contributions to the environmental risk, thereby allowing the calculation of their relative priorities during decision making. Thus, environmental decision-makers can use this approach to develop alternative management strategies for proposed, ongoing, and completed PG tailing dams.

Participatory video-assisted evaluation of truck drivers' work outside cab: deliveries in two types of transport.

PubMed

Reiman, Arto; Pekkala, Janne; Väyrynen, Seppo; Putkonen, Ari; Forsman, Mikael

2014-01-01

The aim of this study was to identify risks and ergonomics discomfort during work of local and short haul delivery truck drivers outside a cab. The study used a video- and computer-based method (VIDAR). VIDAR is a participatory method identifying demanding work situations and their potential risks. The drivers' work was videoed and analysed by subjects and ergonomists. Delivery truck drivers should not be perceived as one group with equal risks because there were significant differences between the 2 types of transportation and specific types of risks. VIDAR produces visual material for risk management processes. VIDAR as a participatory approach stimulates active discussion about work-related risks and discomfort, and about possibilities for improvement. VIDAR may be also applied to work which comprises different working environments.

Low levels of exposure to libby amphibole asbestos and localized pleural thickening.

PubMed

Christensen, Krista Yorita; Bateson, Thomas F; Kopylev, Leonid

2013-11-01

To explore the relationship between low levels of exposure to Libby amphibole asbestos (LAA) and pleural abnormalities, specifically localized pleural thickening (LPT). Three studies presenting the risks associated with quantitative LAA exposure estimates were reviewed, paying particular attention to lower exposure ranges. Studies reviewed were conducted among workers exposed to LAA at mining and milling operations in Libby, Montana, at a vermiculite processing facility in Marysville, Ohio, and community residents exposed to LAA from a vermiculite processing facility in Minneapolis, Minnesota. Pleural abnormalities were evaluated using radiographs. Despite differences in study populations and design, each study found that cumulative inhalation LAA exposure was associated with increased risk of LPT even at low levels of exposure. Inhalation exposure to LAA is associated with increased risk of LPT even at the lowest levels of exposure in each study.

Risk management in a large-scale CO2 geosequestration pilot project, Illinois, USA

USGS Publications Warehouse

Hnottavange-Telleen, K.; Chabora, E.; Finley, R.J.; Greenberg, S.E.; Marsteller, S.

2011-01-01

Like most large-scale infrastructure projects, carbon dioxide (CO 2) geological sequestration (GS) projects have multiple success criteria and multiple stakeholders. In this context "risk evaluation" encompasses multiple scales. Yet a risk management program aims to maximize the chance of project success by assessing, monitoring, minimizing all risks in a consistent framework. The 150,000-km2 Illinois Basin underlies much of the state of Illinois, USA, and parts of adjacent Kentucky and Indiana. Its potential for CO2 storage is first-rate among basins in North America, an impression that has been strengthened by early testing of the injection well of the Midwest Geological Sequestration Consortium's (MGSC's) Phase III large scale demonstration project, the Illinois Basin - Decatur Project (IBDP). The IBDP, funded by the U.S. Department of Energy's National Energy Technology Laboratory (NETL), represents a key trial of GS technologies and project-management techniques. Though risks are specific to each site and project, IBDP risk management methodologies provide valuable experience for future GS projects. IBDP views risk as the potential for negative impact to any of these five values: health and safety, environment, financial, advancing the viability and public acceptability of a GS industry, and research. Research goals include monitoring one million metric tonnes of injected CO2 in the subsurface. Risk management responds to the ways in which any values are at risk: for example, monitoring is designed to reduce uncertainties in parameter values that are important for research and system control, and is also designed to provide public assurance. Identified risks are the primary basis for risk-reduction measures: risks linked to uncertainty in geologic parameters guide further characterization work and guide simulations applied to performance evaluation. Formally, industry defines risk (more precisely risk criticality) as the product L*S, the Likelihood multiplied by the Severity of negative impact. L and S are each evaluated on five-point scales, yielding a theoretical spread in risk values of 1 through 25. So defined, these judgment-based values are categorical and ordinal - they do not represent physically measurable quantities, but are nonetheless useful for comparison and therefore decision support. The "risk entities" first evaluated are FEPs - conceptual Features, Events, and Processes based on the list published by Quintessa Ltd. After concrete scenarios are generated based on selected FEPs, scenarios become the critical entities whose associated risks are evaluated and tracked. In IBDP workshops, L and S values for 123 FEPs were generated through expert elicitation. About 30 experts in the project or in GS in general were assigned among six facilitated working groups, and each group was charged to envision risks within a sphere of project operations. Working groups covered FEPs with strong spatial characteristics - such as those related to the injection wellbore and simulated plume footprint - and "nonspatial" FEPs related to finance, regulations, legal, and stakeholder issues. Within these working groups, experts shared information, examined assumptions, refined and extended the FEP list, calibrated responses, and provided initial L and S values by consensus. Individual rankings were collected in a follow-up process via emailed spreadsheets. For each of L and S, three values were collected: Lower Bound, Best Guess, and Upper Bound. The Lower-Upper Bound ranges and the spreads among experts can be interpreted to yield rough confidence measures. Based on experts' responses, FEPs were ranked in terms of their L*S risk levels. FEP rankings were determined from individual (not consensus or averaged) results, thus no high-risk responses were damped out. The higher-risk FEPs were used to generate one or more concrete, well defined risk-bearing scenarios for each FEP. Any FEP scored by any expert as having associated risk of

Overcoming Learning Aversion in Evaluating and Managing Uncertain Risks.

PubMed

Cox, Louis Anthony Tony

2015-10-01

Decision biases can distort cost-benefit evaluations of uncertain risks, leading to risk management policy decisions with predictably high retrospective regret. We argue that well-documented decision biases encourage learning aversion, or predictably suboptimal learning and premature decision making in the face of high uncertainty about the costs, risks, and benefits of proposed changes. Biases such as narrow framing, overconfidence, confirmation bias, optimism bias, ambiguity aversion, and hyperbolic discounting of the immediate costs and delayed benefits of learning, contribute to deficient individual and group learning, avoidance of information seeking, underestimation of the value of further information, and hence needlessly inaccurate risk-cost-benefit estimates and suboptimal risk management decisions. In practice, such biases can create predictable regret in selection of potential risk-reducing regulations. Low-regret learning strategies based on computational reinforcement learning models can potentially overcome some of these suboptimal decision processes by replacing aversion to uncertain probabilities with actions calculated to balance exploration (deliberate experimentation and uncertainty reduction) and exploitation (taking actions to maximize the sum of expected immediate reward, expected discounted future reward, and value of information). We discuss the proposed framework for understanding and overcoming learning aversion and for implementing low-regret learning strategies using regulation of air pollutants with uncertain health effects as an example. © 2015 Society for Risk Analysis.

Health Risk-Based Assessment and Management of Heavy Metals-Contaminated Soil Sites in Taiwan

PubMed Central

Lai, Hung-Yu; Hseu, Zeng-Yei; Chen, Ting-Chien; Chen, Bo-Ching; Guo, Horng-Yuh; Chen, Zueng-Sang

2010-01-01

Risk-based assessment is a way to evaluate the potential hazards of contaminated sites and is based on considering linkages between pollution sources, pathways, and receptors. These linkages can be broken by source reduction, pathway management, and modifying exposure of the receptors. In Taiwan, the Soil and Groundwater Pollution Remediation Act (SGWPR Act) uses one target regulation to evaluate the contamination status of soil and groundwater pollution. More than 600 sites contaminated with heavy metals (HMs) have been remediated and the costs of this process are always high. Besides using soil remediation techniques to remove contaminants from these sites, the selection of possible remediation methods to obtain rapid risk reduction is permissible and of increasing interest. This paper discusses previous soil remediation techniques applied to different sites in Taiwan and also clarified the differences of risk assessment before and after soil remediation obtained by applying different risk assessment models. This paper also includes many case studies on: (1) food safety risk assessment for brown rice growing in a HMs-contaminated site; (2) a tiered approach to health risk assessment for a contaminated site; (3) risk assessment for phytoremediation techniques applied in HMs-contaminated sites; and (4) soil remediation cost analysis for contaminated sites in Taiwan. PMID:21139851

Managing distrust-induced risk with deposit in supply chain contract decisions.

PubMed

Han, Guanghua; Dong, Ming; Sun, Qi

2014-01-01

This paper studies the trust issue in a two-echelon supply chain information sharing process. In a supply chain, the retailer reports the forecasted demand to the supplier. Traditionally, the supplier's trust in the retailer's reported information is based on the retailer's reputation. However, this paper considers that trust is random and is also affected by the reputation and the demand gap. The supplier and retailer have been shown to have different evaluations regarding the degree of trust. Furthermore, distrust is inherently linked to perceived risk. To mitigate perceived risk, a two-stage decision process with an unpayback deposit contract is proposed. At the first stage, the supplier and the retailer negotiate the deposit contract. At the second stage, a Stackelberg game is used to determine the retailer's reported demand and the supplier's production quantity. We show that the deposits from the retailer's and supplier's perspectives are different. When the retailer's reported demand is equal to the supplier's forecasted demand, the retailer's evaluation of the deposit is more than that of supplier's. When the retailer's reported demand is equal to the retailer's forecasted demand, the deposit from the retailer's perspective is at the lowest level.

Eating habits of preschool children and the risk of obesity, insulin resistance and metabolic syndrome in adults.

PubMed

Kostecka, Małgorzata

2014-01-01

Background & Objective : Nutrient excess and nutrient deficiency in the diets of preschool children can lead to permanent modification of metabolic pathways and increased risk of diet-dependent diseases in adults. Children are most susceptible to the adverse consequences of bad eating habits.The objective of this study was to evaluate the eating habits and the diets of preschool children as risk factors for excessive weight, obesity, insulin resistance and the metabolic syndrome. Methods : The study was conducted on 350 randomly selected preschool children attending kindergartens in south-eastern Poland. Three-day dietary recalls were processed and evaluated in the Dieta 5 application. Results : The analyzed diets were characterized by low diversity and a high share of processed foods, such as pate, sausages, ketchup, mayonnaise, fried meat, French fries and fast-food. The dietary content of vegetables, raw fruit, dairy products and whole grain products was alarmingly low. Conclusions : Diets characterized by excessive energy value and nutritional deficiency can lead to health problems. In most cases, excessive weight gain in children can be blamed on parents and caretakers who are not aware of the health consequences of high-calorie foods rich in fats and sugar.

Managing Distrust-Induced Risk with Deposit in Supply Chain Contract Decisions

PubMed Central

Han, Guanghua; Dong, Ming; Sun, Qi

2014-01-01

This paper studies the trust issue in a two-echelon supply chain information sharing process. In a supply chain, the retailer reports the forecasted demand to the supplier. Traditionally, the supplier's trust in the retailer's reported information is based on the retailer's reputation. However, this paper considers that trust is random and is also affected by the reputation and the demand gap. The supplier and retailer have been shown to have different evaluations regarding the degree of trust. Furthermore, distrust is inherently linked to perceived risk. To mitigate perceived risk, a two-stage decision process with an unpayback deposit contract is proposed. At the first stage, the supplier and the retailer negotiate the deposit contract. At the second stage, a Stackelberg game is used to determine the retailer's reported demand and the supplier's production quantity. We show that the deposits from the retailer's and supplier's perspectives are different. When the retailer's reported demand is equal to the supplier's forecasted demand, the retailer's evaluation of the deposit is more than that of supplier's. When the retailer's reported demand is equal to the retailer's forecasted demand, the deposit from the retailer's perspective is at the lowest level. PMID:25054190

Investigating the Gap Between Estimated and Actual Energy Efficiency and Conservation Savings for Public Buildings Projects & Programs in United States

NASA Astrophysics Data System (ADS)

Qaddus, Muhammad Kamil

The gap between estimated and actual savings in energy efficiency and conservation (EE&C) projects or programs forms the problem statement for the scope of public and government buildings. This gap has been analyzed first on impact and then on process-level. On the impact-level, the methodology leads to categorization of the gap as 'Realization Gap'. It then views the categorization of gap within the context of past and current narratives linked to realization gap. On process-level, the methodology leads to further analysis of realization gap on process evaluation basis. The process evaluation criterion, a product of this basis is then applied to two different programs (DESEU and NYC ACE) linked to the scope of this thesis. Utilizing the synergies of impact and process level analysis, it offers proposals on program development and its structure using our process evaluation criterion. Innovative financing and benefits distribution structure is thus developed and will remain part of the proposal. Restricted Stakeholder Crowd Financing and Risk-Free Incentivized return are the products of proposed financing and benefit distribution structure respectively. These products are then complimented by proposing an alternative approach in estimating EE&C savings. The approach advocates estimation based on range-allocation rather than currently utilized unique estimated savings approach. The Way Ahead section thus explores synergy between financial and engineering ranges of energy savings as a multi-discipline approach for future research. Moreover, it provides the proposed program structure with risk aversion and incentive allocation while dealing with uncertainty. This set of new approaches are believed to better fill the realization gap between estimated and actual energy efficiency savings.

Wild Fire Risk Map in the Eastern Steppe of Mongolia Using Spatial Multi-Criteria Analysis

NASA Astrophysics Data System (ADS)

Nasanbat, Elbegjargal; Lkhamjav, Ochirkhuyag

2016-06-01

Grassland fire is a cause of major disturbance to ecosystems and economies throughout the world. This paper investigated to identify risk zone of wildfire distributions on the Eastern Steppe of Mongolia. The study selected variables for wildfire risk assessment using a combination of data collection, including Social Economic, Climate, Geographic Information Systems, Remotely sensed imagery, and statistical yearbook information. Moreover, an evaluation of the result is used field validation data and assessment. The data evaluation resulted divided by main three group factors Environmental, Social Economic factor, Climate factor and Fire information factor into eleven input variables, which were classified into five categories by risk levels important criteria and ranks. All of the explanatory variables were integrated into spatial a model and used to estimate the wildfire risk index. Within the index, five categories were created, based on spatial statistics, to adequately assess respective fire risk: very high risk, high risk, moderate risk, low and very low. Approximately more than half, 68 percent of the study area was predicted accuracy to good within the very high, high risk and moderate risk zones. The percentages of actual fires in each fire risk zone were as follows: very high risk, 42 percent; high risk, 26 percent; moderate risk, 13 percent; low risk, 8 percent; and very low risk, 11 percent. The main overall accuracy to correct prediction from the model was 62 percent. The model and results could be support in spatial decision making support system processes and in preventative wildfire management strategies. Also it could be help to improve ecological and biodiversity conservation management.

Effects of Acoustic Impulses on the Middle Ear

DTIC Science & Technology

2017-10-01

conditioned response; middle ear; damage-risk criteria; health hazard evaluation ACCOMPLISHMENTS: What were the major goals of the project? The...participants declined to participate after the study was described during the informed consent process. The results of V1 were used to evaluate participant...0.64 0.73 4000 Hz 0.82 0.78 0.85 0.68 0.63 0.73 1 or 2 kHz 0.93 0.90 0.95 – – – 13 Evaluation of RTs Analyses of reflexive tasks

Multiple attribute decision making model and application to food safety risk evaluation.

PubMed

Ma, Lihua; Chen, Hong; Yan, Huizhe; Yang, Lifeng; Wu, Lifeng

2017-01-01

Decision making for supermarket food purchase decisions are characterized by network relationships. This paper analyzed factors that influence supermarket food selection and proposes a supplier evaluation index system based on the whole process of food production. The author established the intuitive interval value fuzzy set evaluation model based on characteristics of the network relationship among decision makers, and validated for a multiple attribute decision making case study. Thus, the proposed model provides a reliable, accurate method for multiple attribute decision making.

Mouse Models for Unraveling the Importance of Diet in Colon Cancer Prevention

PubMed Central

Tammariello, Alexandra E.; Milner, John A.

2010-01-01

Diet and genetics are both considered important risk determinants for colorectal cancer, a leading cause of death worldwide. Several genetically engineered mouse models have been created, including the ApcMin mouse, to aid in the identification of key cancer related processes and to assist with the characterization of environmental factors, including the diet, which influence risk. Current research using these models provides evidence that several bioactive food components can inhibit genetically predisposed colorectal cancer, while others increase risk. Specifically, calorie restriction or increased exposure to n-3 fatty acids, sulforaphane, chafuroside, curcumin, and dibenzoylmethane were reported protective. Total fat, calories and all-trans retinoic acid are associated with an increased risk. Unraveling the importance of specific dietary components in these models is complicated by the basal diet used, the quantity of test components provided, and interactions among food components. Newer models are increasingly available to evaluate fundamental cellular processes, including DNA mismatch repair, immune function and inflammation as markers for colon cancer risk. Unfortunately, these models have been used infrequently to examine the influence of specific dietary components. The enhanced use of these models can shed mechanistic insights about the involvement of specific bioactive food and components and energy as determinants of colon cancer risk. However, the use of available mouse models to exactly represent processes important to human gastrointestinal cancers will remain a continued scientific challenge. PMID:20122631

Risk perception and decision processes underlying informed consent to research participation.

PubMed

Reynolds, William W; Nelson, Robert M

2007-11-01

According to the rational choice model, informed consent should consist of a systematic, step-by-step evaluation of all information pertinent to the treatment or research participation decision. Research shows that people frequently deviate from this normative model, however, employing decision-making shortcuts, or heuristics. In this paper we report findings from a qualitative study of 32 adolescents and (their) 31 parents who were recruited from two Northeastern US hospitals and asked to consider the risks of and make hypothetical decisions about research participation. The purpose of this study was to increase our understanding of how diabetic and at-risk adolescents (i.e., those who are obese and/or have a family history of diabetes) and their parents perceive risks and make decisions about research participation. Using data collected from adolescents and parents, we identify heuristic decision processes in which participant perceptions of risk magnitude, which are formed quickly and intuitively and appear to be based on affective responses to information, are far more prominent and central to the participation decision than are perceptions of probability. We discuss participants' use of decision-making heuristics in the context of recent research on affect and decision processes, and we consider the implications of these findings for researchers.

Genetically Predicted Body Mass Index and Alzheimer’s Disease Related Phenotypes in Three Large Samples: Mendelian Randomization Analyses

PubMed Central

Mukherjee, Shubhabrata; Walter, Stefan; Kauwe, John S.K.; Saykin, Andrew J.; Bennett, David A.; Larson, Eric B.; Crane, Paul K.; Glymour, M. Maria

2015-01-01

Observational research shows that higher body mass index (BMI) increases Alzheimer’s disease (AD) risk, but it is unclear whether this association is causal. We applied genetic variants that predict BMI in Mendelian Randomization analyses, an approach that is not biased by reverse causation or confounding, to evaluate whether higher BMI increases AD risk. We evaluated individual level data from the AD Genetics Consortium (ADGC: 10,079 AD cases and 9,613 controls), the Health and Retirement Study (HRS: 8,403 participants with algorithm-predicted dementia status) and published associations from the Genetic and Environmental Risk for AD consortium (GERAD1: 3,177 AD cases and 7,277 controls). No evidence from individual SNPs or polygenic scores indicated BMI increased AD risk. Mendelian Randomization effect estimates per BMI point (95% confidence intervals) were: ADGC OR=0.95 (0.90, 1.01); HRS OR=1.00 (0.75, 1.32); GERAD1 OR=0.96 (0.87, 1.07). One subscore (cellular processes not otherwise specified) unexpectedly predicted lower AD risk. PMID:26079416

Dual process interaction model of HIV-risk behaviors among drug offenders.

PubMed

Ames, Susan L; Grenard, Jerry L; Stacy, Alan W

2013-03-01

This study evaluated dual process interaction models of HIV-risk behavior among drug offenders. A dual process approach suggests that decisions to engage in appetitive behaviors result from a dynamic interplay between a relatively automatic associative system and an executive control system. One synergistic type of interplay suggests that executive functions may dampen or block effects of spontaneously activated associations. Consistent with this model, latent variable interaction analyses revealed that drug offenders scoring higher in affective decision making were relatively protected from predictive effects of spontaneous sex associations promoting risky sex. Among drug offenders with lower levels of affective decision making ability, spontaneous sexually-related associations more strongly predicted risky sex (lack of condom use and greater number of sex partners). These findings help elucidate associative and control process effects on appetitive behaviors and are important for explaining why some individuals engage in risky sex, while others are relatively protected.

Dual Process Interaction Model of HIV-Risk Behaviors Among Drug Offenders

PubMed Central

Grenard, Jerry L.; Stacy, Alan W.

2012-01-01

This study evaluated dual process interaction models of HIV-risk behavior among drug offenders. A dual process approach suggests that decisions to engage in appetitive behaviors result from a dynamic interplay between a relatively automatic associative system and an executive control system. One synergistic type of interplay suggests that executive functions may dampen or block effects of spontaneously activated associations. Consistent with this model, latent variable interaction analyses revealed that drug offenders scoring higher in affective decision making were relatively protected from predictive effects of spontaneous sex associations promoting risky sex. Among drug offenders with lower levels of affective decision making ability, spontaneous sexually-related associations more strongly predicted risky sex (lack of condom use and greater number of sex partners). These findings help elucidate associative and control process effects on appetitive behaviors and are important for explaining why some individuals engage in risky sex, while others are relatively protected. PMID:22331391

Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals

PubMed Central

Beronius, Anna; Vandenberg, Laura N.

2016-01-01

The possibility that endocrine disrupting chemicals (EDCs) in our environment contribute to hormonally related effects and diseases observed in human and wildlife populations has caused concern among decision makers and researchers alike. EDCs challenge principles traditionally applied in chemical risk assessment and the identification and assessment of these compounds has been a much debated topic during the last decade. State of the science reports and risk assessments of potential EDCs have been criticized for not using systematic and transparent approaches in the evaluation of evidence. In the fields of medicine and health care, systematic review methodologies have been developed and used to enable objectivity and transparency in the evaluation of scientific evidence for decision making. Lately, such approaches have also been promoted for use in the environmental health sciences and risk assessment of chemicals. Systematic review approaches could provide a tool for improving the evaluation of evidence for decision making regarding EDCs, e.g. by enabling systematic and transparent use of academic research data in this process. In this review we discuss the advantages and challenges of applying systematic review methodology in the identification and assessment of EDCs. PMID:26847432

A Community Health Advisor Program to reduce cardiovascular risk among rural African-American women

PubMed Central

Cornell, C. E.; Littleton, M. A.; Greene, P. G.; Pulley, L.; Brownstein, J. N.; Sanderson, B. K.; Stalker, V. G.; Matson-Koffman, D.; Struempler, B.; Raczynski, J. M.

2009-01-01

The Uniontown, Alabama Community Health Project trained and facilitated Community Health Advisors (CHAs) in conducting a theory-based intervention designed to reduce the risk for cardiovascular disease (CVD) among rural African-American women. The multiphased project included formative evaluation and community organization, CHA recruitment and training, community intervention and maintenance. Formative data collected to develop the training, intervention and evaluation methods and materials indicated the need for programs to increase knowledge, skills and resources for changing behaviors that increase the risk of CVD. CHAs worked in partnership with staff to develop, implement, evaluate and maintain strategies to reduce risk for CVD in women and to influence city officials, business owners and community coalitions to facilitate project activities. Process data documented sustained increases in social capital and community capacity to address health-related issues, as well as improvements in the community’s physical infrastructure. This project is unique in that it documents that a comprehensive CHA-based intervention for CVD can facilitate wide-reaching changes in capacity to address health issues in a rural community that include improvements in community infrastructure and are sustained beyond the scope of the originally funded intervention. PMID:19047648

Using systematic reviews for hazard and risk assessment of endocrine disrupting chemicals.

PubMed

Beronius, Anna; Vandenberg, Laura N

2015-12-01

The possibility that endocrine disrupting chemicals (EDCs) in our environment contribute to hormonally related effects and diseases observed in human and wildlife populations has caused concern among decision makers and researchers alike. EDCs challenge principles traditionally applied in chemical risk assessment and the identification and assessment of these compounds has been a much debated topic during the last decade. State of the science reports and risk assessments of potential EDCs have been criticized for not using systematic and transparent approaches in the evaluation of evidence. In the fields of medicine and health care, systematic review methodologies have been developed and used to enable objectivity and transparency in the evaluation of scientific evidence for decision making. Lately, such approaches have also been promoted for use in the environmental health sciences and risk assessment of chemicals. Systematic review approaches could provide a tool for improving the evaluation of evidence for decision making regarding EDCs, e.g. by enabling systematic and transparent use of academic research data in this process. In this review we discuss the advantages and challenges of applying systematic review methodology in the identification and assessment of EDCs.

Pilot evaluation of an adolescent risk and injury prevention programme incorporating curriculum and school connectedness components.

PubMed

Chapman, R L; Buckley, L; Sheehan, M; Shochet, I M

2013-08-01

School connectedness is an important protective factor for adolescent risk-taking behaviour. This study examined a pilot version of the Skills for Preventing Injury in Youth (SPIY) programme, combining teacher professional development (PD) for increasing school connectedness (connectedness component) with a risk and injury prevention curriculum for early adolescents (curriculum component). A process evaluation was conducted on the connectedness component, involving assessments of programme reach, participant receptiveness and initial use, and a preliminary impact evaluation was conducted on the combined connectedness and curriculum programme. The connectedness component was well received by teacher participants, who saw benefits for both themselves and their students. Classroom observation also showed that teachers who received PD made use of the programme strategies. Grade 8 students who participated in the SPIY programme were less likely to report violent behaviour at 6-month follow-up than were control students, and trends also suggested reduced transport injuries. The results of this research support the use of the combined SPIY connectedness and curriculum components in a large-scale effectiveness trial to assess the impact of the programme on students' connectedness, risk-taking and associated injuries.

MO-D-213-02: Quality Improvement Through a Failure Mode and Effects Analysis of Pediatric External Beam Radiotherapy

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

Gray, J; Lukose, R; Bronson, J

2015-06-15

Purpose: To conduct a failure mode and effects analysis (FMEA) as per AAPM Task Group 100 on clinical processes associated with teletherapy, and the development of mitigations for processes with identified high risk. Methods: A FMEA was conducted on clinical processes relating to teletherapy treatment plan development and delivery. Nine major processes were identified for analysis. These steps included CT simulation, data transfer, image registration and segmentation, treatment planning, plan approval and preparation, and initial and subsequent treatments. Process tree mapping was utilized to identify the steps contained within each process. Failure modes (FM) were identified and evaluated with amore » scale of 1–10 based upon three metrics: the severity of the effect, the probability of occurrence, and the detectability of the cause. The analyzed metrics were scored as follows: severity – no harm = 1, lethal = 10; probability – not likely = 1, certainty = 10; detectability – always detected = 1, undetectable = 10. The three metrics were combined multiplicatively to determine the risk priority number (RPN) which defined the overall score for each FM and the order in which process modifications should be deployed. Results: Eighty-nine procedural steps were identified with 186 FM accompanied by 193 failure effects with 213 potential causes. Eighty-one of the FM were scored with a RPN > 10, and mitigations were developed for FM with RPN values exceeding ten. The initial treatment had the most FM (16) requiring mitigation development followed closely by treatment planning, segmentation, and plan preparation with fourteen each. The maximum RPN was 400 and involved target delineation. Conclusion: The FMEA process proved extremely useful in identifying previously unforeseen risks. New methods were developed and implemented for risk mitigation and error prevention. Similar to findings reported for adult patients, the process leading to the initial treatment has an associated high risk.« less

Sensitivity analysis for simulating pesticide impacts on honey bee colonies

EPA Science Inventory

Background/Question/Methods Regulatory agencies assess risks to honey bees from pesticides through a tiered process that includes predictive modeling with empirical toxicity and chemical data of pesticides as a line of evidence. We evaluate the Varroapop colony model, proposed by...

Diffusion of Defaults Among Financial Institutions

NASA Astrophysics Data System (ADS)

Demange, Gabrielle

The paper proposes a simple unified model for the diffusion of defaults across financial institutions and presents some measures for evaluating the risk imposed by a bank on the system. So far the standard contagion processes might not incorporate some important features of financial contagion.

A Methodology to Support Decision Making in Flood Plan Mitigation

NASA Astrophysics Data System (ADS)

Biscarini, C.; di Francesco, S.; Manciola, P.

2009-04-01

The focus of the present document is on specific decision-making aspects of flood risk analysis. A flood is the result of runoff from rainfall in quantities too great to be confined in the low-water channels of streams. Little can be done to prevent a major flood, but we may be able to minimize damage within the flood plain of the river. This broad definition encompasses many possible mitigation measures. Floodplain management considers the integrated view of all engineering, nonstructural, and administrative measures for managing (minimizing) losses due to flooding on a comprehensive scale. The structural measures are the flood-control facilities designed according to flood characteristics and they include reservoirs, diversions, levees or dikes, and channel modifications. Flood-control measures that modify the damage susceptibility of floodplains are usually referred to as nonstructural measures and may require minor engineering works. On the other hand, those measures designed to modify the damage potential of permanent facilities are called non-structural and allow reducing potential damage during a flood event. Technical information is required to support the tasks of problem definition, plan formulation, and plan evaluation. The specific information needed and the related level of detail are dependent on the nature of the problem, the potential solutions, and the sensitivity of the findings to the basic information. Actions performed to set up and lay out the study are preliminary to the detailed analysis. They include: defining the study scope and detail, the field data collection, a review of previous studies and reports, and the assembly of needed maps and surveys. Risk analysis can be viewed as having many components: risk assessment, risk communication and risk management. Risk assessment comprises an analysis of the technical aspects of the problem, risk communication deals with conveying the information and risk management involves the decision process. In the present paper we propose a novel methodology for supporting the priority setting in the assessment of such issues, beyond the typical "expected value" approach. Scientific contribution and management aspects are merged to create a simplified method for plan basin implementation, based on risk and economic analyses. However, the economic evaluation is not the sole criterion for flood-damage reduction plan selection. Among the different criteria that are relevant to the decision process, safety and quality of human life, economic damage, expenses related with the chosen measures and environmental issues should play a fundamental role on the decisions made by the authorities. Some numerical indices, taking in account administrative, technical, economical and risk aspects, are defined and are combined together in a mathematical formula that defines a Priority Index (PI). In particular, the priority index defines a ranking of priority interventions, thus allowing the formulation of the investment plan. The research is mainly focused on the technical factors of risk assessment, providing quantitative and qualitative estimates of possible alternatives, containing measures of the risk associated with those alternatives. Moreover, the issues of risk management are analyzed, in particular with respect to the role of decision making in the presence of risk information. However, a great effort is devoted to make this index easy to be formulated and effective to allow a clear and transparent comparison between the alternatives. Summarizing this document describes a major- steps for incorporation of risk analysis into the decision making process: framing of the problem in terms of risk analysis, application of appropriate tools and techniques to obtain quantified results, use of the quantified results in the choice of structural and non-structural measures. In order to prove the reliability of the proposed methodology and to show how risk-based information can be incorporated into a flood analysis process, its application to some middle italy river basins is presented. The methodology assessment is performed by comparing different scenarios and showing that the optimal decision stems from a feasibility evaluation.

Reliability of pathogen control in direct potable reuse: Performance evaluation and QMRA of a full-scale 1 MGD advanced treatment train.

PubMed

Pecson, Brian M; Triolo, Sarah C; Olivieri, Simon; Chen, Elise C; Pisarenko, Aleksey N; Yang, Chao-Chun; Olivieri, Adam; Haas, Charles N; Trussell, R Shane; Trussell, R Rhodes

2017-10-01

To safely progress toward direct potable reuse (DPR), it is essential to ensure that DPR systems can provide public health protection equivalent to or greater than that of conventional drinking water sources. This study collected data over a one-year period from a full-scale DPR demonstration facility, and used both performance distribution functions (PDFs) and quantitative microbial risk assessment (QMRA) to define and evaluate the reliability of the advanced water treatment facility (AWTF). The AWTF's ability to control enterovirus, Giardia, and Cryptosporidium was characterized using online monitoring of surrogates in a treatment train consisting of ozone, biological activated carbon, microfiltration, reverse osmosis, and ultraviolet light with an advanced oxidation process. This process train was selected to improve reliability by providing redundancy, defined as the provision of treatment beyond the minimum needed to meet regulatory requirements. The PDFs demonstrated treatment that consistently exceeded the 12/10/10-log thresholds for virus, Giardia, and Cryptosporidium, as currently required for potable reuse in California (via groundwater recharge and surface water augmentation). Because no critical process failures impacted pathogen removal performance during the yearlong testing, hypothetical failures were incorporated into the analysis to understand the benefit of treatment redundancy on performance. Each unit process was modeled with a single failure per year lasting four different failure durations: 15 min, 60 min, 8 h, and 24 h. QMRA was used to quantify the impact of failures on pathogen risk. The median annual risk of infection for Cryptosporidium was 4.9 × 10 -11 in the absence of failures, and reached a maximum of 1.1 × 10 -5 assuming one 24-h failure per process per year. With the inclusion of free chlorine disinfection as part of the treatment process, enterovirus had a median annual infection risk of 1.5 × 10 -14 (no failures) and a maximum annual value of 2.1 × 10 -5 (assuming one 24-h failure per year). Even with conservative failure assumptions, pathogen risk from this treatment train remains below the risk targets for both the U.S. (10 -4 infections/person/year) and the WHO (approximately 10 -3 infections/person/year, equivalent to 10 -6 DALY/person/year), demonstrating the value of a failure prevention strategy based on treatment redundancy. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Integrating human impacts and ecological integrity into a risk-based protocol for conservation planning

USGS Publications Warehouse

Mattson, K.M.; Angermeier, P.L.

2007-01-01

Conservation planning aims to protect biodiversity by sustainng the natural physical, chemical, and biological processes within representative ecosystems. Often data to measure these components are inadequate or unavailable. The impact of human activities on ecosystem processes complicates integrity assessments and might alter ecosystem organization at multiple spatial scales. Freshwater conservation targets, such as populations and communities, are influenced by both intrinsic aquatic properties and the surrounding landscape, and locally collected data might not accurately reflect potential impacts. We suggest that changes in five major biotic drivers-energy sources, physical habitat, flow regime, water quality, and biotic interactions-might be used as surrogates to inform conservation planners of the ecological integrity of freshwater ecosystems. Threats to freshwater systems might be evaluated based on their impact to these drivers to provide an overview of potential risk to conservation targets. We developed a risk-based protocol, the Ecological Risk Index (ERI), to identify watersheds with least/most risk to conservation targets. Our protocol combines risk-based components, specifically the frequency and severity of human-induced stressors, with biotic drivers and mappable land- and water-use data to provide a summary of relative risk to watersheds. We illustrate application of our protocol with a case study of the upper Tennessee River basin, USA. Differences in risk patterns among the major drainages in the basin reflect dominant land uses, such as mining and agriculture. A principal components analysis showed that localized, moderately severe threats accounted for most of the threat composition differences among our watersheds. We also found that the relative importance of threats is sensitive to the spatial grain of the analysis. Our case study demonstrates that the ERI is useful for evaluating the frequency and severity of ecosystemwide risk, which can inform local and regional conservation planning. ?? 2006 Springer Science+Business Media, Inc.

[Quality of mental health services: a self audit in the South Verona mental health service].

PubMed

Allevi, Liliana; Salvi, Giovanni; Ruggeri, Mirella

2006-01-01

To start a process of Continuous Quality Improvement (CQI) in an Italian Community Mental Health Service by using a quality assurance questionnaire in a self audit exercise. The questionnaire was administered to 14 key workers and clinical managers with different roles and seniority. One senior manager's evaluation was used as a benchmark for all the others. Changes were introduced in the service practice according to what emerged from the evaluation. Meetings were scheduled to monitor those changes and renew the CQI process. There was a wide difference in the key workers' answers. Overall, the senior manager's evaluation was on the 60th percentile of the distribution of the other evaluations. Those areas that required prompt intervention were risk management, personnel development, and CQI. The CQI process was followed up for one year: some interventions were carried out to change the practice of the service. A self audit exercise in Community Mental Health Services was both feasible and useful. The CQI process was easier to start than to carry on over the long term.

Gambler Risk Perception: A Mental Model and Grounded Theory Analysis.

PubMed

Spurrier, Michael; Blaszczynski, Alexander; Rhodes, Paul

2015-09-01

Few studies have investigated how gamblers perceive risk or the role of risk perception in disordered gambling. The purpose of the current study therefore was to obtain data on lay gamblers' beliefs on these variables and their effects on decision-making, behaviour, and disordered gambling aetiology. Fifteen regular lay gamblers (non-problem/low risk, moderate risk and problem gamblers) completed a semi-structured interview following mental models and grounded theory methodologies. Gambler interview data was compared to an expert 'map' of risk-perception, to identify comparative gaps or differences associated with harmful or safe gambling. Systematic overlapping processes of data gathering and analysis were used to iteratively extend, saturate, test for exception, and verify concepts and themes emerging from the data. The preliminary findings suggested that gambler accounts supported the presence of expert conceptual constructs, and to some degree the role of risk perception in protecting against or increasing vulnerability to harm and disordered gambling. Gambler accounts of causality, meaning, motivation, and strategy were highly idiosyncratic, and often contained content inconsistent with measures of disordered gambling. Disordered gambling appears heavily influenced by relative underestimation of risk and overvaluation of gambling, based on explicit and implicit analysis, and deliberate, innate, contextual, and learned processing evaluations and biases.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

RiskLab - a joint Teaching Lab on Hazard and Risk Management

NASA Astrophysics Data System (ADS)

Baruffini, Mi.; Baruffini, Mo.; Thuering, M.

2009-04-01

In the future natural disasters are expected to increase due to climatic changes that strongly affect environmental, social and economical systems. For this reason and because of the limited resources, governments require analytical risk analysis for a better mitigation planning. Risk analysis is a process to determine the nature and extent of risk by estimating potential hazards and evaluating existing conditions of vulnerability that could pose a potential threat or harm to people, property, livelihoods and environment. This process has become a generally accepted approach for the assessment of cost-benefit scenarios; originating from technical risks it is being applied to natural hazards for several years now in Switzerland. Starting from these premises "Risk Lab", a joint collaboration between the Institute of Earth Sciences of the University of Applied Sciences of Southern Switzerland and the Institute for Economic Research of the University of Lugano, has been started in 2006, aiming to become a competence centre about Risk Analysis and Evaluation. The main issue studied by the lab concerns the topic "What security at what price?" and the activities follow the philosophy of the integral risk management as proposed by PLANAT, that defines the process as a cycle that contains different and interrelated phases. The final aim is to change the population and technician idea about risk from "defending against danger" to "being aware of risks" through a proper academic course specially addressed to young people. In fact the most important activity of the laboratory consists in a degree course, offered both to Engineering and Architecture students of the University of Applied Sciences of Southern Switzerland and Economy Students of the University of Lugano. The course is structured in two main parts: an introductive, theoretical part, composed by class lessons, where the main aspects of natural hazards, risk perception and evaluation and risk management are presented and analyzed, and a second part, composed by practical activities, where students can learn specific statistical methods and test and use technical software. Special importance is given to seminars held by experts or members of Civil Protection and risk management institutes. Excursions are often organized to directly see and study practical case studies (Eg. The city of Locarno and the lake Maggiore inundations). The course is organized following a "classical" structure (it's mainly held in a class or in an informatics lab), but students can also benefit from a special web portal, powered by "e.coursers" , the official USI/SUPSI Learning Management System , where they can find issues and documents about natural hazards and risk management. The main pedagogical value is that students can attend a course which is entirely devoted to dealing with natural and man-made hazards and risk, allowing them to resume geological, space planning and economic issues and to face real case studies in a challenging and holistic environment. The final aim of the course is to provide students an useful and integrated "toolbox", essential to cope with and to resolve the overwhelming problems due to vulnerability and danger increase of the present-day society. The course has by now reached the third academic year and the initial results are encouraging: beyond the knowledge and expertise acquired, the graduate students, that are now for the most part working in engineering studies or private companies, have shown to have acquired a mentality devoted to understanding and managing risk. REFERENCES PLANAT HTTP://WWW.CENAT.CH/INDEX.PHP?USERHASH=79598753&L=D&NAVID=154 ECOURSES HTTP://CORSI.ELEARNINGLAB.ORG/ NAHRIS HTTP://WWW.NAHRIS.CH/

Failure mode and effects analysis using intuitionistic fuzzy hybrid weighted Euclidean distance operator

NASA Astrophysics Data System (ADS)

Liu, Hu-Chen; Liu, Long; Li, Ping

2014-10-01

Failure mode and effects analysis (FMEA) has shown its effectiveness in examining potential failures in products, process, designs or services and has been extensively used for safety and reliability analysis in a wide range of industries. However, its approach to prioritise failure modes through a crisp risk priority number (RPN) has been criticised as having several shortcomings. The aim of this paper is to develop an efficient and comprehensive risk assessment methodology using intuitionistic fuzzy hybrid weighted Euclidean distance (IFHWED) operator to overcome the limitations and improve the effectiveness of the traditional FMEA. The diversified and uncertain assessments given by FMEA team members are treated as linguistic terms expressed in intuitionistic fuzzy numbers (IFNs). Intuitionistic fuzzy weighted averaging (IFWA) operator is used to aggregate the FMEA team members' individual assessments into a group assessment. IFHWED operator is applied thereafter to the prioritisation and selection of failure modes. Particularly, both subjective and objective weights of risk factors are considered during the risk evaluation process. A numerical example for risk assessment is given to illustrate the proposed method finally.